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Assessing the impact of an Irish research funder’s recommendation to consider core outcome sets

Abstract

Core outcome sets have the potential to reduce research waste by improving the consistency of outcomes measured in trials of the same health condition. An online resource called COMET initiative https://www.comet-initiative.org/ brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). This resource also has a searchable database of all developing or published COS.
However, this reduction in waste will only be realised through the uptake of COS by clinical trialists. Without uptake, the continued development of COS that are not implemented may add to waste in research. Funders of clinical trials have the potential to have an impact on COS uptake by recommending their use to those applying for funding. It is unclear to what extent grant applicants seeking funding for clinical trials include reference to the inclusion of a Core Outcome Set, or provide rationale for their outcome selection in Ireland. A similar study was carried out in the UK in 2019 (Hughes et al. 2019), which indicated a sub-optimal consideration for COS when submitting grant applications to the funder. Reviewing the inclusion (or consideration) of COS by trial teams at the grant application stage will help identify the extent to which more work is needed to encourage the uptake of COS resources by the funder, and also by the HRB Trials Methodology Research in Ireland.

Aim

The aim of this study is to determine the impact of Health Research Board (HRB) Ireland call guidance on the use of available core outcome sets (COS) in trials and also the rationale behind outcome selection, where a COS was not available.

Intended Impact of the Study

This work ultimately hopes to reduce research waste, and ensure the outcomes of trials are more meaningful for all stakeholders, including patients.

Project Lead

Dr Claire Beecher
https://orcid.org/0000-0001-6581-3756

Project Collaborators

Professor Declan Devane
Dr Sandra Galvin
Anne Cody
Professor Paula Williamson
Dr Karen Hughes
Caitriona Creely
Oonagh Ward
https://orcid.org/0000-0002-9393-7075
https://orcid.org/0000-0002-3444-8896
http://orcid.org/0000-0001-9802-6636
https://orcid.org/0000-0002-8517-8996

Contact Project Author

Keywords

Clinical Trials; Researcher perspective; Trial design; core outcome set; research funding

Research Area(s)

Decision making in funding or publication; Design and conduct of studies; Research use and benefit

Study Design(s)

Document analysis; Qualitative research; Questionnaire, interview or observation study

Data Collection Method(s)

Qualitative

Participant(s)

Researchers

Status

Active

Expected completion date:

Stage

Data analysis; Data collection; Publication (writing, submitting, in review, published)

Study Funding/Support

Not funded through a grant but conducted as part of a funding organisation continuous improvement activity

Dissemination Activity/Activities

Publications (all types); Stakeholder engagement