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Establishing clinical severity for PROMIS® measures in adult patients with rheumatic diseases

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Different patient-reported outcome (PRO) measures are used for rheumatic diseases (RD). The aims of this study are—(1) Identify PROMIS® domains most relevant to care of patients with RD, (2) Collect T-Score metrics in patients with RD, and (3) Identify clinically meaningful cut-points for these domains.


A convenience sample of RD patients was recruited consecutively during clinic visits, and asked to complete computer-adaptive tests on thirteen Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments. Based on discussion with clinical providers, four measures were chosen to be relevant and actionable (from rheumatologists’ perspective) in RD patients. Data from RD patients were used to develop clinical vignettes across a range of symptom severity. Vignettes were created based on most likely item responses at different levels on the T-score metric (mean = 50; SD = 10) and anchored at 5-point intervals (0.5 SDs). Patients with RD (N = 9) and clinical providers (N = 10) participated as expert panelists in separate one-day meetings using a modified educational standard setting method.


Four domains (physical function, pain interferences, sleep disturbance, depression) that are actionable at the point-of-care were selected. For all domains, patients endorsed cut-points at lower levels of impairment than providers by 0.5 to 1 SD (e.g., severe impairment in physical function was defined as a T-score of 35 by patients and 25 by providers).


We used a modified educational method to estimate clinically relevant cut-points to classify severity for PROMIS measures This allows for meaningful interpretation of PROMIS® measures in a clinical setting of RD population.

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  1. Khanna, D., Krishnan, E., Dewitt, E. M., Khanna, P. P., Spiegel, B., & Hays, R. D. (2011). The future of measuring patient-reported outcomes in rheumatology: Patient-Reported Outcomes Measurement Information System (PROMIS). Arthritis Care and Research, 63(Suppl 11), S486-490.

    Google Scholar 

  2. Centers for Disease Control and Prevention, and Centers for Disease Control and Prevention. (2000). Measuring healthy days: Population assessment of health-related quality of life (pp. 4–6). Atlanta: CDC.

    Google Scholar 

  3. Devilliers, H., Amoura, Z., Besancenot, J. F., Bonnotte, B., Pasquali, J. L., Wahl, D., Maurier, F., Kaminsky, P., Pennaforte, J. L., Magy-Bertrand, N., Arnaud, L., Binquet, C., Guillemin, F., & Bonithon-Kopp, C. (2015). Responsiveness of the 36-item Short Form Health Survey and the Lupus Quality of Life questionnaire in SLE. Rheumatology, 54(5), 940–949.

    Article  PubMed  Google Scholar 

  4. Husted, J. A., Gladman, D. D., Farewell, V. T., & Cook, R. J. (2001). Health-related quality of life of patients with psoriatic arthritis: A comparison with patients with rheumatoid arthritis. Arthritis and Rheumatism, 45(2), 151–158.

    Article  CAS  PubMed  Google Scholar 

  5. Uhlig, T., Loge, J. H., Kristiansen, I. S., & Kvien, T. K. (2007). Quantification of reduced health-related quality of life in patients with rheumatoid arthritis compared to the general population. The Journal of Rheumatology, 34(6), 1241–1247.

    PubMed  Google Scholar 

  6. Health, U. S. D. o., Human Services, F. D. A. C. f. D. E., Research, Health, U. S. D. o., Human Services, F. D. A. C. f. B. E., Research, Health, U. S. D. o., Human Services, F. D. A. C. f. D., & Radiological, H. (2006). Guidance for industry: patient-reported outcome measures: Use in medical product development to support labeling claims: Draft guidance. Health Quality Life Outcomes, 4, 79.

    Article  Google Scholar 

  7. Singh, J. A., Saag, K. G., Bridges, S. L. Jr., Akl, E. A., Bannuru, R. R., Sullivan, M. C., Vaysbrot, E., McNaughton, C., Osani, M., Shmerling, R. H., Curtis, J. R., Furst, D. E., Parks, D., Kavanaugh, A., O’Dell, J., King, C., Leong, A., Matteson, E. L., Schousboe, J. T., Drevlow, B., Ginsberg, S., Grober, J., Clair, E. W., Tindall, E., Miller, A. S., & McAlindon, T. (2016). 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatology, 68(1), 1–26.

    Article  PubMed  Google Scholar 

  8. Witter, J. P. (2016). The Promise Of Patient-Reported Outcomes Measurement Information System-turning theory into reality: A uniform approach to patient-reported outcomes across rheumatic diseases. Rheumatic Diseases Clinics of North America, 42(2), 377–394.

    Article  PubMed  Google Scholar 

  9. Cella, D., Yount, S., Rothrock, N., Gershon, R., Cook, K., Reeve, B., Ader, D., Fries, J. F., Bruce, B., Rose, M., & Group, P. C. (2007). The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Medical Care, 45(5 Suppl 1), S3–S11.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Reeve, B. B., Hays, R. D., Bjorner, J. B., Cook, K. F., Crane, P. K., Teresi, J. A., Thissen, D., Revicki, D. A., Weiss, D. J., Hambleton, R. K., Liu, H., Gershon, R., Reise, S. P., Lai, J. S., Cella, D., & Group, P. C. (2007). Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Medical Care, 45(5 Suppl 1), S22-31.

    PubMed  Google Scholar 

  11. Hays, R. D., Liu, H., Spritzer, K., & Cella, D. (2007). Item response theory analyses of physical functioning items in the medical outcomes study. Medical Care, 45(5 Suppl 1), S32–S38.

    Article  PubMed  Google Scholar 

  12. Khullar, O. V., Rajaei, M. H., Force, S. D., Binongo, J. N., Lasanajak, Y., Robertson, S., Pickens, A., Sancheti, M. S., Lipscomb, J., Gillespie, T. W., & Fernandez, F. G. (2017). Pilot study to integrate patient reported outcomes after lung cancer operations into the Society of Thoracic Surgeons Database. The Annals of Thoracic Surgery, 104(1), 245–253.

    Article  PubMed  Google Scholar 

  13. Karantonis, A., & Sireci, S. G. (2006). The bookmark standard-setting method: A literature review. Educational Measurement: Issues and Practice, 25(1), 4–12.

    Article  Google Scholar 

  14. Cook, K. F., Victorson, D. E., Cella, D., Schalet, B. D., & Miller, D. (2015). Creating meaningful cut-scores for Neuro-QOL measures of fatigue, physical functioning, and sleep disturbance using standard setting with patients and providers. Quality of life research, 24(3), 575–589.

    Article  PubMed  Google Scholar 

  15. Cella, D., Choi, S., Garcia, S., Cook, K. F., Rosenbloom, S., Lai, J. S., Tatum, D. S., & Gershon, R. (2014). Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment. Quality of Life Research, 23(10), 2651–2661.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Morgan, E. M., Mara, C. A., Huang, B., Barnett, K., Carle, A. C., Farrell, J. E., & Cook, K. F. (2017). Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS(R)) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers. Quality of Life Research, 26(3), 565–586.

    Article  PubMed  Google Scholar 

  17. University, J. H. (2017). Users’ Guide to Integrating Patient-Reported Outcomes in Electronic Health Records. Retrieved July 29, 2017, from

  18. Cella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., Amtmann, D., Bode, R., Buysse, D., Choi, S., Cook, K., Devellis, R., DeWalt, D., Fries, J. F., Gershon, R., Hahn, E. A., Lai, J. S., Pilkonis, P., Revicki, D., Rose, M., Weinfurt, K., Hays, R., & Group, P. C. (2010). The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Journal of Clinical Epidemiology, 63(11), 1179–1194.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Idzerda, L., Rader, T., Tugwell, P., & Boers, M. (2014). Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets. The Journal of rheumatology, 41(5), 986–993.

    Article  PubMed  Google Scholar 

  20. Bartlett, S. J., Orbai, A. M., Duncan, T., DeLeon, E., Ruffing, V., Clegg-Smith, K., & Bingham, C. O. 3rd. (2015). Reliability and validity of selected PROMIS measures in people with rheumatoid arthritis. PLoS ONE, 10(9), e0138543.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Bartlett, S. J., Hewlett, S., Bingham, C. O. 3rd, Woodworth, T. G., Alten, R., Pohl, C., Choy, E. H., Sanderson, T., Boonen, A., Bykerk, V., Leong, A. L., Strand, V., Furst, D. E., Christensen, R., & Group, O. R. F. W. (2012). Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus. Annals of the Rheumatic Diseases, 71(11), 1855–1860.

    Article  PubMed  Google Scholar 

  22. Mahieu, M. A., Ahn, G. E., Chmiel, J. S., Dunlop, D. D., Helenowski, I. B., Semanik, P., Song, J., Yount, S., Chang, R. W., & Ramsey-Goldman, R. (2016). Fatigue, patient reported outcomes, and objective measurement of physical activity in systemic lupus erythematosus. Lupus, 25, 1190–1199.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. Jensen, R. E., Rothrock, N. E., DeWitt, E. M., Spiegel, B., Tucker, C. A., Crane, H. M., Forrest, C. B., Patrick, D. L., Fredericksen, R., Shulman, L. M., Cella, D., & Crane, P. K. (2015). The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care. Medical Care, 53(2), 153–159.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Basu, N., Jones, G. T., Fluck, N., MacDonald, A. G., Pang, D., Dospinescu, P., Reid, D. M., & Macfarlane, G. J. (2010). Fatigue: A principal contributor to impaired quality of life in ANCA-associated vasculitis. Rheumatology, 49(7), 1383–1390.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Druce, K. L., Jones, G. T., Macfarlane, G. J., & Basu, N. (2015). Patients receiving anti-TNF therapies experience clinically important improvements in RA-related fatigue: Results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Rheumatology, 54(6), 964–971.

    Article  CAS  PubMed  Google Scholar 

  26. Lai, J. S., Beaumont, J. L., Jensen, S. E., Kaiser, K., Van Brunt, D. L., Kao, A. H., & Chen, S. Y. (2017). An evaluation of health-related quality of life in patients with systemic lupus erythematosus using PROMIS and Neuro-QoL. Clinical Rheumatology, 36(3), 555–562.

    Article  PubMed  Google Scholar 

  27. Druce, K. L., Jones, G. T., Macfarlane, G. J., & Basu, N. (2015). Determining pathways to improvements in fatigue in rheumatoid arthritis: Results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Arthritis Rheumatology, 67(9), 2303–2310.

    Article  CAS  PubMed  Google Scholar 

  28. Hifinger, M., Putrik, P., Ramiro, S., Keszei, A. P., Hmamouchi, I., Dougados, M., Gossec, L., & Boonen, A. (2016). In rheumatoid arthritis, country of residence has an important influence on fatigue: Results from the multinational COMORA study. Rheumatology, 55(4), 735–744.

    Article  PubMed  Google Scholar 

  29. Wagner, L. I., Spiegel, D., & Pearman, T. (2013). Using the science of psychosocial care to implement the new american college of surgeons commission on cancer distress screening standard. Journal of the National Comprehensive Cancer Network, 11(2), 214–221.

    Article  PubMed  Google Scholar 

  30. Snyder, C. F., Smith, K. C., Bantug, E. T., Tolbert, E. E., Blackford, A. L., Brundage, M. D., & the PRO Data Presentation Stakeholder Advisory Board. (2017). What do these scores mean? Presenting patient-reported outcomes data to patients and clinicians to improve interpretability. Cancer, 123(10), 1848–1859.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Basch, E., Iasonos, A., McDonough, T., Barz, A., Culkin, A., Kris, M. G., Scher, H. I., & Schrag, D. (2006). Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. The Lancet Oncology, 7(11), 903–909.

    Article  PubMed  Google Scholar 

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The authors thank National Institutes of Health and National Institute of Arthritis and Musculoskeletal and Skin Diseases for funding the study and Dr. D. Khanna (NIH/NIAMS K24 AR 063120), and Dr. Young (NIH/NIAMS T32-AR007080-38).


The study and Dr. D. Khanna were funded by the NIH/NIAMS K24 AR 063120, and Dr. Young by NIH/NIAMS T32-AR007080-38.

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Correspondence to Dinesh Khanna.

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The study was approved by the University of Michigan Institutional Review Board. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individuals who participated in the phase 2 of the study, and from patients and providers who participated in the panel group discussions.

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Nagaraja, V., Mara, C., Khanna, P.P. et al. Establishing clinical severity for PROMIS® measures in adult patients with rheumatic diseases. Qual Life Res 27, 755–764 (2018).

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