PDF(Pubmed)
Abstract：
BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct.
METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of \"brief reflections\" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources.
RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible.
CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct.
BACKGROUND: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .
METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of \"brief reflections\" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources.
RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible.
CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct.
BACKGROUND: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .
摘要：
背景：在研究试验中，参与式研究方法的使用正在增加。一旦与最终用户建立了伙伴关系，关于研究团队可以用来成功纳入最终用户反馈的过程的指导较少。当前的研究描述了使用简短的反思过程来系统地检查和评估最终用户反馈对研究行为的影响。
方法：在共同发生的SUD（COMPASS）研究中，创伤聚焦和非创伤聚焦治疗策略对PTSD的比较有效性是一项随机对照试验，以确定创伤为重点的心理治疗与非创伤为重点的心理治疗对退伍军人事务部内同时发生的创伤后应激障碍和物质使用障碍的退伍军人的有效性。作为对COMPASS研究参与计划的补充评估的一部分，我们开发了“简短反思”过程，并将其与我们的最终用户参与方法配对。在与三个研究参与小组就收到的有关研究问题的反馈进行会议之后，与COMPASS团队进行了30分钟的半结构化讨论。为了评估小组反馈的影响，16次反射被录音，转录，快速分析,并与其他研究数据源集成。
结果：简要反映表明，参与小组在八个方面进行了建议的更改：加强招募；完成研究评估；在研究协调员之间建立统一性；建立与退伍军人参与者的研究协调员联系；研究程序与临床实践之间的不匹配；与使用活性物质的患者的治疗师技能；治疗师倦怠；以及研究结果的传播。一些建议对研究行为产生积极影响，而另一些则影响不一。反思是迭代的，并导致了紧急过程，包括重新审视先前讨论的主题，跨面板的想法交叉授粉，当小组没有提出任何建议或建议时，在小组中引发解决方案是不可行的。
结论：当与最终用户参与方法配对时，简短的反思可以促进对最终用户输入的系统检查，特别是当接触策略稳健时。反思为研究人员提供了一个问责论坛，让他们仔细考虑最终用户的建议，并及时改进研究行为。反思还可以促进对这些建议的评估，并揭示可以有效改善研究行为的最终用户驱动的策略。
背景：ClinicalTrials.gov（NCT04581434），2020年10月9日；https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1。
方法：在共同发生的SUD（COMPASS）研究中，创伤聚焦和非创伤聚焦治疗策略对PTSD的比较有效性是一项随机对照试验，以确定创伤为重点的心理治疗与非创伤为重点的心理治疗对退伍军人事务部内同时发生的创伤后应激障碍和物质使用障碍的退伍军人的有效性。作为对COMPASS研究参与计划的补充评估的一部分，我们开发了“简短反思”过程，并将其与我们的最终用户参与方法配对。在与三个研究参与小组就收到的有关研究问题的反馈进行会议之后，与COMPASS团队进行了30分钟的半结构化讨论。为了评估小组反馈的影响，16次反射被录音，转录，快速分析,并与其他研究数据源集成。
结果：简要反映表明，参与小组在八个方面进行了建议的更改：加强招募；完成研究评估；在研究协调员之间建立统一性；建立与退伍军人参与者的研究协调员联系；研究程序与临床实践之间的不匹配；与使用活性物质的患者的治疗师技能；治疗师倦怠；以及研究结果的传播。一些建议对研究行为产生积极影响，而另一些则影响不一。反思是迭代的，并导致了紧急过程，包括重新审视先前讨论的主题，跨面板的想法交叉授粉，当小组没有提出任何建议或建议时，在小组中引发解决方案是不可行的。
结论：当与最终用户参与方法配对时，简短的反思可以促进对最终用户输入的系统检查，特别是当接触策略稳健时。反思为研究人员提供了一个问责论坛，让他们仔细考虑最终用户的建议，并及时改进研究行为。反思还可以促进对这些建议的评估，并揭示可以有效改善研究行为的最终用户驱动的策略。
背景：ClinicalTrials.gov（NCT04581434），2020年10月9日；https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1。
