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PurposeTo investigate the contribution of demographic trends in countries’ age and gender composition to value set validity and obsolescence.MethodsTime-trade off (TTO) valuation data from 3 EQ-5D-3L value sets of 20 years or older from the United Kingdom, Japan, and the United States were re-analyzed using Bayesian heteroskedastic Tobit models with sex and age group-specific scale parameters. Original value sets were obtained by weighting the original preference structures with the countries’ original demographic composition at the time of the data collection. Updated value sets were created using the original preference structure weighted using the countries’ most recent demographic composition. The differences between the original and updated value sets were monitored and compared based on 95% credible intervals.ResultsThe gender and age composition of the investigated countries changed in all 3 countries over time. The modelled health state preferences also depended on the respondents’ gender and age. However, the overall impact of this demographic change on the investigated value sets was negligeable in all 3 countries and this finding was robust to accounting for the impact of ethnicity trends in the United States.ConclusionValue sets may become redundant and obsolete for various reasons, but demographic change was not identified as a contributing factor.

Over the last 10-15 years, US health care and the practice of medicine itself have been transformed by a proliferation of digital medicine and digital therapeutic products (collectively, digital health tools [DHTs]). While a number of DHT classifications have been proposed to help organize these tools for discovery, retrieval, and comparison by health care organizations seeking to potentially implement them, none have specifically addressed that organizations considering their implementation approach the DHT discovery process with one or more specific outcomes in mind. An outcomes-based DHT ontology could therefore be valuable not only for health systems seeking to evaluate tools that influence certain outcomes, but also for regulators and vendors seeking to ascertain potential substantial equivalence to predicate devices. This study aimed to develop, with inputs from industry, health care providers, payers, regulatory bodies, and patients through the Accelerated Digital Clinical Ecosystem (ADviCE) consortium, an ontology specific to DHT outcomes, the Digital medicine Outcomes Value Set (DOVeS), and to make this ontology publicly available and free to use. From a starting point of a 4-generation-deep hierarchical taxonomy developed by ADviCE, we developed DOVeS using the Web Ontology Language through the open-source ontology editor Protégé, and data from 185 vendors who had submitted structured product information to ADviCE. We used a custom, decentralized, collaborative ontology engineering methodology, and were guided by Open Biological and Biomedical Ontologies (OBO) Foundry principles. We incorporated the Mondo Disease Ontology (MONDO) and the Ontology of Adverse Events. After development, DOVeS was field-tested between December 2022 and May 2023 with 40 additional independent vendors previously unfamiliar with ADviCE or DOVeS. As a proof of concept, we subsequently developed a prototype DHT Application Finder leveraging DOVeS to enable a user to query for DHT products based on specific outcomes of interest. In its current state, DOVeS contains 42,320 and 9481 native axioms and distinct classes, respectively. These numbers are enhanced when taking into account the axioms and classes contributed by MONDO and the Ontology of Adverse Events. DOVeS is publicly available on BioPortal and GitHub, and has a Creative Commons license CC-BY-SA that is intended to encourage stakeholders to modify, adapt, build upon, and distribute it. While no ontology is complete, DOVeS will benefit from a strong and engaged user base to help it grow and evolve in a way that best serves DHT stakeholders and the patients they serve.

The 5-level version of the EQ-5D (EQ-5D-5L) was recently developed. A number of preference-based scoring systems are being developed for several countries around the world. To develop a value set for the EQ-5D-5L based on societal preferences in Canada. We used age, sex, and education quota sampling from the general population from 4 cities across Canada. Composite time trade-off (cTTO) and traditional time trade-off (tTTO) were used as the main elicitation technique. A total of 86 EQ-5D-5L health states grouped into 10 blocks were valued using cTTO, whereas a subset of 18 severe states was also valued using tTTO. Participants meeting predefined inconsistency criteria were excluded from the analyses. For the value set development, we used tTTO and positive cTTO values, while censoring negative and zero cTTO values at zero. Models with the main effects presented using linear terms combined with various additional terms were estimated. The preferred model was selected based primarily on logically ordered coefficients, and secondly model fit. Of the 1209 participants who completed the interview, 136 met criteria that excluded them from the primary analyses. The demographics and socioeconomic status of the remaining 1073 participants were similar to the Canadian general population. The preferred model has 5 linear terms for the main effects, a term for level 4 or 5 for each dimension, and a term for the squared total number of level 4 or 5 beyond the first. For this preferred model, the health utilities ranged from -0.148 for the worst (55555) to 0.949 for the best (11111) EQ-5D-5L states. This is the first TTO-based value set of the EQ-5D-5L for Canada. It can be used to support the health utility estimation in economic evaluations for reimbursement decision making in Canada.

Purpose The objective of this study was to develop an EQ-5D-5L value set based on the health preferences of the general adult population of Vietnam. Methods The EQ-VT protocol version 2.1 was applied. Multi-stage stratified cluster sampling was employed to recruit a nationally representative sample. Both composite time trade-off (C-TTO) and discrete choice experiment (DCE) methods were used. Several modelling approaches were considered including hybrid; tobit; panel and heteroscedastic models. First, models using C-TTO or DCE data were tested separately. Then possibility of combining the C-TTO and DCE data was examined. Hybrid models were tested if it was sensible to combine both types of data. The best-performing model was selected based on both the consistency of the results produced and the degree to which models used all the available data. Results Data from 1200 respondents representing the general Vietnamese adult population were included in the analyses. Only the DCE Logit model and the regular Hybrid model that uses all available data produced consistent results. As the priority was to use all available data if possible, the hybrid model was selected to generate the Vietnamese value set. Mobility had the largest effect on health state values, followed by pain/discomfort, usual activities, anxiety/depression and self-care. The Vietnam values ranged from − 0.5115 to 1. Conclusion This is the first value set for EQ-5D-5L based on social preferences obtained from a nationally representative sample in Vietnam. The value set will likely play a key role in economic evaluations and health technology assessments in Vietnam.

Background The study aims to elicit a value set based on the EQ-VT for the EQ-5D-5L that can be used to support decision-making in Sweden. Methods Participants were recruited from the general population based on age, sex and urban/rural area quota sampling from five regions across Sweden. In total, 785 interviews were conducted from February 2020 to April 2021 using the EQVT 2.1 protocol, and both composite time trade-off (c-TTO) and discrete choice experiments (DCE) were used to elicit health preferences. A variety of models have been tested for the c-TTO data (generalized least square, Tobit, heteroskedastic models) and DCE data (conditional logit model), as well as the combined c-TTO and DCE data (hybrid modelling). Model selection was based on theoretical considerations, logical consistency of the parameter estimates, and significance of the parameters ( p  = 0.05). Model goodness-of-fit was assessed by AIC and BIC, and prediction accuracy was assessed in terms of mean absolute error. The predictions for the EQ-5D-5L health states between models were compared using scatterplots. Results The preferred model for generating the value set was the heteroskedastic model based on the c-TTO data, with the health utilities ranging from -0.31 for the worst (55,555) to 1 for the best (11111) EQ-5D-5L states. Conclusion This is the first c-TTO-based social value set for the EQ-5D-5L in Sweden. It can be used to support the health utility estimation in economic evaluations for reimbursement decision making in Sweden.

Purpose To estimate Swedish experience-based value sets for EQ-5D health states using general population health survey data. Methods Approximately 45,000 individuals valued their current health status by means of time trade off (TTO) and visual analogue scale (VAS) methods and answered the EQ-5D questionnaire, making it possible to model the association between the experience-based TTO and VAS values and the EQ-5D dimensions and severity levels. The association between TTO and VAS values and the different severity levels of respondents' answers on a self-rated health (SRH) question was assessed. Results Almost all dimensions (except usual activity) and severity levels had less impact on TTO valuations compared with the UK study based on hypothetical values. Anxiety/depression had the greatest impact on both TTO and VAS values. TTO and VAS values were consistently related to SRH. The inclusion of age, sex, education and socioeconomic group affected the main effect coefficients and the explanatory power modestly. Conclusions A value set for EQ-5D health states based on Swedish valuations has been lacking. Several authors have recently advocated the normative standpoint of using experience-based values. Guidelines of economic evaluation for reimbursement decisions in Sweden recommend the use of experience-based values for QALY calculations. Our results that anxiety/depression had the greatest impact on both TTO and VAS values underline the importance of mental health for individuals' overall HRQoL. Using population surveys is in line with recent thinking on valuing health states and could reduce some of the focusing effects potentially appearing in hypothetical valuation studies.

Background The EQ VAS component of the EQ-5D questionnaire has been used to assess patients’ valuation of their own health besides its use for self-reporting of overall health status. The objective of the present study was to identify patients’ valuation of EQ-5D-3L health states using the EQ VAS in different patient groups over time and in comparison to the general population. Methods Data were obtained from patients from nine National Quality Registers ( n  = 172,070 patients) at baseline and at 1-year follow-up and compared with data from the general population ( n  = 41,761 participants). The correlation between EQ VAS scores and EQ-5D-3L index based on the Swedish experience-based VAS value set was assessed. Ordinary least squares (OLS) regression models were used to determine the association between EQ-5D-3L dimensions and EQ VAS valuation. Results EQ VAS scores showed consistency with severity of health states both at baseline and at 1-year follow-up in the nine selected EQ-5D-3L health states. The regression models showed mostly consistent decrements by severity levels in each dimension at both time points and similar to the general population. The dimension mainly associated with inconsistency was the self-care severity level three. Problems in the anxiety/depression dimension had the largest impact on overall health status in most of the patient groups and the general population. Conclusion The study has demonstrated the important role EQ VAS can play in revealing patients’ valuation of their health and showed the variation in valuation of EQ-5D-3L dimensions and levels of severity across different patient groups.

BackgroundThe second version of the Short-Form 6-Dimension (SF-6Dv2) classification system has recently been developed. The objective of this study was to develop a value set for SF-6Dv2 based on the societal preferences of a general population in the capital of Iran.MethodsA representative sample of the capital of Iran (n = 3061) was recruited using a stratified multistage quota sampling technique. Face-to-face interviews were conducted using binary choice sets from the international valuation protocol of the discrete choice experiment with duration. The conditional logit was used to estimate the final value set, and a latent class model was employed to assess heterogeneity of preferences.ResultsCoefficients generated from the models were logically consistent and significant. The best model was the one that included an additional interaction term for cases where one or more dimensions reached their most severe levels. It provides a value set with logical consistent coefficients and the lowest percentage of worse than death health states. Predicted values for the SF-6Dv2 were within the range of − 0.796–1. Pain dimension had the largest impact on utility decrement, whereas vitality had the least impact. The presence of preference heterogeneity was evident, and the Bayesian Information Criterion indicated the optimal fit for a latent class model with two classes.ConclusionThis study provided the SF-6Dv2 value set for application in the context of Iran. This value set will facilitate the use of the SF-6Dv2 instrument in health economic evaluations and clinical settings.

Background The EQ-5D is a generic preference-based quality of life measure considered useful for supporting clinical and policy decisions by providing utility values that can easily be converted into quality-adjusted life years to be integrated in cost-utility economic evaluations. Although the three-level classification system of the EuroQol questionnaire (EQ-5D-3L) is still the most popular preference-based instrument used worldwide, several studies reported a ceiling effect on this version, especially in healthy and/or young individuals. In 2009, the EuroQol Group introduced a five-level EQ-5D, which expands the descriptive system from three to five levels within the same five dimensions. For this version to be used in health economic evaluation, societal values need to be assigned to the 3125 health states generated by this instrument. Objectives The aims of this study were to elicit the EQ-5D-5L health state preferences from the general Portuguese population and to derive the Portuguese value set for the EQ-5D-5L. Methods A representative sample of the Portuguese general population aged above 18 years was stratified by age and gender ( n  = 1451). Between October 2015 and July 2016, 28 interviewers carried out a series of 1-h-long computer-assisted personal interviews following the EuroQol Valuation Technology protocol. Each interview included the valuation of ten health states using the composite time trade-off (cTTO) and seven pairs of discrete choice experiments (DCEs). A standardized tool for quality control was used to assess the quality of the data as well as direct supervision and cross-examination of 10% of the global sample size. Data from both cTTO and DCE valuation tasks were modelled using a censored heteroskedastic hybrid model. Results Interviewers complied with the quality control protocol in providing high-quality valuation data. The hybrid econometric model had consistent and significant parameters. The derived societal values for the Portuguese population ranged from − 0.603 to 1. Conclusion This study provided the Portuguese value set for the EQ-5D-5L on the basis of a hybrid econometric model using cTTO and DCE data. These results represent the preferences of the Portuguese population and are recommended to inform health decision-making in Portugal.