Limitations
death
SECONDARY, RECRUITMENT
This study had several limitations. In addition to the typical challenges with secondary analysis of EHR data (eg, missing data or claims data being incompatible across systems), there were other unanticipated issues. A few patients were inappropriately randomized notwithstanding vigorous monitoring. In one case, a patient died shortly after providing informed consent. While the study nurse confirmed participant eligibility status prior to randomization, the death record was not yet available in the VA EHR system. Because in-person contact was not required with the centralized recruiting model, neither the PCC nor study team were aware of the death. Additionally, a few participants were subsequently found to be enrolled in more than one clinical trial. This was difficult to detect because the EHR system was not intended for clinical trial use.The implementation and maintenance of an EHR-based workflow involves a multidisciplinary research team (eg, clinicians, medical informaticians, epidemiologists, biostatisticians, and data scientists). On some occasions, the study team may encounter EHR data problems that are difficult to trace. Although more resources are spent on technological support, it is still worthwhile to apply a centralized EHR-based recruitment model when conducting a pragmatic trial.