Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial
Authors' conclusion
In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events.
Study context
- Population
- ADAPTABLE participants with existing atherosclerotic CVD randomised to aspirin 81 mg or 325 mg daily, with available data
- Participants
- 15,006 participants
- Comparison
- Contribution of data sources to clinical end-point ascertainment
- Participant-reported + EHRn = 8,756
- Participant-reported + EHR + claimsn = 4,291
- EHR onlyn = 1,412
- Participant-reported + claimsn = 262
- EHR + claimsn = 202
- Claims onlyn = 83
- Primary endpoint
- Number of primary end-point events (death, hospitalization for MI, hospitalization for stroke) contributed by EHR or claims data, then by each additional data source
Methodological detailsopen-label, pragmatic, prespecified analysis
- Open-label
- Pragmatic
- Prespecified analysis
Primary result
As reported in the abstract
Events identified by data source (participants with EHR and claims data, n = 4493)
Events identified in EHR or claims data, per outcome
92%-100%
Events contributed by participant-reported data not otherwise available from claims or EHR, all clinical end points
less than 10%
Further findings
| Outcome | Values |
|---|---|
| Age by data source availability | EHR only median 63.7 (IQR 55.8–71.4) years |
- Age by data source availability — Other groups' median age range
- 65.6-71.9 years
Original publication
Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial. JAMA Cardiol. Published 1 September 2024. doi:10.
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