Validity Parameters of the Human Papillomavirus Detection Test Hybrid Capture 2 With and Without Cytology After Laser Destruction and Large Loop Excision of the Transformation Zone Treatment of High-Grade Cervical Intraepithelial Neoplasia Lesions

Objective For the 2019 ASCCP Risk-Based Management Consensus Guidelines, we conducted a systematic review of diagnostic assays for postcolposcopy and posttreatment management. Materials and Methods A literature search was conducted to identify articles reporting on tests/assays for cervical cancer screening, triage, postcolposcopy surveillance, and posttreatment surveillance published between 2012 and 2019 in PubMed and Embase. Titles and abstracts were evaluated by co-authors for inclusion. Included articles underwent full-text review, data abstraction, and quality assessment. Pooled absolute pretest and posttest risk estimates were calculated for studies evaluating management of patients after treatment. Results A total of 2,862 articles were identified through the search. Of 50 articles on postcolposcopy, 5 were included for data abstraction. Of 66 articles on posttreatment, 23 were included for data abstraction and were summarized in the meta-analysis. The pooled posttreatment risk of cervical intraepithelial neoplasia (CIN) 2+ in all studies was 4.8% (95% CI = 3.4%–6.8%), ranging from 0.4%–19.5% (τ2 = 0.57) in individual studies. Among individuals testing negative for human papillomavirus (HPV) posttreatment, the risk of CIN 2+ was 0.69% (95% CI = 0.3%–1.5%); among individuals testing positive for HPV posttreatment, the risk of CIN 2+ was 18.3% (95% CI = 12.1%–26.6%) in all studies. All risk estimates were substantially higher for liquid-based cytology. The HPV–cytology co-testing provided slightly better reassurance compared with HPV alone at the cost of much higher positivity. Conclusions Despite a large number of published studies on postcolposcopy and posttreatment surveillance, only few met criteria for abstraction and were included in the meta-analysis. More high-quality studies are needed to evaluate assays and approaches that can improve management of patients with abnormal screening.

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A Systematic Review of Tests for Postcolposcopy and Posttreatment Surveillance

Clarke

Unger²,

Nelson

et al. 2020

J Low Genit Tract Dis

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Reporting and Assessing the Quality of Diagnostic Accuracy Studies for Cervical Cancer Screening and Management

Clarke

Darragh

Nelson

et al. 2020

J Low Genit Tract Dis

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Objective We adapted the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool for studies of cervical cancer screening and management and used the adapted tool to evaluate the quality of studies included in a systematic review supporting the 2019 Risk-Based Management Consensus Guidelines. Methods We evaluated the quality of all studies included in our systematic review for postcolposcopy (n = 5) and posttreatment (n = 23) surveillance using QUADAS-2 criteria. Subsequently, we adapted signaling questions to indications of cervical cancer screening and management. An iterative process was carried out to evaluate interrater agreement between 2 study authors (M.A.C. and N.W.). Discrepant ratings were discussed, and criteria were adapted accordingly. We also evaluated the influence of study quality on risk estimates and between study variation using stratified subgroup meta-analyses. Results Twelve signaling questions for bias assessment that were adapted to or newly developed for cervical cancer screening and management are described here. Interrater agreement on bias assessment increased from 70% to 83% during the adaptation process. Detailed assessment of bias and applicability showed that all studies on postcolposcopy management and 90% of studies on posttreatment management had high risk of bias in at least 1 domain. Most commonly, high risk of bias was observed for the patient selection domain, indicating the heterogeneity of study designs and clinical practice in reported studies. Conclusions The adapted QUADAS-2 will have broad application for researchers, evidence evaluators, and journals who are interested in designing, conducting, evaluating, and publishing studies for cervical cancer screening and management.

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Validity Parameters of the Human Papillomavirus Detection Test Hybrid Capture 2 With and Without Cytology After Laser Destruction and Large Loop Excision of the Transformation Zone Treatment of High-Grade Cervical Intraepithelial Neoplasia Lesions

Abstract: In this test of cure study, combined testing of cytology with HC2 resulted in a high sensitivity and NPV. Hybrid Capture 2 and cytology-negative women may safely return to routine recall. Cytology alone is not an adequate follow-up strategy in postlaser patients.

Cited by 2 publications

References 22 publications

A Systematic Review of Tests for Postcolposcopy and Posttreatment Surveillance

A Systematic Review of Tests for Postcolposcopy and Posttreatment Surveillance

Reporting and Assessing the Quality of Diagnostic Accuracy Studies for Cervical Cancer Screening and Management

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