WORKSHOP Thursday, May 25, 2:00-4:30
N-of-1: A Novel Method for Investigating CAM Therapies
Speakers: Sunita Vohra, MD, Kristie Cramer, MS, Nick
Barrowman, PhD
By current standards, there is frequently insufficient
data about the effectiveness of pediatric complementary and alternative
medicine (CAM) use. Although the randomized controlled trial (RCT) is
recognized within evidence-based medicine (EBM) as the gold standard
for evaluating treatment efficacy, CAM practitioners resist RCTs, as
they tend to neglect or even eliminate the non-specific effects (i.e.,
the individualized element) that are an essential element of CAM. However,
conventional medical researchers are concerned that non-RCTs leave research
open to bias. A method that provides both rigorous research and an "individual"
approach is therefore required. To be accepted by both conventional
and alternative care providers, methods for studying CAM need to incorporate
its holistic approach and individualized treatment philosophy with methodological
rigor. This workshop will employ a problem-based approach to present
alternative methods for studying CAM. In particular, the N-of-1 trial
will be presented and discussed. Case examples will illustrate how the
N-of-1 trial incorporates patient preference while maintaining methodological
rigor in the investigation of CAM therapies. The advantages and disadvantages
of the N-of-1 trial design will be discussed and participants will learn
when an N-of-1 trial is appropriate and how to design and conduct a
sound N-of-1 trial.