Enhancing the transparency and reporting of randomised trials: update of the SPIRIT 2013 and CONSORT 2010 Statements

随机试验为卫生保健干预措施的有效性（和危害）提供了最好的证据，是循证卫生保健的一个至关重要的组成部分。如果随机试验没有得到很好的报道，临床医生和政策制定者就很难使用最佳证据来指导最佳实践。同样，使用随机试验报告来帮助他们做出决策的患者也依赖于完整和透明的报告。CONSORT（试验报告综合标准）声明于1996年制定，旨在改进随机试验的报告。以检查表和流程图的形式，CONSORT为作者提供了一种标准的方法来准备试验结果报告，促进他们的完整和透明的报告，并帮助他们进行批判性的评估和解释。CONSORT声明最初发表于1996年，先后于2001年和2010年进行了更新。与缺乏清晰透明的试验方案报告相关的类似问题导致2013年制定了SPIRIT（标准方案项目：干预性试验建议）声明。还开发了SPIRIT和CONSORT的扩展，以解决与报告不同类型的试验设计、数据和报告不同类型的干预措施相关的方法学问题。现在有大量且越来越多的证据表明，SPIRIT和CONSORT对发表文章的质量产生了有益的影响。CONSORT和SPIRIT被全球数百家医学期刊和组织使用和认可。CONSORT网站每年的访问量接近25万次。重要的是，SPIRIT和CONSORT保持最新，以反映新的证据和不断变化的意见。《CONSORT》更新至今已有10多年，《SPIRIT》出版至今已有8年。此外，针对特定类型的随机试验，已经开发了SPIRIT和CONSORT的一些扩展。本研究的目的是更新SPIRIT 2013和CONSORT 2010声明，包括关键扩展的整合，并开发基于网络的资源以促进其遵守。我们将采用既定方法制定卫生研究报告准则。首先，我们将对文献进行范围审查，以确定与随机试验方案和结果报告相关的新证据和指导。其次，我们将进行在线德尔菲调查，以决定：(1)修改现有的SPIRIT-CONSORT清单项目；(2)增加新的清单项目（从范围审查中确定或由德尔菲调查参与者建议）。调查参与者将包括经验丰富的临床试验研究人员、知识使用者以及来自供资机构、伦理委员会、医学期刊、监管机构以及患者和公众参与团体的代表。第三，我们将组织一次广泛的利益相关者（在调查中有代表）会议，就更新后的SPIRIT和CONSORT清单中的项目达成共识。最后，我们将开发和发布更新的SPIRIT和CONSORT指导声明以及随附的解释和阐述文件，这些文件解释和说明了更新的声明背后的原则。我们还将创建一个新的SPIRIT-CONSORT联合网站，并增加新的资源。我们将制作一个针对研究人员、期刊编辑和同行评审的在线培训课程，解释SPIRIT和CONSORT指南的主要变化，以及现在应该使用它。我们还将在SPIRIT-CONSORT网站上创建一个单独的新门户，专门针对患者和公众，解释清晰透明的随机试验报告的重要性，以及它们在提供循证医疗保健方面的重要性。

Randomised trials provide the best evidence of the effectiveness (and harms) of health care interventions and are a crucially important part of evidence-based health care. If randomised trials are not well reported it is difficult for clinicians and policymakers to use best evidence to inform best practice. Similarly, patients using the reports of randomised trials to help inform their decision making rely on complete and transparent reporting. The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed in 1996 to try to improve the reporting of randomised trials. In the form of a checklist and flow diagram, CONSORT offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. Originally published in 1996, the CONSORT Statement was updated in 2001 and then in 2010. Similar problems related to lack of clear and transparent reporting of trial protocols led to development of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement in 2013. Extensions to SPIRIT and CONSORT have been also developed to tackle the methodological issues associated with reporting different types of trial designs, data and reporting different types of interventions. There is now a large and increasing body of evidence that SPIRIT and CONSORT have had a beneficial impact on the quality of published articles. CONSORT and SPIRIT are used and endorsed of by hundreds of medical journals and organisations worldwide. The CONSORT website is viewed nearly a quarter of a million times, annually. It is important that SPIRIT and CONSORT are kept up to date to reflect new evidence and changing opinion. It has been more than 10 years since CONSORT was updated and 8 years since publication of SPIRIT. In addition, a number of extensions to SPIRIT and CONSORT have been developed for specific types of randomised trials. The aim of this research study is to update the SPIRIT 2013 and CONSORT 2010 Statements, including integration of key extensions, and to develop web-based resources to promote their adherence. We will use established methods for development of health research reporting guidelines. First, we will conduct a scoping review of the literature to identify new evidence and guidance of relevance to the reporting of protocols and results of randomised trials. Second, we will conduct an online Delphi survey to decide: (1) changes to existing SPIRIT-CONSORT checklist items; (2) adding of new checklist items (identified from the scoping review or suggested by the Delphi survey participants). Survey participants will include experienced clinical trial researchers, knowledge users and representatives from funding bodies, ethics committees, medical journals, regulatory agencies and patient and public involvement groups. Third, we will organise a meeting of a broad range of stakeholders (represented in the survey) to establish consensus on items to be included in the updated SPIRIT and CONSORT checklists. Finally, we will develop and publish the updated SPIRIT and CONSORT guidance Statements and accompanying Explanation and Elaboration documents, which explain and illustrate the principles underlying the updated Statements.We will also create a new joint SPIRIT-CONSORT website and add new resources. We will produce an online training course aimed at researchers, journal editors and peer reviewers explaining the main changes to the SPIRIT and CONSORT guidance and now it should be used. We will also create a separate new portal to the SPIRIT-CONSORT website specifically aimed at patients and the public explaining the importance of clear and transparent reporting of randomised trials and their importance in the delivery of evidence based healthcare.