SynthesisBMJ open2022
Quality of reporting of randomised controlled trials of artificial intelligence in healthcare: a systematic review.
Synthesis in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines.Nature communications · 2024Pooled it
- Prediction models using artificial intelligence and longitudinal data from electronic health records: a systematic methodological review.Journal of the American Medical Informatics Association : JAMIA · 2023Pooled it
- Adherence of randomised controlled trials using artificial intelligence in ophthalmology to CONSORT-AI guidelines: a systematic review and critical appraisal.BMJ health & care informatics · 2023Pooled it
- Review
- The Impact of Artificial Intelligence on Lung Cancer Diagnosis and Personalized Treatment.International journal of molecular sciences · 2025Review
- Understanding the evidence for artificial intelligence in healthcare.BMJ quality & safety · 2025Article
- Health Care Social Robots in the Age of Generative AI: Protocol for a Scoping Review.JMIR research protocols · 2025Article
- Bridging the Gap: From AI Success in Clinical Trials to Real-World Healthcare Implementation-A Narrative Review.Healthcare (Basel, Switzerland) · 2025Review
- The Role of Artificial Intelligence in Cardiovascular Disease Risk Prediction: An Updated Review on Current Understanding and Future Research.Current cardiology reviews · 2025Review
- Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.JMIR research protocols · 2024Article
- Exploring clinical specialists' perspectives on the future role of AI: evaluating replacement perceptions, benefits, and drawbacks.BMC health services research · 2024Article
- Randomised controlled trials evaluating artificial intelligence in clinical practice: a scoping review.The Lancet. Digital health · 2024Article
- Scoping Meta-Review of Methods Used to Assess Artificial Intelligence-Based Medical Devices for Heart Failure.Bioengineering (Basel, Switzerland) · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe aim of this study was to evaluate the quality of reporting of randomised controlled trials (RCTs) of artificial intelligence (AI) in healthcare against Consolidated Standards of Reporting Trials-AI (CONSORT-AI) guidelines.
designSystematic review. DATA SOURCES: We searched PubMed and EMBASE databases for studies reported from January 2015 to December 2021. ELIGIBILITY CRITERIA: We included RCTs reported in English that used AI as the intervention. Protocols, conference abstracts, studies on robotics and studies related to medical education were excluded. DATA EXTRACTION: The included studies were graded using the CONSORT-AI checklist, comprising 43 items, by two independent graders. The results were tabulated and descriptive statistics were reported.
resultsWe screened 1501 potential abstracts, of which 112 full-text articles were reviewed for eligibility. A total of 42 studies were included. The number of participants ranged from 22 to 2352. Only two items of the CONSORT-AI items were fully reported in all studies. Five items were not applicable in more than 85% of the studies. Nineteen per cent (8/42) of the studies did not report more than 50% (21/43) of the CONSORT-AI checklist items.
conclusionsThe quality of reporting of RCTs in AI is suboptimal. As reporting is variable in existing RCTs, caution should be exercised in interpreting the findings of some studies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.