Rather, our intent was to evaluate the effect of the GF on our outcomes of interest. All activities were reviewed and approved by the Institutional Review Boards at Group Health Cooperative (GHC; protocol ID HS-09-040), Stanford University (protocol ID 16513), and SRI International (DHHS Registration/ID No. IRB00000110 and Assurance No. FWA00007933). http://www.selleckchem.com/products/nutlin-3a.html Study Population and Recruitment: Phases 1 and 2 All Phase 1 and Phase 2 participants were recruited from GHC, a large, regional not-for-profit health plan in the Pacific Northwest. Potential participants were identified based on electronic health records (Phases 1 and 2) and a subset of participants in a previous smoking cessation study (Phase 2; Swan et al., 2010), who had been previously genotyped and provided consent to be recontacted.
Potential participants were mailed an invitation letter, contacted by phone, and screened for eligibility. Additional screening and enrollment details are described below. Phase 1 Methods Phase 1A: Expert Opinion Panel We convened a panel of doctorate-level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal, and social implications of genetics research; genetic literacy; patient�Cclinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF, and evaluation. The panel recommended that participants receive supplemental written materials addressing the following topics: the role of genes in medication outcomes and side effects, the role of genes in nicotine dependence, the implications of one��s ANKK1 genotype (A1 vs.
A2) on pharmacotherapy selection (NRT vs. bupropion), and the rationale for genetically matching pharmacotherapy selection based Carfilzomib on enhanced treatment outcomes. It was recommended that materials be kept brief and written in plain language. The panel further advised that phone-based counseling was a reasonable treatment approach and was consistent with the standard care quitline counseling offered to health plan members through their insurance coverage. Despite the limitations of our current knowledge base, it was recommended that the role of genetics in treatment outcome not be downplayed too much, as this could diminish GF participants�� confidence in quitting. This advice informed the design of the pilot study educational materials and treatment protocol. Material design was also influenced by an earlier, transdisciplinary conference of physicians, clinical geneticists, genetic counselors, genetic epidemiologists, and others convened by the National Cancer Institute (NCI) and the National Human Genome Research Institute to educate primary care physicians how to translate genetic technology to medical education and practice (David & Gramling, 2003).