Angelika Lackner1, Martin H Stradner2, Josef Hermann1, Julia Unger3, Tanja Stamm4, Winfried B Graninger1, Christian Dejaco5. 1. Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Auenbruggerplatz 15, 8036 Graz, Austria. 2. Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Auenbruggerplatz 15, 8036 Graz, Austria. Electronic address: martin.stradner@medunigraz.at. 3. Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Auenbruggerplatz 15, 8036 Graz, Austria; Department of Health Studies, Institute of Occupational Therapy, University of Applied Sciences JOANNEUM, Kaiser-Franz-Josef Straße 24, 8344 Bad Gleichenberg, Austria. 4. Division of Rheumatology, Medical University Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria. 5. Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Auenbruggerplatz 15, 8036 Graz, Austria; Rheumatology Service, South Tyrolean Health Trust, Hospital of Bruneck, Spitalstraße 11, 39031 Bruneck, Italy.
Abstract
OBJECTIVES: To develop a questionnaire for the assessment of health-related quality of life (HRQL) in primary Sjögren's syndrome (PSS), and to test its psychometric properties. METHODS: Based on the concepts of a previous qualitative study, a questionnaire for the assessment of HRQL in PSS (PSS-QoL) was developed. Psychometric testing of PSS-QoL was performed after revising the first draft with feedback of patients (n = 6) and clinicians (n = 4). Convergent construct validity was assessed by correlating the score with the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) and Euro-QoL 5D (EQ-5D). Reliability was examined by asking patients to complete the questionnaire twice 1-2 weeks apart. An English Version of the PSS-QoL was developed by using standard methodology with forward and back translation. RESULTS: Out of the 75 PSS patients, 91% were female, mean (±SD) age was 58.5 ± 12.5 years. PSS-QoL consists of 25 questions and can be divided into two main categories: physical (discomfort and dryness) and psychosocial. The internal consistency of the PSS-QoL revealed a Crohnbach's α of 0.892. Strong and moderate correlations were found between the PSS-QoL and ESSPRI (corrcoeff = 0.755) and EQ. 5D-pain/discomfort (corrcoeff = 0.531). Reproducibility of the PSS-QoL was high, yielding an ICC of 0.958 (95% CI: 0.926-0.981). CONCLUSIONS: The PSS-QoL is the first specific tool for the assessment of patients' HRQL in PSS and showed good psychometric properties. It may serve as a novel patient-reported outcome measure in future clinical studies.
OBJECTIVES: To develop a questionnaire for the assessment of health-related quality of life (HRQL) in primary Sjögren's syndrome (PSS), and to test its psychometric properties. METHODS: Based on the concepts of a previous qualitative study, a questionnaire for the assessment of HRQL in PSS (PSS-QoL) was developed. Psychometric testing of PSS-QoL was performed after revising the first draft with feedback of patients (n = 6) and clinicians (n = 4). Convergent construct validity was assessed by correlating the score with the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) and Euro-QoL 5D (EQ-5D). Reliability was examined by asking patients to complete the questionnaire twice 1-2 weeks apart. An English Version of the PSS-QoL was developed by using standard methodology with forward and back translation. RESULTS: Out of the 75 PSSpatients, 91% were female, mean (±SD) age was 58.5 ± 12.5 years. PSS-QoL consists of 25 questions and can be divided into two main categories: physical (discomfort and dryness) and psychosocial. The internal consistency of the PSS-QoL revealed a Crohnbach's α of 0.892. Strong and moderate correlations were found between the PSS-QoL and ESSPRI (corrcoeff = 0.755) and EQ. 5D-pain/discomfort (corrcoeff = 0.531). Reproducibility of the PSS-QoL was high, yielding an ICC of 0.958 (95% CI: 0.926-0.981). CONCLUSIONS: The PSS-QoL is the first specific tool for the assessment of patients' HRQL in PSS and showed good psychometric properties. It may serve as a novel patient-reported outcome measure in future clinical studies.
Authors: Angelika Lackner; Philipp Bosch; Sabine Zenz; Jutta Horwath-Winter; Dieter Franz Rabensteiner; Josef Hermann; Winfried Graninger; Martin Helmut Stradner Journal: Front Med (Lausanne) Date: 2021-04-15