Statistical Versus Clinical Significance for Infants with Brain Injury: Reanalysis of Outcome Data from a Randomized Controlled Study

摘要

By adopting more appropriate statistical methods to appraise data from a previously published randomized controlled trial (RCT), we evaluated the statistical and clinical significance of an intervention on the 18 month neurodevelopmental outcome of infants with suspected brain injury. The intervention group (n =32) received extensive, individualized cognitive/sensorimotor stimulation by public health nurses (PHNs) while the control group (n = 30) received standard follow-up care. At 18 months 43 infants remained in the study (22 = intervention, 21 = control). The results indicate that there was a significant statistical change within groups and a clinical significance whereby more infants in the intervention group improved in mental, motor and neurological functioning at 18 months compared to the control group. The benefits of looking at clinical significance from a meaningful aspect for practitioners are emphasized.