1 Department of Sports Science and Clinical Biomechanics, Det Sundhedsvidenskabelige Fakultet, SDU2 Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, Det Sundhedsvidenskabelige Fakultet, SDU3 Orthopaedics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU4 Harvard Medical School5 Orthopaedics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU
Design and conduct of clinical trials of surgical interventions for osteoarthritis
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.
Journal review article
Osteoarthritis and Cartilage, 2015, Vol 23, Issue 5, p. 798-802