Attrition in a Multi-Component Smoking Cessation Study for Females

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Attrition in a Multi-Component Smoking Cessation Study for Females Robert F. Leeman1, Zandra N. Quiles2, Laurence A. Molinelli3, Donna Medaglia Terwal3, Beth L. Nordstrom4, Arthur J. Garvey3, Taru Kinnunen3 1

Department of Psychiatry, Yale University School of Medicine, New Haven, CT; Lehman College, City University of New York, New York, NY; 3Tobacco Dependence Treatment and Research, Harvard School of Dental Medicine, Boston, MA; 4 Ingenix Pharmaceutical Services, Newton, MA

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ABSTRACT: Limiting attrition (i.e., participant dropout before the conclusion of a study) is a major challenge faced by researchers when implementing clinical trials. Data from a smoking cessation trial for females (N = 246) were analyzed in order to identify baseline smoking-related, demographic and psychological characteristics affecting likelihood of early (i.e., before the quit attempt) and late (i.e., after the quit attempt) dropout. There were a number of significant demographic predictors of attrition. Participants with at least one child living at home were at increased risk of both early and late dropout. Non-Whites were at increased risk of early dropout, while not having a college degree put one at increased risk of late dropout. Age was found to be a protective factor in that the older a participant was, the less likely she was to drop out in the early stages of the trial. With respect to psychological variables, weight concerns increased risk of attrition, as did the experience of guilt. In terms of smoking-related variables, mean cigarettes per day was not a significant predictor of attrition, although length of longest prior quit attempt was a significant predictor of early dropout when age was removed from the regression. INTRODUCTION Participant attrition (i.e., participant dropout before the conclusion of a study) is a threat to the validity of research findings in that attrition introduces sampling bias. Attrition also hurts the cost-effectiveness of research because limited staff time and financial resources are likely to be invested in “dropouts,” who typically yield little to no useable data [1]. Recognizing the importance of attrition, researchers have begun to suggest that analyses should be conducted with completion of treatment

as an outcome variable in addition to abstinence [2 ]. Given the many contrasting and equivocal findings in the small literature on this topic, limited progress has been made up to this point in identifying the characteristics associated with attrition. In the attempt to explain rising attrition rates and the relatively low percentage of successful quit attempts in smoking cessation trials, researchers have put forth the notion that remaining smokers in the population are primarily heavily addicted, long-term users [3, 4], who are resistant to the treatments

60 Leeman R, Quilles ZN, Molinelli LA, Terwal DM, Nordstrom BL, Garvey AJ, Kinnunen T

presently available [5, 6]. Females likely comprise a high percentage of this heavily addicted, long-term population of smokers. While there is d