Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
BMJ. 2020 Sep 9;370:m3210. doi: 10.1136/bmj.m3210.
The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes.The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The SPIRIT-AI extension includes 15 new items, which were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-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 will be integrated, considerations around the handling of input and output data, the human-AI interaction and analysis of error cases.SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.
SPIRIT 2013（标准议定书项目：干预试验推荐意见）声明旨在通过为需要解决的最小项目集提供循证建议，提高临床试验方案报告的完整性。这一指导原则对于促进新干预措施的透明评估起到了重要作用。最近，人们越来越认识到，需要对涉及人工智能的干预措施进行严格的前瞻性评估，以证明其对健康结果的影响。SPIRIT-AI 扩展是评估具有人工智能组件的干预措施的临床试验方案的新报告指南。它是与试验报告的配套声明 CONSORT-AI 同时开发的。这两个指南都是使用分阶段共识过程开发的，涉及文献回顾和专家咨询，生成了 26 个候选项目，并通过国际多利益相关者小组进行了两阶段 Delphi 调查（103 名利益相关者）进行咨询，在共识会议（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。SPIRIT-AI 扩展包括 15 个新条目，这些条目被认为对于人工智能干预临床试验方案非常重要。这些新条目应与核心 SPIRIT 2013 条目一起常规报告。SPIRIT-AI 建议研究人员提供人工智能干预措施的清晰描述，包括使用说明和所需技能、人工智能干预措施将集成的环境、输入和输出数据处理的考虑因素、人机交互以及错误案例分析。SPIRIT-AI 将有助于提高人工智能干预临床试验方案的透明度和完整性。它的使用将有助于编辑和同行评审者以及广大读者理解、解释和批判性评估计划临床试验的设计和偏倚风险。
