Supporting meaningful participation of older people in core outcome set development

The use of core outcome sets (COS) by trials is widely accepted as best practice, aiming to improve research efficiency by enabling comparison and aggregation of results across trials for specific clinical areas.1 A COS is an agreed minimum set of standardized outcomes that should be reported in all trials for a specific clinical area.1 A COS should include only fundamental outcomes, that is, core to evaluating a treatment or intervention, rather than every relevant or important outcome.1, 2 Trials can additionally measure other outcomes.1, 3

Outcomes in a COS should be valid and important for all stakeholders. When developing a COS for hospital deprescribing trials,4 we involved stakeholders that would be affected by the intervention: older patients and their carers; healthcare professionals who care for older people in hospital; hospital managers; and academics researching older people's medicine/deprescribing. We followed COMET (Core Outcome Measures in Effectiveness Trials) guidance for COS development1; this summarizes available methods for COS development but provides limited guidance on how to ensure meaningful involvement of patients, who historically have not been involved in deciding which outcomes should be measured in trials. The INCLUDE framework highlights that older people are often explicitly or implicitly excluded from healthcare research.5 Despite anticipating some barriers to older people's participation in our COS study and addressing these in the study planning, we experienced several challenges to ensuring that the selection of outcomes for the COS included their views. We reflect on these challenges, discuss what worked to address them, and present further refinements that could better support equitable, meaningful participation of older people in COS development. Study registration: COMET (Core Outcome Measures in Effectiveness Trials) database (https://www.comet-initiative.org/Studies/Details/1825).

Aim

We reflect on these challenges, discuss what worked to address them, and present further refinements that could better support equitable, meaningful participation of older people in COS development.

Contributors

Jacqueline Martin-Kerry BAppSci(Hons) PhD, Sion Scott MPharm PhD, Jo Taylor BA (Hons) MRes PhD, David Wright BPharm (Hons) PGCHE PhD, Martyn Patel BMBCh MA, Jennie Griffiths, Victoria L. Keevil PhD BMBCh, Miles D. Witham BM BCh PhD, Allan Clark BSc(Hons) PhD, Ian Kellar PhD, David Turner BSc (Economics) MSc, Debi Bhattacharya BPharm PhD

Publication

Journal: Journal of the American Geriatrics Society
Volume:
Issue:
Pages: -
Year: 2024
DOI: https://doi.org/10.1111/jgs.19179

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This research study was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research stream (award ID PGfAR 200874).This study was supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration East of England (NIHR ARC EoE) at Cambridge and Peterborough NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Health Area

Disease Category: Health care of older people

Disease Name: Deprescribing, Polypharmacy

Target Population

Age Range: 65 - 100

Sex: Either

Nature of Intervention: Drug

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- Service providers
- Service users

Study Type

- COS methods research

Method(s)

- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion

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