Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension
Abstract
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.
Cite this
Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, Melanie Calvert, Alastair Keith Denniston, Ara Wardkes Darzi, … Samuel C. S. Rowley (2020). Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension. Nature Medicine. https://doi.org/10.1038/s41591-020-1034-x
@article{xiaoxuan2020reporting,
title = {Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension},
author = {Liu, Xiaoxuan and Rivera, Samantha Cruz and Moher, David and Calvert, Melanie and Denniston, Alastair Keith and Darzi, Ara Wardkes and Yau, Christopher and Ashrafian, Hutan and Deeks, Jonathan James and Ruffano, Lavinia Ferrante di and Faes, Livia and Keane, Pearse Andrew and Vollmer, Sebastian J. and Lee, Aaron and Jonas, Adrian and Esteva, Andre and Beam, Andrew L. and Panico, Maria Beatrice and Lee, Cecilia S. and Haug, Charlotte J. and Kelly, Christopher J. and Mulrow, Cynthia D. and Espinoza, Cyrus and Fletcher, John and Paltoo, Dina N. and Manna, Elaine and Price, Gary W and Collins, Professor Gary S. and Harvey, Hugh and Matcham, James and Monteiro, João and ElZarrad, M. Khair and Oakden‐Rayner, Lauren and McCradden, Melissa D. and Savage, Richard S. and Sarkar, Rupa and Rowley, Samuel C. S.},
year = {2020},
journal = {Nature Medicine},
doi = {10.1038/s41591-020-1034-x}
}Citations in this library
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