Are Quality Scores in the Centers for Medicaid and Medicare Services Merit-based Incentive Payment System Associated With Outcomes After Outpatient Orthopaedic Surgery?

BACKGROUND: The Medicare Merit-based Incentive Payment System (MIPS) ties reimbursement incentives to clinician performance to improve healthcare quality. It is unclear whether the MIPS quality score can accurately distinguish between high-performing and low-performing clinicians. QUESTIONS/PURPOSES: (1) What were the rates of unplanned hospital visits (emergency department visits, observation stays, or unplanned admissions) within 7, 30, and 90 days of outpatient orthopaedic surgery among Medicare beneficiaries? (2) Was there any association of MIPS quality scores with the risk of an unplanned hospital visit (emergency department visits, observation stays, or unplanned admissions)? METHODS: Between January 2018 and December 2019, a total of 605,946 outpatient orthopaedic surgeries were performed in New York State according to the New York Statewide Planning and Research Cooperative System database. Of those, 56,772 patients were identified as Medicare beneficiaries and were therefore potentially eligible. A further 34% (19,037) were excluded because of missing surgeon identifier, age younger than 65 years, residency outside New York State, emergency department visit on the same day as outpatient surgery, observation stay on the same claim as outpatient surgery, and concomitant high-risk or eye procedures, leaving 37,735 patients for analysis. The database does not include a list of all state residents and thus does not allow for censoring of patients who move out of state. We chose this dataset because it includes nearly all hospitals and ambulatory surgery centers in a large geographic area (New York State) and hence is not limited by sampling bias. We included 37,735 outpatient orthopaedic surgical encounters among Medicare beneficiaries in New York State from 2018 to 2019. For the 37,735 outpatient orthopaedic surgical procedures included in our study, the mean ± standard deviation age of patients was 73 ± 7 years, 84% (31,550) were White, and 59% (22,071) were women. Our key independent variable was the MIPS quality score percentile (0 to 19th, 20th to 39th, 40th to 59th, or 60th to 100th) for orthopaedic surgeons. Clinicians in the MIPS program may receive a bonus or penalty based on the overall MIPS score, which ranges from 0 to 100 and is a weighted score based on four subscores: quality, promoting interoperability, improvement activities, and cost. The MIPS quality score, which attempts to reward clinicians providing superior quality of care, accounted for 50% and 45% of the overall MIPS score in 2018 and 2019, respectively. Our main outcome measures were 7-day, 30-day, and 90-day unplanned hospital visits after outpatient orthopaedic surgery. To determine the association between MIPS quality scores and unplanned hospital visits, we estimated multivariable hierarchical logistic regression models controlling for MIPS quality scores; patient-level (age, race and ethnicity, gender, and comorbidities), facility-level (such as bed size and teaching status), surgery and surgeon-level (such as surgical procedure and surgeon volume) covariates; and facility-level random effects. We then used these models to estimate the adjusted rates of unplanned hospital visits across MIPS quality score percentiles after adjusting for covariates in the multivariable models. RESULTS: In total, 2% (606 of 37,735), 2% (783 of 37,735), and 3% (1013 of 37,735) of encounters had an unplanned hospital visit within 7, 30, or 90 days of outpatient orthopaedic surgery, respectively. Most hospital visits within 7 days (95% [576 of 606]), 30 days (94% [733 of 783]), or 90 days (91% [924 of 1013]) were because of emergency department visits. We found very small differences in unplanned hospital visits by MIPS quality scores, with the 20th to 39th percentile of MIPS quality scores having 0.71% points (95% CI -1.19% to -0.22%; p = 0.004), 0.68% points (95% CI -1.26% to -0.11%; p = 0.02), and 0.75% points (95% CI -1.42% to -0.08%; p = 0.03) lower than the 0 to 19th percentile at 7, 30, and 90 days, respectively. There was no difference in adjusted rates of unplanned hospital visits between patients undergoing surgery with a surgeon in the 0 to 19th, 40th to 59th, or 60th to 100th percentiles at 7, 30, or 90 days. CONCLUSION: We found that the rates of unplanned hospital visits after outpatient orthopaedic surgery among Medicare beneficiaries were low and primarily driven by emergency department visits. We additionally found only a small association between MIPS quality scores for individual physicians and the risk of an unplanned hospital visit after outpatient orthopaedic surgery. These findings suggest that policies aimed at reducing postoperative emergency department visits may be the best target to reduce overall postoperative unplanned hospital visits and that the MIPS program should be eliminated or modified to more strongly link reimbursement to risk-adjusted patient outcomes, thereby better aligning incentives among patients, surgeons, and the Centers for Medicare ad Medicaid Services. Future work could seek to evaluate the association between MIPS scores and other surgical outcomes and evaluate whether annual changes in MIPS score weighting are independently associated with clinician performance in the MIPS and regarding clinical outcomes. LEVEL OF EVIDENCE: Level III, therapeutic study.

The effect of a workplace wellness program on disability, function and pain in healthcare providers workers with low back pain-outcomes of 3040 academic health center employees.

PURPOSE: (1) Identification of musculoskeletal risk factors for healthcare providers suffering low back pain (LBP) and the creation of risk profiles for those individuals and (2) analyze the impact of a workplace wellness program on healthcare providers who suffer from low back pain. METHODS: A total of 3040 employees at an academic healthcare center underwent a computer-adaptive survey of health-related quality of life (HRQOL), biometric tests, and a disability and functional movement assessment as part of the workplace wellness program (WWP). Clinical interventions with a rehabilitation specialist were offered to employees identified as at risk for low back pain. Data collected were analyzed using descriptive methods and multivariable regressions to address the study objectives. RESULTS: Of the 3040 healthcare providers enrolled in this study, 77% identified with non-specific LBP with greater weakness, numbness, reduced flexibility, and physical activity. The major predictive risk factors for LBP were Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference score, PROMIS fatigue, previous work injury, flexibility, numbness, PROMIS social function, level of education, and BMI. Healthcare providers with LBP who completed the WWP improved in most dimensions of HRQOL and disability and functional outcomes. CONCLUSIONS: A high proportion of healthcare providers suffer from LBP as a result of the nature of their work. Disability and functional outcomes measurements and PROMIS results quantitatively assess healthcare providers with LBP. Organizations can develop injury mitigation programs to target employees at high risk of LBP using the risk factors we identify. Completion of the WWP was associated with improvements in disability, HRQOL and functional measures.

A workplace wellness program at an academic health center influences employee health, satisfaction, productivity and the rate of workplace injury.

PURPOSE: Workplace wellness (WP) programs are an employer strategy to improve employee health and satisfaction. Their impact on productivity and benefit expense remains unclear. This study examines the association of a voluntary WP at an academic health center with both employee metrics and employer costs. METHODS: We retrospectively reviewed prospectively collected data from January 2016 to April 2018 for employees who voluntarily underwent screening for a WP at an academic medical center. We used their demographic, social, work, and clinical data to address the central research question. The primary outcomes included wellness measures from the Patient-Reported Outcomes Measurement Information System (PROMIS), secondary wellness outcomes such as body mass index, job-related outcomes such as job satisfaction, and workers' compensation metrics such as the claim amount. The key independent variables were whether an observation was from before or after the WP. For workers' compensation metrics, additional key independent variables were intervention/control group, and an interaction between the before/after and intervention/control variables. We conducted univariate and bivariate/unadjusted analyses, and estimated multivariable linear, logistic, and gamma regression models that also controlled for confounders. RESULTS: The study included 370 employees. Participation in the program was associated with significant improvements in the PROMIS pain interference, fatigue and sleep quality domains. Hip circumference diminished, and functional movement outcomes were improved. Job satisfaction improved by 4.4 percentage points (95% Confidence Interval [CI]: 0.3-8.5, p = 0.04) and self-reported productivity by 14.5 percentage points (95% Confidence Interval [CI]: 9.5-19.5, p < 0.001). The likelihood of a new compensation claim during the 12-month follow-up period fell by 10.1% (95% Confidence Interval [CI]: - 15.5 to - 4.7, p < 0.001). However, the value of a new claim was unchanged. CONCLUSION: Employees who completed a WP at an academic medical center demonstrated improvements in several recognized patient-reported outcome measures, in job satisfaction and self-reported productivity, a decrease in hip circumference, an improvement in functional motion and a decreased rate of compensable injury.

Determining the Generalizability of the PROMIS Depression Domain's Floor Effect and Completion Time in Patients Undergoing Orthopaedic Surgery.

BACKGROUND: Depression is common and can decrease the likelihood that a patient undergoing an orthopaedic procedure will improve after that intervention. Research at a single institution using the Patient-reported Outcomes Measurement Information System (PROMIS) showed that the PROMIS Depression domain had a substantial floor effect (lowest depressive symptoms measurable) in patients with orthopaedic conditions, although the instrument is designed to follow a population-based normal distribution. Patients with the lowest scores (floor) completed the questionnaire more quickly than those who did not have the lowest scores, which suggests that patients may not want to report or discuss depressive symptoms with their orthopaedic surgeon. QUESTIONS/PURPOSES: (1) Do the scores of a large population of patients with orthopaedic conditions completing the PROMIS Physical Function (PF), Pain Interference (PI), and Depression questionnaires follow the normal population distribution used to calibrate the PROMIS instrument? (2) Do the scores of a large population of patients with foot and ankle, spine, upper extremity, multiple orthopaedic subspecialty, or other orthopaedic conditions completing the PROMIS Depression questionnaire follow the normal population distribution used to calibrate the PROMIS instrument? (3) Do all orthopaedic patients with the lowest possible score (floor effect) on the PROMIS Depression questionnaire answer questions more quickly than those who do not? METHODS: Between February 12, 2015 and July 19, 2018, a total of 513,042 patients with orthopaedic conditions at a single urban, tertiary academic medical center were asked to complete the PROMIS PF, PI, and Depression domains. The PROMIS PF, PI, and Depression questionnaires were administered at 433,939 patient encounters (85%), and 325,251 of 433,939 (75%) completed all three questionnaires and were included in our final sample. The remaining encounters were excluded from all analyses because of incomplete PROMIS data. Using this large sample size, we determined the distributions of the PROMIS PF, PI, and Depression domains for all patients with orthopaedic conditions by visual inspection. We calculated the percentage of patients with the lowest possible score on the PROMIS Depression domain ("floor group") for all patients with orthopaedic conditions, as well for patients presenting to orthopaedic subspecialists (foot and ankle, spine, upper extremity, multiple subspecialties, or other specialists). We compared patient and PROMIS characteristics between patients in the floor group and all others ("standard group") using a bivariate analysis, including the total time it took to complete the questionnaires and average time it took to answer each question. RESULTS: Of the three PROMIS domains analyzed, only the PROMIS PF demonstrated a normal distribution on visual inspection. PROMIS PI scores had a measurable ceiling effect (more pain symptoms) (15,520 of 325,251 patient encounters; 5%), while PROMIS Depression scores demonstrated a clear floor effect (65,226 of 325,251; 20%). When analyzed by subspecialty, there was a clear floor effect for the PROMIS Depression in the specialties of foot and ankle (6031 of 29,273 patient encounters; 21%), spine (7611 of 58,266; 13%), upper extremity (9851 of 42,864; 23%), multiple subspecialties (276 of 1662; 17%), and other (41, 454 of 193,185; 22%). Generally, those in the floor group spent less time per question on the PROMIS Depression questionnaire than did those in the standard group (5.3 seconds ± 2.6 seconds versus 8.1 seconds ± 4.6 seconds; mean difference, 2.8 seconds; p < 0.001). CONCLUSIONS: The substantial floor effect of the PROMIS Depression in the setting of hasty completion raises the question of whether such results truly indicate that these patients have minimal depression or whether they simply do not report their true mental health status in an orthopaedic setting. When such patients are seen in clinic, surgeons may benefit from using the PROMIS Depression as an educational opportunity to explain the importance of mental health in orthopaedic care and ensure the questionnaire is completed accurately. This study builds on previous work by suggesting these findings apply to other general and subspecialty orthopaedic patient populations at academic medical centers. Future work may seek to determine the best way of ensuring that the PROMIS Depression questionnaire is completed accurately in orthopaedic clinics. LEVEL OF EVIDENCE: Level II, diagnostic study.

Socioeconomic Status Correlates With Initial Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) Scores but Not the Likelihood of Spine Surgery.

Objective To explore how socioeconomic status and patient characteristics may be associated with initial self-reports of pain and determine if there was an increased association with undergoing spine surgery. Methods Patients at an academic center between 2015 and 2021 who completed the Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) questionnaire were included. Multivariable linear regression models were used to determine the association between insurance type and patient factors with initial reports of pain. Multivariable logistic regression models were used to determine the association between PI and the likelihood of surgery in two time periods, three and 12 months. Results The study included 9,587 patients. The mean PROMIS-PI scores were 61.93 (SD 7.82) and 63.74 (SD 6.93) in the cervical and lumbar cohorts, respectively. Medicaid and Workers' Compensation insurance patients reported higher pain scores compared to those with private insurance: Medicaid (cervical: 2.77, CI (1.76-3.79), p<0.001; lumbar (2.05, CI (1.52-2.59), p<0.001); Workers' Compensation (cervical: 2.12, CI (0.96-3.27), p<0.001; lumbar: 1.51, CI (0.79-2.23), p<0.001). Black patients reported higher pain compared to White patients (cervical: 1.50, CI (0.44-2.55), p=0.01; lumbar: 1.51, CI (0.94-2.08), p<0.001). Higher PROMIS-PI scores were associated with a higher likelihood of surgery. There was no increased association of likelihood of surgery in Black, Medicaid, or Workers' Compensation patients when controlling for pain severity. Conclusion Black patients and patients with Medicaid and Workers' compensation insurance were likely to report higher pain scores. Higher initial pain scores were associated with an increased likelihood of surgery. However, despite increased pain scores, Black patients and those with Medicaid and Workers' Compensation insurance did not have a higher likelihood of undergoing surgery.

Socioeconomic disadvantage is correlated with worse PROMIS outcomes following lumbar fusion.

BACKGROUND CONTEXT: Socioeconomic status (SES) has been associated with differential healthcare outcomes and may be proxied using the area-deprivation index (ADI). Few studies to date have investigated the role of ADI on patient-reported outcomes and clinically meaningful improvement following lumbar spine fusion surgery. PURPOSE: The purpose of this study is to investigate the role of SES on lumbar fusion outcomes using Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. STUDY DESIGN/SETTING: Retrospective review of a single institution cohort. PATIENT SAMPLE: About 205 patients who underwent elective one-to-three level posterior lumbar spine fusion. OUTCOME MEASURES: Change in PROMIS scores and achievement of minimum clinically important difference (MCID). METHODS: Patients 18 years or older undergoing elective one-to-three level lumbar spine fusion secondary to spinal degeneration from January 2015 to September 2021 with minimum one year follow-up were reviewed. ADI was calculated using patient-supplied addresses and patients were grouped into quartiles. Higher ADI values represent worse deprivation. Minimum clinically important difference (MCID) thresholds were calculated using distribution-based methods. Analysis of variance testing was used to assess differences within and between the quartile cohorts. Multivariable regression was used to identify features associated with the achievement of MCID. RESULTS: About 205 patients met inclusion and exclusion criteria. The average age of our cohort was 66±12 years. The average time to final follow-up was 23±8 months (range 12-36 months). No differences were observed between preoperative baseline scores amongst the four quartiles. All ADI cohorts showed significant improvement for pain interference (PI) at final follow-up (p<.05), with patients who had the lowest socioeconomic status having the lowest absolute improvement from preoperative baseline physical function (PF) and PI (p=.01). Only those patients who were in the lowest socioeconomic quartile failed to significantly improve for PF at final follow-up (p=.19). There was a significant negative correlation between socioeconomic level and the absolute proportion of patients reaching MCID for PI (p=.04) and PF (p=.03). However, while ADI was a significant predictor of achieving MCID for PI (p=.02), it was nonsignificant for achieving MCID for PF. CONCLUSIONS: Our study investigated the influence of ADI on postoperative PROMIS scores and identified a negative correlation between ADI quartile and the proportion of patients reaching MCID. Patients in the worse ADI quartile had lower chances of reaching clinically meaningful improvement in PI. Policies focused on alleviating geographical deprivation may augment clinical outcomes following lumbar surgery.

Clinical Improvement After Lumbar Fusion: Using PROMIS to Assess Recovery Kinetics.

STUDY DESIGN: Retrospective review of a single institution cohort. OBJECTIVE: The goal of this study is to identify features that predict delayed achievement of minimum clinically important difference (MCID) following elective lumbar spine fusion using Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. SUMMARY OF BACKGROUND DATA: Preoperative prediction of delayed recovery following lumbar spine fusion surgery is challenging. While many studies have examined factors impacting the achievement of MCID for patient-reported outcomes in similar cohorts, few studies have assessed predictors of early functional improvement. METHODS: We retrospectively reviewed patients undergoing elective one-level posterior lumbar fusion for degenerative pathology. Patients were subdivided into two groups based on achievement of MCID for each respective PROMIS domain either before six months ("early responders") or after six months ("late responders") following surgical intervention. Multivariable logistic regression analysis was used to determine features associated with odds of achieving distribution-based MCID before or after six months follow up. RESULTS: 147 patients were included. The average age was 64.3±13.0 years. At final follow-up, 57.1% of patients attained MCID for PI and 72.8% for PF. However, 42 patients (49.4%) reached MCID for PI by six months, compared to 44 patients (41.1%) for PF. Patients with severe symptoms had the highest probability of attaining MCID for PI (OR 10.3; P =0.001) and PF (OR 10.4; P =0.001) Preoperative PROMIS symptomology did not predict early achievement of MCID for PI or PF. Patients who received concomitant iliac crest autograft during their lumbar fusion had increased odds of achieving MCID for PI (OR 8.56; P =0.001) before six months. CONCLUSION: Our study demonstrated that the majority of patients achieved MCID following elective one-level lumbar spine fusion at long-term follow-up, although less than half achieved this clinical benchmark for each PROMIS metric by six months. We also found that preoperative impairment was not associated with when patients would achieve MCID. Further prospective investigations are warranted to characterize the trajectory of clinical improvement and identify the risk factors associated with poor outcomes more accurately.

Social Vulnerability Index Provides Greater Granularity Compared to the Area Deprivation Index When Assessing Outcomes Following Elective Lumbar Fusion.

STUDY DESIGN: Retrospective review of a single institution cohort. OBJECTIVE: To determine whether Area Deprivation Index (ADI) or Social Vulnerability Index (SVI) is more suitable for evaluating minimum clinically important difference (MCID) achievement following elective lumbar fusion as captured by the Patient Reported Outcomes Measurement Information System (PROMIS). SUMMARY OF BACKGROUND DATA: A total of 182 patients who underwent elective one- to two-level posterior lumbar fusion between January 2015 and September 2021. METHODS: ADI and SVI values were calculated from patient-supplied addresses. Patients were grouped into quartiles based on values; higher quartiles represented greater disadvantage. MCID thresholds for Pain Interference (PI) and Physical Function (PF) were determined via a distribution-based method. Multivariable logistic regression was performed to identify factors impacting MCID attainment. Univariate logistic regression was performed to determine which themes comprising SVI values affected MCID achievement. Statistical significance was set at P<0.05. RESULTS: Multivariate logistic regression demonstrated that ADI and SVI quartile assignment significantly impacted achievement of MCID for PI (P=0.04 and P=0.01 respectively) and PF (P=0.03 and P=0.02 respectively). Specifically, assignment to the third ADI and SVI quartiles were significant for PI (OR: 0.39 and 0.23 respectively), and PF (OR: 0.24 and 0.22 respectively). Race was not a significant predictor of MCID for either PI or PF. Univariate logistic regression demonstrated that among SVI themes, the socioeconomic status theme significantly affected achievement of MCID for PI (P=0.01), while the housing type and transportation theme significantly affected achievement of MCID for PF (P=0.01). CONCLUSION: ADI and SVI quartile assignment were predictors of MCID achievement. While ADI and SVI may both identify patients at risk for adverse outcomes following lumbar fusion, SVI offers greater granularity in terms of isolating themes of disadvantage impacting MCID achievement.

Depression State Correlates with Functional Recovery Following Elective Lumbar Spine Fusion.

OBJECTIVE: To determine how depression state impacts postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores and achievement of minimum clinically important difference (MCID) following lumbar fusion. Depression has been shown to negatively impact outcomes following numerous orthopedic surgeries. Situational and major clinical depression can differentially affect postoperative outcomes. METHODS: Adult patients undergoing elective 1-3 level lumbar fusion were reviewed. Patients with a formal diagnosis of major depression were classified as "clinically depressed" whereas patients with at least "mild" PROMIS Depression scores in the absence of formal depression diagnosis were deemed "situationally depressed." analysis of variance testing was used to assess differences within and between groups. Multivariate regression was used to identify features associated with the achievement of MCID. RESULTS: Two hundred patients were included. The average age was 65.9 ± 12.2 years. 75 patients (37.5%) were nondepressed, 66 patients (33.0%) were clinically depressed, and 59 patients (29.5%) were situationally depressed. Situationally depressed patients had worse preoperative physical function (PF) and pain interference (PI) scores and were more likely to have severe symptoms (P = 0.001, P = 0.001). All groups improved significantly from preoperative baseline scores. All groups met MCID PF at different rates, with highest proportion of situationally depressed reaching this metric (P = 0.03). Rates of achieving MCID PI were not significantly different between groups (P = 0.47). Situational depression was predictive of achieving MCID PF (P = 0.002) but not MCID PI. CONCLUSIONS: Our study investigated the relationship between depression and postoperative PROMIS scores and identified situationally depressed patients as having the worst preoperative impairment. Despite this, the situationally depressed cohort had the highest likelihood of achieving MCID PF, suggestive of a bidirectional relationship between lumbar degenerative disease and subclinical, situational depression. These findings may help guide preoperative counseling on expectations, and patient selection.

Conditional activation of ß-catenin signaling in mice leads to severe defects in intervertebral disc tissue.

OBJECTIVE: The incidence of low back pain is extremely high and is often linked to intervertebral disc (IVD) degeneration. The mechanism of this disease is currently unknown. This study was undertaken to investigate the role of ß-catenin signaling in IVD tissue function. METHODS: ß-catenin protein levels were measured by immunohistochemical analysis of disc samples obtained from patients with disc degeneration and from normal subjects. To generate ß-catenin conditional activation (cAct) mice, Col2a1-CreER(T2) -transgenic mice were bred with ß-catenin(fx(Ex3)/fx(Ex3)) mice. Changes in disc tissue morphology and function were examined by micro-computed tomography, histologic analysis, and real-time polymerase chain reaction assays. RESULTS: ß-catenin protein was up-regulated in disc tissue samples from patients with disc degeneration. To assess the effects of increased ß-catenin levels on disc tissue, we generated ß-catenin cAct mice. Overexpression of ß-catenin in disc cells led to extensive osteophyte formation in 3- and 6-month-old ß-catenin cAct mice, which were associated with significant changes in the cells and extracellular matrix of disc tissue and growth plate. Gene expression analysis demonstrated that activation of ß-catenin enhanced runt-related transcription factor 2-dependent Mmp13 and Adamts5 expression. Moreover, genetic ablation of Mmp13 or Adamts5 on the ß-catenin cAct background, or treatment of ß-catenin cAct mice with a specific matrix metalloproteinase 13 inhibitor, ameliorated the mutant phenotype. CONCLUSION: Our findings indicate that the ß-catenin signaling pathway plays a critical role in disc tissue function.

Racial/ethnic and income-based differences in the use of surgery for cervical and lumbar disorders in New York State: a retrospective analysis.

BACKGROUND CONTEXT: The extent to which use of spine surgeries for patients with cervical and lumbar disorders varies by their race/ethnicity and income is currently unknown. PURPOSE: To assess racial/ethnic and income-based differences in use of spine surgery in New York State (NYS) from 2016 to 2019. STUDY DESIGN: Retrospective observational analysis using 2016 to 2019 New York Statewide Planning and Research Cooperative System (SPARCS) data, direct standardization, and multivariable mixed-effects linear regression models. METHODS: A dataset of patients who underwent surgery for cervical and spinal disorders in NYS in the period 2016 to 2019 was used to determine county-level age- and sex-standardized annual cervical and lumbar surgery rates expressed as number of surgeries per 10,000 individuals. Further sub-analysis was performed with the key independent variables being the combination of individual-level race/ethnicity (non-Hispanic White, non-Hispanic Black, and Hispanic individuals) and income (low-/high-income residing in zip codes below/above state median income); and year. We estimated multivariable mixed-effects linear regression models which controlled county-level variables to determine the adjusted rates of spine surgeries for patients belonging to various race/ethnicity and income group combinations. RESULTS: The study included 29,650 and 42,498 patients in the cervical and lumbar cohorts, respectively. In 2019, the county-level mean cervical and lumbar surgery rates were 3.88 and 5.19 surgeries per 10,000 individuals, respectively. There was a five-fold rate variation across NYS. In 2019, the adjusted cervical rates were 4.59 (White low-income), 4.96 (White high-income), 7.20 (Black low-income), 3.01 (Black high-income), 4.37 (Hispanic low-income), and 1.17 (Hispanic high-income). The adjusted lumbar rates were 5.49 (White low-income), 6.31 (White high-income), 9.43 (Black low-income), 2.47 (Black high-income), 4.22 (Hispanic low-income), and 2.02 (Hispanic high-income). The rates for low-income Black or Hispanic patients were significantly higher than their high-income counterparts. Low-income Black patients had the highest rates. Over the study period, the gap/difference increased significantly between high-income Hispanic and White individuals by 2.19 (95% confidence interval [CI]: -4.27, -0.10, p=.04) for cervical surgery; and between low-income Black and White individuals by 2.82 (2.82, 95% CI: 0.59, 5.06, p=.01) for lumbar surgery. CONCLUSION: There are differences in the rates of spine surgery in New York State, among identifiable groups. Black individuals from poorer zip codes experience relatively higher spine surgery rates. Understanding the drivers of surgical rate variation is key to improving the equitable delivery of spine care. A better understanding of such rate variations could inform health policy.

Remodeling of cortical bone allografts mediated by adherent rAAV-RANKL and VEGF gene therapy.

Structural allograft healing is limited because of a lack of vascularization and remodeling. To study this we developed a mouse model that recapitulates the clinical aspects of live autograft and processed allograft healing. Gene expression analyses showed that there is a substantial decrease in the genes encoding RANKL and VEGF during allograft healing. Loss-of-function studies showed that both factors are required for autograft healing. To determine whether addition of these signals could stimulate allograft vascularization and remodeling, we developed a new approach in which rAAV can be freeze-dried onto the cortical surface without losing infectivity. We show that combination rAAV-RANKL- and rAAV-VEGF-coated allografts show marked remodeling and vascularization, which leads to a new bone collar around the graft. In conclusion, we find that RANKL and VEGF are necessary and sufficient for efficient autograft remodeling and can be transferred using rAAV to revitalize structural allografts.

Mismatch Between Pelvic Incidence and Lumbar Lordosis is the Key Sagittal Plane Determinant of Patient Outcome at Minimum 40 Years After Instrumented Fusion for Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Retrospective review. OBJECTIVE: Assess measures of spinal-pelvic balance in predicting functional outcome in patients who underwent posterior spinal fusion for adolescent idiopathic scoliosis (AIS) at minimum 40-year follow-up. SUMMARY OF BACKGROUND DATA: Back pain and long-term function are considered when choosing levels for surgery in AIS patients. Three hundred and fourteen patients underwent fusion for AIS between 1961 and 1977. One hundred and thirty-four patients were located for potential long-term follow-up. METHODS: With Institutional Review Board approval, medical records and public resources were used to locate patients. Patients completed health-related quality of life (HRQoL) instruments, and returned for assessment including full radiographs. Radiographs were analyzed for scoliosis measures, and recognized spinal-pelvic measures including the lumbar lordosis, sagittal vertical axis (SVA), pelvic incidence, and pelvic tilt (PT). Bivariate and multivariable analyses were performed to assess the association between spinal-pelvic measures and patient-reported outcomes. RESULTS: Thirty-five of 134 patients agreed to return for complete HRQoL and radiographic follow-up. There were no differences at baseline between those agreeing and declining participation. The cohort was 94% female, had an average age of 60.5 years, and average follow-up of 46 years. In bivariate analysis, pelvic incidence and lumbar lordosis difference (PI-LL) was the only spinal-pelvic parameter which statistically discriminated between patients doing well and not, as assessed by the Oswestry Disability Index and the Patient-reported Outcomes Measurement Information System (PROMIS) Pain Interference and Fatigue instruments. In multivariable analysis, (PI-LL > 9°) was associated with worse scores in PROMIS-Pain Interference, Physical Function, Depression, Fatigue, Social Function and the total Oswestry score. An SVA > 50 mm was associated with worse scores in the Scoliosis Research Society-7. CONCLUSION: In a cohort of 35 patients with average follow-up of 46 years after posterior spinal instrumentation with Harrington rods (PSIF) for AIS, spinal-pelvic mismatch as identified by (PI-LL > 9°) was associated with inferior HRQoL outcomes. Other spinal-pelvic measures (SVA and PT) were not reliably associated with inferior HRQoL.Level of Evidence: 4.

Long-Term Health-Related Quality of Life After Harrington Instrumentation and Fusion for Adolescent Idiopathic Scoliosis: A Minimum 40-Year Follow-up.

BACKGROUND: Despite its importance for clinical decisions, the long-term consequences of posterior spinal instrumentation and fusion (PSIF) for adolescent idiopathic scoliosis (AIS), particularly in the lower lumbar spine, remain unclear. This study evaluates the long-term health-related quality of life and the need for a further surgical procedure in patients treated with Harrington instrumentation from 1961 to 1977 according to the lowest instrumented vertebra (LIV) and in comparison with age-matched norms. METHODS: A search was performed to identify and contact the 314 identified patients with AIS treated with PSIF by Dr. L.A. Goldstein. The assessment included identified subsequent spine surgery, the Oswestry Disability Index (ODI), Scoliosis Research Society-7 (SRS-7), EuroQol-5 Dimensions (EQ-5D), and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29). The health-related quality of life was compared with U.S. norms and, within the cohort, was compared by patient factors, LIV, and subsequent spine surgery. RESULTS: In this study, 134 patients (42.7%) were identified; 24 (7.6%) had died, 81 (25.8%) consented to participate in the study, and 29 (9.2%) declined participation. The mean follow-up was 45.4 years (range, 40 to 56 years). There were 81 patients who completed the surveys, 77 patients who completed the SRS-7, 77 patients who completed the ODI, and 76 patients who completed the PROMIS-29 and EQ-5D. There were 12.8% of patients with LIV L3 or proximal and 36.4% with LIV L4 or distal who had an additional surgical procedure (odds ratio, 3.98). Comparing the ODI of patients who had undergone an additional surgical procedure with those who had not showed 42% and 73% minimal disability, 53% and 23% moderate disability, and 5% and 2% severe disability. Of the patients who had not undergone an additional surgical procedure, those with LIV L3 or proximal had mean scores of 14.12 points for the ODI and 23.3 points for the SRS-7 and those with LIV L4 or distal had mean scores of 17.9 points for the ODI and 22.7 points for the SRS-7; these differences were not significant. The mean PROMIS-29 and EQ-5D scores were not different from normal U.S. age-based means. CONCLUSIONS: Patients with AIS treated with PSIF at a mean 45-year follow-up and LIV L4 or distal had a higher rate of undergoing an additional surgical procedure than those with LIV L3 or proximal. Patients undergoing an additional surgical procedure had lower health-related quality of life than those who did not. Despite this, there was no difference in health-related quality of life for patients with LIV L4 or distal compared with patients with LIV L3 or proximal. This cohort of patients with AIS treated with PSIF demonstrates normal self-reported health-related quality of life compared with the age-matched general population. These long-term outcomes of PSIF for AIS are encouraging. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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

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

What patient factors and Patient-Reported Outcomes Measurement Information System domains are associated with worse pain coping in pediatric orthopaedic patients in the United States?

We sought to better understand the relationship between Patient-Reported Outcomes Measurement Information System (PROMIS) mobility, pain interference (PI) and depressive symptoms scores, as well as determine what patient factors and PROMIS domains were associated with worse pain coping (PROMIS PI), in a pediatric orthopaedic population. Between 27 August 2015 and 30 April 2019, new pediatric orthopaedic patients 18 years or younger (or their guardians as a proxy) were asked to complete PROMIS mobility, PI and depressive symptoms domains at an academic medical center pediatric orthopaedic clinic. Pearson correlation coefficients (r) were calculated between each PROMIS domain. Linear multivariate regression analysis was used to determine patient characteristics and PROMIS domains associated with presenting PROMIS PI scores. There was a strong-moderate correlation between PROMIS mobility and PI (r = -0.66, P < 0.001), while the correlation between PROMIS mobility and depressive symptoms was moderate-poor (r = -0.38, P < 0.001). There was a moderate correlation between PROMIS depressive symptoms and PI (r = 0.54, P < 0.001). In multivariate linear regression analysis, female gender (ß = 0.82, P < 0.001), self-reported black race (ß = 0.94, P < 0.001), Medicaid insurance (ß = 0.82, P < 0.001) and worsening depressive symptoms (ß = 0.33, P < 0.001) were associated with worse pain coping mechanisms, while increasing mobility (ß = -0.47, P < 0.001) was associated with better pain coping mechanisms. Poor mobility and worse depressive symptoms are associated with worse pain coping mechanisms. Additionally, Medicaid insurance status, black race and female gender are also associated with worse physical limitations secondary to pain.

Significant Variation in Blood Transfusion Practice Persists Following Adolescent Idiopathic Scoliosis Surgery.

STUDY DESIGN: Retrospective case control study. OBJECTIVE: To review current transfusion practise following Adolescent Idiopathic Scoliosis (AIS) surgery and assess risks of complication from transfusion in this cohort. SUMMARY OF BACKGROUND DATA: No study to date has investigated variation in blood transfusion practices across surgeons and hospitals following AIS surgery. METHODS: Data were extracted from the Statewide Planning and Research Cooperative System. Using International Classification of Diseases (ICD-9) all patients with (ICD-9) code for AIS (737.30) ("idiopathic scoliosis") and underwent spinal fusion between 2000 and 2015 were included. Bivariate and mixed-effects logistic regression analyses were performed to assess patient, surgeon, and hospital factors associated with perioperative allogeneic red blood cell transfusion. Additional multivariable analyses examined the association between transfusion and infectious complications. RESULTS: Of the 7689 patients who underwent AIS surgery, 21.1% received a perioperative blood transfusion. After controlling for patient factors, wide variation in risk-adjusted transfusion rates was present with a 10-fold difference in transfusion rates observed across surgeons (4.4%-46.1%) and hospitals (5.1%-50%). Patient factors did not explain any of the surgeon or hospital variation. Use of autologous blood transfusion, higher surgeon procedure volume, and greater surgeon years in practice were independently associated with lower odds of allogeneic blood transfusion (P < 0.001), and surgeon and hospital characteristics explained 45% of surgeon variation but only 2.4% of hospital variation. Allogeneic blood transfusion was independently associated with postoperative wound infection (OR = 1.87, 95% CI = 1.20-2.93), pneumonia (OR = 1.68, 95% CI = 1.26-2.44), and sepsis (OR = 2.42, 95% CI = 1.11-5.83). CONCLUSION: Significant variation exists across both surgeons and hospitals in perioperative blood transfusion utilization following AIS surgery. Use of autologous blood transfusion and implementing institutional transfusion protocols may reduce unwarranted variation and potentially decrease infectious complication rates.Level of Evidence: 3.

Teriparatide may accelerate healing in delayed unions of type III odontoid fractures: a report of 3 cases.

STUDY DESIGN: Case Report. OBJECTIVE: To report on the treatment of 3 cases of painful delayed unions of type III odontoid fractures with teriparatide. SUMMARY OF BACKGROUND DATA: Fractures of the C2 vertebra, also known as odontoid fractures, are an important subset of cervical spine fractures. Type III odontoid fractures pass through predominately cancellous bone of C2. Generally accepted treatment is external immobilization with either a rigid collar or a halo vest for 8 to 12 weeks. We report 3 patients who, despite external immobilization, developed painful delayed unions of type III odontoid fractures. Teriparatide is a novel anabolic drug therapy for osteoporosis. It has been shown to stimulate osteoblasts, enhance bone connectivity, increase endosteal cortical thickness, and improve bone mineral content. The drug is given through subcutaneous injection of 20 microg/d for between 6 weeks and 2 years. We treated these 3 patients with teriparatide. Each was informed that details of their case would be submitted for publication. METHODS: Retrospective case analysis. RESULTS: All 3 patients experienced both rapid clinical improvement and computed tomography evidence of fracture union. CONCLUSION: These 3 cases represent relatively uncommon clinical scenarios in which type III odontoid fractures in osteoporotic women failed to unite with external immobilization over several months. The patients presented for follow-up with substantial, activity-limiting neck pain. All 3 were begun on teriparatide doses therapeutic for osteoporosis, and all 3 experienced both remarkable resolution of chronic neck pain and computed tomography-confirmed union of the fractures.

Dropped Head Syndrome: An Update on Etiology and Surgical Management.

¼ Dropped head syndrome is a group of disorders with diverse etiologies involving different anatomical components of the neck, ultimately resulting in a debilitating, flexible, anterior curvature of the cervical spine. ¼ Causes of dropped head syndrome include myasthenia gravis, amyotrophic lateral sclerosis, Parkinson disease, radiation therapy, and cumulative age-related changes. Idiopathic cases have also been reported. ¼ Nonoperative treatment of dropped head syndrome includes orthotic bracing and physical therapy. ¼ Surgical treatment of dropped head syndrome consists of cervical spine fusion to correct the deformity. ¼ The limited data available examining the clinical and radiographic outcomes of surgical intervention indicate a higher rate of complications with the majority having favorable outcomes in the long term.

Trends and Characteristics of Spine Research From 2006 to 2015: A Review of Spine Articles in a High Impact General Orthopedic Journal.

STUDY DESIGN: Literature review. OBJECTIVE: To determine characteristics and trends in published spine research over a recent decade in a high impact, general orthopedic surgery journal. SUMMARY OF BACKGROUND DATA: Recent trends in published spine research in a high-impact orthopedic surgery journal are unknown. Such knowledge could guide future research in the field. METHODS: A comprehensive literature review of clinical and basic science spine articles published in The Journal of Bone & Joint Surgery from 2006 to 2015 was conducted. Articles were assessed for: title, year of publication, authorship, academic degrees of the authors, number of citations, institution of origin, and spine topic. Clinical articles were evaluated for: sex and race/ethnicity of the human subjects, level of evidence, and inclusion of patient-reported outcome measures (PROMs). Basic science articles were evaluated for: type of study (animal, cadaver, cell-based), sex of the animals, cadavers or cells studied (male, female, or male and female), and presence of sex-based reporting (defined as reporting of results by sex). RESULTS: A total of 203 spine articles were evaluated from the 10-year study period. At least 35 validated or nonvalidated patient-reported outcome measures were utilized in clinical spine research. The most commonly reported PROMs were the Oswestry Disability Index (24.4%), Short Form-36 Health Survey (23.7%), and Visual Analog Scale for Pain (19.3%). The average level of evidence improved from 3.25 in 2006 to 2.60 in 2015. Only 13.2% of clinical spine articles reported the race/ethnicity of the subjects. CONCLUSION: A consensus regarding validated PROMs in spine research would be valuable. From 2006 to 2015, the level of evidence of spine articles in The Journal of Bone & Joint Surgery improved. Accurate and complete reporting of patient demographics is an area for improvement in spine research in light of studies demonstrating sex and race/ethnicity-related differences in clinical outcome after spine surgery. LEVEL OF EVIDENCE: 5.