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Created: January 2004 Revised: 9/2004, 8/2006 Last Revision: August 2008 Pap Smear Guidelines With proper screening, cervical cancer is avoidable and, if caught early, curable. There is at the same time a high cost associated with the triage and follow up of minimally abnormal Papanicolaou (Pap) smears. By adjusting the screening strategy and taking advantage of new technologies such as the Deoxyribonucleic Acid (DNA) testing of selected Pap samples for highrisk Human Papilloma Virus (HPV) DNA, women can be properly diagnosed and treated with as little inconvenience as possible. I. OVERVIEW INDICATIONS RISKS FACTORS THAT COULD EFFECT PAP TEST RESULTS The Pap smear is a test used to examine cervical cells to screen for cancer. This test can microscopically identify abnormal cells, pre-cancerous cells, and cancer, as well as diagnose inflammation and infections. · Allergy to latex · Pregnancy if unknown · Infection · Douching 2 to 3 days prior to the test (can rinse away cells) · Vaginal medications, creams/jellies and spermicides 2 to 3 days prior to the test. (can hide abnormal cells or alter pH) · Intercourse within 24 hours prior to the test. (inflammation) · Certain medications, such as tetracycline.

2. RECOMMENDATIONS Thin Prep Pap Smears are to be used on all women. RISK CATEGORY Normal/low risk Women up to 30 years of age SERVICES · Perform Pap tests, starting at age 21 or three years after first sexual intercourse up to age 30. · Do not conduct HPV DNA routine testing as the test is inadvisable for adolescents with low grade squamous intraepithelial lesions (LSIL). (In adolescents with HPV infections, the majority of infections spontaneously disappears within two years after infection and is of little long-term clinical significance.

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Normal/low risk Women over 30 years of age

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(American College of Obstetricians and Gynecologists) Conduct Pap with HPV DNA test as indicated. If negative, Pap test does not have to be done for at least 3 years. · Repeat Pap test in 2 to 3 years if any three consecutive Pap smears are normal. · Repeat if Pap is negative but HPV DNA test is positive, repeat Pap and HPV DNA in 6 to 12 months. · Refer for colposcopy, if repeat HPV DNA test is positive or Pap is abnormal. Conduct yearly Pap Smears. Conduct Pap with HPV DNA test as indicated. Repeat, repeat Pap and HPV DNA test in 6 to 12 months if Pap is negative but HPV DNA test is positive. Refer for colposcopy if repeat HPV DNA test is positive or Pap is abnormal.

High Risk women over the age 30. Women are at high risk if they have had cervical cancer previously, are immunosuppressed, were exposed to Diethylstilbestrol in utero, and/or are HIV positive. Women who have undergone hysterectomies

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Discontinue screening in patients who have had removal of the cervix for benign reasons, if they have no history of abnormal or cancerous cell growth. Screen annually, patients with a history of abnormal cell growth (CIN 2 or 3) until they have three consecutive negative vaginal cytology tests, after which they can discontinue routine screening. There is no clear evidence for continuing Pap Smears if previous tests have been normal over the past 10 years. Resume regular testing for women who have a new sexual partner.

· Women 65 years and older · · 3.

ABNORMAL PAP SMEARS CELLS * Atypical Cells of Undetermined Significance(ASCUS) Squamous Intraepithelial Lesion (SIL) TREATMENT RECOMMENDATIONS · Perform colposcopy, if HPV DNA test is positive. · Repeat pap in 6 to 12 months if HPV DNA test is negative.** · Repeat Pap test every year if tests are negative. · · Repeat Pap test in six and twelve months for LSIL (Early, mild changes in the cells). If result are persistent, proceed with a colposcopy. Perform colposcopy for HSIL (Moderate or severe cell changes).

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CELLS Atypical Glandular Cells (AGC)

TREATMENT RECOMMENDATIONS · · · · · ·

(CONTINUED)

Cervical Intraepithelial Neoplasia CIN Adolescents who are younger than 21 with abnormal cells

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Perform further testing for increased risk of pre-cancer or cancer of the cervix, uterus or other reproductive organs. Perform colposcopy with endocervical assessment, possible endometrial evaluation. CIN 1 ­ Perform Pap test at six and twelve months or high risk HPV test at 12 months; Perform colposcopy for any abnormality. CIN 2 ­ Maintain close follow up at four to six month intervals with cytology or colposcopy (not recommended for noncompliant patients) OR Ablative or excisional therapy. CIN 3 ­ Perform ablative or excisional therapy. Perform ASCUS Pap with positive high risk HPV types or LGSIL (low-grade squamous intraepithelial lesions) Pap may be followed with repeat Pap every 6 months x2 or HPV test alone at 12 months o Refer for colposcopy, only adolescents with HSIL or greater on the repeat cytology or those with persistent HVP infection. o Refer for colposcopy at the end of 24 month follow-up, those adolescents with an ASC-US or greater result. o Perform a diagnostic excisional procedure if HSIL persists for 24 months without identification of CIN 2 or 3. Refer to a sub-specialist with expertise in managing cervical dysplasia, if AGC is identified. AGC is rare in adolescents. Perform an immediate colposcopy and endocervical assessment for CIN 2 and 3. Adolescent patients are highly unlikely to develop cervical cancer and then you do not need to be as aggressive with evaluation and treatment.

4. PATIENT EDUCATION · · · Stress to patient the importance of regular screening for cervical cancer. Inform the patient of when they should begin screening; how often; and when they can discontinue screenings. Instruct patient when to call their physician after a Pap screening. (Bleeding, foul smelling discharge, fever/chills, severe abdominal pain).

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* Other abnormal Pap smears should be managed based on the guidelines developed by ACOG. The sensitivity of HPV triage for CIN is equivalent to colposcopy and reduces the need for colposcopy by half . ** Digene © testing for high risk HPV DNA is FDA approved and endorsed by the American College of Obstetricians and Gynecologists (ACOG) and American Cancer Society.

REFERENCE PERSONS: Nicole Moss, M.D. James Brent, D.O. /Ph.D. REFERENCES: American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 45. Vol.102, No.2, 8/03. American Cancer Society Guidelines 2006 (Available online: www.cancer.org) The U.S. Preventive Services Task Force Guidelines January 2003 (Available online: www.ahrq.gov/clinic/uspstf/uspscerv.htm) Cox JT. Atypical Squamous Cells: The case for HPV testing. OBG management March 2004, Vol. 16, No 3. Kim JJ, Wright TC, Goldie SJ. Cost-effectiveness of alternative triage strategies for Atypical Squamous Cells of Undetermined Significance [ASCUS]. JAMA. 2002; 287:2382-2390. Wright TC Jr., Cox JT, Massad LS, et al. 2001 ASCCP: Consensus Guidelines for the Management of Women with Cervical Cytology Abnormalities. JAMA, 2002; Vol 287, 2120-2129. American College of Obstetricians and Gynecologists (ACOG) Committee Opinion No. 330. April 2006; 107(4). American Journal of Obstetrics & Gynecology ­ October 2007: 2006 Consensus Guidelines for the Management of Women with Abnormal Cervical Cancer Screening Tests. American Family Physician (AAFP), October 15, 2006: Practice Guidelines-ACOG Releases Guidelines for Managing Abnormal Cervical Cytology and Histology in Adolescents. Institute for Clinical Systems Improvement (ICSI) Healthcare Guideline: Initial Management of Abnormal Cervical Cytology (Pap Smear) and HPV Testing Medem: Medical Library: ­ American College of Obstetricians and Gynecologists (ACOG): Abnormal Pap Test Results

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