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EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome

Seror, Raphaele; Ravaud, Philippe; Bowman, Simon J.; Baron, Gabriel; Tzioufas, Athanasios; Theander, Elke LU ; Gottenberg, Jacques-Eric; Bootsma, Hendrika; Mariette, Xavier and Vitali, Claudio (2010) In Annals of the Rheumatic Diseases 69(6). p.1103-1109
Abstract
Objective To develop a disease activity index for patients with primary Sjogren's syndrome (SS): the European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI). Methods Thirty-nine SS experts participated in an international collaboration, promoted by EULAR, to develop the ESSDAI. Experts identified 12 organ-specific 'domains' contributing to disease activity. For each domain, features of disease activity were classified in three or four levels according to their severity. Data abstracted from 96 patients with systemic complications of primary SS were used to generate 702 realistic vignettes for which all possible systemic complications were represented. Using the 0-10 physician global assessment (PhGA)... (More)
Objective To develop a disease activity index for patients with primary Sjogren's syndrome (SS): the European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI). Methods Thirty-nine SS experts participated in an international collaboration, promoted by EULAR, to develop the ESSDAI. Experts identified 12 organ-specific 'domains' contributing to disease activity. For each domain, features of disease activity were classified in three or four levels according to their severity. Data abstracted from 96 patients with systemic complications of primary SS were used to generate 702 realistic vignettes for which all possible systemic complications were represented. Using the 0-10 physician global assessment (PhGA) scale, each expert scored the disease activity of five patient profiles and 20 realistic vignettes. Multiple regression modelling, with PhGA used as the dependent variable, was used to estimate the weight of each domain. Results All 12 domains were significantly associated with disease activity in the multivariate model, domain weights ranged from 1 to 6. The ESSDAI scores varied from 2 to 47 and were significantly correlated with PhGA for both real patient profiles and realistic vignettes (r = 0.61 and r = 0.58, respectively, p < 0.001). Compared with 57 (59.4%) of the real patient profiles, 468 (66.7%) of the realistic vignettes were considered likely or very likely to be true. Conclusion The ESSDAI is a clinical index designed to measure disease activity in patients with primary SS. Once validated, such a standardised evaluation of primary SS should facilitate clinical research and be helpful as an outcome measure in clinical trials. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Annals of the Rheumatic Diseases
volume
69
issue
6
pages
1103 - 1109
publisher
British Medical Association
external identifiers
  • wos:000278017700028
  • scopus:77953705028
ISSN
1468-2060
DOI
10.1136/ard.2009.110619
language
English
LU publication?
yes
id
bbfc13d0-6c8d-41ef-b8a7-3b1565f24e2b (old id 1617124)
date added to LUP
2010-06-22 13:23:59
date last changed
2018-07-08 03:35:29
@article{bbfc13d0-6c8d-41ef-b8a7-3b1565f24e2b,
  abstract     = {Objective To develop a disease activity index for patients with primary Sjogren's syndrome (SS): the European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI). Methods Thirty-nine SS experts participated in an international collaboration, promoted by EULAR, to develop the ESSDAI. Experts identified 12 organ-specific 'domains' contributing to disease activity. For each domain, features of disease activity were classified in three or four levels according to their severity. Data abstracted from 96 patients with systemic complications of primary SS were used to generate 702 realistic vignettes for which all possible systemic complications were represented. Using the 0-10 physician global assessment (PhGA) scale, each expert scored the disease activity of five patient profiles and 20 realistic vignettes. Multiple regression modelling, with PhGA used as the dependent variable, was used to estimate the weight of each domain. Results All 12 domains were significantly associated with disease activity in the multivariate model, domain weights ranged from 1 to 6. The ESSDAI scores varied from 2 to 47 and were significantly correlated with PhGA for both real patient profiles and realistic vignettes (r = 0.61 and r = 0.58, respectively, p &lt; 0.001). Compared with 57 (59.4%) of the real patient profiles, 468 (66.7%) of the realistic vignettes were considered likely or very likely to be true. Conclusion The ESSDAI is a clinical index designed to measure disease activity in patients with primary SS. Once validated, such a standardised evaluation of primary SS should facilitate clinical research and be helpful as an outcome measure in clinical trials.},
  author       = {Seror, Raphaele and Ravaud, Philippe and Bowman, Simon J. and Baron, Gabriel and Tzioufas, Athanasios and Theander, Elke and Gottenberg, Jacques-Eric and Bootsma, Hendrika and Mariette, Xavier and Vitali, Claudio},
  issn         = {1468-2060},
  language     = {eng},
  number       = {6},
  pages        = {1103--1109},
  publisher    = {British Medical Association},
  series       = {Annals of the Rheumatic Diseases},
  title        = {EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome},
  url          = {http://dx.doi.org/10.1136/ard.2009.110619},
  volume       = {69},
  year         = {2010},
}