ArticleDrug safety2017
The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.
Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
What it found
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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
30 citing papers in PubMed.
- Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.Drug safety · 2021Trial
- Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway.British journal of clinical pharmacology · 2026Article
- Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Strengthening pharmacovigilance through patient reporting: a scoping review of awareness, barriers, and facilitators.Journal of pharmaceutical policy and practice · 2026Review
- Observational
- Comparison of the Completeness of Spontaneously Reported Adverse Drug Reactions by Consumers, Healthcare Professionals, and Pharmaceutical Companies: An Evaluation of Databases From Two High-Income Countries.Pharmacology research & perspectives · 2025Article
- Self-reporting of adverse drug reactions of nonsteroidal anti-inflammatory drugs in community pharmacies.Journal of pharmaceutical policy and practice · 2025Article
- Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST.JMIR medical informatics · 2024Article
- Accuracy in patient-reported adverse drug reactions and their recognition: a mixed-methods study.International journal of clinical pharmacy · 2024Article
- Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France.Drug safety · 2023Article
- Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.European journal of clinical pharmacology · 2023Article
- The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®.African journal of primary health care & family medicine · 2023Article
- Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers.Scientific reports · 2022Article
- Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus.European journal of clinical pharmacology · 2022Review
- A patient-centred web-based adverse drug reaction reporting system identifies not yet labelled potential safety issues.European journal of clinical pharmacology · 2021Article
- Patient-Reported Adverse Events of Radiopharmaceuticals: A Prospective Study of 1002 Patients.Drug safety · 2021Article
- Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports.Journal of clinical pharmacy and therapeutics · 2020Article
- The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade.International journal of clinical pharmacy · 2020Article
- The Role of European Patient Organizations in Pharmacovigilance.Drug safety · 2019Article
- Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Journal of the American Medical Informatics Association : JAMIA · 2019Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionClinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients.
objectiveThe aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional.
methodsA retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test.
resultsA total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126).
conclusionsIn a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.
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