E De Miguel

Publications (2)7.87 Total impact

• Article: Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: Results from a randomized, multicentre study.

  P Mandl, Pv Balint, Y Brault, M Backhaus, Ma D'Agostino, W Grassi, D van der Heijde, E de Miguel, Rj Wakefield, I Logeart, M Dougados
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  ABSTRACT: OBJECTIVES: To evaluate the metrological properties of composite disease activity indices in rheumatoid arthritis (RA), utilizing information derived from clinical, grey-scale (GS) and Power Doppler (PD) ultrasound examination. To assess the classification of patients according to disease activity using such indices. METHODS: This ancillary study utilized data from a prospective, randomized, parallel-group, multicenter study conducted in subjects with moderate RA, randomized to receive etanercept and methotrexate (ETN+MTX) or usual care (various DMARDs). In multimodal indices the 28-swollen joint count (SJC) was either supplemented or replaced by clinically non-swollen joints in which the presence of synovitis was detected either by GS and/or PD and were calculated according to the DAS28 or SDAI indices. Reliability, external validity and discriminative capacity were calculated at baseline/screening by intraclass correlation coefficient, Pearson's correlation and standardized response mean respectively. RESULTS: Data from 62 patients (age: 53.8±13.2 years; disease duration: 8.8±7.7 years; disease activity: 4.6± 0.5 (DAS28), 20.9± 5.9 (SDAI)) were analyzed, 32 receiving ETN+MTX and 30 receiving DMARDs. The metrological properties were at least as good for GS and/or PD-based indices as for their clinical counterparts. Using GS and PD supplemented indices an additional 67.8% and 32.3% (DAS28-derived and SDAI-derived indices respectively) of patients could be classified as having high disease activity at the screening visit. CONCLUSION: Multimodal indices incorporating ultrasound and clinical data had similar metrological properties as their clinical counterparts; certain indices allowed for a significantly larger number of patients to be classified to either high or moderate disease activity at the screening visit. © 2012 by the American College of Rheumatology.
  Arthritis care & research. 12/2012;
• Article: Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: Results of a multicenter, randomized study

  P. Mandl, P. V. Balint, Y. Brault, M. Backhaus, M.-A. D'Agostino, W. Grassi, D. van der Heijde, E. de Miguel, R. J. Wakefield, I. Logeart, M. Dougados
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  ABSTRACT: Objective To evaluate the intraobserver reliability, face validity, and discriminant capacity of different global ultrasound (US) scoring systems for measuring synovitis in rheumatoid arthritis (RA).Methods This study was ancillary to a 52-week, multicenter, prospective, randomized, open-label, parallel-group outpatient study conducted in patients with moderate RA who were randomized to receive either etanercept combined with methotrexate or various disease-modifying antirheumatic drugs. A total of 66 different synovitis scoring systems were constructed and evaluated, including 11 different joint combinations; data derived from clinical findings, gray-scale US, and power Doppler US (PDUS); and both binary counts and semiquantitative scores.ResultsDue to discontinuation of the trial, only 62 patients, a subset of the initially planned number of patients, were included in this study. Reliability was found to be better for gray-scale US and PDUS than for clinical evaluation of synovitis in patients with stable disease between the screening and baseline visits (range for intraclass correlation coefficient 0.6, 0.95 for gray-scale US and 0.56, 0.93 for PDUS versus 0.31, 0.75 for clinical indices). The median (range) difference in the discriminant capacities of clinical indices versus gray-scale US and versus PDUS was 0.25 (−0.64, 0.96) and −0.025 (−0.59, 0.53), respectively, in the period from baseline to 12 weeks. No relevant differences in metrologic properties were observed regarding the number and composition of joints between the different scoring systems. Our findings suggested that a simplified scoring system referring to gray-scale US and PDUS findings might be sufficient.Conclusion Our findings indicate that gray-scale US and PDUS have better reliability than generally used clinical indices for evaluating synovitis in RA. PDUS has at least as good discriminant capacity as clinical assessment of synovitis for distinguishing between treatment arms.
  Arthritis & Rheumatism 03/2012; 64(4):1272 - 1282. · 7.87 Impact Factor