Publications by authors named "M Sinegre"

Introduction: The Medical Devices Committee (CODIMS) of the Assistance publique-Hôpitaux de Paris (AP-HP) is responsible for deciding whether innovative and costly sterile medical devices (SMD) should be adopted for the AP-HP network and for issuing recommendations on their proper use. The aim of this study was to qualify retrospectively the level of evidence of clinical studies used for the device evaluations by the CODIMS in 2012 and 2013 and to analyze the relationship between levels of evidence and decisions.

Material And Method: Executive summaries written in 2012 and 2013 about studied SMD was analyzed and the level of evidence of clinical studies used was qualified in high/low levels of evidence according to the scale of Sackett et al.

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Objective: We aimed to document amoxicillin-clavulanic acid prescription to improve the proper use of antibiotics in hospital settings. We used three criteria: quality of medical charts, adequacy of indications, and adequacy of treatment duration.

Method: This study was designed as a one-day point prevalence survey carried out by antibiotic lead specialists.

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In 2012, following the Mediator(®) (benfluorex) scandal, France displayed the ambitious goal to implement a regulatory framework for controlling off-label drug use: the "Temporary Recommendations for Use" (RTUs). It aims to regulate the use of pharmaceuticals outside the scope of a marketing authorization (MA) by establishing a framework for patient monitoring and data collection. This is intended to ensure that the benefit/risk ratio is favorable for the indication approved by the RTU.

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