Standardized Outcomes for Randomized Controlled Trials Targeting Early Interventions in Patients With...

Area of Science:

• Neurocritical care research
• Clinical trial methodology
• Traumatic brain injury (TBI) outcomes

Background:

• Traumatic brain injury (TBI) affects over 60 million people globally, causing significant mortality and morbidity.
• Clinical trials in neurocritical care have yielded predominantly negative results, potentially due to limitations in outcome evaluation.
• Patient-centered outcomes are crucial but seldom reported in TBI research.

Purpose of the Study:

• To establish a Core Outcome Set (COS) for moderate-to-severe TBI patients in randomized controlled trials.
• To enhance the consistency and relevance of outcome reporting in neurocritical care research.

Main Methods:

• Systematic review of reported outcomes in TBI trials.
• Semistructured interviews with TBI patients and families to identify priorities.
• Focus groups with healthcare stakeholders (clinicians, researchers, policymakers).
• eDelphi survey and consensus workshop to finalize the COS.

Main Results:

• Systematic review published August 2024.
• 30 patient/relative interviews completed and analyzed by October 2024.
• Ongoing development of stakeholder focus groups; eDelphi and consensus workshop planned for 2025-2026.

Conclusions:

• Establishing a COS will ensure rigorous, transparent, and unbiased reporting in TBI clinical trials.
• The study seeks international collaboration to address its French context limitation.
• Dissemination of findings through publications and patient associations is planned.