英国伦敦帝国理工学院Rachel Phillips团队对随机对照试验出版物中的危害可视化提出共识与建议。这一研究成果于2022年5月16日发表在《英国医学杂志》上。

为了通过制定危害结果可视化的建议，来改善随机对照试验出版物中的危害沟通，研究组进行了一项共识研究。15个临床试验单位在英国临床研究协作组织、学术人口卫生部、罗氏产品公司和英国医学杂志注册。临床试验专家包括20名学术统计学家、1名行业统计学家、1名学术健康经济学家、1名数据图形设计师和2名临床医生。

对统计方法的方法学审查确定了可视化方法以及共识小组成员推荐的方法。与参与者举行的一系列三次会议就可视化建议达成了共识（至少60%的可用票数）。参与者根据商定的框架审查和批判性地评估候选可视化方案，并投票决定是否支持每种可视化方案。略微低于这一阈值（50-60%）的分数会再次进行讨论，并重新投票，直到达成共识。

研究组共考虑了28种可视化方案，其中10种建议研究人员在主要研究结果的出版物中考虑。呈现的可视化选择将取决于结果类型（例如，二进制、计数、事件发生时间或连续）和场景（例如，总结多个新出现的事件或某个感兴趣的事件）。

研究组提出了一个决策树来帮助试验者决定使用哪种可视化。文中提供了每种认可可视化的示例，以及示例解释、潜在限制和代码标志，以便在一系列标准统计软件中实现。临床医生的反馈被纳入建议提供的解释性信息中，以帮助理解和解释。

研究结果表明，可视化为在临床试验中传达危害提供了一个强大的工具，为传统频率表提供了另一种视角。在临床试验手稿和报告中增加对危害结果的可视化使用，将提供更清晰的信息呈现，并提供更多信息的解释。

研究组讨论了每种可视化的局限性，并给出了不适合使用它们的例子。尽管决策树有助于可视化的选择，但统计学家和临床试验团队必须最终为他们的数据和目标确定最合适的可视化。试验人员应继续检查粗略的数据和可视化，以充分了解危害概况。

附：英文原文

Title: Visualising harms in publications of randomised controlled trials: consensus and recommendations

Author: Rachel Phillips, Suzie Cro, Graham Wheeler, Simon Bond, Tim P Morris, Siobhan Creanor, Catherine Hewitt, Sharon Love, Andre Lopes, Iryna Schlackow, Carrol Gamble, Graeme MacLennan, Chris Habron, Anthony C Gordon, Nikhil Vergis, Tianjing Li, Riaz Qureshi, Colin C Everett, Jane Holmes, Amanda Kirkham, Clare Peckitt, Sarah Pirrie, Norin Ahmed, Laura Collett, Victoria Cornelius

Issue&Volume: 2022/05/16

Abstract:

Objective To improve communication of harm in publications of randomised controlled trials via the development of recommendations for visually presenting harm outcomes.

Design Consensus study.

Setting 15 clinical trials units registered with the UK Clinical Research Collaboration, an academic population health department, Roche Products, and TheBMJ.

Participants Experts in clinical trials: 20 academic statisticians, one industry statistician, one academic health economist, one data graphics designer, and two clinicians.

Main outcome measures A methodological review of statistical methods identified visualisations along with those recommended by consensus group members. Consensus on visual recommendations was achieved (at least 60% of the available votes) over a series of three meetings with participants. The participants reviewed and critically appraised candidate visualisations against an agreed framework and voted on whether to endorse each visualisation. Scores marginally below this threshold (50-60%) were revisited for further discussions and votes retaken until consensus was reached.

Results 28 visualisations were considered, of which 10 are recommended for researchers to consider in publications of main research findings. The choice of visualisations to present will depend on outcome type (eg, binary, count, time-to-event, or continuous), and the scenario (eg, summarising multiple emerging events or one event of interest). A decision tree is presented to assist trialists in deciding which visualisations to use. Examples are provided of each endorsed visualisation, along with an example interpretation, potential limitations, and signposting to code for implementation across a range of standard statistical software. Clinician feedback was incorporated into the explanatory information provided in the recommendations to aid understanding and interpretation.

Conclusions Visualisations provide a powerful tool to communicate harms in clinical trials, offering an alternative perspective to the traditional frequency tables. Increasing the use of visualisations for harm outcomes in clinical trial manuscripts and reports will provide clearer presentation of information and enable more informative interpretations. The limitations of each visualisation are discussed and examples of where their use would be inappropriate are given. Although the decision tree aids the choice of visualisation, the statistician and clinical trial team must ultimately decide the most appropriate visualisations for their data and objectives. Trialists should continue to examine crude numbers alongside visualisations to fully understand harm profiles.

DOI: 10.1136/bmj-2021-068983

Source: https://www.bmj.com/content/377/bmj-2021-068983