Developing Core Outcome Sets for Delirium Trials
Research type
Research Study
Full title
Development of core outcome sets for effectiveness trials of interventions to prevent and/or treat delirium (Del-COrS):
IRAS ID
234212
Contact name
Valerie J Page
Contact email
Sponsor organisation
West Hertfordshire Hospitals NHS Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Delirium is a state of acute confusion brought on by illness, infection or drugs. It is common in patients who already have cognitive impairment e.g. dementia and acutely ill hospital patients. Patients who develop delirium have worse outcomes including death within one year, longer stays in hospital, and long-term cognitive impairment.
Clinical studies of delirium frequently report different outcomes. This means study results cannot be compared or combined to decide what is likely to work or not work to prevent or treat delirium. Moreover, outcomes reported may not be important to patients, families or care providers. When a set of main outcomes has been agreed for a health condition, it’s called a ‘core outcome set’. If all studies in delirium measured and reported these core outcomes, we could bring together all studies to get a better understanding of which treatments are best.Our aim is to develop international agreement on two core outcome sets for studies of treatments to 1) prevent, and 2) treat delirium. Because delirium is seen in many different patient groups, we will develop four core outcome subsets in addition to the common core outcome set. These four patient groups are critical care, palliative care, acute hospital patients and older adults in the community/nursing homes.
We will collect all outcomes reported in published delirium trials. We will interview patients who have survived delirium and family members to get their views on what other outcomes are important. We will then invite members of the public, clinicians who care for patients with delirium and other stakeholders to participate in two online surveys to gain consensus on those core outcomes that are most important to them. We will hold meetings to discuss these findings and ask the groups to vote on outcomes they considered the most important.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1321
Date of REC Opinion
20 Nov 2018
REC opinion
Further Information Favourable Opinion