title: OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis.
abstract: To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each challenge raised in the paper, we propose potential solutions. Enrollment poses challenges in maintaining investigator equipoise, managing conflict of interest and anticipating that patient preferences for specific treatments may reduce enrollment. Intervention design and implementation pose challenges relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies for addressing these challenges.
authors.affiliation: Department of Orthopedic Surgery and Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, USA. Electronic address: jnkatz@partners.org.
authors.forename: J N
authors.initials: JN
authors.lastname: Katz
authors.affiliation: Department of Orthopedic Surgery and Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, USA.
authors.forename: E
authors.initials: E
authors.lastname: Losina
authors.affiliation: Department of Orthopedic Surgery, Clinical Sciences Lund, Lund University, Sweden; Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark; Department of Orthopedics and Traumatology, University of Southern Denmark, Denmark.
authors.forename: L S
authors.initials: LS
authors.lastname: Lohmander
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D019637:Orthopedic Procedures / Q000592:standards*; D010003:Osteoarthritis / Q000601:surgery*; D017410:Practice Guidelines as Topic
keywords: Blinding; Cross-over; Randomized trial; Sham; Surgery