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Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials
Patient engagement with treatments potentially poses problems for interpreting the results and meaning of Randomised Control Trials (RCTs). If patients are assigned to treatments that do, or do not, match their expectations, and this impacts their motivation to engage with that treatment, it will af...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247438/ https://www.ncbi.nlm.nih.gov/pubmed/34222273 http://dx.doi.org/10.3389/fmed.2021.648403 |
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author | Truzoli, Roberto Reed, Phil Osborne, Lisa A. |
author_facet | Truzoli, Roberto Reed, Phil Osborne, Lisa A. |
author_sort | Truzoli, Roberto |
collection | PubMed |
description | Patient engagement with treatments potentially poses problems for interpreting the results and meaning of Randomised Control Trials (RCTs). If patients are assigned to treatments that do, or do not, match their expectations, and this impacts their motivation to engage with that treatment, it will affect the distribution of outcomes. In turn, this will impact the obtained power and error rates of RCTs. Simple Monto Carlo simulations demonstrate that these patient variables affect sample variance, and sample kurtosis. These effects reduce the power of RCTs, and may lead to false negatives, even when the randomisation process works, and equally distributes those with positive and negative views about a treatment to a trial arm. |
format | Online Article Text |
id | pubmed-8247438 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-82474382021-07-02 Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials Truzoli, Roberto Reed, Phil Osborne, Lisa A. Front Med (Lausanne) Medicine Patient engagement with treatments potentially poses problems for interpreting the results and meaning of Randomised Control Trials (RCTs). If patients are assigned to treatments that do, or do not, match their expectations, and this impacts their motivation to engage with that treatment, it will affect the distribution of outcomes. In turn, this will impact the obtained power and error rates of RCTs. Simple Monto Carlo simulations demonstrate that these patient variables affect sample variance, and sample kurtosis. These effects reduce the power of RCTs, and may lead to false negatives, even when the randomisation process works, and equally distributes those with positive and negative views about a treatment to a trial arm. Frontiers Media S.A. 2021-06-17 /pmc/articles/PMC8247438/ /pubmed/34222273 http://dx.doi.org/10.3389/fmed.2021.648403 Text en Copyright © 2021 Truzoli, Reed and Osborne. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine Truzoli, Roberto Reed, Phil Osborne, Lisa A. Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials |
title | Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials |
title_full | Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials |
title_fullStr | Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials |
title_full_unstemmed | Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials |
title_short | Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials |
title_sort | patient expectations of assigned treatments impact strength of randomised control trials |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247438/ https://www.ncbi.nlm.nih.gov/pubmed/34222273 http://dx.doi.org/10.3389/fmed.2021.648403 |
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