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Draft Research Plan

Draft Research Plan for Syphilis Infection in Pregnant Women: Screening

This opportunity for public comment expired on July 5, 2017 at 8:00 PM EST

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 Review will form the basis of the USPSTF Recommendation Statement on this topic.

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.

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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

Text Description

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).

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. Does screening for syphilis in pregnant women reduce the prevalence of congenital syphilis in newborns?
  2. What are the harms of screening for syphilis in pregnant women?
  3. What are the harms of treatment of syphilis with penicillin during pregnancy to pregnant women or newborns?

Draft: 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 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 (available at

  Included Excluded
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 (for whom syphilis testing is considered disease management rather than a screening intervention)

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

KQ 3: Treatment of syphilis with penicillin initiated 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 not initiated during pregnancy

Comparisons KQ 1: No screening

KQ 2: No comparator necessary for studies on psychosocial harms; studies on screening test accuracy reporting on false-positive and false-negative results must include a reference standard (e.g., a treponemal test)

KQ 3: No comparator necessary
KQ 1: Alternate screening strategy or no comparator
Outcomes KQ 1: Vertical transmission of syphilis; prevalence of congenital syphilis after implementation of a screening program; 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, fetal harms)
Cost-effectiveness or cost-related outcomes
Setting Primary care and primary care–referable settings (e.g., obstetrics/gynecology 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
Language English-language only Languages other than English
Study quality Fair- or good-quality studies Poor-quality studies
Current as of: June 2017

Internet Citation: Draft Research Plan: Syphilis Infection in Pregnant Women: Screening. U.S. Preventive Services Task Force. June 2017.

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