ABSTRACT
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.
Subject(s)
Humans , Male , Female , Personal Satisfaction , Surveys and Questionnaires/standards , Comprehension , Drug Labeling/standards , Consumer Health Information/methods , Portugal , Publications/standards , Reading , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions , Educational Status , Consumer Health Information/standards , Government AgenciesABSTRACT
Health warnings on tobacco products have emerged as a prominent area of tobacco control policy. Regulatory practice has rapidly evolved over the past decade to the point where health warnings on tobacco products continue to set international precedents for their size and comprehensiveness. The current paper provides a general review of current regulatory practices, including physical design features (such as size and location), message content (pictorial vs. text and content "themes), and regulatory considerations such as rotation period and other novel practices.
Las advertencias sanitarias en los productos de tabaco han llegado a ser una de las políticas públicas principales para el control del tabaco. A través de la última década las prácticas regulatorias han evolucionado mucho y varios países siguen impulsado cambios regulatorios importantes en términos del tamaño y carácter de las advertencias sanitarias que han implementado. Este ensayo resume las prácticas regulatorias actuales alrededor del mundo, incluyendo las características del diseño físico de la advertencia (es decir, tamaño y ubicación), sus contenidos (temas, pictogramas, textos) y otros factores regulatorios importantes (frecuencia de rotación y otras prácticas innovadoras).