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Subclinical cerebral edema in children with diabetic ketoacidosis randomized to 2 different rehydration protocols

Methodology Score: 2/5  
Usefulness Score: 2/5

Pediatrics. 2013 Jan;131(1):e73-80


This pilot randomized controlled trial found that DKA treatment protocols using different rates of fluid infusion were not associated with differences in MRI measures of sub-clinical cerebral edema. JC attendees agreed that while the results were thought provoking, this study was not sufficiently powered (n=18) to be considered practice changing. 
By: Dr. Michael O’Brien
(Presented May 2013)


Epi Lesson - Blinding of Treatment Allocation

Open label trials may be promoted as pragmatic trials but a lack of blinding to treatment allocation is a fundamental threat to internal validity. Blinding reduces ascertainment bias (the likelihood of differential assessment of outcome). It is not always possible to undertake blinding in a RCT. But a critical reader will ask whether it was possible to blind outcome assessors. Doing so mitigates some of the bias introduced by open label trials.  
By: Dr. Lisa Calder

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