title: How to document and report orthopedic complications in clinical studies? A proposal for standardization.
abstract: BACKGROUND
  The documentation of complications is critical for the evaluation of therapeutic interventions in orthopedics. However, there is a lack of accepted methodological standardization and definitions. We propose a concept to support the consensus development of a standardized management and classification of complications in clinical research.
  
  
  METHODS
  Complication events are examined regarding their clinical presentation, their timing of occurrence as well as their potential causal interrelationship for any given patient. Their clinical presentation is distinguished by their likely triggers, their therapeutic management, and their outcome. Complications are events (including relevant deviations from their expected healing process) that are harmful to patients and can be described as local to the treated injury/disease or systemic (when they affect the rest of the body). The treatment of a complication, e.g. by way of an unplanned surgical intervention, and its outcome should be carefully documented. Complication review boards with independent clinicians should be established to validate complication records.
  In this proposal, a number of complication examples are presented to illustrate the concept and demonstrate its practical use. This management and classification system has already proven valuable in the documentation and analysis of complication data from a number of published clinical studies. Because of this new standardized assessment process, it facilitates the communication of complications between clinicians and researchers, and helps to develop clear definitions for specific orthopedic complications.
authors: AO Clinical Investigation and Documentation, AO Foundation, Stettbachstrasse 6, 8600, Dübendorf, Switzerland, laurent.audige@aofoundation.org.
authors: Laurent
authors: L
authors: Audigé
authors: Sabine
authors: S
authors: Goldhahn
authors: Monica
authors: M
authors: Daigl
authors: Jörg
authors: J
authors: Goldhahn
authors: Michael
authors: M
authors: Blauth
authors: Beate
authors: B
authors: Hanson
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D004282:Documentation / Q000592:standards*; D006801:Humans; D019637:Orthopedic Procedures / Q000009:adverse effects*; D011183:Postoperative Complications / Q000453:epidemiology; D012107:Research Design; D012784:Shoulder Fractures / Q000601:surgery