Reporting completeness of clinical trials evaluating large language model interventions in medicine: systematic review

To characterise the reporting completeness of clinical trials involving large language model (LLM) interventions using established reporting guidelines.

Systematic review and meta-research analysis.

Bibliographic databases (Embase, Medline, and CENTRAL) were searched for trial reports and protocols, and trial registries (ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform) were searched for trial registrations published from 1 January 2017 to 6 December 2025.

Trial reports, trial protocols, and trial registrations describing clinical trials of LLM interventions in medicine. LLM interventions used for a healthcare function in a clinical trial setting included patient education, clinical documentation, communication support, triage, care navigation, management recommendations, or clinical decision support. Eligible studies prospectively assigned human participants to the intervention and evaluated a health related biomedical or behavioural outcome.