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Measuring Beneficial and Adverse Events in Osteoarthritis Clinical Trials

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Abstract

Outcome assessment in osteoarthritis (OA) clinical trials is dependent on the use of valid, reliable, and responsive measurement procedures. The measurement of antirheumatic drug efficacy currently lacks international standardization, and current guidelines are not in complete agreement. There remains an urgent need to agree on a core set of outcome measures for hip OA, knee OA, hand OA, and generalized OA clinical trials. A degree of harmonization has been achieved in the measurement of adverse events using the WHO and COSTART systems. However, different methods of eliciting adverse events result in different event rate scores. The optimum method of assessing beneficial and adverse events in OA clinical trials has yet to be elucidated but is the subject of ongoing research and discussion.

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References

  1. Bellamy N. Introduction. In:Musculoskeletal Clinical Metrology. Dordrecht: Kluwer Academic Publishers; 1993:3–4.

    Google Scholar 

  2. Taylor D. A table for the degree of involvement in chronic arthritis. Can Med Assoc J. 1937;36:608–10.

    PubMed  CAS  Google Scholar 

  3. Bellamy N. The evolution of assessment techniques. In: Musculoskeletal Clinical Metrology. Dordrecht: Kluwer Academic Publishers; 1993:5–9.

    Google Scholar 

  4. Bellamy N. Future perspective. In: Musculoskeletal Clinical Metrology. Dordrecht: Kluwer Academic Publishers; 1993:253–68.

    Google Scholar 

  5. WHO. Guidelines for the clinical investigation of drugs used in rheumatic diseases, European Drug Guidelines, Series 5, World Health Organization, Regional Office for Europe, Copenhagen, European League Against Rheumatism. March 1985:1–4.

    Google Scholar 

  6. Guidelines for the clinical evaluation of anti-inflammatory and anti-rheumatic drugs (adults and children). US Department of Health and Human Services. Public Health Services, Food and Drug Administration, April 1988:12–15.

    Google Scholar 

  7. Lequesne M, Brandt K, Bellamy N, et al. Guidelines for the testing slow acting drugs in osteoarthritis. J Rheumatol. 1994;21(Suppl. 41):65–71.

    Google Scholar 

  8. Bellamy N. Osteoarthritis. In: Musculoskeletal Clinical Metrology. Dordrecht: Kluwer Academic Publishers; 1993:169–76.

    Google Scholar 

  9. Bellamy N. WOMAC Osteoarthritis Index - A User’s Guide. London, Canada: Victoria Hospital; 1995.

    Google Scholar 

  10. Lequesne M. Indices of severity and disease activity for osteoarthritis. Semin Arthritis Rheum. 1991;20(Suppl. 2):48–54.

    Article  PubMed  CAS  Google Scholar 

  11. Bellamy N. Health status instruments and functional indices. In: Musculoskeletal Clinical Metrology. Dordrecht: Kluwer Academic Publishers; 1993:77–101.

    Google Scholar 

  12. Drieser R-L, Maheu E, Guillou GB, Caspard H, Grouin J-M. Validation of an algofunctional index for osteoarthritis of the hand. Revue du Rhumatisme, English Edition, Joint Bone, Spine Diseases. 1995;6(Suppl. 1):43S–53S.

    Google Scholar 

  13. Bellamy N, Buchanan WW. Clinical evaluation in the rheumatic diseases. In: Koopman WJ, ed. Arthritis and Allied Conditions, 13th edn. Baltimore: Williams & Wilkins; 1996: [in press].

    Google Scholar 

  14. Hawker G, Melfi C, Paul J, Green R, Bombardier C. Comparison of a generic (SF-36) and a disease specific (WOMAC) instrument in the measurement of outcomes after knee replacement surgery. J Rheumatol. 1995;22:1193–6.

    PubMed  CAS  Google Scholar 

  15. Doyle DV, Dieppe PA, Scott J, Huskisson EC. An articular index for the assessment of osteoarthritis. Ann Rheum Dis. 1981;40:75–8.

    Article  PubMed  CAS  Google Scholar 

  16. Rosenbloom D, Brooks P, Bellamy N, Buchanan W. Osteoarthritis. In: Clinical Trials in the Rheumatic Diseases. A Selected Critical Review. New York: Praeger Publishers; 1985:19–69.

    Google Scholar 

  17. Peloso PMJ. The validation of the patient oriented symptoms index for measuring patient side effects in rheumatology clinical trials. M.Sc. Thesis, University of Toronto, Toronto, Canada, 1994.

    Google Scholar 

  18. COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms, 3rd edn. US Dept of Commerce, National Technical Information Service, Springfield, Virginia, 1989.

    Google Scholar 

  19. WHO. The WHO Adverse Reaction Dictionary. WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden, 1990.

    Google Scholar 

  20. Fries JF, Spitz PW,Williams CA, Bloch DA, Sing G, Hubert HB. A toxicity index for comparison of side effects among different drugs. Arthritis Rheum. 1990;33:121–30.

    Article  PubMed  CAS  Google Scholar 

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© 1997 Springer Science+Business Media Dordrecht

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Bellamy, N. (1997). Measuring Beneficial and Adverse Events in Osteoarthritis Clinical Trials. In: Rainsford, K.D. (eds) Side Effects of Anti-Inflammatory Drugs IV. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-5394-2_5

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  • DOI: https://doi.org/10.1007/978-94-011-5394-2_5

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-6269-5

  • Online ISBN: 978-94-011-5394-2

  • eBook Packages: Springer Book Archive

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