This document discusses quality indicators for colposcopy and proposes updates. It summarizes recent studies on margin status and HPV testing as proof of cure after treatment. It finds that the current quality indicator of 80% clear margins is not useful as margin status is a poor predictor of treatment failure. HPV testing 3-12 months after treatment is a better predictor of cure. It proposes revising the quality indicators to focus on comprehensive colposcopy examinations and HPV-negative proof of cure after treatment. It also discusses the importance of standardized colposcopy to safely manage pre-cancer and avoid unnecessary procedures.

2. QI update and next steps
Karl Ulrich Petry

3. EFC Quality Indicators in Colposcopy
Update and next steps
K. Ulrich Petry, Wolfsburg
Germany

4. 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

5. 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

6. • Use the quality parameters to assess quality in colposcopy.
• Use the quality assessment to evaluate the quality parameters

8. N= 10.869 Luyten A, EJOGRB 2015

9. EFC Quality indicators
2015 EFC satellite meeting Brussels- Consensus revisions
2017 EFC General assembly Paris- Confirmation of revised QI
Parameter Aim
For cervical colposcopy Transformation Zone type (1,2 or 3)
should be documented 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
Petry KU, Eur J Obst Gyn 2018 (free access on Pub Med)

11. German certification for
colposcopy clinics
Nr Kennzahl Zähler
Grundgesamtheit
Soll-vorgabe Wert
(=Nenner)
1
Vorstellung
Tumorkonferenz
Anzahl vorgestellter Pat. mit einem
invasiven Karzinom in der TK des
Gynäkologischen Krebszentrums
Alle Pat. mit einem invasiven
Karzinom
>= 90%
Zähler 55
Nenner 55
% 100
2
Teilnahme interdisziplinäre
Tumorkonferenz
Anzahl Teilnahme Tumorkonferenz
des Gynäkologischen Krebszentrums
---- ≥ 8 Teiln. / Jahr Zähler >8
3
Durchführung
Differenzialkolposkopie
Anzahl Pat. mit einer Exzision, bei
denen eine Differenzialkolposkopie
präoperativ durchgeführt wurde
Alle Pat., bei denen eine Exzision
durchgeführt wurde
>= 95%
Zähler 178
Nenner 178
% 100
4 Auffällige Befunde Exzision
Anzahl Pat. mit Exzision und führender
Histologie>= CIN 2
Alle Pat., bei denen eine Exzision
durchgeführt wurde
>= 85%
Zähler 162
Nenner 178
% 91,01

12. High rates of clear margins may cause more harm
than good
Patients Risk of
preterm birth
<37 w
Risk of
preterm birth
<28 w
P-value
Single
treatment
1,367,023 1.75
(1.49-2.06)
2.54
(1.77-3.63)
< 0.001
Multiple
treatments
1,317,284 3.78
(2.65-5.39)
NA < 0.001
LLETZ 1,445,241 1.56
(1.36-1.79)
< 0.001
M. Kyrgiou, BMJ 2016

13. EFC meta-analysis on margin status as
a predictor of treatment failure

14. What is the best proof of cure?
Systematic Review
Treatment failure was defined as
occurence of residual or recurrent
CIN2+ in studies with a minimum
follow-up of 18 months.
In total the included studies
followed 44,446 women who
underwent excisional treatment
18 studies compared accuracy of
margin status with HPV testing as
Proof of cure test.
M. Arbyn et al, Lancet Oncol 2017

15. Proportion of margin involvement
Method Margin involvement %
Cold Knife conization 1,759 / 11,829 20.2
Laser conization 977 / 5,562 17.8
LLETZ / LEEP 4,332 / 15,515 25.9
53 out of 97 studies did not fulfill the EFC quality QI of less than
20% margin involvement
Arbyn M, Lancet Oncol 2017

16. 0.01
0.05
0.1
0.5
1
5
10
20
50
80
90
95
99
99.5
99.9
Post-testProbability(%) 0.01
0.05
0.1
0.5
1
5
10
20
50
80
90
95
99
99.5
99.9
Pre-testProbability(%)
Pre
(6.90%)
Post(+)
(17.50%)
Post(-)
(3.80%)
Margin status
0.01
0.05
0.1
0.5
1
5
10
20
50
80
90
95
99
99.5
99.9
Post-testProbability(%)
0.01
0.05
0.1
0.5
1
5
10
20
50
80
90
95
99
99.5
99.9
Pre-testProbability(%)
Pre
(6.90%)
Post(+)
(26.08%)
Post(-)
(0.78%)
hrHPV
ROC plot of the sensitivity as a function of the specificity
for residual or recurrent CIN2+ of the marginal status (red)
and harp testing (blue), among women treated for CIN2+.
M. Arbyn et al.; Lancet Oncol 2017

17. Conclusion 1
The EFC quality indicator :
Percentage of excised lesions/conizations with
clear margins >80%
Is not useful.
• The sensitivity of clear margins to predict treatment
failure varied widely from 9% to 94%
• The majority of published trials did not meet the 80%
target

18. Conclusion 2
• Margin involvement indicates an increased risk of
residual or recurrent disease
• HPV testing 3-12 months after treatment is a better
predictor of cure or failure of cure than margin
involvement

19. Proof of cure algorithm
Positive
margins
Routine
Screening
Colposcopy
HPV + Pap
after 6+18
months
Positive
margins
Clear
margins
negative
No risk
factorsECC pos
ACIS
Individual
management
75-80%1-2%
positive
80-85%15-20%

20. Proposal A.01 for the EFC congress 2019 in Rome
Quality indicator Minimum
Aim
Comprehensive
Aim
1. For cervical colposcopy TZ type (1,2 or 3)
should be documented
>95% 100%
2. Percentage of cases having a colposcopic
examination prior to treatment for abnormal
cervical screening test
>95% 100%
3. Excisional treatments/conizations have a
definitive histology of CIN2+. Definitive histology
is highest grade from any diagnostic or
therapeutic biopsies (exclude type 3 TZ and age
45+ years)
>85% >85%
4. Percentage of excised lesions/conizations with
clear margins
75% 80%

21. Do we need more or better QI??
• Colposcopy is a tool to protect women from cervical cancer
and from unnecessary treatment and to reassure our patients
that we care for them.
• Colposcopy is a minimal invasive method to achieve
histological assessment in atypical screening results. Low rates
of histological assessment increase the colposcopy failure rate.

22. 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%

23. Proposal B.01 for new QI for the EFC congress 2019 in Rome
Quality indicator Minimum
Aim
Comprehensive
Aim
% Colposcopy with punch biopsies in type 1 or 2
TZ with minor or major changes and atypical
screning results
80% >90%
% of patients after excisional treatment with
margin involvement that tested negative for
HPV 6-18 months after treatment or were called
for colposcopy
90% 100%
% of patients writing love letters, Twitter likes ,
enthusiastic press reports etc because of the
sensitive counselling, treatment and the overall
empathy of the colposcopist in charge
100% 100%