title: Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial.
abstract: BACKGROUND
  Point-of-care blood C-reactive protein (CRP) testing has diagnostic value in helping clinicians rule out the possibility of serious infection. We investigated whether it should be offered to all acutely ill children in primary care or restricted to those identified as at risk on clinical assessment.
  
  
  METHODS
  Cluster randomised controlled trial involving acutely ill children presenting to 133 general practitioners (GPs) at 78 GP practices in Belgium. Practices were randomised to undertake point-of-care CRP testing in all children (1730 episodes) or restricted to children identified as at clinical risk (1417 episodes). Clinical risk was assessed by a validated clinical decision rule (presence of one of breathlessness, temperature ≥ 40 °C, diarrhoea and age 12-30 months, or clinician concern). The main trial outcome was hospital admission with serious infection within 5 days. No specific guidance was given to GPs on interpreting CRP levels but diagnostic performance is reported at 5, 20, 80 and 200 mg/L.
  
  
  RESULTS
  Restricting CRP testing to those identified as at clinical risk substantially reduced the number of children tested by 79.9 % (95 % CI, 77.8-82.0 %). There was no significant difference between arms in the number of children with serious infection who were referred to hospital immediately (0.16 % vs. 0.14 %, P = 0.88). Only one child with a CRP < 5 mg/L had an illness requiring admission (a child with viral gastroenteritis admitted for rehydration). However, of the 80 children referred to hospital to rule out serious infection, 24 (30.7 %, 95 % CI, 19.6-45.6 %) had a CRP < 5 mg/L.
  
  
  CONCLUSIONS
  CRP testing should be restricted to children at higher risk after clinical assessment. A CRP < 5 mg/L rules out serious infection and could be used by GPs to avoid unnecessary hospital referrals.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02024282 (registered on 14thSeptember 2012).
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Woodstock Road, Oxford, OX2 6GG, UK. jan.verbakel@phc.ox.ac.uk.|Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33J, 3000, Leuven, Belgium. jan.verbakel@phc.ox.ac.uk.
authors.forename: Jan Y
authors.initials: JY
authors.lastname: Verbakel
authors.affiliation: Department of Family Medicine and Primary Health Care, Ghent University, De Pintelaan 185, Gent, 9000, Belgium.
authors.forename: Marieke B
authors.initials: MB
authors.lastname: Lemiengre
authors.affiliation: Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33J, 3000, Leuven, Belgium.
authors.forename: Tine
authors.initials: T
authors.lastname: De Burghgraeve
authors.affiliation: Department of Family Medicine and Primary Health Care, Ghent University, De Pintelaan 185, Gent, 9000, Belgium.
authors.forename: An
authors.initials: A
authors.lastname: De Sutter
authors.affiliation: Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33J, 3000, Leuven, Belgium.
authors.forename: Bert
authors.initials: B
authors.lastname: Aertgeerts
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, 101 Clarendon Road, Leeds, LS29LJ, UK.
authors.forename: Bethany
authors.initials: B
authors.lastname: Shinkins
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Woodstock Road, Oxford, OX2 6GG, UK.
authors.forename: Rafael
authors.initials: R
authors.lastname: Perera
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Woodstock Road, Oxford, OX2 6GG, UK.
authors.forename: David
authors.initials: D
authors.lastname: Mant
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Woodstock Road, Oxford, OX2 6GG, UK.
authors.forename: Ann
authors.initials: A
authors.lastname: Van den Bruel
authors.affiliation: Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33J, 3000, Leuven, Belgium.|Research Institute Caphri, Maastricht University, Universiteitssingel 40, Maastricht, 6229 ER, The Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: Buntinx
mesh_terms: D001530:Belgium; D002097:C-Reactive Protein / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007239:Infections / Q000175:diagnosis*; D008297:Male; D000067716:Point-of-Care Testing; D011320:Primary Health Care / Q000379:methods
chemical_list: D002097:C-Reactive Protein
keywords: C-reactive protein; Child; Point-of-care; Primary care; Serious infection