Abstract
Objectives: Salivary gland ultrasonography (SGUS) is increasingly applied for the management of primary Sjögren's syndrome (pSS). This study aims to: (i) compare the reliability between two SGUS scores; (ii) test the reliability among sonographers with different levels of experience.Methods: In the reliability exercise, two four-grade semi-quantitative SGUS scoring systems, namely De Vita et al. and OMERACT, were tested. The sonographers involved in work-package 7 of the HarmonicSS project from nine countries in Europe were invited to participate. Different levels of sonographers were identified on the basis of their SGUS experience and of the knowledge of the tested scores. A dedicated atlas was used as support for SGUS scoring.Results: Twenty sonographers participated in the two rounds of the reliability exercise. The intra-rater reliability for both scores was almost perfect, with a Light's kappa of 0.86 for the De Vita et al. score and 0.87 for the OMERACT score. The inter-rater reliability for the De Vita et al. and the OMERACT score was substantial with Light's Kappa of 0.75 and 0.77, respectively. Furthermore, no significant difference was noticed among sonographers with different levels of experience.Conclusion: The two tested SGUS scores are reliable for the evaluation of major salivary glands in pSS, and even less-expert sonographers could be reliable if adequately instructed.
Highlights
Primary Sjögren’s syndrome is a systemic autoimmune and lymphoproliferative disease, mainly involving the salivary glands (SGs) [1]
At the current stage of the initiative, this study aims to: (i) evaluate the reliability among sonographers with different levels of expertise in salivary gland ultrasonography (SGUS); (ii) compare the reliability performance between two different semi-quantitative SGUS scores, widely used and easy to perform, being the “extremes” in the year of publication; (iii) provide a data set that will be publicly available, to serve as a standardized benchmark for further studies
Participants and coordinators of work-package 7 (WP7) agreed to use two four-grade semi-quantitative scoring systems, namely De Vita et al score [7] and Outcome Measures in Rheumatology Clinical Trials (OMERACT) score [16], for the assessment of major SGs morphology in Primary Sjögren’s syndrome (pSS) patients enrolled in the HarmonicSS project
Summary
Primary Sjögren’s syndrome (pSS) is a systemic autoimmune and lymphoproliferative disease, mainly involving the salivary glands (SGs) [1]. Active glandular lesions are characterized by inflammation and lymphoproliferation, with varying degrees of glandular damage by fibrosis, fatty accumulation, and loss of acinar and ductal parenchyma [4,5,6] These pathological abnormalities, for whose characterization SG biopsy is the gold standard technique, lead to the typical glandular inhomogeneity detected by salivary gland ultrasonography (SGUS), with hypo/anechoic areas and hyperechoic bands [7,8,9,10]. In order to overcome these issues, the Outcome Measure in Rheumatology (OMERACT) working group on the use of ultrasonography in pSS recently generated, after a three-round Delphi process, the definitions for the SGUS elementary lesions in pSS, and the Abbreviations: ACR-EULAR, American College of Rheumatology/European League Against Rheumatism; GRAAS, Guidelines for Reporting Reliability and Agreement Studies; NU-E, non-users and experts; NU-NE, non-users and non-experts; OMERACT, Outcome Measures in Rheumatology Clinical Trials; OMI, outcome measure instruments; PG, parotid gland; pSS, primary Sjögren’s syndrome; SGs, salivary glands; SGUS, salivary gland ultrasound; SMG, submandibular gland; U-E, user and experts; U-NE, users and non-experts
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