TY  - JOUR
A1  - Benstöm, Carina
A1  - Moza, Ajay
A1  - Meybohm, Patrick
A1  - Stoppe, Christian
A1  - Autschbach, Rüdiger
A1  - Devane, Declan
A1  - Goetzenich, Andreas
T1  - A core outcome set for adult cardiac surgery trials : a consensus study
T2  - PLoS one
N2  - 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.
KW  - Cardiac surgery
KW  - Quality of life
KW  - Clinical trials
KW  - Systematic reviews
KW  - Coronary heart disease
KW  - Measurement equipment
KW  - Surgeons
KW  - Surgical and invasive medical procedures
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/45129
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-451291
SN  - 1932-6203
N1  - Copyright: © 2017 Benstoem et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
VL  - 12
IS  - (11): e0186772
SP  - 1
EP  - 12
PB  - PLoS
CY  - Lawrence, Kan.
ER  -