Reporting of vaccine safety data in publications: systematic review

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. Copyright (C) 2004 John Wiley Sons, Ltd.