Angela Ju1,2,3, Armando Teixeira-Pinto4,2, Allison Tong4,2, Alice C Smith5, Mark Unruh6, Sara N Davison7, Juan Dapueto8, Mary Amanda Dew9, Richard Fluck10, Michael J Germain11, Sarbjit V Jassal12, Gregorio T Obrador13, Donal O'Donoghue14, Andrea K Viecelli15,16, Giovanni Strippoli4,2,17, Marinella Ruospo17, Delia Timofte18, Ankit Sharma4,2, Eric Au1,2, Martin Howell4,2, Daniel S J Costa19, Samaya Anumudu20, Jonathan C Craig21, Claudia Rutherford3,22. 1. Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia angela.ju@sydney.edu.au. 2. Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia. 3. Faculty of Science, Quality of Life Office, School of Psychology, University of Sydney, Sydney, Australia. 4. Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia. 5. Department of Health Sciences, University of Leicester, Leicester, United Kingdom. 6. Division of Nephrology, University of New Mexico School of Medicine, Albuquerque, New Mexico. 7. Division of Nephrology and Immunology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. 8. Departamento de Psicología Médica, Hospital de Clínicas, Facultad de Medicina, Universidad de la República, Montevideo, Uruguay. 9. Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. 10. Department of Renal Medicine, Royal Derby Hospital, Derby, United Kingdom. 11. Division of Nephrology, Renal and Transplant Associates of New England, Baystate Medical Center, University of Massachusetts School of Medicine, Springfield, Massachusetts. 12. Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada. 13. Department of Epidemiology, Biostatistics, and Public Health, Universidad Panamericana School of Medicine, Mexico City, Mexico. 14. Department of Renal Medicine, Salford Royal Hospital, Salford, United Kingdom. 15. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia. 16. Australasian Kidney Trials Network, Centre for Health Services Research, University of Queensland, Brisbane, Queensland, Australia. 17. Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. 18. Department of Dialysis, Emergency University Hospital, Bucharest, Romania. 19. Faculty of Medicine and Health, Pain Management Research Institute, Royal North Shore Hospital, New South Wales, Sydney, Australia. 20. Section of Nephrology, Selzman Institute for Kidney Health, Baylor College of Medicine, Houston, Texas. 21. College of Medicine and Public Health, Flinders University, Adelaide, Australia. 22. The University of Sydney, Susan Wakil School of Nursing and Midwifery, Cancer Nursing Research Unit, Faculty of Medicine and Health, Sydney, Australia.
Abstract
BACKGROUND AND OBJECTIVES: Fatigue is a very common and debilitating symptom and identified by patients as a critically important core outcome to be included in all trials involving patients receiving hemodialysis. A valid, standardized measure for fatigue is needed to yield meaningful and relevant evidence about this outcome. This study validated a core patient-reported outcome measure for fatigue in hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A longitudinal cohort study was conducted to assess the validity and reliability of a new fatigue measure (Standardized Outcomes in Nephrology-Hemodialysis Fatigue [SONG-HD Fatigue]). Eligible and consenting patients completed the measure at three time points: baseline, a week later, and 12 days following the second time point. Cronbach α and intraclass correlation coefficient were calculated to assess internal consistency, and Spearman rho was used to assess convergent validity. Confirmatory factor analysis was also conducted. Hemodialysis units in the United Kingdom, Australia, and Romania participated in this study. Adult patients aged 18 years and over who were English speaking and receiving maintenance hemodialysis were eligible to participate. Standardized Outcomes in Nephrology-Hemodialysis, the Visual Analog Scale for fatigue, the 12-Item Short Form Survey, and Functional Assessment of Chronic Illness Therapy-Fatigue were used. RESULTS: In total, 485 participants completed the study across the United Kingdom, Australia, and Romania. Psychometric assessment demonstrated that Standardized Outcomes in Nephrology-Hemodialysis is internally consistent (Cronbach α =0.81-0.86) and stable over a 1-week period (intraclass correlation coefficient =0.68-0.74). The measure demonstrated convergence with Functional Assessment of Chronic Illness Therapy-Fatigue and had moderate correlations with other measures that assessed related but not the same concept (the 12-Item Short Form Survey and the Visual Analog Scale). Confirmatory factor analysis supported the one-factor model. CONCLUSIONS: SONG-HD Fatigue seems to be a reliable and valid measure to be used in trials involving patients receiving hemodialysis.
BACKGROUND AND OBJECTIVES:Fatigue is a very common and debilitating symptom and identified by patients as a critically important core outcome to be included in all trials involving patients receiving hemodialysis. A valid, standardized measure for fatigue is needed to yield meaningful and relevant evidence about this outcome. This study validated a core patient-reported outcome measure for fatigue in hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A longitudinal cohort study was conducted to assess the validity and reliability of a new fatigue measure (Standardized Outcomes in Nephrology-Hemodialysis Fatigue [SONG-HD Fatigue]). Eligible and consenting patients completed the measure at three time points: baseline, a week later, and 12 days following the second time point. Cronbach α and intraclass correlation coefficient were calculated to assess internal consistency, and Spearman rho was used to assess convergent validity. Confirmatory factor analysis was also conducted. Hemodialysis units in the United Kingdom, Australia, and Romania participated in this study. Adult patients aged 18 years and over who were English speaking and receiving maintenance hemodialysis were eligible to participate. Standardized Outcomes in Nephrology-Hemodialysis, the Visual Analog Scale for fatigue, the 12-Item Short Form Survey, and Functional Assessment of Chronic Illness Therapy-Fatigue were used. RESULTS: In total, 485 participants completed the study across the United Kingdom, Australia, and Romania. Psychometric assessment demonstrated that Standardized Outcomes in Nephrology-Hemodialysis is internally consistent (Cronbach α =0.81-0.86) and stable over a 1-week period (intraclass correlation coefficient =0.68-0.74). The measure demonstrated convergence with Functional Assessment of Chronic Illness Therapy-Fatigue and had moderate correlations with other measures that assessed related but not the same concept (the 12-Item Short Form Survey and the Visual Analog Scale). Confirmatory factor analysis supported the one-factor model. CONCLUSIONS:SONG-HD Fatigue seems to be a reliable and valid measure to be used in trials involving patients receiving hemodialysis.
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