title: Core outcomes and definitions for pediatric fever and neutropenia research: a consensus statement from an international panel.
abstract: BACKGROUND
  There are no specific recommendations for the design and reporting of studies of children with fever and neutropenia (FN). As a result, there is marked heterogeneity in the variables and outcomes that are reported and new definitions continue to emerge. These inconsistencies hinder the ability of researchers and clinicians to compare, contrast and combine results. The objective was to achieve expert consensus on a core set of variables and outcomes that should be measured and reported, as a minimum, in pediatric FN studies.
  
  
  METHODS
  The Delphi method was used to achieve consensus among an international group of clinicians, pharmacists, researchers, and patient representatives. Four surveys focusing on (i) the identification of a core set of variables and outcomes; and (ii) definitions of these variables and outcomes, were administered electronically. Consensus was predefined as more than 80% agreement on any statement.
  
  
  RESULTS
  There were forty-five survey participants and the response rate ranged between 84 and 96%. There was consensus on eight core variables and 10 core outcomes that should be collected and reported in all studies of children with FN. Consensus definitions were identified for all of the core outcomes.
  
  
  CONCLUSIONS
  Using the Delphi method, expert consensus on a set of core variables and outcomes, and their corresponding definitions, was achieved. These core sets represent the minimum that should be collected and reported in all studies of children with FN. This will promote collaboration and ensure consistency and comparability between studies.
authors.affiliation: Department of Infectious Diseases and Infection Control, Peter MacCallum Cancer Centre, Melbourne, Australia; Department of Infectious Diseases, Monash Children's Hospital, Monash Health, Melbourne, Australia; Paediatric Integrated Cancer Service, Victoria, Australia.
authors.forename: Gabrielle M
authors.initials: GM
authors.lastname: Haeusler
authors.forename: Robert S
authors.initials: RS
authors.lastname: Phillips
authors.forename: Thomas
authors.initials: T
authors.lastname: Lehrnbecher
authors.forename: Karin A
authors.initials: KA
authors.lastname: Thursky
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
authors.forename: Roland A
authors.initials: RA
authors.lastname: Ammann
mesh_terms: D000293:Adolescent; D035843:Biomedical Research; D002648:Child; D002675:Child, Preschool; D032921:Consensus; D005260:Female; D005334:Fever / Q000145:classification / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D007223:Infant; D008297:Male; D009503:Neutropenia / Q000145:classification / Q000175:diagnosis / Q000628:therapy; D011795:Surveys and Questionnaires
keywords: child; consensus; definitions; fever; neutropenia; outcomes