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.

Considering Spine Surgery: A Web-Based Calculator for Communicating Estimates of Personalized Treatment Outcomes.

STUDY DESIGN: Prospective evaluation of an informational web-based calculator for communicating estimates of personalized treatment outcomes. OBJECTIVE: To evaluate the usability, effectiveness in communicating benefits and risks, and impact on decision quality of a calculator tool for patients with intervertebral disc herniations, spinal stenosis, and degenerative spondylolisthesis who are deciding between surgical and nonsurgical treatments. SUMMARY OF BACKGROUND DATA: The decision to have back surgery is preference-sensitive and warrants shared decision making. However, more patient-specific, individualized tools for presenting clinical evidence on treatment outcomes are needed. METHODS: Using Spine Patient Outcomes Research Trial data, prediction models were designed and integrated into a web-based calculator tool: http://spinesurgerycalc.dartmouth.edu/calc/. Consumer Reports subscribers with back-related pain were invited to use the calculator via email, and patient participants were recruited to use the calculator in a prospective manner following an initial appointment at participating spine centers. Participants completed questionnaires before and after using the calculator. We randomly assigned previously validated questions that tested knowledge about the treatment options to be asked either before or after viewing the calculator. RESULTS: A total of 1256 consumer reports subscribers and 68 patient participants completed the calculator and questionnaires. Knowledge scores were higher in the postcalculator group compared to the precalculator group, indicating that calculator usage successfully informed users. Decisional conflict was lower when measured following calculator use, suggesting the calculator was beneficial in the decision-making process. Participants generally found the tool helpful and easy to use. CONCLUSION: Although the calculator is not a comprehensive decision aid, it does focus on communicating individualized risks and benefits for treatment options. Moreover, it appears to be helpful in achieving the goals of more traditional shared decision-making tools. It not only improved knowledge scores but also improved other aspects of decision quality. LEVEL OF EVIDENCE: 2.

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.

A Cohort Study of the Natural History of Odontoid Pseudoarthrosis Managed Nonoperatively in Elderly Patients.

OBJECTIVE: Although the primary goal of treatment of type II odontoid fracture is bony union, some advocate continued nonsurgical management of minimally symptomatic older patients who have fibrous union or minimal fracture motion. The risk of this strategy is unknown. We reviewed our long-term outcomes after dens nonunion to define the natural history of Type II odontoid fractures in elderly patients managed nonoperatively. METHODS: A retrospective chart review of 50 consecutive adults aged 65 or older with Type II odontoid fracture initially managed nonsurgically from 1998 to 2012 at a single tertiary care institution was conducted. Particular attention was paid to patients who had orthosis removal despite absent bony fusion. Patients were contacted prospectively by telephone and followed until death, surgical intervention, or last known contact. RESULTS: Fifty patients initially were managed nonsurgically; of these, 21 (42.0%) proceeded to bony fusion, 3 (6%) underwent delayed surgery for persistent instability, and 26 (52%) had orthosis removal despite the lack of solid arthrodesis on imaging. The last group had a median follow-up of 25 months (range 4-158 months), with 20 of 26 (76.9%) followed until death. Of these patients, 1 patient developed progressive quadriplegia and dysphagia 11 months after initial injury. Compared with patients with spontaneous union, patients with nonunion had shorter life expectancy, despite no significant differences between the groups with respect to age, sex, injury mechanism, radiographic variables, or follow-up duration. CONCLUSIONS: Orthosis removal despite fracture nonunion may be reasonable in elderly patients with Type II dens fractures.

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.

Who should have surgery for spinal stenosis? Treatment effect predictors in SPORT.

STUDY DESIGN: Combined prospective randomized controlled trial and observational cohort study of spinal stenosis (SpS) with an as-treated analysis. OBJECTIVE: To determine modifiers of the treatment effect (TE) of surgery (the difference between surgical and nonoperative outcomes) for SpS using subgroup analysis. SUMMARY OF BACKGROUND DATA: The Spine Patient Outcomes Research Trial demonstrated a positive surgical TE for SpS at the group level. However, individual characteristics may affect TE. No previous studies have evaluated TE modifiers in SpS. METHODS: SpS patients were treated with either surgery (n = 419) or nonoperative care (n = 235) and were analyzed according to treatment received. Fifty-three baseline variables were used to define subgroups for calculating the time-weighted average TE for the Oswestry Disability Index (ODI) over 4 years (TE = ΔODIsurgery - ΔODInonoperative). Variables with significant subgroup × treatment interactions (P < 0.05) were simultaneously entered into a multivariate model to select independent TE predictors. RESULTS: Other than smokers, all analyzed subgroups including at least 50 patients improved significantly more with surgery than with nonoperative treatment (P < 0.05). Multivariate analysis demonstrated: baseline ODI ≤ 56 (TE -15.0 vs. -4.4, ODI > 56, P < 0.001), not smoking (TE -11.7 vs. -1.6 smokers, P < 0.001), neuroforaminal stenosis (TE -14.2 vs. -8.7 no neuroforaminal stenosis, P = 0.002), predominant leg pain (TE -11.5 vs. -7.3 predominant back pain, P = 0.035), not lifting at work (TE -12.5 vs. -0.5 lifting at work, P = 0.017), and the presence of a neurological deficit (TE -13.3 vs. -7.2 no neurological deficit, P < 0.001) were associated with greater TE. CONCLUSION: With the exception of smokers, 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, and these data can be used to individualize shared decision making discussions about likely outcomes. Smoking cessation should be considered before surgery for SpS.

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.

Who should have surgery for an intervertebral disc herniation? Comparative effectiveness evidence from the spine patient outcomes research trial.

STUDY DESIGN: Combined prospective randomized controlled trial and observational cohort study of intervertebral disc herniation (IDH), an as-treated analysis. OBJECTIVE: To determine modifiers of the treatment effect (TE) of surgery (the difference between surgical and nonoperative outcomes) for intervertebral disc herniation (IDH) using subgroup analysis. SUMMARY OF BACKGROUND DATA: The Spine Patient Outcomes Research Trial demonstrated a positive surgical TE for IDH at the group level. However, individual characteristics may affect TE. No prior studies have evaluated TE modifiers in IDH. METHODS: IDH patients underwent either discectomy (n = 788) or nonoperative care (n = 404) and were analyzed according to treatment received. Thirty-seven baseline variables were used to define subgroups for calculating the time-weighted average TE for the Oswestry Disability Index (ODI) across 4 years (TE = ΔODI(surgery) -ΔODI(nonoperative)). Variables with significant subgroup-by-treatment interactions (P < 0.1) were simultaneously entered into a multivariate model to select independent TE predictors. RESULTS: All analyzed subgroups improved significantly more with surgery than with nonoperative treatment (P < 0.05). In minimally adjusted univariate analyses, being married, absence of joint problems, worsening symptom trend at baseline, high school education or less, older age, no worker's compensation, longer duration of symptoms, and an SF-36 mental component score (MCS) less than 35 were associated with greater TEs. Multivariate analysis demonstrated that being married (TE, -15.8 vs. -7.7 single, P < 0.001), absence of joint problems (TE, -14.6 vs. -10.3 joint problems, P = 0.012), and worsening symptoms (TE, -15.9 vs. -11.8 stable symptoms, P = 0.032) were independent TE modifiers. TEs were greatest in married patients with worsening symptoms (-18.3) vs. single patients with stable symptoms (-7.8). CONCLUSION: IDH patients who met strict inclusion criteria improved more with surgery than with nonoperative treatment, regardless of specific characteristics. However, being married, without joint problems, and worsening symptom trend at baseline were associated with a greater TE.

Relationship between preoperative expectations, satisfaction, and functional outcomes in patients undergoing lumbar and cervical spine surgery: a multicenter study.

STUDY DESIGN: Analysis of prospectively collected multicenter data. OBJECTIVE: To explore the relationship between preoperative expectations and postoperative outcomes and satisfaction in lumbar and cervical spine surgery. SUMMARY OF BACKGROUND DATA: Back pain is one of the most common health problems, leading to the utilization of health care resources, work loss, and sick benefits. Patient expectations influence posttreatment outcomes, both surgical and nonsurgical. There is little research on the importance of preoperative expectations in spine surgery. Existing studies evaluate the technical aspects of interventions and functional outcomes but fail to take into account patient expectations. The authors hypothesized that expectations dramatically affect spine patient satisfaction independent of functional outcomes. METHODS: Prospectively collected patient-entered data from patients undergoing lumbar and cervical spine surgery from 2 study centers collected using a Web-based patient health survey system were analyzed. The study included patients who underwent operative intervention (decompression with or without fusion) with at least a 3-month period of follow-up. Preoperative expectations were measured using the Musculoskeletal Outcomes Data Evaluation and Management System's (MODEMS) expectation survey. Postoperative satisfaction and fulfillment of expectations were measured using the MODEMS satisfaction survey. Postoperative functional outcomes were measured using the Oswestry Disability Index and 36-item short form health survey. Ordinal logistic regression multivariate modeling was used to examine predictors of postoperative satisfaction. Linear regression multivariate modeling was used to examine predictors of functional outcomes. RESULTS: Greater fulfillment of expectations led to higher postoperative satisfaction and was associated with better functional outcomes. Higher preoperative expectations led to decreased postsurgical satisfaction but were associated with improved functional outcomes. Higher postoperative satisfaction was associated with improved functional outcomes and vice versa. Type of surgery also influenced satisfaction and function, with cervical patients being less satisfied but having better functional outcomes than lumbar patients. CONCLUSION: This study showed that more than functional outcomes matter; preoperative expectations and fulfillment of expectations influence postoperative satisfaction in patients undergoing lumbar and cervical spine surgery. This underlines the importance of taking preoperative expectations into account to obtain an informed choice on the basis of the patient's preferences.

Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation.

STUDY DESIGN: Cost-effectiveness analysis of a randomized plus observational cohort trial. OBJECTIVE: Analyze cost-effectiveness of Spine Patient Outcomes Research Trial data over 4 years comparing surgery with nonoperative care for three common diagnoses: spinal stenosis (SPS), degenerative spondylolisthesis (DS), and intervertebral disc herniation (IDH). SUMMARY OF BACKGROUND DATA: Spine surgery rates continue to rise in the United States, but the safety and economic value of these procedures remain uncertain. METHODS: Patients with image-confirmed diagnoses were followed in randomized or observational cohorts with data on resource use, productivity, and EuroQol EQ-5D health state values measured at 6 weeks, 3, 6, 12, 24, 36, and 48 months. For each diagnosis, cost per quality-adjusted life year (QALY) gained in 2004 US dollars was estimated for surgery relative to nonoperative care using a societal perspective, with costs and QALYs discounted at 3% per year. RESULTS: Surgery was performed initially or during the 4-year follow-up among 414 of 634 (65.3%) SPS, 391 of 601 (65.1%) DS, and 789 of 1192 (66.2%) IDH patients. Surgery improved health, with persistent QALY differences observed through 4 years (SPS QALY gain 0.22; 95% confidence interval, CI: 0.15, 0.34; DS QALY gain 0.34, 95% CI: 0.30, 0.47; and IDH QALY gain 0.34, 95% CI: 0.31, 0.38). Costs per QALY gained decreased for SPS from $77,600 at 2 years to $59,400 (95% CI: $37,059, $125,162) at 4 years, for DS from $115,600 to $64,300 per QALY (95% CI: $32,864, $83,117), and for IDH from $34,355 to $20,600 per QALY (95% CI: $4,539, $33,088). CONCLUSION: Comparative effectiveness evidence for clearly defined diagnostic groups from Spine Patient Outcomes Research Trial shows good value for surgery compared with nonoperative care over 4 years.

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.

Predominant leg pain is associated with better surgical outcomes in degenerative spondylolisthesis and spinal stenosis: results from the Spine Patient Outcomes Research Trial (SPORT).

STUDY DESIGN: As-treated analysis of the Spine Patient Outcomes Research Trial. OBJECTIVE: To compare baseline characteristics and surgical and nonoperative outcomes in degenerative spondylolisthesis (DS) and spinal stenosis (SpS) patients stratified by predominant pain location (i.e., leg vs. back). SUMMARY OF BACKGROUND DATA: Evidence suggests that DS and SpS patients with predominant leg pain may have better surgical outcomes than patients with predominant low back pain (LBP). METHODS: The DS cohort included 591 patients (62% underwent surgery), and the SpS cohort included 615 patients (62% underwent surgery). Patients were classified as leg pain predominant, LBP predominant, or having equal pain according to baseline pain scores. Baseline characteristics were compared between the 3 predominant pain location groups within each diagnostic category, and changes in surgical and nonoperative outcome scores were compared for 2 years. Longitudinal regression models including baseline covariates were used to control for confounders. RESULTS: Among DS patients at baseline, 34% had predominant leg pain, 26% had predominant LBP, and 40% had equal pain. Similarly, 32% of SpS patients had predominant leg pain, 26% had predominant LBP, and 42% had equal pain. DS and SpS patients with predominant leg pain had baseline scores indicative of less severe symptoms. Leg pain predominant DS and SpS patients treated surgically improved significantly more than LBP predominant patients on all primary outcome measures at 1 and 2 years. Surgical outcomes for the equal pain groups were intermediate to those of the predominant leg pain and LBP groups. The differences in nonoperative outcomes were less consistent. Conclusion. Predominant leg pain patients improved significantly more with surgery than predominant LBP patients. However, predominant LBP patients still improved significantly more with surgery than with nonoperative treatment.