Cost and Health Outcomes Patterns in Patients Treated With Spinal Cord Stimulation Following Spine Surgery-A Register-Based Study.

OBJECTIVE: Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pain, has been shown to be effective in patients with persisting neuropathic pain after spine surgery. However, little is known about the long-term cost and quality-of-life (QoL) patterns in SCS-treated patients. The aim is to describe the use of SCS, costs, pre-spine-surgery and post-spine-surgery QoL, and reported pain intensity, in patients who have undergone spine surgery and subsequent SCS implantation. The results will be related to outcome and cost in spine surgery patients in general. MATERIALS AND METHODS: A research database comprised from six Swedish national and regional registers, and the spine surgery quality-of-care register Swespine was utilized. Two cohorts were identified: all patients who had spine surgery (N = 73,765) and patients who had spine surgery and subsequent SCS implantation (N = 239). Costs were analyzed before and after spine surgery for both cohorts, as well as before and after SCS implantation for the second cohort. QoL was explored by estimating patient-reported outcome measures such as pain intensity, Oswestry Disability Index, and EuroQol-5Dimensions from spine surgery up to five years post-spine surgery. RESULTS: In spine surgery patients, mean QoL and pain intensity levels improved following surgery. Patients subsequently treated with SCS had lower reported QoL and higher costs before the initial spine surgery, and spine surgery did not lead to any substantial improvements, however, costs decreased following SCS implantation in these patients.

The Association Between Patient Reported Outcomes of Spinal Surgery and Societal Costs: A Register Based Study.

STUDY DESIGN: Retrospective register-based study using Swedish registers and data prospectively collected in quality register Swespine. OBJECTIVE: Analyze the association of societal costs and spine surgery outcome in low back pain (LBP) patients based on patient reported outcome measures (PROMs). SUMMARY OF BACKGROUND DATA: Studies show that LBP has a substantial impact on societal cost. There are indications that the burden diverges over different patient groups, but little is known about cost patterns in relation to PROMs of LBP surgery. METHODS: We utilized a database with data from six registers. All lumbar spine surgery patients registered in Swespine 2000 to 2012 were identified. Swespine collects PROMs Global Assessment of pain improvement (GA), Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and EuroQol five-dimension scale (EQ-5D). A literature search was conducted to identify threshold changes in ODI, VAS, and EQ-5D representing a significant improvement or deterioration as defined by the minimal clinically important difference (MCID). We categorized patients into groups by their GA response at 2-year follow-up and estimated mean changes in ODI, VAS, and EQ-5D for each group. These changes were compared with the MCID thresholds to determine a GA-anchored classification of surgical outcomes. Costs consisted of out/inpatient care, sick leave, early retirement, and pharmaceuticals. RESULTS: In total, 12,350 patients were included. GA 1-2 ("pain has disappeared"/"pain is much improved") were labeled successful surgery outcomes (67%), GA 3 ("pain somewhat improved"), undetermined (16%), and GA 4-5 ("no change in pain"/"pain has worsened") unsuccessful (17%). Costs of the unsuccessful and undetermined were higher than of the successful during the entire study period, with differences increasing markedly post-surgery. For the successful, a downward cost trend was observed; costs almost returned to the level observed 3 years pre-surgery. No such trend was observed in the other groups. CONCLUSION: Identifying patients with higher probability of responding to surgery could lead to improved health and substantial societal cost savings. LEVEL OF EVIDENCE: 3.

Predicting clinical outcome and length of sick leave after surgery for lumbar spinal stenosis in Sweden: a multi-register evaluation.

PURPOSE: Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies have linked socioeconomic factors to outcome, but no nation-wide studies have been performed. This register-based study, including all patients surgically treated for LSS during 2008-2012 in Sweden, aimed to determine predictive factors for the outcome of surgery. METHODS: Clinical and socioeconomic factors with impact on outcome in LSS surgery were identified in several high-coverage registers, e.g., the national quality registry for spine surgery (Swespine, FU-rate 70-90%). Multivariate regression analyses were conducted to assess their effect on outcome. Two patient-reported outcome measures, Global Assessment of leg pain (GA) and the Oswestry Disability Index (ODI), as well as length of sick leave after surgery were analyzed. RESULTS: Clinical and socioeconomic factors significantly affected health outcome (both GA and ODI). Some predictors of a good outcome (ODI) were: being born in the EU, reporting no back pain at baseline, a high disposable income and a high educational level. Some factors predicting a worse outcome were previous surgery, having had back pain more than 2 years, having comorbidities, being a smoker, being on social welfare and being unemployed. CONCLUSIONS: The study highlights the relevance of adding socioeconomic factors to clinical factors for analysis of patient-reported outcomes, although the causal pathway of most predictors' impact is unknown. These findings should be further investigated in the perspective of treatment selection for individual LSS patients. The study also presents a foundation of case mix algorithms for predicting outcome of surgery for LSS. These slides can be retrieved under Electronic Supplementary Material.

Cost of low back pain: results from a national register study in Sweden.

PURPOSE: To estimate the societal costs of low back pain with/without radiating leg pain (LBP). LBP is a major burden in terms of both personal suffering and societal costs. METHODS: Patients visiting healthcare providers with a LBP-diagnosis in the Western region of Sweden (Västra Götaland) in 2008-2011 were identified in national registers and an administrative patient database. Direct healthcare costs and indirect costs in terms of sick leave and early retirement were summarized over time periods called LBP episodes, starting with a LBP-related healthcare contact or work absence due to LBP and ended when 6 months had elapsed without any LBP-related healthcare contact or work absence. RESULTS: The mean total cost per episode was estimated at €2753 with a mean duration of 51 days. There was a sharp increase in total cost the first month after the LBP episode started and a marked decrease from the second month. Total cost leveled off at a higher level during the 2 years after episode start compared with the 2 years before episode start. The total economic burden of LBP in Sweden including all LBP episodes that started in 2011 was estimated at €740 million, or €78 per capita. CONCLUSIONS: LBP has an apparent impact on the overall resource use and work loss. The results indicate that there is a high short-term cost increase at the beginning of an LBP episode, but also that the costs decrease in the long term after the LBP symptoms have come to clinical attention. These slides can be retrieved under Electronic Supplementary Material.

A health economic lifetime treatment pathway model for low back pain in Sweden.

AIMS: To develop a health economic model to evaluate the long-term costs and outcomes over the healthcare treatment pathway for patients with low back pain (LBP). MATERIALS AND METHODS: A health economic model, consisting of a decision tree structure with a Markov microsimulation model at the end of each branch, was created. Patients were followed from first observed clinical presentation with LBP until the age of 100 years or death. The underlying data to populate the model were based on Swedish national and regional registry data on healthcare resource use and sickness insurance in patients presenting with LBP in the Swedish region Västra Götaland during 2008-2012. Costs (outpatient healthcare visits, inpatient bed days, pharmaceuticals, productivity loss), EUR 2016, and quality-of-life based on EQ-5D data from the registries and published estimates were summarized over the lifetime of the patients with 3% annual discount. A lost quality-adjusted life year (QALY) was valued at €70,000. RESULTS: Mean lifetime total cost was estimated at €47,452/patient, of which indirect costs were 57%. Total lifetime economic burden for all patients coming to clinical presentation in Sweden per year was €8.8bn. The average LBP patient was estimated to face a loss of 2.7 QALYs over their lifetime compared with the general population. For all patients in Sweden coming to clinical presentation in 1 year this gives 505,407 QALYs lost, valued at €35.3bn. Adding the economic burden, the total societal burden amounts to €44.1bn. CONCLUSION: This pathway model shows that most patients with LBP receive conservative care, and a minority consume high-cost healthcare interventions like surgery. The model could be used to see broad economic effects of different patterns of healthcare provision in sub-groups with LBP and to estimate where it is possible to influence these pathways to increase utility for patients and for society.

A Profile of Low Back Pain: Treatment and Costs Associated With Patients Referred to Orthopedic Specialists in Sweden.

STUDY DESIGN: Analysis of Swedish national and regional register data. OBJECTIVES: The aim of this study was to characterize healthcare resource utilization, productivity loss, and costs of patients with low back pain (LBP) with or without leg pain, who have been referred from primary care settings to orthopedic specialist care. SUMMARY OF BACKGROUND DATA: Register data on outpatient and inpatient care, work absence, drug prescriptions, socioeconomics, and mortality were extracted for patients visiting orthopedic specialists for LBP in the Swedish region Västra Götaland (1.6 million inhabitants in 2015) in 2008 to 2011 (4 years). METHODS: Patients were followed with regard to resource use and costs during "LBP episodes," defined as the time period from the first visit to an orthopedic specialist ("index-point") until the last observed resource use registered with an LBP diagnosis. Patients were also followed during fixed time periods of 2 years before and 2 years after the index-point. RESULTS: In total, 16,329 LBP episodes were identified (13,931 unique patients), in six diagnosis groups. Mean societal cost per LBP episode was estimated at &OV0556;6466 (SD 21,884), where indirect cost constituted 74% and half of the 26% remaining direct costs were owing to hospital inpatient care. Patients underwent surgery in 10% of the episodes (n = 1583). Cost per LBP episode varied between diagnosis groups, with a range of &OV0556;18,668 to &OV0556;40,774 in episodes with surgery and &OV0556;978 to &OV0556;10,379 in episodes without surgery. Assessment of the fixed time period of 2 years before and after index-point showed that costs increased gradually during the year before in all groups and declined the year after in all groups. CONCLUSION: The marked decline in total costs the year after referral to an orthopaedic specialist indicates that the treatment provided, regardless of treatment, has an effect and also likely improves the quality of life for the patient. LEVEL OF EVIDENCE: 4.

A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis.

BACKGROUND: The efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials. METHODS: We randomly assigned 247 patients between 50 and 80 years of age who had lumbar spinal stenosis at one or two adjacent vertebral levels to undergo either decompression surgery plus fusion surgery (fusion group) or decompression surgery alone (decompression-alone group). Randomization was stratified according to the presence of preoperative degenerative spondylolisthesis (in 135 patients) or its absence. Outcomes were assessed with the use of patient-reported outcome measures, a 6-minute walk test, and a health economic evaluation. The primary outcome was the score on the Oswestry Disability Index (ODI; which ranges from 0 to 100, with higher scores indicating more severe disability) 2 years after surgery. The primary analysis, which was a per-protocol analysis, did not include the 14 patients who did not receive the assigned treatment and the 5 who were lost to follow-up. RESULTS: There was no significant difference between the groups in the mean score on the ODI at 2 years (27 in the fusion group and 24 in the decompression-alone group, P=0.24) or in the results of the 6-minute walk test (397 m in the fusion group and 405 m in the decompression-alone group, P=0.72). Results were similar between patients with and those without spondylolisthesis. Among the patients who had 5 years of follow-up and were eligible for inclusion in the 5-year analysis, there were no significant differences between the groups in clinical outcomes at 5 years. The mean length of hospitalization was 7.4 days in the fusion group and 4.1 days in the decompression-alone group (P<0.001). Operating time was longer, the amount of bleeding was greater, and surgical costs were higher in the fusion group than in the decompression-alone group. During a mean follow-up of 6.5 years, additional lumbar spine surgery was performed in 22% of the patients in the fusion group and in 21% of those in the decompression-alone group. CONCLUSIONS: Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).

Cost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCT.

STUDY DESIGN: Randomized clinical trial with 2-year follow-up. OBJECTIVE: To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR. METHODS: Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio. RESULTS: The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18-0.50). The mean total cost per patient in the TDR group was &OV0556;87,622 (58,351) compared with &OV0556;74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: -4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from &OV0556;39,748 using EQ-5D (TDR cost-effective) to &OV0556;128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D. CONCLUSION: In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of &OV0556;74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR. LEVEL OF EVIDENCE: 2.

Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture: a Swedish multicenter randomized controlled trial with 2-year follow-up.

STUDY DESIGN: A multicenter, randomized, controlled, cost-effectiveness analysis. OBJECTIVE: To assess the cost-effectiveness of balloon kyphoplasty (BKP) compared with standard medical treatment (control) in patients with acute/subacute (<3 months) vertebral compression fracture (VCF) due to osteoporosis. SUMMARY OF BACKGROUND DATA: Patients with a VCF due to osteoporosis are common and will increase in number in an aging population, putting a substantial strain on health care. Selected patients may benefit from stabilizing the fracture with cement through BKP, a minimally invasive procedure. BKP has been reported to give good short-time clinical results, and economic modeling has suggested that the procedure could be cost-effective after 2 years compared with standard treatment. METHODS: Hospitalized patients with back pain due to VCF were randomized to BKP or to control using a computer-generated random list. All costs associated with VCF and cost-effectiveness were reported primarily from the perspective of society. We used EQ-5D to assess quality of life (QoL). The accumulated quality-adjusted life years (QALYs) gained and costs/QALY gained were assessed using intention to treat. RESULTS: Between February 2003 and December 2005, a total of 63 out of 67 Swedish patients were analyzed: BKP (n = 32) and control (n = 31). Societal cost per patient for BKP was SEK 160,017 (SD = 151,083) = €16,668 (SD = 15,735), and for control SEK 84,816 (SD = 40,954) = €8835 (SD = 4266), a significant difference of 75,198 (95% confidence intervals [CI] = 16,037-120,104) = €7833 (95% CI = 1671-12,511). The accumulated difference in QALYs was 0.085 (95% CI = -0.132 to 0.306) in favor of BKP. Cost/QALY gained using BKP was SEK 884,682 = €92,154 and US $134,043. CONCLUSION: In this randomized controlled trial, it was not possible to demonstrate that BKP was cost-effective compared with standard medical treatment in patients treated for an acute/subacute vertebral fracture due to osteoporosis. However, sensitivity analysis indicated a certain degree of uncertainty, which needs to be considered.

Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up.

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (-45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the "non-difference" in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (-73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.

Cost-effectiveness of lumbar fusion and nonsurgical treatment for chronic low back pain in the Swedish Lumbar Spine Study: a multicenter, randomized, controlled trial from the Swedish Lumbar Spine Study Group.

STUDY DESIGN: A cost-effectiveness study was performed from the societal and health care perspectives. OBJECTIVE: To evaluate the costs-effectiveness of lumbar fusion for chronic low back pain (CLBP) during a 2-year follow-up. SUMMARY OF BACKGROUND DATA: A full economic evaluation comparing costs related to treatment effects in patients with CLBP is lacking. PATIENTS AND METHODS: A total of 284 of 294 patients with CLBP for at least 2 years were randomized to either lumbar fusion or a nonsurgical control group. Costs for the health care sector (direct costs), and costs associated with production losses (indirect costs) were calculated. Societal total costs were identified as the sum of direct and indirect costs. Treatment effects were measured using patient global assessment of improvement, back pain (VAS), functional disability (Owestry), and return to work. RESULTS: The societal total cost per patient (standard deviations) in the surgical group was significantly higher than in the nonsurgical group: Swedish kroner (SEK) 704,000 (254,000) vs. SEK 636,000 (208,000). The cost per patient for the health care sector was significantly higher for the surgical group, SEK 123,000 (60,100) vs. 65,200 (38,400) for the control group. All treatment effects were significantly better after surgery. The incremental cost-effectiveness ratio (ICER), illustrating the extra cost per extra effect unit gained by using fusion instead of nonsurgical treatment, were for improvement: SEK 2,600 (600-5,900), for back pain: SEK 5,200 (1,100-11,500), for Oswestry: SEK 11,300 (1,200-48,000), and for return to work: SEK 4,100 (100-21,400). CONCLUSION: For both the society and the health care sectors, the 2-year costs for lumbar fusion was significantly higher compared with nonsurgical treatment but all treatment effects were significantly in favor of surgery. The probability of lumbar fusion being cost-effective increased with the value put on extra effect units gained by using surgery.