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.
复制标题
DOI：
10.1016/s2589-7500(20)30218-1
复制
发表时间：
2020-10
期刊：
影响因子：
--
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（报告试验的统一标准）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在评价新的干预措施时的透明度。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扩展是一项新的临床试验报告指南，用于评估AI成分的干预措施。它与临床试验方案的配套声明：SPIRIT-AI同时开发。这两项准则都是通过一个分阶段的共识进程制定的，其中包括文献审查和专家咨询，以产生29个候选项目，由一个国际多方利益攸关方小组在两阶段德尔菲调查中（103个利益攸关方）进行评估，在为期两天的共识会议上（31个利益攸关方）达成一致，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干预的输入和输出的处理、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、解释和批判性地评价临床试验设计的质量和报告结果中的偏倚风险。
The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating 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 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. Both guidelines were developed through a staged consensus process, involving a literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a 2-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, which 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 providing 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.