This is a randomized controlled trial involving smoking OEF/OIF veterans that compares smoking cessation in those receiving web based intervention vs those receiving usual care. Evaluation: Importance of Problem Addressed A convincing argument is made that smoking is high in these young veterans and that smoking leads to important morbidity and mortality. Contribution to the VHA If the intervention is successful in reducing smoking an alternative to specialized smoking clinics can be offered that might be less labor intensive. Adequacy of Response to Previous Feedback The response to the 5 major previous SMRB's concerns are adequate. Pilot data is now provided about veterans being able to use web based intervention. More detail about recruitment, stratification and blocked randomization is provided. They now provide data about the assumptions of their power calculations. Specifically, they estimate that reach and efficacy for the control group receiving specialty clinic care is 16% and 25% respectively- thus 7 of 175 control patients will quit (4% overall). For the intervention group they estimate that 52% will access the web based intervention and the efficacy will be 30% thus 27 out of 175 in the intervention group will quit (15.6%). They state that they will be able to detect this 11.6% difference since they have 80% power to detect a 10% difference in smoking cessation. Methods a. Study design: Will use rigorous rct design. b. Approach: The study group will use logistic regression and GEE (ITT) for the main analyses. Standard CE analyses to be performed. Dissemination plans have been expanded with 3 new consultants and 1 new co-investigator from the MIRECC. c. Theoretical Model: The investigative team provides more detail about a model based on social ecological theory (RE-AIM). They also introduce a new complementary cognitive-behavioral model. d. Population and sampling: Subjects will be derived from the Durham VAMC and the pool of eligibles should be sufficient. e. Statistical Power: Seems adequate if assumptions are correct and smoking specialty clinic use is as low as seen in typical primary care patients. f. Key Variables and their Measurement: Outcomes include self reported quit rates, saliva cotine and Qualys. Information about the sensitivity/specificity of saliva vs blood testing and the expected CV for cotine saliva test at Duke University Nicotine Research Program is now provided. They will rerun a blind sample of 5% to assure test accuracy. Letter of support from the Duke Lab and QUITNET are now provided. Limited detail about nicotine replacement protocol is now provided as an Appendix. g. Data analysis plan: Very well written. Power now better addressed but Table 4 was missing. h. Data Collection Issues: Very well described. i. Definition and feasibility of any intervention: No concerns. j. Recognition of methodological issues: They have addressed potential threats to internal validity. Adequacy of Data. The study group has previous experience with collecting such data. Project Organization and Management Still no organizational chart is provided. PI's to meet weekly with staff and monthly with co-investigators. Three new consultants and 1 new co-investigator added. Timeline is detailed monthly. Investigator Qualifications The PI Dr Calhoun is an assistant professor of psychiatry. He lists 32 published peer reviews research publications since 1999. Dr Bastion is an associate professor of general internal medicine and is a well known and respected researcher in the area of tobacco control. The inclusion of both a biostats person and health economist is notable. Human Subjects The investigators are aware of needing to get patient consent for the study. Inclusion of Women and Minorities There are no formal exclusion criteria for these populations. Now estimates are provided about expected recruitment rates for these groups Facilities and Resources The Durham VA MIRECC and HSRD centers have sufficient resources to support this project. Budget The budget overall is within defined limits. Overall Strengths Innovative new approach to address major problem of smoking in young veterans. Strong experienced study team Overall Weaknesses None. Key Issues (Summary Bullets) * Adequate response to previous concerns * Strong design and measurement * Analysis and power well described
Veterans returning from Iraq and Afghanistan are smoking at high rates and are at elevated risk for the development of smoking related illness. Smoking is the most preventable cause of morbidity and mortality in veterans and is associated with an enormous economic burden. Current evidence suggests a significant underutilization of smoking cessation treatment and use of smoking cessation aids within VHA. Effective smoking cessation programs that target returning veterans and increase reach over existing approaches are needed. The goal of the study is to evaluate the impact of an internet-based intervention in comparison to standard VA speciality clinic-based care in promoting smoking cessation in returning veterans.