Gynecologic Consensus Conference
Topic Group V: Monitoring of HPV Rates
June 4, 2011
cap.org
v. 1
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
© 2011 College of American Pathologists. All rights reserved.
2
Background
• ASCCP 2006 Consensus Guidelines
o Provides revised evidence-based
consensus guidelines for managing
women with
− Abnormal cervical screening test results
− Cervical intraepithelial neoplasia (CIN) or
Adenocarcinoma in situ (AIS)
© 2011 College of American Pathologists. All rights reserved.
3
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.
© 2011 College of American Pathologists. All rights reserved.
4
ASCCP 2006 Consensus Guidelines
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
© 2011 College of American Pathologists. All rights reserved.
5
ASCCP 2006 Consensus Guidelines
• ASC-H
o
o
o
o
>65% HPV + no value of reflex HPV
No changes from 2001 consensus
“Review all material” eliminated
Management same as ASC-US +
HR-HPV+
© 2011 College of American Pathologists. All rights reserved.
6
Survey Results
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7
Original Survey Results:
HPV testing practices
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 %
© 2011 College of American Pathologists. All rights reserved.
8
Original Survey Results:
HPV testing practices
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
© 2011 College of American Pathologists. All rights reserved.
87.6%
23.4 %
7.9 %
9
Original Survey Results:
HPV testing practices
• 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 driven
Patient demands
Resolve diagnostic dilemmas
Ordered out of habit
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Online Question Results
•
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
Original Survey Results:
HPV testing practices
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%
© 2011 College of American Pathologists. All rights reserved.
12
Online Question Results
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
o
o
o
o
o
No colposcopic follow up if HPV is negative
If HPV negative, patient returns to routine testing
Useful in resolving diagnostic dilemmas with confidence
Useful in older women with negative history
Useful in pregnant women
Helps PCP decide to go to LEEP or not
© 2011 College of American Pathologists. All rights reserved.
13
Original Survey Results:
HPV testing practices
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 %
© 2011 College of American Pathologists. All rights reserved.
14
Original Survey Results:
HPV testing practices
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 %
© 2011 College of American Pathologists. All rights reserved.
15
Online Question Results
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 interpretations
o
HPV negative cases results in re-evaluations
o
HPV positive cases results in re-evaluations
• To resolve diagnostic dilemmas at any age
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16
Survey Results: Lab Volume Analysis
for HPV Testing Practices
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)
© 2011 College of American Pathologists. All rights reserved.
17
Original Survey Results:
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
© 2011 College of American Pathologists. All rights reserved.
3.3%
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Statements
Based 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
© 2011 College of American Pathologists. All rights reserved.
19
Consensus Questions
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20
Consensus Question - Vote
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%
© 2011 College of American Pathologists. All rights reserved.
21
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%
© 2011 College of American Pathologists. All rights reserved.
22
Consensus Question - Vote
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%
© 2011 College of American Pathologists. All rights reserved.
23
Original Survey Results:
HPV for Quality Assessment
• HR-HPV rates are monitored to determine
potential trends in accuracy of diagnoses:
o ASC-US reflex HR-HPV results (n=510)
−Yes
53.9%
−No
46.1%
o HPV DNA Results (n=364)
−Yes
32.7%
−No
67.3%
© 2011 College of American Pathologists. All rights reserved.
24
Original Survey Results:
HPV for Quality Assessment
• Monitoring of HPV rates (n=392; multiple
responses allowed)
Laboratory
Cytotech
Pathologist
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%
© 2011 College of American Pathologists. All rights reserved.
25
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%
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
© 2011 College of American Pathologists. All rights reserved.
26
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.
© 2011 College of American Pathologists. All rights reserved.
27
Statements
Based on Survey, Literature and Expert Consensus
• 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)
© 2011 College of American Pathologists. All rights reserved.
28
Statements
Based on Survey, Literature and Expert Consensus
• 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.
© 2011 College of American Pathologists. All rights reserved.
29
Statements
Based on Survey, Literature and Expert Consensus
• 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.
© 2011 College of American Pathologists. All rights reserved.
30
Consensus Question - Vote
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%
© 2011 College of American Pathologists. All rights reserved.
31
Consensus Question - Vote
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%
© 2011 College of American Pathologists. All rights reserved.
32
Consensus Question - Vote
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%
© 2011 College of American Pathologists. All rights reserved.
33
Additional Questions - Vote
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%
© 2011 College of American Pathologists. All rights reserved.
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%
© 2011 College of American Pathologists. All rights reserved.
Additional Questions - Vote
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%
© 2011 College of American Pathologists. All rights reserved.