Countrygirl
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http://www.virology.ws/2017/12/13/trial-by-error-the-crawley-chronicles-resumed/
Trial By Error: The Crawley Chronicles, Resumed
13 DECEMBER 2017
By David Tuller, DrPH
So let’s talk about Professor Esther Crawley’s SMILE trial, published in September by the journal Archives of Disease in Childhood, one of the BMJ Publishing Group’s titles. The study reported that a commercial intervention called the Lightning Process was an effective treatment for children with CFS/ME when offered along with what was called “specialist medical care.”
SMILE was an open-label trial relying on subjective responses, a study design notoriously vulnerable to bias. In this case, self-reported physical function was the primary outcome, just as it was one of two primary outcomes in PACE. (The full name of the trial is: “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.”)