Diagnostic Test Accuracy Protocol

Triage with human papillomavirus (HPV) testing versus repeat cytology for underlying high-grade cervical intra-epithelial neoplasia in women with minor cytological lesions

  1. Marc Arbyn1,*,
  2. Cindy Simoens1,
  3. Frank Buntinx2,
  4. Pierre PL Martin-Hirsch3,
  5. Evangelos Paraskevaidis4,
  6. Walter JP Prendiville5

Editorial Group: Cochrane Gynaecological Cancer Group

Published Online: 7 OCT 2009

DOI: 10.1002/14651858.CD008054

How to Cite

Arbyn M, Simoens C, Buntinx F, Martin-Hirsch PPL, Paraskevaidis E, Prendiville WJP. Triage with human papillomavirus (HPV) testing versus repeat cytology for underlying high-grade cervical intra-epithelial neoplasia in women with minor cytological lesions (Protocol). Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD008054. DOI: 10.1002/14651858.CD008054.

Author Information

  1. 1

    Scientific Institute of Public Health, Unit of Cancer Epidemiology, Brussels, Belgium

  2. 2

    Academisch Centrum voor Huisartsgeneeskunde, General Practice, KU Leuven, Belgium

  3. 3

    Royal Preston Hospital, Lancashire Teaching Hospital NHS Trust, Gynaecological Oncology Unit, Preston, Lancashire, UK

  4. 4

    Ioannina University Hospital, Department of Obstetrics and Gynaecology, Ioannina, Greece

  5. 5

    Coombe Lying-In Hospital, Department of Obstetrics and Gynaecology, Dublin 8, Ireland

*Marc Arbyn, Unit of Cancer Epidemiology, Scientific Institute of Public Health, Juliette Wytsmanstreet 14, Brussels, B-1050, Belgium. Marc.Arbyn@iph.fgov.be.

Publication History

  1. Publication Status: New
  2. Published Online: 7 OCT 2009

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Abstract

  1. Top of page
  2. Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

In this meta-analysis, the authors aim to give an answer to the following questions.

Primary objectives

For studies where both triage methods were assessed, what is the:

  1. accuracy of hrHPV testing with HC2 to find underlying CIN2+ or CIN3+?
  2. accuracy of repeat cytology to find underlying CIN2+ or CIN3+? Three different cut-offs to define a positive repeat cytology will be considered: ASCUS or worse (ASCUS+), LSIL or worse (LSIL+), and high-grade squamous intraepithelial lesions or more (HSIL+);
  3. relative sensitivity and relative specificity of HC2 triage compared to repeat cytology?

For studies where only hrHPV testing and the reference standard were applied the objective is as follows.

What is the accuracy (sensitivity and specificity) of HPV DNA testing with HC2 to detect histologically confirmed CIN2+ or CIN3+ in women with an index smear showing ASCUS (triage group I) or LSIL (triage group II)?

The following sources of heterogeneity will be investigated and included in subgroup meta-analysis or summary receiver operating characteristic curve (SROC) regression, or both:

  • different cytological classification systems used to categorise equivocal and mild cytological abnormalities, different subgroups of ASCUS and LSIL according to different cytological classification systems used to define atypically abnormal and mild to low-grade cytological cervical abnormalities;
  • characteristics of the study population (study location, study size, age distribution, first or subsequent observation of ASCUS or LSIL; continuous, random or arbitrary recruitment of study participants);
  • properties of the HPV testing (collection device, transport medium, viral load cut-off);
  • repeat cytology (collection device, preparation method (conventional or liquid-based), cytological threshold);
  • procedures of reference standard verification;
  • the blinding of interpreters for other test results.