Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols
Individuals with chronic illness often are at risk for developing neurobehavioral
impairments due to effects of the disease and/or associated treatments.
The National Cancer Institute (NCI) Neurobehavioral Group has been collecting
neurobehavioral data obtained from the longitudinal psychometric testing of infants,
children, adolescents, and adults with various chronic illnesses enrolled on IRB-approved
protocols at the NIH since the 1980's, many of which are now closed. In addition, we
continue to collect neurobehavioral data obtained from assessments of individuals enrolled
on current IRB-approved protocols.
The neurobehavioral test data from these evaluations, as well as demographic information,
medical values, neurologic findings, and neuroimaging abnormalities, are stored in the
neuropsychological database currently located on the secure NIH mainframe computer system.
Investigating the neurobehavioral functioning of children with chronic illness is important
for identifying and monitoring the effects of the disease and treatments over time,
determining possible at-risk subgroups, evaluating response to therapy, and recommending
educational and rehabilitative interventions. In addition, the data may be used to compare
various aspects of neurobehavioral functioning among different illness groups and validate
novel methodologies to better assess selected domains of functioning, such as a pediatric
quality of life (QOL) scale for children with chronic illnesses with CNS involvement.
To describe the neurobehavioral functioning of individuals with chronic illness based on the
analysis of stored data collected from IRB-approved protocols, consisting of retrospective
data collected on protocols that are now closed and data collected prospectively on current
and future protocols.
Data obtained from infants, children, adolescents, and adults administered neurobehavioral
assessments as part of a past, current, or future IRB-approved protocol.
No data will be collected specifically for this protocol. Retrospective data previously
collected from individuals receiving neurobehavioral assessments as part of past
IRB-approved protocols or prospective data that already will be collected as specified in
current or future IRB-approved protocols and stored in the secure NCI Neurobehavioral
database will be used for data analysis as outlined in this protocol.
Cross-sectional or longitudinal data will be selected from the database for statistical
analysis based on the objective being studied. Since different objectives may be studied
using various types of data, a variety of statistical analyses will be conducted to examine
the stored data depending on the objective being studied.
Pamela L Wolters, Ph.D.
National Cancer Institute (NCI)
United States: Federal Government
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