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Karl Ulrich Petry - Colposcopic practice performance standards

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Karl Ulrich Petry - Colposcopic practice performance standards

  1. 1. Performance standards- how to assess the quality of colposcopy in daily practice? K. Ulrich Petry, Germany
  2. 2. Summary on screening Conclusions • 1.1 Primary HPV-Screening for women (30) 35+ years (I-A) • 1.2 Avoidance of co-testing (HPV plus cytology) (II–A) • 1.4 No HPV-Screening below age 30 years (I–E) • 1.8 The screening interval after a negative HPV-test should be at least 5 years (I-A) • 1.15 Direct referral to colposcopy of all HPV positive women is not recommended (I-D) 036 WHO / IARC / EC 2015
  3. 3. 1 29 2 3 4 5 6 78 9 10 13 16 17 19 20 12 11 21 Screening for cervical cancer in Europe 2018 Pap screening (reimbursed) Nationwide HPV screening Organised HPV screening in progress „Wild“ Pap screening Regional HPV screening Organised Recall Pap Screening Political decision for organised HPV Screening
  4. 4. Organised Screening with call and recall 20-30 yrs > 30 yrs Pap 3 years HPV 5 years Triage (HPV, Biomarker) Triage (HPV, Biomarker) Colposcopy Non-Responder HPV-Self-testing Petry 2016 Level of evidence IA Level of evidence IA-IIB ?
  5. 5. How good is colposcopy as „gold standard“ ? o Screening-Colposcopy showed poor sensitivity and specificity Schneider A, IJC 2000 o HPV-Vaccine trials showed poor sensitivity of colposcopy impression for CIN3+ Stoler M, IJC 2011 o Randomized controlled studies showed that a standardized colposcopy protocol detected as many CIN3+ as immediate LEEP TOMBOLA, BMJ 2010 o Sensitivity of colposcopy guided biopsies for CIN3 ranged from 29-93% in a US trial Pretorius R, JLGTD 2011 o The failure rate of colposcopy (missed CIN3+) is significantly increased in women with positive HPV tests but normal cytology Petry KU, GynOncol 2013 We need to assure quality of colposcopy
  6. 6. Standardized colposcopy is safe – colposcopy without standards may be harmful Standard Detected CIN3+ at 1st colpo Missed CIN3+ in 5 yrs FU Failure rate (missed CIN3+ of all CIN3+) Punch biopsies of any lesion (minor and major changes) in type 1 or 2 TZ 97 3 3% ECC in all type 3 TZ 13 5 27.8% Excisional treatment in HSIL+ and HPV+ 19 0 0 Excisional treatment in CIN2+ and type 3 TZ 7 0 0 Excisional treatment in major changes/HPV+/type 3 TZ 4 0 0 N= 667 women tranferred because of abnormal screening results, 171 CIN3+ Petry KU et al. , Gyn Oncol 2013 66 34 34%
  7. 7. Standardized histological assessment improves the sensitivity of colposcopy • Taking 3 biopsies increased sensitivity for CIN3+ to 95.6% • Only 2% of HSIL were detected by random biopsies from colposcopically normal tissue N. Wentzensen et al , JCO 2015
  8. 8. EFC approval of national QA concepts in practice of colposcopy (“expert colposcopist”) National societies submit their concepts / QA-programs to the EFC executive board. The submission must include : 1. A well defined independent evaluation of the overall case load, as well as numbers of low-grade and high- grade disease seen by individual colposcopists per year 2. Evaluation of the individual performance with the use of the 4 EFC quality indicators EFC approval 1. = Colposcopist fulfilling EFC standards 1.+2. = and member of EFC´s QA program Original slide from the EFC-GA consensus in Prague 2013
  9. 9. Phase 2 EFC Quality indicators for colposcopy E. Moss et al.: European Federation for Colposcopy quality standards Delphi consultation. Eur.J.Obstet.Gynecol.Reprod.Biol. 2013: 170:255
  10. 10. 3 steps to certify a reliable quality in colposcopy Numbers • Competition between different concepts of national societies to control case loads of individual colposcopists Quality parameters • Competition of concepts to assess and optimize the EFC quality indicators Standardized reliable QA •Based on redefined caseload and redefined quality indicators 2014-2016 2014- 2019 Rome 2019
  11. 11. • Use the quality parameters to assess quality in colposcopy. • Use the quality assessment to evaluate the quality parameters
  12. 12. Independent electronic bench-marking 02.05.2009 14(c) asthenis GmbH Data collected were automatically anonymized, encrypted and stored in a secure relational database located within the clinics’ network
  13. 13. Prospective evaluation of QA standards 06.09.2013 | 15 Percentage of excised lesions/conizations with clear margins 0 10 20 30 40 50 60 70 80 90 100 1 2 3 4 5 6 7 total % EFC target Results
  14. 14. Figure 6. Histogram representing the distribution of the proportion of positive margins in women treated for high-grade CIN observed in eligible studies. The red line (20%) represents the maximum positivity considered by EFC as the benchmark of good quality. Risk of treatment failure associated with positive section margins of excisional treatment for high-grade CIN: a systematic review and meta-analysis. Marc Arbyn 2014 review for EFC “The margin status has poor sensitivity to predict treatment outcome. hrHPV is approximately 50% more sensitive and not less specific compared to the margin status.” The importance of margin involvement to assess the risk of post- treatment disease is controversial, especially since a direct link between the size of the excisional specimen and obstetrical outcomes has been shown The majority of colposcopists do not reach the EFC benchmark of >80% clear margins. A revision of this benchmark (>70%) should be considered.
  15. 15. N= 10.869 Luyten A, EJOGRB 2015
  16. 16. Conclusions • Electronic data collection is easy and does not relie on specific software • Independant electronic Q/A (benchmarking) needs special software and support but is feasible • EFC QI can be used for benchmarking but will need a revision • 100% target should not be used in Quality Assessment • Clear margins > 80% should be replaced Luyten A, EJOGRB 2015
  17. 17. Berlin Consensus 2011 QA of each part of the colposcopy service 1. Quality of colposcopic examination / identification of SCJ 2. Colposcopical guidance of excisional CIN therapy 3. Quality of indication/selection for excisional therapy 4. Proof of cure following invasive treatment of CIN 5. Experience
  18. 18. EFC Quality indicators 2015 EFC satellite meeting - Consensus revisions Parameter Aim For cervical colposcopy TZ type (1,2 or 3) should be documented (100%). 100% Percentage of cases having a colposcopic examination prior to treatment for abnormal cervical screening test 100% Percentage of excisional treatments/conizations have a definitive histology of CIN2+. Definitive histology is highest grade from any diagnostic or therapeutic biopsies >85% Percentage of excised lesions/conizations with clear margins >80% Number of colposcopies personally performed each year for a low- grade/minor abnormality on cervical screening >50 Number of colposcopies personally performed each year for high- grade/major abnormality on cervical screening >50
  19. 19. EFC Quality indicators 2015 EFC satellite meeting - Consensus revisions Parameter Aim 1. For cervical colposcopy TZ type (1,2 or 3) should be documented . 100% 2. Percentage of cases having a colposcopic examination prior to treatment for abnormal cervical screening test 100% 3. Percentage of excisional treatments/conizations have a definitive histology of CIN2+. Definitive histology is highest grade from any diagnostic or therapeutic biopsies >85% 4. Percentage of excised lesions/conizations with clear margins >80% 5. Number of colposcopies personally performed each year for a low-grade/minor abnormality on cervical screening >50 5. Number of colposcopies personally performed each year for high-grade/major abnormality on cervical screening >50 The revised EFC Quality Indicators 2017 will be published as full paper but with comments to allow national societies and/or governments to define lower aims for national QA and/or to replace the „clear margin“ QI (No.4)
  20. 20. Better Quality indicators ahead? Quality indicator Aim For cervical colposcopy TZ type (1,2 or 3) should be documented >95% Percentage of cases having a colposcopic examination prior to treatment for abnormal cervical screening test >95% Colposcopy with punch biopsies in </= LSIL and type 1 or 2 TZ with minor or major changes >90% Excisional treatments/conizations have a definitive histology of CIN2+. Definitive histology is highest grade from any diagnostic or therapeutic biopsies (exclude type 3TZ + age 40+) >80% Rate of HPV negative cases 6 months after excisional treatment > 80% A proposal for the EFC congress 2019 in Rome
  21. 21. Conclusions • The basics of colposcopy should be part of any OBGYN training but this does not qualify to practise colposcopy in women with atypical screening results • Colposcopists need to pass a well defined education and training programme with exit assessment • A continous QA of colposcopy practice is needed • External QA is better than self QA. External QA should be organised by national societies for colposcopy and harmonized by EFC. • QA of education, training and practice in colposcopy can be delivered in private and public health sectors, remote and rural as well as urban areas.
  22. 22. Outlook • Full publication of EFC´s revised Quality indicators, core competencies, standards in education and training. • Ongoing improvement of Quality Indicators and standards • Search for financial support to develop a European Colposcopy Benchmarking Pilot Project based on EFC QI and standards

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