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BackgroundChildren who experience a mild Traumatic Brain Injury (mTBI) may encounter cognitive and behavioral changes that often negatively impact school performance. Communication linkages between the various healthcare systems and school systems are rarely well-coordinated, placing children with an mTBI at risk for prolonged recovery, adverse impact on learning, and mTBI re-exposure. The objective of this study is to rigorously appraise the pediatric Mild Traumatic Brain Injury Evaluation and Management (TEaM) Intervention that was designed to enhance diagnosis and management of pediatric mTBI through enhanced patient discharge instructions and communication linkages between school and primary care providers.MethodsThis is a combined randomized and 2 × 2 quasi-experimental study design with educational and technology interventions occurring at the clinician level with patient and school outcomes as key endpoints. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework will be utilized as a mix methods approach to appraise a multi-disciplinary, multi-setting intervention with the intent of improving outcomes for children who have experienced mTBI.DiscussionUtilization of the RE-AIM framework complemented with qualitative inquiry is suitable for evaluating effectiveness of the TEaM Intervention with the aim of emphasizing priorities regarding pediatric mTBI. This program evaluation has the potential to support the knowledge needed to critically appraise the impact of mTBI recovery interventions across multiple settings, enabling uptake of the best-available evidence within clinical practice.

Abstract Objective Rapid developments in understanding the molecular mechanisms underlying cognitive deficits in neurodevelopmental disorders have increased expectations for targeted, mechanism‐based treatments. However, translation from preclinical models to human clinical trials has proven challenging. Poor reproducibility of cognitive endpoints may provide one explanation for this finding. We examined the suitability of cognitive outcomes for clinical trials in children with neurofibromatosis type 1 (NF1) by examining test‐retest reliability of the measures and the application of data reduction techniques to improve reproducibility. Methods Data were analyzed from the STARS clinical trial (n = 146), a multi‐center double‐blind placebo‐controlled phase II trial of lovastatin, conducted by the NF Clinical Trials Consortium. Intra‐class correlation coefficients were generated between pre‐ and post‐performances (16‐week interval) on neuropsychological endpoints in the placebo group to determine test‐retest reliabilities. Confirmatory factor analysis was used to reduce data into cognitive domains and account for measurement error. Results Test‐retest reliabilities were highly variable, with most endpoints demonstrating unacceptably low reproducibility. Data reduction confirmed four distinct neuropsychological domains: executive functioning/attention, visuospatial ability, memory, and behavior. Test‐retest reliabilities of latent factors improved to acceptable levels for clinical trials. Applicability and utility of our model was demonstrated by homogeneous effect sizes in the reanalyzed efficacy data. Interpretation These data demonstrate that single observed endpoints are not appropriate to determine efficacy, partly accounting for the poor test‐retest reliability of cognitive outcomes in clinical trials in neurodevelopmental disorders. Recommendations to improve reproducibility are outlined to guide future trial design.

The effect of repeated subconcussive head impacts in youth and high school sports on the developing brain is poorly understood. Emerging neuroimaging data correlated with biomechanical exposure metrics are beginning to demonstrate relationships across a variety of modalities. The long-term consequences of these changes are unknown. A review of the currently available literature on the effect of subconcussive head impacts on youth and high school-age male football players provides compelling evidence for more focused studies of these effects in these vulnerable populations.

The effect of repeated subconcussive head impacts in youth and high school sports on the developing brain is poorly understood. Emerging neuroimaging data correlated with biomechanical exposure met...