Draft Research Plan
Cervical Cancer: Screening
October 28, 2021
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] immunization 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 immunization 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 immunization 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?
- How do different levels of racism and other factors contribute to inequities in cervical cancer incidence and health outcomes? (For example, the increased incidence and mortality from cervical cancer among Black and Latinx populations.)
- Are there effective interventions that could redress existing inequities in morbidity and mortality from cervical cancer, such as strategies to improve screening rates and followup to abnormal screening results?
The proposed 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||
|Interventions||KQs 1, 3:
|Non-hrHPV screening strategies|
|Comparators||KQs 1, 3: Any alternate test, assay or both; mode of collection or interval of testing
|Study Designs||KQs 1, 3:
|KQs 1, 3:
|Setting||Primary care (e.g., internal medicine, family medicine, obstetrics/gynecology) other settings generalizable to primary care (e.g., university-based health clinics, mobile clinics, sexually transmitted infection clinics, 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 2014 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).
The USPSTF intends to commission a decision model to accompany this evidence review.