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The aim of this study was to develop and to assess a specific Multi-Criteria Decision Analysis (MCDA) framework to evaluate new drugs in an hospital pharmacy and therapeutics committee (P&TC) setting.
A pilot criteria framework was developed based on the EVIDEM (Evidence and Value: Impact on DEcisionMaking) framework, together with other relevant criteria, and assessed by a group of P&TC's members. The weighting of included criteria was done using a 5-point weighting technique. Two drugs were chosen by evaluation: an orphan-drug for Gaucher disease, and a nonorphan drug for the treatment of inflammatory bowel disease. Evidence matrices were developed, and value contribution of each drug was evaluated by P&TC's members. An agreed final framework was obtained through a discussion between the P&TC's members.
After criteria assessment, the pilot framework included eight quantitative criteria: “disease severity,” “unmet needs,” “comparative efficacy/effectiveness,” “comparative safety/tolerability,” “comparative patient-reported outcomes,” “comparative cost consequences-cost of treatment,” “comparative cost consequences-other medical costs,” and “quality of evidence”; and one contextual criterion: “opportunity costs and affordability.” The most valued criteria were: “comparative safety/tolerability,” “disease severity,” and “comparative efficacy/effectiveness.” When assessing the drugs most valued characteristics of the MCDA were the possibility that all team may contribute to drug assessment by means of scoring the matrices and the discussion to reach a consensus in drug positioning and value decision making.
The reflective MCDA would integrate quantitative and qualitative criteria relevant for a P&TC setting, allowing reflective discussions based on the criteria weighting score.
Congenital cardiac diseases are the most frequent congenital malformations. In adult patients, the mineralisation of the aorta due to cardiovascular disease is very common, but vascular mineralisation in paediatric cardiopathies is a topic less studied. This study shows that children with a complex congenital cardiopathy show a high degree of vascular mineralisation in the ascending aorta. This can be part of the cardiac failure pathophysiology due to congenital cardiopathies.
The aim of this study was to determine the presence and degree of vascular mineralisation in samples of the ascending and descending aorta of children with complex congenital cardiopathies.
We conducted a cross-sectional study.
We obtained 34 vascular tissues from the autopsies of 17 children with congenital cardiac disease.
We used a scanning electron microscope with an energy-dispersive X-ray spectroscopy in order to analyse the vascular tissues.
The amount of minerals was two times higher in the ascending aorta than in the descending aorta of children with congenital cardiac disease.
The study provides evidence that vascular mineralisation can start at an early age, and that it is higher in the ascending aorta than in the descending aorta.
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