Evidence map›Paper›PMID 27785888›Full record

ArticleArthritis & rheumatology (Hoboken, N.J.)2017

2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts.

Caroline H Shiboski, Stephen C Shiboski, Raphaèle Seror, Lindsey A Criswell, Marc Labetoulle, Thomas M Lietman, Astrid Rasmussen, Hal Scofield, Claudio Vitali, Simon J Bowman and 2 more

5 registry-linked trialsOpen access · hybridAbstract readConsensus StatementValidation Study
In one paragraph

Article in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 1,043 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,043citing papers in PubMed, 3 pooled it
40.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04493658 completednot on this mapstarted 2021, after this paper: background citation

Differential Diagnosis of Sjögren's Versus Non-Sjögren's Dry Eye

TypeobservationalSponsorJohns Hopkins UniversityRan2021 to 2022Enrolled92ConditionsKeratoconjunctivitis Sicca, Dry Eye Syndromes, Ocular Surface Disease, Sjogren's SyndromeArmsQuestionnaires, Tear fluid sampling, Impression Cytology
NCT06338735 narecruitingnot on this map

Ultra-High Frequency Ultrasonography (UHFUS) Evaluation of Salivary Glands in Patients With Suspected Sjögren's Syndrome

TypeinterventionalSponsorUniversity of PisaRan2016 to 2030Enrolled800ConditionsSjogren's SyndromeArmsUltra-High Frequency Ultrasound scan of minor salivary glands
NCT06440525 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden

TypeinterventionalSponsorResolve TherapeuticsRan2024 to 2027Enrolled106ConditionsPrimary Sjögren SyndromeArmsRSLV-132, Placebo
NCT06454370 unknown statusnot on this mapstarted 2024, after this paper: background citation

Histopathological Analysis of Minor Salivary Gland Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients Suspect Sjogren Syndrome.

Typeobservational_patient_registrySponsorCentre Hospitalier de MâconRan2024 to 2024Enrolled30ConditionsSjogren's Syndrome, Tomography Optical Coherence
NCT07153276 phase4recruitingnot on this mapstarted 2026, after this paper: background citation

Treatment of vaginal dryness in sjögren's disease with co2-laser versus topical promestriene: a prospective randomized study

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2026 to 2030Enrolled60ConditionsSjogren Syndrome, Sjogren Disease, Primary Sjogren SyndromeArmsFractional CO2 laser (vaginal), Promestriene Vaginal
3 · Its place in the literature

Who cites it

1,043 citing papers in PubMed, 3 syntheses or guidelines pooled it, 1,819 citations in OpenAlex.

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  20. [Diagnostics of Sjögren's disease].Zeitschrift fur Rheumatologie · 2026
    Review

983 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 4 countries.

Caroline H ShiboskiUniversity of California, San Francisco.
Stephen C ShiboskiUniversity of California, San Francisco.
Raphaèle SerorUniversité Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Paris, France.
Lindsey A CriswellUniversity of California, San Francisco.
Marc LabetoulleUniversité Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Paris, France.
Thomas M LietmanUniversity of California, San Francisco.
Astrid RasmussenOklahoma Medical Research Foundation, Oklahoma City.
Hal ScofieldOklahoma Medical Research Foundation, University of Oklahoma Health Sciences Center, and Department of Veterans Affairs Medical Center, Oklahoma City.
Claudio VitaliIstituto Villa San Giuseppe, Como, Italy, and Casa di Cura di Lecco, Lecco, Italy.
Simon J BowmanUniversity Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.
Xavier MarietteUniversité Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Paris, France.
International Sjögren's Syndrome Criteria Working Group
University of California, San Francisco · USInserm · FRCasa di Cura San Michele · ITOklahoma Medical Research Foundation · USUniversité Paris-Sud · FRUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Oklahoma Health Sciences Center · US

Funding

Tracking and Evaluation CoreU54GM104938 · NIGMS · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Robert Hal Scofield · 2013 to 2026
$68.2M
Pathogenic B Cells in Sjogren's SyndromeP50AR060804 · NIAMS · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI SIVILS, KATHY L. · 2011 to 2015
$7.9M
SNP Confirmation and High Throughput Genotyping CoreP30AR053483 · NIAMS · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI CHAKRAVARTY, ELIZA F · 2007 to 2017
$6.7M
Pre-Clinical Studies to Identify SLE Therapeutic TargetsU19AI082714 · NIAID · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI JAMES, JUDITH A · 2009 to 2018
$6.2M
Sjögren's International Collaborative Clinical Alliance Next Generation Studies (SICCA-NextGen)U01DE028891 · NIDCR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI SHIBOSKI, CAROLINE HELENE · 2020 to 2024
$4.0M
Genetic Association in Sjogren's SyndromeR01DE015223 · NIDCR · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI HARLEY, JOHN BARKER · 2004 to 2008
$1.9M
Gene Expression Profiling in Sjogren's SyndromeR01AR050782 · NIAMS · UNIVERSITY OF MINNESOTA TWIN CITIES · PI SIVILS, KATHY L. · 2003 to 2006
$1.3M
Susceptibility Genes in Primary Sjogren's SydromeR01DE018209 · NIDCR · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI HARLEY, JOHN BARKER, SIVILS, KATHY L. · 2009 to 2010
$489k
INTERNATIONAL RESEARCH REGISTRY NETWORK FOR SJOGERNS SYNDROME-268032636N01DE032636 · NIDCR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GREENSPAN, JOHN · 2005 to 2006
–
Medical Research Council G0800629NHLBI NIH HHS HHSN268201300057CNIAID NIH HHS U19 AI082714NIAMS NIH HHS P30 AR053483NIAMS NIH HHS P50 AR060804NIAMS NIH HHS R01 AR050782NIDCR NIH HHS N01 DE032636NIDCR NIH HHS R01 DE015223NIDCR NIH HHS R01 DE018209NIDCR NIH HHS U01 DE028891NIGMS NIH HHS U54 GM104938
6 · The paper itself

Abstract

objectiveTo develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with signs and/or symptoms suggestive of SS.

methodsWe assigned preliminary importance weights to a consensus list of candidate criteria items, using multi-criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non-SS controls, with case/non-case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients.

resultsThe final classification criteria are based on the weighted sum of 5 items: anti-SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of ≥1 foci/4 mm

conclusionUsing methodology consistent with other recent ACR/EULAR-approved classification criteria, we developed a single set of data-driven consensus classification criteria for primary SS, which performed well in validation analyses and are well-suited as criteria for enrollment in clinical trials.

Indexed as

Datasets as TopicHumansInternationalityPractice Guidelines as TopicSjogren's SyndromeUnited States

Identifiers

PMID27785888
PMCPMC5650478
OpenAlexW3022289262

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.