Standardized Outcomes in Patients with Moderate to Severe Traumatic Brain Injury: Protocol for the development of a Core Outcome Set for Trials. (Preprint)

Abstract

With more than 60 million new cases around the world each year, traumatic brain injury (TBI) holds 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 of clinical trials in neuro-trauma, leading mostly to negative results. The evaluation of the neurological outcome with clinical scales (Glasgow Outcome Scale) bears limitations that could explain these results. Moreover, patient-centred outcomes are seldom reported despite their recognized clinical relevance. The aim of this project is to establish a core outcome set for moderate-to-severe TBI patients in clinical research.

The aim of this project is to establish a core outcome set for moderate-to-severe TBI patients in clinical research.

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 patient’s and relative’s priorities after TBI and explore potential patient-centred outcomes; 3) stakeholder focus groups with, clinicians, researchers, and policy makers to describe potential outcomes; 4) a Delphi survey with stakeholder groups to elaborate a list of core outcomes previously developed and 5) a consensus workshop to establish a core outcome set for moderate-to-severe TBI clinical trials.

Not Applicable

Establishing a core outcome set, to be consistently measured and reported in TBI trials will ensure rigorous reporting and avoid bias, and improve the integrity, transparency and usability of clinical research. The results of each step of the project will be disseminated throughout abstract, publications and patients’ associations.

Not Applicable