The need for randomization in animal trials: an overview of systematic reviews.

<h4>Background and objectives</h4>Randomization, allocation concealment, and blind outcome assessment have been shown to reduce bias in human studies. Authors from the Collaborative Approach to Meta Analysis and Review of Animal Data from Experimental Studies (CAMARADES) collaboration re...

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Autores principales:	Jennifer A Hirst, Jeremy Howick, Jeffrey K Aronson, Nia Roberts, Rafael Perera, Constantinos Koshiaris, Carl Heneghan
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2014
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/ab7db6967f8749fda4b828412441215b
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spelling	oai:doaj.org-article:ab7db6967f8749fda4b828412441215b2021-11-18T08:16:51ZThe need for randomization in animal trials: an overview of systematic reviews.1932-620310.1371/journal.pone.0098856https://doaj.org/article/ab7db6967f8749fda4b828412441215b2014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24906117/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background and objectives</h4>Randomization, allocation concealment, and blind outcome assessment have been shown to reduce bias in human studies. Authors from the Collaborative Approach to Meta Analysis and Review of Animal Data from Experimental Studies (CAMARADES) collaboration recently found that these features protect against bias in animal stroke studies. We extended the scope the work from CAMARADES to include investigations of treatments for any condition.<h4>Methods</h4>We conducted an overview of systematic reviews. We searched Medline and Embase for systematic reviews of animal studies testing any intervention (against any control) and we included any disease area and outcome. We included reviews comparing randomized versus not randomized (but otherwise controlled), concealed versus unconcealed treatment allocation, or blinded versus unblinded outcome assessment.<h4>Results</h4>Thirty-one systematic reviews met our inclusion criteria: 20 investigated treatments for experimental stroke, 4 reviews investigated treatments for spinal cord diseases, while 1 review each investigated treatments for bone cancer, intracerebral hemorrhage, glioma, multiple sclerosis, Parkinson's disease, and treatments used in emergency medicine. In our sample 29% of studies reported randomization, 15% of studies reported allocation concealment, and 35% of studies reported blinded outcome assessment. We pooled the results in a meta-analysis, and in our primary analysis found that failure to randomize significantly increased effect sizes, whereas allocation concealment and blinding did not. In our secondary analyses we found that randomization, allocation concealment, and blinding reduced effect sizes, especially where outcomes were subjective.<h4>Conclusions</h4>Our study demonstrates the need for randomization, allocation concealment, and blind outcome assessment in animal research across a wide range of outcomes and disease areas. Since human studies are often justified based on results from animal studies, our results suggest that unduly biased animal studies should not be allowed to constitute part of the rationale for human trials.Jennifer A HirstJeremy HowickJeffrey K AronsonNia RobertsRafael PereraConstantinos KoshiarisCarl HeneghanPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 6, p e98856 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Jennifer A Hirst Jeremy Howick Jeffrey K Aronson Nia Roberts Rafael Perera Constantinos Koshiaris Carl Heneghan The need for randomization in animal trials: an overview of systematic reviews.
description	<h4>Background and objectives</h4>Randomization, allocation concealment, and blind outcome assessment have been shown to reduce bias in human studies. Authors from the Collaborative Approach to Meta Analysis and Review of Animal Data from Experimental Studies (CAMARADES) collaboration recently found that these features protect against bias in animal stroke studies. We extended the scope the work from CAMARADES to include investigations of treatments for any condition.<h4>Methods</h4>We conducted an overview of systematic reviews. We searched Medline and Embase for systematic reviews of animal studies testing any intervention (against any control) and we included any disease area and outcome. We included reviews comparing randomized versus not randomized (but otherwise controlled), concealed versus unconcealed treatment allocation, or blinded versus unblinded outcome assessment.<h4>Results</h4>Thirty-one systematic reviews met our inclusion criteria: 20 investigated treatments for experimental stroke, 4 reviews investigated treatments for spinal cord diseases, while 1 review each investigated treatments for bone cancer, intracerebral hemorrhage, glioma, multiple sclerosis, Parkinson's disease, and treatments used in emergency medicine. In our sample 29% of studies reported randomization, 15% of studies reported allocation concealment, and 35% of studies reported blinded outcome assessment. We pooled the results in a meta-analysis, and in our primary analysis found that failure to randomize significantly increased effect sizes, whereas allocation concealment and blinding did not. In our secondary analyses we found that randomization, allocation concealment, and blinding reduced effect sizes, especially where outcomes were subjective.<h4>Conclusions</h4>Our study demonstrates the need for randomization, allocation concealment, and blind outcome assessment in animal research across a wide range of outcomes and disease areas. Since human studies are often justified based on results from animal studies, our results suggest that unduly biased animal studies should not be allowed to constitute part of the rationale for human trials.
format	article
author	Jennifer A Hirst Jeremy Howick Jeffrey K Aronson Nia Roberts Rafael Perera Constantinos Koshiaris Carl Heneghan
author_facet	Jennifer A Hirst Jeremy Howick Jeffrey K Aronson Nia Roberts Rafael Perera Constantinos Koshiaris Carl Heneghan
author_sort	Jennifer A Hirst
title	The need for randomization in animal trials: an overview of systematic reviews.
title_short	The need for randomization in animal trials: an overview of systematic reviews.
title_full	The need for randomization in animal trials: an overview of systematic reviews.
title_fullStr	The need for randomization in animal trials: an overview of systematic reviews.
title_full_unstemmed	The need for randomization in animal trials: an overview of systematic reviews.
title_sort	need for randomization in animal trials: an overview of systematic reviews.
publisher	Public Library of Science (PLoS)
publishDate	2014
url	https://doaj.org/article/ab7db6967f8749fda4b828412441215b
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The need for randomization in animal trials: an overview of systematic reviews.

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