A Core Outcome Set for Adult General ICU Patients.

Summary

Using a multi-method, modified Delphi process and international validation, the authors defined a six-item core outcome set for adult general ICU trials: survival, days free of life support, days free of delirium, time out of hospital, health-related quality of life, and cognitive function.

Key Findings

• Six core outcomes for adult general ICU trials were defined and internationally validated.
• Process included literature synthesis (329 outcomes), Delphi survey (264 participants), and multinational panel validation.
• Outcomes emphasize both survival and patient-centered longer-term domains (HRQoL and cognition).

Clinical Implications

Adoption of the core set can standardize outcome selection in ICU trials, facilitate meta-analyses, and align patient-centered endpoints across studies.

Limitations

• Adult-focused; pediatric ICU outcomes not addressed.
• Operational definitions and measurement instruments for each outcome require further standardization and feasibility work.

Future Directions

Develop standardized measurement protocols and timing for each core outcome, test feasibility in pragmatic trials, and explore alignment with regulatory and payer expectations.