Introduction. Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting patients admitted to the intensive care unit during critical illness. New onset atrial fibrillation (NOAF) affects between 5%-11% of all admission but as many as 46% of all patients admitted with septic shock. NOAF is associated with increased mortality and morbidity and contributes significantly to healthcare associated costs. There is increasing interest in the prevention and management of NOAF however, previous trials have suffered from significant heterogeneity making comparisons and inferences limited. Core outcome sets (COS) aim to standardise outcome reporting, reduce inconsistency between trials and reduce outcome reporting bias. We aim to develop an internationally agreed COS for trials of interventions to prevent and / or treat NOAF in critically unwell adult patients.
Ethics and dissemination. We are obtaining institutional review approval at the University of Liverpool. Participation will be voluntary, and all participant data will be anonymised. We will disseminate the finalised COS-ABACUS via national and international critical care organisations. We will also disseminate COS-ABACUS through publication in peer reviewed open access literature.
Dr Brian Johnston, University of Liverpool, Principle Investigator
Prof. Ingeborg Welters, University of Liverpool, Supervisor
Dr Ruaraidh Hill, University of Liverpool
Dr Oana Cole, University of Liverpool
Prof. Bronagh Blackwood, Queens University Belfast
Disease Category: Heart & circulation
Disease Name: Atrial fibrillation, Critical illness
Age Range: 18 - 99
Sex: Either
Nature of Intervention: Drug
- Clinical experts
- Consumers (patients)
- Epidemiologists
- Methodologists
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus conference
- Delphi process
- Nominal group technique (NGT)
- Survey
- Systematic review
Methods and analysis. We will invite stakeholders including, intensive care physicians, cardiologists, and patients to participate in COS development. 1) We will review outcomes included in trials included in recent systematic reviews, and recently published surveys of clinician practice. 2) Data from stage one will inform a two-stage e-Delphi process conducted online using e-Delphi manager. During stage two stakeholders will be asked to score each outcome on a Likert scale between 1-9 as per the Grading of Recommendations Assessment, Development and Evaluation GRADE scale. Stakeholders will be able to suggest relevant outcomes for inclusion in subsequent e-Delphi rounds. Responses will be summarised group between e-Delphi rounds and hold a consensus meeting held to finalise included core outcomes. 3) Recommended outcome measure instruments will be identified from the literature in stage 1 and a consensus meeting held to agree outcome measure instruments. 4) A final consensus meeting will be held to finalise included outcomes and measurement instruments.