title: Design strategy for a smoking cessation trial of survival.
abstract: Despite unequivocal evidence that smoking cessation is beneficial in terms of survival, there is at present no firm evidence that smoking cessation programs save lives. While they do increase quit rates, the collective evidence from randomized trials is inconclusive with respect to long-term survival. Withdrawal symptoms and the potential for harm when a subjects relapses after a prolonged period of cessation (e.g., 5+ years) might mitigate some or all of the benefits of the sustained quitters. This paper will review the key survival epidemiology and argue for a large randomized field trial of about 30,000 subjects, followed personally for 5 years and collectively for 15 years through the National Death Index. The intervention should be personalized, but reproducible through a treatment assignment algorithm. Personal coaching should be a major part of the intervention. Important short-term data on healthcare utilization should also be collected. Strong financial motivation for quitting (or prevention of smoking in the first place) is also presented. This paper is intended to motivate a large collective effort amongst the US Clinical and Translational Science Awardees to design the intervention and bring together the interested players to conduct the study.
authors.affiliation: Department of Health Outcomes and Policy, University of Florida, Gainesville, Florida, USA.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Shuster
mesh_terms: D000368:Aged; D000465:Algorithms; D006801:Humans; D008875:Middle Aged; D009042:Motivation; D009538:Nicotine / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012107:Research Design; D012907:Smoking; D016540:Smoking Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000401:mortality* / Q000628:therapy*; D057170:Translational Research, Biomedical; D016896:Treatment Outcome; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D009538:Nicotine
keywords: nicotine; personal coach; smoking; smoking relapse