Comparison of the HUI3 with the SF-36 Preference Based SF-6D in a Clinical Trial Setting

AbstractObjectiveTo test the hypothesis that the Health Utilities Index Mark III (HUI3) and the SF-6D, based on the SF-36, generate similar health state values, and to test and compare their discriminant validity and responsiveness.MethodsThe HUI3 and SF-36 were administered to 331 patients enrolled in a double-blind, multinational phase III clinical trial in patients undergoing percutaneous coronary intervention before hospital discharge and 6 months thereafter.ResultsThe mean SF-6D baseline health state score was 0.67 compared to the HUI3 of 0.63 with r of 0.616 and intraclass correlation coefficient of 0.40. The relationship was nonlinear with greatest divergence found at the lower levels of health. Both measures were found to agree with known differences in health and to be responsive to changes over time. Nevertheless, disagreement resulted in different estimates of change from baseline (0.08 vs. 0.154).ConclusionBoth measures deployed in the present study were found to have discriminant validity, and to be responsive to changes over time in coronary artery disease conditions. Nevertheless, the measures generated different estimates of health state values for this patient population. These differences might in part be the consequence of the health status descriptive system for the HUI that may have been more in line with the hospitalized state than that for the SF-6D. These findings seemed to indicate that measures deployed are not interchangeable for use in cost-utility analysis. More head-to-head comparisons between these two measures are needed to further define and compare relationships in different patient populations

Comparisons of Hypertension-Related Costs from Multinational Clinical Studies

Background: This study identifies and compares the individual cost components of hospital and ambulatory services that manage the care of hypertensive patients in eight countries: the US, the UK, France, Spain, Germany, Italy, Canada and Australia. Methods: Hypertension-related costs are classified according to four major cardiovascular events: (i) acute myocardial infarction; (ii) congestive heart failure; (iii) stroke; and (iv) renal failure, which was subdivided into renal failure treated by dialysis and renal failure treated by kidney transplantation. To make cross-country costs comparisons, we used the DRG codes used in the US and DRG-like codes from each country. US cost information was obtained from hypertension data available from the literature and health economics researchers. For costs in other countries, we consulted with national health economics experts in each country, used analyses by the Research Triangle Institute, and performed Medline and international literature searches. When available, we obtained information from the countries Results: There exists considerable variation in hypertension-related costs from multinational clinical studies. This study documents that costs are generally higher in the US than in other countries; however, this is not always true. In particular, costs of treating heart failure in France and the costs of renal failure without transplantation in Germany and the UK are relatively high. Discussion: While analysing multinational hypertensive cost data, this study also addresses the impact of cross-country cost variations on cost analyses. During the last decade, drug-development researchers have drawn extensively upon multinational trials to resolve enrolment problems and drug-registration issues. At the same time, formulary decision-makers are increasingly demanding multinational cost-effectiveness analyses of the clinical differences found between drug-treatment regimens. Since these data are typically not captured by randomised clinical trials, standard cost estimates must be applied to the clinical trials Conclusion: This paper serves as an instrument for identifying which national and event cost data are comparable for analysis as well as highlighting specific problem areas for cost data integration. Although the study focuses on hypertension-related costs, its results may provide insight for multinational cost comparisons of other diseases where similar hospitalisation costs may be analysed.Cost-of-illness, Hypertension

Outcomes Associated with Initial versus Later Vancomycin Use in Patients with Complicated Skin and Skin-Structure Infections

BackgroundBackground Delayed coverage of pathogens including meticillin-resistant Staphylococcus aureus (MRSA) in pneumonia and bacteraemia has been associated with increased mortality and length of hospital stay (LOS). However, less is known about the impact of delayed appropriate coverage in complicated skin and skin-structure infections (cSSSIs). Abstract: ObjectiveObjective To evaluate the clinical and economic outcomes associated with early versus late use of vancomycin in the management of patients hospitalized for cSSSIs. Abstract: MethodsMethods Retrospective analysis was performed using an inpatient claims database of >500 US hospitals in 2005. Using prescription claims, patients with primary or secondary cSSSI admissions were classified into three groups: 1 - early vancomycin monotherapy; 2 - early vancomycin combination therapy; 3 - late vancomycin therapy. Outcomes studied included LOS and inpatient hospital costs. One-way analysis of variance was used for unadjusted analysis and multivariate regression methods were used to control for co-variates. Abstract: ResultsResults A total of 34 942 patients (27.78% of all patients with cSSSIs) were treated with vancomycin. Mean age was 54.7 years and 54.3% of the patients were males. Mean unadjusted total LOS was 8.46, 9.44 and 13.2 days, and hospital costs in 2005 values were $US10 211.94, $US12 361.94 and $US18 344.00 for groups 1, 2 and 3, respectively. In-hospital mortality rate was highest in group 3 (4.18%) and lowest in group 1 (1.75%). Generalized linear models used to control for potential confounding variables between early versus late vancomycin use suggest that among cSSSI patients late vancomycin use is an independent predictor of higher LOS and costs. Abstract: ConclusionConclusion In this large inpatient database, later vancomycin use in patients with cSSSIs appears to be significantly associated with higher LOS and total costs.