Dataset Information

A core outcome set for adult cardiac surgery trials: A consensus study.

ABSTRACT:

Background

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.

Methods

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.

Results

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.

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.

SUBMITTER: Benstoem C

PROVIDER: S-EPMC5667757 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

A core outcome set for adult cardiac surgery trials: A consensus study.

Benstoem Carina C Moza Ajay A Meybohm Patrick P Stoppe Christian C Autschbach Rüdiger R Devane Declan D Goetzenich Andreas A

PloS one 20171102 11

<h4>Background</h4>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 measur ...[more]

PMID: 29095881

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Dataset Information

A core outcome set for adult cardiac surgery trials: A consensus study.

Background

Methods

Results

Conclusion

Publications

A core outcome set for adult cardiac surgery trials: A consensus study.

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