Health And Quality Of Life Outcomes[JOURNAL]
Sun
200 papers
Minimal clinically important difference of EQ-5D-5L, SF-6Dv2, and QLU-C10D in hematologic malignancy patients in China.
Li F, Li J, Zhang A … +4 more , Wu J, Luo N, Liu P, Wang P
Health Qual Life Outcomes · 2025 Oct · PMID 41102712 · Full text
BACKGROUND: To assess the minimum clinically important difference (MCID) of the EuroQol five-dimensional five-level (EQ-5D-5L), Short Form Six-Dimensional version 2 (SF-6Dv2), and Quality of Life Utility-Core 10 Dimensio...
BACKGROUND: To assess the minimum clinically important difference (MCID) of the EuroQol five-dimensional five-level (EQ-5D-5L), Short Form Six-Dimensional version 2 (SF-6Dv2), and Quality of Life Utility-Core 10 Dimensions (QLU-C10D) in Chinese patients with hematologic malignancies. METHODS: Longitudinal data were collected from lymphoma and multiple myeloma patients treated at a tertiary hospital in Shanghai, China. Baseline surveys were conducted in 2022, with follow-ups in 2023 at 3- to 6-month intervals. A total of 200 lymphoma and 139 multiple myeloma patients were enrolled, with 78 and 89 patients completing follow-up. HRQoL was assessed by EQ-5D-5L, SF-6Dv2, and EORTC QLQ-C30 (including QLU-C10D) questionnaires. We estimated MCID values using three methods: (1) anchor-based, using changes in EORTC QLQ-C30 total score and clinical indicators (PET-CT or M protein levels) as benchmarks; (2) distribution-based, calculating MCID using half of the baseline standard deviation (SD) and the standard error of measurement (SEM); and (3) instrument-defined, based on average score changes associated with single-level transitions in health states. RESULTS: Averaging the MCID values from the three calculation methods, the mean values for EQ-5D-5L, SF-6Dv2, and QLU-C10D were 0.070, 0.078, 0.044 for lymphoma patients, and 0.075, 0.087, 0.044 for multiple myeloma patients. The average MCID values from two anchors were 0.064, 0.077, 0.046 (lymphoma patients) and 0.074, 0.091, 0.056 (multiple myeloma patients). The mean distribution-based MCID values, derived from half the SD and the SEM were higher, with the values of 0.086 (EQ-5D-5L), 0.080 (SF-6Dv2), 0.052 (QLU-C10D) for lymphoma patients and 0.097, 0.091, 0.056 for multiple myeloma patients. The lowest mean MCID values, determined using instrument-defined estimates, were 0.061 (EQ-5D-5L) and 0.033 (QLU-C10D) for lymphoma patients, and 0.054 (EQ-5D-5L) and 0.021 (QLU-C10D) for multiple myeloma patients. CONCLUSION: This study provided the MCID estimates for EQ-5D-5L, SF-6Dv2, and QLU-C10D in Chinese patients with lymphoma and multiple myeloma.
Association between ultra-processed food intake, night eating behavior, and sleep quality: a cross-sectional study from Türkiye.
Ekici EM, Çelik ÖM, Göbel P … +1 more , Güzelalp AH
Health Qual Life Outcomes · 2025 Oct · PMID 41102697 · Full text
BACKGROUND: Ultra-processed food (UPF) consumption and night eating behavior are increasingly common in modern dietary patterns and may negatively affect sleep quality. While each factor has been independently associated...
BACKGROUND: Ultra-processed food (UPF) consumption and night eating behavior are increasingly common in modern dietary patterns and may negatively affect sleep quality. While each factor has been independently associated with adverse health outcomes, their combined influence on sleep-related well-being is less understood. METHODS: This cross-sectional study included 1111 adults aged 18–65 years from Türkiye. Data were collected using a structured online questionnaire, including the Screening Questionnaire for Highly Processed Food Consumption (sQ-HPF), Night Eating Questionnaire (NEQ), and Pittsburgh Sleep Quality Index (PSQI). Pearson correlation, multiple linear regression, and binary logistic regression analyses were conducted to explore the associations between UPF intake, night eating behavior, and sleep quality. RESULTS: UPF intake was positively correlated with both night eating (r = 0.288, P < 0.001) and PSQI scores (r = 0.216, P < 0.001). Night eating was also positively associated with poorer sleep quality (r = 0.285, p < 0.001). Regression analyses showed that age, marital status, number of meals and snacks, NEQ scores, and PSQI scores were independently associated with UPF intake. NEQ and UPF scores were also independently associated with poor sleep quality. CONCLUSION: UPF consumption and night eating behavior appear to be important behavioral factors associated with reduced sleep quality. Interventions targeting these dietary behaviors may contribute not only to improved sleep health but also to enhanced overall quality of life in adults.
Validation of the health-related quality of life instrument with 8 items for assessing health-related quality of life in patients with oropharyngeal cancer: a comparison with the EQ-5D-5L.
Hong GU, Koo BS, Kim MJ … +6 more , Sim WJ, Lee AY, An JE, Yu SY, Lee SY, Lee SH
Health Qual Life Outcomes · 2025 Oct · PMID 41102677 · Full text
BACKGROUND: To overcome the limitations of existing health-related quality of life (HRQoL) instruments, the HRQoL Instrument with 8 Items (HINT-8) was developed for the Korean population. We aimed to evaluate the validit...
BACKGROUND: To overcome the limitations of existing health-related quality of life (HRQoL) instruments, the HRQoL Instrument with 8 Items (HINT-8) was developed for the Korean population. We aimed to evaluate the validity, interrater reliability, and agreement of the HINT-8 compared to the EQ-5D-5 L among patients with oropharyngeal cancer (OPC). METHODS: A total of 327 patients with OPC aged ≥ 19 years who received treatment at 14 hospitals in South Korea were recruited between August 2023 and February 2024. HRQoL was assessed using the two instruments. The psychometric evaluation included analyses of validity (convergent and known-group validity), agreement (intraclass correlation coefficient and Bland-Altman analysis), and reliability (internal consistency measured by Cronbach's alpha). The ceiling effects and score distributions were also examined. RESULTS: In total, 299 respondents were included in the final analysis. Both instruments demonstrated high internal consistency (HINT-8: α = 0.872; EQ-5D-5 L: α = 0.845) and good agreement (intraclass correlation coefficient [ICC] = 0.80; 95% confidence interval [CI]: 0.76-0.84). The convergent validity was supported by strong correlations between the HINT-8 index and both the EQ-5D-5 L index (r = 0.805) and EQ VAS (r = 0.715). The ceiling effect of HINT-8 (12.7%) was substantially lower than the EQ-5D-5 L (32.8%). CONCLUSIONS: The HINT-8 is a valid, reliable, and responsive instrument for measuring HRQoL in patients with oropharyngeal cancer. These findings suggest that HINT-8 can serve as a valuable complementary instrument to the EQ-5D-5 L.
Impact of liver cirrhosis on health-related quality of life in Indian patients: interplay of disease severity, alcohol dependence, and malnutrition.
Singh AK, Kumar S, Rajotiya S … +7 more , Mishra S, Nakash P, Pal P, Debnath S, Singh M, Nathiya D, Tomar BS
Health Qual Life Outcomes · 2025 Oct · PMID 41088166 · Full text
BACKGROUND: Liver cirrhosis (LC) significantly impairs health-related quality of life (HR-QoL) due to physical, psychological, and nutritional challenges. Despite its growing burden in India, limited evidence exists on h...
BACKGROUND: Liver cirrhosis (LC) significantly impairs health-related quality of life (HR-QoL) due to physical, psychological, and nutritional challenges. Despite its growing burden in India, limited evidence exists on how disease severity, alcohol dependence, and malnutrition influence HR-QoL in Indian LC patients. METHODS: This cross-sectional study included 565 LC patients attending a tertiary care hospital over 30 months. HR-QoL was assessed using SF-36. Disease severity was graded using the Child-Turcotte-Pugh (CTP) score, while nutritional status and alcohol dependence were evaluated using the RFH-NPT and AUDIT tools. Associations were analysed using Pearson's correlation, ANOVA, and logistic regression. RESULTS: The mean age of participants was 42.5 ± 14.9 years; 81.9% were male, and 58.6% resided in rural areas. Malnutrition was present in 80.9% of patients, and 50.6% were alcohol-dependent. Patients with severe liver cirrhosis (CTP Class C) had significantly lower HR-QoL scores across all domains (p < 0.001). Malnutrition was associated with higher odds of severe liver cirrhosis (OR 1.53; 95% CI: 1.27-1.85), and lower physical function scores were also significantly associated with disease severity (OR 0.89; 95% CI: 0.89-0.95). Severe cirrhosis was additionally marked by elevated serum bilirubin and INR levels, and reduced albumin concentrations. CONCLUSION: HR-QoL declines substantially with worsening cirrhosis, especially in malnourished and alcohol-dependent patients. These findings highlight the need for multidisciplinary interventions focusing on nutrition, lifestyle modification, and psychological support to improve outcomes in LC patients.
Psychometric evaluations of the simplified Chinese version of the Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitors 18 (FACT-EGFRI-18-sC) for measuring dermatologic toxicities in metastatic colorectal cancer patients treated with EGFRIs.
Zhang L, Ni N, Wu L … +15 more , Zhou L, Ning S, Liu C, Wang T, Benjamin Tan JY, Sun D, Zhang H, Shi X, Ma Y, Zhao Z, Jiang N, Wang M, Tian X, Xu H, Liu L
Health Qual Life Outcomes · 2025 Oct · PMID 41074107 · Full text
BACKGROUND: Dermatologic toxicities are common among metastatic colorectal cancer (mCRC) patients receiving epidermal growth factor receptor inhibitors (EGFRIs), adversely affecting their well-being and quality of life (...
BACKGROUND: Dermatologic toxicities are common among metastatic colorectal cancer (mCRC) patients receiving epidermal growth factor receptor inhibitors (EGFRIs), adversely affecting their well-being and quality of life (QoL). Currently, no validated tool exists in China to measure these symptoms. This study validated the Simplified Chinese version of the Functional Assessment of Cancer Therapy-EGFRI 18 (FACT-EGFRI-18-sC) for QoL assessment in mCRC patients. METHODS: A cross-sectional study was performed via convenience sampling to recruit mCRC patients from two tertiary hospitals in Shenyang, China. Sample size adequacy was confirmed by post hoc power analysis (G*Power 3.1; >80% power for r ≥ 0.3, α = 0.05). Acceptability was assessed by item-level missing data. Reliability was evaluated by Cronbach's α and a 2-week test-retest intraclass correlation coefficient (ICC). Criterion validity was evaluated against the Simplified Chinese version of the patient-reported version of CTCAE (PRO-CTCAE-sC) through non-parametric analyses. Construct validity was assessed via correlations with the Simplified Chinese Body Image Scale (BIS-sC), Karnofsky Performance Status (KPS), and cetuximab cycles using Spearman tests. Diagnostic accuracy and cutoff value were determined via receiver operating characteristic (ROC) analysis. RESULTS: The final sample (n = 184) provided sufficient statistical power, with post hoc analysis revealing 98% power (α = 0.05) to detect correlations exceeding 0.3. The FACT-EGFRI-18-sC showed excellent acceptability (no missing data) and satisfactory reliability (Cronbach's α = 0.899, ICC = 0.875). Moderate to strong negative correlations with PRO-CTCAE-sC (r = -0.436 to -0.803, p < 0.001) and significant FACT-EGFRI-18-sC score differences by dermatologic toxicity status (Z = -4.823 to -7.457, p < 0.001) supported criterion validity. Scores of the FACT-EGFRI-18-sC correlated negatively with BIS-sC (r = -0.565 to -0.619, p < 0.001), positively with KPS physical/functional subscales (r = 0.424/0.541, p < 0.001), but not with the social/emotional subscale (r = 0.125, p > 0.05), confirming construct validity. ROC analysis yielded an area under the curve (AUC) of 0.844 and identified an optimal cutoff of 60.00. CONCLUSIONS: The validated FACT-EGFRI-18-sC is a robust tool for QoL assessment in mCRC patients experiencing EGFRI-related dermatologic toxicities, providing a standardized measure to guide toxicity management.
Quality of life in people with herpes zoster: a cross-sectional study in China.
Shen Y, Xia Y, Zhu W … +7 more , Ai J, Cui C, Yuan Y, Wang L, Yin W, Shi Z, He P
Health Qual Life Outcomes · 2025 Oct · PMID 41074056 · Full text
INTRODUCTION: Herpes zoster (HZ), affecting 14.9 million people aged ≥ 50 globally in 2020, imposes a growing burden in aging populations due to its association with chronic pain, psychological distress, and socioeconomi...
INTRODUCTION: Herpes zoster (HZ), affecting 14.9 million people aged ≥ 50 globally in 2020, imposes a growing burden in aging populations due to its association with chronic pain, psychological distress, and socioeconomic disparities. This study aimed to evaluate health-related quality of life (HRQoL) among people with HZ and explore its socioeconomic and clinical determinants in China. METHODS: We conducted a cross-sectional survey to investigate the HRQoL of 2,566 herpes zoster patients across seven Chinese cities using the EQ-5D-5 L and VAS-100 instruments. Multivariate linear regression models quantified the association of age, income, insurance type, herpes zoster related pain, complications, and comorbidities with HRQoL. RESULTS: The average EQ-5D score was 0.83, and the average VAS score was 71.49 among herpes zoster patients in China. Patients aged ≥ 70 years exhibited the most severe decline in both EQ-5D (β = -0.110, p < 0.01) and VAS-100 scores (β = -8.811, p < 0.01), with mobility limitations (OR = 3.696, p < 0.01) and self-care deficits (OR = 2.295, p < 0.01) disproportionately affecting this group. Herpes zoster related pain was associated with lower HRQoL (EQ-5D:β = -0.126, p < 0.01). Patients with comorbidities faced significant HRQoL reductions (VAS: β = -4.014, p < 0.01). CONCLUSION: Our study found that Chinese herpes zoster patients exhibited higher HRQoL scores compared to those reported in most of other studies. Advanced age, lower education levels, inadequate insurance coverage, and pain occurrence were all significantly associated with diminished HRQoL. The observed disparities in HRQoL reductions among patient subgroups highlight the need to address health equity through curative interventions and preventive strategies.
Patient-reported outcomes and measures for vaginal relaxation syndrome management: a systematic review.
Chen H, Meng J, Li Q … +5 more , Luo X, Wang Y, Chen Y, Niu X, Wei D
Health Qual Life Outcomes · 2025 Oct · PMID 41063182 · Full text
BACKGROUND: The heterogeneity of patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in published clinical studies on vaginal relaxation syndrome (VRS) hinders cross-study comparisons and integ...
BACKGROUND: The heterogeneity of patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in published clinical studies on vaginal relaxation syndrome (VRS) hinders cross-study comparisons and integration of evidence-based findings, impeding the development of robust clinical evidence. OBJECTIVE: To comprehensively investigate the current use of PROs and PROMs in VRS research, compile a comprehensive catalog, and provide guidance for selecting outcome measures and tools VRS patients. METHODS: This study systematically searched clinical studies on VRS treatment published up to December 2024 in PUBMED, EMBASE, Web of Science, and Cochrane databases, focusing primarily on pelvic floor muscle training, physical energy therapies, and surgical interventions. PROs and PROMs were extracted, organized into a structured catalog, and categorized by thematic domains. The COSMIN checklist was applied to assess the measurement properties of commonly used PROMs. RESULTS: A total of 69 studies were included, comprising 14 randomized controlled trials (1193 patients) and 55 observational studies (3327 patients), totaling 4520 participants. These studies reported 68 PROs and 57 PROMs. The most commonly used PROMs were the Female Sexual Function Index (FSFI, 47.83%), Vaginal Laxity Questionnaire (VLQ), Visual Analog Scale (VAS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Sexual Satisfaction Questionnaire (SSQ). Notably, 42 PROMs (73.68%) appeared only once. CONCLUSIONS: PROs for surgical and non-surgical VRS treatments are similar, but non-surgical interventions include additional outcomes, such as overall efficacy and patient's vaginal tightness satisfaction. The high proportion of unvalidated PROMs (81.09%) underscores the need for standardized, disease-specific measures. Future Delphi surveys and expert consensus are anticipated to facilitate the development of a comprehensive core outcome set (COS) and core outcome measurement set (COMS) for VRS.
Health-related quality of life in COVID-19 patients: a systematic review and meta-analysis of EQ-5D studies.
Gidey K, Niriayo YL, Asgedom SW … +1 more , Lubetkin E
Health Qual Life Outcomes · 2025 Oct · PMID 41057923 · Full text
BACKGROUND: COVID-19 has affected millions globally, with a significant proportion experiencing long-COVID and impaired health-related quality of life (HRQoL). This systematic review and meta-analysis aimed to synthesize...
BACKGROUND: COVID-19 has affected millions globally, with a significant proportion experiencing long-COVID and impaired health-related quality of life (HRQoL). This systematic review and meta-analysis aimed to synthesize the existing literature on HRQoL in COVID-19 patients. METHODS: We conducted a systematic search of PubMed, Embase, Web of Science, Scopus, and the Cochrane Library for studies published between December 2019 and March 2025. Eligible studies were peer-reviewed and assessed HRQoL in COVID-19 patients using the EQ-5D instrument. Study quality and risk of bias were evaluated using the Newcastle-Ottawa Scale. Pooled health utility values were estimated using a random-effects model, and heterogeneity was assessed via I statistics. Predictors of poor HRQoL were qualitatively narrated. RESULTS: Out of 3539 references, 187 studies with 116,525 participants were analyzed. The majority (80.2%) used the EQ-5D-5 L version. The pooled mean EQ-5D utility score was 0.76 (95% CI 0.74-0.79, I = 99.9%) while the mean EQ-5D Visual Analogue Scale (VAS) score was 70.76 (95% CI 68.48-73.04; I = 99.7%). Pain/discomfort and anxiety/depression were the most affected domains, reported by 51% and 46% of patients, respectively. Subgroup analysis showed significant differences in HRQoL based on national income status (p = 0.038) and geographic region (p < 0.001). Common predictors of lower HRQoL included older age, female gender, disease severity, comorbidities, and post-COVID-19 symptoms. CONCLUSION: This systematic review demonstrates a substantial reduction in HRQoL among COVID-19 patients compared to the general population. The pooled utility values of COVID-19 contribute to understanding patients' HRQoL and can assist in calculating Quality-Adjusted Life Years. This provides essential data for future economic evaluations and informs health policy decisions.
Psychometric evaluation of the PROMIS physical function short form 12a for use by adults with myalgic encephalomyelitis/chronic fatigue syndrome.
Yang M, Keller S, Rafiee P … +1 more , Lin JS
Health Qual Life Outcomes · 2025 Oct · PMID 41053836 · Full text
BACKGROUND: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating, long-term illness that significantly impairs physical functioning. Despite its impact, the use of modern generic instruments to a...
BACKGROUND: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating, long-term illness that significantly impairs physical functioning. Despite its impact, the use of modern generic instruments to assess physical function in this population remains underexplored. This study aims to assess the psychometric properties of the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Short Form (PF-SF) 12a for use in adults with ME/CFS. METHODS: This study included 334 participants (173 with ME/CFS and 161 healthy controls) who took part in a Cognitive and Exercise sub-study of the Multi-Site Clinical Assessment of ME/CFS study from six clinics across the US. Data was used to examine the ceiling/floor effects, internal consistency reliability, known-groups validity, and convergent validity of the PROMIS PF-SF. RESULTS: The mean T-score of the PROMIS PF-SF was 40.5 for participants with ME/CFS, about one standard deviation below the national norm (T-score = 50). The PROMIS PF-SF showed no substantial floor/ceiling effects and high internal consistency (standardized Cronbach's α = 0.88 and ω = 0.92). In addition, this instrument showed good known-groups validity with medium-to-large effect sizes (η = 0.08-0.35). A significant, monotonic increase of the physical function score was found across ME/CFS participant groups with low, medium, and high functional impairment as defined by four different measures. Participants with ME/CFS had significantly worse physical function scores than healthy controls (η = 0.70). The PROMIS PF-SF also demonstrated good convergent validity with high correlations (magnitude of r = 0.47-0.55) with other relevant measures. CONCLUSIONS: The PROMIS PF-SF 12a demonstrated satisfactory reliability and validity for use in ME/CFS research and clinical practice.
Quality of life among individuals with profound intellectual and multiple disabilities: crossed perspectives of institutional caregivers and parents.
Baumstarck K, Hamouda I, Iline N … +7 more , El Ouazzani H, Fouladvand M, Loukkal S, Beltran Anzola A, Del Duca S, Rousseau MC, EVAL-PLH Group
Health Qual Life Outcomes · 2025 Oct · PMID 41053826 · Full text
BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) experience severe limitations in autonomy and communication due to early brain injury. Assessing their quality of life (QoL) is challenging b...
BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) experience severe limitations in autonomy and communication due to early brain injury. Assessing their quality of life (QoL) is challenging but essential for optimizing care and outcomes. Proxy assessments, typically by parents or institutional caregivers, are commonly used, but the degree of agreement between these perspectives remains unclear. This study aimed to compare QoL assessments from both institutional caregivers and parents, and to identify associated factors. METHODS: Data were drawn from the French EVAL-PLH cohort, including individuals with PIMD/polyhandicap cared for in medical and rehabilitation services (MRS) or residential facilities (RF). QoL was measured using the PolyQoL questionnaire, completed by either institutional caregivers or parents. The study analyzed three population sets: those assessed by caregivers, by parents, or by both. Descriptive statistics, univariate analyses, and linear regressions (adjusted for age, care structure, and severity) were performed to identify factors linked to QoL scores. RESULTS: QoL data were available for 335 individuals (caregivers), 144 (parents), and 76 (both). Both respondent sets rated health QoL higher than social QoL. Institutional caregivers generally provided lower global (58 ± 16 vs. 63 ± 15) and social (46 ± 21 vs. 55 ± 19) QoL scores compared to parents. Lower caregiver-rated QoL was associated with older age of the person with PIMD, greater severity, and care in MRS, while parent ratings were less influenced by these factors. These findings were consistent in the set with both assessments. DISCUSSION: The study highlights discrepancies between caregiver and parent perspectives, with caregivers focusing more on clinical severity and parents on social aspects. Both viewpoints are complementary and necessary for comprehensive QoL assessment. Further qualitative research is recommended to deepen understanding of these differences and improve care strategies. TRIAL REGISTRATION: Clinical trial number: NCT02400528 (registered 27/03/2015).
Health-related quality of life in patients with paediatric inflammatory bowel disease: IMPACT-III validation in Germany.
Boerkoel A, Buchholz M, Tischler L … +5 more , Weber N, Hoffmann W, de Laffolie J, Berg NVD, CEDATA Study Group
Health Qual Life Outcomes · 2025 Oct · PMID 41039592 · Full text
BACKGROUND: Health related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) is typically measured using the patient reported outcome measure IMPACT-III. This measure has not yet been v...
BACKGROUND: Health related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) is typically measured using the patient reported outcome measure IMPACT-III. This measure has not yet been validated for German patients using the new 4-domain structure. As Germany has a comparatively high prevalence of paediatric IBD and as the IMPACT-III is the main HRQoL outcome measure in use, a validation in the German population is overdue. OBJECTIVE: To validate the main patient reported outcome measure of health-related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) IMPACT-III in a German patient sample. METHODS: Clinical and HRQoL data was gathered in the CEDATA-GPGE registry. To determine the psychometric performance of the IMPACT-III in a German sample, distribution properties, reliability (Cronbach's alpha) and validity (correlations with clinical values; known-groups validity by age, sex, and self-rated health) were calculated. In addition, a confirmatory factor analysis was performed to determine the appropriateness of the factor structure. RESULTS: The IMPACT-III was filled out by 221 patients (Female 46%; M=14.05; Morbus Crohn n = 126; Ulcerative Colitis n = 79; unclassified IBD n = 18). The total score ranged from 19.29 to 95.00, without the occurrence of ceiling or floor effects. Internal consistency using Cronbach's alpha was excellent (α = 0.91) for the total scale. The total score correlated strongly with the subscales of wellbeing (r = 0.90) and social functioning (r = 0.80). Concerning validity, the subscale of wellbeing correlated with self-reported health and clinical assessments. Younger patients (< 14) reported a significantly better HRQoL than older patients (14-17). The 4-domain structure of IMPACT-III could not be confirmed through factor analysis. CONCLUSIONS: The German version of the IMPACT-III is a valid and reliable instrument to measure HRQoL in paediatric patients with IBD. The subscales of well-being and social functioning explain most of the total score. To interpret the subdomains of the IMPACT-III further research in a longitudinal design needs to be done, especially with age-related phrasing of the items. TRIAL REGISTRATION: German Clinical Trials Register DRKS00015505. Registered on 22.01.2019 Inclusion of patients 01.03.2019; https://drks.de/search/en/trial/DRKS00015505 .
Understanding health-related quality of life of informal carers in amyotrophic lateral sclerosis: a scoping review and conceptual framework.
Bamber R, Carlton J, McDermott C … +1 more , Stavroulakis T
Health Qual Life Outcomes · 2025 Sep · PMID 41024175 · Full text
BACKGROUND: Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, life-limiting neurodegenerative disease. Informal carers provide extensive support, significantly impacting their health-related quality of life (...
BACKGROUND: Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, life-limiting neurodegenerative disease. Informal carers provide extensive support, significantly impacting their health-related quality of life (HRQoL). Current HRQoL measurement using person-reported outcome measures (PROMs) in ALS carers lacks consistency and comprehensiveness, hindering robust assessment and synthesis. There is evident need for a comprehensive conceptual framework of HRQoL, to fully capture the multidimensional nature of caregiving in ALS. Such a framework is essential to inform research and clinical practice, ensuring relevant measurement and meaningful clinical discussions. This study aimed to develop this evidence-based framework. METHODS: This study comprised two stages. Firstly, a scoping review was undertaken in March 2024 using Medline, Embase, and CINAHL to identify primary articles exploring HRQoL in ALS carers. Qualitative, mixed methods and quantitative articles using multi-item PROMs to assess HRQoL in informal ALS carers were included. Relevant themes and subthemes were extracted from articles and PROMs and mapped onto an existing conceptual framework for people with ALS (Quality of Life in ALS, QuALS), which covers physical, psychological, and social HRQoL domains in people with ALS. The Carer-QuALS framework was subsequently developed and refined using existing literature and consultation with ALS carers. PROMs within this review were then indexed against the finalised Carer-QuALS framework. RESULTS: From 715 search results, 82 articles and 44 PROMs were eligible for inclusion. One new subtheme 'physical caring activities' emerged, while seven subthemes lacked support from the literature. In three structured consultation sessions, nine ALS carers, reviewed the draft Carer-QuALS framework (consisting of seven themes and 43 subthemes). Based on their input, one new subtheme 'privacy' was added, six subthemes were removed, and one was retained, despite lacking support from review literature. The final Carer-QuALS framework includes 37 subthemes: 8 physical, 6 social, and 23 psychological. CONCLUSIONS: This review presents a comprehensive conceptual framework encompassing the multidimensional impact of ALS caregiving on the HRQoL of informal carers. The framework provides a resource that can be used by researchers, clinicians, and patient advocacy groups for multiple purposes (e.g., to support PROM selection to measure HRQoL, to guide future PROM development, and to facilitate discussions between informal carers and clinicians).
Development of a PROM set for patients with Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyneuropathy (CIDP): study protocol.
Pelouto F, Haagsma JA, Jacobs BC … +1 more , Terwee CB
Health Qual Life Outcomes · 2025 Sep · PMID 41024042 · Full text
BACKGROUND: Guillain–Barré syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) are rare immune-mediated disorders of the peripheral nervous system. They cause significant physical and mental sympt...
BACKGROUND: Guillain–Barré syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) are rare immune-mediated disorders of the peripheral nervous system. They cause significant physical and mental symptoms and functional impairments that impact patients’ daily lives. Current treatment does not effectively prevent the occurrence of these residual symptoms and functional limitations. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs) are essential tools that capture patients’ perspectives on their own health, which can be used to assess disease impact and evaluate treatment efficacy. The commonly used Inflammatory Rasch-Built Overall Disability Scale (I-RODS) primarily focuses on activity limitations, social participation, but has been noted to have certain clinimetric shortcomings. This highlights the need for a tailored PROM set that comprehensively assesses relevant aspects of health-related quality of life (HRQL) in patients with GBS or CIDP. METHODS: This prospective mixed-method study consists of a multiphase approach for developing a PROM set in a Dutch adult population with GBS and CIDP. The first phase involves a systematic review and an (online) survey with open-ended questions to identify relevant patient-reported outcomes (PROs), which will be analyzed qualitatively. Subsequently, stakeholder panel meetings will be held with patients and healthcare providers to discuss the identified PROs, including generic and disease specific symptoms and existing suitable PROMs, using the generic Patient Reported Outcomes Measurement Information System (PROMIS) as a basis. Following this, cognitive interviews will be performed to pilot-test a new disease-specific symptom checklist. A Delphi study will then be conducted to achieve consensus on the final PROM set. Finally, a validation study of the selected PROMIS measures and the newly developed disease-specific symptom checklist will be performed. The final phase of the study involves a consensus meeting with the stakeholders to discuss dissemination and implementation strategies for the proposed PROM set. DISCUSSION: This PROM set is being developed to measure HRQL outcomes relevant for patients with GBS and CIDP. The aim is to develop a tool for clinical practice and research to evaluate the clinical course and effect of treatments from the perspective of patients. TRIAL REGISTRATION: Not applicable.
Rooting patient-reported outcomes in clinical care: a scoping review on benefits, challenges, and opportunities for patients and clinicians.
Stillman IO, Boyle B, Lencoski K … +3 more , Styliadou M, Muir JM, Sarri G
Health Qual Life Outcomes · 2025 Sep · PMID 41024025 · Full text
BACKGROUND: The patient voice in healthcare continues to grow, through the expanded use of patient-reported outcomes (PRO) and enhanced by the growing use of digital health technologies. Despite these positive signs, wid...
BACKGROUND: The patient voice in healthcare continues to grow, through the expanded use of patient-reported outcomes (PRO) and enhanced by the growing use of digital health technologies. Despite these positive signs, widespread adoption of PRO measures (PROM) in healthcare decision-making continues to lag. We conducted a scoping review to identify the current benefits of and roadblocks to the use of PRO data in the patient-clinician interaction. METHODS: We searched the Embase and MEDLINE databases from 2014 to 2024 for articles that discussed the role of PRO data in patient quality of life, clinical care and value assessment decision-making. We also manually searched the websites of nine national health technology assessment agencies and used a snowballing approach to identify additional publications. Eligible publications were mapped to three key topics of interest: benefits/barriers at the patient, clinician, and healthcare service levels. RESULTS: Our search yielded 1,846 citations; after deduplication and screening, 13 articles were included. At the patient level, benefits included increased care satisfaction and improved patient experience, mainly via enhanced communication. Uncertainty about PROMs and their mechanisms was a main barrier, as were concerns about the variability of clinical application, lack of follow-up, and unfulfilled patient expectations. For clinicians, improved patient symptom clarity, satisfaction with care, and informed decision-making were the main benefits of PROMs, along with improved efficiency during patient visits. The main barrier for physicians was the feasibility of integrating PROMs into daily practice, including establishing the routine use of PROMs, and consistency in the interpretation of PRO data. At the healthcare service level, improvements in efficiency and the identification of unmet needs were benefits, while questions about consistent between-group interpretation were raised, as were questions regarding the basic value of PROMs, as there is currently minimal evidence to indicate that PRO data directly improve care outcomes. CONCLUSION: Much evidence exists indicating PROMs are associated with improvements in patient-clinician communication and improved satisfaction on both parts, although hesitation regarding their widespread adoption remains. More objective data are needed to further quantify the potential benefits of PROM integration in clinical care in order to assess any direct impact on clinical care outcomes and to facilitate their broader use.
Internet of health things and machine learning for continuous quality of life monitoring.
Oliveira PAM, Andrade RMC, Santos Neto PA … +3 more , Santos IS, Junior EC, Oliveira VT
Health Qual Life Outcomes · 2025 Sep · PMID 41024015 · Full text
BACKGROUND: Continuous Quality of Life (QoL) monitoring enables many benefits, such as early healthcare interventions. This work uses Internet of Health Things (IoHT) data and Machine Learning to infer physical and psych...
BACKGROUND: Continuous Quality of Life (QoL) monitoring enables many benefits, such as early healthcare interventions. This work uses Internet of Health Things (IoHT) data and Machine Learning to infer physical and psychological Quality of Life measures. METHODS: We conducted a longitudinal study with 44 participants for six months. Health data were collected daily through smartphones and wearables, and the participants answered the WHOQOL-BREF questionnaire weekly. Then, five Machine Learning models were trained to evaluate their ability to estimate users’ QoL. RESULTS: Random Forest (RF) had the best results considering the Root Mean Squared Error (RMSE). RF got an RMSE of 7.8618 for the physical domain and 7.4591 for the psychological domain. CONCLUSIONS: Overall, it is possible to use IoHT data to infer users’ QoL, considering a certain margin of error; RF had a reasonable performance for this problem and it was not found any decisive feature for the inference process. This last point reinforces that QoL inference using IoHT data is not trivial, and only combining a large number of features can give relevant insights into users’ QoL. Project approved by UFC ethics committee (ID 56153322.0.0000.5054) on March 9, 2022.
Health-related quality of life and financial toxicity in Chinese patients with multiple myeloma: a two-year real-world multicentre study.
Wu W, Wang Y, Wu Y … +7 more , Wu F, Yang W, Tang F, Zhang M, Wu Q, Dong H, Shen A
Health Qual Life Outcomes · 2025 Sep · PMID 41013683 · Full text
BACKGROUND: The introduction of novel therapeutic agents has transformed the treatment landscape and significantly improved survival outcomes for patients with multiple myeloma (MM). However, the effects of these advance...
BACKGROUND: The introduction of novel therapeutic agents has transformed the treatment landscape and significantly improved survival outcomes for patients with multiple myeloma (MM). However, the effects of these advancements on health-related quality of life (HRQoL) and financial toxicity in real-world settings remain insufficiently explored. The aim of this study was to investigate HRQoL and financial toxicity among Chinese patients with MM in the era of novel agents. METHODS: In this longitudinal, multicentre, real-world study, data from Chinese patients with MM were collected between March 2021 and July 2023. HRQoL was assessed using the EQ-5D-5 L, EQ-VAS and FACT-MM, while financial toxicity was measured using the Comprehensive Score for Financial Toxicity (COST). Patients were evaluated at baseline and at 3-, 6-, 12-, and 24-month follow-up visits. Mixed-effect models were employed to examine the factors associated with HRQoL and financial toxicity over time. RESULTS: A total of 441 patients were surveyed at baseline, with 412 (93.5%), 371 (84.1%), 335 (76.0%), and 253 (57.4%) completing the follow-up visits at 3, 6, 12, and 24 months, respectively. At baseline, the mean EQ-5D-5 L, EQ-VAS, FACT-MM, and COST scores were 0.79 (SD = 0.25), 81.96 (SD = 18.73), 117.46 (SD = 21.76), and 21.84 (SD = 5.78), respectively. The EQ-5D-5 L utility values and FACT-MM scores at follow-up visits were significantly higher than those at baseline, whereas the COST scores were significantly lower. Mixed-effect model analyses revealed that higher levels of financial toxicity were significantly associated with lower HRQoL (EQ-5D-5 L: β = 0.006, p < 0.001; FACT-MM: β = 1.60, p < 0.001). Moreover, significant interaction effects between socioeconomic status and COST were observed for both the EQ-5D-5 L (β = -0.001, p < 0.001) and the FACT-MM (β = -0.12, p < 0.001). CONCLUSIONS: HRQoL improved moderately over the 24-month follow-up period, whereas financial toxicity progressively worsened. Greater financial toxicity was significantly associated with poorer HRQoL, particularly among patients with lower SES. These findings may inform future health policy development and economic evaluations aimed at improving the quality of care and financial well-being of patients with MM.
Design and selection of items for a new health-related quality of life instrument with infertility patients (Infertility-QoL): a national multicenter, four-phase, mixed-methods study.
Shi Z, Zheng Y, Mao Z … +3 more , Nie H, Chen G, Li S
Health Qual Life Outcomes · 2025 Sep · PMID 41013678 · Full text
BACKGROUND: Infertility is a global issue that significantly imposes physical and psychosocial burdens on both female and male patients, affecting their health-related quality of life (HRQoL) and family wellbeing. The ai...
BACKGROUND: Infertility is a global issue that significantly imposes physical and psychosocial burdens on both female and male patients, affecting their health-related quality of life (HRQoL) and family wellbeing. The aim of this study was to develop a de novo HRQoL instrument for male and female infertility patients in China, and describe the generation and selection of items for Infertility-QoL. METHODS: This study used a mixed methods design involving 4 steps. The items identified from the systematic review and qualitative interview analysis were used to construct draft candidate items (step 1). In order to ensure item relevance, comprehension, and acceptability, using cognitive interviews prior to quantifying psychometric testing (step 2). In the third step, we conducted a cross-sectional quantitative offline survey for item selection. Classical test theory (CTT) and item response theory (IRT) were used to assess dimensionality and performance of items. Finally, by conducting advisory committee consultations and thematic seminars, the items were further qualitatively evaluated, and developed a formal version of the Infertility-QoL (step 4). RESULTS: Step 1 resulted in the generation of 73 items. Based on CTT and IRT psychometric evidence, 36 items were deleted. Finally, according to the advisory committee consultations for qualitative evaluation, a formal version of the Infertility-QoL with 25 items was developed. The exploratory factor analysis results showed that the 6-factor model was appropriate. The newly developed instrument (Infertility-QoL) consisted of 25 items across six dimensions: physical health, sexual life, emotional status, self-efficacy, subjective wellbeing and social relations. CONCLUSIONS: This study developed the new Infertility-QoL instrument for male and female infertility patients, and preliminarily verified its dimensions.
The role of psychological flexibility and emotion regulation in the relationship between smartphone addiction and psychological wellbeing in adolescents: three-wave longitudinal serial mediation study.
Alkal A
Health Qual Life Outcomes · 2025 Sep · PMID 41013657 · Full text
BACKGROUND: When the increasing prevalence of Smartphone Addiction (SA) and its potential negative effects on mental health among adolescents are taken into consideration, an in-depth investigation of the relationship be...
BACKGROUND: When the increasing prevalence of Smartphone Addiction (SA) and its potential negative effects on mental health among adolescents are taken into consideration, an in-depth investigation of the relationship between SA and Psychological Well-being (PW) is of critical importance. Therefore, using a three-wave longitudinal research design, this study aimed to examine the serial mediation role of Psychological Flexibility (PF) and Emotion Regulation (ER) in the relationship between SA and PW. To our knowledge, this is the first study to examine SA, PF, ER, and PW relationships and mediating mechanisms in an adolescent sample using a longitudinal design. METHODS: The study included 448 adolescents (49.8% female and 50.2% male; Range = 15-19, M = 16.76, SD = 1.12) who responded to the questionnaires in three waves. Participating adolescents responded to a 50-item questionnaire consisting of the Smartphone Addiction Scale-Short Version (SAS-SV), the Five-Dimensional Well-Being Scale for Adolescents (EPOCH), the Multidimensional Psychological Flexibility Inventory Short Form (MPFI-SF), and the Regulation of Emotions Questionnaire (REQ). The questionnaires were filled in using pen and paper in a classroom environment under the supervision of the teacher and the researcher. RESULTS: Compared to those who used their smartphones for 0-2 h and 2-4 h, adolescents who reported to use their smartphones for more than four hours daily were found to have higher SA scores and lower PW, ER, and PF scores across all three time points (T1, T2, and T3). The findings indicated that SA at T1 negatively predicted PW at T3 (β = -0.34, p < .001), PF at T2 (β = -0.39, p < .001), and ER at T2 (β = -0.23, p < .001). On the other hand, PF at T2 positively predicted ER at T2 (β = 0.17, p < .001) and PW at T3 (β = 0.40, p < .001), and ER at T2 positively predicted PW at T3 (β = 0.73, p < .001). Besides, PF at T2 (β = -0.15, SE = 0.03, 95% CI = [-0.2036, -0.1053]) and ER at T2 (β = -0.17, SE = 0.03, 95% CI = [-0.2288, -0.1054]) were found to fully mediate the longitudinal relationship between SA at T1 and PW at T3. The longitudinal serial mediation model accounted for 32% of the variance in PW (R = .32). CONCLUSIONS: This study shows that SA leads to a decrease in adolescents' PF skills and their capacity to effectively manage their emotional reactions over time, which in turn leads to lower PW levels. The findings emphasize the potential of interventions to improve PF and ER skills in alleviating SA-related mental health problems in adolescents. The findings also suggest that both strengthening PF and ER skills separately and addressing them simultaneously could significantly increase the effectiveness of treatment approaches.
Assessing well-being in younger populations in economic evaluations: a scoping review of multidimensional instruments.
Guo Z, Diaz DMN, Lipman SA … +1 more , Roijen LH
Health Qual Life Outcomes · 2025 Sep · PMID 41013479 · Full text
BACKGROUND: To comprehensively evaluate health care interventions in younger populations, outcome measurement in economic evaluation may need to be expanded beyond health-related quality of life to include well-being. Ho...
BACKGROUND: To comprehensively evaluate health care interventions in younger populations, outcome measurement in economic evaluation may need to be expanded beyond health-related quality of life to include well-being. However, whether appropriate well-being instruments exist for children remains uncertain. This study provides a systematic overview of multidimensional well-being instruments for children and assesses their potential applicability for economic evaluation. METHODS: This scoping review was reported following the PRISMA-ScR guidelines. The search strategy included terms related to "well-being," "child or adolescent," and "instrument", and was implemented in four electronic databases, yielding a total of 9622 articles. Two reviewers independently screened articles with ASReview, a machine-learning-based tool for expediting screening, and manually extracted information from relevant articles. Findings were synthesized narratively, highlighting consistency and discrepancies, as well as potential suitability for economic evaluation (using multiple criteria). RESULTS: Twentyfive studies were included, published between 1993 and 2024. On average, instruments assessed well-being with five dimensions and 38 questions. Common dimensions included physical, health, school, satisfaction, relationship(s), emotional and self. Dimensions that capture children's daily experiences, such as family, achievement, education and after-school activities were frequently considered. CONCLUSION: The review highlights the variety of well-being instruments for children. Although many instruments measure well-being comprehensively, only ICECAP-CYP fit all criteria for suitability for economic evaluation. The small number of potentially suitable instruments highlights a growing yet still insufficient interest in moving beyond traditional HRQoL assessments in younger populations.
Insights from using patient-reported outcomes as an intervention during cancer treatment in Denmark: potential reasons for limited effectiveness.
Tolstrup LK, Rasmussen IL, Pappot H
Health Qual Life Outcomes · 2025 Sep · PMID 40993731 · Full text
BACKGROUND: In this comment, we discuss the differences between four Danish randomized controlled trials (RCTs) exploring the effect of electronic patient-reported outcomes (ePROs) as an intervention during cancer treatm...
BACKGROUND: In this comment, we discuss the differences between four Danish randomized controlled trials (RCTs) exploring the effect of electronic patient-reported outcomes (ePROs) as an intervention during cancer treatment and the seven studies included as the basis for the ESMO clinical practice guideline on ePRO in cancer care. We aim to elucidate possible reasons for the lack of effect in a Danish context, which is relevant if ePRO is to be applied in oncological clinical practice on a larger scale. MAIN TEXT: The RCTs underpinning the ESMO guideline demonstrated how the use of ePROs as an intervention improved symptom control, reduced emergency use, hospitalizations, unplanned healthcare episodes, and promoted better physical function. Notably, one study reported an improvement in overall survival. In the Danish studies, the effects were less clear. None of the Danish RCTs investigating ePRO as an intervention during cancer therapy, compared to standard care, showed a significant impact on primary clinical outcomes. We compared the design and performance concerning the number of patients, the questionnaire used for PRO, software, symptom management algorithm, designated staff capacity, primary outcome, and results reported. The Danish studies included fewer patients (138–682) than the ESMO guideline studies (252–1191). A variety of questionnaires and software were used. Six of seven ESMO guideline studies had designated staff to handle the ePROs, whereas three out of four Danish trials lacked this key component. CONCLUSION: We believe that one possible explanation for the lack of effect in the Danish RCTs can be explained by the absence of designated staff capacity to handle ePROs. It is important to take such matters into account before the large-scale application of PRO in health care practice if the effect of PROs in clinical practice is to be achieved.
About
- Frequency
- Sun
- Papers found
- 200
- RSS feed
- Subscribe