Health-related Quality Of Life Outcomes Research Articles

Long-Term Disease-Free Survival and Health-Related Quality of Life Results of High-Dose-Rate Brachytherapy as Monotherapy for Low and Intermediate-Risk Prostate Cancer Treated in a Community Cancer Centre

To determine the long-term disease-free survival, long-term toxicity, and effect on health-related quality of life of a two-fraction regimen of high-dose-rate (HDR) prostate brachytherapy. Patients with low- or intermediate-risk prostate cancer were treated with CT-planned HDR brachytherapy as monotherapy in two implants of 13.5 Gy in one community cancer center. Prostate-specific antigen (PSA), International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires were evaluated at each follow-up visit. Biochemical recurrence (Phoenix definition) was evaluated to determine disease-free survival at 5 and 7 years. Proportion of patients in each IPSS category (mild = 0-7, moderate = 8-18, severe = 19+) was evaluated at each follow-up interval. Thirty patients were accrued to the study between 2014 and 2016. Median prostate-specific antigen was 8,7 (range 4.1-17.5). T stages were T1c = 65%, T2a = 21%, and T2b = 14%. Twenty-seven percent of patients had a Gleason score of 6 and 73% had a Gleason score of 7. 13% were in low risk category and 87% in intermediate risk category. Median follow-up was 84 months. There were no deaths at 84 months after brachytherapy. Disease-free survival was 90% at 5 years and 86% at 7 years. Two patients experienced late Grade 3 GU toxicity (6.6%). This study serves as proof of concept that HDR monotherapy can be performed successfully with excellent long-term outcomes in a community cancer center with adequate training and experience. The long-term disease-free survival rate and the health-related quality of life seem acceptable as compared to other treatment modalities. Further study is ongoing with regard to the optimal dosing regimen for HDR monotherapy.

QOL-14. HEALTH-RELATED QUALITY OF LIFE AND COGNITIVE FUNCTIONING IN SURVIVORS OF OLIGODENDROGLIOMA: AN INTERNATIONAL CROSS-SECTIONAL INVESTIGATION

Abstract BACKGROUND Patients with oligodendroglioma have a relatively favourable prognosis. Treatment modalities used vary, and the long-term impacts of the tumour itself and its treatment on health-related quality of life (HRQOL) and cognition remain largely unclear. We investigated associations between treatment and functioning of oligodendroglioma patients. METHODS In this international cross-sectional observational study, patients with oligodendroglioma (IDH-mutant and 1p/19q-codeleted) diagnosed ≥5 years ago, were recruited through the European Organisation for Research and Treatment of Cancer (EORTC) networks. Diagnosis and treatment data were collected from medical records; patients completed outcomes for HRQOL (EORTC QLQ-C30; BN20), self-reported cognitive functioning (MOS Cognitive Complaints Scale) and cognitive tests (HVLT-R, TMT, COWAT). Associations between HRQOL and cognition outcomes, and clinical variables (time since diagnosis; progression; tumour location; treatments delivered; current medication; Karnofsky Performance Status (KPS)) were explored with regression analyses. RESULTS 242 oligodendroglioma patients on average 9.9 years post-diagnosis (sd=4.3, range=5.0-26.3) took part from 33 sites across 9 countries. Patients were M=52 years old (sd=12, range=23-78), the majority were men (N=145; 60%). Higher KPS, no radiotherapy (ever), no current medication (anxiolytics/sedatives; antidepressants; dexamethasone) were associated with better generic HRQOL outcomes (QLQ-C30 functioning scale models; R2 range 0.068-0.371, all p<.001). Higher KPS, fewer recurrences, no radiotherapy treatment (ever), and no current antidepressant use were linked to better disease-specific HRQOL (BN20 multi-item scale models; R2 range 0.067-0.246, p<0.001). Fewer subjective cognitive complaints were associated with higher KPS and no current antipsychotic medication (R2=0.153, p<0.001). Better KPS, right hemispheric tumours, longer time since diagnosis, no chemotherapy (ever), no radiotherapy (ever), and no current medications (dexamethasone; antipsychotics) were predictive of better cognitive functioning (R2 range 0.056-0.248, p<0.001). CONCLUSION In oligodendroglioma survivors, better HRQOL and cognitive outcomes appeared consistently linked with higher KPS, no current medication use, and never having received radiotherapy. Additionally, better cognitive outcomes were associated with no chemotherapy treatment.

Examining health-related quality of life outcomes among older patients with advanced ovarian cancer treated with niraparib first-line maintenance therapy in context with efficacy and safety findings: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial

Examining health-related quality of life outcomes among older patients with advanced ovarian cancer treated with niraparib first-line maintenance therapy in context with efficacy and safety findings: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial

Health-Related Quality of Life and Financial Burden in Ethiopian Patients With Chronic Myeloid Leukemia Receiving Tyrosine Kinase Inhibitors: A Cross-Sectional Study.

Health-related quality of life (HRQoL) is now an important goal of therapy for patients with chronic myeloid leukemia (CML). However, there is paucity of data for patients living in low-income countries (LICs) and on factors associated with their HRQoL profile. The primary objective was to compare the HRQoL of patients with CML living in an LIC (Ethiopia) with that of patients living in a high-income country (HIC). Adult patients with CML treated with tyrosine kinase inhibitors in Ethiopia were considered eligible for this study. To assess their HRQoL and symptom burden, eligible patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the EORTC Quality of Life Questionnaire Chronic Myeloid Leukemia 24 (QLQ-CML24). A matched case-control analysis was applied to compare the HRQoL profile of the herein-recruited Ethiopian cohort with a sample of patients with CML from an HIC (Italy). Overall, 395 Ethiopian patients were enrolled between February 2021 and June 2021. Except for dyspnea and satisfaction with care, the Ethiopian patients reported lower HRQoL and functioning and higher symptom burden compared with patients with CML living in an HIC. A remarkable proportion of Ethiopian patients (n = 353, 89.4%) reported financial toxicity (FT). Compared with patients without FT, those with FT reported a higher prevalence of clinically important problems and symptoms across all the QLQ-C30 scales. For example, the prevalence of clinically important impairment of social functioning was almost sixfold higher for patients with FT compared with those without FT (41.8%, 7.1%, respectively). Our results indicate that the HRQoL profile of patients with CML living in Ethiopia may be worse across several important functional and symptom domains than that of their peers living in an HIC. In addition, FT is highly prevalent among these patients and it is associated with poorer HRQoL outcomes.

Determinants of quality of life and emotional well-being in a bariatric surgery seeking cohort of 1501 multi-ethnic Asian patients.

The relationship between ethnicity, obesity and health-related quality of life outcomes in a multi-ethnic population remains poorly understood. We aim to investigate the relationship between ethnicity, body mass index (BMI), obesity-associated diseases, as well as determinants of quality of life (QoL) in Southeast Asian patients with obesity. We aim to develop and validate a simple objective score to identify patients with obesity at high risk for major depression. Associations between ethnicity, obesity-associated diseases, BMI and determinants of QoL (Patient Health Questionnaire-9 and 36-Item Short Form Survey) were analysed using multivariate logistic regression in a prospective cohort of 1501 patients with obesity. Multivariate regression and receiver operating characteristics curves were used to develop and validate a novel scoring system to identify patients at risk of major depression. Patients of Chinese, Malay and Indian ethnicity had increased risk of hypertension (odds ratio [OR]: 1.51 [95% confidence interval [CI]: 1.19-1.92, p < .001]), BMI Class 4 (OR: 17.89 [95% CI: 9.53-33.60, p < .001]) and major depression (OR: 1.71 [95% CI: 1.23-2.39, p = .002]), respectively. Factors associated with major depression (gender, ethnicity, age, obstructive sleep apnoea, Physical Component Score and Mental Component Score scores) were used to create and validate a novel scoring system with an area under curve of 0.812 (95% CI: 0.787-0.837). A cutoff of 4 of 7 points was identified with a sensitivity of 70%, specificity of 81%, positive predictive of 53% and negative predictive value of 90%. The prevalence of metabolic complications from obesity significantly varies with ethnicity. We developed a novel and simple scoring tool combining objective demographic and patient-reported outcomes to screen and triage patients at risk of major depression.

A systematic review and meta-analysis of health-related quality of life (HRQoL) outcomes in randomised controlled trials for pulmonary arterial hypertension (PAH)

Abstract Introduction ESC guidelines recognise the under use of disease-specific health-related quality of life (HRQoL) instruments. These include CAMPHOR, PAH-SYMPACT, Emphasis-10 and Living with Pulmonary Hypertension (LPH). Patients highly value HRQoL as a treatment outcome in PAH. This is the first meta-analysis to evaluate HRQoL instruments and outcomes in RCTs in pulmonary arterial hypertension (PAH). Purpose To evaluate which PAH-RCT interventions improve HRQoL outcomes and compare the suitability of HRQoL instruments used. Method We searched MEDLINE (Jan 1970 to Dec 2023) and Cochrane Library from Jan 1990 to Dec 2023 (EMBASE, CT.gov, ICTRP, CINAHL) for RCTs in PAH. Abstracts and unpublished studies were excluded and PRISMA reporting structure followed. Trials meeting final selection criteria included HRQoL instruments sufficiently powered to detect a minimal clinically important difference (MCID). Effective sample sizes were calculated in GPower3.1 from a two independent means model for 80% power, 5% significance, one-tailed test. Meta-analysis was performed in SPSSv28.1. Full search criteria are registered on PROSPERO (ID: CRD42024484021). Results After removal of duplicates, 896 records were screened, 43 studies included a HRQoL endpoint. 8 studies were included in the meta-analysis after exclusion for insufficient data (n=10) or power (n=25). 3 of these did not meet the MCID (&amp;gt;33m) for six-minute walk distance (6MWD) and evaluated separately to discriminate accuracy of HRQoL instrument. Instruments available for comparison were Short Form-36(SF-36), EuroQol (EQ-5D-5L) and Living with Pulmonary Hypertension (LPH). Studies not reaching MCID for 6MWD also showed no change in HRQoL (figure 1). Ambrisentan and exercise training demonstrate a significant improvement (p&amp;lt;0.05) in SF-36 physical(P) component (figure 2). This component was anchored to determine 6MWD MCID; other HRQoL values responded variably. Utility weighting to account for geographical variation was not reported with EQ-5D-5L and SF-36 in multicentre studies however AIR 2002 (Iloprost) was significant for both EQ-5D-5L instruments. The total component score of the disease-specific LPH was more sensitive to functional improvements and overall change in HRQoL compared to EQ-5D-5L (p&amp;lt;0.05). Conclusion Fewer than 10% of all RCTs in PAH have adequately considered a HRQoL outcome measure. 8 RCTs were powered to assess HRQoL. Iloprost, ambrisentan, riociguat and exercise training interventions demonstrate significant improvement in HRQoL. LPH was the only PAH-instrument powered to detect change. LPH was more sensitive to HRQoL than generic instruments and is multidimensional. Geographical indexing should be considered for generic instruments such as EQ-5D-5L and SF-36 in multicentre trials. As a highly valued outcome for patients, future studies should prioritise HRQoL as an endpoint.Figure 1Figure 2

A Scoping Review of Patient Health-Related Quality of Life Following Surgery or Molecular Testing for Individuals with Indeterminate Thyroid Nodules.

Molecular testing can reduce the need for diagnostic thyroidectomy in cytologically indeterminate thyroid nodules. However, the health-related quality of life in patients managed with molecular testing is not well studied. The objective of this scoping review was to identify and analyze the health-related quality of life outcomes in patients with indeterminate thyroid nodules who are expected to undergo or have undergone surgery or molecular testing. A comprehensive search was conducted on PubMed, Scopus, PsychINFO, and Embase to identify relevant studies. The search terms included "thyroid neoplasms" or "thyroid nodule" and "molecular testing" or "surgery" and "quality of life". The included articles were analyzed for their main study objective, study design, participant characteristics, and main results. Eight studies were included in this scoping review. Four evaluated the quality-adjusted life years for patients with indeterminate thyroid nodules. Three of these studies found that molecular testing slightly improved quality-adjusted life years compared to surgery, while one study found no difference. Two studies assessed surgical health-related quality of life outcomes and reported that patients with indeterminate thyroid nodules who were expected to undergo surgery favored surgical procedures, while those who underwent surgery experienced impaired health-related quality of life. Two studies evaluated molecular testing in patients with indeterminate thyroid nodules and found that the final molecular test result significantly impacted health-related quality of life outcomes. Patients with suspicious/positive molecular test results had worse symptoms of goiter, anxiety, and depression, while those with benign results had preserved health-related quality of life scores. Patients with benign results from molecular testing experience better health-related quality of life within the first year compared to those with benign surgical outcomes. This scoping review highlights the importance of considering health-related quality of life outcomes in the management of patients with indeterminate thyroid nodules. Benign molecular testing results yield better quality of life than benign surgical outcomes within the first year, suggesting molecular testing as a preferable option. Further research comparing the impact of surgery and molecular testing on health-related quality of life is needed to improve shared decision-making and patient outcomes.

Health-related quality of life of toddlers during and after cancer treatment

BackgroundThere is a knowledge gap regarding health-related quality of life (HRQOL) in childhood cancer patients below 2 years of age. The aim of this study was therefore to compare HRQOL of young children during and after treatment for cancer, to healthy controls, and to investigate effects of biopsychosocial factors. ProcedureThe study is based on data from an online monitoring program. Parent-proxy reports of HRQOL in 205 children aged 12–24 months were compared to 108 healthy children. The parents filled out the TNO-AZL Preschool Quality of Life questionnaire for young children, which consists of 12 subscales, in addition to a parental distress thermometer. ResultsParticipants undergoing treatment had less favorable HRQOL than children after treatment for eight of the subscales. They also had less favorable HRQOL than healthy children for seven scales, while the only significant difference between children off treatment and healthy controls was for motor functioning. For ten subscales, there were significant relationships between biopsychosocial variables and HRQOL outcomes. Parental distress and treatment with immunotherapy were the variables most frequently associated with lower HRQOL. ConclusionsParental distress should be considered when monitoring young childhood cancer patients. Treatment with immunotherapy is likely to be a marker of disease severity and might represent other underlying factors affecting HRQOL. The association between immunotherapy and HRQOL therefore needs more research. While there was a significant difference depending on treatment status, it cannot be concluded that this represents an improvement in HRQOL after end of treatment.

Quality of life and functional outcome of rectal cancer patients: A prospective cohort study.

In the last decade, the Netherlands has implemented various diagnostic and treatment strategies to enhance rectal cancer outcomes. This study, using data from the Prospective Dutch ColoRectal Cancer (PLCRC) cohort, investigates whether these multidisciplinary advancements have translated into improved health-related quality of life (HRQoL) and functional outcomes for the general Dutch rectal cancer population. Patients with Stage I-III rectal cancer enrolled in the PLCRC cohort were included. HRQoL and functional outcomes were assessed 1 and 2 years after diagnosis using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), EORTC QLQ Colorectal Cancer 29 and the Low Anterior Resection Syndrome score. HRQoL and functional outcomes were compared based on year of diagnosis (2014-2019). A total of 1294 patients were included. Two years after diagnosis, patients diagnosed in 2019 (n = 392) had a clinically relevant higher score on physical (8.2, 95% CI 4.1-12.3), role (13.5, 95% CI 7.3-19.7) and social functioning (5.8, 95% CI 0.3-11.2) compared to those diagnosed in 2014 (n = 65). Additionally, patients diagnosed in 2019 experienced less fatigue 2 years after diagnosis compared to those diagnosed in 2014 (-8.6, 95% CI -14.1 to -3.0). The Low Anterior Resection Syndrome score showed no differences. The findings of this study suggest that over the past decade rectal cancer patients in the Netherlands have witnessed improvements in HRQoL across various domains. Most probably, the improvement is due to a combination of implementation of population screening, a more restrictive neoadjuvant radiotherapy policy and advances in minimally invasive surgery and organ preserving treatment options.

Self-Efficacy Predicts Patient-Reported Outcomes Measurement Information System (PROMIS) Health-Related Quality of Life Outcomes in Turkish Patients on Dialysis Better than the 36-Item Short Form Health Survey (SF-36)

Self-Efficacy Predicts Patient-Reported Outcomes Measurement Information System (PROMIS) Health-Related Quality of Life Outcomes in Turkish Patients on Dialysis Better than the 36-Item Short Form Health Survey (SF-36)

Health-related quality of life of children and adolescents with sickle cell disease: An evolutionary concept analysis

The concept of Health-Related Quality of life (HRQOL) of children and adolescents with Sickle cell disease (SCD) is not clearly understood due to the lack of available studies. This review aimed to elucidate various attributes and related concepts of HRQOL in children and adolescents with SCD using Rodgers' (2000) concept analysis framework. A systematic search was performed to identify studies reporting the attributes, antecedents, consequences, surrogate terms, and related concepts of HRQOL in children and adolescents with SCD. The review included 75 articles, including 70 quantitative, two mixed-methods, and three qualitative studies. These were categorized into attributes, antecedents, consequences, surrogate terms, related concepts, and an exemplar of HRQOL in children and adolescents with SCD. The review identified nine important attributes. It includes multidimensional and dynamic concepts, acknowledging the illness, maintaining emotional balance and self-control, coping with the disease, pain management, stigma and discrimination, treatment burden, palliative care and personal resilience. The antecedents were knowledge and attitude toward the disease, self-efficacy, social support, spirituality and spiritual well-being, disease severity, access to healthcare, environmental factors, and financial considerations. The consequences were independence in personal life, improved physical health outcomes, psychological well-being, family and caregiver well-being, improved family, social and peer relationships and social interactions, improved school performance, and improved overall HRQOL and long-term outcomes. This analysis provides an overview of HRQOL concepts related to children and adolescents with SCD, guiding further research into nursing care and clinical practice.

Postprostatectomy Radiotherapy Timing and Long-Term Health-Related Quality of Life

The association between radiotherapy (RT) timing after radical prostatectomy and long-term patient-reported health-related quality of life (HRQOL) in men with prostate cancer is unknown. To measure long-term HRQOL in men with prostate cancer up to 15 years after prostatectomy with or without RT and examine whether early vs late postprostatectomy RT is associated with differences in sexual, urinary, and bowel HRQOL. A prospective, multicenter, longitudinal cohort analysis using HRQOL data from the PROST-QA (2003-2006) and RP2 consortium (2010-2013) studies was conducted. Men with localized prostate cancer undergoing radical prostatectomy were included. Data were analyzed between May 8, 2023, and March 1, 2024. The study was conducted in 12 high-volume academic medical centers in the US. Men were stratified based on receipt and timing of postprostatectomy RT: prostatectomy only, early RT (<12 months), and late RT (≥12 months). Longitudinal sexual, incontinence, urinary irritation, bowel, and hormonal/vitality HRQOL were measured via the Expanded Prostate Cancer Index Composite at baseline; months 2, 6, and 12; and annually thereafter. Treatment groups were compared using multivariable linear mixed-effects models of change in longitudinal domain scores. Pad use for incontinence was measured longitudinally among men receiving postprostatectomy RT. A total of 1203 men were included in the study: prostatectomy only (n = 1082), early RT (n = 57), and late RT (n = 64). Median age for the entire cohort was 60.5 (range, 38.8-79.7) years, and 1075 men (92.0%) were White. Median follow-up was 85.6 (IQR, 35.8-117.2) months. Compared with men receiving prostatectomy alone, those receiving postprostatectomy RT had significantly greater decreases in sexual, incontinence, and urinary irritation HRQOL. However, timing of postprostatectomy RT, specifically early vs late, was not associated with a long-term decrease in any HRQOL domain. There was evidence of improved recovery of sexual, continence, and urinary irritation scores among men receiving early RT compared with those receiving late RT after prostatectomy. Before the start of postprostatectomy RT, 39.3% of men in the early RT cohort and 73.4% of men in the late RT cohort were pad-free. By the sixth visit post-RT, 67.4% in the early RT cohort and 47.6% in the late RT cohort were pad-free. In this multicenter, prospective analysis, postprostatectomy RT appeared to be negatively associated with long-term HRQOL across all domains. However, receipt of early vs late postprostatectomy RT may result in similar long-term HRQOL outcomes.

Sensory processing sensitivity as a predictor of health-related quality of life outcomes via stress and sleep quality

Sensory processing sensitivity (SPS), linked to processing external and internal stimuli, has drawn attention to its associations with clinical factors, particularly with health-related quality of life (HRQOL) variables. This study examined the relationships among SPS, stress, sleep quality, and HRQOL, establishing an explanation model. Eight hundred adults (M = 26.66 years, SD = 12.24; range age: 18–85 years) completed self-administered questionnaires on SPS, stress, sleep quality, and HRQOL. Correlation analysis and structural equation modeling (SEM) were used to analyze HRQOL pathways. Stress positively correlated with sleep quality disturbances (r = 0.442, p < 0.001), and SPS (r = 0.344, p < 0.001). Sleep quality disturbances were weakly positively associated with SPS (r = 0.242, p < 0.001). Weak negative correlations emerged between stress and physical (r = -0.283, p < 0.001) and mental (r = − 0.271, p < 0.001) health, HRQOL main dimensions. SEM results showed SPS positively influenced sleep quality disturbances (β = 0.242, p < 0.05) stress (β = 0.413, p < 0.001) while negatively affecting physical health (β = − 0.126, p < 0.001). Sleep quality disturbances negatively affected physical (β = − 0.168, p < 0.001), and mental (β = − 0.189 , p < 0.001) health, and stress on mental health (β = − 0.492, p < 0.01). Indirect effects between SPS and physical (β = -0.036, p < 0.001) and mental (β = − 0.091, p < 0.001) health through sleep were observed, as well as a mediation of stress between SPS and mental health (β = − 0.196, p < 0.001). SPS, sleep quality disturbances, and stress emerged as significant predictors of self-rated physical and mental health in adults.

Early outcomes with a fully retrievable SinoCrown transcatheter heart valve in patients with severe aortic stenosis.

This study summarizes and analyzes data from patients suffering from symptomatic aortic stenosis who successfully underwent transcatheter aortic valve implantation (TAVI) using a novel, completely retrievable transcatheter heart valve. We included patients who underwent a TAVI procedure with SinoCrown valves at our center between December 2021 and September 2022. We collected 1-year follow-up data on survival, complications, echocardiographic results, New York Heart Association functional class in heart failure, and patient-reported health-related quality of life outcomes. Eight successive patients (73.3 ± 4.3 years) were included in the study, with a median Society of Thoracic Surgery risk score of 4.26%. The procedure had a 100% success rate. Median postoperative discharge time was 7 days, with no 30-day hospital readmissions. Postoperative aortic valve hemodynamics improved, indicated by decreased transvalvular flow velocity compared with preoperative values (1.9 ± 0.2 vs. 4.9 ± 0.2 m/s, p < 0.0001). The median and maximum follow-up times were 8 and 12 months, respectively. During the follow-up period, there were no serious complications such as death, stroke, valve embolization, or high-grade atrioventricular block. The results from eight initial TAVI cases performed with the SinoCrown valve demonstrated promising safety and efficacy.

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.

The impact of high intensity training and sports on recipients of solid organ transplants: a narrative review.

High intensity exercise in individuals post solid organ transplant (SOT) remains a largely understudied phenomenon, with potential risks and benefits. Additionally, the optimal training protocols are still unclear. This narrative review aimed to explore the impact of high-intensity exercise training and strenuous sports on solid organ transplant recipients (SOTRs). We conducted a narrative review of intervention studies of any design that included high-intensity exercise training and cross-sectional studies of strenuous sports and activities. Additionally, we reviewed individual reports documenting post-SOT performance at highly competitive or physiological levels. We used MEDLINE to search for relevant articles followed by a manual search for additional articles. Data were extracted and results were summarized. High-intensity and strenuous exercise appears to be safe among stable SOTRs. High-intensity protocols consistently demonstrated improvements in VO2peak and a reduction in coronary artery disease prevalence, though findings related to body composition, health-related quality of life outcomes, and cardiovascular exercise variables were inconsistent. Pre-transplant athletes showcase notable achievements and physiological adaptations post-transplantation, highlighting the capacity for athletic performance among this population. However, caution is warranted in interpreting the findings from these studies due to limitations in generalizability and other methodological limitations. As evidenced by current literature, high intensity exercise emerges as a promising exercise method for safely improving various physiological parameters, and reducing the prevalence of coronary heart disease in SOTRs. It can induce similar or greater effects to moderate intensity exercise, however follow-up studies indicate low retention. Further research of higher methodological rigor is warranted in this field to advance understanding, and to guide evidence-based practice.

Health-Related Quality of Life After Neonatal Treatment of Symptomatic Tetralogy of Fallot: Insights from the Congenital Cardiac Research Collaborative.

To evaluate the association between initial management strategy of neonatal symptomatic Tetralogy of Fallot (sTOF) and later health-related quality of life (HRQOL) outcomes. We performed a multicenter, cross-sectional evaluation of a previously assembled cohort of infants with sTOF who underwent initial intervention at ≤ 30days of age, between 2005 and 2017. Eligible patients' parents/guardians completed an age-appropriate Pediatric Quality of Life Inventory, a Pediatric Quality of Life Inventory Cardiac Module Heart Disease Symptoms Scale, and a parental survey. The association between treatment strategy and HRQOL was evaluated, and the entire sTOF cohort was compared to published values for the healthy pediatric population and to children with complex congenital heart disease and other chronic illness. The study cohort included 143 sTOF subjects, of which 59 underwent a primary repair, and 84 had a staged repair approach. There was no association between initial management strategy and lower HRQOL. For the entire cohort, in general, individual domain scores decreased as age sequentially increased. Across domain measurements, mean scores for the sTOF cohort were significantly lower than the healthy pediatric population and comparable to those with other forms of complex CHD and other chronic health conditions. The presence of a genetic syndrome was significantly associated with a poor HRQOL (p = 0.003). Initial treatment strategy for sTOF was not associated with differences in late HRQOL outcomes, though the overall HRQOL in this sTOF cohort was significantly lower than the general population, and comparable to others with chronic illness.

Epidemiology and burden of chronic insomnia disorder in Europe: an analysis of the 2020 National Health and Wellness Survey

Introduction Chronic insomnia disorder (CID) is considered a significant worldwide public health concern; however, its exact burden is unknown. We estimate its prevalence across France, Germany, Italy, Spain, and the United Kingdom, and assess the economic and humanistic burden for a broader insomnia population. Methods This retrospective, cross-sectional, observational study used 2020 National Health and Wellness Survey (NHWS) data. Patients reporting insomnia were characterized to define CID. Health-related quality of life (HRQoL), work productivity, and healthcare resource use (HCRU) outcomes were assessed in four cohorts according to insomnia diagnosis and treatment status and examined using multivariable analyses according to Insomnia Severity Index categories. Results Among 62,319 respondents, 9,035 (21.2%) reported experiencing insomnia over the previous 12 months. CID prevalence rates were 5.5% to 6.7% across the five countries and 6.0% overall. HRQoL outcomes were persistently poorer in cohorts of patients diagnosed with insomnia than those with undiagnosed insomnia. Undiagnosed and treated insomnia patients reported the highest work presenteeism and total work productivity impairment and the highest number of emergency room and hospitalization visits than patients with insomnia (either treated or untreated). After adjusting for covariates, patients with severe insomnia reported significantly worse EQ-5D-5L utility scores, higher absenteeism and presenteeism rates, and more healthcare provider visits over the past 6 months than patients without insomnia (all p < 0.01). Conclusions Our prevalence rates for CID align with published literature. A diagnosis of insomnia, use of sleep medications, and severity of insomnia are associated with poor quality of life, loss of work productivity, and higher HCRU, confirming the high unmet need and substantial humanistic and economic burden of CID.

Clinical and Cardiometabolic Effects of Reducing Sedentary Behavior in Postmenopausal Women with Rheumatoid Arthritis.

We investigated the effects of a 4-month intervention targeting sedentary behavior on sedentary time and physical activity level, clinical parameters, cardiometabolic risk factors, inflammatory markers, and health-related quality of life in post-menopausal women with rheumatoid arthritis. This was a 4-month, parallel-group, randomized controlled trial (ClinicalTrials.gov identifier: NCT03186924). One-hundred-and-three postmenopausal rheumatoid arthritis patients were randomized (1:1) to either a newly developed intervention targeting sedentary behavior (Take a STAND for Health; TS4H) or standard of care (SOC). Sedentary behavior (primary outcome) and physical activity levels, clinical parameters, anthropometric parameters and body composition, blood samples and oral glucose tolerance test, blood pressure, muscle function, and health-related quality of life were assessed at baseline (Pre) and after 4 months (Post). Between- and within-group differences were tested using linear mixed models following the intention-to-treat principle. Total sedentary time, time in prolonged sitting bouts, standing, and stepping did not change in either group (all p ≥ 0.337). No significant between- and within-group differences were detected for any of the clinical parameters, markers of cardiometabolic health and inflammation, and health-related quality of life variables (all p ≥ 0.136). Among responders in TS4H group (those who reduced sedentary time by ≥30 min/d), Pre to Post IL-10 concentrations tended to reduce (group*time: p = 0.086; estimated mean difference [EMD]: -12.0 pg/mL [-23.5 to -0.6], p = 0.037), and general health (group*time: p = 0.047; EMD: 10.9 A.U. [-1.1 to 22.9], p = 0.086) and overall physical health tended to improve (group*time: p = 0.067; EMD: 7.9 A.U. [-0.9 to 16.6], p = 0.089). TS4H did not change sedentary behavior, physical activity levels, clinical, cardiometabolic, inflammatory or health-related quality of life outcomes. However, TS4H tended to reduce IL-10 levels and improve health-related quality of life in responders.

Does sexual rehabilitation work for gay and bisexual prostate cancer patients? Acceptability, feasibility, and efficacy results from the Restore-2 randomized controlled trial.

Sexual minority prostate cancer patients have worse health-related quality of life outcomes than heterosexual patients. We conducted the first study to test whether sexual and urinary rehabilitation tailored for sexual minority patients was acceptable, feasible, and efficacious at improving their sexual and urinary function. Restore-2 was a 24-month randomized controlled trial of an online biopsychobehavioral rehabilitation study for sexual minority men treated for prostate cancer experiencing sexual and/or urinary problems. Participants were 401 US sexual minority men treated for prostate cancer and experiencing sexual and/or urinary problems at baseline. Intervention components included phosphodiesterase-5 inhibitors, sexual aids, a pelvic floor exercise regimen and video, a guide to good gay sex following treatment, and coaching. Quality of life assessments were completed at baseline, 3, 6, 12, 18, and 24months. We confirmed good acceptability and feasibility, but only minimal improvement was observed over time and no differences were found between treatment and control arms. We found no evidence that the intervention improved sexual or urinary outcomes for participants. However, we confirmed excellent acceptability and feasibility for a sexual rehabilitation program tailored to sexual minority participants. In addition, participants reported enduring usage and acceptability of sexual aids (including vacuum pump, anal dilators, and penile constriction rings) as well as masturbation and pelvic floor exercises to accommodate their sexual challenges. Sexual "accommodation," rather than "rehabilitation," may be a more accurate and realistic goal for this population. Patients should be provided sexual aids to help accommodate their sexual and urinary challenges. This study was retrospectively registered with ClinicalTrials.gov, study number: NCT03923582; date: 22/04/2019.