Evaluation of completeness of adverse drug reaction case reports published in biomedical Journals: A preliminary analysis
Journal Title: The Journal of Medical Research - Year 2018, Vol 4, Issue 2
Abstract
Background: Adverse drug reaction (ADR) case reports help to identify potential risks associated with the use of the drug especially serious rare adverse effects, which are often missed during clinical trials. When properly documented, they alert clinicians towards any untoward effect of drugs and help them to make important decisions concerning the health of their patients. However, the completeness of published ADR case reports varies greatly. The lack of relevant details can be misleading & limit their value in clinical practice. Methods: We downloaded 80 ADR case reports published during a period of 1 year from September, 2014 – September, 2015, from 4 biomedical journals (20 from each journal) and analyzed them for their completeness using the International Society of Pharmacoepidemiology (ISPE) & International Society of Pharmacovigilance (ISOP), 2007 guidelines. Results: We found that most of the patient – related & ADR – related details were adequately reported (>90%) whereas the title, most of the drug related details & highly desired parameters were reported poorly (< 90%). The completeness of ADR case reports ranged from 10/17 to 16/17 for required parameters & from 2/13 to 11/13 for highly desired parameters. Conclusions: Our study highlights the deficiencies in published ADR case reports, we suggest the researchers to follow the ISPE & ISOP guidelines while writing an ADR case report & the journal editors to incorporate minimum publishing requirements for publishing ADR case reports to gain the most out of them.
Authors and Affiliations
Jitendra Hotwani, Disha Rambhia, Manthan Mehta
Keywords
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- EP ID EP523671
- DOI 10.31254/jmr.2018.4209
- Views 121
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