Table 1.

Topics of interest in a real-world trial requiring DSMB involvement with example reporting

Topics of interest	Example report
Enrollment and retention numbers and trial characteristics	CONSORT diagram, cohort description table, diversity metrics
Adherence and loss to follow-up	Adherence monitoring diagram
Data pipeline issues	Unlinkable data due to unique identifiers
Data linkage using time stamping across platforms	Timestamp adjudication across devices
Uptake or engagement of the intervention	Notification summaries, wear time
App glitches and software updates	Before/after update comparison
Data sharing and management plans	List of locations data was shared
Variable and endpoint definitions from real-world data	Sensitivity analyses
Fairness of algorithms integrated into interventions	Assessment of exposure and uptake by key subgroups