Final Research Plan
Perinatal Depression: Preventive Interventions
August 11, 2016
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 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.
The draft Research Plan was available for comment from May 19 until June 16, 2016 at 5:00 p.m., ET.
Abbreviation: HrQoL = health-related quality of life.
Figure 1 is the analytic framework that depicts the two Key Questions to be addressed in the systematic review. The figure illustrates how interventions to prevent perinatal depression may result in improved health outcomes for both the mother and infant/child, including decreased incidence of perinatal depression and symptoms; improved quality of life and functioning; improved health, physical, and psychosocial development; and decreased mortality, neglect, and abuse (KQ 1). Additionally, the figure depicts whether interventions to prevent perinatal depression are associated with any harms (KQ 2).
- Do interventions to prevent perinatal depression improve health outcomes in pregnant or postpartum women or their children?
- In trials that limit enrollment to high-risk women, how are participants identified as being at high risk of developing perinatal depression?
- What harms are associated with interventions to prevent perinatal depression in pregnant or postpartum women?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Are there reliable and valid prognostic tools for identifying women who are at high risk of developing perinatal depression?
- When is the most effective time to provide interventions to prevent perinatal depression?
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).
|Aim/Objective||Studies on counseling or pharmacologic interventions to prevent perinatal depression||Studies restricted to screening for and treatment of depression during pregnancy or in the postpartum period|
Studies in mixed populations that include >50% of any of the above populations will be excluded
|Interventions||Counseling and pharmacologic interventions to reduce the risk of perinatal depression initiated during pregnancy or the first year postpartum, including:
||Active intervention (i.e., comparative effectiveness)|
|Outcomes||KQ 1: Maternal health outcomes:
Infant/child health outcomes (for newborn infant or other children in the family):
|KQ 1: Maternal behavioral outcomes (e.g., increase in physical activity)|
|Timing of Outcome Assessment||KQ 1: ≥6 weeks after baseline assessment or intervention initiation
KQ 2: Any time after the intervention is initiated
|KQ 1: <6 weeks after baseline assessment or intervention initiation|
|Study Designs||KQ 1: Randomized, controlled trials; controlled clinical trials
KQ 2: Systematic reviews; meta-analyses; randomized, controlled trials; controlled clinical trials; and large comparative cohort studies (for harms of antidepressant use only)
|All other study designs (e.g., case report, case series)|
|Countries||Countries categorized as “Very High” 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|
|Languages||English||Languages other than English|
|Quality||Fair or good, according to design-specific USPSTF criteria||Poor, according to design-specific USPSTF criteria|
The draft Research Plan was posted on the USPSTF Web site from May 19, 2016 to June 15, 2016. In response to public comments, the USPSTF expanded the scope of the review to include prevention of depression onset during pregnancy as well as the postnatal period, thus changing the focus from postpartum to perinatal depression prevention. In addition, the USPSTF expanded the allowable time window for intervention initiation and outcomes assessment and added more intervention modalities. Additional comments were addressed through clarification of the text.