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Validation of EULAR primary Sjögren's syndrome disease activity (ESSDAI) and patient indexes (ESSPRI). 2015
Raphaèle Seror, and
Elke Theander, and
Johan G Brun, and
Manel Ramos-Casals, and
Valeria Valim, and
Thomas Dörner, and
Hendrika Bootsma, and
Athanasios Tzioufas, and
Roser Solans-Laqué, and
Thomas Mandl, and
Jacques-Eric Gottenberg, and
Eric Hachulla, and
Kathy L Sivils, and
Wan-Fai Ng, and
Anne-Laure Fauchais, and
Stefano Bombardieri, and
Guido Valesini, and
Elena Bartoloni, and
Alain Saraux, and
Matija Tomsic, and
Takayuki Sumida, and
Susumu Nishiyama, and
Roberto Caporali, and
Aike A Kruize, and
Cristina Vollenweider, and
Philippe Ravaud, and
Claudio Vitali, and
Xavier Mariette, and
Simon J Bowman, and
Center of Clinical Epidemiology, Hôpital Hotel Dieu; INSERM U738, Université Paris-René Descartes, Paris, France Department of Rheumatology, INSERM U802, Assistance Publique-Hopitaux de Paris, Hôpital Bicêtre; Université Paris-Sud 11; INSERM U1012, Le Kremlin Bicêtre, France.
OBJECTIVE To validate the two recently developed disease activity indexes for assessment of primary Sjögren's syndrome (SS): the European League Against Rheumatism (EULAR) SS Patient Reported Index (ESSPRI) and the EULAR SS Disease Activity Index (ESSDAI). METHODS A prospective international 6-month duration validation study was conducted in 15 countries. At each visit, physicians completed ESSDAI, SS disease activity index (SSDAI), Sjögren's Systemic Clinical Activity Index (SCAI) and physician global assessment (PhGA); and patients completed ESSPRI, Sicca Symptoms Inventory (SSI), Profile of Fatigue and Discomfort (PROFAD) and patient global assessment (PGA). Psychometric properties (construct validity, responsiveness and reliability) were evaluated and compared between scores. RESULTS Of the 395 patients included, 145 (37%) and 251 (64%) had currently active or current or past systemic manifestations, respectively. EULAR scores had higher correlation with the gold standard than other scores (ESSDAI with PhGA: r=0.59; ESSRPI with PGA: r=0.70). Correlations between patient and systemic scores were very low (ranging from 0.07 to 0.29). All systemic scores had similar large responsiveness in improved patients. Responsiveness of patient scores was low but was significantly higher for ESSPRI compared with SSI and PROFAD. Reliability was very good for all scores. CONCLUSIONS ESSDAI and ESSPRI had good construct validity. All scores were reliable. Systemic scores had a large sensitivity to change in patients whose disease activity improves. Patient scores had a small sensitivity to change, however, significantly better for ESSPRI. Systemic and patient scores poorly correlated, suggesting that they are 2 complementary components that should be both evaluated, but separately.
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