School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK
Centre for Trials Research, Cardiff University, UK.
BMJ. 2020 Jun 17;369:m115. doi: 10.1136/bmj.m115.
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.
适应性设计(ADs)允许对正在进行的试验进行预先计划的更改,而不会影响结论的有效性,因此必须区分预先计划的更改和可能发生的未计划的更改。随机试验中 AD 的报告不一致,需要改进。未充分报告的 AD 随机试验难以重现,难以解释和综合。这反过来又阻碍了它们为实践以及未来的研究提供信息的能力,并导致了研究浪费。更好的透明度和充分的报告将使 AD 的潜在益处得以实现。本 CONSORT 2010 声明的扩展旨在增强随机 AD 临床试验的报告。我们通过来自 21 个国家的公共和私营部门临床试验研究多学科关键利益相关者的两阶段 Delphi 过程以及共识会议,制定了适应性设计 CONSORT 扩展(ACE)指南。CONSORT 小组的成员参与了制定过程。本文介绍了 AD 随机试验报告和摘要的 ACE 检查表,并提供了示例解释,以帮助应用指南。ACE 检查表包括七个新项目、九个修改项目、六个不变项目,这些项目增加了额外的解释性文本,进一步考虑了 AD 的情况,以及 20 个不变项目,不需要进一步的解释性文本。ACE 摘要检查表有一个新项目、一个修改项目、一个不变项目,带有 AD 的额外解释性文本,以及 15 个不变项目,不需要进一步的解释性文本。目的是提高透明度,改进 AD 随机试验的报告,以提高其结果的可解释性和方法、结果和推断的可重现性。我们还希望间接地促进急需的创新试验设计的知识转移,以最大限度地发挥其潜在益处。
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