Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.
Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.
复制标题
DOI：
10.1186/s13063-021-05300-x
复制
发表时间：
2021-05-24
期刊：
影响因子：
2.5
通讯作者：
Gillies K
中科院分区：
文献类型：
--
作者：
Bruhn H;Cowan EJ;Campbell MK;Constable L;Cotton S;Entwistle V;Humphreys R;Innes K;Jayacodi S;Knapp P;South A;Gillies K
向参与者提供试验结果是一种道德义务。现有的研究强调，尽管参与者希望收到他们参与的试验结果，但只有不到三分之一的试验这样做。该范围审查旨在识别、整理和描述与向受试者传播试验结果的任何方面相关的可用证据。通过检索关键数据库（MEDLINE、EMBASE、PsycINFO和2008年1月至2019年8月的护理与相关健康文献累积索引（CINAHL））进行了范围审查，以确定探索向试验参与者传播结果的任何方面的研究。检索策略基于相关的现有综述。识别的证据使用叙述性描述描述了纳入研究的特征，并通过使用描述性统计分析相关数据获得信息。确定并纳入了33项合格研究，包括12，700名参与者（包括患者，医疗保健专业人员，试验团队）。研究中参与者特征（年龄、性别、种族）的报告很差。大多数研究调查了汇总试验结果的传播。据报告，最常见的结果传播方式是邮寄。总体而言，结果报告称，参与者对收到试验结果的评价是积极的，报告的益处包括改善沟通、表达赞赏、提高保留率和参与未来的研究。然而，也有人对传播的资源和效果表示关切，担心对参与者的情绪影响，特别是在报告不利结果时，以及对试验结束和收到结果之间的延迟感到沮丧。该范围审查强调，几乎没有进行高质量的评价性研究，可以提供证据证明向试验参与者提供结果的最佳方式。有相对较少的定性研究，探讨不同人群的观点，那些已经进行的仅限于少数临床领域。从这些研究中获得的经验可以作为进一步研究的平台，并在向参与者传播试验结果时考虑一些关于机遇和挑战的核心指导原则。在线版本包含补充材料，可通过10.1186/s13063-021-05300-x获取。
There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated. The online version contains supplementary material available at 10.1186/s13063-021-05300-x.
登录
查看更多内容
影响因子：
2.8
作者：
Cox, Karen;Moghaddam, Nima;Bird, Lydia;Elkan, Ruth
通讯作者：
Elkan, Ruth
影响因子：
4.4
作者：
Getz, Kenneth;Hallinan, Zachary;Morrison, Briggs
通讯作者：
Morrison, Briggs
影响因子：
1.5
作者：
Dietrich, Julie;Alivojvodic, Jeannine;Jakee, Kelsey
通讯作者：
Jakee, Kelsey
影响因子：
2.7
作者：
Dixon-Woods, Mary;Tarrant, Carolyn;Kenyon, Sara
通讯作者：
Kenyon, Sara
影响因子：
2.5
作者：
Avins AL;Bent S;Padula A;Staccone S;Badua E;Goldberg H
通讯作者：
Goldberg H