对MAGNETIC试验招募的促进因素和障碍的调查。
A survey of facilitators and barriers to recruitment to the MAGNETIC trial.
作者信息
Kaur Geetinder, Smyth Rosalind L, Powell Colin V E, Williamson Paula
机构信息
School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
University College London, 30 Guilford Street, London, WC1N 1EH, UK.
出版信息
Trials. 2016 Dec 23;17(1):607. doi: 10.1186/s13063-016-1724-3.
BACKGROUND
Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool.
METHODS
MAGNETIC is a multicentre randomised trial of nebulised magnesium in acute severe asthma, recruiting 508 children from 30 UK sites. Recruiters were asked to grade a list of factors from -3 to +3 depending on whether the factor was perceived as a strong, intermediate or weak barrier (-3 to -1) or facilitator (+1 to + 3), and using (0) if it was thought to be not applicable. Free text responses were invited on strategies applied to counter the identified barriers.
RESULTS
The commonly identified facilitators were motivation and experience of study teams, effective communication and coordination between teams at site and between sites and the Clinical Trials Unit, the presence of designated research nurses, good trial management, clinical trial publicity, simple inclusion criteria, effective communication with parents and presentation of trial information in a simple and clear manner. The commonly identified barriers were heavy clinical workload, shift patterns of work, Good Clinical Practice (GCP) training, inadequate number of trained staff, time and setting of consent seeking, non-availability of research staff out of hours and parents' concerns about their child taking an experimental medicine. Having a designated research nurse, arranging GCP training and trial-related training sessions for staff were the most commonly reported interventions.
CONCLUSIONS
This study highlights important generic and trial-specific facilitators and barriers to recruitment to a paediatric trial in the acute setting and provides information on the recruitment strategies or interventions that were applied to overcome these barriers. This information can be very useful in informing the design and conduct of future clinical trials with children, particularly in the acute or emergency setting.
TRIAL REGISTRATION
ISRCTN, ISRCTN81456894 . Registered on 15 November 2007.
背景
招募儿童参与随机对照试验具有挑战性。了解促进或阻碍儿童参与临床试验招募的因素至关重要。我们使用先前开发的基于网络的工具，对MAGNETIC试验的招募促进因素和障碍进行了一项调查。
方法
MAGNETIC是一项关于雾化镁治疗急性重症哮喘的多中心随机试验，从英国30个地点招募508名儿童。要求招募人员根据某一因素被视为强、中或弱障碍（-3至-1）或促进因素（+1至+3），对一系列因素进行评分，若认为不适用则评分为（0）。针对用于应对已识别障碍的策略，邀请提供自由文本回复。
结果
常见的促进因素包括研究团队的积极性和经验、各地点团队之间以及地点与临床试验单位之间有效的沟通与协调、有指定的研究护士、良好的试验管理、临床试验宣传、简单的纳入标准、与家长的有效沟通以及以简单明了的方式呈现试验信息。常见的障碍包括繁重的临床工作量、工作轮班模式、良好临床规范（GCP）培训、训练有素的工作人员数量不足、寻求同意的时间和环境、非工作时间研究人员无法提供服务以及家长对其孩子服用试验性药物的担忧。配备指定的研究护士、为工作人员安排GCP培训和与试验相关的培训课程是最常报告的干预措施。
结论
本研究突出了在急性环境中招募儿童参与儿科试验的重要的通用和特定于试验的促进因素及障碍，并提供了有关为克服这些障碍而应用的招募策略或干预措施的信息。该信息对于为未来儿童临床试验的设计和实施提供参考非常有用，尤其是在急性或紧急环境中。
试验注册
ISRCTN，ISRCTN81456894。于2007年11月15日注册。
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