CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts
CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts
复制标题
DOI：
10.7326/m17-0046
复制
发表时间：
2017-07-04
影响因子：
39.2
通讯作者：
Ravaud, Philippe
中科院分区：
文献类型：
--
作者：
Boutron, Isabelle;Altman, Douglas G.;Ravaud, Philippe
不完整和不充分的报告是一种可以避免的浪费，会降低研究的有用性。CONSORT（报告试验的统一标准）声明是一项以证据为基础的报告指南，旨在提高研究透明度并减少浪费。2008年，CONSORT小组对原始声明进行了扩展，解决了非药物治疗（NPT）试验的方法学问题，如手术，康复或心理治疗。本文介绍了该扩展的更新，并提出了一个扩展报告摘要的不扩散条约审判。为了编写这些材料，作者回顾了截至2016年7月发表的相关文献;调查了NPT试验的作者;并与编辑、试验者和方法学家举行了共识会议。NPT试验CONSORT声明扩展的变更包括措辞修改以提高读者的理解，并增加了3个新项目。这些项目涉及是否以及如何评估或增强受试者对干预措施的依从性，描述在不可能设盲的情况下限制偏倚的尝试，以及说明随机化和开始干预之间的延迟。NPT试验摘要的CONSORT扩展包括2个在原始摘要CONSORT声明中未指定的新项目。第一个解决报告的资格标准的中心进行干预和护理提供者。第二个问题是报告干预措施相对于计划的重要变化。更新后的《不扩散核武器条约》试验的CONSORT扩展和《不扩散核武器条约》试验摘要的CONSORT扩展都应有助于作者、编辑和同行评审者提高《不扩散核武器条约》试验报告的透明度。
Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidence-based reporting guideline that aims to improve research transparency and reduce waste. In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists.Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items. These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention. The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers. The second addresses reporting of important changes to the intervention versus what was planned. Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.