PROSPERO

International prospective register of systematic reviews

Evidence for clinical application of extended hpv genotyping in cervical cancer screening
paradigms
Jeff Andrews

Citation
Jeff Andrews. Evidence for clinical application of extended hpv genotyping in cervical cancer
screening paradigms. PROSPERO 2018 CRD42018091093 Available from:
http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018091093

Review question
What is the clinical value of high-risk HPV extended genotype reporting for risk prediction in cervical cancer
screening paradigms, including cytology-based with HPV triage, primary HPV-based, and cotesting.

Searches
We will search the Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews,
PubMed, and the Health Technology Assessment database from 2000 through 2017 for relevant controlled
trials and observational studies. We will supplement by hand-searching of retrieved article reference lists.
Eligible studies include prospective studies of women and retrospective studies of residual specimens from
women that were screened or tested using human papillomavirus DNA tests.

Types of study to be included

We will include data from prospective cohort studies, clinical trials, and surveillance/registry data. We will
exclude cross-sectional, case-control studies, and case reports as it is not possible with these study designs
to measure prospective risks.

Condition or domain being studied

HPV infection, cervical intraepithelial neoplasia, and cervical cancer are the conditions being studied.

Participants/population
Women and residual specimens from women that were screened or tested using human papillomavirus DNA
tests. Ages of subjects will be greater than 21. All settings and follow-up lengths will be included.

Intervention(s), exposure(s)
The diagnostic intervention of interest is an HPV assay with extended genotype reporting.

Comparator(s)/control
There is no comparator for this analysis. We will report cumulative risks in HPV-positive women by genotype.
The risk in HPV-negative women will be reported when available.

Context
All settings.

Primary outcome(s)
Histopathologic result of greater than or equal to CIN3, expressed as cumulative incident risk, risk, positive
predictive value, or outcome.

Timing and effect measures

Cumulative risks at all reported prospective time points will be collected.

Secondary outcome(s)
Histopathologic result of greater than or equal to CIN2, expressed as cumulative incident risk, risk, positive

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International prospective register of systematic reviews

predictive value, or outcome.

Timing and effect measures

Cumulative risks at all reported prospective time points will be collected.

Data extraction (selection and coding)

A standardised form will be used to extract data from the included studies for assessment of study quality
and evidence synthesis.
Extracted information will include:
- first author, publication year, journal
- study period
- study design: prospective, retrospective, post-hoc analysis
- sample size, population, subpopulation
- study setting and population demographics, including age, screening or referral, country
- methods of HPV detection and genotyping
- HPV genotypes included
-outcomes reported (CIn2, CIN3, CIn2+, CIN3+, cancer)
-duration
- statistical approach
Missing data will be requested from study authors.

Risk of bias (quality) assessment

Risk of bias will be assessed according to the GRADE guidelines for observational studies.

Strategy for data synthesis

A quantitative synthesis will be used if the included studies are sufficiently homogenous; otherwise a
descriptive synthesis will be performed.

Analysis of subgroups or subsets

Separate analysis will be done according to each of three established screening paradigms: cytology-based,
HPV-based, cotesting. Separate analysis will be done according to age groups reported in the retrieved
articles: 21 and older, 21-25, 25 and older, 25-29, 30 and older.

Contact details for further information

Jeff Andrews, MD, FRCSC
jeffrey.andrews@bd.com

Organisational affiliation of the review

BD
www.bd.com

Review team members and their organisational affiliations

Dr Jeff Andrews. BD

Anticipated or actual start date

13 March 2018

Anticipated completion date

30 June 2018

Funding sources/sponsors
None

Conflicts of interest
The primary author is a full-time employee of BD, as Worldwide Medical Director of Women's Health and

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 PROSPERO
International prospective register of systematic reviews

Cancer

Language
English

Country
United States of America

Stage of review
Review_Ongoing

Subject index terms status

Subject indexing assigned by CRD

Subject index terms

Cervical Intraepithelial Neoplasia; Early Detection of Cancer; Female; Genotype; Humans; Papillomavirus
Infections; Uterine Cervical Neoplasms

Date of registration in PROSPERO

19 March 2018

Date of publication of this version

19 March 2018

Details of any existing review of the same topic by the same authors
Stage of review at time of this submission

Stage Started Completed

Preliminary searches Yes Yes

Piloting of the study selection process Yes Yes

Formal screening of search results against eligibility criteria Yes Yes

Data extraction Yes No

Risk of bias (quality) assessment No No

Data analysis No No

Versions
19 March 2018

PROSPERO
This information has been provided by the named contact for this review. CRD has accepted this information in good
faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration
record, any associated files or external websites.

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