1,720,965 research outputs found
Farmacoeconomia e outcomes research
Pharmaceutical products are relevant for their contribution to the medicine progress and in health peoples improvement, altough this evidence goes back to the forthy years with the reduction in mortality, morbidity and hospitalisation rates. The ambivalence of drugs, both remedy and poison, needs a careful assessment of risks and benefits. Primitive estimates of health treatments evaluation occurred in the human history but the modern concept of evaluation in health care derived from cost-benefit analysis (welfare economics) and technology assessment. Then a new discipline, pharmacoeconomics and outcomes research, developed with the contribution of health economics, clinical medicine, pharmacology, statistics and epidemiology.?Pharmaceutical products are also relevant because of their responsability of health expenditure growth. From 1992, in Italy, several legislative actions were made to face up the pharmaceutical expenditure. The most important one (L. 537/1993) achieved the maximum decrease of 16,8%, in 1994, and modified radically the pharmaceutical policy. Nevertheless, in the following six years the pharmaceutical expenditure grew more than 93%. ?New actions were made fixing the pharmaceutical expenditure to 13% of health expenditure, any excess being charged to Regions. In the new version for the current year, the excesses will be paid-back by pharmaceutical companies (60%) and Regions (40%). Furtherly, the creation of Agenzia Italiana del Farmaco increases the relevance of cost-effectiveness analyses for drugs reimbursement.?However, pharmacoeconomic evaluations have still many methodological problems. Economic variables should be treated in the same manner of biomedical or epidemiological data, that is, by confidence intervals and sample sizes. There would be an “economic significance” besides to clinical and statistical ones. In this way, pharmacoeconomics and outcomes research would be able to add rationality to health care expenditure
Gli studi di superiorità, di equivalenza e di non inferiorità nelle sperimentazioni cliniche
Health technology assessment: un altro punto di vista
Per tecnologia medica s’intende l’insieme di tecniche, farmaci, attrezzature e procedure praticabili nei sistemi sanitari rivolti alla prevenzione, diagnosi, terapia e riabilitazione. Pertanto, nel suo senso più ampio, essa include vaccini e interventi chirurgici nonché il sistema informatico di un ospedale. La stessa definizione è utilizzata dal WHO e dal nostro Ministero della Salute. Le tecnologie mediche assumono particolare rilevanza per almeno tre aspetti: a esse è attribuito, in gran parte, il miglioramento dello stato di salute della popolazione; sono ritenute responsabili dell’espansione dei costi della sanità; costituiscono un settore produttivo di indubbio interesse economico
L’analisi delle decisioni negli studi di farmacoeconomia
This paper is a review of the decision tree methodology. This is a very useful technique in complex decision making, when the consequences of the decisions are distant in time and the information upon which we can rely is uncertain. Decision trees are the basic structure underlying most applications of decision analysis in medicine. However, in this review we only cover their application to the pharmaco-economic field. ?The main steps of this decision analysis are explained. Thereafter, a case study from the literature is used as an example, i.e. an application of the decision tree analysis to a study aimed at comparing two different drugs in the treatment of gastro-esophageal reflux. ?The main focus of our paper is on the statistical aspects, which include the definition and quantification of the outcome variables, the definition and quantification of the probabilities of occurrence of the uncertain events considered in the decision tree, and the sensitivity analysis. The knowledge of the basic laws of the probability theory is mandatory for assigning correct values to the parameters of the decision tree (outcomes and probabilities). Finally, the sensitivity analysis is an important part of the work to be performed in the last stage of the decision analysis in order to measure the degree of robustness of the results when varying the assumptions
Cost- effectiveness of gastro-duodenal ulcer prevention in regular users of non-steroidal anti-inflammatory drug (NSAID).
Cost-effectiveness analysis of two protocols of sequential combinations of Helicobacter pylori eradication treatments
Objective: To compare the costs and outcomes of two different protocols of three consecutive combinations of eradication therapies in patients with Helicobacter pylori (HP)-positive dyspepsia with or without peptic ulcer disease, from the perspective of the Italian National Health System (INHS).
Design: An open comparative study with a one-year follow-up was performed. A decision tree was used to calculate cost-effectiveness.
Setting: Department of Infectious and Tropical Diseases of the University “La Sapienza”, Rome, Italy.
Interventions: Three different eradication therapies were tested: Amoxicilline + Metronidazole + Omeprazole [AMO]; Clarithromycin + Metronidazole + Omeprazole [CMO]; Tetracycline + Clarithromycin + Bismuth [TCB]. These eradication therapies were consecutively arranged in the CAT protocol (CMO-AMO-TCB) and in the ACT protocol (CMO-AMO-TCB).
Patients and participants: The patients enrolled in the study were 229 and distributed as follows: 104 in the ACT protocol and 125 in the CAT protocol.
Main outcome measures and results: The CAT protocol resulted more effective and costly than the ACT protocol after the first two eradication therapies. The incremental effectiveness was 12 and 22 eradicated patients while the incremental cost was Lit. 221,461 and Lit. 279,948 in patients with and without peptic ulcers, respectively. However, considering the entire therapeutic cycle (three eradication treatments), the total direct cost per patient with initial ulcer was Lit. 1,166,919 for CAT patients (Lit. 1,157,368 for those without ulcer) and Lit. 1,196,571 for ACT ones (Lit. 1,330,648 for those without ulcers).
Conclusions: The CAT protocol resulted more effective and less costly than the ACT ptotocol at the end of the full therapeutic cycle. After a year from diagnosis, the CAT protocol could produce saving to the INHS ranging from Lit. 60 to 520 billions due to lower drug consumption and lower use of diagnostic tests
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