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Development of the ClinESSDAI : A clinical score without biological domain. A tool for biological studies

Seror, Raphaèle; Meiners, Petra; Baron, Gabriel; Bootsma, Hendrika; Bowman, Simon J.; Vitali, Claudio; Gottenberg, Jacques Eric; Theander, Elke LU ; Tzioufas, Athanasios and De Vita, Salvatore, et al. (2016) In Annals of the Rheumatic Diseases 75(11). p.1945-1950
Abstract

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 â € 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... (More)

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 â € 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.

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Contribution to journal
publication status
published
subject
keywords
Disease Activity, Outcomes research, Sjøgren's Syndrome
in
Annals of the Rheumatic Diseases
volume
75
issue
11
pages
6 pages
publisher
British Medical Association
external identifiers
  • scopus:84962168848
  • wos:000386469300011
ISSN
0003-4967
DOI
10.1136/annrheumdis-2015-208504
language
English
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yes
id
3ae596f1-8681-4943-9401-b1a8a77f4a17
date added to LUP
2016-12-05 13:27:41
date last changed
2017-09-10 05:12:43
@article{3ae596f1-8681-4943-9401-b1a8a77f4a17,
  abstract     = {<p>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 â € 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.</p>},
  author       = {Seror, Raphaèle and Meiners, Petra and Baron, Gabriel and Bootsma, Hendrika and Bowman, Simon J. and Vitali, Claudio and Gottenberg, Jacques Eric and Theander, Elke and Tzioufas, Athanasios and De Vita, Salvatore and Ramos-Casals, Manel and Dörner, Thomas and Quartuccio, Luca and Ravaud, Philippe and Mariette, Xavier},
  issn         = {0003-4967},
  keyword      = {Disease Activity,Outcomes research,Sjøgren's Syndrome},
  language     = {eng},
  month        = {11},
  number       = {11},
  pages        = {1945--1950},
  publisher    = {British Medical Association},
  series       = {Annals of the Rheumatic Diseases},
  title        = {Development of the ClinESSDAI : A clinical score without biological domain. A tool for biological studies},
  url          = {http://dx.doi.org/10.1136/annrheumdis-2015-208504},
  volume       = {75},
  year         = {2016},
}