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

Fisher, BA; Jonsson, R; Daniels, T; Bombardieri, M; Brown, RM; Morgan, P; Bombardieri, S; ... Osayi, K; + view all (2017) Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren's syndrome. Annals of the Rheumatic Diseases , 76 (7) pp. 1161-1168. 10.1136/annrheumdis-2016-210448. Green open access

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Abstract

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.

Type: Article
Title: Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren's syndrome
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/annrheumdis-2016-210448
Publisher version: http://doi.org/10.1136/annrheumdis-2016-210448
Language: English
Additional information: Copyright information: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Eastman Dental Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Eastman Dental Institute > EDI MaxFac, Diagnostic, Med and Surg Sci
URI: https://discovery.ucl.ac.uk/id/eprint/1561654
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