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Background: Financial toxicity describes the impairment of financial wellbeing in patients due to the burden of cancer diagnosis and care. The COST: A Functional Assessment of Chronic Illness Therapy Measure of Financial Toxicity (FACIT-COST) is the most widely used cancer-specific measure of subjective financial toxicity, having been validated in multiple languages, but not in Indonesian. This study aimed to validate the Indonesian version of FACIT-COST in a breast cancer sample., Methods: A single-center prospective cohort study was performed in Indonesia. Female breast cancer patients aged ≥ 18 undergoing treatment at baseline were invited to participate and followed for up to six months. The survey included the official Indonesian version of FACIT-COST (v2) which was administered to the patients by interviewers. Clinical information (e.g., metastasis status, disease duration) was provided based on medical records. The following measurement properties of FACIT-COST were tested: distributional characteristics, structural validity (principal component [PCA] and confirmatory factor analyses [CFA]), internal consistency reliability (Cronbach's alpha and McDonald's omega), known-groups validity (Mann-Whitney U or Kruskal-Wallis H test), test-retest reliability, and responsiveness to change., Results: Overall, 300 female patients participated at baseline. No patients reported the best or worst possible FACIT-COST total scores. The PCA proposed a two-factor model structure for the instrument, which was confirmed by the CFA (RMSEA = 0.042, SRMR = 0.049, CFI = 0.99, TLI = 0.99). The internal consistency reliability of the two factors was considered adequate (Cronbach's alpha = 0.774-0.882, McDonald's omega = 0.786-0.888). The FACIT-COST total score significantly discriminated across the following known-groups: age, education, residential setting, income, employment, metastasis status, number of symptoms, and financial coping strategies. The FACIT-COST demonstrated excellent test-retest reliability (intraclass correlation coefficient = 0.96) and satisfactory responsiveness to change (standardized response mean and effect size ranges=|0.39| to |0.92|)., Conclusions: This is the first study to validate the FACIT-COST in patients with breast cancer and to present the measurement properties of the Indonesian version of FACIT-COST. The Indonesian FACIT-COST demonstrates acceptable psychometric performance and shows potential as a valid measure of subjective financial toxicity. The instrument may serve as a valuable tool for informing health policies that focus on providing resource support to improve cancer care in Indonesia., (© 2024. The Author(s).)

Objectives: We aimed to assess the psychometric performance and added value of 9 existing bolt-ons (breathing problems, cognition, hearing, self-confidence, skin irritation, sleep, social relationships, tiredness, and vision) for the EQ-5D-5L in a general population sample., Methods: The EQ-5D-5L, 9 bolt-ons, SF-6Dv1, Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2, PROMIS Global Health, and Satisfaction with Life Scale were completed in an online cross-sectional survey among a general adult population sample in Hungary (n = 1587). The following psychometric properties were tested for the EQ-5D-5L + bolt-on(s): ceiling, divergent and convergent validity, structural validity, known-group validity, and explanatory power., Results: Adding sleep (30%), tiredness (24%), or vision (21%) substantially reduced the ceiling of the EQ-5D-5L (41%). Cognition, sleep, social relationships, and tiredness correlated with corresponding PROMIS and SF-6D items (r s  = ǀ0.32ǀ - ǀ0.73ǀ). All bolt-ons, except cognition and self-confidence, loaded on a different factor from the EQ-5D-5L dimensions. Breathing, hearing, skin irritation, and vision significantly improved known-group validity in relevant health condition groups. The sleep bolt-on improved known-group validity in 9 of 13 chronic health conditions. Tiredness had the largest impact on explaining EQ VAS score variance in 8 of 13 conditions. Hearing and vision improved the ability of the EQ-5D-5L to capture declining health with age, whereas self-confidence and social relationships were valuable for mental health assessment., Conclusions: This study established the validity of multiple bolt-ons for the EQ-5D-5L and highlights the usefulness of including relevant bolt-ons in population-based and patient surveys. Our findings inform the further development of these bolt-ons and the bolt-on item selection for clinical studies., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section. Both authors are members of the EuroQol Group. Views expressed in the article are those of the authors and are not necessarily those of the EuroQol Research Foundation., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) is a widely used generic measure of health status. This study aimed to (1) assess the psychometric properties of the Hungarian PROMIS-GH and to (2) develop general population reference values in Hungary., Methods: An online cross-sectional survey was conducted among the Hungarian adult general population (n = 1700). Respondents completed the PROMIS-GH v1.2. Unidimensionality (confirmatory factor analysis and bifactor model), local independence, monotonicity (Mokken scaling), graded response model fit, item characteristic curves and measurement invariance were examined. Spearman's correlations were used to analyse convergent validity of PROMIS-GH subscales with SF-36v1 composites and subscales. Age- and gender-weighted T-scores were computed for the Global Physical Health (GPH) and Global Mental Health (GMH) subscales using the US item calibrations., Results: The item response theory assumptions of unidimensionality, local independence and monotonicity were met for both subscales. The graded response model showed acceptable fit indices for both subscales. No differential item functioning was detected for any sociodemographic characteristics. GMH T-scores showed a strong correlation with SF-36 mental health composite score (r s  = 0.71) and GPH T-scores with SF-36 physical health composite score (r s  = 0.83). Mean GPH and GMH T-scores of females were lower (47.8 and 46.4) compared to males (50.5 and 49.3) (p < 0.001), and both mean GPH and GMH T-scores decreased with age, suggesting worse health status (p < 0.05)., Conclusion: This study established the validity and developed general population reference values for the PROMIS-GH in Hungary. Population reference values facilitate the interpretation of patients' scores and allow inter-country comparisons., (© 2023. The Author(s).)

Objectives: Dermatology Life Quality index (DLQI) is the most widely used health-related quality of life questionnaire in dermatology. Little is known about existing questionnaire or scoring modifications of the DLQI. We aimed to systematically review, identify, and categorize all modified questionnaire versions and scoring methods of the DLQI., Methods: We performed a systematic literature search in PubMed, Web of Science, CINAHL, and PsychINFO. Methodologic quality and evidence of psychometric properties were assessed using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) and Terwee checklists., Results: The included 81 articles reported on 77 studies using 59 DLQI modifications. Modifications were used for a combined sample of 25 509 patients with 47 different diagnoses and symptoms from 28 countries. The most frequently studied diseases were psoriasis, hirsutism, acne, alopecia, and bromhidrosis. The modifications were categorized into the following nonmutually exclusive groups: bolt-ons or bolt-offs (48%), disease, symptom, and body part specifications (42%), changes in existing items (34%), scoring modifications (27%), recall period changes (19%), response scale modifications (15%), and illustrations (3%). The evidence concerning the quality of measurement properties was heterogeneous: 4 of 13 studies were rated positive on internal consistency, 1 of 3 on reliability, 3 of 5 on content validity, 9 of 22 on construct validity, 6 of 6 on criterion validity, and 1 of 1 on responsiveness., Conclusion: An exceptionally large number of DLQI modifications have been used that may indicate an unmet need for adequate health-related quality of life instruments in dermatology. The psychometric overview of most questionnaire modifications is currently incomplete, and additional efforts are needed for proper validation., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Purpose: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects up to 1% of the population in Europe. The EQ-5D is the most commonly used generic instrument for measuring health-related quality of life among HS patients. This study aims to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with HS., Methods: We recruited 200 consecutive patients with HS (mean age 37 years, 38% severe or very severe HS) to participate in a multicentre cross-sectional survey. Patients completed the EQ-5D-3L, EQ-5D-5L, Dermatology Life Quality Index (DLQI) and Skindex-16 questionnaires., Results: More than twice as many different health state profiles occurred in the EQ-5D-5L compared to the EQ-5D-3L (101 vs. 43). A significant reduction in ceiling effect was found for the mobility, self-care and usual activities dimensions. A good agreement was established between the EQ-5D-3L and EQ-5D-5L with an intraclass correlation coefficient of 0.872 (95% CI 0.830-0.903; p < 0.001) that was confirmed by a Bland-Altman plot. EQ-5D-5L improved both the absolute and relative informativity in all dimensions except for anxiety/depression. EQ-5D-3L and EQ-5D-5L demonstrated similar convergent validity with DLQI and Skindex-16. EQ-5D-5L was able to better discriminate between known groups of patients based on the number of comorbidities and disease severity (HS-Physician's Global Assessment)., Conclusion: In patients with HS, the EQ-5D-5L outperformed the EQ-5D-3L in feasibility, ceiling effects, informativity and known-groups validity for many important clinical characteristics. We recommend using the EQ-5D-5L in HS patients across various settings, including clinical care, research and economic evaluations.

Purpose: We aimed to develop and assess the psychometric characteristics of the Hungarian language version of two well-being capability measures, the ICEpop CAPability measure for Adults/Older people (ICECAP-A/-O), and to establish population norms., Methods: A cross-sectional survey was performed involving a representative sample of the Hungarian population. Socio-demographic characteristics, the use and provision of informal care were recorded. The Minimum European Health Module (MEHM), EQ-5D-5L, WHO-5 well-being index, happiness and life satisfaction visual analogue scale (VAS), Satisfaction with Life Scale (SWLS) measures were applied alongside the ICECAP-A (age-group 18-64) and ICECAP-O (age-group 65+)., Results: Altogether 1568 and 453 individuals completed the ICECAP-A/-O questionnaires, respectively. Cronbach's alpha was 0.86 for both measures (internal consistency). Subgroup analyses showed positive associations between ICECAP-A/-O scores and marital status, employment, income, health status (MEHM) and informal care use (construct validity). Pearson correlations were strong (r > 0.5; p < 0.01) between ICECAP-A/-O indexes and EQ-5D-5L, WHO-5, happiness and satisfaction VAS and SWLS scores (convergent validity). The age, education, and marital status were no longer significant in the multiple regression analysis. Test-retest average (SD) scores were 0.88 (0.11) and 0.89 (0.10) for the ICECAP-A, and equally 0.86 (0.09) for the ICECAP-O (reliability)., Conclusion: This is the first study to provide ICECAP-A/-O population norms. Also, it is the first to explore associations with WHO-5 well-being index which, alongside the MEHM measures, enable estimates from routinely collected international health statistics. The Hungarian ICECAP-A/-O proved to be valid and reliable measurement tools. Socio-demographic characteristics had minor or no impact on ICECAP-A/-O. Other influencing factors deserve further investigation in future research.

Purpose: The EuroQol five-dimension questionnaire (EQ-5D) is the most commonly used instrument to obtain utility values for cost-effectiveness analyses of treatments for Crohn's disease (CD). We aimed to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with CD., Methods: Between 2016 and 2017, a multicentre cross-sectional survey was carried out. Consecutive outpatients with CD completed the 3L, 5L and EQ visual analogue scale (VAS). Disease severity was graded by the Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI). The 3L and 5L were compared in terms of feasibility, agreement, ceiling effect, redistribution properties, discriminatory power, convergent and known-groups validity., Results: Two-hundred and six patients (54.9% male, mean age 35 ± 11 years) participated in the survey. For 3L, 25 unique health states were observed versus 59 for the 5L. The overall ceiling effect decreased from 29.6% (3L) to 25.5% (5L). Absolute discriminatory power improved (mean Shannon index 0.84 vs. 1.18). The 3L correlated stronger with EQ VAS and CDAI scores, whereas the 5L with PDAI. The 5L demonstrated a better known-groups validity on the basis of age, perianal fistulas, extraintestinal manifestations and disability., Conclusions: This is the first study to report the impact of CD on quality of life using the EQ-5D-5L questionnaire. The 5L seems to perform better than 3L in terms of feasibility, ceiling effect, discriminatory power and known-groups validity. Understanding the differences in psychometrics between the 3L and 5L is essential as they have substantial implications for financial decision-making about CD treatments.

The purpose of this study is to assess the measurement properties of EQ-5D-5L compared to EQ-5D-3L in psoriasis patients., Methods: A cross-sectional survey was carried out at an academic dermatology clinic in Hungary. Psoriasis patients completed the EQ-5D-3L, EQ-5D-5L and Dermatology Life Quality Index (DLQI) questionnaires, and Psoriasis Area and Severity Index (PASI) was assessed. The UK value sets were used to calculate the 3L and 5L index scores. We tested the feasibility, ceiling effect, redistribution properties, the level of inconsistency and informativity (Shannon and Shannon Evenness indices). Spearman's rank-order correlations were performed between EQ-5D, EQ VAS, DLQI and PASI scores. Known-groups validity was evaluated by comparing age groups, clinical subtypes and treatment groups., Results: Mean age of the 238 patients was 47 years, and 36.6% of them received biological therapy. Mean EQ-5D index score was 0.77 (SD: 0.26) with the 3L and 0.84 (SD: 0.19) with the 5L. The overall ceiling effect decreased from 37.1 (3L) to 32.9% (5L). Shannon index improved significantly for most dimensions, but Shannon Evenness index improved only in three dimensions. Compared to the 3L, the 5L version confirmed a better convergent validity with PASI, but not with the DLQI. Known-groups validity was equally demonstrated both for the 5L and 3L., Conclusions: The EQ-5D-5L seems to improve measurement properties by reducing ceiling effects, strengthening correlations with PASI and improving informativity. Follow-up studies are needed to test responsiveness and reliability in psoriasis.

Background: Numerous generic, skin‐ and disease‐specific health‐related quality of life (HRQoL) measures are available for patients with hidradenitis suppurativa (HS). Yet, robust psychometric evidence is lacking in many aspects of these outcome measures. Objectives: We sought to determine convergent and known‐groups validity of multiple generic and skin‐specific HRQoL measures and to identify predictors of impaired HRQoL in patients with HS. Methods: Between 2017 and 2019, a multicentre cross‐sectional study was carried out involving 200 consecutive HS patients. HRQoL outcomes included the EQ‐5D‐5L, EQ visual analogue scale (EQ VAS), Skindex‐16, Dermatology Life Quality Index (DLQI) and DLQI‐Relevant (DLQI‐R). Disease severity was graded by HS‐Physician's Global Assessment (HS‐PGA) scale and the Modified Sartorius scale (MSS). Results: Overall, 77%, 56%, 51%, 46% and 28% reported problems in the pain/discomfort, usual activities, anxiety/depression, mobility and self‐care dimensions of EQ‐5D‐5L. Mean ± SD EQ VAS, DLQI and DLQI‐R scores were 64.29 ± 22.68, 11.75 ± 8.11 and 12.19 ± 8.33, respectively. Skindex‐16 responses indicated that the emotional burden of HS (64.55 ± 29.28) far exceeded those of functioning (49.40 ± 34.70) and physical symptoms (46.74 ± 29.36). EQ‐5D‐5L, EQ VAS, DLQI, DLQI‐R and Skindex‐16 total scores had moderate or strong correlations with each other (range: |0.487| to |0.993|), weak or moderate correlations with HS‐PGA (|0.350| to |0.433|) and weak correlations with MSS (|0.324| to |0.389|). DLQI‐R slightly outperformed DLQI both in terms of convergent and known‐groups validity. Being female, lower education level, more severe disease and genital involvement were associated with worse HRQoL (P < 0.05). Conclusion: This study provides high‐quality evidence that among skin‐specific outcomes, the DLQI, DLQI‐R and Skindex‐16, and among generic instruments, the EQ‐5D‐5L are suitable to be used in HS patients. In future research, we recommend the use of existing well‐validated HRQoL tools instead of developing new measures for each study. The development of composite measures that combine physician‐ and patient‐reported outcomes is not supported by evidence in HS. [Correction added on 25 July 2020, after first online publication: in the Abstract section, the ± signs were missing and have been added to this version.] [ABSTRACT FROM AUTHOR]