Registration of trials of digital interventions

JMIDH follows ICMJE policy. Any study that prospectively assigns people or groups to a digital health intervention — such as an app, telemedicine service, decision support tool, AI system or remote monitoring programme — to measure its effect on a health outcome is a clinical trial and must be registered in a WHO ICTRP Primary Registry or ClinicalTrials.gov before the first participant is enrolled. Trials in India must be registered with the Clinical Trials Registry – India (CTRI). The registry name and number must appear at the end of the abstract, and the reported primary outcome must match the registered one. Retrospectively registered trials are considered only exceptionally, with the reason stated. Trial reports must include a data sharing statement.

Prospective registration of systematic review protocols in PROSPERO or a similar registry is strongly encouraged. Registration of protocols for prediction model studies (for example on OSF) is also encouraged.

Reporting guidelines

Authors must follow the relevant EQUATOR Network guideline and upload the completed checklist with page numbers. The most commonly used guidelines at JMIDH are listed below.

•     Prediction models, including machine learning: TRIPOD+AI. For studies using large language models: TRIPOD-LLM.

•     Medical imaging AI: CLAIM (Checklist for Artificial Intelligence in Medical Imaging).

•     Early-stage clinical evaluation of AI decision support: DECIDE-AI.

•     Randomised trials of AI interventions: CONSORT-AI; trial protocols: SPIRIT-AI.

•     Randomised trials of web-based and mobile health interventions: CONSORT-EHEALTH, together with CONSORT (current version).

•     Mobile health interventions: mERA (mHealth Evidence Reporting and Assessment).

•     Implementation of digital health interventions: iCHECK-DH.

•     Diagnostic accuracy studies: STARD 2015.

•     Observational studies: STROBE; studies using routinely collected health data such as EHRs and registries: RECORD.

•     Web-based surveys: CHERRIES; other surveys: CROSS.

•     Systematic and scoping reviews: PRISMA 2020 and PRISMA-ScR.

•     Qualitative research, including usability interviews: COREQ or SRQR.

•     Quality improvement studies: SQUIRE 2.0.

•     Economic evaluations: CHEERS 2022.

•     All studies: SAGER for reporting of sex and gender.

Authors of AI papers are also encouraged to consult the FUTURE-AI principles for trustworthy medical AI and to provide a model card (a short structured description of the model’s intended use, training data, performance and limitations) as supplementary material.