Sociodemographic determinants of vaccination and willingness to pay for COVID-19 vaccines in Hungary, results of a cross-sectional online questionnaire.

BACKGROUND: Several different coronavirus disease (COVID-19) vaccines were authorized and distributed all over the world, including Hungary, but vaccination rates and acceptance of the different vaccines varied through 2021 and subsequent years. In Hungary Western vaccines and the Chinese and Russian vaccines were available in early 2021. Understanding preference and willingness to pay (WTP) for the COVID-19 vaccine could provide information for policy decision making to control the COVID-19 pandemic. We aimed to assess the socio-demographic factors influencing the COVID-19 vaccination and to analyse individual preferences for the available COVID-19 vaccines in Hungary. METHODS: A cross-sectional online questionnaire survey was conducted between 25-05-2021 and 08-06-2021 exploring the vaccine acceptance and WTP for vaccination in the Hungarian general population. To assess the preferences towards the different vaccines available in Hungary at the time of the study, we used a multi-step WTP task. RESULTS: Altogether 2,000 respondents filled out our survey, with the average age of 49.1 (SD = 15.3), out of whom 370 respondents (18.5%) stated that they already had a COVID-19 infection. Age above 65 years, male gender, higher level of education, higher income and residence in the capital or county seats were associated with a higher probability of vaccination. The average WTP ranged from 14.2 to 30.3 EUR for the different vaccine types. CONCLUSIONS: Males, respondents with higher education and income stated a higher WTP value for all vaccines. Better socioeconomic status increased both vaccination coverage and willingness to pay for vaccines.

Population normative data for OxCAP-MH capability scores.

AIM: The study aims to establish the first set of normative data for OxCAP-MH capability instrument and to examine its association with sociodemographic and anxiety/depression severity variables. METHODS: A large-sample cross-sectional online survey was conducted among the Hungarian adult general population in 2021. OxCAP-MH standardized mean scores were compared across age, sex, education level, residence, employment, and marital status. Linear regression analysis was employed to determine the impact of sociodemographic and anxiety/depression severity on the OxCAP-MH score. RESULTS: In total, N = 2000 individuals completed the survey. The sample mean age was 47.1, with female majority (53.4%). Most respondents had completed primary education (51%), were active on labour market (52.4%), lived in larger cities (70.0%), and were married/in relationship (61.1%). Nearly half of the participants reported experiencing depression (48.5%), anxiety (44.3%), and 38.6% reported having both. The mean OxCAP-MH score for the total sample was 67.2 (SD = 14.4), the highest in the non-depressed (74.4) and non-anxious (73.6) subgroups, the lowest among those with extremely severe depression (45.0) and severe anxiety (47.7). Regression results indicated that older individuals (by ß = 0.1), males (ß = 2.3), those with secondary or higher education (ß = 2.7 and 4.5) and students (ß = 6.8) had significantly (p<0.01) higher mental capabilities. Respondents with mild, moderate, severe, or extremely severe depression (ß = -6.6, -9.6, -13.8, -18.3) and those with mild, moderate, or severe anxiety (ß = -4.1, -7.7, -10.3) had lower capability scores. CONCLUSION: The OxCAP-MH instrument effectively differentiated capabilities across sociodemographic groups and highlighting the impact of depression and anxiety severity on general population's mental capability.

Monetary valuation of one year in full capability and health based on demographics, health status, income and well-being.

BACKGROUND: Budget constraints in health-care systems have led to the popularity of Cost Effectiveness Thresholds (CET) to achieve efficient allocation of resources. The capability approach has been hailed for its potentially richer evaluative capabilities compared to the QALY in terms of thresholds. Extensive research, however, is still limited. RESEARCH DESIGN AND METHODS: This study estimated the monetary value of a year in full capability (YFC) and compared it to monetary value of a QALY for the Hungarian population. Data was collected from a large, cross sectional, representative online survey on the adult Hungarian population. Applying the wellbeing valuation method, health, capability, and income were then regressed against wellbeing to estimate 'shadow prices' for one QALY and YFC controlling for gender, age, employment, education, marital and social support. To examine 'core' regression coefficients, a robustness check was conducted. RESULTS: Health (VAS) and capability (ICECAP-A) had a positive and significant effect on Subjective Well-Being. The monetary values of one QALY and one YFC were 39 459 EUR and 58 148 EUR respectively. CONCLUSIONS: These tools provide a systematic approach to determining 'compensating income' for certain illnesses, disabilities and levels of pain. The capability approach shown to be broader than the QALY.

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

OBJECTIVES: This study aimed to provide subjective wellbeing (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 wellbeing instruments. The concentration index (CI) was used to measure the degree of income-related inequality in wellbeing. 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 wellbeing instruments and analyze wellbeing 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.

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.

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.

A concept for multi-winner tenders for medicinal products with balancing between efficient prices, long-term competition and sustainability of supply.

Achieving price efficiency via tenders, the sustainability of competition, and the prevention of shortages are hot topics in the debates about shaping the pharmaceutical markets. Single-winner tenders receive growing criticism for concentrating on achieving low prices at the expense of the long-term maintenance of a competitive pharmaceutical industry, the security of continuous supply, and disregarding the therapeutic needs of patient populations with specific conditions. This paper aims at drafting a concept to assist the design of multi-winner tenders for medicinal products with a focus on supply and sales guarantees, price efficiency, and equity in access. The concept shall be generally applicable to all kinds of medicinal products including generics, biosimilars, and on-patent products in the out- and in-patient sector. Principles for multi-winner tenders for medicinal products are set and a number of delimitations are made in order to get rid of factors that prevent clairvoyance amid the various pricing and reimbursement systems when designing a concept. The steps to plan and implement a multi-winner tendering procedure are drafted on the basis of the defined principles. The tender should consist of planning, bidding, preparation, sales, and evaluation phases. Pharmaceutical companies shall make bids with price and quantity pairs, which shall be ranked by prices and if applicable then taking into account other factors. The tenderer shall predefine market shares to the various places of the ranking. A double ceiling shall be applicable for the sales of the winners: their sales must not exceed their quantity offer and the predefined market share applicable to their place in the ranking. The implementation of the concept will require the careful adjustment of the tender conditions to the specificities of the pharmaceutical market concerned on the one hand and to the local pricing and reimbursement system on the other hand.

The identification of economically relevant health and social care services for mental disorders in the PECUNIA project.

BACKGROUND: Health economic research is still facing significant problems regarding the standardization and international comparability of health care services. As a result, comparative effectiveness studies and cost-effectiveness analyses are often not comparable. This study is part of the PECUNIA project, which aimed to improve the comparability of economic evaluations by developing instruments for the internationally standardized measurement and valuation of health care services for mental disorders. The aim of this study was to identify internationally relevant services in the health and social care sectors relevant for health economic studies for mental disorders. METHODS: A systematic literature review on cost-of-illness studies and economic evaluations was conducted to identify relevant services, complemented by an additional grey literature search and a search of resource use measurement (RUM) questionnaires. A preliminary long-list of identified services was explored and reduced to a short-list by multiple consolidation rounds within the international research team and an external international expert survey in six European countries. RESULTS: After duplicate removal, the systematic search yielded 15,218 hits. From these 295 potential services could be identified. The grey literature search led to 368 and the RUM search to 36 additional potential services. The consolidation process resulted in a preliminary list of 186 health and social care services which underwent an external expert survey. A final consolidation step led to a basic list of 56 services grouped into residential care, daycare, outpatient care, information for care, accessibility to care, and self-help and voluntary care. CONCLUSIONS: The initial literature searches led to an extensive number of potential service items for health and social care. Many of these items turned out to be procedures, interventions or providing professionals rather than services and were removed from further analysis. The resulting list was used as a basis for typological coding, the development of RUM questionnaires and corresponding unit costs for international mental health economic studies in the PECUNIA project.

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 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.

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.

Development of an Instrument for the Assessment of Health-Related Multi-sectoral Resource Use in Europe: The PECUNIA RUM.

BACKGROUND: Measuring objective resource-use quantities is important for generating valid cost estimates in economic evaluations. In the absence of acknowledged guidelines, measurement methods are often chosen based on practicality rather than methodological evidence. Furthermore, few resource-use measurement (RUM) instruments focus on the measurement of resource use in multiple societal sectors and their development process is rarely described. Thorn and colleagues proposed a stepwise approach to the development of RUM instruments, which has been used for developing cost questionnaires for specific trials. However, it remains unclear how this approach can be translated into practice and whether it is applicable to the development of generic self-reported RUM instruments and instruments measuring resource use in multiple sectors. This study provides a detailed description of the practical application of this stepwise approach to the development of a multi-sectoral RUM instrument developed within the ProgrammE in Costing, resource use measurement and outcome valuation for Use in multi-sectoral National and International health economic evaluAtions (PECUNIA) project. METHODS: For the development of the PECUNIA RUM, the methodological approach was based on best practice guidelines. The process included six steps, including the definition of the instrument attributes, identification of cost-driving elements in each sector, review of methodological literature and development of a harmonized cross-sectorial approach, development of questionnaire modules and their subsequent harmonization. RESULTS: The selected development approach was, overall, applicable to the development of the PECUNIA RUM. However, due to the complexity of the development of a multi-sectoral RUM instrument, additional steps such as establishing a uniform methodological basis, harmonization of questionnaire modules and involvement of a broader range of stakeholders (healthcare professionals, sector-specific experts, health economists) were needed. CONCLUSION: This is the first study that transparently describes the development process of a generic multi-sectoral RUM instrument in health economics and provides insights into the methodological aspects and overall validity of its development process.

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.

Time trade-off health state utility values for depression: a systematic review and meta-analysis.

PURPOSE: This study aims to systematically review the literature on health utility in depression generated by time trade-off (TTO) method and to compare health state vignettes. METHODS: Systematic literature search was conducted following PRISMA guideline in 2020 November (updated in 2022 March) in Pubmed, Web of Science, PsycInfo, and Cochrane Database of Systematic Reviews. Random effect meta-analysis was conducted to pool vignette-based utility values of mild, moderate, and severe depression and to compare the preferences of depressed and nondepressed population. RESULTS: Overall, 264 records were found, 143 screened by title and abstract after removing duplicates, 18 assessed full text, and 14 original publications included. Majority of the studies (n = 9) used conventional TTO method, and most of the studies (n = 8) applied 10-year timeframe. Eight studies evaluated self-experienced health (own-current depression). Six studies assessed vignette-based health states of remitted, mild, moderate, and severe depression, half of them applied McSad measure based health description. Altogether, 61 different utility values have been cataloged, mean utility of self-experienced depression states (n = 33) ranged between 0.89 (current-own depression) and 0.24 (worst experienced depression). Pooled utility estimates for vignette-based mild, moderate, and severe depression was 0.75, 0.66 and 0.50, respectively. Meta-regression showed that severe depression (ß = -0.16) and depressed sample populations (ß = -0.13) significantly decrease vignette-based utility scores. CONCLUSION: Our review revealed extent heterogeneity both in TTO methodology and health state vignette development. Patient's perception of depression health states was worse than healthy respondents.

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.