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Table 2 Eligibility criteria for key question 1 (effectiveness and comparative effectiveness)

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+)

– Risk groups: immunocompromised (e.g. HIV, organ transplantation, chemotherapy or chronic use of corticosteroids, use of disease-modifying anti-rheumatic drugs or biologics); risk behaviours (e.g. early sexual debut, women who have sex with women, individuals who have multiple sexual partners, smoking); under or never screened (e.g. transgender individuals, individuals with a history of trauma or abuse); Indigenous peoples; rural populations; immigrants; race or ethnicity; low socioeconomic status; pregnant individuals; HPV-vaccinated populations

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

Intervention

Any screening strategy using hrHPV tests and/or cytology with subsequent follow-up of abnormal tests:

– Primary screening with cytology (conventional or liquid-based)

– Primary screening with hrHPV testing

– Cytology screening, which if abnormal may be followed by triage with an hrHPV test

– hrHPV screening, which if positive may be followed by triage with cytology or other hrHPV test (e.g. full genotyping)

– Other combinations will be considered

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

Urine for sample collection

Point-of-care tests

Co-testing as a strategy (although we will include relevant data for the individual strategies where suitable)

Comparator

Effectiveness:

No routine screening

Comparative effectiveness:

Any screening strategy differing by one or more of the following factors:

– Screening test strategy

– Screening interval

– Universal vs. selective/targeted (e.g. starting age)

– Method of sample collection (e.g. self-collectionb (self-collection at home vs. self-collection in clinic) vs. health provider collection)

– Protocol for evaluation of abnormal screening results (e.g. criteria for immediate colposcopy)

 

Outcomes

Critical outcomes:

– Incidence of invasive cervical cancer (squamous and adenocarcinoma)

– Incidence of cervical intraepithelial neoplasia (CIN) 2 and CIN 3c

– Cervical cancer mortality

– All-cause mortality

– Overdiagnosis of CIN 2 and CIN 3 and invasive cervical cancerc

Important outcomes:

– Number and rates of colposcopy and/or biopsy, including LEEP and other treatments provided during colposcopy (or referral rate) (for comparative effectiveness)

– Adverse pregnancy outcomes from conservative, local management of CIN

– False-positive rate for detecting CIN 2 and CIN 3 and invasive cancerc

 

Timing

No limitation on the duration of follow-up; results will be reported by screening round and longest follow-up

 

Setting

Studies from Very High Human Development Index countries

 

Study design

– Randomized controlled trials

– If insufficient data from randomized controlled trials (by comparison and outcome): non-randomized studies (controlled trials, before-after studies, interrupted time series, individual patient data meta-analysis, cohort studies, case-control studies)

Conference proceedings; government reports; systematic reviews; case reports; editorials

Language

English or French

 

Publication date

1995–present

 
  1. CIN cervical intraepithelial neoplasia, HIV human papillomavirus, LEEP loop electrosurgical excisional procedure
  2. aWe will include studies where up to 25% of the participants had a recent abnormal screening result
  3. bDifferent samples or methods of sample collection
  4. cThe ability to report and analyze findings by CIN 2, CIN 3, and invasive cervical cancer will be determined after reviewing the outcomes used in the identified studies (e.g. CIN 2+ and CIN 3+ will be considered if necessary and may be considered indirect)