RT Journal Article
SR Electronic
T1 Development of the ClinESSDAI: a clinical score without biological domain. A tool for biological studies
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1945
OP 1950
DO 10.1136/annrheumdis-2015-208504
VO 75
IS 11
A1 Seror, Raphaèle
A1 Meiners, Petra
A1 Baron, Gabriel
A1 Bootsma, Hendrika
A1 Bowman, Simon J
A1 Vitali, Claudio
A1 Gottenberg, Jacques-Eric
A1 Theander, Elke
A1 Tzioufas, Athanasios
A1 De Vita, Salvatore
A1 Ramos-Casals, Manel
A1 Dörner, Thomas
A1 Quartuccio, Luca
A1 Ravaud, Philippe
A1 Mariette, Xavier
YR 2016
UL http://ard.bmj.com/content/75/11/1945.abstract
AB Objective To develop and validate ClinESSDAI (Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index), ie, ESSDAI without the biological domain.Patients and methods The 702 fictive vignettes derived from 96 real cases of primary Sjögren's syndrome of the ESSDAI development study were used. As for ESSDAI development, the physician assessment of disease activity (0–10 scale) was used as the ‘gold standard’ in a multivariate model for weighting domains, after removing the biological domain. The reliability, assessed by intraclass correlation coefficient (ICC) between ClinESSDAI and ESSDAI, explored if ClinESSDAI was equivalent to ESSDAI. Its psychometric (ie, measurement) properties were compared with that of ESSDAI in an independent cohort. Also, its use was evaluated on data of two clinical trials.Results In multivariate modelling, all 11 domains remained significantly associated with disease activity, with slight modifications of some domain weights. Reliability between clinESSDAI and ESSDAI was excellent (ICC=0.98 and 0.99). Psychometric properties of clinESSDAI, disease activity levels and minimal clinically important improvement thresholds and its ability to detect change over time in clinical trials were very close to that of ESSDAI.Conclusions ClinESSDAI appears valid and very close to the original ESSDAI. This score provides an accurate evaluation of disease activity independent of B-cell biomarkers. It could be used in various circumstances: (i) in biological/clinical studies to avoid data collinearity, (ii) in clinical trials, as secondary endpoint, to detect change independent of biological effect of the drug, (iii) in clinical practice to assess disease activity for visits where immunological tests have not been done.