RESUMO
BACKGROUND: Economic evaluations alongside implementation trials compare the outcomes and costs of competing implementation strategies to identify the most efficient strategies. The aims of this systematic review were to investigate how economic evaluations are performed in randomized implementation trials in clinical settings and to assess the quality of these evaluations. METHODS: A systematic literature review was conducted on 23 March 2023 to identify studies that reported on economic evaluations embedded in randomized implementation trials in clinical settings. A systematic search was applied across seven databases, and references of relevant reviews were screened for additional studies. The Drummond Checklist was used to assess the quality and risk of bias of included economic evaluations. Study characteristics and quality assessments were tabulated and described. RESULTS: Of the 6,550 studies screened for eligibility, 10 met the inclusion criteria. Included studies were published between 1990 and 2022 and from North America, the United Kingdom, Europe, and Africa. Most studies were conducted in the primary and out-patient care setting. Implementation costs included materials, staffing, and training, and the most common approach to collecting implementation costs was obtaining expense and budget reports. Included studies scored medium to high in terms of economic methodological quality. CONCLUSIONS: Economic evidence is particularly useful for healthcare funders and service providers to inform the prioritization of implementation efforts in the context of limited resources and competing demands. The relatively small number of studies identified may be due to lack of guidance on how to conduct economic evaluations alongside implementation trials and the lack of standardized terminology used to describe implementation strategies in clinical research. We discuss these methodological gaps and present recommendations for embedding economic evaluations in implementation trials. First, reporting implementation strategies used in clinical trials and aligning these strategies with implementation outcomes and costs are an important advancement in clinical research. Second, economic evaluations of implementation trials should follow guidelines for standard clinical trial economic evaluations and adopt an appropriate costing and data collection approach. Third, hybrid trial designs are recommended to generate evidence for effective and cost-effective implementation strategies alongside clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION: The review was prospectively registered with PROSPERO (CRD42023410186).
RESUMO
Engaging in regular preconception physical activity (PA) is associated with benefits, including improved cardiovascular health and mental well-being. However, most women do not meet PA recommendations in the preconception period. This study aimed to investigate enablers and barriers related to PA in preconception women using a sequential mixed method design. An online survey was followed by Zoom interviews with women of reproductive age (aged 18-45 years). A weaving approach and the Capability Opportunity Motivation Behaviour (COM-B) model were used to integrate and present the data. Seven hundred and eighty-eight non-pregnant women from Australia, India, and the US completed the quantitative survey, and 13 Australian-based women participated in a qualitative interview. Physical activity levels were associated with having social support, a desire to improve body image, and becoming a healthier person. Women encountered barriers such as misconceptions about PA, competing priorities, financial constraints, and a lack of accessibility. Enablers for participation in PA included knowledge of its importance, a desire to be healthier, weight loss, social support, and having goals. The multifaceted and intricate nature of enablers and barriers for preconception PA lays the groundwork for developing tailored interventions and policies aimed at promoting preconception PA among women.
