Cap.org v. 1 Gynecologic Consensus Conference Topic Group V: Monitoring of HPV Rates June 4, 2011

cap.org v. 1

Gynecologic Consensus ConferenceTopic Group V: Monitoring of HPV Rates

June 4, 2011

Work Group 5

• Christine Booth MD, FCAP, Chair

• Michael Henry MD, FCAP, Senior Author

• Carol Filomena MD, FCAP

• Marilee Means PhD, SCT(ASCP)

• Patricia Wasserman MD, FCAP

• Christine Bashleben, MT(ASCP) CAP staff

2© 2011 College of American Pathologists. All rights reserved.

Background

• ASCCP 2006 Consensus Guidelineso Provides revised evidence-

based consensus guidelines for managing women with − Abnormal cervical screening test

results− Cervical intraepithelial neoplasia (CIN)

or Adenocarcinoma in situ (AIS)


ASCCP 2006 Consensus Guidelines

HPV TESTING

• Use only analytically and clinically validated tests

• Test for high-risk HPV types only (there is no role for low-risk HPV testing in a cervical cancer screening program)

• Screening can use co-testing with Pap and HPV in women over 30 years. If both tests are negative, re-screen in three years.



HPV TESTING

• HPV testing in adolescents is unacceptable

• Reflex HPV testing for the triage of women with ASC-US is preferred, except in women 20 years of age or under

• Reflex HPV testing for the triage of postmenopausal women with LSIL is an acceptable choice



• ASC-Ho >65% HPV + no value of reflex

HPVo No changes from 2001 consensuso “Review all material” eliminatedo Management same as ASC-US +

HR-HPV+


Survey Results


HPV results obtained at the time of the Pap test are routinely incorporated into the Pap report: (n=525)

Yes 61.9 %

No 38.1 %

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Original Survey Results: HPV testing practices

© 2011 College of American Pathologists. All rights reserved.

How are HR-HPV tests for ASC-US ordered? (n=518; multiple responses allowed)

•Ordered as a "reflex test" by providers

•Ordered reflexively by the laboratory independent of the primary provider initial order

•Offered for reflex testing for women under 21 years of age

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87.6%

23.4 %

7.9 %


• Laboratory limits ASC-US reflex testing to women over the age of 20: (n=512)

Yes 15.6 %

No 84.4 %

If no, why? (from online survey):Clinician drivenPatient demandsResolve diagnostic

dilemmasOrdered out of habit



• 71% of respondents will perform reflex HR-HPV in ASC-US in women under 20 at clinician’s insistence

• 51% of respondents will call clinician to educate about published guidelines before performing reflex HR-HPV in ASC-US in women under 20

• 6% of respondents will not perform reflex HR-HPV in ASC-US in women under 20 despite clinician’s insistence

• Some respondents will perform reflex HR-HPV testing in women under 20 at clinician’s insistence and will include a comment in the report indicating that “modern guidelines do not recommend HPV tests for women equal and less than 20 years of age and if obtained, the results should be ignored for management.”

• Some respondents require that clinicians who wants reflex HR-HPV testing in women under 20 submit a separately collected test directly to virology

© 2011 College of American Pathologists. All rights reserved. 11

Online Question Results


Which HR-HPV tests are reflexively offered from a cytology specimen? (n=520; multiple responses allowed)

•ASC-US reflex 90.6 %

•ASC-H reflex 47.1 %

•AGC or other glandular abnormalities 28.3%

•Pap test with any squamous epithelial abnormality 23.5%

•LSIL with a Pap test regardless of age 20.8 %

•LSIL reflex in postmenopausal women 14.8 %



Does your lab offer HPV reflex testing on ASC-H?•50% offer reflex HR-HPV testing for ASC-H results

•Some respondents state that knowledge of HPV in ASC-H is beneficial in the following cases:o No colposcopic follow up if HPV is negativeo If HPV negative, patient returns to routine testingo Useful in resolving diagnostic dilemmas with

confidenceo Useful in older women with negative historyo Useful in pregnant womeno Helps PCP decide to go to LEEP or not




If an HR-HPV test is not ordered reflexively on a Pap test by the submitting clinician, does the pathologist have the discretion to order an HR-HPV test? (n=520)

•Yes 38.7 %

•No 61.3 %



Laboratory finds it useful to order HR-HPV testing independently of the clinician to resolve diagnostic discrepancies between the cytotechnologist and pathologist in Pap test diagnosed as the following: (n=129; multiple responses allowed)

•ASC-US 75.2 %

•ASC-H 58.9 %

•AGC 31.0 %

•HSIL 19.4 %

•LSIL 18.6 %

•SCC 7.8 %

•ADC 5.4 %



If you do use HR-HPV results to resolve diagnostic discrepancies, please explain how:

• To fine tune ASC-US criteria

• To aid in the CT-P disagreements for ASC-US cases

• In borderline Pap interpretationso HPV negative cases results in re-evaluations

o HPV positive cases results in re-evaluations

• To resolve diagnostic dilemmas at any age




1. Smaller labs are more likely to reflexively order HPV testing independent of the initial order (P=0.001)

2. Larger labs are more likely to reflexively order HPV testing with any squamous abnormality (P=0.001)

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Survey Results: Lab Volume Analysis for HPV Testing Practices


• Laboratory offers low-risk HPV testing: (n=520)o Never 45.6%o Only on request 39.2%o Routinely bundled with HR-HPV 11.9%o Other 3.3%

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StatementsBased on Survey, Literature and Expert Consensus

• Laboratories should only offer HR-HPV testing for GYN specimens

• Laboratories should encourage clinicians to consider the latest consensus guidelines in ordering HR-HPV tests on GYN specimens

• Laboratories should be cautious in using HPV test results to change or influence cytologic interpretations


Consensus Questions


46. Should HR-HPV tests be ordered by the laboratory to be used as a diagnostic test to aid in morphologic dilemmas and resolve diagnostic discrepancies?

A. Yes 15.2%

B. No 75.8%

C. Unsure 9.1%

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Consensus Question - Vote



47. HR-HPV results should aid in down- or upgrading of Pap test interpretations when available prior to sign-out.

A. Yes 8.1%

B. No 83.9%

C. Only in certain circumstances 8.1%


48. It is not appropriate to offer LR-HPV testing on Pap tests:

A. For any clinical circumstance. 80.6%

B. Disagree. It should be offered when clinically requested. 17.91%

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• HR-HPV rates are monitored to determine potential trends in accuracy of diagnoses:oASC-US reflex HR-HPV results

(n=510)−Yes 53.9%−No 46.1%

oHPV DNA Results (n=364)−Yes 32.7%−No 67.3%

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Original Survey Results: HPV for Quality Assessment


• Monitoring of HPV rates (n=392; multiple responses allowed)

Laboratory CytotechPathologist

ASC-US 53.3% 13.8% 21.4%

NILM 21.4% 5.9% 5.9%

LSIL 17.9% 4.3% 5.9%

HSIL 14.8% 3.3% 4.6%

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Original Survey Results: HPV for Quality Assessment


• HPV results are compared to ASC-US/SIL ratios for pathologists to determine potential trends in over or under diagnosis? (n=513)

Yes 28.8%

No 71.2%

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Original Survey Results:HPV for Quality Assessment

If no, why not? (from online survey)• Too complex to get data • Pap and HPV results in separate systems• Does not affect pathologist sign-out tendencies


CAP Checklist CYP.07653

HR-HPV Records

If available, records are maintained for high-risk human papillomavirus (HR-HPV) tests performed on ASC-US including:

1. Total number of HR-HPV tests performed on ASC-US cases

2. Total number of POSITIVE HR-HPV ASC-US cases

NOTE: The percentage of ASC-US cases with a positive HR-HPV result may be a helpful quality metric for both overall laboratory performance and individual performance of pathologists, especially when combined with an individual's ASC-SIL ratio. Data for other HR-HPV testing results (e.g. co-testing with a Pap test in women > 30 years of age) may also be helpful quality metrics but should be kept separately.



• While there is significant variability in interinstitutional HPV-positive rates in ASC-US Pap tests, monitoring the HPV-positive rate in ASC-US Pap tests is a valuable broad measure of quality.

• Performance beyond 2 SD’s of the mean should prompt reassessment of diagnostic criteria used in the evaluation of Pap tests and/or investigation of the prevalence of HPV positivity in the population from which the Pap tests are obtained.

(Tworek et al, Arch Pathol Lab Med. 2007;131:1525–1531)



• Monitoring the HPV-positive rate in other diagnostic categories such as LSIL and the comparison of these HR-HPV rates to published benchmarks is also a valuable broad measure of quality for a laboratory and possibly for individuals.



• When possible, individual ASC-US/HR-HPV results should be compared to ASC-US/SIL ratios for pathologists to determine potential trends in over- and under-diagnosis.



49. If possible, ASC-US/HR-HPV results should be compared to ASC-US/SIL ratios per pathologist as a general quality monitor.

A. Yes 58.5%

B. No 18.9%

C. Unsure 22.6%


50. ASC-US reflex HR-HPV results should be monitored to determine potential trends in accuracy of diagnoses:

A. Yes 71.9%

B. No 18.8%

C. Unsure 9.4%

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51. HR-HPV DNA results for other diagnostic categories should be monitored to determine potential trends in accuracy of diagnoses.

A. Yes 32.3%

B. No 50.8%

C. Unsure 15.4%

D. Other 1.5%



htuniso

There are 4 answers listed in the Excel Doc and only 3 in this PPT?

73. Laboratories should routinely document all available HPV test results performed over the last five years preceding histopathologic diagnoses of cervical carcinoma including laboratory site and date where each HPV test was performed.

A. Yes 69.6%

B. No 17.9%

C. Unsure 12.5%

Additional Questions - Vote


74. Laboratories should routinely document all available HPV test results performed over the last five years preceding histopathologic diagnoses of cervical carcinoma including specific HPV test and platform, including FDA approved versus laboratory developed test

A. Yes 80.1%

B. No 9.6%

C. Unsure 9.6%



75. Is it appropriate for a lab to order a HR-HPV test as a diagnostic test independent of the clinician?

A. Yes 6%

B. No 84%

C. Unsure 10%



Documents

Cap.org v. 1 Gynecologic Consensus Conference Topic Group V: Monitoring of HPV Rates June 4, 2011