Reporting of randomised factorial trials: development of extensions to the CONSORT 2010 and SPIRIT 2013 guidance statements

随机因子试验的报告：CONSORT 2010 和 SPIRIT 2013 指导声明的扩展开发

• 批准号: MR/V020803/1
• 负责人: Alan Montgomery
• 金额: $ 16.74万
• 依托单位: University of Nottingham
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FV020803%2F1
• 关键词: Reporting; randomised; factorial; trials; development

CONTEXTRandomised trials provide the strongest evidence available about the effectiveness of health care interventions. Standards exist for reporting randomised trials so that users of evidence may clearly see strengths or deficiencies in study design or conduct that could affect the validity of the results. Widely adopted and evidence-based, SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) statements provide minimum recommendations for reporting protocols and results of randomised trials.Factorial randomised trials represent the potential for efficient evaluation of more than one intervention in the same study without the need for a larger sample size. In its simplest 2x2 form to test two interventions (A and B), participants are randomised to receive either no intervention, A alone, B alone or both A and B. Factorial trials have specific design and analysis considerations in addition to standard items specified in SPIRIT and CONSORT guidance. While extensions to SPIRIT and CONSORT exist for methodological variations, including different trial designs, interventions and types of data, extensions do not yet exist for factorial trials.AIMThe aim of this study is to develop extensions for reporting factorial randomised trials to the SPIRIT and CONSORT statements.METHODSWe will adopt similar methods as used previously to develop SPIRIT and CONSORT main statements and extensions. We will first conduct a scoping review of the literature to draw up a long list of items that we consider may be useful in reporting factorial trials. The scoping review will be completed prior to starting the present study and does not form part of the request for funding, but is included here for completeness.We will then conduct a Delphi study comprising (1) an online survey, and (2) a consensus meeting. For the online survey, we will contact stakeholders including clinical trials researchers with experience in the design/conduct/analysis/reporting of factorial trials, knowledge users, representatives from funding bodies, journal editors, and PPI (patient and public involvement) representatives. We will identify individuals from relevant publications and through research networks such as the MRC-NIHR Trials Methodology Research Partnership.As there is no formal method for estimating required sample size for a Delphi survey, we will aim to recruit the largest sample in the time available. Previous experience suggests that up to 130 individuals will be invited. Participants will be asked to complete two survey rounds in which they indicate importance of including items identified in the scoping review in a final list. They can also suggest new items in round 1. In round 2, they are presented with their own score from round 1 as well as summary scores from other participants. After survey round 2, we will use pre-defined criteria to define each item as 'consensus in', 'consensus out', or 'no consensus'.Following the survey, items defined as 'consensus out' will be discarded and all others will be taken forward for discussion at a consensus meeting. Participants at the meeting (approximately 30) will comprise stakeholders represented in the survey. Each item will be discussed and voted on for inclusion in the final list of items for SPIRIT and CONSORT extension.The final phase of the study involves writing and disseminating SPIRIT and CONSORT extension guidance and checklists, and a shared Explanation and Elaboration document.BENEFITSThe outputs of this research will provide investigators with a comprehensive framework for the design, conduct, analysis, interpretation and dissemination of factorial randomised trials. CONSORT and SPIRIT extensions will aid in critical appraisal and interpretation for grant reviewers, funding bodies, trial methodologists, journal editors, reviewers, and readers.

背景：随机试验为卫生保健干预措施的有效性提供了最有力的证据。存在报告随机试验的标准，以便证据使用者可以清楚地看到可能影响结果有效性的研究设计或行为的优点或缺点。SPIRIT（标准方案项目：干预性试验建议）和CONSORT（综合试验报告标准）声明被广泛采用并以证据为基础，为随机试验的报告方案和结果提供了最低限度的建议。因子随机试验代表了在同一研究中有效评估多个干预措施的潜力，而不需要更大的样本量。以最简单的2x2形式来测试两种干预措施（A和B），参与者被随机分配为不接受干预，单独接受A，单独接受B或同时接受A和B。除SPIRIT和CONSORT指南中指定的标准项目外，析因试验还具有特定的设计和分析考虑因素。虽然SPIRIT和CONSORT的扩展适用于方法的变化，包括不同的试验设计、干预措施和数据类型，但尚不存在用于析因试验的扩展。目的：本研究的目的是将报告因子随机试验扩展到SPIRIT和CONSORT声明。方法采用与以前类似的方法开发SPIRIT和CONSORT主语句和扩展。我们将首先对文献进行范围审查，以列出一长串我们认为可能对报告析因试验有用的项目。范围审查将在本研究开始之前完成，它不构成申请资金的一部分，但为了完整性起见，在这里包括在内。然后，我们将进行德尔菲研究，包括(1)在线调查和(2)共识会议。对于在线调查，我们将联系利益相关者，包括具有设计/实施/分析/报告析因试验经验的临床试验研究人员、知识使用者、资助机构代表、期刊编辑和PPI（患者和公众参与）代表。我们将从相关出版物和研究网络（如MRC-NIHR试验方法学研究伙伴关系）中确定个人。由于没有正式的方法来估计德尔菲调查所需的样本量，我们的目标是在可用的时间内招募最大的样本。以往的经验表明，将邀请多达130人。参与者将被要求完成两轮调查，在这两轮调查中，他们指出在最终清单中包括范围审查中确定的项目的重要性。他们也可以在第一轮中推荐新项目。在第二轮比赛中，他们会看到自己在第一轮比赛中的得分以及其他参与者的总成绩。在第2轮调查之后，我们将使用预先定义的标准将每个项目定义为“一致同意”，“一致反对”或“不一致”。调查结束后，定义为“协商一致”的项目将被丢弃，所有其他项目将在协商一致会议上进行讨论。会议的参与者（大约30人）将包括调查中所代表的利益相关者。每个项目都将被讨论和投票，以列入SPIRIT和CONSORT扩展的最终项目清单。研究的最后阶段包括编写和传播SPIRIT和CONSORT扩展指南和检查表，以及共享的Explanation和Elaboration文档。本研究的结果将为研究者提供一个设计、实施、分析、解释和传播析因随机试验的综合框架。CONSORT和SPIRIT扩展将有助于对拨款审稿人、资助机构、试验方法学家、期刊编辑、审稿人和读者进行批判性评估和解释。

项目成果

Reporting of randomised factorial trials: development of extensions to the CONSORT 2010 and SPIRIT 2013 guidance statements

随机因子试验的报告：CONSORT 2010 和 SPIRIT 2013 指导声明的扩展开发

• 发表时间: 2021
• 作者: Montgomery A

Reporting Factorial Trials (RAFT): Development of Extensions to CONSORT 2010 and SPIRIT 2013 Statements

报告因子试验 (RAFT)：CONSORT 2010 和 SPIRIT 2013 报表扩展的开发

• 发表时间: 2022
• 作者: Hall, S.S.