Patient and public involvement in pragmatic trials: online survey of corresponding authors of published trials.
Patient and public involvement in pragmatic trials: online survey of corresponding authors of published trials.
复制标题
DOI：
10.9778/cmajo.20220198
复制
发表时间：
2023-09
期刊：
影响因子：
--
通讯作者：
Taljaard M
中科院分区：
文献类型：
--
作者：
Vanderhout S;Nevins P;Nicholls SG;Macarthur C;Brehaut JC;Potter BK;Gillies K;Goulao B;Smith M;Hilderley A;Carroll K;Spinewine A;Weijer C;Fergusson DA;Taljaard M
关于务实试验中患者和公众参与（PPI）的数据很少。我们的目的是描述PPI在实用性试验中的患病率和性质，通过试验特征描述PPI患病率的变化，并将试验作者报告的PPI患病率与试验出版物中报告的PPI患病率进行比较。我们应用检索过滤器来识别2014年至2019年在MEDLINE中发表的实用性试验。我们邀请了语用试验的通讯作者参加一个关于他们具体试验的在线调查。在3163位受邀作者中，2585位发出了邀请，710位（27.5%）报告了710项独特试验并完成了调查; 334位（47.0%）进行了PPI。在进行PPI的人中，许多人的目的是提高研究的相关性（86.3%）或质量（76.5%）。大多数PPI合作伙伴参与方案制定阶段（79.1%），并为干预措施（70.9%）或招募或保留策略（60.5%）的共同设计做出贡献。在涉及儿童的试验、在英国进行的试验、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中，患者和公众参与更为常见。在调查中报告PPI的试验中，不到四分之一（22.8%）也在试验手稿中报告了PPI。在这项调查中，近一半的试验者报告进行了PPI，并列出了这样做的几个好处，但没有进行PPI的研究人员往往认为缺乏对它的要求。需要一致和标准化的报告，以提高生产者价格指数方法、成果、挑战和惠益的透明度。
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. 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. 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. 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.