Progress Towards Optimal Trial End-Points in Rheumatoid Arthritis

Pincus T, Callahan LF. Reassessment of twelve traditional paradigms concerning the diagnosis, prevalence, morbidity, and mortality of rheumatoid arthritis. Scand J Rheumatol 1989; 79Suppl.: 67–95 Kirwan JR. A theoretical framework for process, outcome and prognosis in rheumatoid arthritis. J Rheumatol 1992; 19: 333–6 Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the Health Assessment Questionnaire. J Rheumatol 1982; 9: 789–93 Meenan RF, Gutman PM, Mason JH. Measuring health status in rheumatoid arthritis: the Arthritis Impact Measurement Scales. Arthritis Rheum 1980; 23: 146–52 Meenan RF, Mason JH, Anderson JJ, et al. AIMS2. The content and properties of a revised and expanded Arthritis Impact Measurement Scales health status questionnaire. Arthritis Rheum 1992; 25: 1–10 Ware JE, Donald-Sherbourne C. The MOS 36 item Short Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 6: 473–83 Hunt SM, McKenna SP, McEwen J, et al. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med 1981; 15A: 221–9 Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993: 118: 622–9 Tugwell P, Boers M, for the OMERACT committee. OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: conclusion. J Rheumatol 1993; 20: 590 Wolfe F, Cathey MA. The assessment and prediction of functional disability in rheumatoid arthritis. J Rheumatol 1991; 18: 1298–306 Anderson JJ, Felson DT, Meenan RF, et al. Which traditional measures should be used in rheumatoid arthritis clinical trials? Arthritis Rheum 1989; 32: 1093–9 Gøtzsche PC. Sensitivity of effects variables in rheumatoid arthritis: a meta-analysis of 130 placebo-controlled NSAID trials. J Clin Epidemiol 1990; 43: 1313–8 Van de Heide A, Jacobs WGJ, Dinant HJ, et al. The impact of endpoint measures in rheumatoid arthritis clinical trials. Semin Arthritis Rheum 1992; 21: 287–94 Tugwell P, Boers M, for the OMERACT committee. Developing consensus on preliminary core efficacy endpoints for rheumatoid arthritis clinical trials. J Rheumatol 1993; 20: 555–6 Wall PD. Introduction. In: Wall PD, Melzack R, editors. Textbook of pain. 2nd ed. London: Churchill Livingstone, 1989 Van der Heijde DMFM, van Riel PLCM, van Rijswijk MH, et al. Influence of prognostic features on the final outcome in rheumatoid arthritis: a review of the literature. Semin Arthritis Rheum 1988; 17: 284–92 Bellamy N. Musculoskeletal clinical metrology. London: Kluwer, 1993: 65–76 Felson DT, Anderson JJ, Boers M, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum 1993; 36: 729–40 Pinals RS, Masi AT, Larsen RA. Preliminary criteria for clinical remission in rheumatoid arthritis. Arthritis Rheum 1981; 24: 1308–15 Bombardier C, Raboud J and the Auranofin Cooperating Group. A comparison of health related quality of life measures for rheumatoid arthritis clinical research. Controlled Clin Trials 1991; 12: S243–56 Hazes JMW, Hayton R, Silman AJ. A reevaluation of the symptom of morning stiffness. J Rheumatol 1993; 20: 1138–42 Meenan RF, Pincus T. The status of patient status measures. J Rheumatol 1987; 14: 411–4 Bellamy N. Musculoskeletal clinical metrology. London: Kluwer, 1993: 117–9 Spiegel TM, Spiegel JS, Paulus HE. The joint alignment and motion scale: a simple measure of joint deformity in patients with rheumatoid arthritis. J Rheumatol 1987; 14: 887–92 Parker JW, Harrell PB, Alarcon GS. The value of the joint alignment and motion scale in rheumatoid arthritis. J Rheumatol 1988; 15: 1212–5 Bosi Ferraz M, Atra E, De Oliviera LM. What is the purpose of the joint alignment and motion scale [letter]? J Rheumatol 1989; 16: 853–4 Bosi Ferraz M, de Oliviera LM, Araujo PMP, et al. EPM-ROM Scale: an evaluative instrument to be used in rheumatoid arthritis clinical trials. Clin Exp Rheumatol 1990; 8: 491–4 Vliet Vlieland TPM, Van den Ende CHM, Breedveld FC, et al. Evaluation of joint mobility in rheumatoid arthritis clinical trials: the EPM-range of motion scale. J Rheumatol 1993; 20: 2010–4 Hawley DJ, Wolfe F. Sensitivity to change of the health assessment questionnaire (H AQ) and other clinical and health status measures in rheumatoid arthritis: results of short term clinical trials and observational studies versus long term observational studies. Arthritis Health Care Res 1992; 5: 130–6 Tugwell P, Bombardier C, Buchanan WW, et al. The MACTAR patient preference disability questionnaire: an individualized functional priority approach for assessing improvement in physical disability in clinical trials in rheumatoid arthritis. J Rheumatol 1987; 14: 446–51 Guillemin F, Briançon S, Pourel J. Functional disability in rheumatoid arthritis: two different models in early and established disease. J Rheumatol 1992; 19: 366–9 Cooperating clinics of the American Rheumatism Association. A seven day variability study of 499 patients with peripheral rheumatoid arthritis. Arthritis Rheum 1965; 8: 302–34 Ritchie DM, Boyle JA, Mclnnes JM, et al. Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q J Med 1968; 147: 393–406 Fuchs HA, Pincus T. Reduced joint counts in controlled clinical trials in rheumatoid arthritis. Arthritis Rheum 1994; 37: 470–5 Lansbury J. Report of a three-year study on the systemic and articular indexes in rheumatoid arthritis: theoretic and clinical considerations. Arthritis Rheum 1958; 1: 505–22 Thompson PW, Kirwan JR, Currey HLF. A comparison of the ability of 28 articular indices to detect an induced flare of joint inflammation in rheumatoid arthritis. Br J Rheumatol 1988; 27: 375–80 Klinkhoff AV, Bellamy N, Bombardier C et al. An experiment in reducing inter-observer variability in the examination for joint tenderness. J Rheumatol 1988; 15: 492–4 Prevoo MLL, van Riel PLCM, van’t Hof MA, et al. Validity and reliability of joint indices: a longitudinal study in patients with recent onset rheumatoid arthritis. Br J Rheumatol 1993; 32: 589–94 Van Riel PLCM. Provisional guidelines for measuring disease activity in clinical trials on rheumatoid arthritis. Br J Rheumatol 1992; 31: 793–4 American College of Rheumatology Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Reduced joint counts in rheumatoid arthritis clinical trials. Arthritis Rheum 1994; 37: 463–4 Scott DL, Panayi GS, Van Riel PLCM, et al. Disease activity in rheumatoid arthritis: preliminary report. Clin Exp Rheumatol 1992; 10: 521–35 Van Leeuwen MA, van Rijswijk MH, van der Heijde DMFM, et al. The acute phase response in relation to radiographic progression in early rheumatoid arthritis: a prospective study during the first three years of disease. Br J Rheumatol 1993; 32Suppl. 3: 9–13 Boers M, Tugwell P. The validity of pooled outcome measures (indices) in rheumatoid arthritis clinical trials. J Rheumatol 1993; 20: 568–74 Fries JF, Bloch DA, Sharp JT, et al. Assessment of radiologic progression in rheumatoid arthritis: a randomized controlled trial. Arthritis Rheum 1986; 29: 1–9 Edmonds JP, Scott DL, Furst DE, et al. Antirheumatic drugs: a proposed new classification. Arthritis Rheum 1993; 36: 336–9 Iannuzzi L, Dawson N, Zein N, et al. Does drug therapy slow radiographic deterioration in rheumatoid arthritis? N Engl J Med 1983; 309: 1023–8 Larsen A, Dale K, Eek M. Radiographic evaluation of rheumatoid arthritis and related conditions by standard reference films. Acta Radiol Diagn 1977; 18: 481–91 Sharp JT. Radiologic assessment as an outcome measure in rheumatoid arthritis. Arthritis Rheum 1989; 32: 221–9 Van der Heijde DMFM, van Leeuwen MA, van Riel PLCM, et al. Biannual radiographic assessments of hands and feet in a three-year prospective follow up study of patients with early rheumatoid arthritis. Arthritis Rheum 1992; 35: 26–34 Wassenberg S, Herborn G, Kreutzburg S, et al. Larsen’s method is as precise as Sharp’s method in detecting change in long term observation of radiographs in RA. Arthritis Rheum 1995; 38Suppl.: S329 Van der Heijde DMFM, Van Leeuwen MA, Van Riel PLCM et al. Biannual radiographic assessments of hands and feet in a three-year prospective follow-up of patients with early rheumatoid arthritis. Arthritis Rheum 1992; 35: 26–34 Boers M. The validity of radiography as outcome measure in rheumatoid arthritis. J Rheumatol 1995; 22: 1783–6 Tugwell P, Boers M. OMERACT conference on outcome measures in clinical trials: introduction. J Rheumatol 1993; 20: 528–9 Boers M, Tugwell P, for the OMERACT committee. Conference on outcome measures in rheumatoid arthritis clinical trials, Maastricht, The Netherlands, April 29-May 3, 1992. J Rheumatol 1993; 20: 525–91 Boers M, Tugwell P, Felson DT, et al. World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol 1994; 21Suppl. 41: 86–9 Tugwell P, Boers M, Brooks PM, OMERACT committee. OMERACT II: conference on outcome measures in rheumatoid arthritis clinical trials. J Rheumatol 1995; 22: 980–1433 Edmonds J, editor. Proceedings of the 5th Joint World Health Organization and International League of Associations for Rheumatology Task Force meeting on Rheumatic Diseases. J Rheumatol 1994; 21Suppl. 41: 1–86 Felson DT, Anderson J, Boers M, et al. American College of Rheumatology preliminary criteria for improvement in rheumatoid arthritis patients. Arthritis Rheum 1995; 38: 727–35 Van Gestel AM, Van’t Hof MA, Van Rijswijk MH, et al. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with the preliminary American College of Rheumatology and the World Health Organisation/International League Against Rheumatism Criteria. Arthritis Rheum 1996; 39: 34–40 Van der Heijde DMFM, Van’t Hof MA, Van Riel PLCM, et al. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis 1990; 49: 916–20