Abstract: Importance  The protocol of a randomised 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 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.
Objective  To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial.
Design  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  extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines [template for intervention description and replication (TIDieR)]. The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting.
Findings  Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five 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 enrolment, 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.
Conclusions and Relevance  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, policymakers, regulators, and other reviewers.

Key words: Randomised trial; Protocol; Guideline

摘要： 背景 随机试验方案是研究计划、实施、报告和外部评审的基础。但目前的试验方案在完整性方面差异较大，并且常遗漏设计和实施的关键要素。SPIRIT 声明于2013年首次发布，旨在提高试验方案的完整性。为确保指南与时俱进，该声明需定期整合最新证据和最佳实践进行更新。
目的 更新SPIRIT声明中对随机试验方案应涵盖的必备条目的建议。
方法 我们通过进行范围综述并建立项目专用的实证和理论证据数据库，生成SPIRIT 2013清单可能需要修订的条目列表。该列表整合了现有SPIRIT/CONSORT扩展（不良事件、结局、非药物治疗）及其他报告指南[如干预措施描述与复制模板（template for intervention description and replication，TIDieR）]的主要作者的建议。随后，我们通过3轮德尔菲调查对涉及的修订内容进行了评级，并召开了共识会议。
结果 共317人参与德尔菲调查过程，30位专家出席共识会议。SPIRIT 2025声明最终新增2个方案条目，修订5个条目，删除/合并5个条目，并整合了其他相关报告指南中的重要内容。其值得关注的变化包括新增“开放科学”板块，强调对不良事件的评估、干预措施和对照措施的描述，以及新增关于患者和公众如何参与试验设计、实施和报告的条目。更新后的SPIRIT 2025声明包含1份基于证据的试验方案必备的34项条目清单，以及1个说明试验参与者入组登记、干预和评估时间的图表。为便于实施，我们还制定了SPIRIT 2025声明清单的扩展版本及1份配套的解释和说明文件。
结论 对更新后SPIRIT 2025声明的广泛认可和遵循有可能提高试验方案的透明度和完整性，从而使研究者、试验参与者、患者、资助方、研究伦理委员会、期刊、试验注册平台、政策制订者、监管机构及其他评审人员共同受益。

关键词: 随机试验; 方案; 指南