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

doi:10.1186/s12916-021-02015-3

Abstract

BackgroundTrials 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.MethodsA 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.ResultsItem 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.ConclusionsThis 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.

Highlights

Trials of interventions to prevent or treat delirium in adults in an acute hospital setting report heterogeneous outcomes
Rose et al BMC Medicine (2021) 19:143. This core outcome set (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
To commence the item generation process required for a COS, we conducted a systematic review of outcomes reported in published trials (1980 to December 2016) and registered trial protocols (January 2014 to December 2016) via (1) search term development in collaboration with two senior information specialists and conduct of the search across ten publication databases and grey literature; (2) two authors independently screening citations and extracting data on study characteristics, outcomes, and measures; and (3) assignment of outcomes according to Core Outcome Measures in Effectiveness Trials (COMET) taxonomy [25]

Summary

Introduction

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. The consequences of delirium are serious and include neurocognitive disturbance and cognitive decline [6], prolonged hospitalization [7], discharge to post-acute care facilities, increased caregiver burden [8], decreased functional status [9, 10], adverse events such as falls [11], and mortality [12, 13]. Delirium poses substantial additional costs to healthcare systems; with US healthcare costs attributable to delirium estimated to exceed $182 billion annually [15, 16]

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