Developing a core outcome set for interventions in people with mild cognitive impairment: study protocol
Authors: Gabb Victoria Grace , Harding Sam , McNair Angus , Clayton Julie , Barrett-Muir Winsome , Richardson Alan , Woodward Natalie , Alderman Sophie , Dooley Jemima , Webb Joseph , Rudd Sarah , Coulthard Elizabeth , Turner Nicholas 
Published: July 2024

Introduction

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 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 core outcome set (COS) for adults living with MCI intended for use in interventional and clinical settings.

Methods and analysis

The COS will be developed using a five-stage study design: (1) systematic literature search; (2) qualitative interviews; (3) evidence synthesis from stage 1 and 2; (4) two-round Delphi survey; (5) consensus meetings. 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 a Delphi surveys followed by a consensus meeting will be used to reach stakeholder consensus on which outcomes should be included in the final COS.

Ethics and dissemination

We have received ethical approval from 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.

Trial registration number

Core Outcome Measures in Effectiveness Trials (COMET) Initiative 2117; PROSPERO registration: CRD42023452514.

Strengths and limitations

To our knowledge, this will be the first core outcome set developed to evaluate interventions for people with mild cognitive impairment (MCI).

The study will use a multi-stage process including an umbrella review, qualitative interviews, Delphi surveys, and a consensus meeting to incorporate multidisciplinary stakeholder perspectives including those living with MCI and individuals who know, care for, work with, or provide services for people with MCI.

Development and adoption of this COS is expected to enhance the value of research into MCI and clinical practice through encouraging transparent reporting of agreed meaningful outcomes to stakeholders.

A limitation of this study is that recruitment sites will be based in England only. However, we will aim to recruit international stakeholders to participate in the study and the umbrella review will include international literature. Efforts will be made to include individuals at each qualitative stage with diverse experience, backgrounds, and demographics.

There are many possible outcomes for inclusion in the COS and it may be difficult to reach consensus across stakeholders.