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Activity Number: 233
Type: Contributed
Date/Time: Monday, August 3, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305377
Title: Efficacy with a Diamond Response Design
Author(s): Charlie H. Goldsmith*+
Companies: McMaster University
Address: Biostatistics Unit, Martha H 322, Hamilton, ON, L8N 4A6, Canada
Keywords: Occupational therapy ; breathing retraining ; cross-over ; efficacy ; two periods ; experimental design
Abstract:

Therapy efficacy is usually measured with a 2 group design where one group receives a new therapy and the other group gets a placebo. A diamond response design gives all consenting patients both the new therapy (T) as well as the placebo (P); however the randomization is to the 2 orders: T in the first period and P in the second (TP) as well as P in the first period and T in the second (PT). With common follow-up time in each period, outcome measurements at baseline, and the end of each period, efficacy can be estimated, the delay of period can be estimated, and the possible deterioration from the therapy benefit can be estimated. Plots of response means look like diamonds. This design will be illustrated with a trial on the effect of occupational therapy on rheumatoid arthritis patients and a planned trial on the effect of breathing retraining on patients with low back pain.


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