Clinical Trials in Surgery: A New Paradigm
Randomized clinical trials are often considered the highest level on which medical care should be based.
We hold evidence obtained through randomized clinical trials (RCTs) to be the highest level upon which current medical care should be changed and future care should be based. Unfortunately, the performance of interventional RCTs in surgery comparing modality A versus B is often hampered by poor accrual. It is estimated that one fifth of surgical randomized treatment trials are prematurely terminated.1 A number of barriers to completion of surgical randomized treatment trials have been identified, including inadequate infrastructure, time, and funding.
Increasing emphasis has recently been placed on excess variation in care as a potential source of medical errors. Not surprisingly, policy makers, regulatory agencies, and payers have sought to standardize care delivery processes as a way to potentially impact healthcare outcomes and quality. As an example, the National Quality Forum endorsed 69 surgical quality metrics for 2015; 24 of these involved care processes.2 In response, clinical investigators have begun to address provider- and health care system-risk within the context of randomized treatment trials. These processes-of-care trials more explicitly seek to control and mitigate provider- and healthcare system-risk as a way to standardize surgical care and potentially optimize surgical quality.
Why are processes-of-care trials (POCTs) meaningful? First, they present an opportunity for physicians within a system to rally around a common problem with no obvious solution and try to study it systematically. For example, post-operative ileus is a very common cause of prolonged hospitalization. While it is simple to explain, it remains difficult to improve. Second, POCTs emphasize the use of level 1 evidence and move us away from practice by anecdote. Third, and most importantly, POCTs reshape the culture of acceptance of “meaningless” or “minor” post-operative complications such as catheter associated urinary tract infections, superficial skin infections, and post-op retention. These “initiating” complications often prolong hospitalization and permit “spiraling” complications to set in.
We all espouse scientific rigor in the pursuit of the highest quality of care. Abundant business models focusing on Six Sigma, the Toyota Production System, and best practices have been shown to optimize outcomes, enhance productivity, and even improve revenue. We are uniquely situated in medicine to systematically study processes and then adapt the findings to improve care.
Robert G. Uzzo, MD, FACS, is a Professor and Chairman of the Department of Surgery and the G. Willing "Wing" Pepper Chair in Cancer Research at Fox Chase Cancer Center at Temple University School of medicine in Philadelphia, Pa.
- Kasenda B, von Elm E, You J, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA 2014;311(10):1045-1051.
- National Quality Forum: NQF-Endorsed Measures for Surgical Procedures. 2015