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OBJECTIVES To establish the frequency of cognitive impairment in a population based sample of patients with recently diagnosed relapsing-remitting multiple sclerosis (RRMS), and to determine the relation between cognitive abnormalities and the extent of macroscopic and microscopic tissue damage revealed by magnetic resonance imaging (MRI) and magnetisation(More)
BACKGROUND Global introspection is, with operational algorithms and Bayes' theorem, one of the three main approaches used to assess the causal relationship between a drug treatment and the occurrence of an adverse event. OBJECTIVE To analyze and compare the judgments of five senior experts using global introspection about drug causation on a random set of(More)
BACKGROUND Different methods have been proposed for assessing a possible causal link between a drug treatment and an adverse event in individual patients. They approximately belong to three main categories: expert judgement, operational algorithms and probabilistic approaches. OBJECTIVE To compare, in a set of actual drug adverse event reports, three(More)
AIMS To evaluate agreement between five senior experts when assessing seven causality criteria and the probability of drug causation. METHODS A sample of 31 adverse event-drug pairs was constituted. For each pair, five experts separately assessed (i) the probability of drug causation, which was secondarily divided into seven causality levels: ruled out(More)
Detecting cognitive dysfunction may be clinically important during the early stages of multiple sclerosis (MS). We assessed a self-report questionnaire on cognitive complaints and individual neuropsychological tests to select patients with early relapsing-remitting MS (RRMS) who needed comprehensive cognitive testing. Fifty-seven patients underwent(More)
BACKGROUND AND OBJECTIVE The many methods proposed for causality assessment of adverse drug reaction (ADR) generally rely on algorithms. They have no clear relationship to probabilities, however, a situation we attempted to improve. STUDY DESIGN AND SETTING Thirty ADR cases corresponding to 32 suspect drugs were randomly selected from the French(More)
BACKGROUND AND OBJECTIVES Patients undergoing thyroid surgery need postoperative pain management. Bilateral superficial cervical plexus block by administration of 0.25% bupivacaine with 1:200000 epinephrine at the end of surgery has been shown to improve postoperative analgesia. The objective of this study was to assess the analgesic efficacy in the first(More)
OBJECTIVE Updating a logistic causality assessment method to improve its agreement with consensual expert judgment (CEJ). STUDY DESIGN AND SETTING A random sample of 53 drug-event pairs from a pharmacovigilance database were evaluated independently by CEJ and by a group of experts in pharmacovigilance using the logistic method. Causes of disagreement(More)
A tripartite group, entitled « CRI » (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de (More)
BACKGROUND An updated probabilistic causality assessment method and the Liverpool algorithm presented as an improved version of the Naranjo algorithm, one of the most used and accepted causality assessment methods, have recently been proposed. OBJECTIVE In order to test the validity of the probabilistic method in routine pharmacovigilance, results(More)