Use of population based background rates of disease to assess vaccine safety in childhood and mass immunisation in Denmark: nationwide population based cohort study

Rasmussen, Thomas A; Jørgensen, Martin Ruben Skou; Bjerrum, Stephanie; Jensen-Fangel, Søren; Støvring, Henrik; Østergaard, Lars; Søgaard, Ole Schmeltz

doi:10.1136/bmj.e5823

Cited by 25 publications

(18 citation statements)

References 36 publications

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“…While in other studies this pattern has been reported even for younger age groups [31], our data did not show a clear picture for cases up to the age group of 20-29 years. This might be due to the very limited number of cases in the young population, where already single cases can have pronounced effects on age-specific estimates.…”

Section: Discussioncontrasting

confidence: 55%

“…Studies from Denmark and Canada that had defined GBS cases by ICD codes only found crude [31] as well as age-standardized [32] IRs that were similar to ours; the Danish study was restricted to children up to the age of 17 [31] and showed crude IRs of 0.6 (95% CI 0.5-0.8) for the age group 4-9 years. Our study resulted in an IR of 0.7 (95% CI 0.4-1.2) in this age group.…”

Section: Discussionmentioning

confidence: 99%

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Estimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany - A Retrospective Cohort Study with Electronic Healthcare Data

Hense

Schink²,

Kreisel³

et al. 2014

Neuroepidemiology

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Background: The Guillain-Barré syndrome (GBS) occurs after infections and as an adverse reaction to vaccines. No detailed information on incidence rates (IRs) in Germany is available. Methods: This retrospective cohort study estimated age- and sex-specific IRs of GBS in Germany in the years 2007-2009 based on electronic healthcare data from the German Pharmacoepidemiological Research Database (GePaRD). Two case definitions were applied. GBS cases had a main discharge diagnosis of GBS. GBS_PROCEDURE cases in addition had codes for relevant diagnostic procedures. Crude and standardized IRs (SIRs) with 95% confidence intervals were stratified by year, age group, sex, region and season. IR ratios (IRRs) for each stratification factor were calculated by multivariable Poisson regression. Results: Among 13,297,678 persons, 889 (693) incident GBS (GBS_PROCEDURE) cases were identified. Overall SIRs per 100,000 person years were 2.4 (2.2-2.5) for GBS and 1.8 (1.7-2.0) for GBS_PROCEDURE. (S)IRs increased with age, peaking in the age group 70-79 years (IR GBS: 5.5 (4.7-6.5)) and were higher in males than in females (e.g., IR GBS: IRR = 1.5 (1.3-1.7)) and in February-April, as compared to the rest of the year. No regional pattern was observed. Conclusion: (S)IRs of GBS in Germany differed by age, sex and season and were comparable to those found in other studies. Results might be used as a comparator in vaccine safety monitoring.

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Section: Discussioncontrasting

confidence: 55%

Section: Discussionmentioning

confidence: 99%

Estimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany - A Retrospective Cohort Study with Electronic Healthcare Data

Hense

Schink²,

Kreisel³

et al. 2014

Neuroepidemiology

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“…The searches identified a total of 5 843 potentially eligible studies, of which 49 satisfied our eligibility criteria and were therefore included in this review (see Figure ) . The key characteristics and main findings of all included studies are detailed in Table S1, and the quality assessment of these studies is summarized in Table S2.…”

Section: Resultsmentioning

confidence: 99%

The epidemiology of anaphylaxis in Europe: a systematic review

Panesar

Javad

Silva³

et al. 2013

Allergy

346

220

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Background: Anaphylaxis is an acute, potentially fatal, multi-organ system, allergic reaction caused by the release of chemical mediators from mast cells and basophils. Uncertainty exists around epidemiological measures of incidence and prevalence, risk factors, risk of recurrence, and death due to anaphylaxis. This systematic review aimed to (1) understand and describe the epidemiology of anaphylaxis and (2) describe how these characteristics vary by person, place, and time. Methods: Using a highly sensitive search strategy, we identified systematic reviews of epidemiological studies, descriptive and analytical epidemiological investigations, and studies involving analysis of routine data. Results: Our searches identified a total of 5 843 potentially eligible studies, of which 49 satisfied our inclusion criteria. Of these, three were suitable for pooled estimates of prevalence. The incidence rates for all-cause anaphylaxis ranged from 1.5 to 7.9 per 100 000 person-years. These data indicated that an estimated 0.3% (95% CI 0.1-0.5) of the population experience anaphylaxis at some point in their lives. Food, drugs, stinging insects, and latex were the most commonly identified triggers. Conclusions: Anaphylaxis is a common problem, affecting an estimated 1 in 300 of the European population at some time in their lives. Future research needs to

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“…Comparing CPRD incidence rates to those reported in the literature ( Table 4) the incidence rates we observed in the CPRD are between 10% and 88% lower than those observed in prospective follow-up studies [20,23,24] and electronic heath record studies in the Danish National Hospital Register [11,16] that all included A&E data. The exception is a third Danish study, which also used the Danish National Hospital Register (but only included primary discharge diagnoses) [25]. This illustrates the importance of understanding the methods used to produce the rates .The impact of A&E events is most evident in the VAESCO [16] data that used standardised methodology across several European electronic health record databases and shows a markedly higher incidence in the Danish data source that included A&E data.…”

Section: Discussionmentioning

confidence: 98%

The incidence of childhood and adolescent seizures in the UK from 1999 to 2011: A retrospective cohort study using the Clinical Practice Research Datalink

Sammon

Charlton

Snowball

et al. 2015

Vaccine

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Use of population based background rates of disease to assess vaccine safety in childhood and mass immunisation in Denmark: nationwide population based cohort study

Abstract: Objectives To predict the number of selected outcomes temporally associated but not caused by vaccination, to aid causality assessment of adverse events arising after mass immunisation in a paediatric population.

Cited by 25 publications

References 36 publications

Estimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany - A Retrospective Cohort Study with Electronic Healthcare Data

Estimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany - A Retrospective Cohort Study with Electronic Healthcare Data

The epidemiology of anaphylaxis in Europe: a systematic review

The incidence of childhood and adolescent seizures in the UK from 1999 to 2011: A retrospective cohort study using the Clinical Practice Research Datalink

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