Statistical versus clinical significance for infants with brain injury: reanalysis of outcome data from a randomized controlled study.

By adopting more appropriate statistical methods to appraise data from a previously published randomized controlled trial, the statistical and clinical significance of an intervention on the 18-month neurodevelopmental outcome of infants with suspected brain injury is evaluated. The intervention group (n = 32) receives extensive, individualized cognitive/sensorimotor stimulation by public health nurses while the control group (n = 30) receives standard follow-up care. At 18 months, 43 infants remain in the study (22 intervention and 21 control). The results indicate that there is a significant statistical change within groups and a clinical significance whereby more infants in the intervention group improve 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.

RCT Entities:   Population Interventions Outcomes