Final Research Plan

Breastfeeding: Primary Care Interventions

December 18, 2014

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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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 October 9 until November 5, 2014 at 5:00 p.m., ET.

Text Description is shown below.

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 prenatal, peripartum, and postpartum individual- and health system-level interventions to promote and support breastfeeding may result in improved child and maternal health outcomes (KQ1). Additionally, the figure illustrates how interventions to promote and support breastfeeding may have an impact on the initiation, duration, and exclusivity of breastfeeding (KQ2). Further, the figure depicts whether interventions to promote and support breastfeeding are associated with any adverse events (KQ3).

  1. What are the effects of prenatal, peripartum, and postpartum individual- and health care system–level interventions to promote and support breastfeeding on short- and long-term child and maternal health outcomes?
    1. Does the effectiveness of breastfeeding interventions differ by the population subgroups based on age, race/ethnicity, and socioeconomic status?
    2. Are there intervention characteristics that influence the effectiveness of breastfeeding interventions?
  2. What are the effects of prenatal, peripartum, and postpartum individual- and health care system–level interventions to promote and support breastfeeding on initiation, duration, and exclusivity of breastfeeding?
    1. Does the effectiveness of breastfeeding interventions differ by the population subgroups based on age, race/ethnicity, and socioeconomic status?
    2. Are there intervention characteristics that influence the effectiveness of breastfeeding interventions?
  3. Are there adverse events associated with interventions to promote and support breastfeeding?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What are the effects of breastfeeding on short- and long-term health outcomes in children and mothers?
  2. What are the effects of consuming expressed or donated breast milk on short- and long-term health outcomes in children?

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).

  Include Exclude
Study design
  • Randomized, controlled trials; clustered randomized, controlled trials
  • Controlled before-and-after studies and prospective cohort studies of hospital policies and health system interventions (e.g., the Baby-Friendly Hospital Initiative*, provider training)
  • Systematic evidence reviews
  • Observational studies (except studies of hospital policies)
  • Abstracts, editorials, or theses
Study aim Studies targeting the effects of prenatal, peripartum, and postpartum breastfeeding interventions on child and maternal health outcomes and/or initiation, duration, and exclusivity of breastfeeding Studies with breastfeeding as a secondary outcome, in which the intervention was not specifically targeted at breastfeeding (e.g., studies on increasing the frequency of prenatal visits)
Condition Breastfeeding (including baby to breast, bottle feeding mother’s expressed breast milk, and bottle feeding donated breast milk) Studies with a focus on other forms of infant nutrition (e.g., formula)
Population
  • Early-term (37 0/7 to 38 6/7 weeks), full-term (39 0/7 to 40 6/7 weeks), late-term (41 0/7 to 41 6/7 weeks), and post-term (42 0/7 weeks and beyond) newborns, as well as late-preterm newborns with gestational age ≥34 0/7 weeks or birth weight >2,500 g
  • Members of mother-child support system (e.g., partners, grandparents, or friends)
  • Mothers of preterm or very preterm newborns (<34 weeks of gestation or low or very low birth weight [<2,500 g]), because of their special feeding needs
  • Studies limited to special populations of women or infants (e.g., institutionalized women, infants with prenatal disease, infants born to drug-using mothers, infants in a neonatal intensive care unit, infants born to HIV-positive mothers)
Interventions
  • Intervention must be initiated in, conducted in, or referable from primary care (e.g., primary care referral of mother-infant pair or family to service, support provided in hospital setting at time of delivery or postpartum, primary care collaboration with community services)
  • Type of interventions may include, but are not limited to: individual or group counseling, peer counseling, home visits, structured education, technology- or computer-based support, distribution of written materials, rooming in, restricted pacifier use, or skin-to-skin contact
  • Interventions may take place during the prenatal and/or postnatal period
  • Stand-alone or multicomponent/multidimensional interventions
  • Interventions may be conducted by, but are not limited to: lactation care providers, nurses/nurse practitioners, peer counselors, midwives, doulas, or physicians
  • Health care system interventions (e.g., staff training) and hospital policies, such as full or partial implementation of the Baby-Friendly Hospital Initiative*
  • Mass media campaigns
  • Worksite lactation programs
  • Community interventions not affiliated with primary care
Setting
  • Any setting linked with the health care system and provision of primary care (e.g., hospital, maternity services, home, clinic, or community)
  • Studies conducted in countries categorized as “Very High” on the 2014 Human Development Index (as defined by the United Nations Development Programme)
  • Correctional facilities
  • Worksites
  • Inpatient/residential facilities
  • Studies conducted in countries that are not categorized as “Very High” on the 2014 Human Development Index
Comparators
  • Usual prenatal, peripartum, and/or postpartum care, as defined within each study
  • Another breastfeeding intervention (i.e., comparative effectiveness)
  • Wait list control
  • No attention control
  
Outcomes

KQ 1: Maternal health outcomes associated with breastfeeding intervention (e.g., cessation of menses); child health outcomes associated with breastfeeding intervention (e.g., gastrointestinal symptoms, atopic dermatitis, respiratory symptoms, otitis media, asthma, obesity)

KQ 2: Breastfeeding initiation, duration, or exclusivity, as defined within each study

KQ 3: Adverse events associated with breastfeeding intervention (e.g., feeling criticized by interventionist, guilt related to not breastfeeding, increased anxiety about breastfeeding, postpartum depression, infant failure to thrive)

  
Language English Languages other than English
Quality Fair or good Poor (according to design-specific USPSTF criteria)

* The “Ten Steps to Successful Breastfeeding,” as designated by the Baby-Friendly Hospital Initiative, are: 1) maintain a written breastfeeding policy that is routinely communicated to all health care staff; 2) train all health care staff in skills necessary to implement this policy; 3) inform all pregnant women about the benefits and management of breastfeeding; 4) help mothers initiate breastfeeding within 1 hour of birth; 5) show mothers how to breastfeed and how to maintain lactation, even if they are separated from their infants; 6) give infants no food or drink other than breast milk, unless medically indicated; 7) practice “rooming in” (allowing mothers and infants to remain together 24 hours a day); 8) encourage breastfeeding on demand; 9) give no pacifiers or artificial nipples to breastfeeding infants; and 10) foster the establishment of breastfeeding support groups and refer mothers to them upon discharge from the hospital or clinic.

The draft Research Plan was posted for public comment on the USPSTF Web site from October 9 through November 5, 2014. The majority of comments, while informative, pertained to details and considerations for background information and data abstraction and analysis. There were no changes made to the research plan that changed the scope of the review or the approach to synthesizing the evidence. Minor clarifying text was added.