Aernoud Fiolet

344 Chapter 14 RESULTS Population In 939 of the 945 (99.4%) trial participants the trial identification number was registered in the EHR. The mean age of the participants was 65.8 years (Standard Deviation [SD] 8.5 years), 156 (16.5%) were female, 176 (18.6%) had diabetes, and 777 (82.2%) had a history of acute coronary syndrome (Table S1, Supplementary Materials). Accuracy EHR data retrieval identified 47 of the 51 investigator-reported primary composite endpoints (MACE; sensitivity 92.2%, specificity 86.5%) and 94 of the 114 investigator-reported secondary composite endpoints (MACE+; sensitivity 82.5%, specificity 81.0%; Figure 2). All-cause mortality was recorded in ten of ten patients (sensitivity 100%, specificity 99.8%) and cardiovascular death in six of six patients (sensitivity 100%, specificity 99.4%). EHR data retrieval identified 36 of 38 occurrences of myocardial infarction (sensitivity 94.7%, specificity 85.8%), five of seven occurrences of ischemic stroke (sensitivity 71.4%, specificity 99.3%), and 47 of 63 occurrences of ischemia-driven coronary revascularization (sensitivity 74.6%, specificity 96.7%). EHR data retrieval identified four of five occurrences of venous-thrombotic embolisms (sensitivity 80.0%, specificity 99.6%), 19 of 21 occurrences of atrial fibrillation (sensitivity 90.5%, specificity 97.6%) and nine of ten cases of occurrences of diabetes mellitus (sensitivity 90.0%, specificity 97.1%). Positive predictive values were low to moderate with a wide range between composite and individual endpoints (range 20.7% to 83.3%). Negative predictive values were high with a small range (range 97.5% to 100%; Table S2, Supplementary Materials). A total of 114 of the 154 (74.5%) investigator-reported endpoints were confirmed as endpoint after endpoint adjudication by the endpoint adjudication committee. Additional analyses using adjudicated endpoints as reference yielded similar estimates of accuracy (Table S2, Supplementary Materials). Event-free survival times Cumulative incidence rates for MACE assessed using EHR data retrieval corresponded with cumulative incidence rates based on investigator-reported endpoints (1.9 events per 100 person-years using EHR data retrieval and 2.1