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Simple randomization did not protect against bias in smaller trials

Abstract:

OBJECTIVES: By removing systematic differences across treatment groups, simple randomization is assumed to protect against bias. However, random differences may remain if the sample size is insufficiently large. We sought to determine the minimal sample size required to eliminate random differences, thereby allowing an unbiased estimation of the treatment effect. STUDY DESIGN AND SETTING: We reanalyzed two published multicenter, large, and simple trials: the International Stroke Trial (IST) a...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1016/j.jclinepi.2017.02.010

Authors


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Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Centre for Statistics in Medicine
Role:
Author
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Medical Research Council More from this funder
Stroke Association More from this funder
Canadian Institutes of Health Research More from this funder
Publisher:
Elsevier Publisher's website
Journal:
Journal of Clinical Epidemiology Journal website
Volume:
84
Pages:
105–113
Publication date:
2017-02-28
Acceptance date:
2017-02-21
DOI:
EISSN:
1878-5921
ISSN:
0895-4356
Source identifiers:
686297
Language:
English
Keywords:
Pubs id:
pubs:686297
UUID:
uuid:7bfe2582-8717-47e6-a447-55240b9d0c5f
Local pid:
pubs:686297
Deposit date:
2017-04-25

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