title: [Assessing the effectiveness of medical devices in patient-oriented surgical research].
abstract: 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. (As supplied by publisher).
authors: Studienzentrum der Deutschen Gesellschaft für Chirurgie, Heidelberg. markus.diener@med.uni-heidelberg.de
authors: Markus K
authors: MK
authors: Diener
authors: Colette
authors: C
authors: Dörr-Harim
authors: Inga
authors: I
authors: Rossion
authors: Markus W
authors: MW
authors: Büchler
mesh_terms: D018795:Device Approval / Q000592:standards*; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence / Q000592:standards; D005858:Germany; D006801:Humans; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D009313:National Health Programs / Q000331:legislation & jurisprudence; D018802:Patient-Centered Care; D011358:Product Surveillance, Postmarketing / Q000592:standards; D011785:Quality Assurance, Health Care / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D013523:Surgical Equipment / Q000592:standards*; D013525:Surgical Instruments / Q000592:standards*; D016896:Treatment Outcome