Evidence-based medicine and clinical trials in pain practice and orthopedics.
Medical practices should be based on scientific findings pursuant to the rules of evidence-based medicine. Quality standards for interventional pain therapy and orthopedic clinical studies have been lacking. As a result, the efficacy of many forms of therapy is insufficiently documented, making the level of evidence low. This article identifies common deficiencies in the conduct of clinical trials, as well as limitations in conducting randomized controlled studies. Recommendations for improvement are provided. The discussion provides the clinically active physician with interpretation aids for the evaluation of meta-analyses, supports personal evidence-based decisions, and reviews the most important principles for planning and conducting of experimental clinical studies. Current examples in the literature verify the implementation of these principles and present current findings in accordance with evidence-based medicine (EBM) criteria. In spite of an increasing emergence of EBM-based studies, we conclude that the number of well-designed, high quality, controlled studies conducted in accordance with the guidelines of Good Clinical Practice examining interventional pain therapy and orthopedic clinical studies remains unacceptably low.
Gerdesmeyer
Ludger
L
Technical University Munich, Department of Orthopedic Surgery and Sportstraumatology, Munich, Germany. Gerdesmeyer@aol.com
Gollwitzer
Hans
H
Diehl
Peter
P
Wagner
Klaus
K