Validation of EULAR primary Sjogren's syndrome disease activity (ESSDAI) and patient indexes (ESSPRI)

被引:204
作者
Seror, Raphaele [1 ,2 ,3 ,4 ,5 ]
Theander, Elke [6 ]
Brun, Johan G. [7 ]
Ramos-Casals, Manel [8 ]
Valim, Valeria [9 ]
Doerner, Thomas [10 ]
Bootsma, Hendrika [11 ]
Tzioufas, Athanasios [12 ]
Solans-Laque, Roser [13 ]
Mandl, Thomas [6 ]
Gottenberg, Jacques-Eric [14 ]
Hachulla, Eric [15 ]
Sivils, Kathy L. [16 ]
Ng, Wan-Fai [17 ]
Fauchais, Anne-Laure [18 ]
Bombardieri, Stefano [19 ]
Valesini, Guido [20 ]
Bartoloni, Elena [21 ]
Saraux, Alain [22 ,23 ]
Tomsic, Matija [24 ]
Sumida, Takayuki [25 ]
Nishiyama, Susumu [26 ]
Caporali, Roberto [27 ]
Kruize, Aike A. [28 ]
Vollenweider, Cristina [29 ]
Ravaud, Philippe [3 ,4 ,5 ]
Vitali, Claudio [30 ]
Mariette, Xavier [1 ,2 ]
Bowman, Simon J. [31 ]
机构
[1] Hop Hotel Dieu, Ctr Clin Epidemiol, F-75181 Paris, France
[2] Univ Paris 05, INSERM, U738, Paris, France
[3] Hop Bicetre, AP HP, INSERM, Dept Rheumatol,U802, F-94275 Le Kremlin Bicetre, France
[4] Univ Paris 11, Le Kremlin Bicetre, France
[5] INSERM, U1012, F-94275 Le Kremlin Bicetre, France
[6] Lund Univ, Skane Univ Hosp Malmo, Dept Rheumatol, Malmo, Sweden
[7] Haukeland Hosp, Dept Rheumatol, N-5021 Bergen, Norway
[8] Hosp Clin Barcelona, ICMiD, IDIBAPS, Lab Autoimmune Dis Josep Font, Barcelona, Spain
[9] Univ Fed Espirito Santo, Dept Med, Div Rheumatol, Vitoria, ES, Brazil
[10] Univ Hosp, Charite, Dept Rheumatol, Berlin, Germany
[11] Univ Groningen, Univ Med Ctr Groningen, Dept Rheumatol & Clin Immunol, Groningen, Netherlands
[12] Univ Athens, Sch Med, Dept Pathophysiol, GR-11527 Athens, Greece
[13] Vall Hebron Univ Hosp, Dept Autoimmune Syst Dis, Barcelona, Spain
[14] Univ Strasbourg, Ctr Natl Reference Malad Autoimmunes Rares, Strasbourg Univ Hosp, Dept Rheumatol,INSERM,UMRS 1109,FMTS, Strasbourg, France
[15] Univ Nord France, Claude Huriez Hosp, Dept Internal Med, Lille, France
[16] Oklahoma Med Res Fdn, Arthrit & Clin Immunol, Oklahoma City, OK 73104 USA
[17] Newcastle Univ, Musculoskeletal Res Grp, Newcastle Upon Tyne, Tyne & Wear, England
[18] Univ Hosp, Dept Rheumatol, Limoges, France
[19] Univ Pisa, Dept Internal Med, Rheumatol Unit, Pisa, Italy
[20] Univ Roma La Sapienza, Dept Internal Med, Rheumatol, I-00185 Rome, Italy
[21] Perugia Univ Hosp, Dept Rheumatol, Perugia, Italy
[22] Univ Bretagne Occidentale, Hop Cavale Blanche, Dept Rheumatol, Brest, France
[23] Univ Bretagne Occidentale, EA 2216, Brest, France
[24] Univ Med Ctr Ljubljana, Dept Rheumatol, Ljubljana, Slovenia
[25] Univ Tsukuba, Dept Internal Med, Tsukuba, Ibaraki 305, Japan
[26] Kurashiki Med Ctr, Rheumat Dis Ctr, Kurashiki, Okayama, Japan
[27] Univ Pavia, IRCCS S Matteo Fdn, Dept Rheumatol, I-27100 Pavia, Italy
[28] Univ Med Ctr Utrecht, Dept Rheumatol, Dept Rheumatol & Clin Immunol, Utrecht, Netherlands
[29] German Hosp, Dept Rheumatol, Buenos Aires, DF, Argentina
[30] Inst San Giuseppe, Rheumatol Sect, Lecce, Italy
[31] Univ Hosp Birmingham NHS Fdn Trust, Dept Rheumatol, Birmingham, W Midlands, England
关键词
HEALTH-STATUS INSTRUMENTS; CONTROLLED-TRIAL; EUROPEAN LEAGUE; REPORTED INDEX; RESPONSIVENESS; RITUXIMAB;
D O I
10.1136/annrheumdis-2013-204615
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives To validate the two recently developed disease activity indexes for assessment of primary Sjogren'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), Sjogren'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.
引用
收藏
页码:859 / 866
页数:8
相关论文
共 19 条
[1]  
[Anonymous], 1993, An introduction to the bootstrap
[2]  
[Anonymous], 2008, HLTH MEASUREMENT SCA, DOI DOI 10.1093/ACPROF:OSO/9780199231881.001.0001
[3]  
Bland JM, 1999, STAT METHODS MED RES, V8, P135, DOI 10.1177/096228029900800204
[4]   Sjogrens Systemic Clinical Activity Index (SCAI)a systemic disease activity measure for use in clinical trials in primary Sjgrens syndrome [J].
Bowman, S. J. ;
Sutcliffe, N. ;
Isenberg, D. A. ;
Goldblatt, F. ;
Adler, M. ;
Price, E. ;
Canavan, A. ;
Hamburger, J. ;
Richards, A. ;
Rauz, S. ;
Regan, M. ;
Gadsby, K. ;
Rigby, S. ;
Jones, A. ;
Mathew, R. ;
Mulherin, D. ;
Stevenson, A. ;
Nightingale, P. .
RHEUMATOLOGY, 2007, 46 (12) :1845-1851
[5]   Measurement of fatigue and discomfort in primary Sjogren's syndrome using a new questionnaire tool [J].
Bowman, SJ ;
Booth, DA ;
Platts, RG .
RHEUMATOLOGY, 2004, 43 (06) :758-764
[6]  
Bowman SJ, 2003, J RHEUMATOL, V30, P1259
[7]  
Devauchelle-Pensec V, 2012, ANN RHEUM DIS, V71, P75
[8]   Methods for assessing responsiveness: a critical review and recommendations [J].
Husted, JA ;
Cook, RJ ;
Farewell, VT ;
Gladman, DD .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2000, 53 (05) :459-468
[9]   EFFECT SIZES FOR INTERPRETING CHANGES IN HEALTH-STATUS [J].
KAZIS, LE ;
ANDERSON, JJ ;
MEENAN, RF .
MEDICAL CARE, 1989, 27 (03) :S178-S189
[10]   COMPARISONS OF 5 HEALTH-STATUS INSTRUMENTS FOR ORTHOPEDIC EVALUATION [J].
LIANG, MH ;
FOSSEL, AH ;
LARSON, MG .
MEDICAL CARE, 1990, 28 (07) :632-642