Addressing the Challenges of Recruitment and Retention in Sleep and Circadian Clinical Trials.
Addressing the Challenges of Recruitment and Retention in Sleep and Circadian Clinical Trials.
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解决睡眠和昼夜节律临床试验中招募和保留的挑战。
DOI：
10.1080/15402002.2018.1518230
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发表时间：
2020
影响因子：
3.1
通讯作者：
Harvey,AllisonG
中科院分区：
文献类型：
--
作者：
Yu,StephanieH;Gumport,NicoleB;Mirzadegan,IsaacA;Mei,Yuh-Jang;Hein,Kerrie;Harvey,AllisonG
目的/背景睡眠和昼夜节律紊乱在世界范围内普遍存在，并且经常与身体和精神疾病共病。因此，为睡眠和昼夜节律研究招募和保留样本是当务之急。本文的目的是强调招募和保留睡眠或昼夜节律功能障碍的参与者的障碍，并分享两项随机对照试验（RCT）中使用的策略，以测试睡眠和昼夜节律功能障碍的跨诊断干预（Transdiagnosis Intervention for Sleep and Circadian Dysfunction，TransS-C）的有效性，以应对这些挑战。在行为、认知、情感、身体和社交五个健康领域中至少有一个处于危险之中。第二个随机对照试验招募了121名低收入，种族或少数民族成年人诊断为严重精神疾病（SMI）和共病睡眠或昼夜节律功能障碍。MethodsThe当前的研究检查参与者，环境和研究因素，影响招募和保留参与者睡眠或昼夜节律功能障碍，并确定了加强招募和保留的策略。结果招募参与者的策略包括基于社区的招募，减少耻辱，并减轻繁重的睡眠数据收集工作。在我们的研究中，用于留住参与者的策略包括灵活的时间安排，减轻参与者的障碍，通过移情和积极的互动与参与者建立融洽的关系，创造性的解决问题，咨询参与者网络，以及利用激励和其他积极的参与工具。少数患有SMI和睡眠或昼夜节律功能障碍的成年人在参与研究时遇到了重大障碍。招聘和保留战略是创造性的，以满足这些不同人群的独特障碍。
Objective/BackgroundSleep and circadian disorders are prevalent worldwide and frequently comorbid with physical and mental illnesses. Thus, recruiting and retaining samples for sleep and circadian research are high priorities. The aims of this paper are to highlight barriers to recruitment and retention for participants with sleep or circadian dysfunction, and to share strategies used across two randomized controlled trials (RCTs) testing the efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to address these challenges.ParticipantsThe first RCT recruited 176 adolescents with an evening circadian chronotype, who were at risk in at least one of five health domains: behavioral, cognitive, emotional, physical, and social. The second RCT recruited 121 low-income, racial or ethnic minority adults diagnosed with severe mental illness (SMI) and comorbid sleep or circadian dysfunction.MethodsThe current study examined participant, environment, and research factors that impacted recruitment and retention of participants with sleep or circadian dysfunction, and identified strategies to enhance recruitment and retention.ResultsStrategies used to recruit participants included community-based recruiting, reducing stigma, and alleviating burdensome sleep data collection. Strategies used to retain participants in our studies included flexible scheduling, mitigating participant barriers, building rapport with participants through empathic and positive interactions, creative problem solving, consulting participant networks, and utilizing incentives and other positive engagement tools.ConclusionBoth at-risk adolescents and low-income, minority adults with comorbid SMI and sleep or circadian dysfunction experience significant barriers to research participation. Recruitment and retention strategies were creatively tailored to meet the unique barriers of these diverse populations.