An inventory of European data sources for the long-term safety evaluation of methylphenidate
Open accessAbstract
To compile an inventory of European healthcare databases with potential to study long-term effects of methylphenidate (MPH) in patients with attention deficit hyperactivity disorder (ADHD). Potential databases were identified through expert opinion, the website of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, and literature search. An online survey was conducted among database providers/coordinators to ascertain the databases' appropriateness for inclusion into the inventory. It included questions about database characteristics, sample size, availability of information on drug exposure, clinical data and accessibility. Forty-two databases from 11 countries were identified and their coordinators invited to participate; responses were obtained for 22 (52.4 %) databases of which 15 record ADHD diagnoses. Eleven had sufficient data on ADHD diagnosis, drug exposure, and at least one type of outcome information (symptoms/clinical events, weight, height, blood pressure, heart rate) to assess MPH safety. These were Aarhus University Prescription Database, Danish National Birth Cohort (Denmark); German Health Interview and Examination Survey for Children and Adolescents; Health Search Database Thales, Italian ADHD Register, Lombardy Region ADHD Database (Italy); Avon Longitudinal Study of Parents and Children, General Practice Research Database, The Health Improvement Network, QResearch (UK) and IMS Disease Analyzer (UK, Germany, France). Of the 20 databases with no responses, information on seven from publications and/or websites was obtained; Pedianet and the Integrated Primary Care Information database were considered suitable. Many European healthcare databases can be used for multinational long-term safety studies of MPH. Methodological research is underway to investigate the feasibility of their pooling and analysis.
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The latest meta-analyses of randomized controlled trials of EEG-NF show medium effect sizes for symptom improvements, reduced to trends when only 'probably' blinded raters are included.
“the latest meta-analyses of randomized controlled trials of EEG-NF show medium effect sizes for symptom improvements (Arns et al., 2009), reduced to trends when only “probably” blinded raters are included (Murray et al., 2013; Cortese et al., 2015).”
From Cognitive Neuroscience of Attention Deficit Hyperactivity Disorder (ADHD) and Its Clinical Translation (2018) · cites this paper as Murray et al., 2013
The Discussion (page not provided) mentions EEG only as a measurement that may be missing from databases used to study methylphenidate safety. Searches for blinded raters, EEG neurofeedback trials, and meta-analyses found no passage reporting that symptom improvements were reduced to trends; the portion attributed to Murray et al. cannot be verified from our copy. (LLM, conf=0.76)
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- Authors
- Murray, M. L., Insuk, S., Banaschewski, T., Neubert, A. C., McCarthy, S., Buitelaar, J. K., Coghill, D., Dittmann, R. W., Konrad, K., Panei, P., Rosenthal, E., Sonuga-Barke, E. J., & Wong, I. C. K.
- Affiliations
- UCL School of Pharmacy (GB)
- Heidelberg University (DE)
- Universitätsklinikum Erlangen (DE)
- University College Cork (IE)
- Radboud University Medical Center (NL)
- University of Dundee (GB)
- Universitätsklinikum Aachen (DE)
- Istituto Superiore di Sanità (IT)
- Ghent University (BE)
- Corresponding author
- Murray, Macey L.
- ORCID
- Venue
- European Child & Adolescent Psychiatry
- Published
- 2013-03-19
- Volume
- 22
- Issue
- 10
- Pages
- 605-618
- ISSN
- 1018-8827 (ISSN-L)
- 1435-165X
- PMC
- PMC3830128
- OpenAlex
- W1963955527
- Cited by
- 20
- References
- 33
- Citations by year
- 2025: 1 · 2023: 1 · 2022: 1 · 2021: 3 · 2019: 4 · 2018: 3 · 2017: 2 · 2016: 2 · 2015: 1 · 2014: 2
- FWCI
- 1.18
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- European Child & Adolescent Psychiatry (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (publishedVersion)
- Research Portal (King's College London) (publishedVersion, other-oa)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion, other-oa)
- ePrints Soton (University of Southampton) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- The HKU Scholars Hub (University of Hong Kong) (submittedVersion)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- RWTH Publications (RWTH Aachen) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Funders
- Eli Lilly and Company
- University of Dundee
- London School of Hygiene and Tropical Medicine
- Università degli Studi di Cagliari
- Bundesinstitut für Arzneimittel und Medizinprodukte
- University of Southampton
- King's College London
- University College London
- European Commission (260576)
- University College Cork
- Deutsche Forschungsgemeinschaft
- Universität Heidelberg
- Institut National de la Santé et de la Recherche Médicale
- Radboud Universiteit
- Bundesministerium für Bildung und Forschung
- Istituto Superiore di Sanità
- Servier
- Lilly Deutschland
- School of Pharmacy, University College London
- National Institute of Mental Health
- UCB Pharma
- Cilag
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- methylphenidate, attention deficit hyperactivity disorder, long-term drug safety, pharmacoepidemiology, health databases, primary care databases
- MeSH terms
- Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Child, Preschool, Data Collection, Europe, Humans, Methylphenidate, Registries, Safety, Databases, Factual, Adverse Drug Reaction Reporting Systems, Pharmacovigilance
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