Core Outcome Measures in Effectiveness Trials

Developing a Core Outcome Set for Delirium Prevention and/or Treatment Trials

General Information

Summary:
Aims/Purpose: The overall aim is to develop international consensus on two core outcome sets (COS) appropriate for trials of interventions designed to (1) prevent, and (2) treat delirium, irrespective of study population. We also aim to develop a suite of COS specific to 4 patient groups: (1) critically ill adults and children receiving care in high acuity settings, including ICUs and high dependency units; (2) non-critically ill adults and children hospitalized in an acute care setting including postoperative surgical patients, medical patients, and patients presenting to an emergency department (ED); (3) adults and children receiving palliative care, either in a hospital, hospice or community setting; and (4) older adults (65 and over) living in nursing or residential care homes or living in their own homes and defined as at risk of delirium by study authors.

Background: With increased recognition of delirium as a common, costly, and potentially preventable condition associated with adverse outcomes, the number of observational studies and interventional trials examining interventions to prevent or treat delirium has increased considerably and is accompanied by a proliferation in study outcomes. Currently there is no systematic approach to the selection and reporting of outcomes and their measures in delirium studies. Our COS trials of interventions designed to prevent, and treat delirium for will help to combine and compare study outcomes to develop robust conclusions about effective interventions with the ultimate goal of improving patient outcomes.

Protocol: http://bmjopen.bmj.com/content/7/9/e016371

Contributors:
Dr Louise Rose, TD Nursing Professor in Critical Care Research, Sunnybrook Health Sciences Centre; Associate Professor, University of Toronto; and Research Director at Provincial Centre of Weaning Excellence, Toronto East General Hospital; Toronto, Canada
Dr Valerie Page, Consultant in Critical Care, Watford General Hospital, Vice President European Delirium Association on behalf of European Delirium Association COMET committee.
International Collaborators: American Delirium Society, Australasian Delirium Association.

Further Study Information

Current Stage:
Ongoing
Date:
October 2015 - October 2018
Funding source(s):
None

Health Area

Disease Category
Neurology

Disease Name
Delirium

Target Population

Age Range
2 - 100

Sex
Either


Nature / type of Intervention
Drug
Nonpharmacological

Method(s)

Consensus meeting
Delphi process
Interview
Literature review

Step 1: Systematic review of the evidence base to establish existing study outcomes reported for studies of interventions to prevent or treat delirium.

Step 2: Patient/family semi-structured interviews to establish outcomes important to them.

Step 3: Delphi exercise followed by an internatonal consensus workshop to establish the outcomes to inform the two COS (prevention and treatment) irrespective of study population as well as any additional outcomes specific to our 4 populations of interest.

Step 4: Delphi exercise and nominal group technique to establish measures for the COS outcomes.

In addition we will embed a randomized controlled trial of feedback methods within the two Delphi exercises; conduct semi-structured interviews to determine barriers and facilitators of patient/family engagement/participation; and examine measures for outcomes retained using the Delphi method versus nominal group technique.


Stakeholders Involved

Charities
Clinical experts
Conference participants
Consumers (caregivers)
Economists
Patient/ support group representatives
Pharmaceutical industry representatives
Researchers
Service providers

Study Type

COS for clinical trials or clinical research
Recommended outcome measures (measurement)

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