Development of core outcome sets for effectiveness trials of interventions to prevent and/or treat delirium (Del-COrS): study protocol

Abstract

IntroductionDelirium is a common, serious and potentially preventable condition with devastating impact on the quality of life prompting a proliferation of interventional trials. Core outcome sets aim to standardise outcome reporting by identifying outcomes perceived fundamental for measurement in trials of a specific interest area. Our aim is to develop international consensus on two core outcome sets for trials of interventions to prevent and/or treat delirium, irrespective of study population. We aim to identify additional core outcomes specific to the critically ill, acutely hospitalised patients, palliative care and older adults.Methods and analysisWe will conduct a systematic review of published and ongoing delirium trials (1980 onwards) and one-on-one interviews of patients who have experienced delirium and family members. These data will inform Delphi round 1 of a two-stage consensus process. In round 2, we will provide participants their own response, summarised group responses and those of patient/family participants for rescoring. We will randomise participants to receive feedback as proportion scoring the outcome as critical or as group mean responses. We will hold a consensus meeting using nominal group technique to finalise outcomes for inclusion. We will repeat the Delphi process and consensus meeting to select measures for each core outcome. We will recruit 240 Delphi participants giving us 80% power to detect a 1.0–1.5 point (9-point scale) difference by feedback method between rounds. We will analyse differences for subsequent scores, magnitude of opinion change, items retained and level of agreement.Ethics and disseminationWe are obtaining research ethics approvals according to local governance. Participation will be voluntary and data deidentified. Support from three international delirium organisations will be instrumental in dissemination and core outcome set uptake. We will disseminate through peer-reviewed open access publications and present at conferences selected to reach a wide range of knowledge users.

Melatonin and the Prevention and Management of Delirium: A Scoping Study

“…Similar to the issues with the role of melatonin agonists in preventing delirium, questions regarding agent choice, dose, duration, and outcome measures still remain. Published trial protocols suggest that this is an ongoing area of research ( 63 ) and efforts to develop agreed outcome measures for trials of interventions to prevent or treat delirium are being developed ( 64 ).…”

Benzodiazepines and/or neuroleptics for the treatment of delirium in palliative care?—a critical appraisal of recent randomized controlled trials

“…In hospitals, nursing homes and home care, delirium is a serious problem, leading to substantial health care costs and associated high levels of mortality (21)(22)(23). Delirium is a complex and challenging situation for health care professionals because it is often irreversible and in case of agitated and aggressive patients sometimes even a risk for those involved in caring for the patient (formal and informal caregivers) (24,25). To overcome these situations, benzodiazepines and neuroleptics are widely used to treat delirium in various clinical settings, including palliative care (25,26).…”

“…Delirium is a complex and challenging situation for health care professionals because it is often irreversible and in case of agitated and aggressive patients sometimes even a risk for those involved in caring for the patient (formal and informal caregivers) (24,25). To overcome these situations, benzodiazepines and neuroleptics are widely used to treat delirium in various clinical settings, including palliative care (25,26). Outside the field of palliative care, neuroleptics and benzodiazepines have been examined in trials for example in a postoperative, intensive-care or geriatric setting (15,(27)(28)(29).…”

Delirium in older emergency department patients

“…The development of a delirium core outcome set that can be used across multiple healthcare settings will facilitate the standardized selection and reporting of delirium outcomes. 6 Issues surrounding consent must be addressed, so that those at greatest risk of delirium who would most benefit from the research are appropriately included. The agreement of gold standard testing in the ED, time of first assessment, and time of re-assessment to differentiate between prevalent and incident ED delirium must be clarified.…”