Development of a Core Outcome Set for research studies with older adults in the Emergency Department-CREAT-ED: A multi-stage study protocol

Background: Older adults represent a growing proportion of Emergency Department (ED) attendees and experience high rates of adverse outcomes post discharge from the ED such as functional decline, increased risk of institutionalisation and unplanned hospital readmissions. In response to these issues, there has been a proliferation of studies evaluating various interventions to mitigate these adverse outcomes. However, this expansion of research has been hampered by a lack of agreement on ‘what to measure’ in these studies and a lack of attention to the measurement of patient/ service user reported outcomes. To address these issues, we aim to develop a Core Outcome Set (COS) for intervention studies based, or initiated, in the ED with older adults. Methods: A five-stage approach will be undertaken to develop the COS in conjunction with a Public and Patient Involvement (PPI) panel of older adults and family carers. To generate a long list of outcomes, three stages will be undertaken. 1. A scoping review to identify commonly reported outcomes in intervention studies based/initiated in the ED, associated instruments and measurement timepoints. 2. A rapid qualitative evidence synthesis to identify outcomes of importance to older adults attending the ED. 3. Participatory research methods will be employed to identify outcomes of relevance to older adults and their families/ caregivers, health care Providers and research stakeholders. To achieve consensus on outcomes and associated instruments to include in the COS, a further two stages will be undertaken. 4. A Real-Time Delphi survey study and consensus meeting with key stakeholders to reach consensus on inclusion of outcomes in the COS. 5. A search for existing instruments to evaluate each outcome identified in stage 4 will be conducted. Identified instruments will be evaluated, and a consensus meeting will be held to select one outcome measure instrument for each outcome included in the COS. Discussion: A COS for research with older adults in the ED will serve to enhance future clinical trials, systematic reviews and clinical guidelines by enhancing the availability of comparable data and by ensuring outcomes that matter to all stakeholders are represented. Trial registration: Development of a Core Outcome Set for research studies with older adults in the Emergency Department-CREAT-ED (COMET) initiative 2749 COMET Initiative | Development of a Core Outcome Set for research studies with older adults in the Emergency Department-CREAT-ED. https://www.comet-initiative.org/Studies/Details/2749.