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Serono Symposia International Foundation

Online Course

International Multiple Sclerosis Nursing Care Plan

Introduction

The following is an online course developed and based on the International MS Nursing Care Plan. The International MS Nursing Care Plan was adapted from both the Canadian MS Nursing Care Plan and the United Kingdom Multiple Sclerosis Clinical Management Manual. Both these plans are recognized internationally as excellent educational resources in clinical practice and the International MS Nurse members who contributed to this document are grateful to the Canadian and the United Kingdom groups who helped facilitate this adaptation. The intent of the document was to share evidence-based practice within an educational document. The document was divided into eight chapters, each section contained a brief introduction, a list of learning objectives and following the chapter, a progress check for readers to use for their own education. Contained within each chapter was also a table listing how some of the countries deal with the topic area discussed. The intent was to demonstrate how various countries deal with certain topics and with that, how we may all learn from others' experiences.

International Nursing Steering Committee Sara Dishon The MS Centre, Carmel Medical Centre Haifa, Israel Elida Greinel University of New Mexico School of Medicine Alburquerque, New Mexico, USA Barbara Kieser Kantonsspital Neurologische Klinik Kuttingen, Switzerland Zemma H. Sheraton Dept. of Neurosciences Riyadh, Saudi Arabia Vlasta Jonczyova Faculty Hosp. Of Charle's University Prague, Czech Republic

International MS Nurse Care Plan

Contents

Introduction Chapter 1: Overview of MS

Module 1: MS Profile Module 2: The Nervous System Module 3: The Immune System Module 4: Inflammation, Demyelination and Remyelination Module 5: Clinical Manifestations Progress Check Appendix 1A: Kurtzke Expanded Disability Status Scale

Chapter 2: Diagnosis

Module 1: History Taking and Paraclinical Testing Module 2: Diagnostic Criteria Module 3: Standards of Healthcare and the Role of the Nurse After/At The Time of Diagnosis Module 4: Prognostic Indicators and Survival in MS Progress Check Appendix 2A: Guy's Neurological Disability Scale (GNDS)

Chapter 3: Treatments

Module 1: MS Therapies Module 2: Management of Treatment-Related Side Effects Module 3: Patient Education and Promoting Adherence to Therapy Progress Check Appendix 3A: Treatment Contract: Responsibilities and Stopping Criteria Appendix 3B: WHO Guidelines for Grading LFTs, WBC Counts and Haemoglobin Levels and Recommendations for Management in INF Therapy Appendix 3C: Patient Test After Starting Beta-Interferon Treatment

Chapter 4: Management of MS-Related Symptoms

Module 1: Fatigue Module 2: Bladder Dysfunction Module 3: Bowel Dysfunction Module 4: Pain Module 5: Spasticity Module 6: Tremor Module 7: Altered Mobility Module 8: Speech and Swallowing Difficulties Progress Check Appendix 4A: The Multiple Sclerosis Quality of Life Inventory (MSQLI) Appendix 4B: Pharmacologic Treatment Options for MS-Related Fatigue Appendix 4C: Foothills Hospital (Calgary, Alberta, Canada) Nursing Assessment Form Appendix 4D: Diagnosis of Bladder Dysfunction Appendix 4E: Algorithm for the Management of Bladder Dysfunction from the National Multiple Sclerose Centrum in Melsbroek, Belgium Appendix 4F: Pharmacologic Treatment Options for Bladder Dysfunction in MS Appendix 4G: Pharmacologic Treatment Options for Bowel Dysfunction in MS

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Appendix 4H: Appendix 4I: Appendix 4J: Appendix 4K: Appendix 4L: Appendix 4M: Appendix 4N: Appendix 4O: Short-Form McGill Pain Questionnaire Pharmacologic Treatment Options for MS-Related Pain Ashworth Scale/Spasm Frequency Scale/100 m Walk Pharmacologic Treatment Options for Spasticity Spiral Test Nine-Hole Peg Test Pharmacologic Treatment Options for Tremor Algorithm for the Prevention of Pressure Sores from the Nationaal Multiple Sclerose Centrum in Melsbroek, Belgium

Chapter 5: Psychosocial Implications of MS

Module 1: The Wellness Model in MS Nursing Module 2: Nursing Assessment Module 3: Care Plan for Newly Diagnosed Patients Module 4: Depression Module 5: Cognition Module 6: Sexuality, Family Issues and Pregnancy Module 7: Financial and Vocational Issues Progress Check Appendix 5A: MS Support Team Documentation (University Hospital Birmingham NHS Trust) Appendix 5B: Alternative Medicine and Health-Related Websites

Chapter 6: General Wellness and Management Strategies

Module 1: Lifestyle Modifications Module 2: Coping With Stress Progress Check

Chapter 7: Complementary and Alternative Therapies for MS

Module 1: Overview of Complementary Therapies Used in MS Module 2: Role of the MS Nurse Progress Check

Chapter 8: Treatment Optimization

Module 1: Nursing Approach to Treatment Optimization Module 2: Initial Assessment and Patient Selection for DMT Module 3: Treatment Selection Module 4: Patient Education and Self-injection Training Module 5: Long-term Assessment and Monitoring of Patients Using DMTs

Disclaimer

International MS Nursing Care Plan

Chapter 1: Overview of MS

Introduction

Multiple sclerosis (MS) is an autoimmune-mediated and inflammatory disease of the Central Nervous System that usually presents with a history of an acute onset of neurological symptoms (relapse), or with progressive neurological impairment. The cause of this disease is unknown although, in general, it is believed that a nonspecific viral infection may trigger an autoimmune reaction in a genetically susceptible individual (Hawkins and Wolinsky 2000). The disease affects people almost worldwide, although there is an established epidemiological variation indicating that a higher prevalence is associated with an increasing distance from the equator. It is now accepted that MS is an autoimmune disease and, as is characteristic of autoimmune disorders, it has a predilection for women at a ratio of approximately 2:1. Although MS is not hereditary, it is accepted that there is a genetic link in that it develops in individuals who are born with a genetic predisposition to react to an environmental agent. Although MS can occur at any age, it is most likely to be diagnosed in a young adult, aged 20-40, and is one of the most common causes of disability among adults of working age (Paty et al 1999). Common symptoms include difficulty walking, difficulties with bladder/bowel control and sexual function, numbness, pain and other abnormal sensations, temporary blindness or blurred vision, and extreme fatigue. Typically, when MS starts, there are distinct attacks - perhaps one or two a year - from which the patient may make a full recovery. As the disease progresses, recovery from attacks may not be complete and there is a gradual accumulation of disability.

Chapter Overview

This chapter contains the following 5 modules: Module 1: MS Profile Module 2: The Nervous System Module 3: The Immune System Module 4: Inflammation, Demyelination and Remyelination Module 5: Clinical Manifestations At the end of this chapter, please find a section entitled Progress Check; this section tests your knowledge of the information presented in this chapter.

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Module 1: MS Profile

Introduction

In this module, the classification of MS is reviewed. Prevalence, distribution, and genetic links are discussed. In addition, the economic impact of the disease is examined. In this chapter you will find several references to the Kurtzke Expanded Disability Status Scale (EDSS). This scale is given in Appendix 1A.

Learning Objectives

After completing this module, the reader will be able to: Describe the four types of MS as well as their prevalence rates Describe Marburg's variant of MS Discuss the difficulties associated with disease classification Understand prevalence and distribution of MS Discuss the importance of 'twin studies' in MS Discuss the risks involved if one family member develops MS

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Classification of MS

Once an individual is diagnosed with MS, they often ask what type of MS they have and what clinical course this will take. This has, of late, become a particularly pertinent issue with the prospect of assigning patients to research trials or prescribing them the most appropriate disease-modifying treatments. Fernstein (1999), however, questions the significance of assigning someone to a disease classification. He argues that as MS is such an unpredictable disease, some individuals with MS may experience very mild neurological symptoms for many years and enjoy a full and active lifestyle while others, for no apparent reason, may suddenly enter a more progressive phase and rapidly accumulate disability. In clinical practice it is often impossible to put an individual into a particular disease category. It is not always a straightforward process to identify the type of MS an individual has and it may take considerable time and often requires regular and ongoing assessment of his or her clinical history and clinical course. MS shows individual variability and patients rarely fit neatly into clinical categories. As a consequence, it is essential that due care is taken when discussing disease types and ensuring that the individual realises that their relapsing-remitting MS, for example, will not take on the same course as someone else's. They will not all reach the same level of disability and there can be wide variations in prognosis and functional difficulties between individuals (Burgess 2002). Even as healthcare professionals, describing the clinical course of MS is often difficult and the terminology itself can cause difficulties. Lublin and Reingold (1996) recognised this and carried out an international survey of MS Neurologists with the aim of establishing an agreement pertaining to the various descriptive terms currently in use. Their survey supplied the following definitions of disease courses and types: Relapsing-remitting MS (RRMS) Secondary-progressive MS (SPMS) Primary-progressive MS (PPMS) Progressive-relapsing MS (PRMS) Some experts suggest that based on recent pathological findings and results from clinical trials, a more pragmatic approach to classifying MS is to distinguish between active (relapsing) and non-active disease.

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Relapsing-Remitting Multiple Sclerosis (RRMS) The majority of patients (85%) who develop MS will present with the relapsingremitting form of the disease (Thompson et al 2000). A relapse is an acute episode of neurological symptoms that worsen for some days and then improve or completely subside over time (Poser et al 1983). For the purposes of clinical trials, a relapse lasts at least 24 hours in the context of a normal body temperature (a normal body temperature is essential as there is a syndrome called Uhthoffs phenomenon, which can occur in MS and is associated with hyperthermia, resulting in a reduction of visual acuity). It has also been suggested that a period of 30 days should separate the onset of two events for them to be distinguished as separate attacks (McDonald et al 2001). The person may not experience a full recovery from their relapse, but relapses are clearly distinguishable from periods of remission and during remission there is characteristically a lack of disease progression (see Figure 1). RRMS varies greatly in severity from individual to individual. The annual relapse rate initially averages about 2-2.5 (Barnes 2000) and thereafter will gradually fall as the years progress. It is considered a poor prognostic sign if the person experiences frequent relapses, especially at the onset of the disease (Weinshenker 1995). After 10-15 years, approximately 75% of people with RRMS will enter the secondaryprogressive phase of the disease (Weinshenker et al 1989). The EDSS can provide the Neurologist with an indicator of whether the patient is entering the secondaryprogressive phase of the disease. Weinshenker et al (1991) state that patients at 45.5 on the EDSS scale are those most at risk of developing SPMS. Secondary-Progressive Multiple Sclerosis (SPMS) An initial relapsing-remitting nature of disease tends to develop into a steadily progressive phase of the disease. SPMS is defined as progression of clinical disability (with or without relapses and minor fluctuations) after a relapsing-remitting onset (Barnes 2000). The patient does not recover from relapses/attacks and disability progresses even in between the relapses (see Figure 1). When assessing patients, it can be difficult, at times, to establish when they are converting from RRMS to SPMS. This may only become apparent over a significant length of time. Primary-Progressive Multiple Sclerosis (PPMS) PPMS is found in approximately 10% of the MS population and, as opposed to other forms of MS, the female propensity is absent (Cottrell et al 1999). The disease will be progressive from onset without any discernible relapses or remissions (see Figure 1). The unique clinical characteristics of this form of MS make its diagnosis difficult (Thompson et al 2000). Typically, the patient will be at a later age of onset, experiencing their first symptoms in their 40's onwards, but in rare cases it can occur at an earlier age. It typically presents with an increasing spastic gait that is already affecting their quality of walking. The prognosis is poorer; the time taking to reach EDSS of 6 is approximately 6 years (McDonald and Thompson 1997). Diagnostic criteria for definite PPMS include clinical progression for at least a year (Thompson et al 2000). The MRI of the brain can look normal as the plaques characteristically form in the spinal cord. Consequently, it is essential for a patient to have a spinal MRI in order to diagnose progressive MS.

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International MS Nursing Care Plan Progressive-Relapsing Multiple Sclerosis (PRMS) Initially has a progressive course, but an exacerbation occurs after establishment of the progressive course. This form of MS follows a progressive course from onset, punctuated by relapses. There is significant recovery immediately following a relapse but between relapses there is a gradual worsening of symptoms. Identifying this type of MS has important implications for treatment.

Figure 1. Clinical course of the types of MS. Malignant MS (Marburg's variant) There is also a variant of MS known as malignant MS. This is a rare and severe form of MS characterised by multiple large lesions scattered throughout the CNS. The demyelination and loss of axons are much more extensive and result in a rapid accumulation of significant disability. It is such an atypical form that diagnosis is often very difficult (Burgess 2002). However, it will generally progress rapidly without any lasting remission and results in death within months of onset.

Prevalence

MS affects 1.1 to 2.5 million persons worldwide. The distribution of MS varies throughout the world and appears to be related to geographical location and genetic background. Areas with high rates of MS include North America, Northern Europe, and Australasia (see Figure 2). The prevalence rate is about 1 in 1000 adults in North America and Northern Europe. It has long since been recognised that both environmental and genetic factors contribute to the aetiology of MS and that genetic factors contribute to MS susceptibility. MS is particularly prevalent in people from Northern Europe and their descendants, including those living in Australia, New Zealand and North America. It

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International MS Nursing Care Plan has been suggested that MS is more frequent in areas settled by Vikings and Goths and that migrants from these areas took this susceptibility throughout Europe, the New World, South Africa, Australia and New Zealand (Kurtzke 1997). Other prevalence rates are as follows: United Kingdom: 80­250 per 100,000 Scandinavia: 32­93 per 100,000 Northern United States (above 37oN): 69 per 100,000 Australia: 30 per 100,000 Asia, Africa, South America: 5 per 100,000 Canada: 150­200 per 100,000

Figure 2. Worldwide prevalence of MS.

MS Distribution

Geography It is recognised that MS is unevenly but non-randomly distributed throughout the world (Ebers and Sadovnick 1994) and that environmental factors play a significant role in the onset of MS. Many epidemiology studies have been published that seek to explain these phenomena. Many of these support the existence of a gradient MS prevalence, increasing with distance from the equator in both northern and southern hemispheres. Within Caucasian populations, MS occurs more frequently in countries or regions of northern latitudes in the Northern Hemisphere and in those of southern latitudes in the Southern Hemisphere. A study by Rothwell and Charlton (1998) suggests that the Orkney and Shetland Islands and South East Scotland have the highest prevalence rates in the world. Providing further evidence for the role of geography is the fact that the risk of MS increases in persons migrating from countries of low incidence to countries of high incidence.

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International MS Nursing Care Plan Race MS affects Caucasians more than other races. Until recently, MS was very rare in black Africans (Dean 1967); however, there are now increasing reports of clinically definite MS in this population. Migration studies are particularly interesting when studying the cause of MS. These have suggested that the potential for developing MS may be established in early life and probably by the age of 15 (Paty and Ebers 1998). Thus if a person is born in a high risk area (Northern Europe, Northern USA, Southern Canada, Southern Australia and New Zealand) but moves to a low risk area (Asia, Latin America, Middle East) before the age of 15, he will assume the low risk potential. Age and MS The average age at diagnosis of MS is approximately 30 years. This incidence is worldwide (see Figure 3) although MS can occur at any age. Childhood MS is rare (less than 4% of cases [Paty and Ebers 1998]) although some specialist centres and some specialist MS nurses will have children in their caseload. Childhood MS is more frequent in females; their presentation is generally one of relapses of sensory symptoms, with a relapsing-remitting course in most (Duquette et al 1987). Gender and MS Like the majority of other autoimmune diseases, MS predominately affects women. The ratio of women to men is approximately two women to one man. The only exception to this is PPMS in which the female preponderance is absent. The disease tends to be more severe in men and the male gender is typically associated with a poor prognosis (Barnes 2000).

Figure 3. Age-specific incidence of MS (women).

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Genetics

Despite many studies investigating the genetic link, there is still no one specific genetic marker that has been identified as being responsible for the predisposition to the development of MS. Patients may ask for genetic counselling if they are planning to become pregnant, but because of the complexity of genetic control, any form of genetic screening or counselling is difficult. The inherited pattern that occurs does not resemble patterns seen in other genetic diseases that characteristically display dominant, recessive or X linked modes of inheritance, but it is established that MS will occur in families in a rather irregular pattern. The rate of MS among family members of an individual affected by the disease is higher than would be expected by chance, with 20% of people with MS having a family history of at least one additional case of MS (Ebers and Sadovnick 1994). However, this cannot be entirely attributed to genetics, as it has to be assumed that most family members share a similar environment and similar lifestyle. Although complicated, it is important as nurses to understand this genetic link in order to answer one of the most common questions a newly diagnosed patient will ask, "Is MS inherited?" When counselling MS patients and their relatives it should be explained that the risk for first-degree relatives of people with MS is greater than the risk to second-degree relatives. Overall, siblings have the highest age adjusted risk followed by parents then children then uncles, aunts and cousins (Sandovnick and Ebers 1994). One UK study (Robertson et al 1996) examined the risks of developing MS in both first and second-degree relatives of a person with the diagnosis and reported the following figures: Sister=4.4% Brother=3.2% Parent=2.1% Child=1.8% Where both parents have MS, the risk to their children is obviously higher, approaching 20%. Twin Studies There have been a number of twin studies performed looking at concordance rates. In theory, if genes were solely responsible for determining the risk of the development of MS, then it would follow that if one monozygotic twin were diagnosed with MS, then there would be a 100% chance of the other twin also developing the disease. In fact this is not the case. In a Canadian study of twin pairs, Sadovnick et al 1993 followed up their study group for 7.5 years. They discovered the concordance rate is approximately 30% in monozygotic twins, which contrasts with the rate in dizygotic twins of approximately 4.7%. This is roughly the same risk as in non-twin siblings.

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Economic Implications of Multiple Sclerosis

In 1995 the total cost burden of MS in the UK was estimated at almost £1.2 billion (Holmes et al 1995). This study, together with the majority of others carried out at this time, state that the drug costs in the management of the disease were insignificant. However, these studies were carried out before the implementation of the Department of Health (DoH) Risk-Sharing Scheme (HSC 2002/4) (for further information on the scheme, see Chapter 3: Treatments). Because of the recent changes in the availability of disease-modifying drugs brought about by this scheme, this will of course change in the future. Studies that attempt to calculate the cost of disease will generally take into account the direct, indirect and the intangible costs of the disease: 1. Direct costs are related to the use of resources due to the disease itself or the cost of treatment. They include costs incurred from the health service such as inpatient hospital admissions, investigations, visits to the General Practitioner (GP) and other members of the multi-disciplinary team, input from the district nurses and practice nurses, outpatient appointments, hospital transport, long-term care and so on. They also include the direct costs to the patient such as specialised equipment, adaptations, stair lifts and so on. The latter costs are not always taken into consideration in studies despite the fact that they are considerable! 2. Indirect costs are recognised as the major part of the cost of MS. These costs relate to the loss of production due to the effects of the disease such as the payment of state benefits, loss of taxation if the individual cannot work, losses incurred due to premature death, loss of carer's taxation, carer's benefits and so on. 3. Intangible costs are related to the economic burden incurred by the family relating to a reduction in quality of life. In the United States, the cost of MS is estimated to be approximately $2.5 billion (USD) per year (NIH 2002). The annual cost of a single relapse is estimated to be between $243 (USD) to $12,870 (USD) (O'Brien et al 2003).

Note: The economic implications of MS will vary from country to country.

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References

Barnes D. Multiple Sclerosis. Questions and Answers. Merit Publishing International; 2000. Burgess M. In: Multiple Sclerosis. Theory and Practice for Nurses. London: Whurr Publishers; 2002. Cottrell DA, Kremenchutzky M, Rice GP et al. The natural history of multiple sclerosis: a geographically based study. The clinical features and natural history of primary-progressive multiple sclerosis. Brain 1999;122:625-639. Dean G. Annual incidence, prevalence and mortality rates of MS in white South African born and in white immigrants to South Africa. BMJ 1967;2:724-730. Duqette P, Murray TJ, Pleines J et al. Multiple sclerosis in childhood: Clinical profile in 125 patients. Journal of Paediatr 1987;111:359-363. Ebers GC, Sandovnick AD. The role of genetic factors in multiple sclerosis susceptibility. J Neuroimmunol 1994;54(1-2):1-17. Fernstein A. The clinical neuropsychiatry of multiple sclerosis. University of Cambridge, United Kingdom; 1999. Hawkins CP, Wolinsky J. Principles of Treatments in Multiple Sclerosis. Oxford: Butterworth-Heinermannto; 2000. Holmes J, Madgwick T, Bates D. The cost of multiple sclerosis. British Journal of Health Economics 1995;8:181-193. Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis. Results of an International survey. Neurology 1996;46:907-911. Kurtzke J. The epidemiology of multiple sclerosis. In: Raine CS, McFarland HF, Tourlette WW (eds). Multiple Sclerosis. Clinical and Pathogenetic Basis. London: Chapman and Hall Medical; 1997. McDonald WI, Thompson AJ. How many types of multiple sclerosis are there? In: Thompson AJ, Polman C, Hohfeld R (eds). Multiple Sclerosis. Clinical Challenges and Controversies. London: Martin Dunitz; 1997. McDonald WI, Compston A, Edan G et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the international panel on the diagnosis of multiple sclerosis. Annals of Neurology 2001;50:121-7. National Institute of Neurological Disorders and Stroke. Multiple Sclerosis: Hope Through Research. NIH 2002. O'Brien JA, Ward AJ, Patrick AR, Caro J. Cost of managing an episode of relapse in multiple sclerosis in the United States. BMC Health Serv Res 2003;3(1):17.

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Paty DW, Ebers GC (eds). Multiple Sclerosis. Philadelphia: FA Davis Company; 1998. Paty DW, Hartung H-P, Ebers GC, Soelberg-Sorenson P, Abramsky O, Kesselring J, Delwel GO. Management of relapsing-remitting multiple sclerosis: diagnosis and treatment guidelines. European Journal of Neurology 1999;6(suppl 1):s1-S35. Poser CM, Paty DW, Sheinberg L, McDonald WI, Davis FA, Ebers GC et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Annals of Neurology 1983;13:227-231. Robertson NP, Fraser M, Deans J, Clayton D, Walker N, Compston DA. Ageadjusted recurrence risks for relatives of patients with multiple sclerosis. Brain 1996;119:449-455. Rothwell PM, Charlton D. High incidence and prevalence of multiple sclerosis in Southeast Scotland: evidence of a genetic predisposition. Journal of Neurology, Neurosurgery and Psychiatry 1998;64:730-735. Sadovnick AD, Ebers GC. Genetic Factors in the Pathogenesis of MS. The International MS Journal 1994;1(1):17-24. Sadovnick AD, Armstrong H, Rice GP et al. A population-based study of multiple sclerosis in twins: update. Annals of Neurology 1993;33:281-285. Scheinberg LC, Holland NJ (eds). Multiple Sclerosis. New York: Raven Press; 1987. Thompson AJ, Montalban X, Barkhof F, Brochet B, Fillipi M, Miller DH, Polman CH, Stevenson VL, McDonald WI. Diagnostic criteria for primary-progressive multiple sclerosis: a position paper. Annals of Neurology 2000;47(6):831-835. Weinshenker BG, Bass B, Ricce GPA et al. The natural history of multiple sclerosis: a geographically based study. 1. Clinical course and disability. Brain 1989;112:133146. Weinshenker BG, The natural history of multiple sclerosis. Neurol Clin 1995;13:119146. Weinshenker BG, Rice GP, Noseworthy JH et al. The natural history of multiple sclerosis: a geographically based study. 3. Multivariate analysis of predictive factors and models of outcome. Brain 1991;114:1045-1056.

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Suggested Readings

Blumhardt LD, Wood C. The economics of multiple sclerosis: a cost of illness study. British Journal of Medical Economics 1996;10:99-118. Lassmann H. Neuropathology in multiple sclerosis: new concepts. Multiple Sclerosis 1998;4(3):93-98. Morrison W. Multiple Sclerosis: an overview for nurses. Axon 1999;30(3):55-61. Robertson N, Compston A. Surveying multiple sclerosis in the United Kingdom. Journal of Neurology, Neurosurgery and Psychiatry 1995;58(1):2-6. Watkiss K, Ward N. NT Systems and Diseases. Pathophysiology of multiple sclerosis. Nursing Times 2001;97(14):41-44. Watkiss K, Ward N. NT Systems and Diseases. Pathophysiology of multiple sclerosis. Nursing Times 2001;97(18):43-46. Whetton-Goldstein K, Sloan F, Conover C, Viscusi K, Kulas B, Chesson H. The economic burden of multiple sclerosis. MS Management 1996;3.(1):33-37. Williams R, Rigby AS, Airey M, Robinson M, Ford H. Multiple sclerosis: its epidemiological, genetic, and health care impact. Journal of Epidemiology and Community Health 1995;49:563-569.

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Module 2: The Nervous System

Introduction

The CNS pathology of MS is characterised by the breakdown of the blood-brain barrier followed by inflammation and then neuronal damage. The myelin sheath and the axons are the primary target of the inflammation. Myelin is a fatty coating of the nerve axon and has an insulating effect, enabling electrical impulses to move faster from the brain to the rest of the body and back again. If the myelin is damaged there will be a disturbance of information as it travels along the axons. There is increasing evidence that without the myelin to protect them, the axons themselves will become damaged and can either break or disintegrate. Axonal loss leads to permanent disability.

Learning Objectives

After completing this module, the reader will be able to: List the components of the CNS Describe the function of sensory, motor, and association neurons Describe the structure of neurons Explain the function of myelin List and describe three important types of glial cells

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Central Nervous System

MS is a disease of the CNS; the CNS consists of the brain (i.e., brain stem, mid brain, cerebrum, cerebellum) and spinal cord (see Figure 4). The peripheral nervous system consists of 12 pairs of cranial nerves that radiate from the brainstem and 31 pairs of spinal nerves that arise from the spinal cord. These nerves reach every part of the body.

Figure 4. The central and peripheral nervous systems. The central and peripheral nervous systems consist of networks of neurons (nerve cells). The peripheral nervous system consists of sensory and motor neurons. Sensory neurons respond to stimuli (e.g., heat, pain, colour, etc.) and send impulses to the CNS. Motor neurons transmit messages in the other direction, from the CNS to the peripheral organs and tissues. Therefore, in reality, peripheral nerves are actually bundles of both sensory and motor neurons. Association Neurons Most of the neurons in the CNS are association neurons that transmit impulses between other neurons. The sensory neuron responds to a stimulus such as heat and sends an impulse to an association neuron in the CNS. The association neuron, in turn, activates the motor neuron which causes particular muscles to contract (e.g., muscle contracts to withdraw hand from a hot plate). Figure 5 illustrates the relationship between sensory, association, and motor neurons.

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Figure 5. The relationship between sensory, motor, and association neurons. Components of a Neuron Dendrites conduct impulses to the cell body; the axon conducts impulses from the cell body (see Figure 6). Most axons are covered by a layer of myelin. Myelin is a complex, fat-like substance that insulates the axon. Damage to the myelin sheath and the underlying axon causes the symptoms of MS.

Figure 6. Structure of a typical neuron. The CNS is not made up entirely of neurons: 40% of the total volume consists of neuroglia or glial cells (glia is the Greek word for glue).

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Neuroglia Neuroglia consist of three important types of cells: oligodendrocytes, astrocytes, and microglia (see Figure 7). Oligodendrocytes Oligodendrocytes synthesise myelin. Each oligodendrocyte has several processes that wrap themselves around short sections of nearby axons. While doing so, these processes also produce layers of myelin. Therefore, the myelin sheath of an axon is not continuous, but rather is made up from the processes of many oligodendrocytes, with short lengths of non-myelinated axon between them (see Figure 7). These unmyelinated regions are referred to as the nodes of Ranvier. In the peripheral nervous system, Schwann cells produce myelin (equivalent to oligodendrocytes in the CNS). Astrocytes Astrocytes are star-shaped cells that provide the CNS with its physical structure. Some astrocytes have processes that are in contact with the endothelial cells of cerebral blood vessels, helping to maintain tight junctions between them and thereby excluding large circulating cells. This is the main factor that constitutes the blood-brain barrier and normally prevents circulating cells from coming into contact with CNS neurons and neuroglia. In MS, this barrier is breached. Microglia (Microglial Cells) Microglia have the same precursors as circulating macrophages and fulfil similar functions - digestion of cellular debris and foreign matter. In MS, the function of microglia is corrupted, causing them to attack and destroy myelin (see Module 3: The Immune System in this Chapter for a more detailed discussion of this process).

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Figure 7. Neuroglia. Myelin Nerve impulses are created by small amounts of electricity flowing along neurons. Myelin acts to insulate the neuron from this flow of electricity. The non-myelinated areas of axons are known as nodes of Ranvier. When impulses flow along myelinated axons, the impulses jump over the myelinated areas from one node to the next. This makes the flow of impulses faster and more energy-efficient than in non-myelinated axons. As well as helping the flow of nerve impulses, myelin and oligodendrocytes provide axons with physical support (literally holding them in place and helping preserve their structure) and functional support (by producing chemicals that keep the neurons functioning properly). Grey and White Matter To the naked eye, some of the CNS looks grey, and some of it looks white - hence the terms "grey matter" and "white matter." Grey matter is a mass of neuronal cell bodies and dendrites. White matter includes bundles of myelinated axons. The same neuron can have its cell body in grey matter and its axon in white matter. The cerebrum consists of a thick, outer layer of grey matter - the cortex - which covers an inner core of white matter. An H-shaped core of grey matter runs through the middle of the spinal cord and is surrounded by white matter (see Figure 8).

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International MS Nursing Care Plan Reflex Arc The white matter of the CNS consists of tracts. These tracts are comprised of bundles of myelinated axons that serve similar functions, just as a telephone cable is a bundle of individual telephone wires following the same route. In fact, the white matter is like the "long-distance cabling" of the CNS. There are sensory tracts, conducting impulses to the centre, and motor tracts, conducting impulses from the centre. Two examples of tracts include the pyramidal tract (a long motor tract that is involved in the voluntary, skilled movements of skeletal muscles such as writing, playing tennis, etc.) and the extrapyramidal tract (regulates muscle tone, posture, and walking). A reflex is a direct connection between stimulus and response that does not require conscious thought. They are simple automatic responses and involve either spinal or cranial nerves. A reflex arc is the simplest functional unit of the nervous system, involving the complete pathway of neurons from the receptor, which receives the stimulus, to the effector that produces the response (see Figure 8). The basic threeneuron arc consists of, in order, a sensory neuron, an association neuron and a motor neuron. Descending tracts from the brain interact with association neurons to facilitate or depress spinal reflexes.

Figure 8. A section of the spinal cord.

Demyelination and Axon Damage

In MS, axons in the CNS lose their myelin sheath and, as a result, may break and disintegrate. Many of the typical symptoms of MS affect walking, balance, coordination, bladder function, etc. All of these functions depend on the cabling connecting the brain to the limbs or bladder via the spinal cord. Pain and other sensory disturbances can be explained by demyelination of sensory axons discharging spontaneously or short-circuiting. Loss of muscular control can also result from motor axon damage (i.e., breakage, transection, and degeneration).

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International MS Nursing Care Plan Higher intellectual functions such as language, memory, and reasoning depend on the grey matter of the cortex. Therefore, these functions are often unaffected by MS. Nevertheless, the different parts of the cortex are connected by white matter, so some subtle intellectual impairment is consistent with demyelination and axon damage. Why doesn't MS affect the peripheral nervous system? Peripheral neurons are also myelinated, but the myelin is produced in a different way, by Schwann cells, rather than oligodendrocytes. Schwann cells are not affected in MS.

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Module 3: The Immune System

Introduction

The immune system is the body's defence mechanism against infection by bacteria, viruses, fungi, parasites, cancerous agents, and other foreign material. Although the immune system usually combats disease, it can also cause diseases or illnesses. For example, asthma, hay fever, and other allergic disorders are dysfunctional or exaggerated responses of the immune system to foreign agents such as dust and pollen. In autoimmune diseases such as MS, the immune system is disrupted in such a way that it attacks the body's own cells. Rheumatoid arthritis and systemic lupus erythematosus are other common autoimmune diseases. This module reviews the immune system and presents an immunopathogenic model of MS.

Learning Objectives

After completing this module, the reader will be able to: Describe the functions of T-cells, B-cells, cytokines, and antibodies Understand the role the immune system plays in MS Describe an immunopathogenic model of MS

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Where is the Immune System?

Although the immune system is as vital for sustaining life as the heart or the liver, it is not situated in a single organ (see Figure 9). All immune cells, like every other circulating cell, originate from precursors in bone marrow.

Lymphocyte Maturation

B-cells mature and differentiate in bone marrow, then migrate into the spleen, lymph nodes, and MALT (mucosal-associated lymphoid tissue) ­ the so-called secondary lymphoid organs. B-cells are involved in specific humoral immunity. Antibodies are made by plasma cells derived from B-cells. These antibodies bind to specific recognition sites on an antigen and destroy or inactivate the antigen in a variety of ways. T-cells mature and differentiate (i.e., acquire their specificity) in the thymus then also concentrate in the secondary lymphoid organs. T-cells are involved in specific cell mediated immunity. Each T-cell has an individual receptor that recognises an antigen. These T-cells will, however, only recognise an antigen when it is presented on the surface of a body cell together with a cell marker called major histocompatibility complex (MHC). For instance, T-helper cells recognise antigens that are presented with class II MHC on the surface of macrophages. These T-cells release cytokines to activate the macrophage and enable it to kill intracellular parasites. Cytotoxic T-cells recognise specific antigens when presented with Class I MHC on the surface of infected cells. These T-cells release toxic chemicals which kill the virus and also release other cytokines.

Figure 9. The primary and secondary lymphoid organs.

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An Immunopathogenic Model of MS

Although the cause of MS is unknown, it is generally believed that environmental factors (possible viral infections) trigger an immunological mediated process in individuals of certain genetic background (Polman 2001). When a genetically susceptible person encounters a specific, unknown environmental trigger, a dormant pool of autoreactive T-lymphocytes become active. Proposed sequence of events The proposed sequence of events is as follows: The activated T-lymphocytes cross the blood-brain barrier and searches for their target auto-antigen. The steps associated with inflammation are as follows: An antigen + an antigen presenting cell + a concentration of T-lymphocytes (specific for that antigen) are stimulated to a high threshold On reaching threshold the activated T-lymphocytes release gamma interferon This process attracts other T-lymphocytes and activates the macrophages. Once activated the macrophages: Attack and phagocytose the myelin sheath Release cytokines Present more antigen to T-lymphocytes. The T­lymphocytes multiply by cloning and release even more toxic cytokines. Overall this inflammatory reaction: Damages myelin Damages oligodendrocytes Damages the blood-brain barrier allowing other immune cells such as Blymphocytes, antibody and complement to leak in and cause further damage. The immune cells that leak through cause the following damage: B-lymphocytes may produce autoantibodies that help the T-lymphocytes damage the myelin and oliogodendrocytes Autoantibody encourage macrophage attack Complement destroy oligodendrocytes. This cascade of events continues until, for some as yet unidentified reason, the inflammatory response subsides and the blood-brain barrier is restored.

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Reference

Polman, CH, Thompson AJ, Murray TJ, McDonald, WI. In: Multiple Sclerosis: The Guide to Treatment and Management. New York: Demos Medical Publishing; 2001.

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Module 4: Inflammation, Demyelination and Remyelination

Introduction

MS is a chronic, inflammatory, demyelinating disease of the Central Nervous System with or without secondary axonal involvement. The inflammatory process is driven by a T-cell mediated immune reaction that leads an attack against both the myelin sheath and the cells that produce myelin, the oligodendrocytes. As a result of this inflammatory process, myelin can be stripped from the axon and the process of demyelination can take place. Demyelination will slow down the conduction of impulses as they travel along the nerves and will lead to interruption or loss of function. Although remyelination can occur in early or acute MS (Bruck et al 1994), this process of recovery is limited in the more progressive forms of the disease when repair of the damaged myelin sheath will become impossible. As a result of the demyelination, a process of glios (or sclerosis) takes place, scar tissue will form at the lesion site and axonal loss will occur. If the axonal loss occurs in a strategic area or pathway within the CNS, this will lead to irreversible and chronic clinical symptoms.

Learning Objectives

After completing this module, the reader will be able to: Describe the process of demyelination Understand the role that inflammation plays in disease activity Explain the consequences of demyelination Understand how remyelination may occur

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The Multiple Sclerosis Plaque

The demyelinated plaque is the hallmark of the pathology in MS (Lassmann 1998). They can occur wherever there is CNS myelin and particularly in the more vascular regions. The pattern of plaque formation will be different in each individual and, although they characteristically occur in the white matter, grey matter can also become involved. When examining the images from an MRI scan they are particularly evident in the periventricular area, although they can also be seen along the optic nerve, the midbrain (particularly around the Aqueduct of Sylvius), the pons, the medulla oblongata and the cerebellum. They also commonly occur in the spinal cord, particularly the cervical area. These spinal cord lesions show no regularity in their distribution, and so both lesions and associated atrophy can be scattered through its length (Raine 1993). It is important to acknowledge that plaques can occur without any clinical signs. It is commonly reported that MRI images demonstrate large asymptomatic plaques. This is particularly the case in PPMS where there is often little correlation between number of lesions and level of disability.

Inflammation and Disease Activity

Inflammation within the brain can occur independently of demyelination and can, again, affect both white and grey matter. During the inflammatory process, the meninges can be involved and macrophages, lymphocytes and plasma cells can also be identified in the patient's subarachnoid space. It was considered likely that in the development of the plaque, inflammation is the primary event, with demyelination a secondary sequel, but Lassman (1998) says there is an ongoing debate whether this is indeed the case or whether the inflammation occurs secondary as a result of demyelination. Inflammation is a consistent feature of both relapsing-remitting and secondary-progressive disease, but is much less of a component in primaryprogressive MS (Revesz 1994).

What Happens During an Acute Exacerbation?

An acute exacerbation, or relapse, of MS is defined as: "The occurrence of a symptom or symptoms of neurological dysfunction with or without objective confirmation lasting more than 24 hours" (Poser et al 1983) Typically a relapse will progress over a few days, reaching a maximum at one week. Then it will slowly resolve. Complete recovery of symptoms is common during the initial stages of the disease. This is probably because the oligodendrocytes are more likely to survive during the inflammatory process and remyelination can then occur (Lassmann 1998). An understanding of the pathological disease process that occurs during a relapse is essential for the effective care and management of people with RRMS. This ensures that the individual receives the necessary information to understand what is happening to them and they are then able to understand the rationale behind any treatments that may offered to them.

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The initial process involved in a relapse is immunomediated damage to the bloodbrain barrier. There will be an activation of the T-cells which target the vascular wall and, by secreting cytokines, will recruit other cells including macrophages. Adhesion molecules expressed on the lymphocyte and endothelial cell will allow the adhesion molecules to attach to the vessel wall and then pierce through the cell and into the CNS. Once T-cells enter the CNS, the following may occur: T-cells release cytokines Cytokines cause microglia and macrophages to proliferate and release other cytokines that induce inflammation Microglia and macrophages express HLA Class ll antigens, thereby enabling these phagocytes to act as antigen-presenting cells T-cells release gamma interferon Gamma interferon causes microglia and macrophages to proliferate and release TNF-alpha, IL-1, and other cytokines that induce inflammation; gamma interferon has the same effect on T-cells Gamma interferon causes microglia and macrophages to express HLA Class II antigens, thereby enabling these phagocytes to act as antigen-presenting cells Macrophages and microglia directly attack oligodendrocytes by releasing cytotoxic molecules or by phagocytosis; this results in demyelination and cell death Activated T-cells stimulate B-cells to produce antibodies specific to components of myelin; the antibodies combine with antigens and activate complement; this activation both stimulates phagocytes and directly lyses oligodendrocytes TNF-alpha released from microglia also causes vascular endothelial cells to express adhesion molecules, which causes further accumulation of T-cells at the site T-cells release chemokines which attract and allow secondary influx of macrophages and other inflammatory cells. Figure 10 depicts the process of demyelination.

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Figure 10. The process of demyelination. It is presumed that the end point of this process may be transient inflammation of myelin or, if continued, irreversible destruction of oligodendrocytes and ultimately axonal loss. Although you may think that the process described above could lead to rapid and complete demyelination within hours, many individuals with MS in fact recover from attacks even without treatment. This is because the process is not uncontrolled. Tsuppressor cells and subsets of T-helper cells may play a role here by releasing cytokines (such as IL-4, IL-10) and Transforming Growth Factor (TGF) beta which down-regulate the immune response. Beta interferon may enhance the action of Tsuppressor cells and the relevant T-helper cells.

Epidemiology of the Demyelination Process

A combination of genetic and environmental factors may play a role in the demyelination process of MS. Viruses A number of known facts suggest a viral cause for MS: Viruses can cause other demyelinating diseases in humans and other species Tropical spastic paraparesis is caused by the human T-cell leukemia virus type 1 (HTLV 1)

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International MS Nursing Care Plan Viral infection is consistent with the distribution of MS in cold climates Studies of migrants suggest that susceptibility to MS depends on where a person lived up to the age of 15 years, not where he/she currently lives; therefore, childhood factors appear to play a role in the development of MS Viral infections stimulate the production of interferons; gamma interferon, in particular, appears to play a key role in MS. One hypothesis suggests that, in genetically susceptible individuals, MS results from delayed exposure to a common infectious agent. Although many agents have been examined, such as measles, canine distemper, rubella, and herpes zoster and simplex, no single pathogen has been identified as causing the disease. The possible role of viral infections in MS was the original rationale for the study of gamma interferon as a treatment for MS (since the interferons were known to have antiviral properties). The fact that gamma interferon actually worsened MS helped to elucidate some of the mechanisms of the disease. Genetics The incidence of MS tends to cluster in families. Siblings of a person with MS, for example, are at an increased risk of developing the disease. In fact, the identical twin of a person with MS has a much higher likelihood of developing MS than the nonidentical twin of a person with MS. However, siblings also tend to share the same environment and, therefore, this increased risk among siblings does not prove that MS is inherited.

Consequences of Demyelination

Demyelination makes axons susceptible to inflammation, causing them to break and subsequently degenerate. Severely demyelinated axons lack normal support from oligodendrocytes; many of these axons break or simply degenerate and lead to irreversible neuronal death.

Recovery of Function

It used to be thought that remyelination could not occur in MS. However, it is now known that remyelination can take place, leaving increased numbers of glial cells in otherwise normal white matter (Lassmann 1983). On MRI scans areas of remyelination show up as pale `shadow plaques'. The pathological features of remyelination are uniformly thin myelin and short distances between the nodes of Ranvier (Prineas 1993). The type and amount of remyelination varies between different disease patterns of MS. The factors that determine whether a plaque will or will not remyelinate are not yet known. In common with many aspects of MS, the process appears to be complicated, as there seems to be a feedback mechanism between demyelination and remyelination. It is hypothesised that during demyelination, myelin-breakdown products stimulate

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International MS Nursing Care Plan oligodendrocytes to produce more myelin (Raine 1993). In early MS, remyelination is a prominent feature of the disease, which may be because many oligodendrocytes survive at this stage of the disease. As the disease progresses, less remyelination occurs which may be because oligodendrocytes are targeted at this stage. Overall the pathology of remyelination demonstrates the dynamic nature of MS that accounts for the variance seen in individual presentations of symptoms.

Role of Axonal Pathology in MS

Axonal pathology may play a role in MS. For example, the results of post-mortem studies of patients with MS have noted a large number of broken (transected) axons in active MS lesions. Active lesions are defined as having extensive inflammation. Inflammation is an early event in the pathological process and is more pronounced in the earlier stages of MS. These transected axons were also found, in smaller numbers, on the borders of chronic lesions; very few were found in chronic lesions or normal brain tissues. Axonal breakage has also been noted in patients with both short (2 weeks) and long (26 years) durations of MS, suggesting that axonal transection starts early in the disease process. Axon transection is irreversible; axons degenerate after breaking, leading to permanent disability. The fact that transected axons were found mainly in inflamed and demyelinated areas suggests that demyelinated axons may be susceptible to inflammatory changes that cause axon damage. This is probably the process that leads to axon transection in the early stages of the MS. It should be noted, however, that patients do not show permanent disability in the early phases of MS because the excess capacity of the brain can compensate for the damage through the rerouting of the affected functions. This rerouting is dangerous because it masks the real damage and leads to the misleading perception that the patient is doing well while irreversible damage is accumulating. In secondary-progressive MS, where inflammation is no longer a key feature, axonal degeneration and accumulation of permanent disability continues. The damage appears to result from the chronic demyelination of axons, which means that the axons lack the support normally provided by oligodendrocytes (which help to keep the axons healthy).

Implications for treatment with disease-modifying agents

The finding that axon damage, although present, does not produce symptoms in the early stages of MS (due to rerouting of affected functions) has profound implications for the treatment of MS. The goal of treatment should be to slow irreversible damage to oligodendrocytes and axons and, therefore, delay progression of the disease to irreversible SPMS. The axon and myelin damage is linked to inflammation, which is very pronounced during the first years of MS. In the early stages of MS, for example, new lesions occur 10 times more frequently than clinical signs and are detected by magnetic resonance imaging even when patients are in remission. Therefore,

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International MS Nursing Care Plan treatment initiated at the start of the disease may prevent inflammatory changes that lead to demyelination and axon damage. Interferon dosing is also an important consideration, since higher doses have been shown to be more effective at suppressing inflammatory activity (see Chapter 3: Treatments for a more detailed discussion of interferons).

Summary

Demyelination contributes to irreversible axonal damage and, therefore, to the clinical features of MS and its progression. In the early stages of MS, axonal damage does not produce symptoms, since the brain is able to adapt to the changes caused by the damage. However, at a certain point, the brain is no longer able to compensate for the amount of damage that has accumulated. It is probably when this threshold is reached that relapsing-remitting MS converts to secondaryprogressive MS. At this point, a significant amount of damage has accumulated and disease progression is irreversible and continuous. Therefore, the goal of MS therapy is to impact the disease as early as possible using optimal (highest tolerable) dosing.

Note: As the area of inflammation, demyelination and remyelination is a complex one, it is difficult to discuss it in any great detail in this manual. However, Further Readings at the end of this section provides a list of readings with more in-depth information on this subject.

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References

Bruck W, Scmied M, Suchanek G et al. Oligodendrocytes in the early course of multiple sclerosis. Annals of Neurology 1994;35:65-73. Lassmann H. Pathology of Multiple Sclerosis. In: Compston A, Ebers G, Lassmann H, McDonald I et al (eds). McAlpines Multiple Sclerosis. 3rd ed. London: Churchill Livingstone; 1998. Lassmann H. Comparative Neuropathology of Chronic Experimental Allergic Encephalomyelitis and Multiple Sclerosis. Berlin: Springer-Verlag; 1983. Poser CM, Paty DW, Sheinberg L, McDonald WI, Davis FA, Ebers GC et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Annals of Neurology 1983;13:227-231. Prineas JW, Barnard RO, Kwon EE et al. Multiple sclerosis: remyelination of nascent lesions. Ann Neurol 1993;52(3):199-204. Raine CS, Wu E. Multiple sclerosis: remyelination in acute lesions. J Neuropathol Exp Neurol 1993;52(3):199-204. Revesz T, Kidd D, Thompson AJ et al. A comparison of the pathology of primary and secondary-progressive multiple sclerosis. Brain 1994;117(Pt 4):759-65.

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Suggested Readings

Allen IV, McKeown SR. A histological, histochemical and biochemical study of the macroscopically normal white matter in multiple sclerosis. J Neurol Sci 1979;41:8191. Allen IV, Glover G, Anderson R. Abnormalities in the macroscopically normal white matter in cases of mild or spinal multiple sclerosis Acta. Neuropathol 1981;7:176178. De Stefano et al. Evidence of axonal damage in the early stages of multiple sclerosis and its relevance to disability. Arch Neurol 2001;81(4):65-70. Prineas JW. The Pathology of Multiple Sclerosis. In: Cook S (eds). Handbook of Multiple Sclerosis; 289-234. New York: Marcel Decker Inc.; 2001. Smith KJ, McDonald WI. The pathophysiology of MS: the mechanisms underlying the symptoms and the natural history of the disease. Philos Trans R Soc Lon B Biol Sci 1999;354(1390):1649-1673. Thomson AJ, McDonald WI. Multiple Sclerosis and its Pathophysiology. In: Ashbury AK, McKhann GM, McDonald WI (eds). Diseases of the Nervous System; 12091228. Philadelphia: WB Saunders Company; 1992. Trapp BD, Ransohoff RM, Fisher E. Neurodegeneration in multiple sclerosis: relationship to neurological disability. The Neuroscientist 1999;5:48-57. Wingerchuk DM, Lucchinetti CF, Noseworthy JH. Multiple sclerosis: current pathophysiological concepts. Lab Invest 2001;81(3):263-81.

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Module 5: Clinical Manifestations

Introduction

As a result of inflammation, demyelination or axonal loss, people with MS can experience a diverse range of neurological symptoms. There is no doubt that there are sites of predilection of demyelination (the optic nerves, cervical cord and brainstem) but in clinical practice, an individual's symptomatic experience can never really be predicted. Some people will develop a variety of irritating symptoms that are troublesome but do not necessarily affect quality of life, whereas others develop a whole range of disabling symptoms producing a dramatic impact on their psychosocial functioning. Whatever the symptoms are, it is the treatment of them that is fundamental in the management of MS (Thompson 1998). It cannot be overemphasised that not all symptoms are due to MS and it is crucial that other causes for symptoms are excluded.

Learning Objectives

After completing this module, the reader will be able to: Identify the common sites within the CNS that are more prone to demyelination List and discuss the symptoms that a person may experience if they have spinal lesions List and discuss the symptoms that a person may experience if they have brainstem lesions List the paroxysmal symptoms that people with MS may experience Identify the rarer symptoms that can be attributed to MS

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Symptoms of Multiple Sclerosis

The type of neurological symptoms experienced will in general reflect the parts of the CNS that have been the most heavily demyelinated (Mathews 1998). The management of these symptoms is not only difficult because of their huge number, but also because of the complex way they can interact (Thompson 1998). If a person has mobility difficulties, they may also have spasticity and ataxia. Symptoms can fluctuate in presence and severity on a day-to-day, even hour-to-hour span in time. Symptoms can manifest themselves without any real stimulus to trigger them. Fatigue and/or heat can make some symptoms increase in severity and impact on an individual's disability, albeit on a transient basis. In clinical practice, people with MS often complain that visits to their General Practitioner result in them being told that the ailment, whatever it is, is due to their MS and there is nothing that can be done about it. People with MS will also experience co-occurring disorders such as thyroid disease or diabetes that are totally unrelated to their underlying MS. It is essential that, as nurses, we are familiar with the typical clinical symptoms that can be produced as a result of demyelination, thus enabling us to educate patients on what is typical of MS and what may be uncharacteristic and require further exploration. Most books that are written on MS will detail the clinical features that people will exhibit.

Common sites of demyelination

(Bashir and Whitaker 2002; Paty and Ebers 1998; Van de Noort and Holland 1999) Optic Nerves Abnormalities of vision are commonly due to plaque formation along the optic nerve or chiasm. They can also be due to damage to the optic tract or optic radiation. Optic neuritis is a common presenting symptom of MS occurring in 14-23% of cases. It is generally unilateral. The patient will complain of dimming vision, photophobia and pain on eye movement. They can also experience one or more of the following: loss of colour vision, a central scotoma and loss of visual acuity. Visual loss is seldom total. Spinal Cord Lesions within the spinal cord can produce the following symptoms: Limb weakness: Although this in itself is very incapacitating, it can be compounded by ataxia and tremor. It is often associated with brisk reflexes. Spasticity: Commonly seen in legs although can occur in arms. This will contribute to fatigue. The person may experience spasms, clonus and contractures. L'hermittes's sign: Tingling or electric shock like sensation on neck flexion. Sensory changes: Can be acute (intense, burning, shooting, stabbing) or chronic (dysaesthetic pain, i.e., burning, itching, crawling, prickling, tingling).

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International MS Nursing Care Plan Bladder dysfunction: Person will complain of detrussor instability (frequency, urgency, nocturia, incontinence) or detrussor sphincter dyssynergia (hesitancy, retention, overflow incontinence). Some will experience a combination of both. Bowel dysfunction: Most commonly experienced is constipation, but may have urgency and incontinence. Sexual dysfunction: Male: erectile dysfunction, ejaculatory dysfunction, lack of libido, diminished orgasmic capacity. Females: lack of libido, orgasmic dysfunction, vaginal dryness. Brainstem Lesions within the brainstem can produce the following symptoms: Impairment of ocular motility: This can include nystagmus (usually horizontal, but can also be rotary, upbeating and downbeating), blurred vision, oscillopsia (images jumping) and double vision. Internucleur ophthalmoplegia: This can be unilateral or bilateral. Consists of failure of the eye ipsilateral to the lesion to adduct, wheras the contralateral eye adducts fully, but with horizontal nystagmus. Dysarthria: More common in advanced MS. A particular type of speech disturbance known as scanning speech is typical of MS. In this there is a particular rhythm in which each word and syllable is given emphasis, there are pauses after each syllable and the syllable is pronounced slowly. Facial palsy: Probably from a plaque along the facial nerve. Vertigo: This occurs as an initial symptom in 5% of patients. Eventually it can occur in as many as 50% of people. Can be transient and may also be associated with nausea and vomiting. Auditory disturbance: This is uncommon, but may be experienced. Some patients will have hearing loss, others will complain of tinnitus. Dysphagia: Usually experienced in association with dysarthria. May have a pseudobulbar palsy. Trigeminal neuralgia: Involves one, two or three divisions of the trigeminal nerve. Can be excruciating. Generally remits. Cerebellar Cerebellar lesions can produce the following symptoms: Dysarthria: Ataxic or scanning speech. Tremor: Intention and/or postural tremor.

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International MS Nursing Care Plan Ataxia: One of the most disabling symptoms. Head titubation, gait ataxia, truncal ataxia. Cerebral hemispheres Lesions within the cerebral hemispheres can produce the following symptoms: Cognitive impairment: Memory, conceptual reasoning (especially with frontal lobe lesions), attention, word finding, decreased speed of information processing and emotional lability. Fatigue: Causes a major impact on quality of life. Is unrelated to activity and can be present on waking. Can relapse and remit. Depression: One in two people will experience this (Sadovnick et al 1996). It is unknown whether it is a primary or secondary symptom. Sensory impairment - pain There are 3 types of pain that people with MS may complain of: Dysaesthetic Neuropathic (or neurogenic) pain: tends to be experienced in the hands and feet. Described as burning, pricking, tingling, dull or nagging. The pathology of this is unknown, but is probably due to transmission of abnormal electrical discharges across a demyelinated plaque (Paty and Ebers 1998). Paroxysmal: This pain tends to be abrupt in onset, brief, commonly lasting 30-60 seconds, but severe in nature, and recovers spontaneously. Not associated with or predictive of disability. Examples include trigeminal neuralgia (pain along the trigeminal nerve), L'hermittes phenomenon (electric shock sensation when the patient bends their head into their chest), tonic spasms (often triggered by movement and results in a tonic spasm involving either flexion or extension of a limb. This spasm can last for several seconds and can occur frequently. It tends to settle spontaneously rather than in response to treatment), pruritus (can last 20 minutes or more), optic neuritis (will experience shooting pain behind the eye - this can be spontaneous or on eye movement). Musculoskeletal: Can occur in the spinal area or anywhere where there is a joint. Usually due to mechanical problems such as poor gait and hyperextension of the knee joint. Rare signs and symptoms, but can be attributed to MS Anosmia Sleep disturbance Hiccoughs Deafness Aphasia Yawning Sweating

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References

Bashir K, Whitaker JN. Handbook of Multiple Sclerosis. USA: Lipincott Williams and Wilkins; 2002. Mathews B. Symptoms and Signs of Multiple Sclerosis. In: Compston A, Ebers G, Lassmann H et al (eds). McAlpines Multiple Sclerosis. 3rd ed. London: Churchill Livingstone; 1998. Paty DW, Ebers GC. Clinical Features. In: Paty DW and Ebers GC (eds). Multiple Sclerosis. Philadelphia: F.A.Davis Company; 1998. Sadovnick AD, Remick RA, Allen J et al. Depression and multiple sclerosis. Neurology 1996;46:628-32. Thompson AJ. Symptomatic treatment in multiple sclerosis. Current Opinion in Neurology 1998;11:305-309. van den Noort S, Holland NJ. Multiple Sclerosis in Clinical Practice. New York: Desmos Medical Publishing; 1999.

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Progress Check

1. The prevalence of primary-progressive MS is approximately ____%. The prevalence of relapsing-remitting MS is approximately ____%. 2. Name each type of MS depicted below.

3. The peak age of MS onset is _____ years. 4. The prevalence rate of MS in North America and Northern Europe is about _____ in _____ adults. 5. The risk of developing MS for a person with a sister with MS is ____%. 6. Answer true or false to each of the following statements. a. There is a genetic marker that is significant in MS True False

b. MS affects Caucasians more than any other race. True False

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c. Within Caucasian populations, MS occurs more frequently in countries or regions of southern latitudes in the Northern Hemisphere and northern latitudes in the Southern Hemisphere. True False

d. MS is more common in men than in women. True False

e. The concordance rate of monozygotic twins being diagnosed with MS is 30%. True 7. Label the figure. False

8. Most of the neurons in the central nervous system are _______________ neurons. 9. Explain the main function of the following: a. Axons

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b. Myelin

c. Oligodendrocytes

d. Schwann cells

e. Microglia

10. What do the following consist of? a. Grey matter

b. White matter

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11. Label the figure.

12. What is the consequence of demyelination?

13. Although axon damage is present during the early stages of MS, the damage does not produce symptoms. Why is this dangerous?

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14. List five (5) symptoms and/or signs a person will present with if they have demyelination along their optic nerve. a. b. c. d. e. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

15. List eight (8) symptoms and/or signs a person will present with if they have demyelination in their brainstem. a. b. c. d. e. f. g. h. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

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Appendix 1A: Kurtzke Functional System (FS)

Rating Scale for Neurologic Assessment 1. 0 1 2 3 4 5 6 V 2. 0 1 2 3 4 5 X 3. 0 1 2 3 PYRAMIDAL FUNCTIONS Normal Abnormal signs without disability Minimal disability Mild to moderate paraparesis or hemiparesis (detectable weakness but most function sustained for short periods, fatigue a problem); severe monoparesis (almost no function) Marked paraparesis or hemiparesis (function is difficult), moderate quadriparesis (function is decreased but can be sustained for short periods) or monoplegia Paraplegia, hemiplegia, or marked quadriparesis Quadriplegia Unknown CEREBELLAR FUNCTIONS Normal Abnormal signs without disability Mild ataxia tremor or clumsy movements easily seen, minor interference with function Moderate truncal or limb ataxia (tremor or clumsy movements interfere with functions in all spheres) Severe ataxia in all limbs (most function is very difficult) Unable to perform coordinated movements due to ataxia Weakness (grade 3 or worse on pyramidal) interferes with testing

BRAINSTEM FUNCTIONS Normal Signs only Moderate nystagmus or other mild disability Severe nystagmus, marked extraocular weakness, or moderate disability of other cranial nerves 4 Marked dysarthria or other marked disability 5 Inability to swallow or speak V Unknown

Reproduced from Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983;33:1444-1452; with permission from Lippincott Williams & Wilkins.

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4. 0 1 2 3 4 5 6 V

SENSORY FUNCTIONS Normal Vibration or figure-writing decrease only in one or two limbs Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure writing) decrease alone in three or four limbs Moderate decrease in touch or pain or position sense, and/or essentially lost vibration in one or two limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in three or four limbs Marked decrease in touch or pain or loss of proprioceptive, alone or combined, in one or two limbs; or moderate decrease in touch or pain and/or severe proprioceptive decrease in more than two limbs Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioceptive for most of the body below the head Sensation essentially lost below the head Unknown

5. BOWEL AND BLADDER FUNCTIONS (Rate on the basis of the worse function, either bowel or bladder.) 0 Normal 1 Mild urinary hesitancy, urgency, or retention 2 Moderate hesitancy, urgency, retention of bowel or bladder or rare urinary incontinence (intermittent self-catheterization, manual, compression to evacuate bladder, or finger evacuation of stool) 3 Frequent urinary incontinence 4 In need of almost constant catheterization (and constant use of measures to evacuate stool) 5 Loss of bladder function 6 Loss of bowel and bladder function V Unknown 6. 0 1 2 3 4 5 6 V VISUAL (OR OPTIC) FUNCTIONS Normal Scotoma with visual acuity (corrected) better than 20/30 Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/59 Worse eye with large scotoma, or moderate decrease in fields, but with maximal visual acuity (corrected) of 20/60 to 20/99 Worse eye with marked decrease of fields and maximal visual acuity (corrected) of 20/100 to 20/200; grade 3 plus maximal acuity of better eye of 20/60 or less Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less Grade 5 plus maximal visual acuity of better eye of 20/60 or less Unknown

Reproduced from Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983;33:1444-1452; with permission from Lippincott Williams & Wilkins.

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7. 0 1 2 3 4 5 V

CEREBRAL OR MENTAL FUNCTIONS Normal Mood attention only (does not affect DSS score) Mild decrease in mentation Moderate decrease in mentation Marked decrease in mentation (chronic brain syndrome--moderate) Dementia or chronic brain syndrome - severe or incompetent Unknown

8. OTHER FUNCTIONS (Any other neurological findings attributable to MS) 0 1 2 3 V Spasticity None Mild (detectable only) Moderate (minor interference with function) Severe (major interference with function) Unknown

Others 0 None 1 Any other neurological findings attributed to MS Specify: V Unknown

Reproduced from Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983;33:1444-1452; with permission from Lippincott Williams & Wilkins.

Kurtzke Expanded Disability Status Scale 5.5 Ambulatory without aid or rest for about 100 meters; disability severe enough to preclude full daily activities 6.0 Intermittent or unilateral constant assistance (cane, crutch, brace) required 1.0 No disability, minimal symptoms to walk about 100 meters with or without resting 6.5 Constant bilateral assistance (canes, 1.5 No disability, minimal signs in more crutches, braces) required to walk about than one functional system 20 meters without resting 7.0 Unable to walk beyond approximately five meters even with aid, essentially 2.0 Slightly more disability in one functional restricted to wheelchair; wheels self in standard wheelchair and transfers alone; system up and about in wheelchair some 12 hours a day 0.0 Normal neurologic exam

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International MS Nursing Care Plan 7.5 Unable to take more than a few steps; restricted to wheelchair; may need aid in transfer; wheels self but cannot carry on in standard wheelchair a full day; May require motorized wheelchair 8.0 Essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms 8.5 Essentially restricted to bed much of day; has some effective use of arms retains some self care-functions 9.0 Helpless bed patient; can communicate and eat

2.5 Slightly greater disability in two functional systems

3.0 Moderate disability in one functional system; fully ambulatory 3.5 Fully ambulatory but with moderate disability in one functional system and more than minimal disability in several others 4.0 Fully ambulatory without aid, selfsufficient, up and about some 12 hours a day despite relatively severe disability; able to walk without aid or rest some 500 meters 4.5 Fully ambulatory without aid, up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance; characterized by relatively severe disability; able to walk without aid or rest some 300 meters 5.0 Ambulatory without aid or rest for about 200 meters; disability severe enough to impair full daily activities (work a full day without special provisions)

9.5 Totally helpless bed patient; unable to communicate effectively or eat/swallow

10.0 Death due to MS

Reproduced from Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983;33:1444-1452; with permission from Lippincott Williams & Wilkins.

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Chapter 2: Diagnosis

Introduction

Although there are diagnostic criteria available to support the neurologist, there is still no single diagnostic test for multiple sclerosis (MS). The clinical diagnosis of MS is heavily reliant on the skill of the neurologist in taking and interpreting the patient's medical history, conducting a neurological examination and performing and interpreting magnetic resonance imaging (MRI). Other paraclinical evidence including lumbar puncture (LP) and evoked potentials (EPs) can also be used to diagnose and/or assist in the diagnosis of MS, although whether a patient receives these latter two tests may be dependant on the neurological centre they attend. Their results are also important in the exclusion of other alternative diagnosis that can mimic MS (Barnes 2000). Overall, the classical MS diagnostic criteria that are applicable are evidence that lesions in the CNS are: Disseminated in time Disseminated in space No better diagnosis can be made (Lublin 2002) This will be discussed in more detail in this module. MS presents a number of diagnostic challenges to the physician. There is no single sign or symptom that is specific to MS. To further complicate matters, there are a variety of presenting symptoms. In the early stages of the disease, MS symptoms are usually transitory and, therefore, not directly observable by the physician. A diagnosis of MS evokes an array of emotional responses, such as shock, fear, and grief. The role of the MS nurse is to effectively ease the patient's movement through this emotional roller coaster. In this chapter, the diagnosis of MS is discussed and diagnostic criteria are reviewed. Minimum standards that should be met throughout the diagnostic phase are also presented. The role of the nurse during the diagnostic phase is explored.

Chapter Overview

This chapter contains the following four modules: Module 1: History Taking and Paraclinical Testing Module 2: Diagnostic Criteria Module 3: Standards of Healthcare and the Role of the Nurse After/At The Time of Diagnosis Module 4: Prognostic Indicators and Survival in MS At the end of the chapter, please find a section entitled Progress Check; this section tests your knowledge of the information presented in the chapter.

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Module 1: History Taking & Paraclinical Testing

Introduction

The assessment and diagnosis of the patient with MS begins with a detailed medical and psychosocial history taken by the neurologist. Following the history, the neurologist will perform a neurological examination including an MRI. In this module, strategies for collecting a history from the patient are discussed and various neurological tests are reviewed. Minimum standards of care that should be met throughout the diagnostic phase are also presented.

Learning Objectives

After completing this module, the reader will be able to: Discuss what the neurologist is looking for when he meets a patient suspected of having MS Describe the diagnostic work-up of the patient with MS Explain the roles of MRI, evoked potentials, and oligoclonal banding in the diagnosis of MS

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What is the Neurologist Looking for?

Despite the advancement in technology, the most important aspect of making a diagnosis of MS continues to be the evaluation of a patient's history and clinical presentation by an experienced neurologist (McDonald et al 2001). A diagnosis of definite MS cannot be established after one single episode of disease activity. It has to be established that the patient has evidence of lesions that occur in more than one site in the CNS (disseminated in space) and, evidence that these have appeared over a period of time. There must be at least two episodes separated by a period of at least one month (disseminated in time). Evidence of Lesions A detailed history is essential when diagnosing MS. Certain symptoms and signs are taken as evidence of lesions in specific functional systems of the CNS: Visual disturbances, such as unilateral loss or impaired sight and pain behind the eye are evidence of an optic-nerve lesion Muscle weakness and paralysis of one or more limbs are termed pyramidal symptoms, and are evidence of a pyramidal-tract lesion; abnormal reflexes may also indicate pyramidal-tract lesions Unsteadiness of gait or poor coordination (cerebellar symptoms) are evidence of a lesion in the cerebellum Involuntary eye movements (nystagmus), difficulties in articulating speech, and swallowing problems are evidence of a brain-stem lesion Spastic paraparesis (evidence of a spinal lesion) Sensory functions (touch, pain, positional sense, etc.) Bowel and bladder functions (evidence of spinal lesions) Cerebral functions ­ mood and intellectual capacity

Paraclinical tests

1. Magnetic Resonance Imagery (MRI) MRI images are produced by detecting the differential response of protons of water to strong, pulsed magnetic fields. The major advantage of MRI is that, in contrast to conventional radiography (e.g., computed tomography [CT]), there is no dose of radiation; therefore, the procedure is safe and can be repeated in the same patient many times. MRI is used both for diagnosing (approximately 95% of patients with clinically definite MS have CNS lesions that show up on T2 weighted brain MRI scans [Ormerod et al 1987]) and monitoring MS, and its use is increasing as MRI technology advances. Figure 1 depicts a typical lesion found using MRI. Although MRI is a useful supplement to clinical signs and symptoms, it is by no means a conclusive diagnostic test. However, the use of MRI in MS is still developing, and it may become more accurate in the future. MRI applications

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International MS Nursing Care Plan under development include imaging of the spinal cord and the development of specific measures that reflect various pathological processes such as degree of demyelination and axonal loss. MRI may predict risk of developing MS as well as the future course of the disease. For example, in patients with a single episode of optic neuritis, longitudinal studies have shown that initial MRI-lesion number and load correlate strongly with both the risk of developing MS and future disability. If there is any evidence of brain lesions on MRI, the patient has a greater than 50% chance of developing MS. If the patient has four or more lesions, he/she has a greater than 90% chance of developing MS within 5 years. If the patient has a normal MRI scan his/her chances of developing MS are less than 20%. (Thompson 1994) It is known that normal brain MRI scans are found in 5% of patients with MS. Palace (2001) says this is more likely in patients with mild or early relapsingremitting disease. In primary-progressive disease, there is a likelihood that the brain MRI may be normal as the disease predominately affects the spinal cord. In some instances therefore, both brain and spinal scans are carried out.

Figure 1. Typical MS lesion on MRI scan.

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International MS Nursing Care Plan MRI scans produce valuable information relating to disease activity throughout the illness trajectory. Thompson (1999) states that the appearance of new lesions on MRI correlate reasonably well with relapse activity. However, it is also accepted that MRI scans may detect 10 times more lesions than are apparent through clinical examination (Barkhof 1997). This is because many lesions can form without causing detectable signs or symptoms. Thompson does go on to say that the relationship of MS lesions with the development of disability or irreversible deficit is poor. This is particularly evident in people who have primaryprogressive MS, where there are few lesions seen on MRI, yet there is a steady accumulation of disability. In individuals with relapsing-remitting and secondary-progressive MS, a monthly MRI scan will show that lesions appear at a frequency 5- to 10-fold the frequency of clinical relapses and it is suggested that serial MRI provides a more sensitive marker for disease activity than the logging of relapses or new symptoms (Hartung et al 1998). In the UK, however, repeated use of MRI scanning during the course of the disease is uncommon (an MRI Scan may be performed if a patient with established MS presents with signs and symptoms that are not entirely typical of their disease and there is a need to rule out any other coexisting conditions). The value of MRI scans in the diagnosis of MS, the monitoring of disease activity during clinical trials and as a research tool to track disease activity are undisputed. However, Barnes (2000) questions their clinical value in either the patient who is experiencing a stable period in their disease trajectory and even those who are developing new, but classic MS symptoms. Types of MRI Scans The magnetic field in an MRI scanner is pulsed. During the pulse, protons change their alignment in response to the magnetic field. When the pulse ends, the protons switch back to their original position, producing an electric charge. The signal results from the oscillation of the protons as the pulsed magnetic field goes on and off. Therefore, the nature of the signal depends on the timing and strength of the pulses, as well as the composition of the observed tissue. T1- and T2-Weighted MRI Scans In a T1-weighted scan, pulses occur every 350 ms. In a T2-weighted scan, pulses occur every 4­5 s. In MS, T1-weighted scans are designed to show new, active lesions; the number and volume of T1-weighted lesions are generally used as markers of disease activity. On the other hand, T2-weighted scans are better for detecting established lesions, both new lesions with active inflammation and old lesions in which inflammation has subsided. The total volume of T2-weighted lesions (the lesion load) is generally used a measure of overall disease burden. Gadolinium Enhancement of MRI Scans MRI scans can be made even more sensitive by using gadolinium-DPTA, an injectable contrast medium that highlights fresh and developing lesions by passing through breaches in the blood-brain barrier. Gadolinium enhancement is evidence there is breakdown of the blood-brain barrier; using this technique often doubles the number of new lesions found in patients with

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International MS Nursing Care Plan relapsing-remitting and secondary-progressive MS, and it is thought to represent one of the first events in lesion evolution. (Comi et al 1998; Koudriavtseva et al 1997; Koudriavtseva et al 1996) Figure 2 illustrates T1- and T2-weighted scans.

T2-weighted scan showing several lesions.

T1-weighted scan with gadolinium enhancement in the same patient on the same day.

T2-weighted scan in the same patient 1 month later.

Figure 2. Serial MRI scans. MRI Use in Clinical Trials In clinical trials, MRI is used in the following ways: T1-weighted scans, usually with gadolinium enhancement, are used as markers of disease activity (since these types of scans indicate breaches in the blood-brain barrier). The end points are the number of lesions, the number of new lesions, and the total volume of lesions. T2-weighted scans, which show the overall picture of old and new lesions, are used as markers of disease burden. The end point is the total area or volume of lesions or lesion load/lesion burden. 2. Magnetic Resonance Spectroscopy (MRS) MRS detects the characteristic spectral signature of particular bioactive molecules. Like MRI, MRS uses radiofrequency pulse sequences. The difference between an imaging sequence and a spectroscopy sequence is that, in spectroscopy, the frequency information is used to identify different chemical compounds. This identification is possible because the resonant frequency of atoms varies according to the molecular configuration in which they are embedded. The electron cloud is shifted and this variation in electron shielding is identified by MRS. Proton MRS studies have shown that measurements of the resonance intensity of N-acetylaspartate (NAA) - which is localised exclusively in neurons and neuronal processes in the mature brain - can provide a specific index of axonal damage or dysfunction. In fact, in the last few years, proton MRS has demonstrated decreases in NAA in the brains of individuals with MS. Recent studies have demonstrated a highly significant, negative correlation between changes in NAA and clinical disability in patients with isolated, acute demyelinating lesions and in those with established MS followed through periods

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International MS Nursing Care Plan of relapse and remission. These findings suggest that axonal damage may be a way to assess functional impairment in MS. Relative brain NAA concentration detected by MRS may be a useful marker of disease progression. However, proton MRS is more technically demanding in terms of time, reproducibility, and quantification. Therefore, the procedure is not yet ready to be used in the routine assessment of disease progression. (De Stefano et al 1998; De Stefano et al 1995; McDonald 1994; Davie et al 1995) 3. Evoked Potentials (EPs) MS affects the speed of nerve transmission: demyelination slows the impulses in affected axons. The theory behind evoked-potential tests is to use electroencephalography (EEG; the measurement of electrical activity in the brain) to detect this delayed conduction under controlled conditions. Because the brain is continually active, computer analysis of EEG signals is used to isolate the electrical activity associated with a particular stimulus. When measuring evoked potentials, the stimulus can be visual (an alternating black and white checkerboard pattern), auditory (rapid clicking) or sensory (mild electric shocks). Of these the Visual Evoked Potentials (VEPs) contribute the most in the diagnosis of MS (Palace 2001). VEPs measure conduction speed along the visual pathways. Any delay in the conduction of impulses along them is indicative of demyelination. Abnormal results can supplement information provided by the patient who is suspected of having MS and can provide objective evidence of dissemination of lesions in time and space (McDonald et al 2001). The major weaknesses of evoked-potential tests are that they are not standardised between centres and there is no consensus about what constitutes a normal response. Like MRI and CSF analysis, correct interpretation is essential. 4. Lumbar Puncture (CSF Analysis) In addition to neuroelectrophysiological techniques (VEPs) and neuroimaging (MRI), sensitive methods for the study of cerebrospinal fluid (CSF) have led to the recognition that most MS patients have evidence of abnormal immunoreactivity within the nervous system. CSF abnormalities include elevated immunoglobulin IgG levels (Lumsden 1972), increased IgG index (CSF IgG and CSF albumin ratio is related to the ratio of serum IgG and serum albumin) (Olsson 1992), increased IgG synthesis rate (Tourtellote 1978), and oligoclonal bands (Ebers 1980). The cells in the brain and CSF are the source for the intra-blood brain barrier synthesis of immunoglobulins. The typical immunoglobulin molecule is a glycoprotein consisting of four polypeptide chains. Although there are five isotopes of immunoglobulin detected in the CSF, the immunoglobulin G (IgG) is the most dominant one. IgG is synthesised by only one cell in the blood which is the plasma cell. In healthy individuals there are no plasma cells in the brain and a normal IgG concentration in the CSF is determined by the concentration in the blood, the natural tight junctions of endothelial capillaries in the choroid plexus

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International MS Nursing Care Plan and by CSF turnover (Prineas 1985). Therefore, an abnormally high concentration of IgG in the CSF may be the result of elevated blood IgG concentrations, a reduced CSF turnover and damage in the choroid plexus epithelial capillary junctions. The laboratory finding most useful in the evaluation of an individual suspected to have MS is increased production of IgG in the central nervous system. A lumbar puncture is performed to detect oligoclonal bands in cerebrospinal fluid. Oligoclonal bands result from elevated levels of (IgG) and myelin basic protein, which is a by-product of demyelination. Increased production of CSF IgG is assessed by quantifying the amount of IgG and albumin in serum and in CSF, then evaluating the level of CSF IgG, the CSF IgG index, CSF IgG synthesis rate and CSF IgG/Albumin ratio. The albumin index is used to rule out leakage of protein into the CSF from blood. Leakage of protein from the plasma into the CSF may cause a false elevation of the IgG Index or IgG synthesis rate. Oligoclonal bands are detected by electrophoretic separation of CSF where the immunoglobulin molecules migrate in a classical direction and pattern. In normal CSF the molecules are polyclonal and appear as one diffuse band. In MS the appearance is of two or more bands, reflecting that a few B cell clones have reached the CSF and proliferated. Oligoclonal bands are present in the CSF of approximately 90% of MS patients. A patient is considered positive for CSF oligoclonal bands if there are two or more bands in the CSF that are not present in the serum. In order to confirm local production of oligoclonal IgG in CSF, a matched serum sample is required. Oligoclonal bands present in CSF, but not in serum, indicate that IgG is being synthesised within the central nervous system. It is important to note that oligoclonal bands and elevated levels of CSF IgG may be present in a number of other neurological conditions including encephalitis and Guillain-Barré Syndrome. It is also very important to note that up to 10% of patients with clinically supported MS are negative for oligoclonal bands. Note: The use of lumbar puncture and evoked potentials varies from country to country.

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International MS Nursing Care Plan Country-specific issues regarding history taking and paraclinical tests are shown in Table 1. Table 1. Country-specific issues regarding history taking and paraclinical testing. Country Diagnostic Comment Issue France History The neurologist is not always responsible for and Israel taking taking the patient's medical and psychosocial history. Depending on the centre, neurologist, and type of patient, this is sometimes done by the MS nurse. Ireland and Greece United States Lumbar puncture tests Lumbar puncture tests Some neurologists perform lumbar puncture tests as part of the diagnostic criteria despite positive MRI and evoked potentials. In the eastern portion of the United States, lyme disease may have to be ruled out as part of the diagnostic process using a lumbar puncture test.

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References

Barkhof F, Filippi M, Miller DH et al. Comparison of MRI criteria at first presentation to predict conversion to clinically definite multiple sclerosis. Brain 1997;120:20592069. Barnes D. Multiple Sclerosis. Questions and Answers. England: Merit Publishing International; 2000. Comi G, Filippi M, Rovaris M, Leocani L, Medaglini S, Locatelli T et al. Clinical, neurophysiological, and magnetic resonance imaging correlations in multiple sclerosis [review]. J Neurol Neurosurg Psychiatry 1998;64(suppl 1):S21-S25. Davie CA, Barker GJ, Webb S, Tofts PS, Thompson AJ, Harding AE et al. Persistent functional deficit in multiple sclerosis and autosomal dominant cerebellar ataxia is associated with axonal loss. Brain 1995;118:1583-1592. De Stefano N, Matthews PM, Fu L, Narayanan S, Stanley J, Francis G et al. Axonal damage correlates with disability in patients with relapsing-remitting multiple sclerosis: Results of a longitudinal magnetic resonance spectroscopy study. Brain 1998;121:1469-1477. De Stefano N, Matthews PM, Antel JP, Preul M, Francis G, Arnold DL. Chemical pathology of acute demyelinating lesions and its correlation with disability. Ann Neurol 1995;38:901-909. Ebers GC, Paty DW, Scheinberg L. CSF electrophoresis in one thousand patients. Can J Neurol Sci 1980;7:275-280. Hartung HP, Paty DW, Ebers GC, Sörensen PS, Abramsky O, Delwel GO. Development of clinical practice guidelines for the management of relapsingremitting multiple sclerosis. Mult Sclerosis 1998;4:274. Koudriavtseva T, Thompson AJ, Fiorelli M, Gasperini C, Bastianello S, Bozzao A, et al. Gadolinium enhanced MRI predicts clinical and MRI disease activity in relapsingremitting multiple sclerosis. J Neurol Neurosurg Psychiatry 1997;62:285-287. Koudriavtseva T, Thompson AJ, Gasperini C, Fiorelli M, Bastianello S, Farina D et al. A baseline scan is a useful predictor of clinical and MRI activity in patients with multiple sclerosis. Neurology 1996;46:A366-A367. Lublin F. The diagnosis of multiple sclerosis. Current Opinion in Neurology 2002;15:253-256. Lumsden CE. The proteins of cerebrospinal fluid. In: McAlpine D, Lumsden CE (eds). Multiple Sclerosis: A Re­Appraisal. 543-548. Edinburgh: Churchill Livingstone; 1972.

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International MS Nursing Care Plan McDonald WI. Rachelle Fishman-Matthew Moore Lecture. The pathological and clinical dynamics of multiple sclerosis [review]. J Neuropathol Exp Neurol 1994;53:338-343. McDonald WI, Compston A, Edan G et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the international panel on the diagnosis of multiple sclerosis. Annals of Neurology 2001;50:121-7. Ormerod IEC, Miller DH, McDonald WI et al. The role of NMR imaging in the assessment of multiple sclerosis and isolated neurological lesions. Brain 1987;110:1579-1616. Olsson T. Immunology of Multiple Sclerosis. Current Opinion on Neurology and Neurosurgery 1992; 5:195-202. Palace J. Making the diagnosis of multiple sclerosis. Journal of Neurol, Neurosurg and Psychiatry 2001;71(suppl 2):ii3-ii8. Prineas JW. The Neuropatholgy of Multiple Sclerosis. In: Vinken P, Bryun G, Klawans H, Koeitser J (eds). Handbook of Clinical Neurology. 213-57. Amsterdam: Elsevier; 1985. Thompson A. Mechanisms of disability. In: Thompson A and McDonald I (eds). Key Advances in the Effective Management of Multiple Sclerosis. London: Royal Society of Medical Press Ltd; 1999. Thompson AJ. MRI determinants of prognosis in multiple sclerosis: Annual MS Issues Forum 1994. National Multiple Sclerosis Society; 1994. Tourtellotte WW, Ma BI. Multiple Sclerosis : the blood-brain barrier and measurement of de novo central system IgG synthesis. Neurology 1978; 28:76-83.

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Suggested Readings

Andersson M, Alvarez-Cermeno J, Bernandi G et al. Cerebrospinal fluid in the diagnosis of MS. A consensus report. Journal of Neurology, Neurosurgery and Neuropsychiatry 1994;57:897-902. Bates D. Advances in Diagnosis. In: Thompson A, McDonald I (eds). Key Advances in the Effective Management of Multiple Sclerosis. London: Royal Society Press; 1999. Filippi M, Paty DW, Kappos L, Barkhof F, Compston DA, Thompson AJ et al. Correlations between changes in disability and T2-weighted brain MRI activity in multiple sclerosis: A follow-up study. Neurology 1995;45:255-260. Paty DW. MRI in multiple sclerosis: Implications for diagnosis and treatment. Adelphi Communications; 1997. Thorpe JW, Kidd D, Moseley IF et al. Spinal MRI in patients with suspected multiple sclerosis and negative brain MRI. Brain 1996;119:709-714.

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Module 2: Diagnostic Criteria

Introduction

Because there is, as yet, no single test or clinical feature that can be entirely attributed to MS, there is a need to develop diagnostic criteria that will assist the neurologist in making a definite diagnosis. Schumacher (1965) established the first official criteria, which was later updated by Poser in 1983. Poser (1983) and his colleagues formulated their criteria just months before the first description of the appearance of MS on a MRI Scan and, as a consequence, the value of MRI data to assist the diagnosis was not mentioned in any significant detail. Another flaw in the Poser criteria was that it did not include the diagnostic process involved in primaryprogressive MS (PPMS). Over the past 20 years there has been an increase in knowledge of both the disease process involved in MS and MRI Scanning. To reflect this and other evidence-based material, McDonald (McDonald et al 2001) gathered an international panel of leading MS Neurologists to revise the existing criteria and, where possible, to simplify diagnostic classifications. It can be seen that these new criteria build on the work that has previously been completed. It is hoped that these revised criteria will help diagnose MS sooner and with greater confidence than in the past. It is also hoped that the criteria will lessen the anxiety of patients who wonder whether they do, in fact, have MS or something else.

Learning Objectives

After completing this module, the reader will be able to: Summarise the Poser criteria for the diagnosis of MS Discuss the McDonald criteria and identify the implications of this in clinical practice Show an understanding of the disability assessment scales used in clinical practice

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Summary of Poser Diagnostic Criteria

Table 2 below summarises the Poser Criteria. (Poser et al 1983) Table 2. The Poser Diagnostic Criteria. Reproduced with permission from Poser et al 1983.

Category Attacks Clinical Evidence Paraclinical Evidence CSF OB/IgG*

A. Clinically definite MS (CDMS) CDMS A1 CDMS A2 B. Laboratorysupported definite MS (LSDMS) LSDMS B1 LSDMS B2 LSDMS B3 C. Clinically probable MS (CPMS) CPMS C1 CPMS C2 CPMS C3 D. Laboratorysupported probable MS (LSPMS) 2 2 2 1 1

2 1 1

1 2 1

1 1

+ + +

2 1 1

1 2 1

1

LSPMS D1 2 *OB/IgG=oligoclonal bands or increased IgG

+

Clinically definite MS (CDMS) requires two attacks (at least 24 hours in duration, at least 1 month apart) and clinical evidence of lesions in two places. The evidence can be obtained from examination or history. Alternatively, one of the two lesions can be evidenced by paraclinical evidence, meaning an MRI or evoked-potential test (i.e., CDMS A2). Laboratory-supported definite MS (LSDMS) includes supportive evidence from oligoclonal banding, with various combinations of clinical and paraclinical evidence. Clinically probable MS (CPMS) involves the same combination of clinical and paraclinical evidence, without oligoclonal banding. Laboratory-supported probable MS refers to oligoclonal banding without clinical or paraclinical evidence of lesions.

Note: In general, the Poser's criteria are more commonly used in Europe as they are considered easier to use than the McDonald criteria. Some European countries use both the Poser's and McDonald diagnostic criteria.

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Summary of New, Recommended Diagnostic Criteria for MS (McDonald Criteria)

Tables 3­5 summarise the new, recommended diagnostic criteria for MS developed by an international group of leading MS clinicians (McDonald et al 2001). The new criteria use clinical, laboratory, and MRI data to arrive at a diagnosis of MS. They retain much of the long-standing and well-established criterion that has gone before, but have expanded on the role of the MRI scan in the diagnostic period. They pay less attention to the role of the lumbar puncture. While these criteria are only recommended, and many clinicians will feel differently about their use and validity, they nevertheless may become the standard for clinical trials and for disease verification. They will, of course, need modification as more information on the disease course is established. At the end of diagnostic work-up for MS, under this new criteria, the patient will either have: MS Possible MS (the work up has not confirmed MS by these criteria, but has not excluded it. The diagnostic issue is still open, awaiting evidence of dissemination in time and space) Not MS (the workout has ruled out MS). Country-specific issues with regards to MS diagnostic criteria are shown in Table 6. Table 3. MRI criteria for a brain abnormality. Reproduced with permission from McDonald et al 2001. Three out of four of the following: 1. One gadolinium-enhancing lesion or nine T2-hyperintense lesions if there is no gadolinium-enhancing lesion 2. At least one infratentorial lesion 3. At least one juxtacortical lesion 4. At least three periventricular lesions Note: One spinal-cord lesion can substitute for one brain lesion.

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International MS Nursing Care Plan Table 4. MRI criteria for dissemination of lesions in time. Reproduced with permission from McDonald et al 2001. 1. If a first scan is performed 3 months or more after the onset of the clinical event, the presence of a gadolinium-enhancing lesion is sufficient to demonstrate dissemination in time, provided that it is not at the site implicated in the original clinical event. If there is no enhancing lesion at this time, a follow-up scan is required. The timing of this follow-up scan is not crucial, but 3 months after the first scan is recommended. A new T2 or gadoliniumenhancing lesion at this time then fulfils the criteria for dissemination in time. 2. If the first scan is performed less than 3 months after the onset of the clinical event, a second scan done 3 months or more after the clinical event showing a new gadolinium-enhancing lesion provides sufficient evidence for dissemination in time. However, if no enhancing lesion is seen at this second scan, a further scan not less than 3 months after the first scan that shows a new T2 lesion or an enhancing lesion will suffice. Table 5. New, recommended diagnostic criteria for MS. Reproduced with permission from McDonald et al 2001. Clinical Presentation Additional Data Needed for

MS Diagnosis

2 or more attacks Objective clinical evidence of 2 or more lesions 2 or more attacks Objective clinical evidence of 1 lesion None

Dissemination in space demonstrated by MRI or 2 or more MRI-detected lesions consistent with MS, plus positive CSF or await further clinical attack implicating a different site Dissemination in time demonstrated by MRI or second clinical attack Dissemination in space demonstrated by MRI or 2 or more MRI-detected lesions consistent with MS, plus positive CSF

1 attack Objective clinical evidence of 2 or more lesions 1 attack Objective clinical evidence of 1 lesion (monosymptomatic presentation; clinically isolated syndrome)

AND

Dissemination in time by MRI or second clinical attack

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International MS Nursing Care Plan Table 6. Country-specific issues regarding MS diagnostic criteria. Country Issue(s) Belgium France Ireland Israel Poser's criteria are used more frequently. Poser's criteria are used more frequently. McDonald criteria are used more frequently. Neurologists use the McDonald criteria; however, MoH organizations use the Poser's criteria for defining MS. Both McDonald and Poser criteria are used. McDonald criteria are used more frequently. McDonald criteria are widely used in all clinical trials.

Spain United Kingdom United States

Diagnosing Primary-Progressive MS

The diagnosis in patients presenting with progressive disease takes considerable time and should only be made after a variety of other causes are ruled out, in particular spinal cord compression (Palace 2001). The very fact that a delay occurs in the diagnosis of this particular pattern of the disease generally results in a clear picture of progressive deterioration. As already stated, the patient tends to be in the more mature age range (over 50) and will generally have signs and symptoms correlating to spinal disease. Because of the need to rule out other diagnosis, this group of patients are also more likely to have had a LP and VEPs. McDonald et al (2001) spent considerable time in establishing the criteria necessary to diagnoses PPMS and these are as follows: Positive CSF AND Dissemination in space, demonstrated by 1. Nine or more T2 lesions in the brain or 2. 2 or more lesions in the spinal cord or 3. 4-8 brain, plus 1 spinal cord lesion or 4. abnormal VEPs associated with 4-8 brain lesions, or with fewer than 4 brain lesions plus 1 spinal cord lesion demonstrated by MRI AND Dissemination in time as demonstrated on MRI or Continued progression for 1 year.

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The Kurtzke Expanded Disability Status Scale (EDSS)

The EDSS has become the most widely used assessment tool for measuring impairment and disability in MS. It was developed specifically for MS by Kurtzke in 1955 and then updated by him in 1983 (Kurtzke 1983). It is a 20 step ordinal scale that ranges from 0 (normal status) to 10 (death due to MS). Scores of 0-3.5 mainly rely on the Functional Systems, 4-7.5 rely on ambulation, 8-8.5 will indicate upper arm function, and 9-9.5 indicate bulbar involvement. The assessment is made by a neurologist who carries out a neurological examination and then grades patients according to a set of 8 Functional System Scales and combining these with ambulatory function. An example of this scale is given in Appendix 1A in Chapter 1. Uses and Limitations of the EDSS The EDSS is the most widely used assessment scale in MS (especially in clinical trials). This tool is commonly used by neurologists all over the world and provides a commonly accepted language between them when discussing MS. However, it is not generally regarded as an assessment tool that is appropriate to nursing practice. It can be seen by looking at the scale, that it only provides a snapshot view of a patient at the precise moment in time that they are being examined. It is heavily dependant on walking ability and does not reflect many of the symptoms that are so distressing to people such as fatigue, pain, cognition and continence, neither does it take into account the psychosocial problems people are facing. Advantages of the measure Familiar and widespread scale providing a common language amongst neurologists Easy to perform and is based on a neurological examination Language is understandable Scoring system is relatively straightforward It has evidence to support its reliability. Limitations of the EDSS Heavily based on ambulation Does not examine fatigue, cognition The average time spent at each EDSS varies greatly (see Figure 3). This means that an outcome measure, such as time to progress one point on the EDSS means something different depending on which EDSS stage was the starting point The EDSS is not a linear scale; degree of disability when moving from 0 to 1 is quite trivial when compared to moving from 5 to 6 (The difference between 5 and 6 is walking unaided and walking with assistance) Can be very subjective. The ambulation distance tends to be estimated and this can be inaccurate (Sharrack and Hughes 2000) There are difficulties if the patient scores high on Functional System but has normal ambulation.

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Figure 3. Average time spent at each EDSS stage.

Other Disability Scores

Although the EDSS is the most commonly used disability scale in MS there are others, including the following: The Guy's Neurological Disability Scale (Sharrack and Hughes 1999a) This scale is a 12 item ordinal scale that rates the degree of disability using a six level scoring system. It captures all the aspects of disabilities that can be experienced by people with MS and can be used by any healthcare professional several MS specialist nurses are using it as the basis of their assessment. This scale was reviewed by 33 international experts in MS, 84% of whom expressed their approval of it (Sharrack and Hughes 1999a). The authors also obtained the opinions of 176 patients with MS, 96% of whom felt it was appropriate for their needs and felt it captured the aspects of MS they considered important (Sharrack and Hughes 1999b). The Multiple Sclerosis Composite Score (MSCS) (Rudick et al 1996) A task force developed recommendations for a new multi-dimensional assessment tool based on the use of quantitative measures, which include: Arm function in the form of the 9-hole peg test Ambulation in the form of a timed 25 metre walk Cognitive function in the form of the PASSAT (Paced Auditory Serial addition Test).

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International MS Nursing Care Plan This has the advantage of addressing a more global deficit than other existing scales but is basically unfamiliar and only has a use in patients with a degree of ambulation. It is, however, reliable and valid in measuring impairment and it also has low cost implications. The Multiple Sclerosis Impact Scale (MSIS-29) (Hobart et al 2001) This is a relatively new scale examining the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. This scale is disease specific combining psychometric testing and quality of life issues. Other Disability Scores include: Scripps Neurological Rating Scale (Sipe et al 1984) The Ambulation Index (Hauser et al 1983) The Functional Independence Measure (Keith et al 1987) Note: There is a lack of consensus on the use of any one tool for the assessment of disability in MS. The use of disability scales may vary from country to country and from situation to situation. Country specific issues regarding the use of various disability scales are shown in Table 7.

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International MS Nursing Care Plan Table 7. Country-specific issues regarding the use of disability scales in MS. Scale(s) Country Issue(s) France Guys Not used. MSCS Ireland EDSS Guys Norway Saudi Arabia Spain EDSS and MSCS EDSS and MSCS EDSS Currently being evaluated in clinical trials. In some centres, nurses are responsible for evaluating the patient's EDSS score. Not used. Guys is not used Both scales are used. Used most frequent. Neurologists are responsible for determining scores. Used along with EDSS. Neurologists are responsible for determining scores. Used most frequently in the UK. Currently being evaluated in clinical trials. Not used Currently being used in clinical trials Used extensively in clinical trials and clinically

MSCS

United Kingdom

Guys MSIS-29

United States

Guys MSCS EDSS

MSCS= Multiple Sclerosis Composite Score

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References

Hauser SL, Dawson DM, Lehrich JR et al. Intensive immunosuppression in progressive multiple sclerosis. A randomised, 3 arm study of high dose intravenous cyclophosphamide plasma exchange and ACTH. New England Journal of Medicine 1983;308:173-180. Hobart JC, Lamping DL, Fitzpatrick R et al. The Multiple Sclerosis Impact Scale (MSIS-29); a new patient-based outcome measure. Brain 2001;124:962-973. Keith RA, Grainger CV, Hamilton BB, Sherwin FS. The functional independence measure; a new tool for rehabilitation. In: Advances in Clinical Rehabilitation. 6-18. Eisenberg MG, Grzesiak RC (eds). New York: Springer-Verlag; 1987. Kurtzke J. Rating neurological impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983;33:1444-1452. McDonald WI, Compston DAS, Edan G et al. Recommended Diagnostic Criteria for MS: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Ann Neurol 2001; 50:121-127. Palace J. Making the diagnosis of multiple sclerosis. Journal of Neurol, Neurosurg and Psychiatry 2001;71(suppl 2):ii3-ii8. Poser C, Paty DW, Scheinberg L, McDonald WI, Davis FA, Ebers GC et al. New diagnostic criteria for multiple sclerosis: Guidelines for research protocols. Ann Neurol 1983;13:227-231. Rudick R, Antel J, Confavreux C et al. Recommendations from the National Multiple Sclerosis Society Clinical Outcomes Assessment Task Force. Annals of Neurology 1996;42:379-382. Schumacher GA, Beebe G, Kibler RF et al. Problems of experimental trials of therapy in multiple sclerosis; Report by the panel on the evaluation of experimental trials of therapy in multiple sclerosis. Ann NY Acad Sci 1965;122:552-568 Sharrack B, Hughes RAC. The Guy's Neurological Disability Scale: a new disability scale for multiple sclerosis. Multiple Sclerosis 1999a;5:223-233. Sharrack B, Hughes RAC. Scale development and the Guy's Neurological Disability Scale. Journal of Neurology 1999b;246:236. Sharrack B, Hughes RAC. Clinical disablement scales used in multiple sclerosis. International MS Journal 2000;6(3):97-105. Sipe JC, Knobler RL, Braheny SL et al. A neurologic rating scale (NRS) for use in multiple sclerosis. Neurology 1984;34:1368-1372.

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Suggested Readings

Fredrikson S. Design and interpretation of clinical trials in multiple sclerosis. Proceedings of the MS Forum Modern Management Workshop. Stockholm; 1996. Hobart JC, Lamping DL, Freeman JA et al. Evidenced-based measurement-Which disability scale for neurologic rehabilitation? Neurology 2001; 57:639-44. Miller DH. MRI in diagnosis and treatment of MS. MS Management 1995;2:36-42.

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Module 3: Standards of Healthcare and the Role of the Nurse After/At the Time of Diagnosis

Introduction

It is accepted that the diagnostic period is a particularly stressful and confusing time for people with MS and it needs to be handled very carefully. The MS Society of Great Britain and Northern Ireland (1997) says that despite this, it is often managed in a haphazard and unsupported way. They believe that the way the diagnosis is given significantly influences how individuals and their family adjust and adapt to the stresses of living with this unpredictable disease. As a result of research, the MS Society has developed MS healthcare standards that have recently been revised (2002) that need to be considered by all healthcare professionals during the diagnostic phase. Standards such as these are invaluable to healthcare professionals who care for people with MS. They provide an effective evidence base reflecting the actual needs and requirements of patients and their families and can be used to actively develop or improve the practice, care and services that they provide. These healthcare standards are given in this module. The nurse can play an important role in ensuring that individuals who have just been diagnosed with MS receive the minimum standard of care by providing support and education for people at the time of diagnosis. The role of the nurse during diagnosis is also discussed in this module.

Learning Objectives

After completing this module, the reader will be able to: Describe the standards of healthcare as developed by the MS Society that should be met throughout the diagnostic phase Understand the role of the nurse in supporting and educating people who have just been diagnosed

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Standards of Healthcare for People with Newly-Diagnosed MS

The Standards of Healthcare for People with Multiple Sclerosis (MS Society and National Hospital of Neurology and Neurosurgery) were first published in 1997, following extensive work between both clinicians and people with MS. This type of dual partnership was revolutionary at that particular time. The original recommendations have been revised recently to include the necessary evidence to make them more evidenced based. The resulting piece of work, Developing Healthcare Standards: Evidence-Based Recommendations for Service Providers (MS Society 2002), is both dynamic and extremely informative, and provides a framework to guide and inform service development for the MS community in the NHS. The key issues of Developing Healthcare Standards are reproduced below by permission of the Multiple Sclerosis Society of Great Britain and Northern Ireland. For further details or for a full copy of the standards, please contact the MS Society on 020 8438 0700 or write to MS Society, 372 Edgware Road, London NW2 6ND or email [email protected] The key issues are: Certain and clear diagnosis Appropriate support at diagnosis Access to information Continuing education Certain and clear diagnosis Most people with MS have experienced a range of symptoms over a long period of time, which may not have had a long-term effect, but which will have caused them great concern. In anticipation of a firm diagnosis, a prompt referral to a consultant neurologist will be required, followed by appropriate investigation and prompt feedback. Recommendations Diagnosis should be made by a consultant, preferably with an interest in MS Referral time should be short - the ideal should be four weeks from the referral by a GP to being seen by a consultant Ideally, investigations should be completed on the same day as the initial consultation with the neurologist, or within one month The results should be communicated to the patient within two to four weeks of their completion Note: The time from referral to diagnosis of MS varies from country to country. Ideally, a diagnosis of MS should be made as soon as possible. Appropriate support at diagnosis Diagnosis is a particularly difficult and stressful time for people who have experienced confusing and distressing symptoms of MS over a long period. When the diagnosis is made, people are often only able to absorb a limited amount of information. They need time to digest the implications of what has happened. Any

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International MS Nursing Care Plan communication with the person needs to take account of their reaction to the diagnosis. Recommendations Information about MS should be provided by professionals but it should be presented carefully and slowly, taking into account the often limited ability of the individual to take in information immediately following diagnosis Written information should be provided at diagnosis for people to take away. Ideally an information pack should be available to everyone diagnosed with MS. The MS Society can provide information booklets on request for neurologists and other professionals to give to their patients A contact number for the MS Society and other MS organisations - preferably those that are based locally - should be provided A skilled nurse or other support worker - ideally with specialist knowledge of MS and/or other neurological conditions and counselling experience - should be available in the weeks following diagnosis to provide information and support to the person with MS Referral to expert counselling should be made available following diagnosis The specialist MS nurse or support worker should have a liaising role with people with MS in the community and should be able to visit people in their own homes, if necessary A further appointment with the neurologist is required to discuss technical or medical questions which might arise. Access to information At this initial stage, the patient with MS, their carer and family need access to clear, accurate information, which is crucial in developing a realistic approach to the disease. Recommendation People with MS and their family should have ready access to the specialist nurse, support worker or support service when further information is required. This may be provided by the MS Society and/or other MS charities either locally or nationally. Continuing education Generally there is a lack of specialist facilities or input in this early diagnostic phase, which can add to the stress and anxiety felt by the person with MS. Following the initial period of diagnosis, it is important to increase the knowledge of the person with MS and their family in a structured, amenable way, and to offer them an opportunity to meet with people in a similar situation. The internet also provides a very valuable source of information for many people with MS.

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International MS Nursing Care Plan Recommendation Regular information sessions should be established for people with MS, their families and carers, which would bring them into contact with other people who are newly diagnosed, if they wished. Ideally, such sessions should be facilitated by the MS Society and local neurologist and/or specialist nurse. ©Multiple Sclerosis Society 2002. Reproduced with permission.

Role of the nurse after/at the time of diagnosis of MS

A diagnosis of MS is a life-changing event. Evidence from work carried out by Robinson (1997) suggested that the circumstances and sensitivity of the disclosure can have a direct link on the person's reaction. The nurse is in a key position to provide support and education for people at the time of diagnosis, which can have a real impact on how the person manages their disease (Johnson 1997). It should be noted, however, that consultation with an MS nurse at the time of diagnosis is not always possible in all countries. By the nurse providing clear, accurate evidence-based information the person and their families can feel informed and supported. This approach can be initiated at the time of diagnosis through information sessions. The nurse can listen to fears and worries, assess the patient's perception of the disease, correct misconceptions, explain the pathology of existing symptoms and make appropriate referrals to meet individual needs. The nurse recognises how physical function, social interaction and emotional wellbeing can impact how the person with MS and their family cope and adapt to the diagnosis. By understanding the impact of the diagnosis the nurse can introduce the concept of self-management to the person with MS. There is an increasing amount of literature now available that discusses the role of the nurse at the time of diagnosis (Halper 1999, Brechin and Burgess 2001). Work carried out by Halper (1999) confirms that the newly diagnosed person will have a multitude of needs including living with an uncertain future, experiencing a wide symptomatic variability and needing emotional, spiritual and psychosocial support. She suggests a model of care that indicates to the nurse what a patient and their family need during this difficult time: E = Education (about the disease, its course, symptomatic management and psychosocial implications) A = Adaptation (adjustment, modifying lifestyle, setting priorities, promoting selfcare) S = Support (counselling, providing information on support groups, help in obtaining entitlements) E = Enhancement (self-care, improvement of coping skills, facilitation of communication about needs and concerns). Providing information and continuing support to a person with a chronic illness is fundamental to the nurse's role. MS nurses are in a unique position to help the individual with MS meet their educational needs. As a consequence, a panel of MS

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International MS Nursing Care Plan specialist nurses in the UK met and established a standard of care which proposed a standard for management at and after diagnosis, including: The MS nurse being made aware of all newly diagnosed people with MS within 1 week of diagnosis MS nurse contacts newly diagnosed people within 2 weeks of diagnosis (e.g., by letter or phone) A list of relevant contact numbers and other potential support networks is provided Written information on MS is offered Patients have access to a 24-hour answer machine and messages from this client group are treated as a priority Newly diagnosed courses are run and routinely offered - people have the opportunity to attend within 6 months of diagnosis. (UKMSSNA, RCN and MSRT 2001) This standard of care may act, as a template for management at and after diagnosis as local needs will dictate service provision. Note: An international panel of MS nurses agreed that there are too few MS nurses in several European countries. The panel recommended that every European country establish specialised MS centres. Country-specific issues regarding standards of healthcare for people with newlydiagnosed MS and the role of the nurse in the diagnosis of MS are shown in Table 8.

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Table 8. Country-specific issues regarding standards of healthcare for newly-diagnosed persons and the role of the nurse in the diagnosis of MS.

Country Belgium Czech Republic Denmark France Healthcare Standards Ligue Belge de la Sclérose en Plaques No standards No standards No standards Place of Diagnosis Role of the MS Nurse in Diagnosis DMT Instruction

Hospital MS clinic MS centre and consultant network Public or private hospital

The patient is seen by the MS nurse at the first referral to the MS clinic. MS nurse is present at the time of diagnosis. There is currently no specific role definition for the MS nurse. The MS nurse is present at diagnosis only if the patient requests it. The nurse only meets with the patient once treatment is initiated. Presence of the MS nurse depends on where the diagnosis is made (i.e., public or private hospital). Specific recommendations for the role of the MS nurse are available. Performed at MS Clinic Home instruction

Greece Ireland Portugal Neurological Alliance of Ireland SPEM-ANEM

Hospital

Currently, there is no MS nurse specialist designation; however, many nurses are working toward recognition of such a designation in Portugal. A Spanish-Portuguese care plan is currently being developed. Along with the neurologist, the nurse is present at the time of diagnosis.

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Country Saudi Arabia

Healthcare Standards

Place of Diagnosis

Role of the MS Nurse in Diagnosis Neurologist is primarily responsible for the diagnosis of MS; history and examinations are performed by the consultant neurologist. Primary role of the MS nurse is to ensure that laboratory studies and lumbar punctures for CSF studies are available.

DMT Instruction

Spain

Most hospitals have some standards for MS No standards Some standards, but not adopted countrywide Consortium of MS Centers

Public or private hospital

MS nurse is responsible for patient education.

Switzerland United Kingdom

MS clinic MS clinic or hospital (identified centres only)

The MS nurse sees the patient post diagnosis and once treatment is initiated to provide education and support. MS nurse is present at the time of diagnosis.

Home instruction Various instructional approaches are used (both home- and clinic-based)

United States

Models of care vary throughout North America. MS nurses are frequently involved throughout the spectrum of disease at the MS centers.

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References

Brechin M, Burgess M. Designing an educational tool for patients with multiple sclerosis. Professional Nurse 2001;16(11):1471-1474. Halper J. The needs of people who are newly diagnosed with multiple sclerosis. MS Management 1999; 1-4. Multiple Sclerosis Society of Great Britain and Northern Ireland and National Hospital for Neurology and Neurosurgery. Standards of Healthcare for People with MS; 1997. Multiple Sclerosis Society of Great Britain and Northern Ireland. Developing Healthcare Standards: Evidence-Based Recommendations for Service Providers; 2002. Johnson J. What can specialist nurses offer in caring for people with multiple sclerosis? In: Thompson A, Polman C, Hohfeld R. Multiple Sclerosis Clinical Challenges and Controversies. 335-343. London: Martin Dunitz; 1997. Robinson I. A dispatch from the front line: The views of people with MS about their needs. A qualitative approach. Unpublished from Brunel MS Research Unit; 1997. United Kingdom Multiple Sclerosis Nurse Association, Royal College of Nursing and Multiple Sclerosis Research Trust. Specialist Nursing in MS - the way forward. The key elements for developing MS specialist nurse services in the UK. London: RCN, MSRT; 2001.

Suggested Reading

Wollin J, Dale H, Spenser N, Walsh A. What people with newly diagnosed MS (and their families and friends) need to know. International Journal of MS Care 2000; 2(3):4.

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Module 4: Prognostic Indicators and Survival in Multiple Sclerosis

Introduction

At diagnosis, people with MS often ask whether there is information available that can forecast what life is going to be like for them in the future. This is a difficult area to discuss. Predicting the long-term outcome of an individual diagnosed with MS at the onset of symptoms, or during the early course of the disease, remains a problem and is not, as yet, one that can be fully answered. A survival rate in MS is also an area that is constantly changing. It used to be thought that MS reduced life expectancy considerably, but the work carried out in a series of studies by Weinshenker et al, the latest of which was 1998, provides the information that we are currently using and they say life expectancy is probably reduced by 5-7 years.

Learning Objectives

After completing this module, the reader will be able to: List the clinical indicators that are current when discussing the prognosis of MS Discuss the mortality issues associated with MS

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Prognostic Indicators in Multiple Sclerosis

MS is a disease of uncertainty and unpredictability. Many questions that people ask concerning their future are generally left unanswered or are approached in a vague manner. Ebers (1998) says we tend to err on the optimistic side when conducting conversations regarding long-term outcome of living with MS, especially with the newly diagnosed people, but as the illness progresses it is appropriate to use the prognostic guidelines that are available. It does, of course, have to be emphasised that any clinical indicators available are not, as yet, completely reliable. Instead, Ebers goes on to say, it is reasonable to offer an individual prognosis on the experience of the first 5-10 years of the illness. There are some factors that may predict long-term outcome in MS. commonly accepted as: Positive predictors Younger age at onset Female gender Normal MRI on presentation Complete recovery following first relapse Low relapse rate Long interval to second relapse Low disability at 2 and 4 years. Unfavourable predictors Older age at onset Male sex High lesion load on presentation Lack of recovery from first relapse High relapse rate Early cerebellar involvement Short interval to second relapse Early development of disability Insidious motor onset. (List taken from Costello et al 2003) Note: In the United States, ethnicity is also a predictor of long-term outcome in MS. These are

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Survival in MS

There are many studies published that examine the mortality rates associated with MS. Many of the results of these studies differ, probably due to the widely variable study design, patient sample type and size, methods of ascertainment and completeness of follow up ( Koch-Henriksen and Bronnum-Hansen 1999). However, much of today's current thinking is centred around the studies of Weinshenker et al, the latest performed in 1998. He and his team followed 1000 people with MS and examined their natural data over a 25-year period. He admits the data collected has its limitations, but he clearly states that although life expectancy in MS is shortened overall, it is little affected in Western countries. MS patients live an average of 5-7 years less than the general population. Severe MS disability, as measured by an EDSS of 7.5 or higher, is a major risk factor for death (Pryse-Phillips and Costello 2001)

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References

Costello K, Halper J, Harris C. Nursing Practice in Multiple Sclerosis. A core curriculum. New York: Desmos Medical Publishing; 2003. Ebers G. Natural History of Multiple Sclerosis. In: Compston A, Ebers G, Lassmann H et al (eds). McAlpine's Multiple Sclerosis. 3rd ed. London: Churchill Livingstone; 1998. Koch-Henriiksen N, Bronnum-Hansen H. Survival in Multiple Sclerosis. In: Silva A, Kesselring J, Thompson AJ (eds). Frontiers in Multiple Sclerosis (Volume 2). London: Martin Dunitz; 1999. Pryse-Phillips W, Costello F. The Epidemiology of Multiple Sclerosis. In: Cook SD (ed). Handbook of Multiple Sclerosis. 3rd ed. New York: Marcel Decker; 2001. Weinshenker BG et al. The natural history of multiple sclerosis: Update 1998. Seminars in Neurology 1998;18(3):301-7.

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Progress Check

1. MRI usually detects _____ times more lesions than are apparent through clinical examination. 2. Distinguish between T1- and T2-weighted MRI.

3. List two (2) major weaknesses of evoked potential tests. a. ________________________________________________________ b. ________________________________________________________ 4. Complete the table below. Poser Diagnostic Criteria

Category Attacks Clinical Evidence Paraclinical Evidence CSF OB/IgG

CDMS A1 CDMS A2 B. Laboratorysupported definite MS (LSDMS) LSDMS B1 LSDMS B3 C. Clinically probable MS (CPMS) CPMS C1 CPMS C2

2

2

2 1

1 1

1 1

+ +

1

2

LSPMS D1

2

+

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5. Complete the table below. New, Recommended Diagnostic Criteria for MS Clinical Presentation ADDITIONAL DATA NEEDED FOR

MS DIAGNOSIS

None

2 or more attacks Objective clinical evidence of 1 lesion

Dissemination in time demonstrated by MRI or second clinical attack

1 attack Objective clinical evidence of 1 lesion (monosymptomatic presentation; clinically isolated syndrome)

6. List four (4) reasons why the EDSS is not a perfect assessment tool. a. ________________________________________________________ b. ________________________________________________________ c. ________________________________________________________ d. ________________________________________________________

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Chapter 3: Treatments

Introduction

Therapy prescribed for multiple sclerosis (MS) generally falls into one of the following categories: 1. Relapse-management agents (i.e., corticosteroids) 2. Immunoregulators 3. Disease-modifying agents Glatiramer acetate Interferons 4. Symptomatic therapies In this chapter, immunoregulators and relapse-management and disease-modifying agents are discussed. Therapies for the treatment of MS-related symptoms are reviewed in Chapter 4: Management of MS-Related Symptoms. Strategies for managing treatment-related side effects and promoting adherence to therapy are also presented in this chapter.

Chapter Overview

This chapter contains the following three modules: Module 1: MS Therapies Module 2: Management of Treatment-Related Side Effects Module 3: Patient Education and Promoting Adherence to Therapy At the end of the chapter, please find a section entitled Progress Check; this section tests your knowledge of the information presented in the chapter.

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Module 1: MS Therapies

Introduction

Prior to the advent of the new disease-modifying therapies for MS, pharmacotherapeutic management of MS was largely directed towards the treatment of acute exacerbations and the management of MS-related symptoms. The new disease-modifying agents include the interferon beta-1 (IFN ) therapies (i.e., Avonex , Betaferon®, Rebif ) and glatiramer acetate (Copaxone®). These are the first agents that have been shown to have a direct influence on the course of MS. Although the long-term efficacy of these drugs is not known, they represent an important step forward in the care of individuals with MS. In this module, the disease-modifying therapies indicated for the treatment of MS are described in detail; relapse-management agents and immunoregulators are also discussed.

Learning Objectives

After completing this module, the reader will be able to: List and describe relapse-management agents commonly used in MS List and describe various immunoregulators used in the treatment of MS* Identify and describe the newly available disease-modifying therapies indicated for the treatment of MS List criteria for starting and stopping disease-modifying therapy

*With the exception of mitoxantrone in the United States, France and Switzerland, these agents are not licensed specifically for the treatment of MS.

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Relapse-Management Therapies

A relapse is the occurrence of a symptom(s) of neurological dysfunction that occurs in people with MS that lasts more than 24 hours (Poser et al 1983). People will present with an acute exacerbation of MS symptoms that are generally very disabling. It is essential that before confirming a relapse, any pseudo exacerbating factors such as an infection, menstrual cycle, and emotional stress be excluded. Although acute MS relapses will occur randomly, patients with relapsing-remitting MS (RRMS) may expect about 1.5 relapses a year. The commonest areas within the CNS that are affected will be the optic nerves, cervical spine and the brainstem. Rates of recovery will be variable - some will achieve a complete remission, others will accumulate disability from each relapse. Over time, an individual's disease will change from RRMS to a much more progressive course. During this transition time, relapses will often decrease in both number and severity (Mathews 1998). Corticosteroid Treatment for Acute Relapses The usual treatment for an acute disabling relapse is a course of glucocorticosteroids, such as methylprednisolone. The evidence concerning their efficacy in relapse management is well established. They are effective in hastening a recovery from the attack, but do not usually affect the eventual outcome in terms of degree of recovery or disease progression. The exception to this is in certain patients with optic neuritis where research has suggested that recovery may be improved with steroids (Beck et al 1992). Overall, a short course of steroids is well tolerated and if given only when there is evidence of a clinical relapse, the long-term effects are minimal. Frequency of adverse events correlates with the dose, frequency, route of administration, duration of therapy and underlying disease state. As nurses, it is important that we are aware of the short-term side effects that can occur as a result of steroids and that these are explained fully to patients. Side effects can be: Slight reddening of the face Transient ankle oedema Metallic taste in the mouth Urinary tract infections, candida, glycosuria Mood alterations Alterations to sleep patterns Transient weight gain On rare occasions, epileptic fit(s). Patients need to know what to expect from a course of steroids so they are able to make informed choices. It is important that they are aware of the principle that whether they receive a course of steroids or not, their recovery from the relapse will ultimately be the same.

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International MS Nursing Care Plan Although there is consensus that corticosteroids are beneficial for the treatment of MS relapses, there is no clear, empirical evidence supporting an optimum therapeutic regimen. In fact, corticosteroid dosages and administration schedules vary widely from country to country and even from centre to centre. There have been a variety of clinical trials conducted to determine the optimal course of treatment that should be prescribed when treating acute relapses (Durelli et al 1986, Milligan et al 1987, Barnes et al 1997). There is also research to show that oral steroids are equally as effective as intravenous (Alam et al 1993). Results of a recent meta-analysis of methylprednisolone trials in MS support the use of high-dose intravenous or oral methylprednisolone, to at least 500 mg/day for 5 days, for the treatment of MS relapses. Although this meta-analysis failed to find significant differences in efficacy between high-dose and low-dose methylprednisolone therapy, other studies have found that low-dose therapy may be related to an increase in disease activity (Miller 2000). Regardless of the steroid dose/route of administration, management of the following steroid-related side effects is imperative: Gastrointestinal side effects Arrhythmias Headaches Bone density changes Elevated glucose Acne Long-term effects such as cataracts. Tremlett et al (1998) examined the current practice of prescribing and administering steroids amongst neurologists in the UK. They found that: 80% prescribed steroids in a quarter of relapses Less than 55% never use steroids 5% use oral as first choice 70% rarely, if ever, use oral Despite new evidence regarding oral efficacy, there had been no change in patterns of prescribing Most common regime is 1000 mg/day for 3 days or 500 mg/day for 5 days Most limit courses of steroids to 1 per year. Country-specific issues regarding the use of corticosteroids for the management of acute relapses in MS are shown in Table 1.

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International MS Nursing Care Plan Table 1. Country-specific issues regarding the use of corticosteroid treatment for acute relapses.

Country All European countries Canada Czech Republic Drug(s)/Class Corticosteroids Issue(s) All European countries use corticosteroids for the management of severe relapses; some countries use oral corticosteroids for moderate relapses. Oral prednisone widely used as an alternative to IV methylprednisolone. A care plan is implemented to guide steroid use in MS. Patients receiving steroids are treated as daycases. Oral prednisone is used to a lesser extent. There are currently no nursing protocols for steroid use in MS. Patients receiving steroids are treated as daycases. A high dose of IV methylprednisolone is used (i.e., 3 g/day for 3 days). There are currently no nursing protocols for steroid use in MS. Patients receiving steroids are treated as daycases. The antiaggregant, pentoxyphylline, is used for the management of mild-to moderate relapses; severe relapses are treated with corticosteroids. IV methylprednisolone is initiated upon the consultant neurologist's orders; if the order is 1 g, it will be administered for 3 days; if 500 mg, it will be administered for 5 days; usually followed by oral corticosteroids during dose tapering. Only IFN therapy is interrupted while the patient is taking IV methylprednisolone.

Oral prednisone Steroids in general

France

Oral prednisone/ steroids in general

Portugal

Methylprednisolone/ steroids in general

Russia

Corticosteroids/ pentoxyphylline Methylprednisolone

Saudi Arabia

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Country United Kingdom Drug(s)/Class Oral corticosteroids Issue(s) High-dose oral steroids, with the dose being reduced over 4 days, are as efficacious as IV corticosteroids. Alternatively, 1 g of IV methylprednisolone can be administered in orange juice over 3 days, with gastric protection. Discretion is used in the administration of steroids due to the long-term side effects associated with these agents. IV methylprednisolone is initiated upon the consultant neurologist's orders; if the order is 1 g, it will be administered for 3 days; if 500 mg, it will be administered for 5 days; usually followed by oral corticosteroids during dose tapering. Oral prednisone used as an alternative to IV methylprednisolone in some clinics.

United States

Methylprednisolone

Oral prednisone

Immunoregulators

As previously stated, current thinking surrounding the aetiology of MS is that it is an autoimmune disease. Immunoregulators have already been proven effective in the treatment of other diseases with autoimmune components, such as rheumatoid arthritis and psoriasis. Most of the currently available immunoregulators work by inhibiting cell division and proliferation. Therefore, their use in MS is a rational therapeutic approach. With the exception of mitoxantrone, immunoregulators are used infrequently in MS. Those used in MS include azathioprine, cyclophosphamide, cyclosporine, and methotrexate. However, with the exception of mitoxantrone in the United States, France and Switzerland, no immunoregulator is licensed specifically for the treatment of this disease. Country-specific issues regarding the use of immunoregulators in MS are shown in Table 2. Azathioprine (Imuran ) Azathioprine is an anticancer agent; the main adverse events with this agent include myelosuppression (suppression of blood-cell production in bone marrow leading to increased susceptibility to infection and haemorrhage), teratogenicity (toxicity to the foetus), and nausea/vomiting. In 1991 a meta-analysis of studies examining the efficacy of azathioprine in MS found a slight decrease in relapse rates and a slight slowing down of disability progression with

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International MS Nursing Care Plan this agent. However, the investigators of this study concluded that the level of efficacy is unlikely to outweigh the adverse effects of this drug. (Yudkin1991) A more recent meta-analysis by Palace et al (1997) has suggested that the efficacy of azathioprine may, in fact, be similar to that of the interferon therapies. However, doubleblind, placebo-controlled trials are needed to confirm this finding. A report by the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines considered the various disease-modifying agents currently available. They concluded that the use of azathioprine could possibly reduce the relapse rate in MS, but there was no demonstration of any positive effect on disability progression. (Goodin et al 2002) Cyclophosphamide (Endoxana ) This is an anticancer agent with serious side effects: myelosuppression, teratogenicity, sterility, haemorrhage cystitis (bladder inflammation), alopecia (hair loss), and nausea/vomiting. Its use in the treatment of MS is also controversial. Controlled trials have shown a small clinical benefit with this agent, but at the cost of serious adverse effects such as bladder cancer. As a result of these side effects, many centres no longer use cyclophosphamide. Cyclophosphamide may be reserved for patients who have failed most of the other treatment options or for those experiencing frequent relapses and rapid disease progression. Goodin et al (2002) concluded that cyclophosphamide does not seem to affect the disease course in progressive MS. Cyclosporine (Sandimmune ; Neoral ) Cyclosporine is an immunoregulator commonly used to prevent graft rejection after transplantation. Cyclosporine use is associated with dose-related renal side effects and hypertension. Although cyclosporine has been shown to have a small, positive effect on MS, the adverse effects associated with this agent (see previous paragraph) can be very problematic for patients. Methotrexate Methotrexate (formerly amethopterin) is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Some research suggests that weekly, low-dose, oral methotrexate may help delay progression of impairment in patients with progressive MS and moderate disability. Upper-extremity function seems to be most affected by the medication, while lower-

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International MS Nursing Care Plan extremity function ­ including ambulation ­ is not affected. Low-dose methotrexate appears to be well tolerated. (Goodkin et al 1995) Mitoxantrone (Novantrone ) This is another chemotherapy agent; trials have shown it to be a powerful immunoregulator and for this reason, it has been tested in a small number of patients with MS. Results are contradictory: some researchers have reported that mitoxantrone has positive effects on disease activity and/or measures of disease progression, whereas others have reported no effects. It is mainly used for patients who are experiencing a rapid accumulation of disability over a short period of time. All the units using the drug in the UK have specific policies controlling its usage. Patients are admitted onto the ward for the treatment as it is intravenous. Some Trusts require that it is administered by a trained chemotherapy nurse and not by neurology staff. The main disadvantage of mitoxantrone is its safety profile, in particular its cardiotoxicity. Echocardiograms are performed on the patient prior to receiving the drug, throughout the course of treatment and performed intermittently even when the drug has been stopped. Mitoxantrone use is also associated with nausea and vomiting, hair loss and amenorrhoea. Goodin et al (2002) concluded that Mitoxantrone probably reduces the rate of attacks but clinical benefit in disease progression has not yet been established. Potential toxicity may outweigh clinical benefits. Table 2. Country-specific issues regarding the use of immunoregulators in MS.

Country Czech Republic Denmark and Norway France Drug(s)/Class Immunoregulators Mitoxantrone Mitoxantrone Issue(s) No information is provided to patients initiating immunoregulator therapy. Mitoxantrone treatment/information centres are available. Mitoxantrone is approved for use in MS. MS nurse discusses the role of immunoregulator therapy, side effects, etc. with patient prior to the initiation of therapy. Regular follow-up blood tests should be performed when using mitoxantrone. Azathioprine is not used due to toxicity.

Ireland Russia

Mitoxantrone Azathioprine

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Country Saudi Arabia Drug(s)/Class Mitoxantrone Issue(s) Mitoxantrone will be initiated by the consultant neurologist for the following: Unstable condition Severe progression SPMS Clinical pathways are used to guide mitoxantrone therapy. IFN is discontinued completely once mitoxantrone is initiated. Approved for very aggressive forms of SPMS that have failed disease-modifying therapy. Mitoxantrone is approved for use in MS. Mitoxantrone is not used due to toxicity. If requested, patients initiating immunoregulator therapy are provided with information. FDA approved mitoxantrone for the treatment of RRMS and SPMS. There is anecdotal information on the use of Azathioprine, Methotrexate and Cladribine. Some countries use a combination of immunoregulator agents. There are currently ongoing clinical trials examining the efficacy of combination immunoregulator therapy.

Spain Switzerland Turkey United Kingdom United States

Mitoxantrone Mitoxantrone Mitoxantrone Immunoregulators Mitoxantrone

Various Countries

Combination immunoregulator therapy

Intravenous Immunoglobulin

As with the immunoregulatory drugs, immunoglobulin (obtained from the blood of healthy human donors) is available, but not licensed, for use in MS. A recent study (Fazekas 1997) suggests that immunoglobulin may be a reasonable treatment option in MS. Results of this study showed: A significant positive effect of immunoglobulin on the proportion of patients with improved Kurtzke Expanded Disability Status Scale (EDSS) scores A significant reduction in relapse rates (59%)

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International MS Nursing Care Plan However, no magnetic resonance imaging (MRI) scans were performed in this study, the assessment of adverse events was not blinded, and the optimum dose and dosing interval were not assessed. Although the mode of action of immunoglobulin in MS has not been established, it has been suggested that immunoglobulin may down-regulate antibody and cytokine production, and lymphocyte activity; block the constant-region antibody receptors on macrophages; and bind to activated complement components. Goodin et al (2002) conclude that immunoglobulin is of little benefit in slowing down disease progression. They also state that studies to date have involved small numbers of patients and incomplete outcome data. Further trials are necessary to assess the effectiveness of immunoglobulin as a treatment option in MS. Country-specific issues regarding the use of IV immunoglobulin are shown in Table 3. Table 3. Country-specific issues regarding the use of IV immunoglobulin.

Country Canada France Greece Portugal Saudi Arabia United Kingdom United States Issue(s) Not used Used less frequently than it has been in the past. Used in only one hospital. May be used in combination with other MS therapies. Not used. Used less frequently than it has been in the past. May be used in combination with other MS therapies. Used less frequently than it has been in the past. May be used in combination with other MS therapies.

Disease-Modifying Therapy

The use of disease-modifying therapies is perhaps the most important therapeutic advancement in MS to date. As they all are proteins, they all have to be administered by injection to prevent their breakdown in the G-I Tract. (A trial of oral glatiramer acetate had to be abandoned recently due to its lack of efficacy). Glatiramer Acetate (Copaxone ) Glatiramer acetate is indicated for the treatment of RRMS. It is a synthetic analogue of myelin basic protein (MBP) - a polypeptide made up of random sequences of four amino acids.

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International MS Nursing Care Plan The exact mode of action of this agent is unknown. Glatiramer acetate binds to human leukocyte antigen (HLA) Class II molecules on antigen-presenting cells. This binding may induce a population of myelin-specific T-suppressor cells, and/or block the presentation of myelin-derived autoantigens to T-cells. Both of these actions would suppress the autoimmune attack on myelin seen in MS. Glatiramer acetate is administered daily by subcutaneous injection. Glatiramer Acetate Trials There have been two randomised, placebo-controlled studies of glatiramer acetate in RRMS: a single-centre pilot study performed in New York and a multicentre, phase III trial of MS patients treated for 2 years (Bornstein et al 1987, Johnson et al 1995). The double-blind, randomised, placebo-controlled pilot trial included 50 patients with RRMS who self-injected either 20 mg of glatiramer acetate dissolved in 1 mL of saline or saline alone daily for 2 years. Six of the 23 patients in the placebo group (26%) and 14 of the 25 patients in the glatiramer acetate group (56%) had no exacerbations (p=0.045). There were 62 exacerbations in the placebo group and 16 in the glatiramer acetate group, yielding 2-year averages of 2.7 and 0.6 exacerbations per patient, respectively. Among patients who were less disabled on entry (EDSS=0-2), there were an average of 2.7 exacerbations in the placebo group and 0.3 in the glatiramer acetate group over 2 years. Among patients who were more affected (EDSS=3-6), there was an average of 2.7 exacerbations in the placebo group and 1.0 in the glatiramer acetate group. After 2 years of treatment, less-disabled patients taking glatiramer acetate improved an average of 0.5 EDSS units; those taking placebo worsened by an average of 1.2 EDSS units. Side effects with glatiramer acetate included irritation at injection sites and rare, transient vasomotor responses. (Bornstein et al 1987) In the phase III trial, 251 patients with RRMS were randomised to receive glatiramer acetate 20 mg/day (n=125) or placebo (n=126) by subcutaneous injection for 2 years. The primary end point was the relapse rate. The relapse rates at 2 years were 1.19 0.13 for patients receiving glatiramer acetate and 1.68 0.13 for those receiving placebo, corresponding to a 29% reduction in relapse rates in glatiramer acetate treated patients compared to placebo-treated patients (p=0.007). When the proportion of patients who improved or worsened by one or more EDSS units from baseline to conclusion (2 years) was evaluated, significantly more glatiramer acetate-treated patients were found to have improved than placebo-treated patients; in fact, function (as measured by the EDSS) worsened in placebo-treated patients (p=0.037). Glatiramer acetate was also found to be well tolerated; the most common adverse events were injection-site reactions. Unpredicted, transient, self-limited systemic reactions followed the injection in 15.2% of patients receiving glatiramer acetate and 3.2% of those receiving placebo. (Johnson et al 1995) A recent short, 9-month MRI study of 239 patients with RRMS found that treatment with glatiramer acetate significantly reduced the total number of enhancing lesions compared to placebo (-10.8; 95% confidence interval [CI]= -18.0 to -3.7; p=0.003). Consistent

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International MS Nursing Care Plan differences favouring treatment with glatiramer acetate were seen for almost all secondary end points examined: number of new enhancing lesions (p<0.003), monthly change in the volume of enhancing lesions (p=0.01), and change in volume (p=0.006) and number of new lesions (p<0.003) seen on T2-weighted images. (Comi et al 2001) Glatiramer acetate has not been found to have a significant impact on disease progression. Interferons Interferons are cytokines, either extracted from human cells or produced by using genetically engineered bacterial- or mammalian-cell lines. Interferons differ from conventional drugs in several ways: 1. The traditional pharmacokinetics of blood levels and peak concentrations do not apply: interferons are not detected in plasma after administration. Injected interferons are distributed via the lymphatic system; endogenous interferons act locally and are not disseminated throughout the body. 2. As cytokines, interferons form complexes with cell receptors; these complexes activate several genes and are then internalised and degraded. 3. The adverse-event profile of interferons is unlike that of conventional drugs. 4. The final effects of interferons are difficult to predict due to their complex network of interactions with other cells and cytokines. 5. As biological products, interferons are recognised by the host immune system (especially if they differ from the natural molecule) and they induce the production of antibodies. In some cases, these antibodies neutralise the activity of the drug and reduce its efficacy. The production of neutralising antibodies even occurs, to some extent, with natural interferons extracted from human cells (because they are administered exogenously); however, neutralising-antibody production is more pronounced with interferons that differ from the natural molecule. It is, however important to point out, that the clinical significance of neutralising antibodies is not yet established. Current ABN (UK) Guidelines state that it is not necessary to routinely check for neutralising antibodies in clinical practice. Alpha and Gamma Interferons Several studies have examined the efficacy of alpha interferon in MS; these studies have shown that this type of interferon has no therapeutic effect on MS. Gamma interferon was examined in a small pilot study, which was terminated early because 7 of the 18 patients showed an increased rate of exacerbations. This study supports the theory that gamma interferon may play a role in the pathophysiology of MS relapses. (Camenga et al 1986, Panitch et al 1987)

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International MS Nursing Care Plan IFN (Beta Interferon) Only IFN has been shown to significantly impact three or more MS parameters: IFN significantly reduces relapse rates and the accumulation of new MRI lesions and IFN 1a slows the progression of disability in patients with RRMS. IFN was the first treatment to show efficacy on all major end points of RRMS while maintaining an acceptable tolerability profile. IFN has been proven to slow the progression of disability in patients with secondaryprogressive MS (SPMS) although research using IFN -1a has, to date, not been statistically significant. The IFN agents approved for the treatment of MS in several countries include: Avonex (IFN -1a), Betaferon IFN -1b (also called Betaseron in USA) and Rebif (IFN -1a). IFN -1b (Betaferon ) is produced in the bacterium Escherichia coli, and differs from natural human IFN in that it has a serine rather than a cysteine residue at amino-acid position 17, lacks methionine at the N-terminus (and therefore has 165 amino acids rather than 166), and lacks glycosylation of the asparagine residue at position 80 (i.e., lacks a large carbohydrate group at this position). By contrast, recombinant IFN -1a (Rebif , Avonex ) is produced in a mammalian-cell line (Chinese-hamster ovary cells), is glycosylated, and is virtually identical to the native human protein. Furthermore, the distribution of electrostatic charge in IFN -1a is different from that in IFN -1b (electrostatic charge affects receptor recognition and binding as well as solubility). Essentially, these structural differences mean that, compared with IFN -1b, IFN -1a is: More potent in vitro (i.e., much smaller quantities are needed to produce standardised levels of antiviral and other biological activity) Has higher specific activity Is less likely to induce neutralising antibodies Is more stable (Runkel et al 1998) It is important to state that it is not known whether these differences are of any clinical significance. Table 4 provides a brief overview of the four disease-modifying therapies currently approved for the treatment of MS. Country-specific issues regarding the use of diseasemodifying therapies are shown in Table 5.

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International MS Nursing Care Plan Table 4. Overview of the disease-modifying therapies for MS.

Rebif Manufacturer Description Serono IFN -1a 166 amino-acid glycoprotein Avonex Biogen/Idec IFN -1a 166 amino-acid glycoprotein Betaferon Schering Health Care IFN -1b Purified, sterile, lyophilised protein product Copaxone TevaMarion Partners Glatiramer acetate Synthetic, random mixture of four amino acids RRMS

Indications (as of Feb 2003)

RRMS Progressive MS with relapses Subcutaneous injection Three 22 or 44g injections/ week* Pre-filled syringes Stored at room temperature (< 25º C) for up to 30 days, if fridge unavailable. Refrigerate for periods > 30 days Autoinjector supplied

RRMS

RRMS SPMS with relapses

Administration Dosing

Intramuscular injection One 30- g injection/week Pre-filled syringes Refrigeration required. Once removed from refrigerator, should be used within 12 hours. Autoinjector supplied

Subcutaneous injection One 250- g injection every alternate day Injection components supplied Reconstitution required Stored at room temperature (< 25º C) Vial adapter available for reconstitution Autoinjector supplied

Subcutaneous injection One 20-mg injection/day Injection components supplied Reconstitution required Stored in fridge. Remains stable for up to 7 days at room temperature (< 25º C) if fridge unavailable Autoinjector supplied

Packaging / Storage

*Regardless of dose, each pre-filled syringe contains 0.5 mL of solution.

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International MS Nursing Care Plan Table 5. Country-specific issues regarding the use of disease-modifying therapies.

Country Denmark and Norway Ireland and United Kingdom Drug(s)/Class DMTs in general Avonex Betaferon Issue(s) Patients using DMTs are followed every 6 months. No reconstitution required. Storage temperature has been changed.

Note: LTI scheme employed and, therefore, access to DMTs varies. Russia Saudi Arabia Avonex DMTs in general Patients must pay for Avonex , while the other DMTs are free. Follow-up for patients using DMTs is every 3 months with the MS nurse and every 6 months with the consultant neurologist. Pre-filled syringes are available for Rebif and Avonex (available to be reconstituted as well and as a pre-filled diluent for Betaseron.

United States

Copaxone

DMTs=disease-modifying therapies Table 6 summarises the results of four large, multicentre, double-blind, placebocontrolled clinical trials conducted with IFN in patients with RRMS. 1. IFN Multiple Sclerosis Study Group trial (Paty and Li 1993, The IFN MS Study Group 1993 and 1995) This was a large, phase III clinical trial of Betaferon . Patients (n=372) had at least two relapses within the previous 2 years and EDSS scores up to and including 5.5 (impaired and disabled patients). Patients were randomised to receive Betaferon 50 g (1.6 MIU), 250 g (8 MIU), or placebo, subcutaneously every alternate day. A total of 307 patients (82.5%) completed the 2-year treatment period. These patients were given the option of continuing treatment in a double-blind fashion and, as a result, the study was extended to 5.5 years for some patients. Those who did not complete the trial (19%) were considered to have remained stable from the point at which they dropped out; therefore, the results were not analysed strictly on an intentto-treat (ITT) basis. Primary outcome measures were relapse-based. 2. Multiple Sclerosis Collaborative Research Group (MSCRG) study (Jacobs et al 1996, Rudick et al 1997, Simon et al 1998) In this study, 301 patients with RRMS and EDSS scores of 1.0­3.5 (functionally impaired) with at least two documented relapses in the previous 3 years received Avonex 30 g (6 MIU) or placebo, intramuscularly, once weekly for up to 2 years. As the patient drop-out rate proved to be lower than originally anticipated, the

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International MS Nursing Care Plan investigators ended the study approximately 1 year earlier than originally planned; at this time only 172 patients (57%) had been followed for at least 2 years. Results were not analysed on an ITT basis for all end points. Primary outcome was time to sustained onset of disability. 3. The Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study (PRISMS Study Group 1998 and 2001) This study included 560 patients with RRMS of at least 1 year's duration, with at least two relapses in the previous 2 years, and EDSS scores in the range of 0­5 (i.e., included impaired and disabled patients). Subjects were randomised to receive Rebif 22 g (6 MIU), 44 g (12 MIU), or placebo, subcutaneously, three times per week for 2 years. All results were analysed on an ITT basis. Primary outcome measures were relapse-based. After 2 years, the placebo group was re-randomised to receive Rebif 22 or 44 g three times per week. Patients on therapy continued treatment for an additional 2 years. The study continued for a total of 4 years. 4. OWIMS (Once Weekly Interferon for MS) Study (OWIMS Study Group 1999) This study included 293 patients with RRMS, EDSS scores of 0­5, at least one acute relapse in the previous 2 years, and at least three lesions consistent with MS (revealed by MRI) during pre-study screening. Patients were randomised to treatment with Rebif 22 g, 44 g, or placebo, once weekly for an initial period of 48 weeks. After this period, patients receiving placebo were re-randomised to receive Rebif 22 or 44 g once weekly and all 269 patients (92%) remaining in the study were treated for a further 48 weeks. The primary outcome measure was the number of combined active lesions on monthly MRI scans during the first 24 weeks of therapy.

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International MS Nursing Care Plan Table 6. Key findings of the four major trials of IFN in RRMS. All comparisons are versus placebo in the same study. Reproduced with permission from Chofflon et al 2000.

EDSS score Weekly dose ( g) % reduction in relapse rate at 1 year % reduction in relapse rate at 2 years (ITT)a % increase in time to first relapse % increase in relapsefree patients at 1 year % increase in relapsefree patients at 2 years % increase in time to progression compared to placebo % reduction in MRI activity at 2 years % reduction in MRI activity at 2 years (frequent MRI cohort) % reduction in MRI BOD 0­5.0 22 0 NA NA 0 NA NA IFN -1a Rebif 0­5.0 0­5.0 44 66 19 NA NA 11 NA NA 33* 29* 70* 59 69* 55* 0­5.0 132 37* 32* 113* 87 119* 79* IFN -1a Avonex 1­3.5 30 9.6 18* 31 NA 46 37* IFN -1B Betaferon 0­5.5 0­5.5 175 875 15 13* 18 NA 12.5 (17) 33* 31* 93* NA 56 15

NA NA

NA NA

67* 89*

78* 98*

33* NA

NA 67*

NA 83*

NA

NA

-12.2*

-14.7*

-6.7

-5.1

-17.5*

*Statistically significant (p<0.05) Corrected for relapse-free drop outs Information obtained from Food and Drug Administration (FDA) package insert BOD=burden of disease ( )=Decrease ITT = Intention to treat is a strategy for the analysis of randomised controlled trials that compares patients in the groups to which they were originally randomly assigned. This is generally interpreted as including all patients regardless of whether they actually satisfied the entry criteria, the treatment actually received, and subsequent withdrawal or deviation from the protocol. (Fisher et al. Intention to treat in clinical trials. Statistical issues in drug research and development. 331-350. New York: Marcel Dekker; 1990).

a

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International MS Nursing Care Plan Effect on Relapse All four studies confirmed the beneficial effect of IFN therapy on relapse rate. Furthermore, according to the results of these studies, the impact of IFN is doserelated; the higher the weekly dose the greater the impact on relapse-related endpoints. Effect on Disability Although reducing or eliminating relapses is desirable in RRMS, the accumulation of physical disability associated with the disease is a major factor affecting the lives of many individuals with MS. Only the IFN -1a studies have shown a significant impact of treatment on the progression of disability in RRMS. Impact on MRI activity MRI has been used for a number of years to assist in the diagnosis of MS and is now becoming established as a means of monitoring efficacy in clinical trials, allowing the pathology underlying MS to be assessed directly and in an objective, qualitative fashion. MRI activity significantly decreased with both doses of IFN -1b, and this effect was most marked in the 250- g group. The MSCRG study found that after 2 years of treatment, the proportion of scans showing gadolinium (Gd)-enhancing lesions was lower in patients receiving IFN -1a (Avonex ) than those receiving placebo, reaching borderline significance (p=0.05). In addition, there was a 24% increase in the number of patients with no Gd-enhanced lesions in the treated group compared to the placebo group (71.1% vs 57.3%). The median number of new and enlarging T2 lesions was significantly reduced (by 33%) in patients receiving IFN -1a (Avonex ; p=0.002). The PRISMS study found that the median number of active lesions per patient per scan was reduced by 67% in the IFN -1a (Rebif ) 22- g group and by 78% in the 44- g group (p<0.0001 vs placebo for both doses); the dose effect was statistically significant (p<0.0003 for 44- g vs 22- g group). It is especially noteworthy that the high dose completely suppressed not only the number of enlarging lesions, but also the number of new lesions. In addition, at 2 years, there was a 2.4-fold and a 3.9-fold increase in patients with no active T2 lesions for the 22- and 44- g groups, respectively, compared with placebo. These results were maintained and enhanced over the 4-year period; 44 g IFN -1a (Rebif ) three times a week was proven to be significantly superior to 22 g IFN -1a (Rebif ) three times a week. In the OWIMS study, the weekly 22- g IFN -1a (Rebif ) dose was associated with a non-significant decrease in the number of combined active lesions per patient per scan compared to placebo. With the 44- g dose, the difference became significant (53.5% reduction compared to placebo; p<0.01).

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International MS Nursing Care Plan Reduction in MRI Burden of Disease Over the first 2 years of treatment in the IFN -1b trial, the median change in burden of disease (BOD), defined as the total lesion area revealed by MRI, increased by 16.5% in the placebo group and by 11.4% in the 50- g group, but decreased by 0.8% in the 250g group (p<0.001 for 250 g vs placebo). By contrast, there was no significant difference in percentage change in T2-lesion volume from baseline to 2 years between patients taking IFN -1a (Avonex ) 30 g and placebo-treated patients. In the PRISMS study, BOD increased over the 2-year period in patients who received placebo, but decreased significantly in patients receiving IFN -1a (Rebif ). Over the 4year period, only patients treated for the full 4 years with IFN -1a (Rebif ) 44 g showed a reduction from baseline of 6.2%. Patients treated with lower doses (22 g three times a week) for shorter periods (only 2 years) accumulated BOD. Over the 1year treatment period in the OWIMS study, BOD increased by 5.9% from baseline in the placebo group, but decreased by 2.0% and 1.4%, respectively, among those patients given IFN -1a (Rebif ) 22 and 44 g once weekly (p<0.01).

Comparison Studies

EVIDENCE Study The EVIDENCE (EVidence for Interferon Dose-effect: European-North American Comparative Efficacy Study) trial compared the occurrence of clinical relapses, changes in lesions detected by MRI, and other outcomes in 677 people with RRMS who received either IFN -1a 44 g subcutaneously (SC) three times per week (Rebif ), or IFN -1a 30 g intramuscularly (IM) once per week (Avonex ). The primary endpoint was the proportion of patients who were relapse free at 24 weeks; the principal MRI endpoint was the number of active lesions per patient per scan at 24 weeks. The study was extended to 48 weeks. IFN -1a 44 g SC three times per week (Rebif ) showed a statistically significant benefit over IFN -1a 30 g IM once per week (Avonex ) in terms of proportion of patients remaining without relapses and in terms of lesions seen on MRI after 24 and 48 weeks of treatment. (Panitch et al 2002) INCOMIN Study The INCOMIN study compared the clinical and MRI benefits of IFN -1b 250 g (Betaferon®) administered on alternate days with IFN -1a 30 g administered once weekly (Avonex®) in 188 patients over 2 years. Primary outcome measures were the proportion of patients free from relapses and that of patients free from new T2 lesions at MRI assessment. Several secondary outcome measures were also assessed.

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High-dose IFN -1b 250 g (Betaferon®) administered every other day was shown to be more effective than IFN -1a 30 g administered once weekly (Avonex®) on the primary outcome measures and most of the secondary outcome measures, including delay of confirmed disease progression. (Durelli et al 2002) Rebif® versus Betaferon® Study One study has compared the antiviral (biologic) activities of IFN -1a 44 g three times per week (Rebif ) and IFN -1b 250 g every other day (Betaferon ). This study showed that Rebif has a 14 times greater antiviral activity than that of Betaferon . The study concludes that on the basis of the results there may well be important clinical implications for prescribing. (Antonetti et al 2002) APPLICABLE IN THE UNITED KINGDOM ONLY:

The National Institute for Clinical Excellence (NICE) and The Risk-Sharing Scheme NICE is a part of the NHS in England and Wales. One of its functions is to appraise new drugs and technologies, based on evidence of clinical and cost-effectiveness. It also produces clinical guidelines on disease management. The clinical guideline on the management of MS is currently in process and is due in June 2003. Prior to NICE completing their appraisal of the beta interferons and glatiramer acetate, these treatments were being prescribed in some Health Authorities / Trusts in what became known as "postcode prescribing". After a prolonged appraisal, with several appeals, NICE issued guidelines in January 2002, stating that "On the balance of their clinical and cost-effectiveness neither beta interferon nor glatiramer acetate is recommended for the treatment of multiple sclerosis (MS) in the NHS in England and Wales." The committee also recommended that the Department of Health, the National Assembly for Wales and the manufacturers of the treatments should consider ways to enable the NHS to obtain the treatments in a cost-effective way. The result of this recommendation was The Risk-Sharing Scheme. The Risk-Sharing Scheme involves the detailed monitoring of a large cohort of people being treated with the beta interferons and glatiramer acetate over a 10 year period. The manufacturers of these treatments have entered an agreement with the Department of Health, the National Assembly for Wales, the Scottish Executive and the Northern Ireland Department of Health, Social Services & Public Safety, to supply the treatments at a reduced cost during the monitoring period. The cost to the NHS will be adjusted on a sliding scale during this time or at the end of the monitoring period, depending on whether the outcomes differ from the agreed targets for each product. People eligible for treatment under the scheme are those with relapsing-remitting MS or secondaryprogressive MS where relapses are the dominant feature of the disease. All people must fulfil the Association of British Neurologist's (ABN) criteria for treatment (see below). Assessment will take place at a specialist MS prescribing centre. All people eligible for treatment will be asked to consent to take part in the monitoring process, but refusal to do so will not prevent them receiving treatment. Monitoring of the scheme will be carried out by the Sheffield School of Health and Related Research (ScHAAR). It is envisaged that the cohort (approximately 5000 people) for monitoring will be enrolled into the scheme over an 18 month period (May 2002 ­ Nov 2003). Once the cohort is enrolled, people will still be prescribed treatment during the 10 year monitoring period. Further details on the scheme can be found on the department of health web-site at http://www.doh.gov.uk/publications/coinh.html

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Criteria for Consideration of Therapy in RRMS

Note: Eligibility criteria vary from country to country. According to the Association of British Neurologists' Guidelines for the Use of Beta Interferon and Glatiramer Acetate in Multiple Sclerosis, IFN should be offered to patients with RRMS who fulfil the following four criteria (ABN 2001): Able to walk independently (EDSS 5.5) At least two clinically significant relapses in the last 2 years; where possible, the patient's history of relapses should be confirmed by neurological examination or from another source (e.g., hospital or General Practitioner's records, or through discussions with the patient's main caregiver) Adult age group (18 years or older); no recommendations are possible in the paediatric age group since trials have not been performed in this cohort There are no contraindications. According to the same guidelines, glatiramer acetate is an appropriate treatment to reduce relapse frequency in patients with RRMS provided that these patients fulfil all the following criteria: Able to walk at least 100 m without assistance At least two clinically significant relapses in the last 2 years; where possible, the patient's history of relapses should be confirmed by neurological examination or from another source (e.g., hospital or General Practitioner's records, or through discussions with the patient's main caregiver) Adult age group (18 years or older); no recommendations are possible in the paediatric age group since trials have not been performed in this cohort. The decision to commence treatment in the under 18 is at the neurologists discretion. The Association of British Neurologists cautions that glatiramer acetate has not been shown to prevent sustained increases in disability.

Criteria for Stopping Disease-Modifying Therapy

In some patients, discontinuation of treatment may become necessary because of intolerable adverse effects, rapid disease progression, or when the patient experienced 2 relapses in the previous 12 months, despite disease-modifying therapy. If pregnancy is planned, treatment will be interrupted temporarily.

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International MS Nursing Care Plan The following features likely indicate lack of efficacy and should be used as stopping criteria (ABN 2001): Two disabling relapses, as defined by the examining neurologist, within a 12-month period Secondary progression with an increase in disability observable over 6 months Loss of ability to walk, with or without assistance, persistent for at least 6 months The stopping criteria should be made known to patients and agreed upon before treatment is begun (see Appendix 3A for a sample patient contract that can be used to help ensure patients understand stopping criteria). After each 12-month period of treatment, each patient will undergo a formal review to ensure treatment efficacy. If, at this time, the patient and the neurologist agree that the treatment is having a beneficial effect, it should be continued. Country-specific issues regarding criteria for stopping or switching disease-modifying therapies is shown in Table 7. Table 7. Country-specific issues regarding criteria for stopping or switching disease-modifying therapies.

Country Denmark Issue(s) Criteria for stopping IFN therapy are used when neutralizing antibodies (NAbs) are more than 80% on two consecutive blood samples, with a 6-month interval between samples. There is currently an ongoing study in Denmark examining the role of NAbs in treatment response. Although stopping criteria are included, they are rarely used. Although other countries do not regularly perform NAb assessments on their patients, in Ireland, a NAb positive patient who is doing poorly will be switched to another agent. It is recommended that NAb testing be used in other countries for determining when to discontinue/switch therapies. The ABN (2001) stopping criteria are not applicable in these countries. Physicians do not usually stop DMT after two disabling relapses within a 12-month period or evidence of secondary progression with an increase in disability observable over 6 months. Rather, physicians usually switch therapies when two disabling relapses have occurred or there is evidence of deterioration and/or loss of mobility. Stopping criteria are omitted. For Norway, normal to stop if patient is doing poor and/or Nab is positive. There is an ongoing study in Norway examining the role of Nabs in treatment response. 22-73

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Ireland, France, Belgium and Israel

Germany, Greece, Norway

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Country Portugal Saudi Arabia Issue(s) There are currently no stopping criteria. Stopping or switching criteria used by the consultant neurologist if the patient has experienced more relapses despite treatment or in the presence of elevated laboratory values. Patients are usually switched to another therapy or therapies are combined when there is evidence of intolerability or deterioration. Some patients are required to sign a form to agree to the proposed stopping criteria. See the Disease Management Consensus Statement at www.nmss.org

Spain United Kingdom United States

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References

Alam SM, Kyriakides T, Lawden M, Newman PK. Methylprednisolone in multiple sclerosis: a comparison of oral with intravenous therapy at equivalent high dose. J Neurol Neurosurg Psychiatry 1993;56(11):1219-20. Antonetti F, Fionocchiaro O, Mascia M, Terlizzese MG, Jaber A. A comparison of the biologic activity of two recombinant IFN preparations used in the treatment of relapsing-remitting multiple sclerosis. Journal of Interferon & Cytokine Research. 2002;22:1181-1184. Association of British Neurologists. Guidelines for the use of beta interferon and glatiramer acetate in multiple sclerosis [paper]; January 2001. Barnes D, Hughes RA, Morris RW, Wade-Jones O, Brown P, Britton T et al. Randomised trial of oral and intravenous methylprednisolone in acute relapses of multiple sclerosis. Lancet 1997;349(9056):902-6. Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT et al. A randomised, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med 1992;326(9):581-8. Bornstein MB, Miller A, Slagle S, Weitzman M, Crystal H, Drexler E et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. New Engl J Med 1987;317:408-414. Camenga D, Johnson KP, Alter M, Engelhardt CD, Fishman PS, Greenstein JI et al. Systemic recombinant alpha-2 interferon therapy in relapsing multiple sclerosis. Arch Neurol 1986;43:1239-1246. Chofflon M. Recombinant human interferon beta in relapsing-remitting multiple sclerosis: A review of the major clinical trials. Eur J Neurol 2000;7:369-380. Comi G, Filippi M, Wolinsky JS. European/Canadian multicenter, double-blind, randomised, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol 2001;49:290-297. Department of Health. Cost Effective Provision of Disease Modifying Therapies For People With Multiple Sclerosis. Health Service Circular 2002/004; February 2002. Durelli L, Cocito D, Riccio A, Barile C et al. High-dose intravenous methylprednisolone in the treatment of multiple sclerosis: clinical-immunologic correlations. Neurology 1986;36(2):238-43.

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International MS Nursing Care Plan Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M. Independent Comparison of Interferon (INCOMIN) Trial Study Group. Every-otherday interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study. Lancet 2002;359(9316):1453-60. Fazekas F, Deisenhammer F, Strasser-Fuchs S, Nahler G, Mamoli B. Randomised placebo-controlled trial of monthly intravenous immunoglobulin therapy in relapsingremitting multiple sclerosis. Lancet 1997;349:589-593. Goodin DS, Frohman EM, Garmany GP, Halper J, Likosky WH, Lublin FD, Silberberg DH, Stuart WH, van den Noort S. Disease modifying therapies in multiple sclerosis. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002;58:169-178. Goodkin DE, Rudick RA, VanderBrug Medendorp S, Daughtry MM, Schwetz KM, Fischer J et al. Low-dose (7.5 mg) oral methotrexate reduces the rate of progression in chronic progressive multiple sclerosis. Ann Neurol 1995;37:30-40. Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM et al. Intramuscular interferon beta-1a for disease progression in relapsing remitting multiple sclerosis. The Multiple Sclerosis Collaborative Research Group. Ann Neurol 1996;39:285-294. Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP et al. Copolymer-1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: Results of a phase III multicenter, double-blind, placebo controlled trial. Neurology 1995;45:1268-1276. Mathews B. Symptoms and Signs of Multiple Sclerosis. In: Compston A, Ebers G, Lassmann H et al (eds). McAlpines Multiple Sclerosis. 3rd ed. London: Churchill Livingstone; 1998. Miller DM, Weinstock-Guttman B, Béthoux F, Lee JC, Beck G, Block V et al. A metaanalysis of methylprednisolone in recovery from multiple sclerosis exacerbations. Mult Sclerosis 2000;6:267-273. Milligan NM, Newcombe R, Compston DA. A double-blind controlled trial of high dose methylprednisolone in patients with multiple sclerosis. 1. Clinical effects. J Neurol Neurosurg Psychiatry 1987;50:511-516. National Institute for Clinical Excellence. Beta interferon and glatiramer acetate for the treatment of multiple sclerosis. Technology Appraisal Guidance No.32; January 2002.

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International MS Nursing Care Plan OWIMS Study Group. Evidence of interferon beta-1a dose response in relapsingremitting MS: The OWIMS Study Group 1999;53:679-686. Palace J, Rothwell P. New treatments and azathioprine in multiple sclerosis. Lancet 1997;350:261. Panitch HS, Hirsch RL, Haley AS, Johnson KP. Exacerbations of multiple sclerosis in patients treated with gamma interferon. Lancet 1987;1:893-895. Panitch H, Goodin DS, Francis G et al. Randomised comparative study of interferon 1a treatment regimes in MS. The EVIDENCE Trial. Neurology 2002;59:1496-1506. Paty DW, Li DK. Interferon beta 1b is effective in relapsing-remitting multiple sclerosis II. MRI analysis results of a multicenter, randomised, double-blind, placebo-controlled trial. Neurology 1993;43:662-667. Poser CM, Paty DW, Scheinberg L, McDonald WI, Davis FA, Ebers GC et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Annals of Neurology 1983;13:227-231. PRISMS Study Group. Randomised double-blind placebo-controlled study of interferon -1a in relapsing-remitting multiple sclerosis. Lancet 1998;352:1498-1504. PRISMS Study Group and the University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term efficacy of interferon-beta-1a in relapsing MS. Neurology 2001;56:1628-1636. Rudick RA, Goodkin DE, Jacobs LD, Cookfair DL, Herndon RM, Richert JR et al. Impact of interferon beta-1a on neurologic disability in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group. Neurology 1997;49:358-363. Runkel L, Meier W, Pepinsky RB, Karpusas M, Whitty A, Kimball K et al. Structural and functional differences between glycosylated and nonglycosylated forms of human interferon-beta. Pharmaceut Res 1998;15:641-649. Simon JH, Jacobs LD, Campion M, Wende K, Simonian N, Cookfair DL et al. Magnetic resonance studies of intramuscular interferon beta-1a for relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group. Ann Neurol 1998;43:79-87. The IFN Multiple Sclerosis Study Group. Interferon beta 1b is effective in relapsingremitting multiple sclerosis I. Clinical results of a multicenter, randomised, double-blind, placebo-controlled trial. Neurology 1993;43:655-661. The IFN Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. Interferon beta 1b in the treatment of multiple sclerosis: Final outcome of the randomised controlled trial. Neurology 1995;45:1277-1285.

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Tremlett HL, Luscombe DK, Wiles CM. Use of corticosteroids in multiple sclerosis by consultant neurologists in the United Kingdom. J Neurol Neurosurg Psychiatry 1998;65(3):362-5. Yudkin PL, Ellison GW, Ghezzi A, Goodkin DE, Hughes RA, McPherson K et al. Overview of azathioprine treatment in multiple sclerosis. Lancet 1991;338:1051-1055.

Suggested Readings

Achiron A et al. Intravenous immunoglobulin treatment in multiple sclerosis. Effects on relapses. Neurology 1998;50:398-402. Andersen O. Treatment alternatives in relapsing-remitting multiple sclerosis. In: Siva A, Kesselring J, Thompson AJ (eds). Frontiers in multiple sclerosis. Volume 2. London: Martin Dunitz; 1999. European Study Group on Interferon Beta-1b in Secondary Progressive MS. Placebocontrolled multicentre randomised trial of Interferon beta-1b in treatment of secondary progressive multiple sclerosis. Lancet 1998;352:1491-1497. Multiple Sclerosis Study Group. Efficacy and toxicity of cyclosporine in chronic progressive multiple sclerosis: A randomised, double-blinded, placebo-controlled clinical trial. Ann Neurol 1990;27:591-605. Rudge P, Koetsier JC, Mertin J, Mispelblom Beyer JO, Van Walbeek, Clifford Jones R, et al. Randomised, double-blind, controlled trial of cyclosporine in multiple sclerosis. J Neurol Neurosurg Psychiatry 1989;52:559-565.

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Module 2: Management of Treatment-Related Side Effects

Introduction

The most common side effects associated with IFN therapy are: Injection-site reactions Flu-like symptoms (i.e., myalgia, headache, chills, fever) Spasticity Laboratory-test abnormalities Mood alterations Insomnia The most common side effects noted with glatiramer acetate use are: Injection-site reactions Systemic reactions (i.e., chest pain, palpitations, and anxiety). In this module, protocols for managing these side effects are described.

Learning Objectives

After completing this module, the reader will be able to: Describe the side effects most commonly associated with glatiramer acetate and the IFN therapies. Implement interventions for the treatment and management of side effects associated with these therapies. Discuss the desired outcome(s) of treatment interventions for side effects associated with the disease-modifying therapies.

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Injection-Site Reactions

Description of Problem

The most common injection-site reactions include pain and cutaneous reactions. Injection-site necrosis is rare, but may occur.

Pain Pain is associated with all four agents; however, it is rarely the sole cause for termination of treatment. It can occur immediately upon injection and/or develop 24-48 hours post-injection. Predicting who will experience injection-site reactions is not possible unless there are identifiable risk factors or physical sources for the pain. (Munschauer and Kinkel 1997) Cutaneous Reactions The phase III trial of Copaxone® found that the most commonly occurring injection-site events in patients treated with this agent were localised reactions consisting of mild erythema and induration (i.e., affecting 6% of Copaxone®-treated subjects). In some cases, these reactions persisted for several days. (Johnson et al 1995) In the PRISMS study, injection-site reactions were reported by 39% of subjects receiving low-dose Rebif and 40% of subjects receiving high-dose Rebif compared to 22% of placebo-treated subjects (PRISMS Study Group 1998). In the Avonex trial, 34% of patients receiving Avonex reported muscle aches (Avonex product monograph). The majority of patients receiving Betaferon® (i.e., 85%) report injection-site reactions (Betaferon® product monograph). Betaferon® therapy has also been associated with the development of cutaneous reactions such as ulcerations, erythemas, and deep dermal plaques. Healing of these lesions usually occurs spontaneously over several weeks or months after therapy has been initiated (Elgart et al 1997). Injection-Site Necrosis In the phase III trial of Betaferon®, 5% of patients treated with this agent experienced injection-site necrosis (Betaferon® product monograph). Necrosis was also reported by approximately 4% of patients receiving Rebif® in the PRISMS study (PRISMS Study Group 1998). The mechanism by which IFN induces skin necrosis is unknown. However, possible etiological factors include thrombosis and necrosis of the dermal vessels (Feldmann et al 1997, Weinberg et al 1997). Possible risk factors for necrosis include (Knobler et al 1994): Incorrect injection technique Insufficient needle length Administration of cold IFN solution

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International MS Nursing Care Plan Repeated use of the same injection site Excessive exposure of injection sites to sunlight or ultraviolet rays Interventions Use interventions for the management of injection-site reactions Educate and prepare patient for the advent of possible pain and injection-site problems Instruct patient to: Rotate injection sites Select appropriate injection sites (see Figures 1 and 2) Allow solution to come to room temperature before administration Allow alcohol to dry completely before injecting (if using alcohol to cleanse the skin)* Inject with new needle that has not touched the mixed solution (in the case of reconstituted preparations) Ensure no drops of solution on end of needle (mannitol used in preparation is painful on the skin Use vial adapters (in the case of reconstituted preparations) Inject only into normal, healthy tissue Ensure proper depth of injection (see Figure 3), particularly if the patient is very thin or obese Use a topical anaesthetic to reduce pain Apply ice pre-injection and then again post-injection for up to 5 minutes or PRN Massage site (following IFN injections only) Take paracetamol and/or ibuprofen PRN Avoid exposing the injection site to the sun Evaluate/assess injection sites at each follow-up visit and review injection technique PRN Instruct patient on the use of an autoinjector if patient continually experiences problems during manual injection

*Since some patients are allergic to alcohol, many centres now use soap and water to cleanse the injection site.

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Desired Patient Outcomes Demonstrates appropriate site selection Follows procedures for minimising injection-site reactions (see above.) Country-specific issues regarding the management of injection-site reactions are shown in Table 8.

Note: If injection-site reactions continue to be a problem despite the implementation of commonly accepted interventions, careful consideration should be given to switching agents.

Table 8. Country-specific issues regarding the management of injection-site reactions.

Country Czech Republic Issue(s) Ice, EMLA, analgesic creams, Brufen gel, and cortisone creams are used to manage injection site reactions. Lymph drainage is used for serious skin reactions. Ultrasound is used to reduce redness and nodules at injection sites. Home-care nurses offer patients a support system; these nurses liaison with the MS nurse, who then follows up with the patient should any problems arise. EMLA, ice and non-alcohol wipes are used. Orudis® gel and ice are used most often to reduce site reactions Alcohol wipes are not used. Injection-site management is done by the consultant neurologist, not the nurse. Cold packs, EMLA, anti-inflammatory creams and Burow water are used. Pharmaceutical-company guidelines are used for side-effect management. EMLA and black tea poultice are used to manage pain and redness at the injection site. Lymph drainage or infra-red treatments are used for serious skin reactions. EMLA, ice and topical cortisone creams are used; alcohol wipes are not used. EMLA and topical cortisone creams are used; alcohol wipes are not recommended.

Denmark Ireland

France Norway Portugal Russia Spain Switzerland

United Kingdom United States/Canada

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Figure 1. Possible injection sites for disease-modifying therapies that areadministered subcutaneously.*

Note: Other injection-site locations may include the abdomen above the waistline (maintaining a 2" circle of safety all around the umbilicus that should be avoided), the sides of the thigh and the lower back. In some countries, injections into the back of the arms are not recommended.

*Encourage patients to inject in sites they prefer or that are most comfortable for them; however, always stress the importance of injection-site rotation.

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Figure 2. Possible injection sites for disease-modifying therapies that are administered intramuscularly.*

Note: Many patients find injection in the deltoid region awkward. Some centres may instruct patients in the use of the upper outer quadrant of the buttocks.

*Encourage patients to inject in sites they prefer or that are most comfortable for them; however, always stress the importance of injection-site rotation.

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Figure 3. Proper depths for subcutaneous and intramuscular injections. Necrosis can lead to serious complications such as infection and tissue loss. Therefore, it is imperative that this side effect be properly treated. The first step in determining the appropriate treatment for necrosis is thorough assessment of the following: Severity of the necrosis Activity of the patient's MS Laboratory-test values Cognitive status Caregiver availability The Consultant Neurologist must then decide whether or not to continue the IFN therapy that is causing the necrosis. If IFN therapy is discontinued, the physician may or may not decide to use an alternative immune-modulating treatment during the healing process. The patient must also be assessed for the signs and symptoms of infection at the injection sites. A course of antibiotics may be needed if infection is noted. A full blood count (FBC) must be performed to determine whether the white blood cell (WBC) count is high enough to allow autolysis. Finally, appropriate topical treatment is initiated based on the WBC, the stage of the wound, and the presence or absence of infection.

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Flu-like Symptoms

Description of Problem Approximately 60% of patients experience flu-like symptoms after the first dose of IFN . These symptoms usually begin 2 6 hours after injection and may include (Munschauer and Kinkel 1997, Walther and Hohlfeld 1999): Myalgia Headache Nausea Chills Fatigue Pyrexia Flu-like symptoms usually resolve within 24 hours of injection but may persist either intermittently or with each injection for 3 months or more following the initiation of therapy. Interventions Prepare patient for the advent of flu-like side effects through educational sessions Use titration schedule when initiating disease-modifying treatment* Administer 500mg of paracetamol or Ibuprofen 400mg half-hour before injection and repeat every 4­6 hours or PRN Although it is not used extensively is most countries, some centres may consider the administration of prednisolone 10mg with each injection for the first month of treatment, to reduce side-effects

*Dose escalation should be dependent on the patient's tolerance to therapy. One example of a titration schedule used in some European countries is 20% of the recommended dose for the first 2 weeks of therapy, 50% of the recommended dose for the next 2 weeks of therapy, and 100% of the recommended dose for subsequent treatments. However, this will be dependant on the individual centre / prescriber.

NSAID and/or paracetamol schedules may vary from centre to centre.

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International MS Nursing Care Plan If flu-like symptoms continue, consider the following: Changing time of dose so that peak analgesic effects of paracetamol occur at peak times of side effects Changing time of dose so that peak times of side effects occur during sleep Administering non-steroidal anti-inflammatory drugs (NSAIDs) with or without paracetamol For the occasional patient who is refractory to either paracetamol or NSAID prophylaxis, consider the following: Decreasing IFN dose to 25 50% of usual dose for 3 4 weeks to minimise side effects, then gradually increasing dose (as tolerated) to the recommended level Administering 5­10 mg of oral prednisone on the day of injection for the first 1­2 months of therapy Both these options are at discretion of prescriber. Desired Patient Outcomes Experiences minimal flu-like symptoms Identifies need for analgesics and determines the dosage needed Times medication appropriately to minimise symptoms Describes side effects associated with drug treatment and can intervene appropriately Respects dosage schedules developed to minimise symptoms Understands that flu-like symptoms may last from 3­6 months after the initiation of therapy

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International MS Nursing Care Plan Country-specific issues regarding the management of flu-like symptoms are shown in Table 9. Table 9. Country-specific issues regarding the management of flu-like symptoms.

Country Ireland Issue(s) Home-care nurses offer patients a support system; these nurses liaise with the MS nurse, who then follows up with the patient should any problems arise. Titration schedules vary from centre to centre. Treatment-related side effects are managed by the consultant neurologist, not the MS nurse. Titration schedules plus analgesics commonly used for the management of flu-like symptoms. Titration schedules vary from centre to centre. Analgesics are administered 3-4 days prior to treatment initiation to help prevent side effects. Side effects are perceived to be worse with IFN than with glatiramer acetate.

Norway Russia Spain United Kingdom

Spasticity

Description of Problem Spasticity or worsening of spasticity may occur upon initiation of therapy, particularly in patients with pronounced spasticity prior to therapy or those who are known to have temperature-sensitive symptoms. This drug-induced spasticity usually occurs 3 24 hours after IFN injection and may last for several hours or days (Munschauer and Kinkel 1997, Walther and Hohlfeld 1999). In some patients, discontinuation of treatment may be considered if spasticity is ongoing and problematic. The differential diagnosis of IFN -induced spasticity and spasticity associated with relapse or progression of MS is difficult. Therefore, it is important to evaluate spasticity pre-treatment and monitor changes during follow-up days (Munschauer and Kinkel 1997, Walther and Hohlfeld 1999).

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Interventions Assess whether other contributing factors may be causing spasticity and manage appropriately Refer patient for physiotherapy aimed at reducing Spasticity Temporarily reduce IFN dosage Administer NSAIDs or paracetamol* Administer or increase dosage of antispasticity medications (i.e., oral baclofen 10 20 mg every 4 6 hours or as needed, Tizanidine 2-4 mg. PRN) Consultant neurologist may consider switching patient to a different IFN . Desired Patient Outcomes Experiences reduction in drug-induced spasticity and improvement in function Avoids noxious stimuli that may cause spasticity Adheres to physiotherapy or other regimens for the treatment of spasticity

*In the United Kingdom, analgesics are administered 3-4 days prior to treatment initiation to help prevent side effects.

Laboratory-Test Abnormalities

Description of Problem The most commonly observed laboratory abnormalities in patients receiving IFN therapies are leukopenia, lymphopenia, neutropenia, and raised liver aminotransferase values (e.g., serum glutamic oxaloacetic transaminase [SGOT] and serum glutamic pyruvic transaminase [SGPT]). These abnormalities, however, seldom result in serious complications (Walther and Hohlfeld 1999, Lublin et al 1996). Interventions Obtain laboratory-test values, including urea and electrolytes (U&E's), a full blood count (FBC), thyrotropin (TSH) and liver-function test (LFT) values before initiation of therapy. Test also for monoclonal gammopathy due to risk of a capillary leak syndrome which is potentially fatal. See also the ABN Guidelines (2001) for recommendations for UK

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Assess vascular symptoms before initiation of therapy Monitor laboratory-test values including antibody titres at regular intervals after initiation of therapy and PRN*. See also the ABN Guidelines (2001) for recommendations for UK Prescriber may consider adjusting dosage or interrupting treatment if patient exhibits abnormal blood count, TSH or LFT values, or exhibits other acute and/or subacute toxicities (see Table 10 for tolerable laboratory-test values); In Appendix 3B WHO (World Health Organization) for grading liver-function tests, white blood cell counts and haemoglobin levels is given and recommendations for their management in IFN therapy. Although most laboratory-test abnormalities do not necessitate modification of IFN therapy, continued monitoring of laboratory-test values is recommended since longterm consequences of IFN therapy are unknown Monitor patient for signs of pathology (e.g., increased infection rate)

*Some clinics perform laboratory tests on day 1 of therapy, 1 month following the initiation of therapy, and every 3 months thereafter.

Desired Patient Outcomes Follows up with required blood testing Adheres to follow-up schedule and respects appointments Maintains an accurate diary of treatment events (e.g., symptoms experienced following injection, rotation of injection sites, etc.) Country-specific issues regarding laboratory testing in MS are shown in Table 11.

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International MS Nursing Care Plan Table 10. Proposed limits of tolerable laboratory values when using IFN therapy. Reproduced with permission from Walther et al 1999. Laboratory Test Value Blood count Haemoglobin (g/dL) >10 Leukocytes (g/L) >3.0 Granulocytes (G/L) >1.5 Lymphocytes (G/L) >1.0 Thrombocytes (G/L) >75 LFTs Total bilirubin (mg/dL) <2.5 times initial value Transaminases (SGOT, SGPT) <5 times initial value Alkaline phosphatase <5 times initial value Table 11. Country-specific issues regarding laboratory testing in MS.

Country Ireland Issue(s) Electrophoresis performed on blood samples to determine baseline levels of certain serum proteins such as gamma-protein.

Mood Alterations

Description of Problem The following symptoms of depression are frequent in patients with MS (Walther and Hohlfeld 1999): Changes in sleep patterns and/or diet Lack of interest in personal affairs/life A sense of hopelessness/helplessness Anxiety Hyperactivity It is unclear, however, whether IFN therapy itself causes depressive symptoms or whether these symptoms are due to poor adherence to therapy and/or an inability to cope with MS (Munschauer and Kinkel 1997, Walther and Hohlfeld 1999). In most countries, however, mood alterations are not perceived as drug-related side effects. Nevertheless, many clinicians prefer to start IFN therapy when the patient is, for the most part, emotionally stable or receiving effective treatment for depression.

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Interventions Evaluate and monitor baseline mood state and monitor changes in mood over time (including hyperactivity) Inform patient and family of depressive symptoms and their possible association with IFN therapy Refer patient for psychological or psychiatric treatment (if needed) Monitor patient for signs of suicidal intention Desired Patient Outcomes Patient reports mood changes Patient's support person, MS nurse and General Practitioner recognise and report any changes in the patient's mood Country-specific issues regarding the management of mood alterations are shown in Table 12. Table 12. Country-specific issues regarding the management of mood alterations.

Country France United Kingdom Issue(s) Depressed patients are switched to glatiramer acetate. Patients with mood disorders are started on glatiramer acetate rather than IFN . Patients are screened for depression and treated for the symptomatic problem prior to or during disease modifying therapy.

United States/Canada

Insomnia

Description of Problem Insomnia may occur upon initiation of therapy and may continue indefinitely (Munschauer and Kinkel 1997).

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Interventions Assess whether new symptom Time injections so that side effects are most pronounced during the deepest part of the sleep cycle or administer IFN therapy early in the day Instruct patient on methods of relaxation and meditation techniques Instruct patient to avoid stimulants before bedtime Instruct patient to consult General Practitioner / Consultant Neurologist regarding medications for the treatment of refractory sleep disturbances (e.g., sedatives, analgesics, and/or hypnotics) Desired Patient Outcomes Resumes normal sleeping patterns Adheres to injection schedule that supports normal/regular sleeping patterns Uses analgesics and sedatives appropriately

Systemic Reactions

Description of Problem Approximately 26% of patients with MS who received Copaxone® in the Copaxone® trials reported chest pains (Copaxone® product monograph). Other systemic reactions that may occur immediately following subcutaneous injection are: Flushing Palpitations Anxiety Dyspnea Constriction of the throat Urticaria However, these symptoms were invariably transient and self-limited and did not require specific treatment. These symptoms can occur with any injection, no matter how long the patient has been on treatment.

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Interventions Inform patient receiving Copaxone® of the possibility of immediate post-injection reactions Instruct patient to relax and sit upright in a comfortable chair (symptoms should improve within 15 minutes and be completely resolved within 1 hour) Instruct patient to contact local emergency department for further investigation if symptoms continue Desired Patient Outcomes Is aware of the possibility of immediate post-injection reactions (if receiving glatiramer acetate) and does not panic if these reactions occur Recognises symptoms and understands management strategies for post-injection reactions Country-specific issues regarding the management of systemic reactions are shown in Table 13. Table 13. Country-specific issues regarding the management of systemic reactions.

Country Czech Republic Denmark and Norway Switzerland Issue(s) Phased introduction of glatiramer acetate is used (i.e., initiation of quarter/half doses) to minimize systemic reactions. Patients are initiated on full doses of glatiramer acetate. Phased introduction of glatiramer acetate is used.

Other Side Effects

Other, less frequent side effects of IFN therapy may include: Menstrual disorders Weight change Alopecia Digestive disorders (e.g., diarrhoea and abdominal cramping) Hearing loss Cardiovascular complications (e.g., arrhythmias, palpitations, and shortness of breath)

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If these symptoms are severe or persist for several months after therapy has been initiated, refer the patient for evaluation and possible treatment. Full descriptions of other potential side effects are available in individual product monographs.

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References

Association of British Neurologists. Guidelines for the use of beta interferon and glatiramer acetate in multiple sclerosis [paper]; January 2001. Berlex Laboratories. Betaferon product monograph. Biogen/Idec. Avonex product monograph. Cumberbatch J, Bishop C. Critical pathway for assessment and treatment of Betaseron -induced necrosis [pamphlet]. 1999. Elgart GW, Sheremata W, Ahn YS. Cutaneous reactions to recombinant human interferon beta-1b: The clinical and histologic spectrum. J Am Acad Dermatol 1997;37:553-558. Feldmann R, Low-Weiser H, Duschet P, Gschnait F. Necrotizing cutaneous lesions caused by interferon beta injections in a patient with multiple sclerosis. Dermatology 1997;195:52-53. Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP et al and the Copolymer 1 Multiple Sclerosis Study Group. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: Results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology 1995;45:1268-1276. Knobler RL, Kelly CL, Tantras F, Webster GF, Lubin FD. Interferon beta-1b induced ulcerative skin lesions in MS [abstract]. J Neuroimmunol 1994;64:173. Lublin FD, Whitaker JN, Eidelman BH, Miller AE, Arnason BGW, Burks JS. Management of patients receiving interferon beta-1b for multiple sclerosis: Report of a consensus conference. Neurology 1996;46:12-18. Munschauer FE, Kinkel RP. Managing side effects of interferon-beta in patients with relapsing-remitting multiple sclerosis. Clin Ther 1997;19:883-893. PRISMS (Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised, double-blind, placebo-controlled study of interferon-1a in relapsing-remitting multiple sclerosis. Lancet 1998;352:1498-1504. TevaMarion Partners. Copaxone® product monograph. Walther EU, Hohlfeld R. Multiple sclerosis: Side effects of interferon beta therapy and their management. Neurology 1999;58:1622-1627. Weinberg JM, Wolfe JT, Sood S, Saruk M, Rook AH, Spiers EM. Cutaneous necrosis associated with recombinant interferon injection. Acta Derm Venereol (Stockh) 1997;77:146-148.

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Module 3: Patient Education and Promoting Adherence to Therapy

Introduction

Education on MS and the disease-modifying therapies empowers patients to take control of their disease. This sense of empowerment, in turn, increases the likelihood that patients will adhere to the therapeutic regimen. Adherence is best defined as the active, voluntary, and collaborative involvement of the patient in a mutually acceptable course of behaviour that results in a desired preventive or therapeutic outcome (Brooks 1985, Fischer et al 1999). Thus, the term adherence implies that the patient, nurse, and other healthcare professionals work together to develop the treatment regimen and ensure adherence to this regimen. It has recently been suggested that the term adherence be used to replace the term compliance when referring to therapy since many patients feel compliance is valueladen (i.e., implies that the patient is subordinate to the healthcare professional). (Brooks 1985) In this module, methods for providing effective patient education and strategies for promoting patient adherence to therapeutic regimens are discussed. Criteria for starting and stopping disease-modifying therapy are also presented.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply the psychoeducational approach to patient education List and apply strategies for effective patient education List barriers to adherence Describe the role of the nurse in promoting adherence to therapy Ensure patients set realistic expectations for therapy Reinforce the role of the multidisciplinary team involved in the management of patients with MS Evaluate patient learning Evaluate his/her own effectiveness as an educator

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Patient Education

Primary Goal of Education The primary goal of patient education is to empower patients (through knowledge) to take responsibility for managing their disease. In this way, the patient takes an active role in planning and implementing self-care and self-healing activities. Psychoeducational Approach to Patient Education MS centres throughout North America currently use a psychoeducational approach to patient education. Psychoeducation is a complex educational process that has been found to be effective in promoting adherence to medication regimens and treatment protocols. (Marciniak at al 1991) Unlike the traditional learning model that sets educational objectives according to predetermined learning material, the psychoeducation model requires that patients and their families become actively involved in setting the goals and objectives of education as well as the educational process itself (see Table 14). Table 14. Comparison of the psychoeducational and traditional learning models. Adapted with permission from Marciniak et al 1991.

Learning Model Psychoeducation Initiation Goals and objectives Type of instruction

Learner's perspective is determined before teaching is initiated Established with assistance from the patient Take into account patient's expectations for therapy Dynamic and individualised Reinforced with additional learning materials and hands-on activities

Traditional Learning

Teaching is initiated based on material to be learned Pre-determined by learning material to be covered throughout the course of instruction Standardised May include other learning activities such as additional materials and hands-on activities

Using the psychoeducation model, nurses can respond to each patient's individual needs and concerns regarding the complex injection protocol of the disease-modifying therapies. Furthermore, the model allows for continual assessment of patients' understanding of anticipated side effects and their skill development in the injection process. (Halper and Holland 1997) Strategies for effective patient education using the psychoeducation model are shown in Table 15.

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International MS Nursing Care Plan Table 15. Strategies for effective patient education.

Strategy Provide information in a clear and concise manner Rationale Increased understanding of information by patient helps reduce patient anxiety regarding therapy

Provide a non-distracting, relaxing, and comfortable learning environment

Minimises distractions during learning process Increased understanding of information by patient helps reduce patient anxiety regarding therapy Minimises fears associated with the disease and selfinjection of therapy Helps identify barriers to adherence and thereby facilitates the learning process

Use a variety of educational tools (e.g., oral and written information, videocassettes, practice vials and syringes, and one-on-one demonstrations)

Patients with MS often have some degree of cognitive impairment; therefore, instruction often needs to be repeated Patients experiencing stress or fear regarding MS or injection therapy may forget even the simplest verbal instructions (Kolton and Piccolo 1988); therefore, provide learning material in a variety of media to complement verbal instructions Reinforcement of efforts made will increase patients' sense of control over their disease and promote adherence to the treatment plan Ongoing communication and reinforcement of treatment outcomes reduce unrealistic expectations of being completely exacerbation-free during treatment (Sibley 1996)

Provide patients with reinforcement and acknowledge success

Involve family members in the teaching process

Involvement of family members in patient education has been shown to minimise patients' fears regarding therapy, reinforce learning, and promote adherence to therapy (Sibley 1996)

Note: Type and delivery of patient education varies from country to country and depends on the policies of the specific hospital/clinic/centre as well as the local services available.

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International MS Nursing Care Plan Specific Instructions Since the disease-modifying agents are currently only available in injectable form, the introduction of these therapies requires extensive patient and family education on the following: Drug handling and reconstitution (see individual product monographs) Appropriate self-injection technique Site selection and rotation (see Figures 1 and 2 in Module 2 of this chapter) Monitoring of side effects (see Module 2 of this chapter) Use of contraception during therapy (when applicable) An important first step in this educational process is to establish whether the patient, the nurse, or the patient's caregiver will give the first injection. Ideally, patients should perform the first injection themselves with the assistance of the nurse. It is also important that patients understand the need to administer the drug as directed, especially during the titration period, and that any changes from this dosing can result in either an overdose or treatment inefficacy. Once full dose is achieved, ensure the full dose is taken as prescribed. Furthermore, all patients must be taught a safe, sterile self-injection technique. Appropriate site selection and rotation help to prevent erythema and possible necrosis at the injection site. Demonstration kits are provided by manufacturers of diseasemodifying therapies in order to help facilitate injection-technique instruction. The nurse should regularly review injection techniques and site selection/rotation throughout the initiation of therapy. On-going monitoring and support should be carried out to ensure compliance continues. Educational Materials Use local, unbiased patient-education tools when educating patients. If required, nurses should modify these educational tools so they are appropriate for the individual patient. Timing of Education Although patient education has been shown to promote adherence to therapy, education will only be successful if the learner is motivated and ready to learn. Thus, it is important to time education to the individual patient's needs. The MS nurse must continually assess and monitor the patient's requirements and ability to take in information. Desired Outcomes of Patient Education The desired patient outcomes of education are as follows: Describes rationale of therapy Correctly administers medication Sets expectations for therapy that fit with the known efficacy of disease-modifying agents

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International MS Nursing Care Plan Describes the possible side effects of therapy and manages these side effects appropriately Identifies injection sites and discusses the importance of site rotation Identifies and uses resources for further information Demonstrates proper storage and handling of medication Importance of Evaluating Patient Education Patient education is an integral part of the job of the MS nurse. However, a recent survey of 35 Finnish MS nurses found that unstructured approaches were most commonly used when teaching patients and when evaluating the outcomes of education. Without structured tests or evaluations, it is difficult to assess the outcomes of patient education. Furthermore, structured tests allow nurses to report more systematically on their work and their assessment methods. (Leino-Kilpi and Luoto 2001) The survey also found that patient self-evaluation was rare. However, in order to empower patients to take control of their disease, they should be taught to evaluate their learning. Therefore, MS nurses should continually evaluate patient learning as well as their own effectiveness as educators. See Appendix 3C for a tool that nurses can use to evaluate the outcomes of patient education.

Promoting Adherence to Therapy

Barriers to Adherence The following may act as barriers to patient adherence to disease-modifying therapy (Denis 1999): Perceived low value of treatment Lack of information on therapies and misconceptions regarding these therapies Number and frequency of drugs currently being taken by the patient Patient's perception of MS (e.g., patient is in denial) Cognitive deficits (e.g., memory and judgement problems) Temporary worsening of MS symptoms after therapy has been initiated Drug administration challenges and/or fears of self-injection Difficulty coping with transient flu-like symptoms and other side effects of IFN therapy Social situations and/or cultural beliefs that are incongruent with therapy regimen Financial concerns Role of the Nurse in Promoting Adherence to Therapy Since nurses are the main healthcare professionals to have day-to-day contact with patients, they play a pivotal role in promoting patient adherence to therapy. In fact, the active involvement of nurses in the overall management of patients with MS has been shown to increase patient adherence to MS-treatment regimens. (Collingworth et al 1997)

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International MS Nursing Care Plan The role of nurses in promoting adherence includes (Denis 1999): Establishing a trusting nurse-patient relationship Educating patients about MS and the therapies available for treatment of the disease, in collaboration with the neurologist Ensuring that patients set realistic expectations for treatment outcomes Reinforcing the role of the multidisciplinary team involved in the care of patients with MS Assisting patients in establishing a network of resources (e.g., for advice, information, support) Performing continuous patient follow-up and monitoring (e.g., every week for the first month of titration every month following the first month every 3 months for the first year every year; other centres may monitor the patient at 1, 3, and 6 months following the initiation of therapy and then every 6 months thereafter if the patient's medical examinations are normal) Establishing Nurse-Patient Relationships Before the nurse can ensure that patients adhere to therapy, patients must be confident in the nurse's abilities and professionalism. Establishing patient confidence should begin during the patient's first visit to the clinic or hospital; it requires that the nurse takes time to empathise with the patient and his/her family and that the patient feels a sense of unbiased support from the nurse. Patient Education See Patient Education section earlier in this module. Ensuring Realistic Expectations For Therapy It is important for nurses to assess patients' knowledge of MS and their expectations for treatment outcomes before therapy begins. Nurses should ensure that patients have realistic expectations of the effect of treatment since symptoms and exacerbations will continue. Furthermore, it should be made clear to patients that the aim of IFN or glatiramer acetate treatment is to reduce the number and severity of attacks and slow the progression of MS. Nurses should also ensure that patients realise that IFN treatments: and glatiramer acetate

Are not cures for MS Do not completely eliminate MS symptoms Do not reverse existing damage to the central nervous system Do not completely eliminate future disease activity Are to be taken on an indefinite basis Must be worked into individual lifestyles May impose financial burdens on patients and their families*

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International MS Nursing Care Plan Reinforcing the Role of the Multidisciplinary Team Since nurses usually have day-to-day contact with patients, they often must act as liaisons between patients and other members of the multidisciplinary team involved in the care of patients with MS (i.e., neurologist, family physician, physiotherapist, etc.). Therefore, in order to maintain patient trust in the healthcare team's competence and commitment to the course of treatment, nurses should ensure that all team members provide patients with consistent, reliable information. Establishing a Network of Resources Another important role of MS nurses is to inform patients and their families of clinic, community, and company-funded patient support programmes (if the patient is in financial need) since these programmes provide comfort and also serve as mediums for the exchange of information and release of emotions. Support programmes have also been shown to promote patient adherence to therapy. (Madonna and Keating 1999) Follow-up and Monitoring Follow-up and monitoring of the patient should include: Regular telephone contact Neurological follow-up (e.g., annual examination and MRI) Follow-up with patient support programmes (if necessary) Re-evaluation of the patient's treatment expectations Review of the goals and objectives of therapy Direct patient questioning and review of pharmacy records to determine patient adherence to therapy (if necessary) Informing all team members if a particular patient is at high risk of non-adherence or has actually been non-adherent Continually assessing patient and family adjustment to the disease Desired Outcomes of Adherence The desired patient outcomes of adherence to therapy include: Able to control disease Feels a sense of control over MS Improved quality of life (for both patient and family) Decrease in the number of complications associated with the disease Decrease in the number of hospital admissions

*Financial burden imposed by MS not only varies from patient to patient, but also from country to country.

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International MS Nursing Care Plan Table 16. Country-specific issues regarding the MS nurse's role in patient education, promoting adherence to therapy, and follow-up.

Country Ireland Issue(s) Pharmaceutical-company sponsored homecare nurses play and important role in the education of patients with MS. These homecare nurses are responsible for initiating therapy. Local policies vary with regards to the delegation of tasks related to patient education, promoting adherence to therapy and follow-up. MS Centers nurses, home care nurses and industry supported nurses play a substantial role in initiating and sustaining treatments.

United Kingdom United States/Canada

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References

Brooks NA. Opportunities for health promotion including the chronically ill and disabled. Soc Sci Med 1985;19. Collingworth S, Gould D, Wainwright SP. Patient self-administration of medication: A review of the literature. Int J Nurs Stud 1997;34:256-269. Denis L. Promoting adherence to therapeutic regimens in multiple sclerosis. Presentation made at the Ottawa Hospital, General Campus. Ottawa (ON); November 1999. Fischer J, Miller D, LaRocca N (eds). Multiple sclerosis: Key issues in nursing management. Columbia (MD): Medicalliance, Inc.; 1999. Halper J, Holland N. Comprehensive nursing care in multiple sclerosis. New York: Demos Vermande; 1997. Kolton KA, Piccolo P. Patient compliance: A challenge in practice. Nurse Pract 1988;12:37-50. Leino-Kilpi H, Luoto E. The multiple sclerosis nurse as patient educator. J Neurosci Nurs 2001;33:83-89. Madonna MG, Keating MM. Multiple sclerosis pathways: An innovative nursing role in disease management. J Neurosci Nurs 1999;31:332-335. Marciniak M, Johnson B, Foley FW, Halper, J et al. The use of the Levo chair in the management of multiple sclerosis. Presentation made at the Consortium of Multiple Sclerosis Centres Conference; Halifax (NS); June 15­17, 1991. Sibley WA. Therapeutic claims in multiple sclerosis. New York: Demos Vermande; 1996.

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Progress Check

1. Answer true or false to each of the following statements. a. The most current immunoregulators work by inhibiting cell division and proliferation. True False b. Cyclosporine is licensed for use in MS. True c. The impact of IFN is not dose-related. True False False

2. _____________ is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. 3. _____________ is usually reserved for patients who have failed most of the other treatment options for MS or for those experiencing frequent relapses and rapid progression. 4. List five (5) ways in which interferons differ from conventional drugs. a. b. c. d. e. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

5. Name the four (4) large, multicentre, double-blind, placebo-controlled clinical trials that have been conducted with IFN in patients with RRMS. a. b. c. d. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

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6. Complete the table below.

Rebif Manufacturer Description IFN -1a 166 amino acid glycoprotein Avonex Biogen/Idec IFN -1b Purified, sterile, lyophilised protein product Betaferon Betaseron Copaxone Teva Neuroscience

Indications (as of Feb 2003)

RRMS

RRMS

Administration

Subcutaneous injection

Subcutaneous injection One 20-mg injection/day

Dosing

Packaging / Storage

Injection components supplied Reconstitution required Stored at room temperature(< 25º C)

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7. List five (5) possible risk factors for injection-site necrosis. a. b. c. d. e. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

8. List three (3) possible interventions for injection-site necrosis. a. __________________________________________________ b. __________________________________________________ c. __________________________________________________ 9. List five (5) possible interventions for spasticity. a. b. c. d. e. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

10. List four (4) of the most commonly observed laboratory abnormalities in patients receiving IFN therapy. a. b. c. d. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

11. List five (5) strategies for effective patient education. a. b. c. d. e. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

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12. Explain the difference between the traditional learning model and the psychoeducation model.

13. List seven (7) desired outcomes of patient education. a. b. c. d. e. f. g. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

14. List ten (10) barriers to patient adherence to therapy. a. b. c. d. e. f. g. h. i. j. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

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15. List seven (7) ways in which the MS nurse can help promote patient adherence to therapy. a. b. c. d. e. f. g. __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________

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Appendix 3A: Treatment Contract

Responsibilities and Stopping Criteria To be completed prior to, or upon the initiation of, treatment and filed in medical notes. Copies to be submitted to all parties.

Date: ___________________ Patient name: _____________ Starting date of treatment: ________ Consultant neurologist:_______________ Treatment start date: ________________

I understand and accept my (other if patient is cognitively impaired) responsibilities with respect to this treatment, as per the attached responsibilities sheet. I understand and accept the stopping criteria for this treatment, as per the attached criteria for stopping therapy. _______________________________ ___________________ Client signature Date _______________________________ ___________________ Consultant signature Date _______________________________ ___________________ MS nurse signature Date

Reproduced with permission from Bernadette Porter Clinical Nurse Specialist ­ MS London, United Kingdom

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Your Responsibilities When Treated with Beta-Interferon

As a person using beta-interferon, as prescribed through this betainterferon clinic, you are responsible for the following: Administration of the drug as prescribed using correct technique (if you choose to self-administer) Knowing how to contact the hospital support team Reporting any side effects to your general practitioner (GP), nursing support team, and consultant neurologist Attendance at clinic, as requested, for follow-up and review Monitoring of drug supply and ensuring adequate supply over holiday periods Requesting repeat prescriptions in adequate time Safe storage and transportation of drug under recommended conditions Informing the team if the drug is stopped for any reason

Reproduced with permission from Bernadette Porter Clinical Nurse Specialist ­ MS London, United Kingdom

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Stopping Criteria

Beta-interferon therapy should NOT be discontinued unless: Your side effects are intolerable You are planning a pregnancy You have experienced two (2) disabling relapses (as defined by the consultant neurologist) in a 12-month period You have secondary progression with an increase in disability observable over 6 months You have lost your ability to walk, with or without assistance, and this has been persistent for at least 6 months

Reference Association of British Neurologists. Guidelines for the use of beta interferon and glatiramer acetate in multiple sclerosis [paper]; January 2001.

Reproduced with permission from Bernadette Porter Clinical Nurse Specialist ­ MS London, United Kingdom

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Appendix 3B: WHO Guidelines for Grading LFTs, WBC Counts and Haemoglobin Levels and Recommendations for Management in Interferon Beta Therapy

WHO Grading of Liver Function Tests and Recommendations for Management

Marker Level WHO Gradings Grade 0 Grade I Grade II ALT, AST, GGT and alkaline phosphatase > ULN - 2.5 times ULN 2.6 - 5 times ULN Bilirubin Recommended Management Continue treatment but monitor regularly. Continue treatment but monitor regularly. If Grade II persists, the dose should be reduced (halved) until the LFTs have returned to Grade 0 or 1; the full dose may then recommence at clinical discretion. Interrupt treatment (or reduce/halve dose) until the LFTs have returned to Grade 0 to I; recommence treatment at half dose and increase to full dose at clinical discretion. Interrupt treatment until the LFTs have returned to Grade 0 or I and recommence treatment giving only half dose (ie., do not increase to full dose). Interrupt treatment.

> ULN - 1.5 times ULN 1.6 - 3 times ULN

Grade III

5.1 - 20 times ULN

3.1 - 10 times ULN

Grade IV

> 20 times ULN

> 10 times ULN

Grade V

ALT = alanine transaminase; AST = aspartate transaminase; GGT = -glutamyl transferase; ULN = upper limit of normal

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WHO Grading of Haemoglobin and Recommendations for Management

WHO Grading Grade 0 Grade I Haemoglobin < LLN - 10.0 g/dL < LLN - 100 g/L < LLN - 6.2 mmol/L 8.0 - < 10.0 g/dL 80 - < 100 g/L 4.9 - < 6.2 mmol/L 6.5 - < 8.0 g/dL 65 - < 100 g/L 4.0 - < 4.9 mmol/L < 6.5 g/dL 65 - g/L < 4.0 mmol/L Recommended Management Continue treatment but monitor regularly.

Grade II

Grade III

Grade IV

Grade V

Continue treatment but monitor regularly. If Grade II persists, the dose should be reduced (halved) until haemoglobin levels have returned to Grade 0 or I; the full dose may then recommence at clinical discretion. Interrupt treatment (or reduce/halve dose) until the haemoglobin levels have returned to Grade 0 to I; recommence treatment at half dose and increase to full dose at clinical discretion. Interrupt treatment until haemoglobin levels have returned to Grade O to I and recommence treatment giving only half dose (i.e., do not increase to full dose). Interrupt treatment.

WHO Grading of White Blood Cell Counts and Recommendations for Management

WHO Grading Grade 0 Grade I Grade II White Blood Cell Count (normal level) > 4 3.0 ­ 3.9 2.0 ­ 2.9 Recommended Management Continue treatment but monitor regularly. Continue treatment but monitor regularly. If Grade II persists, the dose should be reduced (halved) until the WBCs have returned to Grade 0 or I; the full dose may then recommence at clinical discretion. Interrupt treatment (or reduce/halve dose) until the WBCs have returned to Grade 0 to I; recommence treatment at half dose and increase to full dose at clinical discretion. Interrupt treatment until WBCs have returned to Grade O to I and recommence treatment giving only half dose (i.e., do not increase to full dose). Interrupt treatment.

Grade III

1.0 ­ 1.9

Grade IV Grade V

< 1.0

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Appendix 3C: Patient Test After Starting Beta-Interferon Treatment

Date: _______/______ 200___ Patient name: _________________________ Date of birth: ___________________ The drug in use (beta-interferon): ________________Dose: _________________ When did you start the medication? _______________

1. What is the mechanism of action of beta-interferons? a) ________________________________________________________________ b) ________________________________________________________________ c) ________________________________________________________________ 2. List the most common side effects associated with beta-interferon use. a) ________________________________________________________________ b) ________________________________________________________________ c) ________________________________________________________________ d) ________________________________________________________________ e) ________________________________________________________________ 3. How do you treat or possibly prevent side effects? a) ________________________________________________________________ b) ________________________________________________________________ c) ________________________________________________________________

Äikää/Salo 29.9.99 Neurological Out-Patient Clinic The South Carelian Central Hospital, Finland

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International MS Nursing Care Plan 4. What would you do if you forgot to inject one day? a) ________________________________________________________________ b) ________________________________________________________________ c) ________________________________________________________________ 5. Where do you store your beta-interferon? ___________________________________________________________________ 6. Are there any special controls (i.e., blood tests, assessments, and/or monitoring that you need on a regular basis) that you need when using betainterferon. If yes, how often do you need these controls? a) ________________________________________________________________ b) ________________________________________________________________ c) ________________________________________________________________ 7. How often do you inject?_____________________________________________ 8. Mark the injection sites

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International MS Nursing Care Plan The answers to the following questions will be used to help us evaluate our educational skills and the teaching process as a whole. Please draw an X at the appropriate place on the line. 9. Did you get enough information about the beta-interferon treatment before you started using it? ________________________________________________ not at all yes, excellent 10. Wash teaching comprehensive? ________________________________________________ not at al l yes, excellent What do you think about the following? 11. The nurse's educational skills ________________________________________________ bad very good 12. The information you received about mechanisms of action ________________________________________________ insufficient very complete 13. The information you received about side effects ________________________________________________ insufficient very complete 14. The information you received about how to deal with possible side effects ________________________________________________ insufficient very complete

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15. What is your opinion of the room facilities (privacy, no disturbing sounds, presence of other people, etc.)? ________________________________________________ bad very good 16. What do you think about the information you received concerning practical issues (where to get the drug, how to store the drug, disposing of needles, regular follow-up visits, etc.)? ________________________________________________ insufficient very complete 17. How easy has it been to contact a nurse or other health-care professional when you have had problems? ________________________________________________ very difficult very easy 18. Do you have any other concerns, comments, or questions regarding the treatment and/or the teaching process as a whole?

Thank you for completing this questionnaire!

Äikää/Salo 29.9.99 Neurological Out-Patient Clinic The South Carelian Central Hospital, Finland

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Chapter 4: Management of MS-Related Symptoms

Introduction

The complaints and symptoms most commonly associated with multiple sclerosis (MS) are: 1. 2. 3. 4. 5. 6. Fatigue Bladder and bowel dysfunctions Pain Spasticity Tremor and alterations in mobility Speech and swallowing difficulties

In this chapter, protocols for the assessment and management of these symptoms are described. The desired outcomes of treatment interventions for these symptoms are also discussed.

Chapter Overview

This chapter contains the following eight modules: Module 1: Fatigue Module 2: Bladder Dysfunction Module 3: Bowel Dysfunction Module 4: Pain Module 5: Spasticity Module 6: Tremor Module 7: Altered Mobility Module 8: Speech and Swallowing Difficulties At the end of the chapter, please find a section entitled Progress Check; this section tests your knowledge of the information presented in the chapter.

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Module 1: Fatigue

Introduction

Patients with MS rank fatigue as one of the MS-related symptoms that most impairs their quality of life (QOL). Fatigue is considered a chronic condition that can be accompanied by neurological exacerbations or no change in neurological symptoms. Fatigue in MS is often characterised as either focal-muscle fatigability or a generalised sense of lassitude. The aetiology of MS-related fatigue is not well understood; however, default conduction of the demyelinated fibres and the presence of circulating cytokines in serum and cerebrospinal fluid may be contributing factors. Furthermore, many MSrelated symptoms may contribute to fatigue, including depression, pain, insomnia, or mobility impairment. Therefore, before appropriate treatment can be administered, the origin of fatigue should be determined. (van den Noort and Holland 1999; CoulthardMorris and Vollmer 1995; Fisk et al 1994; Krupp et al 1989; Multiple Sclerosis Council for Clinical Practice Guidelines 1998; Vercoulen et al 1996). In this module, protocols for assessing fatigue are presented. Interventions for managing fatigue and desired treatment outcomes are also discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of fatigue Implement interventions for the management of fatigue Describe the desired outcomes of fatigue interventions

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Assessment Determine the nature of fatigue Determine if fatigue is a new symptom Determine if symptoms of fatigue are continuous or intermittent Identify possible contributing factors, such as: Relapse Medications Sleep disturbances Depression Concurrent illness (e.g., infection) Level of activity Heat Lifestyle patterns - Diet - Exercise/deconditioning Psychosocial issues Pain Effortful movement Spasticity Ataxia Assess the severity of fatigue by: Administering fatigue measurement scales (see Modified Fatigue Impact Scale [MFIS]* in Appendix 4A: The Multiple Sclerosis Quality of Life Inventory [MSQLI]) or referring patient for fatigue assessment using measurement scales Determining its effect on daily activities Asking patient to complete a fatigue-management diary

*The MFIS is not used in all countries.

Determine the impact of fatigue on other MS-related symptoms Identify existing management strategies and coping behaviours Non-Pharmacological Interventions Promote patient understanding of MS-related fatigue Implement energy-conservation strategies through adaptations to home and work environments

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International MS Nursing Care Plan Encourage appropriate lifestyle modifications with regards to: Nutrition and fluid balance Sleep patterns Activity and rest patterns Temperature control a. Cooling techniques b. Environmental temperature control (e.g., air conditioning) c. Avoiding temperature extremes Refer patient to an occupational therapist for: d. Fatigue-management programme e. Assistive devices at work and at home Refer patient to a physiotherapist for: f. Personal fitness programme to increase stamina g. Assistive devices Inform patient of the following therapies that may contribute to fatigue as well as their side-effect profiles: Antispasticity medications Anticonvulsants/antiepileptics Antidepressants Certain alternative medicines (e.g., chamomile, ginseng, and sage) Provide ongoing evaluation of fatigue-management strategies

Note: Refer to Multiple Sclerosis Council Clinical Practice Guidelines. Fatigue and multiple sclerosis. Evidenced-based management strategies for fatigue in multiple sclerosis. Paralyzed Veterans of America; 1998 or refer to www.pva.org .

Pharmacological Interventions Modify fatigue-contributing medication regimens Inform patient of pharmacologic treatment options as well as their side-effect profiles (see Appendix 4B: Pharmacologic Treatment Options for MS-Related Fatigue).

Agents listed in Appendix 4B may not be available and/or may not be extensively used in all countries.

Desired Patient Outcome Demonstrates improved performance on daily activities in the home and at work, as determined by: Patient self-report Fatigue measurement scales (see the MFIS in Appendix 4A: MSQLI)

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Country specific-issues regarding the assessment and management of patients with MS-related fatigue are shown in Table 1. Table 1. Country-specific issues regarding the assessment and management of patients with MS-related fatigue.

Country Czech Republic Issue(s) Rehabilitation management strategies such as physiotherapy are used. Intramuscular Ig is also used for the management of fatigue. No specific approaches used for the assessment/management of fatigue. The most frequently used pharmacological treatments are modafinil and amantadine. The MS nurse manages fatigue as well as all other MS-related symptoms or the patient is referred to a designated consultant. No benefits are provided and, therefore, patients with MS-related fatigue must continue to work. Patient education on the importance of rest and limiting activities is provided. Commonly used pharmacological treatments include modafinil and amantadine. Pharmacological treatments most frequently prescribed by neurologists include: amantadine, fluoxetine, paroxetine and modafinil. Modafinil and amantadine are used most frequently; however, modafinil is more costly. Exercise is an important component of management. Therefore, an occupational therapist is also involved in the management of MSrelated fatigue. The most commonly used pharmacological treatments are fluoxetine, amantadine, and modafinil; however, modafinil is not licensed for the treatment of fatigue in the United Kingdom. The most frequently used pharmacological treatments are modafinil and amantadine.

Denmark and Norway France Greece and Germany Portugal Saudi Arabia

Spain Switzerland United Kingdom

United States

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References

Coulthard-Morris L, Vollmer T. Multiple sclerosis fatigue: Classification and treatment options. Mult Sclerosis Clin Issues 1995;2:2-6. Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ. The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci 1994;21:9-14. Krupp LB, LaRocca NG, Scheinberg AD. The fatigue severity scale: Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989;46:1121-1123. Multiple Sclerosis Council for Clinical Practice Guidelines. Fatigue and multiple sclerosis: Evidence-based management strategies for fatigue in multiple sclerosis. Paralyzed Veterans of America; 1998. van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.; 1999. Vercoulen JH, Hommes OR, Swanink CM, Jongen PJ, Fennis JF, Galama JM, et al. The measurement of fatigue in patients with multiple sclerosis: A multidimensional comparison of patients with chronic fatigue syndrome and healthy subjects. Arch Neurol 1996;53:642-649.

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Module 2: Bladder Dysfunction

Introduction

Approximately 75­95% of patients with MS experience some type of bladder dysfunction during the course of their disease (Holland 1994). Two neural circuits are thought to control bladder function: the sacral spinal cord for storage and the pontine micturition centre for emptying. Any disruption in the pathways between these circuits may result in a dysfunction. (Blaivas 1980) The three types of bladder dysfunction most commonly associated with MS are (van den Noort and Holland 1999; Andrews and Husmann 1997; Holland 1994; Giannantoni et al 1998): Failure to store Failure to empty Combination failure to store and failure to empty Failure to store (detrusor hyperreflexia) is the most common type of bladder dysfunction in MS, with reported incidences ranging from 26­50%. Failure to store occurs when the bladder is unable to accommodate increasing urine volumes, causing spontaneous contractions within the bladder. Symptoms of this dysfunction include urgency, frequency, and urge. Failure to empty is less common (i.e., incidence=19­40%) but can result in more serious complications than failure to store. It may be caused by one or more of the following: An atonic bladder Detrusor hyperreflexia with poorly sustained contractions Detrusor-sphincter dyssynergia Symptoms of failure to empty include retention, overflow incontinence, and urinary tract infections. Patients will characteristically have a post residual volume of urine of 100 mls or more. Combination failure to store and failure to empty occurs in 24­46% of patients with bladder dysfunction and MS. This condition is often associated with detrusor-sphincter dyssynergia and the only real way to diagnose it is by using Urodynamics. The post residual volume of urine is variable. Symptoms of this type of bladder dysfunction include those associated with both failure to store and failure to empty.

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In this module, protocols for assessing bladder dysfunction are presented. Interventions for managing bladder problems and desired treatment outcomes are also discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of bladder dysfunction Implement interventions for the management of the three main types of bladder dysfunction Describe the desired outcomes of treatment interventions for bladder dysfunction

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Note: The extent to which the MS nurse is involved in the assessment and management of bladder dysfunction varies from country to country. In some countries, patients are referred immediately to continence advisors once the problem has been identified.

Assessment Determine the nature of the bladder problem (see Appendix 4C: Foothills Hospital [Calgary, Alberta, Canada] Nursing Assessment Form and Appendix 4D: Diagnosis of Bladder Dysfunction) Describe symptoms - Frequency (incidence=82%) - Urgency (incidence=85%) - Hesitancy - Burning and discomfort - Incontinence - Incidence of urinary tract infections - Retention - Nocturia Determine onset and duration of symptoms Categorise bladder dysfunction into one of the following categories according to presenting symptoms: Failure to store (i.e., presenting symptoms include frequency, urgency, and incontinence) Failure to empty (i.e., presenting symptoms include hesitancy, dribbling and leaking, retention, and sensations of incomplete emptying) Combination failure to store and failure to empty (i.e., presenting symptoms include a combination of the above-mentioned symptoms) Identify possible contributing factors, such as: Concurrent medical conditions (e.g., urinary tract infection, other infections) Medications Reduced mobility Poor cognition Reduced dexterity Spasticity Ataxia and/or tremor Nutrition and fluid intake (especially if the patient has a high caffeine intake) Lifestyle issues

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Assess the impact of the bladder dysfunction on the following aspects of daily living: Sexual activity Recreation/social activities Employment Quality of Life Carer strain Assess for the presence of the following secondary complications: Infection Skin breakdown Determine the impact of the dysfunction on other MS-related symptoms Assess cognitive function Assess the severity of the dysfunction by administering quality-of-life scales (see Bladder Control Scale in Appendix 4A: The MSQLI) Identify existing management strategies and coping behaviours

Note: It is important to take the time to listen to and communicate fully with the patient regarding his/her concerns about bladder dysfunction.

Interventions Follow algorithm for the management of bladder dysfunction (see Figure 1 or Appendix 4E: Algorithm for the Management of Bladder Dysfunction from the National Multiple Sclerose Centrum in Melsbroek, Belgium). Rule out urinary tract infection (UTI) through: Urinalysis Urine culture

Note: A UTI can lead to significant complications, particularly in persons with MS. Many patients with a UTI are asymptomatic and, therefore, may not be aware of the infection. It is important to educate patients on the frequency of UTIs and how to recognise symptoms of infection. Also, some studies have shown that cranberry juice is effective in the treatment of UTIs. (Avorn et al 1994; Walker et al 1997; Lee et al 2000; Zafriri et al 1989). However, cranberry juice is not recommended for patients taking antibiotics.

Instruct patient to keep a bladder diary to record both intake of fluid and the amount of urine passed as well as the frequency.

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International MS Nursing Care Plan If necessary refer the patient to the Continence Advisor for their assessment. She/he may recommend intermittent self catheterisation. At some MS Clinics, nurses will perform a bladder ultra sound (a postvoid residual of more than 100mls is considered significant and may suggest a patient needs education on how to empty their bladder). Educate the patient on the role of medications and intermittent catheterisation in controlling symptoms. Consider bladder stimulators, e.g., Queens Square Bladder Stimulator. Educate patient about factors that may influence symptoms, such as: Caffeine Drinking sufficient liquids, e.g., 6 glasses of fluid daily Aspartine (a bladder irritant) Alcohol Infection Constipation Certain medications (e.g., antibiotics) Refer patient to a urologist if symptoms remain unmanageable or if complications develop or are suspected; possible treatments for severe cases include: Supra-pubic catheterisation Botulinum toxin (Botox®) injections Inform patient of pharmacological treatment options as well as their side-effect profiles (see Appendix 4F: Pharmacologic Treatment Options for Bladder Dysfunction in MS) Provide ongoing evaluation of management strategies for bladder dysfunction Desired Patient Outcomes Continence Prevention of complications Country-specific issues regarding the assessment and management of bladder dysfunction are shown in Tables 2 and 3.

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Figure 1. Algorithm for the management of bladder dysfunction. van den Noort et al 1999. Reproduced with permission from Demos Medical Publishing Company, New York.

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International MS Nursing Care Plan Table 2. Country-specific issues regarding the management of bladder dysfunction.

Country Belgium Issue(s) Unless the patient is being managed in a MS centre, bladder dysfunction is managed by the neurologist or through referral to a urologist. Continence advisors are available once the problem has been identified. Patient is referred to a urology clinic; some non-specialists are involved in the management of bladder dysfunction. A continence nurse works with the MS nurse to manage bladder dysfunction. MS nurses instruct patients on catheterisation and appropriate catheter care. Fluid balance charts are used. Bladder dysfunction is often managed by company-funded continence nurses. MS nurse manages bladder dysfunction as well as all other MSrelated symptoms or the patient is referred to a designated bladdermanagement consultant. Bladder dysfunction is taken care of by the MS nurse and nurses working with patients in their homes. There are only a few continence nurses in Norway. There are no continence specialists. Botulinum toxin (Botox®) injections are preformed by the urologist. Unless the patient is being managed in a MS centre, bladder dysfunction is managed by the neurologist or through referral to a urologist. Continence advisors are available once the problem has been identified. Specific interventions include training, pharmacological treatment and referral to a urologist for a urodynamic assessment. Bladder dysfunction is often managed by company-funded continence nurses. Urologists in the UK differ on their use of urodynamics. Some centres will advise that they are used others do not. The latter feel that an MS bladder can be assessed by clinical history and ultrasound and they do not require invasive investigations. NHS continence services work with the MS nurse; some urology referrals occur. Follow-up scans are preformed if the patient is on an anticholinergic agent.

Czech Republic Denmark Ireland

France Germany, Greece Norway Portugal Spain

Saudi Arabia Switzerland United Kingdom

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International MS Nursing Care Plan Table 3. The use of specific interventions for bladder dysfunction in various countries.

Intervention ISC Czech Republic France Portugal Spain Switzerland United Kingdom

ISC=intermittent self catheterization

S-P catheter

Indwelling catheter

Pelvic floor physiotherapy

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References

Andrews KL, Husmann DA. Bladder dysfunction and management in multiple sclerosis. Mayo Clin Proc 1997;72:1176-1183. Avorn J, Monane M, Gurwitz JH, Glynn RJ, Choodnovskiy I, Lipsitz LA. Reduction of bacteriuria and pyuria after ingestion of cranberry juice. JAMA 1994;271:751-754. Blaivas JG. Management of bladder dysfunction in multiple sclerosis. Neurology 1980;30:12-18. Giannantoni A, Scivoletto G, Di Stasi SM, Grasso MG, Vespasiani G, Castellano V. Urological dysfunction and upper urinary tract involvement in multiple sclerosis patients. Neurourol Urodyn 1998;17:89-98. Holland N. Bladder management in multiple sclerosis. MS Management 1994;1:7-11. Lee YL, Owens J, Thrupp L, Cesario TC. Does cranberry juice have antibacterial activity? JAMA 2000;283:1691. van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.; 1999. Walker EB, Barney DP, Mickelsen JN, Walton RJ, Mickelsen RA Jr. Cranberry concentrate: UTI prophylaxis. J Fam Pract 1997;45:167-168. Zafriri D, Ofek I, Adar R, Pocino M, Sharon N. Inhibitory activity of cranberry juice on adherence of type 1 and type P fimbriated Escherichia coli to eucaryotic cells. Antimicrob Agents Chemother 1989;33:92-98.

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Suggested Readings

Betts CD, D'Mellow MT, Fowler CJ. Urinary symptoms and the neurological features of bladder dysfunction in multiple sclerosis. J Neurol Neurosurg Psych 1993;56:245-250. Catanzaro M, O'Shaughnessy EJ, Clowers DC, Brooks G. Urinary bladder dysfunction as a remedial disability in multiple sclerosis: A sociologic perspective. Arch Phys Med Rehab 1982;63:472-474. Fowler CJ. Bladder dysfunction in multiple sclerosis: Causes and treatments. Int Mult Sclerosis J 1994;1:99-107. Fowler CJ, van Korrebroeck PE, Nordenbo A, Van Poppel H. Treatment of lower urinary tract dysfunction in patients with multiple sclerosis: Committee of the European Study Group of SUDIMS. J Neurol Neurosurg Psych 1992;55:986-989. Halper J, Holland N. Comprehensive nursing care in multiple sclerosis. New York: Demos Vermande; 1997. Holland NJ. Clinical bulletin: Bladder dysfunction in multiple sclerosis. National Multiple Sclerosis Society; 1998. Kotkin L, Milam DF. Evaluation and management of the urologic consequences of neurologic disease. Tech Urol 1996;2:210-219. Multiple Sclerosis Council for Clinical Practice Guidelines. Urinary dysfunction and multiple sclerosis: Evidence-based management strategies for fatigue in multiple sclerosis. Paralyzed Veterans of America; 1998. Perkash I. Long-term urologic management of the patient with spinal cord injury. Urol Clin North Am 1993;20:423-434. Thompson IM, Lauvetz R. Oxybutynin in bladder spasm, neurogenic bladder and enuresis. Urology 1976;8:452-454. Valiquette G, Herbert J, Meade-D'Alisara P. Desmopressin in the management of nocturia in patients with multiple sclerosis: A double-blind, crossover trial. Arch Neurol 1996;53:1270-1275. Warren JW. Catheter-associated urinary tract infections. Infect Dis Clin North Am 1997;11:609-622.

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Module 3: Bowel Dysfunction

Introduction

Like bladder dysfunction, bowel dysfunction is common among MS patients (i.e., prevalence approximately 68%). It should be noted that many individuals with bladder symptoms do not experience bowel problems. Furthermore, bowel dysfunction does not appear to be associated with the degree of disability. However, it is associated with the duration of MS. (Hinds et al 1990; Chia et al 1995; Fowler et al 1996; Clanet 1994) Neural control of defecation is not as well understood as that of micturation. However, it has been suggested that the pons controls defecation along with influence from spinal cord neural centres and other cortical centres. (Hinds et al 1990) The two main types of bowel dysfunction in MS are constipation and faecal incontinence. Constipation is defined as two or fewer bowel movements per week and/or the use of suppositories, laxatives, or enemas more than once per week to promote bowel movements. Constipation occurs in approximately 36­53% of MS patients. Factors that contribute to constipation include certain medications, weakened abdominal muscles, pubococcygeal spasticity, diet, and immobility. (Hinds et al 1990; Chia et al 1995, van den Noort 1999) Faecal incontinence is defined as the involuntary passage of stool. It occurs in about 25% of patients with MS once per week and 51% of patients less than once a month. Factors contributing to faecal incontinence include constipation that causes rectal distension and overflow, diminished rectal sensation, sphincter dysfunction, certain medications, and diet. (Hinds et al 1990; van den Noort 1999) Because of the private nature of issues surrounding bowel function, patients may be embarrassed to share their concerns in this area. However, MS management should always include an assessment of patients' bowel functioning from initial diagnosis onward. In this module, protocols for assessing bowel dysfunction are presented. Interventions for managing bowel dysfunction and desired treatment outcomes are also discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of bowel dysfunction Implement interventions for the management of constipation and faecal incontinence Describe the desired outcomes of treatment interventions for bowel dysfunction

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Note: The MS nurse is more likely to be involved in the assessment and management of bowel dysfunction than in bladder dysfunction. However, the extent to which the MS nurse is involved varies from country to country. In some countries, patients are referred immediately to designated bowel-management advisors once the problem has been identified.

Assessment Determine the nature of the bowel problem (see Appendix 4C: Foothills Hospital Nursing Assessment Form) Due to the private and sensitive nature of bowel function: - Provide open, non-judgmental atmosphere for discussion - Ensure privacy - Ask the patient's permission before moving on to an area of assessment - Begin with general questions and then move to more specific questions - Normalise and validate the patient's concerns (e.g., say "Many people experience this symptom.") - Provide reassurance Determine onset and duration of symptoms Describe symptoms: - Constipation - Diarrhoea - Incontinence - Flatulence - Bloating - Cramping - Rectal urgency Categorise bowel dysfunction into one of the following categories according to presenting symptoms: Constipation Faecal incontinence Identify possible contributing factors, such as: Concurrent medical conditions Medications Reduced mobility Altered nutrition and/or fluid intake Assess the impact of the bowel dysfunction on the following aspects of daily living: Sexual activity Recreation/social activities Employment

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International MS Nursing Care Plan Assess the severity of the dysfunction by administering quality-of-life scales (see Bowel Control Scale in Appendix 4A: The MSQLI) Assess for the presence of the following secondary complications: Haemorrhoids Impaction or bowel obstruction Infection Determine the impact of the problem on other MS-related symptoms Identify existing management strategies and coping behaviours Identify behaviours that may be contributing to the dysfunction General Interventions Educate patient about the causes of bowel dysfunction Adjust medication regimens that may be contributing to the bowel dysfunction Instruct patient to take advantage of the urge to defecate (this ensures regular emptying of the bowels) Educate patient about the gastrocolic reflex that occurs 20-30 minutes after a meal Educate patient on the use of anal plugs Establish a regular bowel routine individualised to the patient Assist patient in determining a regular time for bowel defecation Encourage dietary changes such as: High fibre intake Adequate fluid intake (1.5­2.0 L/day) Regular mealtimes Encourage regular physical activity, particularly in wheelchair users (e.g., specific yoga movements that promote bowel movements, etc.)

Note: All countries emphasize the importance of diet, fluids and exercise in the management of bowel dysfunction.

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Interventions Specific to Constipation Encourage regular and consistent mealtimes Instruct patient on correct positioning for adequate defecation Patient should bend forward and elevate knees so that they are higher than hips (a footstool may be required) Advise on the following sequential therapies (see Appendix 4G: Pharmacologic Treatment Options for Bowel Dysfunction in MS) Bulk-forming agents Stool softeners Therapies that may be used alone or in combination with bulk-forming agents or stool softeners Interventions Specific to Faecal Incontinence/Involuntary Bowel Movement Ensure adequate evacuation of bowels on a regular basis Rule out bowel infection using stool cultures Avoid unnecessary use of antibiotics Educate patient to: Avoid bowel irritants such as: - Alcohol - Caffeine - Spicy foods - Other identified dietary triggers Avoid unnecessary use of antibiotics Use medication(s) for control of this symptom (see Appendix Pharmacologic Treatment Options for Bowel Dysfunction in MS) Encourage patients to carry an "incontinence rescue kit" containing: Underwear Scented nappy bags Perfume spray Wet wipes Tissues Mirror Consider the use of anal plugs Recognise that anxiety and stress may play a role in this problem

4G:

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International MS Nursing Care Plan Provide ongoing evaluation of bowel dysfunction Desired Patient Outcomes Maintains bowel control as shown by: A regular elimination pattern Continence Prevention of complications Identifies and manages causes of bowel dysfunction Country-specific issues regarding the assessment and management of bowel dysfunction are shown in Table 4. Table 4. Country-specific issues regarding the assessment and management of bowel dysfunction in MS.

Country Belgium Greece and Germany Portugal United Kingdom Issue(s) MS nurse liaises with a stoma nurse for the management of bowel dysfunction. MS nurse manages bowel dysfunction as well as all other MS-related symptoms or the patient is referred to a designated consultant. Rehabilitation specialists are available for complicated cases. Most common general interventions include diet, exercise and high fluid intake. Norgine (Movicol®) is considered the best pharmacological treatment for constipation. Anal plugs may also be used for the management of faecal incontinence/involuntary bowel movements. Enemas used for the management of constipation.

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References

Chia YW, Fowler CJ, Kamm MA, Henry MM, Lemieux MC, Swash M. Prevalence of bowel dysfunction in patients with multiple sclerosis and bladder dysfunction. J Neurol 1995;242:105-108. Clanet M (chair). The symptoms of multiple sclerosis and their management. In: Proceedings of the MS Forum Modern Management Workshop; April 1992; Paris, France. Worthing UK: Professional Postgraduate Services Europe Ltd.; 1994. Fowler CJ, Henry MM. Gastrointestinal dysfunction in patients with multiple sclerosis. Semin Neurol 1996;16:277-279. Hinds JP, Eidelman BH, Wald A. Prevalence of bowel dysfunction in multiple sclerosis: A population survey. Gastroenterol 1990;98:1538-1542. van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.;1999.

Suggested Readings

Caruana BJ, Wald A, Hinds JP, Eidelman BH. Anorectal sensory and motor function in neurogenic faecal incontinence: Comparison between multiple sclerosis and diabetes mellitus. Gastroenterol 1991;100:465-470. Chia YW, Gill KP, Jameson JS, Forti AD, Henry MM, Swash M, et al. Paradoxical puborectalis contraction is a feature of constipation in patients with multiple sclerosis. J Neurol Neurosurg Psych 1996;60:31-35. Hinds JP, Wald A. Colonic and anorectal dysfunction associated with multiple sclerosis. Am J Gastroenterol 1989;84:587-95. Nordenbo AM, Andersen JR, Andersen JT. Disturbances of anorectal function in multiple sclerosis. J Neurol 1996;243:445-451.

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Module 4: Pain

Introduction

Pain is defined as an unpleasant sensory and emotional response to a condition caused by actual or potential tissue damage. Estimates of the prevalence of pain in MS vary from 10% to 80%, depending on the type of pain experienced. Most patients with MS experience chronic pain; acute pain syndromes occur in approximately 10% of patients. (van den Noort and Holland 1999; Clanet 1994; Archibald at al 1994; Moulin 1996; Moulin 1988; Moulin at al 1996) Objective assessments of pain are difficult to obtain since pain is a subjective experience that is not always directly related to the degree of injury experienced by the patient. Furthermore, emotional, cognitive, and behavioural responses, as well as psychosocial factors such as expectations, previous pain experiences, and secondary pain, all influence the pain experience. (Vaney 1996; Harden 1998) The cause of pain in MS depends on whether the pain syndrome is acute, subacute, or chronic. Acute pain is often characterised by paroxysmal attacks that are brief in duration (i.e., lasting seconds) and occur repeatedly. It results from abnormal axon conduction or a "short circuit" in axon conduction. That is, axonal changes from demyelination cause spontaneous electrical discharges that spread or jump to adjacent fibres (ephaptic transmission). If this impulse spreads to a sensory pathway, it may result in a painful sensation such as trigeminal neuralgia. Paroxysmal sensations can be provoked by touch, movement, or hyperventilation. Subacute pain may last days or even weeks. It is caused by demyelination (optic neuritis is the most common) or a secondary source, such as painful bladder spasms associated with a neurogenic bladder and infection or vertebral compression fractures resulting from frequent corticosteroid treatment or prolonged immobility. Chronic neuropathic or dysesthetic pain occurs in about one-third of patients with MS; it is believed to be directly related to the demyelination of sensory pathways, particularly those pathways involving the spinothalamic tracts and posterior columns. Chronic musculoskeletal pain, such as backaches and painful leg spasms, usually results from MS-related symptoms rather than the disease itself. In this module, protocols for assessing pain are presented. Interventions for managing pain and desired treatment outcomes are also discussed.

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Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of pain Implement interventions for the management of: 1. Acute pain 2. Subacute pain 3. Chronic neuropathic pain 4. Chronic musculoskeletal pain Describe the desired outcomes of treatment interventions for acute, subacute, and chronic pain

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Note: The extent to which the MS nurse is involved in the assessment and management of pain varies from country to country. In some countries, patients are referred immediately to a pain specialist once the problem has been identified.

Assessment Determine the nature of pain Determine onset and duration Determine location and severity Determine symptom characteristics such as burning, stabbing, squeezing, or throbbing pain Assess the severity of pain using the following: Short-Form McGill Pain Questionnaire (see Appendix 4H) Visual analogue scales Identify possible contributing factors, such as: Relapse Immobility Concurrent illness (e.g., osteoporosis, disk hernia, migraine) Psychosocial issues Other MS-related symptoms Identify precipitating and alleviating factors Categorise pain into one of the following categories: Acute - Trigeminal neuralgia - Tonic seizures Subacute - Optic neuritis - Steroid-induced compression fractures - Neural palsies secondary to immobility Chronic - Central neuropathic - Musculoskeletal (i.e., back and joint pain, painful spasms) Determine the impact of pain on the following: Daily activities Other MS-related symptoms Psychosocial well-being Identify existing coping behaviours and strategies

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General Interventions for Pain Acknowledge and validate the patient's pain experience Provide ongoing evaluation of pain management strategies for the specific pain category

Note: Nurses in all countries promote the use of any helpful intervention (e.g., pharmacologic agents, relaxation, music or behavioural therapy, hypnotherapy, Chinese medicines, acupuncture, etc.)

Specific Interventions for Acute Pain Inform the patient about the following possible treatment options as well as their side-effect profiles: Anticonvulsants/antiepileptics (see Appendix 4I: Pharmacologic Treatment Options for MS-Related Pain) Surgical treatments such as percutaneous glycerol rhizotomy (chemical interruption of the conduction in trigeminal or spinal nerves by injection of glycerol) Ensure patient is aware that the following may worsen acute pain, particularly trigeminal neuralgia: Chewing Speaking Exposure to wind and extreme temperatures Hyperventilation Certain movements/positions Specific Interventions for Subacute Pain Ensure that the patient is aware that the following may worsen subacute pain: Eye movements (in optic neuritis) Prolonged immobility Ensure patient recognises the contribution of concurrent illness to pain Inform patient of possible pharmacologic therapy options as well as their side-effect profiles (see Appendix 4I: Pharmacologic Treatment Options for MS-Related Pain)

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Specific Interventions for Chronic Neuropathic Pain Instruct patient on the following coping strategies to help minimise pain: Behaviour-modification techniques Relaxation techniques Stress-management techniques Cognitive-behaviour techniques Inform patient of possible pharmacologic therapy options as well as their side-effect profiles (see Appendix 4I: Pharmacologic Treatment Options for MS-Related Pain) or refer patient to the neurologist Refer patient to a designated pain specialist for refractory pain problems Specific Interventions for Chronic Musculoskeletal Pain Refer patient to a physiotherapist and an occupational therapist for assessment and rehabilitative interventions, such as: Assistive equipment Seating, posture, and gait training Exercise programs Ensure patient recognises that the following coexisting conditions may contribute to chronic musculoskeletal pain: Osteoporosis Degenerative disc disease Acknowledge that the following complementary therapies may be effective in managing pain in some patients: Acupuncture Reflexology Yoga Tai chi Massage Music therapy Meditation Others Inform patient of possible therapy options as well as their side-effect profiles (see Appendix 4I: Pharmacologic Treatment Options for MS-Related Pain)

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International MS Nursing Care Plan Desired Patient Outcomes Identifies the type of pain experienced Feels that the health-care provider views the pain experience as real Reduces pain symptoms through the use of behavioural strategies, rehabilitation, drugs, and other interventions Successfully adopts coping behaviours Exhibits improved performance on daily activities in the home and at work as determined by: Patient self-report Pain measurement scales (see Appendix 4H: Short-Form McGill Pain Questionnaire) Country-specific issues regarding the assessment and management of MS-related pain are shown in Table 5. Country-specific issues regarding the use of cannabis for the management of pain in MS are shown in Table 6. Table 5. Country-specific issues regarding the management of pain in MS.

Country Belgium Czech Republic Issue(s) Acute and chronic pain nurses are available. Pain clinics are available. Commonly used therapies include: Phenytoin Alternative and homeopathic therapies Transcutaneous nerve stimulation (TENS) and biofeedback are also used. MS nurse manages pain as well as all other MS-related symptoms or the patient is referred to a designated consultant. Pain clinics are available. Transcutaneous nerve stimulation (TENS) and baclofen are also used. Neurologist usually prescribes carbamazepine or gabapentin; if pain is not relieved with pharmacological therapy, the patient is referred to a pain clinic. Acute and chronic neuropathic pain is managed by the neurologist.

France Greece and Germany Portugal

Saudi Arabia

Spain

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Country Switzerland Issue(s) Adjunctive therapies include: Relaxation techniques Music and behavioural therapy Hypnotherapy Chinese medicines Acupuncture Anticonvulsants such as carbamazepine and gabapentin are often used for the management of neuropathic pain. Other interventions include transcutaneous nerve stimulation (TENS). The use of biofeedback for the management of neuropathic pain is questionable. Neuropathic pain is often seen in MS and is primarily managed with anticonvulsant agents.

United Kingdom

United States

Table 6. Country-specific issues regarding the use of cannabis for the management of MS-related pain.

Country Czech Republic Denmark France Norway Portugal Spain Switzerland Legal status Illegal Illegal Illegal Illegal Illegal. Illegal Legal prescriptions are available. Illegal Considered legal only for cancer patients. Trials using oral cannabis are being conducted. Comment

No trials are currently being conducted. Trials are currently being conducted in some hospitals. Available in tea, oil, fresh-herb, and tablet formulations. Trials with nabilone are being conducted. Nabilone is an antiemetic that is chemically related to marijuana. It is used to prevent the nausea and vomiting that may occur after treatment with cancer medicines.

United Kingdom

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References

Archibald CJ, McGrath PJ, Ritvo PG, Fisk JD, Bhan V, Maxner CE, et al. Pain prevalence, severity, and impact in a clinic sample of multiple sclerosis patients. Pain 1994;58:89-93. Clanet M (chair). The symptoms of multiple sclerosis and their management. In: Proceedings of the MS Forum Modern Management Workshop; April 1992; Paris, France. Worthing UK: Professional Postgraduate Services Europe Ltd.; 1994. Harden RN, Cole PA. New developments in rehabilitation of neuropathic pain syndromes: Interdisciplinary team approach. Neurol Clin 1998;16:937-950. Moulin DE, Foley KM, Ebers GC. Pain syndromes in multiple sclerosis. Neurology 1988;38:1830-1834. Moulin DE. Pain assessment and management in multiple sclerosis. Int Mult Sclerosis J 1996;3:59-63. Moulin DE, Iezzi A, Amireh R, Sharpe WK, Boyd D, Merskey H. Randomised trial of oral morphine for chronic non-cancer pain. Lancet 1996;347:143-147. van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.;1999. Vaney C. Understanding pain mechanisms in multiple sclerosis. MS Management 1996;3:11-18.

Suggested Readings

Beckonja MM, Galer BS. Pain assessment and evaluation of patients who have neuropathic pain. Neurol Clin 1998;16:775-790. Beric A. Central pain and dysesthesia syndrome. Neurol Clin 1998;16:899-918. Dellemijn P. Are opioids effective in relieving neuropathic pain? Pain 1999;80:453-462. Halper J, Holland N. Comprehensive nursing care in multiple sclerosis. New York: Demos Vermande; 1997. Khan OA. Gabapentin relieves trigeminal neuralgia in multiple sclerosis patients. Neurology 1998;51:611-614. Krames ES. Interventional pain management: Appropriate when less invasive therapies fail to provide adequate analgesia. Med Clin North Am 1999;83:787-808.

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MacQuay HJ, Tramer M, Nye BA, Carroll D, Wiffen PJ, Moore RA. A systematic review of antidepressants in neuropathic pain. Pain 1996;68:217-227. Melzack R. The short-form McGill Pain Questionnaire. Pain 1987;30:191-197. Moulin DE. Pain in central and peripheral demyelinating disorders. Neurol Clin 1998;16:889-898. Samkoff LM, Daras M, Tuchman AJ, Koppel BS. Amelioration of refractory dysesthetic limb pain in multiple sclerosis by gabapentin. Neurology 1997;49:304-305. Warnell P. The pain experience of a multiple sclerosis population: A descriptive study. Axon 1991;13:26-28.

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Module 5: Spasticity

Introduction

Spasticity is a common MS-related symptom, particularly in patients experiencing weakness in the lower limbs. Spasticity can be both phasic (spasms) and tonic (constant stiffness). The muscle groups that are most likely to develop spasticity are the quadriceps, hamstrings, and gastrocnemius muscles. (van den Noort and Holland 1999) Mild spasticity is generally treated through passive stretching of the affected joint. Severe spasticity may require medication and surgical interventions such as motor-point blocks, botulinum injections, cord or tendon cutting, and insertion of an intrathecal baclofen pump, in addition to stretching exercises. Severe spasticity, which is most often noted in individuals with restricted mobility, can lead to skin breakdown, seating problems, contractures, and pain. (Shapiro 1998) In this module, protocols for assessing spasticity are presented. Interventions for managing spasticity and desired treatment outcomes are also discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of spasticity Implement interventions for the management of spasticity Describe the desired outcomes of treatment interventions for spasticity

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Note: The extent to which the MS nurse is involved in the assessment and management of spasticity varies from country to country. In some countries, patients are referred immediately to a specialist once the problem has been identified.

Assessment Determine the nature of spasticity Determine location Describe symptoms - Stiffness - Weakness - Flexor or extensor spasms - Clonus - Pain Determine onset and duration Identify possible contributing factors, such as: Relapse Infection Stress and anxiety Tight clothing on legs, e.g., catheter bag straps Constipation Bladder dysfunction Altered skin integrity - Pressure sores - Ingrown toe nails Medications - Glatiramer acetate - Interferon beta (IFN ) Assess the impact of spasticity on the following aspects of daily living: Gait Seating Comfort Energy level Sexual activity Hygiene Sleep Assess severity of spasticity using: Ashworth Scale (see Appendix 4J) Spasm Frequency Scale (see Appendix 4J) Determine impact of spasticity on other MS-related symptoms

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Identify existing coping strategies for the management of spasticity Interventions Consider following an algorithm for the management of spasticity (see Figure 2 for example) Inform patient of the following factors that may contribute to spasticity: Temperature changes Infection Anxiety/stress Constipation Pain Immobility Disruption of skin integrity Bladder dysfunction Medications Educate patient about the causes of spasticity Inform patient about rehabilitative therapies and lifestyle modifications for the management of spasticity Consider alternative strategies: Horseback riding Massage Acupuncture Refer patient to a rehabilitation therapist for: Stretching and exercise programs (physiotherapist) Assistive devices (occupational therapist) Seating modification and positioning (occupational therapist) Inform patient about possible pharmacologic therapy options as well as their sideeffect profiles (see Appendix 4K: Pharmacologic Treatment Options for Spasticity) Inform patient about the following surgical treatment options: Cord or tendon cutting Rhizotomy (interruption of a cranial- or spinal-nerve root) Myelotomy (operation that involves severing tracts in the spinal cord) Localized injection of botulinum toxin (Botox®) Injection of phenol Intrathecal baclofen pump

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Provide ongoing evaluation of management strategies for spasticity Desired Patient Outcomes Experiences a reduction in the frequency of spasms as demonstrated by: Self-reported improved comfort Improvements in Ashworth Scale scores Improvements in Spasm Frequency Scale scores Implements rehabilitative strategies Able to identify the type and cause of spasticity Able to describe the rational for pharmacologic and non-pharmacologic interventions for the management of spasticity Country-specific issues regarding the assessment and management of spasticity are shown in Table 7.

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Figure 2. Algorithm for the management of spasticity. van den Noort et al 1999. Reproduced with permission from Demos Medical Publishing Company, New York.

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Table 7. Country-specific issues regarding the management of spasticity.

Country France and Ireland Greece and Germany Saudi Arabia Issue(s) Phenol injections are not used. MS nurse manages spasticity as well as all other MS-related symptoms or the patient is referred to a designated consultant. Referral to an occupational or physical therapist for training is common. Antispasticity medications also frequently used. Managed by the neurologist. Combination of various approaches often used: rehabilitation, pharmacological treatments, botulinum toxin and intrathecal baclofen pump. Phenol injections are only used in certain centres.

Spain

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References

Shapiro RT. Symptom management in multiple sclerosis. Third edition. New York: Demos Medical Publishing Co. Inc.; 1998. van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.;1999.

Suggested Readings

Currie R. Spasticity: a common symptom of multiple sclerosis. Nursing Standard 2001;15(33):47-52. Dunevsky A, Perel AB. Gabapentin for relief of spasticity associated with multiple sclerosis. Am J Phys Med Rehab 1998;77:451-454. Jarrett L, Leary SM, Porter B et al. Managing spasticity in people with multiple sclerosis: a goal orientated approach to intrathecal baclofen therapy. Int J MS Care 2001;3(4):1021. Jarrett L, Nandi P, Thompson A. Managing lower limb spasticity in multiple sclerosis: does intrathecal baclofen have a role? Journal of Neurology, Neurosurgery and Neuropsychiatry 2002;73(6):705-709. Khan OA, Olek MJ. Clonidine in the treatment of spasticity in patients with multiple sclerosis [letter]. J Neurol 1995;242:712-713. Leary S, Jarrett L, Porter B, Richardson DF, Rosso T, Thompson AJ. A multidisciplinary, goal-orientated approach to intrathecal baclofen therapy in progressive neurological disease. Journal of Neurology, Neurosurgery and Psychiatry 2000;69:412-413. Porter B. A review of intrathecal baclofen in the management of spasticity. Br J Nursing 1997;6(5):253-260. Smith C, Birnbaum G, Carter JL, Greenstein J, Lublin FD. Tizanidine treatment of spasticity caused by multiple sclerosis: Results of a double-blind, placebo-controlled trial. US Tizanidine Study Group. Neurology 1994;44(suppl 9):S34-S43. Smith PF, Darlington CL. Recent developments in drug therapy for multiple sclerosis. Mult Scler 1999;5:110-120. United Kingdom Tizanidine Trial Group. A double-blind, placebo-controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. Neurology 1994;44(suppl 9):S70-S78. Ward N. Spasticity in multiple sclerosis. J. Community Nursing 1999;13(7):4-10.

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Module 6: Tremor

Introduction

Tremor in MS can affect the limbs, trunk, or speech. It is often the most disabling symptom because it is frustrating for patients and difficult to treat. Even a mild tremor can make simple tasks difficult to perform. Tremor is generally classified as either postural, action, or rest tremor. (van den Noort 1999; Clanet 1994; Shapiro 1998) Intention tremor (also known as action, goal-directed, or hyperkinetic tremor) is associated with voluntary movement. The amplitude of the tremor increases as the patient reaches nearer to the target (e.g., when reaching for a cup). It can also increase the more the patient tries to be accurate. This tremor may range from mild to severe in nature and is the most common type of tremor seen in MS. Postural (or attitudinal) tremor occurs whilst voluntarily maintaining a position against gravity. It can occur during a sustained position, such as with outstretched arms or when legs are crossed. This type of tremor is common in patients with MS and may include titubation of the head and neck that requires support. Rest tremor occurs when the patient is relaxed or at rest. Most often seen in Parkinson's disease, rest tremor may occasionally be seen in individuals with MS who have a demyelinating lesion within or near the substantia nigra or nigrostriatal tract. In general, however, rest tremor is rare in MS. In this module, protocols for assessing tremor are presented. Interventions for managing tremor and desired treatment outcomes are also discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of tremor Implement interventions for the management of tremor Describe the desired outcomes of treatment interventions for tremor

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Note: The extent to which the MS nurse is involved in the assessment and management of tremor varies from country to country. In some countries, patients are referred immediately to a specialist once the problem has been identified.

Assessment Determine the nature of tremor Determine onset and duration Determine location, degree of motion (gross or fine), and velocity (fast or slow) Describe symptom characteristics (i.e., tremor at rest, with position, or with voluntary movement) Assess severity of the problem using: Spiral Test (assess tremor using the spiral test prior to and after the initiation of therapy and keep all spiral tests in the patient's chart) Nine-Hole Peg Test Identify possible contributing factors, such as: Lifestyle issues (i.e., alcoholism) Metabolic disorders Coexisting conditions Categorise tremor into one of the following categories: Intention tremor (tremor with voluntary movement or activity) Postural tremor (tremor with certain positioning, e.g., head titubation) Rest tremor (tremor without voluntary movement) Determine the impact of tremor on the following: Activities of daily living Other MS-related symptoms Identify existing coping strategies for the management of tremor Interventions Educate patient about the types and causes of tremor Plan interventions according to the type of tremor Inform patient of the following possible treatment options: Medications (see Appendix 4L: Pharmacologic Treatment Options for Tremor); it is important to note that these agents have limited efficacy in the management of tremor.

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International MS Nursing Care Plan Surgical treatments (for severe cases) - Steriotactic thalamotomy - Thalamic stimulation Note: These procedures are associated with high costs as well as a high risk of complications. Furthermore, the long-term efficacy or benefit of these procedures is still unknown. Some research suggests that these treatments may provide only short-term improvements in tremor. Assist patient in coping with tremor and possible loss of adult role* Refer patient to a rehabilitation specialist for instruction on activities to help manage tremor Patterning (i.e., tracing and repeating basic movement patterns until they become automatic) Immobilisation Weighting Robotic aids, e.g., Handy 1 Robotic Aid Inform patient of the following factors that may affect tremor: Anxiety Caffeine Alcohol (may worsen tremor in some cases while improving tremor in others) Provide ongoing evaluation of tremor management Assess nutritional status regularly in persons with continuous tremor

*Patients with tremor may no longer be able to perform normal adult activities such as feeding or grooming themselves. In fact, patients often rate the inability to feed themselves as the worst consequence of tremor (women also rate the inability to groom themselves as one of the worst consequences). Note: There are limited efficacious treatment and management options for tremor and, as such, continued research in this area is warranted.

Desired Patient Outcomes Experiences a reduction in the frequency of tremor as measured by: Improvement in Spiral Test scores Improvements in Nine-Hole Peg Test scores Able to define cause of tremor Adheres to rehabilitative and pharmacologic treatment regimens to reduce and compensate for tremors

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Demonstrates improved performance in daily activities Country-specific issues regarding the assessment and management of tremor are shown in Table 8. Table 8. Country-specific issues regarding the assessment and management of tremor in MS.

Country Czech Republic Greece and Germany Saudi Arabia Thalatomy is quite common. MS nurse manages tremor as well as all other MS-related symptoms or the patient is referred to a designated consultant. A trial of amantadine, carbamazepine or other agent may be used. Patient is also referred to an occupational therapist. Neurologist responsible for the management of tremor. Pharmacological treatments are used. If tremor is severe, surgical interventions such as thalamic stimulation and thalamotomy are considered. Propranolol is used in England. In general, it is difficult to get physicians in the United Kingdom to prescribe pharmacological treatments for tremor. Issue(s)

Spain

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References

van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.;1999. Clanet M (chair). The symptoms of multiple sclerosis and their management. In: Proceedings of the MS Forum Modern Management Workshop; April 1992; Paris, France. Worthing UK: Professional Postgraduate Services Europe Ltd.; 1994. Shapiro RT. Symptom management in multiple sclerosis. Third ed. New York: Demos Medical Publishing Co. Inc.; 1998.

Suggested Readings

Alushi SH, Worthington J, Glickman S, Bain PG. A study of tremor in multiple sclerosis. Brain 2001. 124:720-730. Cooper IS. Relief of intention tremor of multiple sclerosis by thalamic surgery. JAMA 1967;199:689-694. Critchley GR, Richardson PL. Vim thalamotomy for the relief of intention tremor of multiple sclerosis. British Journal of Neurology 1998;12(6):559-562. Duquette P, Pleines J, du Souich P. Isoniazid for tremor in multiple sclerosis [letter]. J Neurol Neurosurg Psych 1985;48:957. Duquette P, Pleines J, du Souich P. Isoniazid for tremor in multiple sclerosis: A controlled trial. Neurology 1985;35:1772-1775. Freeman R, Miyawaki E. The treatment of autonomic dysfunction. J Clin Neurophysiol 1993;10:61-82. Hallett M. Isoniazid and action tremor in multiple sclerosis [letter]. J Neurol Neurosurg Psych 1985;48:957. Hallett M, Lindsey JW, Adelstein BD, Riley PO. Controlled trial of isoniazid therapy for severe postural cerebellar tremor in multiple sclerosis. Neurology 1985;35:1374-1377. Paty DW, Ebers GC. Multiple sclerosis. Philadelphia: F.A. Davis Company; 1998. Sabra AF, Hallett M, Sudarsky L, Mullally W. Treatment of action tremor in multiple sclerosis with isoniazid. Neurology 1982;32:912-913.

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Module 7: Altered Mobility

Introduction

Mobility is defined as the ability to change and control body position. Symptoms that contribute to altered mobility in MS include spasticity, tremor, ataxia, weakness, loss of balance, pain, fatigue, dizziness, and vertigo. More than 50% of patients with MS need some form of mobility assistance during the course of their disease. (van den Noort 1999) Since the factors contributing to altered mobility vary from patient to patient, proper diagnosis of these factors is necessary before appropriate treatment interventions can be initiated. The main objective of interventions for altered mobility is to ensure that the patient remains as independent as possible. In this module, protocols for assessing altered mobility are presented. Interventions for managing altered mobility and desired treatment outcomes are also discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of mobility Implement interventions for the management of altered mobility Describe the desired outcomes of treatment interventions for altered mobility

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Note: The extent to which the MS nurse is involved in the assessment and management of altered mobility varies from country to country. In some countries, patients are referred immediately to a specialist once the problem has been identified.

Assessment Determine the nature of the mobility alteration Determine onset and duration Determine severity Describe symptom characteristics - Loss of sense of balance - Tripping - Falling - Inability to transfer - Inability to walk Assess severity of altered mobility using the following techniques: Timed walk for 100m (see Appendix 4J) Kurtzke Expanded Disability Status Scale (EDSS) for ambulation (see Appendix 1A in Chapter 1) Identify possible contributing factors, such as: Weakness Fatigue Pain Spasticity Lack of coordination Loss of balance Sensory loss and/or visual impairment Environmental barriers Coexisting conditions Assess pressure-sore risk Determine the impact of altered mobility on the following aspects of daily living: Employment Recreation Social activities Sexual activity Household activities Determine the impact of mobility alterations on other MS-related symptoms (e.g., bladder dysfunction)

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International MS Nursing Care Plan Determine patient's motivation and level of confidence in managing alterations in mobility Identify fears related to altered mobility Identify existing management strategies (including assistive devices used) and coping behaviours Interventions Educate patient about the following: Causes of altered mobility - Spasticity - Weakness - Loss of balance - Sensory changes Potential risks of altered mobility - Falls - Fractures - Reduced capacity for safe driving Potential complications - Contractures - Skin breakdown - Compression neuropathies - Pain - Muscle atrophy - Bowel dysfunction - Alterations in vascular and respiratory functioning - Oedema - Social Isolation Inform patient of therapy options for the management of altered mobility Rehabilitative therapies - Swimming - Water aerobics Lifestyle modifications Medications and their side effects - Antispasticity drugs such as baclofen and tizanidine Refer patient to the rehabilitation team for: Gait assessment and retraining Mobility aids - Electric wheelchair assessment/allocation Stretching and strengthening programs Balance training

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International MS Nursing Care Plan Energy-conservation training Environmental accessibility and adaptive equipment Implement strategies for the prevention of pressure sores (see Appendix 4M: Algorithm for the Prevention of Pressure Sores from the National Multiple Sclerose Centrum in Melsbroek, Belgium) Provide patient with information on community resources that assist persons with mobility problems (see housing, transportation, and accessibility listings) Provide ongoing evaluation of changes in mobility Desired Patient Outcomes Able to define altered mobility in terms of causes and risks Maintains a safe level of activity, as demonstrated by a reduction in the number of falls and complications Demonstrates improved mobility Becomes increasingly involved in activities requiring mobility Country-specific issues regarding the assessment and management of altered mobility are shown in Table 9. Table 9. Country-specific issues regarding the assessment and management of altered mobility in MS.

Country Belgium Issue(s) MS nurse's role in the assessment of altered mobility is to measure timed walks and quality of gait.

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Reference

van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.;1999.

Suggested Readings

Baum HM, Rothschild BB. Multiple sclerosis and mobility restriction. Arch Phys Med Rehab 1983;64:591-596. Di Fabio RP, Choi T, Soderberg J, Hansen CR (1997) Health-related quality of life for people with primary progressive multiple sclerosis: Influence of rehabilitation. Phys Ther 1997;77(12):1716 Freeman JA, Landdon DW, Hobart JC, Thompson AJ. The impact of Inpatient rehabilitation on primary progressive multiple sclerosis. Annals of Neurology 1997;42:236-44. Freeman JA, Landdon DW, Hobart JC; Thompson AJ. Inpatient rehabilitation in multiple sclerosis: do benefits carry over into the community? Neurology 1999;52:50-56. Thompson AJ. Progress in neurorehabilitation in multiple sclerosis. Current Opinion in Neurology 2002;15:267-270.

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Module 8: Speech and Swallowing Difficulties

Introduction

In MS, speech and voice disturbances are usually present as spastic-ataxic dysarthrias that involve disorders of voice intensity, voice quality, articulation, and intonation. Dysarthrias occur in approximately 40% of all patients with MS. The treatment of dysarthria and dysphagia is effective in improving patient function in daily activities. (Merson and Rolnick 1998) Although language disturbances such as aphasia, auditory agnosia, anomia, dysgraphia, and dyslexia are very rare in MS, swallowing disorders are common, particularly if demyelination occurs in the brain stem's sensory-motor pathways (i.e., cranial nerves VII, IX, X or XII) (Merson and Rolnick 1998). Self-reports of chewing and swallowing problems generally increase as the disease progresses (i.e., incidence of these problems is 51% in late stages of MS compared to 19% in early stages of the disease) (Hartlelius and Svensson 1994). Depending on the location and extent of demyelination, swallowing disorders can relapse and remit along with MS exacerbations (Merson and Rolnick 1998). In this module, protocols for assessing speech and swallowing difficulties are presented. Interventions for managing these difficulties and desired treatment outcomes are also discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of speech and swallowing Implement interventions for the management of speech and swallowing difficulties Describe the desired outcomes of treatment interventions for speech and swallowing difficulties

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Note: The extent to which the MS nurse is involved in the assessment and management of speech and swallowing difficulties varies from country to country. In some countries, patients are referred immediately to a specialist once the problem has been identified.

Assessment Determine the nature of symptoms Determine onset and duration Determine severity Describe symptom characteristics - Speech problems o Dysarthria o Dysphonia - Swallowing problems o Choking o Coughing o Delayed swallowing o Chewing difficulties Identify possible contributing factors, such as: Fatigue Emotional upset Cognitive changes Coexisting conditions Other MS-related symptoms Determine whether speech and swallowing problems may be causing the following: Weight loss Malnutrition Dehydration Respiratory compromise Sleep disturbances Changes in social and recreational activities Determine the impact of speech and swallowing difficulties on other MS-related symptoms Identify existing coping strategies for the management of speech and swallowing problems

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Interventions Inform patient about the causes of speech and swallowing problems Refer patient to a rehabilitation specialist or a speech and swallowing therapist for an assessment and modified barium swallow examination (as required) Refer patient to a speech and language therapist (SLT) for speech difficulties and appropriate exercises Refer patient to physiotherapist for assisted coughing education Assist patient in implementing the recommendations of the speech and swallowing specialist as follows: Speech - Oral motor exercises - Appropriate timing and rate of speech - New strategies to help patient communicate - Signing - Hand and facial gestures - Use of assistive devices such as computers and/or letterboards Swallowing - Alertness at mealtimes - Meal supervision, as required - Proper positioning for swallowing - Dietary modifications - Consistency and texture of food - Balance of fluids and solids Inform patient of secretion management strategies Educate patient about body mass index (BMI; see Figure 3) and how to maintain a healthy weight despite difficulties swallowing or refer patient to a dietician for dietary modifications In some cases, educate patient, family, and/or caregivers on how to manage swallowing difficulties safely Heimlich manoeuvre Suctioning Signs and symptoms of aspiration pneumonia Inform and support patient in the placement of a feeding tube to maintain nutritional status when swallowing difficulties are severe

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International MS Nursing Care Plan Provide ongoing evaluation of management strategies for speech and swallowing difficulties Refer patient for surgical consultation if required Percutaneous endoscopic gastrostomy (PEG) Insertion of nasogastric tube Desired Patient Outcomes Able to describe the cause of speech and swallowing difficulties Practices safe eating habits through the utilisation of compensatory strategies Reports reductions in choking and coughing at mealtimes Maintains adequate nutritional status as demonstrated by the following: BMI Weight Serum albumin levels Exhibits improved communication Country-specific issues regarding the assessment and management of speech and swallowing difficulties are shown in Table 10. BMI is calculated by dividing weight in kilograms (kg) by the square of the patient's height in metres (m).

Example:

Weight: 75 kg Height: 180 cm = 1.8 m BMI = 75/(1.8)2 = 23

Generally, a BMI between 19 and 30 is considered ideal. If the patient's BMI falls below 19 or exceeds 30, the patient is at risk for serious health complications and should consult a physician. Figure 3. Calculation of BMI.

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International MS Nursing Care Plan Table 10. Country-specific issues regarding the assessment and management of speech and swallowing difficulties in MS.

Country France, Switzerland, and United Kingdom Issue(s) Nutrition nurses are available to monitor BMI and dietary regimen. Assistive communication devices are primarily privately funded.

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References

Hartlelius L, Svensson P. Speech and swallowing symptoms associated with Parkinson's disease and multiple sclerosis: A survey. Folia Phoniatr Logop 1994;46:917. Merson RM, Rolnick MI. Speech-language pathology and dysphagia in multiple sclerosis. Phys Med Rehab Clin N Am 1998;9:631-641.

Suggested Reading

Merson RM, Rolnick MI. Speech-language pathology and dysphagia in multiple sclerosis. Phys Med Rehab Clin North Am 1998;9:631-641.

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Progress Check

1. List five (5) non-pharmacological interventions for fatigue. a. b. c. d. e. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

2. List and describe the three (3) types of bladder dysfunction most commonly associated with MS. a. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

b.

c.

3. List six (6) interventions for faecal incontinence. a. b. c. d. e. f. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

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International MS Nursing Care Plan 4. Distinguish between acute, subacute, and chronic pain in MS.

5. ________________ and ________________ are two conditions that may contribute to chronic musculoskeletal pain in MS. 6. List five (5) factors and/or actions that may worsen acute pain, particularly trigeminal neuralgia, in MS. a. b. c. d. e. ________________________________ ________________________________ ________________________________ ________________________________ ________________________________

7. List five (5) desired patient outcomes of treatment interventions for pain. a. b. c. d. e. ________________________________ ________________________________ ________________________________ ________________________________ ________________________________

8. List nine (9) factors and/or conditions that may contribute to spasticity. a. b. c. d. e. f. g. h. i. ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________

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International MS Nursing Care Plan 9. Distinguish between intention, postural, and rest tremors.

10. Briefly describe seven (7) interventions for the management of tremor. a. b. c. d. e. f. g. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

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11. Complete the spasticity-management algorithm below.

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International MS Nursing Care Plan 12. List six (6) strategies that the rehabilitation team may use to manage altered mobility. a. b. c. d. e. f. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

13. List seven (7) potential risks and/or complications of altered mobility. a. b. c. d. e. f. g. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

14. List five (5) desired patient outcomes of interventions for speech and swallowing difficulties. a. b. c. d. e. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

15. What is the body mass index (BMI) of a woman who weighs 54 kg and is 175 cm tall? Is this BMI normal? If no, please explain.

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11. Complete the spasticity-management algorithm below.

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International MS Nursing Care Plan 12. List six (6) strategies that the rehabilitation team may use to manage altered mobility. a. Gait and assessment retraining b. Mobility aids c. Stretching and strengthening programs d. Balance training e. Energy-conservation training f. Environmental accessibility and adaptive equipment 13. List seven (7) potential risks and/or complications of altered mobility. a. Falls b. Fractures c. Reduced capacity for safe driving d. Contractures e. Skin breakdown f. Compression neuropathies g. Pain 14. List five (5) desired patient outcomes of interventions for speech and swallowing difficulties. a. Able to describe the cause of speech and swallowing difficulties b. Practices safe eating habits through the utilisation of compensatory strategies c. Reports reductions in choking and coughing at mealtimes d. Maintains adequate nutritional status e. Exhibits improved communication 15. What is the body mass index (BMI) of a woman who weighs 54 kg and is 175 cm tall? Is this BMI normal? If no, please explain. Her BMI is 17.6 (54 1.752). Generally, a BMI between 19 and 30 is considered normal. Since this woman's BMI falls below 19, she may be at risk for serious health complications and should consult a physician.

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Appendix 4A:

Reproduced with permission from the Naitonal Multiple Sclerosis Society.

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Reproduced with permission from the Naitonal Multiple Sclerosis Society.

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International MS Nursing Care Plan Contributors Paul G. Ritvo, Ph.D. Department of Psychology The Toronto Hospital College Wing 2-332 200 Elizabeth Street Toronto, Ontario M5G 2C4 Canada Jill S. Fischer, Ph.D. Mellen Center - U10 Cleveland Clinic Foundation 9500 Euclid Avenue Cleveland, OH 44195 Deborah M. Miller, Ph.D. Mellen Center - U10 Cleveland Clinic Foundation 9500 Euclid Avenue Cleveland, OH 44195 Howard Andrews, Ph.D. Epidemiology of Mental Disorders Research Department New York State Psychiatric Institute - Bin 47 722 West 168th Street New York, NY 10032 Donald W. Paty, M.D. Vancouver Hospital and Health Services Center University of British Columbia UBC Site Room S195 2211 Wesbrook Mall Vancouver, BC V6T 1Z2 Canada Nicholas G. LaRocca, Ph.D. Health Care Delivery and Policy Research Program National Multiple Sclerosis Society 733 Third Avenue New York, NY 10017

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Table of Contents Foreword Background and Development 1. Phase I of Development: Constructing the MSQLI............................................ 1 2. Phase II of Development: Field Testing the MSQLI.......................................... 2 3. Description of the Scales Making up the MSQLI.............................................. 2 4. Utilization of Data Analyses in Item-Scale Reduction......................................... 7 5. Comparison of the MSQLI with Similar Measures............................................. 11 6. How to Use the MSQLI............................................................................ 12 7. A Note on the Reliabilities of the MSQLI Scales............................................... 13 Administration and Scoring 1. List of Instruments Making up the MSQLI...................................................... 17 2. General Instructions Regarding Administration................................................ 17 3. Generic Quality of Life Measure: Health Status Questionnaire (SF-36).................... 18 4. Modified Fatigue Impact Scale (MFIS).......................................................... 23 5. MOS Pain Effects Scale (PES).................................................................... 24 6. Sexual Satisfaction Scale (SSS)................................................................... 25 7. Bladder Control Scale (BLCS).................................................................... 26 8. Bowel Control Scale (BWCS)..................................................................... 26 9. Impact of Visual Impairment Scale (IVIS)...................................................... 27 10. Self-Reported Cognitive Dysfunction: Perceived Deficits Questionnaire (PDQ)......... 27 11. Mental Health Inventory (MHI)..................................................................29 12. Modified MOS Social Support Survey (MSSS)............................................... 31 References............................................................................................. 34 MSQLI Forms

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International MS Nursing Care Plan Acknowledgments The MSQLI owes its existence to a number of people who gave generously of their time and expertise. At the National Multiple Sclerosis Society, Dr. Robert Enteen served as project officer for the MSQLI contract. He was instrumental in guiding the MSQLI project from its inception through completion of the field testing. He assembled an expert panel to assist the investigators in finalizing the selection of instruments for the MSQLI and to provide guidance for the data analysis. The members of that panel were Christopher Bever, Jr., M.D., Robert Kaplan, Ph.D., Sarah Minden, M.D., and John Ware, Ph.D.. Dr. Stephen C. Reingold, Vice President for Research Programs at the NMSS, provided extremely valuable input at many stages of the project. Randall Schapiro, M.D., former President and June Halper, M.S.N., R.N., C.S., Executive Director of the Consortium of Multiple Sclerosis Centers, made it possible for this project to flourish under the auspices of the Consortium. During the early phases of the development of the MSQLI, Dr. Thomas Choi of the University of Minnesota, was a key member of the working group. Data collection for the field testing of the MSQLI was completed at four sites: the Dalhousie Multiple Sclerosis Research Unit, Dalhousie University, Halifax, Nova Scotia; the Mellen Center of the Cleveland Clinic, Cleveland Ohio; the Medical Rehabilitation Research and Training Center for Multiple Sclerosis at St. Agnes Hospital - New York Medical College, White Plains, New York; and St. Michael's Hospital, Toronto, Ontario. In addition, data processing and analysis were completed at the Epidemiology of Mental Disorders Research Department of the New York State Psychiatric Institute, New York, New York and the study as a whole was coordinated from The Toronto Hospital. At each site, a number of individuals made significant contributions to the success of the effort: at Dalhousie, Thomas J. Murray, M.D., F.R.C.P.C., F.A.C.P., director and examining physician, Pauline Weldon, R.N., the site coordinator, Kim Taylor, research assistant, John Fisk, Ph.D., and Catherine Archibald; at Mellen, Richard Rudick, M.D., the center Director, Bianca Weinstock-Guttman, M.D., the examining physician, Janet Perryman, the site coordinator, and Virginia Boldt, the interviewer; at St. Agnes: Charles Smith, M.D., Rene Elkin, M.D., and Ute Traugott, M.D., examining physicians, and Marla ShawarynCornelison, site coordinator and interviewer; at St. Michael's: Paul O'Connor, M.D., Director of the MS Clinic, and Trevor A. Gray, M.D., examining physicians, and Aprile Royal, site coordinator; at The Toronto Hospital: Lynda Robson of the Department of Psychology; at the New York State Psychiatric Institute: Helen Lee did the programming for the processing and analysis of data and Judy Flournoy did the data entry. The authors would also like to thank the many members of our clinical and consumer panels who reviewed the topics to be included in the MSQLI and who made many valuable suggestions which were incorporated in the final version. These panels included neurologists, nurses, physical and occupational therapists, social workers, psychologists, consumers, and family members of persons with MS. We would also like to thank the 300 persons with MS who made the very crucial contribution of agreeing to participate in the study, without them, the MSQLI would never have come to fruition.

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International MS Nursing Care Plan Foreword The Multiple Sclerosis Quality of Life Inventory (MSQLI) was developed as a comprehensive outcomes assessment battery. It evolved in a series of two contracts funded by the Health Care Delivery and Policy Research Program of the National Multiple Sclerosis Society (NMSS) to the Consortium of Multiple Sclerosis Centers (CMSC). Additional funding for the second of the two projects was provided by the Multiple Sclerosis Society of Canada (MSSC). Development of the MSQLI began when the CMSC recognized the need to develop and test health-related quality of life measures for persons with multiple sclerosis (MS). This need reflects, in part, the broad range of outcomes that are of interest to health care professionals and individuals with MS. These outcomes include not only medically oriented goals such as improvement in walking and spasticity but also a variety of quality of life goals such as improving emotional state and enhancing social support. As such, the MSQLI is designed to supplement rather than replace traditional MS outcome measures such as the Expanded Disability Status Scale or magnetic resonance imaging. In developing the MSQLI, the goal of the investigators was to provide a quality of life measure specifically tailored to MS but one that could easily be related to work done with other medical conditions. For this reason, the MSQLI utilizes the SF-36, a widely used generic quality of life instrument, as well as scales specific to MS problems such as bladder dysfunction and fatigue. Wherever possible, published and well-established scales have been used. However, in some instances, we have had to modify these or create our own. The MSQLI thus represents an attempt to achieve an optimal mix of the general and the specific, the old and the new. It is anticipated that the MSQLI will be most useful to MS researchers undertaking clinical studies where there is a need to assess a wide range of outcomes. For example, the MSQLI might be used in a clinical trial to evaluate differences over time in quality of life between patients treated with the active drug and those treated with placebo. The MSQLI could also be used as one of the methods to evaluate differences in outcomes between alternative service delivery models such as an adult day program vs nursing home care. The possible uses of the MSQLI are only limited by the imagination of the investigator. Unlike some quality of life measures, the MSQLI does not provide a single number to summarize quality of life. There is some controversy concerning whether or not a single number can adequately capture the richness and complexity inherent in a concept such as "quality of life". The MSQLI provides several scores, each of which represents one specific facet of quality of life. It is the firm belief of the authors that this multifaceted approach makes the most sense. However, for those investigators interested in utilizing a more global approach to quality of life, the section on Administration and Scoring provides instructions for deriving a physical component summary scale and a mental component summary scale from the 36 items making up the SF-36.

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International MS Nursing Care Plan The MSQLI forms a comprehensive but relatively brief assessment package consisting of 138 items organized into 10 scales. The MSQLI can be administered in 45 minutes in most cases. Wherever possible, it should be used in its entirety. However, some investigators may want to utilize only parts of the package. To accommodate such users, the MSQLI has been supplied as a set of separate scales or "modules" each of which can be used alone. In addition, several of the scales have been supplied in two versions: a full-length version as well as an abbreviated version, reducing administration time for the reduced set of 81 items to approximately 30 minutes. This user's manual provides all the information and materials needed by investigators who are interested in utilizing the MSQLI in their studies. Included is information on the development of the MSQLI, the background of the various scales making up the MSQLI, detailed instructions for administration of the instruments, and algorithms for scoring each scale. In addition, copies of all the MSQLI scales are included so that the user can photocopy these and use them immediately. Absent from this manual is detailed information on the field testing of the MSQLI and analysis of the resulting data. These technical materials have been omitted in order to make this manual more user-friendly, since investigators interested in utilizing the MSQLI may not feel the need to plow through mountains of statistics. However, for those interested in all the details, technical information on the MSQLI is available by contacting Dr. Nicholas LaRocca at the NMSS, telephone: (212) 476-0414. It is hoped that you will find the MSQLI an easy to use and scientifically productive resource. Your comments and suggestions are most welcome and may be forwarded to Dr. LaRocca at the NMSS.

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International MS Nursing Care Plan Background and Development 1. Phase I of Development: Constructing the MSQLI The Multiple Sclerosis Quality of Life Inventory is an outcomes assessment inventory developed in two phases in projects sponsored by the Consortium of Multiple Sclerosis Centers (CMSC) and funded by the Health Care Delivery and Policy Research Program of the National Multiple Sclerosis Society (NMSS). Funding was additionally provided by the Multiple Sclerosis Society of Canada (MSSC). The project was initiated because of the need to develop health-related quality of life (HQL) measures specifically for patients with MS. In Phase I, the investigators reviewed existing HQL literature, both MS-specific and generic, and selected candidate measures for the inventory. These measures were reviewed by panels of clinical-research neurologists and allied clinicians who treated MS patients, and by individuals with MS and their caregivers. Members of the two health professional panels were selected for expertise in MS assessment and clinical intervention. Patient and caregiver panelists were selected by CMSC center directors who solicited participation from individuals who fit detailed descriptions of key characteristics relevant to this panel. The final consumer panel consisted of males and females with mild to moderate physical disability but little or no cognitive impairment, and male and female caregivers of cognitivelyimpaired individuals with MS. A key Phase I goal was identifying HQL domains relevant to individuals with MS and sampling them at an appropriate range and depth. Thus panelists were asked to critically review candidate measures with respect to: 1) domains that should be included in the inventory but were not; 2) domains that were inadequately sampled; and 3) unclear questionnaire instructions. Panelists used a standardized format for critical review and their ratings and comments were reviewed by the investigative group in detail. Items were added when 20% of either the neurologist, allied health professional or consumer panels indicated a given domain was insufficiently sampled. Suggestions from panelists for supplementing existing content were reviewed and new items were then resubmitted to the critical panelists for review. After reviewing and reevaluating the new items, the panelists were polled again. This procedure continued until an approval criteria of > 80% was achieved in all three panels. Table 1 provides a list of domains and responses from the respective panels. As can be seen, panelists identified insufficient sampling in several domains, with additions consequently made to the inventory. Several other areas identified by panelists were, in the investigators' opinion, relevant to living with MS but not to assessing treatment outcomes. These included: knowledge and beliefs about MS; the impact of MS on life decisions; daily activity configuration; dietary practices; coping strategies; and participation in voluntary health groups. While noting their relevance, the investigators deferred the study of these domains for subsequent investigations.

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International MS Nursing Care Plan 2. Phase II of Development: Field Testing the MSQLI In Phase II the MSQLI candidate measures were field tested with 300 persons with MS from four major MS comprehensive care centers. The psychometric characteristics of the field data were analyzed and a reduced set of items, sufficiently brief for administration in clinic settings, were derived. Before the field test began, at the NMSS's suggestion, a distinguished advisory committee reviewed and provided consultation on the project. The committee consisted of: John Ware, Ph.D., Health Institute, New England Medical Center; Robert Kaplan, Ph.D., University of California, San Diego; Sarah Minden, M.D., Abt Associates; and Christopher Bever, M.D., University of Maryland. After a thorough review in September, 1993, several modifications to the instrument reflected a more focal orientation to outcomes assessment. Some alterations were also made to the planned statistical analyses. At the committee's suggestion, the investigative group was joined, at this time, by a distinguished clinical-research neurologist, Don Paty, M.D. of the University of British Columbia. The Phase II field test results are reported in a technical report that is available by call Dr. Nicholas LaRocca at the NMSS at (212) 476-0414. In the following review, emphasis is placed on: describing instrument domains; the theoretical basis of these domains; scales selected to assess them; and the characteristics of these scales. 3. Description of the Scales Making up the MSQLI The MSQLI consists of the following 10 scales containing a total of 138 items. Four of the scales, indicated by an *asterisk, are also available in abbreviated 5 item versions. These abbreviated versions are scientifically sound and reduce the total number of items to 81. However, the shortened scales do not provide as much information as the longer versions. They were constructed to assist users of the MSQLI who may be working under severe time constraints. Use of the four abbreviated scales reduces administration time from 45 to 30 minutes. The full-length versions of the scales should be used whenever possible. The background and development of each scale are described in this section. Information on administration and scoring appears in the section that follows this one. Health Status Questionnaire (SF-36) - 36 items Modified Fatigue Impact Scale (MFIS) - 21 items* MOS Pain Effects Scale (PES) - 6 items Sexual Satisfaction Scale (SSS) - 5 items Bladder Control Scale (BLCS) - 4 items Bowel Control Scale (BWCS) - 5 items Impact of Visual Impairment Scale (IVIS) - 5 items Perceived Deficits Questionnaire (PDQ) - 20 items* Mental Health Inventory (MHI) - 18 items* MOS Modified Social Support Survey (MSSS) - 18 items* *(Abbreviated 5 item versions of these scales are also available) 2

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International MS Nursing Care Plan a) Health Status Questionnaire (SF-36) The General Health Survey of the Medical Outcomes Study (Stewart, Hayes and Ware, 1988) is probably the most widely used generic health status measure in the HQL literature. The Short Form-36 (SF-36) has been used in a great variety of clinical and research settings (Stewart et al., 1989; Stewart, Hayes, Burnam and Rogers, 1989) and has demonstrated a capacity to effectively discriminate between subjects with different chronic conditions and between subjects with different severity levels of the same disease. The SF-36 has also demonstrated a capacity to detect significant treatment effects in a variety of patient populations. For these reasons, the SF36 is a useful measure to employ in comparing the current health status of different illnessaffected populations as well as their responses to specific treatments. Blanket assumptions, however, should not be made that generic measures, like the SF-36, adequately or comprehensively measure status and treatment effects in disease-specific populations, such as MS patients. The development of separate measures specifically suited for MS patients was the primary MSQLI project goal. Our field test results enable investigators and clinicians to begin estimating the appropriate applications for the SF-36 with respect to the MS population. Estimations of SF-36 performance, as well as the performance of other MSQLI subscales, however, are limited by the fact that our field test data is cross-sectional whereas outcomes evaluations are mostly longitudinal. Items perform differently in assessing change in patients over time (Time 1 vs. Time 2),vs. evaluating differences, cross sectionally, in groups assessed at a single point in time. As such, the MSQLI investigative team was cautioned by the Advisory Committee to abbreviate by no more than 25% during Phase II. Dr. John Ware, one of the primary developers of the SF 36 and an Advisory Committee member, was particularly assertive about the need to field test HRQL items longitudinally to properly evaluate their psychometric validity in assessing changes in status over time (for example, in response to treatment). Because items that seem redundant in cross sectional analyses sometimes prove validly sensitive in evaluating change over time, this cautionary principle is especially appropriate to evaluating the relative value of using the SF-36 alone vs. the MSQLI as a whole in clinical treatment trials. Until further longitudinal studies are undertaken where SF-36 measurement alone is compared with the full MSQLI, we strongly advise use of the full MSQLI in assessing outcomes in individuals with MS. b) Modified Fatigue Impact Scale (MFIS) Fatigue, a common and frequently disabling symptom in MS, has been shown to interfere with activities of daily living and to rank with the most troubling symptoms reported by MS patients (Kraft, Freal, and Coryell, 1986). Several studies have confirmed the prevalence and importance of fatigue as an MS symptom, particularly in relation to mental health (Ritvo, Fisk, Archibald, Field and Murray, 1996; Krupp, Alvarez, LaRocca and Scheinberg, 1988; Carter, Sciarra and Merritt, 1950; Clifford and Trotter, 1984). These results are congruent with Phase II field test findings in which patients ranked fatigue as their most distressing and disruptive symptom. 3

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International MS Nursing Care Plan In the MSQLI, fatigue is assessed with a modified form of the Fatigue Impact Scale (FIS) (Fisk, Ritvo and Archibald, 1991), based on items derived from interviews with MS patients about how fatigue impacts their lives. This instrument provides an assessment of fatigue effects in terms of physical, cognitive, and psychosocial functioning. Prior to selection for the MSQLI, the full scale FIS was evaluated with MS patients, Chronic Fatigue Syndrome patients and individuals diagnosed with essential hypertension. Findings demonstrated high internal consistency for the whole scale and within each dimension, as well as the scale's capacity to discriminate fatigue effects in MS patients from those experienced by patients with chronic fatigue and essential hypertension (Fisk, Ritvo, Archibald, Murray, Field and Blanchard, 1992). The FIS was abbreviated during Phase II by eliminating items which appeared both contentredundant and had high inter-item correlations. The current MSQLI version consists of 21 items and is referred to as the Modified Fatigue Impact Scale. A 5 item version of the MFIS is also available if time is limited but investigators are urged to use the 21 item version whenever possible since it provides a breakdown into subscales. c) MOS Pain Effects Scale (PES) More than half of clinic attending MS patients in two studies reported a high prevalence of chronic pain (Moulin, Foley and Ebers, 1988; Archibald, Ritvo, Fisk, Murray and McGrath, 1991). In the second study, 85 clinic-attending MS patients were assessed with the Pain and Disturbing Sensation Inventory, a structured interview instrument. Results indicated 53% of clinic-attending patients reported severe levels of pain and disturbing body sensations during a majority of waking hours. (Archibald, Ritvo, Fisk, Murray and McGrath, 1991). This study also showed that MS patients affected by pain and disturbing sensations had lower Mental Health Inventory scores than patients who reported no pain (p<.05), despite the comparability of the pain/no pain groups in neurological impairment, symptom duration and age. Such findings suggest that pain is also a significant factor in the mental health and management of MS patients. A number of different scales assessing pain and disturbing sensations were evaluated during the field test, including one based solely on interviews with MS patients. The scale with the best psychometric performance was derived from the pain scale contained in the Medical Outcomes Study Functioning and Well-Being Profile, a 149 item health status questionnaire used in the Medical Outcomes Study. Based on Phase II results, the scale was reduced to 6 items assessing the degree to which pain and unpleasant sensations interfere with mood, ability to walk or move, sleep, work, recreation and enjoyment of life. This 6 item scale is called the MOS Pain Effects Scale. d) Sexual Satisfaction Scale (SSS) Changes in sexual functioning are commonly reported by individuals with MS (Valleroy and Kraft, 1984) with any phase of the sexual response affected. This can be the direct result of lesions in the spinal cord or brain, or an indirect effect of physical symptoms that interfere with 4

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International MS Nursing Care Plan sexual activity, or of emotional distress that impairs sexual desire or other aspects of the sexual response (Kalb, LaRocca, and Kaplan, 1987). Because self-report and interviewer-administered measures developed to study sexual dysfunction in other populations were too lengthy, items from the Sexual History Form (Nowinski and LoPiccolo, 1979) were selected to provide an indicator of overall sexual adjustment. This resulted in a 4 item scale addressing the degree of satisfaction experienced with: physically expressed affection; the variety of sexual activities engaged in; and with the sexual relationship generally. A final item addresses the perceived satisfaction experienced by the partner within the relationship.. e) Bladder Control Scale (BLCS) and Bowel Control Scale (BWCS) Bladder and bowel dysfunction are among the most troubling problems associated with MS disease (Kraft, et al., 1984). In the Phase II field test, bladder and bowel problems were ranked as one of the three most distressing and disruptive symptoms by patients (N = 300). Available symptom management methods can either be ineffective or unacceptable and the social stigma sometimes associated with these dysfunctions is often distressing (Scheinberg and Holland, 1987). The MSQLI Bladder Control Scale and Bowel Control scale were based on the items derived from the Bowel-Bladder Function Scale (Turnbull, Hoare, Ritvo, Fisk and Murray, 1992) and the Sickness Impact Profile. Items were added during the Phase I review and psychometrically evaluated in Phase II. There are now 4 items to evaluate bladder control and 5 for bowel control and their impact on lifestyle. These two scales are separately. f) Impact of Visual Impairment Scale (IVIS) The 5 item Impact of Visual Impairment Scale was based on items derived from the Functional Capacities Assessment developed by the Michigan Commission for the Blind. They refer focally to the difficulties patients have with simple visual recognition tasks such as reading that cannot be corrected by glasses or other visual aids. g) Perceived Deficits Questionnaire (PDQ) Cognitive impairment is a common and disabling MS consequence. Cognitivelyimpaired MS patients are less likely to work and socialize, and are more likely to need personal assistance than cognitively-intact MS patients with a comparable physical disability (Rao, Leo, Ellington, Nauertz, Bernardin, and Unverzagt, 1991). A study by Fischer (1993) further suggests that MS patients' perceptions of their memory powerfully impact functional status: patients whose objective memory performance was intact, but who perceived their memory as impaired, were as likely to be unemployed as patients with actual memory deficits. In the MSQLI, the subjective self report of cognitive function is captured in the 20 item Perceived Deficits Questionnaire (Sullivan, Edgley, and Dehoux, 1990). This measure has the advantage of being broader in scope than other current subjective measures and was designed 5

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International MS Nursing Care Plan specifically for use with MS patients. It covers the domains of cognitive function most often impaired in MS: attention; retrospective memory; prospective memory; and planning and organization. A 5 item version of the PDQ is also available if time is limited but investigators are urged to use the 20 item version whenever possible since it provides a breakdown into subscales. h) Mental Health Inventory (MHI) In a recent study of persons with MS (Ritvo, Fisk, Archibald, Murray and Field, 1996) the mean Mental Health Inventory score for 130 clinic-attending MS patients was found to be at the lowest 25th percentile of the normative population assessed during the National Health Insurance Study sample (Veit and Ware, 1983). Altogether, 45.3 per cent of MS patients in this study had scores that fell within the lowest quartile of mental health status relative to the normative sample. This study suggests that the emotional/mental health status of persons with MS patients needs to be a major concern in health service delivery. From all available measures the Mental Health Inventory was selected for inclusion in the MSQLI. The Mental Health Inventory was the primary mental health scale developed during the National Health Insurance Study (Veit and Ware, 1983) and its current form has been refined through extensive studies of reliability, validity, and factor structure. During the National Health Insurance Study, the Mental Health Inventory was administered to over 5000 subjects in a stratified sample from six US cites, over of a three to five year period. The MHI has been found to be reliable and to correlate highly with several other mental health assessment instruments (Sherbourne, Hays, Ordway, DiMatteo and Kravitz, 1992; Veit and Ware, 1983). Depending on the purpose of assessment, an investigator or clinician may choose to use a reduced 18 item version that is highly correlated with the original scale, or a brief 5 item version which is also highly correlated. but less sensitive to changes in distress and well-being. The 18 item version is suggested for the MSQLI. i) MOS Modified Social Support Survey (MSSS) A large body of literature indicates that social interaction is an important construct in understanding individual well-being. Increasing evidence suggests people with chronic illnesses have limited access to social supports due to disease consequences (Heitzmann and Kaplan, 1988). These limitations negatively impact psychosocial functioning and disease management (Kaplan and Toshima, 1990). Social support can thus affect both emotional and physical health outcomes (Heitzmann and Kaplan, 1988; Kaplan and Toshima, 1990; Tilden, 1985). In addition to SF 36 subscales which address social functioning and its impairments, the MOS Social Support Survey, a brief multidimensional self administered instrument, was selected to assess perceived support. The MOS-SSS was developed in the Medical Outcomes Study, a longitudinal study of patients with prevalent chronic illnesses. The original 19 items were factoranalyzed, using responses from 2987 patient-subjects and four dimensions of social support 6

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International MS Nursing Care Plan were discriminated: 1) emotional informational support; 2) tangible support (the provision of material aid or behavioral assistance); 3) positive social interaction (the availability of other persons to do fun things with you); and 4) affectionate support. Subsequent analyses with different populations have, however, indicated relatively high internal consistency estimates for all scale items (C. Sherbourne, 1996, Personal Communication). For the MSQLI, 18 items were selected based on their psychometric field test performance and these constitute the MOS Modified Social Support Survey. A 5 item version of the MSSS is also available if time is limited but investigators are urged to use the 18 item version whenever possible since it provides a breakdown into subscales. 4. Utilization of Data Analyses in Item-Scale Reduction As described previously, an important goal of the Phase II field test was to undertake a 25% reduction in items, making the instrument applicable to clinical trials and activities. Such applications, in turn, will yield better understandings of its responsiveness to change. The item reduction process was initially guided by specific criteria for differentiating `outcome' variables from mediating or moderating `process' variables. Item reduction was further guided by an observed consistency between the theoretically-based item intent and the patient's ability to respond accordingly. Consistency was assessed statistically in terms of `internal consistency' estimates which identified items that did not perform as predicted or intended. Once identified, it was possible to review whether a particular item was inadequately constructed for sampling purposes, sampling at a level too specific or general for the purpose intended. These discriminations were a natural challenge to be increasingly clear about the core defining content of each scale. The content that most articulately described the health concept, addressing it in sufficient (but not overly extensive) detail so as to capture meaningful variance in the experience of patients was reliably identified as the defining core. Specific decisions regarding item deletion can illustrate the process undertaken. For example, in the Impact of Visual Impairment Scale we dropped several items related to the use of visual aids. Because they were dichotomous, they served only to indicate the presence of absence of extreme visual impairment. The items retained more directly referred to visual recognition difficulties which were more common and, in turn, yielded a more variable set of responses from patients. On the other hand, these items also assessed the presence or absence of extreme visual disability. In the Bowel Scale, we deleted several items related to the methods used to assist adequate bowel functioning. Once again, this section only sampled extremes of dysfunction, which were adequately measured in other retained items describing the level and type of dysfunction experienced. Another significant reduction involved the Sexual Functioning Scale where we ultimately opted for summary items relating to satisfaction, in contrast to more detailed inquiries. Our experience with missing data in this section indicated that patients were not prepared to respond to such detailed, explicit queries in a self report format. On the other hand, the more general questions effectively evaluated significant differences in sexual activity and function without the need for such specific detail.

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International MS Nursing Care Plan Other item reductions were more subtle than those described above. We deliberately chose to compare the SIP vs. the SF 36 to assess the relative variance accounted for by these generic HQL measures. Although the SIP accounted for a modest degree of additional variance, its length (136 items) did not justify this additional proportion. Thus, given its relative brevity and its measurement properties, we opted to use the SF-36 rather than the SIP. Similarly, we evaluated two pain scales, one developed specifically for an MS population and one developed for generic purposes. Although the two scales were largely comparable, the generic scale slightly outperformed the MS specific scale. Consequently, we opted to retain that scale and delete the other. We also evaluated two social functioning scales, the MOSSS and the UCLA LonelinessCompanionship scale. The MOSSS was a slightly better performer in statistical terms, and had the added advantage of providing comparisons between MS patients and other chronic disease groups which had been previously tested. Consequently we opted for retaining only the MOSSS. The final deletions were related to defining satisfaction with care as a process rather than outcome variable (i.e. we deleted that scale from the inventory) and to deleting several fatigue items that were suggested for the purpose of discriminating activity- related fatigue vs. endogenous fatigue. Although we see such discriminations as important, they are more readily obtained in a full clinical interview. In a self report format, , they seemed to be too confusing to patients. On a final note regarding deletion, we must point out that although we included a brief neuropsychological battery in the Phase II project, the battery was never considered part of the MSQLI. These assessments are considered `objective' rather than self report measures. They also require skilled technicians, not readily available in settings where self report instruments are used. Furthermore, the selection of neuropsychological measures may substantially vary in accord with the purpose of the clinical or treatment trial conducted. As such, we decided to leave these measures to discretion of the researcher/clinician. We have confidence in the neuropsychological battery administered in the field test, but we see it as only one of several high quality batteries that could be used.

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International MS Nursing Care Plan 5. Comparison of the MSQLI with Similar Measures The development of the MSQLI coincided with that of two other MS quality-of-life profile measures: the MS Quality of Life (MSQOL-54) instrument developed by Vickrey and colleagues (Vickrey, Hays, Narooni, Myers, & Ellison, 1995) and the Functional Assessment of Multiple Sclerosis (FAMS) quality-of-life instrument developed by Cella and colleagues (Cella, Dineen, Arnason, Reder, Webster, Karabatsos, Chang, Lloyd, Mo, Stewart, & Stefoski, 1995). The MSQLI, MSQOL-54, and FAMS have several similarities. First, each combined generic and disease-specific assessment, resulting in some content overlap (see Table 2). Second, input from MS experts was obtained in their development. Patient input was also obtained for the MSQLI and FAMS, however the MSQLI was the only instrument which incorporated caregiver input, particularly useful in understanding patients whose self report is hindered by disease effects (e.g. patients with cognitive deficits). Third, each of the three instruments has undergone reliability and construct validity testing. Several key differences also exist in the development and composition of these instruments. Although all three inventories include a generic HRQL measure, the methods for selecting this measure differed. Cella et al. and Vickrey et al. selected their generic measures a priori. In contrast, two widely-used generic HRQL measures (the SF-36 and the Sickness Impact Profile) were fieldtested to determine, empirically, their applicability in developing the MSQLI. Both performed comparably in terms of subscale reliability, with the SF-36 retained because of its brevity. Vickrey and colleagues also used the SF-36 as their core generic HRQL measure, while Cella and colleagues chose the Functional Assessment of Cancer Therapy scale (FACT-G; Cella, Tulsky, Gray, et al., 1993), a measure not widely applied outside the assessment of cancer patients. Second, most of the disease-specific measures included in the MSQLI are established scales. In contrast, the MSQOL-54 and FAMS were formed by adding individual items to generic measures. One consequence of the latter approach is that symptom clusters, usually evaluated separately, were sometimes combined into a single scale (e.g., the FAMS Thinking/Fatigue scale). Moreover, the use of pre-existing symptom-related scales, in the MSQLI, has the advantage of permitting comparisons of specific symptoms across subject samples, both historically (i.e., with previous studies using these instruments) and concurrently (i.e., within a study). A third and critical difference between the instruments was the method by which they were tested for reliabilty and validity. The MSQLI was tested on consecutive clinic-attending samples carefully recruited to represent the full range of low, moderate and high levels of neurological disability typically seen in the MS population, as well as the typical ratios of female to male patients (2:1). The levels of disability were based on EDSS scores assessed by clinic neurologists, as is standard in clinical trials. In contrast, the MSQOL-54 was tested on a sample of consecutive clinic attenders which did not necessarily represent the full disability range nor gender ratio of the MS population. Most importantly, rather than physician-assessed EDSS, the sample was characterized by EDSS scores derived from patients, themselves. This approach 11

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International MS Nursing Care Plan compromises analyses of reliability-validity due to the confounding of patient-reported HRQL with patient-reported EDSS. Because the EDSS is supposed to be an independent (i.e. objective) criterion against which HRQL 12 scores are compared, deriving it from patient self report is less than optimal. To accept the patients' report of EDSS as an objective measure, one must assume that patients reliably reported their current EDSS scores. This is a difficult assumption as patients whose quality of life is lower have been known to assess their neurological disability as higher. The FAMS field test was also somewhat less than ideal in that the validation sample consisted of 377 subjects surveyed by mail, supplemented by a clinically assessed cohort of 56 subjects. The subjects for both cohorts represented a convenience sample that was not stratified to reflect either disability levels or gender distributions within the MS population. In addition, the EDSS scores for the mailed cohort were not clinically derived (i.e. by neurologists) but were again based on patient self report, introducing the same problems as described above. A fourth important difference was related to the manner in which tests were administered. All MSQLI field test participants completed the instrument in the clinic, with a trained interviewer available to assist when necessary. In addition to undergoing a neurologic exam, MSQLI field test subjects also underwent objective, quantitative assessment of upper-extremity function, lowerextremity function, and neuropsychological function as part of the validation study. In contrast, the MSQOL-54 and FAMS were mailed to patients, who completed them at home, in conditions uncontrolled with respect to assistance from friends and family members. Only a small number of patients in the FAMS study (n = 56) completed the instrument in the clinic under controlled conditions and were examined neurologically at the time of the validation study. Furthermore, no quantitative measures of physical or cognitive function were administered to these patients. In summary, the MSQLI was administered in a more standardized manner, and the MSQLI validation sample can be more thoroughly characterized, especially in reference to criterion ("known groups") validity. Lastly, the sampling plan for the MSQLI field test ensured broad representation in terms of geographic location (Cleveland, Halifax, New York, and Toronto) whereas patients in the MSQOL-54 and FAMS samples were clinic attenders from a single U.S. city (Los Angeles and Chicago, respectively). Thus, the applicability of the MSQLI to the MS population as a whole, regardless of geopgraphic location, has been more adequately established. 6. How to Use the MSQLI How should the MSQLI be used? We strongly recommend the instrument be used in its entirety. As noted earlier, we have presented somewhat abbreviated 5 item versions of four symptomspecific instruments for MS investigators and clinicians to use when brevity is a major concern. However, we caution that important opportunities for comparison of specific symptoms with results of other MS studies and results of studies with other chronically-ill populations may be lost when the abbreviated measures are used. We are confident of the ability of the MSQLI to discriminate among groups of MS patients with different symptom patterns and levels of 12

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International MS Nursing Care Plan disability and would encourage the use of the MSQLI in cross-sectional studies. In addition, we are optimistic about the MSQLI being able to detect functional changes perceived as important by MS patients. However, we must caution that neither we nor other investigators (Cella et al., 1995; Vickrey et al., 1995) have yet documented the sensitivity of these instruments to change over time in MS patients. For this, we must await the completion of longitudinal studies incorporating the MSQLI. As such, we encourage other investigators to extend our work on the MSQLI. 7. A Note on the Reliabilities of the MSQLI Scales This user's manual has been designed to provide, as concisely as possible, all the information necessary for investigators to effectively utilize the MSQLI. To this end, the text has not been burdened with a technical discussion of the extensive statistical analyses that were undertaken as part of the field testing of the MSQLI. However, users of the MSQLI may be interested in knowing the reliabilities of the instruments making up the MSQLI before deciding to use these scales. Tables 3 and 4 summarize the reliability analyses performed on the component scales of the MSQLI. The next two paragraphs provide an explanation of the methods used to assess reliability of the MSQLI scale. Although these two paragraphs are somewhat technical in nature, they provide some insight into the interpretation of Tables 3 and 4. In the present study, we utilized the linear composite model of scale construction in which diverse but related items rated on an ordinal scale are summed to arrive at a total score which approximates the characteristics of an equal interval scale. The most common method for evaluating reliability for such scales is Cronbach's alpha, sometimes referred to as a coefficient of internal consistency. Scale scores are conceptualized as being composed of two components: true variance and error variance. Reliability may be thought of as a way of estimating the proportion of true variance in a score. In this model, Cronbach's alpha is considered to be a lower-bounds estimate of reliability, i.e., the "true" reliability of the scale may be higher than alpha indicates but cannot be lower. Since true variance is by definition reproducible, the terms reliability and reproducibility are sometimes used interchangeably. However, reliability is sometimes confused with reproducibility in the concrete sense of the term, i.e., do subjects given a scale on Monday and Friday get the same scores? This way of assessing reliability is termed test-retest reliability. Like alpha, test-retest reliability is a lower-bounds estimate of the proportion of true variance in a score. However, testretest reliability makes no provision for the fact that the function being measured may itself change in between testings. There are many ways to interpret Cronbach's alpha. As a measure of internal consistency, it tells us the extent to which the individual items in the scale are all "pulling in the same direction," i.e., probably measuring the same thing. Adding together 10 items that are unrelated to one another and that measure different things would result in a low alpha and would be a meaningless scale. The old adage about not adding together apples and oranges applies perfectly here. How high should alpha be? There is no simple answer to that question. However, it is clear that if alpha is 13

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International MS Nursing Care Plan 50 the scale is probably not useful since half of the variation in the score is error. In the present study, it was decided in advance to utilize some general guidelines. Scales with an alpha of .70 or better would be considered adequate for inclusion. Scales with an alpha between .50 and .70 would be considered for deletion or revision to improve reliability. Scales with an alpha below .50 would generally not be retained. Of course our goal would be to achieve alphas higher than .70. However, when using scales for analysis of group trends, moderate reliabilities are considered adequate.

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International MS Nursing Care Plan Administration and Scoring 1. List of Instruments Making up the MSQLI (in order of administration) Health Status Questionnaire (SF-36) - 36 items Modified Fatigue Impact Scale (MFIS) - 21 items* MOS Pain Effects Scale (PES) - 6 items Sexual Satisfaction Scale (SSS) - 5 items Bladder Control Scale (BLCS) - 4 items Bowel Control Scale (BWCS) - 5 items Impact of Visual Impairment Scale (IVIS) - 5 items Perceived Deficits Questionnaire (PDQ) - 20 items* Mental Health Inventory (MHI) - 18 items* MOS Modified Social Support Survey (MSSS) - 18 items* *(Abbreviated 5 item versions of these scales are also available) 2. General Instructions Regarding Administration The MSQLI systematically assesses current health status from the patient's perspective. In the field test, patients were asked to respond based on their functioning during the previous 4 weeks, a time frame that can be modified for other applications. The standard version of the MSQLI is designed to be self-administered by most patients in approximately 45 minutes. While abbreviated versions of four of the MSQLI scales are available which reduce administration time to 30 minutes, use of the full-length MSQLI is strongly encouraged. The MSQLI is intended to supplement but not replace objective measures of physical and cognitive function (e.g., EDSS, quantitative measures of upper and lower extremity function, magnetic resonance imaging, and objective measures of memory and concentration). Also, the MSQLI itself does not cover demographic and medical background information, since many investigators are already collecting this information. Those investigators and clinicians who are looking for systematic ways of collecting these data may want to refer to the Demographic Questionnaire and Health Background Questionnaire in the MSQLIField Test Version which is available from the NMSS by calling Dr. Nicholas LaRocca at (212) 476-0414. The MSQLI is intended to be broadly applicable to all MS patients who can comprehend its instructions and questions, regardless of their level of physical impairment. Under optimal conditions, patients come to a clinic or office and complete the MSQLI independently, with no other person present but with a trained interviewer available to answer any questions that might arise. This approach helps to ensure that responses are indeed coming from the patient (not a family member or friend) and that data are as complete as possible. The MSQLI forms should then be reviewed to ensure that the patient has provided one response for each question. In some circumstances, however, this form of administration may not be practical. In such instances, patients who can complete questionnaires on their own may be given the MSQLI to fill out at home. 17

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International MS Nursing Care Plan Whether completed in the investigator's office or at home, patients should be instructed to mark their responses clearly (usually by circling the appropriate number) and to choose only one response for each item. If a patient has marked two responses for the same item, the patient should be asked to decide which is the best response for that item. If the patient is not available when multiple responses are detected, the investigator or clinician should develop a systematic method for selecting which response to score. Administration of the MSQLI can also be adapted for patients whose MS symptoms limit their ability to complete questionnaires independently. For patients whose visual problems prevent them from reading, the MSQLI should be entirely interview-administered: each item, along with the appropriate response choices, should be read to the patient and his/her response to that item recorded by the interviewer. (This may require some minor wording adaptations, substituting "like" or "such as" for "e.g.", "I" for "the interviewer", etc.) Patients whose sensory or motor problems prevent them from marking their own responses should be given a blank copy of the MSQLI to read, and the instructions should be modified to direct the patient to tell the interviewer the number of the appropriate response for each question. (Sample modified instructions are provided for each scale.) After reading the modified instructions, the interviewer should read the first question in its entirety and prompt the patient for the number of the appropriate response. For subsequent single-item questions, the interviewer can simply prompt the patient with the question number. For multipleitem questions that share a single stem, the interviewer should read the question stem and the first item after the stem, and then prompt the patient with the letter or number corresponding to subsequent items (e.g., "b?"). If subsequent items continue onto a new page or if administration of the MSQLI is interrupted in the midst of a multiple-item question, the interviewer should repeat the stem and the next item, and then resume prompting the patient with the letter or number corresponding to subsequent items. Following administration of the MSQLI, the interviewer does a brief review of the forms for clarity and completeness while the patient is still present. Later, after the patient has left, the answers to each item are entered into the investigators computer system for analysis and interpretation. The next section provides detailed instructions for administering each scale to patients and for scoring each scale once data has been entered into a computer. The net result of scoring the MSQLI is a series of scores, each of which represents a different facet of quality of life. The MSQLI does not provide a single, overall number summarizing quality of life. However, for those investigators who are interested in more global measures, the next section, the Health Status Questionnaire, provides instructions for calculating a physical component summary scale score and a mental component summary scale score using the items on the SF36. 3. Generic Quality of Life Measure: Health Status Questionnaire (SF-36) a) Background The Health Status Questionnaire (SF-36) is a one of the most widely-accepted generic health status measures. It is a brief (36-item) scale developed by Stewart, Hayes and Ware (1988) from 18

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items included in the Medical Outcomes Study. Briefer versions (e.g., SF-20) have also been developed, but given their psychometric limitations, use of the full SF-36 is strongly encouraged. (Investigators and clinicians interested in these short forms are referred to Stewart and Ware (1992).) Manuals describing administration and scoring of this measure are available through the Health Institute's Order Fulfillment Department, New England Medical Center, PO Box 9179, Boston, MA 02118 (Phone: (800) 572-9394). b) Administration The response format and order of administration of some items was modified for th MSQLI based on the results of pilot testing prior to the field test. Most questions are selfexplanatory, although the following clarifications may be useful. Question 1: This refers to a patient's health in general, including his/her MS as well as any other illnesses or non-MS symptoms. The definition of "health" should be left up to the patient, and may include mental as well as physical health. If the patient asks for a time frame, tell him/her "during the past 4 weeks." Otherwise, do not give a time frame for this item. The definition of "getting sick" should be left up to the patient. Some patients may think of their susceptibility to flu, colds, and other viral infections, whereas others may define this in terms of their susceptibility to more serious or chronic illnesses. This question asks the patient to think about their activities "on a typical day". Note that, unlike some of the other questions, a larger number means that the patient is less limited in those activities. The examples of vigorous and moderate activities are given to help define the intensity of these activities; the patient does not need to think of whether his/her health limits his/her ability to perform each of these activities, but rather, should respond in terms of whether his/her health limits these types of activities in general. If the patient asks for a specific time frame, tell him/her to "think of a typical day during the past 4 weeks". For item "j", "3" should be selected only if the patient is completely independent in bathing and dressing. This question refers to pain from any source (including MS) and includes headaches. The patient's response should provide an overall rating of his/her pain, taking into account both frequency and severity of this pain.

Question 2:

Question 4:

Question 6:

Question 7: This question refers to work either outside or inside the home, but not to personal care. 19

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International MS Nursing Care Plan Question 9: Patients may vary greatly in the types of social activities they do and the amount of time they spend doing them. This question asks the patient to use his/her normal social activities as a baseline, which includes any interactions with others either in person, by phone, or in writing. Question 10: For "b", "very nervous" means very anxious, worried or tense. For "e", the patient should define "energy", which can include physical energy, mental energy, or both. For "f", "downhearted and blue" means unhappy or depressed. If the patient asks about the meaning of the word "visiting" in item "j", tell him/her that this can refer to visiting in person or by phone. c) Scoring (Standard 36-item version) The SF-36 has a single item covering change in health status over the last year and 8 multi-item scales. Two summary scales (Physical and Mental) have also been derived using factor analytic methods. Scales are set up so that a higher score indicates better health. To achieve this, responses on 10 items are recoded before being added to other items on the same scale. Raw scale scores are then transformed to a 0-100 scale. Health Transition Item: This single item (Item #3) is scored as indicated on the response form (i.e., no conversion is necessary). Thus, it ranges from 1-5. Physical Functioning Scale (PF): Compute raw score as follows: 4a+4b+4c+4d+4e+4f+4g+4h+4i+4j Raw scores on this scale range from 10-30. Compute transformed score as follows: [(Raw score-10)/20] x 100 Role-Physical Scale (RP): Compute raw score as follows: 5a+5b+5c+5d Raw scores on this scale range from 4-8. Compute transformed score as follows: [(Raw score-4)/4] x 100 Bodily Pain Scale (BP): Assign raw scores for Item #6 responses as follows: None(1) = 6.0 Very mild (2) = 5.4 Mild(3) = 4.2 Moderate(4) = 3.1 Severe(5) = 2.2 Very severe(6) = 1.0 20

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International MS Nursing Care Plan Assign raw scores Item #7 responses as follows: Not at all(1) = 6 if Item #6 response was None(1) or if Item #6 was not answered or 5 if Item #6 response was not None(1) A little bit(2) = 4 if Item #6 was answered (or 4.75 if Item #6 was not answered) Moderately(3) = 3 if Item #6 was answered (or 3.5 if Item #6 was not answered) Quite a bit(4) = 2 if Item #6 was answered (or 2.25 if Item #6 was not answered) Extremely(5) = 1 Compute raw score by adding assigned raw scores for Items 6 and 7. Raw scores on this scale range from 2-12. Compute transformed score as follows: [(Raw score-2)/10] x 100 General Health Scale (GH): Assign raw scores to Item #1 responses as follows: Excellent(1) = 5.0 Very good(2) = 4.4 Good(3) = 3.4 Fair(4) = 2.0 Poor(5) = 1.0 Assign raw scores to Item #2b and d responses as follows: Definitely true(1) = 5 Mostly true(2) = 4 Not sure(3) = 3 Mostly false(4) = 2 Definitely false(5) = 1 No conversion is necessary for scores on Items #2a and c. Compute raw score by adding scores for: 1+2a+2b+2c+2d. Raw scores on this scale range from 5-25. Compute transformed score as follows: [(Raw score-5)/20] x 100 Vitality Scale (VT): Assign raw scores to Items #10a and e responses as follows: All of the time(1) = 6 Most of the time(2) = 5 A good bit of the time(3) = 4 Some of the time(4) = 3 A little of the time(5) = 2 None of the time(6) = 1 No conversion is necessary for Items #10g and I. 21

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Compute raw score by adding scores for: 10a+10e+10g+10i. Raw scores on this scale range from 4-24. Compute transformed score as follows: [(Raw score-4)/20] x 100 Social Functioning Scale (SF): Assign raw scores to Item #9 responses as follows: Not at all(1) = 5 Slightly(2) = 4 Moderately(3) = 3 Quite a bit(4) = 2 Extremely(5) = 1 No conversion is needed for scores on Item 11. Compute raw score by adding scores for Items 9 and 11. Raw scores on this scale range from 2-10. Compute transformed score as follows: [(Raw score-2)/8] x 100 Role-Emotional Scale (RE): Compute raw score by adding the following scores: 8a+8b+8c. Raw scores on this scale range from 3-6. Compute transformed score as follows: [(Raw score-3)/3] x 100 Mental Health Scale (MH): Assign raw scores to Item #10d and h as follows: All of the time(1) = 6 Most of the time(2) = 5 A good bit of the time(3) = 4 Some of the time(4) = 3 A little of the time(5) = 2 None of the time(6) = 1 No conversion is needed for Item #10b, c, and f. Compute raw score by adding the following: 10b+10c+10d+10f+10h. Raw scores on this scale range from 5-30. Compute transformed score as follows: [(Raw score-5)/25] x 100 Physical Components Summary Scale (PCS): Scoring of the PCS involves 3 steps: 1) Standardization of the 8 SF-36 scales (based on means and standard deviations for the US population); 2) Weighting and aggregation of the 8 SF-36 scales; and 3) Transformation of the aggregate scale score to a T-score.

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Z-score standardizations (Step 1) are done as follows: PF_Z = (PF-84.52404)/22.89490 RP_Z = (RP - 81.19907)/33.79729 BP_Z = (BP - 75.49196)/23.55879 GH_Z = (GH - 72.21316)/20.16964 VT_Z = (VT - 61.05453)/20.86942 SF_Z = (SF - 83.59753)/22.37642 RE_Z = (RE - 81.29467)/33.02717 MH_Z = (MH - 74.84212)/18.01189 Z-scores are then aggregated as follows for the PCS: AGG_PHYS = (PF_Z * 0.42402) + (RP_Z * 0.35119) + (BP_Z * 0.31754) + (GH_Z * 0.24954) + (VT_Z * 0.02877) + (SF_Z * -0.00753) + (RE_Z * -0.19206) + (MH_Z * -0.22069) Finally, the aggregate Physical Components score is transformed to a T-score using the following formula: PCS = 50+ (AGG_PHYS * 10) Mental Component Summary Scale (MCS): Scoring of the MCS involves 3 steps: 1) Standardization of the 8 SF-36 scales (based on means and standard deviations for the US population); 2) Weighting and aggregation of the 8 SF-36 scales; and 3) Transformation of the aggregate scale score to a T-score. Z-score standardizations (Step 1) are done as for the Physical Components Summary Score (see above). Z-scores are then aggregated for the MCS as follows: AGG_MENT = (PF_Z * -0.22999) + (RP_Z * -0.12329) + (BP_Z * -0.09731) + (GH_Z * -0.01571) + (VT_Z * 0.23534) + (SF_Z * 0.26876) + (RE_Z * 0.43407) + (MH_Z * 0.48581) Finally, the aggregate Mental Components score is transformed to a T-score using the following formula: MCS = 50+ (AGG_MENT * 10) 4. Modified Fatigue Impact Scale (MFIS) a) Background and Administration Fatigue is an extremely common, but under-recognized, symptom in MS. In fact, 84.0% of the 23

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International MS Nursing Care Plan MSQLI Field Test sample reported fatigue as a current MS symptom. The MSQLI Modified Fatigue Impact Scale (MFIS) consists of 21 items selected from the Fatigue Impact Scale (FIS; Fisk, Ritvo, Ross, Haase, Murray, & Schlech, 1994), a multidimensional scale developed to assess the perceived impact of fatigue on a variety of daily activities. (The 4-item Vitality (VT) scale of the SF-36 provides an additional independent measure of fatigue.) The response format and order of administration of some items was modified for the MSQLI-Field Test based on results of our pilot testing. Items are self-explanatory. b) Scoring (Standard 21-item version) The items of the MFIS can be aggregated into three subscales (Physical, Cognitive, and Psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a patient's activities (i.e., no items are reverse scored). Physical Subscale: This scale can range from 0-36. It is computed by adding raw scores on the following items: 4+6+7+10+13+14+17+20+21. Cognitive Subscale: This scale can range from 0-40. It is computed by adding raw scores on the following items: 1+2+3+5+11+12+15+16+18+19. Psychosocial Subscale: This scale can range from 0-8. It is computed by adding raw scores on the following items: 8+9 Total MFIS Score: The Total MFIS score can range from 0-84. It is computed by adding scores on the Physical+Cognitive+Psychosocial subscales. c) Scoring (5-item version) The Modified Fatigue Impact Scale-5 item version (MFIS-5) consists of the 5 MFIS items correlating the most strongly with the total MFIS score (see Data Analysis section for methodologic details). The following items from the MFIS constitute the MFIS-5: Items 1, 9, 10, 17, and 19. Thus, items from all three subscales are represented. The MFIS-5 total score consists of the sum of the raw scores on these 5 items, and thus, can range from 0-20. 5. MOS Pain Effects Scale (PES) a) Background Pain and other unpleasant sensory symptoms are also under-recognized, but surprisingly common, symptoms of MS. In the MSQLI Field Test, 50.3% of the participants reported 24 Reproduced with permission from the Naitonal Multiple Sclerosis Society.

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International MS Nursing Care Plan experiencing pain as a current symptom of their MS. Six items from the Medical Outcomes Study (Stewart and Ware, 1992) assessing the effects of pain on behavior and mood are incorporated in the MSLQI. (Note that the SF-36 Bodily Pain Scale (BP) provides an additional, independent measure of the severity and impact of pain on the patient's life.) b) Administration These items are designed to be self-explanatory. Some patients may ask what to include in the definition of "pain." Patients should be told that pain is defined broadly, and can include any unpleasant sensory symptom related to MS, as well as pain unrelated to MS (e.g., headaches). Some patients may indicate that their pain and sensory symptoms have been severe, but that they have not allowed their symptoms to restrict their activities. These patients should circle the response that indicates how much their activities have actually been restricted, not how much they could have been restricted. c) Scoring Raw scores on the 6 items that constitute this scale are simply added to form a PES total score. Thus, scores can range from 6-30. Items are scaled so that higher scores indicate a greater impact of pain on a patient's mood and behavior. 6. Sexual Satisfaction Scale (SSS) a) Background Changes in sexual functioning and sexual relationships are also common in MS, although health care practitioners are often unaware of these problems because many patients are reluctant to bring them up. Of the 25 items covering sexual function and satisfaction that were adapted from the Sexual History Form (Schover, Friedman, Weiler, Heiman, & LoPiccolo, 1982) for the MSQLI Field Test, only four sexual satisfaction items were retained for the final MSQLI. (Investigators and clinicians who are interested in problems in sexual function per se are directed to other sources (e.g., Stewart & Ware, 1992).) b) Administration The items are generally self-explanatory. However, due to the sensitive nature of these questions, some patients may need to be reassured about the confidentiality of their responses. If a patient indicates that s/he is not sexually active and wonders whether s/he should respond to these items, the interviewer should say: "These questions concern your satisfaction with your sexual relationships in general, so please try to answer them as best you can." 25

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International MS Nursing Care Plan c) Scoring Raw scores on the 4 sexual satisfaction items (Items 2-5) are summed to create a total score. Thus, this scale can range from 4-24. Higher scores indicate greater problems with sexual satisfaction. 7. Bladder Control Scale (BLCS) a) Background and Administration Bladder problems are a common and often disabling symptom in MS. The MSQLI Bladder Control Scale consists of 4 items written specifically for this study based on input from MS specialists (primarily nurses). Since bladder problems are often embarrassing to patients, they may need to be reassured about the confidentiality of their responses. On Item 3, if the patient indicates that s/he doesn't alter his/her activities but takes steps to ensure that bladder control isn't a problem (e.g., self-catheterizes prior to going out, calls to make sure that restrooms are readily available), this qualifies as altering activities because of bladder problems. Note also that Item 4 requests a rating of the overall impact of bladder problems on a patient's lifestyle, not the number of days or times that bladder problems interfered. b) Scoring Raw scores on the 4 items are summed to create a Bladder Control Scale (BLCS) total score. Scores can range from 0-22, with higher scores indicating greater bladder control problems. 8. Bowel Control Scale (BWCS) a) Background and Administration Bowel problems are also common in MS. The MSQLI Bowel Control Scale consists of 5 items written specifically for this study based on input from MS specialists (primarily nurses). As with the Bladder Control Scale, patients may need to be reassured about the confidentiality of their responses. On Item 4, if the patient indicates that s/he doesn't alter his/her activities but takes steps to ensure that bowel control isn't a problem (e.g., uses a suppository, calls to make sure that restrooms are readily available), this qualifies as altering activities due to bowel problems. Note also that Item 5 requests a rating of the overall impact of bowel problems on a patient's activities, not the number of days or times that bowel problems interfered. b) Scoring Raw scores on the 5 items are summed to create a Bowel Control Scale (BWCS) total score. Scores can range from 0-26, with higher scores indicating greater bowel control problems. 26

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International MS Nursing Care Plan 9. Impact of Visual Impairment Scale (IVIS) a) Background and Administration Visual problems are a common, often disabling, symptom in MS. In the MSQLI Field Test, 42.3% of the patients reported current visual problems. The Impact of Visual Impairment Scale (IVIS) consists of 5 items selected from the Functional Capacities Assessment developed by the Michigan Commission for the Blind. These items assess the extent to which various activities dependent upon vision are affected by MS-related visual problems. They refer to any difficulties that a patient has seeing visual materials, difficulties that cannot be corrected with glasses, contact lenses, or other visual aids. They do not refer to difficulties processing visual information, i.e., difficulties that are more cognitive in nature. For Item 4, the patient should respond in terms of the difficulty s/he has watching TV or seeing faces from standard distances for these activities (i.e., at least several feet away). b) Scoring The VIS total score is computed by adding the raw scores on the 5 items composing this scale. Thus, it can range from 0-15, with higher scores indicating a greater impact of visual problems on daily activities. 10. Self-Reported Cognitive Dysfunction: Perceived Deficits Questionnaire (PDQ) a) Background Cognitive dysfunction occurs frequently in MS. Concentration and recent memory are the functions affected most often, but executive functions (e.g., planning, problem-solving) and other cognitive domains can also be affected. The MSQLI includes the Perceived Deficits Questionnaire (PDQ; Sullivan, Edgley, & Dehoux, 1990) to assess perceived cognitive deficits from the patient's perspective. (A number of items on this scale were derived from earlier work by Mateer and her colleagues (Mateer, Sohlberg, & Crinean, 1987).) Since patients' perceptions of their cognitive function may not be concordant with their objectively-measured function, scores on measures of perceived cognitive function should be interpreted cautiously. Administration of objective neuropsychological measures is also strongly encouraged. b) Administration Minor modifications in the response format and order of administration of some PDQ items was made to improve ease of comprehension, based on results of our pilot testing. Most items are self-explanatory. For Item 19, patients who are not taking any medications should mark "0". 27

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International MS Nursing Care Plan c) Scoring (Standard 20-item version) The PDQ was designed to have four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. Although these were rationallydeveloped, Sullivan and his colleagues (1990) report that they confirmed this 4-factor structure empirically. In contrast, factor analysis of our Field Test data yielded only a single general factor, although this may in part be attributable to methodological differences between these two studies. Scoring procedures for Sullivan et al.'s (1990) 4 subscales are given here, but in light of our failure to confirm this factor structure, caution should be used in interpreting subscale scores. A total PDQ score can also be computed. Higher scores indicate greater perceived cognitive impairment. Attention/Concentration Subscale: Raw scores on Items 1+5+9+13+17 are added to compute this subscale score. Consequently, scores can range from 0-20. Retrospective Memory Subscale: Raw scores on Items 2+6+10+14+18 are added to compute this score. Scores can range from 0-20. Prospective Memory Subscale: Raw scores on Items 3+7+11+15+19 are added to compute this score. Scores can range from 0-20. Planning/Organization Subscale: Raw scores on Items 4+8+12+16+20 are added to compute this score. Scores can range from 0-20. PDQ Total Score: The PDQ Total Score is computed by adding raw scores for all of the PDQ items (or all 4 subscale scores) together. Thus, it can range from 0-80. d) Scoring (5-item version) The Perceived Deficits Questionnaire-5 item version (PDQ-5) consists of the 5 PDQ items correlating the most strongly with the total PDQ score (see Data Analysis section for methodologic details). The following items from the PDQ constitute the PDQ-5: Items 4, 9, 11, 14, and 16. Thus, items from all four subscales are represented. The PDQ-5 total score consists of the sum of the raw scores on these 5 items, and thus, can range from 0-20. 28

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International MS Nursing Care Plan 11. Mental Health Inventory (MHI) a) Background Most MS patients experience significant emotional distress at some point over the course of their illness. The Mental Health Inventory (MHI) is a widely-accepted measure of overall emotional functioning developed by Veit and Ware (1983) for the Rand Health Insurance Experiment. It covers a wide range of negative and positive emotions, not just psychopathology. The 18-item version of the MHI is included in the MSQLI because it is reasonably brief, reliable, and preserves the subscale structure. b) Administration Most items are self-explanatory. Note that the 5-item Mental Health Scale (MH) on the SF-36 is drawn from the MHI. c) Scoring (Standard 18-item version) The MHI has 4 subscales (Anxiety, Depression, Behavioral Control, and Positive Affect) and 1 total score. The subscale and total scores range from 0-100, with higher scores indicating better mental health. MHI-18 Total Score: Assign raw scores to Items #1, 3, 5, 7, 8, 10, 13, and 15 as follows: All of the time(1) = 6 Most of the time(2) = 5 A good bit of the time(3) = 4 Some of the time(4) = 3 A little of the time(5) = 2 None of the time(6) = 1 No conversion is needed for the remaining items. After making the above conversions, compute the Mean MHI Score as follows: Mean MHI Raw Score = [d(Items 1+2+3+....18)]/18 Thus, the mean MHI Raw Score will range from 1-6. Next, compute the MHI Total Score (a transformed score) as follows: MHI Total Score = [(Mean MHI-1)*100]/5 Thus, scores on this scale can range from 0-100. Note: If the patient skipped more than 9 items, the total score should not be computed. 29

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Anxiety Subscale (MHA): Assign raw scores to Item #10 as follows: All of the time(1) = 6 Most of the time(2) = 5 A good bit of the time(3) = 4 Some of the time(4) = 3 A little of the time(5) = 2 None of the time(6) = 1 No conversion is needed for Items #4, 6, 11, and 18. After making the above conversions, compute the mean subscale score for the Anxiety Subscale as follows: Mean Subscale Score = [d(Items 4+6+10+11+18)]/5 Thus, the mean subscale score will range from 1-6. Next, compute the MHA Total Score (a transformed score) as follows: MHA Total Score = [(Mean Anxiety Subscale Score-1)*100]/5 Thus, scores on this scale can range from 0-100. Note: If the patient skipped more than 2 items, the Anxiety Subscale score should not be computed. Depression Subscale (MHD): No conversion of raw scores is needed. Compute the mean subscale score for the Anxiety Subscale as follows: Mean Subscale Score = [d(Items 2+9+12+14)]/4 Thus, the mean subscale score will range from 1-6. Next, compute the MHD Total Score (a transformed score) as follows: MHD Total Score = [(Mean Depression Subscale Score-1)*100]/5 Thus, scores on this scale can range from 0-100. Note: If the patient skipped more than 2 items, the Depression Subscale score should not be computed. Behavior Control Subscale (MHC): Assign raw scores to Items #5 and 8 as follows: All of the time(1) = 6 Most of the time(2) = 5 A good bit of the time(3) = 4 Some of the time(4) = 3 A little of the time(5) = 2 None of the time(6) = 1 No conversion is needed for Items #16 and 17. 30

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International MS Nursing Care Plan After making the above conversions, compute the mean subscale score for the Behavior Control Subscale as follows: Mean Subscale Score = [d(Items 5+8+16+17)]/4 Thus, the mean subscale score will range from 1-6. Next, compute the MHC Total Score (a transformed score) as follows: MHC Total Score = [(Mean Behavior Control Subscale Score-1)*100]/5 Thus, scores on this scale can range from 0-100. Note: If the patient skipped more than 2 items, the Behavior Control Subscale score should not be computed. Positive Affect Subscale (MHP): Assign raw scores to Items #1, 7, 13, and 15 as follows: All of the time(1) = 6 Most of the time(2) = 5 A good bit of the time(3) = 4 Some of the time(4) = 3 A little of the time(5) = 2 None of the time(6) = 1 After making the above conversions, compute the mean subscale score for the Positive Affect Subscale as follows: Mean Subscale Score = [d(Items 1+7+13+15)]/4 Thus, the mean subscale score will range from 1-6. Next, compute the MHP Total Score (a transformed score) as follows: MHP Total Score = [(Mean Positive Affect Subscale Score-1)*100]/5 Thus, scores on this scale can range from 0-100. Note: If the patient skipped more than 2 items, the Positive Affect Subscale score should not be computed. d) Scoring (5-item version) Five MHI items (Items 4, 7, 9, 15, and 17) are also on the SF-36. These are the 5 items that correlated most highly with the full-length (38-item) MHI summary score (cf. Stewart & Ware, 1994). The MHI-5 Total Score should be computed as described above for the Mental Health (MH) subscale of the SF-36. 12. Modified MOS Social Support Survey (MSSS) a) Background The Social Support Survey is a brief multidimensional measure of perceived social support developed by Sherbourne and Stewart (1991) based on the Medical Outcomes Study. Two 31

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International MS Nursing Care Plan additional items from the MOS SSS (one item on network size and one additional perceived support item that was not included in the total score) were included in the Field Test but are not included in the final MSQLI. Consequently, the MSQLI version is referred to as the Modified SSS. Note that the MSSS refers to perceived, not actual, support and that this refers to support from all sources (i.e., all types of support do not have to be available from the same person). b) Administration Although the time frame is not given, patients who ask for a time frame should be instructed to think of the support they had available during the past 4 weeks. The following clarifications may also be useful: Items 1 and 4: If a patient indicates that s/he has never been confined to bed (or always drives himself/herself to the doctor), ask him/her to answer based on how often s/he thinks that someone would be available if s/he were confined to bed (or needed a ride to the doctor). Item 6: "Have a good time with" can refer to getting together with someone either in person, or by phone, through the Internet, etc. and doing something enjoyable. c) Scoring (Standard 18-item version) The MSSS yields 4 subscale scores (Tangible Support, Emotional/Informational Support, Affectionate Support, and Positive Social Interaction), as well as a total score. Each of these scores ranges from 0-100, with higher scores indicating greater perceived support. No reverse scoring is needed. Tangible Support Subscale (TAN): Compute raw score by adding scores on Items 1+4+11+13. Raw scores on this scale range from 4-20. Compute transformed score as follows: [(Raw score-4)/16] x 100 Emotional/Informational Support Subscale (EMI): Compute raw score by adding scores on Items 2+3+7+8+12+14+15+17. Raw scores on this scale range from 8-40. Compute transformed score as follows: [(Raw score-8)/32] x 100 Affectionate Support Subscale (AFF): Compute raw score by adding scores on Items 5+9+18. Raw scores on this scale range from 3-15. Compute transformed score as follows: [(Raw score-3)/12] x 100 32

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Positive Social Interaction Subscale (POS): Compute raw score by adding scores on Items 6+10+16. Raw scores on this scale range from 3-15. Compute transformed score as follows: [(Raw score-3)/12] x 100 MSSS Total Score: The MSSS Total Score is computed as follows: (TAN+EMI+AFF+POS)/4 d) Scoring (5-item version) The Modified Social Support Survey-5 item version (MSSS-5) consists of the 5 MSSS items correlating the most strongly with the total MSSS score (see Data Analysis section for methodologic details). The following items from the MSSS constitute the MSSS-5: Items 4, 6, 9, 11, and 17. Thus, items from all four subscales are represented. The MSSS-5 total score can be computed as follows: Compute raw score by adding scores on these 5 items Raw scores on this scale range from 5-25. Compute transformed score as follows: [(Raw score-5)/20] x 100

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International MS Nursing Care Plan References Archibald, C.J., McGrath, P., Ritvo, P.G., Fisk, J.D., & Murray, T.J. (1994). Pain in multiple sclerosis: prevalence, severity and impact on mental health. Pain, 58, 89-93. Carter, S., Sciarra, D., & Merritt, H. (1950). The course of multiple sclerosis as determined by autopsy proven cases. Research Publications of the Association for Research in Nervous and Mental Diseases, 28, 471-511. Cella, D.F., Dineen, K., Arnason, M., Reder, A., Webster, K.A., Karabatsos, G., Chang, C., Lloyd, S., Mo, F., Steward, J., & Stefoski, D. (1996). Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology, 47, 129-139. Cella, D.G., Tulsky, D.S., Gray, G., et al. (1993). The Functional Assessment of Cancer Therapy (FACT) Scale: development and validation of the general measure. Journal of Clinical Oncology, 11, 570-579. Clifford, D.B. & Trotter, J.L. (1984). Pain in multiple sclerosis. Archives of Neurology, 41(12), 1270-1272. Fisk, J.D., Ritvo, P.G., Ross, L., Haase, D.A., Marrie, T.J., Schlech, W.F. (1994). Measuring the Functional Impact of Fatigue: Initial Validation of the Fatigue Impact Scale. Clinical Infectious Diseases, 18 (Suppl 1), S79-83. Fisk, J.D., Pontefract, A., Ritvo, P.G., Archibald, C.J., & Murray, T.J. (1994). The Impact of Fatigue on Patients with Multiple Sclerosis. Canadian Journal of Neurological Sciences, 21, 914. Heitzmann, C.A., & Kaplan, R.M. (1988). Assessments of methods for measuring social support. Health Psychology, 7 (1), 75-109. Kalb, R.C., LaRocca, N.G., & Kaplan, S.R. (1987). Sexuality. In L.C. Scheinberg, & N.J. Holland (Eds.), Multiple sclerosis: A guide for patients and their families (2nd ed.). New York: Raven Press. Kaplan, R.M. & Toshima, M.T. (1990). The functional effects of social relationships on chronic illness and disability. In B.R. Sarason, I.G. Sarason & G.R. Pierce (Eds.), Social support: An interactional view. New York: John Wiley & Sons. Kraft, G.H., Freal, J.E., Coryell, J.K. (1986). Disability, disease duration and rehabilitation services needs in multiple sclerosis: patient perspectives. Archives of Physical Medicine and Rehabilitation, 67, 164-168. 34

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International MS Nursing Care Plan Krupp, L.B., Alverez, L.A., LaRocca, N.G., & Scheinberg, L.C. (1988). Fatigue in multiple sclerosis. Archives of Neurology, 45, 435-437. LaRocca, N.G, Ritvo, P.G., Miller, D.M., Fischer, J.S., Andrews, H., & Paty, D.W. (1996 ) Quality of life assessment in multiple sclerosis clinical trials: current status and strategies for improving multiple sclerosis clinical trial design. In D. Goodkin and R. Rudick (Eds.), Treatment of multiple sclerosis. London: Springer. Moulin, D.E., Foley, K.M., & Ebers, G.C. (1988). Pain syndromes in multiple sclerosis. Neurology, 38, 1830-1834. Nowinski, J.K., & LoPiccolo, J. (1979). Assessing sexual behavior in couples. Journal of Sex and Marital Therapy, 5, 224-243. Rao, S.M., Leo, G.J., Bernadin, L., & Unverzagt, F. (1991). Cognitive dysfunction in multiple sclerosis. I. frequency, patterns, and prediction. Neurology, 41, 685-691. Ritvo, P.G., Fisk, J.D., Archibald, C.J., Murray, T.J., & Field, C. (1996) Psychosocial and neurological predictors of mental health in multiple sclerosis. Journal of Clinical Epidemiology, 49, 467-472. Scheinberg, L., & Holland, C. (1987). Multiple sclerosis: A guide for patients and their families (2nd ed.) . New York: Raven Press. Schover, L.R., Friedman, J.M., Weiler, S.J., Heiman, J.R., & LoPiccolo, J. (1982). Multiaxial problem-oriented system for sexual dysfunctions. Archives of General Psychiatry, 39, 614-619. Sherbourne, C.D., & Stewart, A.L. (1991). The MOS Social Support Survey. Social Science and Medicine, 32, 705-714. Sherbourne, C.D., Hays, R.D., Ordway, L., DiMatteo, M.R., & Kravitz, R.L. (1992). Antecedents of adherence to medical recommendations: results from the medical outcomes study. Journal of Behavioral Medicine, 15(5), 447-468. Sherbourne, C. (1996). Personal Communication. Sohlberg, M.M. & Mateer, C.A. (1987). Effectiveness of an attention training program. Journal of Clinical and Experimental Neuropsychology, 9, 117-130. Stewart, A.L., Hays, R., Ware, J. (1988). Communication: The MOS Short-form General Health Survey - reliability and validity in a patient population. Medical Care, 26, 7. 35

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International MS Nursing Care Plan Stewart, A.L., Greenfield, S., Hays, R.D., Wells, K., Rogers, W.H., Berry, S.D., McGlynn, E.A. & Ware, Jr., J. (1989). Functional status and well-being of patients with chronic conditions: Results from the Medical Outcomes Study. Journal of the American Medical Association, 262, 907-913. Stewart, A.L., Hays, R.D., & Ware., J.E. (1988). The MOS Short-Form General Health Survey: reliability and validity in a patient population. Medical Care, 26, 724-735. Stewart, A.L., & Ware, J.E. (1992). Measuring functioning and well-being: The Medical Outcomes Study approach. Durham, NC: Duke University Press. Sullivan, J.J.L., Edgley, K., & Dehoux, E. (1990). A survey of multiple sclerosis. Part 1: Perceived cognitive problems and compensatory strategy use. Canadian Journal of Rehabilitation, 4, 99-105. Tilden, V.P. (1985). Issues of conceptualization and measurement of social support in the construction of nursing theory. Research in Nursing and Health, 8, 199-206. Turnbull, G.K., Hoare, C., Ritvo, P.G., Fisk, J.D., & Murray, T. J. (1993). The assessment of bowel and bladder dysfunction in clinic attending MS patients. Presented at Department of Medicine Research Symposium. Dalhousie University, Halifax, Nova Scotia. Valleroy, M.L., & Kraft, G.H. (1984). Sexual dysfunction in multiple sclerosis. Archives of Physical Medicine and Rehabilitation, 65, 125-128. Veit, C., Ware, J. (1983). The structure of psychological distress and well-being in general populations. Journal of Consulting and Clinical Psychology, 51, 730-732. Vickrey, B.G., Hays, R.D., Harooni, R., Myers, L.W., & Ellison, G.W. (1995). A health-related quality of life measure for multiple sclerosis. Quality of Life Research, 4, 187-206. Ware, J.E., Kosinski, M., Bayliss, M.S., McHorney, C.A., Rogers, W.H. & Raczek, A. (1995). Comparison of methods for scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Medical Care, 33 (Suppl), AS264-AS279.

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Appendix 4B: Pharmacologic Treatment Options for MS-Related Fatigue

Medication Amantadine Examples of Brand Names Symmetrel® Description

An antiviral agent and dopamine agonist Widely used to treat fatigue, but mechanism of action not known Usual dose: 100 mg BID Side effects are generally mild and infrequent but may include hallucinations, nausea, hyperactivity, anxiety, insomnia, rash, and constipation Dextroamphetamine Dexedrine® A sympathomimetic agent that has been shown to lessen fatigue and improve mental alertness Usual dose: 5 60 mg/day Side effects may include heart palpitations, increased blood pressure, restlessness, insomnia, tremor, dry mouth, loss of appetite, diarrhea, constipation, and weight loss ® Fluoxetine Prozac An antidepressant Often used for patients who do not respond to amantadine treatment Usual dose: 20 60 mg/day Side effects may include nervousness, anxiety, insomnia, and nausea Modafinil* Alertec® A CNS stimulant Often used to treat the excessive daytime sleepiness associated with narcolepsy Provigil® Usual dose: 200­400 mg/day Side effects may include headache, asthenia, and nausea Should not be used in patients with mitral valve prolapse (MVP) or left ventricular hypertrophy (LVH) TM Sertraline Zoloft A selective serotonin reuptake inhibitor (SSRI) used to treat depression Lustral® Usual dose: 25 200 mg/day Side effects may include agitation, insomnia, male sexual dysfunction, somnolence, dizziness, headache, tremor, anorexia, diarrhea/loose stools, and nausea Note: The agents listed in this table may not be available and/or may not be extensively used in all countries. *Modafinil often used off-label.

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Appendix 4C: Foothills Hospital (Calgary, Alberta, Canada) Nursing Assessment Form

Reproduced with permission from Calgary Regional Health Authority ­ Foothills Medical Centre. Nursing Assessment: Optimus Program. 1997.

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Appendix 4D: Diagnosis of Bladder Dysfunction

A key to the accurate diagnosis of bladder dysfunction is obtaining a complete history of bladder symptoms from the patient. Often, it is helpful for the patient to keep a diary of bladder function for a few days for an accurate report. Critical questions to ask include: 1. What is your chief concern about bladder function? What bothers you the most about how your bladder is currently working? 2. How often do you void during the waking hours (including voluntary and involuntary voiding)? 3. How often do you awake at night to void (nocturia)? 4. Do you leak urine when you cough, sneeze, or laugh? 5. Do you experience a strong urge to void that sometimes results in an accident? How often does this occur? 6. Do you feel you completely empty your bladder when you void? 7. Do you find it hard to begin urinating? 8. Do you wear pads or protection? How often? 9. Have you had bladder, urine, or kidney infections? If so, how often and when was the most recent infection? 10. Do you experience pain or discomfort when you urinate? 11. Have you had blood in your urine? 12. What medications are you currently taking? 13. Have you had your bladder function evaluated before? If so, what tests were done? 14. For women, how may pregnancies have you experienced? How may births? 15. Have you had abdominal surgery? If so, what type of surgery and when? After a complete history is obtained, it is important to have the patient spontaneously void and measure the amount of urine voided. A urine specimen for urinalysis, and culture and sensitivity should be obtained, either from the spontaneous void or the postvoid residual urine. (It is important to note that a urinary tract infection can cause bladder symptoms and change in bladder habits.) If the urinalysis and urine culture are suggestive of a urinary tract infection (+nitrates, bacteria, >100,000 colonies of organism), appropriate therapy should be prescribed.

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Appendix 4E: Algorithm for the Management of Bladder Dysfunction from the Nationaal Multiple Sclerose Centrum in Melsbroek, Belgium

Reproduced with permission. Algorithm for management of bladder dysfunction by Mr. P. Eden (R.N.) and Prof. D. De Ridder (urologist).

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Appendix 4F: Pharmacologic Treatment Options for Bladder Dysfunction in MS

Medication Desmopressin acetate Examples of Brand Names DDAVP nasal spray® Description An antidiuretic hormone analog used to alleviate nocturia Usual dose: 20 µg nightly Side effects may include headaches, nausea, rhinitis, and abdominal cramps A urinary tract antispasmodic used for symptomatic relief of dysuria, urgency, nocturia, frequency, and incontinence Usual dose: 600 800 mg/day Side effects may include dry mouth and throat, difficulty swallowing, urinary hesitance and retention, blurred vision, cycloplegia, palpitations, dizziness, headache, insomnia, mood changes, edema, impotence, interference with normal heat regulation, and severe allergic reactions An anticholinergic/antispasmodic agent used to reduce urgency Usual dose: 5 mg OD TID Side effects may include dry mouth and throat, difficulty swallowing, urinary hesitance and retention, blurred vision, cycloplegia, palpitations, dizziness, headache, insomnia, mood changes, edema, impotence, interference with normal heat regulation, and severe allergic reactions An anticholinergic agent used to treat storage dysfunction Usual dose: 7 15 mg OD TID Side effects may include dry mouth, decreased sweating, ophthalmic problems, urinary retention, insomnia, nausea, constipation, bloated feeling, and drowsiness An anticholinergic/antispasmodic agent used to treat bladder spasms that cause urgency Usual dose: 2 mg BID Side effects may include dry mouth, constipation, abnormal vision, urinary retention, and xerophthalmia

Flavoxate

Urispas®

Oxybutynin

Ditropan®

Propantheline

Pro-Banthine®

Tolterodine

Detrusitol®

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Appendix 4G: Pharmacologic Treatment Options for Bowel Dysfunction in MS

Options for Constipation

Medication Methylcellulose Bulk-Forming Agents Examples of Description Brand Names Celevac® A laxative used for relief of constipation and prevention of straining for bowel movement Dosage depends on form being taken (i.e., tablet, liquid, powder, flakes or granules); dose should be diluted in 8 oz. of cold water or fruit juice) Side effects are rare but may include difficulty swallowing, "lump in throat" sensation, nausea, vomiting, diarrhea, rash, intestinal blockage, and asthma Colace® Stool Softeners Used for relief of occasional constipation Usual dose: 50 250 mg/day Usually well tolerated if used for short periods of time in recommended doses Overuse may cause diarrhea, weak bones, liver disease, poor absorption of fats, colon problems, and low blood levels of potassium, calcium, and magnesium Used for relief of constipation Usual dose: 10 30 g/day Common side effects may include increased thirst, cramps, nausea, diarrhea, and gas Less common side effects include irregular heartbeat, dizziness, confusion, and fatigue

Docusate

Lactulose

Dulphalac®

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Medication Glycerin*

Other Therapies Examples of Description Brand Names Microlax® A suppository used to promote defecation Can be used alone or in combination with bulkforming agents or stool softeners Usual dosage and administration: one adult or pediatric suppository inserted in the rectum and held for 15 min Side effects may include irritation of the mucus membrane in the rectum, nausea, vomiting, headache, confusion, severe dehydration, cardiac arrhythmias, and hyperosmolar nonketotic coma Phillips'® Milk of Magnesia

A saline laxative and antacid used for relief of occasional constipation Can be used alone or in combination with bulkforming agents or stool softeners Usual dose: 5 10 mL/day; should be taken with 8-oz. glass of water Usually well tolerated Norgine Movicol® An oral powder used for the management of constipation or fecal impaction Usual dose for chronic constipation: 2­ 6 sachets daily in divided doses usually for up to 2 weeks; content of each sachet dissolved in 62.5 mL water; maintenance, 2­4 sachets daily Side effects may include abdominal distension and pain, and nausea Not recommended in children Standardized Senokot® A peristaltic stimulant used for relief of sennosides constipation Can be used alone or in combination with bulkforming agents or stool softeners Usual dose: 1 4 tablets/day (each tablet contains 8.6 mg of standardized sennosides and 50 mg of docusate sodium) Usually well tolerated *Some centres use pure glycerin enemas (50­60 cc) as they are less irritating and cause fewer side effects

Magnesium hydroxide

For patients who cannot undergo enemas, many centres advise patients to take 2 tablespoons of paraffin oil with lemon juice

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Options for Fecal Incontinence in MS

Medication Propantheline Examples of Brand Names Pro-Banthine® Description An anticholinergic agent used to treat storage dysfunction Usual dose: 7 15 mg OD TID Side effects may include dry mouth, decreased sweating, ophthalmic problems, urinary retention, insomnia, nausea, constipation, bloated feeling, and drowsiness An anticholinergic/antispasmodic agent used to reduce urgency Usual dose: 5 mg OD TID Side effects may include dry mouth and throat, difficulty swallowing, urinary hesitance and retention, blurred vision, cycloplegia, palpitations, dizziness, headache, insomnia, mood changes, edema, impotence, interference with normal heat regulation, and severe allergic reactions An antispasmodic and anticholinergic agent Usual dose: 80 160 mg/day Side effects may include nausea, vomiting, abdominal pain, dizziness, drowsiness, mental confusion, dyskinesia, speech disturbances, diplopia, mydriasis, ocular tension, rash, urticaria, allergic reactions, apnea, and asphyxia An antidiarrheal agent used only in acute, severe cases of fecal incontinence Usual dose: 2 mg TID QID Side effects may include skin rash, urticaria, nausea, altered taste, headache, chills, dry mouth, cough, and constipation

Oxybutynin

Ditropan®

Dicyclomine

Bentylol® Merbentyl®

Loperamide

Imodium®

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Appendix 4H: Short-Form McGill Pain Questionnaire

Reproduced with permission from Melzack R. Short-Form McGill Pain Questionnaire. Hamilton: McGill University: 1984.

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Appendix 4I: Pharmacologic Treatment Options for MS-Related Pain

NOTE: Nurses should always consult the neurologist before recommending any of the treatments listed below.

Acute Pain Medication Carbamazepine Examples of Brand Names Tegretol Description An anticonvulsant indicated for symptomatic relief of pain associated with trigeminal neuralgia Usual dose: 200 1200 mg/day Side effects may include dry mouth and throat, constipation, impaired urination, decreased sense of taste, dizziness, drowsiness, unsteadiness, loss of appetite, nausea, vomiting, indigestion, and diarrhea An anticonvulsant that many physicians use to treat MS-related pain in patients who fail to respond to either carbamazepine or phenytoin treatment Usual dose: 300 1200 mg/day Side effects may include drowsiness, dizziness, fatigue, ataxia, nystagmus, tremor, nausea, and rhinitis An anticonvulsant Usual dose: 300 1600 mg/day Side effects may include ataxia, drowsiness, confusion, and nystagmus Subacute Pain A nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of mild-to-moderate pain Usual dose: 200 800 mg/day Side effects may include nausea, epigastric pain, heartburn, diarrhea, abdominal distress, vomiting, indigestion, constipation, and bloating An NSAID used to reduce joint and muscle pain Usual dose: 500 1000 mg/day Side effects most commonly associated with NSAID use are gastrointestinal complications such as heartburn, constipation, abdominal pain, nausea, diarrhea, dyspepsia, stomatitis, diverticulitis, gastrointestinal bleeding, hematemesis, melena, peptic ulceration (with or without bleeding and/or perforation), vomiting, and ulcerative stomatitis Some of the above mentioned side effects may be alleviated if the dose is taken with food or milk

Gabapentin

NeurontinTM

Phenytoin

Dilantin Epanutin

Ibuprofen

Advil Brufen Motrin

Naproxen

Naprosyn

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Medication Amitriptyline

Baclofen

Carbamazepine Gabapentin Morphine sulphate

Baclofen Celecoxib Codeine

Dantrolene

Ibuprofen

Naproxen

Chronic Neuropathic Pain Examples of Description Brand Names A tricyclic antidepressant often used to treat painful Elavil paresthesias in the arms and legs Usual dose: 10 150 mg/day Tryptizol Side effects may include drowsiness, dizziness, insomnia, blurred vision, rash, and dry mouth A muscle relaxant sometimes used to treat pain in Lioresal MS Usual dose: 40 80 mg/day Side effects may include transient drowsiness, daytime sedation, dizziness, weakness, and fatigue See above Tegretol NeurontinTM See above A narcotic analgesic used for the treatment of MS Contin moderate-to-severe pain Dosage should be individualized according to the patient's age, weight, medical and analgesic history, and the severity of pain Side effects may include sedation, nausea and vomiting, constipation, lightheadedness, dizziness, and sweating Chronic Musculoskeletal Pain See above Lioresal TM Celebrex See above Codeine A narcotic analgesic used for the treatment of mild-tomoderate pain Dosage should be individualized according to the patient's age, weight, medical and analgesic history, and the severity of pain Side effects may include sedation, nausea and vomiting, constipation, lightheadedness, dizziness, and sweating A skeletal muscle relaxant often used in the treatment Dantrium of spasticity Usual dose: 50 400 mg/day Side effects may include drowsiness, weakness, dizziness, fatigue, and diarrhea May cause drug-induced hepatitis; therefore, patients should be monitored regularly See above Advil Brufen Motrin See above Naprosyn

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Medication Paracetamol with codeine

Examples of Brand Names Solpadeine®

Description Combination of the analgesic effects of the centrally acting analgesic codeine and the peripherally acting analgesic paracetamol Used for the relief of mild to moderate pain Dosage should be adjusted according to severity of pain and patient response; however, keep in mind that tolerance to codeine can develop with continued use and that the incidence of side effects is doserelated Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects Side effects may include lightheadedness, dizziness, sedation, shortness of breath, nausea, and vomiting

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Appendix 4J: Ashworth Scale/Spasm Frequency Scale/100m Walk

SPASTICITY

UE Elbow Flexors Elbow Extensor Pronators Wrist Flexors R L LE Hip Extensors Hip Flexors Hip Abductors Knee Extensors Knee Flexors Ankle Plantar Flexors Totals UE Total UE Avg. Totals LE Total LE Avg. 3 Considerable increase in tone; passive movement difficult 4 Affected part rigid in flex or ext. 2 More marked increase in tone but affected part easily flexed R L

ASHWORTH SCALE

0 No increase in tone 1 Slight increase in tone, giving a "catch" when affected part moved in flex or ext.

SPASM FREQUENCY

Score________________________ Scoring 0 No spasms 1 Mild induced by stimulation

100 METRE WALK

____ ____ ____ . ____ ____ (sec) Aids used List:___________________

Circle: 2 Infrequent full spasms occurring <1/hour 3 Spasms occurring >1/hour 4 Spasms occurring >10/hour

UN = Unable NA = Not Attempted

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Appendix 4K: Pharmacologic Treatment Options for Spasticity

Medication

Baclofen

Egs of Brand Names

Lioresal

Description

A muscle relaxant Usual dose: 40 80 mg/day; however, dose may vary between 15 and 160 mg/day Side effects may include transient drowsiness, daytime sedation, dizziness, weakness, and fatigue An anticonvulsant Usual dose: 200 1200 mg/day Side effects may include dry mouth and throat, constipation, impaired urination, decreased sense of taste, dizziness, drowsiness, unsteadiness, loss of appetite, nausea, vomiting, indigestion, and diarrhea An antihypertensive agent that has been shown to reduce muscle resistance and tension Usual dose: 0.1 0.6 mg/day Side effects are generally mild and transient in nature but may include drowsiness, dizziness, dry mouth, sedation, and constipation A skeletal muscle relaxant Usual dose: 50 400 mg/day Side effects may include drowsiness, weakness, dizziness, fatigue, and diarrhea May cause drug-induced hepatitis; therefore, patients should be monitored regularly A sedative that may be used to relieve muscle tension Usual dose: 2 10 mg TID QID Side effects may include fatigue, drowsiness, muscle weakness, and ataxia An anticonvulsant Usual dose: 300 1200 mg/day Side effects may include drowsiness, dizziness, fatigue, ataxia, nystagmus, tremor, nausea, and rhinitis An anticonvulsant Usual dose: 300 1600 mg/day Side effects may include ataxia, drowsiness, confusion, and nystagmus An alpha2-adrenergic agonist used for the shortterm relief of spasticity Usual dose: 8 24 mg/day (relieves/reduces spasticity for 3 to 6 hours)* Side effects may include dry mouth, somnolence/sedation, asthenia, and dizziness

Carbamazepine

Tegretol

Clonidine

Catapres

Dantrolene

Dantrium

Diazepam

Valium

Gabapentin

NeurontinTM

Phenytoin

Epanutin

Tizanidine (oral)

Zanaflex

*Some clinics initiate tizanidine at 4 mg/day and increase dose gradually in 2­4-mg increments

as indicated.

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Appendix 4L: Pharmacologic Treatment Options for Tremor

Medication

Clonazepam

Examples of Brand Names

Rivotril

Description

An anticonvulsant Dosage should be individualized according to the patient's age, clinical response, and tolerance for the agent Side effects may include CNS depression and alterations in behaviour such as increased aggression, agitation, depression, euphoria, irritability, and forgetfulness An antituberculosis agent Dosage should be individualized according to the patient's weight Side effects may include peripheral neuropathy, nausea, vomiting, and epigastric distress A selective 5-HT3 antagonist used for the prevention of nausea and vomiting after chemotherapy; also used in the treatment of MS-related tremor Usual dose: 8 32 mg/day Generally well tolerated A beta-adrenergic receptor-blocking agent indicated for the treatment of essential tremor Dosage should be individualized (range, 80 240 mg/day) Side effects may include congestive heart failure, bronchospasm, anorexia, nausea, vomiting, diarrhea, and abdominal pain

Isoniazid*

RifaterTM

Ondansetron

Zofran

Propranolol

Inderal

*Not commonly used; however, may be administered in some clinics

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Appendix 4M: Algorithm for the Prevention of Pressure Sores from the Nationaal Multiple Sclerose Centrum in Melsbroek, Belgium

Reproduced with permission. Algorithm for management of bladder dysfunction by Mr. P. Eden (R.N.) and Prof. D. De Ridder (urologist).

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Chapter 5: Psychosocial Implications of MS

Introduction

The impact of MS on the individual and their family is wide reaching and cannot be underestimated. Individuals respond both to diagnosis and the progression of the disease in many different ways, both positive and negative. These may include low selfesteem, depression and withdrawal, which can lead to increased stresses on close relationships. Many people also respond to the continued impact on their quality of life, e.g. social and financial status, employment and independence, in a similar way. (Bradshaw et al 1996) Despite the abundance of literature on the psychosocial needs of individuals with MS and despite increased individual access to MS clinics and team interventions, the psychosocial component of individual care remains largely unattended to. A recent survey, for example, found that although individuals with MS identified their psychological needs more than any other need category as important or very important, they were dissatisfied with the quality of psychosocial care provided to them. (Koopman et al 1999; Bates at al 1999) This weakness in adequately addressing the psychosocial needs of individuals with MS is evidenced by the lack of tools available for assessment of these issues. There are currently hundreds of articles on the importance of appropriate psychosocial assessment and intervention in MS. Research suggests that using an orderly and systematic approach to assessing psychosocial problems, determining appropriate interventions, initiating a collaborative plan, and evaluating the efficacy of this plan can significantly increase individual adherence to therapy, improve self-care skills, and assist individuals in adapting to MS. (Taylor 1987) This chapter describes the wellness nursing process and proposes ways to assess and evaluate psychosocial problems related to a new diagnosis, depression, cognition, sexuality, family issues, and vocational and financial concerns. Plans and interventions for dealing with these issues are also discussed.

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Chapter Overview

This chapter contains the following seven modules: Module 1: The Wellness Model in MS Nursing Module 2: Nursing Assessment Module 3: Care Plan for Newly Diagnosed Individuals Module 4: Depression Module 5: Cognition Module 6: Sexuality, Family Issues and Pregnancy Module 7: Financial and Vocational Issues At the end of the chapter, please find a section entitled Progress Check; this section tests your knowledge of the information presented in the chapter.

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Module 1: The Wellness Model in MS Nursing

Introduction

Due to the variable nature of MS and the uncertainty and loss of control associated with the disease, the MS nurse must develop dynamic interventions that meet each individual's needs. Clark's Wellness Model can assist nurses in this process. In the traditional nursing model, the nurse performs and the individual receives. The Wellness Model, on the other hand, promotes a partnership between the nurse and the person with MS; the goal of this partnership is to empower the person with MS to develop selfawareness and to take responsibility for their own health. (Halper et al 1997; Clark 1986) In this module, Clark's Wellness Model is described and the implications of this model to the nursing process are discussed.

Learning Objectives

After completing this module, the reader will be able to: Compare the wellness nursing process to the traditional nursing process Apply the wellness nursing process to his/her clinical practice Describe the roles of the various members of the multidisciplinary team involved in the care and treatment of persons with MS

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Clark's Wellness Model

Because MS has no cure, the person with MS and their family, must assume ongoing responsibility for healthcare and self-monitoring. Clark's Wellness Model promotes individual self-responsibility and emphasises "whole-person" wellness (see Table 1). In this model, a person can be ill but still have a deep appreciation for the joy of living. Table 1. Comparison of the traditional nursing and wellness nursing processes. Adapted with permission from Halper et al 1997.

Traditional Nursing Process Assess individual Diagnose Set goals Develop nursing care plan Wellness Nursing Process Teach individual how to assess their own level of health Assess unique learning needs based on the individuals needs and beliefs Teach the individual to set wellness goals meaningful to him or her Individual develops plan of action with the nurse and takes responsibility for carrying out the plan themselves Teach the person with MS how to effectively manage their own health Teach the individual to self-evaluate results

Carry out nursing interventions Evaluate results

The use of wellness models in various countries is discussed in Table 2. Care Models in MS Comprehensive care in MS is an organised system of healthcare designed to address the medical, vocational, emotional, and educational needs of people with MS and their families. Comprehensive care models emphasise a wellness approach in which the individual takes an active role in planning and implementing healthcare and self-care activities; the individual also acts as a consultant to the multidisciplinary care team, which may consist of a neurologist, nurse, occupational therapist, physiotherapist, psychologist, social worker, counsellor, dietician, speech and language therapist, continence advisor, general practitioner, etc. (Halper et al 1997; Halper et al 1994)

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The individual with MS must learn to adapt and change in response to alterations in their physical functioning. Therefore, the individual and the multidisciplinary healthcare team must be committed to a clearly defined wellness programme that looks beyond the illness to each person's full potential. (Halper et al 1997; Cobble et al 1985; Brechin et al 2001) Providing dynamic care in MS often requires care plans ­ also called clinical pathways, or multidisciplinary action plans. Care plans outline the optimal sequencing and timing of interventions and include desired individual outcomes, timelines, collaboration, and comprehensive aspects of care. (Halper et al 1997; Ignatavicius et al 1995) Table 2. The use of wellness models in various countries.

Country Czech Republic France Portugal Spain Wellness models used Yes No No Yes Patients are referred to various professionals in the multidisciplinary team to assist with coping problems. Comment Wellness models are starting to be used more frequently.

Switzerland United Kingdom

No Yes Various wellness models are used. UK MS nurses emphasize the use of wellness models and the importance of focusing on ability not disability. Expert Patient Programmes are available; in these programs, patients are encouraged to take control of their lives while living with MS. Various wellness models are used. North American MS nurses emphasize the use of wellness models and the importance of focusing on ability not disability. Expert Patient Programmes are available; in these programs, patients are encouraged to take control of their lives while living with MS.

United States/Canada

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The Multidisciplinary Team

In most countries, the care and management of patients with MS involves a multidisciplinary team approach. In addition to the neurologist, the MS nurse, and the GP, the multidisciplinary healthcare team involved in the care of individuals with MS generally includes (Halper et al 1997): Physiotherapist Occupational therapist Social worker Psychologist and/or counsellor Speech and language therapist Continence advisor Physiotherapist The physiotherapist assists the person with MS in improving or maintaining physical functioning through exercise. For example, gentle, sustained stretching exercises are beneficial in the management of spasticity. Consideration needs to be given to the temperature of the environment in which the physiotherapy takes place, as a cooler environment will reduce the risk of elevating body temperature which leads to fatigue. (Halper et al 1997) Occupational Therapist The occupational therapist focuses more specifically on functioning with respect to activities of daily living. They also advise / provide aids and adaptations to enable the individual to maintain their maximum level of independence and health. In an individual experiencing fatigue, for example, the occupational therapist may assess how the person with MS plans daily activities and will provide recommendations on how to minimise fatigue and/or perform activities during times when energy levels are higher. The occupational therapist may also recommend weighted eating utensils and cups to decrease tremor during eating. (Halper et al 1997) Social Worker The social worker assesses the individual and their family's overall living situation and assists in such areas as financial arrangements and benefit entitlements, community resources and care packages, employment issues and alternative living situations. (Halper et al 1997) Psychologist The psychologist can also help the person with MS and their family psychologically prepare for active participation in rehabilitation. The psychologist may assess psychological status, coping styles, problem-solving skills, and cognitive function. Through counselling, the psychologist assists the individual in developing or strengthening the tools needed to cope during periods of extreme stress or turmoil. (Halper et al 1997)

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Note: Fragmentation of the multidisciplinary team is always a concern and, therefore, regular communication among team members is imperative.

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References

Bates D, Fieschi C, Lucas K, Sheridan P, Ebers G. Clinicians and people with MS: Views on MS and its management. Presentation made at the European Committee for Treatment and Research in Multiple Sclerosis Fourth Annual Meeting of America's Committee for Treatment and Research in Multiple Sclerosis; Sept 15 18, 1999; Basel, Switzerland. Presentation made at the MS Forum's Fifth Interactive Symposium; Sept 16, 1999. Bradshaw B, Tinker M. MS relationships and codependency. MS Management 1996;3:19-24. Brechin M, Burgess M. Designing and education tool for individuals with MS. Professional Nurse 2001;16(11): 1471-4. Clark CC. Wellness Nursing. New York: Springer; 1986. Cobble ND, Burks JS. The team approach to the management of multiple sclerosis. In: Interdisciplinary rehabilitation of multiple sclerosis and neuromuscular disorders. Maloney F, Burks JS, Ringel SR (eds). Philadelphia: JB Lippincott; 1985. Halper J, Burks JS. Care patterns in multiple sclerosis. NeuroRehab 1994;4:67-75. Halper J, Holland N. Comprehensive nursing care in multiple sclerosis. New York: Demos Medical Publishing; 2003. Ignatavicius DD, Hausman KA. Philadelphia: WB Saunders; 1995. Clinical pathways for collaborative practice.

Koopman W, Schweitzer A. The journey to multiple sclerosis: A qualitative study. J Neurosci Nurs 1999;31:17-26. Taylor CM, Cress SS. The indispensable care plan guide: Nursing '87 nursing diagnosis cards. Springhouse (PA): Springhouse Corporation; 1987.

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Module 2: Nursing Assessment

Introduction

MS can affect the individual's parental, relationship, vocational, and social roles and can significantly impair peoples' quality of life. Therefore, in addition to the assessment of physical aspects of the disease, the assessment of psychosocial issues is an integral component in the comprehensive care and management of individuals with MS. Ideally, newly diagnosed individuals will be seen by the MS nurse for an initial consultation on each visit to the clinic (Burgess 2002). During these visits, the nurse should elicit basic information on the individual's physical status followed by either a complete assessment of their psychosocial/socio-economic status (in the case of new individuals) or a review of information collected during previous visits. If, during the visit, the nurse believes that the clinical or functional status of a particular individual is impaired, further information should be elicited to determine the effect of MS on the individual's mobility, ability to engage in work, the need for any aids or adaptations, and the availability of personal support. A referral to the appropriate rehabilitation or vocational service is made once both the perceived and actual needs of the individual are determined and the purpose of the service as well as process involved in participating in this service is discussed in detail with the individual.(LaRocca and Kalb 1997) When collected in a systematic way, the information elicited during the assessment interview can be used to identify relevant psychosocial issues faced by people with MS (O'Connor and Eggert 1994). In addition, this information may serve as a framework for assessment and management by referral sources and other healthcare professionals involved in the care of people with MS. For more information and advice on nursing assessment, please refer to Appendix 4C: Nursing Assessment Form in Chapter 4 and Appendix 2A: Guy's Neurological Disability Scale in Chapter 2. In this module, the goals and objectives of the initial nursing interview are discussed and nursing assessment strategies are described.

Learning Objectives

After completing this module, the reader will be able to: Discuss the goals and objectives of the initial nursing interview Describe and apply nursing assessment strategies

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Goals and Objectives of the Nursing Interview Assist the individual and their family in coping with actual or potential changes in daily living resulting from MS Identify the physical, emotional, spiritual, and educational needs of the individual Formulate a plan for individual care and management Refer individual to appropriate members of the multidisciplinary healthcare team Provide a mechanism for longitudinal follow-up and evaluation Assessment Note: Multidisciplinary team assessment and database access are considered imperative and should be instituted in all countries. Identify specific symptoms patient is experiencing Determine the symptoms and/or issues that are of most concern to the individual* Assess how the individual, family, and/or primary caregiver are coping with the physical and functional disabilities associated with MS through assessment of coping behaviours Assess whether the following factors may influence coping strategies: Support provided by family, friends and significant others Other stressors not necessarily related directly to the MS Educational needs Previous experience with health problems Spirituality Alterations in social/leisure activities Employment issues Assess how the individual is coping with the diagnosis and identify what crisis stage(see Figure 1) or adjustment stage (see Table 3) the individual is currently in; adjust counselling strategies and interventions accordingly Perception of event (i.e., does individual feel this is a crisis situation?) Preservation of emotional balance and self-image Maintenance of significant relationships Preparedness for an unpredictable future

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*Always remember to ask the individual what symptoms/issues are of most concern to him or her as these may differ from those the nurse and/or doctor believe are of most concern.

In the United States, access to transportation is also an issue that must be considered in the assessment stage.

Assess type of coping skills: Problem-focused - Seeks information - Establishes goals - Rehearses alternatives Emotion-focused - Denies or minimises problems - Requests reassurance or support - Finds a general purpose or meaning in life Assess for the following non-pharmacological health-maintenance behaviours: Exercise Proper diet Use of stress-reduction techniques Adequate rest/sleep Use of alternative therapies Assess whether any of the following issues need to be immediately addressed: Employment Disability Financial Child care Identify therapy options and make appropriate referrals Consider using a Nursing Assessment Form such as the MS Support Team Documentation used by University Hospital Birmingham as a model for assessment and adapt as appropriate (see Appendix 5A)

It is important to note that there is no specific formal, standardised assessment tool used by all countries. However, MS nurses throughout the world perform similar assessments using a wide-variety of both paper- or computer-based tools that are either countryspecific or used at an international level. Country-specific issues regarding the use of nursing assessment tools are shown in Table 4.

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Note: When assessing psychosocial functioning, the nurse should always consider his/her level of knowledge in the area as well as scope of practice, and ensure that appropriate referral(s) can be made if the needs of the individual are beyond his/her capabilities.

Shock Stage "It's not true ­ it can't be happening to me!"

Reaction Stage "It won't get me down."

Re-orientation Stage "I know it's there but I don't think much about it."

Restoration Stage "I guess I have to face it."

Figure 1. Cullberg's crisis theory (Cullberg 1992; Ruutiainen 1996). Shock Stage According to Cullberg's theory, the shock stage is of short duration and immediately follows the crisis. The individual is experiencing extreme confusion and inner turmoil but appears calm on the surface. Afterward, the individual may have difficulty remembering what happened after the shock phase. For example, the individual may claim that he/she was told of the diagnosis in a very hurried and unsympathetic manner with little, if any, explanation about the disease. During this phase, the nurse should build a strong nurse-individual relationship and ensure that the individual receives initial information about the disease. The nurse should also ensure that information and advice given during this stage are repeated later. Reaction Stage During the reaction stage, the individual can no longer shut out the painful truth about the disease and may begin to express strong emotions. The reaction stage may last from a few months to a year. During this stage, the individual may resort to many negative coping strategies such as denial, projection, and regression. Sometimes a individual may remain in the reaction stage for years, seeking help from miracle cures and alternative medicines. As the reaction phase progresses, the person with MS becomes ready to participate in educational programmes or activities that will help him/her gather resources that are vital for managing their own health.

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1. Denial: Patient is not ready to deal with the loss of good health and, therefore, denies illness. This denial can take a dangerously defiant form. 2. Anger: Patient becomes angry at everything and everyone. To the patient, it seems as if everyone around him/her is going on as if the disease does not exist. Alternatively, the patient may feel as if everyone is hovering over him/her. Patients who stay in this stage become bitter and others may begin to avoid them. 3. Depression: The patient begins to cry, feel sorry for him/herself and generally gives up. Sorrow can lead to depression and hopelessness. 4. Bargaining: The patient makes a last attempt at reaching a compromise with reality, e.g., "If I do this, I won't have another relapse." 5. Acceptance: Having gone through the previous four stages, the patient now accepts the illness as part of the "self", a reality to be lived with, not escaped. The patient recognizes that his/her best chance for happiness lies in understanding MS and developing a commitment to manage the disease.

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Table 4. Country-specific issues regarding the use of nursing assessment tools.

Country Czech Republic Denmark France Portugal Spain Switzerland United Kingdom United States/Canada Issue(s) Formal, paper-based tools are used most frequently. IMED and MS BASE are also used for nursing/social assessment. Formal PC-based tools are used as well as MS CNS data entry. Formal tools include the MS BASE program sponsored by Serono. Formal paper-based tools and individualized evaluations for counselling purposes are used most frequently. Formal paper-based tools are used most frequently. Various tools are used; most of these are paper-based. Various tools are used; most of these are paper-based.

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References

Burgess M. Diagnosing MS. In: Multiple Sclerosis: Theory and Practice for Nurses. London: Whurr; 2002. Cullberg J. Kris och utveckling. Third edition. Häftad; 1992. LaRocca NG, Kalb RC. Psychosocial issues in multiple sclerosis. In: Halper J, Holland N. Comprehensive Nursing Care in Multiple Sclerosis. New York: Demos Vermande; 1997. O'Connor FW, Eggert LL. Psychosocial assessment for treatment planning and evaluation. J Psychosoc Nurs 1994;32:31-42. Ruutiainen J. 25 years of experience in adaptation training in MS. In: Miscellaneous topics in MS. Ketealer P, Battaglia M (eds). Genova: A.I.S.M.; 1996.

Suggested Readings

Aronson KJ, Goldenberg E, Cleghorn G. Socio-demographic characteristics and health status of persons with multiple sclerosis and their caregivers. MS Management 1996;3:3-5. Burgum V. Knowledge for ethical care: Nursing ethics. Int J Health Care Profess 1994;1:72-79. Burnfield A. The psychosocial impact of MS. Int MS J 1995;2:33-35. Decker TW, Decker BB. Effects of multiple sclerosis on physical and psychosocial functioning. Percep Mot Skill 1994;79:753-754. Dyck I. Hidden geographies: The changing lifeworlds of women with multiple sclerosis. Soc Sci Med 1995;40:307-320.

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Module 3: Care Plan for Newly Diagnosed Individuals

Introduction

Nurses play a critical role in the education and support of newly diagnosed individuals and their families. This role demands that nurses have a comprehensive understanding of the disease process and the effects of MS on overall individual health and life status. Nurses should also be able to communicate this knowledge effectively to individuals and/or their families. (Lesaux et al 1999) A diagnosis of MS can evoke an array of emotional responses that range from shock, grief, anger, and fear, to profound relief in the knowledge that the reason for symptoms has finally been discovered. Therefore, nurses should develop care plans that effectively ease individuals' movement through this emotional roller coaster and assist in the development of an effective nurse-individual. relationship (Van Manen 1998; McGuiness et al 1999) In this module, a care plan for newly diagnosed individuals is presented (see Table 5).

Learning Objective

After completing this module, the reader will be able to: Implement a care plan for newly diagnosed MS individuals

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Table 5. Care plan for newly diagnosed individuals.

Nursing Diagnosis Anxiety relating to: Knowledge deficit of disease process Intervention Review individual's present knowledge and understanding of MS Expand individual's present knowledge base Rationale Basic knowledge may already be present Individual may have misconceptions about the disease Desired Individual Outcome(s) Understands disease process

Uncertainty about future physical and social capabilities

Provide positive information Expand individual's present knowledge base

Positive information allows the individual to remain hopeful throughout the disease process

Confident about the future

Worries regarding parenting

Provide relevant information about pregnancy and parenting issues in relation to MS

Given all relevant information, parenting should be an individual decision

Understands issues related to MS and parenting

Inability to recognise the symptoms of an attack Nonadherence relating to: Denial of diagnosis

Provide information about what constitutes a true attack

Knowledge of symptoms of true and pseudo attacks reduces anxiety

Distinguishes between the symptoms of a true MS attack and those of a pseudo attack

Review diagnostic criteria and classification

Individual may be confused about the certainty of the diagnosis

Acknowledges denial and progresses towards acceptance of the disease

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Nursing Diagnosis Powerlessness relating to: Unpredictable nature of disease

Intervention

Rationale

Desired Individual Outcome(s)

Review individual's comprehension of his/her prognosis

Individual may have preconceived ideas and misconceptions about future abilities Grieving allows the individual to move forward

Possesses realistic expectations of disease process and future abilities

Grief relating to: Loss of former self Confusion relating to: Difficulty in distinguishing which symptoms are related to MS and which are related to other conditions Information-seeking relating to: Need to confirm present knowledge Need to make informed decisions about available treatment options, resources, and supports

Reinforce that grieving is acceptable

Accepts changes imposed by MS

Educate the individual about the disease process and other conditions that may coexist with MS Promote individual wellness

Wellness and an understanding of the disease process promote a healthy outlook on life

Recognises that other conditions may be responsible for symptoms

Direct individual to appropriate information resources (e.g., library, literature packages supplied by clinics, MS society, MS Trust, reputable websites; see Appendix 5B: Alternative Medicine and Health-Related Websites) and other appropriate local resources

Empowerment is gained through knowledge

Possesses correct knowledge of disease

Need for control Note: The plan for educational sessions with newly diagnosed individuals should include discussions on how the diagnosis is made and the definitiveness of the diagnosis. The individual should be encouraged to guide the course of the session. In order to promote individual understanding, the function and purpose of paraclinical tests should be reinforced.

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References

Lesaux J, Jadback G, Harraghy C. Improving the convenience of home-based interferon beta-1a therapy for multiple sclerosis. J Neurosci Nurs 1999;31:174-179. McGuiness S, Peters S. The diagnosis of multiple sclerosis: Peplau's interpersonal relations model in practice. Rehab Nurs 1999;24:30-33. United Kingdom Multiple Sclerosis Specialist Nurse Association. The key elements for developing MS Specialist Nurse Services in the UK. Multiple Sclerosis (Research) Charitable Trust 2001. London, UK. Van Manen M. Modalities of body experience in illness and health. Qualit Health Res 1998;8:7-24.

Suggested Reading

Holland N, Murray TJ, Reingold SC. Multiple sclerosis: A guide for the newly diagnosed. New York: Demos Vermande; 1996

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Module 4: Depression

Introduction

Depression is very common among individuals with MS. The lifetime prevalence for major depression in MS ranges from 25­50% (Feinstein 1999). The uncertainty of the future, coupled with the perceived loss of a "normal" life, causes most individuals to feel depressed at least occasionally. (Schapiro 1991; van den Noort S et al 1999; Halper et al 1997) The symptoms of depression include (Halper et al 1997): Feelings of hopelessness, despair, and guilt Fatigue Insomnia Suicidal ideation Researchers believe that MS-related depression may be due to a combination of the following (van den Noort S et al 1999): Psychological reactions to the diagnosis of a chronic illness Neuropathology of the disease process Anxiety related to the uncertainty of future events Grieving over the perceived loss of former self Few diseases are as affected by emotional status as MS. Research has shown, for example, that individuals' function and performance are much better when they are in good emotional health than when they are depressed or anxious. (Schapiro 1991; van den Noort S et al 1999) In this module, tools for the assessment, management and treatment of depression are presented.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply assessment tools for depression Develop and apply care plans for depression

Note: Due to the rather protracted referral process, distinct lack of service provision and lack of standardized referral criteria, all countries require increased counseling and psychiatric input, preferably as part of the multidisciplinary team. Furthermore, all MS nurses should become familiar with psychiatric/cognitive nursing literature. Further nursing research in the assessment and management of depression and cognition is required to improve the care provided by the MS nurse in these areas.

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Depression Assess individual's psychosocial well-being using the Multiple Sclerosis Quality of Life Inventory (MSQLI) (see Appendix 4A in Chapter 4) or refer individual to a psychologist/psychiatrist for assessment . Follow care plan for depression (see example in Table 6) Note: Neuropsychometric assessments are not routine and can be difficult to access in many countries. In some centres/clinics, the nurse may not be equipped to assess and/or manage depression or cognitive difficulties, and therefore, referral to a neuropsychologist, psychologist is warranted. Also, remember that MS is not always the cause of psychosocial problems/difficulties.

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Table 6. Care plan for depression.

Nursing Diagnosis Depression due to diagnosis (reactive) Intervention Assess for suicidal ideation Educate and reassure individual of appropriateness of response Involve partner/carer and/or family in interventions Administer depression assessment tools (i.e., Modified Beck Inventory) if appropriate [Note: Use of these tools depends on the individual nurse and his/her own level of knowledge on their use] Inform family physician and consulting psychiatrist of assessment Document all assessments and conversations with the individual Refer patient to local MS Society for support and further information Rationale Depression is treatable, regardless of cause Involving partner/carer and/or family in interventions helps ensure that the individual adheres to treatment Documentation ensures professionalism and provides a record for determining accountability Desired Individual Outcome(s) Experiences no or fleeting suicidal ideation Verbalises understanding that depression is not an unexpected reaction to the diagnosis

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Nursing Diagnosis Depression related to disease process

Intervention Assess for suicidal ideation Involve partner/carer and/or family in interventions Inform general practitioner of diagnosis Document all assessments and conversations with the individual

Rationale Depression is treatable, regardless of cause Involving partner/carer and/or family in interventions helps ensure that the individual adheres to treatment Documentation ensures professionalism and provides a record for determining accountability Other factors may be responsible for depression Depression is treatable, regardless of cause Involving partner/carer and/or family in interventions helps ensure that the individual adheres to treatment Documentation ensures professionalism and provides a record for determining accountability

Desired Individual Outcome(s) Experiences no or fleeting suicidal ideation Verbalises acceptance of the unpredictability of the disease course Verbalises and acknowledges the symptoms of depression and expresses a willingness to seek treatment Verbalises understanding that depression is common in MS

Depression/irritability due to fatigue and/or pain

Assess for suicidal ideation Perform health assessment Assess sleep/rest patterns Perform pain assessment using an appropriate assessment tool or refer to occupational therapist for fatigue/pain assessment Involve partner/carer and/or family in interventions Inform general practitioner and consulting psychiatrist of diagnosis Document all assessments and conversations with the individual

Experiences no or fleeting suicidal ideation Adopts strategies to ensure adequate rest Adopts strategies to reduce pain

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References

Feinstein A. MS and Depression: an etiologic conundrum. Canadian Journal of Psychiatry 1995;40:573-6. Feinstein A. The clinical neuropsychiatry of multiple sclerosis. Toronto. Cambridge University Press; 1999. Halper J, Holland N. Comprehensive nursing care in multiple sclerosis. New York: Demos Medical Publishing; 2003. Sadovnick AD, Remick RA et al. Depression and Multiple Sclerosis. Neurology 1996;46:628-32. Schapiro RT. Multiple sclerosis: A rehabilitation approach to management. New York: Demos Publishing; 1991. van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.; 1999.

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Module 5: Cognition

Introduction

Cognitive changes are also common in MS; they occur in approximately 40­70% of individuals with MS. These changes range from mild to severe in nature and may occur early in the course of the disease and in the absence of physical changes. Even relatively mild deficits can have an impact on individuals' day-to-day lives. Therefore, nominal assessment of cognitive function should be part of the ongoing neurological and nursing assessment of individuals with MS. (van den Noort S et al 1999; Sadovnick 1996) The cognitive functions most commonly affected by MS are short term memory, attention span, concentration, speed of information processing, executive functions, visuospatial perception and construction, and the ability to perform calculations. In many instances, cognitive difficulties are incorrectly attributed to depression or other emotional disturbances. However, proper identification of cognitive problems is necessary for the development of appropriate management and treatment strategies. (Halper et al 1997) In this module, tools for assessing cognitive problems are presented, as is a care plan for the management and treatment of these difficulties.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply assessment tools for cognitive function Develop and apply care plans for cognitive difficulties

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International MS Nursing Care Plan Cognition Evaluate the individual's own perspective on his/her cognitive deficits Refer the individual to a psychologist for the following tests (if necessary): Mini-Mental Exam Standard battery of neuropsychological tests Perceived Deficit Questionnaire (PDQ) of the MSQLI Educate the individual about the above-mentioned tests (if necessary) No pass or fail Results will help the neurologist and/or neuropsychologist determine the cognitive areas that the individual may need assistance in Follow care plan for cognitive difficulties (see example in Table 7) Country-specific issues regarding cognitive assessments in MS are shown in Table 8. Note: Remember that MS is not always the cause of psychosocial problems/difficulties.

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Table 7. Care plan for cognitive difficulties.

Nursing Diagnosis Impaired memory Intervention Provide written instructions as well as other memory aids such as lists, calendars, and daily activity logs Assist individual in reorganising work and home environments so that frequently used items are in familiar places Involve partner/carer and/or family in interventions Poor concentration and/or impaired comprehension Provide quiet environment for learning Provide simple, step-by-step instructions including the "obvious" Complement verbal instructions with written instructions Repeat instructions Ensure educational sessions are short in duration Involve partner/carer and/or family in interventions Quiet environment and simple and repeated instructions enhance learning Verbalises understanding of instructions Rationale Visual aids enhance recall and enable the individual to maintain independence Memory impairment impedes learning Desired Individual Outcome(s) Effectively uses strategies to compensate for impaired memory

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Nursing Diagnosis Impaired speed of information processing or poor abstract reasoning

Intervention Provide safe, non-threatening environment for learning Provide simple, step-by-step instructions including the "obvious" Repeat instructions/information and provide written instruction for important points Introduce change slowly, one step at a time Perform general health assessment Refer for formal cognitive assessment by occupational therapist Refer to occupational therapist for home safety assessment and assessment of work environment Refer for formal driving assessment Involve partner/carer and/or family in interventions

Rationale Quiet environment and simple and repeated instructions enhance learning

Desired Individual Outcome(s)

Demonstrates an understanding of instructions and the ability to carry out newly learned tasks

Impaired visuospatial perception and executive function

Impairments in visuospatial perception and executive function can pose significant safety risks to the individual Formal assessment helps identify specific deficits and allows for the implementation of compensatory strategies and/or possible cognitive rehabilitation Allows family and/or partner/carer to monitor the individual's safety on an ongoing basis

Adopts compensatory behaviours that enhance his/her ability to perform activities of daily living

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International MS Nursing Care Plan Table 8. Country-specific issues regarding cognitive assessments in MS.

Country Ireland United States/Canada Issue(s) The potential role of the occupational therapist in the cognitive assessment of patients with MS is recognized. Neuropsychological assessment is done by Psychologists or a Neuropsychologist. Occupational Therapists and speech and language Pathologists can be very helpful in managing the consequences of the deficits.

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References

Halper J, Holland N. Comprehensive nursing care in multiple sclerosis. New York: Demos Medical Publishing, 2003. Sadovnick AD, Remick RA et al. Depression and Multiple Sclerosis. Neurology 1996;46:628-32. Schapiro RT. Multiple sclerosis: A rehabilitation approach to management. New York: Demos Publishing; 1991. van den Noort S, Holland NJ. Multiple sclerosis in clinical practice. Second edition. New York: Demos Medical Publishing Co. Inc.; 1999.

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Module 6: Sexuality, Family Issues and Pregnancy

Introduction

The private and intimate nature of issues surrounding sexuality makes it difficult for both individuals and healthcare professionals to discuss these issues. Furthermore, individuals may be unaware that sexual problems can be related to MS and may be embarrassed to share their concerns, believing that nurses or other healthcare professionals will somehow think less of them. However, if individuals' concerns about their sexuality go unattended following the initial diagnosis, it becomes more likely that they will never be addressed as the disease progresses. Therefore, MS management should always include an assessment of individuals' sexual functioning from initial diagnosis onward. (Taylor et al 1987; Halper et al 1997; SOGC 1987; SHSBCRS 19978). It is also important to note that sexual dysfunction affects women as well as men. Family issues are also often overlooked during the nursing assessment as individuals may find it difficult to discuss these issues. However, in order to achieve a full understanding of the burden of illness and implement appropriate interventions, it is important for nurses to determine the impact of MS on individuals' families. Furthermore, the nurse plays a significant role in ensuring both individuals and their families remain positive throughout the lifestyle accommodations and adjustments that may be needed throughout the disease process. (Hartrick et al 1995; Aronson et al 1996; Paty et al 1999) Because MS is frequently diagnosed in women of childbearing age, nurses will often find themselves involved with pregnancy issues. Nurses play an important role not only in answering individual's questions about pregnancy and how to cope as a mother with a disability, but also in ensuring that these women are given evidenced-based and upto-date information concerning this specific area of care. In this module, strategies for assessing sexual and family issues are discussed. Care plans for the management of difficulties in these areas are also presented. Information on pregnancy and MS is provided in a question and answer format.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply strategies for the assessment of sexuality and family issues Develop and apply care plans for difficulties related to sexuality and the family Answer individual's questions about MS and pregnancy

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Sexuality Assess own knowledge of human sexuality and evaluate personal attitudes, values, and beliefs towards sex and sexuality (as nurse's own comfort level with sexuality will have a significant effect on the efficacy of interventions) Assess the following: History of the specific sexual problem Perceptions of how MS has affected sexual functioning Marital status/gender(s) of sexual partner(s) Significance of sexual relationship to the individual/spouse/significant other Usual pattern of sexual activity Attitude toward modifying usual sexual pattern Knowledge of available treatment options Assess sexual health using the Sexual Health Assessment Framework (see Table 9) Apply the PLISSIT model (see Figure 2) to guide nursing interventions (this model provides a systematic way of addressing sexual health concerns) Provide the individual with preliminary education based upon the outcome of both the PLISSIT model and the sexual-health assessment and refer individual to the appropriate professional when specific suggestions and interventions are required that are beyond the nurse's level of expertise Follow care plan for individuals who have difficulty discussing sexual issues and needs (see Table 10) Country-specific issues regarding sexuality and MS are shown in Table 11. Note: Remember that MS is not always the cause of psychosocial problems/difficulties.

The importance of addressing sexual issues with tact and openness cannot be overemphasized. In some cases, it may be more appropriate for the patient's general practitioner to consult with the patient regarding sexual issues, particularly if he/she has known the patient longer than the MS nurse.

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Figure 2. The PLISSIT model. When dealing with sexual issues, the PLISSIT model can assist nurses in deciding the level of intervention needed for a particular individual. PLISSIT is an acronym for permission, limited information, specific suggestions, and intensive therapy. These components of the acronym form the levels of the pyramid shown above. Permission, at the base of the pyramid, applies to the majority of individuals, while intensive therapy, at the top of the pyramid, applies to relatively few individuals. (McBride and Rines 2000). Each of these levels is described below in detail. 1. Permission As the foundation of the pyramid, permission is the most important level because it provides an opportunity for individuals and/or their partners to begin discussing their sexual concerns. Permission includes verbally acknowledging individuals' concerns about their sexuality and telling them that these concerns are normal. 2. Limited Information At this level of the pyramid, individuals are asked to discuss their concerns in more detail and are also offered some general information aimed at dispelling myths about sexuality and disabilities. 3. Specific Suggestions At this level, individuals and/or their partners receive specific information in response to their questions and concerns about sexuality. Although this level of intervention requires a broader knowledge base than is needed for the limited information level, nurses can successfully intervene at this level by applying their knowledge of MS to individuals' situations. For example, the nurse may give a particular individual suggestions on how to manage spasticity during sexual activity based on information about what triggers and relieves spasms.

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4. Intensive Therapy This level of intervention requires specialised knowledge and training in the area of sexuality and MS (such as a psychosexual counsellor). Therefore, it may be necessary to refer the individual to a healthcare professional that is more qualified to implement intensive therapy (Eckland and McBride 1997). However, nurses whose area of expertise is sexuality and MS may be able to respond to individuals' concerns at this level. The level of intervention used will vary from individual to individual and will also vary depending on the nurse's comfort level, sexual knowledge, values, and beliefs. Table 9. Sexual Assessment Framework. Adapted from Szasz 1989

This framework can assist nurses in identifying individuals' sexual concerns and can also be used to guide nursing assessments and interventions for managing changes to sexuality resulting from MS. (McBride and Rines 2000; Eckland and McBride 1997; Szasz 1989; Breen and Rines 1996)

Assessment Sexual knowledge Description Determine the individual's understanding of changes to sexuality that result from MS Determine the individual's values and beliefs about sex and sexuality Do not make any assumptions regarding the individual's knowledge or values; always clarify the individual's perceptions of the impact of MS on sexual function and sexuality Determine the individual's sexual self-view (i.e., individuals with MS may remain sexual but may be challenged to define their sexual self-view; for example, prior to requiring a wheelchair, individuals may view persons in wheelchairs as not being sexual; this belief will influence how individuals may view themselves if they require a wheelchair) Determine the individual's ability to engage in sexual activity by assessing motor abilities, balance, strength, and bowel and bladder function Determine whether activities such as dressing and undressing, transferring, and affectionate activities such as hugging and petting need to be re-examined Instruct the individual on new positions and techniques; instruction will need to be individualised according to individuals' comfort level, interests, and physical abilities; this function may require referral to a specialist in sexual health Determine the individual's sexual response Sexual response in women refers to general physiological changes (e.g., increased heart rate and blood pressure, skin flush) as well as genital vasodilatation, vaginal lubrication, nipple erection, and orgasm (Breen and Rines 1996) Sexual response in men includes general physiological changes (as above), penile erection, testicular elevation, pre-ejaculation, ejaculation, and orgasm Changes to sexual response will vary greatly from individual to individual and are dependent upon the level of disability Determine the individual's ability to initiate or maintain social/sexual relationships; maintaining such relationships is a fundamental concern for most individuals More detailed assessments of the individual's values and beliefs, social and communication skills, and sexual history may be needed Assess whether the individual's partner has assumed any care-giving activities that may threaten the individual's role as a lover

Sexual self-view

Sexual activity

Sexual response

Sexual interest and behaviour

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Table 10. Care plan for individuals who have difficulty discussing sexual issues and needs.

Intervention

Provide an open, non-judgmental atmosphere for discussion

Rationale

Facilitates open expression of feelings about perceived changes in sexuality

Expected Individual Outcome

Effectively communicates sexual concerns and needs Expresses actual or perceived limitations imposed by MS and openly verbalises feelings regarding changes in sexual identity Effectively communicates sexual concerns and needs Expresses actual or perceived limitations imposed by MS and openly verbalises feelings regarding changes in sexual identity Effectively communicates sexual concerns and needs Expresses actual or perceived limitations imposed by MS and openly verbalises feelings regarding changes in sexual identity

Ensure privacy

Conveys respect for the individual and the sensitive nature of the individual's concerns

Ask the individual's permission before moving on to an area of assessment (e.g., "Is it okay if I ask you some questions about the sexual part of your life?" Later on in the interview ask, "May I ask about what changes you've experienced in body sensations?") Begin with general questions and then move to more specific questions Use neutral language

Conveys respect for the individual and the sensitive nature of the individual's concerns

Conversation should progress from the least sensitive areas to most sensitive areas (e.g., ask about changes in bladder and bowel function before asking about changes in sexual function) (McBride and Rines 2000) Allows individual to express concerns without fear of being judged Neutral words such as "partner" facilitate a more open discussion of sexual concerns ­ regardless of sexual orientation ­ than words such as "husband" or "wife" Neutral phrases such as "changes in erections" have less of a negative impact on individuals' self-esteem than words such as "impotence"

Effectively communicates sexual concerns and needs

Demonstrates an increased understanding of the limitations imposed by MS Expresses a willingness to seek more expert assessment and treatment Demonstrates an improved level of knowledge of available options

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Intervention

Normalise and validate the individual's concerns (e.g., say, "Many people feel this way" or "Women often ask that question.") Provide reassurance based on facts

Rationale

Ensures that the individual does not feel alone or unusual for having sexual concerns

Expected Individual Outcome

Demonstrates an improved self-perception of desirability and self-image Explores alternate sexual behaviours/patterns Demonstrates an improved understanding of the limitations imposed by MS

Kind words that are not based on factual information may instil false hope in the individual (McBride and Rines 2000)

Other general interventions include: Providing patient and partner with appropriate educational materials/booklets on sexuality and MS Referring patient/partner to MS Society on Sexuality.

Table 11. Country-specific issues regarding sexuality and MS.

Country Saudi Arabia United Kingdom Issue(s) Due to the Saudi Arabian culture, male patients will not discuss sexual issues with a female nurse, only with a male consultant. Clinics specializing in sexual function are available and provide patients with valuable resources. Pharmacological agents for the treatment of sexual dysfunction are also used (eg, Viagra®). Support groups for gay members of the MS community are available. Clinics specializing in sexual function are available and provide patients with valuable resources. Pharmacological agents for the treatment of sexual dysfunction are also used (eg, Viagra®). Support groups for gay members of the MS community are available.

United States/Canada

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International MS Nursing Care Plan Family Issues Assess family coping behaviours and problem-solving techniques Assess family support system (e.g., spiritual practices) Assess family activities and financial resources Assess assumed and/or expected family roles and the impact MS has on these roles Assess the perceived impact of MS on the family's assumed and expected roles Assess family interaction and communication patterns, including expressions of: Anger Fear Despair Affection Assess family members' level of understanding and knowledge of MS Encourage the expression of feelings related to perceived or potential losses and determine the impact of these feelings on the family's well-being Encourage patients/families/partners/caregivers to attend support groups Follow care plan for difficulties related to family issues (see example in Table 12) Note: Remember that MS is not always the cause of psychosocial problems/difficulties .

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Table 12. Care plan for difficulties related to family issues (Taylor et al 1987; Hartrick et al 1995; Aronson et al 1996; Paty et al 1999; Hyde et al 1986; Amason et al 1995).

Nursing Diagnosis Grief Underlying Cause Loss of "normal" family unit Intervention Encourage family to identify source of fear Educate family (including children) on MS Refer family to appropriate counsellor and to family and community support groups Assist individual and family in understanding the grieving process Ensure individual and family understand that feelings of grief are "normal" under the circumstances Refer for family counselling and/or to support groups Provide family (including children) and individual with outlets for expressing anger Educate family (including children) and individual with respect to positive coping strategies Refer for family counselling and/or to support groups Educate family (including children) on disease process Rationale Identifying the source of fear reduces the likelihood that the nurse will implement ineffective interventions by making false assumptions about the source of fear Education and support help the family cope with MS Expected Individual and Family Outcome(s) Use supports to reduce fear Communicate feelings of comfort and understanding Develop or refine coping strategies that enable them to adapt to the demands of the illness without destroying family balance

Anger

Diagnosis of a chronic illness

Recognition of anger leads to the development of more positive coping strategies

Vent anger in a positive fashion

Fear

Related to the uncertainty of future events

Improved knowledge reduces fears

Demonstrate an improved understanding of the disease process Fear future events less

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Nursing Diagnosis Guilt

Underlying Cause Disease pathogenesis or process itself

Intervention Allow expression of guilt Provide reassurance Ensure individual and family (including children) understand that feelings of guilt are "normal" under the circumstances Refer for family counselling and/or to support groups Assess family's knowledge of the disease and disease process Educate the family (including children) on the diagnosis and the disease process Provide family with the opportunity to express their interpretation of the individual's situation Acknowledge denial as a reasonable response to a potentially devastating diagnosis Support individual through the disease process Refer for family counselling and/or to support groups

Rationale Expression and alleviation of guilt help maintain healthy family dynamics

Expected Individual and Family Outcome(s) Demonstrate an increased understanding of the disease process Acknowledge that guilt is an allowable emotion Understand that the individual acquiring the disease was no one's fault

Denial

Refusal to acknowledge disease process

Refusal may be due to lack of information Understanding the family's own interpretation of the individual's situation reduces the possibility that the nurse will make erroneous assumptions when planning appropriate care Acknowledging denial legitimises the family's initial response as acceptable under the circumstances Education and support improve the family's understanding of MS and their response to the disease Reinforces the family's acceptance of individual responses to MS Provides an opportunity to revisit the potential problematic responses to denial and promotes future acceptance of the disease

Acknowledge disease Increase level of trust in the nurse Facilitate opportunity to revisit potential problematic response to denial and promote future acceptance of the disease

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International MS Nursing Care Plan Pregnancy and Childcare Note: Advice regarding contraception must be documented. Because MS is frequently diagnosed in women of child-bearing age, nurses are often asked specific questions to do with both pregnancy and childcare. Nurses play a vital role as an educator of patients and their families and the following is written in a question and answer format to assist nurses when discussing these particular issues. Country-specific issues regarding pregnancy in MS are shown in Table 13. Will I pass MS on to my child? MS is not an inherited condition, although there is a slightly higher chance of your child developing the disease compared to the average population. The risk to a child with a parent who has MS is estimated at between 1 and 4%, but this is considered low and should not discourage you and your partner from having a family. Rationale: Although MS is not inherited, and in the majority of cases affects just one member of the family, approximately 20% of people with MS will have another family member with the condition (Sadovnick et al 1993). In the general population the risk of MS is approximately 0.1%, but for a person whose sibling or parent has MS, this increases to a 2-4% chance of developing the disease. This risk is considered low, and as the genes involved in MS have not been identified, there is no genetic test available. During the pre-conception period, the family incidence will obviously need to be discussed and the couple counselled accordingly. Will having a baby make my MS worse in the long term? No. There have been a variety of studies carried out in this particular area showing that pregnancy does not alter the long-term course of MS. Rationale: Prior to 1949 neurologists advised women with MS not to become pregnant because they would be unfit mothers, their MS would get worse, they would become more disabled, and they would pass the disease on to their child. There was no data to support or refute this practice, which was based more on anecdotal testimony than scientific evidence. It is now accepted that these beliefs are clinical myths (which occasionally, even now, are reported by women with MS!). A landmark study was published in 1950 demonstrating there was no substantial evidence that pregnancy affected levels of disability, and advice given to women wanting to become pregnant began to change. There is evidence that women will forego pregnancy once a diagnosis of MS is made (Damek and Shuster 1997), even though it is now established that the long-term course of MS is unaffected by pregnancy (Thompson et al 1986, Rouillet et al 1993, Confavreux et al 1998). There have been numerous reputable studies published examining the effect of MS on pregnancy and in particular the

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International MS Nursing Care Plan incidence of relapses. Most of these studies have focused on women who have a mild form of relapsing remitting disease and, are generally able to care for themselves and as a consequence, these results cannot be generalised to women with more progressive disease. Will MS affect my fertility? No. It is well established that MS does not affect fertility, conception or gestation, nor does it affect the chances of a baby being born with abnormalities. There is no evidence that MS causes an increase in ectopic pregnancies or has any effect on your chances of miscarriage or premature birth. The birth weight of your baby will be unaffected. Rationale: Infertility is no more common in women with MS than the general population (Confavreux et al 1998). This particular study also demonstrated that MS does not have any adverse effects on the either the pregnancy, the delivery or the unborn child (other than the familial link as previously mentioned). Although the disease does not have any direct effect on fertility, the frequency of childlessness is significantly greater in people with MS than the general population (Runmarker and Andersen 1993) and it is commonly accepted that women severely disabled by MS choose to not become pregnant. The other issue to consider is that sexual dysfunction is common in women with MS and again, whilst this does not affect biological fertility, it is known that MS can reduce sexual libido and orgasmic capacity (Hulter and Lundberg 1995), which may have an impact on sexual relationships and hence chances of conception. Am I likely to have a relapse during my pregnancy? Relapse rates are often affected during pregnancy and the first few months after delivery. Your risk of relapse during early pregnancy will probably not alter, but you are at a lower risk of relapse during the later months of pregnancy. However, you should be aware that the chance of having a relapse in the first few months after the birth is high. Once your baby is 6 months old, your relapse rate will have returned to its pre-pregnancy rate. Overall, the number of relapses you experience in the 12 month period of your pregnancy and the immediate time after, is considered to be the same as the 12 months prior to your pregnancy. Rationale: In 1984 an Israeli study (Kom-Lubetzi et al) was one of the first to demonstrate that relapse rate in the third trimester of pregnancy was significantly reduced, although there was a significant increase in relapses in the first 3 months postpartum. Other studies published since have supported this finding (Birk et al 1990, Rouillet et al 1993, Confavreux et al 1998). Women are therefore advised that there is a trend towards lower relapse rate during the third trimester of pregnancy but they face an increased risk of experiencing a relapse during the post-partum period. Confavreux et al

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International MS Nursing Care Plan (1998) also demonstrated that disease activity, as shown by MRI scanning, was reduced particularly during the third trimester, but does increase again in the first 3 months post-partum (Bashir and Whitaker 2002). However, because the relapse rates decline during the 9 months of pregnancy, but then generally increase in the first 3 months post-partum, the overall effect of pregnancy on MS is considered neutral. These changes are thought to be due to the relationship between the endocrine and immune systems. It is believed that oestrogen inhibits T-cell mediated diseases such as MS by altering T-cell activation, reducing the production of pro-inflammatory cytokines, and interfering with maturation of macrophages (Houtchens et al 2000). These changes explain why the relapse rate decreases late in pregnancy, when oestrogen production is high, and also the two to three fold increase in relapse rate post delivery when oestrogen levels plummet (Confavreux et al 1998). In one study (Achiron 1996), women who had previously experienced childbirth associated relapses were given prophylactic treatment with intravenous gamma globulin. This treatment was found to significantly reduce their risk of relapse postpartum in a subsequent pregnancy. The UK is currently participating in a European trial to determine whether the results of this study can be replicated on a larger scale. Will pregnancy make my current symptoms worse? Most women with MS feel well during the pregnancy and the majority will complete it with no new problems. However, for a few women there is a possibility that some symptoms they already experience such as fatigue and bladder problems, may increase. However, this is individual and any changes or increase in symptoms should be discussed with either your midwife, MS nurse, Obstetrician or GP. Rationale: Although women with MS are generally well during pregnancy, some symptoms may be exacerbated, and may be difficult to distinguish from pregnancy symptoms (Smeltzer 1994). Women should be warned of these possibilities when contemplating a pregnancy. Fatigue is extremely common in MS, and frequently occurs in early pregnancy in healthy individuals. It is therefore to be expected that fatigue will be exacerbated in women with MS, particularly in the first trimester. Bladder symptoms, e.g., frequency and urgency, may increase because of pressure on the bladder from the gravid uterus. Similarly, in late pregnancy, mobility problems can worsen, due to the increasing weight of the foetus and changes to posture. What about the medication I am on at the moment? This should be discussed with your GP or Neurologist. As some medications are harmful to the baby during pregnancy, you may be advised to come off them, or have an alternative treatment prescribed before you become pregnant.

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International MS Nursing Care Plan Many of the medications used to treat multiple sclerosis symptoms are contraindicated during pregnancy, e.g., Amitriptyline, Carbamazepine, Oxybutynin, and women require accurate advice on withdrawing certain treatments and hence managing their symptoms or disease prior to conception. Can I receive steroids if I have a relapse during pregnancy? Steroids are best avoided in pregnancy where possible, but under certain exceptional circumstances (e.g., severe relapse) your neurologist and yourself may decide that the benefits outweigh the small risks. Current advice is that steroids should be avoided in the first trimester of pregnancy because of the possibility of congenital abnormalities, e.g., cleft palate, although the evidence for this is not convincing (British Medical Association, Royal Pharmaceutical Society of Great Britain 2001). Prolonged or repeated courses of steroids may lead to intrauterine growth retardation. Prednisolone crosses the placenta in much smaller quantities than Dexamethasone (British Medical Association, Royal Pharmaceutical Society of Great Britain 2001). As steroids are known only to hasten recovery from relapses, and do not influence outcome, it is rarely essential that they are used in MS. (See case study 1).

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International MS Nursing Care Plan Case Vignette 1 Jenny a 24-year-old lady is married to Joe. She was diagnosed with MS 12 months ago. At her diagnosis, she asked the consultant whether she could become pregnant. His reply was yes, but `sooner rather than later'. Joe contacts you to say that Jenny is experiencing a major relapse and she is now 11 weeks pregnant. They are overjoyed at the pregnancy, but are now frightened and anxious about Jenny's condition. She is currently a patient in a small district hospital unable to walk more than a few steps, she is ataxic and experiencing regular falls. She is unable to care for herself and is dependent on others for all activities of daily living. She is having problems swallowing food and drink and the speech therapist is due to see them to discuss the insertion of a naso-gastric tube. The situation is made worse by the fact that Jenny is slightly confused and keeps forgetting she is pregnant. Joe asks you whether Jenny should have a course of steroids to treat her relapse. This treatment has been offered to them, but Joe is anxious that there is a risk to the baby. Joe feels that he has to make the decision regarding steroids on behalf of Jenny, as she is not capable of deciding for herself. After much discussion with relevant healthcare professionals, it was decided that Jenny should not receive steroids. Despite experiencing such a disabling relapse, this medication would not alter, in the long term, the degree of her recovery. It took 5 weeks before Jenny was discharged home, but she did make a good recovery. She is now 36 weeks pregnant and the rest of the pregnancy has been uneventful. What about receiving steroids when I am breastfeeding? Steroids can appear in small quantities in breastmilk, especially in the high doses used to treat relapses. It may therefore be advisable that you do not breastfeed whilst receiving a course of steroids. Some mothers will express extra milk prior to commencing the course of steroids, which can be kept in the fridge or freezer and be given to your baby while you are having treatment. You may want to discuss this with an appropriate healthcare professional, e.g., health visitor or MS Specialist Nurse.

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International MS Nursing Care Plan I am taking a disease modifying drug (Beta Interferon or Copaxone) but want to become pregnant what should I do? You are advised to discontinue treatment approximately 3 months prior to having unprotected sex. You can recommence it again after the baby is born, but neither of these drugs should be taken if you are going to breastfeed. Rationale: Women taking Beta Interferon are advised to discontinue the treatment approximately 3 months before they stop taking contraception. Neither of these drugs has been formally tested for their safety in either women wishing to become, or are already pregnant. Whilst there have been reported cases of women having normal pregnancies and healthy babies who continue on Beta interferon and Copaxone it is not recommended (Hutchinson 1997). Women are also advised not to breastfeed if taking these drugs (British Medical Association, Royal Pharmaceutical Society of Greta Britain 2001). Will my MS affect either my labour and/or delivery? Usually no. Even if you experience fatigue, the best advice is that whenever possible you should have a normal delivery and not opt for a caesarean section. Rationale: Women often express concerns about an instrumental delivery or caesarean section, but in reality, women with MS rarely need to be treated differently. Certain circumstances dictate careful consideration, e.g., fatigue is common in MS, and could potentially interfere with the second stage of labour, hindering active pushing. Although this is more likely if the first stage of labour is lengthy, it is no justification for shortening labour artificially (e.g., by augmenting with Syntocinon). For some women, lower limb weakness or spasticity may mean that it is difficult to have an active labour, or to assume certain positions for delivery, e.g., squatting. This should be discussed by the midwife and obstetric physiotherapist in the antenatal period, and the use of equipment and alternative positions explored (see case study 2). There are no absolute contraindications for any of the usual pain relief options during labour, i.e., TENS, entonox, pethidine, epidural anaesthesia. However, there is the possibility of TENS machines exacerbating lower limb spasms in some women with MS. Although epidural anaesthesia has in the past been implicated as the cause of relapses, a recent study confirmed that there are no adverse effects on MS (Confavreux et al 1998). Needless to say, it is of great benefit for women with MS to be cared for in labour by a midwife who knows them, and their physical limitations, well.

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Case Vignette 2 Sally, aged 28, has secondary progressive MS with weakness and stiffness in the lower limbs affecting her mobility. Prior to her first (planned) pregnancy she withdrew antispasmodic medication on medical advice, but suffered increased spasms. Late in pregnancy she experienced spasms of the hip adductor muscles (on the inside of the thighs), which made abducting the legs difficult. Obviously, changing position during labour, and delivering the baby in the traditional semi-recumbent position would be hard. Prior to delivery the midwife and obstetric physiotherapist worked with Sally to explore alternative delivery positions. She eventually had a full-term normal delivery (without analgesia) in the left lateral position, with her husband supporting the right leg. Will I pass MS on to my baby if I breastfeed and will it make my MS worse? You cannot pass on MS through breast milk. Breastfeeding will have no negative effects on either yourself or your baby. In fact, one study suggested that breastfeeding may have a positive effect on the disease and MS activity may possibly slow down if you breastfeed, however this is still under investigation and, as yet, cannot be confirmed. If you have problems with numbness or weakness in your arms or hands, you may find it is difficult to position the baby when you are breastfeeding and may need assistance. Again discuss any problems such as this with your midwife or MS nurse, who may be able to make suggestions. The other symptom that may affect your ability to breastfeed is fatigue. All new mothers face the prospect of fatigue and this will be more likely for a mother who has MS. Again, it is important that you discuss concerns such as these with the professionals who are caring for you. They will be able to offer you advice in an attempt to limit its effect on your day to day living. Rationale: Mothers should be reassured that there is no danger of transferring MS through breast milk. It has been established that breastfeeding does not have any adverse effects on disease course. Confavreux et al (1998) even noted that there was a trend towards less disease activity with breastfeeding. Unfortunately the numbers were too small to reach any statistical significance

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International MS Nursing Care Plan How will I cope once the baby is born? If you have relapsing remitting disease you stand a higher risk of having a relapse in the first 3-6 months after the baby is born. The relapse may be more severe than those you normally experience (Worthington et al 1994). This is important to consider when planning for the baby as you will need to arrange extra support from your family and friends during this time. By 6 months after the birth, your relapse rate should return to your pre-pregnancy rate (Worthington et al 1994, Confavreux 1998). Are there any support groups for mothers with disabilities? There are several organisations that provide a variety of relevant information and practical assistance for disabled parents. Topics covered include: Information on childbirth Practical parenting tips Peer support Equipment ideas for disabled parents (e.g., clothing, cribs, cots, lifting, carrying and transporting the child, feeding, bathing and changing issues) Useful publications, videos Newsletters Networking (the opportunity to link up with other disabled parents in your area) Campaigning to improve services for disabled people Most of these support organisations also provide information and act as a resource for professionals. A list of organisations, publications and websites are given in Table 14. Table 13. Country-specific issues regarding pregnancy in MS.

Country Italy Portugal Russia Issue(s) There are currently clinical trials evaluating the efficacy of IV Ig in minimizing severe postpartum relapses. Treatment is discontinued 1 year prior to pregnancy. Some neurologists discourage pregnancy; this may be due to traditional views and failure to keep abreast of current research in this area.

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Table 14. Support for mothers with disabilities

Organisation/ Publication/ Website Disability, Pregnancy and Parenthood international DPPi Disabled Parents Network Contact information/ website National Centre for Disabled Parents Unit F9, 89-93 Fonthill Road London N4 3JH Tel no: 020 7263 3088 www.dppi.org.uk National Centre for Disabled Parents For address see above Tel no: 08702 410 450 www.DisabledParentsNetwork.org.uk Alexandra House Oldham Terrace, Acton London W3 6NH Tel no: 0208 992 8637 c/o National Childbirth Trust For address see above 12 City Forum, 250 City Road London EC1V 8AF Tel no: 0207 2503222 www.radar.org.uk www.disabledparents.net www.nursing.villanova.edu/ womenwithdisabilities/Parenting/ coverpage.html MS Society, London Available from: Radcliffe Medical Press Ltd. 18 Marcham Road, Abingdon Oxon OX14 1AA Tel no: 01235 528820 Overview This is a national organisation of disabled parents or people who hope to become pregnant. Offers a network with other disabled parents, practical helpline (0800 018 4730), a newsletter, backing for parents who are having difficulties, training for professionals. UK nationwide network of disabled parents, aiming to build up local and national networks of peer support, increase public awareness, and work for improvement in services. Information is available on tape, computer diskette or large print upon request. Provides information, publications, and networks. There are branches throughout the country. Also provides ante- and post-natal groups. This is a branch of the National Childbirth Trust. It supports the rights of disabled people to be well resourced for the tasks of parenting. Range of information and publications. Campaigns for better lifestyles for people with disabilities and their families. Useful website for information on disabled parenting. Hosts international peer support and email network of disabled parents. This is a US website designed to address health related information for women with disabilities. It advocates the rights of disabled women. There is a specific section on pregnancy and parenting issues providing practical tips and support. MS Society Leaflet By Michelle Wates. Published in association with the N.C.T.

National Childbirth Trust

ParentAbility Radar

Parents with Disabilities online Women with Disabilities

Pregnancy Factsheet (2001) Disabled Parents: Dispelling the Myths

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Summary

There is a wealth of evidence-based information, and invaluable support networks available for people with MS who aspire to start a family. Despite this, people continue to receive outdated or inaccurate advice, and are unaware of services or organisations which could benefit them. Consequently prospective parents with MS may feel unnecessarily isolated, lonely or anxious, or even relinquish having a family. Providing care and information in this situation can be satisfying for the healthcare professional as the outcomes can be very positive. Healthcare professionals can do much to dispel myths and allay fears, thus empowering people with MS to approach pregnancy and parenthood well equipped and with confidence.

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References

Achiron A., Rotstein Z, Noy S et al. Intravenous Immunoglobulin treatment in the prevention of childbirth-associated acute exacerbations in multiple sclerosis. Journal of Neurology 1996;243:25-28. Amason B, Bates D, Battaglia M, Choi T, Ebers G, Enteen R, et al. Psychosocial factors in multiple sclerosis. Presentation made at the MS Forum Modern Management Workshop; April 1995; Rome, Italy. Annon JS. Behavioral treatment of sexual problems. New York: Harper & Row; 1976. Aronson KJ, Goldenberg E, Cleghorn G. Socio-demographic characteristics and health status of persons with MS and their caregivers. MS Management 1996;3:3-5. Bashir K, Whitaker JN. Handbook of Multiple Sclerosis. Lipincott Williams and Wilkins 2002. Birk K, Ford C, Smeltzer S, Ryan D, Miller, Ruddick RA. The clinical course of multiple sclerosis during pregnancy and the pueperium. Archives of Neurology 1990;47:738-742. Breen S, Rines B. Sexual health care in British Columbia: A model of service delivery. SCI Nursing 1996;13:2-5. British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. BMA. London 2001. Confavreux C, Hutchinson M, Hours M et al. Rate of pregnancy-related relapse in multiple sclerosis. New England Journal of Medicine 1998;339:285-291. Damek DD, Shuster EA. Pregnancy and multiple sclerosis. Mayo Clin Proc 1997;72:977-989. Eckland M, McBride K. Sexual health care: The role of the nurse. Can Nurse 1997;93:34-37. Halper J, Holland N, editors. Comprehensive nursing care in multiple sclerosis. New York: Demos Vermande; 1997. Hartrick GA, Lindsey AE. The lived experience of family: A contextual approach to family nursing practice. J Fam Nurs 1995;1:148-170. Houtchens M, Gregori N, Rose J. Understanding fluctuations of multiple sclerosis across the Menstrual Cycle. International Journal of MS Care 2000;2(4):2.

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International MS Nursing Care Plan Hulter B, Lundberg P. Sexual function in women with advanced multiple sclerosis. Journal of Neurology, Neurosurgery and Psychology 1995;59:83-86. Hutchinson M. Does pregnancy make multiple sclerosis better or worse? In: Thompson AJ, Polman C, Hohlfeld R, (eds). Multiple Sclerosis: Clinical Challenges and Controversies. London: Martin Dunitz; 1997:121­129. Hyde JS, Delamater JD. Understanding of human sexuality. New York: McGraw-Hill; 1986. Kom-Lubetzki I, Kahana E, Cooper G et al. Activity of multiple sclerosis during pregnancy and peuperium. Annals of Neurology 1984;16:299-231. McBride K, Rines B. Sexuality and spinal cord injury: A road map for nurses. SCI Nursing 2000;17:8-13. Paty DW, Hartung H, Ebers GC, Soelberg-Sorensen P, Abramsky O, Kesseiring J et al. Management of relapsing-remitting multiple sclerosis: Diagnosis and treatment guidelines. Eur J Neur 1999;6(Suppl 1): S1-S35. Rouillet E, Verdier-Tallefer MH, Amarenco P, Gharbi G, Alperovitch A, Mateau R. Pregnancy and multiple sclerosis: a longitudinal study of 125 remittent patients. Journal of Neurology, Neurosurgery and Psychiatry 1993;56:1062-1065. Runmarker B, Andersen O. Pregnancy is associated with a lower risk of onset and a better prognosis in multiple sclerosis. Brain 1993;118: 253-261. Sadovnick A et al. A population based study of multiple sclerosis in twins: update. Annals of Neurology 1993;33(3):281-285. Sexual Health Service of the British Columbia Rehabilitation Society (SHSBCRS). Mission Statement. Vancouver: Vancouver Hospital & Health Sciences Centre, 1997 1998. Smeltzer S. The concerns of pregnant women with multiple sclerosis. Qualitative Health Research 1994;4(4):480-502 Social and Sexual Issues Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC). Sexuality and The Disabled. SOGC Bulletin. March/April, 1987. Szasz G. Sexuality in persons with severe physical disability: A guide to the physician. Can Fam Physician 1989;35:345-351. Taylor CM, Cress SS. The indispensable care plan guide: Nursing '87 nursing diagnosis cards. Springhouse (PA): Springhouse Corporation; 1987.

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International MS Nursing Care Plan Thompson DS, Nelson LM, Burns A et al. The effects of pregnancy in multiple sclerosis: a retrospective study. Neurology 1986;36:1097-1099. Worthington J, Jones R, Crawford M, Forti A. Pregnancy and multiple sclerosis--a 3year prospective study. J Neurol 1994;241(4):228-33.

Suggested Readings

Kalb RC. The impact of multiple sclerosis on the family. Int MS J 1996;3:65-69. Burgess M. Sexuality and Pregnancy, Chapter 7. In: Multiple Sclerosis: Theory and Practice for Nurses. London: Whurr; 2002.

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Module 7: Financial and Vocational Issues

Introduction

Financial and vocational issues are not always thoroughly examined during medical visits as many healthcare professionals believe they can play only a limited role in addressing these issues. However, when collected in a systematic way, financial and vocational information can be used to identify and successfully manage psychosocial issues. (O'Connor and Eggert 1994) Assessments of individuals' financial and vocational status should include detailed evaluations of the following: Source of income Individual's social support networks Nature of the individual's current occupation Impact of MS on the individual's ability to fulfil vocational roles Issues regarding transportation and accessibility Accommodations made by employers to create an accessible environment and modify the individual's vocational duties Knowledge of resources that can assist the individual financially during relapse events Nurses should also be cognisant of: legislation and services that support the employment of persons with disabilities; Disability Rights Act; Disability Discrimination Act and government-linked financial support programmes available through disability living allowance, etc. In addition, nurses should inform individuals and their families that there may be local community/employee support programmes that may help address issues specific to their situations (Friehe et al 1996; McLaughlin 1998). To find out more about these, it is best to contact the Citizens Advice Bureau (CAB) or the local branch of the MS Society. It may also be useful to search internet websites for local resources. Beyond the financial aspect of gainful employment, many patients find the social contribution associated with employment to be important. Therefore, even voluntary work is an important consideration for patients with MS. People with MS need to be advised they have to contact the Driving Vehicle Licensing Association (DVLA) that they have been given this diagnosis. The DVLA will send through relevant forms for the patient to complete and will also request a neurology report. People with MS also need to inform insurance companies regarding their diagnosis.

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International MS Nursing Care Plan In this module, tools for assessing vocational and financial difficulties are discussed and a care plan for managing these difficulties is presented.

Learning Objectives

After completing this module, the reader will be able to: List tools for the assessment of financial and vocational issues Develop and apply care plans for financial and vocational difficulties

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Financial and Vocational Issues Implement care plan for anxiety/anger resulting from financial and/or vocational difficulties (see example in Table 15) Country-specific issues regarding financial and vocational issues in MS are shown in Table 16.

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Table 15. Care plan for anxiety/anger resulting from financial and vocational difficulties.

(O'Connor and Eggert 1994; Friehe et al 1996; McLaughlin 1998; Gulick 1991; Gulick 1997; Burgess 2002)

Underlying Cause(s) of Anxiety/Anger Reduced social/financial status, earning potential, ability to work and/or inability to work at a regular job Intervention Identify individual limitations Direct individual to appropriate resources: - Job Centre - National patient societies e.g. MS Society, MS Trust - Social worker/ - Local social-service offices - Housing referral - Income support - Tax credits Refer individual to the appropriate rehabilitation or vocational services Rationale Allows nurse to verify individual's perceived limitations Guiding the individual through the social/employment system empowers the individual to take the measures necessary to ensure personal well-being Expected Individual Outcome(s) Expresses specific limitations in ability to perform vocational roles Contacts appropriate resource (as dictated by the individual's specific needs) Understands how MS may alter social and vocational functioning Accepts limitations and implements strategies to improve quality of life Helps the individual come to terms with the losses imposed by MS by providing a structure within which the individual's capabilities are assessed and matched to an appropriate activity or type of work Expresses a willingness to attend vocational assessment programmes Attends referral to a rehabilitation/vocational service and participates in programmes structured to determine specific capabilities

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Underlying Cause(s) of Anxiety/Anger Discrimination and prejudice in the workplace

Intervention Provide individual with an opportunity to express feelings and describe events that were deemed discriminatory Determine whether discrimination was an isolated event Determine whether the discriminatory event was due to the behaviour of a single person (e.g., colleague or superior) Determine whether services in the workplace exist that address the individual's concerns and encourage the individual to make the appropriate report Refer individual to a social worker or citizens advice bureau for further guidance Direct individual to a local ombudsman/human rights centre Inform individual of legislation and services supporting the employment of persons with disabilities

Rationale Allows individual to express feelings about a discriminatory incident Validates the individual's right not to expect discriminatory treatment based on disability Clarifies details of the discriminatory event Social workers can implement strategies to help the individual cope with anger, anxiety, and frustration Education about legal rights empowers the individual to secure these rights Collaboration with large organisations dedicated to meeting the quality-of-life needs of individuals with MS helps identify common concerns and influence public-policy-making initiatives

Expected Individual Outcome(s)

Aware of rights Expresses satisfaction or a sense of achievement as demonstrated by avoidance of helpless behaviours and appropriate expression of anger

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Underlying Cause(s) of Anxiety/Anger Financial difficulties

Intervention Examine the individual's financial needs and how well these needs are currently being met Discuss the availability of alternate financial support (e.g., family, friends, benefits, occupational pension) Inform individual of possible eligibility for financial assistance e.g. DLA, incapacity, income support etc. Refer individual to financial assistance services e.g. CAB, Welfare Rights Inform individual of Disability Rights Act.

Rationale Identification of the individual's specific financial needs helps to develop realistic individual expectations about available resources Knowledge of financial services and resources may help the individual achieve greater financial independence

Expected Individual Outcome(s) Identifies areas of financial need and available financial resources Follows up on suggestions to contact social services, a social worker, and/or other appropriate community resources

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International MS Nursing Care Plan Table 16. Country-specific issues regarding financial and vocational issues in MS.

Country Russia Turkey United Kingdom Issue(s) Most patients have difficulty obtaining social welfare due to mismanagement of resources. There is no social welfare; therefore, the patient/family must provide all financial support. Nurses require more training on employment benefits and disability rights. MS Society courses for employment advice are available.

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References

Burgess M. Health Promotion and self-management for people with MS, Chapter 10. Diagnosing MS. In: Multiple Sclerosis: Theory and Practice for Nurses. London: Whurr; 2002. Friehe M, Anune B, Leuenberger J. Career service needs of college students with disabilities. Career Develop Quart 1996;44:289-300. Gulick EE. Reliability and validity of the work assessment scale for persons with multiple sclerosis. Nurs Res 1991;40:102-112. Gulick EE. Correlates of quality of life among persons with multiple sclerosis. Nurs Res 1997;46:305-311. Kubler-Ross E. On Death and Dying. 1st ed. New York: Macmillan; 1969. McLaughlin CM. Community programs and resources for persons with multiple sclerosis. Phys Med Rehab Clin North Am 1998;9:689-702. O'Connor FW, Eggert LL. Psychosocial assessment for treatment planning and evaluation. J Psychosoc Nurs 1994;32:31-42.

Suggested Readings

Gulick EE. Model for predicting work performance among persons with multiple sclerosis. Nurs Res 1992;41:266-272. Holland N, Wiesel-Levison P, Madonna M. Community care of the individual with multiple sclerosis. Rehab Nurs 1984;9:18-20. Klaib RC. Multiple sclerosis: The questions you have. The answers you need. New York: Demos Publications; 1996. Lundmark P, Branholm IB. Relationship between occupation and life satisfaction in people with multiple sclerosis. Disab Rehab 1996;18:449-453. Verdier-Tailefer MH, Sazdovitch V, Borgel F, Cesaro P, Kurtz A, Millet MT, et al. Occupational environment as risk factor for unemployment in multiple sclerosis. Acta Neur Scand 1995;92:59-62.

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Progress Check

1. List five (5) objectives of the nursing interview.

a. b. c. d. e.

________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________

2. Match the crisis stage to the appropriate description. Stage Reaction Re-orientation Shock Restoration Description Individual experiences extreme confusion and inner turmoil, but appears calm on the surface. Individual begins to look to the future. Individual may resort to many primitive defence strategies such as denial, projection, and regression. The individual learns to live with MS and the limitations relating to the disease.

3. List seven (7) interventions for depression due to fatigue and/or pain. a. b. c. d. e. f. g. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

4. List three (3) interventions for impaired memory. a. ___________________________________________________________ b. ___________________________________________________________ c. ___________________________________________________________

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5. Complete the care plan for newly diagnosed individuals below.

Nursing Diagnosis Anxiety relating to: Knowledge deficit of disease process Intervention Review individual's present knowledge and understanding of MS Expand individual's present knowledge base Uncertainty about future physical and social capabilities Confident about the future Desired Individual Outcome

Provide relevant information about pregnancy and parenting issues in relation to MS Inability to recognise the symptoms of an attack

Understands issues related to MS and parenting

Distinguishes between the symptoms of a true MS attack and those of a pseudo attack

Nonadherence relating to: Denial of diagnosis

Powerlessness relating to: Unpredictable nature of disease

Review individual's comprehension of his/her prognosis

Reinforce that grieving is acceptable

Accepts disease

Confusion relating to: Difficulty in distinguishing which symptoms are related to MS and which are related to other conditions Direct individual to appropriate information resources

Recognises that other conditions may be responsible for symptoms

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7. Complete the care plan for difficulties related to family issues below.

Nursing Diagnosis Grief Underlying Cause Loss of "normal" family unit Expected Individual and Family Outcomes

Intervention

Anger

Diagnosis of a chronic illness

Fear

Related to the uncertainty of future events

Guilt

Disease pathogenesis or process itself

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International MS Nursing Care Plan 8. List five (5) interventions for individuals with financial difficulties. a. b. c. d. e. ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________

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Appendix 5A: MS Support Team Documentation

Name of MS Nurse Signature

Patient Details

Patient name Date of birth and age

Address

Telephone Number Occupation/Date stopped work Religion Ethnic Origin

White Afrocar European Other

Irish Asian African

Next of Kin Relationship Contact telephone number Consultant (Hospital) Hospital registration number General Practitioner Surgery Address

Telephone Number Referral Source Date of Referral Type of Referral (ie letter, call) Research (Trials)

Yes/No

Samantha Colhoun & Richard Warner MS Support Team University Hospital Birmingham NHS Trust

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Record of Patient Contact with MS Nurse

Nature of Contact (Home Visit, Clinic, Telephone, Correspondence Time Management Date Time Duration Summary Letters Sent (Date) GP Patient Notes

University Hospital Birmingham NHS Trust

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First Contact Assessment Profile

Home Situation Lives with Type of accommodation (description of location of toilet, bedrooms, kitchen and access) Adaptations/Equipment already in place Service and/or activity Mon Time Tues Time Care Matrix Wed Thur Time Time Fri Time Sat Time Sun Time

Support and other Services (eg, respite,Day care,MS groups,benefits) Name/Title/Benefit Telephone Number Description

University Hospital Birmingham NHS Trust

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Date referral made

University Hospital Birmingham NHS Trust

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Drug Name

End Date

University Hospital Birmingham NHS Trust

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Start End Date Date

Drug Name and Dose

Drug Effect

Good/Moderate/Poor

Date

Blood Results

Blood Results N/AbN Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

Date

Blood Results

N/AbN

University Hospital Birmingham NHS Trust

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International MS Nursing Care Plan Medical History (Excluding MS)

MS History

Prediagnosis History (experience of symptoms, significant events) Onset: symptoms : walking aid : wheelchair Diagnosis Investigation MRI Head (with contrast) Y/N MRI Spine (with contrast) Y/N Lumbar Puncture OCB VEP'S/SEP'S NCS/EMG Bloods: Date

Other:

Type of MS

Date of diagnosis Benign Relapsing Remitting Secondary Progressive (with Relapses) Secondary Progressive (without Relapses) Primary Progressive Unknown

Family History

University Hospital Birmingham NHS Trust

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Relapse History Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse

Oral steroids

IV steroids

No treatment

Oral steroids

IV steroids

No treatment

Oral steroids

IV steroids

No treatment

Oral steroids

IV steroids

No treatment

University Hospital Birmingham NHS Trust

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Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse Date Main Symptoms Eg motor right upper limb Confirmed by Treated Duration of relapse

Oral steroids

IV steroids

No treatment

Oral steroids

IV steroids

No treatment

Oral steroids

IV steroids

No treatment

Oral steroids

IV steroids

No treatment

University Hospital Birmingham NHS Trust

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International MS Nursing Care Plan Kurtzke Functional Scores

Date Pyramidal Cerebellar Brain Stem Sensory Bladder/Bowel Visual Cerebral Total Score Signature

(estimated) Kurtzke Disability Scale

Date Score

University Hospital Birmingham NHS Trust

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Neurological Disability Scale Date Cognition Mood Vision Speech and Communication Swallowing Upper Limb Lower Limb Bladder Bowel Sexual Fatigue Other (pain, spasm or dizziness) Total Score Nurse Signature University Hospital Birmingham NHS Trust

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Date Signature

University Hospital Birmingham NHS Trust

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Appendix 5B: Alternative Medicine and Health-Related Websites

Alternative Medicine at NOAH (New York Online Access to Health) http://www.noah.cuny.edu/alternative/alternative.html Alternative Medicine Digest http://www.alternativemedicine.com Canadian Health Network http://www.canadian-health-network.ca Canadian Medical Association http://www.cma.ca Complementary and Alternative Medicine Links http://www.ohsu.edu/ohmig/cam.html Dr. Bower's Complementary and Alternative Medicine Homepage http://www.people.virginia.edu/~pjb3s/ComplementaryHomePage.html Health Action Network Society (HANS) http://www.hans.org Health Canada Online http://www.hc-sc.gc.ca Health Care Information Resources: Alternative Medicine http://www-hsl.mcmaster.ca/tomflem/altmed.html Healthy Way, Sympatico http://www.healthyway.sympatico.ca Institute for Traditional Medicine http://www.itmonline.org International Federation of Multiple Sclerosis Societies http://www.ifmss.org.uk MedWeb, Electronic Publications http://www.MedWeb.Emory.Edu/MedWeb/ MS Centre-Complementary & Alternative Medicine http://www.ms-cam.org Tzu Chi Institute http://www.tzu-chi.bc.ca University of Pittsburgh Medical Center http://www.UPMC.edu

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Chapter 6: General Wellnes and Management Strategies

Introduction

In this chapter, some of the physical, and psychological therapies commonly used by patients with MS are described. Lifestyle modifications and stress-management strategies that promote overall general health and wellbeing are also reviewed.

Chapter Overview

This chapter contains the following two modules: Module 1: Lifestyle Modifications Module 2: Coping With Stress At the end of the chapter, please find a section entitled Progress Check; this section tests your knowledge of the information presented in the chapter. Note: Cultural and religious beliefs, education, family and social support play an important role in general wellbeing and management strategies. Therefore, these strategies may vary form country to country.

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Module 1: Lifestyle Modifications

Introduction

Lifestyle modifications, such as proper diet and regular exercise, can improve patients' overall health and wellbeing and may assist patients in achieving their therapeutic goals. In addition, some physical and psychological therapies may be beneficial to patients with MS. In this module, lifestyle modifications and other non-pharmacological strategies that promote general health and wellbeing in patients with MS are discussed.

Learning Objectives

After completing this module, the reader will be able to: Describe the following lifestyle modifications that can improve overall patient health: Regular exercise Proper diet Reducing fat intake Achieving and maintaining a healthy body weight Describe and compare physical and psychological therapies commonly used by patients with MS

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Regular Exercise

Many physicians advise their patients with MS not to exercise in order to avoid elevations in body temperature and fatigue. However, a study found that fatigue, neurological function, and emotional state improved significantly in people with MS who engaged in regular physical activity (i.e., three 40-minute sessions per week) for 15 weeks (Petajan et al 1996). Another study concluded that people with MS who were assigned to 3 weeks of inpatient rehabilitation showed an improvement in disability and overall health-related quality of life. (Solari et al 1999) Physical activity should be incorporated into daily living and may be increased by pursuing more active recreation and eventually developing a structured exercise programme (Petajan and White 1999). Nurses should therefore encourage their patients to engage in a regular physical-activity programme that has been designed in collaboration with a physiotherapist and/or physician.

Proper Diet

To promote healthy and well-balanced meal consumption, nurses should advise patients to plan their meals according to most European food guides. For most people this may mean eating more carbohydrates, fruit and vegetables. These guides recommend that foods from the following five food groups be consumed on a daily basis. Variety of these foods is essential. 1. Bread, other cereals and potatoes The food guides recommend that adults consume at least 5 portions of these carbohydrates per day. These foods should be in the main part of any meal and make up to 33% of our total daily intake. Bread, rolls and chapattis Plantains, green bananas Breakfast cereals (try whole-grain, not Peas, beans and lentils sugar-coated), oats Pasta, noodles Maize, millet and cornmeal dishes Rice Potatoes and sweet potatoes

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2. Fruits and Vegetables Most European food guides recommend that adults consume at least 5 portions of fruits and vegetables per day. Some vegetables, salad and fruit should be included and again variety is important. They should make up to 33% of our total daily intake. Some examples of a portion are: 1 whole fruit such as an apple, 2 small fruits such as satsumas, plums banana or pear or kiwis Plantains, green bananas 1 small glass of unsweetened fruit or vegetable juice (150 mls) Peas, beans and lentils 1 slice of large fruit such as melon or pineapple Maize, millet and cornmeal dishes 1 dessert bowel full of salad 2-3 tablespoons of tinned, frozen or 2 tablespoons of fresh, tinned or stewed fruit frozen vegetables 1 handful of grapes or strawberries ½ - 1 tablespoon of dried fruit such as apricots 3. Milk and Dairy Products European food guides recommend that adults consume 2 4 servings of milk products per day making up to 15% of our total daily intake. Lower fat versions of these foods should be chosen whenever possible. Below are examples of one serving of milk products: 200 mls semi-skimmed or skimmed milk 1 oz (25 gms) of hard cheese Small pot of yoghurt 4oz (100 gms) cottage cheese 4. Meat, fish and alternatives It is recommended that adults consume 2 3 servings (12% of our total daily intake) of meat, fish or alternatives per day, preferably leaner meats, poultry, fish, dried peas, beans, and lentils. Below are examples of one serving of meat or meat alternative products: 2.0-3.5 oz (50-100 gms) of fish, chicken, or lean meat 1-2 eggs (limited to 4 a week) 3 tablespoons peas, beans or lentils 2 tablespoons peanut butter or nuts Soya products and other meat alternatives

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5. Fats The final 7% of our total daily intake should be of fats and treats (see below). Fats are to be used sparingly and should be high in polyunsaturates or monounsaturates and include: Butter ­ if still used, spread very thinly Margarine and low-fat spreads Cooking oils Mayonnaise and oily salad dressings Treats are foods containing sugar or having a high fat content that can be enjoyed occasionally and in small portions. Included in this list are: Biscuits Sweetened drinks Cakes Sweets Puddings Ice cream Chocolate Crisps Nurses should also encourage patients to consume 30 gms of fibre per day. Fibrerich foods include: Whole-grain breakfast cereals Brown rice Pasta and breads containing whole grains such as wheat, oats, and barley Peas, beans and lentils Most fruits and vegetables, particularly apples (with skin), dried fruit, green peas, potatoes, and brussel sprouts Nuts such as peanuts In order to avoid constipation, nurses should remind patients to increase their fibre intake gradually and to drink plenty of water when consuming high-fibre products. Everyone should be encouraged to drink a third of their body weight in pints per day, e.g., a 9 stone person should drink 3 pints per day. This should be mainly water and decaffeinated drinks. Patients should also be advised to limit salt, alcohol, and caffeine intake. The following are strategies for reducing salt intake (Lindsay 1996): Use pepper, herbs, and other low-sodium spices instead of salt to flavour foods Use half or none of the amount of salt recommended in recipes Avoid convenience items, such as frozen meals, whenever possible since these food items tend to be high in salt Do not add salt to food at the table Cut down on salty snack foods like crisps or nuts Reduce salted meats

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International MS Nursing Care Plan Men can be advised that they can drink up to 4 units of alcohol per day. Women are advised that they can drink up to 3 units of alcohol per day. The following are examples of one unit of alcohol: 1 /2 pint ordinary beer or cider 1 /4 pint of strong beer or cider 1 pub measure of fortified wine 1 small glass of wine 1 pub measure of spirits

Reduce Fat Intake

It is important to note that even high-fat meals can be part of a healthy eating plan as long as these meals are balanced with lower-fat meals on other days. Therefore, it is the average intake of fat over the course of weeks and months that is important, not the fat content of each individual food and meal consumed. The following are strategies for reducing fat intake: Drink semi-skimmed or skimmed milk Use low-fat salad dressings Limit the use of vegetable oils, butter and margarine when cooking Buy low-fat cottage cheese and yoghurt Limit portion sizes of meat to 2-3 oz Choose fish, poultry and beans instead of red meats Limit the consumption of prepared foods that are fried or breaded Use non-stick pans when cooking instead of oil or butter Drain fat when cooking meats and poultry Remove skin from poultry before cooking

Achieve and Maintain a Healthy Body Weight

Despite the vast amounts of money spent annually on weight-loss products and publicity, nearly 20% of the European population is overweight (note that the prevalence of obesity and other weight-related problems varies from country to country). In addition, the prevalence of eating disorders, particularly among young women, is increasing dramatically. The current preoccupation with body weight and body image, and the relentless pursuit of thinness have prompted healthcare professionals to examine issues surrounding body weight and weight management more intensely. Many healthcare professionals believe that people need to focus on healthy living in general rather than focussing on body weight alone. Healthy living involves eating well, being active, and feeling good about oneself. By following such an approach, a healthy weight and vitality can be achieved in a positive and safe way.

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International MS Nursing Care Plan A healthy body weight is often defined as a weight range appropriate for a particular height and body type. It is also described as a weight at which the person feels energetic, fit, and flexible, and is at a lower risk of developing weight-related health problems.

Commonly used Physical, and Psychological Therapies in MS

Some of the most commonly used physical, energy, and psychological therapies in MS are acupuncture, chiropractic, massage therapy, meditation, reflexology, Tai Chi, and yoga. Each of these therapies is described in Table 1.

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International MS Nursing Care Plan Table 1. Commonly used physical, energy, and psychological therapies in MS.

Therapy

Acupuncture

Description

A form of therapy in which fine needles are placed along a network of invisible energy channels (called meridians) with the aim of unblocking these channels and allowing energy to flow freely throughout the body Goal of therapy is to promote recovery from illness A form of therapy that involves kneading and rubbing parts of the body to promote circulation, suppleness, or relaxation

Advantages

Releases endorphins and therefore may reduce pain associated with MS

Disadvantages

Does not alter disease course Some patients experience discomfort during needle insertion

Massage therapy

Meditation

A form of therapy that involves thinking about something deeply or reflecting deeply on spiritual matters

Reflexology Tai Chi

A form of therapy in which the soles of the feet are massaged A form of martial art that focuses on coordinating movements of the head, eyes, arms, hands, body, and legs with respiration; also involves meditation

May relieve spasticity and pain associated with MS May promote relaxation and a general sense of wellbeing May help patients with MS cope with the physical and psychological burdens of the disease May promote relaxation May promote relaxation May improve muscle flexibility, balance, and mental wellbeing May reduce fatigue Can be performed by patients of any age or level of disability, including patients in wheelchairs Inexpensive May increase flexibility and muscle strength May promote relaxation

Costly Effects are short-lived

Requires concentration and therefore may be difficult for those patients with cognitive impairments

Costly Effects are short-lived Requires concentration and therefore may be difficult for those patients with cognitive impairments

Yoga

A form of therapy that involves physical and mental exercises aimed at creating a state of complete awareness and tranquillity

Many of the exercises are difficult for patients with spasticity and other mobility impairments

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References

Lindsay Anne. Smart Cooking: Quick and Tasty Recipes for Healthy Living. Toronto: Macmillan Canada; 1996. Petajan JH, Gappmaier E, White AT, Spencer MK, Mino L, Hicks RW. Impact of aerobic training on fitness and quality of life in multiple sclerosis. Ann Neurol 1996;39:432-441. Petajan JH, White AT. Recommendations for physical activity in patients with multiple sclerosis. Sports Med 1999;27:179-191. Solari A, Filippini G, Gasco P, Colla L, Salmaggi A, La Mantia L, et al. Physical rehabilitation has a positive effect on disability in multiple sclerosis patients. Neurology 1999;52:57-62.

Suggested Reading

Health Education Authority. Enjoy Healthy Eating ­ The Balance of Good Health; 1995.

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Module 2: Coping With Stress

Introduction

Many researchers are beginning to explore the connection between stress and MS attacks. Some studies suggest that there is, in fact, a correlation between MS activity (lesions detected on magnetic resonance imaging [MRI]) and stress. However, it is not clear from these studies whether the two variables have a cause-and-effect relationship. Many people with MS report that they experience more symptoms during stressful periods. By examining how individuals generally cope with stress, researchers have learned why this occurs. During times of stress, more energy is required to carry on everyday jobs. Every individual has different coping abilities and, during demanding times, these abilities can be overstretched. At this time, any difficulty, including dealing with MS symptoms, becomes more challenging.

Learning Objectives

After completing this module, the reader will be able to: Assist patients in identifying symptoms which indicate increased levels of stress Assist patients in reducing and managing stress

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Symptoms that Indicate Increased Levels of Stress

Mental and Emotional Symptoms Irritability Continual boredom Excessive anxiety/worrying every day Being easily distracted Expecting the worst Finding it difficult to make decisions Physical Symptoms Clammy hands Constipation/diarrhoea Dry mouth Headache Palpitations Stomach aches, cramps Muscle spasms Lump in the throat Fatigue/weariness Sleeping too much/too little Short and shallow breathing (National MS Society 2001)

Strategies to Reduce Stress

Thinking Positively To help reduce stress levels in their patients, nurses should promote positive-thinking patterns. For example, the patient may say, "I am a failure at everything I do!" The nurse can respond to this negative statement by saying, "You did a pretty good job this time maybe we can try to do better next time." Talking It Out Nurses can also help patients relieve stress by encouraging them to talk about their thoughts, feelings, and opinions. Building a support group of patients (as well as others) who know about their illness and the difficulties they face will help patients cope. If the patient does not feel comfortable talking with family members or friends, nurses can suggest contacting MS societies, which often have support networks. Many patients find it easier discussing their feelings about the difficulties posed by the disease in the presence of a social worker or nurse.

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Expressing Anger Sometimes patients relieve stress by expressing anger or frustration. Nurses can explain to patients that this is normal and acceptable provided that patients are not blaming others. For example, nurses can encourage patients to say, "I'm so angry," instead of, "You make me so angry." Other Strategies There are several ways in which patients can reduce their stress levels on a daily basis. Although each individual needs to find his/her own manner in which to deal with stress, nurses can suggest a few of the following strategies to their patients: Simplify life by: - Prioritising tasks - Planning ahead for situations that may induce stress - Obtaining more rest the day before a big event - Learning to say "no" to requests from others - Asking for help when they need it Becoming more practical by - Doing chores as they arise; procrastination will only build stress at the end of the day - Keeping the car and important appliances in good working order - Using labour-saving devices - Do unpleasant chores at the beginning of the day so that they do not need to be dealt with later - Carry a notebook in which they write notes to themselves throughout the day - Take deep breaths Note: The MS nurse may also wish to explore Expert Patient Programmes literature as well as literature related to other chronic diseases such as rheumatology. Some complementary and alternative therapies may also be useful for the management of stress (see Chapter 7).

Getting by During the Day: Mental and Physical Exercises to Help Reduce Stress

Multi-disciplinary team members can help patients in this area. The Occupational Therapist is particularly skilled at fatigue management / prioritisation of daily tasks and relaxation. Physiotherapists will prescribe a daily exercise programme. Morning Nurses can encourage patients with MS to make their mornings simpler in order to reduce stress. Patients should be strongly encouraged to find time in the morning to sit and relax for at least 5 minutes and break down their tasks into smaller parts. Planning the day in advance will help reduce stress later. Patients should try to do one task at a time; the previous task should be finished before the patient starts a new one. Nurses

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International MS Nursing Care Plan The nurse should help the patient through the entire relaxation programme the first time. The patient should be wearing comfortable, loose-fitting clothes and should be sitting in a comfortable chair. The focus should always be on how the muscles feel before, during, and after each individual exercise. 1. 2. 3. 4. 5. It is best to be in a chair with arms and a high back: use a cushion in the small of your back if it helps and make sure you are warm. Sit upright and well back in the chair so that your thighs and back are supported. Gently rest your hands on your lap or thighs. Let your feet rest on the floor. Gently close your eyes. Make sure that your eyelids are gently resting over your eyes and there is no tension or strain. Begin by breathing out....then slowly breathe in just as much air as you need and gently breathe out with a slight sigh. Do this once more ... gently breathe in and out and as you breathe out, feel the tension begin to drain away. Keep your breathing nice and gentle with no effort involved as we move our attention onto other things. Now direct your thoughts to your body, to the muscles and joints. Think first about your right foot, your toes and your ankle. They are resting heavily on the floor. Let your heel sink down into the mat and let your foot relax. Now think about your left foot, your toes and ankle. Let that heel sink into the mat. Let both your feet, your toes and your ankles start to relax and as they relax, they will start to feel warm and heavy. Now move your attention to your legs. Your thighs and knees roll outward as they relax, so let them go .....and let you feet flop to the sides. As the tension drains out of your muscles, let your calves and thighs relax and let the muscles spread as the tension drains away and your legs start to feel warm and heavy. Now think about your spine and back. Let the tension drain away from your spine and back. Follow your breathing and each time you breathe our, relax your spine and back a little more. Let your abdominal muscles become loose.... There is no need to hold your stomach in tight, so let it go and let it gently rise and fall as you breathe. There should be no tension in your chest. Keep your breathing gentle and easy and without any effort. Remember each time you breathe out to let the tension go.

6.

7.

8.

9.

10. Now think about your right hand. Your fingers are curved, limp and quite still. Now your left hand....your fingers are soft and still. Let this feeling of relaxation spread up your arms and let your arms feel warm and heavy as they start to relax. 11. Let this feeling spread to your neck and shoulders. Let your shoulders sag and drop and, as the tension eases away, let your shoulder blades spread and separate. Let your head be supported by the chair, allowing your neck muscles to relax and the tension to ease away.

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International MS Nursing Care Plan 12. Before we move on, just check that all parts of your body are still relaxed. Your feet, legs, back and spine, neck and shoulders. Keep your breathing nice and gentle and remember to let go of the tension as you breathe out. 13. Now think about your face. Let the expression come off your face. Let your forehead feel wide and smooth out your brow. Let your eyebrows drop. Make sure that your eyes are just gently closed. Let your jaw unwind and your teeth part slightly as you relax. Feel the relief of letting go as the tension drains away. Now think about your tongue. Let your tongue drop down to the bottom of your mouth and relax completely. Relax your tongue and throat and your lips... lightly together with no pressure between them. Let all the muscles in your face unwind and let go ....just let it relax more and more. 14. Now, instead of thinking about yourself in parts... think of yourself as a whole and feel the all-over sensation of letting go and of quiet and rest. Check to see if you are still relaxed. 15. Stay like this for a few moments and listen to your breathing and let your body become heavier with each breath you breathe out. Enjoy this time of relaxation. 16. Coming back.....slowly wriggle your hands a little and your feet. When you are ready, open your eyes and sit quietly for a while. Stretch if you want to yawn and slowly start to move. Practising this relaxation can help reduce daily stress and prepare the patient for a good night's sleep.

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References

Halper J, Holland N. Comprehensive Nursing Care in Multiple Sclerosis. New York: Demos Medical Publishing, 2003. Heron C. The Relaxation Therapy Manual. Winslow; 1996. National Multiple Sclerosis Society. Taming Stress [brochure]. 2001.

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Progress Check

1. European food guides recommend that adults eat at least______ portions of bread, other cereals and potatoes per day. These should make up to __% of our total daily intake. 2. Most European food guides recommend that adults eat ______ portions of fruits and vegetables per day. These should make up to __% of our total daily intake. 3. European food guides recommend that adults consume ______ servings of milk and dairy products per day, making up to __ % or our total daily intake. 4. It is recommended that adults eat ______ portions of protein per day, preferably leaner meats, poultry, fish, dried peas, beans, and lentils. __% of our total daily intake should come from this food group. 5. The final __% of our total daily intake should be made up from foods high in fat or sugar. They should be used sparingly. 6. Nurses should also encourage patients to eat ______ of fibre per day. 7. Men may drink up to __ units alcohol per day. Women may drink up to __ units of alcohol per day. 8. List 3 strategies that can help patients reduce their salt intake. a. ________________________________________________________________ b. ________________________________________________________________ c. ________________________________________________________________ 9. List 10 strategies that can help patient reduce their fat intake. a. b. c. d. e. f. g. h. i. j. ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________

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10. Complete the following deep-breathing instructions: a. b. c. d. e. f. Sit _____________________________________________________________ Place your hand on your belly, in order to feel your breathing Inhale ____________________ and concentrate on ______________________ As the air reaches your belly, let your stomach muscles ___________________ Draw in as much air as you can and ___________________________________ When you start to exhale, ___________________________________________; concentrate ______________________________________________________ g. Feel your stomach muscles relax h. When you have finished the deep breath, ______________________________ i. Repeat this procedure ______ to ______ times. 11. Complete the following relaxation exercise: The nurse should help the patient through the entire relaxation programme the first time. The patient should be wearing comfortable, ____________ clothes and should be sitting in a comfortable chair. The focus should always be on how the muscles feel before, during, and after each individual ____________. 1. It is best to be in a chair with _____________________: use a cushion in the small of your back if it helps and make sure you are warm. 2. Sit upright and well back in the chair so that your _______________ are supported. 3. Gently rest your ______ on your lap or thighs. Let your feet rest on the floor. 4. Gently close your eyes. Make sure that your ________ are gently resting over your eyes and there is no tension or ________. 5. Begin by breathing out....then slowly breathe in just as much air as you need and gently breathe out with a ____________. Do this once more ... gently breathe in and out and as you breathe out, feel the ________ begin to drain away. Keep your breathing nice and gentle with no effort involved as we move our attention onto other things. 6. Now direct your thoughts to your body, to the _____________. Think first about your right foot, your toes and your ankle. They are resting heavily on the floor. Let your _________sink down into the mat and let your foot relax. Now think about your left foot, _______________. Let that heel sink into the mat. Let both your feet, your toes and your ankles _____________ and as they relax, they will start to feel warm and heavy. 7. Now move your attention to your legs. Your thighs and knees roll outward as they relax, so let them go .....and let you _____ flop to the sides. As the tension drains out of your muscles, let your _______________ relax and let the muscles spread As the tension drains away and your legs start to _____________ and heavy.

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International MS Nursing Care Plan 8. Now think about your spine and ________. Let the tension drain away from your spine and back. Follow your breathing and each time you breathe our, relax your spine and back a little more. 9. Let your ___________ muscles become loose.... There is no need to hold your stomach in tight, so let it go and let it gently rise and fall as you breathe. There should be no tension in your chest. Keep your breathing _____________ and without any effort. Remember each time you breathe out to let the tension go. 10. Now think about your ________________. Your fingers are curved, ____ and quite still. Now your left hand....your fingers are soft and still. Let this feeling of _____________ spread up your arms and let your arms feel warm and heavy as they start to relax. 11. Let this feeling spread to your neck and shoulders. Let your shoulders _______________ and, as the tension eases away, let your shoulder blades spread and separate. Let your _____be supported by the chair, so allowing your neck muscles to relax and the tension to ease away. 12. Before we move on, just check that all parts of your body are still relaxed. Your feet, legs, back and spine, neck and shoulders. Keep your breathing _____________ and remember to let go of the tension as you breathe out. 13. Now think about your _____. Let the expression come off your face. Let your forehead feel wide and smooth out your ____. Let your ________ drop. Make sure that your eyes are just gently closed. Let your jaw unwind and your teeth part slightly as you relax. Feel the relief of letting of as the tension drains away. Now think about your tongue. Let your __________________ to the bottom of your mouth and relax completely. Relax your tongue and throat and your lips... lightly together with no _________ between them. Let all the muscles in your face unwind and let go ....just let it relax more and more. 14. Now, instead of thinking about yourself in parts... think of yourself as a whole and feel the all over ___________of letting go and of quiet and rest. Check to see if you are ________________. 15. Stay like this for a few moments and listen to your ____________ and let your body become heavier with each breath you breathe out. Enjoy this time of ___________. 16. Coming back.....slowly _________ your hands a little and your feet. When you are ready, open your eyes and sit quietly for a while. Stretch if you want to _____ and slowly start to move. Practising this relaxation can help reduce daily stress and prepare the patient for a good night's sleep.

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12. List eleven (11) physical symptoms that indicate increased levels of stress. a. b. c. d. e. f. g. h. i. j. k. ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________

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13. Complete the following table of physical, energy, and psychological therapies commonly used in MS.

Therapy Acupuncture Description Advantages Releases endorphins and therefore may reduce pain associated with MS Disadvantages Does not alter disease course Some patients experience discomfort during needle insertion

Massage therapy

A form of therapy that involves kneading and rubbing parts of the body to promote circulation, suppleness, or relaxation A form of therapy that involves thinking about something deeply or reflecting deeply on spiritual matters May provide relaxation Costly Effects are short-lived Requires concentration and therefore may be difficult for those patients with cognitive impairments

Meditation

Reflexology

Tai Chi

May improve muscle flexibility, balance, and mental wellbeing May reduce fatigue Can be performed by patients of any age or level of disability, including patients in wheelchairs Inexpensive A form of therapy that involves physical and mental exercises aimed at creating a state of complete awareness and tranquillity

Yoga

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Chapter 7: Complementary and Alternative Therapies for MS

Introduction

What are complementary and alternative therapies? Complementary medicine is a broad term used to describe a variety of distinct therapies. It describes anything that lies outside of established medical practice. For the purpose of this manual, we will define them as: "therapies that can work alongside and in combination with orthodox medical treatment" (McMillan Cancer Relief 2002) The term "Complementary and Alternative Therapies" refers to a broad and complex combination of interventions and is also interchangeably called holistic, unorthodox, unconventional, natural, traditional or non traditional, according to your cultural beliefs (Nienstedt 1998). This chapter will use the term complementary therapies to refer to all these approaches. The use of complementary therapies and the amount of information about them is on the increase. There are now approximately 180 different complementary therapies practiced in the UK, with between a third and one half of the population using one or more of these therapies (Kelly 2002). Complementary therapies also appear to be widely used by people with MS although their potential benefits in the treatment of MS remain controversial, not least because there is little evidence base to support their usage. Conclusive evidence about the effectiveness and safety of most forms of complementary therapy is not available (Bowling 2001). Much of what is written is anecdotal. However, many people with MS will turn to these therapies in the belief that they will help relieve some of their symptoms. Some of the specific reasons people with MS may turn to complementary therapies include: Frustration with conventional medicines and their undesirable side effects. Lack of a cure for MS. Increased patient desire to play a role in the management of their disease ­ complementary therapies often encourage the individual to become actively involved in their treatment and patients feel they share in any decision-making that is necessary. They can help the individual feel more positive about themselves and their health.

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International MS Nursing Care Plan Some people with MS truly believe that complementary therapy works for them and they can feel a direct benefit from receiving it. Alleged ability of some complementary therapies to provide short-term relief of MSrelated symptoms. (However, since MS symptoms commonly go into remission spontaneously, it is often difficult to determine whether complementary treatment is indeed responsible for remission or improvements in the condition). They often treat the whole person, not just the disease. Complementary practitioners generally spend more time with people and will give treatment throughout the course of the disease. People with MS often complain that they have a complex array of symptoms and their appointments with the healthcare team are not long enough to discuss these in any detail. Many people also say that healthcare professionals are constantly changing and that they never see the same face twice. Given the intense patient interest in complementary therapies and the well-publicised misconceptions regarding the efficacy of these agents, it is important that both nurses and patients are equally well informed about these therapies. Controversy and confusion surround this type of medicine, and addressing issues raised by patients interested in complementary therapies may be considered a particularly challenging area to healthcare professionals (Bowling et al 2000). In this chapter, the complementary therapies most frequently used by patients for the management of MS are described in detail. The role of nurses in ensuring that patients make informed decisions regarding the use of complementary therapies is also discussed. DISCLAIMER: Some health-care professionals do not support the use of complementary therapies for the management and treatment of MS since there have been few scientific studies conducted in this area. However, it is imperative that we do not confuse unproven with ineffective and thereby dismiss an individuals attempt to gain some control over their own condition.

Chapter Overview

This chapter contains the following two modules: Module 1: Overview of Complementary Therapies Used in MS Module 2: Role of the MS Nurse At the end of the chapter, please find a section entitled Progress Check; this section tests your knowledge of the information presented in the chapter.

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Module 1: Overview of Complementary Therapies Used in MS

Introduction

In this module, the complementary therapies most frequently used by patients with MS and those that may be potentially harmful in MS are described in detail.

Learning Objectives

After completing this module, the reader will be able to: Describe the prevalence of complementary therapy use among patients with MS Describe, in detail, the complementary therapies most frequently used in MS Describe the complementary therapies that may be potentially harmful for patients with MS

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Complementary Therapy Use in MS

As mentioned earlier, complementary therapies are becoming more and more popular among patients with MS. For example, a recent survey conducted at the Rocky Mountain Multiple Sclerosis Center in Englewood, Colorado, found that complementarytherapy use among patients with MS was double that of the general population. Of the 244 patients surveyed in this study, almost 66% were using some form of complementary therapy. However, only 4% were using complementary therapies exclusively; the remainder were using complementary therapies in addition to conventional medicines (Bowling 2000). Among the study participants, vitamins, particularly multivitamins and vitamin E, were the most commonly used complementary therapies (66%). Fifty percent of survey respondents reported using prayer and exercise and 30 40% reported using special diets, massage therapy, and/or evening primrose oil. Dietary supplements, chiropractic therapy, acupuncture, relaxation techniques, and/or herbal medicines were used by 25% of patients. The most commonly used, highly publicised therapies were removal of mercury amalgam dental fillings (18%), St. John's Wort (12%), and bee venom (6%) (Bowling 2000). Fawcett et al (1996) reported that the most frequently used alternative therapies for MS in the USA were physical therapy (44%), nutritional therapy (38%), massage (38%) and psychological counselling (38%). In addition 31% of the sample used homeopathy, acupuncture or dental therapy. Winterholler et al (1997, cited in Huntley and Ernst 2000) surveyed 129 German MS patients, reporting that 64% had used complementary therapies with a total of 87 therapies having being used and some people having tried up to 9 different treatments. The majority of patients had used relaxation methods (38), homeopathy (35), herbs (32) and various diets (21) Bowling (2000) reported that the most common reason reported for using complementary therapies was to improve general health. Other reported reasons included attempts to: Control symptoms Control emotions Alter the course of the disease Country-specific issues regarding the use of complementary and alternative therapies in MS are shown in Table 1.

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Literature on Complementary Therapies

Medical Literature The results of high-quality clinical trials demonstrate that glatiramer acetate and the interferon beta-1a/1b therapies are effective therapies for treating MS. However, as yet, no such comparable trials have been conducted on any complementary therapy used in MS and there is limited objective information on the use of complementary therapies in MS. It does need to be acknowledged, however, that although there is a lack of scientific research in this area, we must bear in mind there is also a lack of funds and patient pool to do robust clinical trials as is regularly carried out amongst conventional treatments. Who would have a vested interest enough to fund the research? Some people in the MS community believe that we should not hide behind the notion of being purely evidence based and completely dismiss what is yet unproven as ineffective. Popular Literature A review of 33 books discussing complementary-therapy use in MS found that: 48% of these books recommended dietary interventions; 45% vitamins; 33% evening primrose oil; and 25% exercise and acupuncture for patients with MS. Approximately 15 20% of the books reviewed recommended massage, calcium, and yoga. In general, the therapies most often recommended in books were also those used most frequently by patients with MS (Bowling 2000). Commonly Used Complementary Therapies in MS Complementary products used in MS include various herbal medicines, vitamins, dietary supplements and other products. Some of these products are listed below and Table 2 describes each of these products in detail including their indications, contraindications and any known drug interactions. Other complementary therapeutic approaches used in MS are also listed below and their main advantages and disadvantages are given in Table 3. A brief overview of herbal medicines, vibrational medicines and diet is given below. However, as an in-depth analysis of complementary therapies is beyond the scope of this manual, the reader is referred to Suggested Readings at the end of this module for literature covering this area in more detail.

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International MS Nursing Care Plan Some of the complementary products most frequently used in MS include: Bee pollen Coenzyme Q10 Cranberry Evening primrose oil Flaxseed oil Garlic Ginseng Ginkgo biloba Grape seed extract Kava-kava Cannabis/Marijuana St. John's Wort Vitamin B complex Less commonly used complementary products include: Psyllium Shark cartilage Valerian Other therapeutic approaches used in MS are: Acupuncture Aromatherapy Chiropractic/osteopathy Guided imagery and visualisation Homeopathy Hyperbaric oxygen Hypnotherapy Magnetic therapy Massage Meditation Reflexology Reiki Tai chi/yoga Herbal Medicines Use of herbal medicine has grown extensively over the past decade. Much of the literature regarding this form of therapy arises from the United States. A study by Linde et al (1996) states that approximately $5 billion is spent annually in the United States on herbal remedies. Many people with MS in the UK also use these remedies. Exact figures are unknown, but MS magazines and websites are often full of advertisements or articles about their usage.

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International MS Nursing Care Plan Herbal therapies are often very accessible. When patients use herbal products, it is important for nurses to stress that these products are not regulated and, therefore, the quality and composition of different herbal preparations vary widely. There are many misconceptions about herbs, one of the most common is that herbs are `natural' and therefore completely safe. Also there is often lack of information regarding their adverse effects. In addition, different brands of a particular herb may contain very different compounds, some of which may be toxic or interact with conventional drugs used for the treatment and management of MS. Nurses should also caution those patients who are adamant about using herbal products to limit their use for benign, self-limited conditions and for a short period of time. They should also advise against using several different types of herbal medications at the same time. Nurses should instruct women who are pregnant or breast-feeding, patients with multiple medical problems, and those taking several medications to avoid herbal products altogether (Bowling 2000). In addition, natural supplements can be very dangerous for individuals about to undergo surgery. Doctors advise patients to discontinue herbal use for 1­2 weeks before surgery and 3­5 days post-operatively. If a particular patient insists on using herbal therapies, the nurse should advise patients to use products from a reliable company. Energy or vibrational medicines As nurses we are familiar with the concept of holistic care ­ the principle of treating the person as a whole. The same principles apply to many complementary therapies known as "energy or vibrational medicines". Vibrational medicine embraces a number of complementary therapies including acupuncture, aromatherapy, homeopathy and reiki. Whilst conventional medicine works on the basis of identifying muscles, bones, nerves, tissues, etc. in the body, vibrational medicine and therapists work generally on the energetic level. The principle of vibrational medicine is that our bodies are energetic and electromagnetic in nature, and therefore there is an energy field operating within and around an individual. For centuries and across cultures these energy fields have been recognised and documented. The energy circuits in the body are commonly known as meridian points, the concentrated energy points are known as the chakras and the physical, emotional and mental energetic fields surrounding the body are known as the aura. If the energy is free flowing and positive, the person will feel balanced and in good health. However, if any of the energy fields are blocked or imbalanced the person will feel unwell or `out of sorts'. The aim is to identify and realign areas of imbalance within the body and its surrounding energy field. The patient may experience a `healing crisis' whilst using an energy medicine or therapy due to the detoxifying effects of changing energy vibrations within and around the body. This can manifest physically, emotionally or mentally through, for example, nausea,

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International MS Nursing Care Plan change in bowel movements, rhinitis, sweating, mood swings and the resurfacing of old forgotten painful memories. Whilst many may deem these negative side effects, they are taken to be a positive, beneficial indicator that realignment and balance is occurring within the individual. It is the body's way of eliminating the detoxifying effects of changing energy vibrations within and around the body. Diet Nutrition and diet are particularly controversial areas in MS management and beyond the remit for this chapter. Again much of what is written is anecdotal; there is no direct evidence that nutrition is involved in the aetiology of MS (Payne 2001). The majority of healthcare professionals recommend a sensible healthy diet. There is no need to be regimented in eating nor is there any need to spend vast amounts of money on specialist foods. Kosich (2003) writes that many of the dietary regimes that are claimed to benefit people with MS are not harmful, but often require rigorous and stressful attention to detail, without any real improvement to symptoms. Judy Graham (1992) writes extensively about the role of nutrition and diet in MS ­ some of her writing reflects her own views while some of it examines the evidence she has discovered which advocates a change in diet for people with MS. MS Nurses may not always possess an extensive knowledge of nutrition and may find it useful, in particular circumstances, to refer the person with MS to this particular text. Further information on a healthy diet is given in Chapter 6.

Note: The use of complementary and alternative therapies is influenced by religious beliefs, customs, and law; therefore, depending on what is available and permitted, the use of complementary and alternative therapies varies extensively from country to country.

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Table 1. Country-specific issues regarding the use of complementary and alternative therapies in MS.

Country Germany Therapy Hippotherapy Issue(s) Hippotherapy uses the multidimensional movement of the horse for the management of movement dysfunction. Specific riding skills are not taught (as in therapeutic riding), but rather a foundation is established to improve neurological function and sensory processing. This foundation can then be generalized to a wide range of daily activities. Not used; only conventional therapies are used.

Saudi Arabia

All complementary and alternative therapies Hyperbaric oxygen All complementary and alternative therapies

United Kingdom United States/Canada

Hyperbaric oxygen once per week may be used. There are many clinical settings working collaboratively with complementary and alternative therapy programs. There are websites and many sources of information and support.

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International MS Nursing Care Plan Table 2. Complementary products commonly used by patients with MS (Boehringer Ingelheim).

Therapy Bee pollen Source Concentrated flower pollens collected by worker bees and mechanically removed when the insects return to the hive N/A Constituents Vitamins Minerals Enzymes Amino acids Medicinal Action Believed to have anti-inflammatory properties Pharmacology and Indication(s) Believed to provide energy and essential nutrients Recommended for a broad range of conditions including arthritis, heart disease, symptoms of menopause, and food intolerances/ allergies Recommended for the treatment of cardiovascular diseases Toxicity and Contraindications May cause allergic reactions in individuals with known pollen allergies Drug Interactions N/A Dosage 6­15 g/day

Coenzyme Q10

Ubiquinone

Cranberry

Red acidic fruit of the shrubby Viburnum of North America and Europe

Anthocyanidins

Believed to play a vital role in energy production at the cellular level Believed to revitalize the immune system Believed to have anti-oxidant properties and bacteriostatic effects

N/A

N/A

N/A

Recommended for the prevention of urinary tract infections

N/A

N/A

N/A

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Therapy Evening primrose oil

Source Seed (historically, the leaves and bark were used)

Constituents -linolenic acid (GLA) Oleic acid Palmitic acid Stearic acid Linoleic acid Mixed tocopherols

Medicinal Action Believed to have anti-inflammatory and immunostimulant properties

Pharmacology and Indication(s) Recommended for the treatment of symptoms associated with premenstrual syndrome, particularly myalgia, dysmenorrhea, and depression Believed to help control the symptoms of MS and other autoimmune conditions

Toxicity and Contraindications May cause occasional headache and nausea if taken on an empty stomach May exacerbate temporal lobe epilepsy and mania High doses may cause diarrhoea and reduce Tcell function

Drug Interactions May increase the incidence of seizures when used with phenothiazines and anticonvulsants May reduce tremors in persons with bipolar (manicdepressive) disorder using lithium

Dosage 2­4 g/day or as directed on label

Flaxseed oil

Seed

-linolenic acid (ALA) 3 series of essential fatty acids

Believed to act as a purgative, demulcent, and emollient

Believed to provide essential fatty acids that may control MS symptoms Believed to help lower cholesterol, blood triglycerides, and prevent clot formation

N/A

N/A

N/A

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Therapy Garlic

Source Bulb of garlic

Constituents Alliin Allinase Allicin Vitamins

Medicinal Action Believed to act as an antimicrobial, hypotensive, hypolipidaemic, and expectorant

Pharmacology and Indication(s) Recommended for the treatment of high blood pressure and blood cholesterol Believed to increase immunity to respiratory illnesses Believed to have anticancer benefits

Grape seed extract

Grape seeds

Pycnogenol

Believed to have anti-oxidant and anti-inflammatory properties

Recommended for the treatment of MS-related pain

Toxicity and Contraindications Contraindicated in lactating women because it can be passed to infants in breast milk and cause colic May interfere with blood clotting ability under general anaesthesia; therefore, should be avoided in patients about to undergo surgery N/A

Drug Interactions May increase the effects of anticoagulant drugs

Dosage 2­5 mg/day of allicin 2­5 mg/day of garlic oil 2­5 mg/day of fresh airdried garlic 400­1200 mg/day of fully dried powder

N/A

N/A

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Therapy Ginseng (Korean)

Source Root

Constituents Ginsenosides (panaxosides) Sterols Acetylenic compounds Pepticoglycans (panaxans)

Medicinal Action Believed to act as a tonic, stimulant, and adaptogenic agent

Pharmacology and Indication(s) Recommended for the treatment of fatigue and stress Believed to enhance the immune system

Toxicity and Contraindications May be harmful in pregnant women and individuals with high blood pressure Overuse may cause symptoms of overstimulation such as hypertension, diarrhoea, restlessness, nervousness, euphoria, insomnia, and skin eruptions May interfere with blood clotting ability under general anaesthesia; therefore, should be avoided in patients about to undergo surgery

Drug Interactions May cause hypnotic effects or catalepsy when used with centrally acting drugs (e.g., pentobarbital and haloperidol) May reduce the efficacy of antihypertensive medications May cause headaches and tremors when used concurrently with stimulants May enhance or reduce the effects of anticoagulants

Dosage 0.6­2 g/day of root dried by decoction 100 mg o.d. t.i.d. of standardised extract (4­ 8% ginsenoside) Usually taken in the morning

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Therapy Ginkgo biloba

Source Leaves

Constituents Flavoglycoside s Terpenes

Medicinal Action Believed to act as an antiasthmatic, bronchodilator, and plateletactivating factor (PAF) inhibitor

Pharmacology and Indication(s) Believed to increase blood flow to the brain, improve memory loss in patients with Alzheimer's disease, and inhibit blood clotting Recommended for the treatment of asthma, stress, vertigo, and tinnitus

Kava-kava

Ground rhizome of the Piper methysticum (a member of the pepper family)

Kavalactones

Believed to act on the brain's limbic system

Recommended for the treatment of anxiety and stress

Toxicity and Contraindications May cause gastrointestinal upset, headache, and allergic skin reactions May cause spontaneous bleeding, including subarachnoid haemorrhage, in some cases May interfere with blood clotting ability under general anaesthesia; therefore, should be avoided in patients about to undergo surgery Should be used with caution in patients with fatigue due to sedative effects Overuse may cause dry scaly lesions on the skin, yellow skin, and rashes May augment the effects of anaesthesia and cause excessive sedation; therefore, should be avoided in patients about to undergo surgery

Drug Interactions May cause drug interactions when used with warfarin and/or aspirin

Dosage 40 80 mg t.i.d. of standardized oral extract (24% ginkgoflavone glycosides and 6% terpenoids) Should be taken with food

N/A

45 70 mg t.i.d. of kavalactone s

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Medicinal Action N/A Pharmacology and Indication(s) May help reduce spasticity, tremor, muscle spasms, pain, or fatigue Toxicity and Contraindications Illegal in most European countries but may be prescribed in some circumstances Contraindicated in patients with intestinal obstruction and colonic atony Contraindicated in patients taking proprietary medicines used to increase colonic activity May lower blood glucose and, therefore, should be used with caution in patients with diabetes

Therapy Marijuana

Source Leaves

Constituents N/A

Drug Interactions N/A

Dosage N/A

Psyllium

Dried, ripe seeds (including husks)

10­30% mucilage Monoterpene alkaloids Triterpenes A fixed oil rich in polyunsaturate d fatty acids

Believed to act as a demulcent, laxative, astringent, and hydrophilic bulking agent

Believed to promote peristalsis and the hydration of faeces May be used as part of a "detox" program

With the exception of lithium salts and oral hypoglycemic agents, psyllium appears to have little effect on drug absorption

Shark cartilage

Connective tissue of sharks

N/A

N/A

Believed to regulate immune function and stop tumour growth in cancer patients Recommended for the treatment of inflammations such as arthritis

N/A

N/A

5­10 g of seeds soaked for several hours in warm water taken up to three times daily or one or more teaspoons of powder as directed Should be taken with water Daily fluid intake should be increased when using this agent N/A

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Therapy St. John's Wort

Source Herb

Constituents Volatile oils containing sesquiterpene compounds Dianthrone derivatives Flavonoids Xanthones Coumarins Volatile oil containing valerinic acid, isovaleric acid, and valeranone Sesquiterpene s Valepotriates Volatile alkaloids Resin Gum

Medicinal Action Believed to act as an anxiolytic, sedative, antiviral agent, and astringent

Pharmacology and Indication(s) Believed to improve symptoms commonly associated with mildto-moderate depression, including insomnia, morning depression, anorexia, and feelings of low self-esteem

Valerian

Root and rhizomes

Believed to act as a nervine, sedative, hypotensive, antispasmodic, and expectorant

Recommended for the treatment of nervousness, headaches, high blood pressure, and stomach and menstrual cramps

Toxicity and Contraindications May cause photosensitivity Foods and drinks with a high tyramine content should be avoided when using this agent (e.g., cheese, game, beer, and wine) Contraindicated in pregnant women Long-term use of high doses may cause headaches, giddiness, restlessness, nausea, and/or agitation May augment the effects of anaesthesia and cause excessive sedation; therefore, should be avoided in patients about to undergo surgery

Drug Interactions Should not be used concomitantly with drugs known to interact with monoamine oxidase inhibitors (i.e., amphetamines, sympathomimetics, tyrosine, and tryptophan) Should not be used concurrently with alcohol, anaesthetics, or other centrallyacting agents

Dosage 300­900 mg/day of standardized oral extract (0.3% hypericin) in divided doses or 2­4 g t.i.d. of dried herb

2­3 g of raw herb or 50 mg of standardized extract several times daily; can also be taken as one dose at bedtime

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Therapy Vitamin B complex

Source N/A

Constituents N/A

Medicinal Action N/A

Pharmacology and Indication(s) Believed to promote red-bloodcell production and maintain cellular longevity May also help prevent nerve damage by maintaining the protective myelin sheaths of nerves

Toxicity and Contraindications N/A

Drug Interactions N/A

Dosage 100 mg t.i.d.

Note: Some health-care professionals do not recommend using the above-mentioned complementary products for the treatment and management of MS due to insufficient scientific evidence supporting the efficacy of these products.

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International MS Nursing Care Plan Table 3. Other complementary therapies used by patients with MS.

Therapy Aromatherapy Description Uses essential oils to promote well-being Advantages Can be done via massage, compresses, inhalations, baths Relaxation Aim to restore health by manipulation of the bones, muscles and tissues, especially in the spine, principally to benefit the nervous system (in Chiropractic) or the blood supply (in osteopathy) Claims to be able to treat disorders of pain, pins and needles and numbness amongst other symptoms Relaxation Reduces anxiety & pain ? Improve immune system Well tolerated and safe Can be bought over the counter as well as by consultation Cruelty free ­ not animal tested Some claim it improves symptoms or maintain their condition Disadvantages Privately funded A healing crisis can occur Use with caution if pregnant Privately funded Caution in those with back pain No conclusive research evidence

Chiropractic / osteopathy

Body work, using techniques including soft tissue stretching, rhythmic passive joint movement to improve joint mobility or high velocity thrust techniques to improve the range of movement of a joint Treat the musculoskeletal system as well as joints

Guided imagery and visualisation

The individual is either guided or creates images that induce relaxation or other beneficial effects on the body

Use cautiously in patients with psychiatric disturbance Not usually available unless pay privately Largely privately funded Requires an in-depth consultation when used correctly and seen by a homeopath Some claim it worsened their symptoms or felt no change Can be expensive Potentially dangerous if not administered correctly Can feel claustrophobic No conclusive research evidence Use cautiously in patients with psychiatric disturbance Not usually available unless pay privately Bad press of hypnotists as opposed to hypnotherapists

Homeopathy

Hyperbaric oxygen

Basic tenant of treating `like with like', a minimum dose of substance that would induce symptoms in a healthy person is given in a highly diluted concentration to a sick person Mainly used as a preventative measure Breathing oxygen in a pressurised chamber

Hypnotherapy

Induce a heightened state of awareness to modify or dispel emotional, mental or physical problems Post hypnotic suggestions are made in order to prolong or maintain positive thoughts, feelings or behaviours beyond the session itself

Usually safe Can be taught self hypnosis Symptomatic management or relief from pain, anxiety, control Well tolerated

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Therapy Magnetic therapy Description Based on the principle that the cells in the body respond to magnetism Advantages Thought to alleviate tremors Realigning the magnetic fields of the body improves the blood circulation and aids healing Claims to enhance the immune system Relaxation Can be given `hands on' or off Patient do not undress Very simple & safe method Disadvantages Privately funded Over the counter magnetic bracelets are not individualised No conclusive research evidence Privately funded A healing crisis can occur

Reiki

Utilises the natural universal life energy, which is within and around all living things

Acupuncture, Massage, Reflexology, Meditation and Tai chi/yoga are listed and identified in the previous Chapter 6: General Wellbeing and Management Strategies.

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International MS Nursing Care Plan Potentially Harmful Complementary Products Certain herbs may worsen the symptoms associated with MS or interact with conventional medications used in the management of MS (see Table 4). Therefore, these herbal products should be used with caution in patients with MS. Currently, some evidence suggests that high levels of free radicals damage myelin and nerve tissues. Therefore, many patients with MS use antioxidant vitamins (mainly vitamins A,C and E) since these vitamins have been shown to decrease the levels of free radicals in the body. However, antioxidants may also stimulate the immune system (in particular T cells and macrophages) and thus pose a theoretical risk. Therefore, they should be used with caution in patients with autoimmune diseases such as MS. Furthermore, high doses of some vitamins and minerals may have toxic effects (see Table 4). It should also be noted that vitamin A and beta-carotene are contraindicated in patients who smoke, and coenzyme Q10, vitamin E, and vitamin K are contraindicated in patients taking warfarin. St John's Wort is contraindicated when taking other antidepressants. Although zinc is sometimes used to prevent or limit the severity of the common cold, the mineral may stimulate certain cells in the immune system and, therefore, may pose risks to patients with MS. The Medicines Control Agency (MCA) has launched a new information service on its website, which is dedicated to providing up to date safety information on herbal medicines called Herbal Safety News. This is available at: www.mca.gov.uk/ourwork/licensingmeds/herbalmeds/herbalsafety.htm This has been published for the public, herbalists, the herbal industry and all healthcare professionals.

Herbs should be used with caution and their use should be discussed with a doctor.

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International MS Nursing Care Plan Table 4. List of potentially harmful herbal remedies in MS.

Therapy Alfalfa Aloe Bayberry Borage seed oil Cat's claw Chamomile Precaution May have immune-stimulating effects; therefore, should be used with caution in patients with MS May worsen side effects associated with steroid use; therefore, should be used with caution in patients taking steroids May worsen side effects associated with steroid use; therefore, should be used with caution in patients taking steroids May cause liver damage May have immune-stimulating effects; therefore, should be used with caution in patients with MS May have sedative effects; therefore, should be used with caution in patients with fatigue or patients taking sedating medications such as baclofen and diazepam May augment the effects of anaesthesia and cause excessive sedation; therefore, should be avoided in patients about to undergo surgery May cause liver damage May cause liver damage May have immune-stimulating effects; therefore, should be used with caution in patients with MS May have immune-stimulating effects; therefore, should be used with caution in patients with MS May have immune-stimulating effects; therefore, should be used with caution in patients with MS May worsen side effects associated with steroid use; therefore, should be used with caution in patients taking steroids May have sedative effects; therefore, should be use with caution in patients with fatigue or patients taking sedating medications such as baclofen and diazepam May have immune-stimulating effects; therefore, should be used with caution in patients with MS May have sedative effects; therefore, should be use with caution in patients with fatigue or patients taking sedating medications such as baclofen and diazepam May worsen side effects associated with steroid use; therefore, should be used with caution in patients taking steroids May cause multiple toxic effects in patients with MS May have immune-stimulating effects; therefore, should be used with caution in patients with MS May have sedative effects; therefore, should be used with caution in patients with fatigue or patients taking sedating medications such as baclofen and diazepam May have sedative effects; therefore, should be used with caution in patients with fatigue or patients taking sedating medications such as baclofen and diazepam May have sedative effects; therefore, should be used with caution in patients with fatigue or patients taking sedating medications such as baclofen and diazepam

Chaparral Comfrey Echinacea Garlic Ginseng (Siberian and Asian)

Goldenseal

Liquorice Lobelia Melatonin Nettle Passionflower Sage

Note: Some health-care professionals feel that the above-mentioned herbal remedies should be collectively avoided in patients with MS.

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International MS Nursing Care Plan Table 5. Potential toxic dosages of various vitamins and minerals.

Vitamin/Mineral Beta-carotene Vitamin A Vitamin B6 Vitamin C Dosage >10,000 IU/day >10,000 IU/day >50 mg/day >1000 IU/day Possible Effects May cause liver damage and birth defects May cause liver damage and birth defects May cause nerve damage May cause diarrhoea and renal calculi May interfere with blood clotting ability under general anaesthesia; therefore, should be avoided in patients about to undergo surgery May impair bone metabolism and cause liver damage May cause nausea, diarrhoea, and liver damage May cause numerous toxic effects

Vitamin D Niacin Selenium

>1000 IU/day >500 mg/day >200 g/day

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References

Boehringer Ingelheim. A pharmacist's practical introduction to common herbs [manual]; 1996. Bowling AC. Alternative Medicine and Multiple Sclerosis. New York: Demos Medical Publishing; 2001. Bowling AC. Complementary and Alternative Medicine in MS [paper]. Englewood, Colorado: Rocky Mountain MS Center; 2000. Bowling AC, Ibrahim R, Stewart TM. Alternative Medicine and Multiple sclerosis. International Journal of MS Care 2000;2:3. Ernst E, Resch KL, Mills S, Hill R, Mitchell A, Willoughhby M, White A. Complementary Medicine ­ a definition. British Journal of General Practitioners 1995;45:506. Fawcett J, Hanson MJS, Riley-Lawless K et al. Alternative therapies and multiple sclerosis: two case reports. Altern Ther Health Med 1996;2(5):67-69. Graham J. Multiple Sclerosis. The Self Help guide. 3rd ed. London: Harper Collins Publishers; 1992. Kelly J. Toxicity and adverse effects of herbal complementary therapy. Professional Nurse 2002;17(9):562-565. Kosich D. Diet and Nutrition. In: Shapiro RT (ed). Managing the Symptoms of Multiple Sclerosis. 4th ed. New York: Demos Medical Publishing; 2003. Linde K, Ramirez G, Mulrow CD et al. St John's Wort for depression ­ an overview and meta analysis of randomized clinical trials. BMJ 1996;313:253-258. McMillan Cancer Relief. Complementary Therapy Services in UK Cancer Care. McMillan Cancer Relief 2002, Cambridge, UK. Winterholler M, Erbguth F, Neundorfer B. Use of alternative medicine by patients with multiple sclerosis ­ users characteristics and patterns of use. 1997. Cited in Huntley A and Ernst E. Complementary and alternative therapies in treating multiple sclerosis symptoms: a systematic review. Complementary Therapies in Medicine 2000; 8:97-105. Nienstedt BC. The definitional dilemma of alternative medicine. In: Gordon RJ, Nienstedt BC and Gesler WM (eds). Alternative Therapies. New York: Springer Publishing Company; 1998.

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Suggested Readings

Bowling, Allen C. Alternative Medicine and Multiple Sclerosis. New York: Demos. 2001. Web site: http://www.ms-cam.org Chopra D. Quantum Healing. New York: Bantam Books; 1990. Eden D. Energy Medicine. Piatkus; 1998. Eskinazi DP. Factors that shape alternative medicine. JAMA 1998;280:1621-1623. Hay LL. You Can Heal Your Life. London: Eden Grove Editions; 1996. Huntley A, Ernst E. Complementary and alternative therapies for treating multiple sclerosis symptoms: a systematic review. Complementary Therapies Medicine 2000;8. 97-105. Maguire BL. The effects on attitudes and moods in multiple sclerosis patients. Altern Ther Health Med 1996;2(5):75-79. Medicines and Healthcare products Regulatory Agency (MHRA). Herbal Safety News. http://medicines.mhra.gov.uk/ourwork/licensingmeds/herbalmeds/herbalsafety.htm Oschman JL. Energy Medicine: The Scientific Basis. New York: Churchill Livingstone; 2002. Page CR. Frontiers Of Health: From Healing To Wholeness. Essex, UK: CW Daniel & Co Ltd; 2002. Payne A. Nutrition and diet in the clinical management of multiple sclerosis. J Hum Nutr Dietet 2001;14:349-357. Shapiro D. Your Body Speaks Your Unconscious Mind. Piatkus; 1998. Sibley WA. Therapeutic Claims in Multiple Sclerosis. New York: Demos Vermande; 1996. Whitmarsh TE. Homeopathy and multiple sclerosis. Way Ahead 2001;5(3)12-13. Whitmarsh TE. Homeopathy in Multiple Sclerosis. Complementary Therapies in Nursing and Midwifery 2003;9(1):5-9.

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Module 2: Role of the MS Nurse

Introduction

As stated previously, complementary therapies are becoming increasingly popular amongst people with MS. However, since the majority of these therapies have not been scientifically examined, it is often difficult to ensure their safety and efficacy. Bowling (2000) states that the combination of lack of scientifically sound information for patients and a potential clash of value systems of patients and healthcare professionals may lead to significant problems when MS patients make decisions about using complementary therapy. He goes on to say that patients can make decisions about these therapies with inadequate information and lack of input from healthcare providers; this he feels is a potentially dangerous situation. Therefore, nurses specialising in the treatment and management of MS should ensure that patients make informed decisions regarding the use of complementary therapies. In this module, nursing responsibilities with regard to complementary therapies are discussed. Resources that provide patients and healthcare professionals with reliable information on complementary therapies are also presented.

Learning Objectives

After completing this module, the reader will be able to: Describe nursing responsibilities with respect to complementary therapies List resources that provide reliable information on complementary therapies List points that patients should consider before beginning a particular complementary therapy

Note: The extent to which the MS nurse should have a comprehensive knowledge of complementary and alternative therapies is a matter of some debate. The varying level of competence and expertise in this area should be recognized. Furthermore, culturally sensitive issues and practices with regards to complementary and alternative therapies should be respected.

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Professional Accountability

Nurses must accept accountability when discussing and/or suggesting possible complementary therapies to their patients. Therefore, it is important for nurses not to advocate any therapy until a thorough assessment of the risks and benefits has been made and the appropriate professional has been consulted. Furthermore, nurses should discourage "herbal roulette," the practice of continuously self-administering complementary therapies without fully researching the effects of these therapies.

Nursing Responsibilities

Although the final decision to use complementary therapies lies with patients, nurses can play a major role in helping patients make informed decisions regarding the use of these therapies. However, nurses should ask themselves the following questions before they can assist patients in making informed choices (Rodgers 1996): 1. Is it appropriate to provide information about complementary therapies? Do I have the knowledge, skill, and judgement to assess the appropriateness of this therapy for this particular patient? - What is the patient's health state? - What are the available interventions? Do I have enough information about this therapy to answer the following questions: - What is the anticipated effect of this therapy? - What are the potential benefits of this therapy? - What are the potential risks of this therapy? - What is the expected outcome of this therapy? Does the patient have access to relevant information regarding the risks and benefits of this particular therapy? Has the therapy been recognised as an acceptable intervention within my agency/organisation? 2. Can I recommend agencies or practitioners who have the required knowledge, skills, and judgement to provide this therapy safely and effectively as well as provide ongoing assessment and evaluation of the effects of the therapy? 3. Do I understand and can I deal with the possible outcomes of this therapy? Nurses who answer "no" to any of these questions may want to educate themselves more thoroughly about complementary therapies or refer patients to healthcare professionals with the knowledge and skills needed to assist patients in making informed choices about complementary therapies. Nurses who answer "yes" to all of the above questions and who feel they are qualified to educate patients on complementary therapies should provide patients with access to reliable information.

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Nurses should support patients in their decision to use complementary medicines. To be anything other than supportive of the patient's decision to use complementary therapies may force the person to go `underground' and not declare what other remedies, products or therapies they are using. This is, of course, the patient's prerogative, but we will never know the true extent of medicine/therapy interaction if we do not promote firstly, an open, non-judgmental relationship and secondly, communicate to the patient that these therapies/products should be complementary approaches with conventional treatments as opposed to alternative approaches. Quite often the patient may know someone personally who is practicing these therapies; indeed it may be a family member. This may be an ideal route and opportunity for the nurse to practice true collaborative care involving the patient, family, friends and healthcare workers.

Access to Reliable Information for the Nurse and Patient

Training standards vary enormously across therapies, and even within particular therapies. Not every therapy has an enforceable regulatory mechanism and due to common law in the UK, anyone with or without training can set themselves up as a complementary therapist. There is no one single statutory body that regulates and controls minimum standards in complementary therapies, although there are some organisations trying to do this. This means that reliable information on the efficacy of complementary therapies is often hard to come by. Information about complementary therapies is often obtained through magazines, newspapers, newsletters, and advertisements. However, material obtained through these sources can often be misleading or biased. Therefore, it is important for nurses to refer patients to more reliable sources of information such as physicians and pharmacists who are knowledgeable in both conventional and complementary approaches, nutritionists, physiotherapists, journals specific to complementary medicines (e.g., Alternative and Complementary Therapy, Alternative Medicine Review, and Quarterly Review of Natural Medicine), bookstores and health-food stores, complementary-therapy associations and organisations, and medical-services librarians. The following are considered reputable organisations where information and sometimes a list of accredited therapists can be obtained. They all vary in the resources they provide. British Homeopathic Association 15 Clerkenwell Close London EC1R OAA www.trusthomeopathy.org

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International MS Nursing Care Plan British Acupuncture Council 63 Jedda Road London W12 9HQ [email protected] Foundation for Integrated Medicine International House 59 Compton Road London N1 2YT British Chiropractic Association Langham House West Luton Bedfordshire LU1 2NA www.osteopathy.org The Research Council for Complementary Medicine 60 Great Ormond Street London WC1N 3JF www.rccm.org This charity was founded in 1983 its aims are: The promotion of scientific research into complementary medicine The dissemination of research results Improved collaboration between orthodox and complementary practitioners Closer international links among researchers and governments It has an information service based on an extensive research database. Complementary Therapies in Nursing and Midwifery Journal www.harcourt-international.com/journals/ctnm Complementary Therapies in Nursing Forum Royal College of Nursing 20 Cavendish Square London W1M OAB www.rcn.org Multiple Sclerosis Resource Centre 7 Peartree Business Centre Peartree Road Stanway Colchester Essex CO3 5JN www.msrc.co.uk

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International MS Nursing Care Plan Well-aware (www.well-aware.co.uk/clinic/cam_suite/cam_index.php) is a health website that has teamed up with two leading specialists to produce a clinic on complementary therapies. It is run by Professor Edzard Ernst, the UK's only professor of complementary therapy and Dr David Peters, Clinical Director of the School of Integrated Health. Professor Ernst and Dr Peters are both based at Exeter University. All information is freely available to patients and professionals alike, and designed to identify how complementary treatments may be of benefit ­ or not! The Internet also contains a wealth of medical and health information. However, information on the Internet can also be misleading and biased. Therefore, nurses should suggest that patients use their discernment and always question the validity of what they read online and check the date information was last updated. Patients should also be cautious of websites that have disclaimers. Some useful websites are listed below: Organization MS Australia Consortium of Multiple Sclerosis Centers (U.S.) National Multiple Sclerosis Society (U.S.) Multiple Sclerosis Association of America The Multiple Sclerosis Society of Canada National Organization of Neurological Disorders and Stroke MS page (U.S.) The MS Trust (UK) International Organization of MS Nurses International Journal of MS Care International MS Support Foundation Website www.mssociety.com.au www.mscare.org www.nmss.org www.msaa.com www.mssociety.ca www.ninds.nih.gov/health_and_medical/disorders /multiple_sclerosis.htm www.mstrust.org.uk www.iomsn.org www.mscare.com www.imssf.org/ms/

Nurses should also instruct patients to consider the following when assessing information gathered from various resources: Publications may reflect the opinions of the author and not necessarily the "real" facts Foreword or prologue sections of particular publications may contain information that can help the patient determine the purpose of the book and the author's intention in writing it An author's credentials and affiliation can add to the credibility of the information

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International MS Nursing Care Plan Therapies that are endorsed or recognised by health officials and/or government agencies are generally more credible than therapies that do not have such endorsements.

Points Patients Should Consider

Nurses should ensure that patients consider the following questions before beginning a particular complementary therapy: What claims are being made about the treatment or product? What qualifications does the individual providing the treatment have? Training for some therapies can be anything from a simple correspondence study, to a weekend course, to a degree or practitioner level. Who recommends the treatment? Who has tried this treatment? Has the treatment been effective in others who have used it? Can the therapist name any satisfied clients? What does the therapy involve? How does the therapy work? What kind of testing, if any, has been done on this therapy? How much will it cost me? What are the risks associated with this therapy? Does the therapy have any side effects or contraindications? What are the benefits associated with the therapy? Has this treatment been shown to have a placebo effect? What are their expectations? Cure or symptom relief? Nurses should also instruct patients to: Consult a physician about the possible side effects and drug interactions of using a complementary therapy or product Discontinue complementary therapy immediately and notify a physician if side effects occur Continually monitor both positive and negative effects of therapy Continue taking medications prescribed by their physicians Use complementary products cautiously since labels on these products do not always list all ingredients and, therefore, may contain toxic substances

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Adverse Event Reporting

Nurses should report any adverse drug reactions resulting from complementary therapy use to the appropriate authorities.

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Reference

Rodgers S. Complementary therapies: What is your role? College of Nurses of Ontario; June 1996.

Suggested Readings

Alternative medicine. Expanding medical horizons: A report to the National Institutes of Health on alternative medical systems and practices in the United States. Washington (DC): Government Printing Office; 1994. Canadian Medical Association. A patient's guide to choosing unconventional therapies. Can Med Assoc J 1998;158:1161-1165. Cant S, Sharma U. Complementary and alternative mediums: Knowledge in practice. London: Free Association Press; 1996. Dillard J, Ziporyn T. Alternative medicine for dummies. New York: IDC Books Worldwide; 1998. McGuinness H. Holistic Therapies. Hodder & Stoughton; 2000. Oppel L. Protecting patients against "quackery." Can Fam Phys 1998;44:487-488. Ramsay C, Walker M, Alexander J. Alternative medicine in Canada: Use and public attitudes. Public Policy Sources. Fraser Institute; 1999. Verhoef MJ. Complementary medicine: Impact on physicians. Paper presented at the Insight Information Symposium; Nov 1998; Toronto, Ontario. Wilson E, Lewith G. Natural Born Healers. Collins & Brown Ltd; 1997.

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Progress Check

1. List four (4) of the most common reasons reported by MS patients for using complementary therapies. a. _________________________ b. _________________________ c. _________________________ d. _________________________ 2. In vibrational medicines, state three (3) energy fields within or around the body. a. ________________________ b. ________________________ c. ________________________ 3. What is a `Healing Crisis' due to in vibrational medicine? __________________________________________________________________ __________________________________________________________________ 4. List four (4) ways how a healing crisis may manifest while using vibrational medicine: a. _______________________ b. _______________________ c. _______________________ d. _______________________ 5. List ten (10) of the most commonly used complementary therapies in MS. a. _________________________ b. _________________________ c. _________________________ d. _________________________ e. _________________________ f. _________________________ g. _________________________ h. _________________________ i. _________________________ j. _________________________

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6. Fill in the blanks. Recommended for the treatment of symptoms associated with premenstrual syndrome Believed to provide energy and essential nutrients Believed to improve symptoms associated with mild-to-moderate depression Recommended for the prevention of urinary tract infections Believed to provide essential fatty acids that may control MS symptoms Recommended for the treatment of MS-related pain 7. List eight (8) complementary therapies that may have immune-stimulating effects and should therefore be used with caution in patients with MS. a. _________________________ b. _________________________ c. _________________________ d. _________________________ e. _________________________ f. _________________________ g. _________________________ h. _________________________ 8. List six (6) complementary therapies that may have sedative effects and should therefore be used with caution in patients with fatigue or those taking sedating medications. a. _________________________ b. _________________________ c. _________________________ d. _________________________ e. _________________________ f. _________________________ 9. Doses of _______________ greater than 1000 IU/day may impair bone metabolism and cause liver damage. 10. Doses of _______________ and _______________ greater than 10,000 IU/day may cause liver damage and birth defects. 11. Doses of vitamin B6 greater than _______________ may cause nerve damage.

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12. List three (3) complementary therapies that are contraindicated in patients taking warfarin. a. _________________________ b. _________________________ c. _________________________

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13. Complete the following table: Therapy Description

Aromatherapy Uses essential oils to promote well-being

Advantages

Disadvantages

Privately funded A healing crisis can occur Use with caution if pregnant

Chiropractic / osteopathy

Aim to restore health by manipulation of the bones, muscles and tissues, especially in the spine, principally to benefit the nervous system (in Chiropractic) or the blood supply (in osteopathy) Claims to be able to treat disorders of pain, pins and needles and numbness amongst other symptoms The individual is either guided or creates images that induce relaxation or other beneficial effects on the body

Privately funded Caution in those with back pain No conclusive research evidence

Guided imagery and visualisation

Use cautiously in patients with psychiatric disturbance Not usually available unless pay privately Can be bought over the counter as well as by consultation Cruelty free ­ not animal tested Some claim it improves symptoms or maintain their condition

Homeopathy

Basic tenant of treating `like with like', a minimum dose of substance that would induce symptoms in a healthy person is given in a highly diluted concentration to a sick person Mainly used as a preventative measure Breathing oxygen in a pressurised chamber

Hyperbaric oxygen

Hypnotherapy

Usually safe Can be taught self hypnosis Symptomatic management or relief from pain, anxiety, control. Well tolerated Based on the principle that the cells in the body respond to magnetism Thought to alleviate tremors Realigning the magnetic fields of the body improves the blood circulation and aids healing Claims to enhance the immune system Relaxation

Use cautiously in patients with psychiatric disturbance Not usually available unless pay privately Bad press of hypnotists as opposed to hypnotherapists

Magnetic therapy

Reiki

Utilises the natural universal life energy, which is within and around all living things

Privately funded A healing crisis can occur

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14. What should nurses do before assisting patients in making informed choices about complementary therapies?

15. List six (6) instructions nurses should give to patients who are considering the use of complementary therapies. a. ________________________________________________________________ b. ________________________________________________________________ c. ________________________________________________________________ d. ________________________________________________________________ e. ________________________________________________________________ f. ________________________________________________________________

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Chapter 8: Treatment Optimization

Introduction

As mentioned in Chapter 3: Treatments, interferon beta-1a (IFN -1a; Rebif , Avonex ), interferon beta-1b (IFN -1b; Betaseron®) and glatiramer acetate (Copaxone®) are the first agents that have been shown to have a direct influence on altering the course of relapsing multiple sclerosis (MS). However, ensuring optimal medical and health outcomes for patients using these disease-modifying therapies (DMTs) depends on more than just initiating treatment. Rather, achieving optimal treatment outcomes depends on several factors, including (Denis et al., 2004): patient appropriateness for and readiness to initiate treatment treatment efficacy adequate education about MS, available therapies and self-injection training monitoring and management of possible treatment-related adverse events the patient's physical, cognitive, and psychosocial status adherence to an effective therapeutic regimen Since nurses are the main healthcare professionals to have day-to-day contact with patients, they play a pivotal role in identifying and overcoming problems in each of these areas and, thereby, help ensure optimal clinical, psychosocial, and quality-of-life outcomes for patients with MS using DMTs (Denis et al., 2004). The purpose of this chapter is to guide and assist nurses through this challenging, long-term process of obtaining and maintaining optimal health outcomes in MS patients a process known as treatment optimization. Since not all the DMTs have the same benefit-to-risk profile, treatment optimization ensures that all patients with MS are treated optimally and within established guidelines.

Chapter Overview

This chapter contains the following five modules: Module 1: Nursing Approach to Treatment Optimization Module 2: Initial Assessment and Patient Selection for DMT Module 3: Treatment Selection Module 4: Patient Education and Self-injection Training Module 5: Long-term Assessment and Monitoring of Patients Using DMTs

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Module 1: Nursing Optimization

Introduction

Approach

to

Treatment

Since MS can progress silently, physicians, nurses and patients need to take all the necessary steps to manage the disease. Treatment optimization refers to the process used to ensure the best possible clinical, subclinical (e.g., magnetic resonance imaging [MRI]), psychosocial, and quality-of-life outcomes for patients with MS using DMTs (Denis et al., 2004). Central to this process is the use of an optimal therapy or, in other words, a therapy that offers the best benefit-to-risk profile. This module outlines an evidence-based nursing approach that is designed to guide and assist nurses through this demanding and long-term process of treatment optimization. The remainder of the modules in this chapter discuss, in detail, each step in this nursing approach.

Learning Objectives

After completing this module, the reader will be able to: Describe and apply the nursing approach to long-term treatment optimization in patients with MS using DMTs

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Nursing Approach to Treatment Optimization

Figure 1 illustrates a nursing approach to long-term treatment optimization in patients with MS using DMTs developed by the North American MS Nurses Treatment Optimization Group. The primary goal in the first three steps of the nursing approach initial assessment and patient selection, treatment selection, and patient education and self-injection training is to achieve treatment optimization by ensuring that the patient (Denis et al., 2004): is both suitable for (ie, using approved Eligibility Criteria; see Module 1 of Chapter 3: Treatments) and ready to initiate DMT receives the most appropriate therapy possible receives adequate education about MS and the available therapies as well as self-injection training Once treatment is initiated, the nursing approach to treatment optimization requires long-term clinical, subclinical, laboratory, and psychosocial assessments and the monitoring of treatment adherence. The ultimate goal in each step of this nursing approach is to maximize the benefits and minimize the risks in patients with MS using DMTs.

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International MS Nurse Care Plan Figure 1. Nursing approach to long-term treatment optimization in patients with MS using DMTs. Reprinted with permission from Denis, L., et al. (2004). Long-term treatment optimization in individuals with multiple sclerosis using disease modifying therapies: A nursing approach. Journal of Neuroscience Nursing, 36, 11. Copyright 2004 by the American Association of Neuroscience Nurses.

Note: The number of visits recommended for patient education and self-injection training varies from country to country. Note: In some countries, patients undergo MRI scans only at the time of diagnosis. Therefore, the monitoring of MRI outcomes following treatment initiation is not possible.

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Module 2: Initial Selection for DMT

Introduction

Assessment

and

Patient

The process of long-term treatment optimization begins with a thorough clinical and psychosocial assessment of the patient to ensure that he or she is an appropriate candidate for DMT and is ready to select and initiate therapy (Denis et al., 2004). In this module, strategies for the initial assessment and appropriate selection of patients for DMT are described.

Learning Objectives

After completing this module, the reader will be able to: Apply a patient-centered interview process during the initial assessment Discuss the importance of establishing a trusting nurse-patient relationship Describe and address clinical and psychosocial factors that may be barriers to appropriate treatment selection and initiation Apply currently available local and/or national criteria to ensure patient appropriateness for DMT Ensure and promote treatment readiness prior to the initiation of DMT

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Initial Assessment

The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nur The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage.

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International MS Nurse Care Plan During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns

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International MS Nurse Care Plan about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. The primary objective of the Initial Assessment and Patient Selection step in the nursing approach to treatment optimization is to ensure that the patient is both appropriate for and ready to select and initiate therapy. By ensuring treatment readiness prior to therapy selection, the nurse increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. se increases the likelihood of treatment optimization at a later stage. During the initial assessment, it is important that the nurse use the patientcentered interview process to assess the full spectrum of the patient's concerns about MS and therapy. The goals of this type of interview are to reach shared expertise with the patient and support the patient's autonomy (Larivaara et al., 2001). The patient-centered interview process is described in Table 1. Table 1. The patient-centered interview process.

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International MS Nurse Care Plan Adapted from Larivaara P, Kiuttu J, Taanila A. The patient centered interview: the key to biopsychosocial diagnosis and treatment. Scand J Prim Health Care 2001;19:8-13.

1. Establish the patient's perceptions of the illness. A good interview should begin with a patient-led storytelling process in which the patient has influence over the "headlines" and details of the story told. Skilled interviewers convey warmth and attention by their forward posture, eye contact and expressive face, gesture and tone. By allowing the patient the opportunity to describe his or her own complaints, the skilled interviewer can more efficiently recognize patterns that are relevant for the particular patient's problems. Patients are often anxious about diagnostic information, especially if the information includes some bad news. Therefore, this information needs to be brief and succinct. All experiences of symptoms and illness produce many emotions in patients and their families. In order to get to the heart of the patient's problems, the nurse must somehow perceive these emotions and respond to them either verbally or non-verbally. In this phase of the interview, it is important to assess the patient's baseline knowledge of the illness by asking such questions as, "What do you think might be causing your symptoms?" Again, as patients are often fearful of diagnostic information, it is important not to provide patients with too much information during the initial assessment. Information that is provided should be succinct. Finally, it is important to assess the patient's understanding of the information provided to him/her during the initial assessment.

2. Ensure a basic diagnosis has been made.

3. Respond to the patient's feelings about the diagnosis.

4. Assess the patient's knowledge of the illness.

5. Provide details diagnosis.

of

the

6. Assess the patient's understanding of the disease/therapies.

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International MS Nurse Care Plan Establishing the Nurse-Patient Relationship The nurse-patient relationship is viewed as a core component of long-term treatment optimization. The manner in which the nurse responds to the patient's emotions during the initial assessment will, to a large extent, determine the quality of the overall nurse-patient relationship (Larivaara et al., 2001). Therefore, to establish a trusting nurse-patient relationship at the time of the initial assessment and onward, the nurse must take the time to empathize with the patient and provide unbiased support throughout the interview process (Denis et al., 2004). Warmth, sensitivity, and good communication in the nurse-patient relationship have all been identified as having a positive influence on patient outcomes. Establishing a trusting relationship with the patient also requires that the relationship be nurtured at every visit, and this means taking adequate time to educate and counsel patients. In addition, the nurse should attempt to ensure the patient receives consistent and accurate messages about MS and the available therapies.

Evaluation of Clinical and Psychosocial Factors The initial assessment should also include a thorough evaluation of clinical and psychosocial factors that may be barriers to appropriate treatment selection and initiation at a later stage. The level of the patient's disability, concomitant illnesses, and cognitive and physical functioning may all have a significant impact on both treatment decisions and adherence to long-term treatment protocols (Denis et al., 2004). For example, poor hand-eye coordination, tremor and fatigue are all barriers to optimal self-care, particularly to self-injection of therapy. Furthermore, progressive disease and higher disability levels have been associated with a reduced likelihood of achieving acceptance of therapy (Holland et al., 2001a). Cognitive impairments such as memory loss, difficulty in learning and recalling new information, and slowed information processing speed can also interfere with a patient's ability to understand the rationale for therapy as well as the complex treatment regimen (Holland et al., 2001a). Therefore, patients who are physically and/or cognitively compromised may require extra assistance in dealing with treatment logistics. Psychosocial factors such as the availability of support networks, financial resources, and the patient's sense of control over MS may also affect overall patient outcomes. For example, patient registry data have shown that patients with lower incomes and educational levels, and those with less private insurance coverage are less likely to adhere to therapeutic regimens (Vollmer, 2002). This non-adherence, in turn, may negatively impact the process to treatment optimization. In addition, patients who believe that health is determined by outside forces (external locus of control) are less likely to initiate or adhere to treatment than patients who believe that health is under their control (internal

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International MS Nurse Care Plan locus of control) (Rotter,1966). However, nurses can help patients feel more in control of their disease by ensuring that they actively participate in the clinical decision-making process and by providing access to support networks and financial resources (Denis et al., 2004).

Appropriateness for Therapy

In collaboration with the neurologist, the MS nurse should ensure that the patient is indeed an appropriate candidate for DMT by using local and/or national selection criteria. Criteria for consideration of therapy in relapsing-remitting MS are discussed in Module 1 of Chapter 3: Treatments.

Treatment Readiness

Simply educating patients about the available therapies is not enough to enable them to consider initiating treatment. The common patient question that nurses need to address in this step of the nursing approach is, "I'm feeling OK, so why do I need to start on treatment?" According to the theory of adult learning, people become ready to learn when they have a need to know something in order to cope more satisfactorily with tasks or problems (Knowles, 1980). The transtheoretical model of behavior change is useful in determining patient readiness for treatment (Holland et al., 2001b; Prochaska et al., 1994). This model describes the process of change as long-term and dynamic, in which persons with MS pass through five stages as they incorporate lifestyle changes: (a) precontemplation (b) contemplation (c) preparation (d) action (e) maintenance In the precontemplative stage, the patient is unaware of, or is unconcerned about, the benefits of treatment with a DMT, and denies the personal need for therapy. The patient actively considers therapy in the contemplative stage and expresses a determination to initiate therapy in the preparation stage. In the action stage, the patient engages in the administration of therapy and, in the maintenance stage, continues treatment indefinitely (Holland et al., 2001b). Using this model, nurses can determine the appropriate time to encourage therapy (see Table 2).* The goal is to match interventions to the individual's stage of change (Holland et al., 2001b).

*Note: Other models of behaviour change are available and may be used by the MS nurse to determine the appropriate time to encourage therapy.

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International MS Nurse Care Plan Table 2. Transtheoretical model of change and sustained use of DMTs. Reprinted with permission from Holland, N., et al. Adherence to disease-modifying therapy in multiple sclerosis: Part II. Rehabilitation Nursing, 26, 221-226. Copyright 2004 by the Association of Rehabilitation Nurses.

Patient Attitude

Precontemplative Stage

A. Individual is unaware of, or unconcerned about, benefits of treatment with DMTs, particularly early intervention. Individual denies personal need for therapy, e.g., "I don't need treatment yet. I have benign MS," etc.

Contemplative Stage

Individual is actively considering therapy (initiation or resumption) though may be somewhat ambivalent; i.e., patient may plan to start therapy within 6 months or, for example, in the summer when the children are away at camp.

Preparation Stage

Individual expresses determination to initiate or resume therapy; plans to take action within the next months.

Action Stage

Individual engages in administration of therapy.

Maintenance Stage

Individual continues therapy indefinitely unless serious side effects develop, severe relapses occur, the disease rapidly progresses, or more effective therapy becomes available. Healthcare team continues support and periodic followup

B.

Healthcare Intervention

A. Explore the individual's understanding of MS, personal beliefs about therapeutic agents, and obstacles to initiation or continuation of treatment. B. Use information, such as National MS Society Consensus Statements, to address educational and personal barriers to initiation, continuation or resumption of therapy. C. Validate fears such as dislike of needles. D. Modify impression that MS is an "untreatable disease." A. Provide information about the process of initiating or resuming therapy, anticipated benefits, limitations, and potential side effects. Initiate follow-up to continue support and answer questions. A. Address details of initiating or resuming therapy; e.g., call the physician, nurse, pharmaceutical assistance program*, insurance plan or prescription plan. B. Establish a more convenient time for administration of therapy. C. Enlist help from family member, care partner, or friend if physically necessary or emotionally helpful. D. Provide ongoing support to individual. E. Help the patient develop a personal support network. A. B. Plan of action is developed and initiated. Individual is able to move to Action Stage. A. Have nurse available to answer questions and address concerns. Provide proactive follow-up and ongoing high level of support.

B.

B.

Outcomes

A. Individual is able to articulate understanding of his or her own MS disease state and personal barriers to treatment. Individual is able to move to Contemplative Stage. 1. Individual is able to describe process of therapy and potential benefits and side effects. Individual is able to move to Preparation Stage. Individual commits to remain on therapy for 6 months unless physician discontinues it or side effects are intolerable. Individual continues therapy indefinitely or as indicated by the physician.

B.

2.

Note: MS patients may move back and forth between these stages and re-enter the system at any point.

*Note: Pharmaceutical assistance programs are not available in some countries.

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Patient Expectations of Therapy*

It is also important for the nurse to assess and address the patient's expectations of treatment before therapy begins, since these expectations can greatly affect overall patient outcomes at a later stage. One study found that 34­57% of patients who begin IFN therapy have unrealistically optimistic pretreatment expectations (Mohr et al., 1996). Those patients who maintained unrealistic treatment expectations, despite therapy-related educational interventions, were significantly less likely to adhere to therapy than patients with more realistic expectations. Non-adherence to an effective therapeutic regimen will negatively impact the benefit achieved by treatment. Therefore, direct nursing support to setting realistic treatment expectations prior to therapy selection and initiation may help ensure treatment adherence at a later stage and, thereby, promote treatment optimization particularly in situations where treatment benefit is not immediately obvious (Denis et al., 2004). Even if the patient is not yet ready to initiate treatment, an individualized care plan should be developed at this point, in collaboration with the patient as well as his or her family. This plan should be flexible, dynamic, and responsive to the changing needs and level of readiness of the patient and family (Denis et al., 2004). A care plan for ensuring treatment readiness prior to the initiation of therapy is shown in Table 3.

*Note: Some MS nurses recommend that patient expectations of therapy be examined even before the initial assessment and that these expectations be revisited following the assessment.

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International MS Nurse Care Plan Table 3. Care plan for ensuring treatment readiness.

Initial Assessment Interventions Desired Patient/Family Outcomes

Understand the disease process, the importance of therapy, and personal barriers to treatment Express readiness to start treatment Demonstrate trusting relationship with nurse/healthcare professionals Incorporate plan into everyday lives and commit to plan in the long-term Knowledgeable about available support networks and use these networks Demonstrate positive coping and health-promoting behaviors Feel self-care decisions are respected

Evaluation

Review clinical records and disease/health history Assess patient knowledge base of: Disease Treatment options Assess the following in a patient-centered interview: Patient's worst fears of MS and treatment Patient's expectations of treatment, nurse/healthcare team Determine locus control Internal External of

Implement strategies to address physical and/or cognitive deficits that may impact treatment decisions/initiation and refer to appropriate healthcare professional as required Validate fears and modify impression that MS is "untreatable" Tailor and provide education on disease and treatment options according to patient's readiness to learn and individual concerns/psychosocial issues Establish a trusting/supporting nursepatient relationship Ensure optimal support networks are available and mobilize patient resources such as counseling, physical therapy, etc. Provide information about support agencies and financial assistance services* Develop a dynamic and individualized care plan, in collaboration with patient and family, that incorporates beliefs and perceptions of health

Ongoing review of care plan Care plan accommodates changing needs Developmental/life changes Changing expectations Readiness to engage in therapy Physical and social changes Patient selects initiates treatment and

Impact on treatment optimization (optimal vs suboptimal)

Identify possible support networks/resources Assess cultural and lifestyle values Assess financial needs/resources* Recognize specific needs age-

Assess patient and family adjustment to diagnosis and existing coping behaviors

*Note: Knowledge and availability of financial services and resources varies from country to country. In some countries, MS nurses are not involved in examining patients' financial needs nor are they responsible for directing patients to financial assistive services.

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Module 3: Treatment Selection

Introduction

The next step in the nursing approach to long-term treatment optimization is Treatment Selection. Sustained treatment with the DMTs in patients with relapsingremitting MS has been associated with several positive outcomes and, therefore, international guidelines emphasize the need to start treatment with these agents early in the disease course (Freedman et al., 2002). However, the process of treatment selection is not a simple one since the four DMTs differ in their mode of action, preparation, dosage level, adverse-event profile, route of administration and their proven efficacy on outcomes such as relapses, disease progression and MRI activity. The major clinical trials of DMTs in MS are discussed in Chapter 3: Treatments. In this module, strategies are provided to ensure that patients receive the most effective therapy possible based on their individual needs. Choosing the most appropriate treatment with the best benefit-to-risk profile from the onset will help achieve long-term treatment optimization.

Learning Objectives

After completing this module, the reader will be able to: Discuss the importance of patient collaboration in the treatment decision-making process Describe patient issues that should be assessed prior to treatment selection Discuss the clinical utility of DMTs based on supporting evidence Apply strategies to assist patients in choosing the most appropriate therapy based on their individual needs

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Patient Collaboration & Empowerment

To promote patient empowerment, the patient should be encouraged to collaborate fully in the treatment decision-making process. For some patients, however, decisions regarding treatment can be very difficult, and they may rely on their nurse or neurologist for the appropriate decision. Therefore, throughout the treatment selection process, the nurse should verify the degree of decision-making control that is comfortable for the patient (Denis et al., 2004).

Assessment of Patient Issues

Cultural, lifestyle, and financial issues will have a significant impact on treatment decisions and, therefore, should be assessed thoroughly prior to treatment selection. The objective of these assessments is to ensure that the selected treatment regimen corresponds with the patient's lifestyle and cultural values (Denis et al., 2004). The costs associated with DMTs will also affect treatment decisions. Knowledge of financial services and resources may help the patient achieve greater financial independence. Therefore, the nurse should examine the patient's and family's financial needs and direct them to community-, employee- or government-linked financial support programs or other financial assistive services that may help address issues specific to their financial situation* (Denis et al., 2004). Family and emotional support are also critical for ensuring optimal treatment outcomes (see Module 6 in Chapter 5: Psychosocial Implications of MS for strategies to involve patients' families in the care and management of MS.). Therefore, the nurse, in collaboration with family- and community-based healthcare professionals, should ensure appropriate support networks are available to the patient (Denis et al., 2004). It is also important for the nurse to assess the patient's existing knowledge base on DMTs and the reliability of external information provided to him or her about these therapies as this will also impact treatment decisions. In cases where the information provided or source of information is questionable, the nurse should reeducate the patient on treatment efficacy, approved product indications, and sideeffect profiles (Denis et al., 2004). See Module 1 of Chapter 3: Treatments for an overview of the DMTs.

*Note: Knowledge and availability of financial services and resources varies from country to country. In some countries, MS nurses are not involved in examining patients' financial needs nor are they responsible for directing patients to financial assistive services. Note: In some cases, there is no family support available or the patient may not want others to be aware of treatment. In such cases, alternate support resources should be considered.

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Efficacy of DMTs

The therapeutic efficacy of the currently approved DMTs for relapsing-remitting MS has been well established in large clinical trials (see Table 4). (For a more detailed discussion of the major clinical trials of DMTs, see Chapter 3: Treatments) The nurse plays a paramount role in providing complete and objective information on each of the DMTs. Prior to treatment selection, the effect of each of the available DMTs on relapse frequency and severity, disease progression, and MRI findings should be discussed, and reference should be made to the approved labeling and indications of each agent, as well as to the key findings of major clinical trials on DMTs (Denis et al., 2004).

Table 4. Summary of significant results from pivotal trials of DMTs in relapsing-remitting MS.

Agents

IFN -1a SC1,2

(Rebif )

Relapse rate

Progression disability

of

MRI BOD

MRI Gd T1

IFN -1a IM3

(Avonex )

**

NA*

IFN -1b4,5

(Betaseron )

GA6,7

(Copaxone )

t

t

t

*Gd not available at the time of this study; 9-month results from a separate study; = primary endpoint; BOD = burden of disease; Gd = gadolinium; IFN = interferon; GA = glatiramer acetate; IM = intramuscularly; SC = subcutaneously 1. 2. 3. 4. 5. 6. 7. PRISMS Study Group. Lancet 1998;352:1498-504 Li et al. Ann Neurol 1999;46:197-206 Jacobs et al. Ann Neurol 1996;39:285-94 The IFNß Multiple Sclerosis Study Group. Neurology 1993;43:655-61 Paty et al. Neurology 1993;43 662-7 Johnson al. Neurology 1995;45:1268-76 Comi et al. Ann Neurol 2001;49:290-7

**It should be noted that the intention-to-treat analysis of all patients treated with IFN -1a IM (Avonex ) for the entire study period found only an 18% reduction in relapse rate compared to placebo.3 Note: The studies indicated above were not designed to compare different therapies under the same conditions; thus, conclusions regarding comparisons should be made with caution.

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The Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology recently assessed the clinical utility of DMTs and provided recommendations for their use based on an analysis of the supporting evidence for each therapy (Goodin et al., 2002). Table 5 summarizes the rating of evidence classification scheme used for this analysis and Table 6 summarizes the Subcommittee's recommendations. If a patient asks for more detailed information on the efficacy of DMTs, the nurse may review the supporting literature with the patient and/or refer the patient to the neurologist.

Table 5. Rating of evidence classification scheme. Adapted from Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002;58:169-178.

Recommendation Rating

A - established as effective, ineffective, or harmful for the given condition in the specified population.

Rating of Therapeutic Article

Class I: Prospective, randomized, controlled clinical trial with masked outcome assessment in a representative population. The following are required: a. primary outcome(s) is/are clearly defined b. exclusion/inclusion criteria are clearly defined c. adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias d. relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences Class II: Prospective matched group cohort study in a representative population with masked outcome assessment that meets a-d above, or a randomized controlled trial in a representative population that lacks one of the criteria from a-d (above). Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome assessment is independent of patient treatment.

B ­ probably effective, ineffective, or harmful for the given condition in the specified population. C ­ possibly effective, ineffective, or harmful for the given condition in the specified population.

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Table 6. Recommendations on the use of DMTs based on supporting evidence. Adapted from Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002;58:169-178.

IFN

On the basis of several consistent Class I studies, IFN has been demonstrated to reduce the relapse rate (whether measured clinically or by MRI) in patients with relapsing-remitting MS (Type A recommendation). Treatment of MS with IFN produces a beneficial effect on MRI measures of disease severity, such as T2 disease burden, and probably also slows sustained disability progression (Type B recommendation). On the basis of Class I and II studies and several pieces of consistent Class III evidence, it is considered probable that there is a dose-response curve associated with the use of IFN for the treatment of MS (Type B recommendation). It is possible, however, that a portion of this apparent doseeffect may be due to differences in the frequency of IFN administration (rather than dose) between studies. On the basis of Class II evidence, the route of administration of IFN is probably not of clinical importance, at least with regards to efficacy. The sideeffect profile, however, does differ between routes of administration.

Glatiramer Acetate

On the basis of Class I evidence, glatiramer acetate has been demonstrated to reduce the relapse rate (whether measured clinically or by MRI) in patients with relapsing-remitting MS (Type A recommendation). Treatment with glatiramer acetate produces a beneficial effect on MRI measures of disease severity, such as T2 disease burden, and possibly slows sustained disability progression (Type C recommendation).

.

Treatment Philosophy of the Healthcare Team

Another important factor to consider in the Treatment Selection stage of the nursing approach is the treatment philosophy of the healthcare team responsible for the care and management of the patient. Despite evidence that early and sustained treatment with the DMTs has a significant positive effect on the disease process, some physicians continue to believe that the majority of patients have a "benign" course and, therefore, delay prescribing therapy until the disease progresses (Holland et al., 2001a). Another study found that over 60% of patients who discontinued therapy were told to do so by their physician (Hadjimichael & Vollmer, 1999). However, to ensure treatment optimization, it is imperative that the healthcare team, as well as the patient, are committed to the selection and initiation of the treatment that provides the best benefit-to-risk profile and to the long-term treatment protocol (Denis et al., 2004). A care plan for ensuring optimal treatment selection is shown in Table 7.

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International MS Nurse Care Plan Table 7. Care plan for ensuring optimal treatment selection.

Assessment

Encourage patient to collaborate in treatment decision-making process Verify degree of decisionmaking control that is comfortable for the patient Assess patient's and family's cultural/lifestyle values Assess patient's knowledge base of treatments and reliability of source of knowledge ­ Internet ­ Publications ­ Other patients/health professionals Assess available networks support

Interventions

Ensure patient/family participate fully in the decision-making process Assist patient in selecting a therapy that provides the best benefit-to-risk profile Provide patient with reliable information regarding treatment efficacy, sideeffect profile, etc. Direct patient and family to community-, employee- or government-linked financial services* Ensure appropriate support networks are available to the patient

Desired Outcomes

Patient

Evaluation

Impact on treatment optimization (optimal vs suboptimal) Adherence treatment regimen to

Makes informed decision regarding treatment Most effective therapy chosen based on individual needs/resources Therapeutic regimen corresponds with lifestyle/cultural values

Assess patient's financial needs and how well these needs are currently being met* Examine treatment philosophy of the healthcare team

*Note: Knowledge and availability of financial services and resources varies from country to country. In some countries, MS nurses are not involved in examining patients' financial needs nor are they responsible for directing patients to financial assistive services.

Country-specific issues regarding treatment selection and discussions surrounding therapy are shown in Table 8.

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International MS Nurse Care Plan Table 8. Country-specific issues discussions surrounding therapy.

Country

Austria

regarding

treatment

selection

and

Issue(s)

Patient is seen by the MS nurse after treatment is chosen by the consulting neurologist. Patient is seen by the MS nurse after treatment is chosen by the consulting neurologist. Consulting neurologist is usually responsible for treatment selection. Good drug coverage is available. Many patients are interested in the use of alternative therapies and, therefore, the use of such therapies should be addressed (see Chapter 7: Complementary and Alternative Therapies for MS). Patient is seen by the MS nurse after treatment is chosen by the consulting neurologist. Patients are seen by the MS nurse from the time of diagnosis; discussions regarding the use of DMT occur once it is determined that the patient is eligible to begin DMTs (ie, patients must have had two relapses in the 2 years prior to treatment consideration). A website funded by the United Kingdom Department of Health is available to assist patients in the United Kingdom with treatment decisions. The website is available at: http://www.msdecisions.org.uk

Norway Spain

Sweden

Switzerland

United Kingdom

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Module 4: Patient Education and Self-injection Training

Introduction

The primary goal of patient education is to empower patients through knowledge to take an active role in planning and implementing self-care and self-healing activities. This sense of empowerment and self-efficacy has been shown to be a significant predictor of adherence to immunomodulating therapy (Fraser et al., 2001) and, therefore, may promote long-term treatment optimization. In this module, strategies for effective patient education on MS and the available therapies, as well as self-injection training are provided.

Learning Objectives

After completing this module, the reader will be able to: Apply strategies to assess and promote patient self-efficacy Describe and apply strategies for effective patient education and self-injection training

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Self-Efficacy

Self-efficacy is defined as an "individual's judgment of his or her ability to organize and implement a course of action necessary to accomplish a task. The task may be perceived as novel, unexpected, or stressful" (Bandura, 1997). An individual's perception of self-efficacy will influence how much effort he or she will expend and how long he or she will persist when faced with obstacles or adverse experiences. Individuals with stronger self-efficacy are more likely to select challenging tasks, persist at them longer, and perform them successfully. The MS Self-Efficacy Scale (MSSE) is an excellent tool for assessing self-efficacy in the MS population (Schwartz, 1996). An excerpt from the Control Subscale of the MSSE is shown in Table 9. Table 9. Control subscale of the MSSE.* How certain are you that you can control your fatigue? How certain are you that you can deal with the frustration of MS? How certain are you that you can deal with the uncertainty of MS? How certain are you that you can continue most of your daily activities?

*Note: The MSSE is not used in some countries.

Strategies to enhance self-efficacy include: providing skills for self-care stressing the positive providing praise enlisting social support and enhancing problem-solving skills Furthermore, performance of a task is the most effective way to strengthen an individual's beliefs that he or she is capable of achieving a desired goal. Vicarious experience and verbal persuasion also strengthen beliefs of ability (Bandura, 1997). Therefore, nurses can apply these strategies to help promote patient self-efficacy.

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Patient Education

Although education helps promote optimal patient outcomes, it will only be successful if the learner is motivated to learn. Thus, it is important for the nurse to time education to patient readiness to learn. The nurse can help patients feel the need to learn by (Knowles, 1980): Exposing them to new possibilities for self-fulfillment Helping them clarify their own aspirations for improved health and/or behavior Helping them diagnose the gap between their aspirations and their present level of knowledge or performance Helping them identify any problems they are experiencing because of these gaps

Psychoeducational Approach As discussed in Module 3 of Chapter 3: Treatments, the multifaceted psychoeducational approach to patient education is often used in MS centers. This approach requires that patients and their families become actively involved in setting the goals and objectives of education as well as the educational process itself. Using this model, instructional methods are tailored to the individual needs of each patient (Halper & Holland, 1997; Marciniak et al., 1991). Furthermore, the model allows for continual assessment of the patient's understanding of anticipated side effects and his or her skill development in the injection process (Halper & Holland, 1997). Strategies for effective patient education using the psychoeducation model are shown in Module 3 of Chapter 3. It is important to note that education does not end once the patient has learned to self-administer therapy. Rather, education in MS is an ongoing process that responds to the changing needs of patients throughout the course of their disease. Furthermore, patients should be instructed to evaluate their learning on a regular basis. Self-evaluation of learning empowers patients to take control of their disease. In addition, education can be supported through participation in patient support groups.

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Self-Injection Training

Since the DMTs are currently only available in injectable form, the introduction of these therapies requires extensive patient and family education on the following: Appropriate self-injection technique, including proper drug handling and reconstitution Site selection, rotation, and injection-site management Management of treatment-related systemic side effects The primary goal of this step of the nursing approach to treatment optimization is to ensure optimal treatment outcomes by ensuring the patient self-injects appropriately and successfully manages adverse events and injection-site reactions. It is important that patients understand the need to administer the drug as directed, especially if there is a titration period, and that any changes from this dosing can result in either an overdose or treatment inefficacy. Once full dose is achieved, the nurse should ensure the full dose is taken as prescribed (Denis et al., 2004). Furthermore, all patients must be taught a safe, clean self-injection technique. Appropriate site selection and rotation help to prevent erythema and possible necrosis at the injection site. Demonstration kits are provided by manufacturers of DMTs in order to help facilitate injection-technique instruction. The nurse should regularly review injection techniques and site selection/rotation throughout therapy initiation. The desired outcome of self-injection training is that the patient will inject successfully on an on-going basis. Self-injection education, like all adult education, should be based on teaching according to the patient's needs. Therefore, assessment of the patient's knowledge base, learning style, and readiness to learn are important (Denis et al., 2004). Subcutaneous injection-site reactions are common in patients using IFN or glatiramer acetate and include pain and cutaneous reactions. It is important that the nurse instruct patients to report skin reactions at every visit. Ideally, the patient should be seen in person, since it is difficult to assess skin integrity over the phone. The patient should also be instructed on non-pharmacological and pharmacological interventions for minimizing injection-site reactions (Denis et al., 2004). Systemic side effects associated with IFN therapy include flu-like symptoms such as myalgia, headaches, chills, and fever. These symptoms usually resolve within 24 hours of injection, but may persist for 3 months or more following the initiation of therapy (Munschauer & Kinkel, 1997; Walther & Hohlfeld, 1999). Nurses can help patients manage these systemic side effects in a variety of ways (see Module 2 of Chapter 3: Treatments). It is important that patients are not taken off IFN therapy until all options to manage systemic side effects have been explored. Systemic side effects noted immediately post glatiramer acetate injection have been reported in approximately 41% of patients (European SPC, 2004). These symptoms include chest pain, palpitations, flushing, anxiety, and dyspnea. In some patients, glatiramer acetate has also been associated with localized lipoatrophy at the site of injection (Drago et al., 1999; Hwang & Orengo, 2001). In fact, a recent study found

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International MS Nurse Care Plan the prevalence of lipoatrophy in patients using glatiramer acetate to be much higher than originally expected: approximately 45% of patients examined had evidence of lipoatrophy in at least one injection-site area (Edgar et al., 2004). Lipoatrophy can be disfiguring and, therefore, the psychological impact of this adverse event can be significant (Edgar et al., 2004). It is, therefore, important that patients be aware of the possibility of lipoatrophy, be able to identify it and discontinue injecting in areas where it is identified (Edgar et al., 2004). Furthermore, regular injection-site rotation may help to prevent lipoatrophy. Care plans for the management of injection-site reactions and systemic side effects are provided in Module 2 of Chapter 3: Treatments.

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Module 5: Long-Term Assessment and Monitoring of Patients Using DMTs

Introduction

The nursing approach to treatment optimization requires regular and long-term clinical, subclinical and laboratory assessment of the patient, including the assessment of physical and cognitive functioning, the evaluation of psychosocial functioning, and the monitoring of adherence to therapy. It should be emphasized that clinical, subclinical, laboratory and psychosocial outcomes, and treatment adherence are interrelated (see Module 1: Figure 1) such that suboptimal outcomes on one of these parameters may impact the other parameters (Denis et al., 2004). This module outlines, in detail, assessment and monitoring strategies that will help ensure patients attain and maintain optimal health outcomes.

Learning Objectives

After completing this module, the reader will be able to: Describe factors to be considered when judging treatment response Apply strategies for assessing clinical, subclinical and psychosocial outcomes and promoting optimal outcomes in these areas Apply strategies for monitoring and promoting adherence to therapy

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Clinical and Subclinical Assessment

A thorough clinical and subclinical assessment should include the evaluation of relapses, progression, MRI outcomes, laboratory values, adverse events, and physical and cognitive functioning. In addition, the nurse needs to ascertain that the patient is adhering to the treatment and needs to monitor injection sites and technique (Denis et al., 2004). Experts have recommended that patients be seen frequently during the first 2 years after MS is diagnosed and treatment is initiated (e.g., every 3­6 months). A quantitative neurological examination should be performed at each visit, and relapses, progression, and MRI findings should be documented* (Bashir et al., 2002). Bashir et al. (2002) recently proposed a model for assessing treatment response based on these outcomes. This model ranks outcomes as being "notable", "worrisome" or "actionable". Relapses Relapse rate and severity, as well as speed and extent of recovery after a relapse, are all judged to be important factors in determining an acceptable versus a lessthan-optimal treatment response. With regards to relapse rate, a 50-75% reduction is a good indicator that the treatment is working. Evaluation should begin 6 months after treatment is initiated (Bashir et al., 2002). With regards to relapse severity, the following should be taken into consideration: the effect of the relapse on activities of daily living the type and number of systems involved (i.e., relapses that are polysymptomatic or that affect the cerebellar/motor systems tend to be more severe) whether or not a course of steroids was required Regarding recovery, relapses that do not respond to early steroid treatment are worrisome, particularly early in the disease process (in later stages, relapses may prove refractory to steroids). Recovery that takes more than a few months or that is incomplete should also raise concerns that the patient may be experiencing a suboptimal response to therapy (Bashir et al., 2002). A model for assessing treatment response based on relapse outcomes is shown in Table 10.

*Note: In some countries, frequent follow-up assessments and regular MRI examinations following the initiation of therapy are not possible.

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International MS Nurse Care Plan Table 10. Model for assessing treatment response based on relapse outcomes. Adapted from Bashir K, Buchwald L, Coyle PK, et al. MS patient management: optimizing the benefits of immunomodulatory therapy. Int J MS Care 2002(suppl).

NOTABLE Relapse rate/severity Single, mild attack WORRISOME Single, moderate attack in year, beginning 6 months after initiation of therapy ACTIONABLE >1 moderate or 1 severe attack in year, beginning 6 months after initiation of therapy

Relapse recovery

Rapid following prompt steroid treatment

Slow following prompt steroid treatment

Incomplete

Progression Progression can be measured using the Kurtzke Expanded Disability Status Scale (EDSS), the MS Functional Composite (MSFC) and a well-documented clinical examination. Regardless of the method used, assessment of disability must be quantifiable. Progression in disability indicates that response to treatment is suboptimal (Bashir et al., 2002). However, it is important to note that day-to-day fluctuations in MS symptoms lead to significant measurement variability. Therefore, in order to accurately interpret observed treatment effects, it has been suggested that, in an individual patient, a 20% change on functional tests can be considered the threshold that reliably indicates a true change in function (Freedman et al., 2004). Other factors that may influence measures of progression include: depression, cognitive function, fatigue, and the presence or absence of infection. In particular, depression is often undetected and untreated in MS patients (Feinstein, 2002). However, depression may significantly impact the measurement of disease progression and, therefore, should be assessed at regular intervals. A care plan for the assessment and management of depression is provided in Module 4 of Chapter 5: Psychosocial Implications of MS. Various tools to assess depression are discussed in this Chapter.*

*Note: It has been suggested that the Beck's Depression Inventory is not appropriate for the assessment of depression in MS patients.

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International MS Nurse Care Plan It is also important that progression be confirmed over time in order to distinguish true, sustained progression from transient progression resulting from incomplete relapse recovery or other disease processes. The time interval at which disease progression is reassessed varies considerably in clinical practice.* It has been suggested that, at a minimum, progression should be assessed annually in stable patients and every 3 months in patients who are not doing well (Freedman et al., 2004). When documenting progression clinically, EDSS increases that are due to changes in multiple domains (e.g. changes in motor and cerebellar subscores) are often more predictive of true, sustained disability progression and, therefore, are recognized as being of high concern (Freedman et al., 2004). A model for assessing treatment response based on disease progression is shown in Table 11. Table 11. Model for assessing treatment response based on disease progression. Reproduced with permission from Bashir K, Buchwald L, Coyle PK, et al. MS patient management: optimizing the benefits of immunomodulatory therapy. Int J MS Care 2002(suppl).

NOTABLE WORRISOME 2 point change 1 point change

minor Some motor, cognitive, or more pronounced sensory

ACTIONABLE >2 point change >1 point change

Pronounced motor, cognitive, etc.

EDSS 3.5 EDSS 4 Clinically documented progression

<2 point change <1 point change

No motor, sensory

*Note: In the United Kingdom, progression is assessed every 3 months in the first year following treatment initiation, and every 6 months thereafter.

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International MS Nurse Care Plan MRI Although significant MRI activity is not desirable, standards for interpreting MRI activity are still under development. MRI measures of disease activity include a new gadolinium (Gd)-enhancing lesion, new or enlarging T2 hyperintense lesions, new or enlarging T1 hypointense lesions, and atrophy. Progression in disability and evidence of new or enlarging lesions are indicative of suboptimal treatment responses (Bashir et al., 2002). A model for assessing treatment response based on MRI activity is shown in Table 12. Table 12. Model for assessing treatment response based on MRI outcomes.* Reproduced with permission from Bashir K, Buchwald L, Coyle PK, et al. MS patient management: optimizing the benefits of immunomodulatory therapy. Int J MS Care 2002(suppl).

CHANGE RE PREVIOUS MRI NOTABLE WORRISOME ACTIONABLE

New Gd-enhancing lesions New T2 lesions Enlarging T2 (burden Changes in of disease) categories New T1 hypointense lesions Enlarging T1 hypointense lesions Increased atrophy 2 Changes categories in 3 Changes in categories >3

*Note: In many countries, regular MRI assessments are not possible and, therefore, treatment outcomes are assessed through an annual review of relapse rates and disease progression.

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International MS Nurse Care Plan Analog Model for Determining Treatment Response Based on their progression, relapse, and MRI models (Tables 10, 11, and 12), Bashir et al. (2002) proposed an overall analog model for assessing the effectiveness of therapeutic strategies (see Figure 2). Each gauge in the model represents a continuum from "no concern" (0 [zero]) to a low level of concern (notable), to a moderate level of concern (worrisome), all the way to a high level of concern (actionable). Treatment modification for any particular patient should be considered if all three gauges read "notable", any two read "worrisome", or a single one reads "actionable". As the primary patient contact, the MS nurse is usually the first healthcare professional to notice signs of exacerbations, disease progression, and other suboptimal clinical outcomes. In such cases, the patient is scheduled or referred for the appropriate examinations and assessments. If the results of these assessments show that treatment response is indeed suboptimal, the nurse should collaborate with the patient and neurologist in identifying alternative management strategies or selecting a more appropriate therapy (Denis et al., 2004).

Figure 2. Analog model for assessing the effectiveness of therapeutic strategies. Each gauge represents a continuum from no concern (0 [zero]) all the way to a high level of concern (actionable), and can be used to guide clinical decision-making. Reproduced with permission from Bashir K, Buchwald L, Coyle PK, et al. MS patient management: optimizing the benefits of immunomodulatory therapy. Int J MS Care 2002(suppl).

Relapses

Progression

MRI

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Laboratory Assessment

As mentioned in Module 2 of Chapter 3: Treatments, the most commonly observed laboratory abnormalities in patients receiving IFN therapy are leukopenia, lymphopenia, neutropenia, and raised liver aminotransferase values (e.g., alanine aminotransferase [ALT] and aspartate aminotransferase [AST]). These abnormalities, however, seldom result in serious complications (Lublin et al.,1996; Munschauer & Kinkel, 1997). Nonetheless, the nurse should educate patients on the importance of regular laboratory assessments and ensure patients complete laboratory evaluations at appropriate intervals. If the patient exhibits abnormal or acute/subacute toxicities, dosage adjustments may be required (Denis et al., 2004). Treatment with IFN is also associated with the production of neutralizing antibodies (NAbs). NAbs occur in up to one-third of patients treated with IFN (Rice et al., 1999). The rate of NAb production, however, appears to be less with IFN -1a than with IFN -1b treatment, depending on the dose, frequency and mode of injection (Bertolotto et al., 2002). Although evidence suggests that NAbs may reduce the bioavailability and clinical efficacy of IFN treatment (The IFN Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group, 1996), one study found no definitive relationship between NAb formation and the loss of clinical or MRI response (Antonelli et al., 1998). Furthermore, the effects of NAbs appear to be transitory, occurring primarily in the first few years of therapy, with the majority of NAbs disappearing over time (Rice et al., 1999). Therefore, based on current evidence, The Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (Goodin et al., 2002) and the MS Council for Clinical Practice Guidelines (2001) state that the clinical utility of measuring NAbs in patients on IFN therapy is uncertain. At present, clinical decisions regarding therapy should be based on medical and health outcomes, not the presence of NAbs (Polman et al., 2003). Nonetheless, nurses should stay abreast of current trends in NAb measurement. Although glatiramer acetate is not considered a product to which NAbs can develop, one study found that all glatiramer acetate-treated patients developed binding antibodies and that there was a tendency toward fewer relapses in patients who developed the highest titers (Brenner et al., 2001). More recently, a small, preliminary study found that less than 50% of glatiramer acetate-treated patients were found to have binding antibodies, and those patients with higher titers were reported not to fare as well clinically (Salama et al., 2003). Thus the role of binding antibodies to glatiramer acetate is still unclear.

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Adverse Events

As mentioned earlier, treatment-related adverse events such as injection-site reactions and systemic side effects can also have a negative impact on patient outcomes and, therefore, monitoring of these events and the implementation of strategies to minimize and/or eliminate them are critical (see strategies in Module 2 of Chapter 3: Treatments).

Physical and Cognitive Functioning

As mentioned earlier, physical impairments such as motor and sensory symptoms, visual deficits, and fatigue may be barriers to optimal self-management, particularly to self-injection of a DMT. The MS nurse should provide on-going education and support to improve the patient's physical functioning, quality of life, and independence (Denis et al., 2004). Cognitive changes occur in 40-70% of persons with MS (Halper, 2001). Cognitive changes range from mild to severe in nature and may occur early in the course of the disease and in the absence of physical (e.g., motor, sensory) changes. Even relatively mild deficits can have an impact on patients' day-to-day lives. In many instances, cognitive difficulties are incorrectly attributed to depression or other emotional disturbances. However, proper identification and management of cognitive problems is necessary to ensure optimal patient outcomes (Denis et al., 2004). Nurses may need to alter their working styles to accommodate the needs of cognitively impaired individuals. For example, nurses may need to speak more slowly, repeat themselves, or provide written suggestions for the patient to take home. Furthermore, patients with MS should be encouraged to prepare for their healthcare visits, and to ask family members and friends to help them make a list of concerns. They may need to bring notes to their appointments to remind themselves of their questions/concerns, take notes of their meetings, or bring a tape recorder. There is also growing interest in cognitive rehabilitation as a viable treatment intervention for cognitive difficulties. Cognitive rehabilitation is typically offered by neuropsychologists, speech/language pathologists, and occupational therapists. The goal of rehabilitation is to support the person's efforts to function more effectively in his or her environment. The compensatory approach to cognitive rehabilitation teaches people how to substitute viable strategies and tools for the impaired cognitive functions. Using this approach, for example, memory books, family calendars, and filing systems are tailored to the person's individual needs, capabilities, and lifestyle. A care plan for the assessment and management of cognitive difficulties is provided in Chapter 5: Module 5.

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International MS Nurse Care Plan Suboptimal cognitive or physical functioning will require re-education and interventions designed to optimize functioning; improvements in functioning will help ensure optimal patient outcomes in the long-term (Denis et al., 2004).

Psychosocial Assessment

Due to the unpredictable nature of MS and the changing needs of patients throughout their lifetimes, long-term assessment should include a comprehensive evaluation of the patient's psychosocial functioning. Psychosocial issues such as dysphoric mood, lack of support networks, and financial concerns can have a significant impact on treatment outcomes. The lifetime prevalence for major depression in MS ranges from 40­60% (Sadovnick et al., 1996). The symptoms of depression include feelings of hopelessness, despair and guilt, fatigue, insomnia, and suicidal ideation (Halper & Holland, 1997). In fact, compared to the general population, an increased suicide rate has been reported in MS (Sadovnick et al., 1991). Depression reduces the patient's willingness or desire to take medication or improve well-being. Mohr et al. (1997) found that 41% of patients reported new or increased depression within 6 months after starting therapy, and that these patients were more likely to discontinue therapy than nondepressed patients. However, when treatment for depression was administered (i.e., antidepressants or psychotherapy), patients were more likely to continue on immunomodulating therapy (Mohr et al., 1997). Therefore, the MS nurse should assess for depression and suicidal ideation and refer the patient to his/her family physician or a consulting psychiatrist/psychologist for treatment (if available).* If medication for depression is prescribed, treatment response should be monitored. A care plan for depression is provided in Module 4 of Chapter 5: Psychosocial Implications of MS. Patients may also react negatively to the multiple changes and losses imposed by the diagnosis and progressive disability, such as role changes, loss of social/financial status, employment and independence, and sexuality and family issues At this time, many patients abdicate responsibility for themselves and their own care. However, the availability and use of support networks and programs* have been shown to promote self-management and adherence (Madonna & Keating, 1999) and, thereby, may promote treatment optimization. These programs provide comfort as well as media for exchange of information and emotions. Voluntary and self-help groups can provide a powerful sense of identity and control over the illness. They can facilitate growth in confidence, trust, self-valuing, pride, identity, determination, responsibility, ability, knowledge and sensitivity to others.

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International MS Nurse Care Plan Therefore, in addition to the assessment of physical aspects of the disease, the assessment of psychosocial issues is an integral component of long-term treatment optimization. Suboptimal psychosocial functioning requires re-education and interventions designed to optimize functioning. The ultimate goal in this step of the nursing approach is to help ensure treatment optimization by obtaining optimal psychosocial functioning.

*Note: The availability of consulting psychiatrists/psychologists as well as support networks and program varies from country to country.

Country-specific issues regarding psychosocial assessments in MS are shown in Table 13. Table 13. Country-specific issues regarding psychosocial assessments in MS.

Country

Austria

Issue(s)

Psychologists are usually responsible for the assessment and management of sexual and family issues. Illness reduces the likelihood that a young women can mate for marriage; therefore, this should be considered in the psychosocial assessment of women with MS. Psychologists are usually responsible for the assessment and management of sexual and family issues.

Muslim countries

Switzerland

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Treatment Adherence

Adherence is best defined as the active, voluntary, and collaborative involvement of the patient in a mutually acceptable course of behavior that results in a desired preventive or therapeutic outcome (The Multiple Sclerosis Nurse Specialists Consensus Committee, 1998). Although adherence to therapy is important for ensuring optimal treatment outcomes, in some circumstances, treatment discontinuation may be warranted, particularly in situations where treatment response is suboptimal (Denis et al., 2004). One of the most frequently cited reasons for discontinuing a DMT is perceived lack of treatment benefit (Vollmer, 2002). In addition, one survey found that of the 350 patients who volunteered information on their past drug history, 90% had been switched to another agent. Lack of treatment efficacy was the primary reason cited for the change in therapy (Eyring et al., 2002). Therefore, when monitoring treatment adherence, it is important for the nurse and neurologist to first determine if perceived and/or actual treatment ineffectiveness is responsible for non-adherence. In such cases, the nurse should collaborate with both the neurologist and patient to determine if alternative strategies can be implemented or if switching to another DMT is required. The nurse should also identify whether any of the following possible barriers to adherence are present (Holland et al., 2001a): Perceived low value of treatment Lack of information on therapies or misinformation Unrealistic expectations for therapies Number and frequency of drugs currently being taken by the patient Patient's perception of MS (e.g., patient is in denial) Cognitive deficits (e.g., memory and judgment problems) Temporary worsening of MS symptoms after therapy has been initiated Drug administration challenges and/or fears of self-injection Difficulty coping with side effects of therapy Social situations and/or cultural beliefs that are incongruent with therapy regimen Financial concerns (e.g., lack of coverage for treatment expense)* Contradictory messages from healthcare providers and peers Lack of professional support

*Note: Knowledge and availability of financial services and resources varies from country to country. In some countries, MS nurses are not involved in examining patients' financial needs nor are they responsible for directing patients to financial assistive services.

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International MS Nurse Care Plan Tips for facilitating adherence to DMT are shown in Table 14 (also see Module 3 of Chapter 3: Treatments). The quality of the nurse-patient relationship and clinic setting also have a significant impact on treatment adherence. Many patients report that the way they are treated by their healthcare team has a significant impact on whether or not they follow medical advice. Long waits, feeling rushed, not having opinions valued or time to ask questions, feeling patronized and being ignored in the decision-making process have all been reported by patients to have a negative impact on the patientprofessional relationship and medication adherence (Feuerstein et al., 1998). One study found the highest rates of adherence to immunomodulating therapy at clinics where nurses and other healthcare professionals were considered more empathetic, where a sense of purpose was instilled in the patients, and where less formal relationships with patients were promoted (Mohr et al., 1999). In fact, the active involvement of nurses in the overall management of patients with MS has been shown to increase patient adherence to MS-treatment regimens (Collingworth et al., 1997). Therefore, the nurse should create an environment where dialogue is encouraged and where patients feel at ease discussing problems.

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International MS Nurse Care Plan Table 14. Tips for facilitating adherence to treatment in MS. Adapted from Holland N, Wiesel P, Cavallo P, et al. Adherence to disease-modifying therapy in multiple sclerosis: part I. Rehabil Nurs 2001a;26:172-176.

Commit to developing a caring relationship with the patient and to understanding the patient's perspectives and needs. Recognize the patient's readiness to change and match arguments in support of treatment accordingly. Don't present all the information at the initial diagnostic visit. Build trust, provide a protected environment for discussion, and sense when the time is right for honest discussion. Foster an appreciation that initiating or continuing on treatment is doing something about their disease and not giving into it. Choose terminology carefully; use positive phrases to help alter negative perceptions. Provide simple, understandable and complete written instructions of the treatment regimen. Assess concomitant medication to avoid drug-drug interactions. Attempt to prevent side effects that will influence maintenance. Encourage strong and trusting nurse-patient relationship and a supportive clinical setting where patients are not "rushed through." Be alert to patients who appear discouraged and give them extra support and encouragement. Be attentive to the patient's family members so that they will support and not undermine the patient's treatment. Train family member or friend to do the injections so they can give weary patients a break from self-injections, assist during relapses and/or help with difficult-to-reach sites Encourage patients to join support groups and other activities that combat isolation. Take advantage of pharmaceutical company-sponsored patient support programs. Intervene early and repeatedly. Follow-up with regular contact. Foster hope and a sense of what may be possible.

Finally, as mentioned earlier, 34­57% of patients who initiate a DMT have unrealistically optimistic expectations for therapy; these patients are less likely to succeed on therapy when side effects occur (Mohr et al., 1996). Throughout the course of therapy, the nurse plays a critical role in realigning unrealistic therapeutic expectations (Denis et al., 2004). Any suboptimal response in patient outcomes, laboratory evaluations, or adverse event management, and treatment adherence requires re-education, additional assessment and monitoring (see Figure 1 in Module 1) and, in some cases, that treatment choice be reconsidered.

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References

Albrecht H, Wotzel C, Erasmus LP, et al. Day-to-day variability of maximum walking distance in MS patients can mislead to relevant changes in the Expanded Disability Status Scale (EDSS): average walking speed is a more constant parameter. Mult Scler 2001;7:105-109. Antonelli G, Bagnato F, Pozzilli C, et al. Development of neutralizing antibodies in patients with relapsing-remitting multiple sclerosis treated with IFN-beta 1a. J Interferon Cytokine Res 1998;18:345-350. Bandura. Self-efficacy: the exercise of control. New York: W. H. Freeman Company; 1997. Bashir K, Buchwald L, Coyle PK, et al. MS patient management: optimizing the benefits of immunomodulatory therapy. Int J MS Care 2002(suppl). Bertolotto A, Malucchi S, Sala A, et al. Differential effects of three interferon betas on neutralizing antibodies in patients with multiple sclerosis: a follow up study in an independent laboratory. J Neurol Neurosurg Psychiatry 2002;73:148-153. Brenner T, Arnon R, Sela M, et al. Humoral and cellular immune responses to Copolymer 1 in multiple sclerosis patients treated with Copaxone . J Neuroimmunol 2001;115:152-160. Collingworth S, Gould D, Wainwright SP. Patient self-administration of medication: a review of the literature. Int J Nurs Stud 1997;34:256-269. Comi G, Filippi M, Wolinsky JS. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol 2001;49:290-7. Denis L, Namey M, Costello K, et al. Long-term treatment optimization in individuals with MS using disease-modifying therapies: a nursing approach. J Neurosci Nurs 2004;36:10-22. Drago F, Brusati C, Marncardi G, et al. Localized lipoatrophy after glatiramer acetate injection in patients with remitting-relapsing multiple sclerosis. Arch Dermatol 1999;135:1277-1278. Edgar CM, Brunet DG, Fenton P, et al. Lipoatrophy in patients with multiple sclerosis on glatiramer acetate. Can J Neurol Sci 2004;31:58-63. European Summary of Product Characteristics (SPC), Glatiramer Acetate; 2004. Eyring S, Wood C, Sherman S, Simone M. Efficacy of MS therapy is the key driver in therapy choice. Poster presentation at the Second Joint Meeting of the Americas and European Committees for Treatment and Research in Multiple Sclerosis (ACTRIMS and ECTRIMS). Baltimore, Maryland; September 18-21, 2002. Feinstein A. An examination of suicidal intent in patients with multiple sclerosis. Neurology 2002;59:674-678. Chapter 8: Treatment Optimization 42-49

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Feuerstein M, Lieb-Juckstock V, Schnaus H, Springmann E, Weber B, Wunderlich M. Compliance ­ a joint effort of the patient and doctor. In: Compliance in Epilepsy (Epilepsy Res Suppl 1). Schmidt D, Leppik IE (eds). Elsevier Scientific; 1998. Fraser C, Hadjimichael O, Vollmer T. Predictors of adherence to Copaxone therapy in individuals with relapsing-remitting multiple sclerosis. J Neurosci Nurs 2001;33:231-239. Freedman MS, Blumhardt ID, Brochet B, et al. & The Paris Workshop Group. International consensus statement on the use of disease-modifying agents in multiple sclerosis. Mult Scler 2002;8:19-23. Freedman MS, Patry DG, Grand'Maison F, et al. Treatment optimization in multiple sclerosis. Can J Neurol Sci 2004;31:157-168. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002;58:169-178. Hadjimichael O, Vollmer TL. Adherence to injection therapy in MS: patient's survey. Neurology 1999;April (suppl 2):52. Halper J (ed). Advanced Concepts in Multiple Sclerosis Nursing Care. New York: Demos Medical Publishing, Inc.; 2001. Halper J, Holland N. Comprehensive Nursing Care in Multiple Sclerosis. New York: Demos Vermande; 1997. Holland N, Wiesel P, Cavallo P, et al. Adherence to disease-modifying therapy in multiple sclerosis: part I. Rehabil Nurs 2001a;26:172-176. Holland N, Wiesel P, Cavallo P, et al. Adherence to disease-modifying therapy in multiple sclerosis: part II. Rehabil Nurs 2001b;26:221-226. Hwang L, Orengo I. Lipoatrophy associated with glatiramer acetate injections for the treatment of multiple sclerosis. Cutis 2001;68:287-288. IFN Multiple Sclerosis Study Group. Interferon beta 1b is effective in relapsing-remitting multiple sclerosis I. Clinical results of a multicenter, randomized, double-blind, placebocontrolled trial. Neurology 1993;43:655-661. IFN Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. Neutralizing antibodies during treatment of multiple sclerosis with interferon beta-1b: experience during the first three years. Neurology 1996;47:889-994. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing remitting multiple sclerosis. The Multiple Sclerosis Collaborative Research Group. Ann Neurol 1996;39:285-294.

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Johnson KP, Brooks BR, Cohen JA, et al. Copolymer-1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, doubleblind, placebo controlled trial. Neurology 1995;45:1268-1276. Knowles MS. The Modern Practice of Adult Education: From Pedagogy to Andragogy. Chicago: Follen Publishing Company; 1980. Larivaara P, Kiuttu J, Taanila A. The patient centered interview: the key to biopsychosocial diagnosis and treatment. Scand J Prim Health Care 2001;19:8-13. Li DK, Paty DW. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis. Prevention of Relapses and Disability by Interferon-beta1a Subcutaneously in Multiple Sclerosis. Ann Neurol 1999;46:197-206. Lublin FD, Whitaker JN, Eidelman BH, et al. Management of patients receiving interferon beta-1b for multiple sclerosis: report of a consensus conference. Neurology 1996;46:12-18. Madonna MG, Keating MM. Multiple sclerosis pathways: an innovative nursing role in disease management. J Neurosci Nurs 1999;31:332-335. Marciniak M, Johnson B, Foley FW, et al. The use of the Levo chair in the management of multiple sclerosis. Presentation made at the Consortium of Multiple Sclerosis Centres Conference; Halifax (NS); June 15­17, 1991. Mohr DC, Goodkin DE, Likosky W, et al. Therapeutic expectations of patients with multiple sclerosis upon initiating interferon beta-1b: relationship to adherence to treatment. Mult Scler 1996;2:222-226. Mohr DC, Goodkin DE, Likosky W, et al. Treatment of depression improves adherence to interferon beta-1b therapy for multiple sclerosis. Arch Neurol 1997;54:531-533. Mohr DC, Goodkin DE, Masuoka L, et al. Treatment adherence and patient retention in the first year of a phase-III clinical trial for the treatment of multiple sclerosis. Mult Scler 1999;5:192-197. Multiple Sclerosis Council for Clinical Practice Guidelines. Disease Modifying Therapies in Multiple Sclerosis: Evidence-Based Management Strategies for Disease ModifyingTherapies in Multiple Sclerosis. Paralyzed Veterans of America; 2001. Multiple Sclerosis Nurse Specialists Consensus Committee. Multiple sclerosis: key issues in nursing management. Columbia, MD: Medicalliance, Inc; 1998. Munschauer FE, Kinkel RP. Managing side effects of interferon-beta in patients with relapsing-remitting multiple sclerosis. Clin Ther 1997;19:883-893. Noseworthy JH, Vandervoort MK, Wong CJ, Ebers GC. Interrater variability with the Expanded Disability Status Scale (EDSS) and Functional Systems (FS) in a multiple sclerosis clinical trial. The Canadian Cooperation MS Study Group. Neurology 1990; 40: 971-975. Chapter 8: Treatment Optimization

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Paty DW, Li DK. Interferon beta 1b is effective in relapsing-remitting multiple sclerosis II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993;43:662-667. Polman C, Kappos L, White R, et al. Neutralizing antibodies during treatment of secondary progressive MS with interferon -1b. Neurology 2003;60:37-43. PRISMS Study Group. Randomized double-blind placebo-controlled study of interferon -1a in relapsing-remitting multiple sclerosis. Lancet 1998;352:1498-1504. Prochaska JO, Redding CA, Harlow LL, et al. The transtheoretical model of change and HIV prevention: a review. Health Educ Q 1994;21:471-486. Rice GP, Paszner B, Oger J, Lesaux J, Paty D, Ebers G. The evolution of neutralizing antibodies in multiple sclerosis patients treated with interferon beta-1b. Neurology 1999;52:1277-1279. Rotter JB. Generalized expectancies for internal versus external control of reinforcement. Psychol Monogr 1966;80:1-28. Sadovnick AD, Eisen K, Ebers GC, Paty DW. Cause of death in patients attending multiple sclerosis clinics. Neurology 1991;41:1193-1196. Sadovnick AD, Remick RA, Allen J, et al. Depression and multiple sclerosis. Neurology 1996;46:628-632. Salama HH, Hong J, Zang YC, et al. Blocking effects of serum reactive antibodies induced by glatiramer acetate treatment in multiple sclerosis. Brain 2003;Aug 22 [Epub ahead of print; DOI: 10.1093/brain/awg269]. Schwartz CE, Coulthard-Morris L, et al. Measuring self-efficacy in people with multiple sclerosis: a validation study. Arch Phys Med Rehabil. 1996;77(4):394-8. Vollmer TL. Patient use of and compliance to disease modifying agents for MS. Presentation made at the Consortium of MS Centers Annual Meeting, Baltimore, MD. Walther EU, Hohlfeld R. Multiple sclerosis: side effects of interferon beta therapy and their management. Neurology 1999;58:1622-1627.

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International MS Nurse Care Plan

Progress Check

1. According to one study by Mohr et al in 1996, ____ % to _____ % MS patients who begin IFNb therapy have unrealistically optimistic expectations at the start of therapy. 2. A study by Hadjimichael & Vollmer in 1999 found that ___ % of MS patients who discontinued therapy were told to do so by their physician. 3. The MS Self-Efficacy Scale (MSSE) asks MS patients to consider all of the following when self-assessing their condition except the following; 4. According to several studies (Munschauer & Kinkel, 1997; Walther & Hohlfeld, 1999), flu-like symptoms associated with IFNb therapy usually resolve within 24 hours but may last up to ____ months. 5. Lipoatrophy in post glatiramer acetate injection site areas were found in ____ % of patients examined according to one study (Edfar et al, 2004) 6. Day to day fluctuations in MS symptoms do not account for significant measurement variability. True False

7. According to the Bashir et al model for assessing treatment response based on disease progression, a MS patient with an EDSS greater than 4 experiences a 1 point change in EDSS and has clinically documented progression of some motor, cognitive or pronounced sensory would likely be categorized as: A. Notable B. Worrisome C. Actionable D. Not enough information 8. One study (Mohr et al, 1999) found that ____ % of MS patients reported new or increased depression within 6 months after starting therapy. 9. According to one study (Eyring et al, 2002) this was the primary reason why MS patients changed therapy treatments. A. Site reactions B. Cost C. Unable to administer treatment D. Lack of Treatment efficacy

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International MS Nurse Care Plan 10. One study (Mohr et al, 1999) found that nurses and other healthcare professionals were quite influential in maintaining patient adherence of immunomodulatory therapy. All of the following were found to be factors in this adherence except one, when nurses and healthcare professionals were; A. Given a structured, formal relationship B. More empathic C. Providing a sense of purpose D. Provided more informal relationships with patients

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EVALUATION FORM 1) Overall how satisfied are you with this on-line program? 5 Very Satisfied 4 Good 3 Satisfactory 2 Fair 1 Poor 2) Please evaluate the following statements concerning this on-line program a. The program met the stated objectives. Provide an overview of Multiple Sclerosis 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree Learn more on the MS Diagnostic criteria 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree Discuss immunoregulators, relapse-management and disease-modifying agents 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree Description of protocols for the assessment and management of MS-Related Symptoms 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree

Description of the wellness nursing process and ways to assess and evaluate psychosocial problems related to a new diagnosis 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree Description of physical, and psychological therapies commonly used by patients with MS 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree Description of Complementary therapies 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree Learn more about treatment optimization 5 Strongly Agree 4 Agree 3 Neutral 2 Disagree 1 Strongly Disagree b. How would you rate the faculty's effectiveness presenting the material 5 excellent 4 Good 3 Satisfactory 2 Fair 1 Poor

3) Do you think the on-line program was fair, well balanced, and without commercial bias Yes No If no please explain

4) How long did this on-line program actually take you to complete (total time dedicated to this course) Less than a week More than a week More than two weeks More than three weeks More than four weeks 5) Do you think what you leaned from this program will impact health care outcomes Yes No Please explain why not

6) How would you improve this program

7) What issues do you encounter in your work that might be addressed by continuing education programs

Contact Information (please print clearly)

Surname Name Primary Profession Area of Practice Institute Department Address City Country Telephone Please specify an alternative address if you wish to receive there your certificate : Fax E-mail Postal Code

Informative Document ex. Art. 13, Legislative Decree n. 196, 30 June 2003 (Italian Privacy Protection Law) In compliance with the article 13 of Legislative Decree n. 196, 30 June 2003, we hereby give you the following information: 1. 2. personal data will be processed, with or without the use of electronic or automated means, via suitable tools that will guarantee security and confidentiality; Personal data from you supplied will be communicated to Continuing Medical Education Accreditation Authorities, to agencies that will take care of the whole accreditation process and agencies that will take care of the logistics of the event; should we not receive the above requested data, we will not be able to process the assignment of your CME credits. 3. At anytime you may exercise your rights as laid down in the art. 7 of Legislative Decree n. 196, 30 June 2003 of the Italian Law, by contacting the Data Controller Serono Symposia International Foundation (Salita di San Nicola da Tolentino 1/b, 00187, Rome, Italy) in the person of Data Processor, Michèle Piraux.

Disclaimer

The International Multiple Sclerosis Nursing Care Plan ("Plan") and the information, policies, procedures, advice and recommendations contained in the Plan have been based upon and prepared pursuant to information provided by contributing nurses and health professionals who practice in the area of multiple sclerosis care. This Plan and all information contained in it, is intended as general guidance only and should not be relied on as a substitute for medical advice. Serono Symposia International Foundation, its officers, employees and the contributing nurses and health professionals, have used their best endeavours in the preparation of this Plan. However the information set out in this Plan is based on the views of the contributors and does not represent an endorsement or recommendation on the part of Serono Symposia International Foundation and should not be construed in any way, as being medical advice from Serono Symposia International Foundation. Whilst all care has been taken in the preparation of this Plan, Serono Symposia International Foundation and its officers, employees and the contributing nurses and health professionals, are not liable nor responsible in any way for the accuracy of the information contained in this Plan, for the results of any actions or the failure to act by users of the Plan, and accepts no responsibility nor liability for any loss or damage which may be suffered or incurred by any person or party acting in reliance on the information published in this Plan. To the fullest extent permitted by law, Serono Symposia International Foundation and its officers and employees, expressly disclaim any and all liability to any user of this Plan. To the fullest extent permitted by law, Serono Symposia International Foundation liability for any consequential loss or damage, is limited to the resupply of the Plan. The information in the Plan is intended as general information and guidelines only and should not be relied on in place of specific professional medical advice. The Plan must not be

construed as taking part in the professional health management of multiple sclerosis sufferers and patients. For the treatment of all multiple sclerosis sufferers and patients, specific professional advice should be sought and users of this Plan must take into account each individual patient's condition, obtain professional advice and consult medically approved monographs and multiple sclerosis product information before following any procedures or treatment that are based on information set out in the Plan. This Plan, including any policies, procedures, guidelines or recommendations contained in the Plan, are made available on the basis that Serono Symposia International Foundation and the contributing nurses and health professionals: 1. Are not engaged in providing medical advice by making this Plan available; 2. Are not liable or responsible for any errors, omissions, misstatements or mistakes in this Plan; 3. Are not liable or responsible in any way for the results of any action or failure to act by any user of this Plan; 4. Are not liable or responsible for any loss or damage which may be suffered or incurred by any person acting in reliance on information published in this Plan; and 5. Strongly recommends all users of this Plan obtain professional advice before taking part in the management, in any way, of multiple sclerosis sufferers and patients. This Plan is subject to copyright. No part of this Plan may be reproduced in any form without the prior express written consent of Serono Symposia International Foundation. All rights are reserved. © Serono Symposia International Foundation. 2005-2009

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