A Core Outcome Set for Adult General ICU Patients

Area of Science:

• Critical Care Medicine
• Clinical Trial Methodology
• Patient-Centered Outcomes Research

Background:

• Harmonized outcomes are crucial for clinical practice, especially in large, pragmatic trials.
• Existing core outcome sets exist for specific ICU subsets (e.g., respiratory failure, delirium, COVID-19), but not for general adult ICU populations.
• A need exists for a universally applicable core outcome set for adult general ICU patients.

Purpose of the Study:

• To develop and internationally validate a core outcome set for adult general intensive care unit (ICU) patients.
• To establish a standardized set of outcomes for use in clinical research and trials involving this patient group.

Main Methods:

• A modified Delphi consensus process was employed, incorporating literature reviews, surveys, and semi-structured interviews.
• The study involved five Danish research panels and was internationally validated across 14 countries.
• Participants included adult ICU survivors, family members, clinicians, and researchers.

Main Results:

• An initial set of 329 outcomes was identified, with 50 included in a 264-participant Delphi survey.
• Semi-structured interviews with 82 participants did not yield additional outcomes.
• The final, internationally validated core outcome set includes six outcomes: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function.

Conclusions:

• A core outcome set comprising six core outcomes has been successfully developed and validated.
• This core outcome set is intended for use in research, particularly in clinical trials involving adult general ICU patients.
• The established set promotes standardized outcome measurement in critical care research.