The effectiveness of health-related quality of life (HRQOL) model in people with HIV: A cross sectional study.

Background and Aims: Acquired immune deficiency syndrome (AIDS) are a chronic and disabling disease that has a significant impact on quality of life due to weakening of physical health, financial problems and social stigma. This study aims to validate the Health-related quality of life (HRQOL) model in people with human immunodeficiency viruses (HIV) in Iran. Methods: Four hundred and fifty-two people with HIV from Imam Khomeini Hospital between the age of 18 and 65 years (men: 308, women: 144) participated in the research. anonymously completed a battery of questionnaires, namely the Persian basic psychological need satisfaction and frustration scale, SF-36, PSQI and mindful attention awareness scale. The method of the present study was the structural equation model. Results: Current findings indicated there is a significant positive between mindfulness and need satisfaction, physical and mental health and, significant negative between mindfulness and quality and quantity of sleep. Mindfulness and need satisfaction are significant positive predictors of quality of life in people with HIV. Quality and quantity of sleep are significant negative predictors of quality of life in people with HIV. There is a positive significance between need satisfaction and physical and mental health but there is a negative significance between need satisfaction and quality and quantity. there is a negative significant between the quality and quantity of sleep with physical and mental health. Mindfulness facilitates the satisfaction of more psychological needs and improves the quality of sleep. The quality of sleep is a negative significant predictor for physical and mental health but the quantity of sleep is a negative significant predictor for physical health. Conclusion: The HRQOL model can explain 18% of physical health and 16% of mental health in people with HIV in Iran. The elements of this model can be useful in evaluating and treating people with HIV in the Iranian Population. They also can use the models to plan for better services.

Patient-reported outcomes in chronic hepatitis delta: An exploratory analysis of the Phase III MYR301 trial of bulevirtide.

BACKGROUND & AIMS: Once-daily treatment of chronic hepatitis delta (CHD) with bulevirtide is well tolerated and associated with significant reductions in HDV RNA in the blood and in biochemical liver disease activity. This study explored the effects of 48-week bulevirtide treatment on health-related quality of life (HRQoL) in patients with CHD. METHODS: In an open-label, randomised, Phase 3 trial, 150 patients with CHD and compensated liver disease were stratified by liver cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks. HRQoL was evaluated by the following patient-reported outcome (PRO) instruments at baseline, 24 weeks, and 48 weeks: EQ-5D-3L, Hepatitis Quality of Life Questionnaire (HQLQ), and Fatigue Severity Scale (FSS). RESULTS: Patient characteristics and HRQoL scores were balanced at baseline between the treatment (2 mg, n = 49; 10 mg, n = 50) and control (n = 51) groups. Patients receiving 2-mg bulevirtide reported significant improvements compared with controls on the HQLQ domains of role physical, hepatitis-specific limitations, and hepatitis-specific health distress. Numerically higher scores for general health, hepatitis-specific limitations, and hepatitis-specific health distress domains were reported by patients with cirrhosis who received bulevirtide vs control. FSS scores remained stable across treatment groups throughout. At week 48, patients in the 2-mg group showed greater mean improvement from baseline in health status compared with controls on the EQ-5D-3L visual analogue scale. CONCLUSION: PROs indicate that 48-week treatment with bulevirtide monotherapy may improve aspects of HRQoL in patients with CHD. IMPACT AND IMPLICATIONS: Bulevirtide 2 mg is the only approved treatment for patients with chronic hepatitis delta (CHD) in the EU. Patients with CHD have worse quality of life scores than those with chronic hepatitis B. Bulevirtide treatment for 48 weeks reduced HDV RNA and alanine aminotransferase levels and was well tolerated among patients with CHD. For the first time, this study shows that patients who received bulevirtide therapy for 48 weeks reported improvements in physical and hepatitis-related quality of life domains compared to those who did not receive therapy (control group). CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT03852719.

Age of onset of major depressive episode and association with lifetime psychiatric disorders, health-related quality of life and impact of gender: A cross sectional and retrospective cohort study.

OBJECTIVE: To assess the long-term impact of the age of onset (AOO) of the first major depressive episode (MDE) according to 3 age groups and considering gender. METHODS: Data were extracted from NESARC III, a representative U.S. SAMPLE: We included 8053 participants with an MDE history in a cross-sectional and retrospective cohort study. We defined 3 AOO groups: childhood-onset (< 13 yo), adolescence-onset (13-18 yo), and adult-onset (> 18 yo). We compared sociodemographic characteristics, lifetime psychiatric disorders per DSM-5 criteria, and health-related quality of life (HRQOL) in each group and performed gender-stratified analyses. RESULTS: Prevalence of childhood-onset MDE was 10.03 %, adolescence-onset was 14.12 %, and adult-onset was 75.85 %. Suicide attempts (AOR = 3.61; 95 % CI 2.90-4.50), anxiety disorders (AOR = 1.92; 95 % CI 1.62-2.27), and personality disorders (AOR = 3.08; 95 % CI 2.56-3.71) were more frequent in the childhood-onset than in the adult-onset one. Adolescence-onset group showed similar results. Physical Disability scale (p < 0.001) and Mental Disability scale (p < 0.001) were significantly lower in the childhood-onset group. Results were more nuanced in the adolescence-onset group. Women in childhood-onset and adolescence-onset groups had poorer outcomes than the adult-onset group. Differences were less pronounced in men. LIMITATIONS: Recall and classification biases inherent to survey design. CONCLUSION: Individuals, particularly women, who experienced their first MDE during childhood or adolescence exhibit higher lifetime psychiatric disorder prevalence and poorer HRQOL than those with adult-onset MDE. These findings highlight the importance of preventive measures, early diagnosis, and treatment of youth depression.

The BDNF Val66Met polymorphism and health-related quality of life in youth with obesity.

The brain derived-neurotrophic factor (BDNF) Val66Met polymorphism causes functional changes in BDNF, and is associated with obesity and some psychiatric disorders, but its relationship to health-related quality of life (HRQoL) remains unknown. This study examined, in youth with obesity, whether carriers of the BDNF Val66met polymorphism Met-alleles (A/A or G/A) differed from noncarriers (G/G) on HRQoL. The participants were 187 adolescents with obesity. Ninety-nine youth were carriers of the homozygous Val/Val (G/G) alleles, and 88 were carriers of the Val/Met (G/A) or Met/Met (A/A) alleles. Blood samples were drawn in the morning after an overnight fast for genotyping. HRQoL was measured using the Pediatric-Quality of Life core version. Compared to carriers of the Val66Met Val (G/G) alleles, carriers of the Met-Alleles reported significantly higher physical -HRQoL (p = 0.02), school-related HRQoL, (p = 0.05), social-related HRQoL (p = 0.05), and total HRQoL (p = 0.03), and a trend for Psychosocial-HRQoL. Research is needed to confirm our findings and determine whether carriers of the BDNF Val66Met homozygous Val (G/G) alleles may be at risk of diminished HRQoL, information that can influence interventions in a high-risk population of inactive youth with obesity.

Creating an SF-6Dv2 social value set for New Zealand.

The SF-6D health descriptive system and its second version published in 2020, the SF-6Dv2, is used worldwide for valuing health-related quality of life (HRQoL) for economic evaluation and measuring patient-reported health outcomes. In this study, a valuation tool was developed and applied to create a social value set, comprising 18,750 health state values, for the SF-6Dv2 for New Zealand (NZ). This tool was adapted and extended from the one used to create a social value set for the EQ-5D-5L, a simpler health descriptive system with fewer dimensions and health states. The tool implements the PAPRIKA method, a type of adaptive discrete choice experiment, and a binary search algorithm to identify health states worse than dead and has extensive data quality controls to ensure the validity and reliability of the social value set derived from participants' personal value sets. The tool, accompanied by a short introductory video designed specifically for the SF-6Dv2, was distributed via an online survey to a large representative sample of adult New Zealanders in June-July 2022. The tool's data quality controls enabled participants who failed to understand or sincerely engage with the valuation tasks to be identified and excluded, resulting in the participants being pared down to a sub-sample of 2985 'high-quality' participants whose personal value sets were averaged for the social value set. These results, including participants' positive feedback, demonstrate the feasibility and acceptability of using the tool to value larger health descriptive systems such as the SF-6Dv2. Having successfully created an SF-6Dv2 social value set for NZ, the valuation tool can be readily applied to other countries, used to generate personal value sets for personalised medicine and adapted to create value sets for other health descriptive systems.

Measuring health related quality of life (HRQoL) in Lysosomal Storage Disorders (LSDs): a rapid scoping review of available tools and domains.

BACKGROUND: Lysosomal storage diseases (LSDs) are a group of rare inherited metabolic disorders, consisting of over 70 diseases that are characterised by lysosomal dysfunction. Due to their varied and progressive symptoms, LSDs have a continual impact on patients' health-related quality of life (HRQoL). Several recently published studies have provided insight into the HRQoL of individuals with LSDs. However, it is challenging to meaningfully synthesise this evidence, since studies often focus upon a particular type of LSD and / or utilise different self-report questionnaires or patient-reported outcome measures (PROMs) to assess HRQoL. AIMS: The aim of this study was to review the published literature in LSDs, to identify the PROMs which have been used to assess HRQoL and generate a conceptual map of HRQoL domains measured in individuals diagnosed with LSDs. METHODS: Three electronic databases were searched in March 2022. Primary studies of any design which utilised multi-item PROMs to assess at least one aspect of HRQoL in individuals with LSDs since 2017 were identified. Data were extracted to assess both the characteristics of each study and of the PROMs utilised within each study. The extraction of HRQoL domains and synthesis were informed by an a priori framework, inductively modified to reflect data emerging from the identified literature. Selection and extraction was undertaken independently by two reviewers; discrepancies were ratified by a third reviewer. RESULTS: Sixty nine studies were identified which were published 2017-2022, with a combined total of 52 PROMs (71 variants) used to assess HRQoL in individuals with LSDs. The final extracted HRQoL framework included 7 domains (Activities; Physical sensations; Autonomy; Cognition; Feelings and emotions; Self-identity; Relationships), characterised by 37 sub-domains. CONCLUSIONS: This review highlights the breadth and variety of HRQoL domains assessed in individuals with LSDs, across three broad domains of physical, psychological and social functioning. The resultant framework and mapped PROMs will aid researchers and clinicians in the selection of PROMs to assess aspects of HRQoL in people living with LSDs, based on their conceptual coverage.

Correlation analyses of radiographic progression-free survival with clinical and health-related quality of life outcomes in metastatic castration-resistant prostate cancer: Analysis of the phase 3 VISION trial.

BACKGROUND: [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) plus protocol-permitted standard of care (SOC) prolonged overall survival (OS) and radiographic progression-free survival (rPFS) versus SOC in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 VISION study, in addition to beneficial effects on symptomatic skeletal events (SSEs) and health-related quality of life (HRQOL). METHODS: Post hoc analyses used the full analysis set from the VISION study (N = 831) overall and by randomized treatment arm (177Lu-PSMA-617 plus SOC, n = 551; SOC, n = 280). Correlations were determined between OS and rPFS and between rPFS or OS and time to SSE or to worsening HRQOL (Functional Assessment of Cancer Therapy-Prostate [FACT-P] and 5-level EQ-5D [EQ-5D-5L]). Correlation analyses used an iterative multiple imputation copula-based approach (correlation coefficients [rho] of <0.3 were defined as weak, ≥0.3 and <0.5 as mild, ≥0.5 and <0.7 as moderate, and ≥0.7 as strong). RESULTS: In the overall population, rPFS correlated strongly with OS (rho, ≥0.7). Correlations between rPFS or OS and time to SSE without death were weak or mild. Time to worsening in the FACT-P total score and emotional and physical well-being domains correlated mildly or moderately with rPFS and moderately with OS. Correlation coefficients for time-to-worsening EQ-5D-5L scores were mild to moderate for both rPFS and OS. Correlation coefficients were similar between treatment arms. CONCLUSIONS: In this analysis of the VISION study, rPFS correlated strongly with OS but not with time to SSE or worsening HRQOL. These findings require further investigation.

Health-related quality of life in children with childhood acute myeloid leukemia in China: A five-year prospective study.

Purpose: This study aims to identify the key factors influencing health-related quality of life (HRQoL) of pediatric acute myeloid leukemia (AML) patients following their initial diagnosis and examine their impact on the five-year survival prognosis. Methods: A chart review and follow-up were conducted for children with AML who participated in a prospective cohort study between 2017 and 2020. We identified factors influencing HRQoL through Pediatric Quality of Life Inventory™ (PedsQL™ 4.0), PedsQL™ Cancer Module 3.0 (CM 3.0) and PedsQL™ Family Impact Module 2.0 (FIM 2.0), as well as assessed the impact of impaired HRQoL on the overall outcomes of patients. Results: Sixty-four subjects enrolled in the study had complete HRQoL outcome data, and 61 of them completed the 5-year follow-up. In CM 3.0, age was positively associated with parental proxy reports (p = 0.040), whereas divorced families were negatively associated with child self-reports (p = 0.045). A positive medical history correlates with FIM 2.0 (p = 0.025). Residence (p = 0.046), the occupation of caregivers (p = 0.014), disease severity (p = 0.024), and the only child (p = 0.029) exhibited statistically significant associations with the impairment of HRQoL. Impaired HRQoL scores shown by the PedsQL™4.0 parent proxy report (p = 0.013) and FIM 2.0 (p = 0.011) were associated with a reduced 5-year survival rate. Conclusions: This study demonstrated that early impairment of HRQoL in pediatric acute myeloid leukemia patients has predictive value for long-term prognosis. Once validated, these findings may provide some guidance to clinicians treating children with AML.

Functional outcomes of bony sarcoma (BS) in Adolescent and Young Adult Oncology (AYAO) patients-a scoping review.

BACKGROUND: Sarcomas are heterogeneous rare cancers, and while they affect 1% of all adult cancers, they affect 10-20% of adolescents and young adults (AYAs). The 5-year survival rates range between 50-60% but have remained stagnant. While the management of bony sarcomas (BS) usually involves systemic treatment and major morbid surgeries, functional outcomes and quality of life have been largely overlooked. METHODS: A literature search was conducted on PubMed and ScienceDirect using key search terms of "Adolescent and young adult", "AYAO", "bone sarcoma, osteosarcoma, Ewing sarcoma", "functional outcomes" and "health-related quality of life" from 1st January 2003 to 13 March 2023. A total of 858 results in total were screened by two independent authors, and 18 selected papers were included in the scoping review. RESULTS: AYAs have poorer outcomes in all aspects-physical, social and psychological in BS survivorship, as many changes from disease and treatment are usually persistent and irreversible, with significant impact on mobility, function and body image. Current tools to assess health-related quality of life (HRQoL) in AYAs are not standardized or validated in this age group. Subjective tools measuring physical outcomes do not correlate to objective measures of physical function. CONCLUSIONS: These outcomes have a direct connection to their independence, self-confidence and future job endeavors, yet hardly any specific research has gone into it. They are stricken with a cancer diagnosis during the prime of their lives and it is essential to manage them holistically to preserve and maximize their functional outcomes. More research is required to monitor their outcomes long-term post-treatment and into survivorship.

Statistical Analysis Methods and Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Cancer Conducted in Japan: A Systematic Review.

The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative was established in 2016 to assess the quality and standardization of patient-reported outcomes (PRO) data analysis in randomized controlled trials (RCTs) on advanced breast cancer. The initiative identified deficiencies in PRO data reporting, including nonstandardized methods for handling missing data. This study evaluated the reporting of health-related quality of life (HRQOL) in Japanese cancer RCTs to provide insights into the state of PRO reporting in Japan. The study reviewed PubMed articles published from 2010 to 2018. Eligible studies included Japanese cancer RCTs with ≥50 adult patients (≥50% were Japanese) with solid tumors receiving anticancer treatments. The evaluation criteria included clarity of the HRQOL hypotheses, multiplicity testing, primary analysis methods, and reporting of clinically meaningful differences. Twenty-seven HRQOL trials were identified. Only 15% provided a clear HRQOL hypothesis, and 63% examined multiple HRQOL domains without adjusting for multiplicity. Model-based methods were the most common statistical methods for the primary HRQOL analysis. Only 22% of the trials explicitly reported clinically meaningful differences in HRQOL. Baseline assessments were reported in most trials, but only 26% reported comparisons between the treatment groups. HRQOL analysis was based on the intention-to-treat population in 19% of the trials, and 74% reported compliance at follow-up; however, 41% did not specify how missing values were handled. Although the rates of reporting clinical hypotheses and clinically meaningful differences were relatively low, the current state of HRQOL evaluation in the Japanese cancer RCT appears comparable to that of previous studies.

Patient-reported outcomes with selpercatinib treatment in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial.

BACKGROUND: This post-hoc retrospective study describes long-term patient-reported outcomes (PROs) for REarranged during Transfection (RET)-altered non-small-cell lung cancer (NSCLC), medullary thyroid cancer (MTC), non-MTC thyroid cancer (TC), and tumor agnostic (TA) patients (Data cut-off: January 2023) from the LIBRETTO-001 trial. PATIENTS AND METHODS: Patients completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30). Patients with MTC also completed a modified version of the Systemic Therapy-Induced Diarrhea Assessment Tool (mSTIDAT). The proportion of patients with improved, stable, or worsened status after baseline was reported. PROs were summarized at 3 years (cycle 37) post-baseline for the NSCLC and MTC cohorts, and at 2 years (cycle 25) post-baseline for the TC and TA cohorts. Time-to-event outcomes (time to first improvement or worsening and duration of improvement) were reported. RESULTS: The baseline assessment was completed by 200 (63.3%), 209 (70.8%), 50 (76.9%), and 38 (73.1%) patients in the NSCLC, MTC, TC, and TA cohorts, respectively. The total compliance rate was 80%, 82%, 70%, and 85%, respectively. Approximately 75% (NSCLC), 81% (MTC), 75% (TC), and 40% (TA) of patients across all cohorts reported improved or stable QLQ-C30 scores at year 3 (NSCLC and MTC) or year 2 (TC and TA) with continuous selpercatinib use. Across cohorts, the median time to first improvement ranged from 2.0 to 19.4 months, the median duration of improvement ranged from 1.9 to 28.2 months, and the median time to first worsening ranged from 5.6 to 44.2 months. The total compliance rate for the mSTIDAT was 83.7% and the proportion of patients with MTC who reported diarrhea on the mSTIDAT was reduced from 80.8% at baseline to 35.6% at year 3. CONCLUSIONS: A majority of patients with RET-driven cancers improved or remained stable on most QLQ-C30 domains, demonstrating favorable health-related quality of life as measured by the QLQ-C30 during long-term treatment with selpercatinib.

Harm-to-self from gambling: A national study of Australian adults.

Aims: Understanding how gambling harm is distributed is essential to inform effective harm reduction measures. This first national Australian study of gambling harm-to-self examined the extent, distribution, risk factors, and health related quality of life (HRQoL) impacts of this harm. Methods: A Random Digit Dialling sample of 15,000 Australian adults was weighted to key population variables. Key measures included the Gambling Harms Scale-10 (GHS-10), PGSI, SF-6D, gambling behaviours, and demographics. Analyses included ordinal logistic regression. Results: Amongst gamblers, 14.7% reported harm on the GHS-10, including 1.9% reporting high-level harm. While high-level harm occurred mainly in the problem gambling group (77.3%), other PGSI groups accounted for most of the more prevalent low (98.5%) and moderate (87.2%) harms reported. Proximal predictors of greater harm were use of online gambling and more frequent gambling on electronic gaming machines (EGMs), race betting sports betting, poker, skin gambling, scratchies, and loot box purchasing. Distal predictors were being younger, male, single, Aboriginal or Torres Strait Islander, and speaking a non-English language at home. At the population level, the greatest aggregate HRQoL impacts were amongst lower-risk gamblers, confirming the results of other studies regarding the 'prevention paradox'. Conclusions: The distribution of harm across gambler risk groups indicates the need for preventive measures, not just interventions for problem gambling. Reducing harm requires modifying product features that amplify their risk, especially for EGMs, race betting and sports betting that are both inherently risky and widely used. Gambling harm exacerbates health disparities for disadvantaged and vulnerable groups, requiring targeted resources and support.

A domain specific health-related quality of life of omani patients living with chronic wounds.

AIM: Chronic wounds, defined as wounds that do not heal in a logical set of stages, impact patients' quality of life by disrupting their self-esteem, sleep, social interaction, work capacity, and psychological well-being. Chronic wounds are a prevalent problem in Oman due to the high number of patients with diabetes, sickle cell disease, road traffic accidents, and decubitus ulcer. Therefore, it is paramount to analyse the health-related quality of life (HRQOL) of these patients with chronic wounds. MATERIAL AND METHODS: An observational, cross-sectional, descriptive study with a quantitative approach was conducted among 275 adult patients with chronic wounds in three tertiary hospitals of Muscat from June to December 2021 using a self-reported Cardiff life wound impact questionnaire and the Bates-Jensen wound assessment tool. Data were analysed with IBM SPSS version 23 using inferential statistics and chi-square test. RESULTS: We found that the majority of participants were men (178; 64.7 %), aged between 41 and 60 years (107; 38.9 %), predominantly with diabetic wounds (80; 29.1 %). Respondents reported poor HRQOL across all domains: well-being (63.24 ± 18.092), physical (53.24 ± 18.387), and social (59.54 ± 19.025). Statistically significant poorer HRQOL was observed among the elderly above 60 years, illiterates, those with traumatic wounds, and those receiving medication and dressing as treatment. CONCLUSIONS: Our findings indicate that Omani patients with chronic wounds experience low HRQOL. It is imperative for healthcare providers to offer comprehensive care to these patients. To enhance their quality of life and alleviate suffering, evaluating both the wounds and HRQOL is essential. Such assessments will enable the optimisation of treatment and coping strategies for patients.

Transcultural adaptation and validation of IMPACT-III and IMPACT-III-P in Spanish families: a multicenter study from SEGHNP.

IMPACT-III and IMPACT-III-P are health-related quality of life (HRQoL) questionnaires for patients with pediatric inflammatory bowel disease (p-IBD) and their parents/caregivers. We aimed to perform a transcultural adaptation and validation for the Spanish context. Translation, back-translation, and evaluation of the questionnaires were performed by an expert committee and 12 p-IBD families. We recruited p-IBD patients aged 10-17 and their parents/caregivers. Utility, content, and face validity were considered. Validation was performed with Cronbach's alpha coefficient and varimax rotation. We confirmed the adequacy of the factor analysis using Kaiser-Meyer-Olkin (KMO) and Bartlett's sphericity tests. A confirmatory factor analysis was performed using the following goodness indexes: chi-square, Normed Fit Index (NFI), Root Mean Square Error of Approximation index (RMSEA), Standardized Root Mean Square Residual (SRMR), and Comparative Fit Index (CFI). The correlation coefficient between IMPACT-III and IMPACT-III-P was analyzed. We included 370 patients and 356 parents/caregivers (37 hospitals). Both questionnaires had good content and face validity and were considered user-friendly. The KMO measure (0.8998 and 0.9228, respectively) and Bartlett's sphericity test (p-value < 0.001 for both) confirmed the adequacy of the factor analysis. The 4-factor model, complying with Kaiser's criterion, explained 89.19% and 88.87% of the variance. Cronbach's alpha (0.9123 and 0.9383) indicated excellent internal consistency. The CFA showed an adequate fit (NFI 0.941 and 0.918, RMSEA 0.048 and 0.053, SRMR 0.037 and 0.044, and CFI 0.879 and 0.913). The correlation coefficient was excellent (0.92). CONCLUSION: The SEGHNP versions of IMPACT-III and IMPACT-III-P are valid and reliable instruments for Spanish p-IBD families. WHAT IS KNOWN: • IMPACT-III and parent-proxy IMPACT-III (IMPACT-III-P) are useful questionnaires for assessing health-related quality of life (HRQoL) in pediatric inflammatory bowel disease (p-IBD) patients and their parents/caregivers and have been translated and validated in several countries. • To date, no transcultural adaptation and validation of these questionnaires have been published for Spanish patients with p-IBD and their families. WHAT IS NEW: • This is the first transcultural adaptation and validation of IMPACT-III and IMPACT-III-P for Spanish p-IBD families. • These are valid and reliable instruments for assessing HRQoL in Spanish families of patients with p-IBD.

Health-related quality of life and influencing factors of patients with paroxysmal nocturnal hemoglobinuria in China.

BACKGROUND: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder, leading to various complications and impairments in patients' health-related quality of life (HRQOL). Limited research has been conducted to evaluate the HRQOL of Chinese patients with PNH. Understanding the HRQOL in this specific population is crucial for providing effective healthcare interventions and improving patient' health outcomes. This study aimed to assess HRQOL of Chinese patients with PNH, and identify key determinants. METHODS: A cross-sectional study was conducted during 2022 to recruit patients with PNH in China. The study population was recruited from PNH China, one of the largest public welfare PNH patient mutual aid organization in China. Data were collected via an online questionnaire including the EQ-5D-5L (5L), and social-demographic and clinical characteristics. Descriptive statistics were employed to summarize the characteristics of the participants and their HRQOL. Multiple linear and logistic regression analyses were adopted to explore key factors affecting HRQOL. RESULTS: A total of 329 valid questionnaires were collected. The mean (SD) age of the patients was 35.3 (10.0) years, with 52.3% of them being male. The patients reported more problems in Anxiety/Depression (81.5%) and Pain/Discomfort (69.9%) dimensions compared to the other three 5L dimensions. The mean (SD) of 5L health utility score (HUS) and EQ-VAS score were 0.76 (0.21) and 62.61 (19.20), respectively. According to multiple linear regression, initial symptoms (i.e., Anemia [fatigue, tachycardia, shortness of breath, headache] and back pain) and complication of thrombosis were significant influencing factors affecting 5L HUS. Total personal income of the past year, initial symptom of hemoglobinuria and complication of thrombosis were significantly influencing factors of VAS score. Social-demographic and clinical characteristics, such as gender, income, and thrombosis, were also found to be significantly related to certain 5L health problems as well. CONCLUSION: Our study manifested the HRQOL of PNH patients in China was markedly compromised, especially in two mental-health related dimensions, and revealed several socio-demographic and clinical factors of their HRQOL. These findings could be used as empirical evidence for enhancing the HRQOL of PNH patients in China.

Differences in health-related quality of life and somatic symptoms in employed and unemployed patients with epilepsy.

This study compared overall and specific aspects of health-related quality of life (HRQOL) and self-report of somatic, anxiety, and depressive symptoms between employed (n = 71) and unemployed (n = 48) patients with epilepsy (PWE). The Quality of Life in Epilepsy (QOLIE-89) and the Personality Assessment Inventory (PAI) were examined. The unemployed group reported significantly worse overall HRQOL including aspects of HRQOL related to epilepsy, physical health, mental health, and cognitive function. Among these four, physical health related HRQOL revealed the most difference between groups. While there were no differences between the groups in the level of social support and social isolation, the unemployed group reported worse social function with respect to work and driving. The unemployed group reported significantly greater somatic symptoms, but not anxiety and depressive symptoms. When specifically examining the subscales of the Somatic Concerns scale, conversion and health concerns, but not somatization, were greater in the unemployed group. Among the Depression subscales, the unemployed group reported greater physiologically manifested depressive symptoms. These findings suggest that along with optimizing seizure control, identifying and addressing presence of physical limitations, dysfunction, and somatic symptoms are also of importance in the care of PWE, particularly for those who are unemployed.

Stressors in Atopic Dermatitis.

As with other inflammatory skin disorders, atopic dermatitis has a tendency to cause stress and also be exacerbated by it. Patients with atopic dermatitis have several disease-associated stressors, some of which include physical discomfort due to itching and altered appearance due to flare-ups. These stressors have been shown to effect patients psychosocially by altering sleep patterns, decreasing self-esteem, and interfering with interpersonal relationships. In combination with its direct effect on patients, atopic dermatitis also causes stress for parents and caregivers. Studies suggest that atopic dermatitis is strongly correlated with co-sleeping habits, which can negatively impact the health and mood of parents or caregivers. It has also been reported to interfere with the formation of a strong mother-child relationship. In order to optimize treatment for patients with atopic dermatitis, it is important to note the impact that it has on quality of life. By implementing patient counseling, sleep-targeted therapies, and the use of quality of life (QoL) indices, atopic dermatitis patients and caregivers have the potential to experience greater satisfaction with treatment.

Efficacy and Safety of Laughter Yoga in Cancer Patients: A Scoping Review of Randomized Controlled Trials.

The use of laughter yoga as a complementary and alternative medicine (CAM) strategy has recently gained interest as a potential supportive intervention for cancer patients. In this review, we aimed to assess the impact of laughter yoga on the quality of life of cancer patients, with a focus on evidence from randomized controlled trials (RCTs). Our analysis indicates that laughter yoga can significantly improve the quality of life of cancer patients by improving emotional and physical functioning and reducing symptoms of depression and stress. These findings suggest that laughter yoga is a promising CAM practice for enhancing cancer patients' psychological and physical health. Future research should aim to extend these studies to more extensive and more diverse populations to validate and expand upon these findings.

Association between adverse childhood experiences and health related quality of life in adult cancer survivors in the United States.

PURPOSE: The impact of adverse childhood experiences (ACEs) on health-related quality of life (HRQOL) is increasingly recognized, however, this has not been studied in cancer survivors in the United States. This study investigates if ACEs are associated with HRQOL in cancer survivors. METHODS: We conducted a cross-sectional analysis of the 2020 Behavioral Risk Factor Surveillance System from states that administered ACEs and Cancer Survivorship modules. Eligibility criteria included being a cancer survivor and not currently receiving cancer treatment. Primary exposure was number of ACEs (categorized as 0, 1-2, 3, or ≥ 4). Primary outcomes were self-reported measures of HRQOL including worse overall health and ≥ 14 unhealthy days (mentally or physically) per month. Mantel-Haenszel stratified analyses were performed and prevalence ratios were adjusted for age. RESULTS: Of 5,780 participants, 62.0% were female and 67.8% were ≥ 65 years. Prevalence of worse overall health was 22.5% for individuals with no ACEs compared to 30.2% for 2-3 ACEs (aPR = 1.4, 95% CI 1.2, 1.5) and 38.5% for ≥ 4 ACEs (aPR = 1.7, 95% CI 1.5, 2.0). Prevalence of ≥ 14 unhealthy days was 18.1% with no ACEs compared to 21.0% for 1 ACE (aPR = 1.3, 95% CI 1, 1.3), 29.0% for 2-3 ACEs (aPR = 1.6, 95% CI 1.4, 1.8), and 44.8% for ≥ 4 ACEs (aPR = 2.2, 95% CI 2.0, 2.5). CONCLUSIONS: Our study provides novel evidence of the association of multiple ACEs with higher prevalence of poor HRQOL in cancer survivors. IMPLICATIONS FOR CANCER SURVIVORS: Screening for ACEs is warranted in all patients to guide targeted interventions to improve HRQOL and mitigate the impact of ACEs on HRQoL in cancer survivors.

Pain and Health-Related Quality of Life in Autosomal Dominant Polycystic Kidney Disease: Results from a National Patient-Powered Registry.

Rationale & Objective: Autosomal dominant polycystic kidney disease (ADPKD) affects health-related quality of life (HRQoL) including pain, discomfort, fatigue, emotional distress, and impaired mobility. Stakeholders prioritized kidney cyst-related pain as an important core outcome domain in clinical trials, leading to the development of disease-specific assessment tools. Study Design: The ADPKD Registry is hosted online with multiple disease-specific patient-reported outcomes modules to characterize the patient experience in the United States. Setting & Participants: The ADPKD Registry allows consented participants access to a Core Questionnaire that includes demographics, comorbid conditions, current symptoms, and kidney function. Participants complete subsequent modules on a 3-month schedule, including 2 validated HRQoL tools, the ADPKD-Pain and Discomfort Scale (ADPKD-PDS), the ADPKD Impact Scale (ADPKD-IS) and a Healthcare Access and Utilization module. Exposures: Patient-reported latest estimated glomerular filtration rate or creatinine used to calculate stage of chronic kidney disease. Outcomes: Health-related quality of life, measured using validated ADPKD-specific tools; access to polycystic kidney disease-specific health care. Analytical Approach: For the 2 HRQoL tools, scores were calculated for physical, emotional, and fatigue domains; pain severity; and pain interference (based on the licensed user manuals). Associations to health care access were also assessed. Results: By July 2022, 1,086 individuals with ADPKD completed at least 1 of the HRQoL modules, and 319 completed 4 over a year. Participants were an average age of 53. In total, 71% were women, and 91% were White, with all chronic kidney disease (CKD) stages represented. In total, 2.5% reported being treated with dialysis, and 23% had a kidney transplant. CKD stage 4/5 participants reported the most dull kidney pain, whereas sharp kidney pain was evenly distributed across early CKD stages. Dull kidney pain had an impact on sleep regardless of CKD stage. There was a strong positive correlation between the ADPKD-PDS and ADPKD-IS. Patients with a neutral or positive HRQoL were less likely to have been denied access to imaging or other care. Limitations: Currently, all the information collected is patient reported without health record validation of clinical variables. Conclusions: Use of the HRQoL tools in the ADPKD Registry provided a broad cross-sectional assessment in the United States and provided granular information on the burden of pain across the CKD spectrum in ADPKD. The ADPKD Registry allowed assessment of ADPKD impact in a community that experiences decline in health and kidney function over decades.

The Autosomal Dominant Polycystic Kidney Disease Registry is a longitudinal, patient-powered research tool created with the goal to better understand the impacts of ADPKD on affected individuals in the United States. Here, we analyze pain and other health-related quality of life outcomes in 1,086 individuals using validated tools and comment on the utility of these tools for future use in clinical trials and observational studies. We found that sharp pain, dull pain, fullness discomfort, and other related impacts affected individuals across the disease spectrum, although some participants reported more dull pain in later stages (CKD stages 4 and 5). Future analysis of these trends over time will be valuable in understanding how to assess and address the burden of pain in autosomal dominant polycystic kidney disease.