Gabb Victoria Grace, Harding Sam, McNair Angus G K, Clayton Julie, Barrett-Muir Winsome, Richardson Alan, Woodward Natalie, Alderman Sophie, Dooley Jemima, Webb Joseph, Rudd Sarah, Coulthard Elizabeth, Turner Nicholas
ReMemBr Group, Bristol Medical School, University of Bristol, Bristol, UK
Mental Health, NIHR Bristol Biomedical Research Centre, Bristol, UK.
BMJ Open. 2025 Jan 20;15(1):e090818. doi: 10.1136/bmjopen-2024-090818.
There is no standardised national guidance on clinical management for people living with mild cognitive impairment (MCI), and therapeutic interventions are limited. Understanding what outcomes are important and meaningful to people living with MCI and developing a core outcome set (COS) for research and clinical practice will improve the impact of clinical research and contribute towards developing effective care pathways for MCI. This study aims to develop a COS for adults living with MCI intended for use in interventional and clinical settings.
The COS will be developed using a five-stage study design: (1) systematic literature search, (2) qualitative interviews, (3) evidence synthesis from stages 1 and 2, (4) two-round Delphi survey and (5) consensus meeting(s). First, we will conduct an umbrella review of existing MCI interventional studies and extract a list of outcomes. Qualitative interviews will be held with key stakeholders including individuals living with MCI, friends and family, and relevant professionals to identify further outcomes considered important. Outcomes from the review and interviews will be synthesised into a 'long list' of outcomes for potential inclusion in the COS. Two rounds of Delphi surveys followed by a consensus meeting will be used to reach stakeholder consensus on which outcomes should be included in the final COS.
We have received ethical approval from the London-Queen Square Research Ethics Committee (23/PR/1580). Patient and public involvement and engagement are central to developing the COS. The results will be disseminated via conferences, peer-reviewed publications, briefing notes to key agencies, to the public via social media and blog posts and directly to stakeholders who participate in the project.
Core Outcome Measures in Effectiveness Trials Initiative 2117; PROSPERO registration: CRD42023452514.
对于轻度认知障碍（MCI）患者，目前尚无标准化的国家临床管理指南，且治疗干预措施有限。了解哪些结果对MCI患者重要且有意义，并为研究和临床实践制定核心结局集（COS），将提高临床研究的影响力，并有助于为MCI制定有效的护理路径。本研究旨在为成年MCI患者制定一个用于干预和临床环境的COS。
COS将采用五阶段研究设计来制定：（1）系统文献检索，（2）定性访谈，（3）第1和第2阶段的证据综合，（4）两轮德尔菲调查，（5）共识会议。首先，我们将对现有的MCI干预研究进行系统回顾，并提取一份结局清单。将与包括MCI患者、朋友和家人以及相关专业人员在内的关键利益相关者进行定性访谈，以确定其他被认为重要的结局。文献回顾和访谈的结果将综合成一份可能纳入COS的结局“长清单”。两轮德尔菲调查之后召开共识会议，以就哪些结局应纳入最终的COS达成利益相关者共识。
我们已获得伦敦女王广场研究伦理委员会的伦理批准（23/PR/1580）。患者和公众的参与对于制定COS至关重要。研究结果将通过会议、同行评审出版物、向关键机构提供简报、通过社交媒体和博客文章向公众传播，并直接传达给参与该项目的利益相关者。
有效性试验倡议中的核心结局指标2117；PROSPERO注册号：CRD42023452514。
