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Table 3 Eligibility criteria for key question 2 (comparative diagnostic accuracy)

From: Screening for the prevention and early detection of cervical cancer: protocol for systematic reviews to inform Canadian recommendations

Criterion

Inclusion

Exclusion

Population

Individuals with a cervix, 15 years of age and older, who have been sexually active, and who have no symptoms of cervical cancera

Population subgroups:

– By age group (15–19, 20–24, 25–29, 30–69, 70+)

– HPV-vaccinated populations

Study population includes > 25% individuals with recent abnormal screening results

Index screening test

– Primary high-risk HPV testing with HPV nucleic acid testsb alone

– High-risk HPV testing with HPV nucleic acid tests, followed by some form of triage (e.g. cytology or HPV testing with partial genotyping for HPV 16 or 18, sequential partial genotyping for HPV 16 or 18 followed by cytology to further triage those positive for HPV 16 or 18).

Subgroups:

– Method of sample collection for high-risk HPV testing (i.e. self-collected (home vs. in clinic) vs. clinician-collected)

– Type of assay (i.e. generic, partial genotyping, full genotyping)

– HPV test threshold for a positive result (i.e. 1 pg/mL, 2 pg/mL)

HPV test using in situ hybridization, p16 immunostaining, or HPV viral load

Earlier versions of commercial tests that have been replaced (e.g. Hybrid Capture 1)

Urine for sample collection

Point-of-care tests

Comparator screening test

– Conventional or liquid-based cytology, with or without follow-up by high-risk HPV testing

– High-risk HPV testing with HPV nucleic acid tests, followed by different forms of triage than in the index test

– hrHPV testing with HPV nucleic acid tests, using a different method of sample collection (i.e. self-sampled (home vs. clinic) vs. clinician-sampled)

Visual inspection with acetic acid or visual inspection with Lugol’s iodine

Reference standards

• Colposcopy with histologic examination of tissue specimens, when indicated.

• Study protocol stipulates that reference standard is applied to:

– All patients, or

– All screening test-positive patients and a subset (e.g. random 10%) of screening test-negative patients

Reference standard only applied to screen-positive patients

Outcomes and target conditions

Diagnostic test accuracy:

Number and proportion of people positive and negative on each test (TP, FP, TN, FN), sensitivity and specificity to screen for high-grade cervical lesions (CIN 2, CIN 3, HSIL), and/or invasive cervical cancer (squamous cell carcinoma or adenocarcinoma)

 

Timing of reference standard

Reference standard test performed before any management based on the index test result

 

Setting

Studies from Very High Human Development Index countries

 

Study design

– Observational studies (e.g. prospective or retrospective cohorts, or cross-sectional studies) in which all participants receive both the index and comparator screening test, followed by verification of disease status using the reference standard in all patients or in all screening test-positive patients and a subset (e.g. random 10%) of screening test-negative patients

– Randomized controlled trials where participants are randomized to different screening tests but all receive the same reference standard

Conference proceedings; government reports; systematic reviews; case reports; case-control studies; editorials

Language

English or French

 

Publication date

1995–present

 
  1. AGC atypical glandular cells, AIS adenocarcinoma in situ, CIN cervical intraepithelial neoplasia, FN false negative, FP false positive, HPV human papillomavirus, HSIL high-grade squamous intraepithelial lesions, TN true negative, TP true positive
  2. aWe will include studies where up to 25% of the participants had a recent abnormal screening result
  3. bEligible HPV tests include generic assays, as well as partial and full genotyping assays able to detect at least some high-risk HPV genotypes (e.g. HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) and available commercially in Canada or reasonably perceived to potentially be available in Canada. Examples of eligible high-risk HPV tests include the Cobas 4800 HPV Amplification/Detection Kit (Roche Molecular Systems, Inc.), Linear Array HPV Genotyping Test (Roche), Aptima HPV assay (Hologic, Inc.), Aptima HPV 16 18/45 Genotype Assay (Hologic), Cervista HPV HR assay (Hologic), Abbott RealTime High-Risk HPV (Abbott Molecular), Digene DML-2000 HPV Test Hybrid Capture 2 (Qiagen Sciences LLC), and Xpert HPV test (Cepheid)