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

描述(由申请人提供)：在社区环境中加强治疗研究和治疗之间的联系(即生态有效性)，对于将最近得到经验支持的方法转化为将从这些方法中受益最大的个人至关重要。最近一系列得到联邦支持的倡议侧重于通过以下方式提高生态有效性：(A)将联邦资助的疗效试验的结果转化为现实世界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建立)，以及(B)推进量化方法，专门用于解决现实世界背景下治疗研究中出现(并已被扼杀)的复杂性。在这份R01申请中提议的调查结合了正在进行的临床试验网络(CTN)有效性试验的工作，该试验针对女性可用的最广泛的共病药物滥用和创伤后应激障碍的治疗，寻求安全，并在治疗小组成员本身随着时间的推移而设计发生变化时，继续开发、完善和扩展统计方法，以处理来自治疗小组的数据。尽管在开发方法来处理来自开放登记(也被称为“滚动”)治疗组的纵向数据方面取得了进展，但对于药物滥用治疗研究中的利益相关者来说，几个突出的关键问题仍然没有得到解决，并且在这项调查中具有主要的方法学意义。这包括模拟小组成员更替对(A)长期康复管理过程的影响，(B)在生态有效的治疗试验中确定有效成分，以及(C)(次)治疗组中的最佳患者组合和治疗组稳定性的测量。拟议的二级数据分析调查的最终目标是将更强大的分析和方法学工具交到药物滥用和酒精中毒治疗研究人员手中，用于(A)以更有说服力的方式分析来自公开登记小组的现有数据，最大限度地避免错误推断的可能性(即，倡导一种可能在现实中无效的治疗方法)，并以分析的方式捕捉开放登记小组试验的全部复杂性，和/或(B)提交新的申请，用于行为治疗研究的所有领域，其方案更接近社区环境中的治疗。除了该项目中方法学发展的实际好处(例如，关于治疗有效性的更准确的推断，在数据分析模型中更好地反映开放登记过程)，这项应用代表着进一步传播的机会，以及对迄今为止最大的寻求安全的随机临床试验的更细微的检查。拟议的项目寻求开发更准确的方法来分析来自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，小组成员随时间的变化)。如果我们成功地继续开发和改进新的建模工具，以解决开放注册试验中的分析复杂性，药物滥用治疗研究人员将能够开发联邦资助的开放注册治疗试验，更类似于社区环境中的治疗。这些进展还可能有助于为资助机构建立一个“社区友好”的治疗研究组合，以支持药物滥用和酒精中毒治疗研究。

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.