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.
Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Moorfields Eye Hospital NHS Foundation Trust, London, UK; Health Data Research UK, London, UK.
Lancet Digit Health. 2020 Oct;2(10):e549-e560. doi: 10.1016/S2589-7500(20)30219-3. Epub 2020 Sep 9.
The SPIRIT 2013 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 has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that 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 for 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 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。本指南在促进新干预措施的透明评估方面发挥了重要作用。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。SPIRIT-AI（标准干预试验议定书项目建议-人工智能）扩展是评估具有 AI 组件的干预措施的临床试验方案的新报告指南。它是与报告指南 CONSORT-AI（人工智能临床试验报告统一标准）同时开发的。这两个指南都是通过分阶段共识过程开发的，涉及文献综述和专家咨询，以生成 26 个候选项目，这些项目在由国际多利益相关者小组进行的两阶段 Delphi 调查（103 名利益相关者）中进行了咨询，在共识会议（31 名利益相关者）上达成一致，并通过检查表试点（34 名参与者）进行了细化。SPIRIT-AI 扩展包括 15 个新的项目，这些项目被认为对于人工智能干预临床试验方案非常重要。除了核心 SPIRIT 2013 项目外，这些新项目应定期报告。SPIRIT-AI 建议研究人员清楚地描述 AI 干预措施，包括使用说明和所需技能、AI 干预措施将集成的环境、输入和输出数据处理的考虑因素、人机交互和错误案例分析。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人员以及广大读者理解、解释和批判性评估计划临床试验的设计和偏差风险。
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