Trial reportRheumatology (Oxford, England)2009
Sensitivity to change of the modified Rodnan skin score in diffuse systemic sclerosis--assessment of individual body sites in two large randomized controlled trials.
Trial report in Rheumatology (Oxford, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05016804 (Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis), which is not on this map. Cited by 22 papers, 2 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.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- Pooled it
- Assessment of skin involvement in systemic sclerosis.Rheumatology (Oxford, England) · 2017Pooled it
- Insulin Resistance in Systemic Sclerosis: Decoding Its Association with Severe Clinical Phenotype.Journal of clinical medicine · 2026Article
- Observational
- Relaxin as a treatment for musculoskeletal fibrosis: What we know and future directions.Biochemical pharmacology · 2024Review
- Spatial frequency domain imaging for the assessment of scleroderma skin involvement.Biomedical optics express · 2023Article
- The value of shear wave elastography in diagnosis and assessment of systemic sclerosis.Rheumatology advances in practice · 2023Article
- Unenhanced Cardiac Magnetic Resonance may improve detection and prognostication of an occult heart involvement in asymptomatic patients with systemic sclerosis.Scientific reports · 2022Article
- Imaging in Diagnosis of Systemic Sclerosis.Journal of clinical medicine · 2021Review
- The Updated Role of Ultrasound in Assessing Dermatological Manifestations in Systemic Sclerosis.Open access rheumatology : research and reviews · 2021Review
- How to perform high ultrasound examination of skin involvement among patients with systemic sclerosis - proposition of a unified protocol.Reumatologia · 2021Article
- Factors Associated With Post-traumatic Growth Among Healthcare Workers Who Experienced the Outbreak of MERS Virus in South Korea: A Mixed-Method Study.Frontiers in psychology · 2021Article
- The Role of IL-6 in Skin Fibrosis and Cutaneous Wound Healing.Biomedicines · 2020Review
- How much of skin improvement over time in systemic sclerosis is due to normal ageing? A prospective study with shear-wave elastography.Arthritis research & therapy · 2020Article
- Correlation between circulating fibrocytes and dermal thickness in limited cutaneous systemic sclerosis patients: a pilot study.Rheumatology international · 2019Article
- An Interim Report of the Scleroderma Clinical Trials Consortium Working Groups.Journal of scleroderma and related disorders · 2019Article
- High-frequency ultrasound of the skin in systemic sclerosis: an exploratory study to examine correlation with disease activity and to define the minimally detectable difference.Arthritis research & therapy · 2018Article
- Existing and novel biomarkers for precision medicine in systemic sclerosis.Nature reviews. Rheumatology · 2018Review
- Nearest Consensus Clustering Classification to Identify Subclasses and Predict Disease.Journal of healthcare informatics research · 2018Article
- Subclinical dermal involvement is detectable by high frequency ultrasound even in patients with limited cutaneous systemic sclerosis.Arthritis research & therapy · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
Abstract
objectiveThe modified Rodnan skin score (MRSS) is a standard outcome measure for skin disease in SSc and calculated by summation of skin thickness in 17 different body sites (total score = 51). Our objective was to evaluate the sensitivity of change over time of individual body sites used in the calculation of total MRSS.
methodsWe analysed two randomized placebo controlled clinical trials investigating the effect of either recombinant human relaxin or type I oral collagen in dcSSc. Both trials used MRSS as the primary outcome measure. We used a change of >10 mm (on a 0-100 VAS) in the patient global assessment (PGA) as the clinically important improvement. We calculated the mean change and the effect size (ES) for each individual body site used in the total MRSS for each study. Magnitude of ES was assessed using Cohen's rule of thumb for ES.
resultsIn the relaxin and collagen studies, 71 of 199 patients (36%) and 54 of 129 (42%) of patients had an improvement >10 mm on the PGA at 6 and 12 months, respectively. Total MRSS had large ES in both studies (0.85-0.98); the chest, forearms and hands had moderate ES (0.50-0.74); and the lower extremities, face, abdomen and fingers had small ES (0.16-0.49).
conclusionCertain body sites (hands, forearms and chest) are more sensitive to change compared with other body sites in two randomized clinical trials. It remains to be seen whether decreasing the number of body sites by exclusion of relatively static areas would further increase the sensitivity to change over time of the total MRSS.
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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.