Journal of neurotrauma
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Journal of neurotrauma · Jun 2012
Review Meta AnalysisA quantitative analysis of clinical trial designs in spinal cord injury based on ICCP guidelines.
Clinical studies of spinal cord injury (SCI) have evolved into multidisciplinary programs that investigate multiple types of neurological deficits and sequelae. In 2007, the International Campaign for Cures of SCI Paralysis (ICCP) proposed best practices for interventional trial designs, end-points, and inclusion criteria. Here we quantitatively assessed the extent to which SCI trials follow ICCP guidelines and reflect the overall patient population. ⋯ Age inclusion criteria skew older than the overall population. ASIA status criteria reflect the population, but neurological lesion criteria could be broadened. Investigators should make trial designs and results available in a complete manner to enable comparisons of populations and outcomes.
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Journal of neurotrauma · Jun 2012
Review Meta AnalysisQuality of life in children and adolescents post-TBI: a systematic review and meta-analysis.
Traumatic brain injury is (TBI) a leading cause of morbidity and mortality in children and adolescents in first-world nations. Research from our team investigating adult survivors of pediatric TBI indicate that survivors of severe TBI are particularly vulnerable to global impairments, including poorer school performance, greater employment difficulties, poor quality of life (QoL), and increased risk of mental health problems. Investigation into less observable consequences, including QoL, has emerged recently as an important outcome to assess in TBI populations. The status of QoL in pediatric TBI populations is mixed, likely a reflection of the varied methodological and theoretical perspectives on QoL. ⋯ This systematic study will clarify the nature of QoL in survivors of pediatric TBI, and identify predictors of QoL in this group. Of 419 articles identified, 11 studies met our inclusion criteria, and 9 were ultimately analyzed in this review. Four studies reported good QoL and 5 poor QoL. The difference between good and poor QoL was statistically significant due to TBI severity [chi-square(3)=77.38, p<0.001], timing of outcome assessment [chi-square(1)=565, p<0.001], and definition of QoL [chi-square(3)=34.73, p<0.001]. The odds of having a poor QoL increased 5.8 times (RR=1.21) when injuries were more severe. Good outcomes are contingent on milder injuries, proxy reporting, and early assessment, whereas poor outcomes reflect more severe injuries and later assessment (≤ 6 months versus ≥ 1 year post-trauma, respectively).