| Autor: |
Murray DM; National Institutes of Health, Bethesda, MD., Heagerty P; Department of Biostatistics, University of Washington, Seattle, WA., Troendle J; Office of Biostatistical Research, National Heart, Lung, and Blood Institute, Bethesda, MD., Lin FC; Department of Biostatistics, University of North Carolina, Chapel Hill, NC., Moyer J; National Institutes of Health, Bethesda, MD., Stevens J; Departments of Nutrition and Epidemiology, University of North Carolina, Chapel Hill, NC., Lytle L; Departments of Health Behavior and Nutrition, University of North Carolina, Chapel Hill, NC., Zhang X; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, Bethesda, MD., Ilias M; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, Bethesda, MD., Masterson MY; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, Bethesda, MD., Redmond N; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD., Tonwe V; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, Bethesda, MD., Clark D; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, Bethesda, MD., Mensah GA; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, Bethesda, MD. |
| Abstrakt: |
NHLBI funded seven projects as part of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Initiative. They were expected to collaborate with community partners to (1) employ validated theoretical or conceptual implementation research frameworks, (2) include implementation research study designs, (3) include implementation measures as primary outcomes, and (4) inform our understanding of mediators and mechanisms of action of the implementation strategy. Several projects focused on late-stage implementation strategies that optimally and sustainably delivered two or more evidence-based multilevel interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and to improve population health in high-burden communities. Projects that were successful in the three-year planning phase transitioned to a 4-year execution phase. NHLBI formed a Technical Assistance Workgroup during the planning phase to help awardees refine study aims, strengthen research designs, detail analytic plans, and to use valid sample size methods. This paper highlights methodological and study design challenges encountered during this process. Important lessons learned included (1) the need for greater emphasis on implementation outcomes, (2) the need to clearly distinguish between intervention and implementation strategies in the protocol, (3) the need to address clustering due to randomization of groups or clusters, (4) the need to address the cross-classification that results when intervention agents work across multiple units of randomization in the same arm, (5) the need to accommodate time-varying intervention effects in stepped-wedge designs, and (6) the need for data-based estimates of the parameters required for sample size estimation. |
