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- Title
Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis.
- Authors
Blaser, David; Eaneff, Stephanie; Loudon-Griffiths, James; Roberts, Stephanie; Phan, Paulina; Wicks, Paul; Weatherall, James
- Abstract
Background: While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in which patients experience medications in real world settings. However, the relationship between these two data sources has not been closely examined. Methods: To understand how rates of medication side effects compare between a source of PGHD and medication labels, the current study compares adverse drug reaction rates from FDA medication labels with those self-reported by patients from an online patient community, PatientsLikeMe (PLM). The linear association between medication label and PLM nausea rates was evaluated using Spearman correlation, with an associated 95% confidence interval calculated based on 10,000 bootstrap iterations. The reporting ratio of PLM nausea rates to medication label nausea rates was defined for all treatments with non-zero medication label nausea rates. Lognormality of the distribution of this reporting ratio was assessed based on a Kolmogorov-Smirnov test (α = 0.05). Results: Nausea rates for 163 medications were compared between the two data sources. Overall rates ranged from 0 to 60% for medication labels and 0 to 36% for PLM data with median rates of 6.4 and 3.7%, respectively. In general, nausea rates reported by patients in the online community were lower than those found in medication labels. This inconsistency was attributed to a variety of factors, including differences in data collection mechanisms and product use factors. Conclusions: Quantifiable and consistent differences exist between side effect rates reported on medication labels and those self-reported by patients based on real-world use. In general, self-reported rates of nausea associated with medication use were lower than those reported in medication labels. Although considered a definitive resource for medication information, this discrepancy demonstrates that medication labels may not comprehensively describe the patient experience. Results suggest that a combination of information from different sources may provide a more rounded and holistic view on medication safety and tolerability.
- Subjects
MEDICATION abuse; DRUG abuse; NAUSEA treatment; PATIENTSLIKEME Inc.; KOLMOGOROV complexity
- Publication
AAPS Open, 2017, Vol 3, Issue 1, p1
- ISSN
2364-9534
- Publication type
Article
- DOI
10.1186/s41120-017-0020-y