@article{31dde57ff51d44d9b5a3014827b4179d,
title = "Methodology for computing the burden of disease of adverse events following immunization",
abstract = "Purpose: Composite disease burden measures such as disability-adjusted life-years (DALY) have been widely used to quantify the population-level health impact of disease or injury, but application has been limited for the estimation of the burden of adverse events following immunization. Our objective was to assess the feasibility of adapting the DALY approach for estimating adverse event burden. Methods: We developed a practical methodological framework, explicitly describing all steps involved: acquisition of relative or absolute risks and background event incidence rates, selection of disability weights and durations, and computation of the years lived with disability (YLD) measure, with appropriate estimation of uncertainty. We present a worked example, in which YLD is computed for 3 recognized adverse reactions following 3 childhood vaccination types, based on background incidence rates and relative/absolute risks retrieved from the literature. Results: YLD provided extra insight into the health impact of an adverse event over presentation of incidence rates only, as severity and duration are additionally incorporated. As well as providing guidance for the deployment of DALY methodology in the context of adverse events associated with vaccination, we also identified where data limitations potentially occur. Conclusions: Burden of disease methodology can be applied to estimate the health burden of adverse events following vaccination in a systematic way. As with all burden of disease studies, interpretation of the estimates must consider the quality and accuracy of the data sources contributing to the DALY computation.",
keywords = "Adverse events, Disability-adjusted life-years, Disease burden, Methodology, Pharmacoepidemiology, Vaccination",
author = "Mcdonald, {Scott A.} and Danielle Nijsten and Kaatje Bollaerts and Jorgen Bauwens and Nicolas Praet and {van der Sande}, Marianne and Vincent Bauchau and {de Smedt}, Tom and Miriam Sturkenboom and Susan Hahn{\'e}",
note = "Funding Information: Innovative Medicines Initiative Joint Undertaking, Grant/Award Number: ADVANCE Grant agreement n° 115557; European Union's Seventh Framework Programme, Grant/Award Number: FP7/2007‐2013 Funding Information: Our principal objective was to assess the feasibility of adapting current disease burden methodology for computing the population‐ level disease burden of vaccination‐attributable adverse events. This work was carried out as part of the “Accelerated development of vaccine benefit‐risk collaboration in Europe” (ADVANCE) project, launched in 2013, funded by the Innovative Medicines Initiative (http://www.advance‐vaccines.eu). The aim of ADVANCE is to help health professionals, regulatory agencies, public health institutions, vaccine manufacturers, and the general public make well‐informed and timely decisions on benefits and risks of marketed vaccines by establishing a framework and toolbox to enable rapid delivery of reliable data on vaccine benefits and risks. Funding Information: Innovative Medicines Initiative Joint Under-taking, Grant/Award Number: ADVANCE Grant agreement n? 115557; European Union's Seventh Framework Programme, Grant/Award Number: FP7/2007?2013. Funding Information: The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under ADVANCE grant agreement no. 115557, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007‐2013) and EFPIA companies' in kind contribution. The study sponsor(s) had no role in study design, in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the report for publication. Publisher Copyright: {\textcopyright} 2018 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.",
year = "2018",
month = jul,
doi = "10.1002/pds.4419",
language = "English",
volume = "27",
pages = "724--730",
journal = "Pharmacoepidemiology and Drug Safety",
issn = "1053-8569",
publisher = "John Wiley & Sons Inc.",
number = "7",
}