Risk of bias in randomized trials of pharmacological interventions in children and adults

Sinha, YK; Craig, JC; Sureshkumar, P; Hayen, A; Brien, JAE

Risk of bias in randomized trials of pharmacological interventions in children and adults

Sinha, YK Craig, JC Sureshkumar, P Hayen, A

Brien, JAE

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Publication Type:: Journal Article
Citation:: Journal of Pediatrics, 2014, 165 (2)
Issue Date:: 2014-01-01

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Field	Value	Language
dc.contributor.author	Sinha, YK	en_US
dc.contributor.author	Craig, JC	en_US
dc.contributor.author	Sureshkumar, P	en_US
dc.contributor.author	Hayen, A https://orcid.org/0000-0003-4046-8030	en_US
dc.contributor.author	Brien, JAE	en_US
dc.date.available	2014-03-28	en_US
dc.date.issued	2014-01-01	en_US
dc.identifier.citation	Journal of Pediatrics, 2014, 165 (2)	en_US
dc.identifier.issn	0022-3476	en_US
dc.identifier.uri	http://hdl.handle.net/10453/118287
dc.description.abstract	Objective To determine whether randomized controlled trials of pharmacologic interventions in children are more likely to be biased than similar trials in adults. Study design Trials involving only children and published in MEDLINE between January 2008 and October 2009 (n = 100) were randomly selected and matched, by drug class and therapeutic area, with a similar trial completed in adults. The Cochrane risk of bias tool was used to compare the pediatric and adult trials. Results The characteristics of adult and pediatric trials included were similar, except that adult studies were more likely to be conducted in Europe and published in specialty journals. Two-thirds of all trials were single center, and 62% had 100 or fewer participants. Many trials had an unclear risk of bias for allocation concealment (65% adult, 52% pediatric). More pediatric trials had a low risk of bias for random sequence generation (59% pediatric, 41% adult, P =.002) and blinding of outcome assessment (63% pediatric, 48% adult, P =.04) than adult trials; however, a sensitivity analysis of trials published since 2008 (and so matched by year of publication) did not confirm this finding, suggesting year of publication was an important confounder. Conclusions When randomized controlled trials are matched for drug class and therapeutic area, trials involving children display a similar risk of bias. Differences in the risk of bias between pediatric and adult trials are not caused by differences in the capacity of researchers to conduct and report trials of high quality. Copyright © 2014 Elsevier Inc. All rights reserved.	en_US
dc.relation.ispartof	Journal of Pediatrics	en_US
dc.relation.isbasedon	10.1016/j.jpeds.2014.03.058	en_US
dc.subject.classification	Pediatrics	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Risk Assessment	en_US
dc.subject.mesh	Bias (Epidemiology)	en_US
dc.subject.mesh	Adult	en_US
dc.subject.mesh	Child	en_US
dc.subject.mesh	Outcome Assessment (Health Care)	en_US
dc.subject.mesh	Randomized Controlled Trials as Topic	en_US
dc.subject.mesh	Bias	en_US
dc.subject.mesh	Outcome Assessment, Health Care	en_US
dc.title	Risk of bias in randomized trials of pharmacological interventions in children and adults	en_US
dc.type	Journal Article
utslib.citation.volume	2	en_US
utslib.citation.volume	165	en_US
utslib.for	1114 Paediatrics and Reproductive Medicine	en_US
utslib.for	111706 Epidemiology	en_US
utslib.for	1106 Human Movement and Sports Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Public Health
utslib.copyright.status	closed_access
pubs.issue	2	en_US
pubs.publication-status	Published	en_US
pubs.volume	165	en_US

Abstract:

Objective To determine whether randomized controlled trials of pharmacologic interventions in children are more likely to be biased than similar trials in adults. Study design Trials involving only children and published in MEDLINE between January 2008 and October 2009 (n = 100) were randomly selected and matched, by drug class and therapeutic area, with a similar trial completed in adults. The Cochrane risk of bias tool was used to compare the pediatric and adult trials. Results The characteristics of adult and pediatric trials included were similar, except that adult studies were more likely to be conducted in Europe and published in specialty journals. Two-thirds of all trials were single center, and 62% had 100 or fewer participants. Many trials had an unclear risk of bias for allocation concealment (65% adult, 52% pediatric). More pediatric trials had a low risk of bias for random sequence generation (59% pediatric, 41% adult, P =.002) and blinding of outcome assessment (63% pediatric, 48% adult, P =.04) than adult trials; however, a sensitivity analysis of trials published since 2008 (and so matched by year of publication) did not confirm this finding, suggesting year of publication was an important confounder. Conclusions When randomized controlled trials are matched for drug class and therapeutic area, trials involving children display a similar risk of bias. Differences in the risk of bias between pediatric and adult trials are not caused by differences in the capacity of researchers to conduct and report trials of high quality. Copyright © 2014 Elsevier Inc. All rights reserved.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/118287