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.
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.
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.
Bibliographical noteFunding 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).
This work was funded by the Canadian Institutes of Health Research (CIHR). Prof Dale Needham holds NIH/NIA NIDUS funding: grant R24AG054259
© 2021, The Author(s).
Copyright 2021 Elsevier B.V., All rights reserved.
- Clinical trials
- Core outcome set
ASJC Scopus subject areas