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Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial

BACKGROUND: Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with r...

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Autores principales: Rahn, Anne C., Backhus, Imke, Fuest, Franz, Riemann-Lorenz, Karin, Köpke, Sascha, van de Roemer, Adrianus, Mühlhauser, Ingrid, Heesen, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5029009/
https://www.ncbi.nlm.nih.gov/pubmed/27650788
http://dx.doi.org/10.1186/s12911-016-0362-8
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author Rahn, Anne C.
Backhus, Imke
Fuest, Franz
Riemann-Lorenz, Karin
Köpke, Sascha
van de Roemer, Adrianus
Mühlhauser, Ingrid
Heesen, Christoph
author_facet Rahn, Anne C.
Backhus, Imke
Fuest, Franz
Riemann-Lorenz, Karin
Köpke, Sascha
van de Roemer, Adrianus
Mühlhauser, Ingrid
Heesen, Christoph
author_sort Rahn, Anne C.
collection PubMed
description BACKGROUND: Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. METHODS: We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) “average weight” version and (3) “worm prophylaxis” version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. RESULTS: Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42–1.69), p = 0.002). The questionnaire’s internal consistency was moderate (Cronbach's alpha = 0.56). CONCLUSIONS: The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00008561. Registered 8th of June 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12911-016-0362-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-50290092016-09-22 Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial Rahn, Anne C. Backhus, Imke Fuest, Franz Riemann-Lorenz, Karin Köpke, Sascha van de Roemer, Adrianus Mühlhauser, Ingrid Heesen, Christoph BMC Med Inform Decis Mak Research Article BACKGROUND: Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. METHODS: We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) “average weight” version and (3) “worm prophylaxis” version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. RESULTS: Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42–1.69), p = 0.002). The questionnaire’s internal consistency was moderate (Cronbach's alpha = 0.56). CONCLUSIONS: The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00008561. Registered 8th of June 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12911-016-0362-8) contains supplementary material, which is available to authorized users. BioMed Central 2016-09-20 /pmc/articles/PMC5029009/ /pubmed/27650788 http://dx.doi.org/10.1186/s12911-016-0362-8 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
Rahn, Anne C.
Backhus, Imke
Fuest, Franz
Riemann-Lorenz, Karin
Köpke, Sascha
van de Roemer, Adrianus
Mühlhauser, Ingrid
Heesen, Christoph
Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
title Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
title_full Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
title_fullStr Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
title_full_unstemmed Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
title_short Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
title_sort comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5029009/
https://www.ncbi.nlm.nih.gov/pubmed/27650788
http://dx.doi.org/10.1186/s12911-016-0362-8
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