Readability of medicinal package leaflets: a systematic review

Revista de Saude Publica - Tập 49 Số 0 - 2015
Carla Pires1, Marina Vigário2, Afonso Cavaco3
1Programa de Pos-Graduacao - Doutoramento em Socio-Farmacia. Departamento de Socio-Farmacia Instituto de Investigacao do Medicamento. Faculdade de Farmacia. Universidade de Lisboa. Lisboa, Portugal
2Departamento de Linguistica. Faculdade de Letras. Universidade de Lisboa. Lisboa, Portugal
3Departamento de Socio-Farmacia. Faculdade de Farmacia. Instituto de Investigacao do Medicamento. Universidade de Lisboa. Lisboa, Portugal

Tóm tắt

OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use.METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online,comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded.RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions.CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

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Revista de Saude Publica

Tập 49 Số 0

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