Trial reportDrug safety2015
Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.
Trial report in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 5 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
29 citing papers in PubMed, 5 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- 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
- Continuing education meetings and workshops: effects on professional practice and healthcare outcomes.The Cochrane database of systematic reviews · 2021Pooled it
- Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature.BMC medicine · 2016Pooled it
- Adverse drug reaction reporting with the Med Safety app in Uganda: a cluster-randomised, controlled trial.The Lancet. Global health · 2025Trial
- Effectiveness of the modified TaWai mobile application for reporting adverse drug reaction in Lao PDR: a cluster randomized controlled trial.Scientific reports · 2024Trial
- Bridging the Gap: Promoting Adverse Drug Reaction Reporting through Innovative Strategies in Zero-reporting Zones at Karaikal - An Educational Intervention Study at Adverse Drug Reaction Monitoring Center.Journal of research in pharmacy practice · 2026Article
- Promoting pharmacovigilance through educational strategies: impact of a national training intervention on the knowledge and practice of healthcare providers in Jordan.Journal of pharmaceutical policy and practice · 2025Article
- Implementing Best Practices for Nurses in Detecting and Reporting Adverse Drug Reactions in a Tertiary Hospital in Tabriz, Iran: A Mixed-Method Study.Health science reports · 2024Article
- Impact of the Role of the Clinical Pharmacist on the Underreporting of Adverse Drug Reactions at a Peruvian hospital.Hospital pharmacy · 2023Article
- Nurses' responsibilities and tasks in pharmaceutical care: A scoping review.Nursing open · 2022Article
- Effectiveness of a structured stimulated spontaneous safety monitoring of medicines reporting program in strengthening pharmacovigilance system in Tanzania.Scientific reports · 2022Article
- The development of a pharmacovigilance system in Bahrain.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022Article
- Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus.European journal of clinical pharmacology · 2022Review
- The NUPHAC-EU Framework for Nurses' Role in Interprofessional Pharmaceutical Care: Cross-Sectional Evaluation in Europe.International journal of environmental research and public health · 2021Article
- Rapid review of suspected adverse drug events due to remdesivir in the WHO database; findings and implications.Expert review of clinical pharmacology · 2021Article
- Knowledge, attitudes and practices of health care professionals towards adverse drug reaction reporting in public sector primary health care facilities in a South African district.European journal of clinical pharmacology · 2020Article
- Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey.Pharmacoepidemiology and drug safety · 2019Review
- Adverse Drug Reactions in Norway: A Systematic Review.Pharmacy (Basel, Switzerland) · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs).
objectivesTo assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system.
methodsA spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months.
resultsIntervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55).
conclusionsPharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas. A high baseline notification rate could account for the educational program having a moderate effect.
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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.