Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis
Tóm tắt
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. 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). 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. 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.
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