1. Beaton DE, Schemitsch E: Measures of health-related quality of life and physical function. Clin Orth Rel Res 2003, 413:90–105. A thorough review of patient-reported outcome measures developed for musculoskeletal research.
2. Bellamy N, Kirwan J, Boers M, et al.: Recommendations for a core set of outcome measures for future Phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 1997, 24:799–802. Summarizes the recommended domains to be assessed in RCTs in OA.
3. Altman R, Brandt K, Hochberg M, Moskowitz R: Design and conduct of clinical trails in patients with osteoarthritis: recommendations from a task force of the osteoarthritis research society. Osteoarthritis Cartilage 1996, 4:217–243.
4. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Devices and Radiologic Health: Guidance for industry: clinical development programs for drugs, devices and biological products intended for the treatment of osteoarthritis. Washington, DC: US Department of Health and Human Services; 1999.
5. European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit, Committee for Proprietary Medicinal Products: Points to Consider on Clinical Investigation of Medicinal Products Used in the Treatment of Osteoarthritis. London: EMEA; 1998.