A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). The findings highlight the need for better integration of patient-reported health data into pragmatic research studies.

Results of the study were published in JAMA Cardiology.

Patient-reported health data can assist investigators in capturing clinical events in pragmatic clinical trials. However, little information is available about the fitness for use of patient-reported data in large-scale health research.

In this study, analysts evaluated the concordance of a set of variables that were both reported by patients through an online portal and available in the EHR as part of the trial. The validity of participant self-report varied by the method of data collection, the participant population, and the type of information collected. For example, patient report of clinical events had low sensitivity compared with EHR data for myocardial infarction, stroke, and major bleeding events. Coronary revascularization was the most concordant event by data source, but agreement was only moderate.

“As the use of direct-to-participant research designs grows, it’s important to understand how participant-reported data lines up with other data types,” said Emily O’Brien, an associate professor in population health sciences at Duke University and the lead author of the study.

“Our findings suggest that some caution is warranted in this space—especially if relying on participant report alone for capture of cardiovascular events—and we need more research on how to best design questions and set up participant portals to maximize validity of this type of data,” O’Brien said.

ADAPTABLE, the first major randomized comparative effectiveness trial conducted by the National Patient-Centered Clinical Research Network (PCORnet), seeks to determine the optimal dose of aspirin therapy for secondary prevention of atherosclerotic cardiovascular disease. The trial relies on both existing EHR data sources and patient-reported health data captured through an online portal.

This is the first study to assess validity of participant-reported health data collected through an online portal. The study’s results are consistent with prior evidence suggesting that the validity of participant-reported events varies by data collection modality, participant subgroup, and the type of information collected.

This work was supported by a supplemental grant award to the NIH Pragmatic Trials Collaboratory Coordinating Center from the National Center for Complementary and Integrative Health.

Read the full report in JAMA Cardiology.