JMIR Publications

ABSTRACT

Background:

Background:

With more than 60 million new cases around the world each year, traumatic brain injury (TBI) causes substantial mortality and morbidity. The management of TBI is a major human, social and economic burden. In the last 20 years, there has been an increase in clinical trials in neurocritical care, leading mostly to negative results. The evaluation of the neurological outcome, mostly as primary outcome, with clinical scales (Glasgow Outcome Scale) has limitations that could explain these results. Moreover, patient-centred outcomes are seldom reported despite their recognized clinical relevance.

Objective:

Objective:

The aim of this project is to establish a core outcome set for moderate-to-severe TBI patients in randomized control trials in neurocritical care research.

Methods:

Methods:

5 distinct steps: 1) systematic review to identify outcomes that have been reported in trials; 2) semi-structured interviews with patients and families to identify patients’ and their family’s priorities after TBI and explore potential patient-centered outcomes; 3) healthcare stakeholder focus groups with clinicians, researchers, and policy makers to describe potential outcomes; 4) a eDelphi survey with stakeholder groups to make a list of previously identified core outcomes and 5) a consensus workshop to establish a core outcome set for moderate-to-severe TBI clinical trials.

Results:

Results:

The systematic review was published in August 2024. Regarding Step 2, 30 semi-structured interviews of patients and relatives were performed from July 2021 to December 2023 and analyses were just achieved in October 2024. Step 3 is currently under development and Step 4 is planned for the end of 2025. Step 5 is expected during fall/winter 2026.

Conclusions:

Conclusions:

Establishing a core outcome set, to be consistently measured and reported in TBI trials in neurocritical care will ensure rigorous reporting, avoid bias, and improve the integrity, transparency and usability of clinical research. The French context of the study is the main limitation, but we are seeking international collaboration on the project. The results of each step of the project will be disseminated through abstracts, publications and patient associations. Clinical Trial: Not Applicable.