Assessing the effectiveness of medical devices in patient-oriented surgical research

被引：3

作者：

Diener, Markus K. ^{[1
,2
]}

Doerr-Harim, Colette ^{[1
]}

Rossion, Inga ^{[1
]}

Buechler, Markus W. ^{[2
]}

机构：

[1] SDGC, Heidelberg, Germany

[2] Univ Klinikum Heidelberg, Klin Allgemein Viszeral & Transplantat Chirurg, Neuenheimer Feld 110, D-69120 Heidelberg, Germany

来源：

ZEITSCHRIFT FUR EVIDENZ FORTBILDUNG UND QUALITAET IM GESUNDHEITSWESEN | 2012年 / 106卷 / 05期

关键词：

clinical research; surgery; effectiveness; medical devices;

D O I：

10.1016/j.zefq.2012.05.005

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Surgery depends on the application of therapeutic procedures that are based on scientific evidence. It legitimises its claim in patient care through operations with proven benefit consisting of cure or improvement of symptoms. Moreover, clinical research and evaluation of surgical technique, strategy and innovation is closely entangled with medical devices. These surgical trials are regulated beyond the German drug and medical devices law, but scientific and ethical rules still follow the principles of clinical epidemiology and evidence-based medicine. Standardisation of surgical and perioperative care is the inevitable prerequisite in clinical trials to define and to evaluate effectiveness of surgical devices. The Study Centre of the German Surgical Society has established an efficient infrastructure for such trials in Germany and is working to refine the scientific methodology in order to improve the current basis of evidence.

引用

页码：336 / 340

页数：5

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