Outcome Reporting in Cardiac Surgery Trials: Systematic Review and Critical Appraisal

Abstract

BackgroundThere 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.Methods and ResultsWe 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.ConclusionsOutcome 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.

Systematic review of preoperative physical activity and its impact on postcardiac surgical outcomes

“…The heterogeneity in reporting of outcomes can lead to considerably different conclusions across studies. 30 Attempts should also be made to ensure other clinically important outcomes are captured, such as the addition of 30 day events. Only one study in this review compared physically active versus inactive patients preoperatively and reported on the individual postoperative events within 30 days.…”

“… 20 Collectively, uniform outcome reporting and appropriate outcome definitions are recommended when examining the outcomes of cardiac surgery. 30 …”

Validation of days at home as an outcome measure after surgery: a prospective cohort study in Australia

“…In any case such information is an incomplete description of the overall success of surgery and other perioperative care, and does not describe the impact of such complications on functioning and need for institutionalisation. Similar challenges occur when nominating endpoints in clinical trials, including a lack of standardisation, 7 need for adjudication, and uncertainty about the overall health impact of each endpoint on a patient’s recovery. There is a growing acceptance that outcome measures used in clinical trials should be determined in partnership by patients and physician-researchers, aiming to identify outcomes that are important to patients.…”

Minimally invasive mitral valve surgery: a systematic safety analysis

“…In previously mentioned studies, there is no consistency in definitions for adverse events, serious adverse events, major adverse cardiac events and major adverse cardiac and cerebrovascular events (MACCEs), which is a known issue in surgical research. 12 The Mitral…”