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Non-adherence in non-inferiority trials: pitfalls and recommendations

Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers...

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Detalles Bibliográficos
Autores principales: Mo, Yin, Lim, Cherry, Watson, James A, White, Nicholas J, Cooper, Ben S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327542/
https://www.ncbi.nlm.nih.gov/pubmed/32611541
http://dx.doi.org/10.1136/bmj.m2215
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author Mo, Yin
Lim, Cherry
Watson, James A
White, Nicholas J
Cooper, Ben S
author_facet Mo, Yin
Lim, Cherry
Watson, James A
White, Nicholas J
Cooper, Ben S
author_sort Mo, Yin
collection PubMed
description Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome reporting to reduce bias in treatment estimates and improve transparency in reporting.
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spelling pubmed-73275422020-07-02 Non-adherence in non-inferiority trials: pitfalls and recommendations Mo, Yin Lim, Cherry Watson, James A White, Nicholas J Cooper, Ben S BMJ Research Methods & Reporting Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome reporting to reduce bias in treatment estimates and improve transparency in reporting. BMJ Publishing Group Ltd. 2020-07-01 /pmc/articles/PMC7327542/ /pubmed/32611541 http://dx.doi.org/10.1136/bmj.m2215 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by/4.0/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 Research Methods & Reporting
Mo, Yin
Lim, Cherry
Watson, James A
White, Nicholas J
Cooper, Ben S
Non-adherence in non-inferiority trials: pitfalls and recommendations
title Non-adherence in non-inferiority trials: pitfalls and recommendations
title_full Non-adherence in non-inferiority trials: pitfalls and recommendations
title_fullStr Non-adherence in non-inferiority trials: pitfalls and recommendations
title_full_unstemmed Non-adherence in non-inferiority trials: pitfalls and recommendations
title_short Non-adherence in non-inferiority trials: pitfalls and recommendations
title_sort non-adherence in non-inferiority trials: pitfalls and recommendations
topic Research Methods & Reporting
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327542/
https://www.ncbi.nlm.nih.gov/pubmed/32611541
http://dx.doi.org/10.1136/bmj.m2215
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