SF-36 Physical Component Score Research Articles

P213 High baseline serum IL-6 predicts increased sarilumab treatment response for patient reported symptoms and health-related quality of life among RA patients with inadequate response to MTX

Abstract Background IL-6, a key cytokine in rheumatoid arthritis (RA) pathogenesis, is elevated in patient serum and synovial fluid. However, the impact of baseline IL-6 levels on patient-reported RA symptoms and health-related quality of life (HRQoL) following IL-6 blockade has not been explored. Sarilumab targets IL-6 receptor alpha, and sarilumab+methotrexate (MTX) significantly improved clinical and patient-reported outcomes vs MTX alone among MTX inadequate responders (IR) in MOBILITY/NCT01061736. This post-hoc analysis evaluated whether baseline IL-6 levels predict greater improvements in symptoms and HRQoL with sarilumab+MTX vs MTX. Methods 1,193 patients with moderate-to-severely active RA received MTX or MTX plus subcutaneous sarilumab at 200 mg (recommended dose) or 150 mg (recommended for management of laboratory abnormalities) every 2 weeks (q2w) and were grouped into tertiles according to baseline IL-6 levels. Patient-reported RA symptoms and HRQoL were measured at baseline and post-treatment (Weeks [W] 24 and 52). Results Baseline IL-6 tertiles among 1193 patients were 1.6-9.6 (low), 9.8-30.7 (medium), and 31.2-648.7 pg/mL (high). At baseline, patients with high IL-6 had greater disease activity, more radiographic structural damage, elevated CRP levels, and worse HRQoL (pain visual analog scale [VAS], SF36-physical component scores [PCS], and sleep VAS) vs those with low IL-6 (nominal p < 0.05) and generally reported greater improvements in symptoms and HRQoL with sarilumab+MTX vs placebo+MTX. Significant differences (nominal p < 0.005) between high and low tertiles were evident in improvement of pain VAS (W52) and SF-36 PCS (W24/W52) with sarilumab 200 mg q2w vs placebo, SF-36 mental component scores (both doses; W52) and FACIT-fatigue scores (both doses; W24/W52) vs placebo. Treatment-emergent adverse events were similar across IL-6 tertiles. Conclusion Among MTX-IR RA patients, high baseline IL-6 may predict better improvements in symptoms and HRQoL with sarilumab vs placebo, which was consistent with previous analyses across clinical/radiographic endpoints in the same study population. Disclosures V. Strand: Consultancies; AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celltrion, CORRONA, Crescendo, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi and U. J. Msihid: Corporate appointments; Employee of Sanofi. Shareholder/stock ownership; Sanofi. T. Kimura: Corporate appointments; Employee of Regeneron Pharmacueticals Inc. Shareholder/stock ownership; Regeneron Pharmacueticals Inc. A. Boyapati: Corporate appointments; Employee of Regeneron Pharmacueticals Inc. Shareholder/stock ownership; Regeneron Pharmacueticals Inc. G. St John: Corporate appointments; Employee of Regeneron Pharmacueticals Inc. Shareholder/stock ownership; Regeneron Pharmacueticals Inc. W. Wei: Corporate appointments; Employee of Regeneron Pharmacueticals Inc. Shareholder/stock ownership; Regeneron Pharmacueticals Inc.

Health-Related Quality of Life in Motorcycle Crash Victims One Year After Injury: A Longitudinal Study in Ho Chi Minh City, Vietnam.

Despite the burden of injury associated with motorcycle crashes and injuries in Vietnam, there are no studies investigating health-related quality of life (HRQoL) following a nonfatal motorcycle crash in this country. Therefore, this study aimed to evaluate the change of HRQoL preinjury, and at 6 and 12 months postinjury motorcycle crash in Ho Chi Minh City, Vietnam. Outcome measures were Physical Component Scores (PCS) and Mental Component Scores (MCS) of the Short Form 12 Health Survey (SF-12) version 2 and the EQ-5D. Multilevel mixed models were undertaken. A total of 352 hospitalized motorcyclists were followed-up. Compared with preinjury, the SF-12 PCS reduced by 6.61 points (95% confidence interval [CI] = -8.21 to -5.03) and 5.12 points (95% CI = -6.74 to -3.51) at 12 months postinjury. MCS also reduced by 4.23 points (95% CI = -5.99 to -2.47) at 6 months but increased by 1.29 points (95% CI = -0.49 to 3.08) at 12 months postinjury. The EQ-5D Visual Analogue Scale score decreased by 10.41 points (95% CI = -11.49 to -9.33) at 6 months and 6.48 points (95% CI = -7.58 to -5.38) at 12 months postinjury. The HRQoL among injured motorcycle riders improved between 6 and 12 months after injury but had not returned to the levels before injury.

Gender differences in health-related quality of life in people with severe mental illness.

The purpose was to analyze socioeconomic and clinical factors of psychosocial functioning and self-perception in relation to health-related quality of life (HRQOL) in people with severe mental health illness (SMI) by gender. A cross-sectional study was conducted on a sample of 133 women and 90 men. Recorded variables: HRQOL, SF-36 Physical Component Scores (PCS) and Mental Component Scores (MCS); sociodemographic and clinical data on psychosocial and self-perception functioning. Correlational studies using raw and adjusted linear regression models to evaluate the factors associated with HRQOL by obtaining coefficients, p-values and respective confidence intervals. The mean PCS for women and men was 44.6 and 49.0 (p = 0.004) and 36.4 and 37.5 (p = 0.575), respectively for MCS. The factors associated with PCS in women were age, -0.2(-0.4:0); in work, 4.2(0.3:8.2); with an income higher than 700 euros/month, 4.4(1:7.7). In men, these factors were education level, 6.1(0.4:11.7); belief that they would not need help in the future, 4.6(0.1:9.2) and a higher need for psychosocial services, -6.6(-11.1:-2). Factors associated with MCS in women were, in work, 6.1(1.5:10.7); and having a high number of friends, 6.6(2.1:11.1). In men, these factors were, living alone, -7.1(-12.7:-1.4); lack of economic benefits, 8.5(3.2:13.8); and a higher need for psychosocial and social services, -3.6(-7.1:-0.2) and -7.7(-13.4:-2). The dimensions affected and the factors that are associated with HRQOL for people with SMI differ by gender. Therefore, these differences should to be taken into account when designing interventions for improving HRQOL.

Lack of early dislocation for dual mobility vs. fixed bearing total hip arthroplasty: A multi-center analysis of comparable cohorts

BackgroundDislocation is a major cause of morbidity and revision surgery following total hip arthroplasty (THA). To address such issues, dual mobility (DM) bearings were introduced as a more stable alternative to fixed-bearing (FB) prostheses. As such, we compared DM and FB systems in a cohort study in terms of dislocations, readmissions, and revisions. MethodsA 27 multi-center retrospective review was performed of 664 DM and 218 FB cases from the same manufacturer with mean follow-up of 2.09 years and 1.83 years, respectively. Patient reported outcome measures (PROMs) including Harris Hip Score (HHS), SF12, EQ5D, and Lower Extremity Activity Score (LEAS) were evaluated as well as dislocation rates, readmissions, and revisions rates. We also performed a survivorship analysis through Kaplan-Meier estimator. Students t-test was used for normally distributed continuous data and Fisher exact test (P < 0.05) was used for discrete data. ResultsThere were 0 dislocations in the DM (0%) group and 2 dislocations in the FB (0.92%) group (p = 0.06). Latest follow up HHS revealed a significant difference between groups (91.44 DM and 87.81 FB; p = 0.006). In addition, there was significant difference between DM and FB on SF12 Physical Component Score (PCS) (46.83 and 44.55, respectively, p = 0.015). Also, readmission rates at 30, 60 and 90 days remained lower for DM than for FB at each time point (1.05% vs. 2.75%, 1.81% vs. 2.75%, and 1.81% vs. 2.75, respectively). Overall, DM had a lower revision rate at 1.51% compared to 2.29% for FB (p = 0.24). The revision breakdown for DM revealed 0 (0%) for both Anatomic Dual Mobility (ADM) and Modular Dual Mobility (MDM) due to the acetabular component.) There was a difference, 14 (87.5%) for ADM and 2 (12.5%) due to the femoral component. The survivorship analysis revealed no significance difference between DM and FB at 4 years (97.90% and 97.26%, respectively). ConclusionIn comparison to patients who undergo FB THA, DM bearings have improved PROMs and a lower rate of dislocation, readmission, and revision.

Is the Neck Disability Index an Appropriate Measure for Changes in Physical Function After Surgery for Cervical Spondylotic Myelopathy?

The Neck Disability Index (NDI) is a 10-item questionnaire about symptoms relevant to cervical spine pathology, originally validated in the physical therapy literature. It is unclear if all of the items apply to spine surgery. The purpose of this study was to determine if improvements in the composite NDI score or specific NDI domains are appropriate measures for tracking changes in physical function after surgical intervention for cervical spondylotic myelopathy (CSM). A retrospective cohort review of patients treated at a major academic medical center was undertaken. Baseline and postoperative standardized outcome measurement scores, including composite NDI, NDI subdomain, and SF-12 physical component score (PCS), were collected. Wilcoxon signed-rank test was used to determine whether patients exhibited improvement in each of the outcome measures included. Multiple linear regression was performed to determine whether change in NDI composite or subdomain scores predicted change in physical function after surgery for CSM-compared with the well-validated PCS score-controlling for factors such as age, sex, etc. Baseline data were collected on 118 patients. All outcome measures exhibited significant improvement after surgery based on the Wilcoxon signed-rank test. On linear regression, work (β = -2.419 [-3.831, -1.006]; P = .001) and recreation (β = -1.354 [-2.640, -0.068]; P = .039), as well as the NDI composite score (β = -0.223 [-0.319, -0.127]; P < .001), were significant predictors of change in physical function over time. Although the NDI composite score did predict change in PCS over time, only 2 of the 10 NDI subdomains were found to be associated with change in physical function over time. Based on these results, the item bank and composite scoring of the NDI are inappropriate for evaluating quality of life in studies of surgically treated cervical spondylotic myelopathy patients. NDI may not be a valid tool in the determination of physical function changes after surgery for CSM. III.

Usefulness of a Nurse-Led Program of Care for Management of Patients with Chronic Heart Failure.

BackgroundThe aims of the present study were to determine whether a nurse-led program of care can improve medication adherence, quality of life (QoL), rates of rehospitalization, and all-cause mortality for chronic heart failure (CHF) patients.Material/MethodsCHF patients were randomly assigned into either a control group or an intervention group. At 12 weeks, patients were followed up to evaluate the rate of medication adherence, QoL (as assessed by SF-12 physical and mental component score [PCS and MCS]), rehospitalization, and all-cause mortality.ResultsWe recruited 152 patients. No significant differences in demographics, comorbidities, CHF severity, or etiology at baseline were observed. At discharge, no significant differences in medications prescription, PCS (46 vs. 45), or MCS (55 vs. 56) were observed. However, at 12-week follow-up, compared to the control group, patients in the intervention group were more likely to keep on medications therapy, with a significantly higher use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker [73.8% vs. 59.7%], beta-blocker (62.5% vs. 51.4%), and aldosterone receptor antagonist (60% vs. 54.2%). Both PCS (35 vs. 40) and MCS (42 vs. 49) were also significantly lower in the control group versus the intervention groups (P<0.05). Patients in the control group had higher incident rate of rehospitalization (8.0% vs. 5.2% per person-week) than in the intervention group, with an incident rate ratio of 1.54 (95% confidence interval [CI]: 1.06–2.23).ConclusionsA nurse-led discharge program of care can be a cost-effective and feasible approach for management of CHF patients in China.

The Relationship Between Pain Level and Sleep Quality, Quality of Life and Psychological Status in Patients with Chronic Neck Pain

Objectives: Chronic neck pain is one of the most common musculoskeletal diseases. This pain may negatively affect the quality of sleep, quality of life, and psychological status of individuals. This study aimed to investigate the relationship between pain level and quality of life, quality of sleep, and psychological status in patients with chronic neck pain. Materials And Methods: Seventy-three female n=56 and male n=17 patients mean age 47.04±13.54 years with chronic neck pain were included in the study. Pain severity was evaluated by McGill Melzack Pain Questionnaire MMPQ , quality of sleep was evaluated by Pittsburgh Sleep Quality Index PSQI , quality of life was evaluated by Short Form-36 SF-36 , depression level was evaluated by Beck Depression Inventory BDI , and anxiety level was evaluated by Beck Anxiety Inventory BAI . Results: The pain level score of the patients was found 32.12±16.86; sleep quality score was severe 7.24±3.11 ; SF-36 physical function component score was low 71.23±20.52 ; SF-36 pain component score was low 57.32±17.30 ; depression and anxiety level scores were mild 10.50±7.73, 15.00±10.14, respectively . There was a negative correlation between the level of pain of patients and sleep quality and a positive correlation between the level of pain of patients and SF-36 pain component score and anxiety level. Conclusion: . It is thought that sleep quality, quality of life, and anxiety management should be taken into consideration during the rehabilitation of patients with chronic neck pain.

Cross-cultural adaptation and validation of an Arabic version of the American Orthopedics Foot and Ankle Score (AOFAS)

BackgroundThe evaluation process is essential to optimize the management of patients with foot and ankle pathologies and disorders. This study aimed to translate and culturally adapt the four scoring systems of the American Orthopedics Foot and ankle Score (AOFAS) into Arabic and explore its psychometric properties. MethodsA multicenter observational design was used, following the forward-backward translation method. One hundred and twenty patients with foot and ankle problems were included. Construct validity and test-retest reliability were analyzed using Intra-class correlation coefficients; internal consistency was analyzed with Cronbach’s alpha, and the responsiveness was analyzed using a paired-sample test. ResultsThe validity ranged from 0.303 to 0.542 and from 0.018 to 0.753 when correlated to the SF-12 physical and mental component scores, respectively. Test-retest reliability ranged from 0.727 to 0.974; from 0.826 to 0.983 for internal consistency and from 0.001 to 0.182 for sensitivity. ConclusionThe AOFAS’s four systems were successfully translated and culturally adapted into Arabic with sufficient psychometric properties. Level of clinical evidence: II.

Predicting completion of follow-up in prospective orthopaedic trauma research.

Objective:Orthopaedic trauma studies that collect long-term outcomes are expensive and maintaining high rates of follow-up can be challenging. Knowing what factors influence completion of follow-up could allow interventions to improve this. We aimed to assess which factors influence completion of follow-up in the 12 months following surgery in prospective orthopaedic trauma research.Design:Prospective Cohort Study.Setting:Level 1 Trauma Center, Vancouver, Canada.Participants:Eight hundred seventy patients recruited to 4 prospective studies investigating the outcomes of operatively treated lower extremity fractures.Main outcome measurements:Completion of follow-up defined as completion of all outcome measures at all time points up to 12 months following injury.Results:Univariate analysis and subsequent analysis by building a reductive multivariate regression model allowed for estimation of the influence of factors in completion of follow-up.Eight hundred seventy patients with complete data had previously been recruited and were included in the analysis. Seven hundred seven patients (81.2%) completed follow-up to 12 months. Factors associated with completion of follow up included higher physical component score of SF-36 at baseline, not being on social assistance at the time of injury, being married and having a higher level of educational attainment.Conclusions:Our study has demonstrated several important factors identifiable at baseline which are associated with a failure to complete follow-up. Although these factors are not modifiable themselves, we advocate that researchers designing studies should plan for additional follow-up resources and interventions for at risk patients.Level of Evidence:Level IV

Comparison of functional and patient-reported outcomes between direct anterior and lateral surgical approach one-year after total hip arthroplasty in a Canadian population: A cross-sectional study

BackgroundFrom a clinical perspective, it is important to understand the outcomes that occur after total hip arthroplasty (THA) and do these vary with surgical approach. The objective of the study was to compare physical performance-based and patient-report outcomes between the Direct Anterior (DA) and Direct Lateral (DL) surgical approach at one-year after THA surgery. MethodsWe evaluated patients attending their one-year follow-up assessment after primary elective unilateral THA surgery for osteoarthritis of the hip. The Activities-specific Balance Confidence Scale, Falls Risk in Older People in a Community Setting, Timed Up and Go Test, 30-Second Chair Stand Test, Step Test, 6-Meter Walk Test, Harris Hip Score (HHS), Short-form 12 and the Western Ontario and McMaster Osteoarthritis Index (WOMAC) were assessed. The standardized mean difference (SMD) and 95% confidence intervals (CI) was calculated to evaluate the statistical difference between groups and the magnitude of the effects. ResultsIn total, 135 individuals met the inclusion criteria and participated in the study. A statistically significant and clinically important difference in favor of the DA was found for the WOMAC (0.60, 95% CI (0.25, 0.95), p = .004), SF-12 Physical component (0.42, 95% CI (0.07, 0.76), p = .01) and 6-Meter Walk Test (0.52, 95% CI (−0.86, −0.17), p = .009). Small effect sizes, though not statistically significant differences, were found in favor of the DA approach for the other patient-report and physical performance-based measures. ConclusionThe WOMAC, gait speed and SF-12 Physical component scores were significantly different in favor of the DA procedure at one-year after THA. However, only the WOMAC scores exceeded a clinically important threshold in favor of DA approach. The other self-report and physical performance measures were not significantly different between the two procedures at one-year postoperatively.

LIFESTYLE PHYSICAL ACTIVITY IN OLDER WOMEN: ASSOCIATIONS OF CHANGE, SELF-EFFICACY, AND WELL-BEING

Reduction of cardiovascular disease risk in undeserved populations, such as older women, is a top priority of the U.S. Our innovative trial tested a new approach to PA promotion for older women—motivational interviewing (MI), shifting the paradigm from structured exercise to self-selected activities. We present data comparing stage of change (SOC), self-efficacy for exercise (SEE), and well-being: 8 dimensions (physical, social, role limitations, emotional, general mental health, vitality, health perceptions and pain) and associations with physical activity outcomes in the Lifestyle Physical Activity for Women (LPAW) clinical trial. Methods: 106 women, > 60 years old, who did not engage in regular PA, and were not frail, participated in a clinical trial of a tailored MI intervention to increase PA. We report baseline, 3 and 6 month repeated measures and PA associations with SOC, SEE, and well-being (SF36). Results: Of 106 women, 36% were Black and 63% White, with a mean age of 69. Significant improvement in SOC in both arms noted but the proportion in action/maintenance was significantly higher in the PA arm at 3 mos (78% vs. 55%, P=0.045) and 6 mos (79% vs. 50%, P= 0.019). A decrease in SEE for control (p=.001), but not for PA arm (p=.45); at 6 months, The PA arm had greater SEE compared to control. There were significant arm difference for physical component scores of SF36 (p=.02), but not for mental scores. Associations with PA will be tabulated. Conclusions: Preliminary results support the PA intervention, more data to be presented.

Comparison of the Association between Circulating Vitamin D3 Levels and Clinical Outcomes in Patients with Asthma and Chronic Obstructive Pulmonary Disease: A Prospective Observational Study.

Vitamin D has an immune-modulating effect, related to the pathophysiology of asthma and chronic obstructive pulmonary disease (COPD). However, few studies have focused on the difference between patients with asthma and COPD in the association of circulating vitamin D levels with clinical outcomes. We sought to investigate the associations of circulating vitamin D levels with health-related QOL (HR-QOL), severity, and exacerbations. Subjects included 152 asthma patients and 50 COPD patients. We measured plasma concentrations of 25-hydroxyvitamin D3 [25(OH)D3]. HR-QOL was assessed using the EuroQoL 5-Dimension (EQ-5D) and the 12-item Short Form Health Survey (SF-12) scales. Exacerbations were recorded during a one-year follow-up. Associations between plasma 25 (OH)D3 concentrations and outcome variables were evaluated using linear regression. Plasma concentrations of 25(OH)D3 were positively associated with the EQ-5D index value and the SF-12 physical component score in patients with asthma; however, such associations were not observed in patients with COPD. A significant association between severity and plasma concentrations of 25(OH)D3 was found only in patients with COPD. The hazard ratios (95% confidence interval) of plasma 25(OH)D3 concentrations (per 1 ng/mL decrease) for time to first exacerbation was 1.38 (1.10-1.75; p = 0.006) and 0.95 (0.87-1.03; p = 0.179) in patients with COPD and asthma, respectively. Lower concentrations of plasma 25(OH)D3 contributed to lower HR-QOL in patients with asthma, and were associated with severity and risk of future exacerbations in patients with COPD.

Should Sagittal Spinal Alignment Targets for Adult Spinal Deformity Correction Depend on Pelvic Incidence and Age?

Retrospective analysis. Determine whether deformity corrections should vary by pelvic incidence (PI). Alignment targets for deformity correction have been reported for various radiographic parameters. The T1 pelvic-angle (TPA) has gained in applications for adult spinal deformity (ASD) surgical-planning since it directly measures spinal alignment separate from pelvic- and lower-extremity compensation. Recent studies have demonstrated that ASD corrections should be age specific. A prospective database of consecutive ASD patients was analyzed in conjunction with a normative spine database. Clinical measures of disability included the Oswestry Disability Index (ODI) and Short Form 36 Survey (SF-36) Physical Component Score (PCS). Baseline relationships between TPA, age, PI, and ODI/SF-36 PCS scores were analyzed in the ASD and asymptomatic patients. Linear regression modeling was used to determine alignment targets based on PI and age-specific normative SF-36-PCS values. Nine hundred three ASD patients (mean 53.7 yr) and 111 normative subjects (mean 50.7 yr) were included. Patients were subanalyzed by PI: low, medium, high (<40, 40-75, >75); and age: elderly (>65 yr, n = 375), middle age (45-65 yr, n = 387), and young (18-45 yr, n = 141). TPA and SRS-Schwab parameters correlated with age and PI in ASD and normative subjects (r = 0.42, P < 0.0001). ODI correlated with PCS (r = 0.71, P < 0.0001). Linear regression analysis using age-normative SF-36-PCS values demonstrated that ideal spinopelvic alignment is less strict with increasing PI and age. Targets for ASD correction should vary by age and PI. This is demonstrated in both asymptomatic and ASD subjects. Using age-normative SF-36 PCS values, alignment targets are described for different age and PI categories. High-PI patients do not require as rigorous realignments to attain age-specific normative levels of health status. As such, sagittal spinal alignment targets increase with increasing age as well as PI. 3.

Self-reported Physical Function Decline and Mortality in Older Adults Receiving Hemodialysis

Rationale & ObjectiveTimely recognition of functional decline in older adults receiving dialysis will allow clinicians to pursue interventions to prevent further disability and/or lead patient-centered goals of care discussions. Annual change in the 12-Item Short Form Health Survey (SF-12) physical component score (PCS) could identify patients with functional decline. Our objectives were to assess SF-12 PCS change over a year, risk factors associated with SF-12 PCS change, and the association of SF-12 PCS change with mortality in a survivor cohort of older adults receiving dialysis.Study DesignRetrospective study.Setting & Participants1,371 adults 65 years or older receiving hemodialysis for 6 or more months who completed SF-12 PCSs 300 or more days apart from 2012 to 2013.ExposuresSerum albumin level; hemodialysis access type; SF-12 PCS change (for mortality analyses).OutcomesSF-12 PCS change and mortality.Analytical ApproachMultivariable-adjusted linear regression model; Cox proportional hazards model.ResultsWe excluded 24% (n = 801) of our cohort for death before the second SF-12 PCS. Among the 1,371 with sufficient SF-12 PCS data, mean age was 79.9 ± 4.5 years. Average SF-12 PCS change in 1 year was minimal (−0.9 ± 9.6), but 39.3% (n = 539) and 32.2% (n = 442) had clinically relevant SF-12 PCS decline and improvement, respectively. Albumin level and access type were not statistically associated with SF-12 PCS change. SF-12 PCS change was not associated with mortality (adjusted HR, 0.98; 95% CI, 0.96-1.00).Limitations2 time points to assess SF-12 PCS change; covariate assessment only at baseline; survivor bias.ConclusionsIn this cohort of older adults receiving hemodialysis, nearly one-fourth died, while among survivors, it was more common for SF-12 PCS to decline than improve in a year. Annual SF-12 PCS change was not associated with traditional risk factors for functional impairment or mortality risk. Additional research is needed to identify appropriate measures and frequency of assessment for functional decline.

The Impact of Race and Ethnicity Upon Health-Related Quality of Life and Mortality in Dialysis Patients

Rationale & ObjectiveHealth-related quality of life (HRQoL) has been recognized as a strong predictor of mortality among hemodialysis patients. However, differences in the association of HRQoL with survival across diverse racial/ethnic groups have not been well studied in this population.Study DesignObservational cohort study.Setting & ParticipantsWe examined the relationship between HRQoL and mortality in a prospective cohort of racially/ethnically diverse hemodialysis patients recruited from 18 outpatient dialysis units during 2011 to 2016.ExposureUsing the 36-Item Short Form Health Survey (SF-36) administered every 6 months, HRQoL was ascertained by 36 questions summarized as 2 Physical and Mental Component and 8 subscale scores.OutcomeAll-cause mortality.Analytical ApproachAssociations of time-varying SF-36 scores with mortality were estimated using Cox models in the overall cohort and within racial/ethnic subgroups.ResultsAmong 753 hemodialysis patients who met eligibility criteria, expanded case-mix analyses showed that the lowest quartiles of time-varying Physical and Mental Component scores were associated with higher mortality in the overall cohort (reference: highest quartile): adjusted HRs, 2.30 (95% CI, 1.53-3.47) and 1.54 (95% CI, 1.05-2.25), respectively. In analyses stratified by race/ethnicity, the lowest quartile of Physical Component scores was significantly associated with higher mortality across all groups: adjusted HRs, 2.64 (95% CI, 1.31-5.29), 1.84 (95% CI, 1.01-3.38), and 3.18 (95% CI, 1.13-8.91) for Hispanic, African American, and other race/ethnicity patients, respectively. The lowest quartile of time-varying physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, and pain subscale scores were associated with higher mortality in the overall cohort and particularly in Hispanics and blacks.LimitationsResidual confounding cannot be excluded.ConclusionsLower SF-36 Physical Component and subscale scores were associated with higher mortality in hemodialysis patients, including those of minority background. Further studies are needed to determine whether interventions that augment physical health might improve the survival of these diverse populations.

65. A risk/benefit analysis of increasing surgical invasiveness relative to frailty status in adult spinal deformity surgery

BACKGROUND CONTEXT The Adult Spinal Deformity Invasiveness Index incorporates deformity-specific components to assess the magnitude of correction. It's unknown how invasiveness relates to outcomes in each frailty state. PURPOSE Investigate the relationship between increasing invasiveness and outcomes in adult spinal deformity (ASD) surgery in each frailty states. STUDY DESIGN/SETTING Retrospective review of prospective, consecutively enrolled multicenter ASD database. PATIENT SAMPLE One hundred ninety-five ASD patients with baseline demographic and surgical details. OUTCOME MEASURES Invasiveness, frailty, minimal clinically important differences (MCID) for the Oswestry Disability Index, SF-36 Physical Component Scores, and Scoliosis Research Society Scores. METHODS ASD patients (scoliosis ≥20°, SVA ≥5cm, PT ≥25°, or TK ≥60°) with baseline frailty and invasiveness scores. Invasiveness index included: posterior: decompression (1), fusion (2), instrumentation (1); osteotomies: 3-coloumn (14), Ponte (1), interbody fusion: anterior lumbar (8), transforaminal/posterior lumbar (2), iliac fixation (2), revision surgery (3). Invasiveness scores were calculated within different frailty states (not frail, NF, 0.5). Logistic regression analysis assessed the relationship between increasing invasiveness and major complications or reoperations and meeting MCID for any of the measured HRQLs at 3 years. Decision tree analysis assessed thresholds for an invasiveness risk benefit cutoff point, above which experiencing complications or reoperations and not reaching MCID were higher. Significance was set to p RESULTS Of the 322 patients, 195 met inclusion criteria. Baseline demographic info: age 59.9±14.4, 75% female, BMI 27.8±6.2, CCI 1.7±1.7. Baseline surgical info: 61% osteotomy, 52% decompression, 11.0±4.1 levels fused. There were 98 NF, 65 F, and 30 SF patients. For the entire cohort, binary regression analysis found a significant relationship between increasing invasiveness and experiencing a major complication or reoperation (1.01[1.00-1.02], p=0.01). Within each frailty subgroup, the results were 1.01([1.00-1.03], p=0.05) for NF, 1.01([1.01-1.02], p CONCLUSIONS Increasing invasiveness is associated with increased odds of major complications and reoperations. A risk/benefit cutoff for decreasing major complications/reoperations and meeting MCID was found to be 79.3 for NF patients, 111 for F patients, and 53.3 for SF patients. Above these thresholds, increasing invasiveness is associated with increasing the risk of major complications or reoperations and not meeting MCID at 3 years. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

49. Increasing surgical invasiveness relative to frailty status in cervical deformity surgery: a risk benefit analysis

BACKGROUND CONTEXT The Adult Spinal Deformity Invasiveness Index incorporates deformity-specific components to assess the magnitude of correction. It's unknown how invasiveness relates to outcomes in each frailty state. PURPOSE Investigate the relationship between increasing invasiveness and outcomes in ASD surgery in each frailty states. STUDY DESIGN/SETTING Retrospective review of prospective, consecutively enrolled multicenter ASD database. PATIENT SAMPLE A total of 195 ASD patients with baseline demographic and surgical details. OUTCOME MEASURES Invasiveness, frailty, minimal clinically important differences (MCID) for the Oswestry Disability Index, SF-36 Physical Component Scores, and Scoliosis Research Society Scores. METHODS ASD patients (scoliosis ≥20°, SVA ≥5cm, PT ≥25°, or TK ≥60°) with baseline frailty and invasiveness scores. Invasiveness index included; posterior: decompression (1), fusion (2), instrumentation (1), osteotomies: 3-coloumn (14), Ponte (1), interbody fusion; anterior lumbar (8), transforaminal/posterior lumbar (2), iliac fixation (2), revision surgery (3). Invasiveness scores were calculated within different frailty states (not frail, NF, 0.5). Logistic regression analysis assessed the relationship between increasing invasiveness and major complications or reoperations and meeting MCID for any of the measured HRQLs at 3 years. Decision tree analysis assessed thresholds for an invasiveness risk benefit cutoff point, above which experiencing complications or reoperations and not reaching MCID were higher. Significance was set to p RESULTS One hundred ninety-five of 322 patients met inclusion criteria. Baseline demographic info: age 59.9 ± 14.4, 75% female, BMI 27.8 ± 6.2, CCI 1.7 ± 1.7. Baseline surgical info: 61% osteotomy, 52% decompression, 11.0 ± 4.1 levels fused. There were 98 NF, 65 F, and 30 SF patients. For the entire cohort, binary regression analysis found a significant relationship between increasing invasiveness and experiencing a major complication or reoperation (1.01 [1.00-1.02], p=0.01). Within each frailty subgroup, the results were 1.01 ([1.00-1.03], p=0.05) for NF, 1.01 ([1.01-1.02], p CONCLUSIONS Increasing invasiveness is associated with increased odds of major complications and reoperations. A risk/benefit cutoff for decreasing major complications/reoperations and meeting MCID was found to be 79.3 for NF patients, 111 for F patients, and 53.3 for SF patients. Above these thresholds, increasing invasiveness is associated with increasing the risk of major complications or reoperations and not meeting MCID at 3 years. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

278. The impact of older age on functional recovery after surgical decompression for degenerative cervical myelopathy: results from an international, multicentre, prospective dataset in 757 patients

BACKGROUND CONTEXT Surgical decompression has been shown to improve long-term function, disability and quality of life (QOL) in degenerative cervical myelopathy (DCM); however, the role of surgery, and the effect on functional and QOL outcomes, in elderly patients with DCM is controversial. PURPOSE To investigate the effect of older age (over 70) on the functional and QOL impairment and outcomes after DCM surgery compared to younger adults. STUDY DESIGN/SETTING Prospective, multicentre observational studies on the outcomes of surgery for DCM; the AO Spine CSM-North America and the CSM-International studies. PATIENT SAMPLE A harmonized, combined dataset of 757 patients enrolled from both studies. OUTCOME MEASURES Functional assessment was performed with the modified Japanese Orthopedic Association score (mJOA). QOL outcomes were measured by the SF-36 physical and mental component scores. METHODS Of 757 patients enrolled in both studies, 107 patients were identified as elderly (70 years or older) at the time of surgery. Outcomes and functional status were assessed at 6-, 12- and 24-month intervals. In addition to unadjusted univariate analyses, multiple linear regression was used to evaluate the effect of age ≥70 on change in outcome scores adjusting for diabetes, cardiac comorbidities, cigarette smoking, psychiatric disorders, number of operated levels, surgical approach and baseline mJOA. RESULTS The baseline mJOA in the elderly group was significantly lower than the younger group (11.0 [95% CI 10.4-11.5] vs 12.9 [12.7-13.1]; p= CONCLUSIONS In this combined dataset from 2 large prospectively collected multicentre studies on DCM surgery, the group aged 70 or greater demonstrated significantly worse functional and QOL recovery when compared to the younger cohort after adjusting for the effect of comorbidities, number of operated levels, surgical approach and baseline mJOA. Elderly patients undergoing surgery for DCM should therefore be counseled appropriately regarding expectations of surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

217. Impact of previous lumbar spine surgery on outcome of lumbar total disc replacement: analysis of prospective five-year follow up study data

BACKGROUND CONTEXT FDA-regulated prospective trials evaluating lumbar total disc replacement (LTDR) have included patients with previous lumbar surgeries. Unitedhealth care, one of the largest insurers in the United States recently issued a positive coverage policy for LTDR that disqualifies patients with previous lumbar surgeries of any kind from treatment with LTDR. However, such patients were included in FDA IDE trials that led to approval of these devices. PURPOSE The purpose of this study was to compare LTDR outcomes in patients with prior lumbar spine surgery to outcomes in those without prior surgery. STUDY DESIGN/SETTING The study was a post hoc analysis of data collected prospectively as part of an FDA-regulated trial with 5-year follow-up. PATIENT SAMPLE The study was based on 376 patients from the activL® IDE study population. All patients were treated for single-level symptomatic degenerative disc disease at L4-L5 or L5-S1 unresponsive to at least 6 months of nonoperative care. OUTCOME MEASURES Clinical outcome measures used in the study included Oswestry Disability Index (ODI), Visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events and reoperations. Radiographic outcome evaluations were based on flexion/extension range of motion (ROM) and translation of the operated segment. METHODS Patients were divided into two groups: prior lumbar surgery (PLS, n=92) and no prior lumbar surgery (NPLS, n=284). PLS patients had undergone one or more of the following procedures: intradiscal electrothermal annuloplasty (IDET) (n=5), percutaneous nucleoplasty (n=4), microdiscectomy (n=81), hemilaminectomy (n=17), laminotomy (n=36) or other (n=1) prior to receiving a LTDR. Patients with prior lumbar fusion were excluded from the IDE study. Baseline characteristics, functional and pain outcomes, serious adverse events and reoperations were statistically compared between the groups preoperatively and postoperatively at 6 weeks, 3 and 6 months and 1, 2, 3, 4 and 5 years. RESULTS Patient baseline demographics were very similar between the two groups. When comparing pre- to postoperative scores, ODI, VAS back pain and leg pain and the SF-36 Physical Component Score improved significantly (p CONCLUSIONS Prior lumbar spine surgery was not related to compromised outcomes among patients undergoing LTDR. There were no statistically significant differences in ODI, SF-36, pain scores or safety rates between PLS and NPLS patients. These results are in line with findings from earlier studies that prior surgery is not a contraindication for LTDR provided that other selection criteria are met. These results do not support the denial by an insurer to give patients and providers the option of receiving LTDR for DDD unresponsive to nonoperative care as described in the FDA approved device usage labeling. FDA DEVICE/DRUG STATUS activL (Approved for this indication), ProDisc-L (Approved for this indication), Charite (Approved for this indication)

31. Development of clinical prognostic models for postoperative survival and quality of life in patients with surgically treated metastatic epidural spinal cord compression

BACKGROUND CONTEXT Surgery is generally considered for patients with metastatic epidural spinal cord compression (MESCC) with a life expectancy of at least 3 months. No existing clinical prognostic models (CPMs) of survival are consistently used, and no CPMs exist which predict quality of life (QoL) following surgical treatment. These knowledge gaps are important given the challenges involved in managing MESCC. PURPOSE We aimed to develop the first CPMs of postoperative survival and QoL, using the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines, and based on a large sample of prospective data of surgical patients with MESCC. STUDY DESIGN/SETTING Cohort study (retrospective analysis of prospectively collected data). PATIENT SAMPLE A total of 258 patients with MESCC who underwent surgical treatment. OUTCOME MEASURES There were two outcome measures: (1) the 1-year survival measured as the number of postoperative days until death from any cause; (2) the achievement of the minimal clinical important difference of 0.06 on the postoperative EQ-5D scores at different time frames. METHODS Using TRIPOD guidelines and data from 258 patients (AOSpine North America (NA) MESCC study and Nottingham MESCC registry), we created 1-year survival and QoL CPMs using Cox model and logistic regression with manual backward elimination. The outcome measure for QoL was the minimal clinical important difference (MCID) in EQ-5D scores. Internal validation involved 200 bootstrap iterations; calibration and discrimination were evaluated. RESULTS Longer survival was associated with higher SF-36 physical component score (PCS) (HR: 0.96) whereas primary tumor other than breast, thyroid, and prostate (unfavorable, HR: 2.57; others, HR: 1.20), organ metastasis (HR: 1.51), male sex (HR: 1.58), and preoperative radiotherapy (HR: 1.53) were not (c-statistic: 0.69, 95% CI: 0.64-0.73). KPS CONCLUSIONS We developed and internally validated the first CPMs of survival and QoL at 3 months postoperatively in patients with MESCC using TRIPOD guidelines. A web-based calculator is available ( http://spine-met.com ) to assist clinical decision-making in this complex patient population. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.