Results of the 2017 inspection campaign of French phase I/II research sites in Île-de-France following the BIA 10-2474 accident: Medical vs. regulatory relevance.

Aims: Following the serious adverse events that occurred in January 2016 during the BIA 10-2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all research sites conducting phase I/II clinical trials of experimental drugs. The aim of this study was to assess the medical relevance of the inspections made in Île-de-France (Paris region) in 2017.

Methods: All 30 sites of Île-de-France region fully authorized to perform phase I/II trials were inspected by a public health physician and a public health pharmacist.

[Routine electrocardiographic criteria for the diagnosis of left ventricular hypertrophy: performance in Black Africans].

Objective: To determine, in Black Africans, the performance of routine electrocardiographic criteria in the diagnosis of left ventricular hypertrophy (LVH).

Methods: Thirty voluntary healthy subjects and 154 patients were explored at echocardiography (according to Pen convention) and 12-lead electrocardiography (ECG). The performance of Lewis, Sokolow and Cornell (Cornell S1 for a threshold of 28 mm in men, and Cornell S2, for a threshold of 24 mm) criteria were defined by their sensitivity, specificity, positive and negative predictive values.

[The European Evaluation of Vertigo (EEV) scale: a clinical validation study].

Up until now, the questionnaires used to evaluate vertigo have been self-administered questionnaires that rate either symptoms and/or their consequences. In contrast, the European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that only assesses symptoms of the vestibular syndrome: illusion of movement, duration of illusion, motion intolerance, neurovegetative signs, and instability. Twenty-six ear, nose, and throat (ENT) specialists participated in this validation study conducted among 123 patients suffering from different types of vertigo.

[Estimation of the incidence of eight malignant tumours in France, on the basis of health insurance's statistics].

This work has for aim to suggest coefficients of adjustment applicable to the statistics of malignant tumours refunded through the health insurance as long-term diseases. Those coefficients would allow to evaluate the morbidity rate of cancer in the general population in France. To reach this target, we compared the figures of health insurance to those of the registers of cancers in six french departments, after we made the necessary adjustments to make the comparison possible.

[Morbidity estimates of beneficiaries of national health insurance for seven chronic conditions].

This work is aimed at providing improved coefficients applicable to the statistics of Health Insurance concerning the long-lasting conditions in order to assess morbidity of Health Insurance members concerning diseases invoked legislation on long-lasting conditions. To reach this objective, we have applied the consequences of successive equivalence (between diseases and their specific treatment, and between the use of special prescriptions for exempting diseases and the acknowledgment of long-lasting conditions by Health Insurance) to the results of a survey on medicines carried out by the Caisse Nationale d'Assurance Maladie des Travailleurs Salariés in 1993 on the basis of a representative sample. Improved coefficients were equal to the inverse of the proportion of special prescriptions within the whole of the prescriptions including specific treatment.