SynthesisAnnals of the rheumatic diseases2022
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.
Synthesis in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 3 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
55 citing papers in PubMed, 3 syntheses or guidelines pooled it, 78 citations in OpenAlex.
- Clinical practice guideline for the treatment of Sjögren's disease through off-label drug use in China (English edition).Clinical rheumatology · 2026Guideline
- British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology (Oxford, England) · 2025Guideline
- A Systematic Review and Meta-Analysis of 19 Randomized Controlled Trials of Iguratimod Combined With Other Therapies for Sjogren's Syndrome.Frontiers in immunology · 2022Pooled it
- Efficacy and safety of iguratimod in patients with primary Sjögren's syndrome: a multicentre randomised controlled trial.RMD open · 2025Trial
- Proteins linked to type II interferon response in Sjögren's disease: novel indicators for disease monitoring and predicting treatment response to leflunomide and hydroxychloroquine combination therapy.Frontiers in immunology · 2025Trial
- Metabolic impact of low dose IL-2 therapy for primary Sjögren's Syndrome in a double-blind, randomized clinical trial.Clinical rheumatology · 2024Trial
- Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren's syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial.Annals of the rheumatic diseases · 2024Trial
- A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjögren's syndrome.Rheumatology (Oxford, England) · 2023Trial
- Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjögren Syndrome: A Randomized Clinical Trial.JAMA network open · 2022Trial
- Efficacy and safety of pharmacological treatment for Sjögren's disease: a network meta-analysis.Zeitschrift fur Rheumatologie · 2026Article
- [How often do patients with Sjögren's syndrome fulfil the activity criteria for immunomodulatory treatment?]Zeitschrift fur Rheumatologie · 2026Article
- Managing Sjögren's Disease in Pediatric Patients.Paediatric drugs · 2026Review
- [Practical management of Sjögren's disease in the era of new treatment options : Current value of available outcome parameters].Zeitschrift fur Rheumatologie · 2026Article
- Time to rethink clinical trial design in Sjögren disease.Nature reviews. Rheumatology · 2026Article
- [Current treatment, foreseeable newcomer and new treatment approaches for Sjögren's disease].Zeitschrift fur Rheumatologie · 2026Review
- Fatigue in Sjögren's Disease - Integrating Biomedical and Psychosocial Aspects: A Narrative Review.Rheumatology and therapy · 2026Review
- An index system for evaluating the data security in trauma centers: a modified Delphi study in China.Journal of translational internal medicine · 2026Article
- Evolving treatments for Sjögren disease: current approaches and emerging targets.Internal medicine journal · 2026Review
- From Molecular Pathophysiology to Clinical Trial Design in Sjögren's Disease: A Three-Axis Framework.International journal of molecular sciences · 2026Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 9 institutions in 6 countries.
Funding
Abstract
objectiveTo develop a composite responder index in primary Sjögren's syndrome (pSS): the Sjögren's Tool for Assessing Response (STAR).
methodsTo develop STAR, the NECESSITY (New clinical endpoints in primary Sjögren's syndrome: an interventional trial based on stratifying patients) consortium used data-driven methods based on nine randomised controlled trials (RCTs) and consensus techniques involving 78 experts and 20 patients. Based on reanalysis of rituximab trials and the literature, the Delphi panel identified a core set of domains with their respective outcome measures. STAR options combining these domains were proposed to the panel for selection and improvement. For each STAR option, sensitivity to change was estimated by the C-index in nine RCTs. Delphi rounds were run for selecting STAR. For the options remaining before the final vote, a meta-analysis of the RCTs was performed.
resultsThe Delphi panel identified five core domains (systemic activity, patient symptoms, lachrymal gland function, salivary gland function and biological parameters), and 227 STAR options combining these domains were selected to be tested for sensitivity to change. After two Delphi rounds, a meta-analysis of the 20 remaining options was performed. The candidate STAR was then selected by a final vote based on metrological properties and clinical relevance.
conclusionThe candidate STAR is a composite responder index that includes all main disease features in a single tool and is designed for use as a primary endpoint in pSS RCTs. The rigorous and consensual development process ensures its face and content validity. The candidate STAR showed good sensitivity to change and will be prospectively validated by the NECESSITY consortium in a dedicated RCT.
Indexed as
Identifiers
What OpenQuestion holds
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.