Invasive off- or on-pump cardiac surgery (elective and emergency procedures, excluding transplants are routinely performed to treat complications of ischaemic heart disease. Randomised controlled trials (RCT) evaluate the effectiveness of treatments in the setting of cardiac surgery. However, the impact of RCTs is weakened by heterogeneity in outcome measuring and reporting, which hinders comparison across trials. Core outcome sets (COS, a set of outcomes that should be measured and reported, as a minimum, in clinical trials for a specific clinical field) help reduce this problem. In light of the above, we developed a COS for cardiac surgery effectiveness trials.
Potential core outcomes were identified a priori by analysing 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.
Eighty-six participants from 23 different countries involving adult cardiac patients, cardiac surgeons, anaesthesiologists, 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 hospitalisation and 4) Measure of cerebrovascular complication to be included in adult cardiac surgery trials.
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.
Carina Benstoem ,
- COS for clinical trials or clinical research
- Delphi process
- Systematic review
To systematically review outcomes used in previous systematic reviews of randomised trials on cardiothoracic pre-, intra- or postsurgical interventions related to adult heart surgery to identify a list of potential outcomes for a COS.
To identify patient-centred and salutogenic focused outcomes reported in these trials.
To develop a core outcome set for clinical trials on cardiothoracic pre,- intra- or post surgical interventions.
We will perform a systematic review of reviews to determine the type and number of outcomes reported in current cardiac surgery intervention based research. We will assess to what extent these outcomes are patient centred and focused on salutogenesis. For the conduct of this review we interpret salutogenic outcomes as those relating to optimum, positive health and well-being.
In a subsequent step, this unique list of outcomes provides the basis of possible outcomes to be included in a minimum core outcome set for non-minimal-invasive on-pump cardiothoracic clinical trials investigating pre-, intra- or postsurgical interventions. It is intended to reach consensus via a 3-round eDelphi survey from the perspective of key stakeholders.
The setting will be multinational comprising cardio-thoracic surgeons, anaesthesiologists, nursing staff involved with adult cardiothoracic patients (intensive care and normal care), researchers with expertise in this particular field of medical research and patient representatives from the responsible ethical committee.