Health And Quality Of Life Outcomes[JOURNAL]
Sun
200 papers
Health-related quality of life in Chinese kidney transplant recipients assessed by Chinese medicine quality of life-11 dimensions (CQ-11D).
Guo S, Jia Y, Yang X … +5 more , Pan J, Zhu W, Yu W, Sun H, Liu H
Health Qual Life Outcomes · 2026 Mar · PMID 41872845 · Full text
BACKGROUND: Health-related quality of life (HRQoL) in kidney transplant recipients (KTRs) is a key concern influenced by physiological, social, and cultural factors. However, yet commonly used assessment tools in previou...
BACKGROUND: Health-related quality of life (HRQoL) in kidney transplant recipients (KTRs) is a key concern influenced by physiological, social, and cultural factors. However, yet commonly used assessment tools in previous studies do not adequately capture the unique sociocultural context of Chinese populations. The objective of this study was to assess the HRQoL in KTRs using the CQ-11D questionnaire and analyze factors associated with HRQoL to enhance the HRQoL of KTRs. METHODS: We conducted a cross-sectional study. Data were collected from two tertiary hospitals in Beijing and Changsha, China. Demographic and clinical data were collected using a structured questionnaire. The CQ-11D was used to measure HRQoL. Other scales, including the Constitution in Chinese Medicine Questionnaire (CCMQ), the Hospital Anxiety and Depression Scale (HADS), and the Pittsburgh Sleep Quality Index (PSQI), were used to assess TCM constitution, psychological distress, and sleep quality, respectively. Data were analyzed using IBM SPSS 26.0, including bivariate analysis, generalized linear models, and multiple regression analysis. RESULTS: A total of 215 KTRs were enrolled. The median CQ-11D health utility value was 0.918. There were differences across the 11 dimensions of the CQ-11D in KTRs. After the age of 40, the proportion of reported problems generally increased with age. This trend was particularly evident in dimensions such as SY, SM, and JS, where individuals over 50 reported significantly more problems than other age groups. The biased constitutions and poor sleep quality were associated with a higher likelihood of reporting problems in most CQ-11D dimensions. Factors such as sleep quality, TCM constitution, and regular exercise were significantly associated with HRQoL. CONCLUSION: Sleep quality, TCM constitution, and regular physical activity were associated with HRQoL of KTRs. Healthcare professionals should prioritize interventions targeting these factors, especially in older KTRs and those with a biased constitution, to improve their HRQoL.
Interpreting patient-reported outcomes after ischemic stroke: defining minimal important difference in EQ-5D across recovery phases.
Li P, Zhao M, Huang Y … +5 more , Sun W, Wang L, Jin X, Xie F, Li H
Health Qual Life Outcomes · 2026 Mar · PMID 41864919 · Full text
BACKGROUND: The EQ‑5D is widely applied to measure patient-reported outcomes, yet its minimally important difference (MID) has not been clearly established across distinct recovery phases after stroke. This study aimed t...
BACKGROUND: The EQ‑5D is widely applied to measure patient-reported outcomes, yet its minimally important difference (MID) has not been clearly established across distinct recovery phases after stroke. This study aimed to determine phase‑specific MIDs in EQ‑5D following stroke and to explore heterogeneity by estimation method, direction of change, and stroke etiology. METHODS: A total of 9978 adults with neuroimaging‑confirmed acute ischemic stroke were included in a prospective longitudinal cohort study. EQ‑5D and modified Rankin Scale (mRS) scores were recorded at admission (V1), hospital discharge (V2), 3-month (V3), and 1-year since admission (V4). Anchor-based MIDs were estimated at both group and individual levels and triangulated by distribution-based and instrument-defined approaches. Changes during the recovery phases (V1–V2, V2–V3, and V3–V4) were grouped into 3 categories: improved, no change, and deteriorated. Subgroup analyses were conducted according to the TOAST classification. Credibility of MID estimates was assessed using a validated instrument for anchor-based methods. RESULTS: Phase-specific group-level MIDs for improvement decreased over time: anchor-based estimates were 0.19 at V2, 0.14 at V3, and 0.11 at V4, while deterioration MIDs were smaller. Distribution-based and instrument-defined estimates fluctuated slightly around the anchor-based values but followed a similar downward trend over time. Individual‑level analyses yielded MIDs with acceptable discriminative power (area under the curve ≥ 0.70) only for improvement at V2 (0.10) and V3 (0.01). Cardioembolic strokes had higher MIDs than large-artery atherosclerosis and small-artery occlusion, while baseline utilities showed the reverse. Credibility assessment confirmed high reliability. CONCLUSION: This study provides the phase‑specific MIDs for utility measures after ischemic stroke, showing a declining trend from acute to chronic recovery and confirming robustness across multiple estimation methods. While group‑level MID ranges are recommended for effect size interpretation, trial design, and evidence certainty rating, individual‑level thresholds should be reserved for personalized evaluation. These values assist in the interpretation of patient‑reported outcome changes and evaluation of healthcare interventions across different recovery phases. TRIAL REGISTRATION: ClinicalTrials.gov NCT02470624. Registered 10 June 2015.
Cross-cultural adaptation and validation of the Pediatric Chemotherapy-Induced Neuropathy (P-CIN) using a patient-reported outcome measure for Chinese pediatric oncology patients.
Mao T, Yorke J, Shi Y … +11 more , Shen N, Cheng FWT, Wang H, Lam KKW, Liu Q, Yang F, Wang L, He M, Liu X, Lavoie Smith EM, Ho KY
Health Qual Life Outcomes · 2026 Mar · PMID 41862927 · Full text
BACKGROUND: Chemotherapy induced peripheral neuropathy (CIPN) is a symptom commonly reported by pediatric oncology patients who receive neurotoxicity agents. Early identification is imperative for the intervention implem...
BACKGROUND: Chemotherapy induced peripheral neuropathy (CIPN) is a symptom commonly reported by pediatric oncology patients who receive neurotoxicity agents. Early identification is imperative for the intervention implementation. Currently, the Pediatric Chemotherapy-Induced Neuropathy (P-CIN) is an age-appropriate, patient-reported outcome (PRO) for pediatric CIPN. However, it has not been used in China, and importantly does not contain a cut-off value to guide healthcare professionals for clinical decision making. OBJECTIVES: We aimed to cross-cultural adapt the P-CIN into Chinese context, and assess its psychometric properties. DESIGN: Methodological and descriptive study. SETTINGS: Shenzhen Children’s Hospital, Henan Cancer Hospital and Shanghai Children’s Medical Center in China. PARTICIPANTS: 313 pediatric oncology patients were conveniently sampled. METHODS: The Chinese P-CIN version was cross-culturally adapted and validated according to the established methodological guidelines. Participants were asked to provide demographic and clinical information, complete the translated P-CIN, Wong-baker FACES Pain Rating scale, and Pediatric Quality of Life Inventory (PedsQL) Cancer Module, and nerve conduction study. RESULTS: The Chinese P-CIN version showed satisfactory internal consistency (Cronbach’s alpha coefficient: 0.771) and good test-retest reliability for 2-week interval (intraclass correlation coefficient: 0.810). Excellent content validity was demonstrated; the item content validity index (CVI) ranged from 0.90 to 1.00, the average-CVI was 0.98 and the universal-CVI was 0.85. The total score of the translated P-CIN was strongly correlated with the Wong-baker FACES Pain Rating scale (Spearman’s correlation coefficient (r): 0.909, p < 0.001) and PedsQL Cancer Module (r = -0.710, p < 0.001), presenting good convergent validity. Using the clinician diagnosis of pediatric CIPN as a reference criterion, the area under the curve was 0.894. The optimal cut-off value to identify significant symptom burden of CIPN was 9. Exploratory factor analysis yielded a two-factor model (Sensory symptoms and Functional Task Performance Ability). The confirmatory factor analysis results supported the good fit of the two-factor model. Known-group validity was supported by the significant differences in the translated P-CIN score between patients grouped by neurotoxic chemotherapy agents (p = 0.014, ηp²=0.019) and cancer diagnosis (p = 0.026, ηp²=0.016). Besides, 82% of the participants completed the translated P-CIN independently. CONCLUSIONS: The Chinese P-CIN version was found to be a reliable and feasible PRO for pediatric CIPN. It shall be adopted as a routine tool for the detection of CIPN among Chinese pediatric oncology patients. REGISTRATION: Clinicaltrial, NCT07053579. Registered 18/06/2025, retrospectively registered.
Health-related quality of life in immunocompromised adults with mild-moderate COVID-19 treated with nirmatrelvir-ritonavir: results from the randomized, double-blinded EPIC-IC trial.
Mokgokong R, Cislo P, Tudone E … +2 more , Weinstein E, Cappelleri JC
Health Qual Life Outcomes · 2026 Mar · PMID 41857593 · Full text
BACKGROUND: Little is known about health-related quality of life (HRQoL) in immunocompromised people during and after COVID-19 illness. We describe HRQoL outcomes from the EPIC-IC trial, which included participants with...
BACKGROUND: Little is known about health-related quality of life (HRQoL) in immunocompromised people during and after COVID-19 illness. We describe HRQoL outcomes from the EPIC-IC trial, which included participants with immunocompromise and mild–moderate COVID-19. METHODS: EPIC-IC was a randomized, double-blind trial. Participants were assigned 1:1:1 to 5-day, 10-day, or 15-day nirmatrelvir-ritonavir (NMV/r) and completed the SF-36 and EQ-5D-5L through Week (W)24. HRQoL was analyzed across and by treatment arms for the evaluable population (N = 150) and in post hoc subpopulations with severe (n = 57) and non-severe (n = 93) immunocompromise. Mixed-effects longitudinal models compared 5-day vs. 10-day or 15-day NMV/r. RESULTS: In the overall sample, mean baseline SF-36 domain scores (norm-based; mean = 50, SD = 10) ranged from 35.7 to 44.1, mean Physical Component Summary (PCS) score was 37.9, and mean Mental Component Summary (MCS) score was 41.5 – all substantially worse than cancer comparator norms and age-matched general population (AMGP) norms. Baseline mean EQ-5D-5L Index score was 0.65; participants reported problems with pain/discomfort (90% of participants), usual activities (73%), mobility (50%), anxiety/depression (48%), and self-care (29%). These proportions improved through Day (D)15 (change from baseline [CFB]: − 49%-points for pain/discomfort, − 38%-points usual activities, − 22%-points mobility, − 24%-points anxiety/depression, − 19%-points self-care) and then stabilized. From the earliest post-baseline assessment (EQ-5D-5L: D5, SF-36: D10), all overall-sample outcomes improved significantly (-5D-5p < 0.05), with all mean improvements exceeding published minimum important difference thresholds (SF-36: 2–4-point; EQ-5D-5L Index: 0.03–0.05-point). Mean EQ-5D-5L Index score surpassed AMGP norms from D5 and peaked at D15 (0.21-point CFB). Mean SF-36 outcomes improved through W12; PCS surpassed AMGP norms at W12, while MCS approached but remained below AMGP norms. Improvements were sustained through W24 (W24 CFB: PCS, 10-point; MCS, 8-point; EQ-5D-5L Index, 0.20-point). EQ-5D-5L improvements appeared similar across immunocompromised subpopulations, whereas SF-36 improvements appeared slower and smaller in severely vs. non-severely immunocompromised participants. No significant treatment-arm differences were observed, except lower D10 PCS scores among severely immunocompromised participants treated with 5-day vs. 10-day NMV/r (p = 0.03). CONCLUSION: Immunocompromised individuals with mild–moderate COVID-19 experienced various HRQoL decrements, followed by rapid improvements during treatment that were sustained through W24. Interpretation is limited by the absence of an untreated control group. CLINICAL TRIAL REGISTRATION: Clinical trial number: NCT05438602. Registry: ClinicalTrials.gov. Registration date: June 28, 2022. URL: https://clinicaltrials.gov/ct2/show/NCT05438602 .
Development and content validation of a health assessment item bank for regional health big data: a sequential mixed-methods approach.
Zhang Y, Chen H, Zhu W … +3 more , Zhao G, Li Y, Sun H
Health Qual Life Outcomes · 2026 Mar · PMID 41851870 · Full text
BACKGROUND: Health assessment instruments are essential for individual health monitoring, yet most existing tools rely on periodic surveys and lack the capacity to integrate large-scale digital health data. With the incr...
BACKGROUND: Health assessment instruments are essential for individual health monitoring, yet most existing tools rely on periodic surveys and lack the capacity to integrate large-scale digital health data. With the increasing availability of regional health big data, there is a need to establish comprehensive indicator resources that can inform the development of validated instruments tailored to local health contexts. This study aimed to develop and validate a health assessment item bank based on regional health big data, providing a structured foundation for subsequent instrument development. METHODS: A sequential mixed-methods design was adopted. First, semi-structured interviews were conducted with experts from diverse health-related disciplines to identify key health categories and subcategories. A preliminary conceptual framework was produced through a directed qualitative content analysis process. Second, data elements were extracted from the national Regional Health Information Platform Interaction Standard (WS/T 790) of China and related standards. These data elements were vectorized using a Chinese pre-trained RoBERTa model, clustered with the DBSCAN algorithm, and matched to the conceptual framework through cosine similarity. Finally, experts reviewed and rated the semantic matching results by scoring the matching relevance from 1 to 5, agreement among experts were evaluated with the Fleiss' Kappa analysis, and consensus discussions were conducted to refine the item pool and ensure content validity. RESULTS: The resulting item bank comprised 430 indicators distributed across five main categories and 17 subcategories. The main categories are Physiological health, Psychological health, Health behaviors, Social health, and Environment and healthcare services. Expert review yielded high agreement (mean score = 4.95/5.00; Fleiss' Kappa = 0.626), supporting the adequacy of content validity. The Social support and Health service subcategories contained no mapped indicator, highlighting areas requiring integration of additional data sources. CONCLUSIONS: This study established a comprehensive and validated item bank for health assessment based on regional health big data, offering a structured foundation for future development, calibration, and psychometric testing of health assessment instruments. This work contributes to advancing data-driven, context-specific approaches for monitoring health at the individual level.
Item generation for a tooth wear-specific patient-reported outcome measure.
Sin M, Holliday R, Rogers H … +1 more , Karanjkar R
Health Qual Life Outcomes · 2026 Mar · PMID 41845456 · Full text
INTRODUCTION: The effective management of tooth wear is one of the biggest challenges faced in modern dentistry. Tooth wear can significantly impact oral health-related quality of life, yet there is no existing condition...
INTRODUCTION: The effective management of tooth wear is one of the biggest challenges faced in modern dentistry. Tooth wear can significantly impact oral health-related quality of life, yet there is no existing condition-specific patient-reported outcome measure (PROM) available to accurately capture and comprehensively measure this impact. This study aims to qualitatively explore patient perspectives of tooth wear to generate items for a condition-specific PROM. METHODS: Adults referred to Newcastle Dental Hospital for management of diagnosed tooth wear were invited to participate in a semi-structured qualitative interview. Participants were purposively selected from a range of ages, genders, with varied tooth wear aetiology and severity, and at different stages of treatment. Recruitment continued until purposive sampling requirements had been met, and data saturation was reached. Thematic analysis was undertaken independently by two researchers, prior to discussion to reach agreement on the identified themes. RESULTS: Seventeen participants with a range of tooth wear aetiologies, severity and at different stages of treatment were interviewed. Thematic analysis produced three broad themes including psychosocial impact of tooth wear, effect on function and knowledge and understanding of tooth wear. CONCLUSIONS: This study demonstrates the broad impacts that tooth wear can have on patients’ oral health-related quality of life, and has generated a wealth of items to inform generation of a condition-specific PROM. Understanding how tooth wear can impact on oral health-quality of life from a patients perspective is a critical first step in generation of a condition-specific patient-reported outcome measure.
Anticipating incomplete patient-reported outcomes in schizophrenia: a machine learning approach to predict the occurrence of missing data.
Barbalat G, Plasse J, Chéreau-Boudet I … +4 more , Gouache B, Legros-Lafarge E, Guillard-Bouhet N, Franck N
Health Qual Life Outcomes · 2026 Mar · PMID 41832549 · Full text
BACKGROUND: Missing data in patient-reported outcome (PRO) databases is a pervasive challenge, particularly in psychiatry and psychosocial rehabilitation. Incomplete data may reduce the generalizability of findings and i...
BACKGROUND: Missing data in patient-reported outcome (PRO) databases is a pervasive challenge, particularly in psychiatry and psychosocial rehabilitation. Incomplete data may reduce the generalizability of findings and introduce selection bias. It may also signal loss of access to care, potentially hindering recovery and rehabilitation efforts. Proactively anticipating missingness can help mitigate this issue by identifying individuals at risk of missing values, enabling services to take timely and targeted actions in response. However, the predictability of incomplete PRO data remains underexplored. METHODS: We used data from the French multicentric psychosocial rehabilitation database REHABase, focusing our analysis on patients with schizophrenia. We developed an ensemble machine learning model to predict missing data occurrence across six PROs, incorporating treatment center affiliation, sociodemographic features and clinical predictors. To ensure interpretability, we applied the concept of Shapley values to quantify individual predictor contributions to missing data patterns. RESULTS: Our sample comprised N = 2,363 participants. Averaged areas under the receiving operating curve (AUC) measured on the holdout testing observations ranged from 0.73 to 0.78 across the six PRO scales, demonstrating good predictive performance of our ensemble model. Treatment center affiliation emerged as a critical predictor of missing data. The ten most influential patient-level predictors were: being a disabled worker beneficiary; educational attainment; housing status; duration of illness; antipsychotic medication; origin of the referrer; number of suicide attempts; addictions comorbidity; having a forensic history; and sex. We also identified directional contributions distinguishing positive (increased likelihood of missing values) and negative effects (decreased likelihood). CONCLUSIONS: To our knowledge, this work represents the first predictive analytics framework for the occurrence of missing PRO data in psychosocial rehabilitation. Our ensemble algorithm holds dual potential: improving data collection strategies and informing targeted interventions to enhance patient engagement and retention. By proactively identifying at-risk individuals and refining study designs, our model could also indirectly support better functional recovery outcomes for schizophrenia patients.
Health-related quality of life and six-month hospitalization in older outpatients with heart failure with reduced ejection fraction: a prospective observational study.
Nguyen HT, Nguyen HTM, Nguyen HQ
Health Qual Life Outcomes · 2026 Mar · PMID 41827075 · Full text
BACKGROUND: Health-related quality of life (HRQoL) is an important component of heart failure (HF) management but remains insufficiently characterized among older outpatients in low- and middle-income countries. The prim...
BACKGROUND: Health-related quality of life (HRQoL) is an important component of heart failure (HF) management but remains insufficiently characterized among older outpatients in low- and middle-income countries. The primary objective of this study was to determine the prevalence of impaired HRQoL in older Vietnamese outpatients with heart failure with reduced ejection fraction (HFrEF). The secondary objectives were to identify factors associated with impaired HRQoL and to examine factors associated with six-month HF hospitalization. METHODS: We conducted a prospective observational study between August 2024 and June 2025 among outpatients aged ≥ 60 years with confirmed HFrEF at two specialized HF clinics. HRQoL was assessed using the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23), with impaired HRQoL defined as a score < 50. Participants were followed for six months for first HF hospitalization. Multivariable logistic regression was used to assess factors associated with impaired HRQoL, and Cox proportional hazards models were applied to evaluate factors associated with hospitalization. RESULTS: Among 310 patients (median age 71 years), 48 (15.5%) had impaired HRQoL at baseline. Depression (odds ratio [OR] 4.12, 95% confidence interval [CI] 1.70–9.97; P = 0.002) and New York Heart Association (NYHA) class III (OR 6.55, 95% CI 3.01–13.9; P < 0.001) were independently associated with impaired HRQoL. During follow-up, 92 patients (29.7%) experienced a first HF hospitalization, of whom 32 (34.8%) had impaired HRQoL at baseline. Age ≥ 75 years (hazard ratio [HR] 1.93, 95% CI 1.22–3.06; P = 0.005), limitations in instrumental activities of daily living (HR 2.34, 95% CI 1.16–4.73; P = 0.018), and impaired HRQoL (HR 2.10, 95% CI 1.26–3.51; P = 0.004) were independently associated with a higher risk of hospitalization. Receipt of quadruple therapy was associated with a lower risk (HR 0.63, 95% CI 0.40–0.99; P = 0.047). CONCLUSIONS: In older outpatients with HFrEF, impaired HRQoL was observed in approximately one-sixth of patients and was associated with depression and NYHA class III. Over six months, impaired HRQoL, advanced age, and limitations in instrumental activities of daily living were associated with an increased risk of HF hospitalization, whereas receipt of quadruple therapy was associated with a reduced risk. CLINICAL TRIAL NUMBER: This study was not registered as a clinical trial.
Trajectories of health-related quality of life after cancer diagnosis in a cohort of Australian women: a longitudinal study.
Rahman MM, Steinberg J, David M … +7 more , Yu XQ, Byles J, Rutherford C, Banks E, Zhang H, Canfell K, Yap ML
Health Qual Life Outcomes · 2026 Mar · PMID 41821019 · Full text
BACKGROUND: With increasing cancer survival rates, optimising health-related quality of life (HRQL) has become a major priority. However, longitudinal assessments of HRQL outcomes in people with cancer are limited. This...
BACKGROUND: With increasing cancer survival rates, optimising health-related quality of life (HRQL) has become a major priority. However, longitudinal assessments of HRQL outcomes in people with cancer are limited. This study aimed to examine changes in HRQL outcomes following a cancer diagnosis and to identify the long-term trajectories of HRQL outcomes and associated factors. METHODS: This study included 1414 women diagnosed with primary invasive cancer from 1996 to 2019 and 2828 women without cancer from a large cohort (born in 1946-51) of the Australian Longitudinal Study on Women’s Health, linked to the Australian Cancer Database. Generalised linear models were used to estimate changes in HRQL outcomes, adjusting for sociodemographic factors and other health conditions. Group-based multitrajectory modelling was applied to identify HRQL trajectories over time. RESULTS: In the short-term (≤ 3 years), we found a significant decline in the adjusted mean difference (AMD) across all HRQL domains from pre-cancer to post-cancer surveys, with the largest decrease in general health (AMD − 10.3, 95% CI: -11.43, -9.18). The corresponding changes within the same period among women without cancer were not significant at p < 0.05, except for physical functioning. In the long-term (≤ 15 years), four HRQL trajectory groups were identified: very low HRQL trajectory (n = 184, 13%), moderate HRQL trajectory (n = 355, 25%), moderate-high HRQL trajectory (n = 532, 38%), and high HRQL trajectory (n = 343, 24%). In the control sample, a greater proportion of women belonged to the high HRQL trajectory group (29% versus 24%). Cancer survivors in the very low or moderate HRQL trajectory groups had significantly lower HRQL domain scores than the corresponding trajectory groups in the control group (p < 0.05). Compared with the high HRQL trajectory group, the very low HRQL trajectory group experienced greater difficulties in managing their available income (60% versus 22%, p < 0.01) and had ≥ 2 comorbidities (42% versus 9%, p < 0.01). CONCLUSIONS: Our findings suggest the importance of measuring HRQL soon after diagnosis as a baseline measure and considering both baseline and ongoing HRQL when guiding supportive care for women cancer survivors. Additionally, targeted initiatives that prevent and manage comorbidities and financial hardship in those with low HRQL at baseline are critical for equitable care.
Psychometric evaluation of the Chinese CancerSupportSource-Caregiver among family caregivers to colorectal cancer patients using CTT and Rasch analyses.
Xia R, Tian D, Zhou Y … +10 more , Zhong M, Lin Y, He J, Lin W, Li J, Li H, Yang Y, Wang Q, Xiao X, Su X
Health Qual Life Outcomes · 2026 Mar · PMID 41807938 · Full text
BACKGROUND: Family caregivers of colorectal cancer (CRC) patients often experience significant distress, yet no validated instrument exists in China to screen for this distress. This study aimed to translate the CancerSu...
BACKGROUND: Family caregivers of colorectal cancer (CRC) patients often experience significant distress, yet no validated instrument exists in China to screen for this distress. This study aimed to translate the CancerSupportSource™-Caregiver (CSS-Caregiver) scale into Chinese and evaluate its psychometric properties among CRC family caregivers. METHODS: A cross-sectional study was conducted with 340 family caregivers of CRC patients from three tertiary hospitals in Guangzhou. The Chinese CSS-Caregiver was translated and culturally adapted. Its psychometric properties were assessed using both Classical Test Theory and Rasch analysis. Reliability was evaluated via internal consistency and test-retest reliability. Validity was examined through confirmatory factor analysis (CFA), item-total correlations, and convergent validity. Measurement invariance was tested using multi-group CFA and Differential Item Functioning (DIF). The optimal cut-off score was determined via ROC analysis. RESULTS: The Chinese CSS-Caregiver demonstrated excellent internal consistency (Cronbach’s α = 0.902) and test-retest reliability (ICC = 0.935). CFA supported the original five-factor structure with good model fit (χ²/df = 2.064, CFI = 0.956, RMSEA = 0.073). Rasch analysis indicated generally satisfactory item fit and person separation. The scale exhibited strict measurement invariance across sex, age, and residence, with negligible DIF. Strong convergent validity was demonstrated by correlations with the criterion measures (r = 0.81 ~ 0.85). An optimal cut-off score of 18.5 was established. CONCLUSIONS: The Chinese CSS-Caregiver is a valid and reliable instrument for assessing distress among family caregivers of CRC patients in China, facilitating early identification and timely psychosocial support.
Are we reporting well enough? A systematic survey of missing data in patient-reported outcomes from non-small cell lung cancer randomized trials.
Ma J, He W, Jing F … +2 more , Li M, Li Z
Health Qual Life Outcomes · 2026 Mar · PMID 41787397 · Full text
BACKGROUND: Missing patient-reported outcome (PRO) data represent a frequent and significant challenge in clinical trials. Inadequate handling or reporting of such data may introduce bias, undermine the validity of findi...
BACKGROUND: Missing patient-reported outcome (PRO) data represent a frequent and significant challenge in clinical trials. Inadequate handling or reporting of such data may introduce bias, undermine the validity of findings, and limit the interpretability of treatment effects, particularly in oncology research where patient experience is a key outcome. PURPOSE: This systematic survey evaluated how missing PRO data were handled in randomized controlled trials (RCTs) involving patients with non-small cell lung cancer (NSCLC). METHODS: A comprehensive search was conducted in PubMed, Embase, Web of Science, Scopus, and ClinicalTrials.gov for NSCLC RCTs reporting PROs (up to June 6, 2024). Two independent reviewers assessed study eligibility and extracted predefined data on the extent of missing PROs and the statistical methods used to address them. Descriptive statistics and logistic regression analyses were performed. RESULTS: Of 13,019 records screened, 252 RCTs met the inclusion criteria. Most trials (70.2%) reported missing PRO data; however, only 45.2% specified statistical handling methods, most commonly complete case analysis, mixed-effects models, or mixed-effects model for repeated measures. Among 52 trials with PROs as primary outcomes, only 12 reported sensitivity analyses. Trials with larger sample sizes or those with PROs as primary endpoints were significantly more likely to report missing data. Clinical events (e.g., death or disease progression) were the predominant reasons for missingness, while procedural or methodological causes were less frequently reported. CONCLUSION: The reporting and statistical management of missing PRO data in NSCLC RCTs remain suboptimal. Most trials relied on conventional methods with limited use of advanced techniques or sensitivity analyses, raising concerns about bias and interpretability. Future trials should prioritize prespecified strategies, robust statistical modeling, and transparent reporting to enhance the validity and clinical relevance of PRO evidence.
Psychometric properties of the health-related quality of life instrument with 8 items: a systematic review and meta-analysis.
Lee TK, Lee SY, Cho E
Health Qual Life Outcomes · 2026 Mar · PMID 41781987 · Full text
BACKGROUND: The Health-Related Quality of Life Instrument with 8 items (HINT-8) is a preference-based generic measure developed in 2014 for the Korean population. HINT-8 encompasses eight domains: climbing stairs, pain,...
BACKGROUND: The Health-Related Quality of Life Instrument with 8 items (HINT-8) is a preference-based generic measure developed in 2014 for the Korean population. HINT-8 encompasses eight domains: climbing stairs, pain, vitality, working, depression, memory, sleep, and happiness. With the increasing use of HINT-8 in diverse research settings, a comprehensive synthesis is needed to clarify its psychometric performance and clinical utility. This study evaluated the properties of HINT-8 through a systematic review and meta-analysis. METHODS: We systematically searched PubMed, KoreaMed, KMbase, KISS, and Google Scholar for studies published from January 2019 to December 2024 reporting HINT-8 outcomes. Data on HINT-8 index scores and domain-level outcomes were extracted for quantitative synthesis. Four pooled analyses were conducted: (1) construct validity using correlation with EQ-5D and SF-36, (2) reliability using Cohen’s kappa and intraclass correlation coefficients, (3) overall and domain-specific ceiling effects based on response distributions, and (4) subgroup specific HINT-8 index scores across demographic and clinical characteristics. Random-effects meta-analyses were performed, and statistical heterogeneity was assessed using I² and τ² statistics. RESULTS: Among the 70 studies reporting HINT-8 outcomes, 23 contributed to the quantitative synthesis. Lower HINT-8 index scores were observed among female, older adults, and individuals with lower socioeconomic status compared with their respective reference groups. Correlation coefficients demonstrated expected construct validity with higher correlations for similar domains. Distinct HINT-8 domains such as vitality, working, memory and sleep showed low correlations with EQ-5D or SF-36, reflecting its unique construct coverage. Reliability assessed by Cohen’s kappa ranged from 0.237 to 0.521 across domains, while intraclass correlation coefficients indicated substantial agreement. HINT-8 showed lower ceiling effects (5.4% [95%CI: 2.3–8.6]) than EQ-5D (41.0% [25.4–56.6]), indicating better discriminatory ability. HINT-8 index values showed clear differences across various health conditions and demographic factors. CONCLUSION: With enriched domains, HINT-8 demonstrated sensitivity and utility as a generic measure for capturing diverse health statuses when applied with established tariff-derived index scores. As all included studies were conducted in Korea, further validation in diverse settings is warranted.
Developing a utility value set for the Alcohol Quality of Life Scale-Brief (AQoLS-Brief) using a discrete choice experiment.
Luquiens A, Panjo H, Pelletier-Fleury N
Health Qual Life Outcomes · 2026 Feb · PMID 41742291 · Full text
BACKGROUND: The Alcohol Quality of Life Scale-Brief (AQoLS-Brief) is a patient-reported outcome measure developed with input from individuals with alcohol use disorder (AUD). This study aimed to develop a utility set for...
BACKGROUND: The Alcohol Quality of Life Scale-Brief (AQoLS-Brief) is a patient-reported outcome measure developed with input from individuals with alcohol use disorder (AUD). This study aimed to develop a utility set for the AQoLS-Brief based on general population preferences to support cost-utility analyses. METHODS: We conducted a discrete choice experiment with duration in a probabilistic sample of French adults (n = 704). Participants chose between paired comparisons of health states described by seven AQoLS-Brief dimensions of varying survival durations. Conditional logit models with interactions between attribute levels and time were used to estimate utility decrements. These anchored coefficients were used to compute quality-adjusted life years (QALY) weights for all 16,384 possible AQoLS-Brief health states. RESULTS: Respondents reported that the tasks were understandable, realistic, and that all attributes were considered. Utility weights ranged from 1 for full health state to − 1.1 for worst state; 23.9% of states were valued as worse than dead. The two items most heavily weighing down the utility set were “Missing out on family life” (–0.59) and “Financial difficulties” (–0.45), highlighting the central role of social and economic functioning in the perceived burden of AUD. Substantial decrements were also observed for “Feeling of wasting my life” and “Life revolving around alcohol.” CONCLUSIONS: This study provides a QALY-anchored value set for the AQoLS-Brief, enabling its use in cost-utility analyses. The findings underscore the importance of social, emotional, and financial domains in AUD-related quality of life. Further cross-cultural validation and responsiveness testing in clinical settings are needed.
Psychometric properties of the Persian version of the childhood epilepsy questionnaire-16 (QOLCE-16) in a sample of parents of children with epilepsy.
Nemati H, Ghaemmaghami P, Roosta L … +2 more , Dehghani SL, Alamolhoda M
Health Qual Life Outcomes · 2026 Feb · PMID 41742275 · Full text
BACKGROUND: As a chronic neurological condition, epilepsy adversely affects multiple dimensions of quality of life in pediatric and adolescent populations. The aims of the study were translation and cultural adaptation (...
BACKGROUND: As a chronic neurological condition, epilepsy adversely affects multiple dimensions of quality of life in pediatric and adolescent populations. The aims of the study were translation and cultural adaptation (TCA) of the Persian version of the 16-item Quality of Life in Childhood Epilepsy (QOLCE-16) and assessment of its psychometric properties in children and adolescents with epilepsy. METHODS: A total of 290 parents of children with epilepsy were eligible to participate in this study and completed the questionnaire. TCA procedures were used to adapt the English version of the QOLCE-16 into Persian. Reliability, internal consistency, item analysis, test-retest reliability, convergent validity, discriminant validity, and confirmatory factor analysis (CFA) were conducted to evaluate the psychometric properties of the Persian version of the QOLCE-16. RESULTS: Internal consistency measured by Cronbach’s alpha coefficients was excellent, ranging from 0.80 to 0.92. The items were significantly related to the total scores (p < 0.05). Intraclass correlation coefficients were satisfactory across all domains. Convergent and discriminant validity were supported for all subscales based on predefined correlation-based criteria. The results of CFA confirmed a second-order model with excellent fit based on significant standardized estimates of factor loadings and favorable goodness-of-fit indices (CFI = 0.979, TLI = 0.973, RMSEA = 0.062, 90% CI [0.048, 0.076], and SRMR = 0.062). CONCLUSIONS: The Persian version of the QOLCE-16 has good reliability and validity in assessing the health-related quality of life of children with epilepsy in Iran. The translated version, as a brief and valuable measurement tool, can be applied in clinical research of a Persian-speaking population.
Ethnic disparities in health-related quality of life and cognitive function after stroke in the Netherlands.
Lee YX, Jellema K, Vlieland TPMV … +3 more , van den Wijngaard IR, Hofs DECM, Arwert HJ
Health Qual Life Outcomes · 2026 Feb · PMID 41742265 · Full text
BACKGROUND/OBJECTIVE: European data regarding ethnic disparities in health-related quality of life (HRQOL) post- stroke is scarce and none used the Patient-Reported Outcomes Measurement Information System (PROMIS). This...
BACKGROUND/OBJECTIVE: European data regarding ethnic disparities in health-related quality of life (HRQOL) post- stroke is scarce and none used the Patient-Reported Outcomes Measurement Information System (PROMIS). This study explores whether ethnicity is related to HRQOL using PROMIS and cognitive function after stroke in the Netherlands. METHODS: Patients hospitalized with a first-ever stroke were included. Outcome assessments included the PROMIS Profile, the EuroQoL-5D-3 L for HRQOL and the PROMIS Cognitive Function for cognitive functioning. Measurements were done at admission, after 3 and 12 months (EQ-5D and EQ-5D-VAS only at 12 months). Ethnicity (migration background yes/no), demographics and stroke characteristics were collected. Outcomes were compared between patients with and without a migration background by a multivariate linear mixed-effects model, adjusted for age, sex, education level, severity of stroke and other relevant variables at baseline were also included (smoking before admission, acute intervention in case of an ischemic stroke and length of hospital stay). RESULTS: 262 patients were included of which 74 (28.2%) had a migration background. This group had worse scores compared to patients without a migration background, with a significant difference at admission for the physical function (estimate = 3.30, SE = 1.25, p = 0.01), at three months for anxiety (estimate=-2.95, SE = 1.48, p = 0.05) and twelve months for sleep disturbance (estimate=-5.43, SE = 1.61, p < 0.01). The EQ-5D index and EQ-5D VAS at twelve months follow-up was also significantly lower in this group compared to patients without a migration background (respectively adjusted B -0.09 (95% CI -0.17; -0.01)) and adjusted B -7.27 (95% CI (-13.99; -0.56)). CONCLUSION: Up to twelve months, stroke patients with a migration background had worse scores and a different trajectory regarding several domains of HRQOL compared to patients without a migration background.
Anxiety and depression may amplify self-reported physical health problems: evidence from EQ-5D-5L data.
Hong Y, Yang Z, Luo N … +1 more , Busschbach J
Health Qual Life Outcomes · 2026 Feb · PMID 41742241 · Full text
INTRODUCTION: Our previous study has shown that individuals with poor positive mental well-being (measured by the Short Warwick-Edinburgh Mental Well-being Scale, SWEMWBS) tend to report more problems on the EQ-5D-5L. An...
INTRODUCTION: Our previous study has shown that individuals with poor positive mental well-being (measured by the Short Warwick-Edinburgh Mental Well-being Scale, SWEMWBS) tend to report more problems on the EQ-5D-5L. Another study has shown that the anxiety/depression item of the EQ-5D-5L and all items of SWEMWBS loaded onto the same factor in an exploratory factor analysis, suggesting they measure the same construct. This study aims to analyze the potential impact of anxiety/depression on responses to the four physical health dimensions of the EQ-5D-5L. METHODS: An online survey and face-to-face interviews were conducted to collect data from participants with and without different health conditions. Generalized ordered logistic regression was employed to examine the influence of anxiety/depression on responses to the four physical health dimensions of the EQ-5D-5L. Multiple linear regression analysis was conducted to explore the effects of anxiety/depression on EQ-VAS and utility values. A directed acyclic graph (DAG) was used to identify the minimum set of variables required to adjust for confounding. RESULTS: 500 participants completed online surveys, 509 participated in face-to-face interviews; 237 healthy individuals, 430 individuals with physical conditions, 234 with mental conditions, and 108 with both physical and mental conditions. According to graphical rules applied to the DAG, the final minimally sufficient adjustment set comprised age, carers, education level, sex, and health conditions. Generalized ordered logistic regression indicated that individuals with higher levels of anxiety/depression were more likely to report problems in the four physical health dimensions. Multiple linear regression analysis demonstrated that anxiety/depression was significantly associated with EQ-5D-5L utility values and EQ-VAS scores, with individuals experiencing high levels of anxiety/depression reporting lower values for both measures. CONCLUSION: Mental health conditions, particularly anxiety and depression, may lead to heightened perceptions of problems in physical health dimensions, potentially biasing self-reported health data. Addressing anxiety and depression in clinical and therapeutic settings may not only improve mental health outcomes but also positively influence perceived physical health. Future research is needed to establish causal relationships.
Validity and reliability of the Japanese Adult Social Care Outcomes Toolkit four-level Self Completion Tool (ASCOT SCT4) in community mental health service users in Japan.
Nara M, Yamaguchi S, Moriyama Y … +9 more , Okada T, Usuda K, Hada A, Usui K, Iwanaga M, Kawaguchi T, Sato S, Kuroda N, Fujii C
Health Qual Life Outcomes · 2026 Feb · PMID 41715161 · Full text
BACKGROUND: Outcome evaluations using patient-reported outcome measures (PROMs) are becoming increasingly important in healthcare, including long-term care and disability support. The Adult Social Care Outcomes Toolkit (...
BACKGROUND: Outcome evaluations using patient-reported outcome measures (PROMs) are becoming increasingly important in healthcare, including long-term care and disability support. The Adult Social Care Outcomes Toolkit (ASCOT) is a self-reported measure that assesses social care-related quality of life (SCRQoL), which can be affected by long-term care services. This study examined the validity and reliability of the Japanese ASCOT four-level Self-Completion Tool (SCT4) for people with mental illnesses who used community services. METHODS: We conducted a cross-sectional survey of persons with mental illnesses who used community services in 22 facilities across Japan. Confirmatory factor analysis (CFA) was performed to confirm the factor structure. Spearman’s rank correlation coefficients were calculated to assess the convergent validity of health-related quality of life (HRQoL), personal agency, well-being, depressive symptoms, functional assessment, and objective quality of life (QoL). Cronbach’s alpha and intra-class correlation coefficients (ICC) were computed to assess internal consistency and test-retest reliability, respectively. RESULTS: In total, 397 service users agreed to participate, and 64 completed the Japanese ASCOT SCT4 twice to assess test-retest reliability. The model fit indices indicated chi-squared statistic /degrees of freedom (CMIN/df) = 1.069 (p = 0.375), root mean square error of approximation (RMSEA) = 0.013, standardized root mean square residual (SRMR) = 0.026, comparative fit index (CFI) = 0.998, and Tucker-Lewis index (TLI) = 0.997. The Japanese ASCOT SCT4 demonstrated significant correlations with HRQoL (ρ = 0.619, p < 0.001), personal agency (ρ = 0.502, p < 0.001), well-being (ρ = 0.657, p < 0.001), depressive symptoms (ρ = -0.657, p < 0.001), and functional assessment (self-reported version: ρ = -0.616, p < 0.001; observer-reported version: ρ = -0.242, p < 0.001), and objective QoL (ρ = 0.240, p < 0.001). Cronbach’s alpha and ICC were 0.76 and 0.71, respectively. CONCLUSIONS: The Japanese ASCOT SCT4 can be potentially useful as a PROM to easily assess the SCRQoL of individuals with mental illness who use community services. Future studies should use additional validity tests with more diverse samples.
Discrimination experiences and their associations with sociodemographic factors, health and quality of life-a latent class analysis.
Friesinger JG, von Heimburg D, Ness O … +2 more , Haugland SH, Vederhus JK
Health Qual Life Outcomes · 2026 Feb · PMID 41715126 · Full text
BACKGROUND: Discrimination has adverse effects on people's health and quality of life (QoL). This study aimed to identify distinct intersecting patterns of discrimination experiences, examine their associations with soci...
BACKGROUND: Discrimination has adverse effects on people's health and quality of life (QoL). This study aimed to identify distinct intersecting patterns of discrimination experiences, examine their associations with social categories and health factors, and assess the impact of perceived discrimination (PD) on health and QoL outcomes beyond specific self-reported reasons for PD. METHODS: We utilized data from the Norwegian Counties Public Health Survey (NCPHS) conducted in Agder County in 2023 and employed latent class analysis (LCA) to explore how patterns of discrimination reasons cluster. The selected classes were then further examined to determine how they differed by comparing each class to the reference class with no PD. Lastly, we assessed the estimated marginal means of each class on health and overall QoL using ANCOVA. RESULTS: The study identified six classes of PD: Massive PD, Gender/Age PD, No PD, Function/Illness PD, Ethnicity/Skin PD, and Political PD. ANCOVA analyses revealed significant differences across self-rated health, mental distress, and QoL. Notably, the Massive PD, Gender/Age PD, and Function/Illness PD groups reported significantly poorer self-rated health and QoL compared to the No PD group. All PD classes scored significantly higher in mental distress than the No PD group, with the Massive PD class exceeding the clinical cut-off, indicating elevated psychological distress. CONCLUSIONS: Our findings reveal persistent health and QoL disparities between individuals experiencing PD and those who do not, despite a robust welfare system. Service providers must consider the interplay of factors such as age, gender, income, and health conditions with PD to ensure fair service delivery.
Incorporating patients' input in the development and validation of patient-reported outcome measures in oncology: a comprehensive scoping review.
Shakhnenko I, Hovsepyan S, Holthuis EI … +3 more , Bulbeck H, van der Graaf WTA, Husson O
Health Qual Life Outcomes · 2026 Feb · PMID 41709210 · Full text
BACKGROUND: Patient-reported outcome measures (PROMs) play a crucial role in evaluating oncological interventions. Although PROMs are developed to assess the patient’s health status, it remains unknown if patients’ persp...
BACKGROUND: Patient-reported outcome measures (PROMs) play a crucial role in evaluating oncological interventions. Although PROMs are developed to assess the patient’s health status, it remains unknown if patients’ perspectives are considered when developing and validating PROMs. This review aims to describe the nature of patient involvement in PROM development and validation in oncology research. METHODS: A scoping review was conducted to identify relevant articles on patient involvement in PROM development and validation in cancer research published between 1993 and 2023 using PubMed/Medline, Embase, Scopus, and Cochrane databases, with the aim of exploring the extent and nature of patient involvement in developing and validating PROMs specifically in cancer research. RESULTS: Out of 1354 initially identified articles, 34 met the inclusion criteria, and included various cancer types. The majority of studies (76%) engaged patients in item development through methods such as focus groups and interviews. Patient involvement across all phases of development and validation was documented in 35% of the studies. The value of patient involvement was illustrated by the improved relevance of the PROM content, leading to the inclusion of issues that were meaningful to patients. CONCLUSION: This scoping review demonstrates that even though the nature and extent of involvement varied throughout the stages of PROM development, the value of patients’ voices was not in question. A potential next step could be to introduce standardized terminology and develop guidelines to enhance a consistent and effective integration of patients’ input into the development of PROMs in the oncology setting. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12955-026-02500-4.
Associations between physical activity and quality of life in university students during the COVID-19 pandemic.
Luz TDD, de Oliveira Luz LG, Giudicelli BB … +6 more , da Cunha Júnior AT, da Silva Oliveira EA, do Carmo BCM, de Albuquerque Maranhão Neto G, Baptista LCP, Martins RAS
Health Qual Life Outcomes · 2026 Feb · PMID 41689008 · Full text
BACKGROUND/PURPOSE: The present study investigated variance in overall quality of life in relation to a broad spectrum of correlates, including sociodemographic characteristics, health self-reports related to the COVID-1...
BACKGROUND/PURPOSE: The present study investigated variance in overall quality of life in relation to a broad spectrum of correlates, including sociodemographic characteristics, health self-reports related to the COVID-19 pandemic, sedentary behavior, and habitual physical activity, as well as examined the relationship between habitual physical activity and quality of life domains in university students during the first year of the COVID-19 pandemic. METHODS: This cross-sectional observational study was conducted with 4059 undergraduate students (1859 men). Data were collected between June and October 2020. The electronic questionnaire comprised four main domains: sociodemographic characteristics, self-reported health conditions related to the COVID-19 pandemic, sedentary behavior and physical activity level, and quality of life. RESULTS: Students reported a mean score of 58.3 (± 21.2) for overall quality of life (males: 59.7 ± 21.0; females: 57.2 ± 21.4, p < 0.001). Male students exhibited significantly higher scores than female students across all quality of life domains, with the exception of the social domain (p > 0.05). Notably, a set of variables was associated with higher quality of life scores across both sexes including having private health insurance, sleeping between 7 h and 9 h per night, and engaging in moderate or high levels of physical activity. Students classified as physically active associated with better perception in all quality of life domains across both sexes. CONCLUSION: While these findings are consistent with the existing literature, they further underscore the importance of addressing the interplay of sociodemographic, lifestyle, and health-related factors in strategies aimed at improving quality of life in university students during lockdown.
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