title: Adherence of randomized trials within children's surgical specialties published during 2000 to 2009 to standard reporting guidelines.
abstract: BACKGROUND
  Randomized clinical trials (RCTs) are uncommon in pediatric surgical specialties and the quality of reporting is unknown. Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
  
  
  METHODS
  Published RCTs from January 1, 2000 through December 31, 2009 were reviewed. The trials were evaluated for the presence of 7 CONSORT guidelines and also graded according to the Jadad scale.
  
  
  RESULTS
  Two hundred and twenty-eight trials were included. Five trials met all 7 CONSORT criteria (2%) and 53 had a Jadad score of ≥3 (23%). Slightly more than 50% of all trials specified primary outcomes and <25% described power calculations according to CONSORT. Adherence to CONSORT guidelines for allocation concealment, randomization description, and attrition details was even lower. There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines. Pediatric general surgery had the largest number of published RCTs. Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 (40%).
  
  
  CONCLUSIONS
  Adherence to CONSORT guidelines is low across the spectrum of children's surgical specialties, although significant differences do exist. Future RCTs in children's surgical specialties should specifically focus on areas of low adherence to reporting guidelines.
authors: Department of Pediatric Surgery, Monroe Carell Jr Children's Hospital, Nashville, TN 37232, USA. martin.blakely@vanderbilt.edu
authors: Martin L
authors: ML
authors: Blakely
authors: Lillian S
authors: LS
authors: Kao
authors: Kuojen
authors: K
authors: Tsao
authors: Eunice Y
authors: EY
authors: Huang
authors: Anthony
authors: A
authors: Tsai
authors: Stacy
authors: S
authors: Tanaka
authors: Shiraz
authors: S
authors: Younas
authors: Zengqi
authors: Z
authors: Lu
authors: Kevin P
authors: KP
authors: Lally
mesh_terms: D002648:Child; D019983:Guideline Adherence / Q000592:standards*; D006801:Humans; D010372:Pediatrics / Q000592:standards*; D011643:Publishing / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D013043:Specialties, Surgical / Q000592:standards*