Despite existing research on factors influencing quality of life (QOL) in older adults with chronic diseases, the underlying mechanisms by which health literacy (HL) and e-health literacy (eHL) contribute to QOL improvement remain underexplored. This study aimed to elucidate the complex relationships among HL, eHL, health behaviors, psychosocial factors, and QOL, and to identify the driving pathways of HL and eHL in enhancing QOL. A cross-sectional study was conducted between March and June 2025 at a tertiary hospital in Xi'an, China. A total of 304 older adults with chronic diseases participated in the study. Participants completed assessments for HL, eHL, cognitive function, frailty, nutrition, physical activity, sleep quality, family function, depression, and QOL (including Physical and Mental Component Summaries, PCS and MCS). Grip strength was also measured. Multiple linear regression, network analysis, and path analysis were employed to determine influencing factors and structural relationships. Higher HL and eHL levels were associated with younger age, higher socioeconomic status, longer daily smartphone usage, and having personal interests; HL was additionally linked to better family function. Network and path analyses revealed that depression, frailty, physical activity, grip strength, and family function were primary direct predictors of QOL, PCS and MCS. Depression and frailty were identified as key risk factors, while sleep quality and nutritional status served as significant mediators. Although HL and eHL did not directly influence QOL, they functioned as upstream variables that indirectly improved QOL by positively influencing these intermediary health behaviors and psychosocial factors. HL and eHL indirectly enhance QOL in older adults with chronic diseases by driving improvements in health behaviors and psychological status. Interventions should target depression, frailty, sleep quality, and nutrition as critical modifiable factors. Future programs aiming to improve HL and eHL should prioritize older individuals with low socioeconomic status and limited digital experience, incorporating age-friendly designs, social interaction, and family involvement.
Adolescents' health-related quality of life (HRQoL) is influenced by multiple domains, including school, family, and individual lifestyle. However, evidence remains limited on accurately predicting adolescent HRQoL and identifying modifiable determinants. This study aimed to develop a machine-learning prediction model for adolescent HRQoL and to determine key contextual factors associated with low quality of life. This cross-sectional study included 20,236 adolescents (51.71% female; mean age 15.97 years). HRQoL was assessed using the validated Quality of Life Scale for Children and Adolescents (QLSCA). Twenty predictors covering school adjustment, family characteristics, and health behaviours were entered into 9 machine-learning classifiers and logistic regression. Feature contributions were examined using permutation importance, partial dependence plots (PDPs), and SHapley Additive exPlanations (SHAP). Stratified analyses by sex and school stage were conducted to identify group-specific determinants. School adjustment was the primary predictor of HRQoL, with self-management and peer relations contributing most. Family factors ranked next, particularly more frequent exercise with parents, which was associated with higher HRQoL. Among lifestyle behaviours, higher physical activity and healthier dietary patterns were associated with better HRQoL, whereas excessive screen time was associated with poorer HRQoL. In stratified analyses, peer relations and physical activity were more influential among boys, while self-management, exercising with parents, and adequate sleep contributed more among girls. Middle school students showed more adverse associations with disruptive/antisocial behaviours and screen time, whereas high school students derived greater benefits from family interaction and health behaviours. Explainable machine-learning analyses highlight school adjustment as a central correlate of adolescent HRQoL, alongside family characteristics and health behaviours. These findings provide multidimensional evidence to support targeted interventions in educational, family, and public health settings to improve adolescents' HRQoL.
Good oral health is crucial for overall well-being; yet many people experience pain, discomfort, or social difficulties due to oral problems. Understanding how Australians' oral health and quality of life have changed over time helps identify whether national dental policies and access to care have improved. The study aimed to assess temporal changes in oral health-related quality of life (OHRQoL) and identify associated risk indicators using the short Oral Health Impact Profile (OHIP-14) instrument among Australian adults. Data were sourced from the two most recent nationally representative surveys in Australia: National Survey of Adult Oral Health, NSAOH-1 (2004-06) and NSAOH-2 (2017-18). Both are population-based cross-sectional studies conducted in Australia, targeting adults aged 15 years and older. The outcome of interest was oral health-related quality of life (OHRQoL), measured using the validated short-form Oral Health Impact Profile (OHIP-14). Survey-weighted negative binomial regression models were employed to estimate both unadjusted and adjusted mean ratios (MRs) and their 95% confidence intervals (CIs) for OHIP-14 scores. Blinder-Oaxaca decomposition analysis was used to assess the contribution of changes in measured population characteristics to differences in mean OHIP-14 scores between two surveys. In total, 4,170 participants completed the OHIP-14 questionnaire in 2004-06, and 2,836 did so in 2017-18. Between the two survey waves, the mean OHIP-14 score decreased from 7.3 to 5.5. After adjusting for all covariates, participants in NSAOH-1 had a 61% higher mean OHIP-14 score compared to those in NSAOH-2 (MR = 1.61; 95% CI: 1.53-1.70). Higher OHIP-14 scores were found among older adults, lower-educated, lower-income individuals, those with poorer health, smokers, frequent toothache sufferers, and people whose last dental visit was for a problem. The decomposition analysis showed that 41% of the difference in mean OHIP-14 scores was explained by measured population characteristics, Household income, and usual reason for dental visiting made the largest contributions to the explained component (80%), followed by smoking status (15%) and education level (9%). OHRQoL among Australian adults improved over 14 years, reflected by lower mean OHIP-14 scores in NSAOH-2 than NSAOH-1. However, poorer OHRQoL remained associated with older age, female sex, socioeconomic disadvantage, poorer self-rated health and oral health, smoking, toothache, and problem-oriented dental visiting. Decomposition analysis suggested that changes in income and dental visiting patterns partly explained this improvement.
Over the last decade, South Africa has prioritized infrastructure development, focusing on an energy transition and resource efficiency as key areas of reform. However, while the country has reported some socio-economic benefits, it continues to deal with significant health issues, which impose a substantial cost in terms of DALYs and quality of life. This study therefore examines the asymmetric effects of access to clean energy, natural resource endowment, and institutional quality on sustainable, healthy living outcomes (DALYs and quality of life) in South Africa. The study also considers the moderating role of institutional quality. The study employed quantile regression and non-parametric Granger causality in quantiles on quarterly data covering the period from Q1 2000 to Q4 2022. The findings suggest that access to clean energy is the most significant factor in reducing DALYs from all causes and improving quality of life, with the greatest benefits realized by population groups with relatively low DALYs. Natural resource endowment has no direct effect on DALYs or quality of life, indicating the difficulty of converting resource riches into welfare advantages. Institutional quality has an important, albeit asymmetric, direct effect. Furthermore, the results confirm the moderating role of institutional quality in reducing DALYs among moderately to highly vulnerable population groups. These findings are corroborated by the robustness tests. They suggest that the South African government and its partners should accelerate the transition to clean energy by increasing investment in clean energy resources and/or providing incentives and subsidies. They also show the importance of effective institutions to ensure the health and environmental benefits of energy systems and natural resource management.
Health-related quality of life (HRQOL) measures patients' overall well-being and can help guide survivorship care. Evidence comparing individual patients' HRQOL pre- and post-diagnosis is limited due to the unpredictable nature of cancer onset. Our study aims to evaluate trends in HRQOL in elderly colon cancer patients and identify predictors of HRQOL change across two key transitions: (1) pre- to post-diagnosis, and (2) at diagnosis versus 2 years later, with the goal of identifying at-risk patients for a significant HRQOL decrease. Utilizing the SEER-Medicare Health Outcomes Survey (SEER-MHOS), patients diagnosed with colon cancer between 1998 and 2019, ≥ 65 years old, and at least two HRQOL surveys were identified and grouped. Group 1 comprised patients with an initial survey pre-diagnosis and a follow-up survey within 1 year from diagnosis, while Group 2 included patients with an initial survey within 1 year from diagnosis and a follow-up survey 2 years later. Bayesian linear regression identified predictors of physical (PCS) and mental (MCS) score changes, incorporating demographic, socioeconomic, comorbidity, and cancer-related variables. The analysis included 1139 patients (Group 1: 571; Group 2: 568). PCS and MCS scores decreased substantially at diagnosis (4.4 and 2.2 points, respectively) compared to baseline but changed minimally from baseline (-0.3 and +0.6 points, respectively) 2 years post-diagnosis. Advanced disease stage and baseline ADL limitations were the strongest predictors of HRQOL decline, both from pre- to post-diagnosis and from diagnosis to 2 years later. Conversely, positive baseline health perception was protective (probability of direction > 90% for all estimates). Among colon cancer patients, patient-reported baseline health perception and functional limitations emerged as critical determinants of HRQOL trajectories, outweighing socioeconomic and treatment-related factors. These factors remain consistent upon diagnosis and during survivorship. Assessment of these factors could estimate HRQOL outcomes and facilitate early identification of at-risk patients.
Effective health-promoting interventions can support older adults in maintaining and regaining good health and can foster healthy aging. The Reflective STRENGTH-Giving Dialogues (STRENGTH) intervention was created to optimise a holistic healthcare delivery that supports older adults in learning to live with long-term musculoskeletal pain. Findings from previous studies indicate that the dialogues contributed to an increased sense of well-being and had an immediate pain-alleviating effect. The aim of this extended study was to explore the health effects of the STRENGTH intervention among older community-dwelling adults living with long-term health problems. Older adults (n = 47) in Sweden completed questionnaires inquiring about levels of well-being, impact of health problems on daily life, depression symptom occurrences, health-related quality of life, physical performance, and consumption of care using a quasi-experimental design. Descriptive statistics were used to explain and compare results within groups. Data were collected before, during, and after the STRENGTH intervention in autumn 2017 and spring 2018. It consisted of health-care professionals engaging in recurrent dialogues to guide and support older adults in ways that increase sense of well-being, joy, strength, and meaning in life through carrying out small and large life projects. According to self-reports, the STRENGTH intervention had immediate positive effects on perceived well-being and health problems. From a longitudinal perspective, although no significant differences in health outcomes were found based on comparisons of baseline and follow-up data within groups, positive effects were shown. To contribute to healthy aging, HCPs need favourable conditions for conversations in care encounters, extensive knowledge about the importance and potential of dialogues, and an understanding of how to integrate dialogues into health and social care.
Generic measures of health-related quality of life (HRQoL), such as the EQ-5D, may inadequately capture the impact of cognitive impairment in schizophrenia, resulting in incorrect QALY estimates in economic evaluations. This study aimed to obtain health utilities by valuing key items of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument. First, expert interviews and psychometric analysis of the 28-item version of the PRECIS were performed to identify the best-performing and most relevant items. Second, health states based on the four selected PRECIS items representing memory, communication, executive function and attention (each with five levels of severity) were valued by the UK general public through a discrete choice experiment (DCE) survey and composite time trade-off (cTTO) interviews. To estimate a utility scoring algorithm, the DCE data were analyzed using mixed logit models and rescaled onto a 0-1 (dead to full health) utility scale using the cTTO results. The cTTO utility for the best health state (level 1, "not at all hard", across all domains) had a mean utility of 0.992 (SD 0.038) while the worst state (level 5, "very hard", across domains) had a mean utility of 0.292 (SD 0.479). All domains significantly predicted larger utility decrements with increasing impairment severity. This study demonstrated the feasibility of quantifying health utility values for patient-reported cognitive impairment domains using the validated PRECIS instrument. The resulting utilities can capture the HRQoL impact of cognitive impairment, supporting more accurate future economic evaluations of therapies targeting cognitive function in schizophrenia. New treatments are under development that aim to improve cognitive impairment in schizophrenia. Studies estimating the costs and benefits of these treatments, used for reimbursement decisions, often underestimate the benefits because generic questionnaires used to measure the quality of life of patients, don’t include questions on cognition. This study addresses how to more accurately capture and quantify the impact of cognitive impairment in schizophrenia on quality of life to make accurate reimbursement decisions. Based on an existing questionnaire that assesses the patient-reported cognitive impairment in schizophrenia (PRECIS) the most important aspects of cognitive impairment for patients were selected. The UK general public was asked to value the importance of the selected four items and their answer options, Results showed that the selected aspects, memory, communication, executive function, and attention all had an impact on quality of life with worse quality of life outcomes when the level of impairment was larger. This study contributed to a method for more accurate estimates of the benefits of new treatments aiming to improve cognitive impairment in schizophrenia.
The worldwide impact of multimorbidity and frailty is accelerating among older adults, particularly in India, where healthcare systems face resource constraints. Multimorbidity defined as the coexistence of two or more chronic health conditions, and frailty-a state of heightened vulnerability-jointly result in functional disability, decreased quality of life, and increased healthcare use. Despite this, primary healthcare frameworks in India lack integrated geriatric care models. The study addresses this gap by evaluating a culturally appropriate, multicomponent intervention to improve quality of life related to health status and wellbeing among older adults in urban Odisha. The Multimorbidity-Frailty among elderly (Multi-FrAME) study is a phase 3, two-arm, cluster-randomized, observer-blinded trial that will be conducted across 10 urban Primary Healthcare Centres (UPHCs) in Bhubaneswar, Odisha. Eligible participants will be enrolled and randomized at the cluster level. The intervention group will receive a structured, monthly multicomponent package delivered through UPHCs whereas the control group will be given standard care. The primary outcome will include change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) quality of life score at 6 and 12 months, and secondary outcomes will be a change in frailty, function, healthcare use, medication adherence and mortality. Data will be collected by trained, blinded assessors using validated tools and analyzed using mixed-effects regression models. Institutional ethical clearance was obtained for the study. The Multi-FrAME trial addresses a critical gap in geriatric care by evaluating a scalable, multicomponent intervention for frailty and multimorbidity within India's primary healthcare system. Leveraging existing infrastructure and non-specialist staff, it integrates medical, nutritional, physical, and psychosocial support. Findings will inform policy and offer a replicable model for integrated elder care in Low and Middle Income Countries (LMICs). Trial Registration was done in Clinical Trial Registry of India (linked to WHO registry of trials) with registration no CTRI/2024/09/073487 on 5th September,2024.
This study aimed to compare the mid-to long-term effects of pirarubicin chemotherapy and Bacillus Calmette-Guérin (BCG) immunotherapy on recurrence control, bladder function and health-related quality of life in patients with non muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumour (TURBT). This retrospective cohort study comprised 126 patients with NMIBC who underwent TURBT followed by intravesical therapy between January 2018 and December 2023. Patients received either pirarubicin (n = 68) or BCG (n = 58). Propensity score matching was performed to reduce baseline imbalance, yielding 48 matched patients in each group. Recurrence outcomes, recurrence-free survival (RFS), bladder function parameters, quality-of-life scores and adverse events were compared. After matching,the recurrence rate was lower in the BCG group than in the pirarubicin group (18.75% vs 37.50%, p = 0.041). Time to first recurrence was longer with BCG than with pirarubicin (28.47 ± 8.31 vs 20.96 ± 7.84 months, p = 0.016), and Kaplan-Meier analysis showed improved RFS (median RFS: 45 [34-56] vs 31 [22-40] months; log-rank p = 0.011). At 12 months,the BCG group had lower post-void residual urine volume, higher maximum urinary flow rate,higher European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) global health and functional scores and lower symptom and Quality of Life Questionnaire-Bladder Cancer Module 30 (QLQ-BLM30) urinary symptom scores than the pirarubicin group (all p < 0.05). Subgroup analysis showed that the benefit of BCG was evident in patients with high-grade tumours.No severe treatment-related adverse events occurred in either group. In patients with NMIBC after TURBT, intravesical BCG was associated with better recurrence control and more favourable mid-to long-term functional and quality-of-life outcomes than pirarubicin, particularly in high-grade disease.
To evaluate the physical component of the quality of life of patients with post-traumatic defects of the upper and middle part of the visceral skull. The study included 78 patients over the age of 18 with post-traumatic defects and deformities of the middle zone of the face. All patients underwent an analysis of the mechanism of injury and the nature of the damage. The physical component of quality of life was assessed using the SF-36 questionnaire in several key areas: physical functioning, limitations in daily life due to health problems, as well as pain intensity and overall perception of one's condition. The SF-36 physical component summary score assessment showed that all patients experienced moderate pain (48.1±7.9 points) and significant limitation of physical activity (47.3±6.1 points), which led to noticeable difficulties in daily life and overall health deterioration. Diplopia (r=0.83), pain in the injured area (r=0.85), and limited jaw mobility (r=0.80) (p <0.0001) also lead to significant limitations and poor health outcomes. The prospects of this study are the standardization and digitalization of the preoperative examination protocol for patients with injuries to the bones of the visceral part of the skull. The results are of great clinical importance for the development of comprehensive rehabilitation programs for patients with post-traumatic deformities of the middle zone of the facial part of the skull, which corresponds to modern approaches to personalized treatment strategies. Оценка физического компонента качества жизни (КЖ) пациентов с посттравматическими дефектами верхней и средней зон висцерального отдела черепа. В исследование были включены 78 пациентов старше 18 лет с посттравматическими дефектами и деформациями средней зоны лица. У всех пациентов проведен анализ механизма травмы и характер повреждений. Физический компонент КЖ у оценивали с помощью опросника SF-36 по нескольким ключевым направлениям: способность к физическим нагрузкам, ограничения в повседневной жизни, вызванные проблемами со здоровьем, а также интенсивность боли и общее восприятие своего состояния. Оценка качества физического компонента КЖ по шкале SF-36 показала, что все пациенты испытывали боль средней интенсивности (48,1±7,9 балла) и значительное ограничение физической активности (47,3±6,1 балла), что привело к заметным трудностям в повседневной жизни и общему ухудшению состояния здоровья. Кроме того, к существенным ограничениям и ухудшению качества здоровья приводят диплопия (r=0,83), боль в области нанесения удара (r=0,85) и ограничение подвижности челюсти (r=0,80; p<0,0001). Перспективы настоящего исследования заключаются в стандартизации и цифровизации протокола предоперационного обследования пациентов с травмами костей висцерального отдела черепа. Результаты имеют важное клиническое значение для разработки комплексных программ реабилитации пациентов с посттравматическими деформациями средней зоны лицевого отдела черепа, что соответствует современным подходам персонализированной стратегии лечения.
Improving health status, including symptoms and quality of life, is a key goal in the management of atrial fibrillation (AF). However, whether improvements in patient-reported health status are associated with subsequent clinical outcomes remains unclear. To evaluate the association between changes in health status and long-term adverse clinical outcomes in patients with AF. This cohort study used data from a prospective multicenter registry in Japan that enrolled patients aged 22 to 94 years with newly diagnosed AF or who were newly referred for AF management between September 20, 2012, and May 22, 2018. The registry collected follow-up data for up to 5 years. Eligible patients completed the Atrial Fibrillation Effect on Quality of Life patient-reported outcome measure (PROM) questionnaire at both baseline and 1-year follow-up. Clinical outcomes were assessed for 4 years following the 1-year AF PROM assessment. Data were analyzed between February 7 and July 14, 2025. One-year change in the AF PROM overall summary score. The primary outcome was a composite of all-cause death, heart failure hospitalization, and stroke or transient ischemic attack over 4 years. Multivariable hierarchical regression models adjusted for baseline score, clinical factors, and comorbidities were used to evaluate associations between 1-year change in AF PROM overall summary score and outcomes. Among 2744 patients (mean [SD] age, 67.8 [11.1] years; 1868 male [68.1%]; 1357 [49.6%] with paroxysmal AF), 1408 (51.3%) had improved health status (overall summary score increase of ≥5 points), 833 (30.4%) had stable health status, and 503 (18.3%) had worsened health status (overall summary score decrease of ≥5 points). During a mean (SD) follow-up of 3.1 (1.4) years after the 1-year assessment, the primary outcome occurred in 283 patients (10.3%). After adjustment for baseline characteristics (including baseline AF PROM score), improvement in the AF PROM overall summary score was associated with a lower risk of adverse outcomes (per 5-point increase: hazard ratio, 0.93 [95% CI, 0.89-0.96]; P < .001). This cohort study of patients with AF in Japan found that greater improvements in 1-year AF PROM scores were associated with a lower risk of subsequent adverse clinical events. These findings support the prognostic value of PROMs and highlight the importance of monitoring health status in AF management.
This study examined the association of health literacy with quality-of-life outcomes among Jordanian adults with chronic diseases using two patient-reported outcome measures, the Long-Term Conditions Questionnaire (LTCQ) and the EuroQol five-dimension, three-level questionnaire (EQ-5D-3L). It also compared conventional regression and machine-learning (ML) approaches for modelling these relationships. In this cross-sectional online study, Arabic-language questionnaires were completed by Jordanian adults aged 18 years or older with at least one chronic physical, mental, or neurological condition. The survey, designed to take 10-12 minutes, included the LTCQ, EQ-5D-3L, Medication Adherence Report Scale (MARS-5), and 12-item Health Literacy Scale (HLS-Q12). A total of 901 complete responses were analyzed. Data were split into training (n = 633) and test (n = 268) sets. Multiple linear regression was used for LTCQ, Tobit regression for EQ-5D-3L index scores, and ML models were trained to explore nonlinear associations. Health literacy and medication adherence were positively associated with both LTCQ (beta = 3.923 and 2.219, respectively; both p < 0.001) and EQ-5D-3L index scores (beta = 0.025, p = 0.001; beta = 0.020, p = 0.009). Number of medications was inversely associated with both outcomes. In 10-fold cross-validation, Extreme Gradient Boosting (XGBoost) showed the lowest average root mean square error (RMSE) for LTCQ (9.18; coefficient of determination [R²] = 0.384) and EQ-5D-3L (0.172; R² = 0.193), although differences between the leading models were modest. LTCQ and EQ-5D-3L showed overlapping but distinct association patterns. LTCQ was more strongly linked with psychosocial and self-management variables, whereas EQ-5D-3L was more closely aligned with medication burden and clinical comorbidity. These findings should be interpreted as associative rather than causal and as differences in captured dimensions rather than evidence of instrument superiority.
Given that cancer survivors often face psychological problems, this study explores the effect of acceptance and commitment therapy (ACT) to improve death anxiety (DA), experiential avoidance (EA), meaning in life (MIL), and quality of life (QoL). The study was conducted from June to November 2023, encompassing recruitment, an 8-week intervention (July-August 2023), and follow-up to 3 months post-intervention at a tertiary cancer hospital in China. A total of 50 cancer survivors were randomized (25 per group). The weekly intervention was delivered through in-person, one-on-one sessions over 8 weeks. Each session (approximately 35-45 min) was structured to cover distinct thematic modules of ACT. The primary outcome was DA and other secondary outcomes included EA, MIL, as well as QoL. Data were collected at T0 (pre-intervention), T1 (post-intervention), T2 (1 month post-intervention), and T3 (3 months post-intervention). The intervention effects were estimated using generalized estimating equation models. Participants had various cancer types, primarily head and neck (28%), lung (28%), and breast (24%). Cancer stages included I-II (54%), III (44%), and IV (2%). Participants in the ACT group revealed significantly greater reductions on DA than those in the wait-list control group at T1 (95% CI: -3.449 to -2.631), T2 (95% CI: -4.899 to -3.821), and T3 (95% CI: -5.311 to -3.969), as well as on EA and the symptom domain of quality of life at three time points. In addition, the intervention demonstrated significantly greater improvements on MIL, the functional domain and global health status of quality of life at T1, T2, and T3. In this study with a wait-list control group rather than an active comparator, the in-person ACT-based intervention reduced death anxiety, experiential avoidance, and symptom-related quality of life impairments while enhancing meaning in life, functional quality of life, and global health status in cancer survivors. These benefits were sustained for up to 3 months post-intervention, though generalizability may be limited by the sample's cancer types and stages. Chinese Clinical Trial Registry (ChiCTR2300074472). https://www.chictr.org.cn/.
Depressive symptoms are highly prevalent among individuals with an ostomy and their informal caregivers, negatively affecting quality of life and healthcare outcomes. Although the Patient Health Questionnaire-9 (PHQ-9) is widely used for depression screening, its psychometric properties have not previously been examined simultaneously in ostomy patients and their informal caregivers, limiting its applicability in this clinical context. To evaluate the validity, reliability and measurement invariance of the PHQ-9 in a European sample of ostomy patients and their informal caregivers. This secondary analysis used data from a multicenter observational study including 523 ostomy patients (63.9% males, mean age 68.65 years) and 252 informal caregivers (80.6% females, mean age 58.7 years) recruited from outpatient clinics across Italy. Structural validity was examined using confirmatory factor analysis, comparing unidimensional and bidimensional models. Measurement invariance across patients and caregivers was assessed using multigroup confirmatory factor analysis. Internal consistency was assessed using omega coefficients and construct validity was tested through correlations with ostomy-specific and generic quality of life measures. Confirmatory factor analysis supported a bidimensional structure of the PHQ-9, reflecting somatic and cognitive symptoms for both patients and caregivers, with excellent model fit. Internal consistency was adequate, with omega coefficients ranging from 0.71 to 0.88. Construct validity was supported by significant negative correlations between PHQ-9 scores and quality of life measures. Scalar measurement invariance was established, indicating the PHQ-9 functions equivalently in patients and caregivers. The PHQ-9 is a valid and reliable instrument for assessing depressive symptoms in patients with ostomy and their caregivers and can be confidently used for depression screening in both clinical and community care settings. Its use in routine nursing practice can support early identification and management of depression in both clinical and community care contexts. This is the first study validating the PHQ-9 in patients with ostomy and their caregivers. The PHQ-9 showed excellent validity and reliability and scalar measurement invariance was demonstrated across patients and caregivers. The PHQ-9 can support nurse-led depression screening in ostomy care settings. This study was reported in accordance with the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) reporting guideline for studies on measurement properties. No patient or public contribution.
While traditional disease-management regarding fecal incontinence (FI) primarily focuses on symptom-control and health-related quality of life (HrQoL) outcomes, patients often prioritize broader aspects of health, like well-being. This study evaluates the psychometric performance of ICEpop CAPability measure for Adults (ICECAP-A), a capability-based well-being instrument, alongside two established HrQoL-instruments, EQ-5D-5L and the FI quality of life (FIQL) questionnaire, in an outpatient-population with FI. Data were obtained from patients with FI recruited from a randomized-controlled trial evaluating the efficacy of anal plugs for FI ((The CONFIDEnCE trial, NCT04657588). Psychometric evaluation of ICECAP-A involved the assessment of the convergent validity, known-group validity (examined across predefined subgroups), acceptability, and floor and ceiling effects. Among 72 participants (mean age 67.3years; 83.3% female), the mean ICECAP-A capability score (0.86, scale 0-1) exceeded the mean EQ-5D-5L utility (0.71, scale - 0.446-1) and the FIQL score (2.34, scale 1-5). ICECAP-A showed good convergent validity (76.6% predefined hypotheses confirmed). Known-group validity was comparable across instruments; ICECAP-A demonstrating significant differences by EQ-VAS, anxiety, and education level, but not outperforming EQ-5D-5L or FIQL. EQ-5D-5L showed stronger effect sizes for anxiety (p < 0.001), depression and symptom severity (non-significant), while FIQL was stronger for education level (p = 0.002). Questionnaire completion was 84.7% overall, reflecting trial dropout only (100% among completers) with no substantial floor or ceiling effects. In patients with FI, ICECAP-A showed psychometric performance comparable to EQ-5D-5L and FIQL, despite its broader conceptual scope. Well-being appeared less influenced by symptom severity, possibly reflecting coping or adaptation. Further research is warranted evaluating ICECAP-A's psychometric advantage over traditional HrQoL-instruments in this clinical context. Not applicable.
Diabetic foot ulcers (DFUs) are a major cause of morbidity, amputation, and mortality among individuals with diabetes, with disproportionate impact on underserved populations. Comprehensive real-world data on DFU management and outcomes are lacking. To describe the design and methodology of the STEADY (Structured Evaluation and Analysis of Diabetic Foot Ulcers in the US) registry, a national prospective cohort study of patients with DFUs in the United States whose objective is to evaluate DFU treatment patterns, outcomes, and health care resource utilization in real-world settings, to assess comparative effectiveness, cost effectiveness, and safety of DFU therapies and therapy combinations, and to advance disease management through risk- and site-stratified treatment optimization models. STEADY is a 10-year prospective multicenter observational study with an aim of enrolling 5000 adults with active DFUs in the United States. Data sources include electronic case report forms, electronic medical records (EMRs), patient-reported outcomes via mobile app, and optional insurance claims. Primary and secondary end points will include time and incidence of partial and complete wound closure; wound and disease characteristics; rates of recurrence, infection, ischemic events, and amputation; health care utilization, including surgical procedures; health-related quality of life; work productivity; and additional patient reported outcomes. Descriptive, survival, and comparative effectiveness analyses will be performed. Data governance ensures full regulatory compliance and robust data security and integrity, supporting the potential use of the registry dataset as a synthetic control arm in future clinical research. STEADY leverages an artificial intelligence (AI)-enabled platform to integrate multisource data, including wound photography, social determinants of health, patient reported outcomes and caregiver information. The platform uses AI for transcription and interpretation of patient and provider dictation, supports patient-controlled EMR synchronization for comprehensive longitudinal tracking across providers, offers participant incentives to enhance engagement, and ensures rigorous, automated data quality assurance at all stages.
Hearing-related quality of life is a crucial outcome for adults with cochlear implants. The Cochlear Implant Quality of Life (CIQOL)-35 Profile is a patient-reported outcome measure originally developed in English. In a previous study, this instrument was cross-culturally adapted into German to address the need for standardized assessment tools in German-speaking regions. To ensure the adapted instrument meets psychometric criteria, validation is required. The German adaptation of the CIQOL-35 Profile was validated through an online survey including questions on demographics, the German CIQOL-35 Profile, and the German Nijmegen Cochlear Implant Questionnaire (NCIQ). The collected data were analyzed for reliability and validity. A total of 204 adults (aged 19-87 years) with bilateral hearing loss completed the online survey. Cronbach's α between 0.84 and 0.91 demonstrates good internal consistency for all subscales of the CIQOL-35 Profile and the global outcome. Moderate to strong correlations (rs = 0.55-0.85) between the CIQOL and NCIQ indicate good convergent validity. Confirmatory factor analysis established construct validity for the German CIQOL instruments. These findings confirm that the adapted German version of the CIQOL instruments is a reliable and valid measure for assessing hearing-related quality of life in adults with cochlear implants and demonstrates higher validity than the NCIQ. The availability of the CIQOL in multiple languages facilitates international comparability of research results and increases clinical application. Implementing quality of life instruments in clinical practice enables a more comprehensive evaluation of patient outcomes and may help identify patient needs that may be addressed in therapy and rehabilitation.
Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone. A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol<420 nmol/L (biochemical adrenal insufficiency) are randomised 1:1 to supplemental hydrocortisone or placebo during mild to moderate stress ('sick-days') for 6 months or until daily prednisolone is stopped. The goal is 200 patients completing ≥3 months intervention period. Patients continue prednisolone tapering according to PMR/GCA guidelines. In the event of severe stress (risk of adrenal crisis), patients receive open-label hydrocortisone treatment. 95 patients with stimulated cortisol ≥420 nmol/L serve as control group. The primary outcome is HRQoL measured as fatigue using ecological momentary assessments (EMA) of the General Fatigue scale from the Multidimensional Fatigue Inventory-20, five times daily in situations of stress ('sick-days'). EMA will be administered via a smartphone application 'EMA live'. Differences in mean fatigue scores during sick-days between hydrocortisone and placebo will be analysed using mixed models for repeated measures. Secondary outcomes include daily smartphone-based symptom reporting, additional HRQoL questionnaires, adrenal crises, adverse effects from glucocorticoid excess, serial ACTH tests and biomarkers of adrenal insufficiency. The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient's last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations. EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.
This study aimed to systematically evaluate the efficacy and safety of different doses of domperidone (DOM) combined with esomeprazole (ESM) in the treatment of reflux esophagitis, providing a basis for precise clinical medication. This prospective single-center study enrolled a total of 376 eligible patients with reflux esophagitis (intention-to-treat [ITT] population) between January 2022 and December 2024, among whom 361 completed the full treatment course (per-protocol [PP] population). A total of 361 patients were randomly divided into four groups: control group (oral ESM, n = 90), low-dose group (oral ESM + 5 mg DOM, n = 92), medium-dose group (oral ESM + 10 mg DOM, n = 91), and high-dose group (oral ESM + 15 mg DOM, n = 88), all for an 8-week duration. The primary outcome was the endoscopic remission rate at 8 weeks, defined as the achievement of Los Angeles classification grade 0 or A (ITT and PP population). Secondary outcomes (PP population) included changes in symptom scores (Gastroesophageal Reflux Disease Questionnaire, Reflux Symptom Index, Reflux Disease Questionnaire), quality of life (GERD-Health Related Quality of Life scale, EuroQol Five-Dimension Five-Level Scale), high-resolution esophageal manometry parameters, 24-hour impedance-pH monitoring indices, serum inflammatory cytokine levels, and the incidence of adverse events. The medium-dose DOM combination group demonstrated the most favorable efficacy across all key endpoints. Its endoscopic remission rate was significantly higher than that of the other three groups (P < 0.05). The results of the ITT analysis were highly consistent with the PP analysis. In the ITT population, the medium-dose group demonstrated a significantly superior endoscopic remission rate (94.68%) compared to the other three groups (P < 0.05). This finding was corroborated by the PP analysis, which also showed the optimal efficacy in the medium-dose group (97.80%). Concurrently, this group exhibited the most pronounced improvements in symptom scores and quality of life, the greatest recovery in esophageal motility parameters, the most significant reduction in all types of reflux episodes, and the greatest decrease in inflammatory cytokine levels (all P < 0.05). The high-dose group ranked second in efficacy, while the low-dose group showed superiority over the control group only in partial indicators. Although there was no significant difference in the incidence of adverse events as reported in the study, the overall event incidence and the increasing trend among different groups suggest the possible existence of a dose-response relationship, especially in the high-dose group. Based on standard esomeprazole therapy, the addition of medium-dose DOM (10 mg three times daily) synergistically improves reflux control, mucosal healing, motility recovery, and inflammatory status. This dose achieves an optimal balance between efficacy and safety, providing high-level evidence for implementing individualized and precise medication strategies in clinical practice. Although overall adverse event rates did not differ significantly among groups, a dose-dependent trend was observed. Higher doses offer no additional benefit and may increase safety concerns.
Care and case management (CCM) is considered a promising approach to bridging gaps in cross-sectoral coordination for high-need patients, aiming to improve access, continuity, and overall care experiences. Despite promising pilot initiatives, comprehensive models that investigate both the "how" (implementation and sustainable scaling) and the "what" (patient outcomes) are lacking. To address this gap, the "LEX LOTSEN OWL" (LLO) project (registered under DRKS00034188) employs a hybrid study design, combining implementation research with a classic randomized controlled trial (RCT) across seven districts in the German East Westphalia-Lippe (Ostwestfalen-Lippe, OWL) region. By examining governance structures and organizational frameworks, LLO seeks to provide insights into the broader applicability and feasibility of CCM programs. This study encompasses two interlinked components: (1) Implementation research via a process evaluation framework accompanying the establishment of "CCM offices" (Lotsenbüros) in seven districts, introduced in a staggered manner. Qualitative and quantitative methods (including interviews, document analysis, and process metrics) will be applied to identify facilitating factors and barriers, guided by a governance framework and rapid ethnographic assessments. (2) Outcome research via RCT at the patient level. Adults with complex care needs will be randomized into a care and case management group or a control group receiving usual care. The primary endpoints are relational coordination (system level), which is assessed via the Gittell Relational Coordination Questionnaire, and experienced quality of care (Patient Experience of Integrated Care Scale, PEICS). The secondary endpoints include (re)hospitalization, mortality, health-related quality of life, patient self-management, and caregiver self-efficacy, allowing a comprehensive assessment of clinical and patient-centered outcomes. This dual design aims to generate evidence of both structural and process-related factors influencing implementation while evaluating the potential clinical effectiveness of CCM. The results may inform how an indication-independent CCM can be seamlessly integrated into diverse healthcare settings. By providing insights into governance, organizational strategies, and patient-specific benefits, LLO may inform future policy and practice, foster improved coordination, enhance continuity, and increase patient engagement in routine health systems. Additionally, the project explores scalability factors critical for decision-makers. Collectively, this initiative has the potential to contribute to the development of sustainable, patient-centered care models. This study is prospectively registered in the German Clinical Trials Register (DRKS, DRKS00034188 ) on 17 May 2024.