Plain English summary With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement?We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported. Abstract Background Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials [J Comp Eff Res 2012, 1:181-94, JAMA 2012, 307:1587-8]. Since POR's inception, questions have been raised as to how best to achieve this goal.We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main goal was to describe the characteristics of published trials engaging patients in research, and to identify the extent of patient engagement activities reported in these trials. Methods The MEDLINE®, EMBASE®, Cinahl, PsycINFO, Cochrane Methodology Registry, and Pubmed were searched from May 2011 to June 16th, 2016. Title, abstract and full text screening of all reports were conducted independently by two reviewers. Data were extracted from included trials by one reviewer and verified by a second. All trials that report patient engagement for the purposes of research were included. Results Of the 9490 citations retrieved, 2777 were reviewed at full text, of which 23 trials were included. Out of the 23 trials, 17 were randomized control trials, and six were non-randomized comparative trials. The majority of these trials (83%, 19/23) originated in the United States and United Kingdom. The trials engaged a range of 2-24 patients/ community representatives per study. Engagement of children and minorities occurred in 13% (3/23) and 26% (6/23) of trials; respectively. Engagement was identified in the development of the research question, the selection of study outcomes, and the dissemination and implementation of results. Conclusions The prevalence of patient engagement in patient-oriented interventional research is very poor with 23 trials reporting activities engaging patients. Research dedicated to determining the best practice for meaningful engagement is still needed, but adequate reporting measures also need to be defined.

中文翻译：

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患者参与已发表试验的患病率：系统评价。

简洁的英语摘要随着越来越多的患者参与研究，人们被问到谁参与了患者以及他们如何参与。在国际上，研究小组正在支持和资助以患者为中心的研究活动，这些活动将使患者参与研究重点的确定以及研究的设计，进行和采用。在前进的过程中，我们需要了解有意义的患者参与度如何，如何使研究和临床实践受益，以及患者参与度的障碍是什么？研究。我们既包括随机对照试验，也包括非随机对照试验。我们查看了这些试验的重要研究特征，包括患者的参与方式，以便更好地了解试验中使用的做法。重要的是，我们还讨论了报告患者参与实践的试验相对于所有已发表试验的数量。我们发现，尽管有许多主要的资助组织广泛支持，但很少有试验报告任何患者参与活动。我们的工作结果将通过展示如何使患者参与并强调需要更好地报告患者参与实践来推进以患者为中心的研究。摘要背景以患者为中心的研究（POR）是患者所接受的研究，并且集中在对他们重要的方面。POR的基本组成部分是将患者纳入从概念到传播和实施的整个研究过程中，并扩展为：从基础研究到实际试验的整个研究过程[J Comp Eff Res 2012，1：181-94，JAMA 2012，307：1587-8]。自POR成立以来，人们就如何最好地实现这一目标提出了疑问。我们对随机对照试验和非随机比较试验进行了系统的回顾，这些试验报告了患者参与研究的情况。我们的主要目标是描述使患者参与研究的已发表试验的特征，并确定这些试验中报告的患者参与活动的程度。方法从2011年5月至2016年6月16日，对MEDLINE®，EMBASE®，Cinahl，PsycINFO，Cochrane方法注册处和Pubmed进行搜索。所有报告的标题，摘要和全文均由两名审阅者独立进行。由一名审阅者从纳入的试验中提取数据，并由第二名进行验证。包括所有报告患者参与研究的试验。结果在检索到的9490篇文献中，对2777篇文献进行了全文审查，其中包括23项试验。在23项试验中，有17项是随机对照试验，有6项是非随机对照试验。这些试验中的大多数（83％，19/23）起源于美国和英国。这项研究每个研究招募了2-24位患者/社区代表。在试验中，有13％（3/23）和26％（6/23）的儿童和少数民族参与其中；分别。在研究问题的发展，研究结果的选择以及结果的传播和实施中确定了参与度。结论在以患者为中心的干预研究中，患者参与的患病率很低，有23个试验报告了患者参与的活动。仍然需要致力于确定有意义的参与的最佳实践的研究，但是还需要定义适当的报告措施。