School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Health Research Board-Trials Methodology Research Network, School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Trials. 2022 Mar 9;23(1):205. doi: 10.1186/s13063-021-05984-1.
Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials. The People's Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims by actively involving them in all aspects of trial design. This was done by involving the public in the design, conduct, and dissemination of a randomised trial.
Using a reflexive approach, we describe the processes of development, conduct, and dissemination of The People's Trial.
Over 3000 members of the public, from 72 countries, participated in The People's Trial. Through a series of online surveys, the public designed a trial called The Reading Trial. They chose the question the trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e. 'Does reading a book in bed make a difference to sleep in comparison with not reading a book in bed?' We report the processes of The People's Trial in seven phases, paralleling the steps of a randomised trial, i.e. question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned.
The People's Trial involved the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims.
ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.
随机对照试验被认为是提供干预有效性确凿证据的金标准。然而，很少有举措来帮助公众更多地了解随机对照试验是什么以及为什么它们很重要。这限制了公众对临床试验的总体接受程度和参与度。“人民试验”旨在帮助公众了解随机对照试验，了解其重要性，并通过积极让他们参与试验设计的各个方面，使他们更有能力批判性地思考健康声明。这是通过让公众参与随机对照试验的设计、实施和传播来实现的。
我们使用反思的方法，描述了“人民试验”的开发、实施和传播过程。
来自 72 个国家的 3000 多名公众参与了“人民试验”。通过一系列在线调查，公众设计了一项名为“阅读试验”的试验。他们选择了试验要尝试回答的问题，并决定了试验问题的组成部分。2019 年 12 月，991 名参与者被招募到一项试验中，以回答公众确定并优先考虑的问题，即“与不躺在床上看书相比，在床上看书对睡眠有影响吗？”我们报告了“人民试验”的七个阶段的过程，与随机试验的步骤平行，即问题识别和优先排序、招募、随机化、试验实施、数据分析和结果共享。我们描述了我们做出的决策、使用的过程、遇到的挑战和吸取的教训。
“人民试验”成功地让公众参与了随机试验的设计、实施和传播，证明了此类举措有潜力帮助公众了解随机试验，了解其重要性，并使他们更有能力批判性地思考健康声明。
ClinicalTrials.gov NCT04185818。于 2019 年 12 月 4 日注册。
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