Evidence map›Paper›PMID 19561361›Full record

ArticleAnnals of the rheumatic diseases2010

EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome.

Raphaèle Seror, Philippe Ravaud, Simon J Bowman, Gabriel Baron, Athanasios Tzioufas, Elke Theander, Jacques-Eric Gottenberg, Hendrika Bootsma, Xavier Mariette, Claudio Vitali and 1 more

Erratum issued 4 registry-linked trialsAbstract readConsensus Statement
In one paragraph

Article in Annals of the rheumatic diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 412 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
412citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT03430388 nacompletednot on this mapstarted 2018, after this paper: background citation

Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2018 to 2019Enrolled600ConditionsSystemic Lupus, Rheumatoid Arthritis, Spondyloarthritis, Inflammatory MyopathyArmsYellow Fever vaccine (17D)
NCT04793646 nacompletednot on this mapstarted 2021, after this paper: background citation

Prospective Randomized, Double-blind Controlled Clinical Study of N-acetylcysteine for Treatment of Dryness Symptoms Due to Primary Sjogren's Syndrome

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2021 to 2025Enrolled60ConditionsSjögren Syndrome, Sicca SyndromeArmsN-acetylcysteine syrup, Placebo syrup
NCT05879419 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Efficacy, Immunogenicity and Safety of Recombinant Vaccine Against Herpes Zoster (RZV or SHINGRIX®) in Patients With Autoimmune Rheumatic Diseases

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2023 to 2032Enrolled2,005ConditionsRheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus ErythematosusArmsRecombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation, MMF Discontinuation, Placebo, MTX maintain
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

412 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

11 authors.

Raphaèle SerorDepartment of Epidemiology, Biostatistics and Clinical Research, Hôpital Bichat, INSERM U738, Hôpital Bichat, 46 rue Henri Huchard, Paris 75018, France. raphaele.se@gmail.com
Philippe Ravaud
Simon J Bowman
Gabriel Baron
Athanasios Tzioufas
Elke Theander
Jacques-Eric Gottenberg
Hendrika Bootsma
Xavier Mariette
Claudio Vitali
EULAR Sjögren's Task Force

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo develop a disease activity index for patients with primary Sjögren's syndrome (SS): the European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI).

methodsThirty-nine SS experts participated in an international collaboration, promoted by EULAR, to develop the ESSDAI. Experts identified 12 organ-specific 'domains' contributing to disease activity. For each domain, features of disease activity were classified in three or four levels according to their severity. Data abstracted from 96 patients with systemic complications of primary SS were used to generate 702 realistic vignettes for which all possible systemic complications were represented. Using the 0-10 physician global assessment (PhGA) scale, each expert scored the disease activity of five patient profiles and 20 realistic vignettes. Multiple regression modelling, with PhGA used as the dependent variable, was used to estimate the weight of each domain.

resultsAll 12 domains were significantly associated with disease activity in the multivariate model, domain weights ranged from 1 to 6. The ESSDAI scores varied from 2 to 47 and were significantly correlated with PhGA for both real patient profiles and realistic vignettes (r=0.61 and r=0.58, respectively, p<0.001). Compared with 57 (59.4%) of the real patient profiles, 468 (66.7%) of the realistic vignettes were considered likely or very likely to be true.

conclusionsThe ESSDAI is a clinical index designed to measure disease activity in patients with primary SS. Once validated, such a standardised evaluation of primary SS should facilitate clinical research and be helpful as an outcome measure in clinical trials.

Indexed as

Severity of Illness IndexAdultAgedFemaleHumansMaleMiddle AgedObserver VariationReproducibility of ResultsSjogren's Syndrome

Identifiers

PMID19561361
PMCPMC2937022

What OpenQuestion holds

Textmetadata
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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.