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

随机试验为医疗保健干预措施的有效性（和危害）提供了最佳证据，是循证医疗保健的重要组成部分。如果随机试验没有得到很好的报告，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，使用随机试验报告帮助他们做出决策的患者依赖于完整和透明的报告。CONSORT（Consolidated Standards of Reporting Trials）声明于1996年制定，旨在改善随机试验的报告。CONSORT以清单和流程图的形式为作者提供了一种标准的方法来编写试验结果报告，促进他们完整和透明的报告，并帮助他们进行批判性评估和解释。CONSORT声明最初发表于1996年，于2001年和2010年进行了更新。与缺乏明确和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。现在有越来越多的证据表明，SPIRIT和CONSORT对已发表文章的质量产生了有益的影响。CONSORT和SPIRIT被全球数百种医学期刊和组织使用和认可。CONSORT网站每年被浏览近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。自CONSORT更新以来已有10多年，自SPIRIT发布以来已有8年。此外，SPIRIT和CONSORT的一些扩展已被开发用于特定类型的随机试验。这项研究的目的是更新2013年SPIRIT和2010年CONSORT声明，包括整合关键扩展，并开发基于网络的资源，以促进遵守。我们将使用已建立的方法制定健康研究报告指南。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南。其次，我们将进行在线德尔菲调查，以决定：（1）对现有SPIRIT-CONSORT检查表项目的变更;（2）添加新的检查表项目（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资助机构、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（参与调查的代表）会议，就更新后的SPIRIT和CONSORT清单中的项目达成共识。最后，我们将制定和发布最新的SPIRIT和CONSORT指导声明以及随附的解释和说明文件，这些文件解释和说明了最新声明的基本原则。我们还将创建一个新的SPIRIT-CONSORT联合网站，并添加新的资源。我们将针对研究人员、期刊编辑和同行评审人员制作一个在线培训课程，解释SPIRIT和CONSORT指南的主要变化，现在应该使用它。我们还将创建一个单独的新门户网站SPIRIT-CONSORT网站，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及其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.