Developing a core outcome set for interventions in people with mild cognitive impairment: study protocol.

Area of Science:

• Neurology
• Gerontology
• Clinical Research Methodology

Background:

• Mild cognitive impairment (MCI) lacks standardized national clinical management guidelines and therapeutic interventions.
• Understanding patient-important outcomes is essential for improving clinical research impact and developing effective care pathways for MCI.

Purpose of the Study:

• To develop a Core Outcome Set (COS) for adults living with mild cognitive impairment (MCI).
• The COS will be intended for use in interventional studies and clinical practice settings to standardize outcome measurement.

Main Methods:

• A five-stage study design will be employed: systematic literature search, qualitative interviews, evidence synthesis, a two-round Delphi survey, and consensus meetings.
• An umbrella review of MCI interventional studies will identify outcomes, supplemented by qualitative interviews with stakeholders (patients, families, professionals).
• Outcomes will be synthesized into a long list, followed by Delphi surveys and consensus meetings to finalize the COS.

Main Results:

• The study is currently in the methodology development phase.
• Ethical approval has been obtained from the London-Queen Square Research Ethics Committee.
• Patient and public involvement are integral to the COS development process.

Conclusions:

• The development of a COS for MCI is a critical step towards improving research consistency and clinical care.
• Standardized outcomes will enhance the ability to evaluate interventions and develop effective management strategies for MCI.
• Dissemination of results through publications, conferences, and public channels will ensure broad impact.