Dataset Information

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:

Introduction

The 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 analysis

Take 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 dissemination

Ethical 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 number

ACTRN12615000316505; Results.

SUBMITTER: Takagi M

PROVIDER: S-EPMC6443052 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Publications

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.

Takagi Michael M Babl Franz E FE Anderson Nicholas N Bressan Silvia S Clarke Cathriona J CJ Crichton Ali A Dalziel Kim K Davis Gavin A GA Doyle Melissa M Dunne Kevin K Godfrey Celia C Hearps Stephen J C SJC Ignjatovic Vera V Parkin Georgia G Rausa Vanessa V Seal Marc M Thompson Emma Jane EJ Truss Katie K Anderson Vicki V

BMJ open 20190224 2

<h4>Introduction</h4>The 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 ...[more]

PMID: 30804026

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Project description:INTRODUCTION:Current management of concussion consists of early education, rest until symptom free, with gradual return to school and physical activity protocols. Although this management strategy is effective for most youth who sustain a concussion, it is not an appropriate strategy for youth with persistent postconcussion symptoms. Prolonged rest and periods of restricted activity may place youth at risk for secondary issues and contribute to the chronicity of postconcussion symptoms. The purpose of this study is to evaluate the efficacy of an active rehabilitation protocol for youth who are slow to recover from concussion. It is hypothesised that an active rehabilitation intervention can reduce persistent postconcussion symptoms, improve function and facilitate return to activity. This article describes the research protocol. METHODS AND ANALYSIS:This is a randomised clinical trial with blinded outcome measurement. Participants will be recruited and randomly assigned to 1 of 2 treatment groups, an active rehabilitation intervention or a standard care education group. Both groups will receive standard care education. However, the active rehabilitation group will participate in an additional low-intensity exercise programme consisting of aerobic, coordination and visualisation exercises. Both the active rehabilitation and the standard care education interventions will be 6?weeks in duration. The primary outcome measure is postconcussion symptoms. Secondary outcome measures include functional recovery (cognitive, motor, psychosocial and emotional functioning) and return to activity. Outcome measures will be administered preintervention and postintervention. The primary outcome measure will also be repeated 2?weeks into the intervention period. ETHICS AND DISSEMINATION:This study has been approved by the Holland Bloorview Kids Rehabilitation Hospital research ethics board (REB # 13-459). The findings from this study will be shared with the general public, sport associations, relevant brain injury organisations and healthcare professionals. TRIAL REGISTRATION NUMBER:NCT02257749.

Project description:ImportancePersistent (>4 weeks) postconcussion symptoms (PPCS) are challenging for both patients and clinicians. There is uncertainty about the effect of commonly applied nonpharmacological treatments for the management of PPCS.ObjectiveTo systematically assess and summarize evidence for outcomes related to 7 nonpharmacological interventions for PPCS in adults (aged >18 years) and provide recommendations for clinical practice.Data sourcesSystematic literature searches were performed via Embase, MEDLINE, PsycINFO, CINAHL, PEDro, OTseeker, and Cochrane Reviews (via MEDLINE and Embase) from earliest possible publication year to March 3, 2020. The literature was searched for prior systematic reviews and primary studies. To be included, studies had to be intervention studies with a control group and focus on PPCS.Study selectionA multidisciplinary guideline panel selected interventions based on frequency of use and need for decision support among clinicians, including early information and advice, graded physical exercise, vestibular rehabilitation, manual treatment of neck and back, oculomotor vision treatment, psychological treatment, and interdisciplinary coordinated rehabilitative treatment. To be included, studies had to be intervention studies within the areas of the predefined clinical questions, include a control group, and focus on symptoms after concussion or mild traumatic brain injury.Data extraction and synthesisExtraction was performed independently by multiple observers. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for data abstraction and data quality assessment. Included studies were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) tool and the Cochrane Risk of Bias (randomized clinical trials) tool. Meta-analysis was performed for all interventions where possible. Random-effects models were used to calculate pooled estimates of effects. The level and certainty of evidence was rated and recommendations formulated according to the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework.Main outcomes and measuresAll outcomes were planned before data collection began according to a specified protocol. The primary outcomes were the collective burden of PPCS and another outcome reflecting the focus of a particular intervention (eg, physical functioning after graded exercise intervention).ResultsEleven systematic reviews were identified but did not contribute any primary studies; 19 randomized clinical trials comprising 2007 participants (1064 women [53.0%]) were separately identified and included. Evidence for the 7 interventions ranged from no evidence meeting the inclusion criteria to very low and low levels of evidence. Recommendations were weak for early information and advice, graded physical exercise, vestibular rehabilitation, manual treatment of the neck and back, psychological treatment, and interdisciplinary coordinated rehabilitative treatment. No relevant evidence was identified for oculomotor vision treatment, so the panel provided a good clinical practice recommendation based on consensus.Conclusions and relevanceBased on very low to low certainty of evidence or based on consensus, the guideline panel found weak scientific support for commonly applied nonpharmacological interventions to treat PPCS. Results align with recommendations in international guidelines. Intensified research into all types of intervention for PPCS is needed.

Project description:BackgroundAerobic exercise has emerged as a useful treatment to improve outcomes among individuals who experience a concussion. However, compliance with exercise recommendations and the effect of exercise volume on symptom recovery require further investigation.PurposeTo examine (1) if an 8-week aerobic exercise prescription, provided within 2 weeks of concussion, affects symptom severity or exercise volume; (2) whether prescription adherence, rather than randomized group assignment, reflects the actual effect of aerobic exercise in postconcussion recovery; and (3) the optimal volume of exercise associated with symptom resolution after 1 month of study.Study designCohort study; Level of evidence, 2.MethodsIndividuals randomized to an exercise intervention (n = 17; mean age, 17.2 ± 2.0 years; 41% female; initially tested a mean of 11.3 ± 2.8 days after injury) or standard of care (n = 20; mean age, 16.8 ± 2.2 years; 50% female; initially tested a mean of 10.7 ± 3.2 days after injury) completed an aerobic exercise test within 14 days of injury. They returned for assessments 1 month and 2 months after the initial visit. The aerobic exercise group was instructed to exercise 5 d/wk, 20 min/d (100 min/wk), at a target heart rate based on an exercise test at the initial visit. Participants reported their exercise volume each week over the 8-week study period and reported symptoms at each study visit (initial, 1 month, 2 months). Because of low compliance in both groups, there was no difference in the volume of exercise between the 2 groups.ResultsThere were no significant symptom severity differences between the intervention and standard-of-care groups at the initial (median Post-Concussion Symptom Inventory, 15 [interquartile range = 10, 42] vs 20 [11, 35.5]; P = .26), 1-month (4 [0, 28] vs 5.5 [0.5, 21.5]; P = .96), or 2-month (6.5 [0, 27.5] vs 0 [0, 4]; P = .11) study visits. Exercise volume was similar between groups (median, 115 [54, 225] vs 88 [28, 230] min/wk for exercise intervention vs standard of care; P = .52). Regardless of group, those who exercised <100 min/wk reported significantly higher symptom severity at the 1-month evaluation compared with those who exercised ≥100 min/wk (median, 1.5 [0, 7.5] vs 12 [4, 28]; P = .03). Exercising ≥160 min/wk successfully discriminated between those with and those without symptoms 1 month after study commencement (classification accuracy, 81%; sensitivity, 90%; specificity, 78%).ConclusionGreater exercise volume was associated with lower symptom burden after 1 month of study, and an exercise volume >160 min/wk in the first month of the study was the threshold associated with symptom resolution after the first month of the study. Because our observation on the association between exercise volume and symptom level is a retrospective and secondary outcome, it is possible that participants who were feeling better were more likely to exercise more, rather than the exercise itself driving the reduction in symptom severity.

Project description:BackgroundPersistent concussion symptoms (PCS) negatively affects common activities of daily living including deficits in both single and dual-task (DT) gait. DT gait deficits are present post-concussion; however, task prioritization and the effects of differing cognitive challenge remain unexplored in the PCS population.Research questionThe purpose of this study was to investigate single and dual-task gait performance in individuals with persistent concussion symptoms and to identify task priorization strategies during DT trials.MethodsFifteen adults with PCS (age: 43.9+11.7 y.o.) and 23 healthy control participants (age: 42.1+10.3 y.o.) completed five trials of single task gait followed by fifteen trials of dual task gait along a 10-m walkway. The cognitive challenges consisted of five trials each of visual stroop, verbal fluency, and working memory cognitive challenges. Groups were compared on DT cost stepping characteristics with independent samples t-test or Mann-Whitney U tests.ResultsThere were significant overall gait Dual Task Cost (DTC)difference between groups for gait speed (p = 0.009, d=0.92) and step length (p = 0.023, d=0.76). Specific to each DT challenge, PCS participants were slower during Verbal Fluency (0.98 + 0.15 m/s and 1.12 + 0.12 m/s, p = 0.008; d=1.03), Visual Stroop (1.06 + 0.19 m/s and 1.20 + 0.12 m/s, p = 0.012, d=0.88), and Working Memory (1.02 + 0.15 m/s and 1.16 + 0.14 m/s, p = 0.006, d=0.96). There were significant cognitive DTC differences between groups for WM accuracy (p = 0.008, d=0.96), but not for VS accuracy (p = 0.841, d=0.061) or VF total words (p = 0.112, d=0.56).SignificanceThe PCS participants displayed a posture-second strategy whereby gait performance generally decreased in the absence of cognitive changes. However, during the Working Memory DT, PCS participants had a mutual interference response whereby both motor and cognitive performance decreased suggesting the cognitive task plays a key role in the DT gait performance of PCS patients.

Project description:IntroductionAfter the acute Sars-CoV-2-infection, some athletes suffer from persistent, performance-impairing symptoms, although the course of the disease is often mild to moderate. The relation between cardiopulmonary performance and persistent symptoms after the acute period is still unclear. In addition, information about the development of this relationship is lacking.ObjectiveTo assess the prevalence of persistent symptoms over time and their association with the performance capability of athletes.MethodsWe conducted two cardiopulmonary exercise tests (CPET) in a three months interval with 60 athletes (age: 35.2±12.1 years, 56.7% male) after infection with Sars-CoV-2 (t0: study inclusion; t1: three months post t0). At each examination, athletes were asked about their persistent symptoms. To evaluate the change of Peak VO2/BM (Body Mass) between the time before infection and the first examination, the VO2/BM (predVO2) before infection was predicted based on anthropometric data and exercise history of the athletes. For data analysis, athletes were grouped according to their symptom status (symptom-free, SF; persistent symptoms, PS) and its progression from the first to the second examination 1) SF-SF, 2) PS-SF and 3) PS-PS.ResultsComparing the SF and PS groups at t0, significant differences for Max Power/BM, Max Power/lbm (lean body mass), Peak VO2, Peak VO2/BM, Peak VO2/lbm, Peak VO2/HR, Peak VE, Peak Vt and VE/VCO2-Slope were observed. Regarding the progression over three months, an increase in Max Power/BM was shown in SF-SF and PS-SF (tendency). Max Power/lbm increased in SF-SF and PS-PS (tendency). A decrease of VE/VCO2-Slope in PS-PS was found.ConclusionCOVID-19 led to a decline in performance that was greater in PS than in SF. Additionally, PS had decreased ventilatory parameters compared to SF. Furthermore, an improvement over time was observed in some CPET parameters and a partial recovery was observed judging by the decrease in various symptoms.

Project description:IntroductionComprehensive studies mapping domain-specific trajectories of recovery after stroke and biomarkers reflecting these processes are scarce. We, therefore, initiated an exploratory prospective observational study of stroke cases with repeated evaluation, the FIND Stroke Recovery Study. We aim to capture trajectories of recovery from different impairments, including cognition, in combination with broad profiling of blood and imaging biomarkers of the recovery.Methods and analysisWe recruit individuals with first-ever stroke at the stroke unit at the Sahlgrenska University Hospital, Sweden, to FIND. The inclusion started early 2018 and we aim to enrol minimum 500 patients. Neurological and cognitive impairments across multiple domains are assessed using validated clinical assessment methods, advanced neuroimaging is performed and blood samples for biomarker measuring (protein, RNA and DNA) at inclusion and follow-up visits at 3 months, 6 months, 1 year, 2 years and 5 years poststroke. At baseline and at each follow-up visit, we also register clinical variables known to influence outcomes such as prestroke functioning, stroke severity, acute interventions, rehabilitation, other treatments, socioeconomic status, infections (including COVID-19) and other comorbidities. Recurrent stroke and other major vascular events are identified continuously in national registers.Ethics and disseminationFIND composes a unique stroke cohort with detailed phenotyping, repetitive assessments of outcomes across multiple neurological and cognitive domains and patient-reported outcomes as well as blood and imaging biomarker profiling. Ethical approval for the FIND study has been obtained from the Regional Ethics Review Board in Gothenburg and the Swedish Ethics Review Board. The results of this exploratory study will provide novel data on the time course of recovery and biomarkers after stroke. The description of this protocol will inform the stroke research community of our ongoing study and facilitate comparisons with other data sets.Trial registration numberThe protocol is registered at http://www.Clinicaltrialsgov, Study ID: NCT05708807.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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.

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