PubMed · 15303681
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Dagmara Scalise. 2004. Quality. Going mobile.. https://pubmed.ncbi.nlm.nih.gov/15303681/
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BACKGROUND: Although it is well known that a variety of antibacterials may incidentally cause malignant arrhythmia, the list of drugs causing arrhythmia and the impact of these adverse effects are still uncertain. We investigated on this topic by using a large prescription database with different observational designs. METHODS: Prescription data on all incident users of several antibacterial and antiarrhythmic drugs over the period July 1997 through December 1999 were retrieved from the Drug Prescription Database (DPD) of the Italian Province of Varese. The association between the use of antibacterial and antiarrhythmic drugs was investigated by applying prescription sequence symmetry, cohort and nested case-control designs. RESULTS: Lower proarrhythmic effects were on an average obtained from prescription sequence symmetry approach with respect to both cohort and nested case-control. Evidence of association between exposure to drugs (erythromycin and ciprofloxacin) and the risk of arrhythmia was consistently found by the three approaches. No other signals were generated from the prescription sequence symmetry analysis. Two drugs (clarithromycin and levofloxacin) showed patterns compatible with an arrhythmic effect according to both cohort and nested case-control designs. CONCLUSIONS: Prescription databases are useful tools to explore drug safety through both conventional and emerging observational designs. In spite of its appealing features, prescription sequence symmetry design shows lower sensitivity with respect to conventional designs. Evidence about the association between the use of certain macrolides and fluoroquinolones and the onset of arrhythmia is confirmed by this study.
PURPOSE: To assess current reporting practices of immunisation safety data in the scientific literature. METHODS: Systematic literature search for recent prospective clinical studies on vaccines in humans. The main outcome measures were methodological differences in the assessment, definition, analysis and presentation of 'adverse events following immunisation' (AEFI). RESULTS: In total, 182 published articles possibly satisfied defined inclusion criteria, of which 149 were included. Overall, the presentation of data on AEFI was inadequate: 45% of articles did not mention AEFI at all; if mentioned, case definitions of AEFI were not specified in the majority of articles; there was inconsistency of AEFI reporting between 'Methods' and 'Results' in up to 24% of articles; the observation period following immunisation and the method of follow-up with study subjects was not reported in 28% and 32% of studies respectively. CONCLUSIONS: We identified a lack of reporting of AEFI data as well as a heterogeneity of case definitions and methods for data collection, analysis and presentation of AEFI in recently published articles. Guidelines for standardised collection, analysis and publication of such data and standardised case definitions for AEFI are needed. Ideally, journal editors would agree on a minimum set of guidelines for structured presentation of vaccine safety data in publications.
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