Worse Health-related Quality Of Life Research Articles

Quality of life and its predictors in adults with tuberous sclerosis complex (TSC): a multicentre cohort study from Germany

BackgroundTuberous sclerosis complex (TSC) is a monogenetic, multisystemic disease characterised by the formation of benign tumours that can affect almost all organs, caused by pathogenic variations in TSC1 or TSC2. In this multicentre study from Germany, we investigated the influence of sociodemographic, clinical, and therapeutic factors on quality of life (QoL) among individuals with TSC.MethodsWe assessed sociodemographic and clinical characteristics and QoL among adults with TSC throughout Germany using a validated, three-month, retrospective questionnaire. We examined predictors of health-related QoL (HRQoL) using multiple linear regression analysis and compared the QoL among patients with TSC with QoL among patients with other chronic neurological disorders.ResultsWe enrolled 121 adults with TSC (mean age: 31.0 ± 10.5 years; range: 18–61 years, 45.5% [n = 55] women). Unemployment, a higher grade of disability, a higher number of organ manifestations, the presence of neuropsychiatric manifestations or active epilepsy, and a higher burden of therapy-related adverse events were associated with worse QoL, as measured by two QoL instruments (EuroQoL-5 dimensions [EQ-5D] and Quality of Life in Epilepsy Patients [QOLIE-31]). Neuropsychiatric and structural nervous system manifestations, the number of affected organs, and therapy-related adverse events were also associated with higher depression, as measured by the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E). In multiple regression analysis, more severe therapy-related adverse events (large effect, p < 0.001), active epilepsy (large effect, p < 0.001), and neuropsychiatric manifestations (medium effect, p = 0.003) were independently associated with worse HRQoL, explaining 65% of the variance (p < 0.001). The HRQoL among patients with active TSC-associated epilepsy was worse than that among patients with drug-refractory mesial temporal lobe epilepsy (p < 0.001), and the generic QoL among patients with more than three TSC organ manifestations was similar to those of patients with severe migraine and uncontrolled asthma.ConclusionsActive epilepsy, neuropsychiatric manifestations (such as anxiety and depression), and therapy-related adverse events are important independent predictors of worse quality of life among adults with TSC. Generic quality of life in TSC with several manifestations is similar to uncontrolled severe chronic diseases and significantly negatively correlates with TSC severity.Trial registrationDRKS, DRKS00016045. Registered 01 March 2019.

Multiple Myeloma Symptom Burden, Perceived Control, and Quality of Life: Findings from the Cancer Experience Registry

Background: The 5-year survival rate for multiple myeloma (MM) has nearly doubled from 25% in the 1970s to 49% (NCI SEER). Survivors can experience complications and adverse effects from treatment, yet our understanding of the psychosocial effects of MM has not kept pace with therapeutic advances. The goals of this study were to explore how MM patients describe their quality of life compared to other US population groups and to identify cancer-related correlates of poorer health-related quality of life.Methods: 288 individuals with MM enrolled in the Cancer Support Community's online Cancer Experience Registry, provided sociodemographic and clinical history, and completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29v1.0) health-related quality of life survey. We used multiple regression analysis to identify predictors of continuous T-scores for PROMIS subscales (physical and social functioning, anxiety, depression, fatigue, and sleep disturbance). Independent variables included physical symptom burden (daily interference from peripheral neuropathy, bone pain, GI toxicity, and infection) and perceived control over four areas: emotional responses to MM, physical side effects of MM and its treatment, follow-up care, and MM course (i.e., MM recurrence/progression or development of another cancer). Other covariates included sociodemographic factors (age, gender, income, and race) and clinical history (time since diagnosis, relapse, number and type of bone marrow transplants, kidney disease, currently receiving treatment, and type(s) of therapy received).Results: The sample was 54% female, 90% White, 6% Black. Mean age was 62 (SD=9) years; time since MM diagnosis was 4 (SD=4) years. 54% received one or two autologous transplants and 10% three or more; 5% received allogeneic transplant; 31% had not received a stem cell transplant. 85% had received chemotherapy, and 73% reported currently receiving treatment. 39% had experienced a relapse of MM, and 12% reported MM-related kidney disease. On average, PROMIS T-scores for MM patients were worse than national averages for the U.S. population (95% CI) for anxiety (50.5-52.8), fatigue (53.4-55.9), sleep disturbance (51.9-53.3), physical functioning (42.7-44.6), and social functioning (44.8-47.1). When considering individual responses, many MM respondents reported substantially worse quality of life (>1 SD) than the national average for physical functioning (37% of respondents), fatigue (34%), social functioning (29%), anxiety (20%), depression (17%), and sleep disturbance (6%). Only 27% felt they had control (moderate, a great deal or complete) over the course of MM; 48% felt control over the physical side effects of MM; 84% felt they had control over their emotional responses to MM; and 88% over the follow-up care they receive.All regression models predicting PROMIS subscales were significant (R2 = .15 to .44, p s< .001). Greater symptom burden was associated with worse scores on all PROMIS subscales (semipartial r s = .23 to -.48, p s < .001). Perceiving less control over the physical side effects of MM and its treatment was associated with worse physical functioning (semipartial r=.11, p < .05). Perceiving less control over emotional responses to MM was associated with worse anxiety, depression, fatigue, sleep disturbance, and social functioning (semipartial r s = .17 to -.50, p s < .01). Additionally, Black race was associated with worse physical functioning (semipartial r= -.11, p < .05). Currently receiving treatment was associated with fatigue and sleep disturbance (semipartial r s = .13 to .14, p s < .01), and having received chemotherapy was associated with worse social functioning (semipartial r= -.13, p < .02). Having had a relapse of MM was associated with anxiety and worse social functioning (semipartial r s = .11 to -.12 p s < .05).Conclusion: Significant proportions of MM survivors experience worse health-related quality of life compared to the general U.S. population. Symptom burden, as well as a sense of less control over physical and emotional symptoms, were associated with poorer quality of life. These results suggest the need for more comprehensive symptom management efforts for people with MM throughout survivorship care, including increased access to palliative and supportive care services. DisclosuresLeBlanc:Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees; Helsinn Therapeutics: Consultancy, Honoraria; AstraZeneca: Research Funding; Pfizer: Consultancy; American Cancer Society: Research Funding; Cambia Health Foundation: Research Funding; Otsuka: Membership on an entity's Board of Directors or advisory committees; Flatiron Health: Consultancy; Janssen: Honoraria; Seattle Genetics: Research Funding; Celgene: Honoraria. Buzaglo:Pharmacyclics, Inc: Research Funding; Pfizer Oncology: Research Funding; Novartis: Research Funding; Janssen Biotech, Inc: Research Funding; Genentech, Inc: Research Funding; Eli Lilly and Company: Research Funding; Celgene Corporation: Research Funding; Bristol-Myers Squibb: Research Funding; Boehringer Ingelheim: Research Funding; Bayer: Research Funding; Amgen Corporation: Research Funding; AbbVie: Research Funding; Takeda Oncology: Research Funding.

Health-Related Quality of Life in Adults Treated with Blinatumomab Using the Acute Lymphoblastic Leukemia Symptom Scale

Health-Related Quality of Life in Adults Treated with Blinatumomab Using the Acute Lymphoblastic Leukemia Symptom Scale

Sedentary behavior and health outcomes in patients with heart failure: a systematic review and meta-analysis.

A better understanding of the association between sedentary behavior and heart failure is essential for the development of interventions to improve patients' outcomes. Therefore, a systematic review was conducted to determine the association between sedentary behavior and all-cause mortality, health-related quality of life, and depression in heart failure patients. We searched Web of Science, PubMed, Embase, and Cochrane Library and articles in references on 7 May 2021. The search results were limited to articles on heart failure patients over the age of 18, observational studies investigating the association between sedentary behavior and heart failure, and studies reporting one or more outcomes of interest. Two reviewers independently screened the literature and extracted data. Strengthening the Reporting of Observational Studies in Epidemiology was used to assess the quality of articles. Nine observational studies were included, of which, four were of high quality. Four cohort studies indicated that sedentary behavior was significantly associated with increased all-cause mortality (hazard ratio: 1.97; 95% confidence interval: 1.60 to 2.44; I2 = 38.9%). In addition, subgroup analysis based on geographical regions was conducted (hazard ratio: 1.82; 95% confidence interval: 1.46 to 2.29; I2 = 0%). Sedentary behavior was associated with worse health-related quality of life in patients with heart failure, and the regression coefficients ranged from 0.004 to 0.033 (95% confidence interval: 0.0004 to 0.055). Although sedentary behavior was associated with increased all-cause mortality and worse quality of life in patients with heart failure, further studies are needed to determine whether this association is causal.

Racial/ethnic differences in health-related quality of life among female breast cancer survivors: cross-sectional findings from the Medical Expenditure Panel Survey

ObjectivesBreast cancer survivors have reported worse health-related quality of life (HRQoL) outcomes on some subscales when compared with members of the general population. However, the increased attention to breast cancer survivorship should have improved the HRQoL of these survivors. Our aim was to examine whether physical and mental component scores (PCS-12 and MCS-12) using the Short Form (SF-12) questionnaire were different for racial/ethnic minorities, specifically for Black and Hispanic women relative to White women. Furthermore, we stratified the data by age group to evaluate these racial/ethnic differences in HRQoL of breast cancer survivors. Study designCross-sectional study. MethodsPooled cross-sectional analyses using data from the Medical Expenditure Panel Survey between 2008 and 2016 were conducted. Pooled ordinary least squares (OLS) regression was used to examine the racial/ethnic differences in PCS-12 and MCS-12 scores of breast cancer survivors. Furthermore, stratified analyses by age group were conducted to evaluate racial/ethnic differences in HRQoL by the age of breast cancer survivors. ResultsAfter adjusting for confounders, there was no association between race/ethnicity and PCS-12 scores. However, Hispanic breast cancer survivors had statistically significantly lower MCS-12 scores (by 1.9 points [95% confidence interval {CI}: −3.53 to −0.37]) when compared with White breast cancer survivors. For PCS-12, after stratifying by age, the adjusted analyses showed no significant differences in PCS-12 scores when White female breast cancer survivors were compared with the other racial/ethnic categories. On the other hand, Black female survivors aged <50 years had 4.3 points (95% CI: 0.46–8.13) higher MCS-12 scores when compared with their White counterparts, while Hispanic breast cancer survivors aged <50 years had 3.1 points (95% CI: −0.40–6.69) higher MCS-12 scores relative to White women. Furthermore, among female breast cancer survivors aged ≥50 years, Hispanic women had 3.2 points (95% CI: −4.98 to −1.40) lower MCS-12 scores than White women. ConclusionOur study generated findings showing the racial/ethnic differences in HRQoL of breast cancer survivors and presented results stratified by age group. These findings provide the much-needed rationale for targeted and racial/ethnic-specific HRQoL improvement strategies among breast cancer survivors.

Severity of protein-energy wasting and obesity are independently related with poor quality of life in peritoneal dialysis patients

Protein-energy wasting (PEW) and poor health-related quality of life (HRQoL) are independently associated with morbi-mortality in continuous ambulatory peritoneal dialysis (CAPD). PEW may reduce HRQoL; however, we hypothesized HRQoL is affected differentially by PEW degrees or by individual criteria of nutritional status. AimTo evaluate HRQoL according to PEW severity and nutritional status indicators in CAPD.This is a cross-sectional study in 151 patients. Subjective global assessment (SGA) was employed, and nutritional status classified as normal, mild-moderate PEW, and severe PEW. HRQoL was evaluated using Kidney Disease Quality of Life Short Form™, including physical (PCS), mental (MCS) and kidney disease (KDCS) components, and their subscales. Dietary intake, anthropometric and biochemical variables were measured.Forty-six percent of patients were well-nourished, 44% had mild-moderate PEW, and 10% severe PEW. Compared with well-nourished patients, those with mild-moderate (p=0.06) and severe (p=0.005) PEW had lower HRQoL score [68 (52–75), 55 (45–72), 46 (43–58), respectively]. PCS, MCS, and KDCS and their subscales had lower values as PEW was more severe. Patients with obesity and hypoalbuminemia had significantly lower HRQoL overall and component scores than their counterparts. Dietary intake was not associated with quality of life. In multivariate analysis obesity, PEW (by SGA), hypoalbuminemia, and low educational level predicted poor HRQoL (χ2 58.2, p<0.0001).As conclusion, PEW severity was related with worse HRQoL, either as overall score or in every component or subscale in CAPD patients. Poor HRQoL was predicted independently by PEW severity and obesity; additional predictors were hypoalbuminemia and low education.

Utility of the Hospital Frailty Risk Score Derived From Administrative Data and the Association With Stroke Outcomes.

Conditions associated with frailty are common in people experiencing stroke and may explain differences in outcomes. We assessed associations between a published, generic frailty risk score, derived from administrative data, and patient outcomes following stroke/transient ischemic attack; and its accuracy for stroke in predicting mortality compared with other measures of clinical status using coded data. Patient-level data from the Australian Stroke Clinical Registry (2009–2013) were linked with hospital admissions data. We used International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes with a 5-year look-back period to calculate the Hospital Frailty Risk Score (termed Frailty Score hereafter) and summarized results into 4 groups: no-risk (0), low-risk (1–5), intermediate-risk (5–15), and high-risk (>15). Multilevel models, accounting for hospital clustering, were used to assess associations between the Frailty Score and outcomes, including mortality (Cox regression) and readmissions up to 90 days, prolonged acute length of stay (>20 days; logistic regression), and health-related quality of life at 90 to 180 days (quantile regression). The performance of the Frailty Score was then compared with the Charlson and Elixhauser Indices using multiple tests (eg, C statistics) for predicting 30-day mortality. Models were adjusted for covariates including sociodemographics and stroke-related factors. Among 15 468 adult patients, 15% died ≤90 days. The frailty scores were 9% no risk; 23% low, 45% intermediate, and 22% high. A 1-point increase in frailty (continuous variable) was associated with greater length of stay (ORadjusted, 1.05 [95% CI, 1.04 to 1.06), 90-day mortality (HRadjusted, 1.04 [95% CI, 1.03 to 1.05]), readmissions (ORadjusted, 1.02 [95% CI, 1.02 to 1.03]; and worse health-related quality of life (median difference, −0.010 [95% CI −0.012 to −0.010]). Adjusting for the Frailty Score provided a slightly better explanation of 30-day mortality (eg, larger C statistics) compared with other indices. Greater frailty was associated with worse outcomes following stroke/transient ischemic attack. The Frailty Score provides equivalent precision compared with the Charlson and Elixhauser indices for assessing risk-adjusted outcomes following stroke/transient ischemic attack.

Functional outcomes rather than complications predict poor health-related quality of life at 6months after robot-assisted radical prostatectomy.

The objective is to evaluate the effect of robot-assisted radical prostatectomy (RARP)-related postoperative complications on the 6-month postoperative health-related quality of life (HRQoL). A total of 1008 patients underwent a RARP with or without pelvic lymph node dissection (PLND) between 2012 and 2020 and were invited to complete questionnaires about HRQoL and functional outcomes (urinary incontinence (UI), erectile dysfunction (ED) and urinary complaints (UC)) before and 6months after RARP. Patient characteristics and postoperative complications up to 90days after surgery were prospectively recorded. Associations between complications and HRQoL/functional outcomes were assessed by multivariate linear regression analyses. In total, 528 patients (52.4%) were included in the analyses. Complications occurred in 165/528 (31.3%) patients, of which 30/165 (18.2%) had a Clavien-Dindo ≥ III complication. In multivariate regression analyses, postoperative complications were not significantly associated with postoperative HRQoL, UI and ED (p = 0.73, p = 0.72 and p = 0.95, respectively), but were significantly associated with a minor increase in UC (β = 1.7, p < 0.001). More specifically, infectious and urological complications were significantly associated with an increase in UC (β = 1.9, p < 0.001 and β = 0.9, p = 0.004, respectively). The presence of UTI, in particular, was significantly associated with this minor increase (β = 1.5, p = 0.002). Functional outcomes were all significantly associated with the HRQoL at 6months postoperatively. No significant associations were found between postoperative complications and HRQoL at 6months after RARP. However, worse functional outcomes were associated with a worse HRQoL at 6months postoperatively. In addition, postoperative infectious and urological complications were significantly associated with a minor increase in UC.

Health-related quality of life in Dutch adult survivors of childhood cancer: A nation-wide cohort study

AimTo investigate the health-related quality of life (HRQOL) of Dutch adult childhood cancer survivors (CCS) and to identify risk factors of impaired HRQOL. MethodsAdult CCS (age >18, diagnosed <18, ≥5 years since diagnosis) from the Dutch LATER registry completed the Medical Outcome Study Short Form 36 (SF-36) to measure HRQOL and provided sociodemographic characteristics. Age-adjusted mean SF-36 scale scores of CCS were compared to the Dutch general population for men and women separately using t-tests, with effect size d. Multivariate logistic regression models were built to identify sociodemographic and cancer-related risk factors for impaired physical and mental HRQOL. ResultsBoth male and female CCS (N = 2301, mean age = 35.4 years, 49.6% female) reported significantly (p ≤ .005) worse HRQOL than the general population on almost all scales of the SF-36 (−.11 ≤ d ≤ −.56). Largest differences were found on vitality and general health perceptions. Significant risk factors (p ≤ .05) for impaired physical HRQOL were female sex, older age at diagnosis, not having a partner, low educational attainment, disease recurrence and exposure to radiotherapy, specifically to lower extremity radiation. Odds ratios (ORs) ranged from 1.6 to 3.7. Significant risk factors for impaired mental HRQOL were age 26–35 years, male sex, not having a partner and low educational attainment. ORs ranged from 1.3 to 2.0. ConclusionAdult CCS had worse HRQOL than the general population. CCS most at risk were those with low educational attainment and without a partner. Adult CCS could benefit from routine surveillance of their HRQOL. Special attention for CCS’ vitality and health perceptions and beliefs is warranted.

Impact of Depression and Anxiety on Dimensions of Health-Related Quality of Life in Subjects with Parkinson's Disease Enrolled in an Association of Patients.

Parkinson’s disease (PD) is a complex disorder characterized by a wide spectrum of symptoms. Depression and anxiety are common manifestations in PD and may be determinants of health-related quality of life (HRQoL). The objective of this study is to determine the association of depression and anxiety with the dimensions of HRQoL in subjects with PD enrolled in an association of patients. Ninety-five community-based patients with PD diagnosis at different disease stages were studied. HRQoL was assessed using the Parkinson’s Disease Questionnaire (PDQ-39); depression and anxiety were assessed using the Beck Depression Inventory (BDI-II) and the State-Trait Anxiety Inventory (STAI), respectively. Our results showed that depression and anxiety were negatively associated with HRQoL measured by PDSI. Higher motor dysfunction measured by Hoehn and Yahr (H&Y) staging was also associated with worse HRQoL. Depression was the most influential variable in the model. All PDQ-39 dimensions except social support and bodily discomfort were associated with depression. Anxiety was associated with the emotional well-being and bodily discomfort dimensions. These results suggest that physicians should pay attention to the presence of psychiatric symptoms and treat them appropriately.

Racial Discrimination and Health-Related Quality of Life: An Examination Among Asian American Immigrants.

ObjectivesWe aimed to examine the relationship between everyday and major racial discrimination with health-related quality of life (HRQOL), which consists of self-rated health, days of poor physical health, mental health, and activity limitation.DesignIn a cross-sectional analytic sample of 524 foreign-born Asian adults, aged 18 years and older, we conducted multivariable logistic regression and multivariable negative binomial regression to examine associations between discrimination and HRQOL. Furthermore, potential effect modification was tested by gender, ethnicity, and social support.ResultsAssociations were found between everyday racial discrimination and days of poor physical health (incidence rate ratio, IRR = 1.05), mental health (IRR = 1.03), and activity limitation (IRR = 1.05). Stronger significant associations were observed between major racial discrimination and days of poor physical health (IRR = 1.21), mental health (IRR = 1.16), and activity limitation (IRR = 1.53), adjusting for all covariates. Racial discrimination was not associated with poor self-rated health. In addition, gender significantly modified the relationship between continuous racial discrimination and activity limitation days with associations of greater magnitude among men, while social support significantly modified the association between categorized major racial discrimination and physically unhealthy days. When stratified, the association was only significant among those with low social support (IRR = 3.04; 95% CI: 1.60, 5.79) as opposed to high social support.ConclusionsThis study supports the association between racial discrimination and worse HRQOL among Asian Americans, which can inform future interventions, especially among men and those with low social support, aimed at improving the quality of life in this population.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40615-021-01067-8.

PMU59 Predictors and Health Related Quality of Life Associated with Renal Diseases in Cancer Patients in United States

Cancer survivors are projected to increase from 16.9 million people in 2019 to 22.2 million people in 2030. Cancer patients are exposed to more nephrotoxic agents than general population and are hence at a higher risk of developing kidney complications and renal diseases. Renal diseases in cancer patients are associated with a negative prognostic factor for overall survival, worse health-related quality of life (HRQoL) more healthcare utilization. This study determines the predictors of renal diseases and health-related quality of life (HRQoL) associated with renal diseases in cancer patients. This was a retrospective cross-sectional study with data obtained from 2009 – 2018 Medical Expenditure Panel Survey for cancer patients above the age of 18. HRQoL is determined by Mental Component Summary (MCS) and Physical Component Summary (PCS) using Short Form 12 item (version 2). Unadjusted and adjusted analyses were done using t-test, chi square tests, multivariable linear and logistic model while controlling for covariates. All analyses were weighted to get national estimates with α=0.05 in SAS v9.4. Out of the 11,820 cancer patients, 1,969 were diagnosed with a renal disease. Significant predictors (p < 0.05) for renal disease were Female (OR = 1.73), Hispanic (OR = 1.84), Black (OR = 2.01), High School Education (OR = 1.43), Living in south (OR = 0.76), Low income (0.91). Adjusted mean PCS and MCS score for cancer patients without renal disease was 49.2 and 47.6 respectively. Mean PCS and MCS score for cancer patients with renal disease was 45.1 and 41.8 indicating worse HRQoL (p = 0.02) Race, sex, education, census region and income were found to be the significant predictors of renal disease in cancer patients. HRQoL in cancer patients with renal disease is worse as compared to patients with just cancer diagnosis.

PCN217 Health State Utility Values of Patients With Locally Advanced or Metastatic Urothelial Carcinoma: Analysis Based on the JAVELIN Bladder 100 Trial

Metastatic urothelial carcinoma (mUC) is an aggressive, symptomatic cancer that impacts quality of life. In the phase 3 JAVELIN Bladder 100 trial (JB-100) [NCT02603432], avelumab (anti–PD-L1) first-line (1L) maintenance + best supportive care (BSC) significantly prolonged overall survival (primary endpoint) vs BSC alone in patients with mUC without disease progression with 1L chemotherapy. Mean utilities at each scheduled assessment, presented previously, were similar between avelumab + BSC and BSC. This study estimated health-state utilities required for cost-utility analysis. Data from the JB-100 trial were analyzed to determine health-state utilities for progression-free and progressive disease health states. EQ-5D-5L questionnaires were administered at day 1 of each 4-week treatment cycle, at the end of treatment/withdrawal, and at 3 follow-up visits. Following NICE guidelines, EQ-5D-5L responses were converted to EQ-5D-3L responses using a published algorithm, and utility scores were obtained using UK tariffs. No missing data were imputed. Exploratory analyses using mixed-effects repeated measures linear regression were conducted to investigate the effect of tumor progression and proximity to death (defined as ≤30 days until death) as time-varying covariates. Of 700 patients enrolled in JB-100, 653 (93.3%) had available utility data at both baseline and ≥1 follow-up visit and were eligible for analysis. Tumor progression had a negative impact on health-related quality of life (HRQOL): EQ-5D utility decrement was 0.075 (95% CI, 0.064-0.085, p<0.001). The utilities for progression-free and progressed patients were 0.772 (95% CI, 0.760-0.785) and 0.698 (95% CI, 0.684-0.712), respectively. Furthermore, within the 30-day period before death, utilities were lower by −0.202 (95% CI, −0.246 to −0.158; p<0.001). Tumor progression and proximity to death were associated with a statistically significant worsening in HRQOL among patients with mUC. Therefore, treatments that delay progression and death likely provide longer quality-adjusted life-years.

CN4 Patient-Reported Outcomes from the Phase 3, Randomized Study of Acalabrutinib with or without Obinutuzumab Versus Chlorambucil PLUS Obinutuzumab for Treatment-Naïve Chronic Lymphocytic Leukemia (ELEVATE-TN)

Report patient-reported outcomes of fatigue and health-related quality of life (HRQoL) from the randomized, phase 3, ELEVATE-TN study (NCT02475681) in patients with treatment-naïve chronic lymphocytic leukemia (CLL). Patients received acalabrutinib alone (A), A plus obinutuzumab (AO), or chlorambucil plus obinutuzumab (CO). Assessments included the FACIT-Fatigue Global Fatigue Score (GFS) (scale: 0–52; lower score=worse outcome [clinically meaningful improvement: ≥+3]) and the EORTC QLQ-C30 Global Health Status (GHS) score (scale: 0–100; lower score=worse HRQoL [clinically meaningful improvement: >+8]) in all patients (excluding those who progressed) and those with severe fatigue at baseline (GFS ≤34), analyzed using mixed-model repeated measures methodology. A post-hoc analysis assessed time to clinically meaningful deterioration (TTD; change ≤−3) in GFS. Among 535 randomized patients, 449 completed the GFS (A, n=156; AO, n=152; CO, n=141) and 450 completed the GHS (A, n=157; AO, n=151; CO, n=142) at baseline. Overall, 151 randomized patients had severe fatigue (A, n=56; AO, n=53; CO, n=42); all completed both questionnaires at baseline. In all arms, GFS and GHS improvements were observed by week 4 (mean changes: 2.76 and 5.35 for A [n=136, n=137], 2.33 and 2.17 for AO [n=138, n=138], 1.26 and 2.53 for CO [n=121, n=122]) and maintained at 96 weeks (4.94 and 7.01 for A [n=81, n=82], 3.91 and 5.25 for AO [n=92, n=92], 3.86 and 2.41 for CO [n=38, n=38]); this benefit was larger in patients with severe fatigue. Median TTD in fatigue was longer in acalabrutinib-containing arms (A: 16.9 mo; AO: 16.7 mo) versus CO (5.7 mo [P=0.0376 vs A; P=0.1596 vs AO]). In ELEVATE-TN, all treatments improved fatigue scores; TTD of fatigue was significantly longer with acalabrutinib-containing treatment. The previously reported statistically significant progression-free survival increases with A/AO versus CO (Lancet. 2020;395:1278-91) were accompanied by clinically meaningful HRQoL benefits.

Health-Related Quality of Life in Tuberculosis Patients in Eritrea: Comparison Among Drug-Susceptible and Rifampicin/Multidrug-Resistant Tuberculosis Patients.

BackgroundDespite the negative impact of tuberculosis (TB) on patients’ quality of life, TB control programs focus on biological and clinical parameters to manage and monitor TB patients. In our setting, patients’ perception of their experience with TB and the impacts of TB on patients’ physical, mental, and social wellbeing remain unknown.ObjectiveThe objective of this study was to evaluate the health-related quality of life (HRQOL) among rifampicin/multidrug-resistant TB (RR/MDR-TB) in comparison to drug-susceptible TB (DS-TB) patients in Eritrea.MethodsA cross-sectional study was conducted in RR/MDR-TB and DS-TB patients under treatment. Anonymized data collected using the WHOQOL-BREF questionnaire were analyzed using SPSS version 23. Frequency, mean and standard deviation were used to describe the data. Mean group score comparison and relationship between variables were assessed using t-test. Domain score was calculated with a mean score of items within each domain and scaled positively, a higher (increasing) score denoting a higher quality of life. Internal consistency was measured using Cronbach’s alpha and statistical significance was set at p < 0.05.ResultsA total of 92 patients (46 RR/MDR-TB and 46 DS-TB) participated in the study. Environmental (40.63 ± 10.72) and physical domains (61.80 ±17.18) were the two most affected domains in RR/MDR-TB and DS-TB patients, respectively. The psychological domain was the least affected domain in RR/MDR-TB (48.28 ± 20.83) and DS-TB patients (76.63 ±15.32). RR/MDR-TB patients had statistically lower mean scores in all domains than DS-TB patients.ConclusionHRQOL was impaired in both groups, but RR/MDR-TB patients had a worse health-related quality of life.

Insomnia Disorder in Adult Attention-Deficit/Hyperactivity Disorder Patients: Clinical, Comorbidity, and Treatment Correlates.

Introduction: Several investigations have been performed on insomnia symptoms in adult attention-deficit/hyperactivity disorder (ADHD). However, the relationship between insomnia disorder and adult ADHD has been neglected in research. The main objective of the current study is to analyze the differences between adult ADHD patients with and without insomnia disorder, in terms of ADHD clinical severity, medical and psychiatric comorbidity, psychopharmacological treatment, and quality of life.Material and Methods: Two hundred and fifty-two adult patients with ADHD (mean age 37.60 ± 13.22 years; ADHD presentations—combined: 56.7%, inattentive: 39.7%, hyperactive/impulsive: 3.6%) were evaluated with an exhaustive clinical and psychological evaluation protocol including semistructured interviews (for comorbidities and ADHD assessment) and symptom rating scales for ADHD. The diagnosis of ADHD and insomnia disorder was made according to DSM-5 criteria. Furthermore, the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Epworth Sleepiness Scale were administered.Results: Insomnia disorder was found in 44.4% of adult ADHD patients and was more common in combined presentation (64.3%) and in patients with more ADHD severity. Comorbidities (both medical and psychiatric), especially mood disorders (42%), anxiety disorder (26.8%), personality disorder (39.3%), and any substance use disorder (11.6%), were associated with a higher insomnia disorder prevalence. ADHD stimulant treatment was related to lower insomnia disorder compared to patients without medication, as well as ADHD stable treatment. Additionally, worse health-related quality of life was associated with insomnia disorder.Conclusion: Insomnia disorder is highly prevalent in adult ADHD and is related to higher ADHD severity and more psychiatric and medical comorbidities. Some stimulants and stable pharmacological ADHD treatment are associated with better outcomes of insomnia disorder.

A higher quality of life by the Cervantes Short-Form Scale is related to a better sexual desire in postmenopausal women

Objective Evaluate the association between health relate quality of life and sexual desire in postmenopausal women and the influence of demographic descriptors on sexual desire. Methods A observational-cross-sectional study was conducted in 521 postmenopausal women in La Zarzuela Hospital between 2018-2020. Cervantes-short form (Cervantes-SF) scale and Brief profile female sexual function (B-PFSF) scale were filled out in the consultation. High score in Cervantes-SF implies worse health-related quality of life (HR-QoL). If score is lower or equal to 20 in B-PFSF implies diagnosis of hypoactive sexual desire disorder. Results There is a positive relationship between HR-QoL measured by Cervantes-SF and sexual desire measured by B-PFSF (p < .001; correlation coefficient: .223). The mean score on Cervantes-SF was 30.8 ± 14.9 and on B-PFSF was 18.7 ± 7.4. The B-PFSF score was worse in those women using systemic or vaginal hormonal treatment versus using non-hormonal treatment (18.7 ± 7.8 or 17.2 ± 7.4 vs 19.7 ± 6.5; p = .033. Smoking (b exp: .384; p = .029) and using vaginal hormonal treatment (b exp: 1.759; p = .033) are independent factors related to sexual desire. No difference was found in the wellbeing perceived by women in the different treatments (mean of minimal clinically important difference score was 2.9 in systemic vs. 3.0 in vaginal hormonal treatment). Conclusions Improvement on HR-QoL is related to improvement on sexual desire. Sexual desire is better in women with non-hormonal treatment than in women with systemic or vaginal hormonal treatment. The vaginal hormonal treatment and being current smoker are independent factors of low and high sexual desire, respectively.

Health-related quality of life (HRQoL) in patients (pts) with myelodysplastic syndromes (MDS) in the Connect Myeloid Disease Registry.

7040 Background: At diagnosis, disease risk and transfusion burden (TB) can impact HRQoL in pts with MDS. The impact of disease status and higher transfusion requirements on HRQoL has not been well studied. We used data from the Connect Myeloid Disease Registry, an ongoing, prospective, observational cohort study that includes adult pts with lower-risk (LR) and higher-risk (HR) MDS, to investigate factors influencing baseline (BL) and subsequent HRQoL. Methods: BL and Month 6 (M6) data from pts enrolled from Dec 12, 2013 to Mar 6, 2020 (data cutoff) were analyzed. Pts were stratified by International Prognostic Scoring System (IPSS) risk (LR, HR), treatment (Tx) within 45 days post-enrollment (no Tx, best supportive care [BSC], active Tx), and TB 16 weeks post-BL (non-transfusion dependent [NTD], low TB [LTB]; 1−3 transfusions, high TB [HTB]: ≥4 transfusions). Pts completed EQ-5D, FACT-An trial outcome index (TOI), and FACT-Fatigue (FACT-F) questionnaires at BL and quarterly thereafter. Clinically meaningful change, based on minimally important differences, was defined as a change of ±0.07 for EQ-5D, ±6 for FACT-An TOI, and ±3 for FACT-F. Results: At data cutoff, 830 (489 LR, 341 HR) pts were enrolled. Median age was 74 years. 278 pts received no initial Tx, 161 BSC, and 378 active Tx. At BL, 470 were NTD, 197 LTB, and 163 HTB. Of 670 pts still on-study at M6, 462 completed the questionnaires at both BL and M6. At BL , clinically meaningful differences were observed in FACT-An TOI and FACT-F scores, but not EQ-5D, between LR- and HR-MDS and the Tx subgroups . From BL to M6, no clinically meaningful changes were observed in mean scores for each questionnaire. For the TB subgroups, meaningful differences were observed at BL in FACT-An TOI and FACT-F scores, but not EQ-5D (Table). From BL to M6, meaningful decreases in scores were reported by 26%, 30%, and 35% of NTD, LTB, and HTB pts in EQ-5D, 41%, 43%, and 48% for FACT-An TOI, and 40%, 42%, and 48% for FACT-F; increases were reported by 19%, 19%, and 20% pts for EQ-5D, 31%, 32%, and 39% for FACT-An TOI, and 30%, 39%, and 40% for FACT-F. Conclusions: This preliminary analysis suggests that pts with HR-MDS, and transfusion-dependent pts, generally had worse HRQoL at BL, providing further support to initiating active Tx in pts with TB. Possible limitations of the analysis are lower completion rates in pts with more severe disease, and EQ-5D may not capture changes in these subgroups at M6. A longer follow-up may help delineate the impact of Tx on HRQoL assessments in pts with MDS. Clinical trial information: NCT01688011. [Table: see text]

Health-related quality of life (HRQoL) among pediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibroma (PN) in the United States (U.S.).

10042 Background: PNs occur in 30-50% of pediatric patients with NF1, often resulting in debilitating pain and dysfunction. Children with NF1 PN report significantly worse HRQoL than the general population, though real-world evidence is limited. Research is needed to better characterize HRQoL among this patient population in the US. Methods: Patients ages 8-18 years with NF1 PN in the US who were treatment naïve or new users of selumetinib (≤1 month of use) were recruited through the Children’s Tumor Foundation to participate with their caregivers in an online cross-sectional survey in December 2020 and January 2021. Caregivers of similar patients ages 2-7 years also participated. Measures included the Pediatric Quality of Life Inventory (PedsQL; Acute version), EQ-5D-Y, Pain Interference Index (PII), Numeric Rating Scale (NRS-11), and the Patient-Reported Outcomes Measurement Information System (PROMIS) mobility and upper extremity functioning subscales. Patients provided self-reported responses; caregivers provided proxy responses and patient demographic and clinical characteristics. Results: 61 patients and 82 caregivers responded to the survey. Median (range) age of patients was 12.0 (8-14) years, and 53.7% were female. Most were treatment naïve (97.6%), white/Caucasian (85.4%), and had an NF1 and PN diagnosis for &gt; 5 years (80.5% and 68.3%, respectively). On the PedsQL (range: 0-100; higher = better; mean scores typically &gt; 80 among healthy patients), mean patient scores were 50.3 (school functioning), 56.1 (emotional functioning), 60.7 (social functioning), and 63.7 (physical functioning); the mean total score was 58.5.Caregiver-proxy mean scores were similar, ranging from 54.0 for school functioning to 65.0 for physical functioning, with a mean total score of 59.1. On the EQ-5D-Y, more than half of patients reported experiencing “some” or “a lot” of problems with pain or discomfort (65.6%) and with feeling worried, sad or unhappy (62.3%). Among patients with pain in the last 7 days, mean scores on the PII (range: 0-6; higher = more interference) were 3.0 for patients and 2.7 for caregiver proxies. Almost 75% of them reported moderate or severe pain on the NRS-11. Among patients with movement difficulty in the past 7 days, mean t-scores from the PROMIS scales (distribution mean = 50; higher = better) were 40.2 for mobility and 39.5 for upper extremity functioning among patients and 36.0 and 29.1, respectively, among caregivers. Within dyads, patients generally reported better functioning, on average, than their caregiver proxies. Conclusions: The humanistic burden of NF1 PN among this pediatric patient population is substantial, especially regarding pain, emotional functioning, and physical functioning. Results highlight an unmet need to be addressed for improving HRQoL in pediatric patients with NF1 and PN.

Prevalence, Associated Factors and Health-related Quality of Life of Dual Sensory Impairment in Residential Care Facilities in Singapore

ABSTRACT Purpose: To investigate the prevalence of dual sensory impairment (DSI), its associated factors and relationship with health-related quality of life (HR-QoL) in residential care facilities (RCF) in Singapore. Methods: This was a cross-sectional study of 123 residents aged ≥40 years from six RCFs, conducted between 2016 and 2018. DSI was defined as concomitant presenting visual acuity (better-eye) >0.3 logarithm of the minimum angle of resolution and a pure-tone air conduction threshold (better-ear) >40 dB HL in any of the four tested frequencies (500, 1000, 2000 and 4000 Hz). HR-QoL was quantified using the EuroQol five-dimension questionnaire. Multivariable Poisson regression was used to determine the associated factors of DSI. Multivariable linear regression was used to determine the association between DSI and HR-QoL adjusted for traditional confounders. Results: Of the 123 residents (age [mean±standard deviation] 75.3 ± 10.8 years; 56.9% male), 97 (78.9%[95% confidence interval(CI):71.6%, 86.1%]) had DSI, with 110 (98.2%) not on follow-up care for their sensory disabilities. In multivariable models, male gender (prevalence ratio(PR) [95%CI] = 1.3[1.1, 1.6]), older age (per 10-year increase (1.2[1.1, 1.3])), education ≤6 years (1.3[1.1, 1.7]) and the presence of cataract (1.3[1.0, 1.7]) were independently associated with DSI. DSI was independently associated with a substantial worsening in HR-QoL (β = −0.61; 95%CI: −0.76, −0.45; p < .001). Conclusions: DSI affects four in five residential care residents and is substantially associated with reductions in HR-QoL in these residents. Our finding highlights an urgent need for the implementation of routine vision and hearing screening and follow-up care for residents living in these facilities.