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:
- The role that characteristics of techniques and devices play in surgical outcomes. Complex approaches and specific device characteristics, all underscored by the constant evolution of tools and techniques, can have substantial impacts on reliability and consistency, which makes assessment of safety and effectiveness difficult. In order to accommodate these issues, the framework highlights the necessity of documentation of approaches and techniques, and reasoning for these choices in order to assess and interpret relevant outcomes.
- The role that characteristics of the operator play in outcomes. Different operators present different preferences, skill, and interpretations, which have substantial impacts on technological adoption in the real world. These preferences may be driven by institutional or financial concerns, volume, patient population, or even sheer habit. The framework highlights the role that learning curve plays in technological adoption and advancement in surgery.
- The role of individual patient characteristics. Since initial trials are often conducted in highly controlled, carefully selected patient populations, real world adoption often substantially widens the pool of patients receiving a certain technique or device. This diffusion of new technology often has a significant effect on outcomes.
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.