A Core Outcome Set for Adult General ICU Patients.

Summary

Using a modified Delphi across multi-stakeholder panels, the authors defined and internationally validated a six-item core outcome set for adult general ICU trials: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. This harmonizes endpoints that matter to patients, families, clinicians, and researchers.

Key Findings

• Identified 329 published outcomes; 50 advanced to Delphi with 264 participants.
• Six core outcomes finalized after international validation: survival, free of life support, free of delirium, out of hospital, health-related quality of life, cognitive function.
• High participation and consensus across 14 countries and 22 panels (5 Danish, 17 international).

Clinical Implications

ICU trials should incorporate these six core outcomes to standardize endpoints, enable cross-trial comparisons, and ensure patient-centered relevance.

Limitations

• Initial development centered in Denmark may introduce geographic bias
• Operationalization and measurement tools for each outcome still require standard selection

Future Directions

Develop standardized measurement instruments and timing for each core outcome; promote adoption in registries, RCTs, and funder mandates; assess applicability in LMICs.