ArticleBMJ open2018
Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation.
Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 29 papers, 5 of them syntheses that pooled it.
What it found
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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.
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Who cites it
29 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Development of Indirect Health Data Linkage on Health Product Use and Care Trajectories in France: Systematic Review.Journal of medical Internet research · 2023Pooled it
- A systematic review of how missing data are handled and reported in multi-database pharmacoepidemiologic studies.Pharmacoepidemiology and drug safety · 2021Pooled it
- Risk Minimisation Evaluation with Process Indicators and Behavioural or Health Outcomes in Europe: Systematic Review.Pharmaceutical medicine · 2020Pooled it
- Pooled it
- Impact of medicines regulatory risk communications in the UK on prescribing and clinical outcomes: Systematic review, time series analysis and meta-analysis.British journal of clinical pharmacology · 2020Pooled it
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- Addressing the Underestimated Burden of RSV in Older Adults in Europe: Epidemiology, Surveillance Gaps, and Public Health Implications.Vaccines · 2025Review
- Transparency in the secondary use of health data: assessing the status quo of guidance and best practices.Royal Society open science · 2025Article
- INSIGHT: A Tool for Fit-for-Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine Safety.Pharmacoepidemiology and drug safety · 2025Article
- Real-World Research on Retinal Diseases Using Health Claims Database: A Narrative Review.Diagnostics (Basel, Switzerland) · 2024Review
- Overview of global real-world data sources for pediatric pharmacoepidemiologic research.Pharmacoepidemiology and drug safety · 2024Review
- Advancing pediatric medication safety using real-world data: Current problems and potential solutions.Journal of hospital medicine · 2023Article
- [BeoNet-Halle-development of a multifunctional database for the automated extraction of healthcare data from general practitioner and specialist practices].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2023Review
- Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert.International breastfeeding journal · 2022Review
- Register-based information on thyroid diseases in Europe: lessons and results from the EUthyroid collaboration.Endocrine connections · 2022Article
- Recommendations for respiratory syncytial virus surveillance at the national level.The European respiratory journal · 2021Article
- Intolerance to Angiotensin Converting Enzyme Inhibitors in Asthma and the General Population: A UK Population-Based Cohort Study.The journal of allergy and clinical immunology. In practice · 2021Article
- Development and Validation of a Method to Estimate COPD Severity in Multiple Datasets: A Retrospective Study.Pulmonary therapy · 2021Article
- Common Problems, Common Data Model Solutions: Evidence Generation for Health Technology Assessment.PharmacoEconomics · 2021Article
Corrections and comments
- Erratum issuedCorrection:2019
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveElectronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across Europe complicates the conduct of multidatabase studies. In this paper, we provide insight into available EHDs to support regulatory decisions on medicines.
methodsEHDs were identified from publicly available information from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance resources database, textbooks and web-based searches. Databases were selected using criteria related to accessibility, longitudinal dimension, recording of exposure and outcomes, and generalisability. Extracted information was verified with the database owners.
resultsA total of 34 EHDs were selected after applying key criteria relevant for regulatory purposes. The most represented regions were Northern, Central and Western Europe. The most frequent types of data source were electronic medical records (44.1%) and record linkage systems (29.4%). The median number of patients registered in the 34 data sources was 5 million (range 0.07-15 million) while the median time covered by a database was 18.5 years. Paediatric patients were included in 32 databases (94%). Completeness of information on drug exposure was variable. Published validation studies were found for only 17 databases (50%). Some level of access exists for 25 databases (73.5%), and 23 databases (67.6%) can be linked through a personal identification number to other databases with parent-child linkage possible in 7 (21%) databases. Eight databases (23.5%) were already transformed or were in the process of being transformed into a common data model that could facilitate multidatabase studies.
conclusionA Few European databases meet minimal regulatory requirements and are readily available to be used in a regulatory context. Accessibility and validity information of the included information needs to be improved. This study confirmed the fragmentation, heterogeneity and lack of transparency existing in many European EHDs.
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What OpenQuestion holds
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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.