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改善心理健康临床试验招募情况的策略:一项范围综述(RE-MIND研究)

Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study).

作者信息

Iflaifel Mais, Hall Charlotte L, Green Heidi R, Willis Andrew, Rennick-Egglestone Stefan, Juszczak Edmund, Townsend Mark, Martin Jennifer, Sprange Kirsty

机构信息

Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.

NIHR MindTech MedTech Co-operative, Institute of Mental Health, School of Medicine, Mental Health and Clinical Neurosciences, University of Nottingham, Innovation Park, Triumph Road, Nottingham, UK.

出版信息

Trials. 2024 Dec 18;25(1):832. doi: 10.1186/s13063-024-08665-x.

Abstract

BACKGROUND

Lower-than-expected recruitment continues to be one of the major causes of trial delays, and trials to improve mental health are no exception. Indeed, recruitment challenges in trials of vulnerable populations, such as those living with mental health illness, can even be exacerbated. To address this, researchers are turning to digital and online recruitment strategies, e.g. web-based approaches and multi-media in order to (1) increase recruitment efficiency (recruit to target and on time) and (2) improve diversity in mental health clinical trials to be more inclusive and reduce health inequity. There is, however, inconclusive evidence on the success of digital and online recruitment strategies in mental health clinical trials. The RE-MIND study comprised a scoping review to assess the impact of using such recruitment strategies in mental health clinical trials to inform a more systematic scoping review.

METHODS

A cohort of 191 recently published RCTs and randomised feasibility studies were identified from the NIHR Journals Library and top two mental health journals (based on citation metrics), Lancet Psychiatry and JAMA Psychiatry. Population characteristics including gender, ethnicity and age were summarised for inclusivity using descriptive statistics, and recruitment strategies were compared to examine differences in their success in recruiting to target.

RESULTS

After screening, 97 articles were included for review. The review findings showed no evidence that offline or mixed strategies were superior for achieving recruitment targets in mental health trials. However, there was a suggestion that trials using a mixed recruitment strategy improved inclusivity and tended to recruit closer to the target.

CONCLUSIONS

The key finding was that consideration should be given to a mixed methods approach to recruitment not only to enable wider and more diverse participation in mental health trials but also to realize greater efficiency.

摘要

背景

招募人数低于预期仍是试验延迟的主要原因之一,改善心理健康的试验也不例外。事实上,针对弱势群体(如患有精神疾病的人群)的试验中的招募挑战甚至可能会加剧。为了解决这一问题,研究人员正在转向数字和在线招募策略,例如基于网络的方法和多媒体,以便(1)提高招募效率(按目标准时招募),以及(2)改善心理健康临床试验的多样性,使其更具包容性并减少健康不平等现象。然而,关于数字和在线招募策略在心理健康临床试验中的成功与否,证据并不确凿。RE-MIND研究包括一项范围综述,以评估在心理健康临床试验中使用此类招募策略的影响,为更系统的范围综述提供信息。

方法

从英国国家卫生研究院期刊图书馆以及排名前两位的心理健康期刊(根据引用指标)《柳叶刀·精神病学》和《美国医学会杂志·精神病学》中,识别出一组191项最近发表的随机对照试验和随机可行性研究。使用描述性统计总结包括性别、种族和年龄在内的人群特征,以衡量包容性,并比较招募策略,以检查它们在按目标招募方面的成功差异。

结果

经过筛选,纳入97篇文章进行综述。综述结果表明,没有证据表明线下或混合策略在实现心理健康试验的招募目标方面更具优势。然而,有迹象表明,采用混合招募策略的试验提高了包容性,并且往往更接近目标进行招募。

结论

关键发现是,应考虑采用混合方法进行招募,这不仅能使更多样化的人群参与心理健康试验,还能提高效率。

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