Roger Zemek

Systematic review of randomized controlled trials examining written action plans in children: what is the plan?

OBJECTIVES To evaluate the independent effect of a written action plan vs no plan and to compare different plans to identify characteristics of effective plans in children with asthma. DATA SOURCES We searched the Cochrane Airways Group Clinical Trials Register until March 2006, including MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials, for randomized controlled trials that evaluated asthma action plans in the pediatric population. STUDY SELECTION Eligible studies were randomized or quasi-randomized controlled trials with participants aged 0 to 17 years diagnosed with asthma. Of 428 citations, 1 trial compared a peak flow-based plan with none and 4 parallel-group trials compared symptom-based plans with peak flow-based plans. Intervention Provision of a written action plan. Control groups received no action plan or another type of plan. All co-interventions (both medical and educational) were similar in both groups. Main Outcome Measure The number of children with at least 1 acute care asthma visit. RESULTS Written action plan use significantly reduced acute care visits per child as compared with control subjects. Children using plans also missed less school, had less nocturnal awakening, and had improved symptom scores. As compared with peak flow-based plans, symptom-based plans significantly reduced the risk of a patient requiring an acute care visit. CONCLUSIONS Although there are limited data to firmly conclude that provision of an action plan is superior to none, there is clear evidence suggesting that symptom-based plans are superior to peak flow-based plans in children and adolescents.

Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED

IMPORTANCE Approximately one-third of children experiencing acute concussion experience ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as persistent postconcussion symptoms (PPCS). However, validated and pragmatic tools enabling clinicians to identify patients at risk for PPCS do not exist. OBJECTIVE To derive and validate a clinical risk score for PPCS among children presenting to the emergency department. DESIGN, SETTING, AND PARTICIPANTS Prospective, multicenter cohort study (Predicting and Preventing Postconcussive Problems in Pediatrics [5P]) enrolled young patients (aged 5-<18 years) who presented within 48 hours of an acute head injury at 1 of 9 pediatric emergency departments within the Pediatric Emergency Research Canada (PERC) network from August 2013 through September 2014 (derivation cohort) and from October 2014 through June 2015 (validation cohort). Participants completed follow-up 28 days after the injury. EXPOSURES All eligible patients had concussions consistent with the Zurich consensus diagnostic criteria. MAIN OUTCOMES AND MEASURES The primary outcome was PPCS risk score at 28 days, which was defined as 3 or more new or worsening symptoms using the patient-reported Postconcussion Symptom Inventory compared with recalled state of being prior to the injury. RESULTS In total, 3063 patients (median age, 12.0 years [interquartile range, 9.2-14.6 years]; 1205 [39.3%] girls) were enrolled (n = 2006 in the derivation cohort; n = 1057 in the validation cohort) and 2584 of whom (n = 1701 [85%] in the derivation cohort; n = 883 [84%] in the validation cohort) completed follow-up at 28 days after the injury. Persistent postconcussion symptoms were present in 801 patients (31.0%) (n = 510 [30.0%] in the derivation cohort and n = 291 [33.0%] in the validation cohort). The 12-point PPCS risk score model for the derivation cohort included the variables of female sex, age of 13 years or older, physician-diagnosed migraine history, prior concussion with symptoms lasting longer than 1 week, headache, sensitivity to noise, fatigue, answering questions slowly, and 4 or more errors on the Balance Error Scoring System tandem stance. The area under the curve was 0.71 (95% CI, 0.69-0.74) for the derivation cohort and 0.68 (95% CI, 0.65-0.72) for the validation cohort. CONCLUSIONS AND RELEVANCE A clinical risk score developed among children presenting to the emergency department with concussion and head injury within the previous 48 hours had modest discrimination to stratify PPCS risk at 28 days. Before this score is adopted in clinical practice, further research is needed for external validation, assessment of accuracy in an office setting, and determination of clinical utility.

Prognosticators of Persistent Symptoms Following Pediatric Concussion: A Systematic Review

OBJECTIVE To identify predictors of persistent concussion symptoms (PCS) in children following concussion. DATA SOURCES We searched MEDLINE, Embase, and the Cochrane Library to April 2012. STUDY SELECTION A systematic review of the literature to identify prognosticators of PCS following pediatric concussion was conducted. Studies evaluating patients aged 2 years to 18 years with PCS were eligible. MAIN OUTCOME MEASURES The association of clinically available factors with PCS development. RESULTS A literature search yielded 824 records; 561 remained after removal of duplicates. Fifteen studies were included in descriptive analysis; heterogeneity precluded a meta-analysis. Larger prospective studies concluded that the risk for PCS was increased in older children with loss of consciousness, headache, and/or nausea/vomiting. Smaller studies noted that initial dizziness may predict PCS. Patients with premorbid conditions (eg, previous head injury, learning difficulties, or behavioral problems) may also have increased risk. CONCLUSIONS Minimal, and at times contradictory, evidence exists to associate clinically available factors with eventual development of PCS in children. Future trials must be adequately powered to determine which variables best predict the time to full symptom resolution. Expert consensus should delineate which postconcussion assessment measures are preferred to reduce heterogeneity going forward. Research to improve care for the epidemic of pediatric concussion depends on early identification of those most in need of intervention.

Lorazepam vs Diazepam for Pediatric Status Epilepticus: A Randomized Clinical Trial

IMPORTANCE Benzodiazepines are considered first-line therapy for pediatric status epilepticus. Some studies suggest that lorazepam may be more effective or safer than diazepam, but lorazepam is not Food and Drug Administration approved for this indication. OBJECTIVE To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus. DESIGN, SETTING, AND PARTICIPANTS This double-blind, randomized clinical trial was conducted from March 1, 2008, to March 14, 2012. Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible. There were 273 patients; 140 randomized to diazepam and 133 to lorazepam. INTERVENTIONS Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously, with half this dose repeated at 5 minutes if necessary. If status epilepticus continued at 12 minutes, fosphenytoin was administered. MAIN OUTCOMES AND MEASURES The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes. The primary safety outcome was the performance of assisted ventilation. Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status. Outcomes were measured 4 hours after study medication administration. RESULTS Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 (72.1%) in the diazepam group and 97 of 133 (72.9%) in the lorazepam group, with an absolute efficacy difference of 0.8% (95% CI, -11.4% to 9.8%). Twenty-six patients in each group required assisted ventilation (16.0% given diazepam and 17.6% given lorazepam; absolute risk difference, 1.6%; 95% CI, -9.9% to 6.8%). There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated (66.9% vs 50%, respectively; absolute risk difference, 16.9%; 95% CI, 6.1% to 27.7%). CONCLUSIONS AND RELEVANCE Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam. These findings do not support the preferential use of lorazepam for this condition. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00621478.

Association Between Early Participation in Physical Activity Following Acute Concussion and Persistent Postconcussive Symptoms in Children and Adolescents

Importance Although concussion treatment guidelines advocate rest in the immediate postinjury period until symptoms resolve, no clear evidence has determined that avoiding physical activity expedites recovery. Objective To investigate the association between participation in physical activity within 7 days postinjury and incidence of persistent postconcussive symptoms (PPCS). Design, Setting, and Participants Prospective, multicenter cohort study (August 2013-June 2015) of 3063 children and adolescents aged 5.00-17.99 years with acute concussion from 9 Pediatric Emergency Research Canada network emergency departments (EDs). Exposures Early physical activity participation within 7 days postinjury. Main Outcomes and Measures Physical activity participation and postconcussive symptom severity were rated using standardized questionnaires in the ED and at days 7 and 28 postinjury. PPCS (≥3 new or worsening symptoms on the Post-Concussion Symptom Inventory) was assessed at 28 days postenrollment. Early physical activity and PPCS relationships were examined by unadjusted analysis, 1:1 propensity score matching, and inverse probability of treatment weighting (IPTW). Sensitivity analyses examined patients (≥3 symptoms) at day 7. Results Among 2413 participants who completed the primary outcome and exposure, (mean [SD] age, 11.77 [3.35] years; 1205 [39.3%] females), PPCS at 28 days occurred in 733 (30.4%); 1677 (69.5%) participated in early physical activity including light aerobic exercise (n = 795 [32.9%]), sport-specific exercise (n = 214 [8.9%]), noncontact drills (n = 143 [5.9%]), full-contact practice (n = 106 [4.4%]), or full competition (n = 419 [17.4%]), whereas 736 (30.5%) had no physical activity. On unadjusted analysis, early physical activity participants had lower risk of PPCS than those with no physical activity (24.6% vs 43.5%; Absolute risk difference [ARD], 18.9% [95% CI,14.7%-23.0%]). Early physical activity was associated with lower PPCS risk on propensity score matching (n = 1108 [28.7% for early physical activity vs 40.1% for no physical activity]; ARD, 11.4% [95% CI, 5.8%-16.9%]) and on inverse probability of treatment weighting analysis (n = 2099; relative risk [RR], 0.74 [95% CI, 0.65-0.84]; ARD, 9.7% [95% CI, 5.7%-13.7%]). Among only patients symptomatic at day 7 (n = 803) compared with those who reported no physical activity (n = 584; PPCS, 52.9%), PPCS rates were lower for participants of light aerobic activity (n = 494 [46.4%]; ARD, 6.5% [95% CI, 5.7%-12.5%]), moderate activity (n = 176 [38.6%]; ARD, 14.3% [95% CI, 5.9%-22.2%]), and full-contact activity (n = 133 [36.1%]; ARD, 16.8% [95% CI, 7.5%-25.5%]). No significant group difference was observed on propensity-matched analysis of this subgroup (n = 776 [47.2% vs 51.5%]; ARD, 4.4% [95% CI, -2.6% to 11.3%]). Conclusions and Relevance Among participants aged 5 to 18 years with acute concussion, physical activity within 7 days of acute injury compared with no physical activity was associated with reduced risk of PPCS at 28 days. A well-designed randomized clinical trial is needed to determine the benefits of early physical activity following concussion.

Triage nurse initiation of corticosteroids in pediatric asthma is associated with improved emergency department efficiency.

OBJECTIVE: To assess the effectiveness of nurse-initiated administration of oral corticosteroids before physician assessment in moderate to severe acute asthma exacerbations in the pediatric ED. METHODS: A time-series controlled trial evaluated nurse initiation of treatment with steroids before physician assessment in children with Pediatric Respiratory Assessment Measure score ≥4. One-to-one periods (physician-initiated and nurse-initiated) were analyzed from September 2009 through May 2010. In both phases, triage nurses initiated bronchodilator therapy before physician assessment, per Pediatric Respiratory Assessment Measure score. We reviewed charts of 644 consecutive children aged 2 to 17 years for the following outcomes: admission rate; times to clinical improvement, steroid receipt, mild status, and discharge; and rate of return ED visit and subsequent admission. RESULTS: Nurse-initiated phase children improved earlier compared to physician-initiated phase (median difference: 24 minutes; 95% confidence interval [CI]: 1–50; P = .04). Admission was less likely if children received steroids at triage (odds ratio = 0.56; 95% CI: 0.36–0.87). Efficiency gains were made in time to steroid receipt (median difference: 44 minutes; 95% CI: 39–50; P < .001), time to mild status (median difference: 51 minutes; 95% CI: 17–84; P = .04), and time to discharge (median difference: 44 minutes; 95% CI: 17–68; P = .02). No differences were found in return visit rate or subsequent admission. CONCLUSIONS: Triage nurse initiation of oral corticosteroid before physician assessment was associated with reduced times to clinical improvement and discharge, and reduced admission rates in children presenting with moderate to severe acute asthma exacerbations.

The HEADS-ED: A Rapid Mental Health Screening Tool for Pediatric Patients in the Emergency Department

BACKGROUND AND OBJECTIVE: The American Academy of Pediatrics called for action for improved screening of mental health issues in the emergency department (ED). We developed the rapid screening tool home, education, activities/peers, drugs/alcohol, suicidality, emotions/behavior, discharge resources (HEADS-ED), which is a modification of “HEADS,” a mnemonic widely used to obtain a psychosocial history in adolescents. The reliability and validity of the tool and its potential for use as a screening measure are presented. METHODS: ED patients presenting with mental health concerns from March 1 to May 30, 2011 were included. Crisis intervention workers completed the HEADS-ED and the Child and Adolescent Needs and Strengths-Mental Health tool (CANS MH) and patients completed the Children’s Depression Inventory (CDI). Interrater reliability was assessed by using a second HEADS-ED rater for 20% of the sample. RESULTS: A total of 313 patients were included, mean age was 14.3 (SD 2.63), and there were 182 females (58.1%). Interrater reliability was 0.785 (P < .001). Correlations were computed for each HEADS-ED category and items from the CANS MH and the CDI. Correlations ranged from r = 0.17, P < .05 to r = 0.89, P < .000. The HEADS-ED also predicted psychiatric consult and admission to inpatient psychiatry (sensitivity of 82% and a specificity of 87%; area under the receiver operator characteristic curve of 0.82, P < .01). CONCLUSIONS: The results provide evidence to support the psychometric properties of the HEADS-ED. The study shows promising results for use in ED decision-making for pediatric patients with mental health concerns.

What is the difference in concussion management in children as compared with adults? A systematic review

Aim To evaluate the evidence regarding the management of sport-related concussion (SRC) in children and adolescents. The eight subquestions included the effects of age on symptoms and outcome, normal and prolonged duration, the role of computerised neuropsychological tests (CNTs), the role of rest, and strategies for return to school and return to sport (RTSp). Design Systematic review. Data sources MEDLINE (OVID), Embase (OVID) and PsycInfo (OVID). Eligibility criteria for selecting studies Studies were included if they were original research on SRC in children aged 5 years to 18 years, and excluded if they were review articles, or did not focus on childhood SRC. Results A total of 5853 articles were identified, and 134 articles met the inclusion criteria. Some articles were common to multiple subquestions. Very few studies examined SRC in young children, aged 5–12 years. Summary/conclusions This systematic review recommends that in children: child and adolescent age-specific paradigms should be applied; child-validated symptom rating scales should be used; the widespread routine use of baseline CNT is not recommended; the expected duration of symptoms associated with SRC is less than 4 weeks; prolonged recovery be defined as symptomatic for greater than 4 weeks; a brief period of cognitive and physical rest should be followed with gradual symptom-limited physical and cognitive activity; all schools be encouraged to have a concussion policy and should offer appropriate academic accommodations and support to students recovering from SRC; and children and adolescents should not RTSp until they have successfully returned to school, however early introduction of symptom-limited physical activity is appropriate. Systematic review registration PROSPERO 2016:CRD42016039184

What is the physiological time to recovery after concussion? A systematic review

Aim or objective The aim of this study is to consolidate studies of physiological measures following sport-related concussion (SRC) to determine if a time course of postinjury altered neurobiology can be outlined. This biological time course was considered with respect to clinically relevant outcomes such as vulnerability to repeat injury and safe timing of return to physical contact risk. Design Systematic review. Data sources PubMed, CINAHL, Cochrane Central, PsychINFO. Eligibility criteria for selecting studies Studies were included if they reported original research on physiological or neurobiological changes after SRC. Excluded were cases series <5 subjects, reviews, meta-analyses, editorials, animal research and research not pertaining to SRC. Results A total of 5834 articles were identified, of which 80 were included for full-text data extraction and review. Relatively few longitudinal studies exist that follow both physiological dysfunction and clinical measures to recovery. Summary/conclusions Modalities of measuring physiological change after SRC were categorised into the following: functional MRI, diffusion tensor imaging, magnetic resonance spectroscopy, cerebral blood flow, electrophysiology, heart rate, exercise, fluid biomarkers and transcranial magnetic stimulation. Due to differences in modalities, time course, study design and outcomes, it is not possible to define a single ‘physiological time window’ for SRC recovery. Multiple studies suggest physiological dysfunction may outlast current clinical measures of recovery, supporting a buffer zone of gradually increasing activity before full contact risk. Future studies need to use generalisable populations, longitudinal designs following to physiological and clinical recovery and careful correlation of neurobiological modalities with clinical measures.

A double-blind, placebo-controlled intervention trial of 3 and 10 mg sublingual melatonin for post-concussion syndrome in youths (PLAYGAME): study protocol for a randomized controlled trial

BackgroundBy the age of sixteen, one in five children will sustain a mild traumatic brain injury also known as concussion. Our research found that one in seven school children with mild traumatic brain injury suffer post-concussion syndrome symptoms for three months or longer. Post-concussion syndrome is associated with significant disability in the child and his/her family and yet there are no evidence-based medical treatments available. Melatonin has several potential mechanisms of action that could be useful following mild traumatic brain injury, including neuroprotective effects. The aim of this study is to determine if treatment with melatonin improves post-concussion syndrome in youths following mild traumatic brain injury. Our hypothesis is that treatment of post-concussion syndrome following mild traumatic brain injury with 3 or 10 mg of sublingual melatonin for 28 days will result in a decrease in post-concussion syndrome symptoms compared with placebo.Methods/DesignNinety-nine youths with mild traumatic brain injury, aged between 13 and 18 years, who are symptomatic at 30 days post-injury will be recruited. This study will be conducted as a randomized, double blind, placebo-controlled superiority trial of melatonin. Three parallel treatment groups will be examined with a 1:1:1 allocation: sublingual melatonin 3 mg, sublingual melatonin 10 mg, and sublingual placebo. Participants will receive treatment for 28 days. The primary outcome is a change on the Post-Concussion Symptom Inventory (Parent and Youth). The secondary outcomes will include neurobehavioral function, health-related quality of life and sleep. Neurophysiological and structural markers of change, using magnetic resonance imaging techniques and transcranial magnetic stimulation, will also be investigated.DiscussionMelatonin is a safe and well-tolerated agent that has many biological properties that may be useful following a traumatic brain injury. This study will determine whether it is a useful treatment for children with post-concussion syndrome. Recruitment commenced on 4 December 2014.Trial registrationThis trial was registered on 6 June 2013 at ClinicalTrials.gov. Registration number: NCT01874847.