Health-related Quality Of Life In People Research Articles

Self-Care and Quality of Life of Ostomy Patients: A Structural Equation Modeling Analysis

Background. Previous research has shown that patients with ostomy frequently exhibit a low health-related quality of life (HRQoL). Self-care is a key element that influences their HRQoL. However, the evidence regarding the relationship between these two constructs in patients with ostomy is still not clear. Materials and Methods. This was a secondary analysis of an Italian multicenter, observational, longitudinal study. Participants were recruited from seven outpatient ostomy care clinics in central and northern Italy. The Stoma-Specific Quality of Life Questionnaire (Stoma QoL) and the Ostomy Self-Care Index (OSCI) were administered to the participants. The relationship between self-care and HRQoL was analyzed using structural equation modeling. Results. A total of 521 patients were enrolled. Our results emphasized that self-care is a predictor of HRQoL among people with ostomy. Self-care maintenance and self-care monitoring had a positive effect on HRQoL (self-care maintenance: β = 0.506, p < 0.001; self-care monitoring: β = 0.303, p < 0.001). The model exhibited acceptable fit indices: χ2 (151, n= 521) = 516.447, p ≤ 0.001, comparative fit index (CFI) = 0.97, Tucker–Lewis index (TLI) = 0.96, root mean square error of approximation (RMSEA) = 0.068 (90% CI, 0.062–0.075), p < 0.001, and standardized root mean square residual (SRMR) = 0.038. Conclusions. The structural equation model tested the causal relationship between self-care and HRQoL in people with a stoma, demonstrating for the first time that inadequate self-care in patients with ostomy may lead to lower HRQoL. Thus, to enhance HRQoL, interventions should be designed to improve self-care behaviors. Future research should investigate potential mediating variables in the relationship between self-care and HRQoL.

Baseline patient reported outcomes in patients with peripheral artery disease and type 2 diabetes from STRIDE: a phase 3, 52-week, randomised, double-blind, placebo-controlled trial

Abstract Introduction Lower extremity peripheral artery disease (PAD) is caused by atherosclerotic steno-occlusive arterial lesions in the lower extremities and can lead to intermittent claudication, severe functional impairment and reduced health-related quality of life (HRQoL). People living with type 2 diabetes (T2D) are at higher risk of developing PAD than those without T2D. The most common clinical manifestation of PAD, functional impairment, can be stratified based on severity using Fontaine classification (stages I-IV). There are a limited number of therapies approved for the management of PAD related functional impairment and no glucose-lowering medication has been shown to improve functional capacity in people with PAD and T2D. STRIDE is a phase 3 clinical trial investigating once-weekly subcutaneous (s.c.) semaglutide treatment in people with PAD (Fontaine IIa claudication) and T2D. Purpose To report the patient-reported outcomes (PROs) at baseline from STRIDE and elucidate the impact that PAD has on the functional capacity and HRQoL in this early-stage symptomatic PAD population with T2D. Methods STRIDE enrolled 792 participants with PAD (Fontaine IIa claudication) and T2D who were randomised to receive either 1 mg once-weekly s.c. semaglutide or placebo for 52 weeks. The primary outcome of STRIDE is the change in maximum walking distance at week 52 on a constant load treadmill. Baseline PRO assessments included two Patient Global Impression of Severity (PGI-S) questions and three patient-reported questionnaires: the six items version of the Vascular Quality of Life questionnaire (VascuQoL-6), the Walking Impairment Questionnaire (WIQ) and the Medical Outcomes Short Form 36 (SF-36). Results Baseline responses to both PGI-S questions showed that two thirds of patients reported a moderate-to-severe limitation in their ability to walk (64.9%) and reported that the impact of poor blood circulation in their legs on their HRQoL was also moderate-to-severe (62.5%) (Figure 1A and B). The baseline VascuQoL-6 median score was 15 (score range: 6-24, with a low score indicating more severe impact) and details of impact on the six domains are presented in Table 1. Baseline responses to the WIQ indicated that 20.1% of participants found the degree of difficulty to walk 200 meters either ‘much difficulty’ or were ‘unable to do so’ and 21.8% reported the same when climbing 2 flights of stairs. The secondary supportive outcome assessed in the SF-36 questionnaire was the domain physical functioning where a median baseline value of 38.09 was observed (score range: 19.03-57.60, with a low score indicating more impact). Conclusion Participants in STRIDE, characterized as having early-stage symptomatic PAD, have reported moderate-to-high impact on their physical functioning and HRQoL at baseline. These findings highlight the need for better therapies that improve the functional capacity and HRQoL in people with PAD and T2D.

CARD-SARC: mixed-method study to develop a disease-specific health-related quality of life tool for cardiac sarcoidosis

Abstract Introduction Sarcoidosis is a rare inflammatory condition caused by the formation of lumps (granulomas) of abnormal tissue in any organ, and can affect physical, functional, mental, social and economic aspects of life. People living with cardiac sarcoidosis (CS) are likely to have worse clinical outcomes and greater impairment on health-related quality of life (HRQoL) than other sarcoidosis manifestations. HRQoL is the main concern for people living with sarcoidosis. However, measuring HRQoL in people with CS is difficult as existing tools focus on other forms of sarcoidosis (for example, lung, eye or skin involvement) or for specific cardiac symptoms (for example, atrial fibrillation, angina or heart failure), but not specifically for CS. Purpose To develop a disease-specific patient-reported outcome measure (CARD-SARC) to assess the impact of CS on HRQoL. Methods A sequential exploratory mixed-method, multicentre observational cohort study using a clinimetric approach was conducted. The McMaster Framework for evaluative instruments involved three steps (item selection, item scaling and item reduction) which were complemented with recommendations from the consensus-based standards for the selection of health measurement instruments (COSMIN). The item-generation process connected data from quantitative (theory, research findings and systematic review) and qualitative components (qualitative semistructured interviews, clinical observations and experts’ opinion). A simultaneous triangulation (QUAN+qual) method was followed to ensure a comprehensive list of preliminary items. The formatting of items was guided by patient and public involvement (PPI) with a 2-weeks recall period. The item reduction strategy was led by PPI and an international multidisciplinary clinical CS-experts. Results 740 potential items were generated by converging all the different sources and techniques. After removal of duplicates and simultaneous triangulation, a preliminary list with 111 items was reviewed by the CS-expert panel with 26 members (including 11 pulmonologists, 7 cardiologists, 5 CS-patients and 3 specialist-nurses). After a consensus meeting, the CARD-SARC included 61 relevant items in six sections for pilot-testing: "functioning", "social, leisure and occupation", "emotional", psychological", "physical" and "healthcare/self-care". Conclusions This study combined a robust methodology with active PPI engagement to develop the first disease-specific HRQoL tool for CS. Each data source was planned independently, however the input from PPI members was critical during the simultaneous triangulation for item-generation. The contributions of CS-experts (members of the PPI group and clinical multidisciplinary experts) enhanced the content validity of the CARD-SARC. The CARD-SARC has the potential to influence clinical management and treatment options, future research and health-economic stakeholders’ decisions for CS.

Health-related quality of life assessment in health economic analyses involving type 2 diabetes.

Incorporating health-related quality of life (HRQoL) measures into health economic analyses can help to provide evidence to inform decisions about how to improve patient outcomes in the most cost-effective manner. The aim of this narrative review was to assess which HRQoL instruments have been used in economic evaluations of type 2 diabetes management including in Indigenous communities. MEDLINE (Ovid), Embase (Ovid) and Cochrane were searched from inception to June 2022. Studies included patients with type 2 diabetes; economic evaluations, derived scores from direct questioning of individuals; and were in English. Records were assessed for bias using the JBI critical appraisal tools. A total of 3737 records were identified, with 22 publications meeting the criteria for inclusion. Across those 22 articles, nine HRQoL instruments had been utilised. Generic tools were most frequently used to measure HRQoL, including EQ-5D (-3 L and -5 L) (n = 10, 38%); SF-12 (n = 5, 19%); and SF-36 (n = 4, 15%). Two tools addressing the specific stressors faced by people with type 2 diabetes were utilised: Problem Areas In Diabetes tool (n = 1, 4%) and Diabetes Distress Scale (n = 1, 4%). Two publications reported whether the study population included Indigenous peoples. A wide range of HRQoL instruments are used in economic evaluations of type 2 diabetes management, with the most frequent being varying forms of the EQ-5D. Few economic evaluations noted whether Indigenous peoples were featured in the study population. More research into HRQoL in people living with type 2 diabetes is urgently needed to improve evidence on effectiveness and cost-effectiveness of interventions.

Prevalence, factors and quality of life associated with frailty and pre‐frailty in middle‐aged and older adults living with HIV in Zimbabwe: A cross‐sectional study

AbstractObjectivesWe investigated associations between HIV, frailty and health‐related quality of life (HRQoL).MethodsThis cross‐sectional study recruited men and women aged ≥40 years in Zimbabwe. A researcher collected clinical and HRQoL data, and performed physical assessments and HIV testing. Frailty was defined using five criteria: unintentional weight loss, exhaustion, low physical activity, low gait speed, low handgrip strength. The presence of three or more criteria defined frailty, one to two pre‐frailty, and zero non‐frail. Data analysis used adjusted regression modelling.ResultsOf 1034 adults (mean ± SD, 62.0 ± 14.0 years), 21.6% (n = 223) were living with HIV: 93.3% knew their status, of whom 96.2% were on antiretroviral therapy (ART) and 89.7% of these had a viral load <50 copies/mL. Mean age at HIV diagnosis was 44.6 ± 10.4 years (only 8.1% were ≥70 years), people had been living with HIV for 9.8 ± 5.0 years and had been on ART for 9.4 ± 5.2 years. Overall, HIV was not associated with frailty: adjusted odds ratio (aOR) was 0.99 [95% confidence interval (CI): 0.42–2.33] for frailty versus non‐frailty. However, each 5 years lived with HIV was associated with twice the odds of frailty/pre‐frailty (aOR = 2.03, 95% CI: 1.03–4.13), independent of age and ART duration. Furthermore, each 5 years of ART use was associated with 60% lower odds of frailty/pre‐frailty (aOR = 0.39, 95% CI: 0.19–0.78), independent of age and years lived with HIV. Older age, minimal education and poverty were associated with frailty. Frailty was associated with lower HRQoL in people both with and without HIV.ConclusionReduced survival and good viral suppression may explain the lack of association between HIV and frailty. Early ART initiation could reduce future risk of frailty.

Impairment of health-related quality of life among people with type 2 diabetes and advanced liver fibrosis

People with type 2 diabetes mellitus (T2DM) show a high prevalence of steatotic liver disease (SLD), and especially metabolic dysfunction-associated steatotic liver disease (MASLD), with liver fibrosis. Their health-related quality of life (HRQL) is affected by multiple in part overlapping factors and aggravated by metabolic and liver-related comorbidities, including liver fibrosis stage. The aim of this study was to investigate the effect size of advanced fibrosis (AF) on the HRQL in people with T2DM. A total of 149 individuals with T2DM treated at a primary care provider within the German disease management program (DMP) were included in the final analysis. Vibration-controlled transient elastography (VCTE) was used to non-invasively detect steatosis and AF. The EQ-5D-3L questionnaire was used to assess the HRQL. Uni- and multivariable linear regression models were used to identify independent predictors of impaired HRQL. The majority was male (63.1%), and the median age was 67 years (IQR 59; 71). In the entire cohort, the prevalence of MASLD and AF was 70.7% and 19.5%, respectively. People with T2DM and AF had an overall lower HRQL in comparison to those without AF (p < 0.001). Obesity (β: − 0.247; 95% CI − 0.419, − 0.077) and AF (β: − 0.222; 95% CI − 0.383, − 0.051) remained independent predictors of a poor HRQL. In turn, T2DM-related comorbidities were not predictive of an impaired HRQL. Obesity and AF negatively affect the HRQL in patients with SLD and T2DM in primary care. Awareness of liver health and specific interventions may improve patient-reported and liver-related outcomes in people with T2DM.

What is the effect of bariatric surgery on health-related quality of life in people with obesity? observational cohort analysis of the United Kingdom national bariatric surgery registry.

Previous small studies investigating health-related quality of life (HRQoL) following bariatric surgery have demonstrated heterogenous effects. This study aimed to use National Bariatric Surgery Registry (NBSR) records to investigate the relationship between weight and HRQoL in people undergoing bariatric surgery in the UK. In this observational study using United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022, patients undergoing primary bariatric surgery with one baseline and at least one follow-up visit within one year from surgery were eligible for inclusion. Models estimated the relationship between EuroQol Five Dimension 5-level (EQ-5D) and BMI at baseline and longitudinally. Further analyses stratified by type 2 diabetes, type of operation (adjustable gastric band, sleeve, or bypass) and domain of EQ-5D. 5,587 observations of 2,160 patients were analysed. At baseline, mean BMI was 45.7±7.8kg/m2 and mean EQ-5D was 0.78±0.22. A 1kg/m2 higher BMI was associated with 0.005 (95%CI[-0.006,-0.004]) lower EQ-5D. In the month following surgery, EQ-5D increased to 0.91±0.2 while BMI decreased to 39.8±7.1kg/m2 (P<0.001 for both); subsequently EQ-5D plateaued (0.90±0.17 at 12 months) while BMI continued to decrease (31.5±6.2kg/m2 at 12 months, P<0.001). Each 1kg/m2 decrease in BMI was associated with a 0.006 (95%CI [-0.007,-0.005]) increase in EQ-5D. Remission of T2D was independently associated with increase in EQ-5D (0.037, 95%CI [0.015,0.059]); type of operation was not. Decreases in BMI were associated with improvements in all five domains of EQ-5D. In this large dataset, greater weight loss and T2D remission were independently associated with greater improvements in HRQoL following bariatric surgery. The HRQoL-BMI relationship for people undergoing bariatric surgery differs to that which has previously been estimated following behavioural interventions. Use of the estimates generated here will be important for clinical and political decision making.

The development of a disease-specific patient-reported outcome measure (CARD-SARC) to assess the impact of cardiac sarcoidosis on health-related quality of life

Abstract Introduction Sarcoidosis is a rare inflammatory condition caused by the formation of lumps (granulomas) of abnormal tissue in any organ, and can affect physical, functional, mental, social and economic aspects of life. People living with cardiac sarcoidosis (CS) are likely to have worse clinical outcomes and greater impairment on health-related quality of life (HRQoL) than other sarcoidosis manifestations. HRQoL is the main concern for people living with sarcoidosis. However, measuring HRQoL in people with CS is difficult as existing tools focus on other forms of sarcoidosis (for example, lung, eye or skin involvement) or for specific cardiac symptoms (for example, atrial fibrillation, angina or heart failure), but not specifically for CS. Purpose To develop a disease-specific patient-reported outcome measure (CARD-SARC) to assess the impact of CS on HRQoL. Methods A sequential exploratory mixed-method, multicentre observational cohort study using a clinimetric approach was conducted. The McMaster Framework for evaluative instruments was combined with the consensus-based standards for the selection of health measurement instruments (COSMIN) recommendations, involving three steps: item selection, item scaling and item reduction. The item-generation process used simultaneous triangulation (QUAN+qual) method, connecting quantitative data (theory, research findings and systematic review) with complementary qualitative components (interviews, clinical observations and experts’ opinion). The formatting of items was guided by patient and public involvement (PPI). The item reduction strategy was led by PPI and an international multidisciplinary clinical CS-experts. Results 740 potential items were generated by converging all the different sources and techniques. After removal of duplicates and simultaneous triangulation, a preliminary list with 111 items was reviewed by the CS-expert panel (including 11 pulmonologists, 7 cardiologists, 5 CS-patients and 3 specialist-nurses). After a consensus meeting, the CARD-SARC included 61 relevant items in six sections for pilot-testing: "functioning", "social, leisure and occupation", "emotional", psychological", "physical" and "healthcare/self-care". Conclusions This study used a robust methodology and active PPI involvement to develop the first disease-specific HRQoL tool for CS. The engagement and contributions of the PPI group in each step of the framework enhanced the content validity of the CARD-SARC. The CARD-SARC has the potential to influence clinical management and treatment options, future research and health-economic stakeholders’ decisions for CS.

Improving Quality of Life in Bipolar Disorders with an Immersive Virtual Reality Remediation Training Randomized Controlled Trial (RCT).

Background: Health-related quality of life (H-QoL) is a critical measure in bipolar disorder (BD). Recent trials using virtual reality (VR) have shown potential in improving H-QoL. However, VR's effect on the H-QoL of people with BD needs to be further explored. Methods: This study involved a secondary analysis of a feasibility randomized controlled trial, focusing on "quality of life". Participants (aged 18-75) diagnosed with bipolar disorder were randomized into two groups. The experimental group used the CEREBRUM VR app, while the control group received the usual care. Quality of life was assessed using the Short-Form Health Survey (SF-12). Results: A total of 39 individuals in the experimental group and 25 in the control group represent the final samples. The results showed a greater improvement in the SF-12 total score in the experimental group (8.7%) compared to the control group (F = 66.851 p < 0.0001), specifically in the dimension of physical activity limitation, emotional impact, concentration, pain, calmness, energy levels, discouragement, and social activities. Conclusions: This study demonstrated an improvement in QoL for individuals with BD following a VR intervention. As a feasibility study, this secondary outcome needs to be confirmed by further phase III studies. If confirmed, VR could offer valuable rehabilitation tools and insights into the pathogenesis and treatment of BD.

How Much Does Dysphagia Cost? Understanding the Additional Costs of Dysphagia for New Zealand in Patients Hospitalised with Stroke

Introduction: Dysphagia (i.e., disordered swallowing) is a consequence of stroke. Existing literature on the marginal cost of dysphagia after stroke is limited and ignores long-term impacts. Our aim was to determine the marginal 12-month cost attributable to dysphagia, including health-related quality of life (HRQoL) impacts, among patients hospitalised with stroke in New Zealand. Methods: Secondary analysis of observational data from the REGIONS Care study, a national study from New Zealand of consecutively hospitalised patients with acute stroke between May 1, 2018, and October 30, 2018, including an outcome survey at 12 months among those who provided consent. Patients were identified as dysphagic if they received a swallow screen in hospital resulting in a speech language therapist review. Patients that required a nasogastric feeding tube in hospital were classified as “severe.” Optimal linear propensity score matching was utilised to provide a group of patients to compare with stroke and dysphagia. All costs were converted to 2021NZD. Results: Overall, of the 2,379 patients in the REGIONS cohort (51% male, median age: 78), 40% (944/2,379) were dysphagic (52% male, median age: 78), and 5% (111/2,379) were classified as severely dysphagic. Within 12 months of hospital discharge, dysphagia reduced HRQoL overall by 0.06 index points (95% CI: 0.028–0.100), and severe dysphagia by 0.12 index points (95% CI: 0.03–0.20). The estimated marginal 12-month cost attributable to stroke-related dysphagia was NZD 24,200 on average per patient. This estimate includes the additional hospitalisation costs (NZD 16,100), community rehabilitation services (NZD 570), hospital level aged residential care (NZD 4,030), and reduced HRQoL (NZD 3,470) over a 12-month period post-hospital discharge. The overall total marginal cost for those with severe dysphagia was NZD 34,000 per patient. Conclusion: We report cost estimates to 12 months from a national perspective on the additional costs and HRQoL outcomes of dysphagia for people hospitalised with stroke in New Zealand. Findings provide a novel contribution internationally since few prior studies have extended beyond the acute hospital phase of care. By quantifying the economic burden, we provide information to decision makers to improve dysphagia management strategies and ultimately enhance the overall HRQoL for people with stroke and dysphagia.

Relationship between depression, anxiety, stress, and health-related quality of life in adults with and without chronic diseases: A cross-sectional study.

Health-related quality of life (HRQoL) in patients with chronic diseases is an important tool to measure patient-reported health outcomes and evaluate the usefulness of treatment, management, and rehabilitation programs. Patients with chronic diseases are more likely than those without to experience psychological problems such as depression, anxiety, and stress, all of which can affect HRQoL. This study evaluated the impact of psychological problems such as depression, anxiety, and stress on HRQoL in people with and without chronic diseases in South Korea. The study's descriptive survey included 501 participants (191 with and 310 without chronic diseases). Data were collected using structured questionnaires between April and May 2021. The general characteristics, DASS-21, and HRQOL of this study were analyzed using descriptive statistics. Differences in DASS-21 and HRQoL based on general characteristics were analyzed using t tests and ANOVA. The study analyzed the factors influencing the participants' HRQoL using stepwise multiple regression analysis with SPSS Win 27.0. HRQoL was generally lower for patients with chronic diseases than for patients without. In patients with chronic diseases, the major variables affecting HRQoL were depression (β = -0.244, t = -3.582, P < .001), exercise (β = 0.201, t = 2.927, P = .004), and economic status (β = -0.150, t = -2.184, P = .030), of which depression was the most influential. These variables explained 12.5% of the variance in the regression model for total HRQoL. These results emphasize the need to explore intervention measures that can reduce depression in patients with chronic diseases and anxiety in patients without chronic diseases to improve their HRQoL. In addition, national efforts are needed to provide economic support, as economic status is an influential factor in HRQoL regardless of the presence of chronic disease. The study's limitations include the fact that neither did it consider disease severity among chronically ill patients nor did it examine all the variables affecting HRQoL.

Predictors of poor health-related quality of life among people living with HIV aged ≥60 years in the PISCIS cohort: Findings from the Vive+ project.

Advancements in and accessibility to effective antiretroviral therapy has improved the life expectancy of people living with HIV, increasing the proportion of people living with HIV reaching older age (≥60 years), making this population's health-related quality of life (HRQoL) more relevant. Our aim was to identify the determinants of poor HRQoL in people living with HIV aged ≥60 years and compare them with those of their younger counterparts. We used data from the 'Vive+' study, a cross-sectional survey conducted between October 2019 and March 2020, nested within the PISCIS cohort of people living with HIV in Catalonia and the Balearic Islands, Spain. We used the 12-item short-form survey (SF-12), divided into a physical component summary (PCS) and a mental component summary (MCS), to evaluate HRQoL. We used the least absolute shrinkage and selection operator for variable selection and used multivariable regression models to identify predictors. Of the 1060 people living with HIV (78.6% males) who participated in the study, 209 (19.7%) were aged ≥60 years. When comparing older people living with HIV (≥60 years) and their younger counterparts, older people exhibited a worse PCS (median 51.3 [interquartile range {IQR} 46.0-58.1] vs. 46.43 [IQR 42.5-52.7], p < 0.001) but a similar MCS (median 56.0 [IQR 49.34-64.7] vs. 57.0 [IQR 48.9-66.3], p = 0.476). In the multivariable analysis, cognitive function correlated with a PCS (β correlation factor [β] -0.18, p = 0.014), and depressive symptoms and satisfaction with social role correlated with an MCS (β 0.61 and β -0.97, respectively, p < 0.001) in people living with HIV aged ≥60 years. Depressive symptoms, poor cognitive function, and lower satisfaction with social roles predict poorer HRQoL in older people living with HIV. These factors need to be considered when designing targeted interventions.

Longitudinal evaluation of health-related quality of life after removal of high-risk melanoma in a setting where adjuvant therapy is not available.

To evaluate health-related quality of life (HRQoL) of people with a high-risk skin melanoma after completion of the primary surgical treatment over time, as well as, to identify factors associated with better HRQoL at the beginning and at the end of follow-up. The study included subjects with histopathologically confirmed high-risk skin melanoma in clinical stages IIC, IIIA, IIIB, and IIIC, in whom clinical and radiographic signs of the disease were not confirmed after primary surgical treatment. The HRQoL was evaluated using Short Form-36 (SF-36) after completion of primary surgical treatment (start of follow-up) and after 6 to 12months (end of follow-up). A total of 71 people completed SF-36 at both points in time. There were no significant differences between the initial and the follow-up total HRQoL score (t = 1.118; p = 0.267). At the start of follow-up, having fewer depressive symptoms, better functional status and lower vitamin D serum levels were associated with a better total HRQoL score. At the end of follow-up, having lower Breslow depth and being employed at the start of follow-up, having fewer depressive symptoms and lower C-reactive protein (CRP) serum levels at follow-up, and not developing metastases over follow-up were associated with a higher total HRQoL scores. The HRQoL of people with high-risk melanoma did not change in the year following the complete removal of the tumor. However, presence of depressive symptoms and metastases seem to have the strongest impact on poorer quality of life after surgery.

Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study.

Multiple sclerosis (MS) negatively affects health-related quality of life (HRQoL). To evaluate HRQoL in people with highly active relapsing MS treated with cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years) in CLARIFY-MS. Changes in the MS quality of life (MSQoL)-54 scores were analysed using a repeated mixed-effects linear model. Subgroup analyses were performed for participants who were pretreatment-naïve and those pretreated with disease-modifying therapies (DMTs) before initiating CladT. Safety and tolerability of CladT were also assessed. MSQoL-54 physical (mean change = 4.86; 95% confidence interval (CI) = 3.18, 6.53) and mental health (4.80; 95% CI = 3.13, 6.46) composite scores (primary endpoints) showed significant improvement at Month 24 versus Baseline (p < 0.0001). Changes in the MSQoL-54 scores were consistent across the pretreatment-naïve and DMT-pretreated subgroups. No new severe or opportunistic infections occurred. Most post-baseline lymphopenia events were Grade 1-2 in severity. Transient Grade-3 lymphopenia was observed in 19.7% (95/482) of participants. Grade-4 lymphopenia was not observed. CladT treatment significantly improved the mean MSQoL-54 physical and mental health composite scores over 2 years. CladT efficacy in HRQoL, relapse rates and Expanded Disability Status Scale scores demonstrates its multidimensional effects in MS treatment.

Health Status in Heart Failure and Cancer: Analysis of the Medicare Health Outcomes Survey 2016-2020

BackgroundPeople with heart failure (HF) and cancer experience impaired physical and mental health status. However, health-related quality of life (HRQOL) has not been directly compared between these conditions in a contemporary population of older people. ObjectivesThe authors sought to compare HRQOL in people with HF vs those with lung, colorectal, breast, and prostate cancers. MethodsThe authors performed a pooled analysis of Medicare Health Outcomes Survey data from 2016 to 2020 in participants ≥65 years of age with a self-reported history of HF or active treatment for lung, colon, breast, or prostate cancer. They used the Veterans RAND-12 physical component score (PCS) and mental component score (MCS), which range from 0-100 with a mean score of 50 (based on the U.S. general population) and an SD of 10. The authors used pairwise Student’s t-tests to evaluate for differences in PCS and MCS between groups. ResultsAmong participants with HF (n = 71,025; 54% female, 16% Black), mean PCS was 29.5 and mean MCS 47.9. Mean PCS was lower in people with HF compared with lung (31.2; n = 4,165), colorectal (35.6; n = 4,270), breast (37.7; n = 14,542), and prostate (39.6; n = 17,670) cancer (all P < 0.001). Participants with HF had a significantly lower mean MCS than those with lung (31.2), colon (50.0), breast (52.0), and prostate (53.0) cancer (all P < 0.001). ConclusionsPeople with HF experience worse HRQOL than those with cancer actively receiving treatment. The pervasiveness of low HRQOL in HF underscores the need to implement evidence-based interventions that target physical and mental health status and scale multidisciplinary clinics.

Anxiety and Depression and Health-Related Quality of Life in Adults with Gastroesophageal Reflux Disease: A Population-Based Study.

Adults with gastroesophageal reflux disease (GERD) are susceptible to mental disorders that might significantly affect their health-related quality of life (HRQoL). Therefore, the purpose of this study was to evaluate how HRQoL in individuals with GERD is related to coexisting anxiety and depression. A cross sectional study was conducted among 3068 adult patients 22 years of age and older with GERD diagnoses have been identified using the data from the Medical Expenditure Panel Survey from 2017 to 2020 for United States adults. Data are gathered by MEPS using an overlapping panel design over a period of two and a half years. HRQoL was established using the Physical and Mental Component Summary (PCS & MCS) values from the SF-12. Multivariate forward linear regression analysis was used to assess the relationship between anxiety, depression, and HRQoL in people with GERD after accounting for various factors. Of the 3068 people with GERD who had been identified, 56.4% were women, 59.4% were in their 50s or 60s and 64.8% were employed. Thirteen per cent of people with GERD had depression, thirteen per cent had anxiety, and ten per cent had both. Adults with concurrent anxiety and depression had the lowest mean PCS and MCS scores compared to those with GERD. After adjusting for all independent factors, GERD patients with anxiety (MCS = -10.819, p-value < 0.0001), depression (MCS = -6.395, p-value < 0.0001), and both (MCS= -42.869, p-value < 0.0001) had substantially worse HRQoL than those without these comorbidities. Notably, better HRQoL scores were positively associated with marital status, employment, perceived overall health, and physical activity. The results from this nationally representative sample shed insight into the relationships between low HRQoL and anxiety and depression among individuals with GERD. It also demonstrated the detrimental impacts of co-occurring chronic illnesses, low socioeconomic status, and the positive benefits of employment and exercise on HRQoL. This study emphasizes the clinical, policy, and public health implications for better healthcare, allocation of resources, and promotion of lifestyle modifications to improve the HRQoL in patients with GERD.

Health-related quality of life in a systematically assessed cohort of children and adults with urea cycle disorders

PurposeIndividuals with urea cycle disorders (UCDs) may develop recurrent hyperammonemia, episodic encephalopathy, and neurological sequelae which can impact Health-related Quality of Life (HRQoL). To date, there have been no systematic studies of HRQoL in people with UCDs. MethodsWe reviewed HRQoL and clinical data for 190 children and 203 adults enrolled in a multicenter UCD natural history study. Physical and psychosocial HRQoL in people with UCDs were compared to HRQoL in healthy people and people with phenylketonuria (PKU) and diabetes mellitus. We assessed relationships between HRQoL, UCD diagnosis, and disease severity. Finally, we calculated sample sizes required to detect changes in these HRQoL measures. ResultsIndividuals with UCDs demonstrated worse physical and psychosocial HRQoL than their healthy peers and peers with PKU and diabetes. In children, HRQoL scores did not differ by diagnosis or severity. In adults, individuals with decreased severity had worse psychosocial HRQoL. Finally, we show that a large number of individuals would be required in clinical trials to detect differences in HRQoL in UCDs. ConclusionIndividuals with UCDs have worse HRQoL compared to healthy individuals and those with PKU and diabetes. Future work should focus on the impact of liver transplantation and other clinical variables on HRQoL in UCDs.

Health-related quality of life and knowledge of sign language as a second language in adults with prelingual deafness using cochlear implant

The article aims to find an answer to the question whether the knowledge of sign language in the subjective assessment of study participants is connected to health-related quality of life (HRQOL) specific in terms of deafness/hearing and life satisfaction. The study involved 107 people with prelingual deafness using cochlear implants since childhood, adolescence, or adulthood. The results show significant relationship between the quality of life related to deafness/hearing assessed using the Nijmegen Cochlear Implant Questionnaire and the level of knowledge of sign language the following areas: advanced auditory perception and speech perception. Participants fluent in sign language obtained significantly lower results in these areas. Moreover, it was fund that the proportion of people who do not use telephones was larger in the group with a high level of knowledge of sign language than in the groups with medium or no knowledge of sign language. However, there were no significant difference, due to knowledge of sign language, in relation to life satisfaction measured using the Satisfaction with Life Scale. The discussed issue of the role of sign language in relation to the HRQOL in people with prelingual deafness requires further research, including, among others, objective assessment of linguistic competence in Polish Sign Language and the age and method of their acquisition, as well as qualitative research.

Validation of a patient-reported outcome measure for giant cell arteritis.

GCA is systemic vasculitis manifesting as cranial, ocular or large vessel vasculitis. A prior qualitative study developed 40 candidate items to assess the impact of GCA on health-related quality of life (HRQoL). This study aimed to determine final scale structure and measurement properties of the GCA patient reported outcome (GCA-PRO) measure. Cross-sectional study included UK patients with clinician-confirmed GCA. They completed 40 candidate items for the GCA-PRO at times 1 and 2 (3 days apart), EQ-5D-5L, ICECAP-A, CAT-PROM5 and self-report of disease activity. Rasch and exploratory factor analyses informed item reduction and established structural validity, reliability and unidimensionality of the final GCA-PRO. Evidence of validity was also established with hypothesis testing (GCA-PRO vs other PRO scores, and between participants with 'active disease' vs those 'in remission') and test-retest reliability. The study population consisted of 428 patients: mean (s.d.) age 74.2 (7.2), 285 (67%) female; 327 (76%) cranial GCA, 114 (26.6%) large vessel vasculitis and 142 (33.2%) ocular involvement. Rasch analysis eliminated 10 candidate GCA items and informed restructuring of response categories into four-point Likert scales. Factor analysis confirmed four domains: acute symptoms (eight items), activities of daily living (seven items), psychological (seven items) and participation (eight items). The overall scale had adequate Rasch model fit (χ2 = 25.219, degrees of freedom = 24, P = 0.394). Convergent validity with EQ5D-5L, ICECAP-A and Cat-PROM5 was confirmed through hypothesis testing. Internal consistency and test-retest reliability were excellent. The final GCA-PRO is a 30-item, four-domain scale with robust evidence of validity and reliability in measuring HRQoL in people with GCA.

The effect of a novel, digital physical activity and emotional well-being intervention on health-related quality of life in people with chronic kidney disease: trial design and baseline data from a multicentre prospective, wait-list randomised controlled trial (kidney BEAM)

BackgroundPhysical activity and emotional self-management has the potential to enhance health-related quality of life (HRQoL), but few people with chronic kidney disease (CKD) have access to resources and support. The Kidney BEAM trial aims to evaluate whether an evidence-based physical activity and emotional wellbeing self-management programme (Kidney BEAM) leads to improvements in HRQoL in people with CKD.MethodsThis was a prospective, multicentre, randomised waitlist-controlled trial, with health economic analysis and nested qualitative studies. In total, three hundred and four adults with established CKD were recruited from 11 UK kidney units. Participants were randomly assigned to the intervention (Kidney BEAM) or a wait list control group (1:1). The primary outcome was the between-group difference in Kidney Disease Quality of Life (KDQoL) mental component summary score (MCS) at 12 weeks. Secondary outcomes included the KDQoL physical component summary score, kidney-specific scores, fatigue, life participation, depression and anxiety, physical function, clinical chemistry, healthcare utilisation and harms. All outcomes were measured at baseline and 12 weeks, with long-term HRQoL and adherence also collected at six months follow-up. A nested qualitative study explored experience and impact of using Kidney BEAM.Results340 participants were randomised to Kidney BEAM (n = 173) and waiting list (n = 167) groups. There were 96 (55%) and 89 (53%) males in the intervention and waiting list groups respectively, and the mean (SD) age was 53 (14) years in both groups. Ethnicity, body mass, CKD stage, and history of diabetes and hypertension were comparable across groups. The mean (SD) of the MCS was similar in both groups, 44.7 (10.8) and 45.9 (10.6) in the intervention and waiting list groups respectively.ConclusionResults from this trial will establish whether the Kidney BEAM self management programme is a cost-effective method of enhancing mental and physical wellbeing of people with CKD.Trial RegistrationNCT04872933. Registered 5th May 2021.