TY - JOUR
T1 - Guidelines for clinical trial protocols for interventions involving artificial intelligence
T2 - the SPIRIT-AI extension
AU - SPIRIT-AI and CONSORT-AI Working Group
AU - Cruz Rivera, Samantha
AU - Liu, Xiaoxuan
AU - Chan, An Wen
AU - Denniston, Alastair K.
AU - Calvert, Melanie J.
AU - Darzi, Ara
AU - Holmes, Christopher
AU - Yau, Christopher
AU - Moher, David
AU - Ashrafian, Hutan
AU - Deeks, Jonathan J.
AU - Ferrante di Ruffano, Lavinia
AU - Faes, Livia
AU - Keane, Pearse A.
AU - Vollmer, Sebastian J.
AU - Lee, Aaron Y.
AU - Jonas, Adrian
AU - Esteva, Andre
AU - Beam, Andrew L.
AU - Panico, Maria Beatrice
AU - Lee, Cecilia S.
AU - Haug, Charlotte
AU - Kelly, Christophe J.
AU - Mulrow, Cynthia
AU - Espinoza, Cyrus
AU - Fletcher, John
AU - Paltoo, Dina
AU - Manna, Elaine
AU - Price, Gary
AU - Collins, Gary S.
AU - Harvey, Hugh
AU - Matcham, James
AU - Monteiro, Joao
AU - ElZarrad, M. Khair
AU - Ferrante di Ruffano, Lavinia
AU - Oakden-Rayner, Luke
AU - McCradden, Melissa
AU - Keane, Pearse A.
AU - Savage, Richard
AU - Golub, Robert
AU - Sarkar, Rupa
AU - Rowley, Samuel
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85090498378&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85090498378&partnerID=8YFLogxK
U2 - 10.1038/s41591-020-1037-7
DO - 10.1038/s41591-020-1037-7
M3 - Article
C2 - 32908284
AN - SCOPUS:85090498378
SN - 1078-8956
VL - 26
SP - 1351
EP - 1363
JO - Nature Medicine
JF - Nature Medicine
IS - 9
ER -