With more than 60 million new cases of traumatic brain injury [1] and 90 million new stroke [2], acute brain injuries are a major health-care concern worldwide. In the past 30 years of neuro-critical care, numerous therapies and medication have failed to improve patients’ neurological recovery: progesterone [3] or EPO after trauma [4], magnesium [5] or statins [6] after stroke. Recently, major concerns have raised regarding the clinical relevance of the scales which assess neurological recovery [7], along with methodological flaws such as high inter-rater variability [8] and the lack of patient assessment of his/her situation within these scales[7]. These issues could explain the failure in identifying promising new therapeutics after acute severe brain injury. Owing the catastrophic waste in research funding, the development of Core Outcome Sets is urgently needed. Core Outcome Sets in clinical research could enhance the relevance of outcomes in clinical research and thus help clinicians and health-care systems is the clinical decision process. The aim of our group is to develop a Core Outcome Set in patients with acute focal brain injury (stroke, haemorrhage, trauma) and clinical severity, requiring hospitalization in a critical care unit.
References:
[1] GBD 2016 Traumatic Brain Injury and Spinal Cord Injury Collaborators. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019;18:56–87. doi:10.1016/S1474-4422(18)30415-0.
[2] GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol 2017;16:877–97. doi:10.1016/S1474-4422(17)30299-5.
[3] Skolnick BE, Maas AI, Narayan RK, van der Hoop RG, MacAllister T, Ward JD, et al. A clinical trial of progesterone for severe traumatic brain injury. N Engl J Med 2014;371:2467–76. doi:10.1056/NEJMoa1411090.
[4] Robertson CS, Hannay HJ, Yamal J-M, Gopinath S, Goodman JC, Tilley BC, et al. Effect of Erythropoietin and Transfusion Threshold on Neurological Recovery After Traumatic Brain Injury. Jama 2014;312:36. doi:10.1001/jama.2014.6490.
[5] Dorhout Mees SM, Algra A, Vandertop WP, van Kooten F, Kuijsten HAJM, Boiten J, et al. Magnesium for aneurysmal subarachnoid haemorrhage (MASH-2): a randomised placebo-controlled trial. Lancet 2012;380:44–9. doi:10.1016/S0140-6736(12)60724-7.
[6] Vergouwen MDI, de Haan RJ, Vermeulen M, Roos YBWEM. Effect of statin treatment on vasospasm, delayed cerebral ischemia, and functional outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis update. Stroke 2010;41:e47–52. doi:10.1161/STROKEAHA.109.556332.
[7] Tsyben A, Guilfoyle M, Timofeev I, Anwar F, Allanson J, Outtrim J, et al. Spectrum of outcomes following traumatic brain injury-relationship between functional impairment and health-related quality of life. Acta Neurochir (Wien) 2018;160:107–15. doi:10.1007/s00701-017-3334-6.
[8] Wilson JTL, Slieker FJA, Legrand V, Murray G, Stocchetti N, Maas AIR. Observer variation in the assessment of outcome in traumatic brain injury: experience from a multicenter, international randomized clinical trial. Neurosurgery 2007;61:123–8–discussion128–9. doi:10.1227/01.neu.0000279732.21145.9e.
Raphaël CINOTTI. Anaesthesia and Critical care. Hôpital Laennec. University Hospital of Nantes, France
Yoann LAUNEY. Anaesthesia and Critical care. Hôpital Pontchaillou. University Hospital of Rennes, France
Claire DAHYOT-FIZELIER. Anaesthesia and Critical care department. University Hospital of Poitiers, France
Amandine CHENET. Physical and rehabilitation. Hôpital Saint Jacques. University Hospital of Nantes, France
Lydia OUJAMAA. Physical and rehabilitation. University Hospital of Saint-Étienne, France
Julie PAQUEREAU. Physical and rehabilitation. Hôpital de Garches, Assistance Publique des Hôpitaux de Paris, Paris, France
Bertrand GLIZE. Physical and rehabilitation. University Hospital of Bordeaux, France
Kévin BILLET-BUFFENOIR. Neurosurgery. Hôtel Dieu. University Hospital of Nantes, France
Philippe DECQ. Neurosurgery. Hôpital Beaujon, Clichy, Assistance Publique des Hôpitaux de Paris, Paris, France
Fanny FEUILLET. Methodologist, Statisticians. University Hospital of Nantes, France
Véronique SÉBILLE. Methodologist, Statisticians. University Hospital of Nantes, France
Disease Category: Neurology
Disease Name: Acquired brain injury
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Focus group(s)
- Nominal group technique (NGT)
- Systematic review
Our group will follow the guidelines of the COMET group in the elaboration of our COS. The protocol of the entire process will be published in order to ensure exhaustivity and transparency. This will also facilitate potential collaboration with other groups worldwide which would be interested in this project.
First, we will elaborate a systematic review of outcomes in patients with acute brain injury (stroke, trauma). The systematic review will be published.
Second, focus groups with the nominal group technique will be elaborated with patients and caregivers in France. The results of these focus groups will be published.
A Delphi process will be then performed in order to reach consensus within the expert group. The results of the Delphi process will be published.