title: Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: a systematic review.
abstract: BACKGROUND
  Acute appendicitis is the most common surgical emergency in children. Despite this, there is no core outcome set (COS) described for randomised controlled trials (RCTs) in children with appendicitis and hence no consensus regarding outcome selection, definition and reporting. We aimed to identify outcomes currently reported in studies of paediatric appendicitis.
  
  
  METHODS
  Using a defined, sensitive search strategy, we identified RCTs and systematic reviews (SRs) of treatment interventions in children with appendicitis. Included studies were all in English and investigated the effect of one or more treatment interventions in children with acute appendicitis or undergoing appendicectomy for presumed acute appendicitis. Studies were reviewed and data extracted by two reviewers. Primary (if defined) and all other outcomes were recorded and assigned to the core areas 'Death', 'Pathophysiological Manifestations', 'Life Impact', 'Resource Use' and 'Adverse Events', using OMERACT Filter 2.0.
  
  
  RESULTS
  A total of 63 studies met the inclusion criteria reporting outcomes from 51 RCTs and nine SRs. Only 25 RCTs and four SRs defined a primary outcome. A total of 115 unique and different outcomes were identified. RCTs reported a median of nine outcomes each (range 1 to 14). The most frequently reported outcomes were wound infection (43 RCTs, nine SRs), intra-peritoneal abscess (41 RCTs, seven SRs) and length of stay (35 RCTs, six SRs) yet all three were reported in just 25 RCTs and five SRs. Common outcomes had multiple different definitions or were frequently not defined. Although outcomes were reported within all core areas, just one RCT and no SR reported outcomes for all core areas. Outcomes assigned to the 'Death' and 'Life Impact' core areas were reported least frequently (in six and 15 RCTs respectively).
  
  
  CONCLUSIONS
  There is a wide heterogeneity in the selection and definition of outcomes in paediatric appendicitis, and little overlap in outcomes used across studies. A paucity of studies report patient relevant outcomes within the 'Life Impact' core area. These factors preclude meaningful evidence synthesis, and pose challenges to designing prospective clinical trials and cohort studies. The development of a COS for paediatric appendicitis is warranted.
authors.affiliation: Faculty of Medicine, University of Southampton, Southampton, UK. n.j.hall@soton.ac.uk.|Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK. n.j.hall@soton.ac.uk.
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Hall
authors.affiliation: Toronto Outcomes Research in Child Health (TORCH), SickKids Research Institute, Toronto, Canada. mufiza.kapadia@sickkids.ca.
authors.forename: Mufiza Z
authors.initials: MZ
authors.lastname: Kapadia
authors.affiliation: Developmental Biology Programme, UCL Institute of Child Health, London, UK. s.eaton@ucl.ac.uk.
authors.forename: Simon
authors.initials: S
authors.lastname: Eaton
authors.affiliation: Toronto Outcomes Research in Child Health (TORCH), SickKids Research Institute, Toronto, Canada. winnie.chan@sickkids.ca.
authors.forename: Winnie W Y
authors.initials: WW
authors.lastname: Chan
authors.affiliation: Hospital Library and Archives, The Hospital for Sick Children, Toronto, Canada. cheri.nickel@sickkids.ca.
authors.forename: Cheri
authors.initials: C
authors.lastname: Nickel
authors.affiliation: Division of General and Thoracic Surgery, The Hospital for Sick Children, Toronto, Canada. agostino.pierro@sickkids.ca.
authors.forename: Agostino
authors.initials: A
authors.lastname: Pierro
authors.affiliation: Toronto Outcomes Research in Child Health (TORCH), SickKids Research Institute, Toronto, Canada. martin.offringa@sickkids.ca.
authors.forename: Martin
authors.initials: M
authors.lastname: Offringa
mesh_terms: D000208:Acute Disease; D001064:Appendicitis / Q000628:therapy*; D002648:Child; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome