Keys to diagnosis and management of spinal epidural abscesses: 9 years of institutional experience.

OBJECTIVE: Spinal epidural abscesses (SEA's) are a challenge to diagnose, particularly if there are non-contiguous (skip) lesions. There is also limited data to predict which patients can be treated with antibiotics alone and which require surgery. We sought to assess which demographics, clinical and laboratory findings can guide both diagnosis and management of SEA's. METHODS: All patients with SEA (ICD9 324.1, ICD10 G06.1) between April 2011-May 2019 at a single tertiary center were included. A retrospective EMR review was completed. Patient and disease characteristics were compared using appropriate statistical tests. RESULTS: 108 patients underwent initial surgical treatment versus 105 that were treated medically initially; 22 (21 %) of those failed medical management. Patients who failed medical management had significantly higher CRP, longer symptom duration, and had higher rates of concurrent non-spinal infections. 9% of patients had skip lesions. Patients with skip lesions had significantly higher WBC, ESR, as well as higher rates of bacteremia and concurrent non-spinal infections. Demographic characteristics and proportion with IVDU, smoking, malignancy, and immunosuppression were similar among the three treatment groups. CONCLUSIONS: 21 % of SEA patients failed initial medical management; they had significantly greater CRP, longer symptom duration, more commonly had neurologic deficits, and concurrent non-spinal infections. 9% of patients had skip lesions; they had significantly higher WBC, ESR, rates of bacteremia and infections outside the spine. These variables may guide diagnostic imaging, and identify those at risk of failing of medical management, and therefore require more involved clinical evaluation, and consideration for surgical intervention.

Patient-Reported Allergies, a Marker of Preoperative Pain and Disability in Elective Spine Surgery.

STUDY DESIGN: Retrospective review. OBJECTIVE: Previous literature demonstrates mixed results regarding the relationship between patient-reported allergies and pain, function, and satisfaction scores. The objective of this study was to investigate the correlation between patient-reported allergies and preoperative Oswestry Disability Index (ODI), Neck Disability Index (NDI), and Patient-Reported Outcomes Measurement System (PROMIS) scores. METHODS: All patients undergoing elective cervical, lumbar procedures between May 2017 and October 2018 were included. Baseline demographic information was recorded, as well as all reported allergies or adverse reactions. Preoperative PROMIS, ODI, and NDI scores were recorded. Hierarchical multiple linear regressions were used to assess the relationship between total number of allergies and the preoperative pain and function scores. RESULTS: A total of 570 patients were included (476 lumbar, 94 cervical). The mean number of allergies reported was 1.89 ± 2.32. The mean preoperative ODI and NDI scores were 46.39 ± 17.67 and 43.47 ± 16.51, respectively. The mean preoperative PROMIS Physical Health and PROMIS Mental Health scores were 37.21 ± 6.54 and 43.89 ± 9.26, respectively. Hierarchical multiple linear regression showed that total number of reported allergies shared a statistically significant negative relationship with all of the following scores: ODI (B = 0.83, P = .02), NDI (B = 1.45, P = .02), PROMIS Physical Health (B = -0.29, P = .013), and PROMIS Mental Health (B = -0.38, P = .024). CONCLUSIONS: Patient-reported allergies share a statistically significant negative relationship with preoperative pain and function scores; as patients have increasing total number of allergies, the ODI/NDI scores become worse (increase) and the PROMIS scores become worse (decrease).

Reducing Radiation and Lowering Costs With a Standardized Care Pathway for Nonoperative Thoracolumbar Fractures.

STUDY DESIGN: Retrospective observational study. OBJECTIVE: There is marked variation in the management of nonoperative thoracolumbar (TL) compression and burst fractures. This was a quality improvement study designed to establish a standardized care pathway for TL fractures treated with bracing, and to then evaluate differences in radiographs, length of stay (LOS), and cost before and after the pathway. METHODS: A standardized pathway was established for management of nonoperative TL burst and compression fractures (AOSpine classification type A1-A4 fractures). Bracing, radiographs, costs, complications, and LOS before and after pathway adoption were analyzed. Differences between the neurosurgery and orthopedic spine services were compared. RESULTS: Between 2012 and 2015, 406 nonoperative burst and compression TL fractures were identified. A total of 183 (45.1%) were braced, 60.6% with a custom-made thoracolumbosacral orthosis (TLSO) and 39.4% with an off-the-shelf TLSO. The number of radiographs significantly reduced after initiation of the pathway (3.23 vs 2.63, P = .010). A total of 98.6% of braces were custom-made before the pathway; 69.6% were off-the-shelf after the pathway. The total cost for braced patients after pathway adoption decreased from $10 462.36 to $8928.58 (P = .078). Brace-associated costs were significantly less for off-the-shelf TSLO versus custom TLSO ($1352.41 vs $3719.53, respectively, P < .001). The mean LOS and complication rate did not change significantly following pathway adoption. The orthopedic spine service braced less frequently than the neurosurgery service (40.7% vs 52.2%, P = .023). CONCLUSIONS: Standardized care pathways can reduce cost and radiation exposure without increasing complication rates in nonoperative management of thoracolumbar compression and burst fractures.

A 5-Year Review of Hospital Costs and Reimbursement in the Surgical Management of Degenerative Spondylolisthesis.

BACKGROUND: To evaluate charges, expenses, reimbursement, and hospital margins with noninstrumented posterolateral fusion in situ (PLF), posterolateral fusion with pedicle screws (PPS), and PPS with interbody device (PLIF) in degenerative spondylolisthesis with spinal stenosis. METHODS: A retrospective chart review was performed from 2010 to 2014 based on ICD-9 diagnoses of degenerative spondylolisthesis with spinal stenosis in patients undergoing single-level fusions. All charges, expenses, reimbursement, and margins were obtained through financial auditing. A multivariate linear regression model was used to compare demographics, charges, etc. A 1-way analysis of variance with Tukey post hoc analysis was used to analyze reimbursements and margins based upon insurances. RESULTS: Two hundred thirty-three patients met inclusion criteria. The overall charges and expenses for PLF were significantly less compared to both types of instrumented fusions (P < .0001). Medicare and private insurance were the most common insurance types; Medicare and private insurance mean reimbursements for PLF were $36,903 and $47,086, respectively; for PPS, $37,450 and $53,851, and for PLIF $40,171 and $51,640. Hospital margins for PPS and PLIF in Medicaid patients were negative (-$3,702 and -$6,456). Hospital margins were largest for both worker's compensation and private insurance patients in all fusion groups. Hospital margins with Medicare for PLF, PPS, and PLIF were $24,347, $19,205, and $23,046, respectively. Hospital margins for private insurance for PLF, PPS, and PLIF were $37,569, $36,834, and $33,134, respectively. CONCLUSIONS: As more instrumentation is used, the more it costs both the hospital and the insurance companies; hospital margins did not increase correspondingly. CLINICAL RELEVANCE: Improved understanding of related costs and margins associated with lumbar fusions to help transition to more cost effective spine centers.

Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT).

STUDY DESIGN: Randomized trial with a concurrent observational cohort study. OBJECTIVE: To compare 8-year outcomes between surgery and nonoperative care and among different fusion techniques for symptomatic lumbar degenerative spondylolisthesis (DS). SUMMARY OF BACKGROUND DATA: Surgical treatment of DS has been shown to be more effective than nonoperative treatment out to 4 years. This study sought to further determine the long-term (8-year) outcomes. METHODS: Surgical candidates with DS from 13 centers with at least 12 weeks of symptoms and confirmatory imaging were offered enrollment in a randomized controlled trial (RCT) or observational cohort study (OBS). Treatment consisted of standard decompressive laminectomy (with or without fusion) versus standard nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and yearly up to 8 years. RESULTS: Data were obtained for 69% of the randomized cohort and 57% of the observational cohort at the 8-year follow up. Intent-to-treat analyses of the randomized group were limited by high levels of nonadherence to the randomized treatment. As-treated analyses in the randomized and observational groups showed significantly greater improvement in the surgery group on all primary outcome measures at all time points through 8 years. Outcomes were similar among patients treated with uninstrumented posterolateral fusion, instrumented posterolateral fusion, and 360° fusion. CONCLUSION: For patients with symptomatic DS, patients who received surgery had significantly greater improvements in pain and function compared with nonoperative treatment through 8 years of follow-up. Fusion technique did not affect outcomes. LEVEL OF EVIDENCE: 1.

Reoperation for Recurrent Intervertebral Disc Herniation in the Spine Patient Outcomes Research Trial: Analysis of Rate, Risk Factors, and Outcome.

STUDY DESIGN: This study was a post-hoc subgroup analysis of prospectively collected data in the Spine Patient Outcomes Research Trial (SPORT). OBJECTIVE: The aim of this study was to determine the risk factors for and to compare the outcomes of patients undergoing revision disc excision surgery in SPORT. SUMMARY OF BACKGROUND DATA: Risk factors for reherniation and outcomes after revision surgery have not been well-studied. This information is critical for proper patient counseling and decision-making. METHODS: Patients who underwent primary discectomy in the SPORT intervertebral disc herniation cohort were analyzed to determine risk factors for undergoing revision surgery. Risk factors for undergoing revision surgery for reherniation were evaluated using univariate and multivariate analysis. Primary outcome measures consisted of Oswestry Disability Index (ODI), the Sciatica Bothersomeness index (SBI), and the Short Form 36 (SF-36) at 6 weeks, 3 months, 6 months, and yearly to 4 years. RESULTS: Of 810 surgical patients, 74 (9.1%) received revision surgery for reherniation. Risk factors for reherniation included: younger age (hazard ratio [HR] 0.96 [0.94-0.99]), lack of a sensory deficit (HR 0.61 [0.37-0.99]) lack of motor deficit (HR 0.54 [0.32-0.91]), and higher baseline ODI score (HR 1.02 [1.01-1.03]). The time-adjusted mean improvement from baseline to 4 years was less for the reherniation group on all outcome measures (Bodily Pain Index [BP] 39.5 vs. 44.9, P = 0.001; Physical Function Index [PF] 37.1 vs. 44.5, P < 0.001; ODI 33.9 vs. 38.3, P < 0.001; SBI 8.7 vs. 10.5, P < 0.001). At 4 years, only SBI (-9 vs. -11.4, P = 0.002) was significantly lower in the reherniation group. CONCLUSION: Younger patients with higher baseline disability without neurological deficit are at increased risk of undergoing revision surgery for reherniation. Those considering revision surgery for reherniation will likely improve significantly following surgery, but possibly not as much as with primary discectomy. LEVEL OF EVIDENCE: 3.

Long-term outcomes of lumbar spinal stenosis: eight-year results of the Spine Patient Outcomes Research Trial (SPORT).

STUDY DESIGN: Randomized trial with a concurrent observational cohort study. OBJECTIVE: To compare 8-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during 4 years, but longer-term data are less clear. METHODS: Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort. Treatment was standard, decompressive laminectomy versus standard nonoperative care. Primary outcomes were SF-36 (MOS 36-Item Short-Form Health Survey) Bodily Pain and Physical Function scales and the modified Oswestry Disability Index assessed at 6 weeks, 3 months, 6 months, and yearly up to 8 years. RESULTS: Data were obtained for 55% of participants in the randomized group and 52% of participants in the observational group at the 8-year follow-up. Intent-to-treat analyses showed no differences between randomized cohorts; however, 70% of those randomized to surgery and 52% of those randomized to nonoperative had undergone surgery by 8 years. As-treated analyses in the randomized group showed that the early benefit for surgery out to 4 years converged over time, with no significant treatment effect of surgery seen in years 6 to 8 for any of the primary outcomes. In contrast, the observational group showed a stable advantage for surgery in all outcomes between years 5 and 8. Patients who were lost to follow-up were older, less well-educated, sicker, and had worse outcomes during the first 2 years in both surgical and nonoperative arms. CONCLUSION: Patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between 4 and 8 years, whereas outcomes in the observational group remained stable. Loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates.

The SPORT value compass: do the extra costs of undergoing spine surgery produce better health benefits?

BACKGROUND: The Spine Patient Outcomes Research Trial aimed to determine the comparative effectiveness of surgical care versus nonoperative care by measuring longitudinal values: outcomes, satisfaction, and costs. METHODS: This paper aims to summarize available evidence from the Spine Patient Outcomes Research Trial by addressing 2 important questions about outcomes and costs for 3 types of spine problem: (1) how do outcomes and costs of spine patients differ depending on whether they are treated surgically compared with nonoperative care? (2) What is the incremental cost per quality adjusted life year for surgical care over nonoperative care? RESULTS: After 4 years of follow-up, patients with 3 spine conditions that may be treated surgically or nonoperatively have systematic differences in value endpoints. The average surgical patient enjoys better health outcomes and higher treatment satisfaction but incurs higher costs. CONCLUSIONS: Spine care is preference sensitive and because outcomes, satisfaction, and costs vary over time and between patients, data on value can help patients make better-informed decisions and help payers know what their dollars are buying.

Surgical versus nonoperative treatment for lumbar disc herniation: eight-year results for the spine patient outcomes research trial.

STUDY DESIGN: Concurrent prospective randomized and observational cohort studies. OBJECTIVE: To assess the 8-year outcomes of surgery versus nonoperative care. SUMMARY OF BACKGROUND DATA: Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical with nonoperative treatment remain controversial. METHODS: Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting Spine Patient Outcomes Research Trial eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain and Physical Function scales and the modified Oswestry Disability Index-AAOS/Modems version assessed at 6 weeks, 3 months, and 6 months, and annually thereafter. RESULTS: Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive nonadherence to treatment assignment (49% patients assigned to nonoperative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (bodily pain, physical function, Oswestry Disability Index). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [P > 0.005], satisfaction with symptoms [P > 0.013], and self-rated improvement [P > 0.013]) in long-term follow-up. An as-treated analysis showed significant surgical treatment effects for primary outcome measures (mean change, surgery vs. nonoperative care; treatment effect; 95% confidence interval): bodily pain (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5); and Oswestry Disability Index (-36.2 vs. -24.8; -11.3; -13.6 to -9.1). CONCLUSION: Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients; there was little to no degradation of outcomes in either group (operative and nonoperative) from 4 to 8 years. LEVEL OF EVIDENCE: 2.

Who should undergo surgery for degenerative spondylolisthesis? Treatment effect predictors in SPORT.

STUDY DESIGN: Combined prospective randomized controlled trial and observational cohort study of degenerative spondylolisthesis (DS) with an as-treated analysis. OBJECTIVE: To determine modifiers of the treatment effect (TE) of surgery (the difference between surgical and nonoperative outcomes) for DS using subgroup analysis. SUMMARY OF BACKGROUND DATA: Spine Patient Outcomes Research Trial demonstrated a positive surgical TE for DS at the group level. However, individual characteristics may affect TE. METHODS: Patients with DS were treated with either surgery (n = 395) or nonoperative care (n = 210) and were analyzed according to treatment received. Fifty-five baseline variables were used to define subgroups for calculating the time-weighted average TE for the Oswestry Disability Index during 4 years (TE = [INCREMENT] Oswestry Disability Index(surgery)- [INCREMENT] Oswestry Disability Index(nonoperative)). Variables with significant subgroup-by-treatment interactions (P< 0.05) were simultaneously entered into a multivariate model to select independent TE predictors. RESULTS: All analyzed subgroups that included at least 50 patients improved significantly more with surgery than with nonoperative treatment (P< 0.05). Multivariate analyses demonstrated that age 67 years or less (TE -15.7 vs.-11.8 for age >67, P= 0.014); female sex (TE -15.6 vs.-11.2 for males, P= 0.01); the absence of stomach problems (TE -15.2 vs.-11.3 for those with stomach problems, P= 0.035); neurogenic claudication (TE -15.3 vs.-9.0 for those without claudication, P= 0.004); reflex asymmetry (TE -17.3 vs.-13.0 for those without asymmetry, P= 0.016); opioid use (TE -18.4 vs.-11.7 for those not using opioids, P< 0.001); not taking antidepressants (TE -14.5 vs.-5.4 for those on antidepressants, P= 0.014); dissatisfaction with symptoms (TE -14.5 vs.-8.3 for those satisfied or neutral, P= 0.039); and anticipating a high likelihood of improvement with surgery (TE -14.8 vs.-5.1 for anticipating a low likelihood of improvement with surgery, P= 0.019) were independently associated with greater TE. CONCLUSION: Patients who met strict inclusion criteria improved more with surgery than with nonoperative treatment, regardless of other specific characteristics. However, TE varied significantly across certain subgroups. LEVEL OF EVIDENCE: 3.

Psychometric evaluation of a decision quality instrument for treatment of lumbar herniated disc.

STUDY DESIGN: Retrospective and prospective patient surveys and a physician survey using a sample from American Medical Association master file. OBJECTIVE: To evaluate the performance of a new instrument designed to measure the quality of decisions about treatment of herniated disc. SUMMARY OF BACKGROUND DATA: There is growing consensus on the importance of engaging and informing patients to improve the quality of significant medical decisions, yet there are no instruments currently available to measure decision quality. METHODS: The herniated disc-decision quality instrument (HD-DQI) was developed with input from clinical experts, survey research experts, and patients. The HD-DQI produces 2 scores each scaled to 0% to 100%, with higher scores indicating better quality: (1) a total knowledge score and (2) a concordance score (indicating the percentage of patients who received treatments that matched their goals). We examined hypotheses relating to the acceptability, feasibility, validity, and reliability of the instrument, using data from 3 samples. RESULTS: The HD-DQI survey was feasible to implement and acceptable to patients, with good response rates and low missing data. The knowledge score discriminated between patients who had seen a decision aid or no decision aid (55% vs. 38%, P < 0.001) and between providers and patients (73% vs. 46%, P < 0.001). The knowledge score also had good retest reliability (intraclass correlation coefficient = 0.85). Most patients (78%) received treatments that matched their goals. Patients who received treatments that matched their goals were less likely to regret the decision than those who did not (13% vs. 39%, P = 0.004). CONCLUSION: The HD-DQI met several criteria for high-quality patient-reported survey instruments. It can be used to determine the quality of decisions for treatment of herniated disc. More work is needed to examine acceptability for use as part of routine patient care.

Lumbar disc herniation in the Spine Patient Outcomes Research Trial: does educational attainment impact outcome?

STUDY DESIGN: Randomized trial with concurrent observational cohort. A total of 1171 patients were divided into subgroups by educational attainment: high school or less, some college, and college degree or above. OBJECTIVE: To assess the influence of education level on outcomes for treatment of lumbar disc herniation. SUMMARY OF BACKGROUND DATA: Educational attainment has been demonstrated to have an inverse relationship with pain perception, comorbidities, and mortality. METHODS: The Spine Patient Outcomes Research Trial enrolled surgical candidates (imaging-confirmed disc herniation with at least 6 weeks of persistent signs and symptoms of radiculopathy) from 13 multidisciplinary spine clinics in 11 US states. Treatments were standard open discectomy versus nonoperative treatment. Outcomes were changes from baseline for 36-Item Short Form Health Survey (SF-36), bodily pain (BP), and physical function (PF) scales and the modified Oswestry Disability Index (ODI) at 6 weeks, 3 months, 6 months, and yearly through 4 years. RESULTS: Substantial improvement was seen in all patient cohorts. Surgical outcomes did not differ by level of education. For nonoperative outcomes, however, higher levels of education were associated with significantly greater overall improvement over 4 years in BP (P = 0.007), PF (P = 0.001), and ODI (P = 0.003). At 4 years a "dose-response" type relationship was shown for BP (high school or less = 25.5, some college = 31, and college graduate or above = 36.3, P = 0.004) and results were similar for PF and ODI. The success of nonoperative treatment in the more educated cohort resulted in an attenuation of the relative benefit of surgery. CONCLUSION: Patients with higher educational attainment demonstrated significantly greater improvement with nonoperative treatment while educational attainment was not associated with surgical outcomes.

Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery.

BACKGROUND: Ketamine is an N-methyl-d-aspartate receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions with variable routes of administration. Little is known regarding its efficacy in opiate-dependent patients with a history of chronic pain. We hypothesized that ketamine would reduce postoperative opiate consumption in this patient population. METHODS: This was a randomized, prospective, double-blinded, and placebo-controlled trial involving opiate-dependent patients undergoing major lumbar spine surgery. Fifty-two patients in the treatment group were administered 0.5 mg/kg intravenous ketamine on induction of anesthesia, and a continuous infusion at 10 microg kg(-1) min(-1) was begun on induction and terminated at wound closure. Fifty patients in the placebo group received saline of equivalent volume. Patients were observed for 48 h postoperatively and followed up at 6 weeks. The primary outcome was 48-h morphine consumption. RESULTS: Total morphine consumption (morphine equivalents) was significantly reduced in the treatment group 48 h after the procedure. It was also reduced at 24 h and at 6 weeks. The average reported pain intensity was significantly reduced in the postanesthesia care unit and at 6 weeks. The groups had no differences in known ketamine- or opiate-related side effects. CONCLUSIONS: Intraoperative ketamine reduces opiate consumption in the 48-h postoperative period in opiate-dependent patients with chronic pain. Ketamine may also reduce opioid consumption and pain intensity throughout the postoperative period in this patient population. This benefit is without an increase in side effects.

Degenerative spondylolisthesis versus spinal stenosis: does a slip matter? Comparison of baseline characteristics and outcomes (SPORT).

STUDY DESIGN: As-treated analysis of the Spine Patient Outcomes Research Trial. OBJECTIVE: To compare baseline characteristics and surgical and nonoperative outcomes between degenerative spondylolisthesis (DS) and spinal stenosis (SPS) patients. SUMMARY OF BACKGROUND DATA: DS and SPS patients are often combined in clinical studies despite differences in underlying pathology and treatment. METHODS: The DS cohort included 601 patients (369 [61%] underwent surgery), and the SPS cohort included 634 patients (394 [62%] underwent surgery). Baseline characteristics were compared between the 2 groups. Changes from baseline for surgical and nonoperative outcomes were compared at 1 and 2 years using longitudinal regression models. Primary outcome measures included the SF-36 bodily pain and physical function scores and the Oswestry Disability Index. RESULTS: The DS patients included more females (69% vs. 39%, P < 0.001), were older (66.1 year vs. 64.6 years, P = 0.021), and were less likely to have multilevel stenosis (35% vs. 61%, P < 0.001) compared with the SPS patients. There were no significant baseline differences on any of the main outcome measures. DS patients undergoing surgery were much more likely to be fused than SPS patients (94% vs. 11%, P < 0.001) and improved more with surgery than SPS patients on all primary outcome measures (DS vs. SPS): physical function (+30.4 vs. +25.3, P = 0.004 at 1 year; + 28.3 vs. +21.4, P < 0.001 at 2 years), bodily pain (+32.3 vs. +27.5, P = 0.006 at 1 year; +31.1 vs. +26.1, P = 0.003 at 2 years), and Oswestry Disability Index (-25.9 vs. -21.0, P < 0.001 at 1 year; -24.7 vs. -20.2, P < 0.001 at 2 years). Patients treated nonoperatively improved less than those treated surgically, and there were no significant differences in nonoperative outcomes between the 2 cohorts. CONCLUSION: Overall, DS and SPS patients had similar baseline characteristics. However, DS patients improved more with surgery than SPS patients. Future studies should probably not combine these heterogeneous patient populations.

Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial.

STUDY DESIGN: Clinical trial subgroup analysis. OBJECTIVE: To compare outcomes of different fusion techniques treating degenerative spondylolisthesis (DS). Summary of Background Data. Surgery has been shown to be more effective than nonoperative treatment out to 4 years. Questions remain regarding the differential effect of fusion technique. METHODS: Surgical candidates from 13 centers in 11 states with at least 12 weeks of symptoms and confirmatory imaging showing stenosis and DS were studied. In addition to standard decompressive laminectomy, 1 of 3 fusion techniques was employed at the surgeon's discretion: posterolateral in situ fusion (PLF); posterolateral instrumented fusion with pedicle screws (PPS); or PPS plus interbody fusion (360 degrees). Main outcome measures were the SF-36 bodily pain (BP) and physical function (PF) scales and the modified Oswestry Disability Index (ODI) assessed at 6 weeks, 3 months, 6 months, and yearly to 4 years. The as-treated analysis combined the randomized and observational cohorts using mixed longitudinal models adjusting for potential confounders. RESULTS: Of 380 surgical patients, 21% (N = 80) received a PLF; 56% (N = 213) received a PPS; 17% (N = 63) received a 360 degrees; and 6% (N = 23) had decompression only without fusion. Early outcomes varied, favoring PLF compared to PPS at 6 weeks (PF: 12.73 vs. 6.22, P < 0.020) and 3 months (PF: 25.24 vs.18.95, P < 0.025) and PPS compared to 360 degrees at 6 weeks (ODI: -14.46 vs. -9.30, P < 0.03) and 3 months (ODI: -22.30 vs. -16.78, P < 0.02). At 2 years, 360 degrees had better outcomes: BP: 39.08 versus 29.17 PLF, P < 0.011; and versus 29.13 PPS, P < 0.002; PF: 31.93 versus 23.27 PLF, P < 0.021; and versus 25.29 PPS, P < 0.036. However, these differences were not maintained at 3- and 4-year follow-up, when there were no statistically significant differences between the 3 fusion groups. CONCLUSION: In patients with DS and associated spinal stenosis, no consistent differences in clinical outcomes were seen among fusion groups over 4 years.

Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT).

STUDY DESIGN: Concurrent, prospective, randomized, and observational cohort study. OBJECTIVE: To assess the 4-year outcomes of surgery versus nonoperative care. SUMMARY OF BACKGROUND DATA: Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to nonoperative treatment remain controversial. METHODS: Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective, randomized (501 participants), and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 months, 6 months, and annually thereafter. RESULTS: Nonadherence to treatment assignment caused the intent-to-treat analyses to underestimate the treatment effects. In the 4-year combined as-treated analysis, those receiving surgery demonstrated significantly greater improvement in all the primary outcome measures (mean change surgery vs. nonoperative; treatment effect; 95% CI): BP (45.6 vs. 30.7; 15.0; 11.8 to 18.1), PF (44.6 vs. 29.7; 14.9;12.0 to 17.8) and ODI (-38.1 vs. -24.9; -13.2; -15.6 to -10.9). The percent working was similar between the surgery and nonoperative groups, 84.4% versus 78.4% respectively. CONCLUSION: In a combined as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients in all primary and secondary outcomes except work status.

Transparency in health care: leading the way.

A one-day conference sponsored by Dartmouth-Hitchcock Medical Center focused on external transparency (sharing data outside an organization) also featured discussion of internal transparency (sharing data inside an organization).

SPORT lumbar intervertebral disk herniation and back pain: does treatment, location, or morphology matter?

STUDY DESIGN: Diskectomy candidates with at least 6 weeks of sciatica and confirmatory imaging were enrolled in a randomized or observational cohort. OBJECTIVE: This study sought to determine: (1) whether diskectomy resulted in greater improvement in back pain than nonoperative treatment, and (2) whether herniation location and morphology affected back pain outcomes. SUMMARY OF BACKGROUND DATA: Previous studies have reported that lumbar diskectomy is less successful for relief of back pain than leg pain and patients with central disc herniations or protrusions have worse outcomes. METHODS: Patients underwent diskectomy or received "usual" nonoperative care. Data from the randomized cohort and observational cohort were combined in an as-treated analysis. Low back pain was recorded on a 0 to 6 point scale, and changes in low back pain were compared between the surgical and nonoperative treatment groups. The effects of herniation location and morphology on back pain outcomes were determined. RESULTS: The combined analysis included 1191 patients with 775 undergoing surgery within 2 years, whereas 416 remained nonoperative. Overall, leg pain improved more than back pain in both treatment groups. Back pain improved in both surgical and nonoperative patients, but surgical patients improved significantly more (treatment effect favoring surgery -0.9 at 3 months, -0.5 at 2 years, P < 0.001). Patients who underwent surgery were more likely to report no back pain than nonoperative patients at each follow-up period (28.0% vs. 12.0% at 3 months, P < 0.001, 25.5% vs. 17.6% at 2 years, P = 0.009). At baseline, central herniations were associated with more severe back pain than more lateral herniations (4.3 vs. 3.9, P = 0.012). Patients with central herniations and protrusionshad a beneficial treatment effect from surgery similar to the overall surgical group. CONCLUSION: Diskectomy resulted in greater improvement in back pain than nonoperative treatment, and this difference was maintained at 2 years for all herniation locations and morphologies.

What is different about workers' compensation patients? Socioeconomic predictors of baseline disability status among patients with lumbar radiculopathy.

STUDY DESIGN: Combined analysis of 2 prospective clinical studies. OBJECTIVE: To identify socioeconomic characteristics associated with workers' compensation in patients with an intervertebral disc herniation (IDH) or spinal stenosis (SpS). SUMMARY OF BACKGROUND DATA: Few studies have compared socioeconomic differences between those receiving or not receiving workers' compensation with the same underlying clinical conditions. METHODS: Patients were identified from the Spine Patient Outcomes Research Trial (SPORT) and the National Spine Network (NSN) practice-based outcomes study. Patients with IDH and SpS within NSN were identified satisfying SPORT eligibility criteria. Information on disability and work status at baseline evaluation was used to categorize patients into 3 groups: workers' compensation, other disability compensation, or work-eligible controls. Enrollment rates of patients with disability in a clinical efficacy trial (SPORT) and practice-based network (NSN) were compared. Independent socioeconomic predictors of baseline workers' compensation status were identified in multivariate logistic regression models controlling for clinical condition, study cohort, and initial treatment designation. RESULTS: Among 3759 eligible patients (1480 in SPORT and 2279 in NSN), 564 (15%) were receiving workers' compensation, 317 (8%) were receiving other disability compensation, and 2878 (77%) were controls. Patients receiving workers' compensation were less common in SPORT than NSN (9.2% vs. 18.8%, P < 0.001), but patients receiving other disability compensation were similarly represented (8.9% vs. 7.7%, P = 0.19). In univariate analyses, many socioeconomic characteristics significantly differed according to baseline workers' compensation status. In multiple logistic regression analyses, gender, educational level, work characteristics, legal action, and expectations about ability to work without surgery were independently associated with receiving workers' compensation. CONCLUSION: Clinical trials involving conditions commonly seen in patients with workers' compensation may need special efforts to ensure adequate representation. Socioeconomic characteristics markedly differed between patients receiving and not receiving workers' compensation. Identifying the independent effects of workers' compensation on outcomes will require controlling for these baseline characteristics and other clinical features associated with disability status.

Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis.

BACKGROUND: Management of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials. METHODS: Surgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years. RESULTS: We enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment. CONCLUSIONS: In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).