Health-related Quality Of Life Domain Scores Research Articles

SARS-CoV-2 vaccine hesitancy and its relationship with health-related quality of life in patients with heart failure - pilot cross-sectional study

Abstract Introduction Heart failure (HF) is a complex disease which influences various aspects of life. The latest COVID-19 outbreak exposed that HF patients were at higher risk of severe outcomes and mortality after being infected with SARS-CoV-2. Therefore, vaccination against SARS-CoV-2 is particularly recommended in that group. However, vaccine hesitancy is a growing problem, and it also affects vulnerable HF patients. Health-related quality of life (HRQoL) may be related to the resignation from vaccination against SARS-CoV-2. Purpose The study aims to assess the relationship between avoiding vaccinations against SARS-CoV-2 and HRQoL using the World Health Organisation Quality of Life Brief questionnaire of Life Brief (WHOQOL-BREF) in patients with heart failure. Methods To evaluate the HRQoL, the WHOQOL-BREF questionnaire was used. 117 patients hospitalized with a diagnosis of HF in 2022 irrespectively of left ventricle ejection fraction (LVEF) at the cardiology department were interviewed. Additionally, a detailed medical history was collected. Until the beginning of 2022, all patients could receive the vaccine. Patients were divided into two groups - vaccinated against SARS-CoV-2 and unvaccinated. HRQoL domain scores and total HRQoL were compared between the mentioned groups using the U-Mann Whitney test. Results The mean age of enrolled patients was 55.3±17.4 years, 21.4% were women, and the mean LVEF was 30.3±14.4%. 13 (11.1%) patients were not vaccinated against SARS-CoV-2 at the time of the interview. There was no difference in total HRQoL (p=0.437) and individual domains scores: somatic (p=0.787), psychological (p=0.171), social (p=0.261) and environmental (p=0.834) between both study groups. Patients avoiding vaccination against SARS-CoV-2 compared to vaccinated patients were younger (39.7±13.8 years vs. 57.3±6.9 years, p<0.001) and had lower LVEF (23.8±14.0% vs. 31.3±14.3%; p=0.04). In the unvaccinated group of patients, the duration of HF was three times shorter (mean 4.3 vs.12.4 years, p=0.002). Conclusions The study revealed no differences in domains of the WHOQoL-BREF questionnaire and overall HRQoL between patients who decided to vaccinate and those with the opposite decision. Almost 90% of the patients with HF were vaccinated against SARS-CoV-2. Younger HF patients are more hesitant to vaccinate against SARS-CoV-2, which is consistent with the trend observed in HF patients [1] and the general population [2]. Further studies could better characterize the patients with heart failure who are vaccine-hesitant. Eventually, it could help develop more specific care to convince them to vaccinate.

Health-Related Quality of Life and its Determinants among School-going Adolescents: A Cross-sectional Study.

Adolescents experience rapid physical, cognitive, and psychosocial growth in their transition from childhood to adulthood, affecting health outcomes and well-being. Health-related quality of life (HRQoL) is a useful indicator of health outcomes, assessed in the current study along with associated determinants. A cross-sectional study was conducted among 634 randomly selected adolescents from 13 randomly selected schools in Gharwal division, Uttarakhand, India, from August 2019 to September 2020. The students studying in the 8th-11th standard and those providing assent and consent from their parents were included in the study. They were screened using the short version of the Physical Activity Readiness Questionnaire. Along with physical activity and fitness assessment, the Global School-based Student Health Survey questionnaire was administered. The transformed HRQoL domain scores were calculated using the WHOQOL-BREF questionnaire. A univariate and multivariable linear regression model was applied to identify the determinants of HRQoL using SPSS version 23. The study included 324 (51.1%) boys and 310 (48.9%) girls. The mean age of the students was 14.4±1.4 years. The highest mean score was 72.3±21.0 for the social relationship domain and the lowest was 55.6±15.0 for the physical domain. The age, parents using any form of tobacco, a history of ever-use of alcohol and physical fitness were significantly associated with HRQoL domain scores. The non-dominant back stretch test was also significantly associated (Beta coefficient; SE, P-value) with physical (-4.1; 1.4, 0.002), psychosocial (-3.9; 1.5, 0.010) and environmental (-3.5; 1.4, 0.014) domain scores. All domains of HRQoL need to be improved and should address the psychological, social, and mental well-being of adolescents. Physical activity and fitness of students emerged as a strong modifiable predictor affecting almost all the domains of HRQoL, warranting its promotion in schools and the promotion of healthy behavior among parents and adolescents.

Factors Associated with the Health-Related Quality of Life of Malaysian Young Adults Post-Pandemic.

The transition from school to university brings significant adjustments in lifestyle, body weight, and living environment for young adults, potentially impacting their quality of life. Emerging evidence suggests the coronavirus disease of 2019 (COVID-19) pandemic may have exacerbated these changes. This cross-sectional study involved 361 young adults (18-25 years) from Malaysian tertiary institutions, aiming to identify factors associated with health-related quality of life (HRQOL) post-COVID-19 restrictions. Data were collected online between April and July 2022, utilizing the WHOQOL-BREF for HRQOL assessment. Participants, with a median age of 23, scored highest in the physical health domain (mean: 63.2, SD = 16.2) and lowest in psychological health (mean: 58.2, SD = 16.9). Physical health domain scores varied by ethnicity, the field of study, weight category, and prescription medicine usage; environmental health scores by ethnicity and household income; and social health scores by age. Moderate perceived stress and low perceived support were significant predictors of poor HRQOL. Across the weight categories, sleep quality, perceived stress, and support have consistently impacted the HRQOL domain scores. This study underscores the multifaceted influences on young adults' quality of life during the transition to university, especially in post-pandemic adjustments, highlighting the importance of addressing factors such as perceived stress and support to enhance overall well-being.

Quality of life in 583 head and neck cancer survivors assessed with the FACE-Q head and neck cancer module

ObjectivesLong-term health-related quality of life (HRQOL) is frequently affected in head and neck cancer (HNC) survivors. Due to the shortage of studies investigating long-term patient-reported outcomes, we investigated long-term HRQOL using the novel FACE-Q HNC Module. MethodsA retrospective cross-sectional single-center study was performed, including all patients who underwent curative treatment for HNC between 2006 and 2013. All eligible patients (n = 863) were invited to participate of whom 540 completed the questionnaires. Additionally, a prospective longitudinal cohort of 43 HNC patients treated between 2020 and 2022 was included who preoperatively filled in the FACE-Q, and at three, six, and 12 months postoperatively. HRQOL domain scores were analyzed to visualize group characteristics by tumor site and type of surgical resection. ResultsBoth surgical and non-surgical HNC treatments predominantly affected long-term functional HRQOL domains (eating, salivation, speech, and swallowing), eating distress, and speaking distress, with distinct profiles depending on tumor site and type of treatment. In contrast, few long-term intergroup differences between HNC patients were observed for appearance, smiling, drooling distress, and smiling distress. Longitudinal data showed significant deterioration across all functional HRQOL domains in the short-term following treatment. Patients predominantly reported long-lasting negative treatment effects at 12 months follow-up for functional domains, whereas psychological domains showed near-complete recovery at group level. ConclusionsAt long-term, various function-related and psychosocial HRQOL domains still are affected in head and neck cancer survivors. The results may serve to better inform patients with regard to specific treatments and highlight HRQOL domains which may potentially be optimized.

Effects of Idecabtagene Vicleucel (Ide-Cel) Versus Standard Regimens on Health-Related Quality of Life (HRQoL) in Patients with Triple-Class-Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM) Who Received at Least 3 Lines of Prior Antimyeloma Regimens in the KarMMa-3 Phase 3 Randomized Controlled Trial

Introduction: Patients with TCE RRMM have a high disease burden and often report worsening HRQoL with additional lines of therapy. The single-arm, phase 2 KarMMa study demonstrated that ide-cel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell therapy, improved HRQoL from baseline in patients with TCE RRMM who had received ≥ 3 prior regimens (Delforge M, et al. Blood Adv 2022;6:1309-1318). Furthermore, in the phase 3 KarMMa-3 clinical trial (NCT03651128), ide-cel significantly improved progression-free survival and response compared with standard regimens in patients with TCE RRMM who had received 2-4 prior regimens (Rodriguez-Otero P, et al. N Engl J Med 2023;388:1002-1014). Here we assessed the comparative effects of ide-cel versus standard regimens on HRQoL in patients with TCE RRMM who had received 3-4 prior regimens including an immunomodulatory agent, a proteasome inhibitor, and daratumumab (an anti-CD38 monoclonal antibody) using data from the KarMMa-3 study. Methods: Patient-reported outcomes (PROs) were assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30), EORTC Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20), and EQ-5D-5L. The pre-specified primary domains of interest included EORTC QLQ-C30 global health status/QoL, physical functioning, cognitive functioning, fatigue, and pain; EORTC QLQ-MY20 disease symptoms and side effects of treatment; and the EQ-5D-5L visual analog scale (EQ-5D VAS). PROs were collected at screening (baseline), the day of ide-cel infusion (ide-cel) or first treatment dose (standard regimens), monthly from 2 to 28 months, and thereafter every 3 months. Comparisons were performed on least squares (LS) mean changes from baseline through 28 months between arms using constrained longitudinal data analysis (cLDA). Effect size was estimated by Hedges' g. The comparative effects of ide-cel versus standard regimens on time to confirmed improvement and time to confirmed deterioration (defined by prespecified change thresholds) were assessed via stratified Cox proportional hazards regression analyses. All P values are nominal and not adjusted for multiple testing. Statistical significance was set at P < 0.05. Results: Baseline characteristics were well balanced among the patients in the ide-cel arm (n = 167) and the standard regimen arm (n = 93), with a median age of 63 years and a median time of 4.7 years from RRMM diagnosis to study screening. Completion rates of HRQoL assessments were high over time for most visits (> 75%). At baseline, mean HRQoL domain scores were similar between arms. Overall LS mean changes from baseline to 28 months showed significant differences in favor of ide-cel versus standard regimens (nominal P < 0.05) for 11 domains (effect sizes of 0.26-0.82), and 7 (4 primary: global health status/QoL, cognitive functioning, pain, EQ-5D VAS; 3 secondary: dyspnea, insomnia, constipation) of them exceeded the prespecified MID thresholds (Table). Time to confirmed improvement was significantly shorter (nominal P < 0.05) in the ide-cel arm than in the standard regimen arm for 10 domains, including all primary domains except pain. Time to confirmed deterioration was longer in the ide-cel arm than the standard regimen arm for most domains, with significant differences in emotional functioning, cognitive functioning, and dyspnea (EORTC QLQ-C30). Finally, side effects of treatment favored the ide-cel versus standard regimen arm (EORTC QLQ-MY20) (Table). Conclusions: These patient-reported findings demonstrate that compared with standard regimens, treatment with ide-cel improved MM-relevant disease symptoms, functioning, and overall health status/HRQoL of patients with TCE RRMM in the KarMMa-3 trial. These data further substantiate the superior treatment outcomes of ide-cel over standard regimens in this patient population. Overall, treatment with ide-cel may help alleviate detriments to HRQoL in these patients with complex disease.

A Comparative Study of Health-Related Quality of Life among Adults with Pulmonary Tuberculosis in Southwest Nigeria

Background: Current models of care for tuberculosis (TB) focus on bacteriological cures with less emphasis on the effect of TB on physical, mental, and social well-being. There is also a paucity of data on normative values for Nigeria against which health-related quality of life (HRQOL) measures of TB patients could be assessed. The objective of this study was to compare HRQOL of adults diagnosed with TB against a comparator group from similar socio-demographic backgrounds.
 Methods: A comparative cross-sectional study was undertaken with 210 patients with pulmonary TB and a comparator group of 285 individuals from catchment communities. The World Health Organization Quality of Life Questionnaire-Short Version (WHOQOL-BREF) was used to assess HRQOL. Patients were selected using a multi-stage sampling technique. Data were analysed using IBM-SPSS version 23. A multiple linear regression model was used to identify potential predictors of HRQOL. Ethical approval was obtained from the Lagos State University Teaching Hospital health research ethics committee.
 Results: More than half of the TB patients and those in the comparator group were men (63.3% and 59.0%, respectively), and their mean ages were 36.40±11.76 years and 36.69±12.30 years, respectively. Respondents with TB had significantly lower HRQOL domain scores across all domains (p<0.001). Domain scores for HRQOL ranged between 45.3 ±14.5 (environmental domain) and 50.9±17.3 (social relationships). Independent predictors of quality of life among TB patients included education, employment, and socio-economic status. 
 Conclusion: Tuberculosis was significantly associated with an impairment in health-related quality of life. The environment domain was most affected among respondents with PTB. Employment status, socio-economic class and educational level were predictive of HRQOL.

The "Non-Treated" Versus "LT3-Treated" Protocols of Short-Term Hypothyroidism Induction in Differentiated Thyroid Cancer: An Analysis of Hypothyroid Complications, Mood Disorders, and Quality of Life.

This study aimed to compare "non-treated" versus "levotriiodothyronine (LT3)-treated" protocols of short-term hypothyroidism induction prior to radioactive iodine (RAI) ablation therapy in differentiated thyroid cancer (DTC). A total of 120 DTC patients who had thyroxine withdrawal either via 4-week hypothyroidism induction (non-treated group, n=60) or 2-week administration and then 2-week withdrawal of LT3 (LT3-treated group, n=60) to induce hypothyroid state prior to RAI ablation after initial surgery were included. Complications related to hypothyroidism-induction, Beck Depression Inventory (BDI), Hospital Anxiety-Depression Scale (HADS), and SF-36 health-related quality of life (HRQoL) scores were recorded. In the non-treated group, transition from euthyroid to hypothyroid state was associated with significant increase in the likelihood of moderate-to-severe depression on BDI (p<0.001), presence of depression on HADS-D (p<0.001), presence of anxiety on HADS-A (6.7% during euthyroid state vs. 33.3% during hypothyroid state, p<0.001), and major syndrome on BPRS (0.0 vs. 10.0%, p=0.001) as well as significant decrease in all SF-36 HRQoL domain scores (p<0.001 for each). In conclusion, our findings indicate the likelihood of L3-treatment to enable a more favorable transition period from euthyroid to hypothyroid state without experiencing a deterioration in depression, anxiety, or HRQoL.

PD15-02 LONG-TERM HEALTH RELATED QUALITY OF LIFE IN PROSTATE CANCER PATIENTS REQUIRING RADIOTHERAPY AFTER RADICAL PROSTATECTOMY

PD15-02 LONG-TERM HEALTH RELATED QUALITY OF LIFE IN PROSTATE CANCER PATIENTS REQUIRING RADIOTHERAPY AFTER RADICAL PROSTATECTOMY

Psychosocial functioning of parents of Dutch long-term survivors of childhood cancer.

To describe health-related quality of life (HRQoL), post-traumatic stress and post-traumatic growth of parents of long-term survivors of childhood cancer (CCS) and study associated factors. Parents of survivors of the Dutch Childhood Cancer Survivor Study LATER cohort below 30years and diagnosed 1986-2001 were invited to complete the TNO-AZL Questionnaire for Adult's HRQoL (e.g., sleep and aggressive emotions), Self-Rating Scale for Post-traumatic Stress Disorder, Post-traumatic Growth Inventory, and Illness Cognition Questionnaire. HRQoL domain scores were compared to references using Mann-Whitney U tests. Correlations between post-traumatic stress, growth and HRQoL were evaluated. Medical characteristics of their child and illness cognitions were studied as associated factors of HRQOL, post-traumatic stress and growth. p<0.05 was considered statistically significant. Parents (n=661 of n=448 survivors, 56% female, mean time since child's diagnosis: 21.3 [SD: 3.3] years) reported better HRQoL in social functioning and aggressive emotions than references (r=.08-0.17). Mothers additionally reported better HRQoL in pain, daily activities, sexuality, vitality, positive and depressive emotions (r=.07-0.14). Post-traumatic stress was symptomatic in 3%, and associated with worse HRQoL (r=-0.27-0.48). Post-traumatic growth was positively associated to post-traumatic stress and better HRQoL (r=0.09-0.12). Cancer recurrence was associated to better HRQoL (β=0.37-0.46). Acceptance illness cognitions were associated to better (β=0.12-0.25), and helplessness to worse outcomes (β=0.14-0.38). HRQoL of parents of young adult survivors of CCS is comparable to references or slightly better. Only a small proportion reports symptomatic post-traumatic stress. Improving acceptance and reducing feelings of helplessness may provide treatment targets for parents with psychosocial problems.

External validation and updating of prediction models for estimating the 1-year risk of low health-related quality of life in colorectal cancer survivors

ObjectivesTimely identification of colorectal cancer (CRC) survivors at risk of experiencing low health-related quality of life (HRQoL) in the near future is important for enabling appropriately tailored preventive actions. We previously developed and internally validated risk prediction models to estimate the 1-year risk of low HRQoL in long-term CRC survivors. In this article, we aim to externally validate and update these models in a population of short-term CRC survivors. Study Design and SettingIn a pooled cohort of 1,596 CRC survivors, seven HRQoL domains (global QoL, cognitive/emotional/physical/role/social functioning, and fatigue) were measured prospectively at approximately 5 months postdiagnosis (baseline for prediction) and approximately 1 year later by a validated patient-reported outcome measure (European Organization for Research and Treatment of Cancer Quality of life Questionnaire–Core 30). For each HRQoL domain, 1-year scores were dichotomized into low vs. normal/high HRQoL. Performance of the previously developed multivariable logistic prediction models was evaluated (calibration and discrimination). Models were updated to create a more parsimonious predictor set for all HRQoL domains. ResultsUpdated models showed good calibration and discrimination (AUC ≥0.75), containing a single set of 15 predictors, including nonmodifiable (age, sex, education, time since diagnosis, chemotherapy, radiotherapy, stoma, and comorbidities) and modifiable predictors (body mass index, physical activity, smoking, anxiety/depression, and baseline fatigue and HRQoL domain scores). ConclusionExternally validated and updated prediction models performed well for estimating the 1-year risk of low HRQoL in CRC survivors within 6 months postdiagnosis. The impact of implementing the models in oncology practice to improve HRQoL outcomes in CRC survivors needs to be evaluated.

The Impact of Cancer-Related Fatigue on HRQOL in Survivors of Childhood Cancer: A DCCSS LATER Study.

Simple SummarySurvivors of childhood cancer have an increased risk to experience symptoms of severe and persistent fatigue. We studied how fatigue might affect the health-related quality of life of these survivors. Questionnaire items asking about a broad range of daily life aspects were compared between fatigued survivors, survivors without fatigue and the general Dutch population. A total of eleven aspects were studied which were all negatively affected by fatigue, with the largest impact seen for Vitality (how much energy does a person have), General Health (perception of current and future health) and Role Limitations (work-related activities). Results show the negative impact fatigue can have on the daily lives of survivors and why it is important to treat fatigue adequately. Background: Early detection and management of late effects of treatment and their impact on health-related quality of life (HRQOL) has become a key goal of childhood cancer survivorship care. One of the most prevalent late effects is chronic fatigue (CF). The current study aimed to investigate the association between CF and HRQOL in a nationwide cohort of CCS. Methods: Participants were included from the Dutch Childhood Cancer Survivor Study (DCCSS) LATER cohort, a nationwide cohort of CCS. Participants completed the Checklist Individual Strength (CIS) to indicate CF (CIS fatigue severity subscale ≥ 35 and duration of symptoms ≥6 months) and the Short Form-36 (SF-36) and TNO (Netherlands Organization for Applied Scientific Research) and AZL (Leiden University Medical Centre) Adult’s Health-Related Quality of Life questionnaire (TAAQOL) as measures for HRQOL. Differences in mean HRQOL domain scores between CF and non-CF participants were investigated using independent samples t-tests and ANCOVA to adjust for age and sex. The association between CF and impaired HRQOL (scoring ≥ 2 SD below the population norm) was investigated using logistic regression analyses, adjusting for confounders. Results: A total of 1695 participants were included in the study. Mean HRQOL domain scores were significantly lower in participants with CF. In addition, CF was associated with impaired HRQOL on all of the domains (except physical functioning) with adjusted odds ratios ranging from 2.1 (95% CI 1.3–3.4; sexuality domain) to 30.4 (95% CI 16.4–56.2; vitality domain). Conclusions: CF is associated with impaired HRQOL, urging for the screening and regular monitoring of fatigue, and developing possible preventative programs and interventions.

Physical and Psychosocial Concept Domains Related to Health-Related Quality of Life (HRQL) in 50 Girls and 52 Boys Between 5 and 18 Years Old in Poland Using the Parent-Reported 50-Item Child Health Questionnaire (CHQ-PF50)

BackgroundWe used the parent-reported 50-item Child Health Questionnaire (CHQ-PF50) to evaluate parental by-proxy responses regarding 102 healthy Polish children and adolescents, aged 5 to 18 years, in 13 physical and psychosocial concept domains linked to health-related quality of life (HRQL) to determine which domains pose the greatest limitations to health.Material/MethodsParticipants were 50 healthy female and 52 healthy male school children (nursery, primary, junior-high, and high), selected randomly and found eligible from 585 participants originally recruited; participants with diseases/ailments and incomplete questionnaires were excluded. The CHQ-PF50 has 50 questions divided into 13 domains that represent physical and mental well-being; parents gave their retrospective responses from memory. Scores were expressed numerically using a standard algorithm and ranged from 0 to 100; higher scores represented more favorable HRQL outcomes. Summary statistics were performed, and age and sex effects were assessed.ResultsMean HRQL domain scores never attained 100 (maximum value). They were lowest (P<0.004) for domains of Family Cohesion (66.57), Parental Emotional (77.21), and General Health Perceptions (75.41), while highest (but still significantly <100, P<0.047) in Physical Functioning (97.11), Role/Social Emotional-Behavioral (96.51), and Role/Social-Physical (96.24). Neither age nor sex significantly affected domain scores. Outcomes were comparable to European and US studies but differed from a previous small-scale Polish study.ConclusionsNone of the CHQ-PF50 domain mean values reached the maximum in apparently healthy Polish children. HRQL was lowest in Family Cohesion, Parental Emotional, and General Health Perceptions. Outcomes are considered a useful control baseline in Polish studies on disease.

Generic and disease-specific health-related quality of life in patients with Hirschsprung disease: A systematic review and meta-analysis.

BACKGROUNDPatients with Hirschsprung disease (HD) are at risk of persistent constipation, fecal incontinence or recurrent enterocolitis after surgical treatment, which in turn may impact physical and psychosocial functioning. Generic health-related quality of life (HRQoL) and disease-specific health-related quality of life are relevant outcome measures to assess the impact of HD on the QoL of these patients. AIMTo summarize all available evidence on HRQoL of patients with HD after surgery and the impact of possible moderating factors. METHODSPubmed, Web of Sciences, PsycInfo and Embase were searched with search terms related to ‘Hirschsprung disease’, ‘Pediatrics’ and ‘Quality of life’. Mean and standard deviation of generic HRQoL overall and domain scores were extracted from each study, as well as data describing potential factors associated with QoL. Random effect models were used for meta-analytic aggregation of generic HRQoL scores. Meta-regression was used to assess the relationship between patient and clinical characteristics and generic HRQoL. Disease-specific HRQoL outcomes of patients with HD were systematically reviewed. RESULTSSeventeen articles were included in the systematic review (n = 1137 patients) and 15 in the quantitative meta-analysis (n = 1024 patients). Four studies reported disease-specific HRQoL. Patient’s age ranged between 0 and 21 years. Meta-analytic aggregation showed a non-significantly impaired generic HRQoL (d = -0.168 [95%CI: -0.481; 0.145], P = 0.293, I2 = 94.9) in patients with HD compared to healthy controls. Physical (d = -0.042 [95%CI: -0.419; 0.335], P = 0.829, I2 = 95.1), psychosocial (d = -0.159 [95%CI: -0.458; 0.141], P = 0.299, I2 = 93.6) and social HRQoL (d = -0.092 [95%CI: -0.642; 0.457], P = 0.742, I² = 92.3) were also not significantly lower compared to healthy controls. There was no relation between health-related outcomes and the sex of the patients and whether generic HRQoL was measured by parental proxy or self-report. Disease-specific complaints of patients with HD impaired physical HRQoL, but not psychosocial and social HRQoL. CONCLUSIONIn this systematic review and meta-analysis, no evidence was found for impaired generic HRQoL in patients with HD compared to healthy controls, neither for moderating effects of sex, parental proxy or self-report.

Chronic disease management practices and factors associated with health-related quality-of-life for persons with chronic myeloid leukemia receiving tyrosine kinase inhibitor therapy.

The main objective of this study was to explore health-related quality of life (HRQoL) profiles, chronic disease management practices and key factors associated with HRQoL in 540 patients with chronic myeloid leukemia in chronic phase (CML-CP) administered tyrosine kinase inhibitors (TKIs). Adult CML-CP patients treated with TKIs in Henan Cancer Hospital from March 2015 to October 2019 were assessed via questionnaires, including demographic characteristics, TKI medications, participation in CML disease management, and HRQoL, in a cross-sectional investigation. Respondents were anonymous. Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) was used to measure HRQoL. A multivariate linear regression model with stepwise entry was used to investigate variables independently associated with HRQoL domain and total scores. Totally, 540 respondents were included; 302 (55.93%) were male. Mean participant age was 42.90±13.00 years; 169 (31.3%), 178 (32.9%) and 193 (35.7%) individuals had a low, moderate or high disease management level, respectively. Except for insignificant event-free survival information, participants with higher disease management levels also had significantly higher rates of completing re-examination, drug withdrawal, cytogenetic response (CcyR) and/or major molecular response (MMR) (all P<0.01). Moreover, higher disease management level was accompanied by eight significantly higher HRQoL domains (all P<0.01). In multivariate linear regression analysis, variables significantly associated with a higher HRQoL included: (I) high disease management level (B=3.68, P=0.046); (II) transportation convenience (B=6.67, P<0.001); (III) family annual income >10,000 CNY (B=5.97, P<0.001); (IV) completed re-examination (B=4.58, P=0.036); (V) MMR (B=3.75, P=0.021) and CcyR (B=5.15, P=0.035). Female sex (B=-3.53, P=0.010), single status or divorce (B=-1.89 and -2.94, P=0.005 and 0.011), and low education level (B=-1.44, P=0.019) were significantly associated with lower HRQoL. Higher disease management level was significantly associated with higher elevated treatment efficacy and HRQoL in Chinese individuals with CML-CP administered TKIs. These data indicate the importance of chronic disease management on people's HRQoL and clinical outcome.

Disease-specific quality of life in patients with diabetic neuropathy

To compare health-related quality of life (HRQoL) among patients with diabetes mellitus (DM) and diabetic neuropathy (DN) (D+N) with patients with DM without DN (D-DN) and healthy participants. To evaluate factors associated with poor HRQoL in patients with DN. This study included 306 participants residing in Bisha, Saudi Arabia. Patients with DM were screened for DN using the Michigan Neuropathy Screening Instrument. Neuropathy severity, disability and HRQoL were determined using the Neuropathy Severity Scale (NSS), the Neuropathy Disability Score (NDS), and the Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) tool, respectively. Nerve conduction studies (NCSs) were also performed. The D+DN group had poorer overall and domain HRQoL scores compared to the D-DN group (p<0.001). There was a strong correlation between overall HRQoL score and both NDS and NSS scores in the D+DN group (ρ= -0.71 and p<0.0001; ρ= -0.81 and p<0.0001, respectively). There was also a significant difference in all mean HRQoL domain scores between D+DN participants with normal and abnormal NCS. Physical inactivity (p=0.043), duration of DM (p<0.0001), abnormal NCS, NSS (p<0.0001), and NDS (p<0.0001) predicted HRQoL in the D+DN group. D+DN participants had a worse HRQoL compared with D-DN and healthy counterparts. NDS, NNS, physical inactivity, abnormal NCS, and duration of DM independently predicted poor HRQoL in D+DN participants.

A cross-sectional observational study of health-related quality of life in adults with multiple myeloma.

The purpose of this manuscript is to describe health-related quality of life (HRQoL) outcomes in a United States (US)-based sample of multiple myeloma (MM) patients and identify characteristics associated with poor HRQoL. MM patients identified through the Tumor Registry of a Southeastern US medical center were mailed surveys assessing patient characteristics and HRQoL outcomes. HRQoL outcomes were measured using PROMIS short form instruments which included measures of global health (global physical health and global mental health), physical function, and ability to participate in social roles and activities (social function). HRQoL domain scores were summarized, and best subset linear regression was used to identify predictors of HRQoL. A total of 690 patients completed and returned surveys for a response rate of 64.7%. Respondents reported global physical health (44.9), global mental health (47.5), and physical function (44.1) significantly worse than the general population mean of 50 (p < .0001). Social function (49.5) did not differ significantly (p = .09). Worse socioeconomic status, higher comorbidities, not being in remission, and past receipt of radiation therapy were significantly associated with worse HRQoL. Treatment status and time since diagnosis were not associated with HRQoL outcomes. Patients with MM have significantly worse HRQoL than the general population. These findings warrant increased attention from clinicians and researchers. More research is needed to better describe the relationship between treatment patterns and HRQoL in patients with MM, and to identify effective interventions.

Health-Related Quality of Life in Patients with Haemophilia and Its Association with Depressive Symptoms: A Study in Croatia and Slovenia.

There are only a few studies in patients with haemophilia (PWH) that examined both quality of life and depressive symptoms, with only few studies examining their association. Aim of this study was to examine the association between depressive symptoms and health-related quality of life (HRQoL) in PWH from Croatia and Slovenia. A total of 112 adult PWH on prophylactic (73%) or on-demand (27%) treatment were included in the study (median age 46 years, range 18-73 years). Depressive symptoms were assessed with BDI-II, HRQoL with SF-36v2, demographic and socioeconomic data were collected using a questionnaire, and clinical data were obtained from medical records. All HRQoL scores were significantly negatively correlated with BDI-II in the -0.42 to -0.70 range (all p<0.05). Socio-demographic and clinical variables explained 28-51% of HRQoL variance scores. Depressive symptoms explained additional variance for six HRQoL domain scores, with incremental variance being larger for mental domain scores (ranging between 10-27%), and for Mental Component Summary score (26%). This study's findings support that having depressive symptoms is associated with HRQoL of PWH, more so in the mental health than in the physical health domains.

Relationship of Hydroxyurea Adherence to Depression and Fatigue Among Children and Adolescents with Sickle Cell Disease: A Longitudinal Cohort Study

▪Background:Sickle cell disease (SCD) is the most common genetic disorder in the United States, seen in 100,000 Americans. SCD complications include pain episodes, chronic anemia and long-term end organ damage, leading to significant impairment in health-related quality of life (HRQOL) across the lifespan. Hydroxyurea (HU) reduces morbidity and mortality, improves HRQOL and lowers healthcare utilization, yet adherence remains suboptimal. Limited evidence from cross-sectional studies demonstrates an association between lower HU adherence and worse HRQOL scores.Objective:To assess the longitudinal relationship of HU adherence to HRQOL domains, including fatigue and depression. We hypothesized that higher HU adherence over time would be associated with improvement in HRQOL domain scores, especially depression and fatigue.Methods:In this longitudinal cohort study (NCT04675645), patients were enrolled from the comprehensive sickle cell clinic at Lurie Children's Hospital of Chicago. Patients were eligible if they were ³8 years old, had SCD (any genotype), and on HU with a stable dose for ³2 months. Study assessments included PROMIS ® measures for depression and fatigue, self-report of adherence using visual analogue scale (VAS), and patient demographics. Assessments were completed at baseline and every 3 months with a total of 5 visits (0, 3, 6, 9 and 12 months). Laboratory markers of adherence collected from chart review, including fetal hemoglobin (HbF%) and mean corpuscular volume (MCV). We conducted bivariate correlations among demographic variables, adherence markers and HRQOL scores as well as among adherence variables (VAS, HbF, MCV) at each visit. We conducted different multilevel models (MLMs), fixed and random effects, to understand the extent to which between- and within-person variation in adherence was associated with HRQOL scores over the 12-month period. We report unstandardized betas (B) and 95% Confidence Intervals (CI) from the MLMs.Results:Twenty-three patients have been enrolled (96% HbSS, 65% females, 100% Black, median age 15 [range 9-22] years old). At baseline, participants had a median Hb level of 9.5 (IQR 8.3-10.3 g/dl) with a HbF of 16.4% (IQR 13.1-28.7%) and MCV of 106.5 fl (IQR 91.6-113.9 fl). Participants' MCV levels significantly correlated with HbF% and VAS at visit 1 (r=0.58, P <0.01; r=0.6, P <0.01), visit 2 (r=0.66, P <0.01; r=0.63, P <0.01), visit 4 (r=0.76, P <0.01; r=0.72, P <0.01) and visit 5 (r=0.71, P <0.01; r=0.59, P <0.05), respectively. Participants' VAS adherence levels significantly increased from visit 1 to visit 5 (median 72 [IQR 60-92] vs. 88 [IQR 75-95], P=0.04, respectively) along with significant improvement in their fatigue scores (median 52.8 [IQR 35.1-70.5] vs. 30.8 [IQR 13.2-48.4], P=0.001, respectively).Variation in fatigue and depression scores across the study period was due to between-person differences (38% and 71%, respectively) or within-person fluctuations (62% and 29%, respectively). Using fixed and random effect MLMs, between-person differences in HU adherence over 12 months using VAS and HbF% were significantly related to participants' reported depression (B -0.43, 95% CI -0.69 to -0.17, P <0.01; B -0.58, 95% CI -1 to -0.15, P <0.05, respectively) (Figure 1) and fatigue scores (B -0.42, 95% CI -0.68 to -0.16, P <0.01; B -0.43, 95% CI -0.78. to -0.06, P <0.05, respectively) (Figure 2). In contrast, we found no statistically significant effects of within-person variation in adherence, using VAS and HbF, on participants' reported fatigue and depression scores over 12 months, which could be due our small sample size.Conclusions:Children and adolescents who were more adherent to HU across the entire study period were less likely to experience fatigue and depression, compared to those who were less adherent. Participants' self-report and laboratory markers of adherence were significantly correlated across study visits. Within-person fluctuations in adherence were not associated with changes in fatigue and depression scores across the study period. Future multi-institutional studies with a larger sample size are needed to better understand the within-person effects of variation in HU adherence on HRQOL scores over time. Behavioral interventions, such as mHealth apps, that are focused on improving HU adherence among children and adolescents with SCD has the potential to improve HRQOL and other important health outcomes. [Display omitted] DisclosuresBadawy: Bluebird Bio Inc: Consultancy; Vertex Pharmaceuticals Inc: Consultancy; Sanofi Genzyme: Consultancy. Thompson: Biomarin: Research Funding; Baxalta: Research Funding; bluebird bio, Inc.: Consultancy, Research Funding; Celgene/BMS: Consultancy, Research Funding; CRISPR Therapeutics: Research Funding; Vertex: Research Funding; Editas: Research Funding; Graphite Bio: Research Funding; Novartis: Research Funding; Agios: Consultancy; Beam: Consultancy; Global Blood Therapeutics: Current equity holder in publicly-traded company. Cella: FACIT: Membership on an entity's Board of Directors or advisory committees.

Frequency of Vaso-Occlusive Crises Is Associated with Health-Related Quality of Life in Pediatric Patients with Sickle Cell Disease: US Cross-Sectional Surveys of Adolescents and Caregivers

▪Introduction: Pediatric patients with sickle cell disease (SCD) experience considerable disease-related burden. SCD-related morbidity is characterized by vaso-occlusive crises (VOCs), which are acutely painful events that may cause chronic and potentially life-threatening complications, contributing to the early mortality associated with SCD. Two cross-sectional observational surveys were fielded to evaluate the relationship between VOC frequency and health-related quality of life (HRQoL) in pediatric patients with SCD in the United States (US).Methods: Surveys were administered in 2 populations: adolescents with SCD ages 12-17 years (n=247) and caregivers (n=167) of children with SCD ages 2 months-11 years in the US. Adolescent participants first provided assent to participate, and their guardians provided permission. Adolescents then completed an online survey that included the Child Health Questionnaire-Child Form 45 (CHQ-CF45) and the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) pain and sleep impact domains. After providing informed consent, caregivers completed an online survey assessing the HRQoL of their child with SCD; survey content was tailored to the age of their child. Caregivers of children ages 5-11 completed the CHQ-Parent Form 50 (CHQ-PF50) and the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and sleep disturbance short forms (8a and 4a, respectively). Caregivers of children <5 completed the Infant/Toddler Quality of Life Questionnaire-Short Form 47 (ITQOL-SF47). Children were stratified according to the number of VOCs they experienced in the past 12 months (0-2 VOCs; ≥3 VOCs), and a series of general linear models were conducted to examine the relationship between VOC frequency and HRQoL domain scores, with children's age included as covariate. Statistical significance was evaluated using a significance level of 0.05; p-values were also compared to a Benjamini-Hochberg adjusted critical value.Results: In adolescents ages 12-17, higher frequencies of VOCs were associated with lower HRQoL: adolescents with more frequent VOCs reported greater impacts than adolescents with less frequent VOCs across all domains of HRQoL measured by the CHQ-CF45, including general health, physical functioning, role/social limitations, mental health, and family activities (p<0.05 for all) (Table 1). Pain and sleep (ASCQ-Me domains) were also associated with VOC frequency: greater impacts were observed among adolescents with more frequent VOCs (p<0.001 for both). Similar to adolescents, children < 12 who experienced more frequent VOCs exhibited lower HRQoL as reported by caregivers on most CHQ-PF50 and ITQOL-SF47 domains except those related to behavior and the ITQOL-SF47 change in health domain (Table 2). Children with more frequent VOCs also experienced greater pain interference and sleep disturbance than those with less frequent VOCs (p<0.01 for both PROMIS domains; Table 2). Among caregivers of children ages 5-11, those whose children experienced more frequent VOCs reported greater impacts on CHQ-PF50 parental time/emotions and family activity domains than those whose children experienced less frequent VOCs (p<0.01 for all; Table 2). Caregivers of children ages 2 months-4 years also reported a similar association between VOC frequency and the ITQOL-SF47 parental time domain (p<0.01; Table 2). ITQOL-SF47 parental emotional impact scores also differed when compared to a significance level of 0.05, but were not statistically different after adjusting for multiple comparisons.Conclusions: Via both self- and caregiver-reports, these surveys demonstrated significant detrimental impact of VOCs on pediatric patients with SCD. Decrements were observed across various domains of HRQoL, including general health, physical functioning, pain, sleep, role/social limitations, and mental health. VOC frequency negatively impacted family activities and caregiver time and emotions, confirming anecdotal evidence that the effects of VOCs extend beyond the child to the caregiver. Given the cross-sectional study design, these analyses did not establish a temporal or causal relationship between VOCs and HRQoL; however, it is plausible that treatments aimed at reducing the frequency of VOCs may alleviate some of the burden experienced by pediatric patients with SCD and their families. [Display omitted] DisclosuresCampbell: Novartis Pharmaceuticals Corporation: Consultancy, Research Funding. Rizio: Novartis Pharmaceuticals Corporation: Other: Avery Rizio is employed by QualityMetric Incorporated, LLC, which received funding from Novartis to conduct this research. McCausland: Novartis Pharmaceuticals Corporation: Other: Kristen McCausland is an employee of QualityMetric Incorporated, LLC, which received funding from Novartis to conduct this research. Iorga: Novartis Pharmaceuticals Corporation: Current Employment, Current equity holder in publicly-traded company. Yen: Novartis Pharmaceuticals: Current Employment; Merck & Co., Inc.: Current holder of stock options in a privately-held company, Ended employment in the past 24 months. Paulose: Novartis Pharmaceuticals Corporation: Current Employment. Lee: Novartis Pharmaceuticals Corporation: Current Employment.

736 PL11.04 HEALTH-RELATED QUALITY OF LIFE OF PATIENTS WITH ESOPHAGEAL CANCER FOLLOWING ESOPHAGECTOMY TREATED WITH NEOADJUVANT CHEMORADIOTHERAPY OR CHEMOTHERAPY: EUROPEAN MULTICENTER STUDY

Abstract Curative treatment for patients with esophageal cancer consists of neoadjuvant treatment and radical surgical resection. Two different strategies exist; patients can either be treated with perioperative chemotherapy (CT) or neoadjuvant chemoradiotherapy (CRT). Both strategies improve 5-year survival rates, it is however not known if these treatments affect long-term Health-Related Quality of Life (HR-QoL) differently. The aim of this study was to compare HR-QoL between patients following CT and CRT followed by esophagectomy for esophageal cancer. Methods The LASER study database comprises data of a multicenter European study, with focus on HR-QoL among disease-free patients at least one year following an esophagectomy for esophageal or junctional cancer. Included patients completed the LASER, EORTC-QLQ-C30 and EORTC-QLQ-OG25 questionnaires. From this database we extracted patients either treated with CT or CRT for analysis. The primary endpoint was the mean difference in all long-term HR-QoL domains and LASER key symptom scores, using univariable and multivariable logistic regression analysis. The secondary endpoint was to compare the reported HR-QoL domain scores in the study population to the reference values of the general population. Results Among the 565 included patients, 349 (61.8%) received CRT, and 216 (38.2%) were treated with CT. The mean age was 63.7 years (±SD 8.6), and mean time since surgery was 4.3 years (±SD 1.7). After multivariable analysis, patients treated with CT reported worse outcomes on ‘Social Functioning’ (∆means 4.56, p-value&amp;lt;0.05), more symptomatology on domains ‘Insomnia’ (∆means 5.65 p-value&amp;lt;0.05) and ‘Diarrhea’ (∆means 5.93 p-value&amp;lt;0.05) of the QLQ-C30 questionnaire, and more symptomatology on domains ‘Reflux’ (∆means 7.40, p-value&amp;lt;0.05), ‘Odynophagia’(∆means 4.66 p-value&amp;lt;0.05) and ‘Pain and discomfort’(∆means 4.34, p-value&amp;lt;0.05) of the QLQ-OG25 questionnaire. No differences were observed for the LASER key symptoms. Conclusion Significant differences in favor of CRT were observed in several long-term HR-QoL domains for patients following esophagectomy for cancer. However, none of the observed differences in the reported long-term HR-QoL domains between patients treated with CT or with CRT, were clinically relevant (∆means≠ ≥ 10 points). Selection of neoadjuvant therapy should therefore be based on patient characteristics.