Derivation of Patient-Defined Adverse Cardiovascular and Noncardiovascular Events Through a Modified Delphi Process

IMPORTANCE: There is little evidence to support patient-centered outcomes in patients with cardiovascular disease. OBJECTIVE: To derive patient-defined adverse cardiovascular and noncardiovascular events (PACE) through a consensus-based process. DESIGN, SETTING, AND PARTICIPANTS: This pan-Canadian, consensus-based, qualitative study used an iterative Delphi method to achieve consensus within a 35-member panel consisting of patients with cardiovascular diseases and their caregivers and clinicians. The process included 4 rounds of online questionnaires, followed by an in-person final consensus meeting. Data analysis was performed in September 2019. MAIN OUTCOMES AND MEASURES: Defining PACE as a 5-item composite outcome. RESULTS: Thirty-five potential panelists consented to participate, including 11 clinicians (8 men [73%]) and 24 patients and caregivers (13 men [54%]). Twenty-nine (83%), 28 (80%), 26 (74%), and 23 (66%) of the panelists participated in each of respective the online rounds. A shortlist of 11 patient-defined items was further refined at the in-person meeting, which 20 of the panelists attended. The PACE definition that was decided through the consensus process was a composite of severe stroke necessitating hospitalization for 14 days or longer or inpatient rehabilitation, ventilator dependence, new onset or worsening heart failure, nursing home admission, or new onset dialysis. CONCLUSIONS AND RELEVANCE: This study defined PACE as a versatile, patient-centered outcome through a consensus process with input from patients, caregivers, and clinicians. Given the paucity of patient-centered outcomes in cardiovascular research, PACE may be considered as a potential outcome after methodological evaluation of its reliability.