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Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.
Nature Medicine ( IF 82.9 ) Pub Date : 2020-09-09 , DOI: 10.1038/s41591-020-1037-7
Samantha Cruz Rivera 1, 2, 3 , Xiaoxuan Liu 3, 4, 5, 6, 7 , An-Wen Chan 8 , Alastair K Denniston 1, 3, 4, 5, 6, 9 , Melanie J Calvert 1, 2, 3, 6, 10, 11, 12 , , ,
Affiliation  

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.



中文翻译:

涉及人工智能的干预临床试验方案指南:SPIRIT-AI 扩展。

SPIRIT 2013 声明旨在通过为要解决的最少项目集提供基于证据的建议来提高临床试验方案报告的完整性。该指南有助于促进对新干预措施的透明评估。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(标准协议项目:介入试验建议-人工智能)扩展是一项新的报告指南,用于评估具有 AI 组件的干预措施的临床试验协议。它与试验报告的配套声明同时开发:CONSORT-AI(报告试验综合标准——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 26 个候选项目,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)中对其进行咨询,并在共识会议上达成一致意见(31 个利益相关者)并通过清单试点(34 名参与者)进行改进。SPIRIT-AI 扩展包括 15 个新项目,这些项目被认为对人工智能干预的临床试验方案足够重要。除了核心 SPIRIT 2013 项目之外,还应定期报告这些新项目。SPIRIT-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,集成人工智能干预的环境、处理输入和输出数据的考虑因素、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协议的透明度和完整性。它的使用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计划临床试验的设计和偏倚风险。

更新日期:2020-09-10
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