Novel approaches to clinical trials: device-related infections.
The explosive growth in the use of cardiac devices and the continued large number of thoracic operations produce a significant number of costly infectious complications. These infections represent a leading cause of death and disability after device implantation or surgery. Unfortunately, few objective data are available to validate the clinical epidemiology of surgical and device-related infections, and although the number of randomized trials is increasing, too few have tested strategies for prophylaxis or treatment, particularly in the cardiac arena. Because of the expected increase in invasive vascular procedures and device implantations, it is timely to consider innovative approaches to clinical research that will hasten the translation of effective therapeutic strategies and technologies into clinical practice. Because of the multidisciplinary nature of the care of patients undergoing thoracic surgery or device implantation, bringing together existing networks and several arms of the Federal government could rapidly advance this field to provide a definitive base of evidence to guide clinical practice and improve clinical outcomes. The remainder of the articles in this supplement discuss specific issues on the diagnosis and treatment of device-related or surgical infection. The purpose of this manuscript is to discuss issues about the design of studies and their organization.
Califf
Robert M
RM
Division of Cardiology, Duke University Medical Center and the Duke Clinical Research Institute, Durham, NC 27715, USA. calif001@mc.duke.edu
Fowler
Vance
V
Cabell
Christopher H
CH
Corey
G Ralph
GR
D019072:Antibiotic Prophylaxis; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D002986:Clinical Trials as Topic; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000639:trends; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000639:trends; D006353:Heart-Assist Devices / Q000009:adverse effects / Q000639:trends; D006801:Humans; D017063:Outcome Assessment, Health Care; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000639:trends; D011183:Postoperative Complications / Q000517:prevention & control*; D016459:Prosthesis-Related Infections / Q000517:prevention & control / Q000628:therapy*; D011785:Quality Assurance, Health Care; D012042:Registries; D012107:Research Design; D015607:Stents / Q000009:adverse effects / Q000639:trends; D014481:United States