title: Clinical experience may affect clinician compliance with assigned treatment in randomized trials.
abstract: OBJECTIVE
  To examine the relationship between clinical experience and clinician compliance with the study protocol in randomized clinical trials.
  
  
  METHODS
  A recent randomized trial of surgical techniques for tibial fracture fixation. We consider rates of treatment crossovers and other noncompliance as a function of the relevant experience of the surgeon. We also examined the effects of noncompliance on patient outcomes.
  
  
  RESULTS
  Crossovers from assigned treatment to the alternative occurred much more frequently in one arm than the other. The impact of surgical experience on crossovers was less clear, although there was some evidence that noncompliance with more difficult surgery was more frequent for less experienced surgeons. This raises the possibility that experience may be an important factor in other scenarios, affecting both compliance and patient outcomes.
  
  
  CONCLUSIONS
  In randomized clinical trials, noncompliance by clinicians with the randomly assigned treatment can be highly detrimental to the power of the study. Further research is needed in this area to identify, quantify, and understand the factors associated with noncompliance, including clinical experience.
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, CRL233 Hamilton, Ontario L8N 3Z5, Canada. walter@mcmaster.ca
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Walter
authors.forename: Afisi S
authors.initials: AS
authors.lastname: Ismaila
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Cook
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
authors.forename: Kari A O
authors.initials: KA
authors.lastname: Tikkinen
authors.forename: Gordon H
authors.initials: GH
authors.lastname: Guyatt
mesh_terms: D002983:Clinical Competence; D005592:Fracture Fixation / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D010818:Practice Patterns, Physicians'; D016032:Randomized Controlled Trials as Topic / Q000592:standards / Q000639:trends; D012107:Research Design; D011795:Surveys and Questionnaires; D013978:Tibial Fractures / Q000601:surgery*; D016896:Treatment Outcome