title: OARSI Clinical Trials Recommendations: Design, conduct, and reporting of clinical trials for knee osteoarthritis.
abstract: The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA.
authors.affiliation: Division of Rheumatology, Tufts Medical Center, 800 Washington Street, Box 406, Boston, MA 02111, USA.
authors.forename: T E
authors.initials: TE
authors.lastname: McAlindon
authors.affiliation: Division of Rheumatology, Tufts Medical Center, 800 Washington Street, Box 406, Boston, MA 02111, USA. Electronic address: jeffrey.driban@tufts.edu.
authors.forename: J B
authors.initials: JB
authors.lastname: Driban
authors.affiliation: Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège, Belgium; Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne, Belgium.
authors.forename: Y
authors.initials: Y
authors.lastname: Henrotin
authors.affiliation: Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia; Rheumatology Department, Royal North Shore Hospital, Sydney, NSW, Australia.
authors.forename: D J
authors.initials: DJ
authors.lastname: Hunter
authors.affiliation: Sanofi Biosurgery, Development Franchise of Immunology & Inflammation, 55 Cambridge Pkwy, Cambridge, MA 02142, USA.
authors.forename: G-L
authors.initials: GL
authors.lastname: Jiang
authors.affiliation: Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5000 Odense, Denmark; Orthopaedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.
authors.forename: S T
authors.initials: ST
authors.lastname: Skou
authors.affiliation: Global Pharmaceutical R&D, Abbvie, 1 North Waukegan Rd, North Chicago, IL 60064, USA.
authors.forename: S
authors.initials: S
authors.lastname: Wang
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.
authors.forename: T
authors.initials: T
authors.lastname: Schnitzer
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D019468:Disease Management; D006801:Humans; D020370:Osteoarthritis, Knee / Q000628:therapy*; D017410:Practice Guidelines as Topic
keywords: Clinical trial; Consensus statement; Knee; Osteoarthritis