Zoher Ghogawala, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Tanya Logvinenko, Neil R. Malhotra, Stephen J. Dante, R. John Hurlbert, Andrea F. Douglas, Subu N. Magge, Praveen V. Mummaneni, Joseph S. Cheng, Justin S. Smith, Michael G. Kaiser, Khalid M. Abbed, Daniel M. Sciubba and Daniel K. Resnick
There is significant practice variation and considerable uncertainty among payers and other major stakeholders as to whether many surgical treatments are effective in actual US spine practice. The aim of this study was to establish a multicenter cooperative research group and demonstrate the feasibility of developing a registry to assess the efficacy of common lumbar spinal procedures using prospectively collected patient-reported outcome measures.
An observational prospective cohort study was conducted at 13 US academic and community sites. Unselected patients undergoing lumbar discectomy or single-level fusion for spondylolisthesis were included. Patients completed the 36-item Short-Form Survey Instrument (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) questionnaires preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: 125 patients with lumbar disc herniation, and 35 with lumbar spondylolisthesis. All patient data were entered into a secure Internet-based data management platform.
Of 249 patients screened, there were 198 enrolled over 1 year. The median age of the patients was 45.0 years (49% female) for lumbar discectomy (n = 148), and 58.0 years (58% female) for lumbar spondylolisthesis (n = 50). At 30 days, 12 complications (6.1% of study population) were identified. Ten patients (6.8%) with disc herniation and 1 (2%) with spondylolisthesis required reoperation. The overall follow-up rate for the collection of patient-reported outcome data over 1 year was 88.3%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, VAS, and SF-36 scores (p ≤ 0.0002), which persisted over the 1-year follow-up period (p < 0.0001). By the 1-year follow-up evaluation, more than 80% of patients in each cohort who were working preoperatively had returned to work.
It is feasible to build a national spine registry for the collection of high-quality prospective data to demonstrate the effectiveness of spinal procedures in actual practice. Clinical trial registration no.: 01220921 (ClinicalTrials.gov).
Edward C. Benzel and Zoher Ghogawala
Claire Blumenthal, Jill Curran, Edward C. Benzel, Rachel Potter, Subu N. Magge, J. Frederick Harrington Jr., Jean-Valery Coumans and Zoher Ghogawala
It is not known whether adding fusion to lumbar decompression is necessary for all patients undergoing surgery for degenerative lumbar spondylolisthesis with symptomatic stenosis. Determining specific radiographic traits that might predict delayed instability following decompression surgery might guide clinical decision making regarding the utility of up-front fusion in patients with degenerative Grade I spondylolisthesis.
Patients with Grade I degenerative lumbar spondylolisthesis (3–14 mm) with symptomatic stenosis were prospectively enrolled from a single site between May 2002 and September 2009 and treated with decompressive laminectomy without fusion. Patients with mechanical back pain or with gross motion (> 3 mm) on flexion-extension lumbar radiographs were excluded. The baseline radiographic variables measured included amount of slippage, disc height, facet angle, motion at spondylolisthesis (flexion-extension), and sagittal rotation angle. Data were analyzed using multivariate forward selection stepwise logistic regression, chi-square tests, Student t-test, and ANOVA.
Forty patients were enrolled and treated with laminectomy without fusion, and all patients had complete radiographic data sets that were available for analysis. Reoperation was performed in 15 (37.5%) of 40 patients, with a mean follow-up duration of 3.6 years. Reoperation was performed for pain caused by instability at the index level in all 15 cases. Using multivariate stepwise logistic regression with a threshold p value of 0.35, motion at spondylolisthesis, disc height, and facet angle were predictors of reoperation following surgery. Facet angle > 50° was associated with a 39% rate of reoperation, disc height > 6.5 mm was associated with a 45% rate of reoperation, and motion at spondylolisthesis > 1.25 mm was associated with a 54% rate of reoperation. Patients with all 3 risk factors for instability had a 75% rate of reoperation, whereas patients with no risk factors for instability had a 0% rate of reoperation (p = 0.14).
Patients with motion at spondylolisthesis > 1.25 mm, disc height > 6.5 mm, and facet angle > 50° are more likely to experience instability following decompression surgery for Grade I lumbar spondylolisthesis. Identification of key risk factors for instability might improve patient selection for decompression without fusion surgery. Clinical trial registration no.: NCT00109213
Nathan R. Selden, Zoher Ghogawala, Robert E. Harbaugh, Zachary N. Litvack, Matthew J. McGirt and Anthony L. Asher
Outcomes-directed approaches to quality improvement have been adopted by diverse industries and are increasingly the focus of government-mandated reforms to health care education and delivery. The authors identify and review current reform initiatives originating from agencies regulating and funding graduate medical education and health care delivery. These reforms use outcomes-based methodologies and incorporate principles of lifelong learning and patient centeredness.
Important new initiatives include the Accreditation Council for Graduate Medical Education Milestones; the pending adoption by the American Board of Neurological Surgery of new requirements for Maintenance of Certification that are in part outcomes based; initiation by health care systems and consortia of public reporting of patient outcomes data; institution by the Centers for Medicare & Medicaid Services of requirements for comparative effectiveness research and the physician quality reporting system; and linking of health care reimbursement in part to patient outcomes data and quality measures. Opportunities exist to coordinate and unify patient outcomes measurement throughout neurosurgical training and practice, enabling effective patient-centered improvements in care delivery as well as efficient compliance with regulatory mandates. Coordination will likely require the development of a new science of practice based in the daily clinical environment and utilizing clinical data registries. A generation of outcomes science and quality experts within neurosurgery should be trained to facilitate attainment of these goals.
Anthony L. Asher, Paul C. McCormick, Nathan R. Selden, Zoher Ghogawala and Matthew J. McGirt
Patient care data will soon inform all areas of health care decision making and will define clinical performance. Organized neurosurgery believes that prospective, systematic tracking of practice patterns and patient outcomes will allow neurosurgeons to improve the quality and efficiency and, ultimately, the value of care. In support of this mission, the American Association of Neurological Surgeons, in cooperation with a broad coalition of other neurosurgical societies including the Congress of Neurological Surgeons, Society of Neurological Surgeons, and American Board of Neurological Surgery, created the NeuroPoint Alliance (NPA), a not-for-profit corporation, in 2008. The NPA coordinates a variety of national projects involving the acquisition, analysis, and reporting of clinical data from neurosurgical practice using online technologies. It was designed to meet the health care quality and related research needs of individual neurosurgeons and neurosurgical practices, national organizations, health care plans, biomedical industry, and government agencies. To meet the growing need for tools to measure and promote high-quality care, NPA collaborated with several national stakeholders to create an unprecedented program: the National Neurosurgery Quality and Outcomes Database (N2QOD). This resource will allow any US neurosurgeon, practice group, or hospital system to contribute to and access aggregate quality and outcomes data through a centralized, nationally coordinated clinical registry. This paper describes the practical and scientific justifications for a national neurosurgical registry; the conceptualization, design, development, and implementation of the N2QOD; and the likely role of prospective, cooperative clinical data collection systems in evolving systems of neurosurgical training, continuing education, research, public reporting, and maintenance of certification.
Zoher Ghogawala, Edward C. Benzel, Sepideh Amin-Hanjani, Fred G. Barker II, J. Fred Harrington, Subu N. Magge, John Strugar, Jean-Valéry C.E. Coumans and Lawrence F. Borges
Object. There is considerable debate among spine surgeons regarding whether fusion should be used to augment decompressive surgery in patients with symptomatic lumbar spinal stenosis involving Grade I degenerative spondylolisthesis. The authors prospectively evaluated the outcomes of patients treated between 2000 and 2002 at two institutions to determine whether fusion improves functional outcome 1 year after surgery.
Methods. Patients ranged in age from 50 to 81 years. They presented with degenerative Grade I (3- to 14-mm) spondylolisthesis and lumbar stenosis without gross instability (< 3 mm of motion at the level of subluxation). Those in whom previous surgery had been performed at the level of subluxation were excluded. Each patient completed Oswestry Disability Index (ODI) and Short Form—36 (SF-36) questionnaires preoperatively and at 6 to 12 months postoperatively.
Some patients underwent decompression alone (20 cases), whereas others underwent decompression and posterolateral instrumentation-assisted fusion (14 cases), at the treating surgeon's discretion. Baseline demographic data, radiographic features, and ODI and SF-36 scores were similar in both groups. The 1-year fusion rate was 93%.
Both forms of surgery independently improved outcome compared with baseline status, based on ODI and SF-36 physical component summary (PCS) results (p < 0.001). Decompression combined with fusion led to an improvement in ODI scores of 27.5 points, whereas decompression alone was associated with a 13.6-point increase (p = 0.02). Analysis of the SF-36 PCS data also demonstrated a significant intergroup difference (p = 0.003).
Conclusions. Surgery substantially improved 1-year outcomes based on established outcomes instruments in patients with Grade I spondylolisthesis and stenosis. Fusion was associated with greater functional improvement.