Internet-Based Smoking Cessation for OEF/OIF Veterans

描述： 这是一项随机对照试验，涉及吸烟的OEF/OIF退伍军人，比较了接受网络干预的戒烟人员和接受常规护理的戒烟人员。 评估： 解决问题的重要性 一个令人信服的论点是，这些年轻退伍军人中吸烟的比例很高，吸烟会导致重要的发病率和死亡率。 对VHA的贡献 如果干预措施在减少吸烟方面取得成功，可以提供一种可能不那么劳动密集型的专门吸烟诊所的替代方案。 对先前反馈的反应是否充分 对SMRB之前的5个主要关切的回应是足够的。现在提供了关于退伍军人能够使用基于网络的干预的试点数据。提供了关于招募、分层和分组随机化的更多细节。他们现在提供了有关电力计算假设的数据。具体地说，他们估计接受专门诊所护理的对照组的覆盖率和有效性分别为16%和25%-因此175名对照组患者中有7人将退出(总体为4%)。对于干预组，他们估计52%的人将访问基于网络的干预，有效性将为30%，因此，干预组175人中有27人将退出(15.6%)。他们声称，他们将能够检测到11.6%的差异，因为他们有80%的能力来检测10%的戒烟差异。 方法 A.研究设计： 将采用严格的随机对照试验设计。 B.方法： 研究小组将使用Logistic回归和GEE(ITT)进行主要分析。要执行的标准CE分析。扩大了传播计划，增加了3名新的顾问和1名来自MIRECC的新的合作调查员。 C.理论模型： 调查小组提供了基于社会生态理论的模型(RE-AIM)的更多细节。他们还引入了一种新的补充认知-行为模型。 D.人口和抽样： 科目将从Durham VAMC派生，符合条件的人员池应该足够。 E.统计权力： 如果假设是正确的，并且吸烟专科诊所的使用量与典型的初级保健患者一样低，似乎就足够了。 F.关键变量及其测量： 结果包括自我报告的戒烟率、唾液可卡因和Qualys。 现提供杜克大学尼古丁研究项目唾液与血液检测的敏感性/特异性以及棉花唾液检测的预期变异系数的信息。他们将重新进行5%的盲样测试，以确保测试的准确性。 现提供杜克实验室和QuitNet的支持函。 关于尼古丁替代方案的有限细节现作为附录提供。 G.数据分析计划： 写得很好。电源现在得到了更好的解决，但表4丢失了。 H.数据收集问题： 描述得很好。 I.任何干预措施的定义和可行性： 不用担心。 J.认识到方法学问题： 他们已经解决了对内部有效性的潜在威胁。 数据的充分性。 研究小组以前有过收集此类数据的经验。 项目组织与管理 但仍未提供组织结构图。PI每周与工作人员会面，每月与协查人员会面。增加了三名新的顾问和一名新的合作调查员。时间表是每月详细的。 调查员资格 卡霍恩博士是精神病学的助理教授。他列举了自1999年以来发表的32种同行评议研究出版物。Bastion博士是普通内科副教授，在烟草控制领域是一位知名和受人尊敬的研究员。值得注意的是，生物统计学家和健康经济学家都被包括在内。 人类受试者 研究人员意识到，这项研究需要征得患者的同意。 包容妇女和少数群体 对于这些人口，没有正式的排斥标准。现在提供了对这些群体的预期招聘率的估计 设施和资源 达勒姆、VA、MIRECC和HSRD中心有足够的资源支持这一项目。 预算 总体而言，预算在规定的范围内。 综合实力 创新的新方法，解决年轻退伍军人吸烟的主要问题。 强大的经验丰富的学习团队 整体上的弱点 没有。 关键问题(摘要项目符号) *对之前的担忧做出了足够的回应 *强大的设计和测量能力 *分析和功率描述得很好

Description: 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