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

  • Protocol
  • Diagnostic



This is a protocol for a Cochrane Review (Diagnostic test accuracy). 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.