Emery, C. A.3; Roos, Ewa M.10; Verhagen, E.4; Finch, C. F.5; Bennell, K. L.6; Story, B.7; Spindler, K.8; Kemp, J.5; Lohmander, L. S.11
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 University of Calgary4 VU University Medical Center5 Federation University Australia6 University of Melbourne7 DePuy Synthes8 Cleveland Clinic9 Orthopaedics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU10 Department of Sports Science and Clinical Biomechanics, Det Sundhedsvidenskabelige Fakultet, SDU11 Orthopaedics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU
Design and conduct of clinical trials for primary prevention of osteoarthritis by joint injury prevention in sport and recreation
The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for injury prevention RCTs are critical to informing evidence-based practice and policy decisions in health care, public health and the community. Recommendations regarding the interpretation and conduct of injury prevention RCTs will inform the highest level of evidence in the field. These recommendations will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact.
Journal review article
Osteoarthritis and Cartilage, 2015, Vol 23, Issue 5, p. 815-825