Draft Research Plan
Draft Research Plan for Bacterial Vaginosis in Pregnant Women to Prevent Preterm Delivery: Screening
This opportunity for public comment expires on March 21, 2018 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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Draft: Proposed Key Questions to Be Systematically Reviewed
- Does screening for bacterial vaginosis in asymptomatic pregnant women reduce preterm delivery and related morbidity and mortality?
- Does the effect of screening vary by baseline risk (e.g., low- vs. high-risk) for preterm delivery?
- Does the effect of screening vary by race/ethnicity?
- Does the effect of screening vary by age?
- What is the diagnostic accuracy of tests used to screen for bacterial vaginosis?
- Does diagnostic accuracy vary based on pregnancy status?
- What are the harms of screening for bacterial vaginosis in asymptomatic pregnant women?
- Does treatment of bacterial vaginosis during pregnancy reduce preterm delivery and related morbidity and mortality?
- Does the effect of treatment vary by baseline risk (e.g., low- vs. high-risk) for preterm delivery?
- Does the effect of treatment vary by race/ethnicity?
- Does the effect of treatment vary by age?
- Does the effect of treatment vary for women who are asymptomatic and diagnosed based on screening?
- What are the harms of treatment of bacterial vaginosis in pregnant women?
Draft: Proposed Contextual Questions
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the association between bacterial vaginosis and preterm delivery?
- What is the association between bacterial vaginosis and other known risks for preterm delivery?
- What is the uptake or use of various diagnostic tests for bacterial vaginosis in clinical practice?
- What are the adverse drug events related to oral or topical metronidazole or clindamycin when used to treat bacterial vaginosis in nonpregnant women?
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).
|Population||KQs 1, 3: Asymptomatic pregnant women and adolescents; studies that include mixed populations of symptomatic and asymptomatic participants will be included if the results for asymptomatic participants are reported separately or if less than 20% of the study population is characterized as symptomatic for bacterial vaginosis
KQ 2: Reproductive-age women and adolescents, including pregnant or nonpregnant study participants
KQs 4, 5: Pregnant women and adolescents with diagnosed bacterial vaginosis
|KQs 1, 3, 4, 5: Nonpregnant women and adolescents
KQs 1, 3: Women and adolescents with symptomatic bacterial vaginosis
All KQs: Women and adolescents living with HIV infection
Treatment interventions (oral or vaginal):
|Comparison||Screening reference standards:
|Outcomes||KQs 1, 4:
KQ 2: Sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, normalized frequency (e.g., x of y tests are true positives or false positives)
KQ 3: Anxiety, distress
|KQs 1, 2, 4: Outcomes not specifically listed as included|
|Timing||Intervention timing: Treatment provided after diagnosis
KQs 1, 3, 4, 5: Outcomes measured during current pregnancy at any point after screening or treatment, up to 30 days postdelivery; for outcomes related to harms of fetal exposure, outcomes measured at any time point will be included
KQ 2: Screening test and reference standard assessed at same encounter
KQs 1, 3, 4, 5: Outcomes not measured during current pregnancy or within 30 days of delivery, except for harms related to fetal exposure
KQ 2: Screening test and reference standard not assessed at same encounter
||Studies conducted in countries not categorized as “very high” on the Human Development Index|
|Study design||KQs 1, 4: RCTs, controlled trials, or systematic reviews of RCTs or controlled trials that use study selection criteria similar to this review†
KQ 2: Diagnostic test accuracy studies using cross-sectional designs or systematic reviews of diagnostic test accuracy that use study selection criteria similar to this review†
KQs 3, 5: RCTs, controlled trials, cohort studies, case-control studies, or systematic reviews that use study selection criteria similar to this review†
|Editorials, narrative reviews, letters to the editor, and study designs not listed as specifically included (e.g., case reports, case series, studies without a comparison group); publications not reporting original research|
|Language||English language||Languages other than English|
|Study quality||Good- and fair-quality studies (i.e., studies with low risk of bias or studies for which risk of bias cannot be determined)||Poor-quality studies (i.e., studies with high risk of bias) will be excluded from the main analyses but will be synthesized in sensitivity analyses|
* Other diagnostic tests will be included if the following criteria are met: 1) test is feasible for use in primary care settings, 2) test is evaluated in a separate cohort from the one in which the test was initially developed and validated, and 3) test is evaluated with a priori defined test thresholds.
† Only the most recent systematic review will be included if there are multiple reviews from the same group of investigators using the same review protocol. When there are several systematic reviews on the same topic and similar included primary studies, the review with a low risk of bias and the latest cutoff date for the literature search will be selected.
Abbreviations: FDA=U.S. Food and Drug Administration; RCT=randomized, controlled trial.
Internet Citation: Draft Research Plan: Bacterial Vaginosis in Pregnant Women to Prevent Preterm Delivery: Screening. U.S. Preventive Services Task Force. February 2018.