Trial reportBMC clinical pharmacology2011
Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study.
Trial report in BMC clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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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
9 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Improving adverse drug event reporting by healthcare professionals.The Cochrane database of systematic reviews · 2024Pooled it
- Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic Review and Meta-analysis.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024Pooled it
- Adverse drug reaction reporting with the Med Safety app in Uganda: a cluster-randomised, controlled trial.The Lancet. Global health · 2025Trial
- Evaluation of a simplified pharmacovigilance tool for general practitioners: 5 years of insight.Scientific reports · 2024Article
- Under-Reporting of Adverse Drug Reactions in Finland and Healthcare Professionals' Perspectives on How to Improve Reporting.Healthcare (Basel, Switzerland) · 2022Article
- Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus.European journal of clinical pharmacology · 2022Review
- Traditional Lectures Actually Improve the Body of Knowledge, Skills, and Attitudes of Health Care Professional for Health Incident Reporting System.Hospital pharmacy · 2021Article
- Survey of healthcare professionals' practices, expectations, and attitudes towards provision of patient information leaflets in Thailand.International journal of clinical pharmacy · 2020Article
- A comprehensive intervention for adverse drug reactions identification and reporting in a Pediatric Emergency Department.International journal of clinical pharmacy · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSpontaneous reporting of adverse drug reactions (ADRs) is an important method for pharmacovigilance, but under-reporting and poor quality of reports are major limitations. The aim of this study was to evaluate if repeated one-page ADR information letters affect (i) the reporting rate of ADRs and (ii) the quality of the ADR reports.
methodsAll 151 primary healthcare units in the Region Västra Götaland, Sweden, were randomly allocated (1:1) to an intervention (n = 77) or a control group (n = 74). The intervention consisted of one-page ADR information letters administered at three occasions during 2008 to all physicians and nurses in the intervention units. The number of ADR reports received from the 151 units was registered, as was the quality of the reports, which was defined as high if the ADR was to be reported according to Swedish regulations, that is, if the ADR was (i) serious, (ii) unexpected, and/or (iii) related to the use of new drugs and not labelled as common in the Summary of Product Characteristics. A questionnaire was administered to evaluate if the ADR information letter had reached the intended recipient.
resultsBefore the intervention, no significant differences in reporting rate or number of high quality reports could be detected between the randomization groups. In 2008, 79 reports were sent from 37 intervention units and 52 reports from 30 control units (mean number of reports per unit ± standard deviation: 1.0 ± 2.5 vs. 0.7 ± 1.2, P = 0.34). The number of high quality reports was higher in intervention units than in control units (37 vs. 15 reports, 0.5 ± 0.9 vs. 0.2 ± 0.6, P = 0.048). According to the returned questionnaires (n = 1,292, response rate 57%), more persons in the intervention than in the control group had received (29% vs. 19%, P < 0.0001) and read (31% vs. 26%, P < 0.0001) an ADR information letter.
conclusionsThis study suggests that repeated ADR information letters to physicians and nurses do not increase the ADR reporting rate, but may increase the number of high quality reports.
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