A state-of-the-art multi-criteria model for drug benefit-risk analysis

Drug benefit-risk analysis is based on firm clinical evidence related to various safety and efficacy outcomes, such as tolerability, treatment response, and adverse events. In this paper, we propose a new approach for constructing a supporting multi-criteria model that fully takes into account this evidence. Our approach is based on the Stochastic Multicriteria Acceptability Analysis (SMAA) methodology, which allows us to compute the typical value judgments that support a decision, to quantify uncertainty, and to compute a comprehensive benefit-risk profile. As an example, we constructed a multi-criteria model for the therapeutic group of second-generation antidepressants. We analyzed Fluoxetine, Paroxetine, Sertraline, and Venlafaxine according to relative efficacy and absolute rates of several common adverse drug reactions using meta-analytical data from the literature. Our model showed that there are clear trade-offs among the four drugs. Based on our experiences from this study, SMAA appears to be a suitable approach for quantifying trade-offs and decision uncertainty in drug benefit-risk analysis.

Modelling the health-economic impact of the next influenza pandemic in The Netherlands

To optimally develop or adjust national contingency plans to respond to the next influenza pandemic, we developed a decision type model and estimated the total health burden and direct medical costs during the next possible influenza pandemic in the Netherlands on the basis of health care burden during a regular epidemic. Using an arithmetic decision tree-type model we took into account population characteristics, varying influenza attack rates, health care consumption according to the Dutch health care model and all-cause mortality. Actual direct medical cost estimates were based on the Dutch guidelines for pharmaco-economic evaluation. In the base-case scenario with no preventive measure available and an average influenza attack rate of 30%, 4,958,188 influenza infections, 1,552,687 GP consultations, 83,515 hospitalizations and 173,396 deaths will take place in The Netherlands. The burden is highest in adults aged 20 to 64 years. If minimizing the total mortality and sustaining highest net economic returns is the objective, this group needs to be targeted in interventions. (c) 2006 Elsevier Ltd. All rights reserve

Prospective cohort study of routine use of risk assessment scales for prediction of pressure ulcers

Objective To evaluate whether risk assessment scales can be used to identify patients who are likely to get pressure ulcers.Design Prospective cohort study.Setting Two large hospitals in the Netherlands.Participants 1229 patients admitted to the surgical, internal, neurological, or geriatric wards between January 1999 and June 2000.Main outcome measure Occurrence of a pressure ulcer of grade 2 or worse while in hospital.Results 135 patients developed pressure ulcers during four weeks after admission. The weekly incidence of patients with pressure ulcers was 6.2% (95% confidence interval 5.2% to 7.2%). The area under the receiver operating characteristic curve was 0.56 (0.51 to 0.61) for the Norton scale, 0.55 (0.49 to 0.60) for the Braden scale, and 0.61 (0.56 to 0.66) for the Waterlow scale; the areas for the subpopulation, excluding patients who received preventive measures without developing pressure ulcers and excluding surgical patients, were 0.71 (0.65 to 0.77), 0.71 (0.64 to 0.78), and 0.68 (0.61 to 0.74), respectively. In this subpopulation, using the recommended cut­off points, the positive predictive value was 7.0% for the Norton, 7.8% for the Braden, and 5.3% for the Waterlow scale.Conclusion Although risk assessment scales predict the occurrence of pressure ulcers to some extent, routine use of these scales leads to inefficient use of preventive measures. An accurate risk assessment scale based on prospectively gathered data should be developed