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

提高随机试验的透明度和报告：更新 SPIRIT 2013 和 CONSORT 2010 声明

• 批准号: MR/W020483/1
• 负责人: Sally Hopewell
• 金额: $ 28.49万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FW020483%2F1
• 关键词: Enhancing; transparency; reporting; randomised; trials

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.

随机试验提供了医疗干预措施有效性（和危害）的最佳证据，并且是基于证据的医疗保健至关重要的一部分。如果据报道，随机试验尚未得到充分报道，临床医生和决策者很难使用最佳证据来为最佳实践提供信息。同样，使用随机试验的报告来帮助他们的决策依赖于完整和透明的报告。 1996年制定了配偶（报告试验的合并标准）声明，以试图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方式，以准备试验结果的报告，促进其完整透明的报告，并协助他们的批判性评估和解释。该Consort声明最初于1996年发表，于2001年更新，然后在2010年更新。与缺乏清晰透明的试验协议报告有关的类似问题，导致Spirit的发展（标准协议项目：介入试验的建议）在2013年的陈述。还开发了对精神和配偶的扩展，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论问题。现在有大量的证据表明，精神和配偶对已发表文章的质量产生了有益的影响。全世界数百种医学期刊和组织都使用并认可配偶和精神。每年，每年都会浏览Consort网站将近四分之一百万次。重要的是，精神和配偶保持最新状态，以反映新的证据和不断变化的意见。自从Consort更新以来已有10多年的历史，自精神出版以来已有8年了。此外，已经为特定类型的随机试验开发了许多对精神和配偶的扩展。这项研究的目的是更新2013年精神和2010年的Consort声明，包括关键扩展的整合，并开发基于Web的资源以促进其依从性。我们将使用既定方法来制定健康研究报告指南。首先，我们将对文献进行范围审查，以确定与报告协议报告和随机试验结果相关的新证据和指导。其次，我们将进行在线Delphi调查，以决定：（1）更改现有的Spirit-Consort清单项目； （2）添加新的清单项目（从范围审查中确定或由Delphi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，知识使用者和资助机构，伦理委员会，医学期刊，监管机构以及患者和公共参与小组的代表。第三，我们将组织各种利益相关者（在调查中代表）的会议，以在更新的精神和配偶清单中建立对项目的共识。最后，我们将开发和发布更新的精神和配偶指导声明以及随附的解释和详细文档，这些声明和说明了更新的陈述的原则。我们将开设一个针对研究人员，期刊编辑和同行评审者的在线培训课程，以解释精神和配偶指导的主要变化，现在应该使用它。我们还将为专门针对患者的Spirit-Consort网站创建一个单独的新门户，并解释了清晰透明的随机试验报告的重要性及其在提供基于证据的医疗保健方面的重要性。

项目成果

A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010.

范围界定审查发现了多个建议修改 SPIRIT 2013 和 CONSORT 2010 的评论。

• DOI: 10.1016/j.jclinepi.2023.01.003
• 发表时间: 2023
• 期刊: Journal of clinical epidemiology
• 影响因子: 7.2
• 作者: Nejstgaard CH