The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.
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ABSTRACT:
SUBMITTER: Kleijnen S
PROVIDER: S-EPMC5548837 | biostudies-literature | 2017 Sep
REPOSITORIES: biostudies-literature
Publications
The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.
Kleijnen Sarah S Leonardo Alves Teresa T Meijboom Kim K Lipska Iga I De Boer Anthonius A Leufkens Hubertus G HG Goettsch Wim G WG
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 20170411 9
<h4>Purpose</h4>The aim of this study is to investigate the role of health-related quality-of-life (QoL) data in relative effectiveness assessments (REAs) of new anti-cancer drugs across European jurisdictions, during health technology assessment procedures.<h4>Methods</h4>Comparative analysis of guidelines and publicly available REAs in six European jurisdictions of anti-cancer drugs approved by EMA between 2011 and 2013.<h4>Results</h4>Fourteen anti-cancer drugs were included, adding up to 79 ...[more]
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| S-EPMC4542123 | biostudies-literature
Project description:BackgroundThe quantification of diabetes-related quality of life (DR-QoL) is an essential step in making Type 2 Diabetes (T2DM) self-management arrangements. The European General Practitioners Research Network (EGPRN) initiated the EUROBSTACLE study to develop a broadly conceptualised DR-QoL instrument for diverse cultural and ethnic groups; high and low-income countries. In 2016 the Diabetes Obstacles Questionnaire-30 (DOQ-30) was introduced.ObjectivesThe research aimed to study obstacles a patient with diabetes (PWD) may face in everyday life. First, we assessed how descriptive and clinical characteristics and the residential country were associated with the obstacles. Secondly, we calculated the proportion of respondents who expressed obstacles.MethodsData were collected in 2009 in a cross-sectional survey in Belgium, France, Estonia, Serbia, Slovenia, and Turkey. Multiple linear regressions were computed to detect associations between descriptive and clinical characteristics, residential country, and obstacles. Percentages of respondents who perceived obstacles were calculated.ResultsWe found that although descriptive and clinical characteristics varied to quite a great extent, they were weakly associated with the perception of obstacles. The residential country was most often associated with the existence of some obstacle. The highest percent (48%) of all respondents perceived 'Uncertainty about Insulin Use' as an obstacle.ConclusionDescriptive and clinical characteristics were weakly associated with perceived obstacles. However, the residential country plays an essential role in the decline of the QoL of PWDs. Education of both PWDs and healthcare professionals (HCPs) plays an essential role in countering the fear of insulin.
| S-EPMC8330755 | biostudies-literature
Project description:When healthcare interventions prolong life, people consume medical and non-medical goods during the years of life they gain. It has been argued that the costs for medical consumption should be included in cost-effectiveness analyses from both a healthcare and societal perspective, and the costs for non-medical consumption should additionally be included when a societal perspective is applied. Standardized estimates of these so-called future costs are available in only a few countries and the impact of inclusion of these costs is likely to differ between countries. In this paper we present and compare future costs for five European countries and estimate the impact of including these costs on the cost-effectiveness of life-prolonging interventions. As countries differ in the availability of data, we illustrate how both individual- and aggregate-level data sources can be used to construct standardized estimates of future costs. Results show a large variation in costs between countries. The medical costs for the Netherlands, Germany, and the United Kingdom are large compared to Spain and Greece. Non-medical costs are higher in Germany, Spain, and the United Kingdom than in Greece. The impact of including future costs on the ICER similarly varied between countries, ranging from €1000 to €35,000 per QALY gained. The variation between countries in impact on the ICER is largest when considering medical costs and indicate differences in both structure and level of healthcare financing in these countries. Case study analyses were performed in which we highlight the large impact of including future costs on ICER relative to willingness-to-pay thresholds.
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Project description:IntroductionTo make efficient use of available resources, decision-makers in healthcare may assess the costs and (health) benefits of health interventions. For interventions aimed at improving mental health capturing the full health benefits is an important challenge. The Mental Health Quality of Life (MHQoL) instrument was recently developed to meet this challenge. Evaluating the pyschometric properties of this instrument in different contexts remains important.MethodsA psychometric evaluation of the MHQoL was performed using existing international, cross-sectional data with 7155 respondents from seven European countries (Denmark, France, Germany, Italy, Portugal, The Netherlands, Portugal and the United Kingdom). Reliability was examined by calculating Cronbach's alpha, a measure of internal consistency of the seven MHQoL dimensions, and by examining the association of the MHQoL sum scores with the MHQoL-VAS scores. Construct validity was examined by calculating Spearman's rank correlation coefficients between the MHQoL sum scores and EQ-5D index scores, EQ-VAS scores, EQ-5D anxiety/depression dimension scores, ICECAP-A index scores and PHQ-4 sum scores.ResultsThe MHQoL was found to have good internal consistency for all seven countries. The MHQoL sum score and the MHQoL-VAS had a high correlation. Spearman's rank correlation coefficients were moderate to very high for all outcomes.ConclusionOur results, based on data gathered in seven European countries, suggest that the MHQoL shows favourable psychometrical characteristics. While further validation remains important, the MHQoL may be a useful instrument in measuring mental health-related quality of life in the Western European context.
| S-EPMC9434504 | biostudies-literature
Project description:Environmental protection is critical to maintain ecosystem services essential for human well-being. It is important to be able to rank countries by their environmental impact so that poor performers as well as policy 'models' can be identified. We provide novel metrics of country-specific environmental impact ranks - one proportional to total resource availability per country and an absolute (total) measure of impact - that explicitly avoid incorporating confounding human health or economic indicators. Our rankings are based on natural forest loss, habitat conversion, marine captures, fertilizer use, water pollution, carbon emissions and species threat, although many other variables were excluded due to a lack of country-specific data. Of 228 countries considered, 179 (proportional) and 171 (absolute) had sufficient data for correlations. The proportional index ranked Singapore, Korea, Qatar, Kuwait, Japan, Thailand, Bahrain, Malaysia, Philippines and Netherlands as having the highest proportional environmental impact, whereas Brazil, USA, China, Indonesia, Japan, Mexico, India, Russia, Australia and Peru had the highest absolute impact (i.e., total resource use, emissions and species threatened). Proportional and absolute environmental impact ranks were correlated, with mainly Asian countries having both high proportional and absolute impact. Despite weak concordance among the drivers of environmental impact, countries often perform poorly for different reasons. We found no evidence to support the environmental Kuznets curve hypothesis of a non-linear relationship between impact and per capita wealth, although there was a weak reduction in environmental impact as per capita wealth increases. Using structural equation models to account for cross-correlation, we found that increasing wealth was the most important driver of environmental impact. Our results show that the global community not only has to encourage better environmental performance in less-developed countries, especially those in Asia, there is also a requirement to focus on the development of environmentally friendly practices in wealthier countries.
| S-EPMC2862718 | biostudies-literature
Project description:Internal validity is often the primary concern for health technology assessment agencies when assessing comparative effectiveness evidence. However, the increasing use of real-world data from countries other than a health technology assessment agency's target population in effectiveness research has increased concerns over the external validity, or "transportability", of this evidence, and has led to a preference for local data. Methods have been developed to enable a lack of transportability to be addressed, for example by accounting for cross-country differences in disease characteristics, but their consideration in health technology assessments is limited. This may be because of limited knowledge of the methods and/or uncertainties in how best to utilise them within existing health technology assessment frameworks. This article aims to provide an introduction to transportability, including a summary of its assumptions and the methods available for identifying and adjusting for a lack of transportability, before discussing important considerations relating to their use in health technology assessment settings, including guidance on the identification of effect modifiers, guidance on the choice of target population, estimand, study sample and methods, and how evaluations of transportability can be integrated into health technology assessment submission and decision processes.
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| S-EPMC10581102 | biostudies-literature
Project description:PURPOSE: This research conducted a face validation study of patient responses to the application of an HRQOL assessment research tool in a comprehensive community cancer program setting across a heterogeneous cohort of cancer patients throughout the natural history of diagnosed malignant disease, many of whom would not be considered candidates for clinical research trial participation. METHODS: Cancer registries at two regional cancer treatment centers identified 11072 cancer patients over a period of nine years. The EORTC QLQ-C30 was administered to patients at the time of their initial clinical presentation to these centers. To determine the significance of differences between patient subgroups, two analytic criteria were used. The Mann-Whitney test was used to determine statistical significance; clinical relevance defined a range of point differences that could be perceived by patients with different health states. RESULTS: Univariate analyses were conducted across stratification variables for population, disease severity and demographic characteristics. The largest differences were associated with cancer diagnosis and recurrence of disease. Large differences were also found for site of origin, mortality and stage; minimal differences were observed for gender and age. Consistently sensitive QoL scales were appetite loss, fatigue and pain symptoms, and role (work-related), social and physical functions. CONCLUSIONS: 1) The EORTC QLQ-C30 collected meaningful patient health assessments in the context of non-research based clinical care, 2) patient assessment differences are manifested disparately across 15 QoL domains, and 3) in addition to indicating how a patient may feel at a point in time, QoL indicators may also reveal information about underlying biological responses to disease progression, treatments, and prospective survival.
| S-EPMC4053440 | biostudies-literature
Project description:OBJECTIVES:The aim of this study was to adapt the Systemic Sclerosis Quality of Life Questionnaire (SScQoL) into six European cultures and validate it as a common measure of quality of life in systemic sclerosis (SSc). METHODS:This was a seven-country (Germany, France, Italy, Poland, Spain, Sweden and UK) cross-sectional study. A forward-backward translation process was used to adapt the English SScQoL into target languages. SScQoL was completed by patients with SSc, then data were validated against the Rasch model. To correct local response dependency, items were grouped into the following subscales: function, emotion, sleep, social and pain and reanalysed for fit to the model, unidimensionality and cross-cultural equivalence. RESULTS:The adaptation of the SScQoL was seamless in all countries except Germany. Cross-cultural validation included 1080 patients with a mean age 58.0 years (SD 13.9) and 87% were women. Local dependency was evident in individual country data. Grouping items into testlets corrected the local dependency in most country specific data. Fit to the model, reliability and unidimensionality was achieved in six-country data after cross-cultural adjustment for Italy in the social subscale. The SScQoL was then calibrated into an interval level scale. CONCLUSION:The individual SScQoL items have translated well into five languages and overall, the scale maintained its construct validity, working well as a five-subscale questionnaire. Measures of quality of life in SSc can be directly compared across five countries (France, Poland Spain, Sweden and UK). Data from Italy are also comparable with the other five countries although require an adjustment.
| S-EPMC6029637 | biostudies-other