Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets : a cross-sectional descriptive study
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2019-09-01
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Associacao Paulista de Medicina
Resumo
BACKGROUND: Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce. OBJECTIVE: To validate a new tool for assessing subjects’ satisfaction with medicine package leaflets (LiS-RPL). DESIGN AND SETTING: Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre). METHODS: 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. RESULTS: 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. CONCLUSION: LiS-RPL is a validated tool for evaluating subjects’ satisfaction with medicine package leaflets.
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Publisher Copyright: © 2019 by Associação Paulista de Medicina.
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CIÊNCIAS FARMACÊUTICAS, MEDICAMENTOS, INFORMAÇÃO EM SAÚDE, REGULAÇÃO DA SAÚDE, ESCALAS DE AVALIAÇÃO, PHARMACEUTICAL SCIENCES, DRUGS (PHARMACOLOGY), HEALTH INFORMATION, HEALTH REGULATION, ASSESSMENT SCALES
Citação
Pires, C, Rosa, P J, Vigário, M & Cavaco, A 2019, 'Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets : a cross-sectional descriptive study', Sao Paulo Medical Journal, vol. 137, no. 5, pp. 454-462. https://doi.org/10.1590/1516-3180.2019.0123160919