JSM Preliminary Online Program
This is the preliminary program for the 2008 Joint Statistical Meetings in Denver, Colorado.

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Activity Number: 233
Type: Contributed
Date/Time: Tuesday, August 5, 2008 : 8:30 AM to 10:20 AM
Sponsor: Section on Health Policy Statistics
Abstract - #300517
Title: Using a Yardstick Approach To Enrich Understanding of Treatment Effect on Urge To Smoke: An Application to a Smoking Cessation Trial
Author(s): Joseph C. Cappelleri*+ and Andrew G. Bushmakin and Riad Dirani
Companies: Pfizer, Inc. and Pfizer, Inc. and Johnson & Johnson Pharmaceutical R&D, LLC
Address: 50 Pequot Avenue, New London, CT, 06320,
Keywords: effect size ; clinical significance ; patient-reported outcome ; urge to smoke ; smoking cessation ; varenicline
Abstract:

We illustrate a way to enrich the interpretation of treatment effect on patient-reported outcomes. The study involved 1,025 smokers randomized to receive varenicline, bupropion, or placebo for 12 weeks. Urge to smoke, a patient-reported outcome, was measured by the Minnesota Nicotine Withdrawal Scale (MNWS). We divided the treatment effect size (difference between treatments on urge to smoke averaged over the first 7 weeks of treatment) by the criterion effect size (difference between non-smokers and smokers on urge to smoke at week 12 in the placebo group). Compared with placebo, varenicline reduced urge to smoke on MNWS that was about six-tenths of the way found between non-smokers and smokers. By benchmarking against two distinct clinical groups, the interpretation of treatment effect on patient-reported outcomes can be enriched.


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Revised September, 2008