Patient and public involvement in pragmatic trials: online survey of corresponding authors of published trials.

CMAJ open Pub Date : 2023-09-19 Print Date: 2023-09-01 DOI:10.9778/cmajo.20220198
Shelley Vanderhout, Pascale Nevins, Stuart G Nicholls, Colin Macarthur, Jamie C Brehaut, Beth K Potter, Kate Gillies, Beatriz Goulao, Maureen Smith, Alicia Hilderley, Kelly Carroll, Anne Spinewine, Charles Weijer, Dean A Fergusson, Monica Taljaard
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Abstract

Background: There are few data on patient and public involvement (PPI) in pragmatic trials. We aimed to describe the prevalence and nature of PPI within pragmatic trials, describe variation in prevalence of PPI by trial characteristics and compare prevalence of PPI reported by trial authors to that reported in trial publications.

Methods: We applied a search filter to identify pragmatic trials published from 2014 to 2019 in MEDLINE. We invited the corresponding authors of pragmatic trials to participate in an online survey about their specific trial.

Results: Of 3163 authors invited, 2585 invitations were delivered, 710 (27.5%) reported on 710 unique trials and completed the survey; 334 (47.0%) conducted PPI. Among those who conducted PPI, for many the aim was to increase the research relevance (86.3%) or quality (76.5%). Most PPI partners were engaged at protocol development stages (79.1%) and contributed to the co-design of interventions (70.9%) or recruitment or retention strategies (60.5%). Patient and public involvement was more common among trials involving children, trials conducted in the United Kingdom, cluster randomized trials, those explicitly labelled as "pragmatic" in the study manuscript, and more recent trials. Less than one-quarter of trials (22.8%) that reported PPI in the survey also reported PPI in the trial manuscript.

Interpretation: Nearly half of trialists in this survey reported conducting PPI and listed several benefits of doing so, but researchers who did not conduct PPI often cited a lack of requirement for it. Patient and public involvement appears to be significantly underreported in trial publications. Consistent and standardized reporting is needed to promote transparency about PPI methods, outcomes, challenges and benefits.

Abstract Image

患者和公众参与实用试验:对已发表试验通讯作者的在线调查。
背景:在实用试验中,很少有关于患者和公众参与(PPI)的数据。我们的目的是在实用试验中描述PPI的患病率和性质,根据试验特征描述PPI患病率的变化,并将试验作者报告的PPI发病率与试验出版物中报告的进行比较。方法:我们应用搜索过滤器来识别2014年至2019年在MEDLINE上发表的语用试验。我们邀请了语用试验的通讯作者参加一项关于他们具体试验的在线调查。结果:在3163名受邀作者中,2585人收到了邀请,710人(27.5%)报告了710项独特的试验并完成了调查;334例(47.0%)进行PPI。在那些进行PPI的人中,对许多人来说,目的是提高研究相关性(86.3%)或质量(76.5%)。大多数PPI合作伙伴在方案制定阶段(79.1%)参与干预措施的共同设计(70.9%)或招募或保留策略(60.5%)。在涉及儿童的试验中,患者和公众的参与更为常见,在英国进行的试验,集群随机试验,研究手稿中明确标记为“务实”的试验,以及最近的试验。在调查中报告PPI的试验中,只有不到四分之一(22.8%)在试验手稿中也报告了PPI。解释:在这项调查中,近一半的试验人员报告进行了PPI,并列出了这样做的几个好处,但没有进行PPI的研究人员经常指出缺乏对PPI的要求。试验出版物中似乎严重低估了患者和公众的参与。需要一致和标准化的报告,以提高PPI方法、结果、挑战和收益的透明度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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