招募和保留干预措施的随机评估之间的重叠:招募(临床试验招募在线资源)和保留(临床试验保留在线资源)文献的最新回顾

IF 2.2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Clinical Trials Pub Date : 2024-04-05 DOI:10.1177/17407745241238444
Anna Kearney, Laura Butlin, Taylor Coffey, Thomas Conway, Sarah Cotterill, Alison Evans, Jackie Fox, Andrew Hunter, Sarah Inglis, Louise Murphy, Nurulamin M Noor, Terrie Walker-Smith, Carrol Gamble
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While interventions aimed at addressing recruitment challenges can impact retention and vice versa, it is not clear how well they are simultaneously considered within methodological research. This study aims to report the recent update of ORRCA and ORRCA2 with a special emphasis on assessing crossover of the databases and how frequently randomised studies of methodological interventions measure the impact on both recruitment and retention outcomes.MethodsTwo parallel systematic reviews were conducted in line with previously reported methods updating ORRCA (recruitment) and ORRCA2 (retention) with publications from 2018 and 2019. Articles were categorised according to their evidence type (randomised evaluation, non-randomised evaluation, application and observation) and against the recruitment and retention domain frameworks. Articles categorised as randomised evaluations were compared to identify studies appearing in both databases. For randomised studies that were only in one database, domain categories were used to assess whether the methodological intervention was likely to impact on the alternate construct. For example, whether a recruitment intervention might also impact retention.ResultsIn total, 806 of 17,767 articles screened for the recruitment database and 175 of 18,656 articles screened for the retention database were added as result of the update. Of these, 89 articles were classified as ‘randomised evaluation’, of which 6 were systematic reviews and 83 were randomised evaluations of methodological interventions. Ten of the randomised studies assessed recruitment and retention and were included in both databases. Of the randomised studies only in the recruitment database, 48/55 (87%) assessed the content or format of participant information which could have an impact on retention. 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引用次数: 0

摘要

背景临床试验招募在线资源(ORRCA)和临床试验留用在线资源(ORRCA2)的建立是为了整理和绘制临床研究中有关参与者招募和留用的文献。这两个数据库通过独立但平行的系统综述不断更新。然而,研究参与者的招募和保留被广泛认为是相互关联的。虽然旨在解决招募难题的干预措施会影响留用率,反之亦然,但目前还不清楚在方法学研究中如何同时考虑这两个问题。本研究旨在报告 ORRCA 和 ORRCA2 最近的更新情况,特别强调评估数据库的交叉性,以及方法学干预措施的随机研究如何经常衡量对招募和留用结果的影响。方法根据之前报告的方法,对 ORRCA(招募)和 ORRCA2(留用)进行了两次平行系统综述,更新了 2018 年和 2019 年的出版物。文章根据其证据类型(随机评估、非随机评估、应用和观察)以及招募和保留领域框架进行分类。对归类为随机评估的文章进行了比较,以确定出现在两个数据库中的研究。对于只出现在一个数据库中的随机研究,则使用领域类别来评估方法干预是否有可能对替代构架产生影响。例如,招募干预措施是否也会对保留率产生影响。结果更新后,招募数据库共筛选出 17,767 篇文章,其中 806 篇被纳入;保留率数据库共筛选出 18,656 篇文章,其中 175 篇被纳入。其中 89 篇文章被归类为 "随机评估",其中 6 篇为系统综述,83 篇为方法干预的随机评估。其中 10 项随机研究对招募和留用情况进行了评估,并同时纳入了两个数据库。在仅纳入招募数据库的随机研究中,48/55(87%)项对参与者信息的内容或格式进行了评估,这可能会对保留率产生影响。结论尽管方法干预的随机研究对招募和留用都有潜在影响,但只有一小部分研究同时评估了对招募和留用的影响。在可能的情况下,综合分析这两个方面的方法应该成为此类评估的新标准,以确保对招聘的改善不会以牺牲留用率为代价,反之亦然。
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The overlap between randomised evaluations of recruitment and retention interventions: An updated review of recruitment (Online Resource for Recruitment in Clinical triAls) and retention (Online Resource for Retention in Clinical triAls) literature
BackgroundThe Online Resource for Recruitment in Clinical triAls (ORRCA) and the Online Resource for Retention in Clinical triAls (ORRCA2) were established to organise and map the literature addressing participant recruitment and retention within clinical research. The two databases are updated on an ongoing basis using separate but parallel systematic reviews. However, recruitment and retention of research participants is widely acknowledged to be interconnected. While interventions aimed at addressing recruitment challenges can impact retention and vice versa, it is not clear how well they are simultaneously considered within methodological research. This study aims to report the recent update of ORRCA and ORRCA2 with a special emphasis on assessing crossover of the databases and how frequently randomised studies of methodological interventions measure the impact on both recruitment and retention outcomes.MethodsTwo parallel systematic reviews were conducted in line with previously reported methods updating ORRCA (recruitment) and ORRCA2 (retention) with publications from 2018 and 2019. Articles were categorised according to their evidence type (randomised evaluation, non-randomised evaluation, application and observation) and against the recruitment and retention domain frameworks. Articles categorised as randomised evaluations were compared to identify studies appearing in both databases. For randomised studies that were only in one database, domain categories were used to assess whether the methodological intervention was likely to impact on the alternate construct. For example, whether a recruitment intervention might also impact retention.ResultsIn total, 806 of 17,767 articles screened for the recruitment database and 175 of 18,656 articles screened for the retention database were added as result of the update. Of these, 89 articles were classified as ‘randomised evaluation’, of which 6 were systematic reviews and 83 were randomised evaluations of methodological interventions. Ten of the randomised studies assessed recruitment and retention and were included in both databases. Of the randomised studies only in the recruitment database, 48/55 (87%) assessed the content or format of participant information which could have an impact on retention. Of the randomised studies only in the retention database, 6/18 (33%) assessed monetary incentives, 4/18 (22%) assessed data collection location and methods and 3/18 (17%) assessed non-monetary incentives, all of which could have an impact on recruitment.ConclusionOnly a small proportion of randomised studies of methodological interventions assessed the impact on both recruitment and retention despite having a potential impact on both outcomes. Where possible, an integrated approach analysing both constructs should be the new standard for these types of evaluations to ensure that improvements to recruitment are not at the expense of retention and vice versa.
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来源期刊
Clinical Trials
Clinical Trials 医学-医学:研究与实验
CiteScore
4.10
自引率
3.70%
发文量
82
审稿时长
6-12 weeks
期刊介绍: Clinical Trials is dedicated to advancing knowledge on the design and conduct of clinical trials related research methodologies. Covering the design, conduct, analysis, synthesis and evaluation of key methodologies, the journal remains on the cusp of the latest topics, including ethics, regulation and policy impact.
期刊最新文献
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