Using Exploratory Trials to Identify Relevant Contexts and Mechanisms in Complex Electronic Health Interventions: Evaluating the Electronic Patient-Reported Outcome Tool.

JMIR formative research(2019)

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摘要
Identifying dominant story lines using narrative analysis helps to identify the most relevant context and process variables likely to influence study outcomes. Normalization process theory emerges as a useful theory to uncover underlying mechanisms because of its emphasis on the social production and normalization of technological, processual, and social aspects of work; all found to be critical to our intervention. The number of complex, overlapping influencing variables suggests that complex interventions such as ePRO require us to pay careful attention to central versus peripheral mechanisms that will influence study outcomes. The narrative methods presented here are shown to be useful in uncovering these mechanisms and help to guide subsequent larger evaluation studies.
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关键词
clinical trial, phase III,eHealth,health care evaluation mechanisms,mHealth,multiple chronic conditions,narrative analysis,qualitative evaluation,quantitative evaluation
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