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Readability of patient information and consent documents in rheumatological studies

BACKGROUND: Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands,...

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Autores principales: Hamnes, Bente, van Eijk-Hustings, Yvonne, Primdahl, Jette
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947296/
https://www.ncbi.nlm.nih.gov/pubmed/27422433
http://dx.doi.org/10.1186/s12910-016-0126-0
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author Hamnes, Bente
van Eijk-Hustings, Yvonne
Primdahl, Jette
author_facet Hamnes, Bente
van Eijk-Hustings, Yvonne
Primdahl, Jette
author_sort Hamnes, Bente
collection PubMed
description BACKGROUND: Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway. METHODS: 24 PICDs from studies were collected and readability was assessed independently using the Gunning’s Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. RESULTS: The mean score for the FOG and SMOG grades were 14.2 (9.0–19.0) and 14.2 (12–17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study. CONCLUSIONS: As the readability level of the PICDs did not match the participants’ educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12910-016-0126-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-49472962016-07-17 Readability of patient information and consent documents in rheumatological studies Hamnes, Bente van Eijk-Hustings, Yvonne Primdahl, Jette BMC Med Ethics Research Article BACKGROUND: Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway. METHODS: 24 PICDs from studies were collected and readability was assessed independently using the Gunning’s Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. RESULTS: The mean score for the FOG and SMOG grades were 14.2 (9.0–19.0) and 14.2 (12–17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study. CONCLUSIONS: As the readability level of the PICDs did not match the participants’ educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12910-016-0126-0) contains supplementary material, which is available to authorized users. BioMed Central 2016-07-16 /pmc/articles/PMC4947296/ /pubmed/27422433 http://dx.doi.org/10.1186/s12910-016-0126-0 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Hamnes, Bente
van Eijk-Hustings, Yvonne
Primdahl, Jette
Readability of patient information and consent documents in rheumatological studies
title Readability of patient information and consent documents in rheumatological studies
title_full Readability of patient information and consent documents in rheumatological studies
title_fullStr Readability of patient information and consent documents in rheumatological studies
title_full_unstemmed Readability of patient information and consent documents in rheumatological studies
title_short Readability of patient information and consent documents in rheumatological studies
title_sort readability of patient information and consent documents in rheumatological studies
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947296/
https://www.ncbi.nlm.nih.gov/pubmed/27422433
http://dx.doi.org/10.1186/s12910-016-0126-0
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