Chan An-Wen, Boutron Isabelle, Hopewell Sally, Moher David, Schulz Kenneth F, Collins Gary S, Tunn Ruth, Aggarwal Rakesh, Berkwits Michael, Berlin Jesse A, Bhandari Nita, Butcher Nancy J, Campbell Marion K, Chidebe Runcie C W, Elbourne Diana R, Farmer Andrew J, Fergusson Dean A, Golub Robert M, Goodman Steven N, Hoffmann Tammy C, Ioannidis John P A, Kahan Brennan C, Knowles Rachel L, Lamb Sarah E, Lewis Steff, Loder Elizabeth, Offringa Martin, Ravaud Philippe, Richards Dawn P, Rockhold Frank W, Schriger David L, Siegfried Nandi L, Staniszewska Sophie, Taylor Rod S, Thabane Lehana, Torgerson David J, Vohra Sunita, White Ian R, Hróbjartsson Asbjørn
Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
Centre for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Paris, France.
JAMA. 2025 Apr 28. doi: 10.1001/jama.2025.4486.
The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial.
We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (harms, outcomes, nonpharmacological treatment) and other reporting guidelines (Template for Intervention Description and Replication [TIDieR]). The potential modifications were rated in a 3-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of 2 new protocol items, revision to 5 items, deletion/merger of 5 items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open-science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document.
Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policy makers, regulators, and other reviewers.
随机试验方案是研究规划、实施、报告及外部评审的基础。然而，试验方案的完整性各异，且常常未涉及设计与实施的关键要素。《SPIRIT（标准方案条目：干预性试验建议）声明》于2013年首次发布，旨在提高试验方案的完整性。需要定期更新以纳入最新证据和最佳实践，确保该指南对用户仍具相关性。在此，我们系统地更新了SPIRIT关于随机试验方案中应涵盖的最低限度条目的建议。
我们完成了一项范围综述，并建立了一个针对该项目的实证和理论证据数据库，以生成对SPIRIT 2013清单可能的修改列表。该列表通过现有SPIRIT/CONSORT（试验报告统一标准）扩展（危害、结局、非药物治疗）的主要作者以及其他报告指南（干预描述与重复模板 [TIDieR]）提供的建议得以丰富。在三轮德尔菲调查及随后的共识会议中对潜在修改进行了评分。总体而言，317人参与了德尔菲共识过程，30位专家出席了共识会议。该过程导致新增了2个方案条目，对5个条目进行了修订，删除/合并了5个条目，并整合了其他相关报告指南中的关键条目。显著变化包括一个新的开放科学部分，对危害评估以及干预和对照的描述给予更多强调，以及一个关于患者和公众将如何参与试验设计、实施和报告的新条目。更新后的SPIRIT 2025声明包括一份基于证据的34个最低限度条目的清单，用于在试验方案中涵盖，以及一张说明试验参与者的入组、干预和评估时间表的图表。为便于实施，我们还制定了SPIRIT 2025清单的扩展版本以及一份附带的解释和阐述文件。
广泛认可并遵循更新后的SPIRIT 2025声明，有可能提高试验方案的透明度和完整性，造福研究者、试验参与者、患者、资助者、研究伦理委员会、期刊、试验注册机构、政策制定者、监管机构及其他评审人员。
