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Outcome measurement in osteoarthritis clinical trials: The case for standardisation

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Summary

Outcome measures for clinical trials to be valid and reliable should also be responsive to change. There are currently no standardised methods of measuring the outcome in osteoarthritis clinical trials. A review of 63 trials of nonsteroidal anti-inflammatory drugs revealed a large degree of variability in the items, instruments and scales employed. The implications of this variability are discussed and methods proposed for rationalising outcome measurement in this area of clinical research.

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References

  1. Carmines, E.G., Zeller, R.A. Reliability and validity assessment. Beverley Hills, Sage Publications, 1979, 5–71.

    Google Scholar 

  2. Reliability and Validity. In: Standards for educational and psychological tests. American Psychological Association Inc. Washington, D.C. 1974, 25–55.

  3. Bellamy, N. Osteoarthritis — An evaluative index for clinical trials. 1982. M.Sc. Thesis. McMaster University, Hamilton, Ontario.

    Google Scholar 

  4. Convery, F.R., Minteer, M.A., Amiel, D., Connett, K.L. Polyarticular disability: a functional assessment. Arch Phys Med Rehabil, 1977, 58, 494–499.

    Google Scholar 

  5. Deniston, O.L., Jette, A., A functional status assessment instrument: validation in an elderly population. Health Serv Res, 1980, 15, 21–34.

    Google Scholar 

  6. Doyle, D.V., Dieppe, P.A., Scott, J., Huskisson, E.C. An articular index for the assessment of osteoarthritis. Ann Rheum Dis, 1981, 40, 75–78.

    Google Scholar 

  7. Eberl, D.R., Fasching, V., Rahlfs, V., Schleyer, I., Wolf, R. Repeatability and objectivity of various measurements in rheumatoid arthritis. Arthritis Rheum, 1976, 19, 1278–1286.

    Google Scholar 

  8. Empire Rheumatism Council. Multicentre controlled trial comparing cortisone acetate and acetyl salicylic acid in the long-term treatment of rheumatoid arthritis. Ann Rheum Dis, 1955, 14, 353–370.

    Google Scholar 

  9. Fries, J.F., Spitz, P., Kraines, R.G., Holman, H.R. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980, 23, 137–145.

    Google Scholar 

  10. Jette, A.M., Deniston, O.L. Interobserver reliability of a functional status instrument. J Chronic Dis, 1978, 31, 573–580.

    Google Scholar 

  11. Jette, A.M. Functional capacity evaluation: An empirical approach. Arch Phys Med Rehabil, 1980, 61, 85–89.

    Google Scholar 

  12. Jette, A.M. Functional status index: Reliability of a chronic disease evaluative instrument. Arch Phys Med Rehabil, 1980, 61, 395–401.

    Google Scholar 

  13. Katz, S., Ford, A.B., Moskiwitz, R.W., Jackson, B.A., Jaf, M.W. Studies of illness in the aged. The index of ADL: a standardised measure of biologicaland psychosomal function. JAMA, 1963, 185, 914–919.

    Google Scholar 

  14. Katz, S., Downs, T.D., Cash, H.R., Grotz, R.C. Progress in development of the index of ADL. The Gerontologist, 1970, 1, 20–30.

    Google Scholar 

  15. Katz, S., Akpom, C.A. A measure of primary sociobiological functions. Int J Health Serv, 1976, 6, 493–507.

    Google Scholar 

  16. Keitel, W., Hoffman, H., Weber, G. Ermittlung der prozentualen funktionsminderung der gelenke durch einen bewengungsfunkionstest in der rheumatologie. Dtsch Gesundheitsw, 1971, 26, 1901–1903.

    Google Scholar 

  17. Lansbury, J. A method for summation of the systemic indices of rheumatoid activity. Am J Med Sci, 1956, 232, 300.

    Google Scholar 

  18. Lansbury, J. Report of a three-year study on the systemic and articular indexes in rheumatoid arthritis. Theoretical and clinical considerations. Arthritis Rheum, 1958, 1, 505–522.

    Google Scholar 

  19. Lansbury, J., Mueller, E.E. A numerical method for summing up total deformity. Am J Med Sci., 1958, 235, 154.

    Google Scholar 

  20. Lansbury, J., Baier, H.N., McCracken, S. Statisical study of variation in systemic and articular indices. Arthritis Rheum., 1962, 5, 445–456.

    Google Scholar 

  21. Lee, P., Jasani, M.K., Dick, W.C., Buchanan, W.W. Evaluation of a functional index in rheumatoid arthritis. Scand J Rheumatol, 1983, 2, 71–77.

    Google Scholar 

  22. Lee, P., Webb, J., Anderson, J., Buchanan, W.W. Method of assessing therapeutic potential of antiinflammatory anti-rheumatic drugs in rheumatoid arthritis. Br Med J, 1973, 2, 685–688.

    Google Scholar 

  23. Lequesne, M. European guidelines for clinical trials of new anti-rheumatic drugs. Eular Bulletin, 1980, 9(Suppl 6), 171–175.

    Google Scholar 

  24. Meenan, R.F., Gertman, P.M., Mason, J.H. Measuring health status in arthritics. The arthritis impact measurement scales. Arthritis Rheum, 1980, 23, 146–152.

    Google Scholar 

  25. Ritchie, D.M., Boyle, J.A., McInnes, J.M., Jasani, M.K., Dalakos, T.G., Grieveso, P., Buchanan, W.W. Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q Med J Med, 1968, 147, 393–406.

    Google Scholar 

  26. Smythe, H.A., Helewa, A., Goldsmith, C.H. “Independent assessor” and “Pooled index” as techniques for measuring treatment effects in rheumatoid arthritis. J Rheumatol, 1977, 4, 144–152.

    Google Scholar 

  27. Steinbrocker, O., Traeger, C.H., Batterman, R.C. Therapeutic criteria in rheumatoid arthritis. JAMA, 1949, 140, 659–662.

    Google Scholar 

  28. Taylor, D. A table for the degree of involvement in chronic arthritis. Can Med Assoc J, 1937, 36, 608–610.

    Google Scholar 

  29. The Co-operating Clinics Committee of the American Rheumatism Association. A seven-day variability study of 499 patients with peripheral rheumatoid arthritis. Arthritis Rheum, 1965, 8, 302–335.

    Google Scholar 

  30. Alarcon Segovia, D. Long-term treatment of symptomatic osteoarthritis with benoxaprofen. Double-blind comparison with aspirin and ibuprofen. J Rheumatol, 1980, 7(Suppl), 89–99.

    Google Scholar 

  31. Andrade, L., Fernandez, Sulindac in the treatment of osteoarthritis: A double-blind 8-week study of comparing sulindac with ibuprofen and 96-weeks of long-term therapy. Eur J Rheum Inflamm, 1978, 1, 36–40.

    Google Scholar 

  32. Barnes, C.G., Berry, H., Carter, M.E., Downie, W.W., Fowler, P.D., Moll, J.M.H., Perry, J.D., Sawaf, M.S., Wright, V. Diclofenac sodium (voltarol) and indomethacin. A multicentre comparative study in rheumatoid arthritis and osteoarthritis. Rheumatol Rehabil, 1979, suppl. 2, 135–143.

    Google Scholar 

  33. Barnes, C.G., Goodman, H.V., Eade, A.W.T., Misra, H.N., Cochrane, G.M., Clarke, A.K., Stoppard, M. A double-blind comparison of naproxen with indomethacin in osteoarthritis. J Clin Pharm, 1975, 15, 347–354.

    Google Scholar 

  34. Blechman, W.J. Crossover comparison of benoxaprofen and naproxen in osteoarthritis. J Rheumatol, 1980, 7 (Suppl), 116–124.

    Google Scholar 

  35. Blechman, W., Willkens, R., Boncaldo, G.L., Hoffmeister, R.T., Lockie, L.M., Multz, C. Naproxen is osteoarthritis. Ann Rheum Dis, 1978, 37, 80–84.

    Google Scholar 

  36. Boardman, P.L., Nuki, G., Hart, F.D. Ibuprofen in the treatment of rheumatoid and osteoarthritis. Ann Rheum Dis, 1967, 26, 560–561.

    Google Scholar 

  37. Bordier, P., Kuntz, D. Sulindac: clinical results of treatment of osteoarthritis. Eur J Rheum Inflamm, 1978, 1, 27–30.

    Google Scholar 

  38. Brackertz, B., Busson, M. Comparative study of sulindac (clinoril) and ibuprofen (brufen) in osteoarthritis. Br J Clin Practice, 1978, 32, 77–80.

    Google Scholar 

  39. Bresnihan, F.P., Grahame, R., Burry, H.C. Ketoprofen in the management of osteoarthritis of the hip: comparison with phenylbutazone. Rheum Rehabil, 1974, 13(3), 125–131.

    Google Scholar 

  40. Bresnihan, B., Hughes, G., Essigman, W.K. Diflunisal in the treatment of osteoarthritis: a double-blind study comparing diflunisal with ibuprofen. Curr Med Res Opin, 1978, 5(7), 562–566.

    Google Scholar 

  41. Brodie, N.H., McGhie, R.L., O'Hara, H., O'Hara, J., Valle-Hones, J.C. Fenclofenac and ibuprofen in the treatment of osteoarthritis: a comparative study in general practice. Br J Clin Pract, 1980, 34, 334–336.

    Google Scholar 

  42. Brooke, J.W. Fenoprofen therapy in large joint osteoarthritis: double-blind comparison with aspirin and long-term experience. J Rheumatol, 1976, 3, (Suppl) 71–75.

    Google Scholar 

  43. Calabro, J.J., Andelman, W.Y., Caldwell, J.R., Gerber, R.C., Hamaty, D., Kaplan, H., Maltz, B.A., Parsons, J.L., Saville, P., Tretbar, H.C., Ward, J.R. A multicentre trial of sulindac in osteoarthritis of the hip. Clin Pharmacol Ther, 1977, 22, 358–363.

    Google Scholar 

  44. Car. A., Jajic, I., Krampa, C., Vitaus, M., Zenic, N. Zivhovk, M. A double-blind muticentre comparison with diclofenac sodium and naproxen in osteoarthritis of the hip. Scand J Rheumatol, 1978, (Suppl) 2, 63–68.

    Google Scholar 

  45. Cardoe, N. Double-blind crossover study of ketoprofen and phenylbutazone in patients with chronic osteoarthritis of the hip. Rheum Rehabil 1976, 15(Suppl) 27–33.

    Google Scholar 

  46. Cardoe, N., A double-blind crossover study to compare the efficacy of 3 dosage levels of flurbiprofen in the treatment of rheumatoid disease and osteoarthritis. Curr Med Res Opin, 1977, 5(1) 99–105.

    Google Scholar 

  47. Caroit, M., Forette, B., Hubault, A., Pasquier, P. Double-blind study of ketoprofen against a placebo in osteoarthritis of the hip. Scand J Rheumatol, 1976, 14 (Suppl) 123–127.

    Google Scholar 

  48. Chahade, W.H., Josef, J. Clinical evaluation of the efficacy and tolerance of sulindac in patients with osteoarthritis of the hip and/or knee during 144 weeks. Comparative study with aspirin during the first 96 weeks. Eur J Rheum Imflamm, 1978, 1, 41–44.

    Google Scholar 

  49. Chiswell, R.J., Grieve, A.P., MacDonald, I.R. An interim report on a multicentre general practice study of voltarol. 2) Osteoarthritis. Br J Clin Pract, 1980, 34, 207–211.

    Google Scholar 

  50. Cochrane, G.M. A double-blind comparison of naproxen with indomethacin in osteoarthritis. Scand J Rheumatol, 1973, Suppl. 2 89–93.

    Google Scholar 

  51. Diamond, H.S. Double-blind crossover study of fenoprofen and aspirin in osteoarthritis. J Rheumatol, 1976, 3(Suppl), 67–70.

    Google Scholar 

  52. Dieppe, P.A., Burry, H.C., Grahame, R., Perera, T. Sulindac inosteoarthritis of the hip. Rheum Rehabil, 1976, 15, 112–115.

    Google Scholar 

  53. Dessain, P., Estabrooks, T.F., Gordon, A.J. Piroxicam in the treatment of osteoarthritis. A multicentre study in general practice involving 1218 patients. J Int Med Res, 1979, 7(5) 335–343.

    Google Scholar 

  54. Dieppe, P.A., Huskisson, E.C. Diflunisal and aspirin: A comparison of efficacy and nephrotoxicity in osteoarthritis. Rheum Rehabil, 1979, 18, 53–56.

    Google Scholar 

  55. Emanueli, A., Mandelli, V., Mascellani, G., Sacchetti, G. Indoprofen, A new nonsteroidal antiinflammatory drug, in the treatment of osteoarthrosis. Report on a multicentre study in 1629 patients. Curr Med Res Opin, 1979, 6(2) 124–135.

    Google Scholar 

  56. Essigman, W.K., Chamberlain, M.A., Wright, V. Diflunisal in osteoarthritis of the hip and knee. Curr Med Res Opin, 1978, 5(7), 550–555.

    Google Scholar 

  57. Famaey, J.P., Colinet, E. A double-blind trial of ketoprofen in the treatment of osteoarthritis of the hip. Rheum Rehabil, 1976, 15(Suppl). 45–49.

    Google Scholar 

  58. Fava, G., Galli, L., Pollini, C., Liverta, C., Vicari, A., Pontiroli, A.E. Single nightly administration of ketoprofen (orudis) ad indomethacin suppositories in the management of osteoarthritis: a double-blind trial. J Int Med Res, 1977, 5(5) 301–307.

    Google Scholar 

  59. Frank, O. A double-blind crossover study to compare the efficacy of 3 dosage levels of flurbiprofen in the treatment of rheumatoid disease and osteoarthrosis. Curr Med Res Opin, 1977, 5(1) 91–98.

    Google Scholar 

  60. Grayson, M.F. A clinical trial of diflunisal against aspirin in osteoarthritis. Rheum Rehabil, 1978, 17, 265–269.

    Google Scholar 

  61. Grayson, M.F. Two trials of diflunisal in osteoarthritis. Curr Med Res Opin, 1978, 5(7), 567–571.

    Google Scholar 

  62. Gordon, A.J., Estabrooks, T.F., Dessain, P. Treatment of osteoarthritis with piroxicam in general practice. Longterm follow-up in a multicentre study. J Int Med Res, 1980, 8(6) 375–381.

    Google Scholar 

  63. Gyory, A.N., Bloch, M., Burry, H.C., Grahame, R. Orudis in management of rheumtoid arthritis and osteoarthritis of the hip: comparison with indomethacin. Br Med J, 1972, 4, 398–400.

    Google Scholar 

  64. Highton, J., Grahame, R. Benoxaprofen in the treatment of osteoarthritis: A comparison with ibuprofen. J Rheumatol, 1980, 7(Suppl), 125–131.

    Google Scholar 

  65. Hingorani, K. A comparative study of azapropazone and ibuprofen in the treatment of osteoarthritis of the knee. Curr Med Res Opin, 1976, 4(1), 57–64.

    Google Scholar 

  66. Hodgkinson, R., Woolf, D. A five-year clinical trial of indomethacin in osteoarthritis of the hip. Practitioner, 1973, 210, 392–396.

    Google Scholar 

  67. Hubault, A., Cardit, M., Forette, B., Pasquier, P. Double-blind trial of ketoprofen compared with placebo in osteoarthrosis of the hip. Rheum Rehabil, 1976, 15(Suppl), 52–55.

    Google Scholar 

  68. Huskisson, E.C., Scott, J. Sulindac-trials of a new anti-inflammatory drug. Ann Rheum Dis, 1978, 37, 89–92.

    Google Scholar 

  69. Joubert, P.H., Kushlick, A.R., McNeill, W.G. Sheard, E.S.C., Mueller, F.D. South African multicentre trial with voltarol in osteoarthritis of the knee. South Afr Med J, 1974, 48, 1973–1978.

    Google Scholar 

  70. Kagyama, T. Clinical evaluation of naproxen in the treatment of osteoarthritisdouble-blind cross-over trial. Scand J Rheumatol, 1973, Suppl. 2, 94–100.

    Google Scholar 

  71. Liyanage, S.P., Steele, C.E. Tolmetin in osteoarthritis of the hip and knee; double-blind crossover trials. Curr Med Res Opin, 1978, 5(4), 299–305.

    Google Scholar 

  72. Loizzi, P., Pipitone, V. Two years therapy with sulindac. Eur J Rheum Inflamm, 1978, 1, 31–33.

    Google Scholar 

  73. Marcolongo, R., Mandelli, V., Magni, E., Sacchetti, G. Indomethacin in knee joint osteoarthritis: A double-blind cross-over clinical trial. J Clin Pharm, 1977, 17, 48–55.

    Google Scholar 

  74. Martinez-Lavin, M., Holman, K.I., Smith, C.J., Vaughan, J.H. A comparison of naproxen, indomethacin and aspirin in osteoarthritis. J Rheumatol, 1980, 7, 711–716.

    Google Scholar 

  75. McMahon, F.G., Hain, A., Onel, A. Controlled evaluation of fenoprofen in geriatric patients with osteoarthritis. J Rheumatol, 1976, 3(Suppl), 76–82.

    Google Scholar 

  76. Melton III, J.W., Lussier, A., Ward, J.R., Neustadt, D., Multz, C. Naproxen vs aspirin in osteoarthritis of the hip and knee. J Rheumatol, 1978, 5, 338–346.

    Google Scholar 

  77. Michotte, L.J., Van Bogaert, P., Wauters, M. The results of long-term treatment of coxarthrosis with indomethacin. Acta Rheum Scand, 1966, 122, 146–152.

    Google Scholar 

  78. Moxley, T.E., Royer, G.L., Hearron, M.S., Donovan, J.F., Levi, L. Ibuprofen versus buffered phenylbutazone in the treatment of osteoarthritis: double-blind trial. J Am Geriatric Soc, 1975, 23, 343–349.

    Google Scholar 

  79. Muller, F.O., Gosling, J.A., Erdmann, G.H. A comparison of tolmetin with aspirin in the treatment of osteoarthritis of the knee. South Afr Med J, 1977, 51, 794–796.

    Google Scholar 

  80. Rondier, J., Cayla, J., Menkes, C.J. A controlled trial of ketoprofen (administered rectally) in arthritis of the hip and knee. Rheum Rehabil, 1976, 15(Suppl), 71–74.

    Google Scholar 

  81. Rothstein, J. Phenylbutazone and aspirin in osteoarthritis — A controlled study. Curr Ther Res., 1975, 17(5), 444–451.

    Google Scholar 

  82. Royer, G.L., Moxley, T.E., Hearron, M.S., Miyara, A., Donovan, J.F. A six-month double-blind trial of ibuprofen and indomethacin in osteoarthritis. Curr Ther Res, 1975, 17(3), 234–248.

    Google Scholar 

  83. Saba, G.C., Orlandi, G. A short-term therapeutic trial with indoprofen vs. indomethacn in osteoarthritis. Curr Ther Res, 1979, 25(2) 260–266.

    Google Scholar 

  84. Sacchetti, G., Dimurro, R., Mandelli, V., Gallico, S. Clinical testing of indoprofen in osteoarthritis. A controlled trial using a balanced incomplete block design. Curr Ther Res, 1978, 24(3), 274–283.

    Google Scholar 

  85. Scharff, U. A double-blind comparison of phenylbutazone and aspirin in osteoarthritis. Curr Ther Res, 1974, 16(120), 1264–1269.

    Google Scholar 

  86. Siraux, P. Diclofenac (voltaren) for the treatment of osteoarthritis: a double-blind comparison with naproxen. J Int Med Res, 1977, 5(3), 169–174.

    Google Scholar 

  87. Tanaka, S., Ito, T., Mori, E., Muroga, T., Nakajima, A., Ohtani, M. Double-blind study of naproxen in osteoarthritis of the knee joint. J Rheumatol, 1976, 3, 27–35.

    Google Scholar 

  88. Tyson, V.C.H., Glynne, A. A comparative study of benoxaprofen and ibuprofen in osteoarthritis in general pactice. J Rheumatol, 1980, 7(Suppl), 132–138.

    Google Scholar 

  89. Valtonen, E.J. Clinical comparison of fenbufen and aspirin in osteoarthritis. Scand J Rheumatol, 1979, Suppl. 27, 1–7.

    Google Scholar 

  90. Wanka, J., St. J. Dixon, A. Treatment of osteoarthritis of the hip with indomethacin: a controlled clinical trial. Ann Rheum Dis, 1964, 23, 288–294.

    Google Scholar 

  91. Wojtulewski, J.A., Walter, J., Gray, J. Diflunisal compared with naproxen in the treatment of osteoarthritis of hip and knee: a double-blind trial. Curr Med Res Opin, 1978, 5(7), 562–566.

    Google Scholar 

  92. Zizic, T.M., Sutton, J.D., Stevens, M.D. Piroxicam and osteoarthritis: A controlled study. In: Royal Society of Medicine. International Congress and Symposium Series. Ed: O'Brien, W.M., Wiseman, E.H. London R.S.M., London Academic Press and New York, Grune and Stratton, 1978, 1, 71–81.

    Google Scholar 

  93. Scott, J., Huskisson, E.C. Graphic representation of pain. Pain, 1976, 2, 175–184.

    Google Scholar 

  94. Huskisson, E.C., Jones, J., Scott, P.J. Application of visual analogue scales to the measurement of functional capacity. Rheum Rehabil, 1976, 15, 185–187.

    Google Scholar 

  95. Scott, P.J., Huskisson, E.C. Measurement of functional capacity with visual analogue scales. Rheum Rehabil, 1977, 16, 257–259.

    Google Scholar 

  96. Scott, J., Huskisson, E.C. Accuracy of subjective measurements made with or without scores. An important source of error in serial measurement of subjective states. Ann Rheum Dis, 197, 38, 558–559.

  97. Warner, K.E., Luce, B.R. Cost-benefit and costeffectiveness analysis in health ccare. Ann Arbor: Health Aministration Press, 1982, 99.

    Google Scholar 

  98. Decker, J.L. Summary: Conference on outcome measures in rheumatological clinical trials. J Rheumatol, 1982, 9, 802–806.

    Google Scholar 

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  1. University of Western Ontario, London

    N. Bellamy & W. W. Buchanan

  2. Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

    N. Bellamy & W. W. Buchanan

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  1. N. Bellamy
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Bellamy, N., Buchanan, W.W. Outcome measurement in osteoarthritis clinical trials: The case for standardisation. Clin Rheumatol 3, 293–303 (1984). https://doi.org/10.1007/BF02032334

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