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What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France

This study aimed to assess patient investigational medication knowledge and to identify factors associated with medication understanding by adult outpatients included in clinical trials. A cross-sectional prospectively designed survey was conducted on consecutive volunteers at 21 university teaching...

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Autores principales: Fronteau, Clémentine, Paré, Maxime, Benoit, Philippe, Tollec, Sophie, Hamon, Catherine, Schwiertz, Vérane, Maillard, Christian, Cransac, Amélie, Volteau, Christelle, Huon, Jean-François, Burgeot, Véronique, Tching-Sin, Martine, Guérin, Corinne, Flet, Laurent
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6692008/
https://www.ncbi.nlm.nih.gov/pubmed/31408456
http://dx.doi.org/10.1371/journal.pone.0220383
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author Fronteau, Clémentine
Paré, Maxime
Benoit, Philippe
Tollec, Sophie
Hamon, Catherine
Schwiertz, Vérane
Maillard, Christian
Cransac, Amélie
Volteau, Christelle
Huon, Jean-François
Burgeot, Véronique
Tching-Sin, Martine
Guérin, Corinne
Flet, Laurent
author_facet Fronteau, Clémentine
Paré, Maxime
Benoit, Philippe
Tollec, Sophie
Hamon, Catherine
Schwiertz, Vérane
Maillard, Christian
Cransac, Amélie
Volteau, Christelle
Huon, Jean-François
Burgeot, Véronique
Tching-Sin, Martine
Guérin, Corinne
Flet, Laurent
author_sort Fronteau, Clémentine
collection PubMed
description This study aimed to assess patient investigational medication knowledge and to identify factors associated with medication understanding by adult outpatients included in clinical trials. A cross-sectional prospectively designed survey was conducted on consecutive volunteers at 21 university teaching hospitals (in France) from February to December 2014. Investigational medication understanding was assessed at the time of the first dispensing using a structured interviewer-administered questionnaire based on information obtained from the literature that provided an 8-point score. Demographic and other baseline data were collected using structured interviews. Of the 236 participants, 139 (58.9%) of the respondents were male, and the median age was 54.9 years (range: 18–83 years). The mean understanding score was 6.24 and 72.5% of the patients had a score of 6 or higher. In univariate analysis, the medication understanding score was negatively correlated with age (r = -0.15, p = 0.0247) and positively correlated with the level of education (r = 0.25, p = 0.0002). In multivariate analysis, prognostic factors of a higher medication understanding score were: graduation from high school or a higher level of education; HIV infection; phase II/III/IV studies; mention of the drug on the prescription form, and the dispensing of a single investigational medication. Only a quarter of the adult outpatients included in clinical trials had a maximum possible investigational medication understanding score. Being old and having a low level of education were found to be important risk factors for inadequate medication understanding. This and other data suggest that sponsors should encourage initiatives aimed at improving investigational medication understanding in adults enrolled in clinical trials.
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spelling pubmed-66920082019-08-30 What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France Fronteau, Clémentine Paré, Maxime Benoit, Philippe Tollec, Sophie Hamon, Catherine Schwiertz, Vérane Maillard, Christian Cransac, Amélie Volteau, Christelle Huon, Jean-François Burgeot, Véronique Tching-Sin, Martine Guérin, Corinne Flet, Laurent PLoS One Research Article This study aimed to assess patient investigational medication knowledge and to identify factors associated with medication understanding by adult outpatients included in clinical trials. A cross-sectional prospectively designed survey was conducted on consecutive volunteers at 21 university teaching hospitals (in France) from February to December 2014. Investigational medication understanding was assessed at the time of the first dispensing using a structured interviewer-administered questionnaire based on information obtained from the literature that provided an 8-point score. Demographic and other baseline data were collected using structured interviews. Of the 236 participants, 139 (58.9%) of the respondents were male, and the median age was 54.9 years (range: 18–83 years). The mean understanding score was 6.24 and 72.5% of the patients had a score of 6 or higher. In univariate analysis, the medication understanding score was negatively correlated with age (r = -0.15, p = 0.0247) and positively correlated with the level of education (r = 0.25, p = 0.0002). In multivariate analysis, prognostic factors of a higher medication understanding score were: graduation from high school or a higher level of education; HIV infection; phase II/III/IV studies; mention of the drug on the prescription form, and the dispensing of a single investigational medication. Only a quarter of the adult outpatients included in clinical trials had a maximum possible investigational medication understanding score. Being old and having a low level of education were found to be important risk factors for inadequate medication understanding. This and other data suggest that sponsors should encourage initiatives aimed at improving investigational medication understanding in adults enrolled in clinical trials. Public Library of Science 2019-08-13 /pmc/articles/PMC6692008/ /pubmed/31408456 http://dx.doi.org/10.1371/journal.pone.0220383 Text en © 2019 Fronteau et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Fronteau, Clémentine
Paré, Maxime
Benoit, Philippe
Tollec, Sophie
Hamon, Catherine
Schwiertz, Vérane
Maillard, Christian
Cransac, Amélie
Volteau, Christelle
Huon, Jean-François
Burgeot, Véronique
Tching-Sin, Martine
Guérin, Corinne
Flet, Laurent
What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France
title What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France
title_full What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France
title_fullStr What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France
title_full_unstemmed What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France
title_short What do adult outpatients included in clinical trials know about the investigational drugs being assessed: A cross-sectional study in France
title_sort what do adult outpatients included in clinical trials know about the investigational drugs being assessed: a cross-sectional study in france
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6692008/
https://www.ncbi.nlm.nih.gov/pubmed/31408456
http://dx.doi.org/10.1371/journal.pone.0220383
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