Implementation of multi-site neurocognitive assessments within a pediatric cooperative group: can it be done?
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BACKGROUND: Neurocognitive functioning is an important construct in childhood cancer survivorship, given the potential neurotoxicity of central nervous system (CNS) diseases and treatments and the relevance for important functional outcomes in adulthood. However, within pediatric oncology cooperative groups there have been significant barriers to neurocognitive data collection that have historically resulted in incomplete data (<30% compliance), thereby limiting progress in understanding the neurocognitive functioning of survivors. This paper describes the development, feasibility, and potential efficacy of a brief neurocognitive battery to maximize collection of psychometrically robust neurocognitive data within a pediatric cooperative group. We hypothesized that a novel set of procedures could result in collection of data from over 80% of eligible children. PROCEDURE: A novel assessment battery (ALTE07C1) that evaluates a child's cognitive, social, emotional, and behavioral functioning was developed. It included measures that were psychometrically sound, normed, widely available, and could be administered by any licensed psychologist. The battery required approximately 1 hour of administration time. A data monitoring team was developed to ensure prompt data collection. RESULTS: Approximately 75% (105 of 140) of institutions with eligible patients opened ALTE07C1; 159 participants have been enrolled. The overall compliance rate for submission of neurocognitive data exceeded 90%. DISCUSSION: Our study supports the feasibility and potential efficacy of a brief neurocognitive battery and a data monitoring team to evaluate children participating in multi-site pediatric oncology trials. Future work will utilize ALTE07C1 as a primary or secondary endpoint for pediatric trials when there is risk for neurocognitive impairment.
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