PT  - JOURNAL ARTICLE
AU  - Seror, Raphaèle
AU  - Theander, Elke
AU  - Brun, Johan G
AU  - Ramos-Casals, Manel
AU  - Valim, Valeria
AU  - Dörner, Thomas
AU  - Bootsma, Hendrika
AU  - Tzioufas, Athanasios
AU  - Solans-Laqué, Roser
AU  - Mandl, Thomas
AU  - Gottenberg, Jacques-Eric
AU  - Hachulla, Eric
AU  - Sivils, Kathy L
AU  - Ng, Wan-Fai
AU  - Fauchais, Anne-Laure
AU  - Bombardieri, Stefano
AU  - Valesini, Guido
AU  - Bartoloni, Elena
AU  - Saraux, Alain
AU  - Tomsic, Matija
AU  - Sumida, Takayuki
AU  - Nishiyama, Susumu
AU  - Caporali, Roberto
AU  - Kruize, Aike A
AU  - Vollenweider, Cristina
AU  - Ravaud, Philippe
AU  - Vitali, Claudio
AU  - Mariette, Xavier
AU  - Bowman, Simon J
AU - on behalf of the EULAR Sjögren's Task Force
TI  - Validation of EULAR primary Sjögren's syndrome disease activity (ESSDAI) and patient indexes (ESSPRI)
AID  - 10.1136/annrheumdis-2013-204615
DP  - 2015 May 01
TA  - Annals of the Rheumatic Diseases
PG  - 859--866
VI  - 74
IP  - 5
4099  - http://ard.bmj.com/content/74/5/859.short
4100  - http://ard.bmj.com/content/74/5/859.full
SO  - Ann Rheum Dis2015 May 01; 74
AB  - Objectives 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.