Abstract
Objectives:
Information on the use of medicinal products should be particularly clear and un-ambiguous, including the information on dosing for children. Age groups of children in patient information leaflets are sometimes described with a “gap” (eg, 2-4 years, 5-12 years) or without a gap (2-4 years, 4-12 years). The first style is based on the view that person’s age is a discrete variable and the second style is based on continuous understanding of person’s age. The aim of this 3-language study was to test if these 2 styles are comprehensive.
Methods:
We presented a dosing chapter from patient information leaflet to 274 volunteers and asked them what dose they would use for a child whose age is on the border between the two age intervals.
Results:
We found that all commonly used styles are ambiguous. On average, 10% to 20% of people understand the instructions differently than the majority.
Conclusions:
A need exists to develop a new, unambiguous style to present this information and prevent suboptimal dosing of drug with a lack of efficacy or additional risks of adverse effects.
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