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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Ann+Rheum+Dis
2017 ; 76
(7
): 1161-1168
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Standardisation of labial salivary gland histopathology in clinical trials in
primary Sjögren s syndrome
#MMPMID27965259
Fisher BA
; Jonsson R
; Daniels T
; Bombardieri M
; Brown RM
; Morgan P
; Bombardieri S
; Ng WF
; 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
Ann Rheum Dis
2017[Jul]; 76
(7
): 1161-1168
PMID27965259
show ga
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.