Valutazione quali-quantitativa degli studi condotti con dispositivi medici rispetto a quelli condotti con terapie farmacologiche
Rosi Sicuro, Luigi Spaziante
Introduction: In the last decades, the management and use of medicines and medical devices (MD) have acquired a comparable relevance both from the clinical point of view (effect on patients health), and from economic point of view (health expenditure). At the same time the need to manage health technologies on the base of available scientific evidence, has grown in importance.
The purpose of this work was the evaluation of the quantitative and qualitative differences, if any, between clinical trials with medicines and with MD using articles review, published on the most relevant international medical journals.
Material and Methods: The original articles, published during 2014 on the 3 journals with higher impact factor (New England Journal of Medicine NEJM, IF: 54.42; The Lancet, IF: 33.63; Journal of The American Medical Association, JAMA, IF: 30.00) have been selected. After a reading of the abstracts, all the studies dealing with MD and medicines have been chosen. Subsequently, the full texts have been acquired for only the prospective studies, in order to apply Jadad scale for quality evaluation.
Results: 548 abstrats were selected, 50 (9.1%) about MD and 228 (41.6%) about medicines. Jadad scale was applied only for the prospective studies included in this analysis (6.8% MD, 33.9% medicines). The Jadad score obtained was 2.3 for MD and 3.4 for medicines.
Conclusions: Clinical trial dealing with MD are fewer and their quality are less than optimal. The main causes are methodological problems while planning clinical trials and European MD regulations.
Key words: medical device, clinical trial, Jadad scale, regulation, evidence based medicine