Herein we develop a user-driven, risk-based tool to inform the design of a standardized label for use with medical devices. Researchers identified 11 labeling inputs found on commercial labels and organized the inputs into a “Device Facts” box at 3 risk levels: high, medium, and low. mock labels and commercial labels were objectively compared by healthcare practitioners using a forced choice methodology where accuracy and response time served as dependent variables. Results suggested that pairwise comparisons between labels (mock vs commercial) within a given risk category (e.g. high) yielded statistically significant differences at a confidence level of 95% for time to correct response. For both medium (p=0.0016) and high risk information (p<0.0001), the mock labels yielded a quicker correct response than their commercial counterparts. Only for low risk information were the commercial labels faster (p<0.0001). The gains in speed made in high/moderate risk information were not attributable trade-off. Mock labels were at least as accurate as their commercial counterparts; low and high risk yielded no sign of significant difference when mock and commercial were compared and participants were significantly more accurate with questions requiring medium risk information for the mock labels.
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