Abstract
Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce. To validate a new tool for assessing subjects' satisfaction with medicine package leaflets (LiS-RPL). Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre). 503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett's sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler's Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability. Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler's Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous. LiS-RPL is a validated tool for evaluating subjects' satisfaction with medicine package leaflets.
Highlights
According to the European Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, package leaflets of medicines need to be simple, clear and comprehensible
In designing package leaflets, special focus should be given to elements such as use of a simple writing style, adequate font size and layout and adequate contrast.[2]
Questionnaires using Likert scales are commonly used in readability/legibility tests to evaluate the readability of package leaflets.[3,4,5,6]
Summary
According to the European Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, package leaflets of medicines (from here on, referred to as package leaflets) need to be simple, clear and comprehensible. Questionnaires using Likert scales (i.e. a psychometric scale for questionnaires comprising an intermediate value and an odd number of alternatives, usually five or seven) are commonly used in readability/legibility tests to evaluate the readability of package leaflets.[3,4,5,6] In these tests, the scores of the Likert scales are often used to check readability after package leaflets have been optimized, i.e. test-retest methodology is usually applied.[3,4,6] These scales are easy to apply and often present high response rates (84-91%) and completion rates (70-85%).[4,7] Another advantage is that 20-item questionnaires in which responses are assessed using a Likert scale can be completed fast: in less than five minutes if the questionnaire is simple. CONCLUSION: LiS-RPL is a validated tool for evaluating subjects’satisfaction with medicine package leaflets
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