Combining electronic health records data from a clinical research network with registry data to examine long-term outcomes of interventions and devices: an observational cohort study

Abstract

Objectives To assess the feasibility of assessing long-term outcomes of peripheral vascular intervention (PVI) by linking data from a clinical registry to electronic health records (EHR) data from a clinical research network.Design Observational cohort study.Setting Vascular Quality Initiative registry linked to INSIGHT Clinical Research Network, which aggregated EHR data from multiple institutions in New York City.Participants Patients receiving PVI during 1 January 2013–30 November 2021 in four centres in New York City.Primary and secondary outcome measures We examined the proportion of registry patients retained in EHR over time and predictors of EHR retention after year 1. We evaluated the implications of EHR attrition by examining amputation-free survival (AFS) in the observed data and predicted data when patients discontinued in the EHR were hypothesised to have increased risks of events than the observed average.Results We included 1405 patients receiving PVI (age=70.8±11.2 years, 51.3% male). Among eligible patients, 75.2% were retained in EHR through year 3. Patients who aged 75 years or above (vs <65: OR 0.34, 95% CI 0.18 to 0.62), had Medicaid (vs Medicare: OR 0.41, 95% CI 0.22 to 0.79), congestive heart failure (OR 0.54, 95% CI 0.32 to 0.90), dialysis (OR 0.47, 95% CI 0.24 to 0.91) and reduced ambulation (OR 0.34, 95% CI 0.15 to 0.75) were less likely to be retained in EHR. When discontinued patients were hypothesised to have increased risks of death or amputation than observed, AFS estimates diverged from the observed data around 6–12 months.Conclusions Studies using registry-EHR data may benefit from the timeliness of the data but may be most appropriate to focus on short-term to intermediate-term outcomes of interventions and devices. Future research is needed to investigate the value of registry-EHR linkage in facilitating short-term to intermediate-term outcome assessment following vascular interventions and advanced statistical approaches to account for non-random missing long-term data.