Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2007
Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis.
Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02663895 (A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.
What it found
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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.
A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- A systematic review of minimum important changes for generic multi-attribute utility instruments and recommendations for their estimation.The European journal of health economics : HEPAC : health economics in prevention and care · 2025Pooled it
- Assessment of skin involvement in systemic sclerosis.Rheumatology (Oxford, England) · 2017Pooled it
- Racial and Ethnic Disparity in Preference-Weighted Quality of Life: Findings from the Selenium and Vitamin E Cancer Prevention Trial.Population health management · 2025Trial
- Impact of intensive lifestyle intervention on preference-based quality of life in type 2 diabetes: Results from the Look AHEAD trial.Obesity (Silver Spring, Md.) · 2016Trial
- Minimally important differences of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument.The Journal of rheumatology · 2011Trial
- Minimally important differences in the Mahler's Transition Dyspnoea Index in a large randomized controlled trial--results from the Scleroderma Lung Study.Rheumatology (Oxford, England) · 2009Trial
- Course of the modified Rodnan skin thickness score in systemic sclerosis clinical trials: analysis of three large multicenter, double-blind, randomized controlled trials.Arthritis and rheumatism · 2009Trial
- A randomized study of scleroderma health state values: a picture is worth a thousand words, and quite a few utiles. [corrected].Medical decision making : an international journal of the Society for Medical Decision MakingTrial
- Psychometric properties of the 12-item short form health survey version 2 among general Thai samples: a Rasch analysis.Journal of pharmaceutical policy and practice · 2025Article
- The Minimal Important Difference of the Fecal Incontinence Quality of Life (FIQL) Questionnaire for Patients with Posterior Compartment Prolapse: A Prospective Cohort Study.Journal of the anus, rectum and colon · 2022Article
- Validity and responsiveness of EQ-5D-5L and SF-6D in patients with health complaints attributed to their amalgam fillings: a prospective cohort study of patients undergoing amalgam removal.Health and quality of life outcomes · 2021Article
- Article
- Evaluation of cognitive function in systemic sclerosis patients: a pilot study.Clinical rheumatology · 2020Article
- The impact of different rheumatic diseases on health-related quality of life: a comparison with a selected sample of healthy individuals using SF-36 questionnaire, EQ-5D and SF-6D utility values.Acta bio-medica : Atenei Parmensis · 2019Article
- Preference-based measure of health-related quality of life and its determinants in sickle cell disease in Nigeria.PloS one · 2019Article
- Unmet Needs in Systemic Sclerosis Understanding and Treatment: the Knowledge Gaps from a Scientist's, Clinician's, and Patient's Perspective.Clinical reviews in allergy & immunology · 2018Review
- Functional disability and other health-related quality-of-life domains: points to consider for clinical trials in systemic sclerosis.Rheumatology (Oxford, England) · 2017Review
- Comparison of EQ-5D and SF-6D utilities in Pompe disease.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2015Article
- Construct validity of SF-6D health state utility values in an employed population.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2015Article
- Associations of cancer and other chronic medical conditions with SF-6D preference-based scores in Medicare beneficiaries.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
objectivesTo evaluate the reliability and validity and estimate the minimally important difference (MID) for the SF-6D in patients with systemic sclerosis (SSc). Subjects We used data from two clinical studies to analyze the SF-6D in patients with SSc: Study 1 was a cross-sectional observational study (N = 107) designed to assess three direct preference measures--the rating scale, time trade-off, and standard gamble (SG) in patients with diffuse SSc and limited SSc, and Study 2 was a 12-month randomized, placebo-controlled, clinical trial (N = 168) assessing oral bovine collagen versus placebo in diffuse SSc.
methodsWe assessed the test-retest reliability of the SF-6D in Study 2 over a mean (SD) 4.8 (3.0)-week interval and the agreement between the SF-6D and direct preference measures in Study 1 using intraclass correlations (ICC). The MID was estimated using three different anchors--the SF-36 change in health item (patients who answered "somewhat better" formed the MID group), the Health Assessment Questionnaire-Disability Index (HAQ-DI; change of > or =0.14 and > or =0.22) and the skin score (change of > or =5.3). Results The mean (SD) SF-6D scores were 0.61 (0.12) in Study 1 and 0.64 (0.13) in Study 2. Test-retest reliability for the SF-6D was high (ICC = 0.82 [95% CI: 0.76, 0.87]). Agreement between the SF-6D and three direct preferences measures was poor to moderate (0.16-0.52). The MID estimate for the SF-6D using the change in SF-36 item -0.012 and this level of change was similar to the no change group. The mean MID estimate for the SF-6D improvement using the HAQ-DI and skin score as anchors was 0.035 (effect size of 0.27).
conclusionThis is the first study to assess the SF-6D in SSc. The SF-6D is reliable and valid in patients with SSc. We provide MID estimates that can aid in calculating sample size for clinical trials involving patients with diffuse SSc.
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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.