Outcome Reporting in Cardiac Surgery Trials: Systematic Review and Critical Appraisal.
BACKGROUND
There is currently no accepted standard for reporting outcomes following cardiac surgery. The objective of this paper was to systematically review the literature to evaluate the current use and definition of perioperative outcomes reported in cardiac surgery trials.


RESULTS
We reviewed 5 prominent medical and surgical journals on Medline from January 1, 2010, to June 30, 2014, for randomized controlled trials involving coronary artery bypass grafting and/or valve surgery. We identified 34 trials meeting inclusion criteria. Sample sizes ranged from 57 to 4752 participants (median 351). Composite end points were used as a primary outcome in 56% (n=19) of the randomized controlled trials and as a secondary outcome in 12% (n=4). There were 14 different composite end points. Mortality at any time (all-cause and/or cardiovascular) was reported as an individual end point or as part of a combined end point in 82% (n=28), myocardial infarction was reported in 68% (n=23), and bleeding was reported in 24% (n=8). Patient-centered outcomes, such as quality of life and functional classification, were reported in 29% (n=10). Definition of clinical events such as myocardial infarction, stroke, renal failure, and bleeding varied considerably among trials, particularly for postoperative myocardial infarction and bleeding, for which 8 different definitions were used for each.


CONCLUSIONS
Outcome reporting in the cardiac surgery literature is heterogeneous, and efforts should be made to standardize the outcomes reported and the definitions used to ascertain them. The development of standardizing outcome reporting is an essential step toward strengthening the process of evidence-based care in cardiac surgery.
Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada (M.G., J.A.).
Michael
M
Goldfarb
Division of Vascular Surgery, McGill University, Montreal, Quebec, Canada (L.D.).
Laura
L
Drudi
Division of Medicine, McGill University Health Center, McGill University, Montreal, Quebec, Canada (M.A.).
Mohammad
M
Almohammadi
Division of Cardiac Surgery, Jewish General Hospital, McGill University, Montreal, Quebec, Canada (Y.L.).
Yves
Y
Langlois
Division of Cardiac Surgery, Centre Hospitalier de L'Université de Montréal, Montreal, Quebec, Canada (N.N.).
Nicolas
N
Noiseux
Division of Cardiac Surgery, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada (L.P.).
Louis
L
Perrault
Division of Cardiology, McGill University Health Center, McGill University, Montreal, Quebec, Canada (N.P.).
Nicolo
N
Piazza
Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada (M.G., J.A.) Centre for Clinical Epidemiology, Lady Davis Institute, McGill University, Montreal, Quebec, Canada (J.A.).
Jonathan
J
Afilalo
D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000401:mortality; D002423:Cause of Death; D002986:Clinical Trials as Topic / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards*; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000401:mortality; D051437:Renal Insufficiency / Q000209:etiology / Q000401:mortality; D012107:Research Design / Q000592:standards*; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome
cardiac surgery; outcomes; systematic review