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Internal Medicine ·

International Delphi study defines core outcomes for ventilation trials in acute brain injury

An international four-round Delphi study involving 78 stakeholders developed a core outcome set for trials of ventilation liberation in patients with acute brain injury. The final set includes 13 outcomes and a three-level hierarchical composite endpoint intended to improve consistency across trials.

Ventilation-liberation studies in patients with acute brain injury have used heterogeneous outcomes, limiting comparisons and evidence synthesis. Researchers used a four-round international Delphi process, following COS-STAD and COS-STAP standards. A multidisciplinary panel from 31 countries scored candidate outcomes on a nine-point scale; 78 stakeholders participated in the first round and 60 completed all rounds. Consensus meetings were used to group outcomes, select measures and ratify an endpoint.

The resulting core outcome set contains 13 outcomes across respiratory function, survival, complications, functional status and quality of life. The hierarchical composite prioritizes, in order, intensive care unit survival, no reintubation within 72 hours, and days alive without mechanical ventilation. Three outcomes identified during Delphi rounds—NIH Stroke Scale, brain death and coma-free days—were not ratified because of disease-specificity or limited applicability. The consensus is intended to standardize outcome reporting in future trials; it does not provide evidence that one ventilation strategy is superior. Its impact will depend on adoption by trialists.

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Source

Intensive Care Medicine: Consensus on a core outcome set for ventilation trials in critically ill patients with acute brain injury: results of an international Delphi consensus study ↗

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