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Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren's syndrome

Lookup NU author(s): Professor Fai Ng



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© 2016 BMJ Publishing Group Ltd & European League Against Rheumatism. Labial salivary gland (LSG) biopsy is used in the classification of primary Sjögren's syndrome (PSS) and in patient stratification in clinical trials. It may also function as a biomarker. The acquisition of tissue and histological interpretation is variable and needs to be standardised for use in clinical trials. A modified European League Against Rheumatism consensus guideline development strategy was used. The steering committee of the ad hoc working group identified key outstanding points of variability in LSG acquisition and analysis. A 2-day workshop was held to develop consensus where possible and identify points where further discussion/data was needed. These points were reviewed by a subgroup of experts on PSS histopathology and then circulated via an online survey to 50 stakeholder experts consisting of rheumatologists, histopathologists and oral medicine specialists, to assess level of agreement (0-10 scale) and comments. Criteria for agreement were a mean score ≥6/10 and 75% of respondents scoring ≥6/10. Thirty-nine (78%) experts responded and 16 points met criteria for agreement. These points are focused on tissue requirements, identification of the characteristic focal lymphocytic sialadenitis, calculation of the focus score, identification of germinal centres, assessment of the area of leucocyte infiltration, reporting standards and use of prestudy samples for clinical trials. We provide standardised consensus guidance for the use of labial salivary gland histopathology in the classification of PSS and in clinical trials and identify areas where further research is required to achieve evidence-based consensus.

Publication metadata

Author(s): Fisher BA, Jonsson R, Daniels T, Bombardieri M, Brown RM, Morgan P, Bombardieri S, Ng W-F, Tzioufas AG, Vitali C, Shirlaw P, Haacke E, Costa S, Bootsma H, Devauchelle-Pensec V, Radstake TR, Mariette X, Richards A, Stack R, Bowman SJ, Barone F

Publication type: Article

Publication status: Published

Journal: Annals of the Rheumatic Diseases

Year: 2017

Volume: 76

Issue: 7

Pages: 1161-1168

Print publication date: 01/07/2017

Online publication date: 13/12/2016

Acceptance date: 19/11/2016

Date deposited: 10/04/2017

ISSN (print): 0003-4967

ISSN (electronic): 1468-2060

Publisher: BMJ Publishing Group


DOI: 10.1136/annrheumdis-2016-210448


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