SF-36 Summary Scores Research Articles

Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study.

Tenofovir alafenamide (TAF) was introduced in the European Union in 2015 as a novel prodrug of tenofovir showing similar efficacy in clinical trials and a more favorable safety profile than tenofovir disoproxil fumarate (TDF). The German TAFNES cohort study (2016-2019) was conducted to generate real-world evidence. Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) receiving elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF), rilpivirine/F/TAF (R/F/TAF) or F/TAF + 3rd agent were included. Month (M) 24 outcomes included virologic effectiveness (HIV RNA <50 copies/mL), treatment persistence, adverse drug reactions (ADRs) and patient-reported outcomes, using the HIV Symptom Index (HIV-SI), 36-Item Short Form Health Survey (SF-36) and HIV Treatment Satisfaction (HIVTSQ) questionnaires. The study included 767 PWH (92% men, median age 46 years; 301 TN, 466 TE; E/C/F/TAF [n = 318], R/F/TAF [n = 192], F/TAF + 3rd agent [n = 257]). Among TN, 35% had late HIV diagnosis (CD4 < 350/μL and/or AIDS). Of TE, 95% were on suppressive antiretroviral therapy (ART) before switching. D:A:D (Data Collection on Adverse Effects of Anti-HIV Drugs) 5-year risks for chronic kidney disease were high for about 1 in 10 TN and 4 in 10 TE. Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet regimens in 13%). M24 viral suppression (missing = excluded) was 96% (479/501). Discontinuations due to virologic failure or ADRs were rare, 2% (12/767) and 4% (30/767), respectively. HIV-SI and SF-36 summary scores improved in TN; HIVTSQ change scores showed an improvement in treatment satisfaction in TE. Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.

Association Between Three Levels of Social Exclusion and Quality of Life in the Oldest Old Australians: An Analysis of the Household, Income and Labour Dynamics in Australia Data.

This study examined associations between three levels of social exclusion and quality of life in the Australian oldest old. We performed cross-sectional analyses of the Household, Income and Labour Dynamics in Australia data using 203 participants aged ≥85. Principal component analysis was used to construct social exclusion variables at an individual level (lack of supportive relationships), neighborhood level (disadvantaged neighborhood social climates), and community level (community disengagement). Quality of life was assessed using physical and mental component summary scores of SF-36. Multiple linear regression analysis was performed separately for men and women. Lack of supportive relationships was negatively associated with physical and mental quality of life in all participants. Among men, community disengagement was associated with low physical quality of life. Policies to reduce social exclusion in this age group should focus on improving supportive relationships to enhance quality of life, rather than neighborhood or community levels.

Impact of diverting ileostomy on functional outcome and quality of life after restorative proctocolectomy and ileal pouch anal anastomosis.

Diverting ileostomy (DS) after restorative proctocolectomy (RPC) can be omitted in selected patients. Its omission could improve functional outcomes and quality of life (QoL), as has been demonstrated in patients after proctectomy. The aim of this study was to report the impact of diverting ileostomy on functional outcomes and QoL after ileal pouch-anal anastomosis (IPAA). This was a retrospective study including all patients operated (2015-2020) for RPC with IPAA. Functional outcome was evaluated by validated scores (LARS, Wexner, Öresland, pouch functional score [PFS] and the ileoanal pouch syndrome severity [IPSS] score). Global health-related QoL was evaluated with the SF-36. We also analysed demographic characteristics, morbidity, correlation between functional outcomes and QoL. Among 179 eligible patients, 150 responded (84%): S- (no stoma = 78; 52%) and S+ (had stoma = 72; 48%). Overall morbidity and anastomotic leak rates were 46% and 9.3%, respectively without difference between the groups. Medians for the functional scores were comparable between the S- and S+ group, respectively: 18 [12.5-31] versus 18 [11-31], p = 0.48 for LARS; 9 [7-11] versus 9 [7-12], p = 0.23 for Wexner's score; 6 [3-13] versus 8 [5-11], p = 0.22 for Öresland's score, 6 [3-13] versus 6.8 [4-12], p = 0.174 for PFS score, and 40 [35-45] versus 46 [42-51], p = 0.045 for IPSS score. The SF-36 summary score was comparable between the two groups without any difference in eight specific health dimensions. After propensity score matching, results were still comparable between the two groups for all scores. Linear regression found a significant correlation between all QoL domains and all functional scores (p < 0.001). DS for IPAA does not alter either functional outcomes or QoL and can be omitted in selected patients.

Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From ELEVATE UC 52 and ELEVATE UC 12.

Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Here, we evaluate the impact of etrasimod 2mg QD on health-related quality of life (HRQoL) in patients with UC. This post hoc analysis used data from the Phase 3 randomized controlled trials, ELEVATE UC 52 and ELEVATE UC 12. HRQoL measures included: Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Survey (SF-36), and Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI:UC) completed at baseline, Week 12 (both trials), and Week 52 (ELEVATE UC 52 only). For IBDQ analyses, patients were stratified by prior exposure to biologics/Janus kinase inhibitors (JAKi) and baseline modified Mayo score (MMS; 4-6 or 7-9). Generally, significantly greater proportions of patients receiving etrasimod (N = 527) vs placebo (N = 260) achieved IBDQ remission (IBDQ total score ≥170) and IBDQ response (IBDQ total score increase from baseline ≥16), with significant improvement in all IBDQ domain scores at Week 12 and maintained through Week 52. Significant differences in IBDQ remission and IBDQ response rates between etrasimod and placebo were more consistent among biologic/JAKi-naive patients vs those who were biologic/JAKi-experienced and in those with baseline MMS 7-9 vs 4-6. Significant improvements were observed in several SF-36 domain and summary scores and WPAI:UC domain scores at Week 12 and Week 52. Etrasimod 2mg QD demonstrated significant and clinically meaningful improvements across multiple HRQoL measures, including WPAI, vs placebo. ClinicalTrials.gov: NCT03945188; NCT03996369.

Postsurgical motor function and processing speed as predictors of quality of life in patients with chronic-phase glioblastoma

PurposePatients with glioblastomas (GBMs) have poor prognosis despite various treatments; therefore, attention should be paid to maintaining the quality of survival. Neurocognitive deficits can affect the quality of life (QOL) in patients with GBM. Most studies concerning QOL and neurocognitive functions have demonstrated a relationship between QOL and self-reported neurocognitive decline, although this method does not accurately reflect damaged functional domains. Therefore, this study aimed to clarify the neurocognitive functions that influence the QOL in patients with GBMs using an objective assessment of neurocognitive functions.MethodsData from 40 patients newly diagnosed with GBMs were analyzed. All patients completed the assessment of QOL and various neurological and neurocognitive functions including general cognitive function, processing speed, attention, memory, emotion recognition, social cognition, visuospatial cognition, verbal fluency, language, motor function, sensation, and visual field at 6 months postoperatively. QOL was assessed using the 36-Item Short Form Survey (SF-36). In the SF-36, the physical, mental, and role and social component summary (PCS, MCS, and RCS, respectively) scores were calculated. Multiple logistic regression analyses and chi-square tests were used to evaluate the association between SF-36 scores and neurocognitive functions.ResultsThe MCS was maintained, while the PCS and RCS scores were significantly lower in patients with GBMs than in healthy controls (p = 0.0040 and p < 0.0001, respectively). Among several neurocognitive functions, motor function and processing speed were significantly correlated with PCS and RCS scores, respectively (p = 0.0048 and p = 0.030, respectively). Patients who maintained their RCS or PCS scores had a higher probability of preserving motor function or processing speed than those with low RCS or PCS scores (p = 0.0026).ConclusionsMotor function and processing speed may be predictors of QOL in patients with GBMs.

Converting PROMIS®-29 v2.0 profile data to SF-36 physical and mental component summary scores in patients with cardiovascular disorders

BackgroundHealth-related quality of life (HRQL) has become an important outcome parameter in cardiology. The MOS 36-ltem Short-Form Health Survey (SF-36) and the PROMIS-29 are two widely used generic measures providing composite HRQL scores. The domains of the SF-36, a well-established instrument utilized for several decades, can be aggregated to physical (PCS) and mental (MCS) component summary scores. Alternative scoring algorithms for correlated component scores (PCSc and MCSc) have also been suggested. The PROMIS-29 is a newer but increasingly used HRQL measure. Analogous to the SF-36, physical and mental health summary scores can be derived from PROMIS-29 domain scores, based on a correlated factor solution. So far, scores from the PROMIS-29 are not directly comparable to SF-36 results, complicating the aggregation of research findings. Thus, our aim was to provide algorithms to convert PROMIS-29 data to well-established SF-36 component summary scores.MethodsData from n = 662 participants of the Berlin Long-term Observation of Vascular Events (BeLOVE) study were used to estimate linear regression models with either PROMIS-29 domain scores or aggregated PROMIS-29 physical/mental health summary scores as predictors and SF-36 physical/mental component summary scores as outcomes. Data from a subsequent assessment point (n = 259) were used to evaluate the agreement between empirical and predicted SF-36 scores.ResultsPROMIS-29 domain scores as well as PROMIS-29 health summary scores showed high predictive value for PCS, PCSc, and MCSc (R2 ≥ 70%), and moderate predictive value for MCS (R2 = 57% and R2 = 40%, respectively). After applying the regression coefficients to new data, empirical and predicted SF-36 component summary scores were highly correlated (r > 0.8) for most models. Mean differences between empirical and predicted scores were negligible (|SMD|<0.1).ConclusionsThis study provides easy-to-apply algorithms to convert PROMIS-29 data to well-established SF-36 physical and mental component summary scores in a cardiovascular population. Applied to new data, the agreement between empirical and predicted SF-36 scores was high. However, for SF-36 mental component summary scores, considerably better predictions were found under the correlated (MCSc) than under the original factor model (MCS). Additionally, as a pertinent byproduct, our study confirmed construct validity of the relatively new PROMIS-29 health summary scores in cardiology patients.

Predictors of health-related quality of life in a large cohort of adult patients living with sickle cell disease in France: the DREPAtient study.

Sickle cell disease (SCD) is an inherited autosomal recessive disorder exhibiting a range of symptoms and acute and/or chronic complications that affect the quality of life. This study aimed to assess health-related quality of life (HRQoL) and to identify the associated factors in adult patients with SCD in France. DREPAtient is a cross-sectional, multicenter study conducted from June 2020 to April 2021 in France and in certain French overseas territories where SCD is highly prevalent. Sociodemographic and clinical data were collected online. HRQoL was assessed by the French version of the 36-Item Short Form Survey (SF-36) questionnaire. HRQoL determinants were identified using multivariable linear regression analysis. In total, 570 participants were included, mostly women (68.9%), with a mean age of 33.3 (±10.7) years. The highest mean score HRQoL was found in the Physical functioning domain (67.5 ± 21.8) and the lowest mean score in the General Health perception domain (37.7 ± 20.3). The mean score of the physical composite (PCS) and mental composite (MCS) of SF-36 summary scores was 40.6 ± 8.9 and 45.3 ± 9.8, respectively. Participants receiving oxygen therapy (β = -3.20 [95%CI: -5.56; -0.85]), those with a history of femoral osteonecrosis (-3.09 [-4.64; -1.53]), those hospitalized for vaso-occlusive crisis (VOC) or acute chest syndrome (ACS) (-2.58 [-3.93; -1.22]), those with chronic complications (-2.33 [-4.04; -0.62]), female participants (-2.17 [-3.65; -0.69]), those with psychological follow-up (-2.13 [-3.59; -0.67]), older participants (-1.69 [-3.28; -0.09]), and those receiving painkillers (-1.61 [-3.16; -0.06]) reported worse PCS score. By contrast, those who had completed secondary or high school (4.36 [2.41; 6.31]) and those with stable financial situation (2.85 [0.94, 4.76]) reported better PCS scores. Worse MCS scores were reported among participants with psychological follow-up (-2.54 [-4.28; -0.80]) and those hospitalized for VOC/ACS in the last 12 months (-2.38 [-3.99; -0.77]), while those who had relatives' support (5.27 [1.92; 8.62]) and those with stable financial situation (4.95 [2.65; 7.26]) reported better MCS scores. Adults with major SCD reported poor physical and mental HRQoL scores. Hospitalization for VOC/ACS, chronic complications, use of painkillers, perceived financial situation, and support from relatives are important predictors of HRQoL in SCD patients. Interventions to improve HRQoL outcomes SCD should be considered.

Quality of life and its associated factors in chronic kidney disease patients undergoing hemodialysis from a Peruvian city: A cross-sectional study.

To assess quality of life and explore its associated factors in a group of patients with chronic kidney disease (CKD) undergoing hemodialysis in Peru. We conducted a cross-sectional analysis of patients with CKD treated at two medical centers in Tacna, Peru; between July and September 2023. We conducted a survey via telephone interviews with eligible patients using the Short Form 36 (SF 36) to assess their quality of life. Of 257 patients with CKD undergoing hemodialysis, we successfully interviewed 207 (59.9% males, median age: 62 years, median time on hemodialysis: 3.5 years). In the context of the SF-36 assessment, the dimensions with the lowest scores were physical role (mean: 13.9), emotional role (32.2), and physical function (32.4). Regarding the SF-36 summary scores, the average scores were 42.2 in the mental health domain and 32.0 in the physical health domain. In the adjusted model, the physical health domain score was higher in males (β = 2.7) and those with economic self-sufficiency (β = 3.0) and lower in older adults (β = -2.5). The score in the mental health domain was higher in those with a higher level of education (β = 4.1), in those with economic self-sufficiency (β = 3.8), and in those receiving care at one of the centers included (β: 4.2). Quality of life was affected, particularly in the realms of physical and emotional well-being. Furthermore, both the physical and mental health domains tend to show lower scores among women, older individuals, those lacking economic self-sufficiency, individuals with lower educational levels, and those with comorbidities.

Utility Scores for Risk-Reducing Mastectomy and Risk-Reducing Salpingo-Oophorectomy: Mapping to EQ-5D.

Risk-reducing mastectomy (RRM) and risk-reducing salpingo-oophorectomy (RRSO) are the most effective breast and ovarian cancer preventive interventions. EQ-5D is the recommended tool to assess the quality of life and determine health-related utility scores (HRUSs), yet there are no published EQ-5D HRUSs after these procedures. These are essential for clinicians counselling patients and for health-economic evaluations. We used aggregate data from our published systematic review and converted SF-36/SF-12 summary scores to EQ-5D HRUSs using a published mapping algorithm. Study control arm or age-matched country-specific reference values provided comparison. Random-effects meta-analysis provided adjusted disutilities and utility scores. Subgroup analyses included long-term vs. short-term follow-up. Four studies (209 patients) reported RRM outcomes using SF-36, and five studies (742 patients) reported RRSO outcomes using SF-12/SF-36. RRM is associated with a long-term (>2 years) disutility of -0.08 (95% CI -0.11, -0.04) (I2 31.4%) and a utility of 0.92 (95% CI 0.88, 0.95) (I2 31.4%). RRSO is associated with a long-term (>1 year) disutility of -0.03 (95% CI -0.05, 0.00) (I2 17.2%) and a utility of 0.97 (95% CI 0.94, 0.99) (I2 34.0%). We present the first HRUSs sourced from patients following RRM and RRSO. There is a need for high-quality prospective studies to characterise quality of life at different timepoints.

A case–control study on health-related quality of life of systemic lupus erythematosus patients

Systemic lupus erythematosus (SLE) is a chronic rheumatic autoimmune condition that can cause a wide range of symptoms and problems that may affect the health-related quality of life. The main objective of the study was to assess the SLE burden by exploring the effect of the disease on health-related quality of life. The study consisted of 29 female SLE patients and 27 healthy female controls; they were matched for age and parity. A 36-item Short Form health survey questionnaire (SF-36) was used to collect data from participants through face-to-face interviews and to assess their health-related quality of life. SF-36 summary scores for the physical and mental components were decreased in the studied patients compared with controls; PCS was 28.81 ± 16.63, 77.25 ± 15.75 for cases and controls, respectively; and MCS was 32.75 ± 18.69, and 78.75 ± 10.63 for cases and controls, respectively (p < 0.05). The high correlation between the two dimensions characterizes this decrease. SLE negatively affected the quality of life of the patients. Measures such as lifestyle modifications, physical activity, and a healthy diet should be taken to improve the health-related quality of life in SLE patients. In addition, raising the patient’s awareness about the disease and its consequences could help to cope with the illness and engage in social and physical activities.

Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health-Related Quality of Life.

Our objective was to evaluate the ability of Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) remission and low disease activity (LDA) to discriminate active drug from placebo and to discriminate outcomes in the patients' perspective (health-related quality of life [HR-QoL]) in SLE trials. This was a post hoc analysis of the pooled Belimumab in Subjects With SLE (BLISS)-52 (NCT00424476) and BLISS-76 (NCT00410384) trials data. SLE-DAS remission and LDA attainment and discrimination between belimumab and placebo at 52 weeks were compared using chi-square tests. At week 52, 36-item Short Form Health Survey (SF-36) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores were compared between patients attaining SLE-DAS remission versus nonremission and SLE-DAS LDA versus non-LDA using the t-test and Mann-Whitney test. Mean changes from week 0 to 52 in SF-36 and FACIT-F scores were compared between groups using multivariate regression analysis adjusted for baseline scores. At week 52, significantly more patients attained SLE-DAS LDA taking belimumab 1 mg/kg (17.9% vs 13.0%; P = 0.023; odds ratio [OR] 1.459; relative risk [RR] 1.377; number needed to treat [NNT] 20.4) and 10 mg/kg (21.7% vs 13.0%; P < 0.001; OR 1.853; RR 1.668; NNT 11.5) compared with placebo. Likewise, more patients attained SLE-DAS remission taking belimumab 10 mg/kg compared to placebo (14.7% vs 10.1%; P = 0.019; OR 1.532; RR 1.454; NNT 21.7). At week 52, patients attaining SLE-DAS remission and LDA presented higher SF-36 domain and summary scores (all P < 0.001) and FACIT-F scores (both P < 0.001). Mean improvements from baseline in SF-36 and FACIT-F scores were significantly higher in patients achieving SLE-DAS remission and LDA. SLE-DAS remission and LDA showed discriminant ability for identifying patients receiving active drug in SLE clinical trials. Attainment of these SLE-DAS targets are associated with better HR-QoL.

Kinematic adaptations from self-selected to fast speed walking in patients with adult spinal deformity.

To investigate kinematic adaptations from self-selected to fast speed walking in ASD patients. 115 primary ASD and 66 controls underwent biplanar radiographic X-rays and 3D gait analysis to calculate trunk, segmental spine and lower limb kinematics during self-selected and fast speed walking. Kinematic adaptation was calculated as the difference (Δ) between fast and self-selected speed walking. ASD with 7 or more limited kinematic adaptation parameters were classified as ASD-limited-KA, while those with less than 7 limited kinematic adaptation parameters were classified as ASD-mild-KA. 25 patients were classified as ASD-limited-KA and 90 as ASD-mild-KA. ASD-limited-KA patients walked with a lesser increase of pelvic rotation (Δ = 1.7 vs 5.5°), sagittal hip movement (Δ = 3.1 vs 7.4°) and shoulder-pelvis axial rotation (Δ = 3.4 vs 6.4°) compared to controls (all p < 0.05). ASD-limited-KA had an increased SVA (60.6 vs -5.7mm), PT (23.7 vs 11.9°), PI-LL (9.7 vs -11.7°), knee flexion (9.2 vs -0.4°) and a decreased LL (44.0 vs 61.4°) compared to controls (all p < 0.05). Kinematic and radiographic alterations were less pronounced in ASD-mild-KA. The limited increase of walking speed was correlated to the deteriorated physical component summary score of SF-36 (r = 0.37). Kinematic limitations during adaptation from self-selected to fast speed walking highlight an alteration of a daily life activity in ASD patients. ASD with limited kinematic adaptations showed more severe sagittal malalignment with an increased SVA, PT, PI-LL, and knee flexion, a decreased LL and the most deteriorated quality of life. This highlights the importance of 3D movement analysis in the evaluation of ASD.

Association among cardiopulmonary and metabolic rehabilitation, arrhythmias, and myocardial ischemia responses of patients with HFpEF or HFmrEF.

There's limited evidence of the potential benefits of cardiopulmonary and metabolic rehabilitation (CPMR) in patients with heart failure with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF) and coronary artery disease (CAD). The aim of this study was to investigate the impact of CPMR on the myocardial ischemia response (MIR), exercise-induced arrhythmias (EIA), New York Heart Association (NYHA) functional class, heart rate recovery (HRR), Borg CR10 perceived symptoms, and the SF-36 physical and mental health summary scores. A prospective cohort study was conducted with 106 patients undergoing 12 weeks of CPMR who completed two exercise tests pre- and post-CPMR: 1) maximum incremental test (CPX) and 2) submaximal constant load test (SUB). After CPMR, the effects on MIR, EIA, NYHA functional class, and HRR during both tests were analyzed. There was a significant change in NYHA functional classes after CPMR, with 96% of the patients in class I (vs 62% pre-CPMR, P<0.0001), 4% in class II (vs 32%), and none in class III (vs 6%). There was a significant reduction in the frequency of EIA (P<0.05) and MIR (P<0.001) and a significantly improved performance on both CPX and SUB tests (P<0.0001). Lastly, there was significant progress in the recovery metrics like HRR (P<0.0001), the Borg CR10 (P<0.0001), and the SF-36 summary scores (P<0.0001). The CPMR resulted in a significant decrease in EIA, delayed ischemia threshold in CPX and SUB tests, increased functional capacity, and improved quality of life.

Scarred for Life? Early-Life Experience of the Post-Reunification Economic Crisis in East Germany and Physical and Mental Health Outcomes in Early Adulthood

Existing research suggests adverse short-term health effects of economic crises during early life, yet, the long-term health effects for children and adolescents exposed to economic crises are still understudied. We investigated the early-adult health implications of experiencing the post-reunification economic crisis in East Germany in the early 1990s during infancy, childhood and adolescence. Using data from the German Socio-Economic Panel (SOEP) and its linkage with German pension records (SOEP-RV), we applied entropy balancing and conditional quantile regression to assess the relationship between the experience of the economic crisis during early life (ages 0-17) and physical and mental health effects (SF-12 summary scores) in N = 2,337 young adults (aged 17-30) from East and West Germany. Our results indicate mainly no significant physical health effects, yet, significant adverse mental health effects for respondents exposed to the economic crisis in East Germany, especially in young women of average and better mental health. Parental unemployment was an additional risk factor for young women’s mental health. Thus, we suggest women who experienced economic crises during early life are at increased risk of adverse mental health effects already early in their adulthood. Support for families in times of economic crisis and early prevention for infants, children and adolescents exposed to economic adversities is warranted.

Impact of walk advice alone or in combination with supervised or home-based structured exercise on patient-reported physical function and generic and disease-specific health related quality of life in patients with intermittent claudication, a secondary analysis in a randomized clinical trial

BackgroundSupervised exercise is an integral part of the recommended first-line treatment for patients with intermittent claudication (IC). By reflecting the patients’ perspectives, patient-reported outcome measurements provide additional knowledge to the biomedical endpoints and are important outcomes to include when evaluating exercise interventions in patients with IC. We aimed to evaluate the one-year impact of three strategies: unsupervised Nordic pole walk advice (WA), WA + six months of home-based structured exercise (HSEP) or WA + six months of hospital-based supervised exercise (SEP) on health-related quality of life and patient-reported physical function in patients with IC.MethodsThis secondary exploratory analysis of a multi-center, randomized clinical trial compared three exercise strategies. The primary outcome of the secondary analysis was the one-year change in the 36-Item Short-Form (SF-36). Secondary outcomes were three- and six-months SF-36 changes alongside three, six- and 12-months changes in the disease-specific Vascular Quality of Life instrument (VascuQoL) and the Patient-Specific Functional Scale (PSFS). The Kruskal–Wallis test with Bonferroni-adjusted post-hoc tests were used for between-group comparisons. Effect size calculations were used to describe the size of observed treatment effects, and the clinical meaningfulness of observed changes in the VascuQoL summary score at one year was studied using established minimally important difference (MID) thresholds.ResultsA total of 166 patients with IC, mean age: 72.1 (SD 7.4) years, 41% women, were randomized. No significant between-group differences were observed over time for the SF-36 or the PSFS scores whereas some significant between-group differences were observed in the VascuQoL domain and summary scores over time, favoring SEP and/or HSEP over WA. The observed SF-36 and VascuQoL domain and summary score effect sizes were small to moderate, and many domain score effect sizes also remained unchanged over time. A significantly higher proportion of the patients in the SEP group reached the VascuQoL summary score MID of improvement in one year.ConclusionClinically important improvements were observed in SEP using the VascuQoL, while we did not observe any significant between-group differences using the SF-36. Whereas effect sizes for the observed changes over time were generally small, a significantly higher proportion of patients in SEP reached the VascuQoL MID of improvement.Trial registrationNCT02341716, January 19, 2015 (retrospectively registered).

953-P: The Use of isCGM Improves the Mental Aspect of Quality of Life in Overweight Individuals with Impaired Glucose Tolerance or Mild Diabetes Mellitus

Objective: We aimed to investigate the relationship between the use of intermittently scanned continuous glucose monitoring (isCGM) and quality of life (QoL) in overweight individuals with impaired glucose tolerance (IGT) or mild type 2 diabetes mellitus (T2DM). Methods: Forty overweight individuals (BMI ≥25kg/m2) having IGT or mild T2DM (without taking antidiabetic drugs and with HbA1c ≤7.0%) were recruited. We randomly divided the subjects into two groups: those using isCGM in addition to diet and exercise therapy (isCGM group) and those treated with diet and exercise therapy alone (control group). We conducted a 6-month intervention and assessed QoL using SF36 before and after the intervention. Results: One participant in the isCGM group withdrew the consent. We thus analyzed 19 participants in the isCGM group (53.8±11.5 years old, BMI 35.2±5.7 kg/m2, HbA1c 6.2±0.3%) and 20 participants in the control group (54.3±14.0 years old, BMI 31.6±6.8 kg/m2, HbA1c 6.2±0.3%). There were no differences in changes in each subscale of the SF36 and component summary scores between the isCGM and control groups. In the isCGM group, Mental Component Summary (MCS) improved significantly after the intervention (43.6/48.2, p&amp;lt;0.05). Changes in SD and Time Above Range (TAR) were negatively correlated with changes in general health perception (GH) (r= -0.50, p&amp;lt;0.05; r= -0.53, p&amp;lt;0.05). The number of scans positively correlated with vitality, mental health, and MCS before and after the intervention. Conclusions: The use of isCGM improved MCS in overweight individuals with IGT or drug-naïve T2DM. The improvement in SD and TAR with the use of isCGM likely contributed to the improvement in GH. In addition, the number of scans correlated with MCS, suggesting that vitality and mental health are essential for the effective use of isCGM. Disclosure S. Nishikage: None. Y. Nakagawa: None. Y. Hirota: Other Relationship; Lilly, Sanofi K.K., Terumo Corporation, Sumitomo Dainippon Pharma Co., Ltd. Research Support; Sumitomo Dainippon Pharma Co., Ltd. K. Yoshimura: None. M. Ueda: None. A. Yamamoto: None. T. Takayoshi: None. A. Matsuoka: None. M. Takahashi: None. K. Yokota: None. T. Nakamura: None. K. Sakaguchi: Research Support; Sumitomo Dainippon Pharma Co., Ltd. W. Ogawa: Advisory Panel; Abbott Japan Co., Ltd. Research Support; Boehringer Ingelheim Japan, Inc., Eli Lilly Japan K.K., Novo Nordisk, Teijin Pharma Limited, Kowa Company, Ltd., Sumitomo Dainippon Pharma Co., Ltd., Abbott Japan Co., Ltd. Speaker's Bureau; Sumitomo Dainippon Pharma Co., Ltd.

The relationship between clinical phenotype and kallikrein-kinin bioregulation in different forms of arthritis

ObjectivePatients with rheumatoid arthritis (RA) have shown increased levels of neutrophils generating kallikrein-kinin peptides in blood which are potent mediators of inflammation. This study investigated the association between the bioregulation of kinin-mediated inflammation with the clinical, quality of life, and imaging characteristics (e.g. ultrasonography) of different arthritides.MethodsPatients with osteoarthritis (OA, n = 29), gout (n = 10) and RA (n = 8) were recruited and screened for clinical symptoms, quality of life, and ultrasonographical assessment of arthritis. Blood neutrophils were assessed for the expression of bradykinin receptors (B1R and B2R), kininogens and kallikreins by immunocytochemistry with visualization by bright field microscopy. Levels of plasma biomarkers were measured by ELISA and cytometric bead array.ResultsQuality of life (SF-36 domains and summary scores; including pain; and, HAQ) was similar across OA, gout and RA patients; with the exception of worse physical functioning scores between OA and gout patients. Synovial hypertrophy (on ultrasound) differed between groups (p = 0.001), and the dichotomised Power Doppler (PD) score of greater than or equal to 2 (PD-GE2) was marginally significant (p = 0.09). Plasma IL-8 were highest in patients with gout followed by RA and OA (both, P < 0.05). Patients with RA had higher plasma levels of sTNFR1, IL-1β, IL-12p70, TNF and IL-6, compared to OA and gout patients (all, P < 0.05). Patients with OA had higher expression of K1B and KLK1 on blood neutrophils followed by RA and gout patients (both, P < 0.05). Bodily pain correlated with B1R expression on blood neutrophils (r = 0.334, p = 0.05), and inversely with plasma levels of CRP (r = −0.55), sTNFR1 (r = −0.352) and IL-6 (r = −0.422), all P < 0.05. Expression of B1R on blood neutrophils also correlated with Knee PD (r = 0.403) and PD-GE2 (r = 0.480), both P < 0.05.ConclusionsPain levels and quality of life were similar between patients with OA, RA and gout with knee arthritis. Plasma inflammatory biomarkers and B1R expression on blood neutrophils correlated with pain. Targeting B1R to modulate the kinin-kallikrein system may pose as a new therapeutic target in the treatment of arthritis.

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.

Validation of the Turkish Version of the Sarcoidosis Health Questionnaire: A cross-sectional study.

Sarcoidosis, a multisystemic granulomatous disease, generally results in a lower quality of life (QoL) because of its unexpected course and diverse clinical symptoms. The Sarcoidosis Health Questionnaire (SHQ) evaluates the QoL for people with sarcoidosis in terms of their health. This study set out to validate the SHQ in a group of Turkish sarcoidosis patients. The study included a total of 146 adult sarcoidosis patients (63 male and 83 female; mean age, 44±3.6 years; range, 27-63 years) between May 2019 and September 2021. Preparation, forward translation, reconciliation, back translation/back translation review, harmonization, finalization, and proofreading comprised the steps of the testing procedure for translation and cultural adaptation. The participants filled out three questionnaires, including the SHQ, 36-Item Short Form (SF-36) Health Survey, and King's Sarcoidosis Questionnaire (KSQ), and underwent pulmonary function tests (PFTs). Of the patients, 95% had lung involvement, with a mean number of 1.3 organs involved. Each SHQ component displayed a moderate to high internal consistency, ranging from 0.806 to 0.844. The whole scale's Cronbach's alpha value was 0.781. The SHQ total score significantly correlated with physical component summary (p< 0.001, r=0.360) and mental component summary (p<0.001, r=0.352) scores of SF-36, and the general health status (p< 0.001, r=0.478), medication component (p<0.001, r=0.456), and eye component scores of KSQ (p<0.001, r=0.545). When patients were divided into groups based on organ involvement (p=0.01), oral steroid medication (p<0.001), and types of symptoms (P=0.021), there were significant differences in the total SHQ scores. The Turkish version of SHQ can be a valid and accurate instrument for assessing the health of sarcoidosis patients in Turkey. When combined with normal physiological, radiological, and serological examinations, SHQ can assess the QoL of sarcoidosis patients and give useful new information.

The Association between Fear of COVID-19 and Health-Related Quality of Life: A Cross-Sectional Study in the Greek General Population.

The aim of this cross-sectional study was to assess the level of fear related to the SARS-CoV-2 virus and the association of fear, and of sociodemographic and clinical characteristics, with health-related quality of life (HRQoL). A large sample of the Greek general population (N = 583) completed the validated versions of the Fear of COVID-19 scale (FCV-19s) and the 12-item Short Form (SF-12), and provided data on socio-demographic status, health history and COVID-19 protective behaviors. Variables were compared with Mann-Whitney and Kruskal-Wallis tests and associations with Spearman's correlations. Gamma regression models investigated the influence of sociodemographic and COVID-related variables on HRQoL. The mean FCV-19s score for the sample was 18.3 ± 5.6, and physical and mental component summary scores were 50.2 ± 7.9 and 46.7 ± 10.1, respectively. More fear of COVID-19 was expressed by females (p &lt; 0.001), individuals with comorbidities (p &lt; 0.01), those with contacts with comorbidities (p &lt; 0.001), and individuals not having caught COVID-19 (p &lt; 0.05). Contrastingly, less fear was expressed by unvaccinated individuals and those with less frequent intake of information about the pandemic. Item level and overall FCV-19s scores were negatively associated with SF-12 summary scores, and fear of COVID-19 was the most important predictor of both physical and mental HRQoL. The findings from this and other similar studies could help to identify specific population groups in need of interventions to improve their physical and mental health, which had deteriorated due to the pandemic.