Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption.We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs. Two case studies were considered: transcatheter aortic valve implantation (TAVI) representing an emerging technology and implantable cardioverter defibrillators (ICDs) representing a mature technology. Economic evaluation studies published as journal articles or within Health Technology Assessment reports were identified through a systematic literature review. A total of 19 studies on TAVI and 41 studies on ICDs were analysed. Learning curve was considered in only 16% of studies on TAVI. Incremental innovation was more frequently mentioned in the studies of ICDs, but its impact was considered in only 34% of the cases. Dynamic pricing was the most recognised feature but was empirically tested in less than half of studies of TAVI and only 32% of studies on ICDs. Finally, organisational impact was considered in only one study of ICDs and in almost all studies on TAVI, but none of them estimated its impact.By their very nature, most of the distinctive features of MDs cannot be fully assessed at market entry. However, their potential impact could be modelled, based on the experience with previous MDs, in order to make a preliminary recommendation. Then, well-designed post-market studies could help in reducing uncertainties and make policymakers more confident to achieve conclusive recommendations.
Background A value set for the EuroQoL 5-Dimensions (EQ-5D)-Y in Slovenia is not yet available, making the calculation of quality-adjusted life-years (QALYs) for children and adolescents using this generic instrument impossible. Objective The main objective of our study was to obtain adult preferences towards EQ-5D-Y health states in Slovenia, following the EQ-5D-Y-3L international valuation protocol. The adults were asked to take the perspective of a hypothetical 10-year-old child. Method A sample of 1074 adults in Slovenia completed an online discrete-choice experiment (DCE) survey on EQ-5D-Y health states. The latent scale issue was addressed by obtaining the value of the anchor (33333) with 200 composite time trade-off (cTTO) interviews. A mixed (random coefficients) logit model was used to estimate the value set. Results All the estimated coefficients of the mixed logit model were statistically significant at the 1% level and had an expected negative sign. The most important health dimension in EQ-5D-Y is pain/discomfort, followed by anxiety/depression, usual activities, and mobility, with self-care being the least important health dimension. Conclusions The study addresses an important research gap and presents the EQ-5D-Y value set for Slovenia. At the time of writing, no published value sets are available for the EQ-5D-Y-3L appropriate for use in QALY calculations, making this value set the first EQ-5D-Y value set in the world.
Background The study aims to present Slovenian EQ-5D-5L population norms for different age and gender subgroups that can be used as reference values in future studies concerning health status. The secondary aim is to compare those norms with population norms from some other countries in Europe and elsewhere. Methods The cross-sectional survey was conducted between November 2019 and February 2020 via online panel. 1071 adults aged 18+ were included in the survey. The general population was sampled using quota sampling in terms of age, gender, and NUTS2 region. In the study, the EQ-5D-5L Slovenian online version was used. Descriptive statistics was used to present health status by age groups and genders for the EQ-5D-5L descriptive system, EQ VAS and the EQ-5D-5L index score. The latter was derived from Slovenian EQ-3D-3L tariff, transformed to five levels using the crosswalk methodology. Results The mean EQ VAS score in the Slovenian population was 79.9, mean utility index was 0.808. 28.2% of the population did not have problems on any dimension and 3.9% of the population had problems on all dimensions. Persons residing in Western Slovenia had, on average, 0.016 higher utility score, compared to Eastern Slovenia. Effect of gender was not significant. Age was negatively associated with both utility index and EQ VAS score. Education was positively correlated to health status. Problems on dimensions were generally increasing with age, except for anxiety/depression dimension, where youngest group (ages 18–29) reported more anxiety/depression compared to older counterparts. Self-reported anxiety/depression was more pronounced in women. Conclusions Similarly to other countries, the health generally deteriorates with age, except for the anxiety/depression dimension where the share of respondents reporting no problems was lowest in the youngest age group. The open question for the future remains, whether population norms from this online sample differ significantly from the actual EQ-5D-5L health status data of the Slovenian general population.
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