Reporting of vaccine safety data in publications: systematic review

Pharmacoepidemiology and Drug Safety
Jan BonhoefferUlrich Heininger

Abstract

To assess current reporting practices of immunisation safety data in the scientific literature. 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). 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. 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 e...Continue Reading

References

May 20, 2000·Journal of Epidemiology and Community Health·T Jefferson
Mar 21, 2001·Vaccine·H Heijbel, T Jefferson
Apr 20, 2001·JAMA : the Journal of the American Medical Association·D MoherUNKNOWN CONSORT Group (Consolidated Standards of Reporting Trials)
Dec 26, 2001·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·R T ChenB Patel

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Citations

Apr 15, 2010·Trials·Natalie McGauranThomas Kaiser
Mar 7, 2014·Wiener klinische Wochenschrift·Christian J Wiedermann
Apr 8, 2010·Expert Review of Vaccines·Pier Luigi LopalcoJohan Giesecke
Jun 18, 2010·Vaccine·Erlend HaugarvollErling O Koppang
Dec 9, 2008·Vaccine·Jan BonhoefferUNKNOWN Brighton Collaboration Methods Working Group
Dec 6, 2008·Vaccine·Jan BonhoefferUNKNOWN Brighton Collaboration Methods Working Group
Aug 9, 2011·Vaccine·Leonoor WijnansMiriam Sturkenboom
Sep 21, 2011·Vaccine·UNKNOWN Science Board of the Brighton Collaboration
Jun 2, 2016·Human Vaccines & Immunotherapeutics·Jennifer A BeelerSaad B Omer
Jul 20, 2005·Expert Review of Vaccines·Terhi Tapiainen, Ulrich Heininger

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