Protocol for a prospective, longitudinal, cohort study of recovery pathways, acute biomarkers and cost for children with persistent postconcussion symptoms: the Take CARe Biomarkers study

Abstract

IntroductionThe majority of children who sustain a concussion will recover quickly, but a significant minority will experience ongoing postconcussive symptoms, known as postconcussion syndrome (PCS). These symptoms include emotional, behavioural, cognitive and physical symptoms and can lead to considerable disability. The neurobiological underpinnings of PCS are poorly understood, limiting potential clinical interventions. As such, patients and families frequently re-present to clinical services, who are often ill equipped to address the multifactorial nature of PCS. This contributes to the high cost of concussion management and the disability of children experiencing PCS. The aims of the present study are: (1) to plot and contrast recovery pathways for children with concussion from time of injury to 3 months postinjury, (ii) evaluate the contribution of acute biomarkers (ie, blood, MRI) to delayed recovery postconcussion and (3) estimate financial costs of child concussion to patients attending the emergency department (ED) of a tertiary children’s hospital and factors predicting high cost.Methods and analysisTake C.A.Re is a prospective, longitudinal study at a tertiary children’s hospital, recruiting and assessing 525 patients aged 5–<18 years (400 concussion, 125 orthopaedic injury) who present to the ED with a concussion and following them at 1–4 days, 2 weeks, 1 month and 3 months postinjury. Multiple domains are assessed: preinjury and postinjury, clinical, MRI, blood samples, neuropsychological, psychological and economic. PCS is defined as the presence of ≥2 symptoms on the Post Concussive Symptoms Inventory rated as worse compared with baseline 1 month postinjury. Main analyses comprise longitudinal Generalised Estimating Equation models and regression analyses of predictors of recovery and factors predicting high economic costs.Ethics and disseminationEthical approval has been obtained through the Royal Children’s Hospital Melbourne Human Research Ethics Committee (33122). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.Trial registration numberACTRN12615000316505; Results.

Examining Microstructural White Matter Differences between Children with Typical and Those with Delayed Recovery Two Weeks Post-Concussion

“…16 The protocol for the Take CARe study can be found in the article by Takagi and coworkers. 17 In brief, the study recruited and assessed children presenting with concussion to the ED and then followed up with the children 1-4 days, 2 weeks, 1 month, and 3 months postinjury. Multiple domains of functioning were assessed at each time point (concussive symptoms, neurocognition, behavior, quality of life, fatigue).…”

Fatigue recovery and connected factors following paediatric concussion

“…Data were collected as part of the ‘Take CARe’ (Concussion Assessment and Recovery Research) study, a single site, prospective, longitudinal study of children and adolescents (referred to as children) presenting to the emergency department (ED) of a tertiary paediatric hospital with a diagnosis of concussion. See Bressan et al 21 and Takagi et al 22 for full details.…”

Examining post-concussion white matter change in a pediatric sample

“…This study was part of a larger single site, prospective, longitudinal study (Take CARe Biomarkers – Concussion Assessment and Recovery research) conducted at a state-wide tertiary pediatric hospital in Melbourne, Australia (see Takagi et al, (2019) for full study details). In brief, the study recruited and assessed children presenting with concussion to the emergency department (ED) and then followed up with the children 1–4 days, two weeks, one month, and three months post-injury.…”