Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.
PLoS One. 2020 Nov 16;15(11):e0242239. doi: 10.1371/journal.pone.0242239. eCollection 2020.
Effective risk communication is challenging. Ensuring potential trial participants' understand 'risk' information presented to them is a key aspect of the informed consent process within clinical trials, yet minimal research has looked specifically at how to communicate probabilities to support decisions about trial participation. This study reports a systematic review of the literature focusing on presentation of probabilistic information or understanding of risk by potential trial participants.
A search strategy for risk communication in clinical trials was designed and informed by systematic reviews of risk communication in treatment and screening contexts and supplemented with trial participation terms. Extracted data included study characteristics and the main interventions/findings of each study. Explanatory studies that investigated the methods for presenting probabilistic information within participant information leaflets for a clinical trial were included, as were interventions that focused on optimising understanding of probabilistic information within the context of a clinical trial.
The search strategy identified a total of 4931 studies. Nineteen papers were selected for full text screening, and seven studies included. All reported results from risk communication studies that aimed to support potential trial participants' decision making set within hypothetical trials. Five of these were randomised comparisons of risk communication interventions, and two were prospectively designed, non-randomised studies. Study interventions focused on probability presentation, risk framing and risk interpretation with a wide variety of interventions being evaluated and considerable heterogeneity in terms of outcomes assessed. Studies show conflicting findings when it comes to how best to present information, although numerical, particularly frequency formats and some visual aids appear to have promise.
The evidence base surrounding risk communication in clinical trials indicates that there is as yet no clear optimal method for improving participant understanding, or clear consensus on how it affects their willingness to participate. Further research into risk communication within trials is needed to help illuminate the mechanisms underlying risk perception and understanding and provide appropriate ways to present and communicate risk in a trial context so as to further promote informed choices about participation. A key focus for future research should be to investigate the potential for learning in the evidence on risk communication from treatment and screening decisions when applied to decisions about trial participation.
有效的风险沟通具有挑战性。确保潜在的试验参与者理解向他们呈现的“风险”信息是临床试验中知情同意过程的关键方面，但很少有研究专门探讨如何传达概率信息以支持关于参与试验的决策。本研究报告了一项系统综述，重点关注潜在试验参与者对概率信息的呈现或对风险的理解。
设计了临床试验中风险沟通的搜索策略，该策略由治疗和筛查背景下风险沟通的系统综述提供信息，并辅以试验参与术语进行补充。提取的数据包括研究特征和每项研究的主要干预措施/发现。纳入了研究参与者信息单页中呈现概率信息方法的解释性研究，以及在临床试验背景下优化对概率信息理解的干预措施。
搜索策略共确定了 4931 项研究。有 19 篇论文被选作全文筛选，其中有 7 篇论文被纳入。所有研究都报告了旨在支持潜在试验参与者在假设试验中做出决策的风险沟通研究结果。其中 5 项是风险沟通干预措施的随机对照比较，2 项是前瞻性设计的非随机研究。研究干预措施侧重于概率呈现、风险框架和风险解释，评估了各种干预措施，并且在评估的结果方面存在很大的异质性。研究结果在如何最好地呈现信息方面存在矛盾的发现，尽管数值，特别是频率格式和一些视觉辅助工具似乎有希望。
临床试验中风险沟通的证据基础表明，目前尚不清楚哪种方法最能提高参与者的理解，也不清楚它如何影响他们参与的意愿。需要进一步研究试验中的风险沟通，以帮助阐明风险感知和理解的机制，并提供在试验背景下呈现和沟通风险的适当方法，以进一步促进对参与的知情选择。未来研究的一个重点应该是调查从治疗和筛查决策中应用于试验参与决策时风险沟通证据中的学习潜力。
