title: Surgical-site infections and postoperative complications: agreement between the Danish Gynecological Cancer Database and a randomized clinical trial.
abstract: OBJECTIVE
  Surgical-site infections are serious complications and thorough follow-up is important for accurate surveillance. We aimed to compare the frequency of complications recorded in a clinical quality database with those noted in a randomized clinical trial with follow-up visits.
  
  
  METHODS
  Evaluation study.
  
  
  METHODS
  Danish Gynecological Cancer Database (DGCD) and the Danish multicenter trial on perioperative oxygen and surgical-site infections (PROXI).
  
  
  METHODS
  Paired data from 222 patients who participated in the PROXI trial taking place at Copenhagen University Hospital, Rigshospitalet between November 2006 and October 2008 and data from the DGCD.
  
  
  METHODS
  Outcomes within 30 days from the trial and the database were compared and levels of agreements were calculated with kappa-statistics.
  
  
  METHODS
  Primary outcome was surgical-site infection. Other outcomes included re-operation, urinary tract infection, pneumonia and sepsis.
  
  
  RESULTS
  Surgical-site infection was found in 21 of 222 patients (9.5%) in the PROXI trial versus 6 of 222 patients (2.7%) in the DGCD (p < 0.01, kappa 0.42). Twelve of 15 superficial and three of six deep or organ-space surgical-site infections were registered in the PROXI trial, but not in the DGCD. Agreements between secondary outcomes were very varying (kappa-value 0.77 for re-operation, 0.37 for urinary tract infections, 0.19 for sepsis and 0.18 for pneumonia).
  
  
  CONCLUSIONS
  The randomized trial reported significantly more surgical-site infections than the clinical database. The DGCD reported only 50% of the deep and organ-space infections, and hence, the low-overall agreement indicates a need for more careful database registration.
authors.affiliation: Gynecological Clinic, Copenhagen University Hospital, Rigshospitalet, Denmark. sleisby@dadlnet.dk
authors.forename: Sofie L
authors.initials: SL
authors.lastname: Antonsen
authors.forename: Christian S
authors.initials: CS
authors.lastname: Meyhoff
authors.forename: Lene
authors.initials: L
authors.lastname: Lundvall
authors.forename: Claus
authors.initials: C
authors.lastname: Høgdall
mesh_terms: D000328:Adult; D000368:Aged; D016208:Databases, Factual; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D005833:Genital Neoplasms, Female / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects*; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010102:Oxygen Inhalation Therapy; D019990:Perioperative Care; D016032:Randomized Controlled Trials as Topic; D013530:Surgical Wound Infection / Q000453:epidemiology* / Q000517:prevention & control