Readability assessment of package leaflets of biosimilars
| Autor: | Piñero-López, María Ángeles, Figueiredo-Escribá, Carlos, Modamio, Pilar, Lastra, Cecilia F, Mariño, Eduardo L |
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| Rok vydání: | 2019 |
| Předmět: |
package leaflet
education Biotecnologia biological medicinal product Humans European Union Biosimilar Pharmaceuticals Drug Labeling Internet Research Publications Drugs Legibility (Printing) patient information Cross-Sectional Studies Reading readability cardiovascular system lipids (amino acids peptides and proteins) Public Health biosimilar Comprehension Llegibilitat Medicaments Biotechnology |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona BMJ Open |
| Popis: | Objectives: To assess the degree of readability and the length of the package leaflets of biosimilars. Setting: The package leaflets analysed were downloaded from the European Medicines Agency (EMA) website. Participants The study sample included the package leaflets written in English of all the biosimilars that were authorised by the EMA on 31 August 2017, and whose content was available via the internet on that date (n=35). Design This was a cross-sectional analytical study. The readability of the package leaflets of all biosimilars authorised by the EMA in August 2017 was determined applying the Flesch and Flesch-Kincaid formulas. The influence of the following variables on the readability and length was also analysed: package leaflet section, type of biosimilar, date of first authorisation of the biosimilar and type of medicine. Results: A considerable variation of the package leaflets length was found (3154±803). The readability of all the package leaflets overtook the recommended value for health-related written materials taking into account Flesch-Kincaid Index, and none of the package leaflets were easy to understand according to the Flesch Index. Statistically significant differences (p |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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