Health And Quality Of Life Outcomes[JOURNAL]
Sun
200 papers
The impact of physical symptoms on depression and quality of life in patients with lung cancer: the moderating effects of illness perceptions and gender.
Yang J, Dong D, He G … +6 more , Ge Z, Chen Z, Han C, Zhao Y, He Y, Chu Q
Health Qual Life Outcomes · 2025 Jun · PMID 40551128 · Full text
BACKGROUND: Physical symptoms negatively affect lung cancer patients' emotional well-being and quality of life. It remains understudied about what psychosocial factors may buffer the negative impact of physical symptoms....
BACKGROUND: Physical symptoms negatively affect lung cancer patients' emotional well-being and quality of life. It remains understudied about what psychosocial factors may buffer the negative impact of physical symptoms. This study examines how illness perceptions moderate the impact of physical symptoms on depression and quality of life, and further considers gender differences. METHODS: A cross-sectional study was conducted on 316 lung cancer patients from Shanghai Chest Hospital in Shanghai, China, between July and September 2021. Participants completed questionnaires assessing physical symptoms, depression, quality of life, and illness perceptions. RESULTS: Hierarchical regression analyses revealed significant two-way interactions between physical symptoms and illness timeline perceptions on both depression (β = 0.12, P = 0.028) and quality of life (β = -0.13, P = 0.010). Additionally, significant three-way interactions involving physical symptoms, illness perceptions, and gender were found. Specifically, illness consequences perceptions interacted with physical symptoms and gender to predict depression (β = 0.17, P = 0.012), while personal control (β = 0.14, P = 0.022) and treatment control (β = 0.17, P = 0.017) interacted similarly to predict quality of life. Simple slope analyses indicated that positive illness perceptions alleviated the negative effects of physical symptoms on depression and quality of life, particularly in females. CONCLUSIONS: These findings indicate that facilitating positive illness perceptions may buffer the adverse effects of physical symptoms on depression and quality of life. Personalized psychological interventions aimed at enhancing patients' illness beliefs through positive psychological and behavioral strategies may contribute to improved coping and overall well-being.
Association between obstructive sleep apnea and quality of life in Korean middle-aged people: a cross-sectional study.
Kim J, Joo MJ, Yong Shin J … +2 more , Nam CM, Park EC
Health Qual Life Outcomes · 2025 Jun · PMID 40518545 · Full text
BACKGROUND: Obstructive sleep apnea (OSA), a serious sleep disorder, can lead to comorbidities and decreased quality of life if untreated. Poor sleep quality from OSA affects concentration, cognitive function, and mental...
BACKGROUND: Obstructive sleep apnea (OSA), a serious sleep disorder, can lead to comorbidities and decreased quality of life if untreated. Poor sleep quality from OSA affects concentration, cognitive function, and mental health, contributing to conditions such as depression and anxiety. OSA prevalence increases with age, and middle-aged adults are particularly at risk owing to age-related social and physical changes. Enhancing sleep quality is essential for improving overall quality of life. The aim of this study was to investigate the relationship between OSA risk and quality of life among middle-aged and older adults in South Korea. METHODS: This study utilized data from the 8th Korea National Health and Nutrition Examination Survey for 2019 and 2021 to investigate the relationship between OSA and health-related quality of life (HRQoL). After excluding missing values, the analysis included 8,109 adults aged ≥ 40 years. The primary variable of interest was OSA risk, with HRQoL measured using the HINT-8 index. Chi-square tests, binary logistic regression, and multinomial logistic regression analyses were conducted to examine the association between OSA and HRQoL. RESULTS: In this study of 4,831 participants, 59.6% were classified as high-risk for OSA. Low quality of life was significantly associated with high-risk OSA (adjusted odds ratio [aOR], 1.17: 95% confidence interval [CI], 1.03-1.33). Subgroup analyses showed higher odds of low quality of life in high-risk OSA individuals, particularly among those not engaged in economic activity (aOR, 1.39; 95% CI, 1.15-1.67), those who consumed alcohol (aOR, 1.24; 95% CI, 1.03-1.49), and those with limited physical activity (aOR, 1.21; 95% CI, 1.03-1.43). Higher OSA risk correlated with poorer quality of life, especially in the lowest quality of life category (aOR, 2.49; 95% CI 1.18-3.43). CONCLUSIONS: The study found that middle-aged and older adults in South Korea at high risk for OSA had a lower quality of life than those at low risk. High-risk individuals who were economically inactive, consumed alcohol, or engaged in low physical activity also showed a lower quality of life. Future research should focus on accurately measuring OSA and further exploring its impact on quality of life in this population.
Optimal DCE design for modelling nonlinear time preferences in EQ-5D-5L valuation studies: exploration of data from Denmark and Peru.
Yu A, Street D, Jonker M … +10 more , Bour S, Mulhern B, Augustovski F, Jensen C, Gudex C, Jensen M, Tejada R, Norman R, Viney R, Stolk E
Health Qual Life Outcomes · 2025 Jun · PMID 40518518 · Full text
BACKGROUND: Discrete choice experiment (DCE) methods are an increasingly popular valuation method, particularly for the EQ-5D-5L. While EQ-5D-5L value sets developed using DCE have traditionally assumed linear time prefe...
BACKGROUND: Discrete choice experiment (DCE) methods are an increasingly popular valuation method, particularly for the EQ-5D-5L. While EQ-5D-5L value sets developed using DCE have traditionally assumed linear time preferences, this assumption has been challenged. This has led to the development of DCE modelling methods that allow for nonlinear time preferences. The aim of this study was to explore the impact of a model that accounts for nonlinear time preferences with DCE choice set formats and design construction methods for EQ-5D-5L value sets. METHODS: This study used a four-arm (2 × 2) between-subjects design to investigate the impact of two commonly used DCE choice set formats (i.e. a third option of either immediate death or full health) and two commonly used DCE design construction methods (i.e. generator-developed and efficient designs) on EQ-5D-5L value sets. Mixed logit models that used exponential discounting to account for nonlinear time preferences were estimated in OpenBUGS. This was tested in a sample of respondents from Peru (n = 942) and Denmark (n = 988). RESULTS: Across all arms and for both countries, discounting was found to be present when modelling explicitly for nonlinear time preferences. Although estimated discount rates varied widely from 1 to 117%, both type of choice set format and type of design construction method influenced the utilities for more severe health states. Choice sets with full health tended to produce a wider range of utility weights, while choice sets with immediate death tended to produce higher estimated discount rates. Generator-developed designs tended to produce the highest and lowest utility weights for health states compared to the efficient designs. CONCLUSIONS: This study provides a comparison of DCE choice set format and design construction method when nonlinear time preferences were explicitly modelled. Limitations to this study are discussed including data quality issues with the Peruvian dataset and small sample sizes. Further investigation is needed to confirm the suitability of models that account for nonlinear time preferences in EQ-5D-5L valuation studies.
Convergent validity, reliability and responsiveness of the AP-7D and EQ-5D-5L based on the survey for the general people in five countries: a new cultural-specific preference-based measure developed in east and southeast asia.
Suzuki Y, Shiroiwa T, Murata T … +3 more , Kamono E, Morii Y, Fukuda T
Health Qual Life Outcomes · 2025 Jun · PMID 40506727 · Full text
BACKGROUND: The AP-7D is a preference-based measure that was recently developed for use in East and Southeast Asia. This study investigated the reliability and convergent validity of the new instrument. METHODS: For this...
BACKGROUND: The AP-7D is a preference-based measure that was recently developed for use in East and Southeast Asia. This study investigated the reliability and convergent validity of the new instrument. METHODS: For this, surveys were conducted in Japan, Korea, China, Thailand, and Singapore. In each country, 500 respondents were selected using quota sampling and were stratified by sex and age. We conducted a face-to-face survey in Japan and a web-based survey in the remaining countries at two time points. The AP-7D and the EQ-5D-5L were collected from all countries, and the SF-6D was only collected in Japan. The instruments' reliabilities were confirmed by comparing the responses using self-report test-retest methods. For convergent validity, we compared responses provided to the AP-7D with those provided to the EQ-5D-5L and the SF-6D based on predetermined hypotheses. RESULTS: The percentage of agreement between the two surveys (in separate categories) was 73.9% (pain/discomfort), 71.2% (mental health), 68.6% (energy), 89.6% (mobility), 82.1% (work/school), 84.3% (social relations), and 86.4% (burden to others) in the five countries. These values demonstrate equivalent performance to those of the EQ-5D-5L. The kappa coefficients for the AP-7D items were similar to those for the EQ-5D-5L. In the correlation matrix between the AP-7D and EQ-5D-5L, correlation exceeded 0.5 in the following items: 0.69 between "mental health" (AP-7D) and "anxiety/depression" (EQ-5D-5L), 0.54 for "pain/discomfort" in both, 0.51 between "energy" (AP-7D) and "anxiety/depression" (EQ-5D-5L), and 0.50 for "mobility" in both. CONCLUSIONS: The results of this survey showed the good test-retest reliability and convergent validity of the AP-7D. The basic psychometric properties of the new instrument were confirmed.
Latent profile analysis of health-related quality of life and its associated factors in postoperative aortic dissection patients: a cross-sectional study.
Huang W, Wu Q, Zhang Y … +1 more , Zhu H
Health Qual Life Outcomes · 2025 Jun · PMID 40483516 · Full text
BACKGROUND: Aortic dissection (AD) is a rare but dangerous cardiovascular condition, and research on the health-related quality of life (HRQOL) of postoperative patients after discharge is limited. This study aimed to cl...
BACKGROUND: Aortic dissection (AD) is a rare but dangerous cardiovascular condition, and research on the health-related quality of life (HRQOL) of postoperative patients after discharge is limited. This study aimed to classify patterns of HRQOL among this population, and to examine the psychological and social factors associated with different HRQOL categories based on the common sense model of self-regulation and the social-cognitive processing model. METHODS: A cross-sectional study was conducted in two tertiary general hospitals in Wuhan from January 2022 to August 2022. HRQOL was assessed via the validated Patient-Reported Outcomes Measurement Information System 29-item Profile. Characteristic categories of HRQOL were identified through exploratory latent profile analysis. Univariate analysis and multinominal logistic regression were employed to explore the factors associated with HRQOL. RESULTS: Among the 379 patients, the mean health utility was 0.36 ± 0.17. A total of 35.4% and 32.5% of the patients had obvious anxiety and depression, respectively. The patients were divided into three HRQOL subgroups: "high psychological distress-pain group" (29.0%), "mild functional impairment-anxiety group" (49.3%), and "mild functional impairment-adaptation group" (21.6%). Significant factors associated with HRQOL included age, AD type, illness cognitive representation, fear of disease progression, daily life management and exercise (P < 0.05). CONCLUSIONS: The self-reported health status of postoperative AD patients is concerning. HRQOL within this population displays significant heterogeneity, and stratified care tailored to each group is recommended. Interventions targeting cognitive representations and fear reduction may enhance HRQOL. Continuous care to facilitate self-management behaviors is essential for improving health outcomes for postoperative AD patients. These findings require further longitudinal and interventional studies to confirm.
The moderating effect of neuroticism on the relationship of migration status and health-related quality of life in Germany: a population-based study.
Farugie A, Maukel LM, Tibubos AN
Health Qual Life Outcomes · 2025 Jun · PMID 40481504 · Full text
PURPOSE: Ample research exists on the association of migration status and health-related quality of life (HRQoL). Specific personality traits linked to the Big Five such as neuroticism, have been found to be predictive o...
PURPOSE: Ample research exists on the association of migration status and health-related quality of life (HRQoL). Specific personality traits linked to the Big Five such as neuroticism, have been found to be predictive of migrants' intercultural success. This study aimed to analyze the moderating effect of neuroticism on migration status and HRQoL in a representative German sample. METHODS: Data from the German Socioeconomic Panel (GSOEP) (N = 29,968) were analyzed. The sample included Germans without migration background (n = 19,749), immigrants (n = 3,491), foreigners residing in Germany (n = 2,460), and refugees (n = 4,268). Gender-stratified moderation analyses were performed using General Linear Models with HRQoL (SF-12; mental and physical health) as outcome, migration status as predictor, and neuroticism (BFI-S) as moderator. RESULTS: Refugees reported the lowest HRQoL (F(3, 29192) = 27.54, p <.001). Refugees also displayed the lowest neuroticism scores. Significant moderation effects of neuroticism on the relationship between migration status and SF-12 mental HRQoL scores were observed, especially for refugees (β = 0.05, CI [0.01 - 0.10], p =.03) and immigrants (β = 0.04, CI [0.00 - 0.08], p =.03; R² = 0.064). Women had lower SF-12 scores compared to men across all groups. Additionally, there was a significant three-way interaction effect for female refugees with neuroticism on mental HRQoL (β = - 0.24; CI [-0.34 - - 0.14]; p <.001). CONCLUSION: The results corroborated research pointing out differences in HRQoL depending on migration status and gender. Refugees seem to benefit particularly from low neuroticism, in terms of emotional stability, as a psychological resource.
Concurrent validity testing of the patient perspective of arrhythmia questionnaire.
Wood KA, Jin Y, Krafty RT … +3 more , James JH, Iyer SK, Badhwar N
Health Qual Life Outcomes · 2025 Jun · PMID 40481491 · Full text
BACKGROUND: Disease-specific patient reported outcome measures (PROMs) are widely used to evaluate not only a patient's view of their symptoms, functional status, and health related quality of life, but also clinical ben...
BACKGROUND: Disease-specific patient reported outcome measures (PROMs) are widely used to evaluate not only a patient's view of their symptoms, functional status, and health related quality of life, but also clinical benefit of treatments. The Patient Perspective of Arrhythmia Questionnaire (PPAQ) was initially developed as a self-administered, disease-specific PROM for patients with supraventricular tachycardia (SVT) assessing the impact of the arrhythmia and symptoms on patients' daily activities and physical, emotional, and social functioning. Preliminary evidence of content and construct validity has been previously demonstrated, but only in SVT patients in the U.S. and Poland. The aim of this study was to further evaluate the concurrent validity of the PPAQ in patients having a variety of arrhythmias and to explore whether differences in symptoms existed by gender. METHODOLOGY: In this cross-sectional study, adult cardiac arrhythmia outpatients from a tertiary care, academic medical center completed the 6-item PPAQ, the SF-12, a Fatigue Visual Analog Scale (VAS), the Brief Symptom Inventory (BSI), and the Patient Health Questionnaire (PHQ-9). Included were patients with atrial fibrillation (82.4%), ventricular tachycardia (15.7%), and atrial tachycardia (2%). Descriptive statistics and independent t-tests, pairwise comparisons with Pearson correlations, Goodman Kruskal gamma statistic for ordinal associations, Cronbach's alpha, and Kuder-Richardson-20 (KR-20) were used to determine concurrent construct validity and internal consistency reliability. RESULTS: Participants (n=51) had a mean age of 59.4 years (± 12.6), were majority male (66.7%) and Caucasian (75%). Preliminary evidence of concurrent construct validity was found based on moderate to strong correlations (range from 0.4 to 0.7) between the PPAQ and other validated measures, as well as strong internal reliability (KR-20 of 0.80 and Cronbach's alpha of 0.91). The most common symptoms reported were fatigue (60.8%) and heart fluttering (52.9%). Blurred vision (p<0.04), dizziness (p<0.01), and fatigue (p<0.04) were seen significantly more frequently in men compared to women. CONCLUSIONS: Results present additional evidence of the validity and reliability of the PPAQ. The PPAQ comprehensively measures the burden of the disease from cardiac arrhythmia patients' perspective. Validated, reliable, disease-specific PROMs are needed to direct personalized clinical decision-making.
Translation, cultural adaptation, and content validation of the Hong Kong Chinese version of Self-completion Adult Social Care Outcomes Toolkit (ASCOT-SCT4) for care service users.
Yu S, Sze JCD, Cheung AWL … +5 more , Wang K, Welch E, Smith N, Xu RH, Wong ELY
Health Qual Life Outcomes · 2025 Jun · PMID 40468338 · Full text
BACKGROUND: In light of the global challenges posed by an ageing population, the evaluation of long-term care (LTC) is of particular importance. The Adult Social Care Outcomes Toolkit Four-Level Self-completion Tool (ASC...
BACKGROUND: In light of the global challenges posed by an ageing population, the evaluation of long-term care (LTC) is of particular importance. The Adult Social Care Outcomes Toolkit Four-Level Self-completion Tool (ASCOT-SCT4) is a preference-based instrument developed to measure long-term care (LTC) related quality of life (QoL). However, it is not yet available in Hong Kong (HK). This study aims to translate and culturally adapt the ASCOT-SCT4 into Chinese and evaluate its content validity in the HK context. METHODS: The study adhered to well-established international guidelines for conducting translation, cultural adaptation, and content validation of instruments. The translation process included forward, backward translations, and expert committee review. Subsequently, LTC users aged 60 or above and experts with diverse professional backgrounds in LTC were involved in content validation in terms of comprehensibility, relevance, and comprehensiveness through cognitive interviews and a content validity index (CVI) survey. For clarity and relevance, an item-level CVI (I-CVI) of ≥ 0.78 and a scale-level CVI (S-CVI) of ≥ 0.90 were considered acceptable. RESULTS: In the translation process, concern was raised about the literal translation of 'Control over daily life' item. During the cognitive interviews, 27 LTC users perceived the instrument's length as acceptable, and experienced no sensitive feelings while completing it. However, seven of the nine items were found to have comprehension and interpretation issues, which were mostly resolved through revisions of wordings. For the 'Food and drink' and 'Dignity' items, alternative terms were used and sentence structure was revised to improve its comprehensibility while ensuring equivalence to the original English version. The final translated version demonstrated acceptable clarity (S-CVI: 0.92, I-CVIs: 0.86-1.00) as evaluated by seven experts. Both LTC users and experts found the items relevant (S-CVI: 0.97, I-CVIs: 0.94 to 1.00), and no additional LTC-related QoL domains were identified as missing from the instrument. CONCLUSIONS: This study provides evidence that the Chinese version of the ASCOT-SCT4 is comprehensible, relevant, and comprehensive for the HK context, which allows for further testing on psychometric properties in a larger population.
The current use and application of thresholds for clinical importance of the EORTC QLQ-C30, the EORTC CAT core and the EORTC QLQ-C15-PAL- a systematic scoping review.
Pilz MJ, Thurner AMM, Storz LM … +2 more , Krepper D, Giesinger JM
Health Qual Life Outcomes · 2025 Jun · PMID 40462199 · Full text
BACKGROUND: Thresholds for clinical importance (TCIs) were previously established for the cancer-specific patient reported outcome (PRO) measures EORTC QLQ-C30, EORTC QLQ CAT Core, and EORTC QLQ-C15-PAL. TCIs aim to aid...
BACKGROUND: Thresholds for clinical importance (TCIs) were previously established for the cancer-specific patient reported outcome (PRO) measures EORTC QLQ-C30, EORTC QLQ CAT Core, and EORTC QLQ-C15-PAL. TCIs aim to aid the interpretation of scores for individual patients at a single point in time. They intend to indicate whether a symptom or functional health limitation is of clinical relevance, i.e., requires to be discussed with healthcare professionals. In this systematic scoping review, we aimed to describe the uptake of TCIs by the research community and discuss opportunities and threats in their application to PRO data. METHODS: We systematically searched PubMed and Web of Science databases that contained search terms on the respective PRO measures and TCIs. Additionally, we performed a hand search on citations of the original TCI articles on Google Scholar. Articles were included if they applied TCIs in the analysis or the interpretation of PRO data or in clinical practice. Data concerning the study design, the use of TCIs, the terminology, and the application of TCIs were extracted. RESULTS: A total of 512 articles were identified. After title, abstract and full-text screening, data extraction was performed on 117 of these articles. Most articles reported on longitudinal-observational (n = 55) or cross-sectional observational (n = 49) studies, whereby the most frequent cancer populations having mixed diagnoses (n = 25), breast cancer (n = 23), haematological malignancies (n = 18), or colorectal cancer (n = 11). Various terms were used to refer to the concept of TCIs, with "thresholds for clinical importance" being the most frequently used term (n = 63; 50.8%). Strikingly, 41 of the 117 articles (35.0%) reported that TCIs were applied to group-level data (e.g. mean scores), which is a clearly unintended application of the TCIs. CONCLUSION: TCIs are frequently used by the research community and thus enhanced the interpretability of PRO data in oncology. While most studies correctly applied TCIs in their analysis and interpretation, further guidance and clarification on their use are required. This article aims to contribute to this endeavour.
Working towards a new normal: a meta-synthesis of patient-reported aspects of a good life with heart disease.
Nebel L, Le Butt TR, Herrmann-Lingen C … +1 more , Broschmann D
Health Qual Life Outcomes · 2025 Jun · PMID 40462145 · Full text
AIMS: This meta-synthesis challenges the medical notion of health-related quality of life (HRQOL) by identifying aspects of the more holistic philosophical concept of the good life from the perspective of patients with h...
AIMS: This meta-synthesis challenges the medical notion of health-related quality of life (HRQOL) by identifying aspects of the more holistic philosophical concept of the good life from the perspective of patients with heart disease. DESIGN: Systematic meta-synthesis. METHODS: Following preregistration on PROSPERO, a systematic literature search was conducted in PubMed, PsycInfo, PsycArticles, and PSYNDEX from February 2023 to March 2024. Studies focusing on the experiences of adults living with heart disease were included based on predefined criteria. Articles were assessed for methodological quality using a modified CASP tool, and data synthesis followed Interpretative Phenomenological Analysis. Reporting adheres to PRISMA and ENTREQ guidelines. RESULTS: Forty-three articles were included, revealing the overarching theme of "Working towards a new normal," with four sub-themes: (1) Feeling safe in my own body again, (2) Important relationships provide security and meaning, (3) Taking my life into my own hands again and (4) Living more consciously. CONCLUSIONS: While HRQOL is a valuable and widely used concept, it primarily captures quality of life from a functional perspective. Qualitative studies on individuals with heart disease reveal the additional aspects of coherence, connectedness, and self-determination that align more closely with the concept of a good life. IMPLICATIONS: To enhance care and counseling for patients with heart disease, the concept of HRQOL should be broadened to incorporate preferences, interests, and needs regarding life planning, aligned with the notion of a good life.
The association of post-COVID-19 fatigue in the acute phase with neuropsychiatric and neurocognitive symptoms trajectory over time and long-term health-related quality of life among Chinese adults.
Zhu Q, Quan X, Luo Z … +10 more , Shang Y, Zhu X, Bao W, Shang M, Li P, Gao F, Wang W, Liu Z, Niu X, Zhang Y
Health Qual Life Outcomes · 2025 May · PMID 40450337 · Full text
BACKGROUND: Post-viral fatigue is a common and debilitating neurological sequela of COVID-19, often accompanied with multidimensional neuropsychiatric symptoms (post-viral fatigue, sleep disturbance, anxiety, depression,...
BACKGROUND: Post-viral fatigue is a common and debilitating neurological sequela of COVID-19, often accompanied with multidimensional neuropsychiatric symptoms (post-viral fatigue, sleep disturbance, anxiety, depression, and post-traumatic stress disorder) and neurocognitive impairment. We sought to characterize the trajectory of these neurological symptoms and investigate the relationship between acute-phase fatigue (< 1 month) and the chronicity of neuropsychiatric and neurocognitive symptoms, as well as long-term health-related quality of life (HRQoL) at 3 months post-infection. METHODS: A prospective, multi-center, longitudinal study was conducted from January to February 2023 within a cohort of individuals with a mild SARS-COV-2 infection and contemporaneous healthy controls (HCs). Comprehensive neuropsychiatric and neurocognitive assessments were collected for COVID-19 survivors during both acute and chronic phase post-infection, with the EQ-5D-5L (a standardized instrument for assessing HRQoL) evaluated at the chronic phase. Healthy controls underwent the same protocol for recruitment to the study. Linear mixed models were used to access the impact of acute-phase fatigue on different neuropsychiatric and neurocognitive scales over time. RESULTS: Three hundred thirty-five COVID-19 survivors and 79 HCs were included in the study. COVID-19 survivors exhibited poorer performance in various neuropsychiatric domains during the acute phase, with the exception of cognitive impairment. A significant amelioration of emotional symptoms, including anxiety and depression, was observed from the acute to chronic phase among COVID-19 survivors, reaching levels comparable to those of HCs. However, at 3 months post-infection, survivors continued to report higher levels of fatigue and poorer sleep quality compared to HCs, although the differences had diminished from the acute phase. The impact of the pandemic event persisted, and no significant changes in cognitive performance were observed. Acute-phase fatigue was associated with poorer sleep and worse emotional problems during the recovery process (from the acute to the chronic phase), and further exacerbated overall HRQoL at 3 months post-infection (EQ index score, p = 0.001, Cohen's d = -0.33; EQ-VAS, p = 0.007, Cohen's d = -0.19). CONCLUSIONS: Our findings provide novel evidence on the distinct temporal trajectories for post-acute COVID-19 sequelae in a longitudinal study, highlighting the negative impact of acute-phase fatigue on the process of neuropsychiatric recovery and long-term HRQoL.
Quality of life post heart failure diagnosis: population-level trends in the U.S.
Alva M, Dolman S, Sikirica S … +4 more , Kolm P, Andrade K, Zhang Z, Weintraub WS
Health Qual Life Outcomes · 2025 May · PMID 40442676 · Full text
BACKGROUND: Individuals with heart failure (HF) experience various symptoms making both diagnosis and disease burden estimates challenging. While HF-specific patient-reported outcome measures (PROMs) are widely used, the...
BACKGROUND: Individuals with heart failure (HF) experience various symptoms making both diagnosis and disease burden estimates challenging. While HF-specific patient-reported outcome measures (PROMs) are widely used, their focus on clinical cohorts limits their generalizability. Preference-based measures like the EQ-5D enable standardized health-related quality of life (HRQoL) comparisons across conditions, supporting resource allocation decisions. The CDC's Healthy Days (HD) Survey-a simple two-question tool that can be mapped to the EQ-5D-offers a broader approach to tracking HRQoL but remains underutilized in HF populations. METHODS: Using a nationally representative U.S. sample, we mapped HD Survey responses to EQ-5D utility scores to compare HRQoL between individuals with and without HF and examined changes in HRQoL over time. We assessed whether HD-derived scores align with HF-specific utility measures to support population-level health monitoring. RESULTS: Individuals with HF report significantly more physically unhealthy days (8.46 vs. 3.42) and mentally unhealthy days (5.42 vs. 3.86) compared to those without HF. HF respondents are, on average, 20 years older than those without HF, consistent with HF's prevalence in older adults. The likelihood of an HF diagnosis is similar for men and women but higher among non-Hispanic whites and blacks than Hispanics and other races. Those with HF are more likely to have health insurance. Adjusting for age, sex, race, and insurance, mean EQ-5D utility scores for individuals with and without HF are 0.785 (95% CI: 0.714-0.825) and 0.840 (95% CI: 0.827-0.851), respectively. Utility scores for HF patients remain significantly lower than those without HF up to 10 years post-diagnosis. CONCLUSION: HF reduces HRQoL by 6.55%, surpassing the clinically significant threshold of a 1-2% decrement. These findings highlight the potential of the HD Survey to inform public health monitoring and underscore the need for tailored interventions to address HRQoL deficits in HF populations.
Patient reported outcomes in the FDA approved drugs for systemic rheumatic diseases (2013-2024).
Xie Y, Liu Y, Qin Y … +3 more , Yin G, Chen X, Xie Q
Health Qual Life Outcomes · 2025 May · PMID 40437506 · Full text
BACKGROUND: Patient-reported outcomes (PROs) in systemic rheumatic diseases (SRDs) are in the forefront of clinical research. However, a comprehensive evaluation of PROs in pivotal trials supporting SRD drug approval is...
BACKGROUND: Patient-reported outcomes (PROs) in systemic rheumatic diseases (SRDs) are in the forefront of clinical research. However, a comprehensive evaluation of PROs in pivotal trials supporting SRD drug approval is lacking. OBJECTIVE: This study aims to systematically characterize the use of PROs in pivotal trials supporting the US Food and Drug Administration (FDA) approval of SRDs treatments and to assess the quality of reporting. METHODS: We reviewed the pivotal trials supporting the approval of SRD indications by FDA since July 2013 to assess the use of PROs, including specific PRO measures (PROMs) and types of endpoints designated. Quality of PRO reporting was assessed according to a modified ISOQoL criteria. RESULTS: From July 1st, 2013, to June 30th, 2024, the FDA approved 43 new SRD indications based on 67 pivotal trials, with 58 trials included in the final analysis. PROs served as multiple types of endpoints in most trials. All 58 reviewed trials utilized PROs as secondary or exploratory endpoints. The numbers of trials that employed PROs as components of primary endpoints, co-primary endpoints, and key secondary endpoints, were 47(81.0%), 4(6.9%), 45(77.6%), respectively. Notably, the inclusion of PROs as components of composite primary endpoints or co-primary endpoints (100% vs. 8.3%, P < 0.001) and key secondary endpoints (93.5% vs. 16.7%, P < 0.001) were significantly higher in inflammatory arthritis compared to other SRDs. Regarding PROM types, 37 trials (63.8%) reported both generic and disease-specific PROMs, covering a broad range of domains. Quality of PRO reporting, influenced by disease type and the presence of additional PRO reports, was moderate to poor in 45 trials (81.8%). Key reporting elements, such as the PRO hypothesis, mode of PROMs completion, and extent and reasons for missing PRO data, were documented in fewer than 30% of the trials. CONCLUSION: PROs significantly impact SRDs drug approval decisions, especially for inflammatory arthritis. However, the overall quality of PRO reporting in pivotal trials of SRDs is suboptimal and needs improvement. Our study provides a comprehensive summary of PRO application in SRDs trials, highlighting the need for strengthening PRO utilization in non-arthritis SRDs and improving PRO reporting quality in future studies.
Oral health-related quality of life in Bangladeshi children of sex workers: socio-behavioural and oral health predictors.
Khan AM, Farook TH, Eusufzai SZ … +6 more , Sharmin M, Shohid S, Zerin T, Shahed L, Hossain SJ, Hossain Hawlader MD
Health Qual Life Outcomes · 2025 May · PMID 40361145 · Full text
BACKGROUND: Children of female sex workers (FSWs) in Bangladesh grow up in a challenging socio-economic environment characterized by parental separation, substance abuse, alcoholism, and limited access to healthcare, inc...
BACKGROUND: Children of female sex workers (FSWs) in Bangladesh grow up in a challenging socio-economic environment characterized by parental separation, substance abuse, alcoholism, and limited access to healthcare, including oral health services. This study aimed to assess the oral health-related quality of life (OHRQoL) and its associative factors among these children. MATERIALS AND METHODS: A cross-sectional study was conducted between March 2023 and February 2024 with a sample of 180 FSW mothers/institutional caregivers and their school-going children, aged 7 to 17. OHRQoL was assessed using the CPQ (Child Perception Questionnaire) for children aged 7 to 11, and the OIDP (Oral Impacts on Daily Performances) for adolescents aged 12 to 17. The Decayed, Missing and Filled Teeth (DMFT/dmft) index was used to assess dental caries, while the gingival index evaluated gingival health. The plaque index and calculus index were employed to assess plaque and calculus levels, respectively. RESULTS: Among children aged 7 to 11, oral symptoms (Mean = 5.36, SD = 3.72) and functional limitations (Mean = 4.57, SD = 4.42) were the most affected parameters. For children aged 12 to 17, 78.2% reported oral impacts on their daily performances (Mean = 6.50, SD = 6.84). Caries status (β = 0.361, p = 0.001) and place of residence (β = 0.329, p = 0.032) were significantly associated with higher CPQ scores. A higher OIDP score was associated with gingivitis (β = 0.265, p = 0.035). CONCLUSION: The study reveals that children aged 7 to 11 in Daulatdia with caries had significantly poorer OHRQoL, while gingivitis was associated with a higher OIDP score in children aged 12 to 17. OHRQoL evaluation is vital in determining the effectiveness of therapeutic and preventive measures aimed at improving the oral health of this vulnerable population. REGISTRY AND REGISTRATION NO. OF THE STUDY: The Institutional Review Board /Ethics Review Committee (IRB/ERC) of North South University reviewed and approved this study(2023/OR-NSU/IRB/0204).
Unmet long-term care needs and their association with health-related quality of life among Chinese oldest-old population.
Qiao J, Qiao Y, Tan J … +6 more , Chen N, Peng N, Mao Z, Zhao Y, Chen C, Yao Y
Health Qual Life Outcomes · 2025 May · PMID 40361111 · Full text
BACKGROUND: Entering the age of 80 or 100, individuals' functional decline and the need for assistance in daily activities increase dramatically, resulting in an inevitable increase in unmet long-term care (LTC) needs. U...
BACKGROUND: Entering the age of 80 or 100, individuals' functional decline and the need for assistance in daily activities increase dramatically, resulting in an inevitable increase in unmet long-term care (LTC) needs. Understanding unmet LTC needs in late life and their association with quality of life is essential for effective health planning and resource allocation. We aim to estimate the prevalence of unmet needs for LTC and the association of unmet needs for LTC and Health-related Quality of life (HRQOL), among the Chinese oldest-old population. METHODS: Data were drawn from the 2017 China Hainan Centenarian Cohort Study. All centenarians and a representative sample of individuals aged between 80 and 99 years old in Hainan province, China were included. Self-perceived unmet LTC needs were reported by the respondents. EQ-5D score was calculated from EQ-5D-3L questionnaire to measure HRQOL in this study. We conducted Tobit regression and the Ordered Probit Model to examine the cross-sectional associations between unmet needs for LTC and HRQOL. RESULTS: 1,444 respondents (mean age 95.75 years [SD 9.13]) were included. The prevalence of unmet LTC needs was 32.69%, and it was higher in rural residents and people with economic deprivation. The results showed that oldest-old individuals with unmet needs for LTC reported lower QALY scores (β=-0.04, p < 0.01). In addition, Unmet LTC needs were significantly correlated with poorer outcomes in mobility (β = 0.18, p < 0.05), self-care (β = 0.19, p < 0.05), pain or discomfort (β = 0.27, p < 0.01), and anxiety or depression (β = 0.09, p < 0.01). CONCLUSIONS: The prevalence of unmet LTC needs was higher in China than its counterpart in high-income countries, especially among those with socio-economic deprivation. Individuals with unmet LTC needs experience lower quality-adjusted life years (QALYs) and higher levels of disabilities across multiple dimensions of health, including mobility, usual activities, self-care, pain/discomfort and depression/anxiety. These findings underscore the importance of addressing unmet LTC needs to improve the overall health outcomes and quality of life for the oldest-old population.
Psychometric validation and cultural adaptation of the Chinese version of the CarerQol-7D instrument.
Xu RH, Xu Y, Zhao M … +4 more , Liu N, Wang P, Liang X, Zhou L
Health Qual Life Outcomes · 2025 May · PMID 40346608 · Full text
OBJECTIVE: This study aims to translate and validate the CarerQol in a sample of informal caregivers in China. METHOD: The CarerQol was translated following a standard process. Validation data was collected from multiple...
OBJECTIVE: This study aims to translate and validate the CarerQol in a sample of informal caregivers in China. METHOD: The CarerQol was translated following a standard process. Validation data was collected from multiple sources, including hospitals, patient associations, and community health centers between September 2023 and December 2024 in China. Caregivers of individuals with disability or long-term care needs were recruited. The psychometric properties of the CarerQol-7D were evaluated through ceiling and floor effects, factorial structure, convergent and divergent validity, known-groups validity, and test-retest reliability. RESULTS: A total of 324 participants completed the survey and provided validated responses. The mean CarerQol level sum score was 12.8 (SD = 2.9). The CarerQol-7D showed no ceiling or floor effects at either dimension or scale levels. Test-retest reliability of the CarerQol-7D was satisfactory, as supported by ICC and Gwet's AC1 measures. Correlation analysis confirmed all hypothesized pairs of dimensions and level sum scores/utility scores between CarerQol-7D, SF-6Dv2, and ICECAP-A. The CarerQol-7D successfully distinguished between risk groups through ANOVA testing. Confirmatory factor analysis revealed that a one-factor model of the CarerQol-7D fit the data. CONCLUSION: This study provides the Chinese version of the CarerQol and confirms its sound psychometric properties for informal caregivers in China. These findings demonstrate the CarerQol's value in cost-effectiveness analyses of caregiving interventions and strategies.
Population norms of health-related quality of life in Iran: findings from a national EQ-5D-5L study.
Rezaei S
Health Qual Life Outcomes · 2025 May · PMID 40335997 · Full text
BACKGROUND: Evaluating health-related quality of life (HRQoL) in the general population is essential for establishing benchmarks for health outcome assessments. This study aimed to generate population norms for the EQ-5D...
BACKGROUND: Evaluating health-related quality of life (HRQoL) in the general population is essential for establishing benchmarks for health outcome assessments. This study aimed to generate population norms for the EQ-5D-5L dimensions, EQ-VAS (EuroQol-Visual Analogue Scale) scores, and EQ-5D-5L index scores in Iran, stratified by sex and age. METHODS: Data for this cross-sectional study were gathered through face-to-face interviews with 3,518 adults from the general population across nine provinces in Iran, employing a multistage sampling approach. Respondents assessed their own health state across the EQ-5D-5L dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-along with the EQ-VAS to evaluate their overall health. The EQ-5D-5L score was calculated using the value set derived from the Iranian general population. Dimension scores and index values (EQ-5D-5L index and EQ-VAS score) were analyzed using multiple logistic regression and generalized linear model (GLM), respectively. RESULTS: The estimated mean ± standard deviation [SD] of EQ-5D-5L index for the general population of Iran was 0.789 ± 0.258, while the EQ-VAS score was estimated at 74.34 ± 18.67. Among the study participants, 35.8% reported being in the best health state (11111), while the remaining 64.2% experienced problems in at least one of the five dimensions. The most commonly reported problems were related to anxiety/depression (49.2%), followed by pain/discomfort (45.3%). Regression analyses revealed that females reported significantly more problems across the five dimensions of the EQ-5D-5L and had lower EQ-5D-5L index and EQ-VAS scores compared to males. Anxiety/depression were more prevalent among younger individuals, while problems in other dimensions tended to increase with age. CONCLUSIONS: The findings indicate that nearly two-thirds of respondents experienced problems in at least one dimension, with anxiety/depression being the most prevalent, particularly among younger individuals. Females reported lower utility scores and more problems across all dimensions in all age groups. To effectively improve the health status of the Iranian population and ensure optimal resource allocation, it is vital to develop and implement targeted interventions that specifically address the needs highlighted in this study.
The influence of socioeconomic position on patient-reported outcome measures following hip fractures - a register-based observational study on 35,206 patients from the Norwegian hip fracture register 2014-2018.
Kjaervik C, Gjertsen JE, Stensland E … +3 more , Olsen JA, Kjaervik C, Soereide O
Health Qual Life Outcomes · 2025 May · PMID 40320519 · Full text
BACKGROUND: Hip fractures are a significant public health concern due to increasing numbers, high mortality and negative impact on health-related quality of life (HRQoL). Socioeconomic position (SEP) affects various heal...
BACKGROUND: Hip fractures are a significant public health concern due to increasing numbers, high mortality and negative impact on health-related quality of life (HRQoL). Socioeconomic position (SEP) affects various health outcomes, but the specific impact on HRQoL and satisfaction after hip fracture remains underexplored. This study assesses whether education and household income influence patient-reported outcome measures (PROMs) after hip fractures, measured by three visual analog scales: EQ-VAS, pain-VAS, and satisfaction-VAS. METHODS: This was a nationwide retrospective cohort study using linked data from the Norwegian Hip Fracture Register and Statistics Norway. PROMs assessed at 4, 12, and 36 months postoperatively in 35,206 hip fracture patients from 2015 to 2018 were included. The SEP data included household income and education levels. Covariance analyses were conducted to evaluate differences in mean VAS scores for general health (EQ-VAS), pain from the operated hip (Pain-VAS), and satisfaction with the result of the operation (Satisfaction-VAS). Analyses adjusted for age, sex, vital status, cognitive impairment, treatment type, and education or income when not used as independent variable. RESULTS: The study included 23,649 women (67.2%) and 11,557 men (32.8%) with median age 83 years. Lower education was linked to worse EQ-VAS and Pain-VAS scores at all follow-ups and to lower Satisfaction-VAS at 12 and 36 months in both unadjusted and adjusted analyses. Lowest level of income had significant lower EQ-VAS at all follow-ups, lower Pain-VAS at 12 months, and lower Satisfaction-VAS at 4 months. There were increasing differences in mean VAS-scores during follow-up. At 36 months the adjusted differences in mean EQ-VAS between highest and lowest level of income was - 2,51 (-4.04 -0.99). Differences across education levels were even stronger associated; -3.58 (-5.19 to -1.98). Mean differences in Pain-VAS between medium and low education compared to high were 4.30 (2.91 to 5.69) and 5.58 (4.08 to 7.08), respectively. Lower levels of education also had significant negative differences in Satisfaction-VAS at 36 months follow-up -4.06(-5.86 to -2.26). CONCLUSIONS: Lower education and income were significantly associated with worse HRQoL and satisfaction after hip fracture. The clinical relevance of these findings warrants further investigation. Addressing SEP disparities should be integral to hip-fracture care strategies aiming to improve postoperative outcomes.
Mapping the ADDQoL to the EQ-5D-5L and SF-6Dv2 among Chinese patients with type 2 diabetes mellitus.
Fang H, Hong T, Liu X … +3 more , Luo C, Hou Y, Xie S
Health Qual Life Outcomes · 2025 Apr · PMID 40307906 · Full text
OBJECTIVE: The Audit of Diabetes-Dependent Quality of Life (ADDQoL) is a widely used instrument for assessing quality of life in Type 2 Diabetes Mellitus (T2DM). However, it does not directly yield health utility values...
OBJECTIVE: The Audit of Diabetes-Dependent Quality of Life (ADDQoL) is a widely used instrument for assessing quality of life in Type 2 Diabetes Mellitus (T2DM). However, it does not directly yield health utility values essential for economic evaluations. This study developed mapping algorithms to predict EQ-5D-5L and SF-6Dv2 utility values from ADDQoL scores in T2DM patients in China. METHODS: Cross-sectional data from 800 T2DM patients in China, stratified by age, sex, and geographical region, were divided into development (80%) and validation (20%) groups. Pearson correlation analyses were conducted to assess the conceptual overlap between ADDQoL and the EQ-5D-5L and SF-6Dv2. Six predictor sets and six regression methods were explored to map ADDQoL scores to EQ-5D-5L and SF-6Dv2 utility values, respectively. Model performance was evaluated using mean absolute error (MAE), root mean square error (RMSE), and intraclass correlation coefficient (ICC). RESULTS: For the development group, the mean (SD) ADDQoL Average Weighted Impact (AWI) score was - 2.426 (1.052), and the mean (SD) utility values for EQ-5D-5L and SF-6Dv2 were 0.928 (0.092) and 0.791 (0.133), respectively. Among all 36 alternative mapping models each for EQ-5D-5L and SF-6Dv2, the best performance was consistently observed in the two-part models that included the ADDQoL AWI, the first overview item, and their squared terms. For the algorithm mapping to EQ-5D-5L utility values, it achieved a MAE of 0.067, a RMSE of 0.095, and an ICC of 0.414; For the algorithm mapping to SF-6Dv2 utility values, the corresponding metrics were an MAE of 0.099, an RMSE of 0.120, and an ICC of 0.517. CONCLUSIONS: This study provides a mapping framework to estimate EQ-5D-5L and SF-6Dv2 utility values from ADDQoL scores. These algorithms could be used to support economic evaluations, specifically tailored for Chinese T2DM populations.
Comparison of statistical methods for the analysis of patient-reported outcomes (PROs), particularly the Short-Form 36 (SF-36), in randomised controlled trials (RCTs) using standardised effect size (SES): an empirical analysis.
Qian Y, Walters SJ, Jacques RM … +1 more , Flight L
Health Qual Life Outcomes · 2025 Apr · PMID 40301969 · Full text
BACKGROUND: The Short-Form 36 (SF-36), a widely used patient-reported outcome (PRO), is a questionnaire completed by patients measuring health outcomes in clinical trials. The PRO scores can be discrete, bounded, and ske...
BACKGROUND: The Short-Form 36 (SF-36), a widely used patient-reported outcome (PRO), is a questionnaire completed by patients measuring health outcomes in clinical trials. The PRO scores can be discrete, bounded, and skewed. Various statistical methods have been suggested to analyse PRO data, but their results may not be presented on the same scale as the original score, making it difficult to interpret and compare different approaches. This study aims to unify and compare the estimates from different statistical methods for analysing PROs, particularly the SF-36, in randomised controlled trials (RCTs), using standardised effect size (SES) summary measure. METHODS: SF-36 outcomes were analysed using ten statistical methods: multiple linear regression (MLR), median regression (Median), Tobit regression (Tobit), censored absolute least deviation regression (CLAD), beta-binomial regression (BB), binomial-logit-normal regression (BLN), ordered logit model (OL), ordered probit model (OP), fractional logistic regression (Frac), and beta regression (BR). Each SF-36 domain score at a specific follow-up in three clinical trials was analysed. The estimated treatment coefficients and SESs were generated, compared, and interpreted. Model fit was evaluated using the Akaike information criterion. RESULTS: Estimated treatment coefficients from the untransformed scale-based methods (Tobit, Median, & CLAD) deviated from MLR, whereas the SESs from Tobit produced almost identical values. Transformed scale-based methods (OL, OP, BB, BLN, Frac, and BR) shared a similar pattern, except that OL generated higher absolute coefficients and BLN produced higher SESs than other methods. The SESs from Tobit, BB, OP, and Frac had better agreement against MLR than other included methods. CONCLUSIONS: The SES is a simple method to unify and compare estimates produced from various statistical methods on different scales. As these methods did not produce identical SES values, it is crucial to comprehensively understand and carefully select appropriate statistical methods, especially for analysing PROs like SF-36, to avoid drawing wrong estimates and conclusions using clinical trial data. Future research will focus on simulation analysis to compare the estimation accuracy and robustness of these methods.
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