■与非西班牙裔白人相比,人口的痴呆症发病率更高,健康状况更差。但它们在医疗保健系统(ePCT)中的务实临床试验中的代表性严重不足。很少有指导来考虑ePCT中与卫生公平有关的问题。
■本报告描述了发展,结构,以及由国家老龄化研究所编写的指导文件的内容嵌入实用AD/ADRD临床试验(IMPACT)协作实验室,以帮助研究人员系统地评估将健康公平性纳入ePCT设计的各个方面。
■由影响调查人员组成的工作组领导,我们对临床试验中健康公平考虑的现有框架进行了文献综述.接下来,ePCT设计领域的优先健康公平相关建议由Collaboratory专家征求.提交的50项建议减少到36项不重叠的最佳做法,并分为6个领域,如下:入门,社区利益相关者参与,设计与分析,干预设计和实施,医疗保健系统和参与者选择,选择结果。每个领域都有6个最佳实践建议,包括一个简洁的主句子,有1到2个解释性句子。通过反复的编辑和修订过程,最终确定了内容。
■尽管特别关注涉及痴呆症护理的ePCT,最佳实践适用于任何ePCT,并可用于促进传统临床试验中的健康公平性.本指导文件为促进全面、将卫生公平结构化地纳入ePCT的设计和实施,这是一个良好的科学问题。
UNASSIGNED: Minoritized populations experience higher rates of dementia and worse health outcomes than non-Hispanic white people, but they are vastly underrepresented in pragmatic clinical trials embedded in health care systems (ePCTs). Little guidance is available to consider health equity-relevant issues in ePCTs.
UNASSIGNED: This report describes the development, structure, and content of a guidance document developed by the National Institute on Aging Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory to help investigators systematically assess the integration of health equity into all aspects of ePCT design.
UNASSIGNED: Led by a task force of IMPACT investigators, a literature review of existing frameworks for health equity considerations in clinical trials was conducted. Next, priority health equity-relevant recommendations in the domains of ePCT design were solicited from Collaboratory experts. The 50 submitted recommendations were reduced to 36 nonoverlapping best practices and categorized into 6 domains, as follows: Getting Started, Community Stakeholder Engagement, Design and Analysis, Intervention Design and Implementation, Health Care System and Participant Selection, and Selecting Outcomes. Each domain had 6 best practice recommendations consisting of a succinctly worded main sentence, with 1 to 2 explanatory sentences. The content was finalized through an iterative process of editing and revision.
UNASSIGNED: Although specifically focused on ePCTs involving dementia care, the best practices are applicable to any ePCT and can be useful to advance health equity in traditional clinical trials. This guidance document provides a first step toward promoting holistic, structured integration of health equity into the design and conduct of ePCTs as a matter of good science.