Design and outcomes of the Patient Centered Outcomes Research Institute coronary heart disease cohort study

BACKGROUND: The Patient Centered Outcomes Research Institute (PCORI) established Clinical Data Research Networks (CDRNs) to support pragmatic research. The objective was to electronically identify, recruit, and survey coronary heart disease (CHD) patients and describe their characteristics, health status, and willingness to participate in future research. METHODS: We developed a computable phenotype and assembled CHD patients 30 years or older and had visits or hospitalizations between 2009 and 2015. A sample of patients was surveyed between August 2014 and September 2015. Survey administration included the following methods: face-to-face, telephone, paper or web portal. Survey items covered broad domains including: health literacy and numeracy, and socio-demographics, physical and mental health, health behaviors, access to medical care, and willingness to participate in future research. RESULTS: Of 5517 approached patients, 2605 completed the survey. Participants were mostly white (∼88%), male (68%) and had a median age of 69 years (interquartile range [IQR] 61–76 years). Most respondents' health literacy and numeracy were adequate (83.2% and 84.3%, respectively). Only 4% of respondents reported that their overall health or physical health was excellent. The majority (∼58%) reported that their health was good or very good, while 40% reported that their general and physical health were fair or poor. The majority reported that their quality of life was good to excellent (81%). Limitations in physical health and function were common, including often/always having fatigue (25%), pain (38.7%), or sleep difficulty (19.7%). A patient sample (n = 1936) was provided with a trial summary which would randomize their aspirin dose; and 63% reported that they would consider participating. CONCLUSION: Many patients with CHD had limitations in physical health. However, the majority reported a good or excellent quality of life.