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儿童和青少年精神病学临床试验中以预防项目为重点的参与者招募问题:文献的荟萃分析综述

Participant Recruitment Issues in Child and Adolescent Psychiatry Clinical Trials with a Focus on Prevention Programs: A Meta-Analytic Review of the Literature.

作者信息

Kilicel Deniz, De Crescenzo Franco, Pontrelli Giuseppe, Armando Marco

机构信息

Developmental Imaging and Psychopathology Lab, Department of Psychiatry, School of Medicine, University of Geneva, 1205 Geneva, Switzerland.

Department of Psychiatry, University of Oxford, Oxford OX1 2JD, UK.

出版信息

J Clin Med. 2023 Mar 16;12(6):2307. doi: 10.3390/jcm12062307.

Abstract

: There is a strong need to conduct rigorous and robust trials for children and adolescents in mental health settings. One of the main barriers to meeting this requirement is the poor recruitment rate. Effective recruitment strategies are crucial for the success of a clinical trial, and therefore, we reviewed recruitment strategies in clinical trials on children and adolescents in mental health with a focus on prevention programs. : We reviewed the literature by searching /, the database, and through December 2022 as well as the reference lists of relevant articles. We included only studies describing recruitment strategies for pediatric clinical trials in mental health settings and extracted data on recruitment and completion rates. : The search yielded 13 studies that enrolled a total of 14,452 participants. Overall, studies mainly used social networks or clinical settings to recruit participants. Half of the studies used only one recruitment method. Using multiple recruitment methods (56.6%, 95%CI: 24.5-86.0) resulted in higher recruitment. The use of monetary incentives (47.0%, 95%CI: 24.6-70.0) enhanced the recruitment rate but not significantly (32.6%, 95%CI: 15.7-52.1). All types of recruitment methods showed high completion rates (82.9%, 95%CI: 61.7-97.5) even though prevention programs showed the smallest recruitment rate (76.1%, 95%CI: 50.9-94.4). : Pediatric mental health clinical trials face many difficulties in recruitment. We found that these trials could benefit from faster and more efficient recruitment of participants when more than one method is implemented. Social networks can be helpful where ethically possible. We hope the description of these strategies will help foster innovation in recruitment for pediatric studies in mental health.

摘要

在心理健康领域,迫切需要针对儿童和青少年开展严格且有力的试验。满足这一要求的主要障碍之一是招募率低。有效的招募策略对于临床试验的成功至关重要,因此,我们回顾了心理健康领域针对儿童和青少年的临床试验中的招募策略,重点关注预防项目。

我们通过检索截至2022年12月的数据库以及相关文章的参考文献列表来回顾文献。我们仅纳入描述心理健康环境中儿科临床试验招募策略的研究,并提取有关招募率和完成率的数据。

检索产生了13项研究,共纳入14452名参与者。总体而言,研究主要利用社交网络或临床环境来招募参与者。一半的研究仅使用一种招募方法。使用多种招募方法(56.6%,95%置信区间:24.5 - 86.0)导致更高的招募率。使用金钱激励(47.0%,95%置信区间:24.6 - 70.0)提高了招募率,但效果不显著(32.6%,95%置信区间:15.7 - 52.1)。尽管预防项目的招募率最低(76.1%,95%置信区间:50.9 - 94.4),但所有类型的招募方法都显示出较高的完成率(82.9%,95%置信区间:61.7 - 97.5)。

儿科心理健康临床试验在招募方面面临许多困难。我们发现,当实施一种以上方法时,这些试验可能会从更快、更高效地招募参与者中受益。在符合伦理的情况下,社交网络可能会有所帮助。我们希望这些策略的描述将有助于促进心理健康领域儿科研究招募方面的创新。

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