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在一项针对严重精神疾病患者的随机对照试验中,在监狱中招募参与者的可行性。

Feasibility of recruiting in prisons during a randomized controlled trial with people with serious mental illness.

机构信息

Department of Social Work, University of Minnesota, Duluth, MN, USA.

School of Social Work, University of North Carolina, Chapel Hill, NC, USA.

出版信息

Clin Trials. 2023 Feb;20(1):22-30. doi: 10.1177/17407745221130757. Epub 2022 Oct 21.

DOI:10.1177/17407745221130757
PMID:36268563
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9974553/
Abstract

BACKGROUND

Successful participant recruitment is vital to the feasibly of intervention research. In the behavioral and social sciences, intervention researchers face a myriad of recruitment barriers, many of which stem from working in real-world settings and among hard-to-access populations. Optimizing recruitment efforts requires being intentional about study planning and resource allocation, carefully documenting the outcomes of recruitment efforts, and developing and implementing procedures and strategies to overcome anticipated recruitment barriers.

METHODS

The current article presents recruitment flowcharts to illustrate (a) the multistep recruitment process and (b) the points of potential participant attrition during recruitment from a two-phase group-based intervention study conducted among individuals with serious mental illness incarcerated in a state prison system in the U.S. In addition, qualitative methods are used to examine strategies employed during the study to support recruitment efforts.

RESULTS

Despite challenges, this study was able to achieve recruitment goals. Analyses found the majority of potential participant attrition occurred prior to informed consent, highlighting the need for studies to track recruitment efforts in more detail than is currently recommended by commonly used guidelines. Strategies to optimize recruitment efforts included maximizing recruiter availability, developing a responsive communication approach, demonstrating respect for facility procedures and operations, and ensuring peak preparedness.

CONCLUSION

Careful documentation of recruitment efforts and the early deployment of recruitment strategies is vital to the feasibility of intervention studies conducted in real-world settings with hard-to-access populations. The publication of recruitment procedures and outcomes can help future researchers anticipate recruitment challenges and inform recruitment goals, timelines, and strategies.

摘要

背景

成功招募参与者对于干预研究的可行性至关重要。在行为和社会科学领域,干预研究人员面临着众多招募障碍,其中许多障碍源于在现实环境中以及在难以接触到的人群中开展工作。优化招募工作需要有计划地进行研究规划和资源分配,仔细记录招募工作的结果,并制定和实施克服预期招募障碍的程序和策略。

方法

本文介绍了招募流程图,以说明(a)多步骤招募过程和(b)在美国州监狱系统中监禁的严重精神疾病个体参与的两阶段基于小组的干预研究中招募过程中的潜在参与者流失点。此外,还使用定性方法来研究在研究中采用的支持招募工作的策略。

结果

尽管存在挑战,但本研究还是能够实现招募目标。分析发现,大多数潜在参与者的流失发生在知情同意之前,这突出表明需要比当前常用指南建议的更详细地跟踪招募工作。优化招募工作的策略包括最大限度地提高招募人员的可用性,制定响应式沟通方法,表现出对设施程序和运营的尊重,并确保做好充分准备。

结论

仔细记录招募工作并尽早部署招募策略对于在现实环境中针对难以接触到的人群进行干预研究的可行性至关重要。公布招募程序和结果可以帮助未来的研究人员预测招募挑战,并为招募目标、时间表和策略提供信息。

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本文引用的文献

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Interventions That Target Criminogenic Needs for Justice-Involved Persons With Serious Mental Illnesses: A Targeted Service Delivery Approach.针对患有严重精神疾病的涉法人员犯罪成因需求的干预措施:一种有针对性的服务提供方法。
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Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.临床试验招募规划:来自临床试验转型倡议的一个拟议框架
Contemp Clin Trials. 2018 Mar;66:74-79. doi: 10.1016/j.cct.2018.01.003. Epub 2018 Jan 9.
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Translating Interventions that Target Criminogenic Risk Factors for use in Community Based Mental Health Settings.
将针对犯罪成因风险因素的干预措施应用于社区心理健康环境中的翻译。
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Key Stakeholders' Perceptions of Motivators for Research Participation Among Individuals Who Are Incarcerated.关键利益相关者对被监禁者参与研究的动机的看法。
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Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials.试验招募失败与人体受试者保护:对近期结束试验的实证分析
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