Review

. 2020 Oct;2(10):e537-e548.

doi: 10.1016/S2589-7500(20)30218-1. Epub 2020 Sep 9.

Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension

Xiaoxuan Liu¹, Samantha Cruz Rivera², David Moher³, Melanie J Calvert⁴, Alastair K Denniston⁵; SPIRIT-AI and CONSORT-AI Working Group

Collaborators, Affiliations

Collaborators

Affiliations

¹ Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Moorfields Eye Hospital NHS Foundation Trust, London, UK; Health Data Research UK, London, UK.
² Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
³ Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
⁴ Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Health Data Research UK, London, UK; National National Institute of Health Research Surgical Reconstruction and Microbiology Centre, and National Institute of Health Research Birmingham Biomedical Research Centre, University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute of Health Research Applied Research Collaborative West Midlands, Birmingham, UK.
⁵ Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute of Health Research Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital London NHS Foundation Trust and University College London, Institute of Ophthalmology, London, UK; Health Data Research UK, London, UK. Electronic address: a.denniston@qiuluzeuv.cn.

PMID: 33328048
PMCID: PMC8183333
DOI: "V体育ios版" 10.1016/S2589-7500(20)30218-1

Review

V体育官网入口 - Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension

Xiaoxuan Liu et al. Lancet Digit Health. 2020 Oct.

. 2020 Oct;2(10):e537-e548.

doi: 10.1016/S2589-7500(20)30218-1. Epub 2020 Sep 9.

Authors (VSports在线直播)

Xiaoxuan Liu¹, Samantha Cruz Rivera², David Moher³, Melanie J Calvert⁴, Alastair K Denniston⁵; SPIRIT-AI and CONSORT-AI Working Group

Collaborators (V体育官网入口)

VSports app下载 - Affiliations

¹ Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Moorfields Eye Hospital NHS Foundation Trust, London, UK; Health Data Research UK, London, UK.
² Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
³ Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
⁴ Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Health Data Research UK, London, UK; National National Institute of Health Research Surgical Reconstruction and Microbiology Centre, and National Institute of Health Research Birmingham Biomedical Research Centre, University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute of Health Research Applied Research Collaborative West Midlands, Birmingham, UK.
⁵ Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute of Health Research Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital London NHS Foundation Trust and University College London, Institute of Ophthalmology, London, UK; Health Data Research UK, London, UK. Electronic address: a.denniston@qiuluzeuv.cn.

PMID: 33328048
PMCID: PMC8183333
DOI: 10.1016/S2589-7500(20)30218-1

V体育官网入口 - Abstract

The CONSORT 2010 statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency in the 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 impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders), and refined through a checklist pilot (34 participants) VSports手机版. The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-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 is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret, and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes. .

PubMed Disclaimer

Figures

**Extended Figure 1.**
**(CONSORT-AI)**: decision tree for inclusion/exclusion and extension/elaboration.

**Extended Figure 2.**
Checklist Development Process

**Figure 1.**
CONSORT 2010 flow diagram - adapted for Al clinical trials

See this image and copyright information in PMC

"V体育平台登录" References

1. Sibbald B, Roland M. Understanding controlled trials. Why are randomised controlled trials important? BMJ. 1998;316(7126):201. - PMC - PubMed
1. Peto R, Collins R, Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol 1995;48(1):23–40. - PubMed
1. Juni P. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001;323(7303):42–46. doi:10.1136/bmj.323.7303.42 - DOI - PMC - PubMed
1. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408–412. - PubMed (V体育2025版)
1. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. - VSports手机版 - PMC - PubMed

V体育2025版 - Publication types

Actions
Actions
Actions

MeSH terms (V体育平台登录)

"VSports app下载" Actions
Actions (V体育官网)
VSports手机版 - Actions
Actions
Actions (V体育安卓版)
"VSports最新版本" Actions
"V体育平台登录" Actions
Actions
Actions
Actions
Actions

Grants and funding

LinkOut - more resources

Full Text Sources
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software (V体育安卓版)

Your RSS Feed