International mission on prognosis and analysis of clinical trials in traumatic brain injury.

IMPACT: International Mission for Prognosis and Analysis of Clinical Trials in TBI.Traumatic Brain Injury (TBI) may afflict us all, but young adult males are particularly at risk. IMPACT is an international multidisciplinary effort to advance clinical research programmes in search of better treatment.Nearly 10 years of work has resulted in the development of a prognostic calculator for establishing prognosis in individual patients, proposals for standardization of data collection in TBI studies (common data elements) and recommendations for improving the design and analysis of TBI studies. It is hoped that these recommendations will substantially increase possibilities for proving efficacy of new treatments. We greatly welcome any feedback you may haveBackgroundTraumatic Brain Injury (TBI) is a dynamic and heterogeneous disease in which many mechanisms and pathways can lead to secondary damage. Many different kinds of therapy and neuroprotective agents with high potential for efficacy have been developed.Unfortunately in trials none of these have shown convincing evidence of benefit in the clinical situation with sufficient generalizibility. Some of these therapies may have been truly ineffective but the risk exists that some therapies may have been wrongly discarded due to the use of insensitive methodology in clinical trials.The TBI population poses several complicated methodological challenges, related to the heterogeneity of the population, outcome-assessment and design issues. IMPACT is focused on tackling these head-on with the aim of providing recommendations for more powerful trials in the future.

Keywords:TRAUMATIC BRAIN INJURY, CLINICAL OUTCOME

Disciplines:Neurosciences, Orthopaedics, Surgery, Nursing, Biological and physiological psychology, Cognitive science and intelligent systems, Developmental psychology and ageing