Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions
Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions
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DOI：
10.1136/bmjopen-2019-035730
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发表时间：
2020-01-01
期刊：
影响因子：
2.9
通讯作者：
Gillies, Katie
中科院分区：
文献类型：
--
作者：
Raza, M. Zulfiqar;Bruhn, Hanne;Gillies, Katie
目的确定由英国研究伦理委员会向参与者提供试验结果并给予有利意见的III期临床试验的比例。设计记录审核。2012年1月1日至2017年12月31日期间在英国研究许可系统（综合研究申请系统）注册的III期临床试验。主要结果测量试验研究者打算向试验参与者提供结果的比例，与研究结束时向伦理委员会报告的结果相比。在1404项III期试验中，87.7% （n=1231）的试验表示他们打算向参与者传播结果，而12.3% （n=173）的试验表示他们不会。在这1231项试验中，18.8% （n=231）的试验打算积极地向参与者传达试验结果或获取结果的方法，另有80.5% （n=991）的试验报告了被动传播的意图，其余（n=9）的试验过程不清楚。在可查阅的370份研究结束报告（占所有纳入研究的30%）中，10份（2.7%）明确提到了向参与者传播研究结果的相关活动，大多数（74.9%）没有提及，另有22.4%的报告无法查阅。在向参与者报告结果传播的10个机构中，大多数（n=6）是通过外行摘要或信件进行的。研究人员向试验参与者传播结果的意愿较高，但缺乏反馈方法的报告。此外，需要建立确保将传播试验结果的意图转化为实际行为的机制，以确保参与试验的人有机会了解结果。
ObjectiveTo determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.DesignAudit of records.SettingPhase III clinical trials registered on the UK's research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.Main outcome measuresProportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.ResultsOut of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.ConclusionsReported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.