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| Systematic review of breastfeeding programs and policies, breastfeeding uptake, and maternal health outcomes in developed countries | |
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| Investigator (PI): | Grodensky, Catherine; Feltner, Cindy; Weber, Rachel; Viswanathan, Meera; Stuebe, Alison; Bann, Carla; Orr, Colin; Jonas, Dan; Woodell, Carol; Jackson, Catherine; Voisin, Christiane; Barrell, Sharon; Monroe, Loraine |
| Performing Organization (PO): |
(Current): RTI International, RTI-UNC Evidence-based Practice Center / (919) 541-6000 |
| Supporting Agency (SA): | Agency for Healthcare Research and Quality (AHRQ) || Centers for Disease Control and Prevention (CDC) || United States Department of Health and Human Services (DHHS), Office of the Assistant Secretary for Health (OASH), Office on Women's Health |
| Initial Year: | 2016 |
| Final Year: | 2017 |
| Record Source/Award ID: | HSR/HHSA290201500011I_HSA29032008T ; PROSPERO/CRD42017079125 |
| Award Type: | Contract |
| Abstract: | Review questions: Key question (KQ) 1a: What are the effectiveness and harms of programs and policies on initiation, duration, and exclusivity of breastfeeding? KQ 1b: To what extent do the effectiveness and harms of programs and policies on initiation, duration, and exclusivity of breastfeeding differ for subpopulations of women defined by sociodemographic factors (e.g., age, race, ethnicity, socioeconomic status)? KQ 1c: To what extent do intervention-related characteristics (e.g., type of breast pump provided--manual or electric; delivery personnel) influence the initiation, duration, and exclusivity of breast feeding? KQ 2a: What are the comparative benefits and harms for maternal health outcomes among women who breastfeed for different intensities and durations? KQ 2b: To what extent do benefits and harms for maternal health outcomes differ for subpopulations of women defined by age, race, ethnicity, and comorbidity? Searches: To identify relevant published literature, we will search the following databases: PubMed/MEDLINE, the Cochrane Library, CINAHL and trial registries. We will conduct two separate search strategies, one for KQ1 and a second for KQ2. The preliminary search strategies formatted for MEDLINE are shown in the appendix and are comprised of medical subject heading (MeSH) terms and natural language terms reflective of breastfeeding interventions and outcomes of interest. The search strategy will be adapted for the other databases as needed. An experienced librarian familiar with systematic reviews will design and conduct all searches in consultation with the review team. We will ask the Technical Expert Panel for feedback on the search terms and strategy. For KQ 1, our literature searches will include articles published since 1980 to ensure that evidence is applicable to current breastfeeding policies and practices. For KQ 2, our literature searches will include articles published after November 1, 2005 (6 months prior to the date of the 2007 AHRQ review searches); we will also check reference lists of the included studies and systematic reviews to confirm that earlier studies were not missed. The literature search will be updated concurrent with the peer review process. We will search the "gray literature" for unpublished studies relevant to this review and will include studies that meet all the inclusion criteria and contain enough methodological information to assess risk of bias. Types of study to be included are, for KQ 1: RCTs; CCTs; prospective cohort studies with concurrent control groups; systematic reviews; for studies assessing policy or system-level interventions, pre-post studies with repeated outcome measures before and after the intervention are also eligible; and, for KQ 2: RCTs; CCTs; cohort studies; case-control studies; systematic reviews. Conditions or domains being studied are, for KQ 1: rates of breastfeeding initiation, duration, and exclusivity of breastfeeding; harms of interventions (e.g., guilt about not breastfeeding, workplace discrimination, and other reported harms); and for KQ 2: postpartum depression (any measure), postpartum weight change, breast cancer, ovarian cancer, osteoporotic fracture, type 2 diabetes, hypertension, cardiovascular outcomes (e.g., stroke, myocardial infarction, cardiovascular disease specific mortality, and composite outcomes). Participants/population are childbearing women and adolescents; we will also search for evidence on subgroups of women defined by age, race, ethnicity, comorbidity, and socioeconomic status (including insurance status and payer type). Intervention(s), exposure(s) are (KQ 1) community, workplace, and health care system-based interventions aimed at promoting and supporting breastfeeding, including the following: health plan benefits; state and federal policies or programs (e.g., WIC programs); workplace and school-based programs; BFHI implementation, including full or partial implementation (defined as three or more steps). We are excluding interventions delivered in primary care settings as part of pre- or postnatal care, and interventions specific to NICU care; and (KQ 2) exposure to breastfeeding. Comparator(s)/control are (KQ 1) no intervention (or usual practice); comparisons of two interventions that differ in content or intensity; and (KQ 2) no breastfeeding; shorter duration (e.g., breastfeeding for 1 month vs. 12 months) and/or less intensive breastfeeding (e.g., exclusive breastfeeding vs. mixed feeding or formula feeding). Primary outcome(s): Primary outcomes are (KQ 1) rates of breastfeeding initiation, duration, and exclusivity of breastfeeding; harms of interventions (e.g., guilt about not breastfeeding, workplace discrimination, and other reported harms); and (KQ 2) postpartum depression (any measure), postpartum weight change, breast cancer, ovarian cancer, osteoporotic fracture, type 2 diabetes, hypertension, cardiovascular outcomes (e.g., stroke, myocardial infarction, cardiovascular disease specific mortality, and composite outcomes). Secondary outcome(s): None. Data extraction (selection and coding): Two members of the research team will independently review all titles and abstracts (identified through searches) for eligibility against our inclusion and exclusion criteria. We will retrieve any publications marked for inclusion by either reviewer for evaluation of the full text. For titles and abstracts that lack adequate information to determine inclusion or exclusion, we will retrieve the full text for review. Then, two investigators will independently review the full texts to determine final inclusion or exclusion. The reviewers will resolve any disagreements by discussion and consensus or by consulting a third member of the review team. All results in both review stages will be tracked in an EndNote database. We will record the principal reason that each excluded full-text publication does not satisfy the eligibility criteria. For studies that meet our inclusion criteria, we will design and use structured data extraction forms to gather pertinent information from each article, including characteristics of study populations, settings, interventions, comparators, study designs, methods, and results. One investigator will extract the relevant data from each included article; all data abstractions will be reviewed for completeness and accuracy by a second member of the team. We will record intention-to-treat results if available. For KQ2, we will abstract results relevant to the association between breastfeeding and health outcomes that are adjusted for potential confounders rather than unadjusted results (when both are provided). All data abstraction will be performed using Microsoft Excel[R] software. Risk of bias (quality) assessment: To assess the risk of bias (i.e., internal validity) of individual studies, we adapted existing tools (ROBINS-I for observational studies, and the Cochrane tool for trials) and used predefined criteria based on the AHRQ Methods Guide for Comparative Effectiveness Reviews. These criteria included questions to assess selection bias, confounding, performance bias, detection bias, and attrition bias; concepts covered include those about adequacy of randomization, similarity of groups at baseline, masking, attrition, whether intention-to-treat analysis was used, method of handling missing data, validity and reliability of outcome measures, and treatment fidelity. In general terms, results from a low risk of bias study are considered to be valid. A study with medium risk of bias is susceptible to some risk of bias, but probably not enough to invalidate its results. A study assessed as high risk of bias has significant risk of bias (e.g., stemming from serious errors in design, conduct, or analysis) that may invalidate its results. To look for evidence of publication bias, we will look for unpublished literature in clinicaltrials.gov. We will evaluate the risk of bias from selection, confounding, measurement of exposure, missing data, measurement of outcomes, and reporting. Based on multiple signaling questions, we will rate the risk of bias for each domain as high, some concerns, or low, and provide justification for the rating. Studies with a high risk of bias in any domain will receive an overall high risk of bias rating. Studies with one or more domains with some concerns will receive an overall rating of medium risk of bias. Studies with low risk of bias in all domains will receive an overall low risk of bias rating. We will describe the results of all included studies regardless of the risk of bias rating. Risk of bias for individual studies influence the aggregate risk of bias rating for the overall strength of evidence for each outcome. Two independent reviewers will assess risk of bias for each study. Disagreements between the two reviewers will be resolved by discussion and consensus or by consulting a third member of the team. For both KQs, we will capitalize on the availability of existing systematic reviews and meta-analyses; these will be captured in our database searches and identified during the literature review. We will assess each potentially relevant review identified during our database searches for relevance. For reviews determined to be relevant, we will rate the risk of bias as low, unclear, or high using the ROBIS tool. Strategy for data synthesis: We will summarize all included studies in narrative form and in summary tables that tabulate the important features of the study populations, design, intervention, outcomes, and results for KQ 1 and KQ 2. KQ 2 is a partial update of the 2007 AHRQ review by Ip and colleagues (Ip S, Chung M, Raman G, Chew P, Magula N, DeVine D, Trikalinos T, Lau J. Breastfeeding and maternal and infant health outcomes in developed countries. Evid Rep Technol Assess (Full Rep). 2007 Apr;(153):1-186); we will synthesize evidence from that review with newly identified evidence and will not report results from that review separately from the body of literature published since. As noted above, we will include other recent (published within the past 5 years) relevant systematic reviews rated low or unclear risk of bias using the ROBIS tool for KQ2. Conclusions from systematic reviews rated high risk of bias may not be valid due to bias stemming from uncertain study eligibility criteria, lack of dual-review during identification and selection of studies, and other factors. For those KQ 2 outcomes for which we include a recent published systematic review, we will first describe the results of the review and then summarize data from primary studies published after the latest search date of those reviews. When recent, relevant existing systematic reviews are identified for a particular outcome, we will assess whether newly identified primary studies are likely to change judgments about conclusions made in existing reviews using an SOE framework (i.e., assessment of study limitations, consistency, precision, directness, and reporting bias). If we deem their results likely to change the conclusions, we will consider conducting a new quantitative synthesis if appropriate (i.e., if conclusions made in existing reviews are based on a pooled analysis of studies). If the new studies are consistent with prior syntheses and would not change the conclusion of the review, we will present the results of the existing review along with an updated qualitative synthesis, including the newly identified studies and an explanation of how they are consistent with the prior findings. We will conduct a new SOE for each outcome and not use SOE grading from existing reviews. We will consider performing meta-analyses when we have at least three unique studies of low or medium risk of bias that we deem sufficiently similar (in population, interventions, comparators, and outcomes). We are aware of the potential biases of meta-analyses that include a small number of studies; before calculating a pooled summary estimate in a meta-analysis, we will carefully consider the heterogeneity across studies. As described above, in cases where we identify a recent eligible meta-analysis for an eligible outcome, we will assess whether to update the analysis by considering how the results of recently published primary studies would change the conclusions of the meta-analyses using a SOE framework. We will synthesize and describe results of all studies regardless of the risk of bias rating. When possible, we will describe whether results of studies rated high risk of bias differ from those rated low or medium risk of bias (narratively, or by noting whether existing systematic reviews or meta-analyses found inconsistent results for studies that varied by risk of bias). Analysis of subgroups or subsets: We will explore evidence on subgroups of women defined by age, race, ethnicity, comorbidity, and socioeconomic status (including insurance status and payer type). Published protocol: https://effectivehealthcare.ahrq.gov/topics/breastfeeding/research-protocol/ |
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| Country: | United States |
| State: | North Carolina |
| Zip Code: | 27709 |
| UI: | 20182021 |
| Project Status: | Completed |
| Record History: | ("This report is based on research conducted by the RTI International-University of North Carolina Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA290201500011I_HSA29032008T). AHRQ is partnering with the Centers for Disease Control and Prevention and Office of Women's Health in initiating and financing the review.",) |