Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.
Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.
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DOI：
10.1186/s12916-018-1196-2
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发表时间：
2018-11-16
期刊：
影响因子：
9.3
通讯作者：
Altman DG
中科院分区：
文献类型：
--
作者：
Dimairo M;Coates E;Pallmann P;Todd S;Julious SA;Jaki T;Wason J;Mander AP;Weir CJ;Koenig F;Walton MK;Biggs K;Nicholl J;Hamasaki T;Proschan MA;Scott JA;Ando Y;Hind D;Altman DG
充分报告适应性设计（AD）可最大限度地提高其在临床试验中的潜在获益。透明的报告可以帮助解决与使用广告有关的一些障碍和问题。目前，AD试验的报告存在缺陷。为了克服这一点，我们开发了一种共识驱动的扩展CONSORT声明，用于使用AD的随机试验。本文描述了用于开发此扩展的过程和方法，而不是详细解释该指南。建立在先前研究的基础上，为指南的需要提供信息;范围界定文献综述，为未来阶段提供信息;起草涉及外部专家小组的第一个清单版本;涉及国际、多学科和跨部门关键利益相关者的两轮德尔菲过程;举行协商一致会议，通过表决建议保留哪些报告项目，并讨论辅助解释和阐述文件的结构;完善和最后确定清单;以及收集和分发辅助解释和阐述文件。我们在七个重叠的阶段制定了该指南：CONSORT执行小组监督整个开发过程。德尔菲调查的回答率在第1轮、第2轮和两轮中分别为94/143（66%）、114/156（73%）和79/143（55%）。来自欧洲、美国和亚洲的27名代表出席了共识会议。主要检查表有7个新项目、9个修改项目和6个不变项目，并扩大了E&E文本，以澄清AD的进一步考虑因素。摘要清单有一个新的和一个修改的项目，以及一个不变的项目，扩展了E&E文本。E&E文件将描述指南的范围、AD的定义以及AD和试验适应的某些类型，并详细解释每个报告项目，包括案例研究。我们希望，使开发过程、方法和所有辅助决策的支持信息透明化，将提高指南的可接受性和快速吸收。这也将有助于其他团体开发类似的CONSORT扩展。该指南适用于所有AD随机试验，并包含最低报告要求。本文的在线版本（10.1186/s12916-018-1196-2）包含补充材料，可供授权用户使用。
Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. Building on prior research to inform the need for a guideline; A scoping literature review to inform future stages; Drafting the first checklist version involving an External Expert Panel; A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; Refining and finalising the checklist; and Writing-up and dissemination of the E&E document. We developed the guideline in seven overlapping stages: The CONSORT Executive Group oversaw the entire development process. Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements. The online version of this article (10.1186/s12916-018-1196-2) contains supplementary material, which is available to authorized users.
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自适应设计中的概述，障碍和未来的工作：来自国立卫生研究院资助的研讨会的观点。
DOI：
10.1177/1740774512461859
发表时间：
2012-12
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Coffey CS;Levin B;Clark C;Timmerman C;Wittes J;Gilbert P;Harris S
通讯作者：
Harris S
影响因子：
2.9
作者：
Bothwell LE;Avorn J;Khan NF;Kesselheim AS
通讯作者：
Kesselheim AS
影响因子：
1.1
作者：
Chuang-Stein, Christy;Beltangady, Mohan
通讯作者：
Beltangady, Mohan
影响因子：
2
作者：
Bauer P;Bretz F;Dragalin V;König F;Wassmer G
通讯作者：
Wassmer G
影响因子：
3.7
作者：
Chow SC;Chang M
通讯作者：
Chang M