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 sourcesWe searched PubMed and EMBASE databases for studies reported from January 2015 to December 2021.Eligibility criteriaWe 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 extractionThe 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.