SF-36 Physical Component Summary Scores Research Articles

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.

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.

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.

Physical activity and health-related quality of life in older adults: depression as a mediator

BackgroundPhysical activity(PA) is associated with health-related quality of life (HRQoL) among older adults, and both are associated with mood, such as depression. However, the indirect effects of PA on HRQoL in older adults have not been clearly established. This study explained how different types and intensities of PA were associated with HRQoL while considering the effects of depression in older adults.MethodsA cross-sectional study was conducted with 7,518 community-dwelling older adults aged 60 years and older. PA (leisure-time, household, and work-related), depression, and HRQoL were measured using the Physical Activity Scale for the Elderly (PASE), the 30-item Geriatric Depression Scale (GDS-30), and the 36-Item Short-Form Health Survey (SF-36), respectively. Information on age, gender, education, monthly income, activities of daily living, smoking, and alcohol drinking was also collected. Regression analysis was used to explore the relationship between PA, depression and HRQoL, and a mediation effect test process was used to verify the mediating mechanism of the depression on this relationship.ResultsThe study showed that after adjusting for a set of covariates, SF-36 Physical Component Summary (PCS) scores were negatively associated with depression (B = -2.046, 95% CI [2.584, -1.509]) and positively with PA (p < 0.001). Similarly, SF-36 Mental Component Summary (MCS) scores were negatively associated with depression (B = -11.657, 95% CI [-12.190, -11.124]). In mediation analyses, we found that depression partially mediated the relationship between different types and intensities PA and PCS (moderate leisure-time PA: B = 0.223, 95%CI [0.153,0.293], P < 0.001; vigorous leisure-time PA: B = 0.323, 95%CI [0.232,0.413], P < 0.001; moderate household PA: B = 0.092, 95%CI [0.045,0.139], P < 0.001; vigorous household PA: B = 0.137, 95%CI [0.085,0.190], P < 0.001; work-related PA: B = 0.193, 95%CI [0.658,0.190], P < 0.001) and MCS (moderate leisure-time PA: B = 1.243, 95%CI [1.008,1.479], P < 0.001; vigorous leisure-time PA: B = 1.800, 95%CI [1.585,2.015], P < 0.001; moderate household PA: B = 0.496, 95%CI [0.274,0.718], P < 0.001; vigorous household PA: B = 0.742, 95%CI [0.521,0.963], P < 0.001; work-related PA: B = 1.026, 95%CI [0.819,1.234], P < 0.001).ConclusionsThis study suggested that leisure-time, household, and work-related PA were negatively associated with depression, while positively affecting HRQoL in Chinese older adults. The relationships between different types and intensities of PA and HRQoL were mediated by depression. Interventions aimed at promoting purposeful exercise and different types of PA may have mental health benefits. It is recommended that geriatric health managers and healthcare planners prioritize interventions to help improve PA intensities, alleviate depressive symptoms to promote beneficial effects on HRQoL in older adults.

Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies.

Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association of BU with quality-of-life (QoL) outcomes. LUCENT-1: 1162 patients randomized 3:1 to intravenous mirikizumab 300mg or placebo every 4 weeks (Q4W) for 12 weeks. LUCENT-2: 544 mirikizumab induction responders re-randomized 2:1 to subcutaneous mirikizumab 200mg or placebo Q4W through Week (W) 40 (W52 of continuous treatment). Patients reported BU severity in the past 24 hours using a validated Urgency Numeric Rating Scale (NRS). In patients with baseline Urgency NRS ≥3, the association between BU Clinically Meaningful Improvement (CMI; ≥3-point decrease) and remission (score 0 or 1) with patient-reported outcomes was assessed at W12 and W52. A significantly greater proportion of patients with versus without BU Remission achieved IBDQ remission (W12: 87.3% vs 42.7%, P < .0001; W52: 91.4% vs 45.5%, p < .0001). Similarly, BU Remission was associated with more patients achieving CMI in SF-36 Physical Component Summary (W12: 69.0% vs 44.4%, P < .0001; W52: 77.5% vs 42.1%, P < .0001) and Mental Component Summary (W12: 53.5% vs 41.0%, P = .0019; W52: 62.0% vs 38.3%, P < .0001) scores. At W12 and W52, patients with BU CMI or Remission showed significant improvements in EQ-5D-5L and Work Productivity and Activity Impairment:UC scores. Significant improvements were also seen in fatigue, abdominal pain, and nocturnal stool. In patients with moderately-to-severely active UC, improvement in BU was associated with improved QoL in phase 3 LUCENT-1 and LUCENT-2 studies. LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.

An Integrated Stroke Transitional Care Intervention Improves Physical Functioning, Self-Management and Patient Experience in Older Adults with Stroke and Multimorbidity: A Multisite Pragmatic Randomized Controlled Trial

Background: The hospital-to-home transition for older adults with stroke is often fragmented, resulting in hospital readmissions and reduced quality of life, patient satisfaction and safety. There is limited evidence for strategies to improve transitions in care for older adults with stroke and multimorbidity. This study aimed to test, in real-world clinical practice, the effectiveness of the Transitional Care Stroke Intervention (TCSI) versus usual care on health outcomes, patient experience, and health and social service use costs in older adults (&gt; 55 years) with stroke and multimorbidity (&gt; 2 chronic conditions).&#x0D; Methods: This pragmatic randomized controlled trial was conducted among older adults with a stroke and multimorbidity discharged from the hospital to the community using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional team from hospital-based outpatient stroke rehabilitation clinics (Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Nurse, and Social Worker). The TCSI is a complex, integrated intervention which includes care coordination/system navigation support, phone/video visits, monthly interprofessional case conferences, and an online resource to support system navigation. Data analysis was performed by intention to treat. The primary outcome was risk of hospital readmission (all-cause) after 6 months. Secondary outcomes were mental and physical functioning, depressive symptoms, stroke self-management, patient experience, number of hospital days and readmissions, number of ED visits, survival rates to first hospital and ED visit, risk of ED visits, and health and social service use costs. Older adults with stroke were engaged as co-investigators and informed the research design, implementation, and evaluation through participation in the Patient Partner Advisory and the TCSI Steering Committees.&#x0D; &#x0D; Results: Ninety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). Most participants were men (60%), with an average of 7 comorbid conditions, and 78% had experienced their first-ever stroke. No significant group differences were seen for the baseline to six-month risk of hospital readmission (all-cause). However, stroke survivors in the intervention group reported higher levels of physical functioning (SF-12 Physical Component Summary Score mean difference: 5.10; 95% CI: 1.58-8.62, p=0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51—11.50, p=0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p=0.005) compared with the usual care group. No significant group differences were seen for the other secondary outcomes.&#x0D; Discussion: The TCSI improved physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs compared to usual care.&#x0D; Conclusion:The results provide evidence for the effectiveness of an integrated intervention to optimize transitional care outcomes for older adults with stroke and multimorbidity receiving outpatient stroke rehabilitation services.&#x0D; Suggestions for future research: Future research is needed to further evaluate this intervention in diverse settings and populations, with a larger sample size and a full economic evaluation. &#x0D; &#x0D; &#x0D;

Relationship between health-related quality of life, depression, and anxiety in older primary care patients and their family members

Objectives Patient-family member dyads experience transitions through illness as an interdependent team. This study measures the association of depression, anxiety, and health-related quality of life (HRQOL) of older adult primary care patient-family member dyads. Methods Baseline data from 1,808 patient-family member dyads enrolled in a trial testing early detection of Alzheimer’s disease and related dementias in primary care. Actor-Partner Independence Model was used to analyze dyadic relationships between patients’ and family members’ depression (PHQ-9), anxiety (GAD-7), and HRQOL (SF-36 Physical Component Summary score and Mental Component Summary score). Results Family member mean (SD) age is 64.2 (13) years; 32.2% male; 84.6% White; and 64.8% being the patient’s spouse/partner. Patient mean (SD) age is 73.7 (5.7) years; 47% male; and 85.1% White. For HRQOL, there were significant actor effects for patient and family member depression alone and depression and anxiety together on their own HRQOL (p < 0.001). There were significant partner effects where family member depression combined with anxiety was associated with the patient’s physical component summary score of the SF-36 (p = 0.010), and where the family member’s anxiety alone was associated with the patient’s mental component summary score of the SF-36 (p = 0.031). Conclusion Results from this study reveal that many dyads experience covarying health status (e.g. depression, anxiety) even prior to entering a caregiving situation.

Systematic literature review and network meta-analysis of therapies for psoriatic arthritis on patient-reported outcomes

ObjectivesHead-to-head clinical trials are common in psoriasis, but scarce in psoriatic arthritis (PsA), making treatment comparisons between therapeutic classes difficult. This study describes the relative effectiveness of targeted synthetic (ts)...

Patient-reported outcomes in patients with primary immunodeficiency diseases in Japan: baseline results from a prospective observational study.

Primary immunodeficiency diseases (PIDs) are rare inherited diseases resulting in impaired immunity. People with PID experience lower health-related quality of life (HR-QOL) and disease-related burdens in daily activities. This ongoing, prospective observational study aims to evaluate disease activity, treatment status, treatment-related burden, daily activities, and HR-QOL in patients with PID in Japan over a 1-year period. In this interim report (database lock: July 29, 2022), we present baseline results. Participants were enrolled between November 2021 and May 2022; data were collected four times/year per participant until May 2023 using an online electronic patient-reported outcomes system. Patients with PID and healthy volunteers aged ≥12 years, residing in Japan, and with access to a smartphone were eligible. HR-QOL (primary endpoint) was assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Work productivity was assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Other aspects of PID and burden were assessed with a new questionnaire developed in-house. The study is registered at the University hospital Medical Information Network clinical trials registry (UMIN000045622). The full interim analysis set comprised 71 patients with PID and 47 healthy volunteers. The most common International Union of Immunological Societies PID category was primary antibody deficiency (56.3% of patients). Complications were common, especially recurrent respiratory tract infections (63.4%). Most patients with PID were treated with immunoglobulin replacement therapy (73.2%); 22.4% of these patients had serum immunoglobulin levels <700 mg/dL. Among patients who did not undergo hematopoietic cell transplantation, EQ-5D-5L (n=67) and SF-36 (n=59) Physical and Mental Component Summary scores were significantly lower than in healthy volunteers (p < 0.001). WPAI absenteeism, work productivity loss, and activity impairment scores were significantly lower in 42 working patients with PID than in 37 working healthy volunteers (p < 0.05). Other results indicated that patients with PID experience substantial burdens related to medical visits, expenses, work, and daily activities. This interim analysis confirms that patients with PID in Japan have lower HR-QOL and work productivity compared with healthy individuals and experience substantial limitations and burdens in their daily lives.

Cerrahi Kliniklerde Çalışan Hemşirelerde Merhamet Yorgunluğu ile Yaşam Kalitesi İlişkisi

Objective: The aim of this study is to determine the relationship between compassion fatigue and quality of life of nurses working in surgical clinics.&#x0D; Materials and Methods: The study is of a descriptive cross-sectional type. Surgical nurses working in university hospitals in the western part of Turkey were reached via WhatsApp groups, in which the research team is also registered. The study was completed with 216 surgical nurses who agreed to participate in the research. An online questionnaire was sent to the participants to collect data. The data collection tools used were the personal information form, SF-12 Quality of Life Scale, and Compassion Fatigue Scale. Descriptive statistics, Student t test, one- way ANOVA, and Pearson's correlation coefficient were used for data evaluation.&#x0D; Results: The nurses' Compassion Fatigue Scale total score was 65.37±25.00. The sub-dimension mean scores were as follows: Secondary Trauma was 23.66±10.56, and Professional Burnout was 41.71±15.98. The SF-12 Physical Component Summary score was 41.74±5.29, and the Mental Component Summary score was 38.01±5.01. There was a high level of positive relationship between the Compassion Fatigue Scale total score and its sub-dimensions, while a negative low-level correlation was observed between the SF-12 sub-dimensions and the Compassion Fatigue Scale total score and sub-dimensions (p

Adverse effects of frailty on the outcomes of surgery for degenerative cervical myelopathy: results from a prospective multicenter international data set of 757 patients.

The goal of this study was to determine the effect of the degree of frailty on long-term neurological and functional outcomes after surgery for degenerative cervical myelopathy (DCM). A combined database of patients enrolled in the Cervical Spondylotic Myelopathy-North America and Cervical Spondylotic Myelopathy-International prospective international multicenter observational studies who underwent surgery for DCM was used as the source data. All patients underwent baseline and follow-up assessment at 2 years after surgery for functional, disability, and quality of life measurements (modified Japanese Orthopaedic Association [mJOA] scale, Neck Disability Index, SF-36 physical and mental component summary scores). Patients were separated into 4 groups according to their baseline modified frailty index 5-point scale score: not frail, pre-frail, frail, and severely frail. Differences among groups were analyzed at baseline and at 2 years after surgery, including change in scores (delta values) and the odds ratio of achieving the minimum clinically important difference (MCID) through univariate and multivariable logistic regression adjusting for age, approach, number of levels treated, and sex. A total of 757 patients (63% male) with a mean age of 56 (95% CI 55.5-57.2) years were included: 470 patients underwent an anterior approach, 310 had a posterior approach, and 23 had a combined anterior/posterior approach. A total of 50% (n = 378) of patients were classified as not frail, with 33% (n = 250) pre-frail, 13% (n = 101) frail, and 4% (n = 28) severely frail. The baseline mJOA score was significantly lower with increasing frailty (14.00 [95% CI 13.75-14.19] for not frail vs 9.71 [95% CI 9.01-10.42] for severely frail patients; p < 0.05), but the change at 2 years was not significantly different among all groups (2.43 [95% CI 2.16-2.71] for not frail vs 2.56 [95% CI 1.10-4.02] for severely frail). The SF-36 delta values were also not different among groups, but significantly worse at baseline with increasing frailty. The odds ratio of achieving MCID for mJOA was significantly higher in the not frail group (1.89 [95% CI 1.36-2.61]; p < 0.05) compared to the other frailty cohorts, which remained after adjusting for age, approach, levels treated, and sex. The odds ratio of achieving MCID for the SF-36 domains was similar among all frailty groups. Increasing frailty is associated with worse baseline functional and quality of life measures in patients undergoing surgery for DCM. Frailty does not affect the magnitude of improvement in outcome measures after surgery, but reduces the chance of achieving the MCID for functional impairment significantly. Preoperative frailty assessment can therefore help guide clinicians in managing expectations after surgery for DCM. Potentially modifiable factors should be optimized in frail patients preoperatively to enhance functional outcomes.

Does the timing of surgery affect outcomes in young and middle-aged patients undergoing surgical stabilization of rib fractures? Feedback was based on real data from physicians, patients, and family caregivers.

There is a general clinical consensus that early surgical stabilization of rib fractures (SSRF, ≤ 48-72h after admission) can benefit patients, and this is only regarding the surgeon's opinions. This study assessed the true outcomes of young and middle-aged patients at different surgical timings. This retrospective cohort study was conducted among patients aged 30-55years who were hospitalized with a diagnosis of isolated rib fractures and underwent SSRF between July 2017 and September 2021. The patients were divided into early (≤ 3days), mid- (4-7days) and late (8-14days) groups, according to the interval (days) between surgery and injury date. The impact of different surgical timings on clinical outcomes, patients, and families was assessed by comparing SSRF-related data during hospitalization and follow-up studies of clinicians, patients themselves, and family caregivers 1-2months after surgery. In this study, 155 complete patient data were finally included, including 52, 64, and 39 patients in the early, mid, and late groups, respectively. Length of operation, preoperative closed chest drainage rate, length of hospital stay, intensive care unit length of stay, duration of invasive mechanical ventilation in the early group were lower than those in the intermediate and late groups. Additionally, hemothorax and excess pleural fluid incidence after SSRF was lower in the early group than in the intermediate and late groups. Postoperative follow-up results showed that patients in the early group had higher SF-12 physical component summary scores and shorter duration of absence from work. Family caregivers had lower Zarit Burden Interview scores than those in the mid- and late groups. From the experience of our institution's SSRF, early surgery is safe and offers additional potential benefits for young and middle-aged patients and families with isolated rib fractures.

Spanish Version of the Anterior Cruciate Ligament-Quality of Life Questionnaire: Translation, Cross-cultural Adaptation, and Validation.

The Anterior Cruciate Ligament-Quality of Life (ACL-QOL) questionnaire is a patient-reported outcome measure used to assess the effect of an anterior cruciate ligament (ACL) injury on the lives of patients. It was originally written in English, which may affect its use when completed by nonnative English speakers. To translate and adapt the ACL-QOL to Spanish and provide evidence of its psychometric properties. Cohort study (diagnosis); Level of evidence, 2. A total of 183 patients with an ACL injury from 4 Catalan hospitals were included: 99 patients who had undergone ACL reconstruction (ACLR) completed the Spanish version of the ACL-QOL (ACL-QOL-Sp) twice (mean interval, 15.2 days) in 2 weeks for test-retest reliability, and 84 patients completed the ACL-QOL-Sp, the Lysholm knee scoring scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner Activity Scale, and the 12-item Short Form Health Survey (SF-12) before and at 4 and 9 months after ACLR to assess responsiveness. The association between the ACL-QOL-Sp and the other outcome measures was evaluated with the Spearman correlation coefficient. The ACL-QOL-Sp showed good internal consistency (Cronbach alpha = 0.96) and test-retest reliability (intraclass correlation coefficient = 0.97). The standard error of measurement was 3.6, also suggesting the precision of measurements. The smallest detectable change was 9.98 in 94% of patients. No association was found between the ACL-QOL-Sp score and the Tegner score or SF-12 mental component summary score; however, a moderate correlation was found with the overall KOOS score (r = -0.545), Lysholm score (r = 0.509), and SF-12 physical component summary score (r = 0.607). The correlation ranged from weak for the KOOS-Symptoms subscore (r = -0.290) to moderate for the KOOS-Quality of Life subscore (r = -0.698). No ceiling or floor effects were observed. The ACL-QOL-Sp showed a moderate effect size (0.73) at 4 months but a large effect size (1.70) at 9 months. The ACL-QOL-Sp showed adequate internal consistency, test-retest reliability, and responsiveness in evaluating quality of life after ACLR in Spanish-speaking patients.

Septic History Limits the Outcome of Tibiotalocalcaneal Arthrodesis.

Joint destruction necessitates tibiotalocalcaneal arthrodesis (TTCA) in cases of clinical deficits that cannot be controlled conservatively, possibly leading to sepsis. We aimed to compare the underlying etiology of posttraumatic joint destruction and the outcomes after TTCA in patients with a septic or aseptic history. Between 2010 and 2022, 216 patients with TTCA were retrospectively enrolled (septic TTCA (S-TTCA) = 129; aseptic TTCA (A-TTCA) = 87). Patient demographics, etiology, Olerud and Molander Ankle Scores (OMASs), Foot Function Index (FFI-D) scores, and Short Form-12 Questionnaire (SF-12) scores were recorded. The mean follow-up period was 6.5 years. Tibial plafond and ankle fractures were the most common causes of sepsis. The mean OMAS was 43.0; the mean FFI-D was 76.7; and the mean SF-12 physical component summary score was 35.5. All the scores differed significantly between the groups (p < 0.001). With an average of 11 operations until the arthrodesis was achieved, the S-TTCA patients underwent about three times as many operations as the A-TTCA patients (p < 0.001), and 41% of S-TTCA patients remained permanently unable to work (p < 0.001). The significantly worse results of S-TTCA compared to A-TTCA show the long and stressful ordeal that patients with a septic history suffer. Further attention must be paid to infection prophylaxis and, if necessary, early infection revision.

Are dietary intake and nutritional status of specific polyunsaturated fatty acids correlated with sarcopenia outcomes in community-dwelling older adults with sarcopenia? – Exploratory results from ENHANce

AimsTo explore the relationship between dietary polyunsaturated fatty acids (PUFAs) intake, nutritional PUFAs status and sarcopenia outcomes in sarcopenic older adults.MethodsThe Exercise and Nutrition for Healthy AgeiNg (ENHANce) is an ongoing 5-armed triple blinded randomized controlled trial, in sarcopenic older adults (> 65y) aiming to assess the effect of combined anabolic interventions (protein, omega-3 supplement and exercise) on physical performance in these adults, compared to single/placebo interventions. Baseline data were used for a secondary, exploratory, cross-sectional analysis. Dietary PUFAs intake was assessed with 4-day food records, status with RBC membrane fatty acids profiles. Spearman’s rho(ρ) correlation coefficients were calculated to explore associations of PUFAs intake and status with sarcopenia-defining parameters (muscle strength, mass and physical performance), physical activity (step count) and quality of life (SF-36, SarQoL).ResultsIn total, 29 subjects (9♂/20♀, mean age 76.3 ± 5.4y) were included. Total omega-3 intake of participants (1.99 ± 0.99 g/d) was below the recommended intake (♂:2.8–5.6 g/d; ♀:2.2–4.4 g/d). Intake and status of PUFAs were not correlated. Regarding correlations with outcomes, α-linolenic acid status was inversely associated with appendicular lean mass (aLM) (ρ:-0.439; p = 0.017), whereas docosahexaenoic acid status was positively associated with aLM (ρ:0.388; p = 0.038). Some omega-3 PUFAs intake and status markers were positively associated with step count, SF-36 and SarQoL scores, whereas gamma-linolenic acid status was inversely associated with SF-36 physical component summary score (ρ = -0.426; p = 0.024).ConclusionsAlthough intake of omega-3 and omega-6 was low, the present exploratory study generated new hypotheses for potential correlations of PUFAs intake and status with sarcopenia outcomes in older adults with sarcopenia.

P194 Bimekizumab is associated with improvement in quality of life in patients across the full spectrum of axial spondyloarthritis at week 16: results from two phase 3 studies

Abstract Background/Aims Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A and has demonstrated rapid and clinically meaningful improvements in disease activity (ASAS40, primary outcome measure) 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 results related to HRQoL instruments (EQ-5D-3L, ASQoL and SF-36) from the two ongoing phase 3 studies at week (wk) 16. Methods BE MOBILE 1 and 2 were conducted in parallel with similar study designs: 16-wk double-blind placebo-controlled period followed by a 36-wk maintenance period. Patients were randomised (1:1 in BE MOBILE 1 and 2:1 in BE MOBILE 2) to BKZ 160 mg Q4W or placebo (PBO). All patients received BKZ 160 mg Q4W from wk16. We report change from baseline (CfB) in the overall EQ-5D-3L utility index, ASQoL and SF-36 Physical component Summary (PCS) scores at wk16 compared to PBO. Missing data is imputed using multiple imputation. Results Overall, 240/254 (94.5%; nr-axSpA) and 313/332 (94.3%; r-axSpA) patients completed the studies up to wk24. Both studies met their primary and all ranked secondary endpoints at wk16. In both studies, BKZ treatment resulted in improved health status as measured with the EQ-5D-3L utility score versus PBO. This improvement at wk16 was consistent across both tumour necrosis factor inhibitor (TNFi)-naive and TNFi-inadequate responders (IR) patients. Significantly greater improvements were also observed with BKZ compared to PBO in ASQoL and SF-36 PCS in both studies (p &amp;lt; 0.001, all comparisons) at wk16 (Table). At wk16, a higher proportion of BKZ- versus PBO-treated patients achieved ≥5-point improvement in SF-36 PCS (nr-axSpA: 64.8% vs 41.3% and r-axSpA: 63.8% vs 49.5%) and ≥4-point improvement in ASQoL (nr-axSpA: 58.6% vs 33.3% and r-axSpA: 57.5% vs 45.0%), respectively. Conclusion Dual inhibition of IL-17A and IL-17F with BKZ improved quality of life measured by EQ-5D-3L, ASQoL and SF-36 PCS scores compared with PBO in patients across the full spectrum of axSpA. Disclosure N. McKay: Member of speakers’ bureau; NM has received Speaker' bureau from Gilead. Other; NM has received travel fees from UCB Pharma and Gilead. A. Bennett: Honoraria; AB has received teaching honorarium from Abbvie Ltd, Pfizer, UCB Pharma, Novartis and Biogen. Grants/research support; AB has received research grants from Pfizer. Other; AB has received advisory board fees from Abbvie Ltd, Pfizer, UCB Pharma, MSD, Novartis and Eli 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: Consultancies; KG has received honoraria or consultancy fees from Novartis, AbbVie, UCB Pharma, Eli Lilly and Pfizer. Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Member of speakers’ bureau; KG has paticipated in speaker's bureau for Novartis, UCB Pharma, AbbVie and Eli Lilly. 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 meeting expenses from AbbVie, Eli Lilly, Roche, Novartis, Pfizer and UCB Pharma.

Quality of Life in Teduglutide-Treated Patients with Short Bowel Syndrome Intestinal Failure-A Nested Matched Pair Real-World Study.

Quality of life (QoL) data of chronic intestinal failure (cIF) patients treated with the GLP-2 analogue teduglutide are scarce. This study aims to analyze QoL changes over time in teduglutide-treated patients and compare the results to a matched non-treated cIF control group in a real-world setting. QoL data (SF-36 and SBS-QoLTM) were obtained from adult cIF patients being treated with teduglutide and compared to previously collected QoL data from a PNLiver trial (DRKS00010993), during which patients had been therapy naive. The dataset was then extended by a pairwise matched control group (non-teduglutide-treated PNLiver trial patients) and follow-up data from this group were collected accordingly. Median teduglutide treatment duration and the follow-up period of controls were both 4.3 years. SBS-QoLTM subscales and the SBS-QoLTM sum score showed significant improvements over time in teduglutide-treated patients, as well as for the SF-36 physical and mental component summary scores (all p < 0.02), while non-treated patients showed no significant changes in any of the mentioned scores. Significant differences of QoL changes between treated and non-treated patients were seen for both SF-36 summary scores (p = 0.031 and 0.012). We herein demonstrate for the first time that QoL significantly improved during teduglutide treatment in SBS-cIF patients in a real-world setting compared to individually matched non-treated SBS-cIF patients, indicating relevant clinical benefits.

Construct validity of the PROMIS PF-10 in patients with inflammatory rheumatic diseases and severe limitations in physical functioning

Objective Assessing the construct validity of the Patient-Reported Outcomes Measurement Information System Physical Function 10-Item Short Form (PROMIS PF-10) in a subpopulation of rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) patients with severe limitations in physical functioning (PF). Method RA/axSpA patients with severe functional limitations completed the PROMIS PF-10, Health Assessment Questionnaire – Disability Index (HAQ-DI for RA) or Bath Ankylosing Spondylitis Functional Index (BASFI for axSpA), 36-item Short Form Health Survey (SF-36), EuroQol 5-dimensions 5-level (index score, EQ-VAS), and performed the Six-Minute Walk Test (6MWT). Construct validity was assessed by computing Spearman rank or Pearson correlation coefficients and testing hypotheses about correlations between the PROMIS PF-10 and measures of PF and quality of life. Results Data from 316 patients (180 RA/136 axSpA, 91.7%/47.8% female, mean ± sd age 58.6 ± 13.2/54.0 ± 11.3 years) were analysed. The median (IQR) PROMIS PF-10 score was 34.5 (31.4–37.6) in RA and 36.0 (32.8–38.3) in axSpA patients. The PROMIS PF-10 correlated strongly with the HAQ-DI, BASFI, and EQ-5D-5L index score (r > 0.6), moderately with the SF-36 Physical Component Summary score, EQ-VAS, and 6MWT (0.30 ≤ r ≤ 0.60), and weakly with the SF-36 Mental Component Summary score (r < 0.30). Five of six hypotheses (83%) were confirmed in both groups. Conclusion The overall strong correlation of the PROMIS PF-10 with measures of PF and moderate to weak correlations with outcomes measuring different constructs were confirmed in subpopulations of RA and axSpA patients with severe functional limitations, supporting its construct validity.

The Impact of Depression and Anxiety on Adult Cancer Patients' Health-Related Quality of Life.

Cancer patients are at high risk for mental illness and, in turn, poorer health-related quality of life. This study used nationally representative United States (US) data to examine nuances of the impact of depression and/or anxiety on HRQoL in different cancer groups (e.g., cancer only, cancer and depression, cancer and anxiety, cancer and both conditions). Adult patients aged 18 years and older with a cancer diagnosis were identified from the Medical Expenditure Panel Survey data for 2012-2016. HRQoL was measured using the SF-12 Physical and Mental Component Summary (PCS & MCS) scores. Multivariate linear regressions were used, controlling for a multitude of factors. Around 12% of the 1712 identified patients with cancer had depression, 13% had anxiety, and 8.4% had both depression and anxiety. Patients with comorbid depression and anxiety had the lowest mean scores of both PCS and MCS compared to patients in other groups. In addition, cancer patients with either depression and/or anxiety were more likely to have lower MCS scores compared to those with cancer only (depression: β = -6.554; anxiety: β = -3.916; both conditions: β = -11.759, p < 0.001). Interestingly, patients with comorbid depression and anxiety were more likely to have higher PCS scores compared to those with cancer only. The psychological burden of cancer is immense, with a substantial impact on patients' HRQoL. Routine screening for depression and anxiety, especially for women and those with low poverty status and comorbidities, should be conducted by healthcare providers to identify those with high odds of having a lower HRQoL. Additionally, early psychiatric interventions, such as psychotherapy and prescription drugs, may positively impact patients' mental well-being and HRQoL.

Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease with a high symptom burden. Data are lacking on the comparative health status of patients with CRSwNP. This analysis compared baseline physical and mental health-related quality of life (HRQoL) and overall health status of patients with severe CRSwNP enrolled in a Phase 3 clinical trial with general population norms and with other chronic diseases. In this post hoc cross-sectional analysis of baseline data from the SINUS-24 study (NCT02912468), HRQoL was measured using the 36-item Short Form (SF-36) questionnaire and general health status was measured using the EuroQol-5 Dimension visual analog scale (EQ-VAS). Analyses included the intention-to-treat (ITT) population and subgroups defined by prior sinonasal surgery, systemic corticosteroid use, and coexisting asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Scores were compared with published values for population norms (50for SF-36 physical component summary (PCS) and mental component summary (MCS), 70.4-83.3 for EQ-VAS) and for rheumatoid arthritis, type 2 diabetes, and asthma. In the ITT population (n=276), mean SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), and EQ-VAS scores were below general population norms (46.4, 48.6, and 66.0, respectively). Mean SF-36 PCS and EQ-VAS scores were below population norms across all subgroups; mean SF-36 MCS scores were below the population norm in all subgroups except no prior surgery. SF-36 PCS and MCS scores from SINUS-24 were generally similar to other chronic diseases, except SF-36 PCS which was lower in rheumatoid arthritis. EQ-VAS scores in SINUS-24 were lower than in other chronic diseases. HRQoL scores weakly correlated with objective measures of disease severity. In patients with severe CRSwNP, including those with coexisting asthma/NSAID-ERD, HRQoL was worse than population norms and as burdensome as diseases such as type 2 diabetes, asthma, and rheumatoid arthritis.