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影响结局研究和临床试验中参与测量选择的问题。

Issues affecting the selection of participation measurement in outcomes research and clinical trials.

机构信息

Department of Research, Craig Hospital, Englewood, CO, USA.

出版信息

Arch Phys Med Rehabil. 2010 Sep;91(9 Suppl):S54-9. doi: 10.1016/j.apmr.2009.08.154.

Abstract

The ever-growing number of participation measures without consensus on which is best makes it difficult to determine which measure to use in rehabilitation research and clinical trials. In an effort to address issues affecting the selection of a participation measure for a specific research purpose, this article (1) outlines the types and characteristics of participation measures, (2) enumerates various uses of participation measures in disability and rehabilitation research, (3) discusses appropriate matching of the type of participation measure with the research task, and (4) offers recommendations for future participation research. Participation instruments vary in terms of their degree of participation specificity, the conceptual model that underlies their development, whether they include multiple domains or take a more global approach, the extent to which they are objective versus subjective, whether they use general population norms, who is the respondent, the method of item and scale development, and their psychometric properties. Participation measures are used in individual and population assessments, observational research, and interventional research. Selection of a participation measure for use in a specific study requires an understanding of the characteristics of available tools and the nature of the research design, but most importantly, it requires matching the instrument to the specific research question or hypothesis. Instruments assessing participation are currently appropriate as secondary outcomes in trials evaluating interventions targeting activity limitation, and they will become appropriate as primary outcomes when interventions are tested that target participation directly. It will be easier to apply participation measures appropriately to their many research uses once substantial progress is made in obtaining better participation measurements and consensus is reached about the best tools.

摘要

由于缺乏对哪种测量方法最佳的共识,参与测量的数量不断增加,这使得很难确定在康复研究和临床试验中使用哪种测量方法。为了解决影响选择特定研究目的参与测量的问题,本文(1)概述了参与测量的类型和特征,(2)列举了参与测量在残疾和康复研究中的各种用途,(3)讨论了将参与测量的类型与研究任务进行适当匹配,(4)为未来的参与研究提供了建议。参与工具在参与的具体程度、其发展所依据的概念模型、是否包括多个领域或采用更全面的方法、其客观性与主观性程度、是否使用一般人群的标准、回答者是谁、项目和量表开发的方法以及他们的心理测量特性方面存在差异。参与测量用于个体和人群评估、观察性研究和干预性研究。在特定研究中选择使用参与测量需要了解可用工具的特点和研究设计的性质,但最重要的是,它需要将仪器与特定的研究问题或假设相匹配。评估参与的仪器目前适用于评估针对活动受限的干预措施的试验中的次要结局,并且当直接针对参与的干预措施进行测试时,它们将适用于主要结局。一旦在获得更好的参与测量和达成关于最佳工具的共识方面取得实质性进展,将更容易将参与测量适当地应用于其众多研究用途。

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