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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., Competing Interests: Competing interests: ZM, FR, ZY and NL are members of the EuroQol Group., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2023. The Author(s).)

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., (© 2023. The Author(s).)

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., (© 2023. The Author(s).)

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.

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., (© 2023. The Author(s).)

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., (© 2023. BioMed Central Ltd., part of Springer Nature.)

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 (r s= │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., (© 2023. The Author(s).)

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., (Copyright © 2023. Published by Elsevier Inc.)

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., (© 2023. The Author(s).)

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., (Copyright © 2022 International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. All rights reserved.)

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 (η 2  = 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., (© 2022. The Author(s).)

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., (Copyright © 2022. Published by Elsevier Inc.)

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., (© 2022. The Author(s).)

Background: Few studies have investigated health-related quality of life (HRQoL) in patients with atopic dermatitis (AD) during the COVID-19 pandemic., Objectives: The objectives of this study were to compare HRQoL in adult AD patients before and during the pandemic and to assess measurement performance of 4 HRQoL measures., Methods: Between 2018 and 2021, a multicenter, cross-sectional survey was conducted, involving 218 adult AD patients. Health-related quality of life outcomes included the EQ-5D-5L, Skindex-16, Dermatology Life Quality Index (DLQI), and DLQI-Relevant (DLQI-R). Severity was measured using objective SCORing Atopic Dermatitis, Eczema Area and Severity Index, and Investigator Global Assessment., Results: The mean ± SD EQ-5D-5L utility, Skindex-16, DLQI, and DLQI-R scores were 0.82 ± 0.22, 56.84 ± 27.46, 13.44 ± 8.46, and 13.76 ± 8.60, respectively. The patients reported more problems during the pandemic ( P < 0.05) regarding pain/discomfort (odds ratio [OR], 1.78), worrying (OR, 1.89), concerns about persistence/reoccurrence of disease (OR, 1.88), and social relationships (OR, 1.69). The HRQoL outcomes showed strong correlations with each other (range of rs , |0.69| to |0.99|). The Skindex-16, DLQI, and DLQI-R were able to discriminate between severity groups with large (η 2 = 0.20-0.23), whereas the EQ-5D-5L with moderate effect sizes (η 2 = 0.08-0.11)., Conclusions: Atopic dermatitis patients experienced significantly more problems in some areas of HRQoL during the pandemic. The EQ-5D-5L, Skindex-16, DLQI, and DLQI-R demonstrated good convergent and known-group validity and can be suitable instruments for HRQoL assessment in clinical and research settings., Competing Interests: Related to this work, M.S. has received support for travel to meetings for the study or other purposes from Lilly. Outside the submitted work, M.S. has received fees for board membership, consultancy, or lecturing from Janssen, Sanofi, Egis, Novartis, Leo Pharma, and Lilly. Outside the submitted work, A.S. has received fees for board membership or lecturing from Janssen, AbbVie, Lilly, and Sanofi. F.R. is a member of the EuroQol Group. Views expressed in the article are those of the authors and are not necessarily those of the EuroQol Research Foundation. K.K.'s work was supported by the Semmelweis 250+ Excellence PhD Scholarship (EFOP-3.6.3-VEKOP-16-2017-00009). Á.S.'s work was supported by the Higher Education Institutional Excellence Program 2020 of the Ministry of Innovation and Technology in the framework of the 'Financial and Public Services' research project (TKP2020-IKA-02) at the Corvinus University of Budapest. F.R.'s work was supported by the János Bolyai Research Scholarship of the Hungarian Academy of Sciences (BO/00304/21) and the New National Excellence Program of the Ministry for Innovation and Technology from the source of the National Research, Development and Innovation Fund (ÚNKP-21-5-CORVINUS-134). The other authors have no conflicts of interest to declare., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Contact Dermatitis Society.)

Objectives: A number of bolt-ons have been proposed for the EQ-5D, including two psoriasis-specific bolt-ons, skin irritation and self-confidence. The study investigates and compares the relevance and comprehensiveness of these psoriasis-specific bolt-ons and the EQ-5D-5L and explores the potential conceptual overlaps between the existing five dimensions and the two bolt-ons., Methods: Psoriasis patients were purposively sampled according to age and gender. Semi-structured interviews, where participants were asked to complete the EQ-5D-5L and the bolt-ons while thinking aloud, were conducted. Probes were used to investigate the thought processes of patients regarding the dimensions, wording, recall period and relevant concepts not captured by the EQ-5D-5L and bolt-ons. Data were analysed thematically. A focus group was used to confirm the findings., Results: Overall, 16 patients completed the interviews. Sixteen and fifteen patients considered skin irritation and self-confidence relevant areas to describe psoriasis problems. Three patients considered itching a form of discomfort, and thus, pointed out a potential overlap between pain/discomfort and skin irritation. Twelve patients reported overall 10 general health- or psoriasis-related concepts that are not captured by the EQ-5D-5L, including itching, social relationships and sex life. Eleven patients reported that the recall period of the EQ-5D-5L might be subject to bias because of the daily or within-day fluctuations of their symptoms., Conclusions: The skin irritation and self-confidence bolt-ons contribute to improve content validity of the EQ-5D-5L in patients with psoriasis. The qualitative approach taken in this study expands the existing methodological framework for the development and testing validity of bolt-ons for the EQ-5D., (© 2022. The Author(s).)

Introduction: Population norms are available for several generic health-related quality of life questionnaires, but rarely for disease- or specialty-specific questionnaires. The aim of our study was to calculate population norms for the Dermatology Life Quality Index (DLQI) score.., Areas Covered: We conducted an online self-completed questionnaire survey on a large sample of the general Hungarian adult population. Respondents' socio-demographic characteristics and dermatology-related quality of life aspects were recorded. A total of 2,001 participants completed the questionnaire, with the average age of 48.2 (SD = 16.6) years, half of the respondents in our sample (n = 981) reported long-standing health problems. The average DLQI score was 1.9 (SD = 4.0) with women having a higher average (2.0, SD = 3.9) than men (1.8, SD = 4.0; p = <0.001). The DLQI score differed among age-groups with younger people having relatively higher DLQI averages. When the multivariate linear regression model was applied, it showed that young age, lower income and unemployment status were associated with higher DLQI scores, while controlling for the existence of skin disease (p < 0.05)., Expert Opinion: This study established DLQI population norms among the general population, which may provide a reference point in health-policy and financing decision-making.

The pathomechanism of various autoimmune diseases is known to be associated with the altered function of programmed cell death 1/programmed cell death ligand 1 (PD-1/PD-L1) axis. We aimed to investigate the role of this pathway and inflammatory cell markers in subtypes of cutaneous lupus erythematosus (CLE): discoid lupus erythematosus (DLE), subacute CLE (SCLE) and toxic epidermal necrolysis (TEN)-like lupus, a hyperacute form of acute CLE (ACLE). Ten skin biopsy samples from 9 patients were analyzed with immunohistochemistry regarding the following markers: CD3, CD4, CD8, Granzyme B, CD123, CD163, PD-1, PD-L1. Our group consisted of 4 SCLE (2 idiopathic (I-SCLE) and 2 PD-1 inhibitor-induced (DI-SCLE)), 4 DLE and 1 TEN-like lupus cases. From the latter patient two consecutive biopsies were obtained 1 week apart. Marker expression patterns were compared through descriptive analysis. Higher median keratinocyte (KC) PD-L1 expression was observed in the SCLE group compared to the DLE group (65% and 5%, respectively). Medians of dermal CD4, Granzyme B (GB), PD-1 positive cell numbers and GB+/CD8 + ratio were higher in the DLE group than in the SCLE group. The I-SCLE and DI-SCLE cases showed many similarities, however KC PD-L1 expression and dermal GB positive cell number was higher in the former. The consecutive samples of the TEN-like lupus patient showed an increase by time within the number of infiltrating GB+ cytotoxic T-cells and KC PD-L1 expression (from 22 to 43 and 30%-70%, respectively). Alterations of the PD-1/PD-L1 axis seems to play a role in the pathogenesis of CLE., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Király, Szepesi, Sebestyén, Kuroli, Rencz, Tóth, Bokor, Szakonyi, Medvecz and Hidvégi.)

Real-world evidence plays an important role in the assessment of efficacy and safety of novel therapies. The increasing use of immune checkpoint inhibitors (ICIs) in patients with advanced melanoma has led to notably improved clinical outcomes, while they are also associated with immune-related adverse events (irAEs). The majority of the available data are based on clinical trials, where the investigated subjects often do not adequately represent the general patient population of the everyday practice. Although there is a niche of objective biomarkers for the future treatment response of ICIs, certain studies suggest that irAEs may be predictive. The aim of this study was to carry out a retrospective analysis of treatment data from patients with advanced melanoma, treated with a single anti-PD-1 agent (pembrolizumab or nivolumab) during a 77-month-long period. Treatment efficacy and occurrence of adverse events were analyzed to identify potential predictive markers. Primary and secondary endpoints were the overall survival (OS) and progression-free survival (PFS). In our cohort, we demonstrated that the occurrence of more than one irAE showed a correlation with response to PD-1 ICI therapy and improved the OS and PFS. Our study suggests, that the grade of toxicity of the irAE may affect the survival rate.

Background: Dermatology Life Quality Index (DLQI) scores are used in many countries as access and reimbursement criteria for costly dermatological treatments. In this study we examined how time trade-off (TTO) utility valuations made by individuals from the general population are related to combinations of DLQI severity levels characterizing dermatologically relevant health states, with the ultimate purpose of developing a value set for the DLQI., Methods: We used data from an online cross-sectional survey conducted in Hungary in 2020 (n = 842 after sample exclusions). Respondents were assigned to one of 18 random blocks and were asked to provide 10-year TTO valuations for the corresponding five hypothetical health states. To analyze the relationship between DLQI severity levels and utility valuations, we estimated linear, censored, ordinal, and beta regression models, complemented by two-part scalable models accommodating heterogeneity effects in respondents' valuation scale usage. Successive severity levels (0-3) of each DLQI item were represented by dummy variables. We used cross-validation methods to reduce the initial set of 30 dummy variables and improve model robustness., Results: Our final, censored linear regression model with 13 dummy variables had R 2  = 0.136, thus accounting for 36.9% of the incremental explanatory power of a maximal (full-information) benchmark model (R 2  = 0.148) over the uni-dimensional model (R 2  = 0.129). Each DLQI item was found to have a negative effect on the valuation of health states, yet this effect was largely heterogeneous across DLQI items, and the relative contribution of distinctive severity levels also varied substantially. Overall, we found that the social/interpersonal consequences of skin conditions (in the areas of social and leisure activities, work and school, close personal relationships, and sexuality) had roughly twice as large disutility impact as the physical/practical aspects., Conclusions: We have developed an experimental value set for the DLQI, which could prospectively be used for quantifying the quality-adjusted life years impact of dermatological treatments and serve as a basis for cost-effectiveness analyses. We suggest that, after validation of our main results through confirmatory studies, population-specific DLQI value sets could be developed and used for conducting cost-effectiveness analyses and developing financing guidelines in dermatological care., (© 2022. The Author(s).)

Background: Hidradenitis suppurativa (HS) is a, chronic skin disease affecting up to 1% of the population in Europe. This study aims to assess the cost-of-illness of HS from a societal perspective in Hungary and to analyze the predictors of costs., Methods: A multicentre, cross-sectional cost-of-illness study was performed among 200 adult HS patients. We evaluated direct medical (physician consultations, inpatient admissions, medical, and surgeries), direct non-medical (transportation and caregiving), and indirect costs (productivity loss)., Results: The mean annual cost-of-illness of HS was €6,791 per patient. The main cost components were productivity loss (53.3%), biological treatment (21.5%), and informal care (9.2%). Patients missed, on average, 26 and 63 days from work annually due to absenteeism and presenteeism, respectively. Male sex, more severe disease, gluteal involvement, and coexisting inflammatory bowel disease were associated with higher direct medical costs, while lower education level and worse quality-of-life outcomes predicted higher indirect costs., Conclusion: This is the first study to assess both direct and indirect costs in HS patients. HS imposes a substantial burden on patients and society, predominantly arising from productivity loss and biological therapy. Resource utilization data and cost-of-illness estimates provide valuable inputs into cost-effectiveness analyses of health interventions in HS.

Background: Capability well-being captures well-being based on people's ability to do the things they value in life. So far, no capability well-being measures have been validated in dermatological patients., Objectives: To validate the adult version of the ICEpop CAPability measure (ICECAP-A) in patients with dermatological conditions. We aimed to test floor and ceiling effects, structural, convergent and known-group validity, and measurement invariance., Methods: In 2020, an online, cross-sectional survey was carried out in Hungary. Respondents with self-reported physician-diagnosed dermatological conditions completed the ICECAP-A, Satisfaction with Life Scale (SWLS), WHO-5 Well-Being Index and two dermatology-specific measures, Dermatology Life Quality Index (DLQI) and Skindex-16., Results: 618 respondents (mean age 51 years) self-reported a physician-diagnosed dermatological condition, with warts, eczema, onychomycosis, acne and psoriasis being the most common. ICECAP-A performed well with no floor and mild ceiling effects. The violation of local independence assumption was found between the attributes of 'attachment' and 'enjoyment'. ICECAP-A index scores correlated strongly with SWLS and WHO-5 (r s  = 0.597-0.644) and weakly with DLQI and Skindex-16 (r s  = - 0.233 to - 0.292). ICECAP-A was able to distinguish between subsets of patients defined by education and income level, marital, employment and health status. Multigroup confirmatory factor analysis indicated measurement invariance across most of these subgroups., Conclusions: This is the first study to validate a capability well-being measure in patients with dermatological conditions. The ICECAP-A was found to be a valid tool to assess capability well-being in dermatological patients. Future work is recommended to test measurement properties of ICECAP-A in chronic inflammatory skin conditions., (© 2021. The Author(s).)

Összefoglaló. Bevezetés: Magyarországon 100 000 olyan értelmi sérült él, akik speciális ellátásra szorulnak. Előzőleg beszámoltunk az akut fogászati ellátás eredményeiről és problémáiról. Ahhoz azonban, hogy a teljes fogászati rehabilitáció felé lépéseket lehessen tenni, ismerni kell az ilyen betegek fogászati állapotát. Célkitűzés: Statisztikailag releváns, nagyobb beteganyagon felmérni az értelmi sérült betegek fogászati állapotát, összehasonlítva mind az orvosi rehabilitációs kezelésben részesülő betegek (főleg testi fogyatékosok), mind az általános populáció adataival. Módszer: A fogászati állapot felmérésére két betegcsoport állt rendelkezésünkre. Összesen 325 beteg statusát rögzítettük. A vizsgáltakat 3 csoportba osztottuk: enyhe (36), közepes (247) és súlyos (42) értelmi sérültek. Az értelmi sérült betegek fogászati állapotát DMF-T-indexszel mértük, és összehasonlítottuk az orvosi rehabilitációs kezelésben részesülő betegek és az általános populáció adataival is. Eredmények: A 325 szellemi sérült össz-DMF-T-indexének átlaga ± szórás: 11,04 ± 7,35; a carieses fogak számának átlaga: D = 3,66 ± 4,61; a hiányzó fogak számának átlaga: M = 5,22 ± 5,74. A fogmegtartó kezelés minimális volt: átlag F = 2,16 ± 3,12. Azoknak az értelmi sérülteknek, akik intézetben élnek, rosszabb a fogazati állapotuk, mint azoknak, akik családban vannak. Következtetések: Az eredményekből látszik, hogy az értelmi sérültek fogai elhanyagoltabbak, mint a normálpopuláció esetében. A DMF-T-index önmagában nem tükrözi ezeket a magállapításokat, csak akkor, ha szétbontva vizsgáljuk az adatokat. Orv Hetil. 2021; 162(42): 1698-1702., Introduction: There are 100,000 mentally disabled individuals in Hungary requiring special care. Previously, we reported the results and problems of acute dental care. However, in order to take the appropriate measures toward holistic dental rehabilitation, clarity regarding the condition of those mentally disabled individuals is necessary., Objective: To measure the dental health of mentally disabled individuals based on a large sample of patients, to compare the results with both differently-abled (i.e., primarily physically disabled) individuals and the general population., Methods: There were two available patient cohorts for the measurement of dental health. With the two cohorts combined, we recorded data about 325 patients. We split the patients into three groups: mild (36), medium (247), and severe (42) mental disability. We used DMF-T index to measure dental health status, and compared the results with those of physically disabled and the general population., Results: The mean ± deviation of DMF-T index of the disabled patients was 11.04 ± 7.35; the mean of decayed teeth: D = 3.66 ± 4.61; the missing teeth: M = 5.22 ± 5.74; the filled teeth: F = 2.16 ± 3.12. Mentally disabled patients living in institutions showed worse dental health than those living with families., Conclusions: The results show that the teeth of mentally disabled patients are more neglected than those of the general population. The DMF-T index does not mirror these conclusions unless we examine each data set separately. Orv Hetil. 2021; 162(42): 1698-1702.

Background: The capability approach has received increasing attention in wellbeing measurement in the past years, but it has still remained an underexplored area in musculoskeletal (MSK) health., Objective: We aimed to explore the capability wellbeing in relation to MSK health, by measuring the associations between the Health Assessment Questionnaire Disability Index (HAQ-DI) physical functioning and the ICECAP-A and ICECAP-O capability wellbeing measures., Design: A cross-sectional survey was performed in 2019 on a representative sample of the Hungarian general adult population., Method: Capability wellbeing was measured by the ICECAP-A (age-group 18-64) and ICECAP-O (age group 65+) questionnaires. MSK health was defined by the HAQ-DI, the mobility domain of the EQ-5D-3L/-5L health status measures, self-reported walking problems and MSK diagnosis (neck/back/low back defects, hip/knee arthrosis, osteoporosis)., Results: Altogether 2021 individuals (female: 50.1%) participated in the survey with mean (SD) age of 48.7 (17.9) years and HAQ-DI of 0.138 (0.390). ICECAP-A (N = 1568, 77.6%) and ICECAP-O (N = 453, 22.4%) scores were on average (SD) 0.894 (0.126) and 0.828 (0.150), respectively. Spearman correlations between the HAQ-DI and ICECAP-A/-O index scores were moderate (r = -0.303 and -0.496; p < 0.05). Both the ICECAP-A/-O index scores differed significantly (ANOVA test, p < 0.05) across all MSK subgroups. In the ordinary least square regressions, marginal effects of ICECAP-A/-O scores on HAQ-DI were significant (-0.149 and -0.123) when controlling for socio-demographic characteristics., Conclusions: MSK health problems are associated with lower capability wellbeing. ICECAP-A/-O might capture effects of MSK conditions not measured by the HAQ-DI or the EQ-5D-5L. Further studies should test these associations in disease-specific samples., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Psoriasis is frequently accompanied by cardiovascular diseases based on the shared immunopathogenic pathway. Authors determined the effect of interleukin (IL)-17 inhibitor therapy on arterial intima-media thickness (IMT) among severe psoriatic patients., Methods: Thirty-one severe psoriatic patients were enrolled. Twenty received secukinumab and 11 received ixekizumab. Before treatment initiation and after 6 months, the carotid-brachial-femoral IMT, the Psoriasis Area Severity Index (PASI), the Dermatology Life Quality of Index (DLQI) and the EuroQol Visual Analogue Scale (EQ VAS) were evaluated., Results: After 6 months, significant ameliorations were observed in PASI ( p < 0.001) from 18 to 0, in DLQI ( p < 0.001) from 17 to 0, in EQ VAS ( p < 0.001) from 60 to 90, in right carotid IMT ( p < 0.001) from 1.1 mm to 0.8 mm, in left carotid IMT ( p < 0.001) from 1.1 mm to 0.7 mm, in right brachial IMT (p < 0.001) from 0.75 mm to 0.6 mm, in left brachial IMT ( p < 0.001) from 0.8 mm to 0.5 mm, in right femoral IMT ( p < 0.001) from 0.9 mm to 0.7 mm and in left femoral IMT ( p < 0.001) from 0.8 mm to 0.7 mm., Conclusions: By reducing the inflammation of the vascular wall, anti-IL-17 therapy may have a beneficial long-term effect on cardiovascular complications of systemic inflammation.

Purpose: Eight of the ten items of the Dermatology Life Quality Index (DLQI) have a 'not relevant' response (NRR) option. There are two possible ways to interpret NRRs: they may be considered 'not at all' or missing responses. We aim to compare the measurement performance of the DLQI in psoriasis patients when NRRs are scored as '0' (hereafter zero-scoring) and 'missing' (hereafter missing-scoring) using Rasch model analysis., Methods: Data of 425 patients with psoriasis from two earlier cross-sectional surveys were re-analysed. All patients completed the paper-based Hungarian version of the DLQI. A partial credit model was applied. The following model assumptions and measurement properties were tested: dimensionality, item fit, person reliability, order of response options and differential item functioning (DIF)., Results: Principal component analysis of the residuals of the Rasch model confirmed the unidimensional structure of the DLQI. Person separation reliability indices were similar with zero-scoring (0.910) and missing-scoring (0.914) NRRs. With zero-scoring, items 6 (sport), 7 (working/studying) and 9 (sexual difficulties) suffered from item misfit and item-level disordering. With missing-scoring, no misfit was observed and only item 7 was illogically ordered. Six and three items showed DIF for gender and age, respectively, that were reduced to four and three by missing-scoring., Conclusions: Missing-scoring NRRs resulted in an improved measurement performance of the scale. DLQI scores of patients with at least one vs. no NRRs cannot be directly compared. Our findings provide further empirical support to the DLQI-R scoring modification that treats NRRs as missing and replaces them with the average score of the relevant items., (© 2021. 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.)

Background: Psoriasis is frequently accompanied by metabolic syndrome. Effect of anti-tumor necrosis factor therapies on increases in body weight is well-known. Data on the effects of interleukin-17 inhibitors are limited. Authors determined the effect of anti-interleukin-17 therapies on the body composition and serum lipid and inflammatory parameters among severe psoriatic patients., Methods: Thirty-five severe psoriatic patients were enrolled. Twenty-two received secukinumab and 13 received ixekizumab as their 2nd-or 3rd-line biological treatment. Before treatment initiation and 6 months later, laboratory examinations measuring metabolic and inflammatory panels and body composition analyses were performed., Results: After 6 months, a significant reduction was observed in psoriasis area severity index ( p < 0.001) from 18 to 0, in c-reactive protein ( p < 0.001) from 6.6 to 4.00 mg/L, in low-density lipoprotein-cholesterol ( p = 0.004) from 3.69 to 3.19 mmol/L, and an improvement in high-density lipoprotein-cholesterol ( p = 0.022) from 1.31 to 1.40 mmol/L. Median baseline body mass index was 32.80 kg/m 2 . The body composition parameters did not show any significant changes., Conclusions: Anti-interleukin-17 therapy of severe psoriatic patients does not cause significant changes in body composition parameters. Improvements in the lipid and inflammatory parameters might have a beneficial effect on patients' cardiometabolic status. This effect might be detectable in high-risk obese psoriatic patients.

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.

Összefoglaló. Bevezetés: Az időalku (time trade-off) egy nemzetközileg széles körben alkalmazott életminőség- és egészséghasznosság-mérési módszer. Az időalkuval mért hasznosságértékek az egészségügyi technológiák költséghatékonysági vizsgálatakor az életminőséggel korrigált életév (quality-adjusted life year, QALY) mutatószám számítására használhatók. Kevés ismerettel rendelkezünk arról, hogy Magyarországon milyen betegségekben állnak rendelkezésre időalkuval mért hasznosságértékek. Célkitűzés: Célunk szisztematikus irodalmi áttekintés keretében összefoglalni és katalogizálni az időalku módszerrel mért hasznosságértékeket közlő publikációkat Magyarországon. Módszer: 2020 januárjában szisztematikus folyóirat-keresést végeztünk a PubMed, Web of Science és Matarka elektronikus adatbázisokban. Beválogatási kritériumaink a következők voltak: (1) eredeti közlemények, melyek (2) időalku módszerrel mértek hasznosságértéket, és (3) magyarországi mintán mért adatokat közöltek. Eredmények: 9 eredeti közleményt válogattunk be, amelyek összesen 7 krónikus betegségben (Crohn-betegség, időskori maculadegeneratio, krónikus migrén, pemphigus, psoriasis, primer dysmenorrhoea és rheumatoid arthritis) 23 egészségi állapot hasznosságát határozták meg. A kutatások mintanagysága 108 és 1996 fő között alakult. Két kutatás betegcsoportokat vizsgált, kettő az általános populációt, és három vizsgálatban szerepelt mindkettő. Hat kutatás használta a hagyományos időalku valamelyik formáját, egy pedig az összetett időalku módszert. Egy kutatásban szerepelt 'rosszabb a halálnál' válaszlehetőség. A leggyakrabban alkalmazott időtáv a standard 10 év volt (71%). Az egyes állapotok hasznosságának átlaga 0,34 (kezeletlen pemphigus vulgaris) és 0,94 (enyhe primer dysmenorrhoea) között változott. A 'non-traderek' aránya az egyes kutatásokban 0 és 29% között változott. Következtetések: Egyre több krónikus betegségben elérhetők a magyar társadalom vagy betegek preferenciáin alapuló egészséghasznosság-értékek. A hazai időalku-vizsgálatok többsége megfelel a nemzetközi minőségi követelményeknek. Az időalku módszer alkalmazása javasolt más krónikus állapotokban is, a felmért hasznosságértékek segíthetik az egészségügyi technológiákkal kapcsolatos finanszírozói döntéshozatalt. Orv Hetil. 2021; 162(14): 542-554., Introduction: Time trade-off (TTO) is a widely used method to assess health-related quality of life and health utilities for economic evaluations of health technologies. Little is known about the use of TTO in the Hungarian context., Objective: To systematically summarize the existing literature on the method in Hungary., Method: In January 2020, we conducted a systematic literature search in three electronic databases (MEDLINE, Web of Science and the Hungarian Periodicals Table of Contents Database). Our inclusion criteria were: (1) original publications, which (2) measured utilities by using TTO, (3) from a Hungarian sample., Results: Nine publications containing seven original studies were included that reported utilities for 23 different health states in seven chronic diseases (age-related macular degeneration, chronic migraine, Crohn's disease, pemphigus, primary dysmenorrhoea, psoriasis and rheumatoid arthritis). Sample sizes ranged from 108 to 1996 respondents. Two studies used general population samples, another two used patient groups and three studies used both. Six studies used a form of conventional TTO and one used composite TTO method. The most frequent timeframe was 10 years (71%). The lowest mean utility was 0.34 (uncontrolled pemphigus vulgaris), while the highest was 0.94 (mild primary dysmenorrhoea). The overall proportion of non-traders ranged between 0 and 29% across studies., Conclusions: A growing number of studies are using TTO to assess utilities for chronic conditions from the general population or patients in Hungary. The majority of Hungarian TTO studies have met international quality standards. The assessment of TTO utilities is recommended also in other chronic conditions to assist health technology assessment. Orv Hetil. 2021; 162(14): 542-554.

Purpose: The CarerQol instrument has been designed and validated as an instrument able to measure both the positive and the negative impacts of caregiving on the quality of life of informal caregivers (CarerQol-7D), as well as their general happiness (CarerQol-VAS). The aim of this study was to assess the construct validity of the CarerQol in the Hungarian context., Methods: The CarerQol was translated into Hungarian. Subsequently, in a cross-sectional online survey, representative for the general Hungarian population (N = 1000), informal caregivers were identified (N = 149, female 51.2%, mean age 53.2). Clinical, convergent and discriminant validity of the CarerQol were evaluated in relation to the caregivers' and care recipients' EQ-5D-5L health status, and caregiving situation characteristics., Results: Average CarerQol-7D and CarerQol-VAS scores were 76.0 (SD 16.2) and 6.8 (SD 2.3), respectively. CarerQol-7D and CarerQol-VAS scores were significantly correlated with caregiving time (r = - 0.257; - 0.212), caregivers' EQ-5D-5L scores (r = 0.453; 0.326) and the CarerQol-7D also with care recipients' EQ-5D-5L scores (r = 0.247). CarerQol-7D scores differed significantly with relevant caregiving characteristics (e.g. nature and severity of care recipients' health status, sharing household) and both the CarerQol-7D and CarerQol-VAS with the overall care experience., Conclusion: Our findings confirmed the validity of the Hungarian language version of the CarerQol and support the cross-cultural validity of the instrument. CarerQol-7D scores performed better in distinguishing caregiving situation characteristics than the general happiness measure CarerQol-VAS. Care recipients' health status was only weakly associated with informal caregivers' care-related quality of life and happiness. Caregivers' own health and caregiving circumstances were more strongly associated with these scores.

Background: We aimed to investigate the acceptability of imperfect health states in relation to age in Hungary and analyse its determinants. Results are contrasted to age-matched actual population health scores and to findings from a previous study in The Netherlands., Methods: A cross-sectional online survey was performed. The same survey questions were applied as in a previous study in The Netherlands in order to enable inter-country comparisons. The descriptive system of the EQ-5D-3L health status questionnaire was used to assess the acceptability of moderate and severe health problems at ages from 30 to 80 by 10-year age-groups. Descriptive statistics were performed and linear regression analysis was used to investigate the determinants of acceptability., Results: Altogether 9281 (female 32.8%) were involved with mean age 36.0 years and EQ-5D-3L index score of 0.852 (SD 0.177). Acceptability of health problems increased with age, differed per health domain and with severity of the problems. Except for 'Self-care', moderate health problems were acceptable by the majority from age 70 and acceptability scores were lower than EQ-5D-3L population norms from that age. The lowest average acceptability age was found in the 'Anxiety/depression' and dimension the highest in the 'Self-care' dimension. Respondents' age, current health, and lifestyle were significant determinants (R 2 : 0.041-0.130). With a few minor exceptions in some health dimensions, acceptability levels and patterns were strikingly similar to the Dutch findings., Conclusion: In Hungary, acceptability of health problems increases with age and the majority found severe problems never acceptable. Views on acceptability of health problems seem to be fairly generalizable across European countries with different health and economic indicators.

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.

Introduction: Health disorders may affect negatively work productivity of individuals, leading to absence from work (absenteeism) and/or decreased functioning in the workplace (presenteeism)., Aim: To assess the health-related work productivity of the adult population in Hungary by the Work Productivity and Activity Impairment questionnaire (WPAI)., Method: A cross-sectional survey was performed in 2019 involving a sample (n = 2023) representative for the adult population of Hungary. Socio-demographic characteristics were recorded. Health-related productivity of the participants was assessed by the WPAI questionnaire, health status was measured by the EQ-5D-3L measurement tool and the Minimum European Health Module (MEHM)., Statistical Analyses: Descriptive statistics were performed, subgroups were compared by Mann-Whitney and Kruskal-Wallis tests. Spearman's rank correlation was applied to analyze the relationship between WPAI, age and EQ-5D-3L index score., Results: Among those in a paid job (n = 1194, 59%), altogether 70 respondents (6%) were absent from work during the week before the survey, which resulted in an average 1.9 (SD = 8.5) work hours loss per week. Presenteeism occurred in 166 (14%) cases. The average absenteeism was 3.6%, presenteeism was 4.4%, and activity impairment in the total sample was 9.5%. Absenteeism did not correlate with age and did not differ significantly across socio-demographic subgroups. Presenteeism was the highest among actively working retired people, disability pensioners and part-time employees. Presenteeism correlated moderately (r = -0.379), absenteeism weakly (r = -0.113) with EQ-5D-3L index. Correlation was significant between activity impairment and age (r = 0.412) as well as the EQ-5D-3L index score (r = -0.592). All WPAI items showed significant worsening across MEHM status levels., Conclusion: This is the first study in Hungary to present population reference values with the WPAI. Productivity loss due to presenteeism deserves special attention from the employers as well as from decision makers in the labour, health and social sectors. Orv Hetil. 2020; 161(36): 1522-1533.

Objectives: In a growing number of countries, patient involvement in medical decisions is considered a cornerstone of broader health policy agendas. This study seeks to explore public preferences for and experiences with participation in treatment decisions in Hungary., Methods: A nationally representative online panel survey was conducted in 2019. Outcome measures included the Control Preferences Scale for the preferred and actual role in the decision, the 9-item Shared Decision Making Questionnaire, and a Satisfaction With Decision numeric rating scale., Results: A total of 1000 respondents participated in the study, 424 of whom reported having had a treatment decision in the preceding 6 months. Overall, 8%, 18%, 51%, 19%, and 4% of the population preferred an active, semiactive, shared, semipassive, and passive role in decision making, respectively. Corresponding rates for perceived role were as follows: 9%, 15%, 35%, 26%, and 15%. Preferred and perceived roles matched for 52% of the population, whereas 32% preferred more and 16% less participation. Better health status, attaining role congruence, and higher 9-item Shared Decision Making Questionnaire scores were positively associated with satisfaction, accounting for 32% of the variation in Satisfaction With Decision scores (P < .05)., Conclusions: This study represents the first national survey on decisional roles in healthcare in Hungary and, more broadly, in Central and Eastern Europe. Shared decision making is the most preferred decisional role in Hungary; nevertheless, there is still room to improve patient involvement in decision making. It seems that patient satisfaction may be improved through tailoring the decisional role to reflect patients' preferences and through practices that encourage shared decision making., (Copyright © 2020 ISPOR--The professional society for health economics and outcomes research. Published by Elsevier Inc. All rights reserved.)

Objectives: The wording of the Hungarian EQ-5D-3L and EQ-5D-5L descriptive systems differ a great deal. This study aimed to (1) develop EQ-5D-3L and EQ-5D-5L value sets for Hungary from a common sample, and (2) compare how level wording affected valuations., Methods: In 2018 to 2019, 1000 respondents, representative of the Hungarian general population, completed composite time trade-off tasks. Pooled heteroscedastic Tobit models were used to estimate value sets. Value set characteristics, single-level transition utilities from adjacent corner health states, and mean transition utilities for all possible health states were compared between the EQ-5D-3L and EQ-5D-5L., Results: Health utilities ranged from -0.865 to 1 for the EQ-5D-3L and -0.848 to 1 for the EQ-5D-5L. The relative importance of the 5 EQ-5D-5L dimensions was as follows: mobility, pain/discomfort, self-care, anxiety/depression, and usual activities. A similar preference ranking was observed for the EQ-5D-3L with self-care being more important than pain/discomfort. The EQ-5D-5L demonstrated lower ceiling effects (range of utilities for the mildest states: 0.900-0.958 [3L] vs 0.955-0.965 [5L]) and better consistency of mean transition utilities across the range of scale. Changing "confined to bed" (3L) to "unable to walk" (5L) had a large positive impact on utilities. Smaller changes with more negative wording in the other dimensions (eg, "very much anxious/feeling down a lot" [3L] vs "extremely anxious/depressed" [5L]) had a modest negative impact on utilities., Conclusion: This study developed value sets of the EQ-5D-3L and EQ-5D-5L for Hungary. Our findings contribute to the understanding of how the wording of descriptive systems affects the estimates of utilities., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Digital health, which encompasses the use of information and communications technology in support of health, is a key driving force behind the cultural transformation of medicine toward people-centeredness. Thus, eHealth literacy, assisted by innovative digital health solutions, may support better experiences of care., Objective: The purpose of this study is to explore the relationship between eHealth literacy and patient-reported experience measures (PREMs) among users of outpatient care in Hungary., Methods: In early 2019, we conducted a cross-sectional survey on a large representative online sample recruited from the Hungarian general population. eHealth literacy was measured with the eHealth Literacy Scale (eHEALS). PREMs with outpatient care were measured with a set of questions recommended by the Organisation for Economic Co-operation and Development (OECD) for respondents who attended outpatient visit within 12 months preceding the survey. Bivariate relationships were explored via polychoric correlation, the Kruskal-Wallis test, and chi-square test. To capture nonlinear associations, after controlling covariates, we analyzed the relationship between eHEALS quartiles and PREMs using multivariate probit, ordinary least squares, ordered logit, and logistic regression models., Results: From 1000 survey respondents, 666 individuals (364 females, 54.7%) were included in the study with mean age of 48.9 (SD 17.6) years and mean eHEALS score of 29.3 (SD 4.9). Respondents with higher eHEALS scores were more likely to understand the health care professionals' (HCPs') explanations (χ 2 9 =24.2, P=.002) and to be involved in decision making about care and treatment (χ 2 9 =18.2, P=.03). In multivariate regression, respondents with lowest (first quartile) and moderately high (third quartile) eHEALS scores differed significantly, where the latter were more likely to have an overall positive experience (P=.02) and experience fewer problems (P=.02). In addition, those respondents had better experiences in terms of how easy it was to understand the HCPs' explanations (P<.001) and being able to ask questions during their last consultation (P=.04). Patient-reported experiences of individuals with highest (fourth quartile) and lowest (first quartile) eHEALS levels did not differ significantly in any items of the PREM instrument, and neither did composite PREM scores generated from the PREM items (P>.05 in all models)., Conclusions: We demonstrated the association between eHealth literacy and PREMs. The potential patient-, physician-, and system-related factors explaining the negative experiences among people with highest levels of eHealth literacy warrant further investigation, which may contribute to the development of efficient eHealth literacy interventions. Further research is needed to establish causal relationship between eHealth literacy and patient-reported experiences., (©Zsombor Zrubka, Óscar Brito Fernandes, Petra Baji, Ottó Hajdu, Levente Kovacs, Dionne Kringos, Niek Klazinga, László Gulácsi, Valentin Brodszky, Fanni Rencz, Márta Péntek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 11.08.2020.)

Introduction : Early biological treatment of rheumatoid arthritis (RA) may reverse the autoimmune response in some patients resulting in favorable long-term outcomes. Although the cost-effectiveness of this strategy has been questioned, biosimilar entries warrant the revision of clinical and pharmaco-economic evidence. Areas covered : We conducted a systematic review of randomized controlled trials (RCTs) published up to 24 May 2018 in Pubmed, EMBASE and Cochrane CENTRAL, comparing infliximab with non-biological therapy in patients with RA naïve to methotrexate. We performed meta-analyses for efficacy outcomes at month 6 and years 1 and 2. Six RCTs were identified, involving 1832 patients. At month 6 ACR70 response and remission, and at year 1 ACR20/ACR70 responses and remission were improved significantly with first-line infliximab versus control. The differences were not significant at year 2. We reviewed cost-utility studies, up to 31 October 2018 in PubMed, Cochrane CENTRAL and the CRD HTA databases. Four studies indicated that first-line use of originator infliximab calculated at 2005-2008 prices was not cost-effective. Expert opinion : We demonstrated the efficacy benefits of first-line infliximab therapy up to 1 year in methotrexate-naïve RA. We highlighted the need for standardized reporting of outcomes and conducting cost-effectiveness analyses of first-line biosimilar therapy in RA.

Introduction: Antidrug antibody (ADA) production may be the reason behind secondary inefficacy of anti-TNF-α therapy in psoriasis., Aim: To investigate the production of ADA, serum tumor necrosis factor α (TNF-α) and drug levels as predictors of clinical response in real-life circumstances., Material and Methods: Serum drug concentrations (TNFi), the presence of ADAs and serum TNF-α levels were measured in 158 patients by the ELISA method. Clinical response was evaluated by calculating PASI. Their correlation has been statistically analysed., Results: In adalimumab and infliximab treated patients, ADA formation was observed in 18.4% and 33%, respectively, and the serum TNFi concentration was significantly higher in the ADA negative groups. In contrast there was no ADA formation detected among etanercept treated patients. The serum TNFi concentration was significantly lower among non-responders ( n = 33). The serum TNF-α level was also measured and the correlation with the concentration of the serum TNFi level was analysed. Having evaluated the results of all patients together, the serum TNFi and TNF-α concentrations showed a significant negative correlation. However, when groups were analysed separately, in case of adalimumab, a significant negative correlation was detected between serum TNFi and TNF-α concentrations. With respect to infliximab, there was no significant correlation, and an inverse correlation was found in the etanercept group. The TNF-α levels and ADA positivity were significantly higher in non-responders., Conclusions: This study revealed the major role of ADAs against TNFi in case of secondary inefficacy in real-life circumstances. ADA levels show a stronger correlation with PASI failure than serum TNFi or TNF-α levels., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2019 Termedia Sp. z o. o.)

Background: We aimed to investigate individuals' subjective expectations regarding health and happiness alongside their provisions on life circumstances for older ages., Methods: A cross-sectional online survey was performed involving a representative sample (N = 1000; mean age 50.9, SD = 15.4; female 54.5%) in Hungary. Subjective expectations on health status (EQ-5D-3L/-5L, GALI, WHO-5), happiness (0-10 VAS), employment status, care time, and forms of care for ages 60, 70, 80, and 90 were surveyed., Results: Current mean EQ-5D-5L was 0.869 (SD = 0.164) and happiness was 6.7 (SD = 2.4). Subjective life expectancy was 80.9 (SD = 11.1), and median expected retirement age was 65. Mean expected EQ-5D-5L for ages 60/70/80/90 was 0.761/0.684/0.554/0.402, and no activity limitations (GALI) were expected by 64%/40%/18%/14%, respectively. Expected happiness score was 6.8/6.7/6.2/5.7, and a decrease in mental well-being (WHO-5) was provisioned. A substantial increase in drug expenses and care time was anticipated, but only 52% thought to have extra income besides pension. The great majority expected to be helped by the family (77%/72%/53%/40%) if needed. Educational level, GALI, and longevity expectations were significant predictors of EQ-5D-5L expectations using a standard 5% significance level of decision. Current happiness was major determinant of expected future happiness., Conclusions: Individuals expect a significant deterioration of health with age but only a moderate decrease in happiness. Overestimation of future activity limitations suggests a gap between statistical and subjective healthy life expectancy. The majority expects to rely on informal care in the elderly. Raise in retirement age is underestimated. Our results can be used as inputs for economic modelling of labor force participation and ageing.

Background: EQ-5D-3L population data are available only from Hungary, Poland and Slovenia in Central and Eastern Europe (CEE). We aimed to compare the accessible studies and estimate a regional EQ-5D-3L population norm for CEE., Methods: A combined dataset using patient-level data of 8850 respondents was created. Based on the European Census of 2011, regional population norm estimates were calibrated by gender, age and education for the joint citizenry of 11 CEE countries., Results: EQ-5D-3L health states were available for 6926 and EQ VAS scores for 6569 respondents. Demographic characteristics of the samples reflected the recruitment methods (Hungary: online; Slovenia: postal survey, Poland: personal interviews). Occurrence of problems differed significantly by educational level in all the five dimensions (p < 0.001). The inter-country differences persisted after controlling for demographic variables. The estimated EQ-5D-3L index CEE norms with UK tariffs for age groups 18-24, 25-34, 35-44, 45-54, 55-64, 65-74 and 75 + were 0.911, 0.912, 0.871, 0.817, 0.762, 0.743 and 0.636 for males and 0.908, 0.888, 0.867, 0.788, 0.752, 0.68 and 0.584 for females, respectively. Estimates were provided also using Polish, European and Slovenian value sets., Conclusions: Besides gender and age, education should be considered during the design and interpretation of quality-of-life studies in CEE. The estimated regional EQ-5D-3L population norm may be used as a benchmark by CEE countries with lack of local dataset. However, the substantial inter-country differences in health status and scarcity of data over age 65 call for harmonized country-specific EQ-5D-3L population norm studies in the CEE region.

Background: In patients with Crohn's disease (CD), luminal disease activity paralleled by perianal fistulas may seriously impair health-related quality of life (HRQoL). Health utility values are not available from patients with CD that reflect the health loss associated with both luminal and perianal CD., Objective: To generate utilities for luminal and concomitant perianal fistulising CD health states directly from patients and from members of the general public., Methods: A cross-sectional survey was undertaken enrolling CD patients and a convenience sample of members of the general population. Respondents were asked to evaluate four common CD heath states [severe luminal disease (sCD), mild luminal disease (mCD), severe luminal disease with active perianal fistulas (sPFCD), and mild luminal disease with active perianal fistulas (mPFCD)] by 10-year time trade-off (TTO). In addition, patients assessed their current HRQoL by the TTO method., Results: Responses of 206 patients (40.8% with perianal fistulas) and 221 members of the general population were analysed. Mean ± SD utilities among patients for sPFCD, sCD, mPFCD and mCD states were 0.69 ± 0.33, 0.73 ± 0.31, 0.80 ± 0.29 and 0.87 ± 0.26. Corresponding values in the general public were: 0.59 ± 0.31, 0.65 ± 0.29, 0.80 ± 0.26 and 0.88 ± 0.25. Patients with active perianal fistulas, previous non-resection surgeries, and higher pain intensity scores valued their current health as worse (p < 0.05)., Conclusions: TTO is a feasible method to assess HRQoL in patients with perianal fistulising disease, often not captured by health status questionnaires. Utilities from this study are intended to support the optimization of treatment-related decision making in patients with luminal disease paralleled by active perianal fistulas.

Background: In the Central and Eastern European region, the British EQ-5D-3L value set is used commonly in quality of life (QoL) studies. Only Poland and Slovenia have country-specific weights. Our study aimed to investigate the impact of value set choice on the evaluation of 18 chronic conditions in Hungary., Methods: Patients' EQ-5D-3L index scores were calculated using the VAS-based Slovenian and European and the time-trade-off-based Polish and British value sets. We performed pairwise comparisons of mean index values by dimensions, diagnoses and age groups. We evaluated disease burden by comparing index values matched by age and gender in each condition with those of the general population of the CEE region in all four value sets., Results: Altogether, 2421 patients (55% female) were included in our sample with the average age of 55.87 years (SD = 17.75). The average Slovenian, European, Polish and British EQ-5D-3L scores were 0.598 (SD = 0.279), 0.661 (SD = 0.257), 0.770 (SD = 0.261) and 0.644 (SD = 0.279), respectively. We found highly significant differences in most diagnoses, with the greatest difference between the Polish and Slovenian index values in Parkinson's disease (0.265). Systematic pairwise comparison across all conditions and value sets revealed greatest differences between the time-trade-off (TTO) and VAS-based value sets as well as varying sensitivity of the disease burden evaluations of chronic disease conditions to the choice of value sets., Conclusions: Our results suggest that the choice of value set largely influences the health state utility results in chronic diseases, and might have a significant impact on health policy decisions.

Backround: Guidelines for economic analyses of health care technologies require local input data for reimbursement decisions in the countries of Central and Eastern Europe (CEE). The aim of this study was to systematically review and analyse the available empirical studies using the EQ-5D instrument as a measure of the health-related quality of life (HRQoL) in patients with neurological diseases., Methods: A systematic literature search was performed up to 1st April 2018 to identify relevant studies in eight selected CEE countries. Original articles reporting on studies of neurological diseases using the EQ-5D instrument were analysed., Results: Thirty-six articles, describing the results of 38 samples of patients and a total of 13,005 patients were included in the review. Most studies were from Hungary (44.4%) and none from Romania or Slovakia. EQ-5D utility scores were reported in 33 (91.7%) articles. In multiple sclerosis (MS) being the most represented disease, the average utility scores ranged from 0.49 in Austria to 0.80 in Poland with a weighted average of 0.69. EQ VAS scores for MS ranged from 39 in Czech Republic to 72.0 in Poland, with weighted average of 59.1. MS patients, together with epilepsy and essential tremor patients, estimated their HRQoL among the highest., Conclusions: EQ-5D research activity in neurology has been increasing through the years in studied CEE countries. There are clinical areas with the significant social burden, such as a migraine or meningitis, that are completely lacking data, other areas, such as stroke or epilepsy, with very scarce data.

Background: To date, a multi-country review evaluating the cost-of-illness (COI) studies from the Central and Eastern European (CEE) region has not yet been published. Our main objective was to provide a general description about published COI studies from CEE., Methods: A systematic search was performed between 1 January 2006 and 1 June 2017 in Medline, EMBASE, The Cochrane Library, CINAHL, and Web of Science to identify all relevant COI studies from nine CEE countries. COI studies reporting costs without any restrictions by age, co-morbidities, or treatment were included. Methodology, publication standards, and cost results were analysed., Results: We identified 58 studies providing 83 country-specific COI results: Austria (n = 9), Bulgaria (n = 16), Croatia (n = 3), the Czech Republic (n = 10), Hungary (n = 24), Poland (n = 11), Romania (n = 3), Slovakia (n = 3), and Slovenia (n = 4). Endocrine, nutritional, and metabolic diseases (18%), neoplasms (12%), infections (11%), and neurological disorders (11%) were the most frequently studied clinical areas, and multiple sclerosis was the most commonly studied disease. Overall, 57 (98%) of the studies explicitly stated the source of resource use data, 45 (78%) the study perspective, 34 (64%) the costing method, and 24 (58%) reported at least one unit costs. Regardless of methodological differences, a positive relationship was observed between costs of diseases and countries' per capita GDP., Conclusions: Cost-of-illness studies varied considerably in terms of methodology, publication practice, and clinical areas. Due to these heterogeneities, transferability of the COI results is limited across Central and Eastern European countries.

Background: We adapted the eHealth Literacy Scale (eHEALS) for Hungary and tested its psychometric properties on a large representative online sample of the general population., Methods: The Hungarian version of eHEALS was developed using forward-backward translation. For the valuation study, 1000 respondents were recruited in early 2019 from a large online panel by a survey company. We tested internal consistency, test-retest reliability and construct and criterion validity using classical test theory, as well as item characteristics using an item-response theory (IRT) graded response model (GRM)., Results: 55% of respondents were female, and 22.1% were ≥ 65 years old. Mean eHEALS score was 29.2 (SD: 5.18). Internal consistency was good (Cronbach's α = 0.90), and test-retest reliability was moderate (intraclass correlation r = 0.64). We identified a single-factor structure by exploratory factor analysis, explaining 85% of test variance. Essential criteria for GRM analysis were met. Items 3 and 4 (search of health resources) were the least difficult, followed by items 5 and 8 (utilisation of health information), and then items 1 and 2 (awareness of health resources). Items 6 and 7 (appraisal of health resources) were most difficult. The measurement properties of eHEALS were not affected by gender, age, education or income levels. Female gender, older age, intensity of health information seeking, formal health education and visit at the electronic health-record website were associated with higher eHEALS scores, as well as best and worst self-perceived health states, BMI < 25 and participation at health screenings over the past year., Conclusions: The Hungarian eHEALS is a useful and valid tool for measuring subjective eHealth literacy.

Background: Pemphigus is a chronic autoimmune blistering disease of the skin and mucosa severely impairing patients' health-related quality of life (HRQoL). To date, no studies have measured subjective well-being in terms of life satisfaction in pemphigus. Our main objective was to evaluate satisfaction with life in patients with pemphigus, and to analyse its relationship with clinical severity and HRQoL., Methods: A cross-sectional survey was carried out enrolling 77 patients with pemphigus. Subjective well-being was measured using the Satisfaction with Life Scale (SWLS). HRQoL was assessed by the Dermatology Life Quality Index (DLQI) and EQ-5D-5L. Disease severity was measured by Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)., Results: Mean ABSIS, DLQI, EQ-5D-5L and SWLS scores of patients were 11.7 (SD 17.3), 5.4 (6.8), 0.84 (0.22) and 4.76 (SD 1.52), respectively. The proportion of patients indicating extreme dissatisfaction, dissatisfaction, slightly below average in life satisfaction, average satisfaction, high satisfaction and very high satisfaction with life was 6 (7.8%), 5 (6.5%), 14 (18.2%), 16 (20.8%), 21 (27.3%) and 15 (19.5%), respectively. Life satisfaction was independent from age, gender, level of education and type of disease. A path analysis revealed that there was no direct relationship between ABSIS and SWLS (beta = - 0.09; p = 0.428); however, the following indirect path was confirmed: ABSIS → DLQI → EQ-5D-5L → SWLS., Conclusions: Disease severity and HRQoL measures regularly used to assess patients' health status may be complemented with a measure of subjective well-being, such as SWLS, to achieve a more holistic assessment of patients' lives and optimise pemphigus care.

Background: The nine-item Shared Decision Making Questionnaire (SDM-Q-9) is one of the most frequently applied instruments for assessing patients' involvement in medical decision-making. Our objectives were to develop a Hungarian version of SDM-Q-9, to evaluate its psychometric properties and to compare its performance between primary and specialised care settings., Methods: In 2019, a sample of adults (n = 537) representative of the Hungarian general population in terms of age, gender and geographic region completed an online survey with respect to a recent health-related decision. Outcome measures included SDM-Q-9 and Control Preferences Scale-post (CPS post ). Item characteristics, internal consistency reliability and the factor structure of SDM-Q-9 were determined., Results: The overall ceiling and floor effects for SDM-Q-9 total scores were 12.3% and 2.2%, respectively. An excellent internal consistency reliability (Cronbach's alpha 0.925) was demonstrated. Exploratory factor analysis resulted in a one-factor model explaining 63.5% of the variance of SDM-Q-9. A confirmatory factor analysis supported the acceptability of this model. Known-groups validity was confirmed with CPS post categories; mean SDM-Q-9 total scores were higher in the 'Shared decision' category (72.6) compared to both 'Physician decided' (55.1, p = 0.0002) and 'Patient decided' (57.2, p = 0.0086) categories. In most aspects of validity and reliability, there was no statistically significant difference between primary and specialised care., Conclusions: The overall good measurement properties of the Hungarian SDM-Q-9 make the questionnaire suitable for use in both primary and specialised care settings. SDM-Q-9 may be useful for health policies targeting the implementation of shared decision-making and aiming to improve efficiency and quality of care in Hungary.

Background: We aimed to determine the acceptability of non-perfect health states with age using the EQ VAS and analyse the influencing factors., Methods: We conducted a cross-sectional survey on a convenience sample from the general population (N = 200). Respondents were asked to indicate on the EQ VAS the health states that are still acceptable for ages between 30 and 80 years in 10-year intervals (VAS acceptable health curve, AHC vas ). We recorded respondents' current health, health-related lifestyle, demographic background and explored the reference person they imagined when evaluating acceptable health states. We evaluated the AHC vas by estimating linear multilevel models including a random intercept (estimated at age 30) and a random slope for age., Results: AHC vas scores were available for 194 respondents (mean age = 42.8 years, range 19-93, 58% female). For ages of 30, 40, 50, 60, 70 and 80 years, mean AHC vas scores were 93, 87, 80, 73, 65 and 57, respectively. The decline of AHC vas was linear with age. Respondents' age, health status, lifestyle and health-related experiences, as well as their reference point taken (e.g. imagining themselves, others or both during the valuation task) influenced significantly the acceptability of health problems., Conclusions: When measured with the EQ VAS, health problems were increasingly acceptable with age. Capturing well the individual variability in the assessment of acceptable health states at different ages, the EQ VAS is a useful addition to EQ-5D-3L descriptive system-based measures of acceptable health.

Background: The recent update of the European Union's (EU) regulation on public procurement has created new opportunity for progress in the purchasing of medical devices by shifting towards focus on value from one purely on price. Patient-reported outcome measures (PROMs) may serve as additional tools for manufacturers to demonstrate value beyond traditional metrics of safety and performance and to differentiate their products in a market of increasing competition. The aim of our study was to investigate the extent to which PROMs are included in registered device studies in the EU and interpret the results in the context of the purchasing of medical devices., Methods: Twelve device groups were searched in clinical trial registries to determine the frequency distribution of PROMs in related studies., Results: Results indicate that clinical studies of the selected device categories are done predominately in the western EU nations and are increasingly including PROMs. In the United Kingdom 121 (65%) study, out of 186 included PROMs, and in Germany, 92 (52%) out of 178 between 1998 and 2018. Few device studies were done in the Central and Eastern European region, and out of 76 studies 27 (35%) included PROMs. Since there is no requirement to include PROMs in device studies for regulatory purposes, it seems probable that their increasing use is driven by competitive market pressures., Conclusion: The trend of increasing use of PROMs might be driven by the demand of purchasers to demonstrate value of devices, but is manifested at different levels in various regions of the EU.