title: How to Use a Randomized Clinical Trial Addressing a Surgical Procedure: Users' Guide to the Medical Literature.
abstract: Because surgical procedures require clinicians to develop and maintain procedural expertise and because blinding in randomized clinical trials of such therapies is often challenging, their critical appraisal raises unique issues. Risk of bias of trials of surgical procedures increases if investigators fail to rigorously conceal allocation and, where possible, to ensure blinding of those involved in the trial. Variability in surgeons' expertise can also increase bias and lead to important limitations in applicability. To address these issues, this Users' Guide to the Medical Literature reviews the use of remote randomization systems, blinding, sham-controlled trials, split-body trials, expertise-based trials, and mechanistic vs practical trials. Consideration of risk of bias and applicability issues will allow clinicians to make optimal use of trials addressing surgical procedures.
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada2Division of Orthopaedics, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Nathan
authors.initials: N
authors.lastname: Evaniew
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada3Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile.
authors.forename: Alonso
authors.initials: A
authors.lastname: Carrasco-Labra
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada4Population Health Research Institute, Hamilton, Ontario, Canada.
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
authors.affiliation: Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland6Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
authors.forename: Kari A O
authors.initials: KA
authors.lastname: Tikkinen
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada7Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
authors.forename: Yutong
authors.initials: Y
authors.lastname: Fei
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada2Division of Orthopaedics, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada8Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Gordon
authors.initials: G
authors.lastname: Guyatt
mesh_terms: D015982:Bias; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012196:Review Literature as Topic; D013514:Surgical Procedures, Operative