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

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

doi:10.1186/s12916-021-02015-3

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

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

^*Corresponding author for this work

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1 Citation (Scopus)

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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 methodscomprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivorsand family members.

Results:

Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. Deduplication 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.

Original language	English
Article number	143
Journal	BMC Medicine
Volume	19
DOIs	https://doi.org/10.1186/s12916-021-02015-3
Publication status	Published - 18 Jun 2021

Bibliographical note

Funding Information:
We thank Becky Skidmore for assistance with search strategy development, Viviane Grassmann for coordinating the systematic review, Angela Sung for help with data extraction, Shelley Gershman for assisting with participant recruitment including managing the Twitter account, and the European Delirium Association for hosting the consensus meeting. DMN acknowledges funding from NIH/NIA (R24AG054259). This Core Outcome Set is registered on the COMET website (http://www.comet-initiative.org/studies/details/796). The systematic review is registered on PROSPERO-ID: CRD42016052704 (https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID = CRD42016052704).

Funding Information:
This work was funded by the Canadian Institutes of Health Research (CIHR). Prof Dale Needham holds NIH/NIA NIDUS funding: grant R24AG054259

Publisher Copyright:
© 2021, The Author(s).

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Keywords

Clinical trials
Core outcome set
Delirium
Hospitalization

ASJC Scopus subject areas

Medicine(all)

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10.1186/s12916-021-02015-3Licence: CC BY

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
Copyright 2021 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 1.18 MBLicence: CC BY

Cite this

Rose, L., Burry, L., Agar, M., Blackwood, B., Campbell, N. L., Clarke, M., Devlin, J. W., Lee, J., Marshall, J. C., Needham, D. M., Siddiqi, N., & Page, V. (2021). 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. BMC Medicine, 19, [143]. https://doi.org/10.1186/s12916-021-02015-3

Rose, Louise ; Burry, Lisa ; Agar, Meera ; Blackwood, Bronagh ; Campbell, Noll L. ; Clarke, Mike ; Devlin, John W. ; Lee, Jacques ; Marshall, John C. ; Needham, Dale M. ; Siddiqi, Najma ; Page, Valerie. / 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. In: BMC Medicine. 2021 ; Vol. 19.

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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 methodscomprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivorsand family members. Results: Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. Deduplication 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.",

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Rose, L, Burry, L, Agar, M, Blackwood, B, Campbell, NL, Clarke, M, Devlin, JW, Lee, J, Marshall, JC, Needham, DM, Siddiqi, N & Page, V 2021, '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', BMC Medicine, vol. 19, 143. https://doi.org/10.1186/s12916-021-02015-3

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

In: BMC Medicine, Vol. 19, 143, 18.06.2021.

Research output: Contribution to journal › Article › peer-review

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T1 - 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

AU - Rose, Louise

AU - Burry, Lisa

AU - Agar, Meera

AU - Blackwood, Bronagh

AU - Campbell, Noll L.

AU - Clarke, Mike

AU - Devlin, John W.

AU - Lee, Jacques

AU - Marshall, John C.

AU - Needham, Dale M.

AU - Siddiqi, Najma

AU - Page, Valerie

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PY - 2021/6/18

Y1 - 2021/6/18

N2 - 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 methodscomprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivorsand family members. Results: Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. Deduplication 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.

AB - 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 methodscomprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivorsand family members. Results: Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. Deduplication 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.

KW - Clinical trials

KW - Core outcome set

KW - Delirium

KW - Hospitalization

U2 - 10.1186/s12916-021-02015-3

DO - 10.1186/s12916-021-02015-3

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JO - BMC Medicine

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SN - 1741-7015

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ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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