• Carla Pires, Pedro Joel Rosa, Marina Vigário, and Afonso Cavaco.
• PhD. Pharmacist and Invited Professor, Department of Pharmacotherapy, Research Center for Biosciences and Health Technologies (CBIOS), Universidade Lusófona, Campo Grande, Lisbon, Portugal.
• Sao Paulo Med J. 2019 Sep 1; 137 (5): 454462454-462.

BackgroundPackage leaflets of medicines need to be intelligible, but tools for their evaluation are scarce.ObjectiveTo validate a new tool for assessing subjects' satisfaction with medicine package leaflets (LiS-RPL).Design And SettingCross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre).Methods503 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.ResultsMinimum 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.ConclusionLiS-RPL is a validated tool for evaluating subjects' satisfaction with medicine package leaflets.

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