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参与者招募与保留方面的经验教训:EXCITE试验

Lessons learned in participant recruitment and retention: the EXCITE trial.

作者信息

Blanton Sarah, Morris David M, Prettyman Michelle G, McCulloch Karen, Redmond Susan, Light Kathye E, Wolf Steven L

机构信息

Center for Rehabilitation Medicine, Emory University School of Medicine, 1441 Clifton Rd NE, Atlanta, GA 30332, USA.

出版信息

Phys Ther. 2006 Nov;86(11):1520-33. doi: 10.2522/ptj.20060091.

Abstract

Participant recruitment is considered the most difficult aspect of the research process. Despite the integral role of recruitment in randomized clinical trials, publication of data defining the recruitment effort is not routine in rehabilitation initiatives. The recruitment process for the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial illustrates obstacles to and strategies for participant accrual and retention that are inherent in rehabilitation clinical trials. The purpose of this article is to increase awareness of the multiple facets of recruitment necessary for successful clinical trials, thus supporting the continued development of evidence-based practice in physical therapy. The Recruitment Index is presented as a variable to measure recruitment efficacy. In addition, ethical aspects of recruitment are explored, including informed consent and the concept of therapeutic misconception.

摘要

参与者招募被认为是研究过程中最困难的方面。尽管招募在随机临床试验中起着不可或缺的作用,但在康复项目中,公布确定招募工作的数据并非惯例。肢体约束诱导疗法评估(EXCITE)试验的招募过程说明了康复临床试验中参与者招募和留存所固有的障碍及策略。本文的目的是提高人们对成功进行临床试验所需招募工作多方面的认识,从而支持物理治疗中循证实践的持续发展。招募指数作为衡量招募效果的一个变量被提出。此外,还探讨了招募的伦理方面,包括知情同意和治疗性误解的概念。

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