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Evidence-Based Medicine 2000;5:36-38; doi:10.1136/ebm.5.2.36
Copyright © 2000 by the BMJ Publishing Group Ltd.
Evidence-Based Medicine 2000; 5:36-38
© 2000 Evidence-Based Medicine

Assessing allocation concealment and blinding in randomised controlled trials: why bother?

Kenneth F Schulz, PhD, MBA

Centers for Disease Control and Prevention Atlanta, Georgia, USA

The scientific community's quest for unbiased research received a strong boost from a recent policy amendment on randomised controlled trials (RCTs) in this journal. Henceforth, the status of allocation concealment will be clearly indicated in the abstracts along with that of blinding, so readers will have additional information by which to judge the internal validity of trials. In this editorial, I address the background of and rationale for these enhancements.

Background

Random allocation to intervention groups remains the only method of ensuring that the groups being compared are on an equivalent footing at study outset, thus eliminating selection and confounding biases. This technique has allowed RCTs to play a key role in advancing medical science.

The success of randomisation depends on 2 interrelated processes.1, 2 The first entails generating a sequence by which the participants in a trial are allocated to intervention groups. To ensure the unpredictability of that allocation sequence, investigators . . . [Full text of this article]


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