Outcome measures for randomised clinical trials and multicentre observational studies of cardiovascular diseases published in major clinical journals: systematic review and evidence mapping
Background Outcome measure choice and definition can determine the result of the study. We describe outcome measures and their definitions for cardiovascular studies in highly cited medical journals. Methods Cardiovascular phase III or IV randomised clinical trials (RCTs) or multicentre observational studies published in the New England Journal of Medicine , Lancet or Journal of the American Medical Association between 1 January 2013 and 6 June 2024 from Embase and Ovid Medline were included. Two independent reviewers selected the studies and extracted the primary and secondary outcome measures from each publication. Results 386 studies (83% RCTs; 17% observational) representing 10 699 147 participants were included. Studies investigated coronary heart disease (51%), cardiomyopathy/heart failure (22%), heart rhythm disease (15%), valvular heart disease (11%) and ‘other’ cardiovascular diseases (1%), with 45% investigating a device and 48% funded by industry. The most frequently reporte
