Evidence map›Paper›PMID 33462778›Full record

ArticleDrug safety2021

Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project.

Corinne Willame, Caitlin Dodd, Lieke van der Aa, Gino Picelli, Hanne-Dorthe Emborg, Johnny Kahlert, Rosa Gini, Consuelo Huerta, Elisa Martín-Merino, Chris McGee and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

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  13. Ionic mitigation of CD4Scientific reports · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 8 countries.

Corinne WillameJulius Global Health, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, The Netherlands. c.willame@umcutrecht.nl.ORCID http://orcid.org/0000-0002-6310-6019
Caitlin DoddJulius Global Health, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, The Netherlands.
Lieke van der AaSciensano, Rue Juliette Wytsmanstraat 14, 1050, Brussels, Belgium.
Gino PicelliEpidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (Pedianet), Padua, Italy.
Hanne-Dorthe EmborgDepartment of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Artillerivej 5, 2300, Copenhagen, Denmark.
Johnny KahlertAarhus University Hospital, Olof Palmes Alle 43-45, 8200, Aarhus, Denmark.
Rosa GiniAgenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy.
Consuelo HuertaSpanish Agency of Medicines and Medical Devices-AEMPS, Madrid, Spain.
Elisa Martín-MerinoSpanish Agency of Medicines and Medical Devices-AEMPS, Madrid, Spain.
Chris McGeeUniversity of Surrey, Oxford, UK.
Simon de LusignanUniversity of Surrey, Oxford, UK.
Giuseppe RobertoAgenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy.
Marco VillaOspedale Val Padana, Cremona, Italy.
Daniel WeibelVACCINE.GRID, Basel, Switzerland.
Lina TitievskyPfizer, New York, NY, USA.
Miriam C J M SturkenboomJulius Global Health, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, The Netherlands.
Heidelberg University · DEAgencia Española de Medicamentos y Productos Sanitarios · ESAgenzia Regionale di Sanità della Toscana · ITUniversity of Surrey · GBAarhus University Hospital · DKErasmus MC · NLPfizer (United States) · USSciensano (Belgium) · BEStatens Serum Institut · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe public-private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits and risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key to allow proper monitoring and assessment. The goals of this study were to compute age-, sex-, and calendar-year stratified incidence rates of nine autoimmune diseases in seven European healthcare databases from four countries and to assess validity by comparing with published data.

methodsEvent rates were calculated for the following outcomes: acute disseminated encephalomyelitis, Bell's palsy, Guillain-Barré syndrome, immune thrombocytopenia purpura, Kawasaki disease, optic neuritis, narcolepsy, systemic lupus erythematosus, and transverse myelitis. Cases were identified by diagnosis codes. Participating organizations/databases originated from Denmark, Italy, Spain, and the UK. The source population comprised all persons registered, with at least 1 year of data prior to the study start, or follow-up from birth. Stratified incidence rates were computed per database over the period 2003 to 2014.

resultsBetween 2003 and 2014, 148,947 incident cases of nine autoimmune diseases were identified. Crude incidence rates were highest for Bell's palsy [23.8/100,000 person-years (PYs), 95% confidence interval (CI) 23.6-24.1] and lowest for Kawasaki disease (0.7/100,000 PYs, 95% CI 0.6-0.7). Specific patterns were observed by sex, age, calendar time, and data sources. Rates were comparable with published estimates.

conclusionA range of autoimmune events could be identified in the ADVANCE system. Estimation of rates indicated consistency across selected European healthcare databases, as well as consistency with US published data.

Indexed as

Autoimmune DiseasesBell PalsyMucocutaneous Lymph Node SyndromeVaccinesDelivery of Health CareHumansIncidenceVaccinationVaccines

Identifiers

PMID33462778
PMCPMC7892524
OpenAlexW3121393276

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.