1. Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events
- Author
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Evan Mayo-Wilson, Nicole Fusco, Tianjing Li, Hwanhee Hong, Joseph K. Canner, Kay Dickersin, Lorenzo Bertizzolo, Terrie Cowley, Peter Doshi, Jeffrey Ehmsen, Gillian Gresham, Nan Guo, Jennifer Haythornthwaite, James Heyward, Diana Pham, Jennifer Payne, Lori Rosman, Elizabeth Stuart, Catalina Suarez-Cuervo, Elizabeth Tolbert, Claire Twose, Swaroop Vedula, Graduate School, APH - Methodology, and APH - Personalized Medicine
- Subjects
Research Report ,Bipolar Disorder ,Drug-Related Side Effects and Adverse Reactions ,Epidemiology ,Data Accuracy ,Quetiapine Fumarate ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Neuralgia ,030212 general & internal medicine ,Gabapentin ,030217 neurology & neurosurgery ,Randomized Controlled Trials as Topic - Abstract
Objective: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials. Study Design and Setting: We examined 21 trials of gabapentin for neuropathic pain (52 sources) and seven trials of quetiapine for bipolar depression (80 sources) using data from the Multiple Data Sources study. We extracted and compared information about nonsystematic AEs (i.e., AEs that were not assessed for every participant), including AEs categorized as “serious.” We recorded whether AEs were grouped by anatomic or physiological system. Results: Trials of the same drug reported information about different AEs. Information in public sources was inadequate for decision-making. No public source reported all AEs, or all serious AEs, identified in nonpublic sources about the same trial. Of trials with only public sources, 2/15 (13%) gabapentin and 0/3 (0%) quetiapine trials grouped AEs by anatomic or physiological system. Conclusion: Public sources contained little information about nonsystematic AEs, including serious AEs. Grouping might make nonsystematic AEs easier to detect; however, most public sources did not report grouped AEs. Standards are needed to improve the collection and reporting of nonsystematic AEs so that stakeholders can use trials to assess the balance of potential benefits and harms.
- Published
- 2019