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Patient Reported Outcomes in Rheumatoid Arthritis Clinical Trials

  • Ana-Maria OrbaiEmail author
  • Clifton O. BinghamIII
Rheumatoid Arthritis (L Moreland, Section Editor)
Part of the following topical collections:
  1. Topical Collection on Rheumatoid Arthritis

Abstract

Patient reported outcomes (PRO) are at the core of assessing RA treatment response with patient assessments of global health or disease activity, pain, and physical function included in the calculation of American College of Rheumatology (ACR) responses. Progress has been made in assessing PROs that include additional patient-valued aspects of disease in recent RA randomized clinical trials (RCTs), particularly fatigue. Importantly, the National Institute of Health (NIH)—Patient Reported Outcomes Measurement Information System (PROMIS) development of psychometrically advanced generic health measures that span the range of symptoms potentially affected in RA, with high precision across the entire range of a symptom are undergoing additional study in RA and other rheumatologic diseases to establish their construct validity, responsiveness, and clinically meaningful cutoffs. PRO measures that are currently used and widely available can provide important perspectives not captured in composite clinical response criteria with the potential of better informing treatment decisions in clinical practice.

Keywords

Rheumatoid arthritis (RA) Patient reported outcomes (PRO) Patient reported outcomes measurement information system (PROMIS) Fatigue Stiffness 

Notes

Compliance with Ethics Guidelines

Conflict of Interest

Ana-Maria Orbai declares the receipt of grant money in the form of a Scientist Development Award from the Rheumatology Research Foundation (RRF). Clifton O. Bingham declares the receipt of grant money via a Patient-Centered Outcomes Research Institute (PCORI) Pilot Project Program Award (1IP2-PI000737-01). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee. Dr. Bingham is a member of the Executive Committee of OMERACT (Outcome Measures in Rheumatology), an international group that develops and evaluates health outcomes; OMERACT receives hands-off funding from more than 23 pharmaceutical and research companies.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by the authors.

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. 1.••
    Boers M, Kirwan JR, Wells G, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014;67:745–53. The newly endorsed OMERACT Filter 2.0 provides a framework and methodology for selecting RCT core sets.CrossRefPubMedGoogle Scholar
  2. 2.
    Tugwell PS, Petersson IF, Boers M, et al. Domains selection for patient-reported outcomes: current activities and options for future methods. J Rheumatol. 2011;38:1702–10.CrossRefPubMedGoogle Scholar
  3. 3.
    Frank L, Forsythe L, Ellis L, Schrandt S, Sheridan S, Gerson J, et al. Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Quality of life research: an international journal of quality of life aspects of treatment, care and rehabilitation. 2015 Jan 6.Google Scholar
  4. 4.
    Frank L, Basch E, Selby JV. The PCORI perspective on patient-centered outcomes research. JAMA. 2014;312(15):1513–4.CrossRefPubMedGoogle Scholar
  5. 5.
    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 Suppl. 1994;41:86–9.PubMedGoogle Scholar
  6. 6.
    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. The committee on outcome measures in rheumatoid arthritis clinical trials. Arthritis Rheum. 1993;36:729–40.CrossRefPubMedGoogle Scholar
  7. 7.
    Kirkham JJ, Boers M, Tugwell P, et al. Outcome measures in rheumatoid arthritis randomised trials over the last 50 years. Trials. 2013;14:324.CrossRefPubMedCentralGoogle Scholar
  8. 8.
    Boers M, Brooks P, Strand CV, et al. The OMERACT filter for Outcome Measures in Rheumatology. J Rheumatol. 1998;25:198–9.PubMedGoogle Scholar
  9. 9.
    van Tuyl LH, Hewlett S, Sadlonova M, Davis B, Flurey C, Hoogland W, et al. The patient perspective on remission in rheumatoid arthritis: ‘You’ve got limits, but you’re back to being you again’. Annals of the rheumatic diseases. 2014 Feb 12.Google Scholar
  10. 10.
    Bingham 3rd CO, Alten R, Bartlett SJ, et al. Identifying preliminary domains to detect and measure rheumatoid arthritis flares: report of the OMERACT 10 RA Flare Workshop. J Rheumatol. 2011;38:1751–8.CrossRefPubMedGoogle Scholar
  11. 11.
    Bingham 3rd CO, Alten R, de Wit MP. The importance of patient participation in measuring rheumatoid arthritis flares. Ann Rheum Dis. 2012;71:1107–9.CrossRefPubMedGoogle Scholar
  12. 12.
    Bartlett SJ, Hewlett S, Bingham 3rd CO, et al. Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus. Ann Rheum Dis. 2012;71:1855–60.CrossRefPubMedGoogle Scholar
  13. 13.
    de Wit M, Abma T, Koelewijn-van Loon M, et al. Involving patient research partners has a significant impact on outcomes research: a responsive evaluation of the international OMERACT conferences. BMJ Open. 2013;3(5).Google Scholar
  14. 14.
    Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45(5 Suppl 1):S3–11.CrossRefPubMedCentralPubMedGoogle Scholar
  15. 15.
    WHO. WHO: The International Classification of Functioning, Disability and Health 2002. http://www.who.int/classifications/icf/training/icfbeginnersguide.pdf?ua=1; 2001 [updated 2001; cited]; Available from: http://www.who.int/classifications/icf/training/icfbeginnersguide.pdf?ua=1.
  16. 16.
    US Food and Drug Administration. US Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (2009). 2009 [updated 2009 2009; cited 2014 1/23/2014]; Available from: www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf.
  17. 17.
    Frost MH, Reeve BB, Liepa AM, et al. What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health. 2007;10 Suppl 2:S94–105.CrossRefPubMedGoogle Scholar
  18. 18.
    Coons SJ, Kothari S, Monz BU, et al. The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims. Clin Pharmacol Ther. 2011;90:743–8.CrossRefPubMedGoogle Scholar
  19. 19.
    Mokkink LB, Terwee CB, Knol DL, et al. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010;10:22.CrossRefPubMedCentralPubMedGoogle Scholar
  20. 20.
    Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res: Int J Qual Life Asp Treat Care Rehabil. 2010;19:539–49.CrossRefGoogle Scholar
  21. 21.
    Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1–eliciting concepts for a new PRO instrument. Value Health: J Int Soc Pharmacoeconomics Outcomes Res. 2011;14:967–77.CrossRefGoogle Scholar
  22. 22.
    Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2—assessing respondent understanding. Value Health: J Int Soc Pharmacoeconomics Outcomes Res. 2011;14:978–88.CrossRefGoogle Scholar
  23. 23.
    Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res: Int J Qual Life Asp Treat Care Rehabil. 2013;22:1889–905.CrossRefGoogle Scholar
  24. 24.
    Brundage M, Blazeby J, Revicki D, et al. Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards. Qual Life Res: Int J Qual LIfe Asp Treat Care Rehabil. 2013;22:1161–75.CrossRefGoogle Scholar
  25. 25.
    Wyrwich KW, Norquist JM, Lenderking WR, et al. Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res: Int J Qual Life Asp Treat Care Rehabil. 2013;22:475–83.CrossRefGoogle Scholar
  26. 26.
    Snyder CF, Aaronson NK, Choucair AK, et al. Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Qual Life Res: Int J Qual Life Asp Treat Care Rehabil. 2012;21:1305–14.CrossRefGoogle Scholar
  27. 27.
    de Wit MP, Berlo SE, Aanerud GJ, et al. European league against rheumatism recommendations for the inclusion of patient representatives in scientific projects. Ann Rheum Dis. 2011;70:722–6.CrossRefPubMedGoogle Scholar
  28. 28.
    Gossec L, Paternotte S, Aanerud GJ, et al. Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative. Ann Rheum Dis. 2011;70:935–42.CrossRefPubMedGoogle Scholar
  29. 29.
    Gossec L, de Wit M, Kiltz U, et al. A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative. Ann Rheum Dis. 2014;73:1012–9.CrossRefPubMedGoogle Scholar
  30. 30.•
    Castrejon I, Gossec L, Carmona L. The EULAR outcome measures library: an evolutional database of validated patient-reported instruments. Ann Rheum Dis. 2015;74:475–6. This article describes the EULAR electronic resource of patient reported outcome measures.CrossRefPubMedGoogle Scholar
  31. 31.
    Methodology Committee of the Patient-Centered Outcomes Research I. Methodological standards and patient-centeredness in comparative effectiveness research: the PCORI perspective. JAMA. 2012;307:1636–40.CrossRefGoogle Scholar
  32. 32.
    Her M, Kavanaugh A. Patient-reported outcomes in rheumatoid arthritis. Curr Opin Rheumatol. 2012;24:327–34.CrossRefPubMedGoogle Scholar
  33. 33.
    Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;9(367):495–507.CrossRefGoogle Scholar
  34. 34.
    van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;9(367):508–19.CrossRefGoogle Scholar
  35. 35.
    Burmester GR, Blanco R, Charles-Schoeman C, et al. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013;381:451–60.CrossRefPubMedGoogle Scholar
  36. 36.
    Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014;370:2377–86.CrossRefPubMedGoogle Scholar
  37. 37.
    Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013;65:28–38.CrossRefPubMedCentralPubMedGoogle Scholar
  38. 38.
    Schiff M, Weinblatt ME, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014;73:86–94.CrossRefPubMedCentralPubMedGoogle Scholar
  39. 39.
    Gabay C, Emery P, van Vollenhoven R, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381:1541–50.CrossRefPubMedGoogle Scholar
  40. 40.
    Kavanaugh A, Fleischmann RM, Emery P, et al. Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study. Ann Rheum Dis. 2013;72:64–71.CrossRefPubMedCentralPubMedGoogle Scholar
  41. 41.
    Smolen JS, Emery P, Fleischmann R, et al. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet. 2014;383:321–32.CrossRefPubMedGoogle Scholar
  42. 42.
    Bingham 3rd CO, Pohl C, Woodworth TG, et al. Developing a standardized definition for disease “flare” in rheumatoid arthritis (OMERACT 9 Special Interest Group). J Rheumatol. 2009;36:2335–41.CrossRefPubMedGoogle Scholar
  43. 43.
    Hewlett S, Sanderson T, May J, et al. ‘I’m hurting, I want to kill myself’: rheumatoid arthritis flare is more than a high joint count—an international patient perspective on flare where medical help is sought. Rheumatology (Oxford, England). 2012;51:69–76.CrossRefGoogle Scholar
  44. 44.
    Bykerk VP, Lie E, Bartlett SJ, Alten R, Boonen A, Christensen R, et al. Establishing a core domain set to measure rheumatoid arthritis flares: report of the OMERACT 11 RA flare Workshop. J Rheumatol. 2014;41:799–809.CrossRefPubMedCentralGoogle Scholar
  45. 45.
    Kirwan JR, Minnock P, Adebajo A, et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol. 2007;34:1174–7.PubMedGoogle Scholar
  46. 46.
    Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727–35.CrossRefPubMedGoogle Scholar
  47. 47.
    Felson DT, Smolen JS, Wells G, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum. 2011;63:573–86.CrossRefPubMedCentralPubMedGoogle Scholar
  48. 48.
    Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23:137–45.CrossRefPubMedGoogle Scholar
  49. 49.
    Pincus T, Summey JA, Soraci SA, et al. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983;26:1346–53.CrossRefPubMedGoogle Scholar
  50. 50.
    Keystone EC, Genovese MC, Hall S, et al. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: results through 2 years of the GO-FORWARD study extension. J Rheumatol. 2013;40:1097–103.CrossRefPubMedGoogle Scholar
  51. 51.
    de Jong PH, Hazes JM, Han HK, et al. Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial. Ann Rheum Dis. 2014;73:1331–9.CrossRefPubMedCentralPubMedGoogle Scholar
  52. 52.
    Fries JF, Cella D, Rose M, et al. Progress in assessing physical function in arthritis: PROMIS short forms and computerized adaptive testing. J Rheumatol. 2009;36:2061–6.CrossRefPubMedGoogle Scholar
  53. 53.
    Sokka T. Long-term outcomes of rheumatoid arthritis. Curr Opin Rheumatol. 2009;21:284–90.CrossRefPubMedGoogle Scholar
  54. 54.•
    Ward MM, Guthrie LC, Alba MI. Clinically important changes in individual and composite measures of rheumatoid arthritis activity: thresholds applicable in clinical trials. Ann Rheum Dis. 2014 May 1. This article redefines the minimally clinically important improvement in RA for the health assessment questionnaire at higher levels. Google Scholar
  55. 55.
    Ward MM, Guthrie LC, Alba MI. Clinically important changes in individual and composite measures of rheumatoid arthritis activity: thresholds applicable in clinical trials. Annals of the rheumatic diseases. 2014May 1.Google Scholar
  56. 56.•
    Hays RD, Spritzer KL, Fries JF, et al. Responsiveness and minimally important difference for the Patient-Reported Outcomes Measurement Information System (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis. Ann Rheum Dis. 2015;74:104–7. This article defines the minimally clinically important difference in RA for the PROMIS 20 item physical functioning form.CrossRefPubMedGoogle Scholar
  57. 57.
    Oude Voshaar MA, Ten Klooster PM, Glas CA, et al. Relative performance of commonly used physical function questionnaires in rheumatoid arthritis and a patient-reported outcomes measurement information system computerized adaptive test. Arthritis Care Res (Hoboken, NJ). 2014;66:2900–8.Google Scholar
  58. 58.
    Bartlett SJ, Orbai AM, Duncan T, et al. How well do generic patient reported outcomes measurement information system instruments capture health status in rheumatoid arthritis? Arthritis Rheum. 2013;65(10 Suppl):972.Google Scholar
  59. 59.
    Broderick JE, Schneider S, Junghaenel DU, et al. Validity and reliability of patient-reported outcomes measurement information system instruments in osteoarthritis. Arthritis Care Res. 2013;65(10):1625–33.Google Scholar
  60. 60.
    Khanna D, Maranian P, Rothrock N, et al. Feasibility and construct validity of PROMIS and “legacy” instruments in an academic scleroderma clinic. Value Health: J Int Soc Pharmacoeconomics Outcome Res. 2012;15:128–34.CrossRefGoogle Scholar
  61. 61.
    Pincus T, Bergman MJ, Yazici Y, et al. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford). 2008;47:345–9.CrossRefGoogle Scholar
  62. 62.
    Pincus T, Swearingen C, Wolfe F. Toward a multidimensional Health Assessment Questionnaire (MDHAQ): assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthritis Rheum. 1999;42:2220–30.CrossRefPubMedGoogle Scholar
  63. 63.
    Pincus T, Yazici Y, Castrejon I. Pragmatic and scientific advantages of MDHAQ/ RAPID3 completion by all patients at all visits in routine clinical care. Bull NYU Hosp Joint Dis. 2012;70 Suppl 1:30–6.Google Scholar
  64. 64.
    Pincus T, Furer V, Keystone E, et al. RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol. Arthritis Care Res. 2011;63:1142–9.CrossRefGoogle Scholar
  65. 65.
    Pincus T, Swearingen CJ, Bergman MJ, et al. RAPID3 (Routine Assessment of Patient Index Data) on an MDHAQ (Multidimensional Health Assessment Questionnaire): agreement with DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) activity categories, scored in five versus more than ninety seconds. Arthritis Care Res. 2010;62:181–9.CrossRefGoogle Scholar
  66. 66.
    Yazici Y, Curtis JR, Ince A, et al. Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study. Ann Rheum Dis. 2012;71(2):198–205.CrossRefPubMedGoogle Scholar
  67. 67.
    Gossec L, Dougados M, Rincheval N, et al. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009;68:1680–5.CrossRefPubMedGoogle Scholar
  68. 68.
    Boers M. RAID: a valid tool to quantify the impact of rheumatoid arthritis. But what impact will it have on the core set for trials? Ann Rheum Dis. 2011;70:884–5.CrossRefPubMedGoogle Scholar
  69. 69.
    Heiberg T, Austad C, Kvien TK, et al. Performance of the Rheumatoid Arthritis Impact of Disease (RAID) score in relation to other patient-reported outcomes in a register of patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70:1080–2.CrossRefPubMedGoogle Scholar
  70. 70.•
    Dougados M, Brault Y, Logeart I, et al. Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis Res Ther. 2012;14:R129. This article defines the minimally clinically important difference for the RAID questionnaire.CrossRefPubMedCentralGoogle Scholar
  71. 71.
    Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.CrossRefPubMedGoogle Scholar
  72. 72.
    Kosinski M, Zhao SZ, Dedhiya S, et al. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. 2000;43:1478–87.CrossRefPubMedGoogle Scholar
  73. 73.
    Busija L, Pausenberger E, Haines TP, et al. Adult measures of general health and health-related quality of life: Medical Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of Well-Being Scale (QWB), and Assessment of Quality of Life (AQoL). Arthritis Care Res. 2011;63 Suppl 11:S383–412.CrossRefGoogle Scholar
  74. 74.
    Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001;33:350–7.CrossRefPubMedGoogle Scholar
  75. 75.
    Ware Jr J, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33.CrossRefPubMedGoogle Scholar
  76. 76.
    Gandek B, Ware JE, Aaronson NK, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51:1171–8.CrossRefPubMedGoogle Scholar
  77. 77.
    Hays RD, Liu H, Spritzer K, et al. Item response theory analyses of physical functioning items in the medical outcomes study. Med Care. 2007;45(5 Suppl 1):S32–8.CrossRefPubMedGoogle Scholar
  78. 78.
    Whalley D, McKenna SP, de Jong Z, et al. Quality of life in rheumatoid arthritis. Br J Rheumatol. 1997;36:884–8.CrossRefGoogle Scholar
  79. 79.
    Kirwan JR, Hewlett S. Patient perspective: reasons and methods for measuring fatigue in rheumatoid arthritis. J Rheumatol. 2007;34:1171–3.PubMedGoogle Scholar
  80. 80.
    Sanderson T, Calnan M, Morris M, et al. Shifting normalities: interactions of changing conceptions of a normal life and the normalisation of symptoms in rheumatoid arthritis. Sociol Health Illn. 2011;33:618–33.CrossRefGoogle Scholar
  81. 81.
    Bartlett SJ, Orbai AM, Duncan T, et al. Can generic PROMIS measures adequately capture fatigue in rheumatoid arthritis? Ann Rheum Dis. 2014;73 Suppl 2:1167.CrossRefGoogle Scholar
  82. 82.
    Yellen SB, Cella DF, Webster K, et al. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manag. 1997;13:63–74.CrossRefGoogle Scholar
  83. 83.
    Cella D, Yount S, Sorensen M, et al. Validation of the functional assessment of chronic illness therapy fatigue scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol. 2005;32:811–9.PubMedGoogle Scholar
  84. 84.
    Hewlett S, Hehir M, Kirwan JR. Measuring fatigue in rheumatoid arthritis: a systematic review of scales in use. Arthritis Rheum. 2007;57:429–39.CrossRefGoogle Scholar
  85. 85.
    Nicklin J, Cramp F, Kirwan J, et al. Measuring fatigue in rheumatoid arthritis: a cross-sectional study to evaluate the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional questionnaire, visual analog scales, and numerical rating scales. Arthritis Care Res. 2010;62:1559–68.CrossRefGoogle Scholar
  86. 86.
    Dures EK, Hewlett SE, Cramp FA, et al. Reliability and sensitivity to change of the Bristol Rheumatoid Arthritis Fatigue scales. Rheumatology (Oxford, England). 2013;52:1832–9.CrossRefGoogle Scholar
  87. 87.
    Oude Voshaar MA, Ten Klooster PM, Bode C, et al. Assessment of Fatigue in Rheumatoid Arthritis: A Psychometric Comparison of Single-item, Multiitem, and Multidimensional Measures. J Rheumatol. 2015 Jan 15.Google Scholar
  88. 88.
    Oude Voshaar MA, Ten Klooster PM, Bode C, Vonkeman HE, Glas CA, Jansen T, et al. Assessment of Fatigue in Rheumatoid Arthritis: A Psychometric Comparison of Single-item, Multiitem, and Multidimensional Measures. The Journal of rheumatology. 2015 Jan 15.Google Scholar
  89. 89.•
    Orbai AM, Smith KC, Bartlett SJ, et al. “Stiffness has different meanings, I think, to everyone”. examining stiffness from the perspective of people living with rheumatoid arthritis. Arthritis Care Res. 2014 May 28. This qualitative research article describes and provides a conceptual framework for stiffness in RA from the patient perspective. Google Scholar
  90. 90.
    Orbai AM, Smith KC, Bartlett SJ, de Leon E, Bingham CO, 3rd. "Stiffness has different meanings, I think, to everyone". examining stiffness from the perspective of people living with rheumatoid arthritis. Arthritis care & research. 2014 May 28.Google Scholar
  91. 91.
    Halls S, Dures E, Kirwan J, Pollock J, Baker G, Edmunds A, et al. Stiffness is more than just duration and severity: a qualitative exploration in people with rheumatoid arthritis. Rheumatology (Oxford). In press.Google Scholar
  92. 92.
    Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, et al. Efficacy of modifiedrelease versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomised controlled trial. Lancet. 2008 Jan 19;371(9608):205-14.Google Scholar
  93. 93.
    Ward MM, Guthrie LC, Alba MI. Brief report: rheumatoid arthritis response criteria and patient-reported improvement in arthritis activity: is an American College of Rheumatology twenty percent response meaningful to patients? Arthritis & rheumatology (Hoboken, NJ). 2014 Sep;66(9):2339-43.Google Scholar
  94. 94.
    Inanc N, Yilmaz-Oner S, Can M, et al. The role of depression, anxiety, fatigue, and fibromyalgia on the evaluation of the remission status in patients with rheumatoid arthritis. J Rheumatol. 2014;41:1755–60.CrossRefPubMedGoogle Scholar
  95. 95.
    Curtis JR, Shan Y, Harrold L, et al. Patient perspectives on achieving treat-to-target goals: a critical examination of patient-reported outcomes. Arthritis Care Res. 2013;65:1707–12.CrossRefGoogle Scholar
  96. 96.
    Kvien TK, Heiberg T, Hagen KB. Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean? Ann Rheum Dis. 2007;66 Suppl 3:iii40–1.PubMedCentralPubMedGoogle Scholar

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© Springer Science+Business Media New York 2015

Authors and Affiliations

  1. 1.Divisions of RheumatologyJohns Hopkins UniversityBaltimoreUSA
  2. 2.Allergy and Immunology, Department of MedicineJohns Hopkins UniversityBaltimoreUSA

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