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Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis.

Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis. Research Abstract Details 

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  • Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis. Abstract Text:

    dinesh khannaDinesh Khanna,daniel e furstDaniel E Furst,weng kee wongWeng Kee Wong,joel tsevatJoel Tsevat,philip j clementsPhilip J Clements,grace s parkGrace S Park,arnold e postlethwaiteArnold E Postlethwaite,mansoor ahmedMansoor Ahmed,shaari ginsburgShaari Ginsburg,ron d haysRon D Hays, ,

    OBJECTIVES: To 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. METHODS: We 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). CONCLUSION: This 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.

    Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis. Publishing Authors By Initials

    d khannaD Khanna,de furstDE Furst,wk wongWK Wong,j tsevatJ Tsevat,pj clementsPJ Clements,gs parkGS Park,ae postlethwaiteAE Postlethwaite,m ahmedM Ahmed,s ginsburgS Ginsburg,rd haysRD Hays, ,

    For similar geographic locations: americas: north america: united states research abstracts see: geographic locations: americas: north america: united states research

    PUBMED ID PMID:

    MEDLINE DATE:

    Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis. Journal Published:

    PUBLICATION TYPE: Validation Studies

    Journal: Quality of life research : an international journa

    VOLUME: 16

    Page Numbers: 1083-92

    Journal Abbreviation:

    ISSN: 0962-9343

    DAY: 3

    MONTH: 04

    YEAR: 2007

    Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis. Information

    Number of References:

    LANGUAGE: eng

    NlmUniqueID: 9210257

    Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis. Keywords Mesh Terms:

    KEYWORDS: United States

    MESH TERMS: psychology

    Chemical & Substance for Abstract: Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis. Information

    Substance Name: Collagen

    Registry Number: 9007-34-5

    Grant and Affiliation Information for Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis.

    AFFILIATION: Division of Immunology, Department of Internal Medicine, University of Cincinnati Medical Center, PO Box 670563, Cincinnati, OH 45267-0563, USA. dinesh.khanna@uc.edu

    Country: Netherlands

    Netherlands Research PublicationNetherlands Research Publication

    AGENCY: United States NCMHD

    GRANT: P20-MD00148-01

    ACRONYM: MD

    MEDLINETA: Qual Life Res

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