ArticleCurrent clinical pharmacology2014
Bridging differences in outcomes of pharmacoepidemiological studies: design and first results of the PROTECT project.
Article in Current clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled 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.
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
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- A systematic review of medication exposure assessment in prospective cohort studies of community dwelling older australians.PloS one · 2015Pooled it
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- Quantitative Benefit-Risk Assessment of COVID-19 Vaccines Using the Multi-Criteria Decision Analysis.Vaccines · 2022Article
- Differential effects of antidepressant subgroups on risk of acute myocardial infarction: A nested case-control study.British journal of clinical pharmacology · 2020Article
- Clinical Infections by Herpesviruses in Patients Treated with Valproic Acid: A Nested Case-Control Study in the Spanish Primary Care Database, BIFAP.Journal of clinical medicine · 2019Article
- Observational
- Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation.BMJ open · 2018Article
- Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.Drug safety · 2018Article
- A methodological comparison of two European primary care databases and replication in a US claims database: inhaled long-acting beta-2-agonists and the risk of acute myocardial infarction.European journal of clinical pharmacology · 2016Article
- Vulnerable Patients and Potential Harms: The Contribution of Observational Research.Drug safety · 2016Article
- The risk of acute liver injury among users of antibiotic medications: a comparison of case-only studies.Pharmacoepidemiology and drug safety · 2016Article
- Do case-only designs yield consistent results across design and different databases? A case study of hip fractures and benzodiazepines.Pharmacoepidemiology and drug safety · 2016Article
- Calcium channel blockers and cancer: a risk analysis using the UK Clinical Practice Research Datalink (CPRD).BMJ open · 2016Article
- Scaling up health knowledge at European level requires sharing integrated data: an approach for collection of database specification.ClinicoEconomics and outcomes research : CEOR · 2016Article
- Review
- Article
- Sales of macrolides, lincosamides, streptogramins, and amoxicillin/clavulanate in the in- and outpatient setting in 10 European countries, 2007-2010.SpringerPlus · 2015Article
- Ascertainment of acute liver injury in two European primary care databases.European journal of clinical pharmacology · 2014Article
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Authors and funding
14 authors.
Funding
Abstract
backgroundObservational pharmacoepidemiological (PE) studies on drug safety have produced discrepant results that may be due to differences in design, conduct and analysis. PURPOSE: The pharmacoepidemiology work-package (WP2) of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) project aims at developing, testing and disseminating methodological standards for design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues using different databases across European countries. This article describes the selection of the safety issues and the description of the databases to be systematically studied.
methodsBased on two consensus meetings and a literature search, we selected five drug-adverse event (AE) pairs to be evaluated in different databases. This selection was done according to pre-defined criteria such as regulatory and public health impact, and the potential to investigate a broad range of methodological issues.
resultsThe selected drug-AE pairs are: 1) inhaled long-acting beta-2 agonists and acute myocardial infarction; 2) antimicrobials and acute liver injury; 3) antidepressants and/or benzodiazepines and hip fracture; 4) anticonvulsants and suicide/suicide attempts; and 5) calcium channel blockers and malignancies. Six European databases, that will be used to evaluate the drug-AE pairs retrospectively, are also described.
conclusionThe selected drug-AE pairs will be evaluated in PE studies using common protocols. Based on consistencies and discrepancies of these studies, a framework for guiding methodological choices will be developed. This will increase the usefulness and reliability of PE studies for benefit-risk assessment and decision-making.
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