New Ontario Cervical Cancer Screening Guidelines

1. New Ontario Cervical Cancer Screening Guidelines Dr. Joan Murphy Clinical Lead, Ont. Cervical Screening Program, Cancer Care Ontario Primary Care Symposium Nov 10, 2012

2. Disclosure Dr. Joan Murphy NONE

3. Objectives: 1. review the evidence that informs best practice in cervical cancer screening, 2. review the new Cancer Care Ontario Cervical Screening Program guidelines, and 3. discuss the imminent and projected Ontario Cervical Screening Program enhancements that will support clinicians and women in achieving optimal screening and follow up

4. Background • CCO 2005 guidelines due for update • Program redevelopment required clarity for initiation / cessation / interval • CCO’s Program in Evidence-Based Care (PEBC) started work in July 2010 • Posted to CCO website Feb 2012 • Published in May 2012 issue of JOGC

5. PEBC Evidence-based Advice Cycle Evidence-based Advice Panel Topic Selection: explicit question Method Selection: adaptation, systematic review, environmental scan, consensus • Draft Report: • evidentiary base • expert interpretation & consensus • draft advice Dissemination & Publication updating • System end-users: • Clinical Council • MOHLTC • Quality Indicator Cycle • Clinical Program Heads updated advice • Review: internal/external • Report Approval Panel • CCO leadership • Peer reviewers • Ontario stakeholders • Final Report: • evidentiary base • expert interpretation and consensus • description of external review • final advice See also PEBC Handbook: https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=50876

6. Core Methodology: Systematic Review • Clearly stated set of objectives with pre-defined eligibility criteria • Explicit, reproducible methodology • Systematic search to identify all studies that would meet eligibility criteria • Assessment of validity of included studies • Systematic presentation and synthesis • 7 RCTs: evidence for Ontario guidelines

7. Evidence: 7 RCTs in the prior 5 years evaluating HPV testing • CCCaST(Canada): Mayrand M, Duarte-Franco E, et al. Human papillomavirus DNA versus papanicolaou screening tests for cervical cancer. New Engl J Med. 2007;357(16):1579-88. • Sankaranarayanan (India): Sankaranarayanan R, Nene BM, et al. HPV screening for cervical cancer in rural India. N Engl J Med. 2009;360(14):1385-94. • POBASCAM (Netherlands): Bulkmans NW, Berkhof J, et al. Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial. Lancet. 2007;370(9601):1764-72.

8. Evidence (cont’d): 7 RCTs in the prior 5 years evaluating HPV testing 4. FPHT (Finland): Leinonen M, Nieminen P, Kotaniemi-Talonen L, Malila N, et al. Age-Specific Evaluation of Primary Human Papillomavirus Screening vs Conventional Cytology in a Randomized Setting. J Natl Cancer Inst 2009;101:1612–1623. 5. NTCC (Italy): Ronco G, Giorgi-Rossi P, et al. Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Lancet Oncol. 2010;11(3):249-57. 6. ARTISTIC (UK): Kitchener HC, Almonte M, et al. HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial. Lancet Oncol. 2009;10(7):672-82.

9. Evidence (cont’d): 7 RCTs in the prior 5 years evaluating HPV testing 7. Swedescreen(Sweden): Naucler P, Ryd W, et al. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N Engl J Med. 2007;357(16):1589-97. • FOCAL (BC): British Columbia is currently conducting a randomized controlled trial, the FOCAL study, which has some early first round data.

10. Ontario Guidelines Summary

11. Changes to Guidelines

12. 1º HPV Management Algorithm HPV testing in women age 30-65 years Negative Positive Repeat HPV testing at 5 year intervals until age 65 Cytology test Negative Positive (≥ASCUS) Repeat HPV testing at 12 months Colposcopy Negative Positive

13. HPV +ve Triage with Cytology • HPV less specific (61-96%) than cytology (91-96%) • Cytology triage of HPV +ve results • Improve specificity of screening • Identify clinically relevant HPV infections • More appropriate referral to colposcopy

14. Disconnect: Science & Reality • Clear evidence for primary HPV screening • HPV test not currently publicly-funded in Ontario • Should implement primary HPV screening within organized program • Updated cytology guidelines to bridge transition to HPV primary screening

15. Updated Cytology Guidelines • Start screening at age 21 • Screen every 3 years • Stop screening at age 70, if adequate and negative screening history

17. Canada1 and United States

18. Europe

19. Organized Program (IARC) YesPartialNo

20. Patient Correspondence • Focus on women aged 21-69 (4.4M women) • May 2012: Provider education tools • Focus on updated cytology guidelines • New patient correspondence (i.e., results) • June 2012: Privacy notices • July 2012: Abnormal/unsatisfactory results • Only to those who received privacy notice and did not opt out of correspondence

21. Implementing Primary HPV Screening: Logistical Issues 21

22. The HPV Test • What do we need to test for (16/18)? • Performance characteristics of the test • Sample stability • Quality standards for HPV test as primary test and for cytology as triage test • Immunized population reaching screening ages • Reflex cytology

23. Laboratory Impacts • Technology - evolving • Throughput/volumes • Costs – individual and aggregate • Quality assurance • Standardized operating procedures • Standardized reporting • Human resources • Competencies and training

24. Colposcopy Capacity • Current volumes • Geographic locations • Colposcopy service not organized • No “formal” training programs, minimum qualifications or quality processes implemented • No comprehensive colposcopy data • Unable to provide performance feedback to practitioner or system

25. Economic Evaluation • HPV test not currently publicly funded • Economic evaluation of entire screening process needed: • 1º HPV screening & cytology triage • Laboratory • Colposcopy • Business case for primary HPV screening to Government

26. Provider Knowledge & Attitudes • What is known about HPV and HPV tests? • Stigma of STIs • Cervical cancer and recommended guidelines • Age, interval, benefits/harms • Management of HPV +ve results • Counseling HPV +ve women • Alignment of physician incentives • Icon of annual Pap/annual health exam

27. Public Knowledge & Attitudes • What is known about HPV and HPV immunization? • Stigma of STIs • Cervical cancer and recommended guidelines • Age, interval, benefits/harms • Icon of annual Pap/myth that “more screening is better” • Longer interval seen as “cost savings”

28. Organizing the Program • 1º HPV screening must be implemented only within an organized program • OCSP not fully organized – underway • Prescribed registry status • Cytology results and health claims data • Patient correspondence starts summer 2012

29. HPV as Primary Test: Approach OCSP Program Quality Standards (Screening and Follow-up) PEBC Cervical Screening Guidelines (2011) Revised Program Quality Standards w/ HPV Testing Follow-up Guidelines and Standards w/ HPV Testing Economic Evaluation and Business Case for HPV Testing to MOH Test Standards Lab Standards ICS Program Design and Implementation Program Design with HPV Test Screening Operations Funding Model Performance Management Service Delivery Education & Comms Data Requirements / Data Collection Approach IT Requirements

30. 1940s Technologies