Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension. (9th September 2020)

• Record Type: Journal Article
• Authors: Rivera, Samantha Cruz; Liu, Xiaoxuan; Chan, An-Wen; Denniston, Alastair K; Calvert, Melanie J
• Other Names: author non-byline.; Ashrafian Hutan author non-byline.; Beam Andrew L author non-byline.; Collins Gary S author non-byline.; Darzi Ara author non-byline.; Deeks Jonathan J author non-byline.; ElZarrad M Khair author non-byline.; Espinoza Cyrus author non-byline.; Esteva Andre author non-byline.; Faes Livia author non-byline.; Ferrante di Ruffano Lavinia author non-byline.; Fletcher John author non-byline.; Golub Robert author non-byline.; Harvey Hugh author non-byline.; Haug Charlotte author non-byline.; Holmes Christopher author non-byline.; Jonas Adrian author non-byline.; Keane Pearse A author non-byline.; Kelly Christopher J author non-byline.; Lee Aaron Y author non-byline.; Lee Cecilia S author non-byline.; Manna Elaine author non-byline.; Matcham James author non-byline.; McCradden Melissa author non-byline.; Moher David author non-byline.; Monteiro Joao author non-byline.; Mulrow Cynthia author non-byline.; Oakden-Rayner Luke author non-byline.; Paltoo Dina author non-byline.; Panico Maria Beatrice author non-byline.; Price Gary author non-byline.; Rowley Samuel author non-byline.; Savage Richard author non-byline.; Sarkar Rupa author non-byline.; Vollmer Sebastian J author non-byline.; Yau Christopher author non-byline.;
• Is Part Of: BMJ. Volume 370(2020)
• Publication Date: 2020-09-09
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj.m3210
• Languages: English
• ISSNs: 0007-1447

Abstract

Abstract: The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) 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 is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items, which 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 around 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.