Evidence map›Paper›PMID 32908283›Full record

GuidelineNature medicine2020

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

Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, Melanie J Calvert, Alastair K Denniston, SPIRIT-AI and CONSORT-AI Working Group

Abstract readGuidelineReview
In one paragraph

Guideline in Nature medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 651 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
651citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

651 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Observational
  14. Article
  15. Review
  16. Review
  17. From Model to Product: Understanding and Teaching AI Evidence.Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry · 2026
    Article
  18. Article
  19. Review
  20. Review

591 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Xiaoxuan LiuMoorfields Eye Hospital NHS Foundation Trust, London, UK.
Samantha Cruz RiveraBirmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
David MoherCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.ORCID http://orcid.org/0000-0003-2434-4206
Melanie J CalvertHealth Data Research UK, London, UK.ORCID http://orcid.org/0000-0002-1856-837X
Alastair K DennistonAcademic Unit of Ophthalmology, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK. a.denniston@bham.ac.uk.ORCID http://orcid.org/0000-0001-7849-0087
SPIRIT-AI and CONSORT-AI Working Group

Funding

Aging eyes and aging brains in studying alzheimer's disease: Modern ophthalmic data collection in the adult changes in thought (ACT) studyR01AG060942 · NIA · WASHINGTON UNIVERSITY · PI Cecilia Sungmin Lee · 2019 to 2026
$39.4M
Predicting Pulmonary and Cardiac Morbidity in Preterm Infants with Deep LearningK01HL141771 · NHLBI · HARVARD SCHOOL OF PUBLIC HEALTH · PI BEAM, ANDREW L. · 2019 to 2023
$832k
Department of HealthMedical Research Council MC_PC_19005Medical Research Council MR/T019050/1NHLBI NIH HHS K01 HL141771NIA NIH HHS R01 AG060942Wellcome Trust
6 · The paper itself

Abstract

The CONSORT 2010 statement provides minimum guidelines for reporting randomized 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). 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.

Indexed as

Artificial IntelligenceHumansPeer Review, ResearchRandomized Controlled Trials as TopicResearch DesignResearch Report

Identifiers

PMID32908283
PMCPMC7598943

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.