Knöll P, Oppermann J, Vehreschild J, Beyer F, Kaulhausen T, Siewe J, Stein G, Otto C, Cornely O, Eysel P, Wyen H, Jakob V, Neugebauer E, Zarghooni K
Klinik für Orthopädie und Unfallchirurgie, Klinikum der Universität Köln, Josef-Stelzmann-Str. 9, 50937, Köln, Deutschland,
Chirurg. 2013 Dec;84(12):1062-6. doi: 10.1007/s00104-013-2519-7.
Conduction of and participation in clinical trials is a major challenge for surgical departments especially as job performance in hospitals has increased immensely during the last few years due to economic aspects. Only 11.7 % of published clinical studies are randomized controlled trials. As more and more treatment procedures in medicine have an evidence-based design the aim must be to present randomized controlled trials with an evidence level 1 for an increasing number of surgical therapies. Since 2006 the German National Surgical Trial Network (CHIR-Net) has been established and funded by the Federal Ministry of Education and Research (BMBF) in order to promote the realization of clinical trials in surgery. Thus the basis for the execution of high quality clinical studies in surgery has been extended further. In the individual CHIR-Net centers clinical trials are planned, organized and supervised which requires extensive knowledge of prevalent international standards. Teaching them to rotating physicians is one of the tasks of CHIR-Net. Therefore, a special curriculum for physicians has been developed which is evaluated in this study.
From December 2010 to March 2011 an online survey of physicians who had previously rotated in the CHIR-Net was conducted, starting from the Surgical Regional Center (CRZ) Witten-Herdecke/Cologne. A total of 19 partly open and partly closed questions concerning the person, training, duration of the rotation, the funding applied for and the generated scientific output were surveyed. In addition, the curriculum for physicians and rotation time was checked by means of 17 questions in an evaluation matrix.
In this article the results of the rotating physician evaluation are presented. The satisfaction of physicians with the training during the rotation is presented as well as an analysis of how many of the submitted publications were directly supported by CHIR-Net. It was also evaluated how many rotating physicians requested funding and what the type of funding was.
With the rotating physician model of CHIR-Net a working concept for the training of surgeons in clinical research and the realization of randomized surgical trials was established as a viable solution for the difficult situation of clinical research in the surgical disciplines with the double burden of research and clinical practice.
开展和参与临床试验对外科部门来说是一项重大挑战,尤其是在过去几年中,由于经济因素,医院的工作业绩大幅增长。已发表的临床研究中只有11.7%是随机对照试验。随着医学中越来越多的治疗程序采用循证设计,目标必须是为越来越多的外科治疗提供证据水平为1级的随机对照试验。自2006年以来,德国国家外科试验网络(CHIR-Net)已由联邦教育与研究部(BMBF)设立并资助,以促进外科临床试验的开展。因此,开展高质量外科临床研究的基础得到了进一步拓展。在CHIR-Net各中心,临床试验的规划、组织和监督工作都需要对现行国际标准有广泛的了解。向轮转医生传授这些知识是CHIR-Net的任务之一。因此,已经为医生制定了一门特殊课程,并在本研究中对其进行评估。
从2010年12月至2011年3月,从维滕-黑尔德克/科隆外科区域中心(CRZ)开始,对曾在CHIR-Net轮转的医生进行了在线调查。共调查了19个部分开放和部分封闭的问题,涉及个人情况、培训情况、轮转时间、申请的资金以及产生的科研成果。此外,通过评估矩阵中的17个问题对医生课程和轮转时间进行了检查。
本文展示了轮转医生评估的结果。展示了医生对轮转期间培训的满意度,以及对所提交的出版物中有多少直接得到CHIR-Net支持的分析。还评估了有多少轮转医生申请了资金以及资金类型。
通过CHIR-Net的轮转医生模式,建立了一种外科医生临床研究培训和随机外科试验实施的工作概念,作为解决外科领域临床研究面临研究和临床实践双重负担这一困境的可行方案。