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

  • 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.
Metadaten
Author:Carina Benstöm, Ajay Moza, Patrick MeybohmORCiDGND, Christian StoppeORCiDGND, Rüdiger Autschbach, Declan Devane, Andreas Goetzenich
URN:urn:nbn:de:hebis:30:3-451291
DOI:https://doi.org/10.1371/journal.pone.0186772
ISSN:1932-6203
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/29095881
Parent Title (English):PLoS one
Publisher:PLoS
Place of publication:Lawrence, Kan.
Contributor(s):Simon Body
Document Type:Article
Language:English
Year of Completion:2017
Date of first Publication:2017/11/02
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2017/11/23
Tag:Cardiac surgery; Clinical trials; Coronary heart disease; Measurement equipment; Quality of life; Surgeons; Surgical and invasive medical procedures; Systematic reviews
Volume:12
Issue:(11): e0186772
Page Number:12
First Page:1
Last Page:12
Note:
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.
HeBIS-PPN:424729725
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 4.0