Expert Consensus on Core Outcomes for Cardiac Trials: An eDelphi Study

Objectives: Cardiac surgery is one of the main treatments for cardiovascular disease (CVD) and clinical trials assessing the outcome of cardiac procedures are frequent. However, the impact of clinical trials is weakened by heterogeneity in outcome measuring and reporting, which hinders comparisons across trials. This problem is encountered by core outcome sets (COS), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field allowing results of trials to be compared, contrasted and combined. In light of the above, we developed a COS for all types of cardiac surgery effectiveness trials.

Methods: Potential core outcomes were identified a priori by analyzing data on 371 RCTs of 58,253 patients. We reached consensus on core outcomes in an international three-round eDelphi exercise. Outcomes for which at least 60% of the participants chose the response option “no” and less than 20% chose the response option “yes” were excluded.

Results: Eighty-six participants from 23 different countries involving adult cardiac patients, cardiac surgeons, anesthesiologists, nursing staff and researchers contributed to this eDelphi. The panel reached consensus on four core outcomes: (1) measure of mortality, (2) measure of quality of life, (3) measure of hospitalization, and (4) measure of cerebrovascular complication to be included in adult cardiac surgery trials.

Conclusion: This study used robust research methodology to develop a minimum core outcome set for clinical trials evaluating the effectiveness of treatments in the setting of cardiac surgery. As a next step, appropriate outcome measurement instruments have to be selected.