A historical perspective, combined with recent developments in health care reform, reinforces the importance of access to high-quality outcomes data in the day-to-day work of healthcare providers. It is vital to analyze national-level clinical data and its translation to meaningful outcomes information, because of the prevalence of widespread quality and patient safety priorities and initiatives.
In 2017, NPA launched a multi-year study, “Effectiveness of Fusion for Grade I Spondylolisthesis,” to determine the optimal surgical approach for patients with the primary diagnosis of spondylolisthesis undergoing one- and two-level decompression alone or decompression and fusion. With increased scrutiny on lumbar fusion surgery, the academic spine community assembled a group of engaged investigators at 12 sites involved with the Quality Outcomes Database (QOD) registry effort to evaluate prospectively the value of surgical interventions for the effectiveness of fusion for spondylolisthesis. Treatment of symptomatic spondylolisthesis ranges from conservative care with multimodal intervention to surgical intervention. Surgical therapy is offered to patients who have failed to respond adequately to optimal medical management. However, experts continue to debate whether decompression alone versus decompression with fusion is the optimal approach for these patients.
Funded by generous grants from the Neurosurgery Research and Education Foundation (NREF), Medtronic and DePuy Synthes, this multi-year study is based on the QOD, which is currently the largest neurosurgical clinical registry in the United States. The QOD provides the platform for a comprehensive and valuable set of clinical and functional metrics in order to assess and establish the effectiveness of fusion for treating grade I spondylolisthesis. Participating sites with the greatest number of enrolled patients with qualifying conditions are reviewing cases individually, verifying diagnoses and procedures and capturing postoperative pain, disability and quality of life metrics through patient-reported outcomes over the course of three years.
“I have been fortunate to work with an exceptional group of investigators and coordinators committed to compiling the largest prospectively collected, validated dataset that will allow us to evaluate real world, meaningful radiographic, clinical and patient-reported outcomes comparing patients undergoing lumbar fusion or decompression”, says Erica F. Bisson, MD, FAANS. “The effort and commitment from each site involved has been remarkable and progress has been excellent. We recently submitted our twelve-month preliminary outcomes for publication and are nearing completion of our primary outcomes at 24 months, with over 80 percent follow-up. This effort hatched a unique collaboration of engaged sites that have the desire and capacity to truly move the ball forward in a transparent evaluation of real-world U.S. spine practice, focusing on improving value for our patients.”
The study includes a protected imaging repository for radiographic analysis, a feat that to-date has not been accomplished in any other large prospective registry. Well-designed studies like this support healthcare providers’ efforts to develop and sustain a culture of safety, value and quality in patient care.
NPA thanks the following centers that are participating in the study:
Atlantic Neurosurgical Specialists
Carolina Neurosurgery & Spine Associates
Geisinger Health System
Goodman Campbell Brain and Spine
Norton Healthcare
Semmes-Murphey Clinic
University of California at San Francisco
University of Miami
University of Michigan
University of Utah
University of Virginia
Weill Cornell Medicine
Erica F. Bisson, MD, MPH, FAANS, is Associate Professor of Neurosurgery and Director of the Complex Spine Fellowship at the University of Utah. After receiving her medical degree from Tufts University, she completed her neurosurgical residency at the University of Vermont and a fellowship in complex spinal disorders at the University of Utah under the direction of Dr. Ronald Apfelbaum. After serving as senior staff at the Lahey Clinic and adjunct faculty at Tufts University School of Medicine, she joined the department of neurosurgery at the University of Utah in 2009.
Dr. Bisson is a fellow of the American Board of Neurological Surgery and a member of the American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS). A principal investigator on several international multicenter trials evaluating effectiveness of surgery in spinal disease, she has published over 50 peer-reviewed articles. Dr. Bisson received a master’s in public health from the University of Utah in 2014, with a focus on cost-effectiveness research and healthcare administration. She serves as the Medical Director of the Neurosurgery Clinic and the Ambulatory Chief Value Officer. She serves on the scientific program committees of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves and the Cervical Spine Research Society and as Chair of the Outcomes Committee.