Rheumatoid Arthritis disease activity assessment in routine care: performance of the most widely used composite disease activity indices and patient-reported outcome measures
Comparison of disease activity indices in RA
Keywords:
rheumatoid arthritis, disease activity, composite disease activity indices, patient-reported outcome measures, tight controlAbstract
Background and aim: To evaluate the convergent and discriminative validity of many continuous composite disease activity indices and patient-reported outcome measures (PROMs) in rheumatoid arthritis (RA). Methods: In consecutive RA patients in moderate or high disease activity, according to the Simplified Disease Activity Index (SDAI) definition, were computed four additional composite disease activity indices, the 28-joint Disease Activity Score – erythrocyte sedimentation rate (DAS28-ESR), the Clinical Disease Activity Index (CDAI), the Chronic Arthritis Systemic Index (CASI), and the Mean Overall Index for RA (MOI-RA), and five PROMs, the Patients’ Activity Scale (PAS), the Rheumatoid Arthritis Impact of Disease (RAID), the 5-item RA Disease Activity Index (RADAI-5), the Routine Assessment of Patient Index Data (RAPID3), and the Clinical Arthritis Activity (PRO-CLARA). Spearman’s rho correlation coefficients were determined to assess their convergent validity, and discriminative performance was calculated by the area under the receiver-operating curve (AUC-ROC). The patients’ opinion of their symptomatic status (PASS) was used as the external criterion. Results: 246 RA patients with moderate (29.3%) or high disease activity (70.7%) have been assessed. The indices all showed a significant correlation (p <0.0001 for all). Among the composite disease activity indices, the CDAI was the one that showed the best discriminating ability compared to the PASS (AUC = 0.962), while among the PROMs the RAID was the most performing (AUC = 0.879). Conclusions: CDAI as composite index of disease activity, and RAID as PROM, are the two instruments with the best performances in relation to PASS. The use of validated disease activity measures can help in clinical practice to adopt treat-to-target strategies in RA patients. (www.actabiomedica.it)
References
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10. Wolfe F, Michaud K, Pincus T. A composite disease activity scale for clinical practice, observational studies, and clinical trials: the patient activity scale (PAS/PAS-II). J Rheumatol 2005; 32: 2410-2415.
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22. Salaffi F, Cimmino MA, Leardini G, Gasparini S, Grassi W. Disease activity assessment of rheumatoid arthritis in daily practice: validity, internal consistency, reliability and congruency of the Disease Activity Score including 28 joints (DAS28) compared with the Clinical Disease Activity Index (CDAI). Clin Exp Rheumatol 2009; 27: 552-559.
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25. Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum 1983; 26: 1346-1353.
26. Ward MM, Castrejon I, Bergman MJ, Alba MI, Guthrie LC, Pincus T. Minimal Clinically Important Improvement of Routine Assessment of Patient Index Data 3 in Rheumatoid Arthritis. J Rheumatol 2019; 46: 27-30.
27. Salaffi F, Bazzichi L, Stancati A, et al. Development of a functional disability measurement tool to assess early arthritis: the recent-onset arthritis disability (ROAD) questionnaire. Clin Exp Rheumatol 2005; 23: 628-636.
28. Salaffi F, Carotti M, Gutierrez M, Di Carlo M, De Angelis R. Patient Acceptable Symptom State in Self-Report Questionnaires and Composite Clinical Disease Index for Assessing Rheumatoid Arthritis Activity: Identification of Cut-Off Points for Routine Care. Biomed Res Int 2015; 2015:930756.
29. Swets JA. Measuring the accuracy of diagnostic systems. Science 1988; 240: 1285-1293.
30. Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology 1983; 148: 839-843.
31. Harth M, Pope J. The measure of our measures. Rheumatology (Oxford) 2004; 43: 1465-1467.
32. Gaujoux-Viala C, Mouterde G, Baillet A, et al. Evaluating disease activity in rheumatoid arthritis: which composite index is best? A systematic literature analysis of studies comparing the psychometric properties of the DAS, DAS28, SDAI and CDAI. Joint Bone Spine 2012; 79: 149-155.
33. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012; 64: 625-639.
34. Anderson JK, Zimmerman L, Caplan L, Michaud K. Measures of rheumatoid arthritis disease activity: Patient (PtGA) and Provider (PrGA) Global Assessment of Disease Activity, Disease Activity Score (DAS) and Disease Activity Score with 28-Joint Counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Patient Activity Score (PAS) and Patient Activity Score-II (PASII), Routine Assessment of Patient Index Data (RAPID), Rheumatoid Arthritis Disease Activity Index (RADAI) and Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), Chronic Arthritis Systemic Index (CASI), Patient-Based Disease Activity Score With ESR (PDAS1) and Patient-Based Disease Activity Score without ESR (PDAS2), and Mean Overall Index for Rheumatoid Arthritis (MOI-RA). Arthritis Care Res (Hoboken) 2011; 63(Suppl 11): S14-S36.
35. 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: 745-753.
36. Vander Cruyssen B, Van Looy S, et al. DAS28 best reflects the physician’s clinical judgment of response to infliximab therapy in rheumatoid arthritis patients: validation of the DAS28 score in patients under infliximab treatment. Arthritis Res Ther 2005; 7: R1063-1071.
37. Soubrier M, Zerkak D, Gossec L, Ayral X, Roux C, Dougados M. Which variables best predict change in rheumatoid arthritis therapy in daily clinical practice? J Rheumatol 2006; 33: 1243-1246.
38. Salaffi F, Ciapetti A, Gasparini S, Carotti M, Bombardieri S; New Indices study group. The comparative responsiveness of the patient self-report questionnaires and composite disease indices for assessing rheumatoid arthritis activity in routine care. Clin Exp Rheumatol 2012; 30: 912-921.
39. Pope JE, Khanna D, Norrie D, Ouimet JM. The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials. J Rheumatol 2009; 36: 254-259.
2. Ramiro S, Sepriano A, Chatzidionysiou K, et al. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis 2017; 76: 1101-1136.
3. Smolen JS, Breedveld FC, Burmester GR, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis 2016; 75: 3-15.
4. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis 2020; 79: 685-699.
5. Möttönen T, Hannonen P, Leirisalo-Repo M, et al. Comparison of combination therapy with single- drug therapy in early rheumatoid arthritis: a randomised trial. FINRACO trial group. Lancet 1999; 353: 1568-1573.
6. Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty- eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995; 38: 44-48.
7. Aletaha D, Smolen J. The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): a review of their usefulness and validity in rheumatoid arthritis. Clin Exp Rheumatol 2005; 23(Suppl 39): S100-S108.
8. Pincus T, Amara I, Segurado OG, Bergman M, Koch GG. Relative efficiencies of physician/ assessor global estimates and patient questionnaire measures are similar to or greater than joint counts to distinguish adalimumab from control treatments in rheumatoid arthritis clinical trials. J Rheumatol 2008; 35: 201-205.
9. Pincus T, Strand V, Koch G, et al. An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial. Arthritis Rheum 2003; 48: 625-630.
10. Wolfe F, Michaud K, Pincus T. A composite disease activity scale for clinical practice, observational studies, and clinical trials: the patient activity scale (PAS/PAS-II). J Rheumatol 2005; 32: 2410-2415.
11. 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: 1680-1685.
12. Leeb BF, Haindl PM, Maktari A, Nothnagl T, Rintelen B. Patient-centered rheumatoid arthritis disease activity assessment by a modified RADAI. J Rheumatol 2008: 35: 1294-1299.
13. Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID-3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol 2008; 35: 2136-2147.
14. Salaffi F, Migliore A, Scarpellini M, et al. Psychometric properties of an index of three patient-reported outcome (PRO) measures, termed the CLinical ARthritis Activity (PRO-CLARA) in patients with rheumatoid arthritis. The NEW INDICES study. Clin Exp Rheumatol 2010; 28: 186-200.
15. Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 2010; 62: 2569-2581.
16. Spaetgens B, Wijnands JM, van Durme C, Boonen A. Content and construct validity of the Rheumatic Diseases Comorbidity Index in patients with gout. Rheumatology (Oxford) 2015; 54: 1659-1663.
17. Iannone F, Salaffi F, Fornaro M, et al. Influence of baseline modified Rheumatic Disease Comorbidity Index (mRDCI) on drug survival and effectiveness of biological treatment in patients affected with Rheumatoid arthritis, Spondyloarthritis and Psoriatic arthritis in real-world settings. Eur J Clin Invest 2018; 48: e13013.
18. Mäkinen H, Kautiainen H, Hannonen P, Sokka T. A new disease activity index for rheumatoid arthritis: Mean Overall Index for Rheumatoid Arthritis (MOI-RA). J Rheumatol 2008; 35: 1522-7.
19. Salaffi F, Peroni M, Ferraccioli GF. Discriminating ability of composite indices for measuring disease activity in rheumatoid arthritis: a comparison of the Chronic Arthritis Systemic Index, Disease Activity Score and Thompson's articular index. Rheumatology (Oxford) 2000; 39: 90-96.
20. Grigor C, Capell H, Stirling A, et al. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet 2004; 364: 263-269.
21. Van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism criteria. Arthritis Rheum 1996; 39: 34-40.
22. Salaffi F, Cimmino MA, Leardini G, Gasparini S, Grassi W. Disease activity assessment of rheumatoid arthritis in daily practice: validity, internal consistency, reliability and congruency of the Disease Activity Score including 28 joints (DAS28) compared with the Clinical Disease Activity Index (CDAI). Clin Exp Rheumatol 2009; 27: 552-559.
23. Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T. 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.
24. Salaffi F, Di Carlo M, Vojinovic J, et al. Validity of the rheumatoid arthritis impact of disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis. Joint Bone Spine 2018; 85: 317-322.
25. Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum 1983; 26: 1346-1353.
26. Ward MM, Castrejon I, Bergman MJ, Alba MI, Guthrie LC, Pincus T. Minimal Clinically Important Improvement of Routine Assessment of Patient Index Data 3 in Rheumatoid Arthritis. J Rheumatol 2019; 46: 27-30.
27. Salaffi F, Bazzichi L, Stancati A, et al. Development of a functional disability measurement tool to assess early arthritis: the recent-onset arthritis disability (ROAD) questionnaire. Clin Exp Rheumatol 2005; 23: 628-636.
28. Salaffi F, Carotti M, Gutierrez M, Di Carlo M, De Angelis R. Patient Acceptable Symptom State in Self-Report Questionnaires and Composite Clinical Disease Index for Assessing Rheumatoid Arthritis Activity: Identification of Cut-Off Points for Routine Care. Biomed Res Int 2015; 2015:930756.
29. Swets JA. Measuring the accuracy of diagnostic systems. Science 1988; 240: 1285-1293.
30. Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology 1983; 148: 839-843.
31. Harth M, Pope J. The measure of our measures. Rheumatology (Oxford) 2004; 43: 1465-1467.
32. Gaujoux-Viala C, Mouterde G, Baillet A, et al. Evaluating disease activity in rheumatoid arthritis: which composite index is best? A systematic literature analysis of studies comparing the psychometric properties of the DAS, DAS28, SDAI and CDAI. Joint Bone Spine 2012; 79: 149-155.
33. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012; 64: 625-639.
34. Anderson JK, Zimmerman L, Caplan L, Michaud K. Measures of rheumatoid arthritis disease activity: Patient (PtGA) and Provider (PrGA) Global Assessment of Disease Activity, Disease Activity Score (DAS) and Disease Activity Score with 28-Joint Counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Patient Activity Score (PAS) and Patient Activity Score-II (PASII), Routine Assessment of Patient Index Data (RAPID), Rheumatoid Arthritis Disease Activity Index (RADAI) and Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), Chronic Arthritis Systemic Index (CASI), Patient-Based Disease Activity Score With ESR (PDAS1) and Patient-Based Disease Activity Score without ESR (PDAS2), and Mean Overall Index for Rheumatoid Arthritis (MOI-RA). Arthritis Care Res (Hoboken) 2011; 63(Suppl 11): S14-S36.
35. 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: 745-753.
36. Vander Cruyssen B, Van Looy S, et al. DAS28 best reflects the physician’s clinical judgment of response to infliximab therapy in rheumatoid arthritis patients: validation of the DAS28 score in patients under infliximab treatment. Arthritis Res Ther 2005; 7: R1063-1071.
37. Soubrier M, Zerkak D, Gossec L, Ayral X, Roux C, Dougados M. Which variables best predict change in rheumatoid arthritis therapy in daily clinical practice? J Rheumatol 2006; 33: 1243-1246.
38. Salaffi F, Ciapetti A, Gasparini S, Carotti M, Bombardieri S; New Indices study group. The comparative responsiveness of the patient self-report questionnaires and composite disease indices for assessing rheumatoid arthritis activity in routine care. Clin Exp Rheumatol 2012; 30: 912-921.
39. Pope JE, Khanna D, Norrie D, Ouimet JM. The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials. J Rheumatol 2009; 36: 254-259.
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Rheumatoid Arthritis disease activity assessment in routine care: performance of the most widely used composite disease activity indices and patient-reported outcome measures: Comparison of disease activity indices in RA. Acta Biomed [Internet]. 2021 Sep. 2 [cited 2024 Jun. 30];92(4):e2021238. Available from: https://mattioli1885journals.com/index.php/actabiomedica/article/view/10831
