Readability of medicinal package leaflets: a systematic review
Autor(a) principal: | |
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Data de Publicação: | 2015 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Revista de Saúde Pública |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102015000100401 |
Resumo: | 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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Readability of medicinal package leaflets: a systematic reviewMedicine Package InsertsComprehensionConsumer Health InformationReviewOBJECTIVE 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.Faculdade de Saúde Pública da Universidade de São Paulo2015-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102015000100401Revista de Saúde Pública v.49 2015reponame:Revista de Saúde Públicainstname:Universidade de São Paulo (USP)instacron:USP10.1590/S0034-8910.2015049005559info:eu-repo/semantics/openAccessPires,CarlaVigário,MarinaCavaco,Afonsoeng2015-10-28T00:00:00Zoai:scielo:S0034-89102015000100401Revistahttp://www.scielo.br/scielo.php?script=sci_serial&pid=0034-8910&lng=pt&nrm=isoONGhttps://old.scielo.br/oai/scielo-oai.phprevsp@org.usp.br||revsp1@usp.br1518-87870034-8910opendoar:2015-10-28T00:00Revista de Saúde Pública - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Readability of medicinal package leaflets: a systematic review |
title |
Readability of medicinal package leaflets: a systematic review |
spellingShingle |
Readability of medicinal package leaflets: a systematic review Pires,Carla Medicine Package Inserts Comprehension Consumer Health Information Review |
title_short |
Readability of medicinal package leaflets: a systematic review |
title_full |
Readability of medicinal package leaflets: a systematic review |
title_fullStr |
Readability of medicinal package leaflets: a systematic review |
title_full_unstemmed |
Readability of medicinal package leaflets: a systematic review |
title_sort |
Readability of medicinal package leaflets: a systematic review |
author |
Pires,Carla |
author_facet |
Pires,Carla Vigário,Marina Cavaco,Afonso |
author_role |
author |
author2 |
Vigário,Marina Cavaco,Afonso |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Pires,Carla Vigário,Marina Cavaco,Afonso |
dc.subject.por.fl_str_mv |
Medicine Package Inserts Comprehension Consumer Health Information Review |
topic |
Medicine Package Inserts Comprehension Consumer Health Information Review |
description |
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. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-01-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102015000100401 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102015000100401 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/S0034-8910.2015049005559 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Faculdade de Saúde Pública da Universidade de São Paulo |
publisher.none.fl_str_mv |
Faculdade de Saúde Pública da Universidade de São Paulo |
dc.source.none.fl_str_mv |
Revista de Saúde Pública v.49 2015 reponame:Revista de Saúde Pública instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Revista de Saúde Pública |
collection |
Revista de Saúde Pública |
repository.name.fl_str_mv |
Revista de Saúde Pública - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
revsp@org.usp.br||revsp1@usp.br |
_version_ |
1748936503280533504 |