SF-36 Physical Component Summary Research Articles

Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial.

Deucravacitinib, a tyrosine kinase 2 inhibitor, was assessed in a phase 2 trial in patients with active psoriatic arthritis (PsA). Here, we report effects of deucravacitinib from the patient perspective. This phase 2, double-blind trial (NCT03881059) randomized patients with active PsA 1:1:1 to deucravacitinib 6 mg once daily (QD), 12 mg QD, or placebo, for 16 weeks. Key secondary end points were changes from baseline (CFBs) at week 16 in Health Assessment Questionnaire-Disability Index (HAQ-DI) and 36-item Short-Form Health Survey (SF-36) physical component summary (PCS) scores. Additional patient-reported outcomes (PROs) assessed disease impact, including fatigue, pain, and mental health. The mean CFBs in PROs and percentages of patients reporting improvements with minimum clinically important differences (MCIDs) or scores of greater than normal values were also assessed. This study comprised 203 patients (51.2% female; mean ± SD age, 49.8 ± 13.5 years). At week 16, the adjusted mean difference (95% confidence interval) versus placebo in HAQ-DI and SF-36 PCS CFB was significant for each deucravacitinib group (HAQ-DI 6 mg, -0.26 [-0.42 to -0.10], P = 0.0020; HAQ-DI 12 mg, -0.28 [-0.45 to -0.12], P = 0.0008; SF-36 PCS 6 mg, 3.3 [0.9 to 5.7], P = 0.0062; SF-36 PCS 12 mg, 3.5 [1.1 to 5.9], P = 0.0042). MCID at week 16 were reported for all PROs with either dose of deucravacitinib. Improvements of MCID or to normative values were reported by more patients receiving deucravacitinib than placebo. Deucravacitinib groups demonstrate significant and clinically meaningful improvements in PROs versus placebo in patients with active PsA, which warrants further study.

Impact of postsurgical rehabilitation on outcomes for degenerative cervical myelopathy.

Despite widespread use, there is limited evidence to support postsurgical rehabilitation to enhance neurological recovery after surgery for degenerative cervical myelopathy (DCM). Outcomes research for DCM seldom accounts for the effect of postsurgical rehabilitation. The aim of this study was to quantify the impact of postsurgical rehabilitation on outcomes after surgery for DCM. This was a retrospective analysis of prospectively collected data from a single center. The study enrolled 66 patients who underwent spinal surgery for DCM. In addition to patient demographic, imaging, and surgical data, chart review was performed to document the timing, type, duration, and outcomes of postsurgical rehabilitation therapy. Outcomes were collected prospectively, including the modified Japanese Orthopaedic Association (mJOA) score, Neck Disability Index (NDI) score, and SF-36 physical component summary (PCS) score. Linear regression models were created to determine the independent effects of type and timing of postsurgical occupational therapy (OT) and physical therapy (PT) on outcomes. A total of 66 patients were included in the analysis. Multivariate regression analysis showed that postsurgical OT was associated with significantly greater improvement in 12-month SF-36 PCS scores (p = 0.009) and mJOA scores (p = 0.019). In the subset of patients who received therapy, delayed therapy (> 42 days after surgery) compared to early therapy (< 42 days after surgery) was associated with less improvement in SF-36 PCS scores (p = 0.03). Postsurgical outpatient rehabilitation was independently associated with improved postsurgical outcomes within the 1st year after surgery for DCM, and early therapy (< 42 days) was associated with superior outcomes compared to delayed therapy. This is one of the first studies to use a prospective database to demonstrate an independent effect for postsurgical rehabilitation on outcomes after surgery for DCM.

Changes in Calcaneal Bone Density and Correlation With Clinical Outcomes Following Ankle Fractures

Introduction: The study investigates the long-term bone quality and its influence on clinical results after surgical treatment of Weber B-type fractures. Methods: Surgery treated isolated Weber B-type fractures between 2006 and 2016 were included. Bone density was determined by ultrasonography densitometry of the calcaneus. American Orthopedic Foot and Ankle Society (AOFAS), Foot Function Index, Olerud-Molander-Ankle-Score, Hannover-Score, and Short Form Health Survey SF 36 were recorded. Results: Sixty patients were followed up. Mean follow-up was 6.6 years (range, 2 to 12 years). Mean bone density T-score of the treated foot was significantly lower than that of the contralateral untreated side (−0.6 versus −0.3; P = 0.05). Higher T-scores on the injured side were significantly and positively correlated with improved outcomes in the AOFAS, Olerud-Molander-Ankle-Score, and SF-36 physical component summary but negatively correlated with the Hannover score (P ≤ 0.05). A significant correlation existed only between the pain scores of the AOFAS and Foot Function Index. Controlling for potential confounding variables, such as age and smoking status, in a linear regression model, increased bone density was only associated with the AOFAS score. Discussion: A significant reduction in bone density persists for more than eight years in some individuals. Statistically significant correlation between reduced bone density and clinical outcomes was found only for the AOFAS scoring system.

E071 Bimekizumab demonstrates sustained improvement in quality of life up to week 52 in patients across the full spectrum of axial spondyloarthritis: results from two phase 3 studies

Abstract Background/Aims Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, has demonstrated rapid and clinically meaningful improvements in disease activity in patients across the full spectrum of axial spondyloarthritis (axSpA; active non-radiographic axSpA [nr-axSpA; BE MOBILE 1, NCT03928704] and ankylosing spondylitis [AS]/ radiographic axSpA [r-axSpA; BE MOBILE 2, NCT03928743]). Here we report health-related quality of life (HRQoL) outcomes (ASQoL, SF-36 and EQ-5D-3L) from the two parallel phase 3 studies up to Week (Wk)52. Methods BE MOBILE 1 and 2 have similar study designs: 16-Wk double-blind placebo (PBO)-controlled period followed by 36-Wk maintenance period. Patients were randomised (1:1 in BE MOBILE 1; 2:1 in BE MOBILE 2) to receive BKZ 160 mg Q4W or PBO. All patients received BKZ 160 mg Q4W from Wk16 to Wk52. We report ASQoL, SF-36 - physical component summary (PCS) and SF-36 - mental component summary (MCS) scores up to Wk52 and proportion of patients with ’no problem’ in each of the 5 EQ- 5D-3L domains (mobility, selfcare, usual activity, pain/discomfort, and anxiety/ depression). The results are presented as observed cases (OC), and missing data were imputed using multiple imputation (MI). Results 254 nr-axSpA (BKZ: 128; PBO: 126) and 332 r-axSpA(BKZ: 221; PBO: 111) patients were randomised with 86.6% and 89.8% completing to Wk52, respectively. At Wk16, BKZ treated patients reported greater improvements in ASQoL and SF-36 PCS compared to PBO (p &amp;lt; 0.001, all comparisons, using Analysis of Covariance [ANCOVA]). By Wk52, these improvements across all HRQoL outcomes were sustained in BKZ treated patients and improved in patients who switched to BKZ at Wk16. (Table). The baseline SF-36 MCS levels indicated that on average patients had normal scores which remained unchanged throughout the study. The proportion of patients reporting ‘no problem’ across all five EQ-5D-3L domains improved over time up to Wk52. In patients with ASQoL ≥4 at baseline, &amp;gt;60% of patients had ≥4-point improvement in ASQoL at Wk52. Conclusion Across the axSpA disease spectrum, treatment with BKZ compared with PBO at Wk16 significantly improved quality of life outcomes measured by EQ-5D-3L, ASQoL and SF-36 PCS scores which were sustained to Wk52. Disclosure N.D. McKay: Consultancies; NDM has received consultancy fees from Gilead and UCB Pharma. Other; NDM has received a registration fees for attendance at a conference from Abbvie, Novartis and UCB Pharma, NDM has received a fee for lecturing from Gilead, NDM has taken part in education meetings, programmes and examinations for a wide range of pharmaceutical companies. A. Bennett: Honoraria; AB received teaching honorarium from Abbvie Ltd, Pfizer, UCB Pharma, Novartis and Biogen. Grants/research support; AB received research grants from Pfizer. Other; AB received advisory board fees from Abbvie Ltd, Pfizer, UCB Pharma, MSD, Novartis and Lilly. N. Goodson: Honoraria; NG has received honoraria from UCB Pharma and Novartis. C. Fleurinck: Other; CF is an employee of UCB Pharma. C. de la Loge: Consultancies; CdlL is a consultant to UCB Pharma, Brussels, Belgium. U. Massow: Other; UM is an employee of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. H. Marzo-Ortega: Grants/research support; HMO has received grants/research support from Janssen, Novartis and UCB Pharma. Other; HMO has received honoraria and/or consultancy and/or speaker fees from Abbvie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB Pharma. K. Gaffney: Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Grants/research support; KG has received grants/research support from NASS, Versus Arthritis, AbbVie, Pfizer, UCB Pharma, Norvartis, Eli Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; KG has received honoraria/ consultation fees from Novartis, AbbVie, UCB Pharma, Lilly and Pfizer, KG has received speaker’s bureau from Novartis, UCB Pharma, AbbVie and Lilly; meeting expenses from AbbVie, Lilly, Roche, Novartis, Pfizer and UCB Pharma.

P170 Ixekizumab significantly improved quality of life and joint pain in patients with psoriatic arthritis, nail disease and distal interphalangeal joint involvement from SPIRIT-H2H

Abstract Background/Aims Among adults with psoriatic arthritis (PsA) in the SPIRIT H2H study, 65% had nail psoriasis (PsO) at baseline and of these, 96.2% had simultaneous distal interphalangeal joint (DIP) disease in ≥ 1 digits at baseline. This analysis describes the impact of ixekizumab (IXE) and adalimumab (ADA) on quality of life (QoL), function and joint pain. Methods This post-hoc analysis included patients from SPIRIT-H2H (NCT03151551) treated with either IXE or ADA who had simultaneous nail and DIP involvement (swelling or tenderness) in ≥ 1 digits at baseline. Nail PsO was measured using Nail Psoriasis Severity Index (NAPSI). Joint involvement was measured by tender/swollen joint count scores. Joint pain was measured by patient’s assessment of pain using Visual Analogue Scale (100 mm). QoL measures included Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Mental and Physical Component Summary Scores (SF-36 MCS/PCS). Patients were evaluated at baseline and Week 4, 8, 12, 16, 24, 32, 40, and 52. Joint pain and SF-36 MCS/PCS changes from baseline were analysed using a mixed effects model of repeated measures. Proportions of patients achieving DLQI ≤1 or HAQ-DI change ≥0.35 (minimal clinically important difference) were analysed using logistic regressions. Non-responder imputation and modified baseline observation carried forward methods were used for missing data. Results 354 SPIRIT-H2H patients had a NAPSI total score &amp;gt;0 and DIP involvement in ≥ 1 digits simultaneously at baseline (IXE, N = 186 and ADA, N = 168). Among them, IXE-treated patients had a significant improvement in joint pain at Week 4 and a larger improvement in joint pain over 52 weeks vs ADA-treated patients. In addition, a larger proportion of IXE-treated patients achieved a DLQI score of 0 or 1, and these statistically significant differences were observed as early as Week 4 and sustained at each visit over 52 weeks. IXE-treated patients also experienced statistically significant improvements in SF-36 MCS at Week 4, 12 and 32 compared to ADA-treated patients; numerically greater improvements in favor of IXE were sustained at all other visits. IXE-treated patients showed a larger improvement in SF-36 PCS over 52 weeks vs ADA-treated patients, and these differences reached statistical significance at Week 24 and 32. Similar proportions of patients treated with IXE or ADA showed a clinically important improvement in HAQ-DI. Conclusion In patients with simultaneous nail and DIP involvement in ≥ 1 digit at baseline, IXE treatment resulted in significant improvements across multiple QoL measures, and greater improvements in joint pain compared to ADA treatment. These data may help health care providers make clinical decisions concerning the care of PsA in patients with nail and DIP involvement. Disclosure C. Ritchlin: Consultancies; C. Ritchlin has received consulting fees and/or honoraria and/or grant support from: AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB Pharma. A. Kavanaugh: Consultancies; A. Kavanaugh has received consulting fees and/or honoraria from: AbbVie, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB Pharma. L. Kristensen: Consultancies; L.E. Kristensen has received consulting fees and/or honoraria and/or research support from: Pfizer, AbbVie, Amgen, UCB Pharma, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. J. Merola: Consultancies; J. F. Merola is a consultant and/or investigator for: Amgen, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly and Company, Novartis, Janssen, UCB Pharma, Sanofi-Regeneron, Sun Pharma, Biogen, Pfizer. B. Strober: Corporate appointments; B. Strober has been serving as an Editor-in-Chief for the Journal of Psoriasis and Psoriatic Arthritis; and serving as scientific co-director and investigator for CorEvitas Psoriasis Registry. Consultancies; B. Strober has served as a speaker for and/or has received consulting fees and/or honoraria from: AbbVie, Alamar, Alumis, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim. Shareholder/stock ownership; reports having stock options in Connect Biopharma, Mindera Health. Honoraria; He is also a consultant for Immunic Therapeutics, Kangpu Pharmaceuticals, Bristol-Myers-Squibb, Connect Biopharma, Dermavant, Evelo Biosciences, Incyte, Janssen, Leo, Eli Lilly and Company, Maruho. Grants/research support; He is also a consultant for Meiji Seika Pharma, Mindera Health, Protagonist, Nimbus, Novartis, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Sanofi-Genzyme, Union Therapeutics, Ventyxbio, vTv Therapeutic. J. Lisse: Consultancies; J. Lisse is employee and stockholder of Eli Lilly and Company. R. Bolce: Shareholder/stock ownership; R. Bolce is employee and stockholder of Eli Lilly and Company. C. Sapin: Shareholder/stock ownership; C. Sapin is employee and stockholder of Eli Lilly and Company. J. Pustizzi: Shareholder/stock ownership; J. Pustizzi is employee and stockholder of Eli Lilly and Company. D. McGonagle: Consultancies; D. McGonagle has received consulting fees and/or honoraria and/or research grants from: AbbVie and Eli Lilly and Company. Grants/research support; His funding sources include or have included the Wellcome Trust-EPSRC, UK NIHR, ARUK, MRC UK and EU FP7 programme.

Minimum 5-Year Clinical and Return-to-Sport Outcomes After Primary Arthroscopic Scapulothoracic Bursectomy and Partial Scapulectomy for Snapping Scapula Syndrome

Background: Snapping scapula syndrome (SSS) is a rare condition that is oftentimes debilitating. For patients whose symptoms are resistant to nonoperative treatment, arthroscopic surgery may offer relief. Because of the rarity of SSS, reports of clinical outcomes after arthroscopic SSS surgery are primarily limited to small case series and short-term follow-up studies. Purpose: To report minimum 5-year clinical and sport-specific outcomes after arthroscopic bursectomy and partial scapulectomy for SSS and to identify demographic and clinical factors at baseline associated with clinical outcomes at minimum 5-year follow-up. Study Design: Case series; Level of evidence, 4. Methods: Patients who underwent arthroscopic bursectomy and partial scapulectomy for SSS between October 2005 and February 2016 with a minimum of 5 years of postoperative follow-up were enrolled in this single-center study. Clinical outcome scores, including the 12-Item Short Form Health Survey (SF-12), American Shoulder and Elbow Surgeons (ASES) Shoulder Score, shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, Single Assessment Numeric Evaluation (SANE), and visual analog scale (VAS) score for pain, were collected at a minimum 5-year follow-up. Additionally, it was determined which patients reached the minimal clinically important difference. Bivariate analysis was used to determine whether baseline demographic and clinical factors had any association with the outcome scores. Results: Of 81 patients eligible for inclusion in the study, follow-up was obtained for 66 patients (age 33.6 ± 13.3 years; 31 female). At a mean follow-up of 8.9 ± 2.5 years (range, 5.0-15.4 years), all of the outcome scores significantly improved compared with baseline. These included the ASES (from 56.7 ± 14.5 at baseline to 87.2 ± 13.9 at follow-up; P < .001), QuickDASH (from 38.7 ± 17.6 to 13.1 ± 14.6; P < .001), SANE (from 52.4 ± 21.2 to 82.7 ± 19.9; P < .001), SF-12 Physical Component Summary (from 39.7 ± 8.3 to 50.3 ± 8.2; P < .001), SF-12 Mental Component Summary (from 48.2 ± 11.7 to 52.0 ± 9.0; P = 0.014) and VAS pain (from 5.2 ± 2.1 to 1.4 ± 2.0; P < .001). The minimal clinically important difference in the ASES score was reached by 77.6% of the patients. Median postoperative satisfaction was 8 out of 10. It was found that 90.5% of the patients returned to sport, with 73.8% of the patients able to return to their preinjury level. At the time of final follow-up, 8 (12.1%) patients had undergone revision surgery for recurrent SSS symptoms. Older age at surgery (P = .044), lower preoperative SF-12 Mental Component Summary score (P = .008), lower preoperative ASES score (P = .019), and increased preoperative VAS pain score (P = .016) were significantly associated with not achieving a Patient Acceptable Symptom State on the ASES score. Conclusion: Patients undergoing arthroscopic bursectomy and partial scapulectomy for SSS experienced clinically significant improvements in functional scores, pain, and quality of life, which were sustained at a minimum of 5 years and a mean follow-up of 8.9 years postoperatively. Higher patient age, inferior mental health status, increased shoulder pain, and lower ASES scores at baseline were significantly associated with worse postoperative outcomes.

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Prognostic and functional importance of both overt and subclinical left ventricular systolic dysfunction in systemic sclerosis

ObjectivesTo quantify the frequency and clinical implications of systemic sclerosis (SSc)-associated left ventricular function (LV) impairment. MethodsAustralian Scleroderma Cohort Study participants meeting ACR/EULAR criteria for SSc with ≥1 echocardiographic LVEF measurement were included. Overt LV dysfunction was indicated by reduced LV ejection fraction (LVEF) and subclinical LV dysfunction was measured using impaired LV global longitudinal strain (LV-GLS>-16 %). Those with secondary causes of LV dysfunction (myocardial ischaemia, valvulopathy and pulmonary arterial hypertension) were excluded. Chi-squared tests, two-sample t-tests or Wilcoxon rank-sum tests were used for between-group comparison as appropriate. Generalised estimating equations(GEE) were used to model longitudinal data. Kaplan-Meier and Cox proportional hazard models were used for survival analyses. ResultsOf 1141 participants with no co-morbid cardiac disease, 2.4 % ever recorded a LVEF<50 %, while only 0.6 % ever recorded a LVEF≤40 %. LV-GLS data were available for 90 % of participants at one centre (n = 218). Impaired LV-GLS was detected in 21 % despite LVEF≥50 %. Those with a LVEF<50 % were more frequently male (p = 0.01) with dcSSc (p < 0.01), higher inflammatory markers (p < 0.02) and skeletal muscle disease (p < 0.05). In multivariable analyses, recording a LVEF<50 % was associated with increased mortality (HR2.3, 95 %CI1.0–4.8, p = 0.04). Impaired LV-GLS was also associated with poorer survival in univariable analyses (HR3.4, 95 %CI1.0–11.8, p = 0.05). Those with a LVEF<50 % more frequently recorded WHO Class III/IV dyspnoea (OR3.5, 95 %CI1.6–7.7, p < 0.01), with shorter six-minute walk distance (p = 0.01), higher Health Assessment Questionnaire-Disability Index scores (p < 0.01) and lower Short Form-36 Physical Component Summary scores (p = 0.02). Increased dyspnoea (WHO Class III/IV dyspnoea; OR3.6, 95 %CI1.4–9.2, p < 0.01) was also seen in those with impaired LV-GLS. ConclusionsBoth overt and subclinical SSc-associated LV dysfunction are associated with worse survival and impaired physical function. The frequency of abnormal LV-GLS in those with consistently normal LVEF suggests an under-appreciated burden of subtle LV systolic dysfunction in SSc that has a significant impact on patient symptomatology.

Patients with neuropsychiatric involvement systemic lupus erythematosus experience poorer health-related quality of life and more fatigue than systemic lupus erythematosus patients with no neuropsychiatric involvement, irrespective of neuropsychiatric activity.

Substantial proportions of patients with systemic lupus erythematosus (SLE) report poor health-related quality of life (HRQoL). Our objective was to investigate the impact of neuropsychiatric involvement (NP) in SLE on patient-reported outcomes. We analysed data from four phase III trials (BLISS-52, BLISS-76, BLISS-SC, EMBRACE; N = 2968). The neuropsychiatric SLE (NPSLE) group comprised individuals with NP-British Isles Lupus Assessment group (BILAG) A/B/C/D or score in any descriptor of the NP-SLEDAI-2K at baseline (N = 350), while the non-NPSLE group consisted of patients with NP-BILAG E (N = 2618). HRQoL was assessed with the SF-36, EQ-5D-3L, and FACIT-F. Full health state (FHS) was defined as "no problems" in all EQ-5D dimensions. NPSLE patients reported lower scores in the SF-36 physical and mental component summary compared with the non-NPSLE population (mean±s.d.: 35.7±9.1 versus 39.6±9.6; p<0.001 and 37.3±12.1 versus 41.4±11.0; p<0.001, respectively). NPSLE patients also exhibited impaired HRQoL in all EQ-5D dimensions compared with non-NPSLE patients (p<0.05 for all). A substantially lower proportion among NPSLE patients experienced FHS in comparison with the non-NPSLE group (3.3% versus 14.5%; p<0.001). NPSLE was associated with severe fatigue (23.8±12.2 versus 31.5±11.6; p<0.001). Notably, our findings revealed no discernible distinctions between active and inactive NPSLE patients with regard to SF-36, EQ-5D, FHS, and FACIT-F scores. Neuropsychiatric involvement in patients with SLE has a detrimental effect on HRQoL experience and is associated with severe fatigue, regardless of the degree of neuropsychiatric disease activity. Early intervention is warranted in NPSLE patients to enhance long-term HRQoL experience.

Risk Factors for Residual Back Pain After Balloon Kyphoplasty for Osteoporotic Vertebral Fracture.

Balloon kyphoplasty (BKP) is a method for the management of osteoporotic vertebral body fracture (OVF). However, improvement in back pain (BP) is poor in some patients, also previous reports have not elucidated the exact incidence and risk factors for residual BP after BKP. We clarified the characteristics of residual BP after BKP in patients with OVF. In this study, we hypothesize that some risk factors may exist for residual BP 2years after the treatment of OVF with BKP. A multicenter cohort study was performed where patients who received BKP within 2months of OVF injury were followed-up for 2years. BP at 6months after surgery and final observation was evaluated by Visual Analog Scale (VAS) score. Patients with a score of 40mm or more were allocated to the residual BP group, and comparisons between the residual back pain group and the improved group were made for bone density, kyphosis, mobility of the fractured vertebral body, total spinal column alignment, and fracture type (fracture of the posterior element, pedicle fracture, presence or absence of posterior wall damage, etc.). Also, Short Form 36 (SF-36) for physical component summary (PCS) and mental component summary (MCS) at the final follow-up was evaluated in each radiological finding. Of 116 cases, 79 (68%) were followed-up for 2years. Two years after the BKP, 26 patients (33%) experienced residual BP. Neither age nor sex differed between the groups. In addition, there was no difference in bone mineral density, BKP intervention period (period from onset to BKP), and osteoporosis drug use. However, the preoperative height ratio of the vertebral body was significantly worse in the residual BP group (39.8% vs. 52.1%; p = 0.007). Two years after the operation, the vertebral body wedge angle was significantly greater in the residual BP group (15.7° vs. 11.9°; p = 0.042). In the multiple logistic regression model with a preoperative vertebral body height ratio of 50% or less [calculated by receiver operating characteristic (ROC) curve], the adjusted odds ratio for residual BP was 6.58 (95% confidence interval 1.64-26.30; p = 0.007); similarly, patients with vertebral body height ratio less than 50% had a lower score of SF-36 PCS 24.6 vs. 32.2 p = 0.08. The incidence of residual BP 2years after BKP was 33% in the current study. The risk factor for residual BP after BKP was a preoperative vertebral body height ratio of 50% or less, which should be attentively assessed for the selection of a proper treatment scheme and to provide adequate stabilization. III.

Arthroscopic rotator cuff repair in active patients younger than 45 Years: a prospective analysis with a mean 5-year follow-up

PurposeTo report clinical and activity specific outcomes after arthroscopic RCR(ARCR) for full-thickness supraspinatus tears in active individuals younger than or equal to 45 years of age. The pre hoc hypothesis was that patients in this age group would demonstrate significant improvements in clinical outcomes following ARCR along with a significant improvement of athletic abilities. MethodsPatients were included in this study if they were (1)active individuals between 18 and 45 years of age at the time of surgery, (2)had a full-thickness rotator cuff tear(RCT) of the supraspinatus tendon with or without anterior or posterior extension and (3)underwent ARCR. Pre- and postoperative patient-reported outcomes scores including the American Shoulder and Elbow Surgeons(ASES) score, Disabilities of Arm, Shoulder and Hand(Quick-DASH), Single Assessment Numeric Evaluation(SANE), Short Form-12 Physical Component Summary(SF-12PCS) were prospectively collected and postoperative patient satisfaction(scale of 1-10) was recorded at a minimum of 2 years postoperatively. Attainment of the minimal clinically important difference(MCID) and patient acceptable symptom state(PASS) for the ASES was calculated. Athletic activity specific outcomes and return to activity(RTA) were investigated prospectively via a custom-made comprehensive questionnaire. ResultsBetween 11/2005 and 6/2020, of 1149 RCRs performed by the senior author, 54 patients (mean age 40.9 years,13 female; follow-up 69.7 ± 35.2 months in a range of 24.6 – 179.6 months) were included into the outcomes analysis. Of those, 4 patients(7.4%) had progressed to revision rotator cuff repair. At a follow-up of 5.8 years, outcome scores had significantly improved compared to preoperative baselines (ASES55.6±13.8to90.1+15.8;p<.001;QuickDASH38.9±18.4to 11.9±17.1;p<.001, SANE60.7±22.7to79.3±27.6;p=.001, SF-12PCS41.6±8.3to51.9±9.0;p<=.001). 93.6% of the patients reached the MCID and 72.6% reached the PASS. Median satisfaction was 9.5/10. 86% of the patients returned to sports, while 67% of the patients returned to a similar level compared to preoperatively. All sport specific metrics such as shoulder strength and endurance(p<.001), intensity(p<.001), and impairments from pain affecting speed(p=0.002), endurance(p=.002) and competition(p<.001) significantly improved postoperatively. ConclusionARCR of full-thickness RCT in active individuals aged 45 or younger results in a clinically relevant improvement of outcomes, function and quality of life at a minimum of 2 years and mean 5.8-year follow-up with a low rate of revision. While 86% of patients were able to RTA and sport specific outcome metrics significantly and substantially improved compared to preoperatively, a return to preinjury levels was not reliably achieved in all patients, with particular limitations observed in overhead active individuals. The data support the hypothesis that patients in this age group demonstrate significant improvements in clinical outcomes following ARCR along with significant improvements in athletic abilities.

The Impact of Symptoms of Depression, Anxiety, and Low Stress-Coping Capacity on the Effects of Telephone Follow-Up on Recovery Measures After Hysterectomy.

To investigate if symptoms of depression, anxiety, and stress-coping capacity have an impact on the effect of telephone follow-up (TFU) on trajectories of six recovery measures after hysterectomy and influence the occurrence of unplanned telephone contacts (uTCs) and unplanned visits (uVs) to health care providers. A post hoc nonrandomized analysis of participants enrolled in a randomized, four-armed, single-blinded, controlled multicenter intervention study comprising 487 women where the women were allocated 1:1:1:1 to one of four TFU models. The Swedish Postoperative Symptom Questionnaire (SPSQ) and two health-related quality of life questionnaires, the EuroQoL-5 dimension with three levels (EQ-5 D-3 L) and the Short-Form-Health Survey (SF-36) assessed the recovery measures. The six recovery measures consisted of the EQ-5D-3L health index, the SF-36 physical component summary (PCS) and mental component summary (MCS), and the maximum and average pain intensity, and symptom sum score obtained from the SPSQ. Psychological distress was evaluated by the psychometric forms, the Hospital Anxiety and Depression Scale and the Stress Coping Inventory. The occurrence of uTC and uV within the 6 weeks of follow-up was registered. Preoperative anxiety, depression, and stress-coping capacity did not modify the effects of the TFU models on the trajectories of the recovery measures, although anxiety and depression were strongly associated with all six recovery measures. uTCs, but not uVs occurred more often in the women with anxiety. Preoperative anxiety, depression, and stress-coping capacity did not appear to influence the effects of TFU contacts on the recovery measures after hysterectomy. Preoperative anxiety seemed to increase the occurrence of uTC. Clinical Trials Registration: ClinicalTrials.gov (NCT01526668).

Efficacy and safety of the Spiration Valve System™ for the treatment of severe emphysema in patients with Alpha-1 antitrypsin deficiency (EMPROVE)

ObjectivesAlpha-1 antitrypsin deficiency (AATD) is a hereditary condition associated with emphysema. This study analyzed the efficacy and safety of Spiration Valve System TM (SVS) among AATD patients with severe emphysema. MethodsThis multicenter prospective study included 20 patients demonstrating AATD as assessed by quantitative levels of AAT and genotype containing two ZZ alleles. Most diseased lobe based on high resolution computed tomography was selected for treatment with endobronchial SVS. The change from baseline in forced expiratory volume in 1 s (FEV1) at 6 months (Primary outcome) and at 12 months, quality-of-life (QoL) measured by St. George's Respiratory Questionnaire (SGRQ) as health status, dyspnea scale measured by mMRC, Chronic obstructive pulmonary disease (COPD) Assessment Test (CAT), 36-item Short Form Health Survey (SF-36) physical component summary (PCS) and safety were assessed. ResultsLung function (FEV1) significantly improved at 6 months (P = 0.02); but did not reach statistical significance at 12 months (P = 0.22). Significant improvement was observed in dyspnea (at all time points), QoL measures (3, 6, and 12 months), CAT score and PCS of SF-36 (1, 3 and 6 months). Response rates based on minimal clinically important difference reached 50–80% for all variables. Overall, 4.4 valves/patient were used to isolate the target lobe, with a mean procedure time of 20.3 min. Serious adverse events included COPD exacerbations (5%), pneumonia (10%), pneumothorax (15%) and death (5%), occurring within first three months. ConclusionSVS endobronchial valve treatment showed improvement in lung function, dyspnea, and QoL in AATD patients with severe emphysema.

Apathy After Stroke: Incidence, Symptom Trajectory, and Impact on Quality of Life and Disability

Apathy is one of the most common symptoms following stroke and is often associated with worse functional outcome and poor quality of life (QoL). The trajectory of apathy symptoms has been previously described, and different trajectories have been identified. We determined group and individual changes in apathy symptomatology from the acute phase until 1 year after stroke. We also examined the association of apathy and depression with disability and QoL 1 year after stroke. We measured apathy in a cohort of ischemic stroke survivors at 4 time points from 0 to 12 months after stroke. The Apathy Evaluation Scale (AES) and Dimensional Apathy Scale (DAS) were administered at each time point. Where possible we obtained apathy measured from carers. Depression was assessed with the Geriatric Depression Scale (GDS). Disability and QoL were assessed with the modified Rankin Scale (mRS) and 36-Item Short Form Survey (SF-36). We examined the cross-sectional and individual trajectory of apathy symptoms in each dimension and looked at associations of apathy and depression soon after stroke with mRS and SF-36 at 1 year. Of 200 participants enrolled, 165 completed apathy measures at 12 months. Patient-rated apathy scores increased in both tests at the group level (AES: χ2(3) = 9.86, p = 0.019; DAS: χ2(3) = 8.49, p = 0.037) and individual level (AES: β = 0.13, p = 0.002; DAS β = 0.13, p = 0.005; DAS: executive β = 0.08, p < 0.001). By contrast, carer-rated apathy did not significantly increase (AES: χ2(3) = 0.75, p = 0.862; DAS: χ2(3) = 2.45, p = 0.484). Apathy scores were associated with worse mRS and SF-36, although most associations were no longer significant when controlling for depression. GDS was associated with worse mRS and SF-36 after controlling for covariates and apathy (mRS: β = 0.08, p = 0.006; SF-36 Mental Component Summary: β = -1.53, p < 0.001; SF-36 Physical Component Summary: β = -0.57, p = 0.016). Self-reported apathy progressively increases after stroke, especially in the executive dimension. Apathy is associated with worse QoL and greater disability, although some of these associations might be mediated by depression.

The Role of Sexual Function in Quality of Life Among Midlife and Older Women: The Study of Women's Health Across the Nation.

Objective: To examine how (1) partnered sexual activity, and (2) sexual functioning, contribute to global quality of life (QOL) and health-related quality of life (HRQL) among midlife and older women, and whether importance of sex modifies these associations. Materials and Methods: Women in the Study of Women's Health Across the Nation (SWAN), a multiethnic/racial cohort study, aged 42-52 at recruitment, were followed for ∼20 years. The Ladder of Life and Short Form-36 physical component summary (PCS) and mental component summary (MCS) assessed Global QOL (N = 3,263) and HRQL (N = 2,576), respectively. Primary predictors were (1) having partnered sexual activity (yes/no), and (2) sexual functioning among those with partnered sexual activity. Sociodemographic, health, lifestyle, and psychosocial covariates were included. Results: Importance of sex modified covariate-adjusted association of having partnered sexual activity with global QOL. Adjusted associations of partnered sexual activity with PCS and MCS were not statistically significant. Sexual functioning, among women with partnered sexual activity, was positively associated with global QOL (adjusted p = 0.03), regardless of importance of sex; unrelated to PCS; but positively associated with MCS (adjusted p = 0.03), particularly when sex was "very/quite important." Conclusions: Partnered sexual activity and better sexual functioning are related to QOL for mid-aged and older women, and are stronger when sex is considered important. Partnered sexual activity and sexual functioning are less consistently related to HRQL when adjusted for covariates, and importance modifies only the association between sexual functioning and MCS. Understanding the importance of sex to midlife and older women contextualizes the impact of sex on QOL.

What is the effect of preoperative depression on outcomes after minimally invasive surgery for adult spinal deformity? A prospective cohort analysis.

Depression has been implicated with worse immediate postoperative outcomes in adult spinal deformity (ASD) correction, yet the specific impact of depression on those patients undergoing minimally invasive surgery (MIS) requires further clarity. This study aimed to evaluate the role of depression in the recovery of patients with ASD after undergoing MIS. Patients who underwent MIS for ASD with a minimum postoperative follow-up of 1 year were included from a prospectively collected, multicenter registry. Two cohorts of patients were identified that consisted of either those affirming or denying depression on preoperative assessment. The patient-reported outcome measures (PROMs) compared included scores on the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back and leg pain, Scoliosis Research Society Outcomes Questionnaire (SRS-22), SF-36 physical component summary, SF-36 mental component summary (MCS), EQ-5D, and EQ-5D visual analog scale. Twenty-seven of 147 (18.4%) patients screened positive for preoperative depression. The nondepressed cohort had an average of 4.83 levels fused, and the depressed cohort had 5.56 levels fused per patient (p = 0.267). At 1-year follow-up, 10 patients still reported depression, representing a 63% decrease. Postoperatively, both cohorts demonstrated improvement in their PROMs; however, at 1-year follow-up, those without depression had statistically better outcomes based on the EQ-5D, MCS, and SRS-22 scores (p < 0.05). Patients with depression continued to experience higher NRS leg scores at 1-year follow-up (3.63 vs 2.22, p = 0.018). After controlling for covariates, the authors found that depression significantly impacted only 1-year follow-up MCS scores (β = 8.490, p < 0.05). Depressed and nondepressed patients reported similar improvements after MIS surgery, except MCS scores were more likely to improve in nondepressed patients.

Predictive Factors of Pain and Functional Outcome 5 Years Following Total Hip Arthroplasty: A Prospective Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement Cohort Study

BackgroundPrevious reports have identified a number of potential predictors of pain and function after total hip arthroplasty (THA). However, the results of these studies were conflicting, and most had a short follow-up after THA. The purpose of this study was to identify factors predictive of pain and function 5 years after THA. MethodsA multicenter cohort of 7,934 primary unilateral THA patients was prospectively enrolled in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement consortium. Demographic data, comorbidities, and patient-reported outcome measures were collected preoperatively and postoperatively at 5 years, including the Hip Disability and OSteoarthritis Outcome Score (HOOS) pain and activities of daily living (ADL) scores. Multivariate logistic regression models with 95% confidence interval were used to identify independent predictors of pain and function at 5 years. ResultsThe patient dissatisfaction percentage was 8.2% at 5 years after THA. The multivariate regression identified the following predictive factors for the HOOS pain score at 5 years: age, educational level, insurance, smoking, race, Charlson Comorbidity Index, back pain severity, number of other lower extremity painful joints, the Knee Injury and Osteoarthritis Outcome Score pain severity of the ipsilateral knee, preoperative Short-Form Health Survey 36-item (SF-36) mental component summary score, and HOOS pain scores. The multivariate regression identified the following predictor factors for HOOS ADL score at 5 years: body mass index, insurance, smoking, race, back pain severity, number of other lower extremity painful joints, Knee Injury and Osteoarthritis Outcome Score pain severity of ipsilateral knee, preop HOOS ADL, and preoperative SF-36 mental component summary score and SF-36 physical component summary score. ConclusionsOverall, 8.2% of patients were dissatisfied 5 years after primary THA. We have identified a number of factors that predict less improvement in pain and function 5 years after THA. These potentially modifiable factors can be targeted with preoperative patient optimization programs to improve patient outcomes and satisfaction after primary THA. Knowledge of these factors that predict less improvement in pain and function can assist the surgeon and patient during shared decision-making, and in setting appropriate patient expectations preoperatively.

Health-related quality of life of oral health workers in primary health care in Salvador, Brazil

This study aimed to determine the level of and identify factors associated with the health-related quality of life (HRQoL) of oral health professionals working in primary health care in Brazil. A cross-sectional survey was carried out among 96 dentists and 65 dental assistants working in the Family Health Strategy in six municipalities in the metropolitan area of Salvador, Brazil. HRQoL was evaluated using the 36-item Short Form Health Survey Questionnaire (SF-36). Higher mean scores in the SF-36 Physical Component Summary were associated with younger age, post-graduate education in public health, and frequent leisure time. The Mental Component Summary was associated with frequent leisure time, &gt;40 weekly working hours, suitable dental offices, satisfaction with colleagues, and satisfaction with working in primary health care. In conclusion, the HRQoL level of oral health professionals working in primary health care in Brazil was comparable to those found in the available literature and associated with several modifiable factors. Incidentally, a literature search found very few studies about the HRQoL of oral health workers that use the SF-36 and those found were produced outside the main scientific centers.

Mobile Critical Care Recovery Program for Survivors of Acute Respiratory Failure

Over 50% of Acute Respiratory Failure (ARF) survivors experience cognitive, physical, and psychological impairments that negatively impact their quality of life (QOL). To evaluate the efficacy of a post-intensive care unit (ICU) program, the Mobile Critical Care Recovery Program (m-CCRP) consisting of a nurse care coordinator supported by an interdisciplinary team, in improving the QOL of ARF survivors. This randomized clinical trial with concealed outcome assessments among ARF survivors was conducted from March 1, 2017, to April 30, 2022, with a 12-month follow-up. Patients were admitted to the ICU services of 4 Indiana hospitals (1 community, 1 county, 2 academic), affiliated with the Indiana University School of Medicine. A 12-month nurse-led collaborative care intervention (m-CCRP) supported by an interdisciplinary group of clinicians (2 intensivists, 1 geriatrician, 1 ICU nurse, and 1 neuropsychologist) was compared with a telephone-based control. The intervention comprised longitudinal symptom monitoring coupled with nurse-delivered care protocols targeting cognition, physical function, personal care, mobility, sleep disturbances, pain, depression, anxiety, agitation or aggression, delusions or hallucinations, stress and physical health, legal and financial needs, and medication adherence. The primary outcome was QOL as measured by the 36-item Medical Outcomes Study Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS), with scores on each component ranging from 0-100, and higher scores indicating better health status. In an intention-to-treat analysis among 466 ARF survivors (mean [SD] age, 56.1 [14.4] years; 250 [53.6%] female; 233 assigned to each group), the m-CCRP intervention for 12 months did not significantly improve the QOL compared with the control group (estimated difference in change from baseline between m-CCRP and control group: 1.61 [95% CI, -1.06 to 4.29] for SF-36 PCS; -2.50 [95% CI, -5.29 to 0.30] for SF-36 MCS. Compared with the control group, the rates of hospitalization were higher in the m-CCRP group (117 [50.2%] vs 95 [40.8%]; P = .04), whereas the 12-month mortality rates were not statistically significantly lower (24 [10.3%] vs 38 [16.3%]; P = .05). Findings from this randomized clinical trial indicated that a nurse-led 12-month comprehensive interdisciplinary care intervention did not significantly improve the QOL of ARF survivors after ICU hospitalization. These results suggest that further research is needed to identify specific patient groups who could benefit from tailored post-ICU interventions. ClinicalTrials.gov Identifier: NCT03053245.

P862 Effects of induction and maintenance therapy with risankizumab on health-related quality of life outcomes in patients with moderately to severely active ulcerative colitis: A post-hoc analysis of Phase 2b/3 trials

Abstract Background Ulcerative colitis (UC) has a detrimental impact on patients’ health-related quality of life (HRQoL).1 Long-term treatment goals for patients with moderately to severely active UC include restoration of HRQoL. This post-hoc analysis evaluated the effect of induction and maintenance treatment with risankizumab (RZB) on HRQoL outcomes. Methods Data from two Phase 2b/3 clinical trials (INSPIRE induction: NCT03398148 and COMMAND maintenance: NCT03398135) were evaluated. Patients received RZB 1200 mg intravenous (IV) or placebo (PBO) induction treatment at weeks 0, 4, and 8. Patients with a clinical response per Adapted Mayo score to RZB IV were randomised 1:1:1 to subcutaneous (SC) RZB 180 or 360 mg, or placebo (PBO [RZB withdrawal] SC) every 8 weeks for 52 weeks of maintenance. The proportion of patients achieving a meaningful within-person change (MWPC) for each HRQoL outcome was reported. HRQoL outcomes included Functional Assessment of Chronic Illness Therapy-Fatigue, disease-specific instruments such as Inflammatory Bowel Disease Questionnaire (IBDQ) and Ulcerative Colitis Symptom Questionnaire (UCSQ), as well as generic quality-of-life questionnaires like Work Productivity and Activity Index-Ulcerative Colitis (WPAI-UC), 36-Item Short-Form Survey (SF-36), and EuroQoL 5 Dimensions 5 Levels. MWPCs were measured from baseline to induction Week 12 and to maintenance Week 52. Estimated differences in proportions with 95% confidence intervals and p-values between RZB and PBO were compared using the Cochran-Mantel-Haenszel test adjusting for baseline strata. Results For RZB 1200 mg IV (n=650) versus PBO IV-treated (n=325) patients, a greater proportion of patients achieved MWPC across all HRQoL outcomes at Week 12 of induction (p&amp;lt;0.01; Table). At Week 52 of maintenance, a greater proportion of patients treated with RZB 180 mg SC (N=179) versus PBO (withdrawal) SC (N=183) achieved MWPC across all HRQoL outcomes (p&amp;lt;0.05), except for absenteeism from WPAI-UC (p=0.33). For RZB 360 mg SC (N=186) versus PBO (withdrawal) SC, a greater proportion of patients achieved MWPC for UCSQ, IBDQ, and SF-36 physical component summary (all p&amp;lt;0.05). Conclusion In this analysis, a greater proportion of patients treated with RZB versus PBO achieved MWPC on various HRQoL outcomes after completing 12-week induction IV therapy. HRQoL improvements were sustained up to Week 52 of treatment. This suggests RZB has the potential to help patients achieve restoration of HRQoL as a long-term goal of treatment in patients with moderately to severely active UC. 1. Mavroudis G. Therap Adv Gastroenterol. 2022;15:17562848211062406.