Best Practice & Research Clinical Rheumatology
Volume 21, Issue 4 , Pages 677-685 , August 2007

A three-page Standard Protocol to Evaluate Rheumatoid Arthritis (SPERA) for efficient capture of essential data from patients and health professionals in standard clinical care and clinical research

  • Theodore Pincus, MD (Director of Outcomes Research)

      Affiliations

    • Corresponding Author InformationTel.: +1212 598 6518; Fax:+1 212 598 6582.

References 

  1. Pincus T, Callahan LF, Sale WG, et al. Severe functional declines, work disability, and increased mortality in seventy-five rheumatoid arthritis patients studied over nine years. Arthritis and Rheumatism. 1984;27:864–872
  2. Wolfe F, Cathey MA. The assessment and prediction of functional disability in rheumatoid arthritis. Journal of Rheumatology. 1991;18:1298–1306
  3. Callahan LF, Bloch DA, Pincus T. Identification of work disability in rheumatoid arthritis: Physical, radiographic and laboratory variables do not add explanatory power to demographic and functional variables. Journal of Clinical Epidemiology. 1992;45:127–138
  4. Wolfe F, Hawley DJ. The longterm outcomes of rheumatoid arthritis: Work disability: A prospective 18 year study of 823 patients. Journal of Rheumatology. 1998;25:2108–2117
  5. Sokka T, Kautiainen H, Möttönen T, Hannonen P. Work disability in rheumatoid arthritis 10 years after the diagnosis. Journal of Rheumatology. 1999;26:1681–1685
  6. Lubeck DP, Spitz PW, Fries JF, et al. A multicenter study of annual health service utilization and costs in rheumatoid arthritis. Arthritis and Rheumatism. 1986;29:488–493
  7. Wolfe F, Zwillich SH. The long-term outcomes of rheumatoid arthritis: A 23-year prospective, longitudinal study of total joint replacement and its predictors in 1,600 patients with rheumatoid arthritis. Arthritis and Rheumatism. 1998;41:1072–1082
  8. Wolfe F, Kleinheksel SM, Cathey MA, et al. The clinical value of the Stanford health assessment questionnaire functional disability Index in patients with rheumatoid arthritis. Journal of Rheumatology. 1988;15:1480–1488
  9. Leigh JP, Fries JF. Mortality predictors among 263 patients with rheumatoid arthritis. Journal of Rheumatology. 1991;18:1307–1312
  10. Pincus T, Brooks RH, Callahan LF. Prediction of long-term mortality in patients with rheumatoid arthritis according to simple questionnaire and joint count measures. Annals of Internal Medicine. 1994;120:26–34
  11. Callahan LF, Cordray DS, Wells G, Pincus T. Formal education and five-year mortality in rheumatoid arthritis: Mediation by helplessness scale scores. Arthritis Care and Research. 1996;9:463–472
  12. Callahan LF, Pincus T, Huston JW, et al. Measures of activity and damage in rheumatoid arthritis: Depiction of changes and prediction of mortality over five years. Arthritis Care and Research. 1997;10:381–394
  13. Söderlin MK, Nieminen P, Hakala M. Functional status predicts mortality in a community based rheumatoid arthritis population. Journal of Rheumatology. 1998;25:1895–1899
  14. Sokka T, Hakkinen A, Krishnan E, Hannonen P. Similar prediction of mortality by the health assessment questionnaire in patients with rheumatoid arthritis and the general population. Annals of the Rheumatic Diseases. 2004;63:494–497
  15. Tugwell P, Wells G, Strand V, et al. Clinical improvement as reflected in measures of function and health-related quality of life following treatment with leflunomide compared with methotrexate in patients with rheumatoid arthritis: Sensitivity and relative efficiency to detect a treatment effect in a twelve-month, placebo-controlled trial. Leflunomide rheumatoid arthritis investigators group. Arthritis and Rheumatism. 2000;43:506–514
  16. Mitchell JM, Burkhauser RV, Pincus T. The importance of age, education, and comorbidity in the substantial earnings losses of individuals with symmetric polyarthritis. Arthritis and Rheumatism. 1988;31:348–357
  17. Pincus T, Brooks RH, Callahan LF. A proposed standard protocol to evaluate rheumatoid arthritis (SPERA) that includes measures of inflammatory activity, joint damage, and longterm outcomes. Journal of Rheumatology. 1999;26:473–480
  18. Fries JF. Time-oriented patient records and a computer databank. The Journal of the American Medical Association. 1972;222:1536–1542
  19. Fries JF. A data bank for the clinician? (editorial). New England Journal of Medicine. 1976;294:1400–1402
  20. Pincus T, Sokka T, Kautiainen H. Further development of a physical function scale on a multidimensional health assessment questionnaire for standard care of patients with rheumatic diseases. Journal of Rheumatology. 2005;32:1432–1439
  21. Wolfe F, Lassere M, van der Heijde D, et al. Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology. Omeract IV: Outcome measures in rheumatology. Cancun, Mexico, April 16–20, 1998. Journal of Rheumatology. 1999;26:484–489
  22. Fuchs HA, Brooks RH, Callahan LF, Pincus T. A simplified twenty-eight joint quantitative articular index in rheumatoid arthritis. Arthritis and Rheumatism. 1989;32:531–537
  23. Fuchs HA, Kaye JJ, Callahan LF, et al. Evidence of significant radiographic damage in rheumatoid arthritis within the first 2 years of disease. Journal of Rheumatology. 1989;16:585–591
  24. Pincus T, Callahan LF, Brooks RH, et al. Self-report questionnaire scores in rheumatoid arthritis compared with traditional physical, radiographic, and laboratory measures. Annals of Internal Medicine. 1989;110:259–266
  25. Sokka T, Pincus T. Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or American College of Rheumatology criteria for remission. Journal of Rheumatology. 2003;30(6):1138–1146
  26. Sokka T, Pincus T. Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor alpha agents in rheumatoid arthritis. Arthritis and Rheumatism. 2003;48(2):313–318
  27. Sokka T, Kautianen H, Toloza S et al. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries. Annals of the Rheumatic Diseases, in press.
  28. Parkerson GR, Broadhead WE, Tse CKJ. The Duke Severity of Illness Checklist (DUSOI) for measurement of severity and comorbidty. Journal of Clinical Epidemiology. 1993;46:379–393
  29. Katz JN, Chang LC, Sangha O, et al. Can comorbidity be measured by questionnaire rather than medical record review?. Medical Care. 1996;34:73–84
  30. Cleves MA, Sanchez N, Draheim M. Evaluation of two competing methods for calculating Charlson's Comorbidity Index when analyzing short-term mortality using administrative data. Journal of Clinical Epidemiology. 1997;50:903–908
  31. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. Journal of Chronic Disease. 1987;40:373–383

PII: S1521-6942(07)00019-8

doi: 10.1016/j.berh.2007.02.003

Best Practice & Research Clinical Rheumatology
Volume 21, Issue 4 , Pages 677-685 , August 2007