Testing the Psychometric Properties of 9 Bolt-Ons for the EQ-5D-5L in a General Population Sample.

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 (rs = 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.

Behind the Scenes: A Qualitative Investigation of Interviewers' Performance in EQ-5D Valuation Studies.

BACKGROUND: The EuroQol Valuation Technology (EQ-VT) protocol is currently employed by the valuation studies of the EQ family of instruments worldwide. To date, all the evidence in support of the quality control (QC) originates from quantitative indicators. OBJECTIVE: We aimed to explore interviewers' conversational patterns in EQ-VT interviews, beyond quantitative QC indicators, and to provide a preliminary exploration of how the interaction between interviewer and respondent impacts data quality. METHODS: Two researchers transcribed and independently coded 24 video-recorded interviews from the Italian EQ-5D-5L valuation study, adopting the conversational analysis framework. The analysis identified positive and negative 'patterns' of conversational practice. These were categorized into themes and sub-themes and were used to score a random sample of 42 video-recorded interviews conducted at different time points by seven interviewers. RESULTS: The conversational analysis identified 20 positive and 14 negative interview patterns, which were grouped into two main themes (i.e., task execution and communication skills). Positive items included appending questions that stimulated respondents' engagement, providing different explanations for an unclear aspect, supporting the participant with useful information for completing the tasks, and increasing the interview's coherence by confirming the respondent answers. Negative patterns included moving forward in the exercise without making sure that the respondent understood, trying to force an answer from the respondent, speaking too fast, and providing incomplete or incorrect explanations of the task. Most interviewers exhibited a moderate increase in positive patterns or a decrease in negative patterns over time. A certain degree of consistency between the quantitative QC results and the qualitative scoring deriving from the interviewer-respondent interaction was observed, with the best and worst performers of the qualitative scoring showing good and bad scores on key QC items, respectively. CONCLUSIONS: The identified positive and negative patterns may be useful to inform the training material of EQ-VT studies worldwide and complement the existing QC process.

Subjective Well-Being Population Norms and Inequalities in Hungary: A Large Cross-Sectional, Internet-Based Survey.

OBJECTIVES: This study aimed to provide subjective well-being (SWB) population norms in Hungary and explore the contribution of explanatory factors of SWB inequality among the Hungarian adult general population. METHODS: The data originated from a large representative internet-based cross-sectional survey in Hungary, which was conducted in 2020. We applied validated multi-item instruments for measuring SWB, namely Satisfaction With Life Scale (SWLS) and World Health Organization-Five Well-Being Index (WHO-5). Multiple linear regressions were used to examine the relationship between demographic-socioeconomic-health status and both well-being instruments. The concentration index (CI) was used to measure the degree of income-related inequality in well-being. RESULTS: A total of 2001 respondents were enrolled with the means ± SD WHO-5 scores and SWLS scores of 0.51 ± 0.21 and 0.51 ± 0.23, respectively. Higher household income, higher educational level, better general health status, and absence of chronic morbidity were significant positive predictors for both WHO-5 and SWLS scores. The CI of WHO-5 scores was lower than that of SWLS scores in the total sample (0.0480 vs 0.0861) and in subgroups by gender (male, 0.0584 vs 0.1035; female, 0.0302 vs 0.0726). The positive CI values implied a slight pro-rich SWB inequality in this population. The regression analyses showed a positive association of SWB with having a higher household income and a better general health status. CONCLUSIONS: This is the first representative study in Hungary to compare population norm of 2 well-being instruments and analyze well-being inequality. Slight pro-rich inequality was found consistently with both SWB measures. Our findings support the need for health and social policies that effectively tackle inequalities in Hungary.

Population Norms for the EQ-5D-5L, PROPr and SF-6D in Hungary.

OBJECTIVES: This study aimed to develop population norms for three preference-accompanied measures [EQ-5D-5L, Patient-Reported Outcomes Measurement Information System (PROMIS)-preference scoring system (PROPr) and Short-Form Six-Dimension (SF-6D)] in Hungary. METHODS: In November 2020, an online cross-sectional survey was conducted among a representative sample of the Hungarian adult general population (n = 1631). Respondents completed the Hungarian versions of the EQ-5D-5L, PROMIS-29+2 version 2.1 and 36-item Short Form Survey version 1 (SF-36v1). The association of utilities with sociodemographic and health-related characteristics of respondents was analysed using multivariate regressions. RESULTS: The proportion of respondents reporting problems ranged from 8 to 44% (self-care to pain/discomfort) on the EQ-5D-5L, 39-94% (physical function to sleep) on PROPr and 38-87% (role limitations to vitality) on the SF-6D. Problems related to physical function, self-care, usual activities/role limitations and pain increased with age, while mental health problems decreased in all three measures. In almost all corresponding domains, respondents indicated the fewest problems on the EQ-5D-5L and the most problems on the SF-6D. The mean EQ-5D-5L, PROPr and SF-6D utilities were 0.900, 0.535 and 0.755, respectively. Female gender (PROPr, SF-6D), a lower level of education (EQ-5D-5L, PROPr), being unemployed or a disability pensioner (EQ-5D-5L), being underweight or obese (SF-6D), lack of physical exercise (all) and polypharmacy (all) were associated with significantly lower utilities. PROPr yielded the lowest and EQ-5D-5L the highest mean utilities in 28 of 30 chronic health conditions. CONCLUSIONS: This study presents the first set of Hungarian population norms for the EQ-5D-5L, PROPr and SF-6D. Our findings can serve as reference values in clinical trials and observational studies and contribute to the monitoring of population health and the assessment of disease burden in Hungary.

Developing and testing culturally relevant bolt-on items for EQ-5D-5L in Chinese populations: a mixed-methods study protocol.

INTRODUCTION: EQ-5D is one of the most frequently used health-related quality of life (HRQoL) measures but has been found to be insensitive in detecting differences in health status in some general populations and disease groups. For example, the appropriateness of applying EQ-5D in the Chinese cultural setting has been widely discussed. Adding additional HRQoL dimensions (bolt-on items) can be a solution to both retain the original descriptive system of EQ-5D, while enhancing its sensitivity to the local context. To date, no studies have proposed culturally relevant bolt-ons for China or examined the psychometric properties of such bolt-on items. This protocol documents the identification, development, selection and psychometric testing of culturally relevant bolt-on items for EQ-5D-5L in China. METHODS AND ANALYSIS: We will identify and develop candidate bolt-on items that are most relevant in the Chinese culture, through former literature reviews on health concepts important for the Chinese population, conducting expert consultations and qualitative interviews. We will quantitatively test the acceptability and measurement properties (including distributional characteristics and construct validity) of the candidate items in both general and disease populations in a cross-sectional setting. The patient group will be followed up to collect two-time-point data to assess test-retest reliability of the candidate items. Bolt-on item selection will consider both the qualitative and quantitative evidence gathered. This protocol outlines a comprehensive mixed-methods process for identifying, developing, selecting and testing bolt-on items that are relevant and culturally appropriate in China. This study may serve as a guide for similar initiatives in other cultural contexts. ETHICS AND DISSEMINATION: This study received ethics approval from the Institutional Review Board of School of Public Health, Fudan University (IRB number: 2022-TYSQ-03-154). Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

Hungarian population norms for the 15D generic preference-accompanied health status measure.

OBJECTIVES: 15D is a generic preference-accompanied health status measure covering a wide range of health areas, including sensory functions. The aim of this study was to establish population norms for the 15D instrument in Hungary. METHODS: 2000 members of the Hungarian adult general population participated in an online cross-sectional survey in August 2021. The sample was broadly representative in terms of gender, age groups, highest level of education, geographical region, and settlement type. Index values were derived using the Norwegian 15D value set. In addition to providing population norms, mean index values were computed for 32 physical and 24 mental health condition groups. RESULTS: Most respondents (78.7%) reported problems in at least one 15D domain. The most problems were reported with sleeping (50.7%), followed by vitality (49.2%), distress (43.6%), discomfort and symptoms (31.2%), depression (31.1%), sexual activities (29.6%), breathing (28.1%), and vision (27.8%). The mean 15D index value was 0.810. With advancing age categories, the 15D index values showed an inverse U-shaped curve. Generally, mean index values in respondents with mental health conditions were lower [range 0.299 (post-traumatic stress disorder) to 0.757 (smoking addiction)] than those of respondents with physical conditions [range 0.557 (liver cirrhosis) to 0.764 (allergies)]. CONCLUSIONS: This study provided 15D population norms of the Hungarian general population; furthermore, this is the first study to provide population norms for the 15D in any country. The values established in this study can serve as benchmarks for evaluating efficacy outcomes in clinical trials, quantifying disease burden and identifying unmet needs.

Time perspective profile and self-reported health on the EQ-5D.

OBJECTIVES: Time perspective (TP) is a psychological construct that is associated with several health-related behaviours, including healthy eating, smoking and adherence to medications. In this study, we aimed to examine the associations of TP profile with self-reported health on the EQ-5D-5L and to detect which domains display response heterogeneity (cut-point shift) for TP. METHODS: We conducted a secondary analysis of EQ-5D-5L data from a representative general population sample in Hungary (n = 996). The 17-item Zimbardo Time Perspective Inventory was used to measure individuals' TP on five subscales: past-negative, past-positive, present-fatalist, present-hedonist and future. The associations between TP subscales and EQ-5D-5L domain scores, EQ VAS and EQ-5D-5L index values were analysed by using partial proportional odds models and multivariate linear regressions. RESULTS: Respondents that scored higher on the past-negative and present-fatalist and lower on the present-hedonist and future subscales were more likely to report more health problems in at least one EQ-5D-5L domain (p < 0.05). Adjusting for socio-economic and health status, three EQ-5D-5L domains exhibited significant associations with various TP subscales (usual activities: present-fatalist and future, pain/discomfort: past-negative and future, anxiety/depression: past-negative, present-fatalist, present-hedonist and future). The anxiety/depression domain showed evidence of cut-point shift. CONCLUSIONS: This study identified response heterogeneity stemming from psychological characteristics in self-reported health on the EQ-5D-5L. TP seems to play a double role in self-reported health, firstly as affecting underlying health and secondly as a factor influencing one's response behavior. These findings increase our understanding of the non-health-related factors that affect self-reported health on standardized health status measures.

Content validity of the EQ-5D-5L with skin irritation and self-confidence bolt-ons in patients with atopic dermatitis: a qualitative think-aloud study.

OBJECTIVES: Two bolt-on dimensions (skin irritation, self-confidence) have been developed for the EQ-5D-5L to improve its content validity and responsiveness in psoriasis. However, the two bolt-ons are not strictly psoriasis-specific and are potentially relevant in other skin conditions. This study aims to explore the content validity of the EQ-5D-5L with two bolt-ons in patients with atopic dermatitis (AD). METHODS: In 2021-2022, qualitative, semi-structured interviews were conducted with 20 adult AD patients at a university dermatology clinic in Hungary. We aimed for a heterogeneous sample in terms of age, gender, education and disease severity. Patients completed the EQ-5D-5L with two bolt-ons using a think-aloud protocol. Probing questions were posed to investigate item relevance, potential conceptual overlaps, missing concepts and the appropriateness of the recall period. Interview transcripts were subjected to thematic analysis. RESULTS: The EQ-5D-5L with the two bolt-ons covered the most important aspects of health-related quality of life in AD patients. Most patients found both the skin irritation and self-confidence bolt-ons relevant. Fifteen potential missing concepts were identified, but only two (social relationships, judgement by others) were identified by more than one patient. A smaller conceptual overlap was found between the skin irritation and pain/discomfort dimensions in 7 patients (35%). Half the patients expressed a preference for a recall period of 1 week rather than of 'today'. CONCLUSIONS: The EQ-5D-5L with skin irritation and self-confidence bolt-ons showed good relevance, comprehensiveness and comprehensibility in patients with AD. However, in terms of comprehensiveness, social relationships and judgement by others (stigma) may be missing from the questionnaire.

Financial Toxicity Experiences of Patients With Cancer in Indonesia: An Interpretive Phenomenological Analysis.

OBJECTIVES: Financial toxicity (FT) is an important adverse effect of cancer. Recent systematic reviews have shown that FT may lead to treatment nonadherence and impaired health-related quality of life, both of which may adversely influence the survival rates of patients. However, less is known about how patients endure FT, particularly in low- and middle-income countries. The purpose of this study was to explore how patients with cancer experience and cope with FT in Indonesia. METHODS: Semistructured in-depth interviews were conducted to explore the experiences of Indonesian patients with cancer. Qualitative data were analyzed using interpretive phenomenological analysis approach. We purposefully recruited 8 patients undergoing active treatment (aged 27-69 years) who had been diagnosed of cancer over 5 years before and possessed health insurance at the time of diagnosis. RESULTS: We identified 2 main themes: (1) the experienced financial burden, with subthemes underinsurance, out-of-pocket nonhealthcare cancer-related costs, and negative income effect from employment disruption, and (2) the financial coping strategies, with subthemes reallocating household budget, seeking family support, rationalizing treatment decisions, and topping up insurance for family members. CONCLUSIONS: This is the first interpretive phenomenological study on FT in the literature and the first qualitative FT study in Indonesia. Our findings provide insight into the occurrence of FT and coping strategies used by Indonesian patients with cancer. The subjective experiences of patients may be considered to further improve oncology care, support the need for measurement of FT, and provide mitigation programs for patients.

Real-World Experience with Cemiplimab Treatment for Advanced Cutaneous Squamous Cell Carcinoma-A Retrospective Single-Center Study.

BACKGROUND: The systemic treatment of advanced cutaneous squamous cell carcinoma (cSCC) has seen significant developments in recent years. The anti-PD1 inhibitor cemiplimab has demonstrated efficacy in clinical trials, but real-world data are still limited. Here, we aimed to evaluate the efficacy and the safety of cemiplimab in a real-world clinical setting. METHODS: A retrospective analysis was carried out for all patients who received at least two doses of cemiplimab at our department between February 2020 and January 2023. Progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), the disease control rate (DCR) and adverse events (AEs) were evaluated. RESULTS: Twenty-five patients were included with a median age of 78 (65-82) years. The median treatment duration was 48 (16-72) weeks. Five (20%) patients were immunocompromised. Sixteen patients (64%) developed AEs, including 36% serious AEs (SAEs) of grade ≥ 3. Six patients (24%) were withdrawn from treatment due to the occurrence of AEs. Among the 25 patients, 52% showed an objective response (3 complete and 10 partial responses), 76% had controlled disease and 24% experienced progression. Among the five immunocompromised patients, the ORR was 60%, while the DCR was 80%. CONCLUSIONS: This retrospective real-world study revealed that locally advanced or metastatic cSCC could be effectively treated with cemiplimab even in elderly, polymorbid and immunocompromised patients.

Societal costs and health related quality of life in adult atopic dermatitis.

BACKGROUND: Cost-of-illness studies are widely used for healthcare decision-making in chronic conditions. Our aim was to assess the cost-of-illness of adult atopic dermatitis (AD) from the societal perspective in Hungary. METHODS: We conducted a multicentre, cross-sectional questionnaire survey between February 2018 and January 2021. Data was collected from consecutive AD patients aged ≥ 18 years and their physicians at dermatology departments in Hungary. We calculated direct and indirect costs, including costs for treatments, outpatient visits, hospital admissions, informal care, travel costs and productivity loss. To assess indirect costs, the Work Productivity and Activity Impairment (WPAI) questionnaire was used to collect data, and costs were estimated with the human capital approach. Generalized linear model was used to analyse predictors of total, direct and indirect costs. RESULTS: Altogether 218 patients completed the survey (57.8% female) with an average age of 31.3 (SD = 11.7). Patients' average Dermatology Life Quality Index (DLQI) score was 13.5 (SD = 8.5). According to Eczema Area and Severity Index (EASI) score, 2.3% (n = 5), 21.2% (n = 46), 54.4% (n = 118) and 22.1% (n = 48) had clear, mild, moderate, and severe AD, respectively. We found that the average total, direct medical, direct non-medical and indirect annual costs per patients were €4,331, €1,136, €747, and €2450, respectively, with absenteeism and presenteeism being the main cost drivers, accounting for 24% and 29% of the total cost of AD. A one-year longer disease duration led to, on average, 1.6%, and 4.2% increase in total and direct non-medical costs, respectively. Patients with worse health-related quality of life (higher DLQI score) had significantly higher total, direct medical, direct non-medical costs, and indirect costs. CONCLUSIONS: Our results indicate a substantial economic burden of AD from a societal perspective, mainly driven by productivity losses.

Psychometric properties and general population reference values for PROMIS Global Health in Hungary.

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 (rs = 0.71) and GPH T-scores with SF-36 physical health composite score (rs = 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.

Health utilities and willingness to pay in adult patients with coeliac disease in Hungary.

BACKGROUND: Coeliac disease (CD) is a life-long food-related disorder with a global prevalence of approximately 1%. Patients with CD often experience reduced health-related quality of life that could improve with a strict adherence to a gluten-free diet (GFD). OBJECTIVES: To obtain visual analogue scale (VAS), time trade-off (TTO) and willingness-to-pay (WTP) values amongst patients with CD. METHODS: In 2020-2021, a cross-sectional online survey was conducted amongst 312 adult CD patients in Hungary. Patients completed the Gastrointestinal Symptom Rating Scale (GSRS) and evaluated their current health and three hypothetical health state vignettes defined based on dietary adherence using VAS, conventional 10-year TTO and WTP. Multivariate regressions were used to explore the effect of patients' demographic and clinical characteristics on utility and WTP values. RESULTS: Mean VAS values for current health and 'CD with strict adherence to GFD', 'CD with loose adherence to GFD' and 'CD without GFD' hypothetical health states were 79.69 ± 18.52, 85.36 ± 16.18, 62.44 ± 19.91 and 36.69 ± 25.83, respectively. Corresponding mean TTO utilities were: 0.90 ± 0.19, 0.91 ± 0.20, 0.87 ± 0.23 and 0.76 ± 0.29. Mean annual WTP values for returning to full health were: €845 ± 1077, €648 ± 1002, €862 ± 1135 and €1251 ± 1496. Older age at diagnosis, male sex, more severe gastrointestinal symptoms (GSRS) and having comorbidities were associated with lower VAS and TTO or higher WTP values for current own health (p < 0.05). CONCLUSION: This is the first study to report TTO utilities for CD health states. Strict adherence to the GFD may result in substantial health gains in symptomatic patients. Utilities and WTP results can be used to estimate benefits of GFD in cost-utility and cost-benefit analyses.

Hungarian PROMIS-29+2: psychometric properties and population reference values.

OBJECTIVES: This study aims to assess psychometric properties of the Hungarian PROMIS-29+2 profile measure and provide general population reference values for Hungary. METHODS: An adult general population sample (n = 1700) completed PROMIS-29+2 v2.1 in an online survey. The following psychometric properties were assessed: floor and ceiling effect, convergent validity with SF-36v1 domains, internal consistency (McDonald's omega), unidimensionality, local independence, monotonicity, graded response model (GRM) fit and differential item functioning (DIF). Age- and gender-specific reference values were established using the US item calibrations. RESULTS: Depending on scale orientation, high floor or ceiling effects were observed for all domains (25.2-60.7%) except for sleep disturbance. McDonald's omega for domains ranged from 0.87-0.97. Unidimensionality, local independence and monotonicity were supported and the GRM adequately fitted for all but one domains. The sleep disturbance domain demonstrated item misfit, response level disordering and low discrimination ability, particularly for item Sleep116 ('refreshing sleep'). Strong correlations were observed between PROMIS-29+2 and corresponding SF-36 domains (rs=│0.60│ to │0.78│). No DIF was detected for most sociodemographic characteristics. Problems with physical function, pain interference and social roles tended to increase, whereas problems with anxiety, depression, fatigue and cognitive function declined with age (p < 0.01). In all domains except for cognitive function, more health problems occurred in females than in males (p < 0.001). CONCLUSION: The Hungarian PROMIS-29+2 shows satisfactory psychometric properties; however, the sleep disturbance domain substantially underperforms that requires further attention. Population reference values were generated that facilitate the interpretation of health outcomes in various patient populations.

A Direct Comparison of the Measurement Properties of EQ-5D-5L, PROMIS-29+2 and PROMIS Global Health Instruments and EQ-5D-5L and PROPr Utilities in a General Population Sample.

OBJECTIVES: We aimed to compare measurement properties of the 5-level version of EQ-5D (EQ-5D-5L) and 2 Patient-Reported Outcomes Measurement Information System (PROMIS) short forms, PROMIS-29+2 and PROMIS Global Health (PROMIS-GH-10), and of EQ-5D-5L and PROMIS-preference scoring system (PROPr) utilities. METHODS: A cross-sectional survey was conducted in a general population sample in Hungary (N = 1631). We compared the following measurement properties at the level of items, domains, and utilities, the latter using corresponding US value sets: ceiling and floor, informativity (Shannon's indices), agreement, convergent, and known-group validity. For the analyses, PROMIS items/domains were matched to EQ-5D-5L domains that cover similar concepts of health. RESULTS: The majority of PROMIS items showed enhanced distributional characteristics, including lower ceilings and higher informativity than the EQ-5D-5L. Good convergent validity was established between EQ-5D-5L and PROMIS domains capturing similar aspects of health. Mean EQ-5D-5L utilities were substantially higher than those of PROPr (0.864 vs 0.535). EQ-5D-5L utilities correlated moderately or strongly with PROPr (r = 0.61), PROMIS-GH-10 physical (r = 0.68), and mental health summary scores (r = 0.53). EQ-5D-5L utilities decreased with age, whereas PROPr utilities slightly increased with age. EQ-5D-5L utilities discriminated significantly better in 12/28 (ratio of F-statistics) and 18/26 (area under the receiver-operating characteristics curve ratio) known groups defined by age, self-perceived health status, and self-reported physician-diagnosed health conditions, including hypertension, diabetes, coronary heart disease, chronic kidney disease, and stroke. CONCLUSIONS: This study provides comparative evidence on the measurement properties of EQ-5D-5L, PROMIS-29+2, and PROMIS-GH-10 and informs decisions about the choice of instruments in population health surveys for assessment of patients' health and for cost-utility analyses.

A head-to-head comparison of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample.

BACKGROUND: The EQ-5D-5L and 15D are generic preference-accompanied health status measures with similar dimensions. In this study, we aim to compare the measurement properties of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample. METHODS: In August 2021, an online cross-sectional survey was conducted in a representative adult general population sample (n = 1887). The EQ-5D-5L and 15D descriptive systems and index values were compared in terms of ceiling and floor, informativity (Shannon's Evenness index), agreement, convergent and known-groups validity for 41 chronic physical and mental health conditions. Danish value sets were used to compute index values for both instruments. As a sensitivity analysis, index values were also estimated using the Hungarian EQ-5D-5L and Norwegian 15D value sets. RESULTS: Overall, 270 (8.6%) and 1030 (3.4*10-6%) unique profiles occurred on the EQ-5D-5L and 15D. The EQ-5D-5L dimensions (0.51-0.70) demonstrated better informativity than those of 15D (0.44-0.69). EQ-5D-5L and 15D dimensions capturing similar areas of health showed moderate or strong correlations (0.558-0.690). The vision, hearing, eating, speech, excretion and mental function 15D dimensions demonstrated very weak or weak correlations with all EQ-5D-5L dimensions, which may indicate potential room for EQ-5D-5L bolt-ons. The 15D index values showed lower ceiling than the EQ-5D-5L (21% vs. 36%). The mean index values were 0.86 for the Danish EQ-5D-5L, 0.87 for the Hungarian EQ-5D-5L, 0.91 for the Danish 15D and 0.81 for the Norwegian 15D. Strong correlations were found between the index values (Danish EQ-5D-5L vs. Danish 15D 0.671, Hungarian EQ-5D-5L vs. Norwegian 15D 0.638). Both instruments were able to discriminate between all chronic condition groups with moderate or large effect sizes (Danish EQ-5D-5L 0.688-3.810, Hungarian EQ-5D-5L 1.233-4.360, Danish 15D 0.623-3.018 and Norwegian 15D 1.064-3.816). Compared to the 15D, effect sizes were larger for the EQ-5D-5L in 88-93% of chronic condition groups. CONCLUSIONS: This is the first study to compare the measurement properties of the EQ-5D-5L and 15D in a general population sample. Despite having 10 fewer dimensions, the EQ-5D-5L performed better than the 15D in many aspects. Our findings help to understand the differences between generic preference-accompanied measures and support resource allocation decisions.

Comparing the psychometric properties of the EQ-5D-3L and EQ-5D-5L descriptive systems and utilities in atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is a common chronic inflammatory skin disorder affecting up to 10% of adults. The EQ-5D is the most commonly used generic preference-accompanied measure to generate quality-adjusted life years (QALYs) for economic evaluations. OBJECTIVES: We aimed to compare psychometric properties of the three-level and five-level EQ-5D (EQ-5D-3L and EQ-5D-5L) in adult patients with AD. METHODS: In a multicentre cross-sectional study, 218 AD patients with a broad range of severity completed the EQ-5D-3L, EQ-5D-5L, Dermatology Life Quality Index (DLQI) and Skindex-16. Disease severity outcomes included the Investigator Global Assessment, Eczema Area and Severity Index and the objective SCORing Atopic Dermatitis. RESULTS: A good agreement was established between the two EQ-5D versions with an intraclass correlation coefficient of 0.815 (95% CI 0.758-0.859, p < 0.001). Overall, 33 different health state profiles occurred in the EQ-5D-3L and 84 in the EQ-5D-5L. Compared to the EQ-5D-3L, ceiling effect was reduced for the mobility, self-care, usual activities and pain/discomfort dimensions by 4.6-11.5%. EQ-5D-5L showed higher average relative informativity (Shannon's evenness index: 0.64 vs. 0.59). EQ-5D-5L demonstrated better convergent validity with EQ VAS, DLQI and Skindex-16. The two measures were similar in distinguishing between groups of patients based on disease severity and skin-specific quality of life with a moderate or large effect size (η2 = 0.083-0.489). CONCLUSION: Both instruments exhibited good psychometric properties in AD; however, the EQ-5D-5L was superior in terms of ceiling effects, informativity and convergent validity. We recommend the use of the EQ-5D-5L to measure health outcomes in clinical settings and for QALY calculations in AD.

Comprehensive Score for Financial Toxicity and Health-Related Quality of Life in Patients With Cancer and Survivors: A Systematic Review and Meta-Analysis.

OBJECTIVES: Financial toxicity is recognized as an important adverse effect of cancer treatment that may decrease patients' health-related quality of life (HRQOL). We aim to perform a systematic review and meta-analysis on studies investigating the association of HRQOL and financial toxicity measured with the Comprehensive Score for Financial Toxicity in patients with cancer and survivors. METHODS: A systematic literature search was completed in PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, and PsycInfo (last update April 2022). Methodological quality of included studies was assessed using the Appraisal Tool for Cross-Sectional Studies and the Critical Appraisal Skills Program Cohort Study Checklist. Where possible, study outcomes were pooled by random-effects meta-analysis. RESULTS: Thirty-one studies were included with a combined sample of 13 481 patients and survivors with more than 25 cancer types from 9 countries. Nineteen different validated HRQOL instruments were used in these studies, with the Functional Assessment of Cancer Therapy - General (n = 9), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (n = 5), and EQ-5D (n = 5) being the most common. All but one included studies reported that higher financial toxicity was significantly associated with worse HRQOL. Ten HRQOL domains were correlated with financial toxicity, including physical health (r = 0.34-0.66), social health (r = 0.16-0.55), mental health (r = 0.21-0.54), and daily functioning (r = 0.23-0.52). The meta-analysis indicated a moderate correlation between financial toxicity and overall HRQOL as measured by the Functional Assessment of Cancer Therapy instruments (r = 0.49, 95% confidence interval 0.44-0.54). CONCLUSIONS: This is the first systematic review and meta-analysis to summarize the literature on the association of financial toxicity and HRQOL in patients with cancer and survivors. Our findings substantiate financial toxicity as a relevant outcome of cancer care that is associated with a decline of HRQOL.

Value Set for the EQ-5D-Y-3L in Hungary.

BACKGROUND: The Hungarian health technology assessment guidelines recommend the use of the EuroQol instrument family in quality-adjusted life-year calculations. However, no national value set exists for the EQ-5D-Y-3L or any other youth-specific instrument. OBJECTIVE: This study aims to develop a national value set of the EQ-5D-Y-3L for Hungary based on preferences of the general adult population. METHODS: This study followed the international valuation protocol for the EQ-5D-Y-3L. Two independent samples, representative of the Hungarian general adult population in terms of age and sex were recruited to complete online discrete choice experiment (DCE) tasks and composite time trade-off (cTTO) tasks by computer-assisted personal interviews. Adults valued hypothetical EQ-5D-Y-3L health states considering the health of a 10-year-old child. DCE data were modelled using a mixed logit model with random-correlated coefficients. Latent DCE utility estimates were mapped onto mean observed cTTO utilities using ordinary least squares regression. RESULTS: Overall, 996 and 200 respondents completed the DCE and cTTO surveys, respectively. For each domain, the value set resulted in larger utility decrements with more severe response levels. The relative importance of domains by level 3 coefficients was as follows: having pain or discomfort > feeling worried, sad or unhappy > mobility > doing usual activities > looking after myself. Overall, 12.3% of all health states had negative utilities in the value set, with the worst health state having the lowest predicted utility of - 0.485. CONCLUSION: This study developed a national value set of the EQ-5D-Y-3L for Hungary. The value set enables to evaluate the cost utility of health technologies for children and adolescents based on societal preferences in Hungary.

Analyzing the Pain/Discomfort and Anxiety/Depression Composite Domains and the Meaning of Discomfort in the EQ-5D: A Mixed-Methods Study.

OBJECTIVES: The EQ-5D has 2 composite domains: pain/discomfort (PD) and anxiety/depression (AD). This study aims to explore how respondents use the composites to self-report health and what the meaning of discomfort is in the EQ-5D for the general public. METHODS: Both qualitative and quantitative data were collected in an online cross-sectional survey involving a nationally representative general population sample in Hungary (n = 1700). Respondents completed the 5-level version of EQ-5D, followed by the composites split into individual subdomains. Open-ended questions were asked to explore respondents' interpretations and experiences of discomfort. RESULTS: Six different response behaviors were identified in the composites: "uniform" (21%-32%), "most severe" (30%-34%), "least severe" (16%-23%), "average" (2%-4%), "synergistic" (4%-5%), and "inconsistent" (13%-15%). Compared with the individual subdomains, many respondents under-reported their problems on both composites (PD 16%-22% and AD 6%-13%, P < .05). In respondents who scored differently in the 2 separate domains, mainly problems with the first subdomain determined responses in the composites (PD 66% and AD 61%). The discomfort subdomain in the EQ-5D captured more than 100 different problems, including pain, nonpain physical discomfort (eg, tiredness, dizziness, and nausea), and psychological discomfort (eg, anxiety, nervousness, and sadness). Women, older adults, and those in worse general health status more often considered discomfort as pain (P < .05). CONCLUSIONS: We found empirical evidence of measurement error in the composite responses on the EQ-5D, including under- and inconsistent reporting, ordering effects, potential differential item functioning, and interdomain dependency. Our findings contribute new knowledge to the development of new and refinement of existing self-reported health status instruments, also beyond the EQ-5D.