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为音乐疗法随机对照试验招募参与者:一个实际案例

Recruiting participants for randomized controlled trials of music therapy: a practical illustration.

作者信息

Porter Sam, McConnell Tracey, Lynn Fiona, McLaughlin Katrina, Cardwell Christopher, Holmes Valerie

机构信息

School of Nursing and Midwifery, Queen's University Belfast School of Sociology, Social Policy and Social Work, Queen's University Belfast School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast

School of Nursing and Midwifery, Queen's University Belfast School of Sociology, Social Policy and Social Work, Queen's University Belfast School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast.

出版信息

J Music Ther. 2014 Winter;51(4):355-81. doi: 10.1093/jmt/thu031.

DOI:10.1093/jmt/thu031
PMID:25504178
Abstract

BACKGROUND

Failure to recruit sufficient numbers of participants to randomized controlled trials is a common and serious problem. This problem may be additionally acute in music therapy research.

OBJECTIVE

To use the experience of conducting a large randomized controlled trial of music therapy for young people with emotional and behavioral difficulties to illustrate the strategies that can be used to optimize recruitment; to report on the success or otherwise of those strategies; and to draw general conclusions about the most effective approaches.

METHODS

Review of the methodological literature, and a narrative account and realist analysis of the recruitment process.

RESULTS

The strategies adopted led to the achievement of the recruitment target of 250 subjects, but only with an extension to the recruitment period. In the pre-protocol stage of the research, these strategies included the engagement of non-music therapy clinical investigators, and extensive consultation with clinical stakeholders. In the protocol development and initial recruitment stages, they involved a search of systematic reviews of factors leading to under-recruitment and of interventions to promote recruitment, and the incorporation of their insights into the research protocol and practices. In the latter stages of recruitment, various stakeholders including clinicians, senior managers and participant representatives were consulted in an attempt to uncover the reasons for the low recruitment levels that the research was experiencing.

CONCLUSIONS

The primary mechanisms to promote recruitment are education, facilitation, audit and feedback, and time allowed. The primary contextual factors affecting the effectiveness of these mechanisms are professional culture and organizational support.

摘要

背景

随机对照试验未能招募到足够数量的参与者是一个常见且严重的问题。在音乐治疗研究中,这个问题可能尤为突出。

目的

利用对有情绪和行为问题的年轻人进行大型音乐治疗随机对照试验的经验,阐述可用于优化招募的策略;报告这些策略的成败情况;并就最有效的方法得出一般性结论。

方法

回顾方法学文献,并对招募过程进行叙述性描述和实证分析。

结果

所采用的策略使研究实现了招募250名受试者的目标,但这只是通过延长招募期才实现的。在研究的方案前阶段,这些策略包括让非音乐治疗临床研究人员参与,并与临床利益相关者进行广泛协商。在方案制定和初始招募阶段,策略包括搜索关于导致招募不足的因素和促进招募的干预措施的系统评价,并将其中的见解纳入研究方案和实践中。在招募的后期阶段,咨询了包括临床医生、高级管理人员和参与者代表在内的各种利益相关者,试图找出研究中招募水平低的原因。

结论

促进招募的主要机制是教育、便利措施、审核与反馈以及所给予的时间。影响这些机制有效性的主要背景因素是专业文化和组织支持。

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