Intracranial pressure monitoring in severe traumatic brain injury in latin america: process and methods for a multi-center randomized controlled trial.

In patients with severe traumatic brain injury (TBI), the influence on important outcomes of the use of information from intracranial pressure (ICP) monitoring to direct treatment has never been tested in a randomized controlled trial (RCT). We are conducting an RCT in six trauma centers in Latin America to test this question. We hypothesize that patients randomized to ICP monitoring will have lower mortality and better outcomes at 6-months post-trauma than patients treated without ICP monitoring. We selected three centers in Bolivia to participate in the trial, based on (1) the absence of ICP monitoring, (2) adequate patient accession and data collection during the pilot phase, (3) preliminary institutional review board approval, and (4) the presence of equipoise about the value of ICP monitoring. We conducted extensive training of site personnel, and initiated the trial on September 1, 2008. Subsequently, we included three additional centers. A total of 176 patients were entered into the trial as of August 31, 2010. Current enrollment is 81% of that expected. The trial is expected to reach its enrollment goal of 324 patients by September of 2011. We are conducting a high-quality RCT to answer a question that is important globally. In addition, we are establishing the capacity to conduct strong research in Latin America, where TBI is a serious epidemic. Finally, we are demonstrating the feasibility and utility of international collaborations that share resources and unique patient populations to conduct strong research about global public health concerns.

Assessing neuropsychological performance in a migrant farm working Colonia in Baja California, Mexico: a feasibility study.

Neuropsychological impairments (NPI) can lead to difficulties in daily functioning and ultimately contribute to poor health outcomes. However, evidence for the feasibility of NPI assessment in resource-limited settings using tests developed in high literacy/high education cultures is sparse. The main objectives were to: (1) determine the feasibility and appropriateness of conducting neuropsychological assessments among a migrant farm worker population in Baja California, Mexico and (2) preliminary describe neuropsychological test performance in this unique population. A neuropsychological test battery was administered to 21 presumably healthy adults (8 men, 13 women) during a two-day international health services and research collaboration. All but one neuropsychological test (i.e. figure learning) was feasible and appropriate to administer to the study population. Contrary to expectations, participants performed better on verbal rather than nonverbal neuropsychological tests. Results support inclusion of neuropsychological tests into future studies among migrant farm worker populations in Baja California, Mexico.