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Nicotine & Tobacco Research Advance Access published online on April 3, 2009
Nicotine & Tobacco Research, doi:10.1093/ntr/ntp035
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© The Author 2009. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: Floating prolonged abstinence

Paul Aveyard, Dechao Wang, Martin Connock, Anne Fry-Smith, Pelham Barton and David Moore

Paul Aveyard, M.D., Ph.D., School of Population and Health Sciences Medical School, University of Birmingham, Birmingham, UK
Dechao Wang, Ph.D., School of Population and Health Sciences Medical School, University of Birmingham, Birmingham, UK
Martin Connock, Ph.D., School of Population and Health Sciences Medical School, University of Birmingham, Birmingham, UK
Anne Fry-Smith, B.A., School of Population and Health Sciences Medical School, University of Birmingham, Birmingham, UK
Pelham Barton, Ph.D., School of Population and Health Sciences Medical School, University of Birmingham, Birmingham, UK
David Moore, Ph.D., School of Population and Health Sciences Medical School, University of Birmingham, Birmingham, UK

Corresponding Author: Paul Aveyard, Ph.D., School of Population and Health Sciences Medical School, University of Birmingham, Birmingham B15 2TT, UK. Telephone: +44 (0)121 414 8529; Fax: +44 (0)121 414 6571; E-mail: p.n.aveyard{at}bham.ac.uk


  Abstract

Introduction: A Society for Research on Nicotine and Tobacco working group recommended outcome measures for cessation-induction trials and aid-to-cessation trials. Cessation-induction trials aim to motivate unwilling quitters to make a quit attempt. Aid-to-cessation trials give either medication or behavioral interventions to increase the rate at which willing quitters succeed in their attempts. Nicotine-assisted reduction programs combine features of both types of interventions by giving nicotine replacement to unwilling quitters. Treatment can be prolonged more than a year, quit attempts can occur and succeed early or late in the program, and renewed quit attempts are an inherent part of the program. Conventional outcome measures are tied to a fixed but arbitrary point in follow-up and cannot capture the true outcome: Prolonged cessation anchored to the point at which a person makes a successful quit attempt.

Discussion: We propose that the outcome should be counted from the successful quit attempt that began during the treatment period and continues for a defined period, ideally 6 months. In particular, if a trial compared a short reduction program with a long reduction program, it would not be possible to obtain an unbiased assessment of the outcome of such a trial using a measure tied to a fixed point in follow-up. Floating prolonged abstinence could provide such an assessment and is suitable for either prolonged cessation-induction trial or combined cessation-induction and aid-to-cessation trials.

Received: June 7, 2008; Accepted: January 12, 2009
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