Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.
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DOI：
10.1016/s2589-7500(20)30219-3
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发表时间：
2020-10
期刊：
影响因子：
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通讯作者：
SPIRIT-AI and CONSORT-AI Working Group
中科院分区：
文献类型：
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作者：
Cruz Rivera S;Liu X;Chan AW;Denniston AK;Calvert MJ;SPIRIT-AI and CONSORT-AI Working Group
SPIRIT 2013声明旨在通过为需要解决的最少项目集提供基于证据的建议，提高临床试验方案报告的完整性。这项指导有助于促进对新干预措施的透明评价。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（标准方案项目：介入试验建议-人工智能）扩展是一项新的报告指南，用于评估具有人工智能成分的干预措施的临床试验方案。它是与试验报告配套声明：人工智能试验报告综合标准（conber - ai）同时制定的。这两个指南都是通过分阶段的共识过程制定的，包括文献回顾和专家咨询，产生26个候选项目，这些项目由国际多利益相关者小组在两阶段德尔菲调查（103名利益相关者）中进行磋商，在共识会议（31名利益相关者）中达成一致，并通过清单试点（34名参与者）进行完善。SPIRIT-AI扩展包括15个被认为对人工智能干预措施的临床试验方案足够重要的新项目。除了SPIRIT 2013核心项目外，这些新项目应定期报告。SPIRIT-AI建议调查人员对人工智能干预提供清晰的描述，包括使用所需的说明和技能、人工智能干预将被整合的环境、对输入和输出数据处理的考虑、人类与人工智能的互动和错误案例的分析。SPIRIT-AI将有助于促进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审稿人以及普通读者理解、解释和批判性地评估计划中的临床试验的设计和偏倚风险。
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.