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Patient-Reported Outcome Measures for Fatigue in Patients on Hemodialysis: A Systematic Review

2018 , Ju, Angela , Unruh, Mark , Davison, Sara N. , Dapueto, Juan , Dew, Mary Amanda , Fluck, Richard , Germain, Michael , Jassal, Sarbjit Vanita , Obrador, Gregorio , O’Donoghue, Donal , Tugwell, Peter , Craig, Jonathan C. , Ralph, Angelique F. , Howell, Martin , Tong, Allison

Background: Fatigue is a prevalent and debilitating symptom in patients receiving hemodialysis. We aimed to identify and evaluate the characteristics and psychometric properties of patient-reported outcome measures for fatigue in patients receiving hemodialysis, to inform the selection of a robust and feasible measure for use in randomized trials in hemodialysis. Study Design: Systematic review of outcome measures for fatigue. Setting & Population: Patients receiving hemodialysis. Search Strategy & Sources: MEDLINE, Embase, PsycINFO, and CINAHL from inception to April 2017 were searched for all studies that reported fatigue in patients receiving hemodialysis. Analytical Approach: With a focus on addressing methods, items (individual questions) from all measures were categorized into content and measurement dimensions of fatigue. We assessed the general characteristics (eg, number of items and cost) and psychometric properties of all measures. © American Journal of Kidney Diseases

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Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop Report

2018 , Ju, Angela , Unruh, Mark , Davison, Sara , Dapueto , Juan , Dew, Mary Amanda , Fluck, Richard , Germain, Michael , Jassal, Sarbjit V. , Obrador, Gregorio , O’Donoghue, Donal , Josephson, Michelle A. , Craig, Jonathan C. , Viecelli, Andrea K. , O’Lone, Emma , Hanson, Camilla S. , Manns, Braden , Sautenet, Benedicte , Howell, Martin , Reddy, Bharathi , Wilkie, Caroline , Rutherford, Claudia , Tong, Allison , Levin, Adeera

Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patient’s ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis. © 2018 by the National Kidney Foundation, Inc.

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Patient Perspectives on the Meaning and Impact of Fatigue in Hemodialysis: A Systematic Review and Thematic Analysis of Qualitative Studies

2019 , Jacobson, Jack , Ju, Angela , Baumgart, Amanda , Unruh, Mark , O’Donoghue, Donal , Obrador, Gregorio , Craig, Jonathan C. , Dapueto, Juan M. , Dew, Mary Amanda , Germain, Michael , Fluck, Richard , Davison, Sara N. , Jassal, Sarbjit Vanita , Manera, Karine , Smith, Alice C. , Tong, Allison

Rationale & objective: Fatigue is a highly prevalent and debilitating symptom in patients on hemodialysis therapy due to the uremic milieu, the hemodialysis treatment itself, and other comorbid conditions. However, fatigue remains underrecognized and the consequences are underappreciated because it may not be visible in clinical settings. This study aims to describe the experience that patients undergoing maintenance hemodialysis have with fatigue. Study design: Systematic review and thematic synthesis of qualitative studies. Setting & study populations: Patients undergoing hemodialysis. Search strategy & sources: MEDLINE, Embase, PsycINFO, CINAHL, reference lists, and PhD dissertations were searched from inception to October 2018. Data extraction: All text from the results/conclusion of the primary studies. Analytical approach: Thematic synthesis. Copyright © 2019 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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Validation of a core patient-reported outcome measure for fatigue in patients receiving hemodialysis : the SONG-HD fatigue instrument

2020 , Ju, Angela , Teixeira-Pinto, Armando , Tong, Allison , Smith, Alice C. , Unruh, Mark , Davison, Sara N. , Dapueto, Juan , Dew, Mary Amanda , Fluck, Richard , Germain, Michael J. , Jassal, Sarbjit V. , Obrador, Gregorio , O’Donoghue, Donal , Viecelli, Andrea K. , Strippoli, Giovanni , Ruospo, Marinella , Timofte, Delia , Sharma, Ankit , Au, Eric , Howell, Martin , Costa, Daniel S.J. , Anumudu, Samaya , Craig, Jonathan C. , Rutherford, Claudia

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 [SONGHD 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. © 2020 by the American Society of Nephrology.