Knop Christian, Reinhold Maximilian, Roeder Christoph, Staub Lukas, Schmid Rene, Beisse Rudolf, Bühren Volker, Blauth Michael
Trauma Surgery and Sports Medicine, Innsbruck Medical University, Innsbruck, Austria.
Eur Spine J. 2006 Nov;15(11):1687-94. doi: 10.1007/s00586-006-0135-7. Epub 2006 May 20.
This article reports about the internet based, second multicenter study (MCS II) of the spine study group (AG WS) of the German trauma association (DGU). It represents a continuation of the first study conducted between the years 1994 and 1996 (MCS I). For the purpose of one common, centralised data capture methodology, a newly developed internet-based data collection system ( http://www.memdoc.org ) of the Institute for Evaluative Research in Orthopaedic Surgery of the University of Bern was used. The aim of this first publication on the MCS II was to describe in detail the new method of data collection and the structure of the developed data base system, via internet. The goal of the study was the assessment of the current state of treatment for fresh traumatic injuries of the thoracolumbar spine in the German speaking part of Europe. For that reason, we intended to collect large number of cases and representative, valid information about the radiographic, clinical and subjective treatment outcomes. Thanks to the new study design of MCS II, not only the common surgical treatment concepts, but also the new and constantly broadening spectrum of spine surgery, i.e. vertebro-/kyphoplasty, computer assisted surgery and navigation, minimal-invasive, and endoscopic techniques, documented and evaluated. We present a first statistical overview and preliminary analysis of 18 centers from Germany and Austria that participated in MCS II. A real time data capture at source was made possible by the constant availability of the data collection system via internet access. Following the principle of an application service provider, software, questionnaires and validation routines are located on a central server, which is accessed from the periphery (hospitals) by means of standard Internet browsers. By that, costly and time consuming software installation and maintenance of local data repositories are avoided and, more importantly, cumbersome migration of data into one integrated database becomes obsolete. Finally, this set-up also replaces traditional systems wherein paper questionnaires were mailed to the central study office and entered by hand whereby incomplete or incorrect forms always represent a resource consuming problem and source of error. With the new study concept and the expanded inclusion criteria of MCS II 1, 251 case histories with admission and surgical data were collected. This remarkable number of interventions documented during 24 months represents an increase of 183% compared to the previously conducted MCS I. The concept and technical feasibility of the MEMdoc data collection system was proven, as the participants of the MCS II succeeded in collecting data ever published on the largest series of patients with spinal injuries treated within a 2 year period.
本文报道了德国创伤协会(DGU)脊柱研究组(AG WS)基于互联网开展的第二项多中心研究(MCS II)。它是1994年至1996年进行的第一项研究(MCS I)的延续。为采用一种通用的、集中式的数据采集方法,使用了伯尔尼大学矫形外科学评估研究所新开发的基于互联网的数据收集系统(http://www.memdoc.org)。关于MCS II的这第一篇出版物的目的是通过互联网详细描述新的数据收集方法以及所开发数据库系统的结构。该研究的目标是评估欧洲德语区新鲜胸腰椎创伤性损伤的当前治疗状况。因此,我们打算收集大量病例以及关于影像学、临床和主观治疗结果的具有代表性的有效信息。得益于MCS II的新研究设计,不仅常见的手术治疗理念,而且脊柱手术不断拓宽的新领域,即椎体/后凸成形术、计算机辅助手术和导航、微创及内镜技术,都得到了记录和评估。我们展示了参与MCS II的来自德国和奥地利的18个中心的首次统计概述和初步分析。通过互联网接入使数据收集系统始终可用,实现了源端实时数据采集。遵循应用服务提供商的原则,软件、问卷和验证程序位于中央服务器上,通过标准互联网浏览器从外围(医院)进行访问。这样,避免了本地数据存储库昂贵且耗时的软件安装和维护,更重要的是,将数据繁琐地迁移到一个集成数据库已不再必要。最后,这种设置还取代了传统系统,在传统系统中,纸质问卷被邮寄到中央研究办公室并手工录入,不完整或不正确的表格始终是一个耗费资源的问题和错误来源。借助MCS II的新研究理念和扩大的纳入标准,收集了1251份包含入院和手术数据的病例记录。在24个月内记录的这一显著数量的干预措施与之前进行的MCS I相比增加了183%。MEMdoc数据收集系统的理念和技术可行性得到了证明,因为MCS II的参与者成功收集了在两年内治疗的最大系列脊柱损伤患者的数据。