Many of the fruits of biomedical advances that neurosurgeons enjoy stem from research in many disciplines outside of neurosurgery. Most such advances are evaluated and proven to be effective through rigorous patient-oriented clinical research (POCR) studies. It may be suggested that the common ground for POCR is the community-at-large, where basic and translational research can be melded and evaluated as potentially therapeutically effective.
However, the community-based neurosurgeon in private practice who is interested in becoming engaged in POCR may be unfamiliar with how to develop such a project, and therefore reluctant to initiate and expand areas of personal interest that may be ideally suited for clinical research. The following template is presented as one example of how POCR can be successfully carried out, resulting in outcomes that potentially influence future surgical care.
A Case in Point
As just one example of neurosurgically related, community-based patient research, I was one of several researchers involved in a prospective, randomized comparison of carotid endarterectomy with carotid angioplasty and stenting in the treatment of carotid stenosis. Designing a protocol to adequately examine carotid stenting necessarily included neurosurgeons and cardiologists with endovascular experience; neurosurgeons with appropriate surgical expertise; neurologists and clinical nurses who provided independent clinical outcome assessment; manufacturers willing to provide stents without charge; and community hospital commitment and support. The results achieved from this community-hospital-based project have been published as the first study to demonstrate equivalency of these forms of treatment.
PI’s Interest Is Paramount Developing a community-hospital-based research project begins with the interest of the prinicipal investigator (PI), the clinical neurosurgeon. Organization of any POCR in the community will mature to a successful outcome largely depending upon the level of dedication, interest and time devoted to it by the PI. Partial interest and limited time commitment translate to a doomed project.
Involve (Non-Neurosurgeon) Colleagues The next step is to recruit co-investigators. The collective involvement of an interested group of non-neurosurgical physicians, cardiologists, for example, ensures the inclusion of an unselected population of patients, in this instance with carotid stenosis, which enhances the acquisition of sufficient sample sizes to enable statistically reliable comparison of modalities. Inclusion of a variety of non-surgical colleagues will only enhance the potential for a successful project.
Inspire Support After organizing a consortium of interested physicians, the next goal is to entice the community hospital to “fund” the project. In this case, the hospital provided an ultrasonography laboratory, diagnostic and endovascular facilities, and intensive care units that were dedicated to this project without generating charges to the patients. In addition, manufacturers provided the endovascular instruments and stents without cost to the hospital. Most community hospitals welcome a “single provider” association with manufacturers and pharmaceutical companies hoping to lower costs, which translates to maximal profits and minimal charges. Thus, the revenue “losses” for providing support to a community-based clinical research project can be easily recovered. “Losses” are translated into “gains” when the community recognizes that its hospital is a leader in delivering the “future of healthcare.” Further, manufacturers and pharmaceutical companies relish becoming a “sole” provider to a community hospital.
Institute Independent Oversight The final facet of the template is the development of a means of independent oversight to determine that outcomes avoid the surgical bias that contributes to the loss of credibility and trust in the “real” outcomes of patients in the context of risk, quality of life, long-term efficacy, and relative cost. For example, for the carotid study a neurologist provided independent medical evaluations, and a nurse assessed other nonmedical outcomes such as return to normal activities.
A Plethora of Potential Topics
Application of this template to other areas of clinical research offers additional opportunities for the community-based neurosurgeon to become actively engaged in POCR. For example, the multiple issues of minimally invasive spinal surgery remain to be appropriately addressed in similar outcome trials. Acquisition of these data would provide the basis for suggesting or rejecting that these novel techniques replace current surgical approaches. Clinical trials organized and carried out in the community by a consortium of private practicing neurosurgeons advisedly include quality- and outcome-based assessments, epidemiologic and health services investigations, and evaluations of behavior modulation as related to prevention of recurrent disease as well as determining the efficacy of new treatments. These studies take on increased importance as third party payers and consumers demand accountability.
Neurosurgeons would do well to initiate a dialogue among community-based neurosurgeons and patients, educate their communities about the relevancy of POCR, and strive to make these endeavors understandable and exciting. Companies and community hospitals are much more likely to respond favorably to these projects if community-based physicians are knowledgeable, interested and devoted to organizing evidence-based outcome trials designed to specifically address new modalities. Becoming an active member of a community-based trial renews the dedication to clinical research that is a tradition of neurosurgery.
William H. Brooks, MD, is in private practice with Neurosurgical Associates PSC in Lexington, Ky.