SPIRIT 2025 statement: updated guideline for protocols of randomised trials.

However, trial protocols vary in their completeness and often do not address key elements of design and conduct.

然而，试验方案的完整性各不相同，往往没有涵盖设计和实施的关键要素。

The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols.

SPIRIT（标准试验协议项目：干预试验推荐）声明首次于2013年发表，旨在作为指导方针以提高试验方案的完整性。

Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users.

需要定期更新，纳入最新的证据和最佳实践，以确保指导方针对用户保持相关性。

Background

To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial.

系统性更新SPIRIT推荐的随机试验协议中应解决的最低项目清单。

Methods

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.

我们完成了范围审查，并开发了一个特定于项目的数据库，其中包含实证和理论证据，以生成SPIRIT 2013清单的潜在变更列表。

The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR).

现有的SPIRIT/CONSORT（临床试验报告统一标准）扩展（不良事件、结果、非药物治疗）的主要作者和其他报告指南（TIDieR）提供的建议丰富了这份清单。

The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting.

潜在的修改在三轮德尔菲调查后，通过共识会议进行评估。

Results

Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting.

总的来说，有317名个体参与了Delphi共识过程，30位专家出席了共识会议。

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.

该过程导致新增了两项新的协议内容，对五项内容进行了修订，删除/合并了五项内容，并整合了其他相关报告指南中的关键内容。

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.

显著变化包括新增的开放科学部分，对评估伤害和描述干预措施及对照组的额外强调，以及一个关于患者和公众如何参与试验设计、实施和报告的新项目。

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.

更新后的SPIRIT 2025声明包括一个基于证据的清单，列出了试验协议中必须解决的34个最低限度的项目，以及一个图表，展示了试验参与者的招募、干预措施和评估的时间表。

To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document.

为了便于实施，我们还开发了SPIRIT 2025清单的扩展版本以及相应的解释和详细说明文档。

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.

广泛认可和遵守更新后的SPIRIT 2025声明，有可能提高试验方案的透明度和完整性，从而惠及研究者、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、监管机构和其他审查者。