Page 238 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 12
FUTURE RESEARCH
The treatment of patients with s-TBI deserves scientific and public attention given the considerable medical and economic burden for patients, proxies, and societies. Treatment decision-making will benefit most from knowing which specific patient will benefit from which specific treatment in terms of cost-effectiveness and patient outcome. Accurate prognostication and the determination of the ‘acceptability’ of outcome are essential parts of the acute treatment decision-making process. Future studies should focus on investigating:
1. New diagnostic and treatment modalities including their (cost-) effectiveness and their effect on short- and long-term patient outcome. 124,125
2. The(patho)physiologicalmechanismsofbraininjuryandit’splasticity.3,126-130
3. Reliable, reproducible, validated, free and easy to use outcome assessment
tools that are sensitive for disabilities commonly present in s-TBI survivors. 52
4. Methods to improve the reliability of prognostic or machine learning
models. 131,132
5. The influence of human values, including a dignified existence and the
wellbeing of patients, proxies and society.
Different study designs will be required to answer different research questions. Randomized controlled trials (RCTs), the cornerstone of evidence-based medicine, might provide answers to point 1, 3 and 4. Although very little translatable evidence has been derived from 191 completed RCTs for acute TBI management 133, more sophisticated large multi-centre RCTs in priority areas might still be able to make a valuable contribution. 133
To allow RCTs in the hyper acute setting of TBI and to increase their quality, efficiency and contribution to the evidence base, optimized research protocols are needed to overcome several complicating factors in the acute and stressful setting, such as; unavailable necessary information (i.e. trauma mechanism, medical history, use of anticoagulants), and a patients’ inability to provide informed consent. A rigorous research protocol is essential for any study to be successful and to obtain institutional review board approval. The increased use of informed consent alternatives, such as deferred consent or exception from consent, has the potential to improve efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent. 134
236