Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Institute of Mental Health, School of Medicine, NIHR MindTech MedTech HRC, Mental Health and Clinical Neurosciences, University of Nottingham, Innovation Park, Triumph Road, Nottingham, UK.
Trials. 2024 Sep 7;25(1):596. doi: 10.1186/s13063-024-08435-9.
BACKGROUND: Ensuring diversity in clinical trials can be a challenge, which may be exacerbated when recruiting vulnerable populations, such as participants with mental health illness. As recruitment continues to be the major cause of trial delays, researchers are turning to online recruitment strategies, e.g. social media, to reach a wider population and reduce recruitment time and costs. There is mixed evidence for the use of online recruitment strategies; therefore, the REcruitment in Mental health trials: broadening the 'net', opportunities for INclusivity through online methoDs (RE-MIND) study aimed to identify evidence and provide guidance for use of online strategies in recruitment to mental health trials, with a focus on whether online strategies can enhance inclusivity. This commentary, as part of the RE-MIND study, focusses on providing recommendations for recruitment strategy selection in future research with the aim to improve trial efficiency. A mixed-methods approach was employed involving three work packages: (I) an evidence review of a cohort of 97 recently published randomised controlled trials/feasibility or pilot studies in mental health to assess the impact of online versus offline recruitment; (II) a qualitative study investigating the experiences of n = 23 key stakeholders on use of an online recruitment approach in mental health clinical trials; (III) combining the results of WP1 and WP2 to produce recommendations on the use of an online recruitment strategy in mental health clinical trials. The findings from WP1 and 2 have been published elsewhere; this commentary represents the results of the third work package. CONCLUSION: For external validity, clinical trial participants should reflect the populations that will ultimately receive the interventions being tested, if proven effective. To guide researchers on their options for inclusive recruitment strategies, we have developed a list of considerations and practical recommendations on how to maximise the use of online recruitment methods.
背景:确保临床试验的多样性可能是一个挑战,当招募弱势群体时,例如有心理健康疾病的参与者,这种挑战可能会加剧。由于招募仍然是试验延迟的主要原因,研究人员正在转向在线招募策略,例如社交媒体,以覆盖更广泛的人群并减少招募时间和成本。在线招募策略的使用效果参差不齐;因此,REcruitment in Mental health trials: broadening the 'net', opportunities for INclusivity through online methoDs (RE-MIND) 研究旨在确定使用在线策略招募心理健康试验的证据并提供指导,重点是在线策略是否可以提高包容性。作为 RE-MIND 研究的一部分,本评论侧重于为未来的研究提供招募策略选择建议,以提高试验效率。采用了一种混合方法,涉及三个工作包:(一)对 97 项最近发表的随机对照试验/心理健康可行性或试点研究的队列进行证据综述,评估在线与线下招募的影响;(二)一项定性研究,调查 23 名关键利益相关者对在线招募方法在心理健康临床试验中的使用经验;(三)将 WP1 和 WP2 的结果结合起来,为心理健康临床试验中使用在线招募策略提供建议。WP1 和 2 的结果已在其他地方发表;本评论代表第三个工作包的结果。
结论:为了保证外部有效性,如果证明有效,临床试验参与者应该反映出最终将接受正在测试的干预措施的人群。为了指导研究人员选择包容性招募策略,我们制定了一份考虑因素和实用建议清单,以最大程度地利用在线招募方法。
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