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Published in: BMC Medicine 1/2021

01-12-2021 | Care | Research article

A core outcome set for studies evaluating interventions to prevent and/or treat delirium for adults requiring an acute care hospital admission: an international key stakeholder informed consensus study

Authors: Louise Rose, Lisa Burry, Meera Agar, Bronagh Blackwood, Noll L. Campbell, Mike Clarke, John W. Devlin, Jacques Lee, John C. Marshall, Dale M. Needham, Najma Siddiqi, Valerie Page

Published in: BMC Medicine | Issue 1/2021

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Abstract

Background

Trials of interventions to prevent or treat delirium in adults in an acute hospital setting report heterogeneous outcomes. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in adults with an acute care hospital admission and not admitted to an intensive care unit.

Methods

A rigorous COS development process was used including a systematic review, qualitative interviews, modified Delphi consensus process, and in-person consensus using nominal group technique (registration http://​www.​comet- initiative.​org/​studies/​details/​796).
Participants in qualitative interviews were delirium survivors or family members. Participants in consensus methods comprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivors and family members.

Results

Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30 outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. De-duplication of outcomes and formal consensus processes involving 110 experts including researchers (N = 32), clinicians (N = 63), and delirium survivors and family members (N = 15) resulted in a COS comprising 6 outcomes: delirium occurrence and reoccurrence, delirium severity, delirium duration, cognition, emotional distress, and health-related quality of life. Study limitations included exclusion of non-English studies and stakeholders and small representation of delirium survivors/family at the in-person consensus meeting.

Conclusions

This COS, endorsed by the American and Australian Delirium Societies and European Delirium Association, is recommended for future clinical trials evaluating delirium prevention or treatment interventions in adults presenting to an acute care hospital and not admitted to an intensive care unit.
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Metadata
Title
A core outcome set for studies evaluating interventions to prevent and/or treat delirium for adults requiring an acute care hospital admission: an international key stakeholder informed consensus study
Authors
Louise Rose
Lisa Burry
Meera Agar
Bronagh Blackwood
Noll L. Campbell
Mike Clarke
John W. Devlin
Jacques Lee
John C. Marshall
Dale M. Needham
Najma Siddiqi
Valerie Page
Publication date
01-12-2021
Publisher
BioMed Central
Keyword
Care
Published in
BMC Medicine / Issue 1/2021
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/s12916-021-02015-3

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