开发一个基于实际经验的小组，为痴呆症护理干预措施的嵌入式实用临床试验设计提供信息。

Development of a Lived Experience Panel to inform the design of embedded pragmatic trials of dementia care interventions.

机构信息

Department of Health Policy and Management, University of North Carolina, Chapel Hill, North Carolina, USA.

Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.

出版信息

J Am Geriatr Soc. 2024 Jan;72(1):139-148. doi: 10.1111/jgs.18621. Epub 2023 Oct 3.

DOI:10.1111/jgs.18621

PMID:37787414

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10841055/

Abstract

BACKGROUND

The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's Disease and Alzheimer's Related Dementia Clinical Trials (IMPACT) Collaboratory convened a Lived Experience Panel (LEP) to inform the development of research priorities and provide input on conducting embedded pragmatic clinical trials (ePCTs) of dementia care interventions. Given the importance of people with lived experience to dementia research, and the unique considerations of engaging people with dementia, we report on our process for the recruitment, selection, and initial convening of the IMPACT LEP.

METHODS

The IMPACT Engaging Partners Team, in partnership with the Alzheimer's Association, sought nominations of individuals with mild cognitive impairment or early-stage dementia, care partners of other people living with dementia (PLWD), and proxy representatives for individuals with mid-to-late stage dementia. The 11-member LEP was composed of individuals with diverse personal experiences in part due to their age, race, ethnicity, gender, sexual orientation, geography, disability, or type of dementia. In its first year, the LEP met with IMPACT's Patient and Caregiver Relevant Outcomes Core and Ethics and Regulation Core.

RESULTS

LEP members provided valuable insights and nuanced discussion of issues relevant to ePCTs in dementia care from a broad range of personal experience. Panelists identified key research priorities and provided insight on outcomes often studied by researchers. The LEP also informed investigators' approaches to waivers and modifications of written informed consent and evaluation of minimal risk. Summary reports of the LEP meetings with each Core are available on the IMPACT website. At the end of the first year, changes were made to the composition of the LEP, and opportunities were identified for expanding panelist engagement with IMPACT investigators, as were priorities and scope for future input.

CONCLUSIONS

The IMPACT LEP provides a model for engaging PLWD and care partners in the research process as collaborators.

摘要

背景

美国国家老龄化研究所（NIA）嵌入式务实阿尔茨海默病和阿尔茨海默病相关痴呆症临床试验（IMPACT）协作组召集了一个生活经验小组（LEP），为制定研究重点提供信息，并就嵌入式务实临床试验（ePCT）痴呆症护理干预措施提供投入。鉴于具有生活经验的人对痴呆症研究的重要性，以及参与痴呆症患者的独特考虑，我们报告了我们招募、选择和初步召集 IMPACT LEP 的过程。

方法

IMPACT 参与合作伙伴团队与阿尔茨海默病协会合作，寻求轻度认知障碍或早期痴呆症患者、其他痴呆症患者的护理伙伴以及中晚期痴呆症患者的代理代表的提名。11 名成员的 LEP 由个人组成，他们的个人经历各不相同，部分原因是他们的年龄、种族、族裔、性别、性取向、地理位置、残疾或痴呆症类型。在第一年，LEP 与 IMPACT 的患者和护理人员相关结果核心以及伦理和法规核心进行了会晤。

结果

LEP 成员从广泛的个人经验出发，就痴呆症护理中的 ePCT 相关问题提供了宝贵的见解和细致入微的讨论。小组成员确定了关键的研究重点，并就研究人员经常研究的结果提供了见解。LEP 还为研究人员在豁免和修改书面知情同意书以及评估最低风险方面提供了信息。LEP 与每个核心的会议总结报告均可在 IMPACT 网站上查阅。在第一年结束时，对 LEP 的组成进行了修改，并确定了扩大小组成员与 IMPACT 研究人员合作的机会，以及未来投入的优先事项和范围。