Healthcare Resource Utilization and Patient-Reported Outcomes Following Elective Surgery for Intradural Extramedullary Spinal Tumors.

BACKGROUND: Healthcare resource utilization and patient-reported outcomes (PROs) for intradural extramedullary (IDEM) spine tumors are not well reported. OBJECTIVE: To analyze the PROs, costs, and resource utilization 1 year following surgical resection of IDEM tumors. METHODS: Patients undergoing elective spine surgery for IDEM tumors and enrolled in a single-center, prospective, longitudinal registry were analyzed. Baseline and postoperative 1-year PROs were recorded. One-year spine-related direct and indirect healthcare resource utilization was assessed. One-year resource use was multiplied by unit costs based on Medicare national payment amounts (direct cost). Patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). RESULTS: A total of 38 IDEM tumor patients were included in this analysis. There was significant improvement in quality of life (EuroQol-5D), disability (Oswestry and Neck Disability Indices), pain (Numeric rating scale pain scores for back/neck pain and leg/arm pain), and general physical and mental health (Short-form-12 health survey, physical and mental component scores) in both groups 1 year after surgery (P < .0001). Eighty-seven percent (n = 33) of patients were satisfied with surgery. The 1-year postdischarge resource utilization including healthcare visits, medication, and diagnostic cost was $4111 ± $3596. The mean total direct cost was $23 717 ± $7412 and indirect cost was $5544 ± $4336, resulting in total 1-year cost $29 177 ± $9314. CONCLUSION: Surgical resection of the IDEM provides improvement in patient-reported quality of life, disability, pain, general health, and satisfaction at 1 year following surgery. Furthermore, we report the granular costs of surgical resection and healthcare resource utilization in this population.

Anticipated Changes in Spine Practice with Advancing Center for Medicare and Medicaid Services-Required Changes.

In providing spinal care to neurosurgical patients, cost and quality metrics are areas of interest to many. The federal government has legislated changes mandated for Centers for Medicare and Medicaid Services-enrolled patient care. The ever-changing administrative and patient-care challenges and opportunities are explored in this article, highlighting the Medicare Access and CHIP (Children's Health Insurance Program) Reauthorization Act of 2015 (MACRA), in the context of the Affordable Care Act. Trends in contemporary spinal care, addressing bundling, patient satisfaction, and ambulatory surgical centers are featured.

Economic value of treating lumbar disc herniation in Brazil.

OBJECT: Lumbar discectomy is one of the most common surgical spine procedures. In order to understand the value of this surgical care, it is important to understand the costs to the health care system and patient for good results. The objective of this study was to evaluate for the first time the cost-effectiveness of spine surgery in Latin America for lumbar discectomy in terms of cost per quality-adjusted life year (QALY) gained for patients in Brazil. METHODS: The authors performed a prospective cohort study involving 143 consecutive patients who underwent open discectomy for lumbar disc herniation (LDH). Patient-reported outcomes were assessed utilizing the SF-6D, which is derived from a 12-month variation of the SF-36. Direct medical costs included medical reimbursement, costs of hospital care, and overall resource consumption. Disability losses were considered indirect costs. A 4-year horizon with 3% discounting was applied to health-utilities estimates. Sensitivity analysis was performed by varying utility gain by 20%. The costs were expressed in Reais (R$) and US dollars ($), applying an exchange rate of 2.4:1 (the rate at the time of manuscript preparation). RESULTS: The direct and indirect costs of open lumbar discectomy were estimated at an average of R$3426.72 ($1427.80) and R$2027.67 ($844.86), respectively. The mean total cost of treatment was estimated at R$5454.40 ($2272.66) (SD R$2709.17 [$1128.82]). The SF-6D utility gain was 0.044 (95% CI 0.03197-0.05923, p = 0.017) at 12 months. The 4-year discounted QALY gain was 0.176928. The estimated cost-utility ratio was R$30,828.35 ($12,845.14) per QALY gained. The sensitivity analysis showed a range of R$25,690.29 ($10,714.28) to R$38,535.44 ($16,056.43) per QALY gained. CONCLUSIONS: The use of open lumbar discectomy to treat LDH is associated with a significant improvement in patient outcomes as measured by the SF-6D. Open lumbar discectomy performed in the Brazilian supplementary health care system provides a cost-utility ratio of R$30,828.35 ($12,845.14) per QALY. The value of acceptable cost-effectiveness will vary by country and region.

Trends for Spine Surgery for the Elderly: Implications for Access to Healthcare in North America.

The proportion of the population over age 65 in the United States continues to increase over time, from 12% in 2000 to a projected 20% by 2030. There is an associated rise in the prevalence of degenerative spinal disorders with this aging population. This will lead to an increase in demand for both nonsurgical and surgical treatment for these disabling conditions, which will stress an already overburdened healthcare system. Utilization of spinal procedures and services has grown considerably. Comparing 1999 to 2009, lumbar epidural steroid injections have increased by nearly 900,000 procedures performed per year, while physical therapy evaluations have increased by nearly 1.4 million visits per year. We review the literature regarding the cost-effectiveness of spinal surgery compared to conservative treatment. Decompressive lumbar spinal surgery has been shown to be cost-effective in several studies, while adult spinal deformity surgery has higher total cost per quality-adjusted life year gained in the short term. With an aging population and unsustainable healthcare costs, we may be faced with a shortfall of beneficial spine care as demand for spinal surgery in our elderly population continues to rise. ABBREVIATION: QALY, quality-adjusted life year.

Impact of clinical trials on neurosurgical practice: an assessment of case volume.

OBJECTIVE: To evaluate the effect of important trials on the practice of neurosurgery. METHODS: We hypothesized that evidence from trials addressing the management of intracranial aneurysms (International Subarachnoid Aneurysm Trial [ISAT]) and nontraumatic intracerebral hemorrhages (Surgical Trial in Intracerebral Hemorrhage [STICH]) and vertebral augmentation for osteoporotic vertebral body fractures had a significant impact on the frequency of the corresponding neurosurgical procedures. A Medicare administrative database was queried for corresponding Common Procedural Terminology codes and units billed per calendar year. The effects of ISAT and STICH were evaluated using a generalized linear model. The effect of the vertebral augmentation study was evaluated using a t test. RESULTS: After publication of ISAT in 2002, the rate of increase in proportion of cerebral aneurysms that were treated with embolization (Common Procedural Terminology code 61624) per year increased from 3.9% to 5.5% (P = 0.01). After publication of STICH in 2005, the number of craniotomies performed for intracerebral hematoma decreased from 2341 in 2002 to 1646 in 2011 (P = 0.03). After 2 publications in 2009, performance of vertebral augmentation decreased from a high of 99,961 in 2009 per year to 77,108 in 2013 (P = 0.002). CONCLUSIONS: Randomized clinical trials remain the gold standard in the medical community to demonstrate efficacy, but their true impact relies on rapid and extensive assimilation into everyday medical practice. However, the described methodology establishes a temporal relationship only and does not prove causation. Nonetheless, trends in procedural volume suggest that the results of these select randomized clinical trials had a significant effect on neurosurgical practice affecting Medicare patients within an interval of a few years.

Results of the AANS membership survey of adult spinal deformity knowledge: impact of training, practice experience, and assessment of potential areas for improved education: Clinical article.

OBJECT: Adult spinal deformity (ASD) surgery is increasing in the spinal neurosurgeon's practice. METHODS: A survey of neurosurgeon AANS membership assessed the deformity knowledge base and impact of current training, education, and practice experience to identify opportunities for improved education. Eleven questions developed and agreed upon by experienced spinal deformity surgeons tested ASD knowledge and were subgrouped into 5 categories: (1) radiology/spinopelvic alignment, (2) health-related quality of life, (3) surgical indications, (4) operative technique, and (5) clinical evaluation. Chi-square analysis was used to compare differences based on participant demographic characteristics (years of practice, spinal surgery fellowship training, percentage of practice comprising spinal surgery). RESULTS: Responses were received from 1456 neurosurgeons. Of these respondents, 57% had practiced less than 10 years, 20% had completed a spine fellowship, and 32% devoted more than 75% of their practice to spine. The overall correct answer percentage was 42%. Radiology/spinal pelvic alignment questions had the lowest percentage of correct answers (38%), while clinical evaluation and surgical indications questions had the highest percentage (44%). More than 10 years in practice, completion of a spine fellowship, and more than 75% spine practice were associated with greater overall percentage correct (p < 0.001). More than 10 years in practice was significantly associated with increased percentage of correct answers in 4 of 5 categories. Spine fellowship and more than 75% spine practice were significantly associated with increased percentage correct in all categories. Interestingly, the highest error was seen in risk for postoperative coronal imbalance, with a very low rate of correct responses (15%) and not significantly improved with fellowship (18%, p = 0.08). CONCLUSIONS: The results of this survey suggest that ASD knowledge could be improved in neurosurgery. Knowledge may be augmented with neurosurgical experience, spinal surgery fellowships, and spinal specialization. Neurosurgical education should particularly focus on radiology/spinal pelvic alignment, especially pelvic obliquity and coronal imbalance and operative techniques for ASD.

Cost-effectiveness of lumbar discectomy and single-level fusion for spondylolisthesis: experience with the NeuroPoint-SD registry.

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.

Minimally invasive versus open transforaminal lumbar interbody fusion for degenerative spondylolisthesis: comparative effectiveness and cost-utility analysis.

BACKGROUND: Minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) for lumbar spondylolisthesis allows for the surgical treatment of back/leg pain while minimizing tissue injury and accelerating the patient's recovery. Although previous results have shown shorter hospital stays and decreased intraoperative blood loss for MIS versus open TLIF, short- and long-term outcomes have been similar. Therefore, we performed comparative effectiveness and cost-utility analysis for MIS versus open TLIF. METHODS: A total of 100 patients (50 MIS, 50 open) undergoing TLIF for lumbar spondylolisthesis were prospectively studied. Back-related medical resource use, missed work, and quality-adjusted life years were assessed. Cost of in-patient care, direct cost (2-year resource use × unit costs based on Medicare national allowable payment amounts), and indirect cost (work-day losses × self-reported gross-of-tax wage rate) were recorded, and the incremental cost-effectiveness ratio was calculated. RESULTS: Length of hospitalization and time to return to work were less for MIS versus open TLIF (P = 0.006 and P = 0.03, respectively). MIS versus open TLIF demonstrated similar improvement in patient-reported outcomes assessed. MIS versus open TLIF was associated with a reduction in mean hospital cost of $1758, indirect cost of $8474, and total 2-year societal cost of $9295 (P = 0.03) but similar 2-year direct health care cost and quality-adjusted life years gained. CONCLUSIONS: MIS TLIF resulted in reduced operative blood loss, hospital stay and 2-year cost, and accelerated return to work. Surgical morbidity, hospital readmission, and short- and long-term clinical effectiveness were similar between MIS and open TLIF. MIS TLIF may represent a valuable and cost-saving advancement from a societal and hospital perspective.

Revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, adjacent-segment disease, or same-level recurrent stenosis. Part 2. A cost-effectiveness analysis: clinical article.

OBJECT: Despite advances in technology and understanding in spinal physiology, reoperation for symptomatic adjacent-segment disease (ASD), same-level recurrent stenosis, and pseudarthrosis in elderly patients continues to occur. While revision lumbar surgery is effective, attention has turned to questions on the utility and value of the revision decompression and fusion procedure. To date, an analysis of the cost and health state gain associated with revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, ASD, or same-level recurrent lumbar stenosis has yet to be performed. The aim of this study was to assess the long-term outcomes and cost-effectiveness of revision surgery in elderly patients with recurrent or persistent back and leg pain. METHODS: After reviewing their institutional database, the authors found 69 patients 65 years of age and older who had undergone revision decompression and instrumented fusion for back and leg pain associated with pseudarthrosis (17 patients), same-level recurrent stenosis (24 patients), or ASD (28 patients) and included them in this study. Total 2-year back-related medical resource utilization and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D, the EuroQol-5D health survey, with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts. The mean total 2-year cost per QALY gained after revision surgery was assessed. RESULTS: The mean (± standard deviation) time between the index surgery and revision surgery was 3.51 ± 3.63 years. A mean cumulative 2-year gain of 0.35 QALY was observed after revision surgery. The mean total 2-year cost of revision surgery was $28,256 ± $3000 (ASD: $28,829 ± $3812, pseudarthrosis: $28,069 ± $2508, same-level recurrent stenosis: $27,871 ± $2375). Revision decompression and extension of fusion was associated with a mean 2-year cost of $80,594 per QALY gained. CONCLUSIONS: Revision decompression and fusion provided a significant gain in health state utility for elderly patients with symptomatic pseudarthrosis, same-level recurrent stenosis, or ASD, with a mean 2-year cost of $80,594 per QALY gained. When indicated, revision surgery for symptomatic ASD, same-level recurrent stenosis, and pseudarthrosis is a valuable treatment option for elderly patients experiencing persistent back and leg pain. Findings in this study provided a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

Cost per quality-adjusted life year gained of laminectomy and extension of instrumented fusion for adjacent-segment disease: defining the value of surgical intervention.

OBJECT: Over the past decade, there has been a dramatic increase in the number of spinal fusions performed in the US and a corresponding increase in the incidence of adjacent-segment disease (ASD). Surgical management of symptomatic ASD consists of decompression of neural elements and extension of fusion. It has been shown to have favorable long-term outcomes, but the cost-effectiveness remains unclear. In this study, the authors set out to assess the cost-effectiveness of revision surgery in the treatment of ASD over a 2-year period. METHODS: Fifty patients undergoing neural decompression and extension of fusion construct for ASD-associated back and leg pain were included in the study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed. RESULTS: The mean (± SD) interval between prior fusion and revision surgery for ASD was 3.07 ± 2.02 years. A mean cumulative 2-year gain of 0.76 QALYs was observed after revision surgery. The mean total 2-year cost of extension of fusion constructs was $47,846 ± $32,712 (surgery cost: $24,063 ± $300; outpatient resource utilization cost: $4175 ± $3368; indirect cost: $19,607 ± $32,187). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $62,955. CONCLUSIONS: In the authors' practice, revision decompression and extension of fusion provided a significant gain in health state utility for patients with symptomatic ASD, with a 2-year cost per QALY gained of $62,995. When indicated, revision surgery for ASD is a valuable treatment option for patients experiencing back and leg pain secondary to ASD. The findings provide a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

Cost per quality-adjusted life year gained of revision neural decompression and instrumented fusion for same-level recurrent lumbar stenosis: defining the value of surgical intervention.

OBJECT: Despite advances in technology and understanding in spinal physiology, reoperation for symptomatic same-level recurrent stenosis continues to occur. Although revision lumbar surgery is effective, attention has turned to the question of the utility and value of revision decompression and fusion procedures. To date, an analysis of cost and heath state gain associated with revision lumbar surgery for recurrent same-level lumbar stenosis has yet to be described. The authors set out to assess the 2-year comprehensive cost of revision surgery and determine its value in the treatment of same-level recurrent stenosis. METHODS: Forty-two patients undergoing revision decompression and instrumented fusion for same-level recurrent stenosis-associated leg and back pain were included in this study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed. RESULTS: The mean (± SD) interval between prior and revision surgery was 4.16 ± 4.64 years. Bone morphogenetic protein was used in 7 cases of revision arthrodesis (16.7%). A mean cumulative 2-year gain of 0.84 QALY was observed after revision surgery. The mean total 2-year cost of revision fusion was $49,431 ± $7583 (surgery cost $21,060 ± $4459; outpatient resource utilization cost $9748 ± $5292; indirect cost $18,623 ± $9098). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $58,846. CONCLUSIONS: In the authors' practice, revision decompression and fusion provided a significant gain in health state utility for patients with symptomatic same-level recurrent stenosis, with a 2-year cost per QALY gained of $58,846. When indicated, revision surgery for same-level recurrent stenosis is a valuable treatment option for patients experiencing back and leg pain secondary to this disease. The authors' findings provide a value measure of surgery that can be compared with the results of future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

Clinical guidelines and payer policies on fusion for the treatment of chronic low back pain.

STUDY DESIGN: Systematic review. OBJECTIVE: The purpose of this review is to provide a critical appraisal of general and fusion-specific clinical practice guidelines on the treatment of chronic nonradicular low back pain and compare the quality and evidence base of fusion guidelines and select payer policies. SUMMARY OF BACKGROUND DATA.: The treatment of lumbar spondylosis associated with low back pain with lumbar arthrodesis, or fusion, has risen fourfold in the past two decades. Given the significant associated health care costs, there is an increase in clinical guidelines and payer policies influencing patient treatment options. Assessment of the medical necessity of a treatment, such as lumbar fusions, based on medical literature will frequently supersede the determination of the physician in the care of their patient. Concerns regarding the effectiveness and costs of the surgical treatment of spinal disorders presenting with low back pain has placed enormous scrutiny on the value of surgical treatments to our patients. As both clinical guidelines and payer policies have a major impact on the perceived effectiveness, or medical necessity, of lumbar fusions for the treatment of chronic nonradicular low back pain, a review of this topic was undertaken. METHODS: An electronic literature search of PubMed, the National Guideline Clearinghouse and the International Network of Agencies for Health Technology Assessment was performed to identify clinical practice guidelines on assessment and treatment of chronic nonradicular low back pain, including those on use of lumbar fusion, as well as relevant technology assessments. A Google search for publicly available private and public payer policies related to fusion was also performed. A hand search was used to identify specific studies cited for support of the recommendations made. A modified Appraisal of Guidelines Research and Evaluation instrument was used to provide a standardized assessment method for evaluating the quality of development of the evidence base and recommendations in guidelines and selected health policies. This was combined with appraisal of the evidence base supporting the recommendations. RESULTS: Three systematic reviews of general guidelines from a PubMed search yielding 94 citations were included. A convenience sample of five guidelines with recommendations on fusion was taken from 182 citations identified by the National Guideline Clearinghouse and the International Network of Agencies for Health Technology Assessment searches. Two guidelines were developed by US professional societies, (neurosurgery and pain management), and three were European-based guidelines (Belgium, United Kingdom, and the European Cooperation in Science and Technology). The general guidelines were consistent with their recommendations for diagnosis, but inconsistent regarding recommendations for treatment. All guidelines and payer policies with recommendations on fusion included some set of the primary randomized controlled trials comparing fusion to other treatment options with the exception of one policy. However, no clear pattern with regard to the quality of development was identified based on the modified Appraisal of Guidelines Research and Evaluation tool. There were differences in specialty society recommendations. CONCLUSION: Three systematic reviews of evidence-based guidelines that provide general guidance for the assessment and treatment of chronic low back pain described consistent recommendations and guidance for the evaluation of chronic low back pain but inconsistent recommendations and guidance for treatment. Five evidence-based guidelines with recommendations on the use of fusion for the treatment of chronic low back pain were evaluated. There is some consistency across guidelines and policies that are government sponsored with regard to development process and critical evaluation of index studies as well as overall recommendations. There were differences in specialty society recommendations. There is heterogeneity in the medical payer policies reviewed possibly due to variations in the literature cited and transparency of the development process. A description of how recommendations are formulated and disclosure of any potential bias in policy development is important. Three-medical payer policies reviewed are of poor quality with one rated as good with respect to their development based on the modified Appraisal of Guidelines Research and Evaluation tool. Medical payer policies influence patient care by defining medical necessity for approving treatments, and should be held to the same standards for transparency and development as guidelines. CLINICAL RECOMMENDATIONS: The spine care community needs to develop (or update) high-quality treatment guidelines. The process should be transparent, methodologically rigorous, and consistent with the Appraisal of Guidelines Research and Evaluation and Institute of Medicine recommendations. This effort should be collaborative across specialty/society groups and would benefit from patient and public input. Payer policies and treatment guidelines need to be transparent and based on the highest quality evidence available. Clinicians from specialty/society groups, guideline developers and policy makers should collaborate on their development. This process would also benefit from public and patient input.

Cost-effectiveness of multilevel hemilaminectomy for lumbar stenosis-associated radiculopathy.

BACKGROUND CONTEXT: Laminectomy for lumbar stenosis-associated radiculopathy is associated with improvement in pain, disability, and quality of life. However, given rising health-care costs, attention has been turned to question the cost-effectiveness of lumbar decompressive procedures. The cost-effectiveness of multilevel hemilaminectomy for radiculopathy remains unclear. PURPOSE: To assess the comprehensive medical and societal costs of multilevel hemilaminectomy at our institution and determine its cost-effectiveness in the treatment of degenerative lumbar stenosis. STUDY DESIGN: Prospective single cohort study. PATIENT SAMPLE: Fifty-four consecutive patients undergoing multilevel hemilaminectomy for lumbar stenosis-associated radiculopathy after at least 6 months of failed conservative therapy were included. OUTCOME MEASURES: Self-reported measures were assessed using an outcomes questionnaire that incorporated total back-related medical resource utilization, missed work, and improvement in leg pain (visual analog scale for leg pain [VAS-LP]), disability (Oswestry Disability Index [ODI]), quality of life (Short Form-12 [SF-12]), and health state values (quality-adjusted life years [QALYs], calculated from EuroQuol 5D [EQ-5D] with US valuation). METHODS: Over a 2-year period, total back-related medical resource utilization, missed work, and improvement in leg pain (VAS-LP), disability (ODI), quality of life (SF-12), and health state values (QALYs, calculated from EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after multilevel hemilaminectomy was assessed. RESULTS: Compared with preoperative health states reported after at least 6 months of medical management, a significant improvement in VAS-LP, ODI, and SF-12 (physical and mental components) was observed 2 years after multilevel hemilaminectomy, with a mean 2-year gain of 0.72 QALYs. Mean±standard deviation total 2-year cost of multilevel hemilaminectomy was $24,264±10,319 (surgery cost, $10,220±80.57; outpatient resource utilization cost, $3,592±3,243; and indirect cost, $10,452±9,364). Multilevel hemilaminectomy was associated with a mean 2-year cost per QALY gained of $33,700. CONCLUSIONS: Multilevel hemilaminectomy improved pain, disability, and quality of life in patients with lumbar stenosis-associated radiculopathy. Total cost per QALY gained for multilevel hemilaminectomy was $33,700 when evaluated 2 years after surgery with Medicare fees, suggesting that multilevel hemilaminectomy is a cost-effective treatment of lumbar radiculopathy.

Cost-effectiveness of transforaminal lumbar interbody fusion for Grade I degenerative spondylolisthesis.

OBJECT: Transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis-associated back and leg pain is associated with improvement in pain, disability, and quality of life. However, given the rising health care costs associated with spinal fusion procedures and varying results of recent cost-utility studies, the cost-effectiveness of TLIF remains unclear. The authors set out to assess the comprehensive costs of TLIF at their institution and to determine its cost-effectiveness in the treatment of degenerative spondylolisthesis. METHODS: Forty-five patients undergoing TLIF for Grade I degenerative spondylolisthesis-associated back and leg pain after 6-12 months of conservative therapy were included. The authors assessed the 2-year back pain visual analog scale (VAS) score, leg pain VAS score, Oswestry Disability Index, and total back-related medical resource utilization, missed work, and health-state values (quality-adjusted life years [QALYs], calculated from EQ-5D with US valuation). Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The mean total 2-year cost per QALY gained after TLIF was assessed. RESULTS: Compared with preoperative health states reported after at least 6 months of medical management, a significant improvement in back pain VAS score, leg pain VAS score, and Oswestry Disability Index was observed 2 years after TLIF, with a mean 2-year gain of 0.86 QALYs. The mean ± SD total 2-year cost of TLIF was $36,836 ± $11,800 (surgery cost, $21,311 ± $2800; outpatient resource utilization cost, $3940 ± $2720; indirect cost, $11,584 ± $11,363). Transforaminal lumbar interbody fusion was associated with a mean 2-year cost per QALY gained of $42,854. CONCLUSIONS: Transforaminal lumbar interbody fusion improved pain, disability, and quality of life in patients with degenerative spondylolisthesis-associated back and leg pain. The total cost per QALY gained for TLIF was $42,854 when evaluated 2 years after surgery with Medicare fees, suggesting that TLIF is a cost-effective treatment of lumbar spondylolisthesis.

Utility of minimum clinically important difference in assessing pain, disability, and health state after transforaminal lumbar interbody fusion for degenerative lumbar spondylolisthesis.

OBJECT: Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice. METHODS: In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index). RESULTS: All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1-5.3; LP-VAS, 2.1-4.7; ODI, 11-22.9; and EQ-5D, 0.15-0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor. CONCLUSIONS: The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.