Ontario Colposcopy Clinical Guidance 2016: Best Practices for Women's Health
This presentation outlines the Ontario Colposcopy Clinical Guidance 2016 document aimed at improving the quality of colposcopy services for women with abnormal cervical screening results. It covers clinical criteria, management pathways, referral criteria, treatment strategies, and considerations for special populations. The goal is to promote evidence-informed practices and equitable access to high-quality care in colposcopy services.
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Ontario Colposcopy Clinical Guidance 2016 Version 1 January XX, 2016
Background This slide presentation provides an overview of Cancer Care Ontario s Clinical Guidance: Recommended Best Practices for Delivery of Colposcopy Services, which was released in Ontario in June 2016 These slides can be accessed at cancercare.on.ca/pcs/screening/cervscreening/hcpresources 2
Purpose and Goal See page 1 Aims to promote adoption of evidence-informed clinical best practices and alignment of organizational best practices Goal: To optimize the quality of colposcopy services for eligible women with an abnormal cervical screening test by: oDefining clinical criteria for entry to, management in and exit from colposcopy oSupporting equitable access to appropriate and consistently high- quality care in colposcopy oCreating a framework to guide the organization of colposcopy services and their integration with cervical screening to ultimately enable system-wide performance management and improvements Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 3
Overview See pages 2, 9 and 10 The document encompasses the spectrum of colposcopy care in 5 pathwaysfor management of women referred for colposcopy after abnormal cervical screening 1. Workup and treatment: SIL referral in women > 25 2. Conservative SIL management of women > 25 in whom child bearing is of concern 3. Post-treatment SIL management, regardless of age 4. Management of women ages 21 24 with SIL 5. Workup, treatment and management of AGC/AIS referral Target audience: Colposcopists and the entire team of health care providers involved in colposcopy services (e.g., primary care providers, nurses, pathologists, administrators) Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 4
Overview, Cont See page 7 The clinical pathways include the following components: Referral criteria and investigation strategies Indications for treatment and preferred therapies Follow-up algorithms for treated and untreated women Criteria for exit from colposcopy and screening intervals following discharge from colposcopy Relevant clinical considerations and guiding principles for colposcopy in special populations (e.g., pregnant women, immune- compromised women and women under age 24) Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 5
Highlights HPV testing provides objective risk assignment to guide management HPV testing for risk stratification At entry for ASCUS and LSIL At exit to inform subsequent screening intervals Pathways where HPV testing not available is also provided For young women and women interested in future pregnancies, conservative management preferred whenever possible Management and follow-up for AIS is clarified Current evidence does not support HPV testing in women under age 30 6
Key Practice Changes HPV testing is available: At entry, women over age 30 with low-grade cytologic abnormalities who test negative for HPV can be discharged to primary care for routine, triennial screening At discharge, treated women of any age or untreated women over 30 with low-grade cytologic abnormalities who test: Negative for HPV can be discharged to primary care for routine, triennial screening Positive for HPV can be discharged to primary care for annual surveillance Women treated after an AGC/AIS referral should be followed in colposcopy for a 5-year period. If all tests are negative during 5- year follow-up, screen annually 7
Key Practice Changes, Cont HPV testing not available: At discharge, untreated women with negative colposcopies at 2 follow-up visits and treated women with negative colposcopies at 3 follow-up visits are at population risk and can be discharged to primary care If 3 negative Paps screen triennially If any combination of negative and low-grade cytology (< LSIL) screen annually 8
Best Practice Pathways The following slides show the detailed pathways and are only meant to provide a high level overview. For more detail, please refer to the full Colposcopy Clinical Guidance document (see slide footnotes). 9
Patient Entry and Flow Across Pathways See page 11 Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 10
Untreated Women: Workup and Treatment: SIL Referral for Women > 25 See page 15 referral cytology: ASCUS, LSIL, HSIL or ASC-H Legend: = colposcopic assessment is negative = colposcopic assessment is positive initial colposcopy colposcopy +/- cytology +/- HPV test (reflex)* = a procedure = a procedure result or outcome = consider pathology review colpo adequate and negative +/- biopsies colpo adequate and positive biopsies colpo inadequate *HPV reflex test should be completed only for women 30 with LSIL, ASCUS or normal cytology, and adequate and negative colposcopy. Or, if requested by clinician due to discordance. ECC, **Consider DEP for inadequate colposcopy in high- grade referrals only. +/- biopsies +/- ECC OR DEP** histo = LSIL or normal or cyto LSIL histo = normal or none and cyto > LSIL cancer or cannot rule out cancer histo = HSIL histo = AIS HPV- HPV+ +/- colposcopy 6 months low risk; exit to Regional Cancer Program manage as per AIS Pathway treatment*** routine screening every 3 years colposcopy *** Acceptable treatment of high-grade lesions: DEP (cold knife, LEEP or laser) Excisional (LEEP or laser) Ablative (laser) +/- DEP +/- biopsies follow Conservative Management Pathway; follow-up in colposcopy with co-testing at 12 months follow Post- Treatment Pathway clinical judgement in individual circumstances must be employed Cryotherapy is not an acceptable treatment for high-grade lesions. Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 11
Untreated Women: Conservative SIL Management of Women > 25 See page 18 at initial colposcopy: cyto or histo LSIL and HPV+ Legend: = colposcopic assessment is negative = colposcopic assessment is positive *Clinical judgement must be employed if colposcopy is inadequate. = a procedure 12 months = a procedure result or outcome ** HPV exit test should be completed only for women 30. Or, if requested by clinician for women ages 25 to 29. = consider pathology review follow-up colposcopy #1 adequate* follow-up cytology #1 HPV exit test** 12 months*** *** After 2 repeat positive HPV tests, repeat HPV testing is not routinely indicated. colpo positive 12 months*** colpo negative biopsies 6 to 12 months HPV- HPV+ histo = HSIL cyto > LSIL HPV and/or cyto inadequate HPV- HPV+ cyto < LSIL elevated risk; screen annually in primary care HPV+ cyto = LSIL HPV- cyto > LSIL HPV+ cyto > LSIL histo = LSIL or normal cyto LSIL low risk; routine screening every 3 years histo = LSIL or normal cyto LSIL cyto LSIL low risk; routine screening every 3 years repeat tests in 3 months recall patient (3 months) +/-colposcopy treatment colposcopy +/- DEP +/- biopsies follow Post- Treatment Pathway clinical judgement in individual circumstances must be employed Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 12
Treated Women: Post-Treatment SIL Management +/- colposcopy See page 21 treatment Legend: = colposcopic assessment is negative 6 months post-treatment = colposcopic assessment is positive follow-up colposcopy #1 adequate* = a procedure * Clinical judgement must be employed if colposcopy is inadequate. = a procedure result or outcome follow-up cytology #1 = consider pathology review colpo negative colpo positive biopsies cyto unsatisfactory/ inadequate repeat Pap in 3 months cyto LSIL cyto > LSIL histo = LSIL or normal cyto LSIL histo = HSIL cyto > LSIL 6 months (earlier recall is also acceptable) colposcopy +/- DEP +/- biopsies co-test co-test +/-colposcopy in 6 to 12 months (12 to 18 months post-treatment) in 6 to 12 months (12 to 18 months post-treatment) re-treatment clinical judgement in individual circumstances must be employed follow-up colposcopy #2 adequate* follow-up cytology #2 HPV exit test 6 months or re-treatment acceptable colpo negative colpo positive 6 months biopsies HPV- HPV- HPV+ HPV+ HPV+ and cyto LSIL HPV- and cyto LSIL low risk; routine screening every 3 years HPV and/or cyto inadequate HPV+ and cyto > LSIL HPV- and cyto > LSIL histo = HSIL cyto > LSIL histo = LSIL or normal cyto LSIL low risk; routine screening every 3 years histo = HSIL cyto > LSIL histo = LSIL or normal cyto LSIL repeat tests in 3 months elevated risk; screen annually in primary care +/-colposcopy re-treatment colposcopy +/- biopsies colposcopy +/- DEP +/- biopsies clinical judgement in individual circumstances must be employed Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 13
Management of Women Ages 2124 See page 24 referral cytology: ASCUS, LSIL, HSIL or ASC-H initial colposcopy colposcopy +/- cytology colpo adequate and negative colpo adequate and positive colpo inadequate ECC, +/- biopsies biopsies +/- biopsies **Consider DEP for inadequate colposcopy in high-grade referrals only. +/- ECC OR DEP** cancer or cannot rule out cancer histo = LSIL, normal or none histo = HSIL histo = AIS cyto LSIL cyto > LSIL conservative management with colposcopy in 6 months for 2 years is preferred; treatment may be acceptable for histologically-confirmed HSIL in younger women manage as per AIS Pathway exit to Regional Cancer Program elevated risk; screen annually in primary care 6 months annual reassessment in colposcopy is acceptable; clinical judgement in individual circumstances must be employed Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 14
Workup, Treatment and Management AGC/AIS Referral referral cytology: AGC-N, AGC-NOS or AIS See page 27 initial colposcopy colposcopy +/- cytology colpo adequate and negative colpo adequate and positive colpo inadequate +/- ECC ECC ECC biopsies *Threshold for DEP is higher in AGC-N. Biospy alone may be acceptable for AGC-NOS. biopsies +/-DEP* biopsies DEP (in AIS) OR DEP* endometrial biopsy if > 35, or abnormal bleeding, or elevated risk for endometrial cancer cancer or cannot rule out cancer histo = LSIL or normal histo = HSIL histo = AIS exit to Regional Cancer Program +/- colposcopy follow Conservative Management Pathway ***DEP (LEEP) is an acceptable form of treatment for AIS under appropriate circumstances. Cold knife cone remains an acceptable option for treatment. Providing the optimal specimen for pathology assessment is the highest priority. DEP in this setting must provide an intact specimen with interpretable margins. treatment** colposcopy treatment*** **If appropriate, manage as per Younger Women Ages 21 to 24 Pathway. ECC histo = LSIL or normal histo = HSIL and/or AIS cancer or cannot rule out cancer positive margins? exit to Regional Cancer Program follow Post- Treatment Pathway colposcopy at 6 months is acceptable; however, immediate re-excision can also be considered NO YES consider hysterectomy if cervix cannot be followed fertility desired? NO clinical judgement in individual circumstances must be employed Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 15
Workup, Treatment and Management AGC/AIS Referral: 5-Year Follow-Up See page 27 Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 16
Comparison of Pathways with and Without HPV Testing 17
Untreated Women: Workup and Treatment: SIL Referral for Women > 25 See pages 15 and 30 Pathway with HPV testing Pathway without HPV testing referral cytology: ASCUS, LSIL, HSIL or ASC-H referral cytology: ASCUS, LSIL, HSIL or ASC-H initial colposcopy colposcopy initial colposcopy colposcopy +/- cytology +/- HPV test (reflex)* +/- cytology colpo adequate and negative +/- biopsies colpo adequate and positive biopsies colpo inadequate colpo adequate and negative +/- biopsies colpo adequate and positive biopsies colpo inadequate ECC, *HPV reflex test should be completed only for women 30 with LSIL, ASCUS or normal cytology, and adequate and negative colposcopy. Or, if requested by clinician due to discordance. ECC, +/- biopsies +/- ECC *Consider DEP for inadequate colposcopy in high-grade referrals only. **Consider DEP for inadequate colposcopy in high- grade referrals only. +/- biopsies +/- ECC OR OR DEP* DEP** cancer or cannot rule out cancer histo = LSIL or normal or cyto LSIL histo = normal or none and cyto > LSIL histo = HSIL histo = AIS histo = LSIL or normal or cyto LSIL histo = normal or none and cyto > LSIL cancer or cannot rule out cancer histo = HSIL histo = AIS +/- colposcopy 6 months HPV- HPV+ treatment** exit to Regional Cancer Program +/- colposcopy manage as per AIS Pathway 6 months low risk; exit to Regional Cancer Program manage as per AIS Pathway treatment*** routine screening every 3 years colposcopy follow Non-HPV Conservative Management Pathway; follow-up in colposcopy at 12 months ** Acceptable treatment of high-grade lesions: DEP (cold knife, LEEP or laser) Excisional (LEEP or laser) Ablative (laser) +/- DEP follow Non-HPV Post-Treatment Pathway colposcopy *** Acceptable treatment of high-grade lesions: DEP (cold knife, LEEP or laser) Excisional (LEEP or laser) Ablative (laser) +/- biopsies +/- DEP follow Conservative Management Pathway; follow-up in colposcopy with co-testing at 12 months +/- biopsies follow Post- Treatment Pathway clinical judgement in individual circumstances must be employed Cryotherapy is not an acceptable treatment for high-grade lesions. clinical judgement in individual circumstances must be employed Cryotherapy is not an acceptable treatment for high-grade lesions. Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 18
Untreated Women: Conservative SIL Management of Women > 25 See pages 18 and 33 at initial colposcopy: cyto or h isto LSIL at initial colposcopy: cyto or h isto LSIL and HPV+ Pathway without HPV testing Pathway with HPV testing * Clinical judgement must be employed if colposcopy is unsatisfactory. 12 months follow-up colposcopy #1 satisfactory* follow-up cytology #1 12 months **After 2 repeat positive HPV tests, repeat HPV testing is not routinely indicated. * Clinical judgement must be employed if colposcopy is unsatisfactory. follow-up colposcopy #1 satisfactory* follow-up cytology #1 HPV exit test 12 months** colpo positive colpo negative 1 biopsies cyto unsatisfactory/ inadequate cyto normal 6 to 12 months colpo negative colpo positive cyto LSIL cyto > LSIL histo = HSIL cyto > LSIL histo = LSIL or normal cyto LSIL 12 months** biopsies repeat Pap in 3 month s recall patient (3 months) 1 colposcopy +/- DEP +/- biopsies 12 months +/- colposcopy 12 months 12 months treatment follow Non-HPV Post- Treatment Path way clinical judgement in individual circumstances must be employed HPV- HPV+ histo = HSIL cyto > LSIL HPV and/or cyto inadequate HPV- HPV+ cyto < LSIL elevated risk; screen annually in primary care HPV+ cyto = LSIL HPV- cyto > LSIL HPV+ cyto > LSIL histo = LSIL or normal cyto LSIL low risk; routine screening every 3 years histo = LSIL or normal cyto LSIL cyto LSIL low risk; routine screening every 3 years repeat tests in 3 month s follow-up colposcopy #2 satisfactory* follow-up cytology #2 recall patient (3 months) +/-colposcopy treatment colposcopy follow Post- Treatment Path way **3 consecutive tests refer to 1 initial colposcopy and cytology, and 2 follow-up tests. +/- DEP +/- biopsies colpo negative colpo positive clinical judgement in individual circumstances must be employed 2 histo = HSIL cyto > LSIL histo = LSIL or normal cyto LSIL cyto unsatisfactory/ inadequate cyto normal cyto LSIL cyto > LSIL repeat Pap in 3 month s recall patient (3 months) if 3 consecutive colpo negative and cyto normal** if 3 consecutive colpo negative and cyto LSIL** consider treatment if patient desires +/- colposcopy colposcopy treatment +/- DEP low risk; routine screening every 3 years elevated risk; screen annually in primary care +/- biopsies clinical judgement in individual circumstances must be employed follow Non-HPV Post- Treatment Path way clinical judgement in individual circumstances must be employed Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 19
Treated Women: Post-Treatment SIL Management See pages 21 and 36 +/- colposcopy Pathway without HPV testing +/- colposcopy Pathway with HPV testing treatment treatment * Clinical judgement must be employed if colposcopy is unsatisfactory. 6 months post-treatment 6 months post-treatment follow-up colposcopy #1 satisfactory* follow-up cytology #1 follow-up colposcopy #1 satisfactory* * Clinical judgement must be employed if colposcopy is unsatisfactory. colpo negative colpo positive follow-up cytology #1 biopsies cyto unsatisfactory/ inadequate repeat Pap in 3 month s cyto normal colpo negative colpo positive h isto = LSIL or normal cyto LSIL h isto = HSIL cyto > LSIL 1 cyto LSIL cyto > LSIL biopsies recall patient (3 months) 1 colposcopy +/- DEP +/- biopsies +/- colposcopy cyto unsatisfactory/ inadequate repeat Pap in 3 month s 6 to 12 months (12 to 18 months post-treatment) 6 to 12 months (12 to 18 months post-treatment) 6 to 12 months (12 to 18 months post-treatment) h isto = HSIL cyto > LSIL h isto = LSIL or normal cyto LSIL cyto LSIL cyto > LSIL re-treatment 6 months (earlier recall is also acceptable) clinical judgement in individual circumstances must be employed colposcopy +/- DEP +/- biopsies follow-up colposcopy #2 satisfactory* co-test co-test +/-colposcopy in 6 to 12 months (12 to 18 months post-treatment) in 6 to 12 months (12 to 18 months post-treatment) re-treatment follow-up cytology #2 colpo negative colpo positive clinical judgement in individual circumstances must be employed biopsies 2 follow-up colposcopy #2 satisfactory* cyto unsatisfactory/ inadequate repeat Pap in 3 month s cyto normal h isto = LSIL or normal cyto LSIL h isto = HSIL cyto > LSIL cyto LSIL cyto > LSIL recall patient (3 months) follow-up cytology #2 +/- colposcopy 6 to 12 months (up to 24 months post-treatment) 6 to 12 months (up to 24 months post-treatment) HPV exit test colposcopy +/- DEP +/- biopsies re-treatment 6 months or re-treatment acceptable, keeping in mind patients child-bearing status 6 months or re-treatment acceptable colpo negative 2 colpo positive 6 months clinical judgement in individual circumstances must be employed biopsies follow-up colposcopy #3 satisfactory* HPV- HPV- HPV+ h isto = HSIL cyto > LSIL follow-up cytology #3 HPV+ HPV+ and cyto LSIL HPV- and cyto LSIL low risk; routine screening every 3 years HPV and/or cyto inadequate HPV+ and cyto > LSIL HPV- and cyto > LSIL h isto = HSIL cyto > LSIL h isto = LSIL or normal cyto LSIL low risk; routine screening every 3 years h isto = LSIL or normal cyto LSIL colpo negative colpo positive repeat tests in 3 month s elevated risk; screen annually in primary care biopsies 3 cyto normal cyto unsatisfactory/ inadequate repeat Pap in 3 month s cyto LSIL cyto > LSIL h isto = LSIL or normal cyto LSIL h isto = HSIL cyto > LSIL recall patient (3 months) +/-colposcopy if 3 consecutive colpo negative and cyto LSIL if 3 consecutive colpo negative and cyto normal consider re-treatment, keeping in mind patients child-bearing status re-treatment +/- colposcopy colposcopy +/- biopsies colposcopy +/- DEP +/- biopsies colposcopy +/- DEP +/- biopsies re-treatment low risk; routine screening every 3 years elevated risk; screen annually in primary care clinical judgement in individual circumstances must be employed clinical judgement in individual circumstances must be employed clinical judgement in individual circumstances must be employed Page numbers refer to the full Colposcopy Clinical Guidance document, which is available at cancercare.on.ca/common/pages/UserFile.aspx?fileId=361450 20
Tools and Resources The Colposcopy Clinical Guidance document and Q&A for providers available at https://www.cancercareontario.ca/en/guidelines-advice/types-of- cancer/43336 The Organization of Colposcopy Services in Ontario: Recommended Framework available at https://www.cancercareontario.ca/en/guidelines-advice/types-of- cancer/2096 Regional Cervical Screening / Colposcopy Leads (CSCLs) are also a resource available to you to support and answer your clinical questions Join the Colposcopy Community of Practice (CoP) by emailing ColposcopyCoP@cancercare.on.ca 21
