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Ann Rheum Dis. 2015 May;74(5):859-66. doi: 10.1136/annrheumdis-2013-204615. Epub 2014 Jan 17.

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

Author information

1
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.
2
Department of Rheumatology, Skane University Hospital Malmö, Lund University, Malmö, Sweden.
3
Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.
4
Laboratory of Autoimmune Diseases "Josep Font", IDIBAPS, ICMiD, Hospital Clinic, Barcelona, Spain.
5
Division of Rheumatology, Department of Medicine, Federal University of Espírito Santo, Brazil.
6
Rheumatology Department, Charité, University Hospital, Berlin, Germany.
7
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
8
Department of Pathophysiology, School of Medicine, University of Athens, Athens, Greece.
9
Departement of Autoimmune systemic Diseases, Vall d'Hebron University Hospital, Barcelona, Spain.
10
Departement of Rheumatology, Centre National de Référence des Maladies Auto-Immunes Rares, INSERM UMRS_1109, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Strasbourg university Hospital, Université de Strasbourg, Strasbourg, France.
11
Department of Internal Medicine, Claude Huriez Hospital, Université Nord de France, Lille, France.
12
Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, USA.
13
Musculoskeletal Research Group, University of Newcastle, Newcastle, UK.
14
Department of Rheumatology, University Hospital, Limoges, France.
15
Rheumatology Unit, Department of Internal Medicine, University of Pisa, Pisa, Italy.
16
Department of Internal Medicine, Rheumatology, La Sapienza Università di Roma, Roma, Italy.
17
Department of Rheumatology, Perugia University Hospital, Perugia, Italy.
18
Department of Rheumatology, Hopital Cavale Blanche, and EA 2216, Université Bretagne occidentale, Brest, France.
19
Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
20
Department of Internal Medicine, University of Tsukuba, Japan.
21
Rheumatic Disease Center, Kurashiki Medical Center, Kurashiki, Japan.
22
Department of Rheumatology, University of Pavia, IRCCS S, Matteo Foundation, Pavia, Italy.
23
Department of Rheumatology & Clinical Immunology, Department of Rheumatology, University Medical Center Utrecht (UMCU), Utrecht, The Netherlands.
24
Department of Rheumatology, German Hospital, Buenos-Aires, Argentina.
25
Department of Rheumatology, INSERM U802, Assistance Publique-Hopitaux de Paris, Hôpital Bicêtre; Université Paris-Sud 11; INSERM U1012, Le Kremlin Bicêtre, France.
26
Sections of Rheumatology, Instituto San Giuseppe, Como and Casa di Cura di Lecco, Lecco, Italy.
27
Center of Clinical Epidemiology, Hôpital Hotel Dieu; INSERM U738, Université Paris-René Descartes, Paris, France.
28
Rheumatology Department, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.

Abstract

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.

KEYWORDS:

Disease Activity; Outcomes research; Sjögren's Syndrome

PMID:
24442883
DOI:
10.1136/annrheumdis-2013-204615
[Indexed for MEDLINE]

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