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患者报告结局中的反应转移:定义、理论和修正模型。

Response shift in patient-reported outcomes: definition, theory, and a revised model.

机构信息

Inserm - University of Nantes - University of Tours, UMR 1246 Sphere "Methods in Patient-Centered Outcomes and Health Research", Nantes, France.

University Hospital of Tours - Inserm, CIC 1415, Unit of Methodology Biostatistics and Data-Management, Tours, France.

出版信息

Qual Life Res. 2021 Dec;30(12):3309-3322. doi: 10.1007/s11136-021-02846-w. Epub 2021 Apr 28.

Abstract

PURPOSE

The extant response shift definitions and theoretical response shift models, while helpful, also introduce predicaments and theoretical debates continue. To address these predicaments and stimulate empirical research, we propose a more specific formal definition of response shift and a revised theoretical model.

METHODS

This work is an international collaborative effort and involved a critical assessment of the literature.

RESULTS

Three main predicaments were identified. First, the formal definitions of response shift need further specification and clarification. Second, previous models were focused on explaining change in the construct intended to be measured rather than explaining the construct at multiple time points and neglected the importance of using at least two time points to investigate response shift. Third, extant models do not explicitly distinguish the measure from the construct. Here we define response shift as an effect occurring whenever observed change (e.g., change in patient-reported outcome measures (PROM) scores) is not fully explained by target change (i.e., change in the construct intended to be measured). The revised model distinguishes the measure (e.g., PROM) from the underlying target construct (e.g., quality of life) at two time points. The major plausible paths are delineated, and the underlying assumptions of this model are explicated.

CONCLUSION

It is our hope that this refined definition and model are useful in the further development of response shift theory. The model with its explicit list of assumptions and hypothesized relationships lends itself for critical, empirical examination. Future studies are needed to empirically test the assumptions and hypothesized relationships.

摘要

目的

现有的反应转移定义和理论反应转移模型虽然有帮助,但也引入了困境和理论争议。为了解决这些困境并激发实证研究,我们提出了一个更具体的反应转移的正式定义和一个经过修订的理论模型。

方法

这项工作是一项国际合作,涉及对文献的批判性评估。

结果

确定了三个主要困境。首先,反应转移的正式定义需要进一步细化和澄清。其次,以前的模型侧重于解释旨在测量的结构的变化,而不是解释多个时间点的结构,并且忽略了至少使用两个时间点来研究反应转移的重要性。第三,现有的模型没有明确区分测量和结构。在这里,我们将反应转移定义为一种效应,即当观察到的变化(例如,患者报告的结果测量(PROM)分数的变化)不能完全由目标变化(即,旨在测量的结构的变化)解释时发生的效应。修订后的模型在两个时间点上区分了测量(例如,PROM)和潜在的目标结构(例如,生活质量)。阐述了主要的可能路径,并阐明了该模型的基本假设。

结论

我们希望这个经过改进的定义和模型对反应转移理论的进一步发展有用。该模型明确列出了假设和假设关系,适合进行批判性、实证检验。未来的研究需要对假设和假设关系进行实证检验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c09/8602159/cfbc203711cb/11136_2021_2846_Fig1_HTML.jpg

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