Cauda Equina Syndrome: Cost Burden After Spinal Decompression.

STUDY DESIGN: Observational cohort study. OBJECTIVE: Cauda equina syndrome (CES) is a rare neurologic condition with potentially devastating consequences. The objective of this study was to compare the 2-year postoperative cost-associated treatments after posterior spinal decompression between patients with and without CES. METHODS: By analyzing a commercial insurance claims database, patients who underwent posterior spinal decompression with a concurrent diagnosis of lumbar spinal stenosis, radiculopathy, or disk herniation in 2017 were identified and included in the study. The primary outcome was the cost of payments for identified treatments in the 2-year period after surgery. Treatments included were (1) physical therapy (PT), (2) pain medication, (3) injections, (4) bladder management, (5) bowel management, (6) sexual dysfunction treatment, and (7) psychological treatment. RESULTS: In total, 3,140 patients (age, 55.3 ± 12.0 years; male, 62.2%) were included in the study. The average total cost of treatments identified was $2,996 ± 6,368 per patient. The overall cost of identified procedures was $2,969 ± 6,356 in non-CES patients, compared with $4,535 ± 6,898 in patients with CES ( P = 0.079). Among identified treatments, only PT and bladder management costs were significantly higher for patients with CES (PT: +115%, P < 0.001; bladder management: +697%, P < 0.001). The difference in overall cost was significant between patients (non-CES: $1,824 ± 3,667; CES: $3,022 ± 4,679; P = 0.020) in the first year. No difference was found in the second year. DISCUSSION: A short-term difference was observed in costs occurring in the first postoperative year. Cost of treatments was similar between patients apart from PT and bladder management.

Microdiscectomy Is More Cost-effective Than a 6-Month Nonsurgical Care Regimen for Chronic Radiculopathy.

BACKGROUND: A recent randomized controlled trial (RCT), performed by the authors, comparing early surgical microdiscectomy with 6 months of nonoperative care for chronic lumbar radiculopathy showed that early surgery resulted in improved outcomes. However, estimates of the incremental cost-utility ratio (ICUR), which is often expressed as the cost of gaining one quality-adjusted life year (QALY), of microdiscectomy versus nonsurgical management have varied. Radiculopathy lasting more than 4 months is less likely to improve without surgical intervention and may have a more favorable ICUR than previously reported for acute radiculopathy. QUESTION/PURPOSE: In the setting of chronic radiculopathy caused by lumbar disc herniation, defined as symptoms and/or signs of 4 to 12 months duration, is surgical management more cost-effective than 6 months of nonoperative care from the third-party payer perspective based on a willingness to pay of less than CAD 50,000/QALY? METHODS: A decision analysis model served as the vehicle for the cost-utility analysis. A decision tree was parameterized using data from our single-center RCT that was augmented with institutional microcost data from the Ontario Case Costing Initiative. Bottom-up case costing methodology generates more accurate cost estimates, although institutional costs are known to vary. There were no major surgical cost drivers such as implants or bone graft substitutes, and therefore, the jurisdictional variance would be minimal for tertiary care centers. QALYs derived from the EuroQoL-5D were the health outcome and were derived exclusively from the RCT data, given the paucity of studies evaluating the surgical treatment of lumbar radiculopathy lasting 4 to 12 months. Cost-effectiveness was assessed using the ICUR and a threshold of willingness to pay CAD 50,000 (USD 41,220) per QALY in the base case. Sensitivity analyses were performed to account for the uncertainties within the estimate of cost utility, using both a probabilistic sensitivity analysis and two one-way sensitivity analyses with varying crossover rates after the 6-month nonsurgical treatment had concluded. RESULTS: Early surgical treatment of patients with chronic lumbar radiculopathy (defined as symptoms of 4 to 12 months duration) was cost-effective, in that the cost of one QALY was lower than the CAD 50,000 threshold (note: the purchasing power parity conversion factor between the Canadian dollar (CAD) and the US dollar (USD) for 2019 was 1 USD = 1.213 CAD; therefore, our threshold was USD 41,220). Patients in the early surgical treatment group had higher expected costs (CAD 4118 [95% CI 3429 to 4867]) than those with nonsurgical treatment (CAD 2377 [95% CI 1622 to 3518]), but they had better expected health outcomes (1.48 QALYs [95% CI 1.39 to 1.57] versus 1.30 [95% CI 1.22 to 1.37]). The ICUR was CAD 5822 per QALY gained (95% CI 3029 to 30,461). The 2-year probabilistic sensitivity analysis demonstrated that the likelihood that early surgical treatment was cost-effective was 0.99 at the willingness-to-pay threshold, as did the one-way sensitivity analyses. CONCLUSION: Early surgery is cost-effective compared with nonoperative care in patients who have had chronic sciatica for 4 to 12 months. Decision-makers should ensure adequate funding to allow timely access to surgical care given that it is highly likely that early surgical intervention is potentially cost-effective in single-payer systems. Future work should focus on both the clinical effectiveness of the treatment of chronic radiculopathy and the costs of these treatments from a societal perspective to account for occupational absences and lost patient productivity. Parallel cost-utility analyses are critical so that appropriate decisions about resource allocation can be made. LEVEL OF EVIDENCE: Level III, economic and decision analysis.

Percutaneous Transforaminal Endoscopic Discectomy Versus Open Microdiscectomy for Lumbar Disc Herniation: A Systematic Review and Meta-analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: To give a systematic overview of effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy (OM) in the treatment of lumbar disk herniation (LDH). SUMMARY OF BACKGROUND DATA: The current standard procedure for the treatment of sciatica caused by LDH, is OM. PTED is an alternative surgical technique which is thought to be less invasive. It is unclear if PTED has comparable outcomes compared with OM. METHODS: Multiple online databases were systematically searched up to April 2020 for randomized controlled trials and prospective studies comparing PTED with OM for LDH. Primary outcomes were leg pain and functional status. Pooled effect estimates were calculated for the primary outcomes only and presented as standard mean differences (SMD) with their 95% confidence intervals (CI) at short (1-day postoperative), intermediate (3-6 months), and long-term (12 months). RESULTS: We identified 2276 citations, of which eventually 14 studies were included. There was substantial heterogeneity in effects on leg pain at short term. There is moderate quality evidence suggesting no difference in leg pain at intermediate (SMD 0.05, 95% CI -0.10-0.21) and long-term follow-up (SMD 0.11, 95% CI -0.30-0.53). Only one study measured functional status at short-term and reported no differences. There is moderate quality evidence suggesting no difference in functional status at intermediate (SMD -0.09, 95% CI -0.24-0.07) and long-term (SMD -0.11, 95% CI -0.45-0.24). CONCLUSION: There is moderate quality evidence suggesting no difference in leg pain or functional status at intermediate and long-term follow-up between PTED and OM in the treatment of LDH. High quality, robust studies reporting on clinical outcomes and cost-effectiveness on the long term are lacking.Level of Evidence: 2.

Greater Socioeconomic Disadvantage Is Associated with Worse Symptom Severity at Initial Presentation in Patients Seeking Care for Lumbar Disc Herniation.

STUDY DESIGN: Retrospective, observational study. OBJECTIVE: To determine the association of patient socioeconomic disadvantage, insurance type, and other characteristics on presenting symptom severity in patients with isolated lumbar disc herniation. SUMMARY OF BACKGROUND DATA: Little is known of the impact of socioeconomic disadvantage and other patient characteristics on the level of self-reported symptom severity when patients first seek care for lumbar disc herniation. METHODS: Between April 2015 and December 2018, 734 patients newly presenting for isolated lumbar disc herniation who completed the Patient-Reported Outcomes Measurement Information System Physical Function (PF), Pain Interference (PI), and Depression Computer Adaptive Tests (CATs) were identified. Socioeconomic disadvantage was determined using the Area Deprivation Index, a validated measure of socioeconomic disadvantage at the census block group level (0-100, 100 = highest socioeconomic disadvantage). Bivariate analyses were used. Multivariable linear regression was used to determine if there was an association between socioeconomic disadvantage, insurance type, and other patient factors and presenting patient-reported health status. RESULTS: Significant differences in age, insurance type, self-reported race, marital status, and county of residence were appreciated when comparing patient characteristics by socioeconomic disadvantage levels (all comparisons, P < 0.01). In addition, significant differences in age, insurance type, marital status, and county of residence were appreciated when comparing patient characteristics by self-reported race (all comparisons, P < 0.01). Being in the most socioeconomically disadvantaged cohort was associated with worse presenting Patient-Reported Outcomes Measurement Information System scores (Physical Function: ß = -3.27 (95% confidence interval [CI]: -4.89 to -1.45), P < 0.001; Pain Interference: ß = 3.20 (95% CI: 1.58-4.83), P < 0.001; Depression: ß = 3.31 (95% CI: 1.08-5.55), P = 0.004. CONCLUSION: The most socioeconomically disadvantaged patients with symptomatic lumbar disc herniations present with worse functional limitations, pain levels, and depressive symptoms as compared to patients from the least socioeconomically disadvantaged cohort when accounting for other key patient factors.Level of Evidence: 3.

Factors Associated With Progression to Surgical Intervention for Lumbar Disc Herniation in the Military Health System.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To determine surgery-free survival of patients receiving conservative management of lumbar disc herniation (LDH) in the military healthcare system (MHS) and risk factors for surgical intervention. SUMMARY OF BACKGROUND DATA: Radiculopathy from LDH is a major cause of morbidity and cost. METHODS: The Military Data Repository was queried for all patients diagnosed with LDH from FY2011-2018; the earliest such diagnosis in a military treatment facility (MTF) was kept for each patient as the initial diagnosis. Follow-up time to surgical intervention was defined as the time from diagnosis to first encounter for lumbar microdiscectomy or lumbar decompression in either a MTF or in the civilian sector. The Military Data Repository was also queried for history of tobacco use at any time during MHS care, age at the time of diagnosis, sex, MHS beneficiary category, and diagnosing facility characteristics. Multivariable Cox proportional hazards models were used to evaluate the associations of patient and diagnosing facility characteristics with time to surgical intervention. RESULTS: A total of 84,985 MHS beneficiaries including 62,771 active duty service members were diagnosed with LDH in a MTF during the 8-year study period. A total of 10,532 (12.4%) MHS beneficiaries, including 7650 (10.9%) active duty, failed conservative management onto surgical intervention with lumbar microdiscectomy or lumbar decompression. Median follow-up time of the cohort was 5.2 (interquartile range 2.6, 7.5) years. Among all healthcare beneficiaries, several patient-level (younger age, male sex, and history of tobacco use) and facility-level characteristics (hospital vs. clinic and surgical care vs. primary care clinic) were independently associated with higher risk of surgical intervention. CONCLUSION: LDH compromises military readiness and negatively impacts healthcare costs. MHS beneficiaries with LDH have a good prognosis with approximately 88% of patients successfully completing conservative management. However, strategies to improve outcomes of conservative management in LDH should address risks associated with both patient and facility characteristics.Level of Evidence: 4.

Total Health Care Expenditure in Patients With a Herniated Lumbar Disk That Ultimately Require Surgery: A 3- and 6-month Cost Comparison of Maximum Nonoperative Treatment.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: To compare the cost of maximum nonoperative therapy (MNT) in patients diagnosed with a herniated lumbar disk undergoing primary (1-3 mo) versus prolonged (4-6 mo) conservative management before microdiscectomy. SUMMARY OF BACKGROUND DATA: Patients diagnosed with a herniated lumbar disk often attempt a 3-month trial of conservative management before microdiscectomy. A paucity of data exists characterizing the cost of a subsequent round of nonoperative therapies in patients who fail their initial trial, rather than undergo surgery. METHODS: Clinical records from patients diagnosed with a herniated lumbar disk undergoing index microdiscectomy surgery from 2007 to 2017 were gathered from a large insurance database. Records were searchable by International Classification of Diseases diagnosis/procedure codes, Current Procedural Terminology codes, and generic drug codes. Two cohorts were established: patients undergoing primary (1-3 mo) versus prolonged (4-6 mo) courses of conservative management. Nonoperative therapy utilization was documented from initial herniation diagnosis to microdiscectomy surgery. "Utilization" encompassed cost billed to patients, prescriptions written, and quantity of units dispensed. RESULTS: The 3-month MNT cohort included 4587 patients and the 6-month MNT cohort contained 1506 patients. A greater percentage of 6-month cohort patients utilized opioids (P=0.0052), muscle relaxants (P=0.0061), and lumbar steroid injections (P<0.0001). When considering the average amount spent on conservative management, 6-month patients ($1824/patient) spent 1.55 times more than 3-month patients ($1178/patient). The 6-month:3-month average spending ratio was <2.0 for all of the nonoperative therapies except nonsteroidal anti-inflammatory drugs (2.66) and epidural steroid injections (2.25). When normalized by the number of opioid users, the number of opioid medications dispensed was proportionally less in 3-month patients compared with 6-month patients, with a 6-month:3-month ratio of 1.52. CONCLUSIONS: The costs associated with a subsequent course of nonoperative therapies for symptomatic lumbar disk herniation seem to be slightly less than that of the primary trial. Assuming a minimal clinical benefit after the initial trial of nonsurgical therapies, the incremental cost-effectiveness ratio of a subsequent trial versus surgery may be unfavorable. Future studies identifying patients likely to benefit from surgery earlier in the treatment course is required. LEVEL OF EVIDENCE: Level III.

The Influence of Depression on Health Care Expenditures Among Adults with Spondylosis, Intervertebral Disc Disorders, and Other Back Problems in the United States.

BACKGROUND: Back pain is a very prevalent complaint, affecting two-thirds of the US population, and it accounts for $100 billion annually in health care expenditures. The occurrence of depression has been reported in existing literature among patients with back pain, but there is limited information regarding health care expenditures among patients with back pain and concurrent depression. OBJECTIVE: To assess excess total and subtypes of health care expenditures among adults with spondylosis, intervertebral disc disorders, and other back problems who reported having depression compared with those without depression in the United States. METHODS: We utilized a cross-sectional design, pooling Medical Expenditure Panel Survey data from 2010-2012. The eligible study sample included adults (age ≥18 years) who reported positive health care expenditure. Total and subtypes of health care expenditures constituted the dependent variable. Ordinary least squares (OLS) regressions on logged expenditures were performed. Four models were developed to assess influence of demographics, functional ability, and concurrent diagnoses on health care expenditures. RESULTS: A total of 6,739 adults with spondylosis, intervertebral disc disorders, and other back problems were assessed, 20.2% (N = 1,316) of whom had concurrent depression. Adults with concurrent depression had significantly higher total health care expenditures ($13,153) compared with the nondepression group ($7,477, P < 0.001). Outpatient and prescription expenditures showed similar findings. After adjusting for demographics, functional disabilities, and comorbidities, excess cost remained higher in the group reporting concurrent depression (46%). CONCLUSIONS: This study demonstrates that the presence of depression in adults with spondylosis, intervertebral disc disorders, and other back problems is associated with greater economic burden. These findings remained consistent after adjusting for all independent sets of variables. The study's findings suggest that interventions resulting in better management of depression have the potential to significantly reduce the economic burden in this population.

Operating Costs of Full-endoscopic Lumbar Spine Surgery in Japan.

For full-endoscopic lumbar discectomy, operating costs are also important because expensive equipment are necessary. We surveyed the operating costs of surgical equipment necessary for full-endoscopic surgery together with surgical procedure reimbursement fees. A total of 295 cases of full-endoscopic surgery via a transforaminal approach were retrospectively analyzed. We calculated the frequency of damage and the unit purchase price of devices such as endoscopes, and surgical instruments such as grasping forceps for nucleotomy, high-speed drill bar, and bipolar forceps, and examined the operating costs in Japanese yen against the procedure fee per case. Endoscope breakage occurred seven times, and a payment of ¥760,000 was necessary for trade-in and purchase of a new endoscope. The total breakage number of grasping forceps was 58, and the purchase price per unit was ¥116,000. Therefore, a total of ¥12,020,000 was required for the 295 cases, and the calculated operating cost that accompanies equipment breakage was ¥40,000 per case. In addition, about ¥118,000 was required for disposable bipolar forceps and high-speed drill bar to be used intraoperatively for each case. Thus, for one case it is calculated that total ¥158,000 is utilized for equipment from the surgical reimbursement fee per case specified by the Japanese Ministry of Health being ¥303,900. Minimally invasive procedures provide great benefit to patients; however, the eventual contribution to hospital profits is small and may not be sufficient. To resolve this issue, the cost of surgical equipment should be lowered and/or the surgical reimbursement fee of the full-endoscopic surgery should be raised.

Regional Differences in the Cost and Utilization of Nonoperative Management Within 3 Months Prior to Lumbar Microdiscectomy.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The purpose of this investigation was to evaluate the regional variations in the use of nonoperative therapies in patients diagnosed with a lumbar intervertebral disc herniation 3 months prior to undergoing microdiscectomy surgery. SUMMARY OF BACKGROUND DATA: Regional variations in the management of chronic pain conditions have been previously identified. Patients suffering from a lumbar intervertebral disc herniation are typically treated with a brief course of conservative management prior to attempting microdiscectomy surgery. Whether regional differences exist in the utilization or costs of maximum nonoperative therapy (MNT) remains unknown. METHODS: Medical records from patients diagnosed with a lumbar intervertebral disc herniation undergoing 1, 2, or 3-level index microdiscectomy operations between 2007 and 2017 were gathered from the HORTHO insurance database consisting of private/commercially insured and Medicare Advantage beneficiaries. Patient regional designation was divided into Midwest, Northeast, South, and West territories and was derived from the insurance claim location. The utilization of MNT within 3 months after initial lumbar herniation diagnosis in adult patients was analyzed. RESULTS: Our population consisted of 13,106 patients who underwent primary index microdiscectomy surgery. Significant regional variation was identified in the nonoperative therapy failure rate (P<0.0001), with the highest proportion of Midwest patients failing (2.7%). There were statistical differences in the regional distribution of patients utilizing NSAIDs (P<0.0001), muscle relaxants (P <0.0001), lumbar epidural steroid injections (P <0.0001), physical therapy and occupational therapy sessions (P <0.0001), chiropractor treatments (P <0.0001), and emergency department services (P = 0.0049). The total direct cost associated with all MNT prior to microdiscectomy was $13,205,924, with 59.6% from the South, 31.1% from the Midwest, 8.3% from the West, and 1.1% from the Northeast. CONCLUSION: These findings indicate that regional differences exist in the utilization and costs of MNT of a lumbar intervertebral herniated disc prior to microdiscectomy surgery. LEVEL OF EVIDENCE: 3.

Small incision discectomy for lumbar disc herniation in 98 patients with 5-year follow-up: A retrospective case series study.

Optimal surgical technique to treat lumbar disc herniation (LDH) remains controversial. We described a small incision discectomy technique (SID), and to evaluate its safety and efficacy. A retrospective study involving 98 consecutive patients with LDH managed by SID was conducted. All patients were followed up for 5 years. Outcomes included visual analogue scale (VAS), Japanese Orthopedic Association (JOA), operative time, length of incision, blood loss, hospital stay, hospitalization costs, x-ray exposure, reoperation, and complications. The results were determined to be excellent, good, fair, or poor according to the MacNab classification. All patients completed the 5-year follow-up. Relative to preoperative scores, VAS and JOA were both significantly improved. As a whole, 93.8% (92/98) patients showed excellent or good results, 3.1% (3/98) fair, and 3.1% (92/98) poor. The operation time, length of incision, blood loss, and hospital stay were 50 ±â€Š11.1 minutes, 2.2 ±â€Š0.3 cm, 35 ±â€Š3.5 mL, and 4.3 ±â€Š0.2 days, respectively. Additionally, compared with previous literature reports, the hospitalization costs and x-ray exposure were apparently less. The reoperation and recurrence rate were 3.2% and 2.1%. No complications were observed. From these data we conclude that SID appears to be a safe, cost-effective technique for LDH, and has lower x-rays exposure time when compared with literature of percutaneous endoscopic lumbar discectomy (PELD).

Cost-utility Analysis for Recurrent Lumbar Disc Herniation: Conservative Treatment Versus Discectomy Versus Discectomy With Fusion.

STUDY DESIGN: This study was an ambispective long-term cost-utility analysis with retrospective chart review and included the prospective completion of health questionnaires by patients. OBJECTIVE: This was a cost-utility analysis, comparing conservative treatment, discectomy, and discectomy with spinal fusion for patients with recurrent lumbar disc herniation after a previous discectomy. SUMMARY OF BACKGROUND DATA: Lumbar disc herniation is an important health problem, with recurrence rates ranging from 5% to 15%. Management of recurrences is controversial due to a lack of high-level evidence. Cost-effectiveness analyses are useful when making clinical decisions. There are economic assessments for first herniations, but not in the context of recurrent lumbar disc herniations. MATERIALS AND METHODS: Fifty patients with disc herniation recurrence underwent conservative treatment (n=11), discectomy (n=20), or discectomy with fusion (n=19), and they completed the Short-Form 36, EuroQol-5D, and Oswestry Disability Index.Baseline case quality-adjusted life year (QALY) values, cost-utility ratios, and incremental cost-utility ratios were calculated on the basis of the SF-36. Direct health costs were calculated by applying the health care system perspective. Both QALY and costs were discounted at a rate of 3%. One-way sensitivity analyses were conducted for uncertainty variables, such as other health surveys or 2-year follow-up. RESULTS: Cost-utility analysis of conservative treatment versus discectomy showed that the former is dominant, mainly because it is significantly more economical (&OV0556;904 vs. &OV0556;6718, P<0.001), while health results were very similar (3.48 vs. 3.18, P=0.887). Cost-utility analysis of discectomy versus discectomy with fusion revealed that discectomy is dominant, showing a trend to be both more economical (&OV0556;6718 vs. &OV0556;9364, P=0.054) and more effective (3.18 vs. 1.92 QALY, P=0.061). CONCLUSIONS: This cost-utility analysis showed that conservative treatment is more cost-effective than discectomy in patients with lumbar disc herniation recurrence. In cases of recurrence in which conservative treatment is not feasible, and another surgery must be performed for the patient, discectomy is a more cost-effective surgical alternative than discectomy with fusion. LEVEL OF EVIDENCE: Level II.

Physiotherapy after anterior cervical spine surgery for cervical disc disease: study protocol of a prospective randomised study to compare internet-based neck-specific exercise with prescribed physical activity.

INTRODUCTION: Patients suffering from remaining disability after anterior cervical decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSEs). Currently, we lack data for the success of either approach. There is also a knowledge gap concerning the use of internet-based care for cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrant increased efforts to investigate and improve cost-effective rehabilitation. The objective is to compare the effectiveness of a structured, internet-based NSE programme, versus PPA following ACDF surgery. METHODS AND ANALYSIS: This is a prospective, randomised, multicentre study that includes 140 patients with remaining disability (≥30% on the Neck Disability Index, NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled at 3 months postsurgery. Patients are then randomised to one of two groups (70 patients/group) for a 3-month treatment programme/period of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, along with physical measures of neck-related function conducted by independent test leaders blinded to randomisation. Measures are collected at inclusion, after the 3-month treatments (end of treatment) and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry. Data on healthcare consumption, drug use and sick leave will be requested from the relevant national registers. ETHICAL CONSIDERATIONS: This study was approved by the Regional Ethical Review Board in Linköping Ref. 2016/283-31 and 2017/91- 32. The scientists are independent with no commercial ties. Patients are recruited after providing written informed consent. Patient data are presented at group level such that no connection to any individual can be made. All data are anonymised when reported, and subject to the Swedish Official Secrets Health Acts. The test leaders are independent and blinded for randomisation. Exercises, both general and neck-specific, have been used extensively in clinical practice and we anticipate no harm from their implementation other than a risk of muscle soreness. Both randomisation groups will receive care that is expected to relieve pain, although the group receiving NSE is expected to demonstrate a greater and more cost-effective improvement versu s the PPA group. Any significant harm or unintended effects in each group will be collected by the test leaders. All questionnaires and test materials are coded by the research group, with code lists stored in locked, fireproof file cabinets, housed at the university in a room with controlled (card-based) access. Only individuals in receipt of a unique website address posted by the researchers can access the programme; patients can neither communicate with each other nor with caregivers via the programme.Study participation might lead to improved rehabilitation versus non-participation, and might therefore be of benefit. The results of this study should also contribute to more effective and flexible rehabilitation, shorter waiting times, lower costs and the possibility to implement our findings on a wider level. DISSEMINATION: If effective, the protocols used in this study can be implemented in existing healthcare structures. The results of the study will be presented in scientific journals and popular science magazines of relevance to health. The findings will also be presented at local, regional, national and international conferences and meetings, as well as in the education of university students and at public lectures. Information about the results will be communicated to the general population in cooperation with patient organisations and the media. TRIAL REGISTRATION: NCT03036007.

Cost-effectiveness of a Bone-anchored Annular Closure Device Versus Conventional Lumbar Discectomy in Treating Lumbar Disc Herniations.

STUDY DESIGN: Cost-utility analysis of an annular closure device (ACD) based on data from a prospective, multicenter randomized controlled trial (RCT) OBJECTIVE.: The aim of this study was to determine the cost-effectiveness of a novel ACD in a patient population at high risk for recurrent herniation following discectomy. SUMMARY OF BACKGROUND DATA: Lumbar disc herniation patients with annular defect widths ≥6 mm are at high risk for recurrent herniation following limited discectomy. Recurrent herniation is associated with worse clinical outcomes and greater healthcare costs. A novel ACD may reduce the incidence of recurrent herniation and the associated burdens. METHODS: A decision analytical modeling approach with a Markov method was used to evaluate the cost-effectiveness of the ACD versus conventional discectomy. Health states were created by projecting visual analogue scale (VAS) onto Oswestry Disability Index (ODI). Direct costs were calculated based on Humana and Medicare 2014 claims to represent private and public payer data, respectively. Indirect costs were calculated for lost work days using 2016 US average annual wages. The incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life year (QALY) was compared to willingness-to-pay thresholds. Sensitivity analyses were also conducted. RESULTS: Patients with the ACD had less symptomatic reherniations, reoperations, and complications and gained 0.0328 QALYs within the first 2 years. Total direct medical costs for the ACD group were similar to control. When productivity loss was considered, using the ACD became $2076 cheaper, per patient, than conventional discectomy. Based on direct costs alone, the ICER comparing ACD to control equaled $6030 per QALY. When indirect costs are included, the ICER became negative, which indicates that superior quality of life was attained at less cost. CONCLUSION: For lumbar disc herniations patients with annular defects ≥6 mm, the ACD was, at 2 years, a highly cost-effective surgical modality compared to conventional lumbar discectomy. LEVEL OF EVIDENCE: 1.

A Prospective Detailed Time Analysis Study of 18 Patients Undergoing Elective Single-Level Open Lumbar Microdiscectomy Spinal Surgery Compared with Centers for Medicare and Medicaid Services Reimbursement Guidelines.

BACKGROUND: Single-level open lumbar microdiscectomy surgery is one of the most straightforward and effective spinal surgeries performed by spinal surgeons today to treat disk herniation. Although a common operation, little in the literature is reported on the exact overall time, cost, and effort associated with the performance of this surgery. The consistency of this operation across institutions and disciplines makes it a good starting point to accurately track the total time and effort of all phases of the surgical intervention. METHODS: Eighteen patients undergoing elective single-level open lumbar microdiscectomy surgery were prospectively enrolled in this study. The time spent interacting with each patient by every member of the surgical team was tracked and recorded along will every phone call and e-mail. All perioperative times associated with the surgery were tracked and analyzed. Each patient was followed from their first interaction through surgery and for the first 3 months postoperatively. RESULTS: The advanced practice providers spent the most time with the patient both pre- and postoperatively followed by the surgeon and resident. A total of 2.98 hours was spent with the patient preoperatively in clinic and 1.69 hours postoperatively. The total time commitment of an institution treating this condition was 12.56 hours. CONCLUSIONS: Comparing our results with the Centers for Medicare and Medicaid Services data, a significant discrepancy and underestimation was observed. As such, we hope our results enable health care providers to more accurately allocate resources for the provision of high-quality medical care to patients with this increasingly common condition.

Lumbar Disk Herniation and SPORT: A Review of the Literature.

The Spine Patient Outcomes Related Trial (SPORT) is arguably one of the most impactful and insightful studies conducted in spine surgery. Designed as a prospective, multicenter study with a randomized and observational cohort, SPORT has provided vast data on the pathogenesis, treatment effects, clinical outcomes, cost effectiveness of both disk herniation and lumbar spinal stenosis. With regards to lumbar disk herniation, SPORT has demonstrated a sustained benefit from surgical intervention and acceptable cost-effectiveness at 2, 4, and 8 years postoperatively. Myriad subgroup analyses have subsequently been performed that have also resulted in clinically relevant findings. These analyses have assessed optimal timing for surgery, incidence and risk factors for reoperation, impact of obesity and other comorbidities, influence of epidural injections, and evaluation of socioeconomic factors. This has resulted in significant findings that may allow spine surgeons to optimize patient outcomes while managing expectations appropriately.

Fusion Techniques Are Related to a Lower Risk of Reoperation in Lumbar Disc Herniation: A 5-Year Observation Study of a Nationwide Cohort in Taiwan.

OBJECTIVE: Lumbar disc herniation (LDH) is a common spinal problem, with reoperation rates of 6%-24%. Although different surgical techniques are used for treatment, there is still debate regarding whether fusion techniques can reduce the reoperation rate in patients with LDH. METHODS: This retrospective study used a 5-year nationwide database to analyze reoperation rates in Taiwan. Patient age groups (≥20 and <90 years) treated by index surgery and reoperation for LDH were identified. Four surgical procedures were included in the analysis: discectomy (DC), anterior lumbar fusion with DC (FA + DC), posterior lumbar fusion (FP), and posterior lumbar fusion with DC (FP + DC). RESULTS: There were 1743 index surgeries between 2008 and 2012, with 184 (10.56%) reoperations. Index surgery DC had the highest reoperation rate (n = 121, 20%). The reoperation risk was significantly lower for patients undergoing fusion procedures (FA + DC vs. DC [hazard ratio (HR), 0.24; 95% confidence interval (CI), 0.12-0.47; P < 0.01], FP versus DC [HR, 0.17; 95% C, 0.09-0.33; P <0.01], FP + DC versus DC [HR, 0.31; 95% CI, 0.22-0.44; P < 0.01]). Fusion procedures had significantly higher treatment costs compared with DC (FA + DC vs. FP vs. FP + DC vs. DC: 5851.74 ± 4808.94 vs. 5116.88 ± 3428.97 vs. 4782.16 ± 2902.19 vs. 3846.79 ± 3584.45 U.S. dollars/patient, respectively; P < 0.0001). CONCLUSIONS: Among surgical procedures for LDH, fusion techniques are related to lower reoperation rates compared with discectomy, but at the expense of higher medical costs.

Increased Volume of Lumbar Surgeries for Herniated Intervertebral Disc Disease and Cost-Effectiveness Analysis: A Nationwide Cohort Study.

STUDY DESIGN: Retrospective cohort study of a nationwide database. OBJECTIVE: The primary objective was to summarize the use of surgical methods for lumbar herniated intervertebral disc disease (HIVD) at two different time periods under the national health insurance system. The secondary objective was to perform a cost-effectiveness analysis by utilizing incremental cost-effectiveness ratio (ICER). SUMMARY OF BACKGROUND DATA: The selection of surgical method for HIVD may or may not be consistent with cost effectiveness under national health insurance system, but this issue has rarely been analyzed. METHODS: The data of all patients who underwent surgeries for HIVD in 2003 (n = 17,997) and 2008 (n = 38,264) were retrieved. The surgical methods included open discectomy (OD), fusion surgery, laminectomy, and percutaneous endoscopic lumbar discectomy (PELD). The hospitals were classified as tertiary-referral hospitals (≥300 beds), medium-sized hospitals (30-300 beds), or clinics (<30 beds). ICER showed the difference in the mean total cost per 1% decrease in the reoperation probability among surgical methods. The total cost included the costs of the index surgery and the reoperation. RESULTS: In 2008, the number of surgeries increased by 2.13-fold. The number of hospitals increased by 34.75% (731 in 2003 and 985 in 2008). The proportion of medium-sized hospitals increased from 62.79% to 70.86%, but the proportion of surgeries performed at those hospitals increased from 61.31% to 85.08%. The probability of reoperation was highest after laminectomy (10.77%), followed by OD (10.50%), PELD (9.20%), and fusion surgery (7.56%). The ICERs indicated that PELD was a cost-effective surgical method. The proportion of OD increased from 71.21% to 84.12%, but that of PELD decreased from 16.68% to 4.57%. CONCLUSION: The choice of surgical method might not always be consistent with cost-effectiveness strategies, and a high proportion of medium-sized hospitals may be responsible for this change. LEVEL OF EVIDENCE: 4.

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation.

INTRODUCTION: Lumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the treatment of lumbar disc herniation. METHOD AND ANALYSIS: In total, 682 patients between 18 and 70 years of age with >10 weeks of radiating pain or with >6 weeks of excessive radiating pain are to be recruited from participating centres. Patients must have an indication for surgery based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Patients are to be randomised to PTED or open microdiscectomy. The primary outcome is self-reported leg pain measured by the 0-100 mm Visual Analogue Scale. Secondary outcomes include self-reported health and functional status, back pain, self-perceived recovery and a physical examination. Outcomes will be measured the day following surgery, at 2, 4 and 6 weeks, and at 3, 6, 9, 12 and 24 months. Physical examination will be performed at 6 weeks, and 3 and 12 months. An economic evaluation will be performed from a societal perspective and cost questionnaires will be used (eg, EQ-5D-5L). The data will be analysed longitudinally; the non-inferiority margin for the primary outcome is 5. Bootstrapping techniques will be used for the economic evaluation. ETHICS AND DISSEMINATION: This study has received approval of the Medical Ethical Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The results will be published in an international peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: NCT02602093; Pre-results, recruiting stage.

Current practice and usual care of major cervical disorders in Korea: A cross-sectional study of Korean health insurance review and assessment service national patient sample data.

Neck pain is a highly common condition and is the 4th major cause of years lived with disability. Previous literature has focused on the effect of specific treatments, and observations of actual practice are lacking to date. This study examined Korean health insurance review and assessment service (HIRA) claims data to the aim of assessing prevalence and comparing current medical practice and costs of cervical disorders in Korea.Current practice trends were determined through assessment of prevalence, total expenses, per-patient expense, average days in care, average days of visits, sociodemographic characteristics, distribution of medical costs, and frequency of treatment types of high frequency cervical disorders (cervical sprain/strain, cervical intervertebral disc displacement [IDD], and cervicalgia).Although the number of cervical IDD patients was few, total expenses, per-patient expense, average days in care, and average days of visits were highest. The proportion of women was higher than men in all 3 groups with highest prevalence in the ≥50s middle-aged population for IDD compared to sprain/strain. Primary care settings were commonly used for ambulatory care, of which approximately 70% chose orthopedic specialist treatment. In analysis of medical expenditure distribution, costs of visit (consultation) (22%-34%) and physical therapy (14%-16%) were in the top 3 for all 3 disorders. Although heat and electrical therapies were the most frequently used physical therapies, traction use was high in the cervical IDD group. In nonnarcotics, aceclofenac and diclofenac were the most commonly used NSAIDs, and pethidine was their counterpart in narcotics.This study investigated practice trends and cost distribution of treatment regimens for major cervical disorders, providing current usage patterns to healthcare policy decision makers, and the detailed treatment reports are expected to be of use to clinicians and researchers in understanding current usual care.