Background Salivary gland ultrasound (SGUS) may have the potential of facilitating diagnosis and therapy monitoring of salivary gland disease in patients with primary Sjögren’s syndrome (pSS). The aim of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) US subgroup on SG is to validate US as an outcome measurement instrument in pSS. Following the OMERACT US stepwise validation approach, preliminary consensus definitions for elementary lesions based on a systematic literature review were developed and subsequently a scoring system has been agreed upon and tested through a web-based Delphi exercise.
Objectives To assess the reliability of consensus based SGUS scoring system in patients with SS.
Methods Nine sonographers conducted an US reliability exercise of the parotid and submandibular glands (PG, SMG) of 9 patients with primary and secondary SS in 3 rounds. A 4-grade semi-quantitative scoring was applied in B-mode for structural lesions as follows: Grade 0: normal, grade 1: mild inhomogeneity without anechoic or hypoechoic areas, grade 2: moderate inhomogeneity with focal anechoic or hypoechoic areas, grade 3: severe; diffuse inhomogeneity with an-/hypoechoic areas occupying all the surface of the gland. Next, presence or absence of typical pSS-lesions was scored in binary fashion. Intrareader and interreader reliability were computed by Cohen and Light kappa. Weighted k coefficients with absolute weighting were calculated for B-mode abnormalities.
Results Light weighted kappa for grading and diagnostic evaluation for intra- and inter-reader reliability was moderate to excellent (see Table for details).
Conclusion The developed US definitions and the scoring system for salivary gland lesions in pSS showed a good to excellent reliability in patients with SS. Next step is to apply the scoring system in clinical trials.
Disclosure of Interests Stephanie Finzel: None declared, Sandrine Jousse-Joulin: None declared, Annamaria Iagnocco: None declared, Esperanza Naredo Consultant for: Abbvie, Speakers bureau: AbbVie, Roche, Bristol-Myers Squibb, Pfizer, UCB, Lilly, Novartis, Janssen, and Celgene GmbH, ALOJZIJA HOCEVAR: None declared, Sarah Ohrndorf: None declared, Petra Hanova: None declared, Maria-Antonietta d’Agostino: None declared, Felicie Costantino: None declared, Lene Terslev Speakers bureau: Speakers fee from : Roche, Novartis, Pfizer, MSD, BMS, Celgene, Helen Keen: None declared, George Bruyn : None declared
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