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Decompressive Craniectomy in Diffuse Traumatic Brain Injury - ICU

Decompressive Craniectomy in Diffuse Traumatic Brain Injury - ICU

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StatisticsProportion of favorable outcomes (def<strong>in</strong>ed as a score of 5 to 8 on theExtended Glasgow Outcome Scale) from 30% among patients receiv<strong>in</strong>gstandard care to 50% among patients undergo<strong>in</strong>g craniectomy, with a twosidedtype I error of 0.05 and a power of 80% with a sample size of 210patients.At the <strong>in</strong>terim analysis (with the study-group assignments concealed), itwas determ<strong>in</strong>ed that if the score on the 8-grade Extended Glasgow OutcomeScore were analyzed by ord<strong>in</strong>al logistic regression, 150 patientswould be required to detect a between-group difference of 1.5 <strong>in</strong> the medianscore with a power of 80% and a two-sided type I error of 0.05.8

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