Final Research Plan
Syphilis Infection in Pregnant Women: Screening
August 31, 2017
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.
The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from June 8 to July 5, 2017.
Figure 1 is the analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how screening for syphilis infection in asymptomatic pregnant women may result in improved health outcomes, including decreased vertical transmission of syphilis and reduced maternal and infant morbidity and mortality (Key Question 1). Additionally, the figure illustrates whether screening for syphilis infection in pregnant women is associated with any harms (Key Question 2). The figure also shows whether treatment to prevent vertical transmission of syphilis is associated with any harms (Key Question 3).
- Does screening for syphilis in pregnant women reduce the prevalence of congenital syphilis in newborns?
- What are the harms of screening for syphilis in pregnant women?
- What are the harms of treatment of syphilis with penicillin during pregnancy to pregnant women or newborns?
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 (KQs). The Reaffirmation Evidence Update for this topic will be conducted using rapid synthesis procedures, as described in Section 4.7 of the USPSTF Procedure Manual.
|Populations||KQs 1, 2: Asymptomatic pregnant adolescent or adult women, at any time during pregnancy, who are not known to have syphilis infection
KQ 3: Studies of penicillin treatment in pregnant women with syphilis infection
|KQs 1, 2: Women who are known to have syphilis infection, have symptoms, or are not pregnant; studies in women living with HIV
KQ 3: Studies of penicillin treatment in nonpregnant women or men; studies of penicillin treatment for any condition other than syphilis
|Interventions||KQs 1, 2: Two-step screening for syphilis with a nontreponemal and treponemal test (traditional or reverse sequence algorithms)
KQ 3: Treatment of syphilis with penicillin started during pregnancy
|KQs 1, 2: Screening tests not currently used in U.S. primary care settings
KQ 3: Other types of treatment of syphilis; treatment of syphilis with penicillin outside of pregnancy
|Comparisons||KQ 1: No screening
KQ 2: No comparator necessary for studies on psychosocial harms; studies on screening test inaccuracy must define their criteria for false-positive and false-negative results
KQ 3: No comparator necessary
|KQ 1: Alternate screening strategy or no comparator|
|Outcomes||KQ 1: Vertical transmission of syphilis (incidence of congenital syphilis); prevalence of congenital syphilis after implementation of a screening program; stillbirth; maternal or infant morbidity and mortality
KQ 2: Harms of screening (e.g., false-positive and false-negative results, labeling, psychosocial harms)
KQ 3: Harms of treatment of syphilis with penicillin during pregnancy (e.g., allergic reaction, premature labor, Jarish-Herxheimer reaction, fetal harms)
|Cost-effectiveness or cost-related outcomes|
|Setting||Primary care and primary care–referable settings (e.g., obstetrics/gynecology clinics, prenatal clinics, ambulatory care, family planning clinics, correctional facilities, sexually transmitted infection clinics)|
|Country||Studies conducted in countries categorized as "high" or "very high" on the Human Development Index (as defined by the United Nations Development Programme)|
|Study design||KQ 1: Randomized, controlled trials; before-after and ecologic studies reporting effect of implementing a widespread screening program with historical or geographic comparator; systematic reviews and meta-analyses (of included study designs)
KQs 2, 3: Randomized, controlled trials; cohort studies; case-control studies; diagnostic accuracy studies; large case series; systematic reviews and meta-analyses (of included study designs)
|Narrative reviews, editorials, and case reports|
|Publication language||English-language only||Languages other than English|
|Study quality||Fair- or good-quality studies||Poor-quality studies|
The draft Research Plan was posted on the USPSTF Web site from June 8 to July 5, 2017. Based on the comments received, the USPSTF made no substantive changes to the KQs, and made minor revisions to the inclusion criteria for clarity. Some comments requested review of the evidence on routine vs. risk-based repeat screening at 28 weeks of gestation, as well as rapid point-of-care syphilis tests. The USPSTF will review any identified evidence about rescreening intervals and point-of-care testing in U.S. primary care settings. Additional comments on data extraction and analysis, contextual issues, and discussion points did not necessitate changes to the Research Plan but will be considered in the preparation of the systematic review.