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

Research output: Contribution to journalArticlepeer-review

Standard

Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren’s syndrome. / Sjögren's histopathology workshop group from ESSENTIAL (EULAR Sjögren's syndrome study group).

In: Annals of the Rheumatic Diseases, Vol. 76, No. 7, 07.2017, p. 1161-1168.

Research output: Contribution to journalArticlepeer-review

Harvard

Sjögren's histopathology workshop group from ESSENTIAL (EULAR Sjögren's syndrome study group) 2017, 'Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren’s syndrome', Annals of the Rheumatic Diseases, vol. 76, no. 7, pp. 1161-1168. https://doi.org/10.1136/annrheumdis-2016-210448

APA

Sjögren's histopathology workshop group from ESSENTIAL (EULAR Sjögren's syndrome study group) (2017). Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren’s syndrome. Annals of the Rheumatic Diseases, 76(7), 1161-1168. https://doi.org/10.1136/annrheumdis-2016-210448

Vancouver

Sjögren's histopathology workshop group from ESSENTIAL (EULAR Sjögren's syndrome study group). Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren’s syndrome. Annals of the Rheumatic Diseases. 2017 Jul;76(7):1161-1168. https://doi.org/10.1136/annrheumdis-2016-210448

Author

Sjögren's histopathology workshop group from ESSENTIAL (EULAR Sjögren's syndrome study group). / Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren’s syndrome. In: Annals of the Rheumatic Diseases. 2017 ; Vol. 76, No. 7. pp. 1161-1168.

Bibtex

@article{2d1e6555edb74f7e8bb23805add223a7,
title = "Standardisation of labial salivary gland histopathology in clinical trials in primary Sj{\"o}gren{\textquoteright}s syndrome",
abstract = "Labial salivary gland (LSG) biopsy is used in the classification of primary Sj{\"o}gren'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.",
keywords = "focal lymphocytic sialadentitis, biomarkers, Sj{\"o}gren{\textquoteright}s syndrome, salivary gland, outcome measures, histology, focus score",
author = "{Sj{\"o}gren's histopathology workshop group from ESSENTIAL (EULAR Sj{\"o}gren's syndrome study group)} and Benjamin Fisher and Roland Jonsson and Troy Daniels and Michele Bombardieri and Rachel Brown and Peter Morgan and Stefano Bombardieri and Wan-fai Ng and Athanasios Tzioufas and Claudio Vitali and Pepe Shirlaw and Erlin Haacke and Sebastian Costa and Hendrika Bootsma and Valerie Devauchelle-Pensec and Timothy Radstake and Xavier Mariette and Andrea Richards and Rebecca Stack and Simon Bowman and Francesca Barone",
year = "2017",
month = jul,
doi = "10.1136/annrheumdis-2016-210448",
language = "English",
volume = "76",
pages = "1161--1168",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",
number = "7",

}

RIS

TY - JOUR

T1 - Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren’s syndrome

AU - Sjögren's histopathology workshop group from ESSENTIAL (EULAR Sjögren's syndrome study group)

AU - Fisher, Benjamin

AU - Jonsson, Roland

AU - Daniels, Troy

AU - Bombardieri, Michele

AU - Brown, Rachel

AU - Morgan, Peter

AU - Bombardieri, Stefano

AU - Ng, Wan-fai

AU - Tzioufas, Athanasios

AU - Vitali, Claudio

AU - Shirlaw, Pepe

AU - Haacke, Erlin

AU - Costa, Sebastian

AU - Bootsma, Hendrika

AU - Devauchelle-Pensec, Valerie

AU - Radstake, Timothy

AU - Mariette, Xavier

AU - Richards, Andrea

AU - Stack, Rebecca

AU - Bowman, Simon

AU - Barone, Francesca

PY - 2017/7

Y1 - 2017/7

N2 - 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.

AB - 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.

KW - focal lymphocytic sialadentitis

KW - biomarkers

KW - Sjögren’s syndrome

KW - salivary gland

KW - outcome measures

KW - histology

KW - focus score

UR - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5530351/

U2 - 10.1136/annrheumdis-2016-210448

DO - 10.1136/annrheumdis-2016-210448

M3 - Article

C2 - 27965259

VL - 76

SP - 1161

EP - 1168

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 7

ER -