Predicting Persistent Postconcussive Problems in Pediatrics (5P)
Condition: Concussions; PCS
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Keywords: Concussions; Persistent post-concussion symptoms; PCS; Clinical Prediction Rule