The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human–AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

CONSORT 2010 声明为报告随机试验提供了最低限度的指南。它的广泛使用有助于确保评估新干预措施的透明度。最近，人们越来越认识到，涉及人工智能 (AI) 的干预措施需要经过严格的前瞻性评估，以证明对健康结果的影响。CONSORT-AI（报告试验综合标准 - 人工智能）扩展是一项新的临床试验报告指南，用于评估具有 AI 组件的干预措施。它是与临床试验方案的配套声明同时开发的：SPIRIT-AI（标准方案项目：介入试验的建议-人工智能）。两个指南都是通过涉及文献审查和专家咨询的阶段性共识过程制定的，以产生 29 个候选项目，由国际多利益相关者小组在两阶段德尔福调查（103 个利益相关者）中评估，并在两天内达成一致共识会议（31 个利益相关者）并通过清单试点（34 名参与者）进行完善。CONSORT-AI 扩展包括 14 个被认为对 AI 干预足够重要的新项目，除了核心 CONSORT 2010 项目外，还应定期报告它们。CONSORT-AI 建议调查人员提供对 AI 干预的清晰描述，包括使用所需的说明和技能、集成 AI 干预的环境、处理 AI 干预的输入和输出，人机交互和提供错误案例分析。CONSORT-AI 将有助于提高报告人工智能干预临床试验的透明度和完整性。它将帮助编辑和同行评审员以及普通读者理解、解释和批判性地评估临床试验设计的质量和报告结果的偏倚风险。