PMID- 26817940 OWN - NLM STAT- MEDLINE DCOM- 20161213 LR - 20240325 IS - 1099-1557 (Electronic) IS - 1053-8569 (Print) IS - 1053-8569 (Linking) VI - 25 IP - 3 DP - 2016 Mar TI - Near real-time vaccine safety surveillance using electronic health records-a systematic review of the application of statistical methods. PG - 225-37 LID - 10.1002/pds.3966 [doi] AB - PURPOSE: Pre-licensure studies have limited ability to detect rare adverse events (AEs) to vaccines, requiring timely post-licensure studies. With the increasing availability of electronic health records (EHR) near real-time vaccine safety surveillance using these data has emerged as an option. We reviewed methods currently used to inform development of similar systems for countries considering their introduction. METHODS: Medline, EMBASE and Web of Science were searched, with additional searches of conference abstract books. Questionnaires were sent to organizations worldwide to ascertain unpublished studies. Eligible studies used EHR and regularly assessed pre-specified AE to vaccine(s). Key features of studies were compared descriptively. RESULTS: From 2779 studies, 31 were included from the USA (23), UK (6), and Taiwan and New Zealand (1 each). These were published/conducted between May 2005 and April 2015. Thirty-eight different vaccines were studied, focusing mainly on influenza (47.4%), especially 2009 H1N1 vaccines. Forty-six analytic approaches were used, reflecting frequency of EHR updates and the AE studied. Poisson-based maximized sequential probability ratio test was the most common (43.5%), followed by its binomial (23.9%) and conditional versions (10.9%). Thirty-seven of 49 analyses (75.5%) mentioned control for confounding, using an adjusted expected rate (51.4% of those adjusting), stratification (16.2%) or a combination of a self-controlled design and stratification (13.5%). Guillain-Barre syndrome (11.9%), meningitis/encephalitis/myelitis (11.9%) and seizures (10.8%) were studied most often. CONCLUSIONS: Near real-time vaccine safety surveillance using EHR has developed over the past decade but is not yet widely used. As more countries have access to EHR, it will be important that appropriate methods are selected, considering the data available and AE of interest. CI - (c) 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. FAU - Leite, Andreia AU - Leite A AD - Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK. FAU - Andrews, Nick J AU - Andrews NJ AD - Statistics, Modelling and Economics Department, Public Health England, London, UK. FAU - Thomas, Sara L AU - Thomas SL AD - Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review PT - Systematic Review DEP - 20160128 PL - England TA - Pharmacoepidemiol Drug Saf JT - Pharmacoepidemiology and drug safety JID - 9208369 RN - 0 (Vaccines) SB - IM MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data MH - Consumer Product Safety/standards MH - Electronic Health Records/*statistics & numerical data MH - Humans MH - Pharmacoepidemiology/*methods/*statistics & numerical data MH - Vaccines/*adverse effects/*standards PMC - PMC5021108 OTO - NOTNLM OT - electronic health records OT - pharmacoepidemiology OT - safety OT - sequential tests OT - statistical process control OT - vaccines EDAT- 2016/01/29 06:00 MHDA- 2016/12/15 06:00 PMCR- 2016/09/13 CRDT- 2016/01/29 06:00 PHST- 2015/06/19 00:00 [received] PHST- 2015/12/16 00:00 [revised] PHST- 2015/12/17 00:00 [accepted] PHST- 2016/01/29 06:00 [entrez] PHST- 2016/01/29 06:00 [pubmed] PHST- 2016/12/15 06:00 [medline] PHST- 2016/09/13 00:00 [pmc-release] AID - PDS3966 [pii] AID - 10.1002/pds.3966 [doi] PST - ppublish SO - Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):225-37. doi: 10.1002/pds.3966. Epub 2016 Jan 28.