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Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results

PURPOSE: To illustrate the impact on the validity of trial results due to excluding patients from a randomized controlled trial for whom no deferred consent could be obtained after randomization because study procedures had already been finished. METHODS: The unadjusted and adjusted primary outcome...

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Autores principales: Jansen, Tim C., Bakker, Jan, Kompanje, Erwin J. O.
Formato: Texto
Lenguaje:English
Publicado: Springer-Verlag 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952110/
https://www.ncbi.nlm.nih.gov/pubmed/20689926
http://dx.doi.org/10.1007/s00134-010-1988-0
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author Jansen, Tim C.
Bakker, Jan
Kompanje, Erwin J. O.
author_facet Jansen, Tim C.
Bakker, Jan
Kompanje, Erwin J. O.
author_sort Jansen, Tim C.
collection PubMed
description PURPOSE: To illustrate the impact on the validity of trial results due to excluding patients from a randomized controlled trial for whom no deferred consent could be obtained after randomization because study procedures had already been finished. METHODS: The unadjusted and adjusted primary outcome measures of a recent randomized controlled multicentre study in the field of intensive care medicine were compared, including (n = 348) or excluding (n = 289) patients with missing deferred consent. RESULTS: Thirty-nine patients (11%) died early, before the patient or his/her proxy could be approached and consent be obtained. In another 20 patients (6%), it was not possible to inform proxies and ask consent within the period of study procedures. A significant treatment effect (p = 0.006) in the adjusted analysis became non-significant (p = 0.35) when the patients with missing deferred consent were excluded. CONCLUSIONS: Exclusion of patients without obtained deferred consent can reduce statistical power, introduce selection bias, make randomization asymmetrical, decrease external validity and thereby jeopardize study results. This may have implications for emergency research in various disciplines.
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spelling pubmed-29521102010-10-21 Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results Jansen, Tim C. Bakker, Jan Kompanje, Erwin J. O. Intensive Care Med Legal and Ethical Issues PURPOSE: To illustrate the impact on the validity of trial results due to excluding patients from a randomized controlled trial for whom no deferred consent could be obtained after randomization because study procedures had already been finished. METHODS: The unadjusted and adjusted primary outcome measures of a recent randomized controlled multicentre study in the field of intensive care medicine were compared, including (n = 348) or excluding (n = 289) patients with missing deferred consent. RESULTS: Thirty-nine patients (11%) died early, before the patient or his/her proxy could be approached and consent be obtained. In another 20 patients (6%), it was not possible to inform proxies and ask consent within the period of study procedures. A significant treatment effect (p = 0.006) in the adjusted analysis became non-significant (p = 0.35) when the patients with missing deferred consent were excluded. CONCLUSIONS: Exclusion of patients without obtained deferred consent can reduce statistical power, introduce selection bias, make randomization asymmetrical, decrease external validity and thereby jeopardize study results. This may have implications for emergency research in various disciplines. Springer-Verlag 2010-08-06 2010 /pmc/articles/PMC2952110/ /pubmed/20689926 http://dx.doi.org/10.1007/s00134-010-1988-0 Text en © The Author(s) 2010 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
spellingShingle Legal and Ethical Issues
Jansen, Tim C.
Bakker, Jan
Kompanje, Erwin J. O.
Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
title Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
title_full Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
title_fullStr Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
title_full_unstemmed Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
title_short Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
title_sort inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
topic Legal and Ethical Issues
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952110/
https://www.ncbi.nlm.nih.gov/pubmed/20689926
http://dx.doi.org/10.1007/s00134-010-1988-0
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