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评价三种策略在招募急性不适的幼儿参与初级保健中进行随机对照试验的影响和成本。

An evaluation of the impact and costs of three strategies used to recruit acutely unwell young children to a randomised controlled trial in primary care.

机构信息

Centre for Academic Primary Care, NIHR School for Primary Care Research, School of Social and Community Medicine, University of Bristol, UK.

出版信息

Clin Trials. 2013 Aug;10(4):593-603. doi: 10.1177/1740774513494503.

DOI:10.1177/1740774513494503
PMID:23900068
Abstract

BACKGROUND

Recruitment to primary care trials, particularly those involving young children, is known to be difficult. There are limited data available to inform researchers about the effectiveness of different trial recruitment strategies and their associated costs.

PURPOSE

To describe, evaluate, and investigate the costs of three strategies for recruiting febrile children to a community-based randomised trial of antipyretics.

METHODS

The three recruitment strategies used in the trial were termed as follows: (1) 'local', where paediatric research nurses stationed in primary care sites invited parents of children to participate; (2) 'remote', where clinicians at primary care sites faxed details of potentially eligible children to the trial office; and (3) 'community', where parents, responding to trial publicity, directly contacted the trial office when their child was unwell.

RESULTS

Recruitment rates increased in response to the sequential introduction of three recruitment strategies, which were supplemented by additional recruiting staff, flexible staff work patterns, and improved clinician reimbursement schemes. The three strategies yielded different randomisation rates. They also appeared to be interdependent and highly effective together. Strategy-specific costs varied from £297 to £857 per randomised participant and represented approximately 10% of the total trial budget.

LIMITATIONS

Because the recruitment strategies were implemented sequentially, it was difficult to measure their independent effects. The cost analysis was performed retrospectively.

CONCLUSIONS

Trial recruiter expertise and deployment of several interdependent, illness-specific strategies were key factors in achieving rapid recruitment of young children to a community-based randomised controlled trial (RCT). The 'remote' recruitment strategy was shown to be more cost-effective compared to 'community' and 'local' strategies in the context of this trial. Future trialists should report recruitment costs to facilitate a transparent evaluation of recruitment strategy cost-effectiveness.

摘要

背景

初级保健试验的招募工作,特别是涉及幼儿的试验,众所周知是困难的。目前可用的数据有限,无法为研究人员提供关于不同试验招募策略的有效性及其相关成本的信息。

目的

描述、评估和研究三种招募发烧儿童参加社区为基础的退热剂随机试验的策略的成本。

方法

该试验中使用的三种招募策略如下:(1)“本地”,初级保健点的儿科研究护士邀请儿童的家长参与;(2)“远程”,初级保健点的临床医生将可能符合条件的儿童的详细信息传真到试验办公室;(3)“社区”,父母在看到试验宣传后,当孩子生病时直接联系试验办公室。

结果

随着三种招募策略的顺序引入,招募率有所提高,招募人员增加,工作人员工作模式灵活,临床医生的报销方案也得到改善。这三种策略产生了不同的随机化率。它们似乎也是相互依存的,并且一起非常有效。特定策略的成本从每位随机参与者的 297 英镑到 857 英镑不等,占总试验预算的 10%左右。

局限性

由于招募策略是顺序实施的,因此很难衡量它们的独立效果。成本分析是回顾性的。

结论

试验招募人员的专业知识和几种相互依存的疾病特定策略的部署是在社区为基础的随机对照试验(RCT)中快速招募幼儿的关键因素。在这项试验中,与“社区”和“本地”策略相比,“远程”招募策略显示出更高的成本效益。未来的试验人员应报告招募成本,以促进对招募策略成本效益的透明评估。

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