Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension
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Published:2020-09
Issue:9
Volume:26
Page:1351-1363
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ISSN:1078-8956
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Container-title:Nature Medicine
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language:en
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Short-container-title:Nat Med
Author:
Cruz Rivera Samantha, Liu XiaoxuanORCID, Chan An-Wen, Denniston Alastair K.ORCID, Calvert Melanie J.ORCID, Darzi Ara, Holmes Christopher, Yau Christopher, Moher David, Ashrafian Hutan, Deeks Jonathan J., Ferrante di Ruffano Lavinia, Faes Livia, Keane Pearse A., Vollmer Sebastian J., Lee Aaron Y., Jonas Adrian, Esteva Andre, Beam Andrew L., Panico Maria Beatrice, Lee Cecilia S., Haug Charlotte, Kelly Christophe J., Yau Christopher, Mulrow Cynthia, Espinoza Cyrus, Fletcher John, Moher David, Paltoo Dina, Manna Elaine, Price Gary, Collins Gary S., Harvey Hugh, Matcham James, Monteiro Joao, ElZarrad M. Khair, Ferrante di Ruffano Lavinia, Oakden-Rayner Luke, McCradden Melissa, Keane Pearse A., Savage Richard, Golub Robert, Sarkar Rupa, Rowley Samuel, , ,
Abstract
AbstractThe 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.
Funder
Wellcome Trust Alan Turing Institute
Publisher
Springer Science and Business Media LLC
Subject
General Biochemistry, Genetics and Molecular Biology,General Medicine
Reference52 articles.
1. Chan, A.-W. et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann. Intern. Med. 158, 200–207 (2013). 2. Chan, A.-W. et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Br. Med. J. 346, e7586 (2013). 3. Sarkis-Onofre, R. et al. Use of guidelines to improve the quality and transparency of reporting oral health research. J. Dent. 43, 397–404 (2015). 4. Calvert, M. et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO Extension. J. Am. Med. Assoc. 319, 483–494 (2018). 5. Dai, L. et al. Standard protocol items for clinical trials with traditional Chinese medicine 2018: recommendations, explanation and elaboration (SPIRIT-TCM Extension 2018). Chin. J. Integr. Med. 25, 71–79 (2019).
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