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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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Concussion, a mild traumatic injury common in children and adolescents, is a complex pathophysiological process affecting the brain. The lay press is inundated with reports of tragic consequences of concussion, and children are not immune.
Persistent postconcussive symptoms (PCS) is defined as the persistence of somatic, cognitive, physical, psychological or behavioural changes lasting more than one month following injury. PCS significantly impacts children and their family's quality of life through school absenteeism, depressed mood and loss of activities.
Validated, easy-to-use prognosticators do not exist for clinicians to identify children at highest risk for PCS. As a result,physicians cannot accurately inform children and parents whether they should expect longer symptoms, nor initiate pharmacotherapy or other management to reduce the occurrence or severity of PCS.
The investigators objective is to derive and validate a clinical prediction rule for the development of PCS in children and adolescents presenting to the emergency department (ED) following acute head injury. The investigators have three aims: (1) determine PCS incidence at one-month follow-up in children aged 5-17 who sustain a concussion; (2) derive a rule to predict PCS from variables present in the history and physical examination; and, (3) assess the accuracy, reliability and acceptability of the prediction rule in a subsequent cohort. Using a prospective, multicentre study at nine large Canadian pediatric EDs, the investigators will recruit the largest prospective epidemiological cohort of children with concussions in the literature.
This work will provide rigorous evidence to determine PCS incidence in children and its impact on quality of life. The results will enable clinicians to identify children at highest risk for PCS, optimize treatment and provide families with realistic anticipatory guidance. This study will also establish a strong and vital evidence base to advance concussion research.
The full protocol has been published in BMJ Open (open access):
Zemek R, Osmond MH, Barrowman N for PERC Concussion Team. Predicting and preventing postconcussive problems in paediatrics (5P) study: protocol for a prospective multicentre clinical prediction rule derivation study in children with concussion. BMJ Open. 2013 Aug 1;3(8). pii:e003550. doi: 10.1136/bmjopen-2013-003550. PubMed PMID: 23906960. https://www.ncbi.nlm.nih.gov/pubmed/23906960
The primary outcome results have been published in JAMA (open access):
Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203. PubMed PMID: 26954410. http://dx.doi.org/10.1001/jama.2016.1203
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| Measure | Description | Time Frame |
|---|---|---|
| Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. | The primary outcome is the number of of children aged 5 - 17 years who have PCS at one-month follow-up. A PCS case is defined as an increase from pre-concussion baseline of three or more symptoms on the validated PCSI at one-month (consistent with the ICD-10 definition of PCS). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury | The PedsQLâ„¢ is a reliable and valid measure of health-related quality of life in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. The inventory covers four domains: physical, emotional, social and school. Items are calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better quality of life. This secondary outcome measure will be used to determine the impact of PCS on quality of life on patients and families. |
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Inclusion Criteria:
Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they:
Exclusion Criteria: Patients will be excluded if they present with traumatic head injuries with any of the following:
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Subjects presenting to one the nine participating Canadian pediatric hospitals (IWK Health Sciences Centre (NS), CHU Sainte-Justine (PQ), Montreal Children's Hospital (PQ), Children's Hospital of Eastern Ontario (ON), The Hospital for Sick Children (ON), Children's Hospital of Western Ontario (ON), Children's Hospital of Winnipeg (MB), Stollery Children's Hospital (AB) and Alberta Children's Hospital (AB)) EDs after sustaining a head injury.
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| Name | Affiliation | Role |
|---|---|---|
| Roger L Zemek, MD | CHEO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Children's Hospital | Edmonton | Alberta | Canada | |||
| Children's Hospital of Winnipeg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36854112 | Derived | Engel J, van Ierssel JJ, Osmond MH, Tsampalieros A, Webster R, Zemek R. Return to the Emergency Department Within 3 Months Following Pediatric Acute Concussion. J Head Trauma Rehabil. 2023 Jul-Aug 01;38(4):319-328. doi: 10.1097/HTR.0000000000000852. Epub 2023 Feb 28. | |
| 32499388 | Derived | Gagnon I, Teel E, Gioia G, Aglipay M, Barrowman N, Sady M, Vaughan C, Zemek R; PEDIATRIC EMERGENCY RESEARCH CANADA (PERC) 5P TEAM. Parent-Child Agreement on Postconcussion Symptoms in the Acute Postinjury Period. Pediatrics. 2020 Jul;146(1):e20192317. doi: 10.1542/peds.2019-2317. Epub 2020 Jun 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Derivation Arm | Inclusion criteria. Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they: (1) are aged 5 to 17 years; (2) have a concussion, defined by Zurich consensus statement; (3) suffered the initial injury in the previous 48 hours; (4) are proficient in English or French. Exclusion criteria. Patients will be excluded if they present with traumatic head injuries with any of the following: GCS ≤13; any abnormality on standard neuroimaging studies,; neurosurgical operative intervention, intubation or PICU care required; multi-system injuries with treatment requiring admission to hospital, operating room or procedural sedation in the ED; severe chronic neurological developmental delay resulting in communication difficulties; intoxication at the time of ED presentation as per clinician judgment; no clear history of trauma as primary event (e.g., seizure, syncope or migraine as primary event); previously enrolled in this same study. |
| FG001 | Validation Arm | Inclusion criteria. Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they: (1) are aged 5 to 17 years; (2) have a concussion, defined by Zurich consensus statement; (3) suffered the initial injury in the previous 48 hours; (4) are proficient in English or French. Exclusion criteria. Patients will be excluded if they present with traumatic head injuries with any of the following: GCS ≤13; any abnormality on standard neuroimaging studies,; neurosurgical operative intervention, intubation or PICU care required; multi-system injuries with treatment requiring admission to hospital, operating room or procedural sedation in the ED; severe chronic neurological developmental delay resulting in communication difficulties; intoxication at the time of ED presentation as per clinician judgment; no clear history of trauma as primary event (e.g., seizure, syncope or migraine as primary event); previously enrolled in this same study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Derivation Cohort | |
| BG001 | Validation Cohort | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. | The primary outcome is the number of of children aged 5 - 17 years who have PCS at one-month follow-up. A PCS case is defined as an increase from pre-concussion baseline of three or more symptoms on the validated PCSI at one-month (consistent with the ICD-10 definition of PCS). | Completed 1-month followup. | Posted | Count of Participants | Participants | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | All enrolled participants. | 0 |
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Selection bias (children presenting to ED as compared to general primary care) may limit generalizability.
There is no control group (e.g., orthopedic injury) to compare symptom scores. Socio-economic status and race data were not collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger Zemek | Children's Hospital of Eastern Ontario | 613-737-7600 | rzemek@cheo.on.ca |
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| 1 month |
| Neuropsychological Evaluation | A separate battery of neuropsychological assessment measures will be administered to those children who choose to participate in this arm of the study. This battery includes measures of intelligence, language, visual-spatial/motor functions, attention, memory/working memory, executive functioning, academic achievement, as well as behavioural/socioemotional functioning. | 1 month and 3 month |
| Winnipeg |
| Manitoba |
| Canada |
| IWK Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Alberta Children's Hospital | Calgary | Ontario | Canada |
| Children's Hospital of Western Ontario | London | Ontario | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| CHU Sainte-Justine | Montreal | Quebec | Canada |
| Montreal Children's Hospital | Montreal | Quebec | Canada |
| 31316452 | Derived | Teel EF, Zemek RL, Tang K, Gioia G, Vaughan C, Sady M, Gagnon IJ; Pediatric Emergency Research Canada (PERC) Concussion Team. The Stability of Retrospective Pre-injury Symptom Ratings Following Pediatric Concussion. Front Neurol. 2019 Jun 27;10:672. doi: 10.3389/fneur.2019.00672. eCollection 2019. |
| 23906960 | Derived | Zemek R, Osmond MH, Barrowman N; Pediatric Emergency Research Canada (PERC) Concussion Team. Predicting and preventing postconcussive problems in paediatrics (5P) study: protocol for a prospective multicentre clinical prediction rule derivation study in children with concussion. BMJ Open. 2013 Aug 1;3(8):e003550. doi: 10.1136/bmjopen-2013-003550. |
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury | The PedsQLâ„¢ is a reliable and valid measure of health-related quality of life in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. The inventory covers four domains: physical, emotional, social and school. Items are calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better quality of life. This secondary outcome measure will be used to determine the impact of PCS on quality of life on patients and families. | Completed PedsQL at 1-month post-concussion. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 month |
|
|
|
| Secondary | Neuropsychological Evaluation | A separate battery of neuropsychological assessment measures will be administered to those children who choose to participate in this arm of the study. This battery includes measures of intelligence, language, visual-spatial/motor functions, attention, memory/working memory, executive functioning, academic achievement, as well as behavioural/socioemotional functioning. | Participants assessed at 4- and 12-weeks post-injury using direct, standardized measures of intellectual functioning, verbal memory, executive functioning, attention/working memory, processing speed and fine motor abilities. | Posted | Count of Participants | Participants | 1 month and 3 month |
|
|
|
| 3,063 |
| 0 |
| 3,063 |
| 0 |
| 3,063 |
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