This investigation represents the first trial of tobacco cessation treatment among adult female Appalachians using the recommendations from the U. S. Public Health Service Clinical Practice Guideline [7
]. To date, few controlled trials of evidence-based tobacco treatment exist among Appalachian populations. Findings from this study indicated that intensive treatment that included free nicotine replacement therapy and a nurse-managed lay-led counseling was effective in promoting point-prevalence abstinence at three and six months post-enrollment, but was not sufficient to maintain longer term abstinence (i.e. 12 month), as compared to control group participants. Abstinence rates at all time points were lower than the estimated 6-month quit rate of 23.4% observed in recent meta-analytic studies [7
]. These results demonstrate the persistent and threatening nature of tobacco dependence in a group of women at high risk for tobacco-attributable disease. Given the increased risk for tobacco use prevalence and morbidity and mortality estimates among residents of the Appalachian region, additional tobacco control efforts are critically needed. It may be necessary to extend pharmacotherapy and counseling beyond current treatment recommendations to sustain cessation and manage relapse-related events.
The sample characteristics of women smokers enrolled in this study were representative of the general population of smokers, with the exception of education [31
]. In the current study, the majority of women had more than a high school education. This finding may be indicative of the decision to use a clinic-based recruitment strategy and enroll women who actively sought health care services in the past two years. On the other hand, the women participants shared many other relevant social factors with current U.S. smokers. The sample, while mostly employed, was primarily composed of blue-collar laborers, living on limited incomes, as noted by the reported low PIR. The lifecourse socioeconomic position of most participants indicated that the majority lived a disadvantaged childhood, which is the critical period for adoption of a smoking behavior [32
]. Of note, approximately one-half of the sample demonstrated depressive symptomatology, as demonstrated by their CES-D scores. This finding may partially explain the resumption of smoking in an attempt to perhaps manage and self-medicate during depressive episodes. Indeed, increased daily tobacco consumption and depressive symptoms accounted for the decreased likelihood of being categorized as abstinent at 12 months, based on the logistic regression analyses. In future studies, the role of depression should be addressed, especially in clinic-based trials, where the disorder can be appropriately managed by a health care provider. Similarly, the interaction between depression and the social environment deserves additional examination, as disadvantage and lifecourse SEP, in the context of an Appalachian culture where tobacco use is socially acceptable, may influence long term cessation outcomes.
Interestingly, a significant portion of intervention group participants underreported post-treatment tobacco use, based on biochemical validation. At three months, approximately 1/3 of self-reported intervention group abstainers were subsequently classified as smokers, when cotinine validation was performed. As previously reported, when demand for abstinence is high, misclassification is more likely to occur [28
]. Given the close, interpersonal nature of a lay-led intervention, underreporting by the participant (even to a trained interviewer who was not directly involved with the intervention) may operate to a greater extent. Thus, consideration should be given to using biochemical confirmation as an outcome measure of abstinence in these types of community-based cessation approaches. This recommendation is consistent with the Society for Research on Nicotine and Tobacco’s position on biochemical verification of tobacco use and cessation [33
]. Demand characteristics may also partially explain the significantly higher attrition rates at three and six month follow-up for intervention group participants, as compared to control condition participants.
With regard to control group participants, the initial quit rates were minimal, which was to be expected, given the self-help approach to treatment [7
] and the format that required the participant to initiate assistance from the clinic provider. However, the increased use of cessation resources and pharmacotherapy over time, accompanied by increased quit rates over the 12 month follow up period, suggest that control condition women were motivated to seek assistance with quitting. For example, at the time this study was conducted, the Ohio Quitline (with access to nicotine replacement therapy at reduced prices) was promoted in a variety of media outlets, including television. Control condition women may have been more inclined to seek resources, as compared to intervention participants who had already been offered pharmacotherapy during the protocol.
Given the increased prevalence of tobacco use in Appalachian counties, which is coupled with the loss of Ohio Master Settlement Funds that, in the past, supported state-wide tobacco treatment for the underserved, 3
clinicians must now accelerate efforts to deliver treatment at point of access. Creative tobacco control efforts must be considered if high risk, vulnerable populations such as these are to be reached. The current study represents an important first step in developing and evaluating a lay-led approach to the delivery of evidence-based treatment among a high-risk vulnerable group [7
Finally, experts have warned that the increasing disparity in prevalence of tobacco use between privileged and disadvantaged groups must be acknowledged [7
]. Public health initiatives have yet to significantly influence tobacco use among poor smokers and it has been suggested that unless the overall life circumstances of deprived groups are improved, future health promotion efforts will not succeed [34
]. Given this perspective, researchers, clinicians and policymakers must continue to broadly develop and test potentially efficacious mechanisms to reduce the present inequality in tobacco use prevalence and cessation.