ArticleTherapeutic advances in drug safety2015
Published cases of adverse drug reactions: has the quality of reporting improved over time?
Article in Therapeutic advances in drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Characteristics of drugs safety signals that predict safety related product information update.Pharmacoepidemiology and drug safety · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeA previous study of cases published approximately 10-30 years ago reveals that substantial improvement in the quality of adverse drug reaction (ADR) case reports is needed. Since that evaluation, recommendations are available concerning the content and formatting of case reports.
objectiveTo compare the quality of recently published ADR case reports to a previously published study of the quality of ADR case reports from 10-30 years ago. A secondary objective is to determine the quality of reporting by specialty journal.
methodsThis was a two-phase study. Phase 1 included an assessment of the 23 patient, drug and ADR variables evaluated in the previous study to allow comparison with recently published case reports in specialty journals. Phase 2 mimicked the methods of Phase 1 with a random selection of available case reports in a 1-year period from a variety of journals.
resultsFor Phase 1, 19 of the 23 variables had significant differences in reporting compared with the previous study. Reporting of active diseases, social history, weight, race, other drugs and dose had frequencies ranging from 25 to 80%, which was an improvement, but affording an opportunity for greater improvement. For Phase 2, 21 of the 23 variables had significant differences compared with the previous evaluation; however illicit drug use, mechanism for ADR and route of administration had significant reductions in reporting.
conclusionProgress has been made in ADR case reporting quality for a variety of journals, but more improvement is required to ensure data are understandable and relatable to patient care.
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Registered trials
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