Objectives: The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies.
Methods: HTA activities ...for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1–agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2–semi-structured telephone interviews with key informants of a sub-sample of agencies.
Results: In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non–MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices.
Conclusions: The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.
The main objective of this article was to explore the use of the patient evaluation of health states in determining the quality of health care program provision among health care providers. The other ...objectives were to explore the effect of size and status of health care providers on patient-reported outcomes.
The EuroQol five-dimensional questionnaire was used in four health care programs (hip replacement, hernia surgery, carpal tunnel release, and veins surgery) to evaluate patients’ health states before and after the procedure, following carefully prepared instructions. Data were collected for a single year, 2011. The number of questionnaires filled by patients was 165 for hip replacement, 551 for hernia surgery, 437 for vein surgery, and 158 for carpal tunnel release. The data were analyzed using linear regression model and the EuroQol five-dimensional questionnaire value set for Slovenia. Differences between providers were determined using the Tukey test. Potential quality-adjusted life-years (QALYs) gained for all four programs were calculated for the optimal allocation of patients among providers.
There are significant differences among health care providers in the share of patients who reported positive changes in health care status as well as in average improvement in patient-reported outcomes in all four programs. In the case of optimal allocation, each patient undergoing hip replacement would gain 2.25 QALYs, each patient undergoing hernia surgery would gain 0.83 QALY, each patient undergoing veins surgery would gain 0.36 QALY, and each patient undergoing carpal tunnel release would gain 0.78 QALY.
The analysis exposed differences in average health state valuations across four health care programs among providers. Further data on patient-reported outcomes for more than a single year should be collected. On the basis of trend data, further analysis to determine the possible causes for differences should be conducted and the possibility to use this approach for measuring health care providers’ performance and its use in contracting should be explored.
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.
Abstract
Introduction
The purpose of this study is to analyse and present the causes of the differences in crude utilization rate in cardiac implantation electronic devices, specifically pacemakers ...and automatic implantable cardioverter-defibrillators, across 5 European countries, with a specific emphasis on Slovenia.
Methods
Based on the results of the analysis of the uptake of cardiac implantation electronic devices across countries studied in MedtecHTA project, the targeted interviews were conducted to explain the factors that impact the differences and explain data in Slovenia.
Results
The reasons for the differences in crude utilization rate across 5 European countries were multiple: the first group of differences refers to the coding system and linkages between coding and financing of health care. The second group of reasons can be qualitatively ascribed to the economic situation, financial situation in health care, and its impact on decision-making. The last reason is the non-existence of the golden rule for optimal crude utilisation rate.
Conclusions
It is evident that the differences in the uptake of cardiac implantation electronic devices among the countries are of organisational nature: they refer to the system of coding, the importance attached to correct coding practices, the link between coding and financing of health care as well as the availability of private clinics and private insurance. According to the interviews, the economic development of the country also impacts those differences, whereas the differences in clinical practice and guidelines are claimed not to play a role in the explanation of the differences.
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.
The main objective of the research was to analyse the study attitudes and study behaviour of online students at DOBA Business School. Furthermore, the aim was to evaluate the interrelationship ...between study attitudes and study behaviour and to assess the predictive value of the two sets of variables for students' general satisfaction with the study programmes. A total of 331 students participated in the web survey. Participants expressed the most positive attitudes towards the use of technology and flexibility of online learning, while the absence of personal contacts was also perceived as highly favourable. Average scores for both deep and strategic approaches were quite high, while the surface approach was much less prominent . Participants were highly engaged with their teamwork assignments, whereas proactive communication was somewhat less developed . Study attitudes seem to be far more powerful predictors of general satisfaction than study behaviour, which is not surprising. Satisfaction is thought to be the result of the complex subjective evaluation of all relevant aspects of the study programme implementation, as they were measured by attitudinal subscales.
Background: Subjective health states valuation has an increasing impact in the last decade and is used more and more in determining the quality of life of population. On its basis the quality ...adjusted life years (QALYs) are calculated that are used in economic cost utility analyses in health care fi eld. Quite in a few countries such analyses are recommended or even demanded in the process of taking decisions on fi nancing new health technology including medicines, equipments and medical procedures. Th e preferences of the population have therefore an enormous impact on the allocation of restricted health care budget and through this on the health care development. Th e question is whether population preferences for health care states or for separate health care states dimensions, that impact the healthrelated quality of life, change in time. Th e goal of the study is to examine the stability and reliability of preferences for the EQ-5D health states in Slovenian population at two points in time. Methods: Two-stage random sample was selected from the adult Slovenian population in years 2000 and 2005. Each time, the respondents valued a subset out of the 243 EQ-5D health states. Regression analysis was used to get the valuations for all EQ-5D states in both years. First, we compared unadjusted and adjusted mean valuations among both groups. Second, we evaluated diff erences in mean valuations among the groups aft er adjusting for other sociodemographic characteristics: age and education.Results: Th e valuations showed the stability of the preferences towards EQ-5D health states in Slovenian population. Conclusions: Within Slovenia, the preferences of Slovenian population are stable in time and proper to use in economic analyses.
EQ-5D is becoming the preferred instrument to measure health-state utilities involved in health technology assessment. The objective of this study is to assess the state of EQ-5D research in ...musculoskeletal disorders in 8 Central and Eastern European countries and to provide a meta-analysis of EQ-5D index scores. Original research articles published in any language between Jan 2000 and Sept 2016 were included, if they reported any EQ-5D outcome from at least two musculoskeletal patients from Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia, or Slovenia. Risk of bias was assessed with the Cochrane Collaboration’s tool. Twenty-nine articles (5992 patients) were included on rheumatoid arthritis (
n
= 7), osteoporosis (
n
= 5), chronic pain (
n
= 5), osteoarthritis (
n
= 4), ankylosing spondylitis (
n
= 2), psoriatic arthritis (
n
= 2), total hip replacement (
n
= 2), and scleroderma (
n
= 2). Low back pain was under-represented, while studies in neck pain, systemic lupus erythematosus, gout, and childhood disorders were lacking. EQ-5D index scores were reported in 24 studies, while the version of the instrument and the value-set was not specified in 41% and 46% of the articles, respectively. Meta-analysis was performed on 24 disease states involving 6876 observation points. Intervention effect was reported in 22 subgroups, out of which risk of bias was low in 41%. This review provides recommendations to improve reporting standards of EQ-5D results and highlights potential areas for future research. Coordinated research in conditions with greatest public health impact as well as a development of a regional value-set could provide locally relevant health-state utilities that are transferable among countries within the region.
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