19 research outputs found
Health state utilities associated with major clinical events in the context of secondary hyperparathyroidism and chronic kidney disease requiring dialysis
Estimating Health-State Utility for Economic Models in Clinical Studies: an ISPOR Good Research Practices Task Force Report
Cost-utility models are increasingly used in many countries to establish whether the cost of a new intervention can be justified in terms of health benefits. Health-state utility (HSU) estimates (the preference for a given state of health on a cardinal scale where 0 represents dead and 1 represents full health) are typically among the most important and uncertain data inputs in cost-utility models. Clinical trials represent an important opportunity for the collection of health-utility data. However, trials designed primarily to evaluate efficacy and safety often present challenges to the optimal collection of HSU estimates for economic models. Careful planning is needed to determine which of the HSU estimates may be measured in planned trials; to establish the optimal methodology; and to plan any additional studies needed. This report aimed to provide a framework for researchers to plan the collection of health-utility data in clinical studies to provide high-quality HSU estimates for economic modeling. Recommendations are made for early planning of health-utility data collection within a research and development program; design of health-utility data collection during protocol development for a planned clinical trial; design of prospective and cross-sectional observational studies and alternative study types; and statistical analyses and reporting
Impact of Major Clinical Events on Utilities in the Context of Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) Treated with Dialysis
A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet
Etelcalcetide for Treating Secondary Hyperparathyroidism: An Evidence Review Group Evaluation of a NICE Single Technology Appraisal
CKD-MBD management: what is the role of parathyroidectomy? Results from a nationwide survey in Italy
Supplementary Material for: An Epidemiological Study of Hemodialysis Patients Based on the European Fresenius Medical Care Hemodialysis Network: Results of the ARO Study
<p><i>Background/Aims:</i> ARO, an observational study of hemodialysis
(HD) patients in Europe, aims to enhance our understanding of patient
characteristics and practice patterns to improve patient outcome. <i>Methods:</i>
HD patients (n = 8,963) from 134 Fresenius Medical Care facilities
treated between 2005 and 2006 were randomly selected from 9 European
countries (Czech Republic, France, Hungary, Italy, Poland, Portugal,
Spain, Slovak Republic and Slovenia) and Turkey. Information was
captured on demographics, comorbidities, medications, laboratory and
dialysis parameters, and outcome. <i>Results:</i> Patients were followed
for 1.4 ± 0.7 years. Wide variation by country was observed for age,
sex and diabetes as a cause of chronic kidney disease. Cardiovascular
disease was present in 73% of patients. Dialysis parameters were
homogeneous across countries. Arteriovenous fistulas were frequently
used (73%). More incident patients had hemoglobin <11 g/dl than
prevalent patients (50 vs. 33%, respectively). Phosphatemia and intact
parathyroid hormone were similar between incident and prevalent patients
(4.7 ± 1.2 mg/dl and 190 vs. 213 ng/l, respectively). Medication use
varied widely by country. In total, 5% of patients underwent renal
transplantation. Overall death rate was 124/1,000 patient-years. <i>Conclusion:</i>
ARO revealed differences in HD practice patterns and patient
characteristics in the 10 participating countries. Future ARO studies
will fill gaps in the knowledge about the care of European HD patients.</p