Construct and criterion validity of several proposed DAS28-based rheumatoid arthritis flare criteria: an OMERACT cohort validation study. Issue 11 (23rd November 2012)

• Record Type: Journal Article
• Authors: van der Maas, Aatke; Lie, Elisabeth; Christensen, Robin; Choy, Ernest; de Man, Yaël A; van Riel, Piet; Woodworth, Thasia; den Broeder, Alfons A
• Is Part Of: Annals of the rheumatic diseases. Volume 72:Issue 11(2013)
• Page Start: 1800
• Page End: 1805
• Publication Date: 2012-11-23
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2012-202281
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: To describe rheumatoid arthritis (RA) worsening that leads to change or re-initiation of treatment, several Disease Activity Score 28 (DAS28)-based flare criteria have been described, but none validated. Methods: Six previously published DAS28-based flare criteria ((1) increase in DAS28 >1.2, or >0.6 if DAS28 >5.1; (2) increase in DAS28 >1.2, or >0.6 if DAS28 ≥3.2; (3) increase >0.6 or DAS28 >3.2; (4) increase in DAS28 >1.2; (5) DAS28 >3.2; (6) DAS28 >2.6) were tested against five hypotheses concerning criterion and construct validity: (1+2) Sensitivity and specificity >70% compared with patient's/physician's judgment; (3) difference in proportion with disease modifying anti-rheumatic drug/corticosteroid initiation/increase >0.2; (4) mean difference in C-reactive protein (CRP) >10 mg/l; and (5) no statistical difference in Short Form-36 Mental Health subscale change. Three different RA patient databases in which flare might occur were used. Sensitivity/specificity, χ 2 and two-sample student t test analyses were done. Results: The analyses included 51, 147 and 744 RA patients, from the three databases. Criterion 2 fulfilled most hypotheses: 4 out of 5. Sensitivity and specificity varied between 63%–78% and 84%–92%. Construct validity was demonstrated with 23% more treatment change, higher mean CRP (11.4 mg/l) and depression scale change of −5. Criteria 3, 5 and 6 were more sensitive, criteria 1, 2 and 4 more specific. Conclusions: An increase in DAS28 >1.2 or >0.6 if DAS28 ≥3.2 appears most discriminating and valid by our predefined validation criteria. Considering the other criteria, sensitivity and specificity shown here might facilitate use in different settings.