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Combining single patient (N-of-1) trials to estimate population treatment effects & to evaluate individual patient responses to treatment

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By Zucker DR, Schmid CH, McIntosh MW, D'Agostino RB, Selker HP, Lau J • www.ProHealth.com • April 10, 1997


When treating individual patients, physicians may face difficulties
using the evidence from center-based randomized control trials
(RCTs) due to limitations in these studies generalizability.
Therefore, they often perform their own "informal" tests of
treatment effectiveness. Single patient ("N-of-1") trials
provide a structured design for more rigorous assessment of
medical treatments of chronic diseases, but are applied only
to the index patient. We present a hierarchical Bayesian
random effects model to combine N-of-1 studies to obtain an
estimate of treatment effectiveness for the population and to
use this population information to aid in the evaluation of an
individual patient's trial results. The model's treatment
effect estimates are adjustments between the population
estimate and the individual's observed results. This
adjustment is based upon the within-patient and
between-patient heterogeneity. We demonstrate this
patient-focused method using published data from 23 N-of-1
trial results comparing amitriptyline and placebo for the
treatment of fibromyalgia.




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