"From Where I Stand": using multiple anchors yields different benchmarks for meaningful improvement and worsening in the rheumatoid arthritis flare questionnaire (RA-FQ).
Flare
Minimally important differences
Patient-reported outcomes
Rheumatoid arthritis
Journal
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
ISSN: 1573-2649
Titre abrégé: Qual Life Res
Pays: Netherlands
ID NLM: 9210257
Informations de publication
Date de publication:
May 2023
May 2023
Historique:
accepted:
02
08
2022
medline:
25
4
2023
pubmed:
9
9
2022
entrez:
8
9
2022
Statut:
ppublish
Résumé
The Rheumatoid Arthritis Flare Questionnaire (RA-FQ) is a patient-reported measure of disease activity in RA. We estimated minimal and meaningful change from the perspective of RA patients, physicians, and using a disease activity index. Data were from 3- to 6-month visits of adults with early RA enrolled in the Canadian Early Arthritis Cohort. Participants completed the RA-FQ, the Patient Global Assessment of RA, and the Patient Global Change Impression at consecutive visits. Rheumatologists recorded joint counts and MD Global. Clinical Disease Activity Index (CDAI) scores were computed. We compared mean RA-FQ change across categories using patients, physicians, and CDAI anchors. The 808 adults were mostly white (84%) women (71%) with a mean age of 55 and moderate-high disease activity (85%) at enrollment. At V2, 79% of patients classified their RA as changed; 59% were better and 20% were worse. Patients reporting they were a lot worse had a mean RA-FQ increase of 8.9 points, whereas those who were a lot better had a -6.0 decrease. Minimal worsening and improvement were associated with a mean 4.7 and - 1.8 change in RA-FQ, respectively, while patients rating their RA unchanged had stable scores. Physician and CDAI classified more patients as worse than patients, and minimal and meaningful RA-FQ thresholds differed by group. Thresholds to identify meaningful change vary by anchor used. These data offer new evidence demonstrating robust psychometric properties of the RA-FQ and offer guidance about improvement or worsening, supporting its use in RA care, research, and decision-making.
Identifiants
pubmed: 36074252
doi: 10.1007/s11136-022-03227-7
pii: 10.1007/s11136-022-03227-7
doi:
Substances chimiques
Antirheumatic Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1307-1318Investigateurs
M Baron
(M)
I Colmegna
(I)
S Fallavollita
(S)
D Haaland
(D)
B Haraoui
(B)
S Jamal
(S)
R Joshi
(R)
B Nair
(B)
P Panopoulos
(P)
L Rubin
(L)
E Villeneuve
(E)
M Zummer
(M)
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
Myasoedova, E., Crowson, C. S., Kremers, H. M., Therneau, T. M., & Gabriel, S. E. (2010). Is the incidence of rheumatoid arthritis rising?: Results from Olmsted County, Minnesota, 1955–2007. Arthritis and Rheumatism, 62, 1576–1582.
pubmed: 20191579
pmcid: 2929692
doi: 10.1002/art.27425
Myasoedova, E., Davis, J. M., 3rd., Crowson, C. S., & Gabriel, S. E. (2010). Epidemiology of rheumatoid arthritis: Rheumatoid arthritis and mortality. Current Rheumatology Reports, 12, 379–385.
pubmed: 20645137
doi: 10.1007/s11926-010-0117-y
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., et al. (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, 1855–1860.
pubmed: 22772326
doi: 10.1136/annrheumdis-2011-201201
Sanderson, T., Morris, M., Calnan, M., Richards, P., & Hewlett, S. (2010). Patient perspective of measuring treatment efficacy: The rheumatoid arthritis patient priorities for pharmacologic interventions outcomes. Arthritis Care Res (Hoboken), 62, 647–656.
pubmed: 20461786
doi: 10.1002/acr.20151
Gossec, L., Dougados, M., Rincheval, N., Balanescu, A., Boumpas, D. T., Canadelo, S., Carmona, L., Daures, J. P., de Wit, M., Dijkmans, B. A., et al. (2009). Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: A EULAR initiative. Annals of the Rheumatic Diseases, 68, 1680–1685.
pubmed: 19054825
doi: 10.1136/ard.2008.100271
Ward, M. M. (2022). Trends in permanent work disability associated with rheumatoid arthritis in the United States, 1999–2015. Arthritis Care Res (Hoboken), 74, 1321–1324.
pubmed: 33544975
doi: 10.1002/acr.24575
Bingham, C. O., III., Pohl, C., Woodworth, T. G., Hewlett, S. E., May, J. E., Rahman, M. U., Witter, J. P., Furst, D. E., Strand, C. V., Boers, M., & Alten, R. E. (2009). Developing a standardized definition for disease “flare” in rheumatoid arthritis (OMERACT 9 Special Interest Group). Journal of Rheumatology, 36, 2335–2341.
pubmed: 19684147
doi: 10.3899/jrheum.090369
Myasoedova, E., Chandran, A., Ilhan, B., Major, B. T., Michet, C. J., Matteson, E. L., & Crowson, C. S. (2016). The role of rheumatoid arthritis (RA) flare and cumulative burden of RA severity in the risk of cardiovascular disease. Annals of the Rheumatic Diseases, 75, 560–565.
pubmed: 25637001
doi: 10.1136/annrheumdis-2014-206411
Smolen, J. S., Breedveld, F. C., Burmester, G. R., Bykerk, V., Dougados, M., Emery, P., Kvien, T. K., Navarro-Compan, M. V., Oliver, S., Schoels, M., et al. (2016). Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Annals of the Rheumatic Diseases, 75, 3–15.
pubmed: 25969430
doi: 10.1136/annrheumdis-2015-207524
Nikiphorou, E., Radner, H., Chatzidionysiou, K., Desthieux, C., Zabalan, C., van Eijk-Hustings, Y., Dixon, W. G., Hyrich, K. L., Askling, J., & Gossec, L. (2016). Patient global assessment in measuring disease activity in rheumatoid arthritis: A review of the literature. Arthritis Research & Therapy, 18, 251.
doi: 10.1186/s13075-016-1151-6
Prevoo, M. L., t’Hof, M. A., Kuper, H. H., van Leeuwen, M. A., van De Putte, L. B., & van Riel, P. L. (1995). Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis and Rheumatism, 38, 44–48.
pubmed: 7818570
doi: 10.1002/art.1780380107
Aletaha, D., & Smolen, J. (2005). The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): A review of their usefulness and validity in rheumatoid arthritis. Clinical and Experimental Rheumatology, 23, S100–S108.
pubmed: 16273793
Oderda, G. M., & Balfe, L. M. (2011). Comparative effectiveness research (CER): A summary of AHRQ’s CER on therapies for rheumatoid arthritis. Journal of Managed Care Pharmacy, 17, S19–S24.
pubmed: 22073936
doi: 10.18553/jmcp.2011.17.s9-b.S19
Bingham, C. O., 3rd., Alten, R., Bartlett, S. J., Bykerk, V. P., Brooks, P. M., Choy, E., Christensen, R., Furst, D. E., Hewlett, S. E., Leong, A., et al. (2011). Identifying preliminary domains to detect and measure rheumatoid arthritis flares: Report of the OMERACT 10 RA Flare Workshop. Journal of Rheumatology, 38, 1751–1758.
pubmed: 21807797
doi: 10.3899/jrheum.110401
Bykerk, V. P., Lie, E., Bartlett, S. J., Alten, R., Boonen, A., Christensen, R., Furst, D. E., Hewlett, S., Leong, A. L., Lyddiatt, A., et al. (2014). Establishing a core domain set to measure rheumatoid arthritis flares: Report of the OMERACT 11 RA flare Workshop. Journal of Rheumatology, 41, 799–809.
pubmed: 24584927
doi: 10.3899/jrheum.131252
Hewlett, S., Sanderson, T., May, J., Alten, R., Bingham, C. O., 3rd., Cross, M., March, L., Pohl, C., Woodworth, T., & Bartlett, S. J. (2012). “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), 51, 69–76.
pubmed: 21565901
doi: 10.1093/rheumatology/keq455
Bartlett, S. J., Barbic, S. P., Bykerk, V. P., Choy, E. H., Alten, R., Christensen, R., den Broeder, A., Fautrel, B., Furst, D. E., Guillemin, F., et al. (2017). Content and construct validity, reliability, and responsiveness of the rheumatoid arthritis flare questionnaire: OMERACT 2016 workshop report. Journal of Rheumatology, 44, 1536–1543.
pubmed: 28811351
doi: 10.3899/jrheum.161145
Bartlett, S. J., Bykerk, V. P., Cooksey, R., Choy, E. H., Alten, R., Christensen, R., Furst, D. E., Guillemin, F., Halls, S., Hewlett, S., et al. (2015). Feasibility and domain validation of rheumatoid arthritis (RA) flare core domain set: Report of the OMERACT 2014 RA flare group plenary. Journal of Rheumatology, 42, 2185–2189.
pubmed: 25684764
doi: 10.3899/jrheum.141169
Wyrwich, K. W., Norquist, J. M., Lenderking, W. R., & Acaster, S. (2013). Methods for interpreting change over time in patient-reported outcome measures. Quality of Life Research, 22, 475–483.
pubmed: 22528240
doi: 10.1007/s11136-012-0175-x
Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status. Ascertaining the minimal clinically important difference. Controlled Clinical Trials., 10, 407–415.
pubmed: 2691207
doi: 10.1016/0197-2456(89)90005-6
Bartlett, S. J., Gutierrez, A. K., Andersen, K. M., Bykerk, V. P., Curtis, J. R., Haque, U. J., Orbai, A. M., Jones, M. R., & Bingham, C. O., 3rd. (2022). Identifying minimal and meaningful change in a patient-reported outcomes measurement information system for rheumatoid arthritis: Use of multiple methods and perspectives. Arthritis Care Res (Hoboken), 74, 588–597.
pubmed: 33166066
doi: 10.1002/acr.24501
Wells, G., Beaton, D., Shea, B., Boers, M., Simon, L., Strand, V., Brooks, P., & Tugwell, P. (2001). Minimal clinically important differences: Review of methods. Journal of Rheumatology, 28, 406–412.
pubmed: 11246688
Beaton, D., Maxwell, L., Grosskleg, S., Shea, B., Tugwell, P. S., Bingham, C. O., III., Conaghan, P., D’Agostino, M. A., Hofstetter, C., March, L., et al. (2021). The OMERACT Handbook 2.1. Ottawa: OMERACT.
U.S. Food and Drug Administration. Discussion Document for Patient-Focused Drug Development Public Workshop on Guidance 3: Select, Develop, or Modify Fit-for-purpose Clinical Outcome Assessments. In Methods to Identify What is Important to Patients & Select, Develop or Modify Fit-for-Purpose Clinical Outcomes Assessments Rockville, MD; Workshop Date October 15–16, 2018.
Strand, V., & Singh, J. A. (2010). Newer biological agents in rheumatoid arthritis: Impact on health-related quality of life and productivity. Drugs, 70, 121–145.
pubmed: 20108988
doi: 10.2165/11531980-000000000-00000
Bykerk, V. P., Jamal, S., Boire, G., Hitchon, C. A., Haraoui, B., Pope, J. E., Thorne, J. C., Sun, Y., & Keystone, E. C. (2012). The Canadian Early Arthritis Cohort (CATCH): Patients with new-onset synovitis meeting the 2010 ACR/EULAR classification criteria but not the 1987 ACR classification criteria present with less severe disease activity. Journal of Rheumatology, 39, 2071–2080.
pubmed: 22896026
doi: 10.3899/jrheum.120029
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). 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, 14, 978–988.
pubmed: 22152166
doi: 10.1016/j.jval.2011.06.013
Reeve, B. B., Wyrwich, K. W., Wu, A. W., Velikova, G., Terwee, C. B., Snyder, C. F., Schwartz, C., Revicki, D. A., Moinpour, C. M., McLeod, L. D., et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22, 1889–1905.
pubmed: 23288613
doi: 10.1007/s11136-012-0344-y
US Food and Drug Administration. (2020). Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, vol. FDA-2020-D-1564. pp. 53820–53822. Food and Drug Administration, Health and Human Services, Docket No. FDA-2020-D-1564; Document Number:2022-01377. https://www.fda.gov/media/141565/download .
Bartlett, S. J., Bykerk, V. P., Fautrel, B., Guillemin, F., den Broeder, A., Alten, R., Christensen, R., Choy, E., Furst, D., Hewlett, S., et al. (2017). The RA Flare Questionnaire (RA-FQ) is responsive to change in ra symptoms and impacts in clinical and observational trials. Annals of the Rheumatic Diseases, 76, 470–470.
Bykerk, V. P., Bingham, C. O., Choy, E. H., Lin, D., Alten, R., Christensen, R., Furst, D. E., Hewlett, S., Leong, A., March, L., et al. (2016). Identifying flares in rheumatoid arthritis: Reliability and construct validation of the OMERACT RA Flare Core Domain Set. RMD Open, 2, e000225.
pubmed: 27252895
pmcid: 4885442
doi: 10.1136/rmdopen-2015-000225
Scott, I. C., & Scott, D. L. (2014). Joint counts in inflammatory arthritis. Clinical and Experimental Rheumatology, 32, 7–12.
Sokka, T., & Pincus, T. (2009). Joint counts to assess rheumatoid arthritis for clinical research and usual clinical care: advantages and limitations. Rheumatic Disease Clinics North America, 35, 713–722.
doi: 10.1016/j.rdc.2009.10.004
Aletaha, D., & Smolen, J. S. (2007). The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) to monitor patients in standard clinical care. Best Practice & Research Clinical Rheumatology, 21, 663–675.
doi: 10.1016/j.berh.2007.02.004
Dhaon, P., Das, S. K., Srivastava, R., & Dhakad, U. (2018). Performances of Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) appear to be better than the gold standard Disease Assessment Score (DAS-28-CRP) to assess rheumatoid arthritis patients. International Journal of Rheumatic Diseases, 21, 1933–1939.
pubmed: 28608433
doi: 10.1111/1756-185X.13110
Yun, H., Chen, L., Xie, F., Patel, H., Boytsov, N., Zhang, X., & Curtis, J. R. (2020). Do patients with moderate or high disease activity escalate rheumatoid arthritis therapy according to treat-to-target principles? results from the rheumatology informatics system for effectiveness registry of the American College of Rheumatology. Arthritis Care & Research, 72, 166–175.
doi: 10.1002/acr.24083
Goldsmith, C. H., Boers, M., Bombardier, C., & Tugwell, P. (1993). Criteria for clinically important changes in outcomes: Development, scoring and evaluation of rheumatoid arthritis patient and trial profiles OMERACT Committee. The Journal of Rheumatology, 20, 561–565.
pubmed: 8478874
Farrar, J. T., Young, J. P., Jr., LaMoreaux, L., Werth, J. L., & Poole, M. R. (2001). Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain, 94, 149–158.
pubmed: 11690728
doi: 10.1016/S0304-3959(01)00349-9
Salaffi, F., Stancati, A., Silvestri, C. A., Ciapetti, A., & Grassi, W. (2004). Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. European Journal of Pain, 8, 283–291.
pubmed: 15207508
doi: 10.1016/j.ejpain.2003.09.004
Terwee, C. B., Peipert, J. D., Chapman, R., Lai, J.-S., Terluin, B., Cella, D., Griffith, P., & Mokkink, L. B. (2021). Minimal important change (MIC): A conceptual clarification and systematic review of MIC estimates of PROMIS measures. Quality of Life Research, 30, 2729–2754.
pubmed: 34247326
pmcid: 8481206
doi: 10.1007/s11136-021-02925-y
Starfield, B., Wray, C., Hess, K., Gross, R., Birk, P. S., & D’Lugoff, B. C. (1981). The influence of patient-practitioner agreement on outcome of care. American Journal of Public Health, 71, 127–131.
pubmed: 7457681
pmcid: 1619620
doi: 10.2105/AJPH.71.2.127
Rohekar, G., & Pope, J. (2009). Test-retest reliability of patient global assessment and physician global assessment in rheumatoid arthritis. Journal of Rheumatology, 36, 2178–2182.
pubmed: 19755617
doi: 10.3899/jrheum.090084
Desthieux, C., Hermet, A., Granger, B., Fautrel, B., & Gossec, L. (2016). Patient-physician discordance in global assessment in rheumatoid arthritis: A systematic literature review with meta-analysis. Arthritis Care Res (Hoboken), 68, 1767–1773.
pubmed: 27059693
doi: 10.1002/acr.22902
Beaton, D. E., Bombardier, C., Katz, J. N., Wright, J. G., Wells, G., Boers, M., Strand, V., & Shea, B. (2001). Looking for important change/differences in studies of responsiveness. OMERACT MCID Working. Group Outcome Measures in Rheumatology. Minimal Clinically Important Difference. J Rheumatol., 28, 400–405.
pubmed: 11246687
Curtis, J. R., Yang, S., Chen, L., Pope, J. E., Keystone, E. C., Haraoui, B., Boire, G., Thorne, J. C., Tin, D., Hitchon, C. A., et al. (2015). Determining the minimally important difference in the clinical disease activity index for improvement and worsening in early rheumatoid arthritis patients. Arthritis Care Res (Hoboken), 67, 1345–1353.
pubmed: 25988705
doi: 10.1002/acr.22606
Anderson, J., Caplan, L., Yazdany, J., Robbins, M. L., Neogi, T., Michaud, K., Saag, K. G., O’Dell, J. R., & Kazi, S. (2012). Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken), 64, 640–647.
pubmed: 22473918
doi: 10.1002/acr.21649
Bykerk, V. P., Akhavan, P., Hazlewood, G. S., Schieir, O., Dooley, A., Haraoui, B., Khraishi, M., Leclercq, S. A., Legare, J., Mosher, D. P., et al. (2012). Canadian Rheumatology Association recommendations for pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs. Journal of Rheumatology, 39, 1559–1582.
pubmed: 21921096
doi: 10.3899/jrheum.110207
Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2003). Defining clinically meaningful change in health-related quality of life. Journal of Clinical Epidemiology, 56, 395–407.
pubmed: 12812812
doi: 10.1016/S0895-4356(03)00044-1