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Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting for clinical trial protocols evaluating interventions with an artificial intelligence (AI) component.
Full bibliographic reference Rivera SC, Liu X, Chan A-W, Denniston AK, Calvert MJ; on behalf of the SPIRIT-AI and CONSORT-AI Working Group. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension.

This guideline was published simultaneously in 3 journals. You can read the guideline in any of these journals using the links below.

BMJ. 2020;370:m3210. PMID: 32907797
Nat Med. 2020;26(9):1351–1363. PMID: 32908284
Lancet Digital Health. 2020;2(10):e549-e560. PMID: 33328049

 
Relevant more generic / specialised reporting guidelines
(i.e. main generic guideline or extension to a generic guideline)
Generic
SPIRIT 2013: Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207. PMID: 23295957

Specialised
SPIRIT-PRO: Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT; and the SPIRIT-PRO Group. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA. 2018;319(5):483-494. Link to abstract

SPIRIT-TCM: Dai L, Cheng CW, Tian R, Zhong LL, Li YP, Lyu AP, Chan AW, Shang HC, Bian ZX. Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med. 2019;25(1):71-79. PMID: 30484022

SPENT 2019: Porcino AJ, Shamseer L, Chan A-W, Kravitz RL, Orkin A, Punja S, Ravaud P, Schmid CH, Vohra S; on behalf of the SPENT group. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ 2020; 368. Link to full-text

 
Reporting guideline website URL http://www.clinical-trials.ai/
Reporting guideline acronym SPIRIT-AI
Study design Study protocols
Applies to the whole report or to individual sections of the report? Whole report
Record last updated on January 11, 2021

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