Status of sedation of the participant/subject

2014-04-01

GENERAL/TBI: Steyerberg EW, Mushkudiani N, Perel P, et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. Aug 2008;5(8):e165. MRC CRASH Trial Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. Feb 2008;336(7641):425-429.

GENERAL:Choose one. We recommend the prognostic models proposed by the IMPACT study group and the CRASH trial collaborators (www.tbi-impact.org and www.crash2.lsthm.ac.uk). The baseline risk assessment should be performed post stabilization but prior to any study intervention. TBI populations are characterized by substantial heterogeneity. This heterogeneity confounds comparison between studies and may also lead to imbalances between treatment groups in clinical trials. Characterization of populations is better performed by calculation of the prognostic risk than by reporting characteristics individually. In clinical trials, the prognostic risk estimate can be used as one of the enrolment criteria (excluding patients with an extreme risk estimate), for purpose of stratification and in the analysis phase for covariate adjustment or assessing outcome in relation to initial prognostic risk (sliding dichotomy approach). We therefore consider calculation of baseline prognostic risk mandatory for all clinical studies on TBI. Calculating the baseline prognostic risk for early mortality or functional outcome can is recommended for all TBI studies. TBI:Choose one.?

Sedation