Evaluation of "appropriate use criteria" for surgical decision-making in lumbar degenerative spondylolisthesis. A controlled, multicentre, prospective observational study.

INTRODUCTION: Selecting patients with lumbar degenerative spondylolisthesis (LDS) for surgery is difficult. Appropriate use criteria (AUC) have been developed to clarify the indications for LDS surgery but have not been evaluated in controlled studies. METHODS: This prospective, controlled, multicentre study involved 908 patients (561 surgical and 347 non-surgical controls; 69.5 ± 9.7y; 69% female), treated as per normal clinical practice. Their appropriateness for surgery was afterwards determined using the AUC. They completed the Core Outcome Measures Index (COMI) at baseline and 12 months' follow-up. Multiple regression adjusting for confounders evaluated the influence of appropriateness designation and treatment received on the 12-month COMI and achievement of MCIC (≥ 2.2-point-reduction). RESULTS: As per convention, appropriate (A) and uncertain (U) groups were combined for comparison with the inappropriate (I) group. For the adjusted 12-month COMI, the benefit of surgery relative to non-surgical care was not significantly greater for the A/U than the I group (p = 0.189). There was, however, a greater treatment effect of surgery for those with higher baseline COMI (p = 0.035). The groups' adjusted probabilities of achieving MCIC were: 83% (A/U, receiving surgery), 71% (I, receiving surgery), 50% (A/U, receiving non-surgical care), and 32% (I, receiving non-surgical care). CONCLUSIONS: A/U patients receiving surgery had the highest chances of achieving MCIC, but the AUC were not able to identify which patients had a greater treatment effect of surgery relative to non-surgical care. The identification of other characteristics that predict a greater treatment effect of surgery, in addition to baseline COMI, is required to improve decision-making.

Evaluation of the Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system as a guide to surgical technique selection.

BACKGROUND CONTEXT: The role of fusion in degenerative spondylolisthesis (DS) is controversial. The Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system was developed to assist surgeons in surgical technique selection based on individual patient characteristics. This system has not been clinically validated as a guide to surgical technique selection. PURPOSE: The purpose of this study was to determine if outcomes vary with different surgical techniques across the CARDS categories. STUDY DESIGN/SETTING: Prospective cohort study performed at one Swiss and one American spine center. PATIENT SAMPLE: Five hundred eight patients with DS undergoing surgical treatment. OUTCOME MEASURES: Core Outcomes Measure Index (COMI) at 3 months and 12 months postoperatively. METHODS: Patients undergoing surgery for DS were enrolled at 2 institutions and classified according to the CARDS system using dynamic radiographs. The Core Outcome Measure Index (COMI) was completed preoperatively, and 3 and 12 months postoperatively. Surgical technique was classified as uninstrumented (decompression alone or decompression with uninstrumented fusion) or instrumented (decompression with pedicle screw instrumentation with or without interbody fusion). Unadjusted analyses and mixed effect models compared COMI scores between the two surgery technique groups (uninstrumented vs instrumented), stratified by CARDS category over time. Reoperation rates were also compared between the surgery technique groups stratified by CARDS category. Partial funding was given through NASS grant for clinical research. RESULTS: Five hundred five out of 508 patients enrolled in the study had sufficient data to be classified according to CARDS. Seven percent were classified as CARDS A, 28% as CARDS B, 48% as CARDS C, and 17% as CARDS D (CARDS A most "stable," CARDS D least "stable"). One hundred and thirty-three patients (26%) underwent decompression alone, 30 (6%) underwent decompression and uninstrumented fusion, 42 (8%) underwent decompression and posterolateral instrumented fusion, and 303 (60%) underwent decompression with posterolateral and interbody instrumented fusion. Patients in the least "stable" categories tended to be less likely to be treated with an uninstrumented technique (CARDS D 19% vs 32% for the other categories, p=.10). There were no significant differences in 3 or 12-month COMI scores between surgical technique groups stratified by CARDS category in the unadjusted or adjusted analyses. In the unadjusted analyses, there was a trend towards less improvement in 12-month COMI change score in the CARDS D patients in the uninstrumented group compared to the instrumented group (-2.7 vs -4.1, p=.10). Reoperation rates were not significantly different between the surgical technique groups stratified by CARDS category. CONCLUSIONS: In general, outcomes for uninstrumented and instrumented surgical techniques were similar across the CARDS categories. Surgeons likely took factors included in CARDS into account during surgical technique selection. This resulted in a low number of CARDS D (n=15) patients being treated with uninstrumented techniques, which limited the statistical power of this analysis. As such, this study does not validate CARDS as a useful classification system for surgical technique selection in DS.

Initial Choice of Spinal Manipulation Reduces Escalation of Care for Chronic Low Back Pain Among Older Medicare Beneficiaries.

STUDY DESIGN: We combined elements of cohort and crossover-cohort design. OBJECTIVE: The objective of this study was to compare longterm outcomes for spinal manipulative therapy (SMT) and opioid analgesic therapy (OAT) regarding escalation of care for patients with chronic low back pain (cLBP). SUMMARY OF BACKGROUND DATA: Current evidence-based guidelines for clinical management of cLBP include both OAT and SMT. For long-term care of older adults, the efficiency and value of continuing either OAT or SMT are uncertain. METHODS: We examined Medicare claims data spanning a five-year period. We included older Medicare beneficiaries with an episode of cLBP beginning in 2013. All patients were continuously enrolled under Medicare Parts A, B, and D. We analyzed the cumulative frequency of encounters indicative of an escalation of care for cLBP, including hospitalizations, emergency department visits, advanced diagnostic imaging, specialist visits, lumbosacral surgery, interventional pain medicine techniques, and encounters for potential complications of cLBP. RESULTS: SMT was associated with lower rates of escalation of care as compared to OAT. The adjusted rate of escalated care encounters was approximately 2.5 times higher for initial choice of OAT vs. initial choice of SMT (with weighted propensity scoring: rate ratio 2.67, 95% confidence interval 2.64-2.69, P < .0001). CONCLUSION: Among older Medicare beneficiaries who initiated long-term care for cLBP with opioid analgesic therapy, the adjusted rate of escalated care encounters was significantly higher as compared to those who initiated care with spinal manipulative therapy.Level of Evidence: 3.

Orthopedic disease burden in adult patients with symptomatic lumbar scoliosis: results from a prospective multicenter study.

OBJECTIVE: Although the health impact of adult symptomatic lumbar scoliosis (ASLS) is substantial, these patients often have other orthopedic problems that have not been previously quantified. The objective of this study was to assess disease burden of other orthopedic conditions in patients with ASLS based on a retrospective review of a prospective multicenter cohort. METHODS: The ASLS-1 study is an NIH-sponsored prospective multicenter study designed to assess operative versus nonoperative treatment for ASLS. Patients were 40-80 years old with ASLS, defined as a lumbar coronal Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20, or Scoliosis Research Society-22 questionnaire score ≤ 4.0 in pain, function, and/or self-image domains. Nonthoracolumbar orthopedic events, defined as fractures and other orthopedic conditions receiving surgical treatment, were assessed from enrollment to the 4-year follow-up. RESULTS: Two hundred eighty-six patients (mean age 60.3 years, 90% women) were enrolled, with 173 operative and 113 nonoperative patients, and 81% with 4-year follow-up data. At a mean (± SD) follow-up of 3.8 ± 0.9 years, 104 nonthoracolumbar orthopedic events were reported, affecting 69 patients (24.1%). The most common events were arthroplasty (n = 38), fracture (n = 25), joint ligament/cartilage repair (n = 13), and cervical decompression/fusion (n = 7). Based on the final adjusted model, patients with a nonthoracolumbar orthopedic event were older (HR 1.44 per decade, 95% CI 1.07-1.94), more likely to have a history of tobacco use (HR 1.63, 95% CI 1.00-2.66), and had worse baseline leg pain scores (HR 1.10, 95% CI 1.01-1.19). CONCLUSIONS: Patients with ASLS have high orthopedic disease burden, with almost 25% having a fracture or nonthoracolumbar orthopedic condition requiring surgical treatment during the mean 3.8 years following enrollment. Comparisons with previous studies suggest that the rate of total knee arthroplasty was considerably greater and the rates of total hip arthroplasty were at least as high in the ASLS-1 cohort compared with the similarly aged general US population. These conditions may further impact health-related quality of life and outcomes assessments of both nonoperative and operative treatment approaches in patients with ASLS.

Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.

OBJECTIVE: Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes. METHODS: The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22. RESULTS: The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD. CONCLUSIONS: The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.

Initial Choice of Spinal Manipulative Therapy for Treatment of Chronic Low Back Pain Leads to Reduced Long-term Risk of Adverse Drug Events Among Older Medicare Beneficiaries.

STUDY DESIGN: Retrospective observational study. OBJECTIVE: Opioid Analgesic Therapy (OAT) and Spinal Manipulative Therapy (SMT) are evidence-based strategies for treatment of chronic low back pain (cLBP), but the long-term safety of these therapies is uncertain. The objective of this study was to compare OAT versus SMT with regard to risk of adverse drug events (ADEs) among older adults with cLBP. SUMMARY OF BACKGROUND DATA: We examined Medicare claims data spanning a 5-year period on fee-for-service beneficiaries aged 65 to 84 years, continuously enrolled under Medicare Parts A, B, and D for a 60-month study period, and with an episode of cLBP in 2013. We excluded patients with a diagnosis of cancer or use of hospice care. METHODS: All included patients received long-term management of cLBP with SMT or OAT. We assembled cohorts of patients who received SMT or OAT only, and cohorts of patients who crossed over from OAT to SMT or from SMT to OAT. We used Poisson regression to estimate the adjusted incidence rate ratio for outpatient ADE among patients who initially chose OAT as compared with SMT. RESULTS: With controlling for patient characteristics, health status, and propensity score, the adjusted rate of ADE was more than 42 times higher for initial choice of OAT versus initial choice of SMT (rate ratio 42.85, 95% CI 34.16-53.76, P < 0.0001). CONCLUSION: Among older Medicare beneficiaries who received long-term care for cLBP the adjusted rate of ADE for patients who initially chose OAT was substantially higher than those who initially chose SMT.Level of Evidence: 2.

Differences in Functional Treadmill Tests in Patients With Adult Symptomatic Lumbar Scoliosis Treated Operatively and Nonoperatively.

STUDY DESIGN: Prospective longitudinal cohort. OBJECTIVES: The aim of this study was to determine whether functional treadmill testing (FTT) demonstrates differences between patients treated operatively and nonoperatively for adult symptomatic lumbar scoliosis (ASLS). SUMMARY OF BACKGROUND DATA: ASLS has become increasingly prevalent as the population ages. ASLS can be accompanied by neurogenic claudication, leading to difficulty walking. FTT may provide a functional tool to evaluate patients with ASLS. METHODS: One hundred and eighty-seven patients who underwent nonoperative (n = 88) or operative treatment (n = 99) of ASLS with complete baseline and 2-year post-treatment FTTs and concurrent patient-reported outcomes were identified. FTT parameters included maximum speed, time to onset of symptoms, distance ambulated, time ambulated, and Back and Leg pain severity before and after testing. RESULTS: At baseline, patients treated operatively reported worse post-FTT back pain (4.39 vs. 3.45, P = 0.032) than those treated nonoperatively, despite similar ODI, SRS-22 Pain and Activity domain scores. Mean time ambulated (+2.15 vs. -1.20 P = 0.001), pre-FTT back pain (+0.19 vs. -1.60, P < 0.000) and leg pain (+0.25 vs. -0.54, P = 0.024) improved in the operative group but deteriorated in the nonoperative group. On the 2-year follow-up FTT, both groups showed improvement in post-FTT back pain (-0.53 vs. -2.64, P < 0.000) and leg pain (-0.13 vs. -1.54, P = 0.001) severity but the improvement was statistically significantly greater in the operative compared to the nonoperative group. CONCLUSION: FTT results at baseline were worse in patients treated operatively than those treated non-operatively. FTT may be a useful adjunct to assess treatment outcomes in patients with ASLS and may help surgeons counsel patients regarding expectations 2 years after operative or nonoperative treatment for ASLS. At 2-year follow-up, time ambulated deteriorated in patients treated nonoperatively but improved in patients treated operatively. Although both groups showed improvement in post-FTT Back and Leg pain at 2 years, the improvement was greater in the operative compared to the nonoperative group. LEVEL OF EVIDENCE: 2.

Epidural Steroid Injections for Management of Degenerative Spondylolisthesis: Little Effect on Clinical Outcomes in Operatively and Nonoperatively Treated Patients.

BACKGROUND: Although epidural steroid injection (ESI) may provide pain relief for patients with degenerative spondylolisthesis in treatment regimens of up to 4 months, it remains unclear whether ESI affects crossover from nonoperative to operative management. METHODS: This retrospective cohort study analyzed 2 groups of surgical candidates with degenerative spondylolisthesis: those who received ESI within 3 months after enrollment (ESI group) and those who did not (no-ESI group). Annual outcomes following enrollment were assessed within operative and nonoperative groups (patients who initially chose or were assigned to surgery or nonoperative treatment) by using longitudinal mixed-effect models with a random subject intercept term accounting for correlations between repeated measurements. Treatment comparisons were performed at follow-up intervals. Area-under-the-curve analysis for all time points assessed the global significance of treatment. RESULTS: The study included 192 patients in the no-ESI group and 74 in the ESI group. The no-ESI group had greater baseline Short Form-36 (SF-36) Bodily Pain scores (median, 35 versus 32) and self-reported preference for surgery (38% versus 11%). There were no differences in surgical rates within 4 years after enrollment between the no-ESI and ESI groups (61% versus 62%). The surgical ESI and no-ESI groups also showed no differences in changes in patient-reported outcomes at any follow-up interval or in the 4-year average. Compared with the nonoperative ESI group, the nonoperative no-ESI group showed greater improvements in SF-36 scores for Bodily Pain (p = 0.004) and Physical Function (p = 0.005) at 4 years, Bodily Pain at 1 year (p = 0.002) and 3 years (p = 0.005), and Physical Function at 1 year (p = 0.030) and 2 years (p = 0.002). Of the patients who were initially treated nonsurgically, those who received ESI and those who did not receive ESI did not differ with regard to surgical crossover rates. The rates of crossover to nonoperative treatment by patients who initially chose or were assigned to surgery also did not differ between the ESI and no-ESI groups. CONCLUSIONS: There was no relationship between ESI and improved clinical outcomes over a 4-year study period for patients who chose or were assigned to receive surgery for degenerative spondylolisthesis. In the nonsurgical group, ESI was associated with inferior pain reduction through 3 years, although this was confounded by greater baseline pain. ESI showed little relationship with surgical crossover. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.

STUDY DESIGN: Longitudinal comparative cohort. OBJECTIVE: The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis. METHODS: Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D. RESULTS: Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment. CONCLUSION: This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis. LEVEL OF EVIDENCE: II.

Longitudinal Spending on Endovascular and Open Abdominal Aortic Aneurysm Repair.

BACKGROUND: Endovascular repair (EVR) has replaced open surgery as the procedure of choice for patients requiring elective abdominal aortic aneurysm (AAA) repair. Long-term outcomes of the 2 approaches are similar, making the relative cost of caring for these patients over time an important consideration. METHODS AND RESULTS: We linked Medicare claims to Vascular Quality Initiative registry data for patients undergoing elective EVR or open AAA repair from 2004 to 2015. The primary outcome was Medicare's cumulative disease-related spending, adjusted to 2015 dollars. Disease-related spending included the index operation and associated hospitalization, surveillance imaging, reinterventions (AAA-related and abdominal wall procedures), and all-cause admissions within 90 days. We compared the incidence of disease-related events and cumulative spending at 90 days and annually through 7 years of follow-up. The analytic cohort comprised 6804 EVR patients (median follow-up: 1.85 years; interquartile range: 0.82-3.22 years) and 1889 open repair patients (median follow-up: 2.62 years; interquartile range: 1.13-4.80 years). Spending on index surgery was significantly lower for EVR (median [interquartile range]: $25 924 [$22 280-$32 556] EVR versus $31 442 [$24 669-$40 419] open; P<0.001), driven by a lower rate of in-hospital complications (6.6% EVR versus 38.0% open; P<0.001). EVR patients underwent more surveillance imaging (1.8 studies per person-year EVR versus 0.7 studies per person-year open; P<0.001) and AAA-related reinterventions (4.0 per 100 person-years EVR versus 2.1 per 100 person-years open; P=0.041). Open repair patients had higher rates of 90-day readmission (12.9% EVR versus 17.8% open; P<0.001) and abdominal wall procedures (0.6 per 100 person-years EVR versus 1.5 per 100 person-years open; P<0.001). Overall, EVR patients incurred more disease-related spending in follow-up ($7355 EVR versus $2706 open through 5 years). There was no cumulative difference in disease-related spending between surgical groups by 5 years of follow-up (-$33 EVR [95% CI: -$1543 to $1476]). CONCLUSIONS: We observed no cumulative difference in disease-related spending on EVR and open repair patients 5 years after surgery. Generalized recommendations about which approach to offer elective AAA patients should not be based on relative cost.

Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts.

OBJECTIVE: Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS. METHODS: Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7). RESULTS: Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes. CONCLUSIONS: Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.

Comparing Patient-reported Outcomes to Patient Satisfaction After a Microdiscectomy for Patient's With a Lumbar Disk Herniation.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: The objective of this study was to determine if patient satisfaction is predicted by improvement in health-related quality of life (HRQOL) metrics. SUMMARY OF BACKGROUND DATA: Patient satisfaction is becoming an increasingly common proxy for treatment quality; however, the correlation between patient satisfaction and HRQOL outcome metrics following a lumbar disk herniation is unclear. METHODS: Patients enrolled in the Spine Patient Outcomes Research Trial (SPORT) study were prospectively enrolled at 13 institutions. A retrospective subgroup analysis of prospectively collected data from the SPORT trial was performed. Receiver operating characteristic curves were used to determine if improvement in HRQOL metrics could accurately identify patient satisfaction. HRQOL metrics included: Short Form-36 (SF-36), Oswestry Disability Index (ODI), Sciatica Bothersomeness Index, Back Pain Bothersomeness Scale, and Leg Pain Bothersomeness Scale. RESULTS: A total of 709 patients who underwent surgery and 319 patients treated without surgery were included. In the surgical cohort, receiver operating characteristic curve analysis demonstrated that SF-36 Physical Component Summary improvement had moderate accuracy [area under the curve (AUC)=0.77 (95% confidence interval, CI: 0.73-0.82)] at predicting satisfaction at 3 months, and it had excellent accuracy at predicting satisfaction at 2 years [AUC=0.81 (95% CI: 0.77-0.85)] and 4 years [AUC=0.81 (95% CI: 0.76-0.85)]. Absolute Physical Component Summary score had excellent accuracy at 3 months [AUC=0.83 (95% CI: 0.79-0.87)], 2 years [AUC=0.87 (95% CI: 0.84-0.9)] and 4 years [AUC=0.84 (95% CI: 0.8-0.89)]. Similarly improvement in the ODI had moderate accuracy of predicting satisfaction at 3 months [AUC=0.77 (95% CI: 0.72-0.81)], 2 years [AUC=0.78 (95% CI: 0.74-0.82)] and 4 years [AUC=0.78 (95% CI: 0.73-0.83)], and the absolute ODI score had excellent accuracy at 3 months [AUC=0.85 (95% CI: 0.82-0.89)], 2 years [AUC=0.89 (95% CI: 0.86-0.92)], and 4 years [AUC=0.88 (95% CI: 0.85-0.92)]. CONCLUSIONS: HRQOL metrics can accurately predict patient satisfaction with symptoms at 3 months, 2 years, and 4 years after surgical intervention for a lumbar disk herniation. Absolute outcome scores were somewhat more predictive than change scores.

Effect of Serious Adverse Events on Health-related Quality of Life Measures Following Surgery for Adult Symptomatic Lumbar Scoliosis.

STUDY DESIGN: Secondary analysis of prospective multicenter cohort. OBJECTIVE: To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS). SUMMARY OF BACKGROUND DATA: Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear. METHODS: The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts. RESULTS: Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001). CONCLUSION: Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively. LEVEL OF EVIDENCE: 2.

Operative Versus Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis.

BACKGROUND: The effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively. METHODS: Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient. RESULTS: Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients. CONCLUSIONS: On the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Retrolisthesis and lumbar disc herniation: a postoperative assessment of outcomes at 8-year follow-up.

BACKGROUND CONTEXT: Lumbar disc herniation and retrolisthesis have been shown to be significant degenerative changes that can be associated with back pain. Current literature has shown evidence that retrolisthesis is associated with similar baseline function in patients with L5-S1 disc herniation, but worse postoperative outcomes 2 years after lumbar discectomy. However, literature comparing long-term postoperative outcomes at 8-year follow-up in patients with L5-S1 disc herniation with retrolisthesis is lacking. PURPOSE: The purpose of the present study is to compare long-term postoperative outcomes at 8-year follow-up in patients with retrolisthesis and L5-S1 disc herniations to patients with L5-S1 disc herniations without retrolisthesis. STUDY DESIGN: Retrospective review of prospectively collected data from the Spine Patients Outcomes Research Trial (SPORT) database. PATIENT SAMPLE: Sixty-five patients who underwent lumbar discectomy for L5-S1 disc herniations with 8-year follow-up from the SPORT. OUTCOME MEASURES: Short Form (SF)-36 bodily pain scale, SF-36 physical function scale, Oswestry Disability Index, Sciatica Bothersomeness Index, and reoperation rate. METHODS: Baseline surgical parameters, length of stay, complication rates, reoperation rates, and outcome measures were recorded in the SPORT database. Follow-up data were collected at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, and 8 years. Retrolisthesis was defined as posterior subluxation ≥8%. Patients with and without retrolisthesis were compared using a mixed-effects model of longitudinal regression. Outcomes were calculated as time-weighted averages over 8 years. Reoperation rates were compared using the log-rank test based on time to first reoperation. RESULTS: One hundred-twenty five patients met inclusion criteria for the present study, including 29 patients with retrolisthesis (23.3%) and 96 patients who did not have retrolisthesis (76.7%). The greatest difference in clinical outcome measures was found at 2 years postoperatively. This was the only point at which both the Short Form-36 Bodily Pain scale (SF-36 BP) and PF showed significant differences between the retrolisthesis and nonretrolisthesis group. At 3 years, SF-36 BP was significantly lower in patients with retrolisthesis (39.9 vs. 52, p=.046). At 8-year follow-up, the presence of retrolisthesis in patients undergoing L5-S1 discectomy was not associated with worse outcome measure scores based on the area under the curve analysis for any metric investigated (SF-36 BP 41.4 vs. 47.1, p=.18; SF-36 Physical Function scale 38.9 vs. 45.4, p=.12; Oswestry Disability Index -39.4 vs. -34.8, p=.23; -11.6 vs. -10.4, p=.25) or a difference in reoperation rate (retrolisthesis group 10%, nonretrolisthesis group 17%, p=.41). CONCLUSIONS: While retrolisthesis can contribute to low back pain and dysfunction in patients undergoing lumbar discectomy for L5-S1 herniated nucleus pulposus in early follow-up, no significant difference was found in postoperative outcomes after 3 years. Additionally, retrolisthesis was not found to be associated with different reoperation rates at 8 years postoperatively.

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.

Understanding the value of minimally invasive procedures for the treatment of lumbar spinal stenosis: the case of interspinous spacer devices.

BACKGROUND CONTEXT: Minimally invasive lumbar spinal stenosis procedures have uncertain long-term value. PURPOSE: This study sought to characterize factors affecting the long-term cost-effectiveness of such procedures using interspinous spacer devices ("spacers") relative to decompression surgery as a case study. STUDY DESIGN: Model-based cost-effectiveness analysis. PATIENT SAMPLE: The Medicare Provider Analysis and Review database for the years 2005-2009 was used to model a group of 65-year-old patients with spinal stenosis who had no previous spine surgery and no contraindications to decompression surgery. OUTCOME MEASURES: Costs, quality-adjusted life years (QALYs), and cost per QALY gained were the outcome measures. METHODS: A Markov model tracked health utility and costs over 10 years for a 65-year-old cohort under three care strategies: conservative care, spacer surgery, and decompression surgery. Incremental cost-effectiveness ratios (ICER) reported as cost per QALY gained included direct medical costsfor surgery. Medicare claims data were used to estimate complication rates, reoperation, and related costs within 3 years. Utilities and long-term reoperation rates for decompression were derived frompublished studies. Spacer failure requiring reoperation beyond 3 years and post-spacer health utilities are uncertain and were evaluated through sensitivity analyses. In the base-case, the spacer failure rate was held constant for years 4-10 (cumulative failure: 47%). In a "worst-case" analysis, the 10-year cumulative reoperation rate was increased steeply (to 90%). Threshold analyses were performed to determine the impact of failure and post-spacer health utility on the cost-effectiveness of spacer surgery. RESULTS: The spacer strategy had an ICER of $89,500/QALY gained under base-case assumptions, and remained under $100,000 as long as the 10-year cumulative probability of reoperation did not exceed 54%. Under worst-case assumptions, the spacer ICER was $482,000/QALY and fell below $100,000 only if post-spacer utility was 0.01 greater than post-decompression utility or the cost of spacer surgery was $1,600 less than the cost of decompression surgery. CONCLUSIONS: Spacers may provide a reasonably cost-effective initial treatment option for patients with lumbar spinal stenosis. Their value is expected to improve if procedure costs are lower in outpatient settings where these procedures are increasingly being performed. Decision analysis is useful for characterizing the long-term cost-effectiveness potential for minimally invasive spinal stenosis treatments and highlights the importance of complication rates and prospective health utility assessment.

Early Effects of Medicare's Bundled Payment for Care Improvement Program for Lumbar Fusion.

STUDY DESIGN: Retrospective analysis of Medicare claims linked to hospital participation in the Center for Medicare and Medicaid Innovation's episode-based Bundled Payment for Care Improvement (BPCI) program for lumbar fusion. OBJECTIVE: To describe the early effects of BPCI participation for lumbar fusion on 90-day reimbursement, procedure volume, reoperation, and readmission. SUMMARY OF BACKGROUND DATA: Initiated on January 1, 2013, BPCI's voluntary bundle payment program provides a predetermined payment for services related to a Diagnosis-Related Group-defined "triggering event" over a defined time period. As an alternative to fee-for-service, these reforms shift the financial risk of care on to hospitals. METHODS: We identified fee-for-service beneficiaries over age 65 undergoing a lumbar fusion in 2012 or 2013, corresponding to the years before and after BPCI initiation. Hospitals were grouped based on program participation status as nonparticipants, preparatory, or risk-bearing. Generalized estimating equation models adjusting for patient age, sex, race, comorbidity, and hospital size were used to compare changes in episode costs, procedure volume, and safety indicators based on hospital BPCI participation. RESULTS: We included 89,605 beneficiaries undergoing lumbar fusion, including 36% seen by a preparatory hospital and 7% from a risk-bearing hospital. The mean age of the cohort was 73.4 years, with 59% women, 92% White, and 22% with a Charlson Comorbidity Index of 2 or more. Participant hospitals had greater procedure volume, bed size, and total discharges. Relative to nonparticipants, risk-bearing hospitals had a slightly increased fusion procedure volume from 2012 to 2013 (3.4% increase vs. 1.6% decrease, P = 0.119), did not reduce 90-day episode of care costs (0.4% decrease vs. 2.9% decrease, P = 0.044), increased 90-day readmission rate (+2.7% vs. -10.7%, P = 0.043), and increased repeat surgery rates (+30.6% vs. +7.1% points, P = 0.043). CONCLUSION: These early, unintended trends suggest an imperative for continued monitoring of BPCI in lumbar fusion. LEVEL OF EVIDENCE: 3.

Health-Related Quality of Life Scores Underestimate the Impact of Major Complications in Lumbar Degenerative Scoliosis Surgery.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To examine Charlson Comorbidity Index (CCMI) as a marker for deterioration in health status not reflected in standard Health Related Quality of Life (HRQOL) measures. SUMMARY OF BACKGROUND DATA: HRQOL has become a primary metric for assessing outcomes following spinal deformity surgery. However, studies have reported limited impact of complications on postoperative HRQOL outcomes. METHODS: We examined serial CCMI, complications, and HRQOL outcomes for 138 adult lumbar deformity patients treated surgically with a minimum two-year follow-up that included 126 females (91%) with a mean age of 59.8 years (range, 40.2-78.5). Patients with no, minor, or major complications were compared at baseline and at one and two years postoperation. RESULTS: Minor complications were observed in 26 patients (19%) and major complications in 15 (11%). Major complications included motor deficit (7), deep vein thrombosis (4), and respiratory failure (3). There was no difference in preoperative SF-36 Physical Component Summary or Scoliosis Research Society-22R (SRS-22R) scores among the groups at baseline. Preoperative CCMI was lowest in the No Complication group (3.52 ± 1.70) followed by the Major (4.00 ± 1.13) and Minor Complication groups (4.15 ± 1.71, p = .165). At one year, there was a significantly greater CCMI deterioration in the Major Complication group (0.80 ± 1.01) compared to both the Minor (0.08 ± 0.27) and No Complication groups (0.27 ± 0.47, p < .001). There was no significant difference in SF-36 Physical Component Summary or SRS-22R scores among the three groups. Similar findings were observed at two years. CONCLUSIONS: Despite similar one- and two-year HRQOL improvement, patients with major complications had greater deterioration in CCMI. As CCMI is predictive of medical and surgical risk, patients who sustained a major complication now carry a greater likelihood of adverse outcomes with future interventions, including any subsequent spinal surgery. Although this increased risk may not alter the patient's perception of his or her current health status, it may be important, and should be recognized as part of the shared decision-making process. LEVEL OF EVIDENCE: Level II, high-quality prognostic study.

Risk Factors for Reoperation in Patients Treated Surgically for Degenerative Spondylolisthesis: A Subanalysis of the 8-year Data From the SPORT Trial.

STUDY DESIGN: Retrospective analysis of prospective data from the degenerative spondylolisthesis (DS) arm of the Spine Patient Outcomes Research Trial. OBJECTIVE: The aim of this study was to identify risk factors for reoperation in patients treated surgically for DS and compare outcomes between patients who underwent reoperation with nonreoperative patients. SUMMARY OF BACKGROUND DATA: Several studies have examined outcomes following surgery for DS, but few have identified risk factors for reoperation. METHODS: Analysis included patients with neurogenic claudication (>12 weeks), clinical neurological signs, spinal stenosis, and DS on standing lateral x-rays. Univariate and multivariate analyses were used to investigate patient characteristics and risk factors. Treatment effects (TEs) were calculated and compared between study groups. RESULTS: Of 406 patients, 72% underwent instrumented fusion, 21% noninstrumented fusion, and 7% decompression alone. At 8 years, the reoperation rate was 22%, of which 28% occurred within 1 year, 54% within 2 years, 70% within 4 years, and 86% within 6 years. The reasons for reoperation included recurrent stenosis or progressive spondylolisthesis (45%), complications such as hematoma, dehiscence, or infection (36%), or new condition (14%). Reoperative patients were younger (62.2 vs. 65.3, P = 0.008). Significant risk factors were use of antidepressants (P = 0.008, hazard ratio [HR] 2.08) or having no neurogenic claudication upon enrollment (P = 0.02, HR 1.82). Patients who were smokers, diabetics, obese, or on workman's compensation were not at greater risk for reoperation. At 8-year follow-up, scores for SF-36 bodily pain (BP), Oswestry Disability Index, American Academy of Orthopaedic Surgeons/Modems version (ODI), and stenosis frequency index were better in nonreoperative patients. TE favored nonreoperative patients for SF-36 BP, physical function, ODI, Stenosis Bothersomeness Index, and satisfaction with symptoms (P < 0.001). CONCLUSION: The incidence of reoperation for patients with DS was 22% 8 years following surgery. Patients with a history of no neurogenic claudication and patients taking antidepressants were more likely to undergo reoperation. Outcome scores and TE were more favorable in nonreoperative patients. LEVEL OF EVIDENCE: 2.