Screening for Syphilis Infection in Nonpregnant Adolescents and Adults
Note: This is a draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF.
The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report will form the basis of the USPSTF Recommendation Statement on this topic.
This draft Research Plan is available for comment from June 26 to July 23, 2014, at 5:00 p.m., ET. You may wish to read the entire Research Plan before you comment.
I. Proposed Analytic Framework
II. Proposed Key Questions to Be Systematically Reviewed
- What is the effectiveness of screening for syphilis infection in asymptomatic, nonpregnant, sexually active adolescents and adults to reduce complications of syphilis and transmission or acquisition of sexually transmitted infections (including the effectiveness of specific screening intervals and screening in population subgroups)?
- What is the effectiveness of risk assessment instruments or other risk stratification methods to identify individuals at increased risk for syphilis infection?
- What is the accuracy of currently used screening tests and testing strategies (e.g., sequence of tests) to detect syphilis infection?
- What are the harms of screening (e.g., labeling and false-positive and false-negative results)?
III. Proposed Contextual Question
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Which subgroups, including men who have sex with men, are at highest risk for incident syphilis infection? Which groups are at highest risk for morbidity and mortality due to syphilis infection?
IV. Proposed Research Approach
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 Report. Criteria are overarching as well as specific to each of the key questions (KQs).
|Disease definition||Positive result for syphilis on any test modality|
|Populations||Asymptomatic, nonpregnant adolescents and adults, including patients coinfected with other STIs (including HIV)||Symptomatic patients; children; pregnant women; studies of HIV patients for whom syphilis testing is a disease management intervention rather than a screening intervention|
|Interventions||KQs 1, 4: Screening effectiveness, including effectiveness of different screening intervals
KQ 2: Risk assessment instruments and other risk stratification methods that identify individuals at increased risk for syphilis infection
KQ 3: FDA-cleared tests available in the U.S. that detect syphilis in biological specimens, including varying testing strategies (e.g., traditional, reverse sequence)
|Comparators||KQ 1, 4: No screening or alternate screening strategy or methods
KQ 2: True disease status
KQ 3: Gold standard
|Outcomes||KQ 1: Reduction in complications of syphilis (e.g., neurosyphilis), disease transmission, other clinical outcomes, and rates of infection and other similar measures of infection
KQ 2: Detection of infection
KQ 3: Diagnostic accuracy
KQ 4: Harms from screening (e.g., labeling and false-negative and false-positive results and their harms, including psychosocial harms)
|KQ 1: Outcomes that are not directly related to health outcomes (e.g., laboratory studies)
KQ 4: Harms related to true positive and true negative tests, including psychosocial harms
|Settings||Primary care settings and primary care–referable settings (e.g., correctional settings and community care, such as schools and STI clinics)|
|Study designs||Good-quality systematic reviews
Benefits (KQs 1, 2, 3): RCTs; observational studies with comparison groups, including ecological studies
Harms (KQ 4): RCTs; observational studies, including cross-sectional studies and ecological studies
|Benefits (KQs 1, 2, 3): Observational studies without comparison groups; case reports
Harms (KQ 4): Case studies
Abbreviations: FDA = U.S. Food and Drug Administration; HIV = human immunodeficiency virus; RCT = randomized, controlled trial; STI = sexually transmitted infection; U.S. = United States.
AHRQ Publication No. 14-05213-EF-5
Current as of June 2014
U.S. Preventive Services Task Force. Screening for Syphilis Infection in Nonpregnant Adolescents and Adults: Draft Research Plan. AHRQ Publication No. 14-05213-EF-5. http://www.uspreventiveservicestaskforce.org/draftresplan.htm