Assessment of the External Validity of Dialogue Support for Predicting Lumbar Spine Surgery Outcomes in a US Cohort.

STUDY DESIGN: External validation using prospectively collected data. OBJECTIVES: To determine the model performance of "Dialogue Support" (DS) in predicting outcomes after lumbar spine surgery. SUMMARY OF BACKGROUND DATA: To help clinicians discuss risk versus benefit with patients considering lumbar fusion surgery, DS has been made available online. As DS was created using a Swedish sample, there is a need to study how well DS performs in alternative populations. PATIENTS AND METHODS: Preoperative data from patients enrolled in the Quality Outcomes Database were entered into DS. The probability for each patient to report satisfaction, achieve success (leg pain improvement ≥3), or have no leg pain 12 months after surgery was extracted and compared with their actual 12-month postoperative data. The ability of DS to identify patients in the Quality Outcomes Database who report satisfaction, achieve success, or have no leg pain 12 months after surgery was determined using Receiver operating characteristic curve analysis, goodness-of-fit tests, and calibration plots. RESULTS: There was a significant improvement in all outcomes in 23,928 cases included in the analysis from baseline to 12 months postoperative. Most (84%) reported satisfaction, 67% achieved success, and 44% were pain-free 12 months postoperative. Receiver operating characteristic analysis showed that DS had a low ability to predict satisfaction [area under the curve (AUC) = 0.606], success (AUC = 0.546), and being pain-free (AUC = 0.578) at 12 months postoperative; poor fit for satisfaction (<0.001) and being pain-free ( P = 0.004), but acceptable fit for success ( P = 0.052). Calibration plots showed underestimation for satisfaction and success, but acceptable estimates for being pain-free. CONCLUSION: DS is not directly transferable to predict satisfaction and success after lumbar surgery in a US population. This may be due to differences in patient characteristics, weights of the variables included, or the exclusion of unknown variables associated with outcomes. Future studies to better understand and improve the transferability of these models are needed.

Quantitative Romberg on a Force Plate: Objective Assessment Before and After Surgery for Cervical Spondylotic Myelopathy.

STUDY DESIGN: Longitudinal Observational Cohort. OBJECTIVES: The purpose of this study was to evaluate the utility of Quantitative Romberg measurements as pre- and post-op balance outcome measures. SUMMARY OF BACKGROUND DATA: Cervical Spondylotic Myelopathy (CSM) is characterized by balance deficiencies produced by impaired proprioception. Evaluation is subjective and binary physical exam findings lack the precision to assess postoperative outcome improvement. METHODS: CSM patients were prospectively enrolled to undergo pre- and postoperative Quantitative Romberg tests on a force plate to record center of pressure (COP) motion for 30 seconds with eyes open followed by eyes closed. Revision cases were excluded. Kinematics of COP movement parameters were compared between pre- and postoperative state for each patient. RESULTS: Twenty-seven CSM patients were enrolled and completed both pre/post testing. Mean age was 60.0 years with 13 (48%) males, 9 (33%) smokers. Mean number of surgical levels was 2.48. The minimum mean follow-up was six months. There was a statistically significant improvement in eyes closed after surgery compared to pre-operative for total COP motion (523.44 cm vs. 387.00 cm, P<0.001), average sway speed (17.41 cm/s vs. 13.00 cm/s, P<0.001) and total lateral COP motion (253.44 cm vs. 186.70 cm, P<0.001). There was no statistically significant improvement in mJOA (13.29 vs. 14.29, P=0.28). CONCLUSION: CSM balance findings on Quantitative Romberg testing significantly improves postoperatively in patients with CSM. These findings support this testing as representative of proprioceptive balance deficiencies seen in CSM. Quantitative Romberg may be used as an objective measure of clinical outcome and assist in stratification of surgical interventions, surgery timing and technique.

Patient safety indicators from a spine surgery perspective: the importance of a specialty specific clinician working with the documentation team and the impact to your hospital.

BACKGROUND CONTEXT: The Hospital Acquired Conditions (HAC) Reduction Program supports the Centers for Medicare and Medicaid Services (CMS) effort to prevent harm to patients by providing a financial incentive to reduce HACs. HAC scores are impacted by Patient Safety Indicators (PSIs), potentially preventable hospital-related events associated with harmful patient outcomes. PSIs are identified using International Classification of Diseases (ICD) coding; however, ICD coding does not always reflect the patient's true medical course. PURPOSE: To evaluate the efficacy of and costs savings associated with a clinical documentation review process in tandem with clinician collaboration in identifying incorrectly generated PSIs. STUDY DESIGN: Retrospective chart review. PATIENT SAMPLE: All patients undergoing spine surgery at a single multi-surgeon tertiary spine center. OUTCOME MEASURES: Occurrence of PSI. METHODS: Over two 11-month periods, all PSIs attributable to spine surgery were determined. The number and type of spine related PSIs were compared before (Control) and after the implementation of a specialty specific clinical review (Intervention) to identify incorrectly generated PSIs. The financial impact of this intervention was calculated in the form of an annual cost savings to our hospital system. RESULTS: During the Control phase, 61 PSIs were reported in 3368 spine cases, representing a total of 3.6 PSIs/month. During Intervention phase, 26 PSIs in 4,482 spine cases, resulting in a statistically significant decrease of 1.5 PSIs per month. The percentage of PSIs across all surgical cases attributable to spine surgery had a statistically significant decrease during the Intervention period compared to the Control period (16% vs. 10%, p=.034), resulting in the avoidance of a 1% CMS cost reduction, an annual cost saving of approximately $3-4 million dollars per year. CONCLUSIONS: The implementation of a clinical documentation review process with clinician collaboration to ensure ICD-10 coding accurately reflects the patient's medical course leads to more accurate PSI reporting, with the potential for substantial cost-savings for hospitals from CMS reimbursement.

Inferior Clinical Outcomes for Patients with Medicaid Insurance After Surgery for Degenerative Lumbar Spondylolisthesis: A Prospective Registry Analysis of 608 Patients.

BACKGROUND: It remains unclear how type of insurance coverage affects long-term, spine-specific patient-reported outcomes (PROs). This study sought to elucidate the impact of insurance on clinical outcomes after lumbar spondylolisthesis surgery. METHODS: The prospective Quality Outcomes Database registry was queried for patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery. Twenty-four-month PROs were compared and included Oswestry Disability Index, Numeric Rating Scale (NRS) back pain, NRS leg pain, EuroQol-5D, and North American Spine Society Satisfaction. RESULTS: A total of 608 patients undergoing surgery for grade 1 degenerative lumbar spondylolisthesis (mean age, 62.5 ± 11.5 years and 59.2% women) were selected. Insurance types included private insurance (n = 319; 52.5%), Medicare (n = 235; 38.7%), Medicaid (n = 36; 5.9%), and Veterans Affairs (VA)/government (n = 17; 2.8%). One patient (0.2%) was uninsured and was removed from the analyses. Regardless of insurance status, compared to baseline, all 4 cohorts improved significantly regarding ODI, NRS-BP, NRS-LP, and EQ-5D scores (P < 0.001). In adjusted multivariable analyses, compared with patients with private insurance, Medicaid was associated with worse 24-month postoperative Oswestry Disability Index (ß = 10.2; 95% confidence interval [CI], 3.9-16.5; P = 0.002) and NRS leg pain (ß =1.3; 95% CI, 0.3-2.4; P = 0.02). Medicaid was associated with worse EuroQol-5D scores compared with private insurance (ß = -0.07; 95% CI -0.01 to -0.14; P = 0.03), but not compared with Medicare and VA/government insurance (P > 0.05). Medicaid was associated with lower odds of reaching ODI minimal clinically important difference (odds ratio, 0.2; 95% CI, 0.03-0.7; P = 0.02) compared with VA/government insurance. NRS back pain and North American Spine Society satisfaction did not differ by insurance coverage (P > 0.05). CONCLUSIONS: Despite adjusting for potential confounding variables, Medicaid coverage was independently associated with worse 24-month PROs after lumbar spondylolisthesis surgery compared with other payer types. Although all improved postoperatively, those with Medicaid coverage had relatively inferior improvements.

Costs associated with potentially unnecessary postoperative healthcare encounters after lumbar spine surgery.

BACKGROUND CONTEXT: Excessive use of postoperative imaging after lumbar surgery has been documented, becoming a target for cutting costs. This must be balanced with the patient's need for information and allay their postoperative concerns. PURPOSE: To determine the incidence and associated costs of patient interactions with the healthcare system, outside the standard follow up routine, in the first postoperative year. STUDY DESIGN: Retrospective longitudinal cohort. PATIENT SAMPLE: Consecutive series of 200 patients who underwent lumbar fusions from 2018 to 2019 from a multi-surgeon single tertiary spine center. OUTCOME MEASURES: All healthcare encounters: phone calls, office and emergency department visits, and additional testing METHODS: A consecutive series of 200 patients who underwent lumbar fusions from 2018 to 2019 were identified. All non-routine healthcare encounters: phone calls, office and emergency department visits, and additional testing were collected. Direct costs for all healthcare services were determined using the Medicare Allowable rates. Indirect costs were determined using local, median income, length of office visits, and distance from the clinic to the patient's home. RESULTS: Of 200 patients, 14 with thoracic fusion were excluded. The mean age of the 186 included patients was 58.26 years and 85 (46%) were male. Forty-seven percent (87/186) had only routine postoperative visits and 24 had revision surgery. Seventy-five patients made a total of 102 phone calls, 55 office visits, leading to 38 diagnostic studies none of which led to an additional intervention. Using Medicare Allowable rates, the mean direct cost was $776 per patient and the using a median income of $16/h the mean indirect cost was $124 per patient. There were no differences in the baseline characteristics among the patients who only had routine post-op encounters, had non-routine encounters or had a repeat surgery. CONCLUSIONS: Forty percent of the patients undergoing lumbar surgery had a healthcare encounter outside their routine follow up that did not result in additional intervention after their index operation. These potentially unnecessary encounters create additional cost and inconvenience to both the patient and healthcare system. Providing patient reassurance is important and providers should identify ways to reduce associated costs through patient education, virtual visits, or new technologies to monitor patient's postoperative progress.

Reaching the medicare allowable threshold in adult spinal deformity surgery: multicenter cost analysis comparing actual direct hospital costs versus what the government will pay.

STUDY DESIGN: Retrospective multicenter cost analysis. OBJECTIVE: To (1) determine if index episode of care (iEOC) costs of Adult Spinal Deformity (ASD) surgeries are below the Medicare Allowable (MA) threshold, and (2) identify variables that can predict iEOC cases that are below MA. Previous studies have suggested that actual direct hospital cost of Adult Spinal Deformity (ASD) surgery is higher than Medicare Allowable (MA) rates, which has become the benchmark reimbursement target for hospital accounting systems. METHODS: From a prospective, multicenter ASD surgical database, patients undergoing long instrumented fusions (> 5 level) with cost data were identified. iEOC cost was calculated utilizing actual direct hospital cost. MA rates were calculated using hospital specific, year-appropriate CMS Inpatient Pricer Payment System. Recursive partitioning identified potentially modifiable variables that can predict iEOC cost < MA. RESULTS: Administrative direct cost data from 210 patients were obtained from 4 of 11 centers. Ninety-five (45%) patients had iEOC cost < MA. There was significant variation across the four centers in both iEOC cost ($56,788-$78,878, p < 0.0001) and reimbursement ($40,623-$91,351, p < 0.0001) across deformity-specific DRGs (453,454,456,457). Academic centers were more likely to have iEOC costs < MA (67.2% vs 8.9%, p < 0.0001). Recursive partitioning (r2 = 0.309) identified rhBMP-2 use of < 24 mg, sagittal plane deformity, a combined anterior/posterior approach, and an SF36-MCS < 39 as predictive for iEOC cost < MA. Performing an anterior/posterior approach reimburses between 14.7% and 121.1% more (2.2-fold) than posterior-only approach. This change in DRG allows iEOC cost to be more likely below the MA threshold. CONCLUSION: There is significant institutional (private vs academic) variation in ASD reimbursement. BMP use, deformity type, approach, and baseline mental health impact ASD surgery cost being below Medicare reimbursement. ASD surgeries with anterior/posterior approaches are in DRGs that can potentially reimburse 2.2-fold the posterior-only surgery, making it more likely to fall below the MA threshold. LEVEL OF EVIDENCE: III.

State-of-the-art: outcome assessment in adult spinal deformity.

Adult spinal deformity (ASD) is a diagnosis that encompasses heterogeneous disorders with an increasing prevalence. This increasing prevalence may be due to greater patient longevity or greater awareness of available treatments. Outcome assessment in ASD has evolved over the last 3 decades from physician-based assessments to a patient-centered perception of improvement. Outcome assessment that is reliable, accurate and responsive to change is especially important in ASD, as surgical treatment is known to carry a high cost and complication rate Glassman (Spine Deform 3:199-203, 2015); Glassman (Spine (Phila Pa 1976) 32: 2764-2770, 2007); Smith (J Neurosurg Spine 25:1-14, 2016). In an era of value-based care, diagnosis associated with such heterogeneity and high cost must provide sound evidence to support the cost versus outcome ratio. Numerous general health and disease specific patient-reported outcome measures (PROMs) have been utilized in ASD. We discuss these instruments in detail in the following state-of-the-art review.

Economic analysis of 90-day return to the emergency room and readmission after elective lumbar spine surgery: a single-center analysis of 5444 patients.

OBJECTIVE: In the future, payers may not cover unplanned 90-day emergency room (ER) visits or readmissions after elective lumbar spine surgery. Prior studies using large administrative databases lack granularity and/or use a proxy for actual cost. The purpose of this study was to identify risk factors and subsequent costs associated with 90-day ER visits and readmissions after elective lumbar spine surgery. METHODS: A prospective, multisurgeon, single-center electronic medical record was queried for elective lumbar spine fusion surgeries from 2013 to 2017. Predictive models were created for 90-day ER visits and readmissions. RESULTS: Of 5444 patients, 729 (13%) returned to the ER, most often for pain (n = 213, 29%). Predictors of an ER visit were prior ER visit (OR 2.5), underserved zip code (OR 1.4), and number of chronic medical conditions (OR 1.4). In total, 421 (8%) patients were readmitted, most frequently for wound infection (n = 123, 2%), exacerbation of chronic obstructive pulmonary disease (n = 24, 0.4%), and sepsis (n = 23, 0.4%). Predictors for readmission were prior ER visit (OR 1.96), multiple chronic conditions (OR 1.69), obesity (nonobese, OR 0.49), race (African American, OR 1.43), admission status (ER admission, OR 2.29), and elevated hemoglobin A1c (OR 1.80). The mean direct hospital cost for an ER visit was $1971, with 75% of visits costing less than $1890, and the average readmission cost was $7347, with 75% of readmissions costing less than $8820. Over the 5-year study period, the cost to the institution for 90-day return ER visits was $5.1 million. CONCLUSIONS: Risk factors for 90-day ER visit and readmission after elective lumbar spine surgery include medical comorbidities and socioeconomic factors. Proper patient counseling, appropriate postoperative pain management, and optimization of modifiable risk factors prior to surgery are areas to focus future efforts to lower 90-day ER visits and readmissions and reduce healthcare costs.

Development and Validation of Cervical Prediction Models for Patient-Reported Outcomes at 1 Year After Cervical Spine Surgery for Radiculopathy and Myelopathy.

STUDY DESIGN: Retrospective analysis of prospectively collected registry data. OBJECTIVE: To develop and validate prediction models for 12-month patient-reported outcomes of disability, pain, and myelopathy in patients undergoing elective cervical spine surgery. SUMMARY OF BACKGROUND DATA: Predictive models have the potential to be utilized preoperatively to set expectations, adjust modifiable characteristics, and provide a patient-centered model of care. METHODS: This study was conducted using data from the cervical module of the Quality Outcomes Database. The outcomes of interest were disability (Neck Disability Index:), pain (Numeric Rating Scale), and modified Japanese Orthopaedic Association score for myelopathy. Multivariable proportional odds ordinal regression models were developed for patients with cervical radiculopathy and myelopathy. Patient demographic, clinical, and surgical covariates as well as baseline patient-reported outcomes scores were included in all models. The models were internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients. RESULTS: Four thousand nine hundred eighty-eight patients underwent surgery for radiculopathy and 2641 patients for myelopathy. The most important predictor of poor postoperative outcomes at 12-months was the baseline Neck Disability Index score for patients with radiculopathy and modified Japanese Orthopaedic Association score for patients with myelopathy. In addition, symptom duration, workers' compensation, age, employment, and ambulatory and smoking status had a statistically significant impact on all outcomes (P < 0.001). Clinical and surgical variables contributed very little to predictive models, with posterior approach being associated with higher odds of having worse 12-month outcome scores in both the radiculopathy and myelopathy cohorts (P < 0.001). The full models overall discriminative performance ranged from 0.654 to 0.725. CONCLUSIONS: These predictive models provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical disease. Predictive models have the potential to be used as a shared decision-making tool for evidence-based preoperative counselling. LEVEL OF EVIDENCE: 2.

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.

Cost-effectiveness of surgical treatment of adult spinal deformity: comparison of posterior-only versus anteroposterior approach.

BACKGROUND CONTEXT: Considerable debate exists regarding the optimal surgical approach for adult spinal deformity (ASD). It remains unclear which approach, posterior-only or combined anterior-posterior (AP), is more cost-effective. Our goal is to determine the 2-year cost per quality-adjusted life year (QALY) for each approach. PURPOSE: To compare the 2-year cost-effectiveness of surgical treatment for ASD between the posterior-only approach and combined AP approach. STUDY DESIGN: Retrospective economic analysis of a prospective, multicenter database PATIENT SAMPLE: From a prospective, multicenter surgical database of ASD, patients undergoing five or more level fusions through a posterior-only or AP approach were identified and compared. METHODS: QALYs gained were determined using baseline, 1-year, and 2-year postoperative Short Form 6D. Cost was calculated from actual, direct hospital costs including any subsequent readmission or revision. Cost-effectiveness was determined using cost/QALY gained. RESULTS: The AP approach showed significantly higher index cost than the posterior-only approach ($84,329 vs. $64,281). This margin decreased at 2-year follow-up with total costs of $89,824 and $73,904, respectively. QALYs gained at 2 years were similar with 0.21 and 0.17 in the posterior-only and the AP approaches, respectively. The cost/QALY at 2 years after surgery was significantly higher in the AP approach ($525,080) than in the posterior-only approach ($351,086). CONCLUSIONS: We assessed 2-year cost-effectiveness for the surgical treatment through posterior-only and AP approaches. The posterior-only approach is less expensive both for the index surgery and at 2-year follow-up. The QALY gained at 2-years was similar between the two approaches. Thus, posterior-only approach was more cost-effective than the AP approach under our study parameters. However, both approaches were not cost-effective at 2-year follow-up.

Assessment of standing balance in normal versus cervical spondylotic myelopathy patients.

BACKGROUND: The Romberg test is used to identify balance issues in patients with Cervical Spondylotic Myelopathy (CSM), but has subjective interpretation. The purpose of this study is to evaluate force plate pressure readings during a Romberg test to quantify postural control. METHODS: Quantitative Romberg force plate readings with eyes open and closed in patients with CSM were obtained and changes in balance measurements were compared to a normal population (N = 28, mean age 39 ± 7 years). RESULTS: We identified 30 CSM patients with a mean age of 58 ± 10 years. Majority of patients presented with pain (90%) and neurologic symptoms (83%). Cord compression on imaging was identified in 90%. Mean eyes closed Romberg measurements were larger compared to eyes open measurements in CSM patients (p < 0.01). There was a larger change in Romberg (∆R) measurements in CSM compared to normals for total sway area (TSA, 14.18 vs 0.02 cm2, p < 0.001) and average speed (AS, 2.07 vs 0.23 cm/s, p < 0.001). The presence of long tract signs produced larger ∆R (TSA, 15.35 vs 0.02 cm2, p = 0.003; AS, 2.21 vs 0.23 cm/s, p = 0.001), and those with identified cord compression on imaging also had larger ∆R (TSA, 15.1 vs 0.02 cm2, p < 0.001; AS, 2.17 vs 0.23 cm/s, p < 0.001). CONCLUSIONS: Standing balance can be quantified in patients with CSM and is worse when compared to a normal population. Long tract signs and cord compression in imaging translates to worse balance in myelopathic patients. The use of quantitative Romberg measurements help evaluate balance in CSM.

Cost-effectiveness of minimally invasive midline lumbar interbody fusion versus traditional open transforaminal lumbar interbody fusion.

OBJECTIVE: The midline transforaminal lumbar interbody fusion (MIDLIF) using cortical screw fixation is a novel, minimally invasive procedure that may offer enhanced recovery over traditional open transforaminal lumbar interbody fusion (TLIF). Little information is available regarding the comparative cost-effectiveness of the MIDLIF over conventional TLIF. The purpose of this study was to compare cost-effectiveness of minimally invasive MIDLIF with open TLIF. METHODS: From a prospective, multisurgeon, surgical database, a consecutive series of patients undergoing 1- or 2-level MIDLIF for degenerative lumbar conditions was identified and propensity matched to patients undergoing TLIF based on age, sex, smoking status, BMI, diagnosis, American Society of Anesthesiologists Physical Status Classification System (ASA) class, and levels fused. Direct costs at 1 year were collected, including costs associated with the index surgical visit as well as costs associated with readmission. Improvement in health-related quality of life was measured using EQ-5D and SF-6D. RESULTS: Of 214 and 181 patients undergoing MIDLIF and TLIF, respectively, 33 cases in each cohort were successfully propensity matched. Consistent with propensity matching, there was no difference in age, sex, BMI, diagnosis, ASA class, smoking status, or levels fused. Spondylolisthesis was the most common indication for surgery in both cohorts. Variable direct costs at 1 year were $2493 lower in the MIDLIF group than in the open TLIF group (mean $15,867 vs $17,612, p = 0.073). There was no difference in implant (p = 0.193) or biologics (p = 0.145) cost, but blood utilization (p = 0.015), operating room supplies (p < 0.001), hospital room and board (p < 0.001), pharmacy (p = 0.010), laboratory (p = 0.004), and physical therapy (p = 0.009) costs were all significantly lower in the MIDLIF group. Additionally, the mean length of stay was decreased for MIDLIF as well (3.21 vs 4.02 days, p = 0.05). The EQ-5D gain at 1 year was 0.156 for MIDLIF and 0.141 for open TLIF (p = 0.821). The SF-6D gain at 1 year was 0.071 for MIDLIF and 0.057 for open TLIF (p = 0.551). CONCLUSIONS: Compared with patients undergoing traditional open TLIF, those undergoing MIDLIF have similar 1-year gains in health-related quality of life, with total direct costs that are $2493 lower. Although the findings were not statistically significant, minimally invasive MIDLIF showed improved cost-effectiveness at 1 year compared with open TLIF.

Cost-effectiveness of Operative versus Nonoperative Treatment of Adult Symptomatic Lumbar Scoliosis an Intent-to-treat Analysis at 5-year Follow-up.

STUDY DESIGN: Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms. OBJECTIVE: The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS. SUMMARY OF BACKGROUND DATA: The appropriate treatment approach for ASLS continues to be ill-defined. NonOp care has not been shown to improve outcomes. Surgical treatment has been shown to improve outcomes, but is costly with high revision rates. METHODS: Patients with at least 5-year follow-up data were included. Data collected every 3 months included use of NonOp modalities, medications, and employment status. Costs for index and revision surgeries and NonOp modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Qualityadjusted life year (QALY) was determined using the SF6D. RESULTS: There were 81 of 95 cases in the Op and 81 of 95 in the NonOp group with complete 5-year follow-up data. Not all patients were eligible 5-year follow-up at the time of the analysis. All patients in the Op and 24 (30%) in the NonOp group had surgery by 5 years. At 5 years, the cumulative cost for Op was $96,000 with a QALY gain of 2.44 and for NonOp the cumulative cost was $49,546 with a QALY gain of 0.75 with an incremental cost-effectiveness ratio (ICER) of $27,480 per QALY gain. CONCLUSION: In an intent-to-treat analysis, neither treatment was dominant, as the greater gains in QALY in the surgery group come at a greater cost. The ICER for Op compared to NonOp treatment was above the threshold generally considered cost-effective in the first 3 years of the study but improved over time and was highly cost-effective at 4 and 5 years. LEVEL OF EVIDENCE: 2.

Does Timing of Primary Total Hip Arthroplasty Prior to or After Lumbar Spine Fusion Have an Effect on Dislocation and Revision Rates?

BACKGROUND: Patients undergoing primary total hip arthroplasty (THA) following lumbar spine fusion have an increased incidence of dislocation compared to those without prior lumbar fusion. The purpose of this study is to determine if timing of THA prior to or after lumbar fusion would have an effect on dislocation and revision incidence in patients with both hip and lumbar spine pathology. METHODS: One hundred percent Medicare inpatient claims data from 2005 to 2015 were used to compare dislocation and revision risks in patients with primary THA with pre-existing lumbar spine fusion vs THA with subsequent lumbar spine fusion within 1, 2, and 5 years after the index THA. A total of 42,300 patients met inclusion criteria, 28,668 patients of which underwent THA with pre-existing lumbar spinal fusion (LSF) and 13,632 patients who had prior THA and subsequent LSF. Patients who had THA first followed by LSF were further stratified based on the interval between index THA and subsequent LSF (1, 2, and 5 years), making 4 total groups for comparison. Multivariate cox regression analysis was performed adjusting for age, socioeconomic status, race, census region, gender, Charlson score, pre-existing conditions, discharge status, length of stay, and hospital characteristics. RESULTS: Patients with prior LSF undergoing THA had a 106% increased risk of dislocation compared to those with LSF done 5 years after THA (P < .001). Risk of revision THA was greater in the pre-existing LSF group by 43%, 41%, and 49% at 1, 2, and 5 years post THA compared to the groups with THA done first with subsequent LSF. Dislocation was the most common etiology for revision THA in all groups, but significantly higher in the prior LSF group (26.6%). CONCLUSION: Results of this study demonstrate that sequence of surgical intervention for concomitant lumbar and hip pathology requiring LSF and THA respectively significantly impacts the fate of the THA performed. Patients with prior LSF undergoing THA are at significantly higher risk of dislocation and subsequent revision compared to those with THA first followed by delayed LSF. LEVEL OF EVIDENCE: 3.

Randomized trial of Cell Saver in 2- to 3-level lumbar instrumented posterior fusions.

OBJECTIVEThe goal of this study was to determine efficacy and cost-effectiveness of Cell Saver in 2- and 3-level lumbar decompression and fusion.METHODSPatients seen at a tertiary care spine center who were undergoing a posterior 2- or 3-level lumbar decompression and fusion were randomized to have Cell Saver used during their surgery (CS group, n = 48) or not used (No Cell Saver [NCS] group, n = 47). Data regarding preoperative and postoperative hemoglobin and hematocrit, estimated blood loss, volume of Cell Saver blood reinfused, number of units and volume of allogeneic blood transfused intraoperatively and postoperatively, complications, and costs were collected. Costs associated with Cell Saver use were calculated based on units of allogeneic blood transfusions averted.RESULTSDemographics and surgical parameters were similar in both groups. The mean estimated blood loss was similar in both groups: 612 ml in the CS group and 742 ml in the NCS group. There were 53 U of allogeneic blood transfused in 29 patients in the NCS group at a total blood product cost of $67,688; and 38 U of allogeneic blood transfused in 16 patients in the CS group at a total blood cost of $113,162, resulting in a cost of $3031 per allogeneic blood transfusion averted using Cell Saver.CONCLUSIONSCell Saver use produced lower rates of allogeneic transfusion but was found to be more expensive than using only allogeneic blood for 2- and 3-level lumbar degenerative fusions. This increased cost may be reasonable to patients who perceive that the risks associated with allogeneic transfusions are unacceptable.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III.

Cost-effectiveness of circumferential fusion for lumbar spondylolisthesis: propensity-matched comparison of transforaminal lumbar interbody fusion with anterior-posterior fusion.

BACKGROUND CONTEXT: Transforaminal lumbar interbody fusion (TLIF) and dual-approach anteroposterior (AP) are common techniques to achieve circumferential fusion for lumbar spondylolisthesis. It is unclear which approach is more cost-effective. PURPOSE: Our goal was to determine the incremental cost-effectiveness ratio (ICER) by calculating the cost per quality-adjusted life year (QALY) for each approach. STUDY DESIGN/SETTING: This study is a propensity-matched cost-effectiveness comparison. PATIENT SAMPLE: Patients with lumbar spondylolisthesis undergoing single-level AP fusion or TLIF and enrolled in a prospective observational surgical database were included in this study. OUTCOME MEASURES: The outcome measures in this study were the Oswestry Disability Index (ODI) and the Short Form-6D (SF-6D). METHODS: From a prospective surgical database, patients with lumbar spondylolisthesis undergoing single-level AP fusion were propensity matched to a TLIF cohort based on age, gender, body mass index, smoking status, workers compensation, preoperative ODI, and back and leg pain numeric scores. Quality-adjusted life years gained were determined using baseline and 1- and 2-yearpostoperative SF-6D scores. Cost was calculated from actual, direct hospital costs and included subsequent postsurgical costs (epidural spinal injections, spine-related emergency department visits, readmissions, and revision surgery). RESULTS: Thirty-one cases of AP fusions were identified and propensity matched to 31 TLIF patients. Patients undergoing TLIF had a shorter mean operative time (270 vs. 328 minutes, p=.039) but no difference in estimated blood loss (526 vs. 548 cc, p=.804) or hospital length of stay (4.5 vs. 6.1 days, p=.146). Quality-adjusted life years gained at 2 years were also similar (0.140 vs. 0.130, p=.672). The mean index surgery and the total 2-year costs were lower for TLIF compared with AP (index: $29,428 vs. $31,466; final: $30,684 vs. $331,880). As overall costs were lower and QALYs gained were similar for TLIF compared with AP fusion, TLIF was the dominant intervention with an ICER of $116,327. CONCLUSIONS: Under our study parameters, surgical treatment of lumbar spondylolisthesis with TLIF is more cost-effective compared with AP fusion. Because of the short-term follow-up, the longevity of this should be further investigated.

Cost-effectiveness of Lumbar Epidural Steroid Injections.

STUDY DESIGN: Longitudinal cohort. OBJECTIVE: To determine the cost per quality-adjusted life-year for lumbar epidural steroid injections (LESI). SUMMARY OF BACKGROUND DATA: Despite being a widely performed procedure, there are few studies evaluating the cost-effectiveness of LESIs. METHODS: Patients who had received LESI between June 2012 and July 2013 with EuroQOL-5D (EQ-5D) scores available before and after LESIs but before any surgical intervention were identified. Costs were calculated on the basis of the Medicare Fee Schedule multiplied by the number of LESIs received between the 2 clinic visits. Quality-adjusted life-years (QALYs) were calculated using the EQ-5D. RESULTS: Of 421 patients who had pre-LESI EQ-5D data, 323 (77%) had post-LESI data available; 200 females, 123 males, mean age: 59.2 ±â€Š14.2 years. Cost per LESI was $608, with most patients receiving 3 LESIs for more than 1 year (range: 1-6 yr). Mean QALY gained was 0.005. One hundred forty-five patients (45%) had a QALY gain (mean = 0.117) at a cost of $62,175 per QALY gained; 127 patients (40%) had a loss in QALY (mean = -0.120) and 51 patients (15%) had no change in QALY. Fourteen of the 145 patients who improved, and 29 of the 178 patients who did not, have medical comorbidities that precluded surgery. Thirty-two (22%) of 131 patients without medical comorbidities who improved and 57 (32%) of 149 patients without medical comorbidities who did not improve subsequently had undergone surgery (P = 0.015). CONCLUSION: LESI may not be cost-effective in patients with lumbar degenerative disorders. For the 145 patients who improved, cost per QALY gained was acceptable at $62,175. However, for the 178 patients with no gain or a loss in QALY, the economics are not reportable with a cost per QALY gained being theoretically infinite. Further studies are needed to identify specific patient populations who will benefit from LESI because the economic viability of LESI requires improved patient selection. LEVEL OF EVIDENCE: 2.

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 of Osteoporotic Fracture After Steroid Injections in Patients With Medicare.

To further evaluate the relationship between steroid injections and osteoporotic fracture risk, we analyzed Medicare administrative claims data on both large-joint steroid injections (LJSIs) into knee and hip and transforaminal steroid injections (TSIs), as well as osteoporotic hip and wrist fractures. Our hypothesis was that a systemic effect of steroid injections would increase fracture risk in all skeletal locations regardless of injection site, whereas a local effect would produce a disproportionate increased risk of spine fracture with spine injection. Patients treated with an LJSI, a TSI, or an epidural steroid injection (ESI) were identified from 5% Medicare claims data. Patients under age 65 years and patients with prior osteoporotic fracture were excluded. Analyses were performed to determine fracture risk (adjusted hazard ratio) for each type of injection. Analysis of the Medicare data revealed that ESIs were associated with decreased osteoporotic spine fracture risk, but the effect was small and might not be clinically relevant. ESIs did not influence osteoporotic hip or wrist fracture risk, but LJSIs reduced the risk.