Kelleher Bridgette L
Purdue University.
Res Sq. 2024 Aug 27:rs.3.rs-4790564. doi: 10.21203/rs.3.rs-4790564/v1.
Integrating patient and community input is essential to the relevance and impact of patient-focused research. However, specific techniques for generating patient and community-informed research decisions remain limited. Here, we describes a novel CASCADE method (Community-Engaged Approach for Scientific Collaborations and Decisions) that was developed and implemented to make actionable, patient-centered research decisions during a federally funded clinical trial.
The CASCADE approach includes 7 key pillars: (1) identifying a shared, specific, and actionable goal; (2) centering community input; (3) integrating both pre-registered statistical analyses and exploratory "quests"; (4) fixed-pace scheduling, supported by technology; (5) minimizing opportunities for cognitive biases typical to group decision making; (6) centering diversity experiences and perspectives, including those of individual patients; (7) making decisions that are community-relevant, rigorous, and feasible. Here, we implemented these pillars within a three-day CASCADE panel, attended by diverse members of a research project team that included community interest-holders. The goal of our panel was to identify ways to improve an algorithm for matching patients to specific types of telehealth programs within an active, federally funded clinical trial.
The CASCADE panel was attended by 27 participants, including 5 community interest-holders. Data reviewed to generate hypotheses and make decisions included (1) pre-registered statistical analyses, (2) results of 12 "quests" that were launched during the panel to answer specific panelist questions via exploratory analyses or literature review, (3) qualitative and quantitative patient input, and (4) team member input, including by staff who represented the target patient population for the clinical trial. Panel procedures resulted in the generation of 18 initial and 12 final hypotheses, which were translated to 19 decisional changes.
The CASCADE approach was an effective procedure for rapidly, efficiently making patient-centered decisions during an ongoing, federally funded clinical trial. Opportunities for further development will include exploring best-practice structural procedures, enhancing greater opportunities for pre-panel input by community interest-holders, and determining how to best standardize CASCADE outputs.
The CASCADE procedure was developed in the context of NCT05999448.
整合患者和社区的意见对于以患者为中心的研究的相关性和影响力至关重要。然而，用于做出基于患者和社区信息的研究决策的具体技术仍然有限。在此，我们描述了一种新颖的级联方法（社区参与科学合作与决策方法），该方法是为在一项由联邦政府资助的临床试验中做出可操作的、以患者为中心的研究决策而开发和实施的。
级联方法包括7个关键支柱：（1）确定一个共同的、具体的且可操作的目标；（2）以社区意见为核心；（3）整合预先注册的统计分析和探索性“探索”；（4）由技术支持的固定节奏安排；（5）尽量减少群体决策中典型的认知偏差机会；（6）以包括个体患者在内的多样性经历和观点为核心；（7）做出与社区相关、严谨且可行的决策。在此，我们在一个为期三天的级联小组中实施了这些支柱，该小组由一个研究项目团队的不同成员参加，其中包括社区利益相关者。我们小组的目标是确定在一项正在进行的、由联邦政府资助的临床试验中改进将患者与特定类型远程医疗项目匹配的算法的方法。
27名参与者参加了级联小组，其中包括5名社区利益相关者。为生成假设和做出决策而审查的数据包括：（1）预先注册的统计分析；（2）在小组期间发起的12项“探索”的结果，这些“探索”通过探索性分析或文献综述来回答小组成员的特定问题；（3）定性和定量的患者意见；（4）团队成员的意见，包括代表该临床试验目标患者群体的工作人员的意见。小组程序产生了18个初始假设和12个最终假设，这些假设转化为19项决策变更。
级联方法是在一项正在进行的、由联邦政府资助的临床试验中快速、有效地做出以患者为中心决策的有效程序。进一步发展的机会将包括探索最佳实践结构程序、增加社区利益相关者在小组前提供意见的更多机会，以及确定如何最好地规范级联产出。
级联程序是在NCT05999448的背景下开发的。
