title: Complication reporting in orthopaedic trials. A systematic review of randomized controlled trials.
abstract: BACKGROUND
  The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials.
  
  
  METHODS
  Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories.
  
  
  RESULTS
  One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications.
  
  
  CONCLUSIONS
  The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.
authors: AO Clinical Investigation and Documentation, Stettbachstrasse 6, 8600 Dübendorf, Switzerland. sabine.goldhahn@aofoundation.org
authors: S
authors: S
authors: Goldhahn
authors: T
authors: T
authors: Sawaguchi
authors: L
authors: L
authors: Audigé
authors: R
authors: R
authors: Mundi
authors: B
authors: B
authors: Hanson
authors: M
authors: M
authors: Bhandari
authors: J
authors: J
authors: Goldhahn
mesh_terms: D035843:Biomedical Research; D006801:Humans; D007431:Intraoperative Complications; D009985:Orthopedics; D011183:Postoperative Complications; D011643:Publishing / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design / Q000592:standards