随机对照试验报告中替代终点的报告(CONSORT-Surrogate):扩展清单及解释和说明。
Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration.
机构信息
MRC/CSO Social and Public Health Sciences Unit, School of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.
出版信息
BMJ. 2024 Jul 9;386:e078524. doi: 10.1136/bmj-2023-078524.
Randomised controlled trials commonly use surrogate endpoints to substitute for a target outcome (outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve their efficiency (through shorter trial duration, reduced sample size, and thus lower research costs), or for ethical or practical reasons. But reliance on surrogate endpoints can increase the uncertainty of an intervention’s treatment effect and potential failure to provide adequate information on intervention harms, which has led to calls for improved reporting of trials using surrogate endpoints. This report presents a consensus driven reporting guideline for trials using surrogate endpoints as the primary outcomes—the CONSORT (Consolidated Standards of Reporting Trials) extension checklist: CONSORT-Surrogate. The extension includes nine items modified from the CONSORT 2010 checklist and two new items. Examples and explanations for each item are provided. We recommend that all stakeholders (including trial investigators and sponsors, journal editors and peer reviewers, research ethics reviewers, and funders) use this extension in reporting trial reports using surrogate endpoints. Use of this checklist will improve transparency, interpretation, and usefulness of trial findings, and ultimately reduce research waste.
随机对照试验通常使用替代终点来替代目标结局(直接关注和与试验参与者、临床医生和其他利益相关者相关的结局,例如全因死亡率),以提高效率(通过缩短试验持续时间、减少样本量,从而降低研究成本),或出于伦理或实际原因。但是,依赖替代终点可能会增加干预治疗效果的不确定性,以及潜在的无法提供干预危害充分信息的风险,这导致人们呼吁改进使用替代终点的试验报告。本报告提出了一个基于替代终点作为主要结局的试验的共识驱动报告指南——CONSORT(临床试验报告的统一标准)扩展清单:CONSORT-Surrogate。该扩展包括从 CONSORT 2010 清单修改的九个项目和两个新项目。每个项目都提供了示例和解释。我们建议所有利益相关者(包括试验研究者和赞助商、期刊编辑和同行评审者、研究伦理审查者和资助者)在报告使用替代终点的试验报告时使用此扩展。使用此清单将提高试验结果的透明度、解释和有用性,并最终减少研究浪费。
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