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An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study
OBJECTIVE: To adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting. DESIGN: The adaptation process involved development and customisation of a questionnaire for eac...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6082480/ https://www.ncbi.nlm.nih.gov/pubmed/30002013 http://dx.doi.org/10.1136/bmjopen-2018-021613 |
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author | Afolabi, Muhammed Olanrewaju Rennie, Stuart Hallfors, Denise Dion Kline, Tracy Zeitz, Susannah Odongo, Frederick S Amek, Nyaguara O Luseno, Winnie K |
author_facet | Afolabi, Muhammed Olanrewaju Rennie, Stuart Hallfors, Denise Dion Kline, Tracy Zeitz, Susannah Odongo, Frederick S Amek, Nyaguara O Luseno, Winnie K |
author_sort | Afolabi, Muhammed Olanrewaju |
collection | PubMed |
description | OBJECTIVE: To adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting. DESIGN: The adaptation process involved development and customisation of a questionnaire for each of the three study groups, modelled closely on the previously validated questionnaire. The three adapted draft questionnaires were further reviewed by two bioethicists and the developer of the original questionnaire for face and content validity. The revised questionnaire was subsequently programmed into an audio computerised format, with translations and back translations in three widely spoken languages by the study participants: Luo, Swahili and English. SETTING: The questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya. PARTICIPANTS: Twenty-five-item adapted questionnaires consisting of close-ended, multiple-choice and open-ended questions were administered to 235 participants consisting of 107 adolescents, 92 parents and 36 young adults. Test-retest was conducted 2–4 weeks after first questionnaire administration among 74 adolescents, young adults and parents. OUTCOME MEASURE: Primary outcome measures included ceiling/floor analysis to identify questions with extremes in responses and item-level correlation to determine the test-retest relationships. Given the data format, tetrachoric correlations were conducted for dichotomous items and polychoric correlations for ordinal items. The qualitative validation assessment included face and content validity evaluation of the adapted instrument by technical experts. RESULTS: Ceiling/floor analysis showed eight question items for which >80% of one or more groups responded correctly, while for nine questions, including all seven open-ended questions,<20% responded correctly. Majority of the question items had moderate to strong test-retest correlation estimates indicating temporal stability. CONCLUSIONS: Our study demonstrates that cross-cultural adaptation and validation of an informed consent comprehension questionnaire is feasible. However, further research is needed to develop a tool which can estimate a quantifiable threshold of comprehension thereby serving as an objective indicator of the need for interventions to improve comprehension. |
format | Online Article Text |
id | pubmed-6082480 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-60824802018-08-10 An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study Afolabi, Muhammed Olanrewaju Rennie, Stuart Hallfors, Denise Dion Kline, Tracy Zeitz, Susannah Odongo, Frederick S Amek, Nyaguara O Luseno, Winnie K BMJ Open Ethics OBJECTIVE: To adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting. DESIGN: The adaptation process involved development and customisation of a questionnaire for each of the three study groups, modelled closely on the previously validated questionnaire. The three adapted draft questionnaires were further reviewed by two bioethicists and the developer of the original questionnaire for face and content validity. The revised questionnaire was subsequently programmed into an audio computerised format, with translations and back translations in three widely spoken languages by the study participants: Luo, Swahili and English. SETTING: The questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya. PARTICIPANTS: Twenty-five-item adapted questionnaires consisting of close-ended, multiple-choice and open-ended questions were administered to 235 participants consisting of 107 adolescents, 92 parents and 36 young adults. Test-retest was conducted 2–4 weeks after first questionnaire administration among 74 adolescents, young adults and parents. OUTCOME MEASURE: Primary outcome measures included ceiling/floor analysis to identify questions with extremes in responses and item-level correlation to determine the test-retest relationships. Given the data format, tetrachoric correlations were conducted for dichotomous items and polychoric correlations for ordinal items. The qualitative validation assessment included face and content validity evaluation of the adapted instrument by technical experts. RESULTS: Ceiling/floor analysis showed eight question items for which >80% of one or more groups responded correctly, while for nine questions, including all seven open-ended questions,<20% responded correctly. Majority of the question items had moderate to strong test-retest correlation estimates indicating temporal stability. CONCLUSIONS: Our study demonstrates that cross-cultural adaptation and validation of an informed consent comprehension questionnaire is feasible. However, further research is needed to develop a tool which can estimate a quantifiable threshold of comprehension thereby serving as an objective indicator of the need for interventions to improve comprehension. BMJ Publishing Group 2018-07-12 /pmc/articles/PMC6082480/ /pubmed/30002013 http://dx.doi.org/10.1136/bmjopen-2018-021613 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ |
spellingShingle | Ethics Afolabi, Muhammed Olanrewaju Rennie, Stuart Hallfors, Denise Dion Kline, Tracy Zeitz, Susannah Odongo, Frederick S Amek, Nyaguara O Luseno, Winnie K An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study |
title | An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study |
title_full | An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study |
title_fullStr | An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study |
title_full_unstemmed | An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study |
title_short | An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study |
title_sort | adapted instrument to assess informed consent comprehension among youth and parents in rural western kenya: a validation study |
topic | Ethics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6082480/ https://www.ncbi.nlm.nih.gov/pubmed/30002013 http://dx.doi.org/10.1136/bmjopen-2018-021613 |
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