Applying mixed methods to pilot feasibility studies to inform intervention trials.

Applying mixed methods to pilot feasibility studies to inform intervention trials.
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将混合方法应用于实行可行性研究以告知干预试验。

DOI:
10.1186/s40814-022-01178-x
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发表时间:
2022-09-26
影响因子:
1.7
通讯作者:
Plano Clark VL
Plano Clark VL
中科院分区:
其他
文献类型:
--
作者:
Aschbrenner KA;Kruse G;Gallo JJ;Plano Clark VL

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试点可行性研究通过检查干预措施的可行性和可接受性以及用于测试干预措施的方法,在为更大规模的干预试验做准备方面发挥着独特的重要作用。混合方法(收集,分析和整合定量和定性数据和结果)可以优化从试点可行性研究中学到的东西,以准备严格的干预试验。尽管在干预试验中越来越多地使用混合方法设计,但关于如何应用这些方法来解决试点可行性研究目标的指导有限。本文的目的是为研究人员如何计划在试点可行性研究中整合定量和定性方法以全面解决关键研究问题提供方法学指导。我们使用了一个非正式的基于共识的过程,通过关键的方法资源和我们团队作为干预研究人员和混合方法学家的互补专业知识来制定应用混合方法的指导,以优化从试点可行性研究中学到的东西。我们开发了这种方法的指导教师在混合方法研究培训计划(MMRTP)的健康科学(R25 MH 104660)由美国国立卫生研究院通过行为和社会科学研究办公室资助。我们为应用混合方法优化试点可行性研究提供以下指导:(1)确定将使用混合方法检查的可行性领域,(2)调整为混合方法选择的领域的定量和定性数据源,(3)确定试点研究流程中定量和定性数据收集的时间,(4)计划使用联合显示的综合分析,以了解可行性,以及(5)准备从综合数据中得出关于可行性和对未来试验的影响的元推断。通过有效地整合试点可行性研究中的定量和定性数据,调查人员可以利用混合方法的潜力,对可行性进行全面和细致的理解。我们的指导可以帮助研究人员考虑在干预试点可行性测试期间所需的关键决策范围,以实现严格的混合方法方法,从而产生增强的见解,为未来的干预试验提供信息。在线版本包含补充材料,可通过10.1186/s40814-022-01178-x获得。
Pilot feasibility studies serve a uniquely important role in preparing for larger scale intervention trials by examining the feasibility and acceptability of interventions and the methods used to test them. Mixed methods (collecting, analyzing, and integrating quantitative and qualitative data and results) can optimize what can be learned from pilot feasibility studies to prepare rigorous intervention trials. Despite increasing use of mixed method designs in intervention trials, there is limited guidance on how to apply these approaches to address pilot feasibility study goals. The purpose of this article is to offer methodological guidance for how investigators can plan to integrate quantitative and qualitative methods within pilot feasibility studies to comprehensively address key research questions. We used an informal consensus-based process informed by key methodological resources and our team’s complementary expertise as intervention researchers and mixed methodologists to develop guidance for applying mixed methods to optimize what can be learned from pilot feasibility studies. We developed this methodological guidance as faculty in the Mixed Methods Research Training Program (MMRTP) for the Health Sciences (R25MH104660) funded by the National Institutes of Health through the Office of Behavioral and Social Science Research. We provide the following guidance for applying mixed methods to optimize pilot feasibility studies: (1) identify feasibility domain(s) that will be examined using mixed methods, (2) align quantitative and qualitative data sources for the domain(s) selected for mixing methods, (3) determine the timing of the quantitative and qualitative data collection within the flow of the pilot study, (4) plan integrative analyses using joint displays to understand feasibility, and (5) prepare to draw meta-inferences about feasibility and implications for the future trial from the integrated data. By effectively integrating quantitative and qualitative data within pilot feasibility studies, investigators can harness the potential of mixed methods for developing comprehensive and nuanced understandings about feasibility. Our guidance can help researchers to consider the range of key decisions needed during intervention pilot feasibility testing to achieve a rigorous mixed methods approach generating enhanced insights to inform future intervention trials. The online version contains supplementary material available at 10.1186/s40814-022-01178-x.