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

Samantha Cruz Rivera; Xiaoxuan Liu; An-Wen Chan; Alastair K Denniston; Melanie J Calvert; SPIRIT-AI and CONSORT-AI Working Group

doi:10.1136/bmj.m3210

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

BMJ. 2020 Sep 9:370:m3210. doi: 10.1136/bmj.m3210.

Authors

Samantha Cruz Rivera^{1

2}, Xiaoxuan Liu^{2

3

4

5

6}, An-Wen Chan⁷, Alastair K Denniston^{8

2

3

4

5

9}, Melanie J Calvert^{1

2

6

10

11

12}; SPIRIT-AI and CONSORT-AI Working Group

Collaborators

Affiliations

¹ Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
² Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
³ Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, UK.
⁴ Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
⁵ Moorfields Eye Hospital NHS Foundation Trust, London, UK.
⁶ Health Data Research UK, London, UK.
⁷ Department of Medicine, Women's College Research Institute, Women's College Hospital, University of Toronto, Ontario, Canada.
⁸ Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. a.denniston@bham.ac.uk.
⁹ National Institute of Health Research Biomedical Research Centre for Ophthalmology, Moorfields Hospital London NHS Foundation Trust and University College London, Institute of Ophthalmology, London, UK.
¹⁰ National Institute of Health Research Surgical Reconstruction and Microbiology Centre, University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
¹¹ National Institute of Health Research Birmingham Biomedical Research Centre, University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
¹² National Institute of Health Research Applied Research Collaborative West Midlands, Birmingham, UK.

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Artificial Intelligence*
Checklist
Clinical Protocols*
Clinical Trials as Topic
Consensus
Humans
Research Design*

Abstract

Publication types

MeSH terms

Grants and funding