Using alternative methodologies for evaluating patient medication leaflets.

A variety of direct and indirect methods have been used to evaluate written medication information; however, no published research has validated assessment tools or presented direct consumer assessment of patient information leaflets (PILs) provided in US community pharmacy (CP). We report on two new instruments: the medication information design assessment scale (MIDAS), an indirect measure of design quality administered by the investigators, and the consumer information rating form (CIRF), a direct measure of comprehensibility, utility, and overall design quality applied by a consumer panel. These were used to assess two types of PILs: 36 CP-PILs obtained from community pharmacies and 3 Model-PILs incorporating recommended design characteristics. The validity of the MIDAS was demonstrated in two ways. First, as predicted, the Model-PILs were rated more positively by consumers. We also found a significant positive correlation between the number of design criteria incorporated in a CP-PIL (as measured by the MIDAS score) and the consumers rating of design quality (CIRF). In conclusion, we confirmed the importance of design characteristics in the production of written medication information and have also developed and validated two easy-to-use tools for the assessment of written medication information.