| The Sjögren's Syndrome Damage Index--a damage index for use in clinical trials and observational studies in primary Sjögren's syndrome. | |
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MedLine Citation:
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PMID: 18524804 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To validate a tool for assessment of accumulated damage in patients with Primary SS (PSS). METHODS: Of the total 114 patients fulfilling American-European Consensus Group (AECG) criteria for PSS 104 were included in the study and assessed by rheumatologists at T (time) = 0 months and T = 12 months. On each occasion, damage and activity data, and autoantibody status were collected. SF-36 and Profile of Fatigue and Discomfort-Sicca Symptoms Inventory (PROFAD-SSI) questionnaires were completed. Cross-sectional analysis of this data was subject to a process of expert validation by 11 ophthalmologists, 14 oral medicine specialists and 8 rheumatologists. Items were removed from the index if >or= 50% of respondents recommended exclusion. Statistical validation was performed on remaining items. Spearman's rank analysis was used to investigate associations between damage scores and other disease status measures and Wilcoxon matched-pair analysis to assess sensitivity to change in the damage score. RESULTS: Based on the expert validation, a 29-item damage score was agreed incorporating ocular, oral and systemic domains. Total damage score correlated with disease duration at study entry (r = 0.436; P < 0.001), physical function as measured by SF-36 (r = 0.250, T = 0 months; r = 0.261 T = 12 months) and activity as measured by the Sjögren's Systemic Clinical Activity Index (r = 0.213, T = 0 months; r = 0.215, T =12 months). Ocular damage score correlated with the 'eye dry' domain of PROFAD-SSI (r = 0.228, T = 0 months; r = 0.365, T = 12 months). Other associations not present on both assessments were considered clinically insignificant. On Wilcoxon analysis, the index was sensitive to change over 12 months (z = -3.262; P < 0.01). CONCLUSION: This study begins validation of a tool for collection of longitudinal damage data in PSS. We recommend further trial in both the experimental and clinical environment. |
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Authors:
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R J Barry; N Sutcliffe; D A Isenberg; E Price; F Goldblatt; M Adler; A Canavan; J Hamburger; A Richards; M Regan; K Gadsby; S Rigby; A Jones; R Mathew; D Mulherin; A Stevenson; P Nightingale; S Rauz; S J Bowman |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Validation Studies Date: 2008-06-04 |
Journal Detail:
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Title: Rheumatology (Oxford, England) Volume: 47 ISSN: 1462-0332 ISO Abbreviation: Rheumatology (Oxford) Publication Date: 2008 Aug |
Date Detail:
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Created Date: 2008-07-17 Completed Date: 2008-12-04 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100883501 Medline TA: Rheumatology (Oxford) Country: England |
Other Details:
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Languages: eng Pagination: 1193-8 Citation Subset: AIM; IM |
Affiliation:
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Academic Unit of Ophthalmology, University of Birmingham, UK. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Aged, 80 and over Disease Progression Dry Eye Syndromes / diagnosis Epidemiologic Methods Female Humans Middle Aged Mouth Diseases / diagnosis Severity of Illness Index* Sjogren's Syndrome / diagnosis* Time Factors |
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