Detailled Information

Name of the Instrument/Tool Sjögren’s Tool for Assessing Response (STAR)
First Description

Seror R, Baron G, Camus M, Cornec D, Perrodeau E, Bowman SJ, et al. Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren's syndrome. Ann Rheum Dis. 2022 Jul;81(7):979-989. doi: 10.1136/annrheumdis-2021-222054. Epub 2022 Apr 7. PMID: 35393271; PMCID: PMC9209686.

Year 2022
Domains
Concept of constructs Disease activity
Population/Disease Disease specific
Originally developed for Sjögren's syndrome
Other rheumatic diseases
where can be applied (only if validated)
---
Additional population with no rheumatic diseases No
Language: Originally published in English
Available in Language ---
REFERENCE IDENTIFICATION
Author/s Seror R, Baron G, Camus M, Cornec D, Perrodeau E, Bowman SJ, Bombardieri M, Bootsma H, Gottenberg JE, Fisher B, Hueber W, van Roon JA, Devauchelle-Pensec V, Gergely P, Mariette X, Porcher R; NECESSITY WP5 - STAR development working group; NECESSITY WP5- STAR development working group.
Title Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren's syndrome.
Journal Ann Rheum Dis
Year 2022
Vol 81
Num 7
Pages 979-989
Country Multinaltional
Language English
Other references of interest
Link https://pubmed.ncbi.nlm.nih.gov/19561361/
Brief Description

Seror R, Ravaud P, Bowman SJ, et al. . EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome. Ann Rheum Dis 2010;69:1103–9. 10.1136/ard.2009.110619 -

Link https://pubmed.ncbi.nlm.nih.gov/24411404/
Brief Description

Seror R, Theander E, Bootsma H, Bowman SJ, Tzioufas A, Gottenberg JE, Ramos-Casals M, Dörner T, Ravaud P, Mariette X, Vitali C. Outcome measures for primary Sjögren's syndrome: a comprehensive review. J Autoimmun. 2014 Jun;51:51-6. doi: 10.1016/j.jaut.2013.12.010. Epub 2014 Jan 8. PMID: 24411404.

Link https://pubmed.ncbi.nlm.nih.gov/27150113/
Brief Description

Outcome measures used within the STAR :

Seror R, et al. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Annals of the Rheumatic Diseases 2011;70:968-72.
Seror R, et al; EULAR Sjögren Task Force. Development of the ClinESSDAI: a clinical score without biological domain. A tool for biological studies. Ann Rheum Dis. 2016 Nov;75(11):1945-1950. doi: 10.1136/annrheumdis-2015-208504. Epub 2016 Jan 25. PMID: 2715011

Hocevar A, et al. Ultrasonographic changes of major salivary glands in primary Sjogren's syndrome. Diagnostic value of a novel scoring system. Rheumatology (Oxford). 2005 Jun;44(6):768-72. doi:10.1093/rheumatology/keh588. Epub 2005 Mar 1. PMID: 15741192.
Whitcher JP, et al. A simplified quantitative method for assessing keratoconjunctivitis sicca from the Sjogren’s Syndrome International Registry. American journal of ophthalmology. 2010;149(3):405–15

Instrument/Tool Translations References
No other References.
DEVELOPER CONTACT INFORMATION
Correspondence to Raphaele Seror
E-Mail raphaele.seror@aphp.fr
Address Paris-Saclay University, INSERM UMR1184: Centre for Immunology of Viral Infections and Autoimmune Diseases, Le Kremlin-Bicetre, France
Website ---
Available ---
Links ---
DESCRIPTION OF THE INSTRUMENT
Type Of Measure Composite Index
Brief Description

Sjögren’s Tool for Assessing Response (STAR) is intended to assess treatment efficacy based on improvement of disease activity in clinical trials of drugs for primary Sjögren’s syndrome (pSS). This composite responder index globally assesses all disease features and for use as an efficacy endpoint in RCTs. The STAR contains 5 domains: systemic activity, symptoms, lacrimal and glandular gland function, and biomarkers of auto-immune activity. The domains are differently weighted.

Number of Items 5
Range 0-9
Responses options/scale Yes
Different points for each domain
Developed for Research, Clinical practice
PRACTICAL APPLICATION
Method of administration Physician
Recommendations to score

Items are summed: systemic activity (3 points), symptoms (3 points), lacrimal (1 point) and glandular (1 point) gland function, and biomarkers of auto-immune activity (1 point).

Score Interpretation The higher the score, the higher the disease activity.
Cut-off points ≥ 5-point score corresponds to a clinically relevant difference, and is the definition of reponse to therapy.
Cut-off points applied to ---
Smallest detectable change if described ---
Smallest detectable change applied to ---
Completion time by the patient - minutes
Scoring time by the assessor - minutes
Training to score Not necessary
Strengths Useful in clinical practice & research, Easy to use
Limitations ---
OTHER COMMENTS
Other Comments ---