Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, UK.
Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
BMJ. 2020 Sep 9;370:m3164. doi: 10.1136/bmj.m3164.
The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating 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 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. Both guidelines were developed through a staged consensus process, involving a 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 on in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The CONSORT-AI extension includes 14 new items, which 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 providing 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（临床试验报告统一标准）声明提供了报告随机试验的最低指南。它的广泛使用对于评估新干预措施的透明度起到了重要作用。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，以证明其对健康结果的影响。CONSORT-AI 扩展是评估具有 AI 组件的干预措施的临床试验的新报告指南。它与临床试验方案的配套声明 SPIRIT-AI 同时开发。这两个指南都是通过分阶段共识过程开发的，涉及文献回顾和专家咨询，生成了 29 个候选项目，这些项目由一个国际多利益相关者小组在两轮 Delphi 调查（103 名利益相关者）中进行评估，在为期两天的共识会议（31 名利益相关者）上达成一致，并通过清单试点（34 名参与者）进行了细化。CONSORT-AI 扩展包括 14 个新的项目，这些项目被认为对于 AI 干预措施非常重要，除了核心的 CONSORT 2010 项目外，还应常规报告。CONSORT-AI 建议研究人员提供 AI 干预措施的清晰描述，包括使用说明和所需技能、AI 干预措施集成的环境、AI 干预措施的输入和输出处理、人机交互以及对错误案例的分析。CONSORT-AI 将有助于提高 AI 干预措施临床试验报告的透明度和完整性。它将帮助编辑和同行评审人员以及广大读者理解、解释和批判性评估临床试验设计的质量和报告结果的偏倚风险。
