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一个新的促进随机对照试验招募的简单六步模型被开发出来并成功实施。

A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented.

作者信息

Realpe Alba, Adams Ann, Wall Peter, Griffin Damian, Donovan Jenny L

机构信息

Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom.

Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom.

出版信息

J Clin Epidemiol. 2016 Aug;76:166-74. doi: 10.1016/j.jclinepi.2016.02.002. Epub 2016 Feb 17.


DOI:10.1016/j.jclinepi.2016.02.002
PMID:26898705
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5045272/
Abstract

OBJECTIVES: How a randomized controlled trial (RCT) is explained to patients is a key determinant of recruitment to that trial. This study developed and implemented a simple six-step model to fully inform patients and to support them in deciding whether to take part or not. STUDY DESIGN AND SETTING: Ninety-two consultations with 60 new patients were recorded and analyzed during a pilot RCT comparing surgical and nonsurgical interventions for hip impingement. Recordings were analyzed using techniques of thematic analysis and focused conversation analysis. RESULTS: Early findings supported the development of a simple six-step model to provide a framework for good recruitment practice. Model steps are as follows: (1) explain the condition, (2) reassure patients about receiving treatment, (3) establish uncertainty, (4) explain the study purpose, (5) give a balanced view of treatments, and (6) Explain study procedures. There are also two elements throughout the consultation: (1) responding to patients' concerns and (2) showing confidence. The pilot study was successful, with 70% (n = 60) of patients approached across nine centers agreeing to take part in the RCT, so that the full-scale trial was funded. CONCLUSION: The six-step model provides a promising framework for successful recruitment to RCTs. Further testing of the model is now required.

摘要

目的:向患者解释随机对照试验(RCT)的方式是该试验招募患者的关键决定因素。本研究开发并实施了一个简单的六步模型,以充分告知患者并帮助他们决定是否参与试验。 研究设计与背景:在一项比较手术和非手术干预治疗髋关节撞击症的试点随机对照试验中,记录并分析了与60名新患者进行的92次会诊。使用主题分析和聚焦对话分析技术对记录进行分析。 结果:早期研究结果支持开发一个简单的六步模型,以为良好的招募实践提供框架。模型步骤如下:(1)解释病情,(2)让患者放心会接受治疗,(3)明确不确定性,(4)解释研究目的,(5)对治疗方法给出平衡的观点,(6)解释研究程序。在整个会诊过程中还有两个要素:(1)回应患者的担忧,(2)表现出信心。试点研究取得成功,九个中心接触的患者中有70%(n = 60)同意参与随机对照试验,因此全面试验获得了资金支持。 结论:六步模型为成功招募随机对照试验患者提供了一个有前景的框架。现在需要对该模型进行进一步测试。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b77/5045272/ff4e8bdfbcf5/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b77/5045272/b8c35ca03145/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b77/5045272/ff4e8bdfbcf5/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b77/5045272/b8c35ca03145/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b77/5045272/ff4e8bdfbcf5/gr2.jpg

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本文引用的文献

[1]
UK FASHIoN: feasibility study of a randomised controlled trial of arthroscopic surgery for hip impingement compared with best conservative care.

Health Technol Assess. 2016-4

[2]
Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II/III colon cancer in Japan (JCOG0404).

Asian J Endosc Surg. 2015-11

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Trials. 2015-3-11

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Trials. 2014-8-13

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J Clin Epidemiol. 2014-5-5

[6]
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Trials. 2014-1-6

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BMJ Open. 2013-6-20

[8]
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J Clin Epidemiol. 2011-4-7

[9]
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Trials. 2011-3-15

[10]
Strategies to improve recruitment to randomised controlled trials.

Cochrane Database Syst Rev. 2010-1-20

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