New Guidelines for the Management of Abnormal Pap Smears: Applications in Family PACT Michael S. Policar, MD, MPH UCSF School of Medicine Sponsored by Office of Family Planning 1 California Department of Public Health Pap Smear Frequency 1989 Consensus Statement • All women who are, or who have been, sexually active, or who have reached 18 years old, should have annual Pap smears After at least 3 consecutive annual negative smears, Pap testing may be done less frequently • No upper age limit on screening • After hysterectomy, vaginal Paps every 3-5 years • Most guidelines used risk factors to define screening intervals 2 2001 Bethesda System: Goal of Screening • The central purpose of screening is to detect high grade lesions – Most LSIL, especially in young women, is due to acute HPV infection, which itself is not dangerous – >90% LSIL lesions resolve without treatment – Evaluate ASC, LSIL Paps because HSIL may exist – Focus on high grade lesions as progression to cancer is more likely, regression is less likely – Detect glandular lesions likely to progress 3 Designing Pap Smear Intervals • Screening interval depends upon – Error rate of screening test – Progression rate of disease • Cervical cancer risk factors don’t impact interval – (Slow) rate of growth is the same, irrespective of behavioral risk factors – If rapid growth is more likely (HIV positive, immunocompromised), screen more often • With improved accuracy of screening test (LBC), longer screening intervals justifiable 4 American Cancer Society Pap Smear Intervals: Made Easy • Start screening – 3 years after first intercourse or 21 years old – Counsel virginal women re: benefits, risks • Stop screening after – Total hysterectomy for benign condition, or – 3 negative Paps if hysterectomy for CIN 3, or – 65 yo, if 3 consecutive benign Paps in prior 10 yrs • While screening – If LBC, every 2 years till 30, then every 2-3 years – If glass, annually till 30, then every 2-3 years – If immunocompromised, repeat annually 5 Screening Interval in Immunecompromised Women ACS, USPSTF 2002; ACOG 2003 Recommendation Perform Pap every 6 months x 2, then yearly if • HIV seropositive • Immunocompromised by organ transplant, chemotherapy, chronic steroid use Rationale • Progression rates from HSIL to cancer more rapid in immunocompromised women 6 Adolescents: Why Wait 3 Years to Screen? • High grade lesions take years to develop – Earliest HSILS are 3 years after sexual debut • High grade lesions are rare – CIN 3 annual incidence 15-19 yo: 3/10,000 – 4 years after HPV infection, CIN 2/3 in <5% • Low grade lesions typically resolve spontaneously – At 3 years, 91% LSIL regress; only 3% progress to HSIL • CIN 2 lesions often act like CIN 1; usually regress 7 Common Questions About Pap Intervals • Are the intervals any different for women – With multiple sexual partners? – Who have sex only with other women? – Who are pregnant? – Using hormonal contraceptives or hormone therapy? • If a Pap is not scheduled or necessary, what about a bimanual pelvic exam? 8 2004 WHO Selected Practice Recommendations for Contraceptive Use • Not recommended as “contributing substantially to safe and effective use of contraceptive method” – Breast or genital tract examination – Cervical cancer screening – STI assessment or lab test screening – Hemoglobin determination – Other routine lab tests • Blood pressure measurement before initiation of – OCs, POPs, DMPA, and implants 9 Implications of 2002 Pap Interval Guidelines • Far fewer Paps for women less than 21 yo • Far fewer Paps for women older than 65-70 yo • One-half as many Paps if LBC smears used • No Paps if total hysterectomy for benign disease • No need for two Pap smears (antepartum and postpartum) in pregnant women – Illogical to do Paps in pregnant women < 21 yo 10 Management of Non-SIL Pap Smear Abnormalities 11 Pap Specimen Adequacy Cytology Finding Action Unsatisfactory • Repeat cytology in 2-4 months Satisfactory, negative for • Repeat cytology within 6 months if SIL, but limited by…few • Unable to clearly visualize the (scant) endocervical cells cervix or sample the endocervical canal • the client is immunosuppressed, • there was a previously abnormal Pap without adequate follow up • A positive HPV-DNA test within the past year, • 3 or more years since the last normal cytology • Otherwise, repeat in one year • If practice-wide rate is > 15%, discuss remediation with cytopathologist 12 Organisms Cytology Finding Action Trichomonas vaginalis • If recently treated, no further evaluation is necessary • If not, notify patient and offer either presumptive treatment or confirmatory testing • Finding may indicate presence of other STIs, although long term colonization also is possible. • Unless unsatisfactory, repeat cytology at scheduled screening interval Fungal organisms • Usually due to asymptomatic Candidal morphologically colonization consistent with • No action is necessary; patient Candida spp. notification is optional • Unless unsatisfactory, repeat cytology at scheduled screening interval 13 Organisms Cytology Finding Action Shift in flora Poor correlation with diagnosis of BV. suggestive of If recently treated, no further evaluation is bacterial necessary. vaginosis (BV) If not, patient notification is optional. If notified, offer confirmatory evaluation Repeat cytology at scheduled screening interval. Bacteria In IUC user, rarely associated with pelvic consistent with actinomycosis. Actinomyces To evaluate, perform pelvic exam or refer for gynecologic consultation. If negative pelvic exam, IUC removal is not required and there is no evidence of benefit of antibiotic therapy 14 Organisms Cytology Action Finding Cellular changes • Strongly suggestive of HSV shedding consistent with • If herpes diagnosis is in medical record, herpes simplex patient notification is optional virus • If not, notify patient of result. Direct tests for herpes virus (culture, DFA) are not indicated • If the patient requests confirmation, a positive HSV type-specific serology will confirm prior infection (not a Family PACT benefit) • Finding may indicate presence of other STIs, although long standing HSV infection also is possible. • Repeat cytology at scheduled interval 15 Other Non-Neoplastic Findings Cytology Finding Action Reactive changes • May be due to GC, Ct, trichomonas, viruses, associated with irritants, (very rarely) cancer (severe) • If recent GC, Ct tests were negative, no further inflammation3 STD evaluation is necessary • If not recently screened, notify patient and offer GC, Ct testing • Do not presumptively treat with topical or oral antibiotics • If unexplained inflammation, repeat cytology in 6- 12 months • If persistent unexplained inflammation, consider colposcopic evaluation Reactive changes • No action is necessary associated with • Patient notification is unnecessary intrauterine • Repeat cytology at scheduled screening interval contraception 16 Other Non-Neoplastic Findings Cytology Finding Action Atrophy • No action is necessary • Patient notification is unnecessary • Repeat cytology at scheduled screening interval Benign • For post-menopausal women, endometrial endometrial cells assessment is recommended (not a Family (including PACT benefit) stromal cells or • For premenopausal women histiocytes) • No action is necessary • Patient notification is unnecessary • Repeat cytology at scheduled screening interval 17 2006 ASCCP Cervical Cytology Management Guidelines • http://www.asccp.org/consensus/cytological.shtml • Guidelines on Management of Women with Cytological Abnormalities – How to manage abnormal Pap results • Guidelines on Management of Women with Histological Abnormalities – How to manage abnormal biopsy results 18 What Are Indications for Colposcopy?-1 • Cytology result with ASC-H, HSIL or suspicion of cancer • Cytology with LSIL in a women >21 years old (unless pregnant or post-menopausal) • Cytology with atypical glandular cells (AGC), unless AGC-atypical endometrial cells and positive endometrial sampling 19 What Are Indications for Colposcopy?-2 • Cytology showing ASC-US in the following circumstances – Women who are unlikely or unwilling to return for follow-up – Repeat cytology test with ASC-US or worse performed during observation period (except adolescents) – High-risk HPV DNA present at initial or subsequent testing (except adolescents) 20 What Are Indications for Colposcopy?-3 • Cervical leukoplakia (visible white lesion) or other unexplained cervical lesion regardless of cytology result • Unexplained or persistent cervical bleeding regardless of cytology result 21 ASCCP 2006: Managing Women with ASC-US 2001 Guideline 2006 Guideline •A program of repeat A program of repeat cervical cytology, or cervical cytological colposcopy, or DNA testing, colposcopy, or testing for high-risk types DNA testing for high-risk of HPV are all acceptable types of HPV are all methods for managing acceptable methods for women with ASC-US. managing women over the (AI) age of 20 with ASC-US. (AI) 22 Managing Women with ASC-US No Major Changes from 2001 Guideline • Acceptable post-colposcopy management options for women who are positive for high-risk types of HPV, but in whom CIN is not identified, are HPV DNA testing at 12 months or repeat cytological testing at 6 and 12 months. (BII) • It is recommended that HPV DNA testing not be performed at intervals less than 12 months. (EIII) 23 ASC-US: Women > 21 Years Old 24 Management of ASC-US Special groups of women Postmenopausal women Immunosuppressed women Adolescents (9-19 years of age) 25 Management of ASC-US Postmenopausal Women 2001 Guideline 2006 Guideline • Providing a course of Postmenopausal intravaginal estrogen women with ASC-US followed by a repeat should be managed in cervical cytology obtained the same manner as approximately a week after completing the women in the general regimen. (CIII) population. (BII) 26 Management of ASC-US Immunosuppressed Women 2001 Guideline 2006 Guideline • Referral for colposcopy is recommended for all Immunosuppressed immunosuppressed women with ASC-US patients with ASC-US. should be managed in (BII) the same manner as • Includes all HIV-infected women in the general women, irrespective of CD4 population. (BII) count, HIV viral load, or antiretroviral therapy. 27 Management of ASC-US Adolescent Women (20 yrs and younger) HPV DNA testing and colposcopy are unacceptable for adolescents with ASC- US. (EII) If HPV testing is inadvertently performed, the results should not influence management 2006 28 ASC-US+ LSIL: Adolescents 29 Summary: ASC-US and LSIL in Adolescent Women ASCCP 2006 • ASC-US and LSIL are managed identically • Colposcopy and (reflex) HPV triage are no longer recommended as initial options • If a follow-up Pap in one year is less than HSIL, perform a second Pap one year later – If result is ASC-US or worse, refer for colposcopy • Follow patients with biopsy proven CIN I or CIN II for at least 2 years to allow for regression 30 ASC-H: Women of All Ages 31 Management of LSIL Key Changes for 2006 Less importance is given as to whether the colposcopic examination is satisfactory and CIN 1 is found Adolescents are managed less aggressively and in the same fashion as those with ASC-US, i.e. repeat cytology 32 LSIL: Women > 21 years Old 33 LSIL: Pregnant Women 34 Management of LSIL Postmenopausal Women • Acceptable options for the management of LSIL in postmenopausal women include "reflex" HPV DNA testing (BII) or colposcopy (BII) • If the HPV DNA test is negative or if colposcopy is negative, repeat cytology in 12 months is recommended – If the HPV DNA test is positive colposcopy is recommended (AII) 35 Management of HSIL Key changes for 2006 • Either a diagnostic excisional procedure or colposcopy with endocervical assessment are acceptable for initial management • If no CIN 2+ is identified on colposcopy either a diagnostic excisional procedure or follow-up are acceptable (not limited to adolescents) 36 Management of HSIL Except Adolescents and Young Women 37 Management of HSIL Adolescents and Young Women 38 Should HPV Testing or Repeat Pap Be Used in the Initial Evaluation of AGC? • A program of repeat cervical cytology is unacceptable in the initial triage of all subcategories of AGC or AIS • HPV DNA testing alone is unacceptable in the initial triage of all subcategories of AGC or AIS 39 Management of AGC Initial Workup (All Ages) 40 Management of AGC Subsequent Workup 41 Management of Cervical Biopsies • Biopsy CIN 1 – Pap ASC-US, ASC-H, LSIL – Pap HSIL, AGC-NOS – Adolescents • Biopsy CIN 2, 3 – Adolescents and Young Women – Adults Excluding Adolescents, Young Women • Adenocarcinoma in Situ (AIS) 42 Biopsy CIN 1 Pap ASC-US, ASC-H, LSIL 43 Biopsy CIN 1 Pap HSIL, AGC-NOS 44 Biopsy CIN 1 Adolescents 45 Biopsy CIN 2, 3 (excluding Adolescents and Young Women) 46 Biopsy CIN 2 or 3 Adolescents and Young Women 47 Adenocarcinoma in Situ (AIS) 48 Processing Forms Download Now: • Evaluation Form • Continuing Education Form • Post Test No Web Access Now: • Call 1-877-FAMPACT for forms • All participants that return an evaluation form will receive a Certificate of Participation • Those requesting CE credit must return evaluation, Post Test and CE Form Complete forms and fax to 213 368-4410 49 Thank you for your participation!
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