July 7, 2015
Dr. Art Sedrakyan, M.D., Ph.D., director of the Patient Centered Comparative Outcomes Research Program at Weill Cornell Medical College and a longtime health services researcher has begun working with members of the CADC and Department of Surgery to improve and increase studies of surgical outcomes and comparative effectiveness.
Surgical comparative effectiveness research (CER) studies face hurdles when implementing basic research concepts such as randomization, blinding, and allocation concealment. Factors such as device-operator interaction and technical complexity also play a major role in outcomes, but are not easily measured. Based on prior work, Dr. Sedrakyan has devised a conceptual framework for CER in surgery. This framework aims to allow for the identification and evaluation of several factors unique to surgical CER research, which should be considered and accounted for when designing these studies.
Key components of the framework are:
Though the framework does not solve all of the challenges inherent to surgical CER research, it presents a helpful resource for those interested in advancing comparative safety and effectiveness of surgery and devices. The hope is that through improved awareness of these key methodological issues, future studies can account for these factors, and potentially improve their designs to limit the impact these issues will have on their results.
For more information on this framework:
Sedrakyan A, Marinac-Dabic D, Normand SL, Mushlin A, Gross T.A. Framework for evidence evaluation and methodological issues in implantable device studies. Med Care. 2010 Jun;48(6 Suppl):S121-8.