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    188宝金博页面版: A core outcome set for all types of cardiac surgery effectiveness trials： a study protocol for an international eDelphi survey t

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    内容提示： STUDY PROTOCOL Open AccessA core outcome set for all types of cardiacsurgery effectiveness trials: a study protocolfor an international eDelphi survey toachieve consensus on what to measure andthe subsequent selection of measurementinstrumentsA. Moza 1? , C. Benstoem 1*? , R. Autschbach 1 , C. Stoppe 1,2 and A. Goetzenich 1AbstractBackground: Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number onecause of death worldwide. From 1990 until today, more people died fro...

    文档格式：PDF | 页数：7 | 浏览次数：890 | 上传日期：2016-04-20 23:23:20 | 文档星级：
    STUDY PROTOCOL Open AccessA core outcome set for all types of cardiacsurgery effectiveness trials: a study protocolfor an international eDelphi survey toachieve consensus on what to measure andthe subsequent selection of measurementinstrumentsA. Moza 1† , C. Benstoem 1*† , R. Autschbach 1 , C. Stoppe 1,2 and A. Goetzenich 1AbstractBackground: Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number onecause of death worldwide. From 1990 until today, more people died from coronary heart disease than from anyother cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgeryand several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, butheterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of researchsynthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measuredand reported, as a minimum, in all clinical trials for a specific clinical field.Methods/design: This study protocol describes the methods used to develop a COS for all types of cardiac surgeryeffectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exerciseinvolving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists,nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcomemeasurement instruments (how to measure) will be determined. Recommendations on COS development givenby the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology(OMERACT) Initiative were followed.Discussion: The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials toensure the comparability of effects of interventions across studies and enable research synthesis. This does not implythat primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability ofresults across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specificclinical endpoints.Keywords: Core outcome set, COS, Domains, Cardiothoracic surgery, Clinical trials, Effectiveness, Health interventions* Correspondence: cbenstoem@ukaachen.de† Equal contributors1 Department of Thoracic and Cardiovascular Surgery, University HospitalRWTH Aachen, Pauwelsstrasse 30, 52074 Aachen, GermanyFull list of author information is available at the end of the article© 2015 Moza et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Moza et al. Trials (2015) 16:545 DOI 10.1186/s13063-015-1072-8

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