Alternative approaches to outcomes assessment: beyond psychometric tests.

Outcomes assessments in clinical trials involving cognition and behavior rely upon IQ and neuropsychological assessments. These procedures provide limited evaluations of everyday functions. Some participants cannot perform cognitive tasks because they are low functioning or may represent missing data because of inability to travel. Interview-based assessments of adaptive behavior yield results that reflect everyday functions and can be done by telephone regardless of level of cognitive functioning. The design of the neurobehavioral component of the follow-up study for the management of myelomeningocele fetal surgery trial is as an example of a clinical trial that incorporates these alternatives.