Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension.
Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension.
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涉及人工智能干预的临床试验报告的报告指南：CONSORT - AI扩展版
DOI：
10.1038/s41591-020-1034-x
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发表时间：
2020-09
期刊：
影响因子：
82.9
通讯作者：
SPIRIT-AI and CONSORT-AI Working Group
中科院分区：
文献类型：
--
作者：
Liu X;Cruz Rivera S;Moher D;Calvert MJ;Denniston AK;SPIRIT-AI and CONSORT-AI Working Group
CONSORT 2010声明提供了报告随机试验的最低指南。它的广泛使用有助于确保新干预措施评价的透明度。最近，人们越来越认识到，涉及人工智能（AI）的干预措施需要进行严格的前瞻性评估，以证明对健康结果的影响。CONSORT-AI（报告试验的统一标准-人工智能）扩展是一项新的临床试验报告指南，用于评估人工智能成分的干预措施。它与临床试验方案的配套声明：SPIRIT-AI（标准方案项目：介入试验-人工智能建议）同时开发。这两项准则都是通过一个分阶段的协商一致进程制定的，其中包括文献审查和专家咨询，以产生29个候选项目，这些项目由一个国际多方利益攸关方小组在两阶段德尔菲调查中进行评估（103个利益攸关方），在为期两天的协商一致会议上达成一致（31个利益攸关方），并通过清单试点（34个参与者）进行完善。CONSORT-AI扩展包括14个新项目，这些项目被认为对AI干预措施足够重要，除了CONSORT 2010核心项目外，还应定期报告。CONSORT-AI建议研究者提供对AI干预的明确描述，包括使用所需的说明和技能、整合AI干预的设置、AI干预的输入和输出处理、人机交互以及提供错误案例分析。CONSORT-AI将有助于提高AI干预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员以及普通读者理解、解释和批判性地评估临床试验设计的质量和报告结果中的偏倚风险。CONSORT-AI和SPIRIT-AI扩展提高了人工智能干预的临床试验设计和试验方案报告的透明度。
The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the 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 impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) 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 (Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence). Both guidelines were developed through a staged consensus process involving 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 upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that 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 provision of an 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. The CONSORT-AI and SPIRIT-AI extensions improve the transparency of clinical trial design and trial protocol reporting for artificial intelligence interventions.
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DOI：
10.1126/science.aaw4399
发表时间：
2019-03-22
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
Finlayson SG;Bowers JD;Ito J;Zittrain JL;Beam AL;Kohane IS
通讯作者：
Kohane IS
影响因子：
64.8
作者：
Esteva A;Kuprel B;Novoa RA;Ko J;Swetter SM;Blau HM;Thrun S
通讯作者：
Thrun S
影响因子：
4.4
作者：
Abramoff, Michael David;Lou, Yiyue;Niemeijer, Meindert
通讯作者：
Niemeijer, Meindert
影响因子：
19.7
作者：
Choi, Kyu Jin;Jang, Jong Keon;Yu, Eun Sil
通讯作者：
Yu, Eun Sil
影响因子：
39.2
作者：
Gagnier, JJ;Boon, H;Bombardier, C
通讯作者：
Bombardier, C