{"id":"0c7ca75a-9b41-4a4f-9d1a-74d5420a6e08","slug":"is-intracranial-pressure-monitoring-still-required-in-the-management-of-severe-traumatic-brain-injury-ethical-and-methodological-considerations-on-conducting-clinical-research-in-poor-and-low-income-2","title":"Is intracranial pressure monitoring still required in the management of severe traumatic brain injury? Ethical and methodological considerations on conducting clinical research in poor and low-income countries","authors":["Juan Sahuquillo","Alberto Biestro"],"abstract":"Background: Long-term disabilities from severe traumatic brain injury (TBI) pose significant challenges for healthcare systems. High intracranial pressure (ICP) is common in comatose TBI patients with abnormal CT scans, leading to poor outcomes if not managed. ICP monitoring has been deemed essential for diagnosis and management, supported by evidence-based guidelines established by the Brain Trauma Foundation. Methods: This article discusses the ethical and methodological considerations surrounding the recent BEST TRIP trial, which compared ICP-based management to care guided by serial CTs and clinical examination in patients with severe TBI. The trial enrolled 324 patients across six hospitals in Bolivia and Ecuador. Results: The BEST TRIP trial concluded that ICP-based management resulted in only a marginal and nonsignificant improvement in favorable outcomes at six months compared to the alternative management strategy. This finding has reignited debate over the necessity of ICP monitoring in TBI management. Conclusion: The ethical implications of conducting clinical trials in low-income countries are highlighted, particularly regarding the relevance of research to local health needs and the potential exploitation of vulnerable populations. The necessity for robust evidence to support clinical practices remains a contentious issue. Keywords: intracranial pressure, traumatic brain injury, clinical trials, ethics, evidence-based guidelines, low-income countries, healthcare management","thumbnailUrl":null,"publishDate":"2014-06-05T00:00:00.000Z","doi":"10.4103/2152-7806.133993","categories":["Original Article"],"fullTextUrl":"http://surgicalneurologyint.com/wp-content/uploads/2015/08/3982/SNI-5-86.pdf"}