title: Predicting and preventing postconcussive problems in paediatrics (5P) study: protocol for a prospective multicentre clinical prediction rule derivation study in children with concussion.
abstract: Persistent postconcussive symptoms (PCSs) is the persistence of somatic, cognitive, physical, psychological and/or behavioural changes lasting more than 1 month following concussion. Persistent concussion impacts the quality of life through impaired cognition, memory and attention affecting school performance, mood and social engagement. No large epidemiological studies have determined the true prevalence of persistent concussion symptoms. Validated, easy-to-use prognosticators do not exist for clinicians to identify children at highest risk. The goal of Predicting and Preventing Postconcussive Problems in Pediatrics study is to derive a clinical prediction rule for the development of persistent postconcussion symptoms in children and adolescents presenting to emergency department following acute head injury.
  
  
  
  This study is a prospective, multicentre cohort study across nine academic Canadian paediatric emergency departments. We will recruit the largest prospective epidemiological cohort of children with concussion. Eligible children will be followed using Post-Concussion Symptom Inventory, a validated tool in children as young as 5 years. Patients will follow-up at 1, 2, 4, 8 and 12 weeks postinjury. The main outcome will be the presence/absence of PCSs defined as three or more persistent concussion symptoms 1 month following the injury. 1792 patients provide adequate power to derive a clinical decision rule using multivariate analyses to find predictor variables sensitive for detecting cases of persistent postconcussion symptoms.
  
  
  
  Results of this large prospective study will enable clinicians to identify children at highest risk, optimise treatment and provide families with realistic and appropriate anticipatory guidance. Ethics has been obtained through the Children's Hospital of Eastern Ontario Research Ethics Board. Results will be disseminated at international conferences and in four manuscripts to peer-reviewed journals.
  
  
  
  This study is registered at Clinicaltrials.gov through the US National Institute of Health/National Library of Medicine (NCT01873287; http://clinicaltrials.gov/ct2/show/NCT01873287).
authors.affiliation: Departments of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Roger
authors.initials: R
authors.lastname: Zemek
authors.forename: Martin H
authors.initials: MH
authors.lastname: Osmond
authors.forename: Nick
authors.initials: N
authors.lastname: Barrowman
keywords: Accident & Emergency Medicine; Epidemiology; Paediatrics; Sports Medicine
references.citation: Lancet. 1975 Nov 22;2(7943):995-7
references.pmid: 53547
references.citation: Clin J Sport Med. 2010 Jan;20(1):21-7
references.pmid: 20051730
references.citation: J Neurol Neurosurg Psychiatry. 2002 Sep;73(3):330-2
references.pmid: 12185174
references.citation: CMAJ. 2003 Jul 22;169(2):124-8
references.pmid: 12874161
references.citation: J Child Psychol Psychiatry. 1999 Jul;40(5):791-9
references.pmid: 10433412
references.citation: J Head Trauma Rehabil. 1999 Aug;14(4):337-50
references.pmid: 10407207
references.citation: J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8
references.pmid: 16983222
references.citation: Ann Emerg Med. 1999 Apr;33(4):437-47
references.pmid: 10092723
references.citation: Clin Sports Med. 2011 Jan;30(1):115-24, ix
references.pmid: 21074086
references.citation: Pediatrics. 2007 Apr;119(4):749-58
references.pmid: 17403846
references.citation: Cochrane Database Syst Rev. 2011 Jan 19;(1):CD008409
references.pmid: 21249708
references.citation: Acad Emerg Med. 2013 Oct;20(10):1041-9
references.pmid: 24127708
references.citation: J Int Neuropsychol Soc. 2009 Jan;15(1):19-30
references.pmid: 19128525
references.citation: Br J Sports Med. 2013 Apr;47(5):250-8
references.pmid: 23479479
references.citation: J Biomed Inform. 2009 Apr;42(2):377-81
references.pmid: 18929686
references.citation: Pediatrics. 2011 Sep;128(3):e666-77
references.pmid: 21859912
references.citation: Pediatrics. 2009 Jan;123(1):114-23
references.pmid: 19117869
references.citation: Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):666-7
references.pmid: 22393173
references.citation: JAMA. 2011 Jul 6;306(1):79-86
references.pmid: 21632470
references.citation: Pediatr Emerg Care. 1997 Feb;13(1):1-4
references.pmid: 9061724
references.citation: Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):615-22
references.pmid: 22393171
references.citation: J Int Neuropsychol Soc. 2011 Sep;17(5):886-95
references.pmid: 21813031
references.citation: Neurotherapeutics. 2010 Jan;7(1):91-9
references.pmid: 20129501
references.citation: Brain Inj. 2000 Dec;14(12):1077-88
references.pmid: 11147580
references.citation: PLoS Med. 2012;9(5):1-12
references.pmid: 22629234
references.citation: CMAJ. 2012 Aug 7;184(11):1257-64
references.pmid: 22711732
references.citation: Br J Sports Med. 2009 May;43 Suppl 1:i13-22
references.pmid: 19433419
references.citation: Stat Med. 1996 Feb 28;15(4):361-87
references.pmid: 8668867
references.citation: Am Fam Physician. 2012 Jan 15;85(2):123-32
references.pmid: 22335212
references.citation: CMAJ. 2010 Mar 9;182(4):341-8
references.pmid: 20142371
references.citation: J Pediatr. 2010 Dec;157(6):873-5
references.pmid: 20888010
references.citation: JAMA Pediatr. 2013 Mar 1;167(3):259-65
references.pmid: 23303474
references.citation: J Pediatr Psychol. 2010 Aug;35(7):716-27
references.pmid: 19995865
references.citation: Neurosurgery. 2012 Oct;71(4):885-91
references.pmid: 22743360
references.citation: Pediatrics. 2010 Aug;126(2):e374-81
references.pmid: 20660554
references.citation: CMAJ. 2012 Feb 7;184(2):189-91
references.pmid: 22271923
references.citation: J Int Neuropsychol Soc. 2005 Jul;11(4):345-57
references.pmid: 16209414
references.citation: JAMA. 1999 Sep 8;282(10):971-3
references.pmid: 10485683
references.citation: J Neurotrauma. 2012 Mar 1;29(4):639-53
references.pmid: 21939389
references.citation: Brain Dev. 2004 Mar;26(2):113-7
references.pmid: 15036430
references.citation: Brain Inj. 2009 Nov;23(12):956-64
references.pmid: 19831492
references.citation: CMAJ. 2011 Aug 9;183(11):1249-56
references.pmid: 21690221
references.citation: Clin Pharmacol Ther. 1981 Jan;29(1):111-23
references.pmid: 7460469
references.citation: N Engl J Med. 2012 Mar 1;366(9):819-26
references.pmid: 22375973
references.citation: J Pediatr. 2010 Dec;157(6):889-93
references.pmid: 20708747
references.citation: Neurosurgery. 2005 Oct;57(4):719-26; discussion 719-26
references.pmid: 16239884
references.citation: Biometrics. 1977 Mar;33(1):159-74
references.pmid: 843571
references.citation: Pediatrics. 2001 Dec;108(6):1297-303
references.pmid: 11731651
references.citation: J Clin Epidemiol. 1996 Dec;49(12):1373-9
references.pmid: 8970487
references.citation: J Head Trauma Rehabil. 2009 Sep-Oct;24(5):303-12
references.pmid: 19858964
references.citation: Stat Med. 2004 May 30;23(10):1631-60
references.pmid: 15122742