Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets: a cross-sectional descriptive study

• Autor(a) principal: Pires,Carla
• Data de Publicação: 2019
• Outros Autores: Rosa,Pedro Joel, Vigário,Marina, Cavaco,Afonso
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: São Paulo medical journal (Online)
• Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-31802019000500454
• topic: Product labelling; Psychometrics; Legislation, pharmacy; Pharmaceutical preparations; Patient satisfaction; Package leaflets; Package inserts; Medicines; Validation; Likert scale; Regulation

ABSTRACT 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.