Modeling the Impact of Group Membership Turnover in Ecologically-Valid Treatment

描述（由申请人提供）：增加治疗研究和治疗之间的联系，因为它是在社区环境中实践的（即，生态效度）对于将最近的经验支持的方法转化为将从中受益最多的个人至关重要。最近一系列由联邦政府支持的举措侧重于通过以下方式提高生态有效性：(A)将联邦政府资助的疗效试验的发现转化为现实环境中的治疗有效性工作（特别是随着国家药物滥用临床试验网络的起源）；(b)推进定量方法，专门针对解决现实环境中治疗研究中出现的复杂性（并已抑制）。本R01申请中提出的研究结合了正在进行的临床试验网络（CTN）有效性试验的工作，该试验是针对女性共病药物滥用和创伤后应激障碍最广泛使用的治疗方法，“寻求安全”，以及持续发展，改进和扩展统计方法，以便在治疗小组成员本身因设计而随时间变化时处理来自治疗小组的数据。尽管在开发处理开放登记（也称为“滚动”）治疗小组纵向数据的方法方面取得了进展，这是社区药物滥用项目中最常见的治疗环境，但对药物滥用治疗研究的利益相关者来说，几个突出的关键问题仍未解决，这是本调查的主要方法学兴趣。这包括对小组成员更替的影响进行建模(a)长期恢复管理过程，(b)确定生态有效治疗试验中的有效成分，以及(c)治疗组（次）最佳患者组合和治疗组稳定性的测量。建议的二级数据分析调查的最终目标是为药物滥用和酒精中毒治疗研究人员提供更强大的分析和方法工具，用于(a)以更可辩护的方式分析来自公开登记组的现有数据，最大限度地避免错误推断的可能性(即，提倡一种可能在现实中无效的治疗方法)，并分析地捕获开放登记组试验的全部复杂性，和/或(b)在行为治疗研究的所有领域提交新的试验申请，其方案更接近于社区环境中的治疗。除了该项目方法学发展的实际好处（例如，更准确地推断治疗效果，更好地反映数据分析模型中的开放注册过程）之外，该应用程序还代表了进一步传播的机会，以及对迄今为止最大的随机临床试验进行更细致的检查。拟议的项目旨在开发更准确的方法来分析公开登记的药物滥用治疗试验的数据，这些试验提出了特殊的分析挑战（即，随着时间的推移，小组成员的变化）。如果我们成功地继续开发和改进新的建模工具，以解决公开登记试验中的分析复杂性，那么药物滥用治疗研究人员将定位于开发联邦资助的公开登记治疗试验，这些试验更类似于在社区环境中实施的治疗。这些发展也可能有助于为支持药物滥用和酗酒治疗研究的资助机构建立一个“社区友好”的治疗研究组合。

DESCRIPTION (provided by applicant): Increasing the connection between treatment research and treatment as it is practiced in community settings (i.e., ecological validity) is essential for translating recent empirically supported approaches to individuals who would benefit most from them. A recent series of federally supported initiatives has focused on enhancing ecological validity by (a) translating findings from federally funded efficacy trials to treatment effectiveness work in real-world settings (particularly with the genesis of the National Drug Abuse Clinical Trials Network) and (b) advancing quantitative methods specifically geared toward addressing the complexities that arise in (and have stifled) treatment research in real-world contexts. The investigation proposed in this R01 application combines work from an ongoing Clinical Trials Network (CTN) effectiveness trial on the most widely used treatment for comorbid substance abuse and PTSD available for women, Seeking Safety, with continuing development, refinement and extension of statistical approaches to handle data from therapy groups when therapy group membership itself changes over time by design. Although progress has been made in developing methods to handle longitudinal data from open-enrollment (also known as "rolling") therapy groups, the most common milieu for treatment delivery in community-based substance abuse programs, several salient critical issues to the stakeholders in substance abuse treatment research remain unresolved and are of primary methodological interest in this investigation. This includes modeling the impact of group membership turnover on (a) the long-term recovery management process, (b) the identification of the active components in ecologically valid treatment trials, and (c) (sub) optimal patient mix in treatment groups and measurement of treatment group (in) stability. The ultimate goal of the proposed secondary data analytic investigation is to place more powerful analytic and methodological tools in the hands of substance abuse and alcoholism treatment researchers for (a) analyzing existing data from open- enrollment groups in a more defensible manner, maximizing the likelihood that incorrect inferences are avoided (i.e., advocating for a treatment that may be ineffective in reality) and that the full complexities of open-enrollment group trials are captured analytically, and/or (b) submitting new applications for trials in all areas of behavioral treatment research with protocols that more closely resemble treatment in community settings. In addition to the practical benefits of the methodological development in this project (e.g., more accurate inferences concerning treatment efficacy, better reflection of the open-enrollment process in data analytic models), this application represents an opportunity for further dissemination, and a more nuanced examination of, what is to date, the largest randomized clinical trial for Seeking Safety. The proposed project seeks to develop more accurate methods to analyze data from open-enrollment substance abuse treatment trials, which present special analytic challenges (i.e., changes in group membership over time). If we are successful in continuing the development and refinement of new modeling tools to address analytic complexities in open-enrollment trials, substance abuse treatment researchers will be positioned to develop federally funded open-enrollment treatment trials that better resemble treatment as it is practiced in community settings. These developments may also facilitate building a "community-friendly" treatment research portfolio for funding agencies that supports substance abuse and alcoholism treatment research.