Final Research Plan
Cervical Cancer: Screening
March 17, 2022
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
- What is the comparative effectiveness of different cervical cancer screening strategies (i.e., test, mode of collection, and interval of testing) on precancer detection, cancer incidence, morbidity, or mortality?
- Does the comparative effectiveness vary by population (e.g., by age, gender, race and ethnicity, or human papillomavirus [HPV] vaccination status)?
- What is the test accuracy of and adherence to self-collected high-risk HPV vaginal samples?
- Does the test accuracy or adherence vary by population (e.g., by age, gender, race and ethnicity, or HPV vaccination status)?
- What are the comparative harms of different cervical cancer screening strategies (i.e., test, mode of collection, and interval of testing)?
- Do the comparative harms vary by population (e.g., by age, gender, race and ethnicity, or HPV vaccination status)?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the comparative test accuracy of high-risk HPV tests used in U.S.-based clinical practice?
- Can extended genotyping and other triage technologies (e.g., DNA methylation testing and immunostaining for p16/Ki67) for abnormal high-risk HPV or cytology screening results reduce burden of testing and diagnostic procedures?
- What are the social risk factors (e.g., race, racism, socioeconomic status, insurance status, or geography) or other risk factors (e.g., history of sexual trauma, smoking, or vaccination status) that contribute to inequities in cervical cancer screening, incidence, and health outcomes?
- What are barriers and implementation considerations (e.g., for the health system, clinician, or patient) to screening and followup testing?
- Are there effective interventions or strategies to improve screening rates and followup to abnormal screening results?
The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.
|Aim||Studies targeting cervical cancer screening||Use of HPV or cytology testing for posttreatment surveillance or other purposes|
|Populations||Persons who have a cervix (any age), including persons at increased risk for cervical cancer or morbidity/mortality from cervical cancer (e.g., by race and ethnicity, income/socioeconomic status, insurance, geography, history of sexual trauma, smoking history, or HPV vaccination status)||Surveillance studies conducted exclusively in persons with HIV, with in utero exposure to diethylstilbestrol, or with previous treatment for cervical cancer or a high-grade precancerous lesion|
|Interventions||KQs 1, 3:
KQ 2: Self-collected hrHPV sample
|Non-hrHPV screening strategies|
|Comparators||KQs 1, 3: Any alternate test (including cytology only) and/or assay, mode of collection, or interval of testing
|Study designs||KQs 1, 3:
|KQs 1, 3:
KQ 2: Diagnostic test accuracy studies without a reference standard
|Setting||Primary care (e.g., internal medicine, family medicine, orobstetrics/gynecology), other settings generalizable to primary care (e.g., university-based health clinics, mobile clinics, sexually transmitted infection clinics, or family planning clinics), or any setting for self-collection of samples||
|Country||Countries with cervical cancer screening programs comparable to those of the United States and categorized as “Very High” or equivalent on the 2020 Human Development Index (as defined by the United Nations Development Programme)||Countries not categorized as “Very High” on the Human Development Index or not applicable to U.S. clinical settings or populations|
|Language||English only||Non-English publications|
|Quality||Fair- or good-quality, according to USPSTF design-specific criteria||Poor-quality, according to USPSTF design-specific criteria|
* HPV tests approved by the U.S. Food and Drug Administration include: the Hybrid Capture 2 High-Risk HPV DNA Test (Qiagen, Hilden, Germany); cobas HPV Test (Roche Molecular Systems, Inc., Pleasanton, CA); APTIMA® HPV and HPV 16, 18/45 Assays (Hologic, Inc., Madison, WI); Cervista™ HPV 16/18 and Cervista™ HR HPV (Hologic, Inc., Madison, WI); and Onclarity HPV™ (Becton Dickinson, Franklin Lakes, NJ).
Abbreviations: CIN2+=cervical intraepithelial neoplasia grade 2; CIN3+=cervical intraepithelial neoplasia grade 3; HPV=human papillomavirus; hrHPV=high-risk human papillomavirus; KQ=key question; USPSTF=U.S. Preventive Services Task Force.
The draft Research Plan was posted on the USPSTF Web site for public comment from October 28 to November 24, 2021. In response to public comment, the USPSTF included pregnant persons in the population of interest and added a contextual question addressing extended genotyping and use of biomarkers following abnormal hrHPV or cytology screening results. In addition, the USPSTF revised the contextual questions and inclusion criteria for clarity. The USPSTF made no other substantive changes that altered the scope of the review.
The USPSTF intends to commission a decision model to accompany this evidence review.