ReviewJournal of scleroderma and related disorders2020
Patient-reported outcome instruments in clinical trials of systemic sclerosis.
Review in Journal of scleroderma and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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
13 citing papers in PubMed.
- Brentuximab vedotin for skin involvement in refractory diffuse cutaneous systemic sclerosis, an open-label trial.Rheumatology (Oxford, England) · 2025Trial
- A distinct gastrointestinal symptom profile characterizes clinically relevant fatigue in systemic sclerosis.Clinical rheumatology · 2026Article
- Social appearance anxiety and its associations with anxiety, depressive symptoms, and health-related quality of life in systemic sclerosis: a cross-sectional study.Clinical rheumatology · 2026Article
- Complement C3c Reflects Acute-Phase Response but Not Clinical Phenotype in Systemic Sclerosis: A Cross-Sectional Study.International journal of molecular sciences · 2026Article
- Capillaroscopic patterns are associated with interstitial lung disease, skin fibrosis, anti-Th/To antibodies and quality of life in systemic sclerosis: a prospective cross-sectional study.Frontiers in medicine · 2026Article
- Lower total serum Immunoglobulin G is associated with impaired patient-reported health-related quality of life in systemic sclerosis: a prospective cross-sectional study.Rheumatology international · 2025Article
- Article
- A Narrative Review of Pathogenetic and Histopathologic Aspects, Epidemiology, Classification Systems, and Disease Outcome Measures in Systemic Sclerosis.Clinical reviews in allergy & immunology · 2023Review
- Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease.Rheumatology (Oxford, England) · 2023Article
- Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: an international collaborative scoping review.Rheumatology (Oxford, England) · 2022Article
- Symptom experience of limited cutaneous systemic sclerosis from the Patients' perspective: A qualitative studySeminars in arthritis and rheumatism · 2022Article
- Considerations for a combined index for limited cutaneous systemic sclerosis to support drug development and improve outcomes.Journal of scleroderma and related disorders · 2021Article
- The need for a holistic approach for SSc-ILD - achievements and ambiguity in a devastating disease.Respiratory research · 2020Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Patient-reported outcome instruments provide valuable insight into disease-related morbidity known only to the patient and complement more objective outcome tools in the clinical trial setting. They are of particular importance in systemic sclerosis owing to the challenges around defining disease activity, the episodic nature of many disease-specific manifestations and the paucity of validated objective surrogate outcome measures for use in clinical trials. Early clinical trials of systemic sclerosis often incorporated legacy patient-reported outcome instruments, but the last 20 years has witnessed the emergence of several scleroderma-specific instruments that are now being routinely used alongside other outcomes in systemic sclerosis clinical trials. More recently, the value of patient-reported outcomes has been highlighted by their prominence in the American College of Rheumatology Combined Response Index for Systemic Sclerosis that has been utilized as the primary endpoint of recent clinical trials of early diffuse systemic sclerosis. This review considers the role and performance of the various patient-reported outcome instruments utilized in systemic sclerosis clinical trials, the current positioning of patient-reported outcome instruments within clinical trial endpoint models across the range of systemic sclerosis disease manifestations and, where applicable, we shall highlight areas for future research.
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