Accuracy of Bayley Scores as Outcome Measures in Trials of...

Introduction Long-term follow-up of high risk preterm infants has become increasingly important as the proportion of infants surviving has increased steadily over the past several decades. It is well known that these infants are at increased risk of cognitive impairment. (Class) With this increase in at risk survivors, many clinical research questions arise that can only be answered by long-term follow-up studies. (Vohr, Teune) Clinical trials that examine common perinatal therapies should also include a long term follow-up component in their research to examine later neurodevelopmental outcomes in their cohorts. Although there is no prescribed protocol dictating which specific neurodevelopmental tests are to be completed during follow-up, the Bayley Scales of Infant and Toddler Development and all its revisions, is the most widely used test to assess neurodevelopment of very preterm infants in the first three years of life (Luttikhuizen) and is a common outcome measure used in clinical researc h trials. Standardized developmental assessments such as the Bayley that are used in a pediatric clinical trial setting as primary outcome measures need to be reliably administered and scored. Trained test administrators and scorers are generally careful that the tests they are administering are conducted and scored correctly. However, given the range of numerical calculations and transcriptions required in scoring the results of these tests, there is always a chance that errors