A new era in surgical research: Getting back to the patient

Abstract

THE PRACTICE OF SURGERY has evolved over the past 50 years in a way that is unprecedented. Surgical dictums that were once revered are no longer valid. Operations that were performed frequently have evolved into obscurity. Our surgical procedures have become less invasive and more refined. We are now concentrating on the patient, not the anatomy; indeed, a patient’s long-term quality of life is as important as the immediate success of the operation. Patient safety in and out of the operatingroom has becomeofparamount importance; we have learned that thousands of patients die each year of medical errors. The healthcare budget is spiraling out of control and the cost of our interventions is under scrutiny. We are being asked to justify both the efficacy as well as the cost of new procedures and technology. Over the next several years, scrutiny from Congress, the Centers for Medicare and Medicaid Services (CMS), other insurers, the Food and Drug Administration, the Agency for Healthcare Research and Quality as well as the public will continue to intensify. Emphasis will be placed on outcomes as well as quality and cost. A surgeon’s anecdotal experience, case reports, or even retrospective analyses, while still valuable, will no longer be acceptable as the primary method to measure and compare surgical results. We as surgeons will be asked to justify our procedures as well as the patients that are selected for these interventions. All of this can only be accomplished only through high-quality clinical research. This new emphasis on health services research represents a paradigm shift for academic surgery. Traditionally, a successful career as a surgical academician was begun during training with a 2-year sojourn into a basic science laboratory, the initiation of an independent laboratory as junior faculty, and eventually peer-reviewed funding. For many years, surgeons studied the physiology of their operations. As molecular medicine has evolved as the preferred method to explore and prove scientific hypotheses, however, basic research has become further removed and less relevant to the daily practice of surgery. This evolution has not been a uniform deterrent of basic science research in surgery. Many excellent molecular surgeons remain. But the aforementioned need for excellent clinical research in surgery now provides an abundance of new opportunities for individuals wishing to establish and advance their academic careers. There is little doubt that clinical research has the potential to improve immediately the way we care for our patients. It is likely over the next decade that clinical investigation will evolve as a dominant form of surgical research. Today, all young and aspiring surgical academicians should consider a career in clinical research. In fact, this is an opportune time for surgeons to embark on this type of career. Congress has mandated the National Institutes of Health (NIH) to redirect its efforts ‘‘toward research that has the potential to impact clinical care within five to ten years.’’ Marking this change in philosophy was a notable article published in 2005 in the New England Journal of Medicine by the then-director of the NIH, Elias Zerhouni, entitled ‘‘Translational and Clinical Science---Time for a New Vision.’’ More than one third of NIH dollars is devoted currently to clinical research, and this number will continue to rise. A product of this reorganization has been the redirection of NIH dollars to Clinical Translational Science Awards (CTSAs), which provide millions of dollars to institutions to create training opportunities and maintain the infrastructure for performing clinical research. More than any other medical discipline, surgeons are poised to benefit from a reemphasis on clinical research. All of our interventions, and there are many, require validation. Although, we could remain complacent and wait for others outside the surgical discipline to evaluate our outcomes, there is little doubt that this task is best accomplished by surgeons, often in partnership with others scientists. The alternative is to allow other physicians, PhDs, or governmental agencies that are not familiar with our patients, procedures, or diseases to determine our effectiveness. This seems not an appealing alternative. The performance of clinical research has become increasingly complex, and formal training is required. Similar to the advent of molecular biology, the required skills of the clinical researcher have become more advanced with the tool chest increasing continuously in size. In this symposium, we will highlight many of the techniques that are used currently to conduct high-quality clinical research. Each of the authors has provided a synopsis of a particular research technique, methodology, or an important aspect of clinical research. Although techniques of clinical research are applicable broadly to all of clinical medicine, we have been careful to include and focus on the surgical perspective. When invasive Accepted for publication April 6, 2009.