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Research ArticleOther Rheumatic Diseases

The State of Patient-Reported Outcome Measures in Rheumatology

Kenrick Manswell, Victoria Le, Kathryn Henry, Maximilian Casey, Natalie Anumolu and Michael S. Putman
The Journal of Rheumatology September 2024, 51 (9) 920-927; DOI: https://doi.org/10.3899/jrheum.2023-1073
Kenrick Manswell
1K. Manswell, BS, V. Le, BS, K. Henry, BS, M. Casey, BS, N. Anumolu, BS, M.S. Putman MD, MSci, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
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Victoria Le
1K. Manswell, BS, V. Le, BS, K. Henry, BS, M. Casey, BS, N. Anumolu, BS, M.S. Putman MD, MSci, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
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Kathryn Henry
1K. Manswell, BS, V. Le, BS, K. Henry, BS, M. Casey, BS, N. Anumolu, BS, M.S. Putman MD, MSci, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
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Maximilian Casey
1K. Manswell, BS, V. Le, BS, K. Henry, BS, M. Casey, BS, N. Anumolu, BS, M.S. Putman MD, MSci, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
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Natalie Anumolu
1K. Manswell, BS, V. Le, BS, K. Henry, BS, M. Casey, BS, N. Anumolu, BS, M.S. Putman MD, MSci, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
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Michael S. Putman
1K. Manswell, BS, V. Le, BS, K. Henry, BS, M. Casey, BS, N. Anumolu, BS, M.S. Putman MD, MSci, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
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  • For correspondence: mputman@mcw.edu
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REFERENCES

  1. 1.↵
    1. Weldring T,
    2. Smith SMS.
    Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs). Health Serv Insights 2013;6:61-8.
    OpenUrl
  2. 2.↵
    1. Barber CEH,
    2. Zell J,
    3. Yazdany J, et al.
    2019 American College of Rheumatology recommended patient-reported functional status assessment measures in rheumatoid arthritis. Arthritis Care Res 2019;71:1531-9.
    OpenUrlPubMed
  3. 3.↵
    1. Gnanasakthy A,
    2. Mordin M,
    3. Evans E,
    4. Doward L,
    5. DeMuro C.
    A review of patient-reported outcome labeling in the United States (2011-2015). Value Health 2017;20:420-9.
    OpenUrl
  4. 4.↵
    1. Gnanasakthy A,
    2. Norcross L,
    3. DeMuro Romano C,
    4. Carson RT.
    A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): counts, categories, and comprehensibility. Value Health 2022;25:647-55.
    OpenUrl
  5. 5.↵
    1. Cruz Rivera S,
    2. McMullan C,
    3. Jones L,
    4. Kyte D,
    5. Slade A,
    6. Calvert M.
    The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders. J Patient Rep Outcomes 2020;4:51.
    OpenUrl
  6. 6.↵
    1. Mercieca-Bebber R,
    2. King MT,
    3. Calvert MJ,
    4. Stockler MR,
    5. Friedlander M.
    The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Relat Outcome Meas 2018;9:353-67.
    OpenUrlPubMed
  7. 7.↵
    1. Calvert M,
    2. Blazeby J,
    3. Altman DG, et al.
    Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013;309:814-22.
    OpenUrlCrossRefPubMed
  8. 8.↵
    1. Kyte D,
    2. Retzer A,
    3. Ahmed K, et al.
    Systematic evaluation of patient-reported outcome protocol content and reporting in cancer trials. J Natl Cancer Inst 2019;111:1170-8.
    OpenUrlCrossRefPubMed
  9. 9.
    1. Brundage M,
    2. Bass B,
    3. Davidson J, et al.
    Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. Qual Life Res 2011;20:653-64.
    OpenUrlCrossRefPubMed
  10. 10.↵
    1. Joly F,
    2. Vardy J,
    3. Pintilie M,
    4. Tannock IF.
    Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Ann Oncol 2007;18:1935-42.
    OpenUrlCrossRefPubMed
  11. 11.↵
    1. Prasad V.
    Do cancer drugs improve survival or quality of life? BMJ 2017;359:j4528.
    OpenUrlFREE Full Text
  12. 12.
    1. Deininger M,
    2. Buchdunger E,
    3. Druker BJ.
    The development of imatinib as a therapeutic agent for chronic myeloid leukemia. Blood 2005;105:2640-53.
    OpenUrlAbstract/FREE Full Text
  13. 13.↵
    1. Atallah E,
    2. Schiffer CA,
    3. Radich JP, et al.
    Assessment of outcomes after stopping tyrosine kinase inhibitors among patients with chronic myeloid leukemia: a nonrandomized clinical trial. JAMA Oncol 2021;7:42-50.
    OpenUrl
  14. 14.↵
    1. Bartlett SJ,
    2. De Leon E,
    3. Orbai AM, et al.
    Patient-reported outcomes in RA care improve patient communication, decision-making, satisfaction and confidence: qualitative results. Rheumatology 2020;59:1662-70.
    OpenUrlPubMed
  15. 15.
    1. Black N.
    Patient reported outcome measures could help transform healthcare. BMJ 2013;346:f167.
    OpenUrlAbstract/FREE Full Text
  16. 16.↵
    1. Black N,
    2. Burke L,
    3. Forrest CB, et al.
    Patient-reported outcomes: pathways to better health, better services, and better societies. Qual Life Res 2016;25:1103-12.
    OpenUrlCrossRefPubMed
  17. 17.↵
    1. Studenic P,
    2. Stamm TA,
    3. Mosor E, et al.
    EULAR points to consider for including the perspective of young patients with inflammatory arthritis into patient-reported outcomes measures. RMD Open 2022;8:e002576.
  18. 18.↵
    1. Ware JE Jr.,
    2. Gandek B.
    Overview of the SF-36 health survey and the international quality of life assessment (IQOLA) project. J Clin Epidemiol 1998;51:903-12.
    OpenUrlCrossRefPubMed
  19. 19.
    1. Chernyshov PV.
    The evolution of quality of life assessment and use in dermatology. Dermatology 2019;235:167-74.
    OpenUrlCrossRef
  20. 20.
    1. Orbai AM,
    2. Bingham CO III
    . Patient reported outcomes in rheumatoid arthritis clinical trials. Curr Rheumatol Rep 2015;17:28.
    OpenUrl
  21. 21.↵
    1. Webster K,
    2. Cella D,
    3. Yost K.
    The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: properties, applications, and interpretation. Health Qual Life Outcomes 2003;1:79.
    OpenUrlCrossRefPubMed
  22. 22.↵
    1. Yosipovitch G,
    2. Reaney M,
    3. Mastey V, et al.
    Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol 2019;181:761-9.
    OpenUrlCrossRefPubMed
  23. 23.
    1. Wells G,
    2. Li T,
    3. Maxwell L,
    4. MacLean R,
    5. Tugwell P.
    Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. J Rheumatol 2007;34:280-9.
    OpenUrlAbstract/FREE Full Text
  24. 24.
    1. Ward MM,
    2. Guthrie LC,
    3. Alba MI.
    Clinically important changes in individual and composite measures of rheumatoid arthritis activity: thresholds applicable in clinical trials. Ann Rheum Dis 2015;74:1691-6.
    OpenUrlAbstract/FREE Full Text
  25. 25.
    1. Strand V,
    2. Singh JA.
    Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care 2008;14:234-254.
    OpenUrlPubMed
  26. 26.
    1. Samsa G,
    2. Edelman D,
    3. Rothman ML,
    4. Williams GR,
    5. Lipscomb J,
    6. Matchar D.
    Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics 1999;15:141-55.
    OpenUrlCrossRefPubMed
  27. 27.
    1. Mease P,
    2. Strand V,
    3. Gladman D.
    Functional impairment measurement in psoriatic arthritis: importance and challenges. Semin Arthritis Rheum 2018;48:436-48.
    OpenUrl
  28. 28.
    1. Kupferberg DH,
    2. Kaplan RM,
    3. Slymen DJ,
    4. Ries AL.
    Minimal clinically important difference for the UCSD shortness of breath questionnaire. J Cardiopulm Rehabil 2005;25:370-7.
    OpenUrlCrossRefPubMed
  29. 29.
    1. Jones PW,
    2. Beeh KM,
    3. Chapman KR,
    4. Decramer M,
    5. Mahler DA,
    6. Wedzicha JA.
    Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med 2014;189:250-5.
    OpenUrlCrossRefPubMed
  30. 30.
    1. Hays RD,
    2. Morales LS.
    The RAND-36 measure of health-related quality of life. Ann Med 2001;33:350-7.
    OpenUrlCrossRefPubMed
  31. 31.
    1. Gallagher EJ,
    2. Liebman M,
    3. Bijur PE.
    Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med 2001;38:633-8.
    OpenUrlCrossRefPubMed
  32. 32.
    1. Fleischmann R,
    2. Weinblatt ME,
    3. Schiff M, et al.
    Patient-reported outcomes from a two-year head-to-head comparison of subcutaneous abatacept and adalimumab for rheumatoid arthritis. Arthritis Care Res 2016;68:907-13.
    OpenUrl
  33. 33.
    1. Cella D,
    2. Yount S,
    3. Sorensen M,
    4. Chartash E,
    5. Sengupta N,
    6. Grober J.
    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.
    OpenUrlAbstract/FREE Full Text
  34. 34.
    1. Bruce B,
    2. Fries JF.
    The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol 2003;30:167-78.
    OpenUrlAbstract/FREE Full Text
  35. 35.
    1. Bruce B,
    2. Fries JF.
    The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes 2003;1:20.
    OpenUrlCrossRefPubMed
  36. 36.↵
    1. Ali FM,
    2. Salek MS,
    3. Finlay AY.
    Two minimal clinically important difference (2MCID): a new twist on an old concept. Acta Derm Venereol 2018;98:715-7.
    OpenUrl
  37. 37.↵
    1. National Institutes of Health, Department of Health and Human Services
    . Clinical trials registration and results information submission. Final rule. Fed Regist 2016;81:64981-5157.
    OpenUrlPubMed
  38. 38.↵
    1. US Food and Drug Administration
    . The Open Public Hearing at FDA Advisory Committee Meetings. [Internet. Accessed June 16, 2024.] Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/open-public-hearing-fda-advisory-committee-meetings
  39. 39.↵
    1. Morand EF,
    2. Furie R,
    3. Tanaka Y, et al.
    Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med 2020;382:211-21.
    OpenUrlCrossRefPubMed
  40. 40.
    1. Furie RA,
    2. Morand EF,
    3. Bruce IN, et al.
    Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol 2019;1:e208-e219.
    OpenUrl
  41. 41.
    1. Putman M.
    Anifrolumab in systemic lupus erythematosus. N Engl J Med 2020;382:1665-6.
    OpenUrl
  42. 42.↵
    1. Tai S,
    2. Anumolu N,
    3. Putman M.
    Challenging wisely: how to move beyond ‘1 mg/kg then taper’. Rheumatology 2022;62:3-6.
    OpenUrl
  43. 43.↵
    1. Moher D,
    2. Altman DG,
    3. Schulz KF,
    4. Simera I,
    5. Wager E
    1. Altman DG,
    2. Simera I.
    Using reporting guidelines effectively to ensure good reporting of Health Research. In: Moher D, Altman DG, Schulz KF, Simera I, Wager E, editors. Guidelines for reporting health research: a user’s manual. New Jersey: Wiley; 2014.
  44. 44.↵
    1. National Library of Medicine
    . Clinicaltrials.gov. FDAAA 801 and the final rule. [Internet. Accessed June 16, 2024.] Available from: https://clinicaltrials.gov/policy/fdaaa-801-final-rule
  45. 45.↵
    1. Edmonds S,
    2. MacGregor A,
    3. Doll A, et al.
    Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19. J Law Biosci 2020;7:lsaa083.
    OpenUrl
  46. 46.↵
    1. Esfandiari A,
    2. Yazdi-Feyzabadi V,
    3. Zarei L,
    4. Rashidian A,
    5. Salari H.
    Transparency in public pharmaceutical sector: the key informants’ perceptions from a developing country. BMC Health Serv Res 2021;21:1316.
    OpenUrl
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The State of Patient-Reported Outcome Measures in Rheumatology
Kenrick Manswell, Victoria Le, Kathryn Henry, Maximilian Casey, Natalie Anumolu, Michael S. Putman
The Journal of Rheumatology Sep 2024, 51 (9) 920-927; DOI: 10.3899/jrheum.2023-1073

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The State of Patient-Reported Outcome Measures in Rheumatology
Kenrick Manswell, Victoria Le, Kathryn Henry, Maximilian Casey, Natalie Anumolu, Michael S. Putman
The Journal of Rheumatology Sep 2024, 51 (9) 920-927; DOI: 10.3899/jrheum.2023-1073
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Keywords

HEALTH ASSESSMENT QUESTIONNAIRE
OUTCOMES
QUALITY OF LIFE
RHEUMATIC DISEASES

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