SynthesisPharmacoepidemiology and drug safety2016
Near real-time vaccine safety surveillance using electronic health records-a systematic review of the application of statistical methods.
Synthesis in Pharmacoepidemiology and drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Guillain-Barré syndrome and influenza vaccines: current evidence.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019Pooled it
- Near real-time vaccine safety surveillance using electronic health records-a systematic review of the application of statistical methods.Pharmacoepidemiology and drug safety · 2016Pooled it
- Robust Alpha Spending for Unstable Data.Statistics in medicine · 2026Article
- Adaptive Sequential Multiple Hypotheses Testing for Concomitant Vaccine Safety Surveillance.Statistics in medicine · 2026Article
- Sequential analysis for post-marketing drug safety surveillance using routinely collected electronic healthcare data: a scoping review.Therapeutic advances in drug safety · 2026Article
- Article
- Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge.Therapeutic advances in drug safety · 2022Review
- Vaccine Safety Surveillance Using Routinely Collected Healthcare Data-An Empirical Evaluation of Epidemiological Designs.Frontiers in pharmacology · 2022Article
- Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design.Frontiers in pharmacology · 2022Review
- The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing.Frontiers in digital health · 2021Article
- The use of natural language processing to identify Tdap-related local reactions at five health care systems in the Vaccine Safety Datalink.International journal of medical informatics · 2019Article
- Alpha spending for historical versus surveillance Poisson data with CMaxSPRT.Statistics in medicine · 2019Article
- Use of routinely collected electronic healthcare data for postlicensure vaccine safety signal detection: a systematic review.BMJ global health · 2019Article
- Exact conditional maximized sequential probability ratio test adjusted for covariates.Sequential analysis · 2019Article
- Benefit-Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project.Drug safety · 2018Article
- Type I Error Probability Spending for Post-Market Drug and Vaccine Safety Surveillance With Poisson Data.Methodology and computing in applied probability · 2018Article
- Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.Statistics in medicine · 2018Article
- Do delays in data availability limit the implementation of near real-time vaccine safety surveillance using the Clinical Practice Research Datalink?Pharmacoepidemiology and drug safety · 2018Article
- Article
- Assessing recording delays in general practice records to inform near real-time vaccine safety surveillance using the Clinical Practice Research Datalink (CPRD).Pharmacoepidemiology and drug safety · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePre-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.
methodsMedline, 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.
resultsFrom 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-Barré syndrome (11.9%), meningitis/encephalitis/myelitis (11.9%) and seizures (10.8%) were studied most often.
conclusionsNear 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.