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Leah Y. Carreon, Steven D. Glassman, Zoher Ghogawala, Praveen V. Mummaneni, Matthew J. McGirt and Anthony L. Asher

OBJECTIVE

Transforaminal lumbar interbody fusion (TLIF) has become the most commonly used fusion technique for lumbar degenerative disorders. This suggests an expectation of better clinical outcomes with this technique, but this has not been validated consistently. How surgical variables and choice of health utility measures drive the cost-effectiveness of TLIF relative to posterolateral fusion (PSF) has not been established. The authors used health utility values derived from Short Form-6D (SF-6D) and EQ-5D and different cost-effectiveness thresholds to evaluate the relative cost-effectiveness of TLIF compared with PSF.

METHODS

From the National Neurosurgery Quality and Outcomes Database (N2QOD), 101 patients with spondylolisthesis who underwent PSF were propensity matched to patients who underwent TLIF. Health-related quality of life measures and perioperative parameters were compared. Because health utility values derived from the SF-6D and EQ-5D questionnaires have been shown to vary in patients with low-back pain, quality-adjusted life years (QALYs) were derived from both measures. On the basis of these matched cases, a sensitivity analysis for the relative cost per QALY of TLIF versus PSF was performed in a series of cost-assumption models.

RESULTS

Operative time, blood loss, hospital stay, and 30-day and 90-day readmission rates were similar for the TLIF and PSF groups. Both TLIF and PSF significantly improved back and leg pain, Oswestry Disability Index (ODI) scores, and EQ-5D and SF-6D scores at 3 and 12 months postoperatively. At 12 months postoperatively, patients who had undergone TLIF had greater improvements in mean ODI scores (30.4 vs 21.1, p = 0.001) and mean SF-6D scores (0.16 vs 0.11, p = 0.001) but similar improvements in mean EQ-5D scores (0.25 vs 0.22, p = 0.415) as patients treated with PSF. At a cost per QALY threshold of $100,000 and using SF-6D–based QALYs, the authors found that TLIF would be cost-prohibitive compared with PSF at a surgical cost of $4830 above that of PSF. However, with EQ-5D–based QALYs, TLIF would become cost-prohibitive at an increased surgical cost of $2960 relative to that of PSF. With the 2014 US per capita gross domestic product of $53,042 as a more stringent cost-effectiveness threshold, TLIF would become cost-prohibitive at surgical costs $2562 above that of PSF with SF-6D–based QALYs or at a surgical cost exceeding that of PSF by $1570 with EQ-5D–derived QALYs.

CONCLUSIONS

As with all cost-effectiveness studies, cost per QALY depended on the measure of health utility selected, durability of the intervention, readmission rates, and the accuracy of the cost assumptions.

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Anthony L. Asher, Matthew J. McGirt and Zoher Ghogawala

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Robert G. Whitmore, Jill N. Curran, Zarina S. Ali, Praveen V. Mummaneni, Christopher I. Shaffrey, Robert F. Heary, Michael G. Kaiser, Anthony L. Asher, Neil R. Malhotra, Joseph S. Cheng, John Hurlbert, Justin S. Smith, Subu N. Magge, Michael P. Steinmetz, Daniel K. Resnick and Zoher Ghogawala

OBJECT

The authors have established a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures using prospectively collected outcomes. Collection of these data requires an extensive commitment of resources from each site. The aim of this study was to determine whether outcomes data from shorter-interval follow-up could be used to accurately estimate long-term outcome following lumbar discectomy.

METHODS

An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level lumbar discectomy for treatment of disc herniation were included. SF-36 and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Quality-adjusted life year (QALY) data were calculated using SF-6D utility scores. Correlations among outcomes at each follow-up time point were tested using the Spearman rank correlation test.

RESULTS

One hundred forty-eight patients were enrolled over 1 year. Their mean age was 46 years (49% female). Eleven patients (7.4%) required a reoperation by 1 year postoperatively. The overall 1-year follow-up rate was 80.4%. Lumbar discectomy was associated with significant improvements in ODI and SF-36 scores (p < 0.0001) and with a gain of 0.246 QALYs over the 1-year study period. The greatest gain occurred between baseline and 3-month follow-up and was significantly greater than improvements obtained between 3 and 6 months or 6 months and 1 year(p < 0.001). Correlations between 3-month, 6-month, and 1-year outcomes were similar, suggesting that 3-month data may be used to accurately estimate 1-year outcomes for patients who do not require a reoperation. Patients who underwent reoperation had worse outcomes scores and nonsignificant correlations at all time points.

CONCLUSIONS

This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. Three-month outcome data may be used to accurately estimate outcome at future time points and may lower costs associated with registry data collection. This registry effort provides a practical foundation for the acquisition of outcome data following lumbar discectomy.

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Praveen V. Mummaneni, Robert G. Whitmore, Jill N. Curran, John E. Ziewacz, Rishi Wadhwa, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Joseph S. Cheng, R. John Hurlbert, Andrea F. Douglas, Justin S. Smith, Neil R. Malhotra, Stephen J. Dante, Subu N. Magge, Michael G. Kaiser, Khalid M. Abbed, Daniel K. Resnick and Zoher Ghogawala

Object

There is significant practice variation and uncertainty as to the value of surgical treatments for lumbar spine disorders. The authors' aim was to establish a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures by using prospectively collected outcomes.

Methods

An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level fusion for spondylolisthesis or single-level lumbar discectomy were included. The 36-Item Short Form Health Survey (SF-36) and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: lumbar disc (125 patients) and lumbar listhesis (35 patients). The quality-adjusted life year (QALY) data were calculated using 6-dimension utility index scores. Direct costs and complication costs were estimated using Medicare reimbursement values from 2011, and indirect costs were estimated using the human capital approach with the 2011 US national wage index. Total costs equaled $14,980 for lumbar discectomy and $43,852 for surgery for lumbar spondylolisthesis.

Results

There were 198 patients enrolled over 1 year. The mean age was 46 years (49% female) for lumbar discectomy (n = 148) and 58.1 years (60% female) for lumbar spondylolisthesis (n = 50). Ten patients with disc herniation (6.8%) and 1 with listhesis (2%) required repeat operation at 1 year. The overall 1-year follow-up rate was 88%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, visual analog scale, and SF-36 scores (p = 0.0002), which persisted at the 1-year evaluation (p < 0.0001). By 1 year, more than 80% of patients in each cohort who were working preoperatively had returned to work. Lumbar discectomy was associated with a gain of 0.225 QALYs over the 1-year study period ($66,578/QALY gained). Lumbar spinal fusion for Grade I listhesis was associated with a gain of 0.195 QALYs over the 1-year study period ($224,420/QALY gained).

Conclusions

This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. These data are useful for demonstrating return to work and cost-effectiveness following surgical treatment of single-level lumbar disc herniation or spondylolisthesis. One-year cost per QALY was obtained, and this cost per QALY is expected to improve further by 2 years. This work sets the stage for real-world analysis of the value of health interventions.

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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

Object

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.

Methods

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.

Results

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.

Conclusions

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).

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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.

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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.