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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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Identifying dimensions of fatigue in haemodialysis important to patients, caregivers and health professionals: An international survey

2019 , Ju, Angela , Unruh, Mark , Davison, Sara N. , Dapueto, Juan , Dew, Mary A. , Fluck, Richard , Germain, Michael , Jassal, Sarbjit V. , Obrador, Gregorio , O'Donoghue, Donal J. , Howell, Martin , O'Lone, Emma , Shen, Jenny I. , Craig, Jonathan C. , Tong, Allison

Background: Patient-reported outcome measures of fatigue used in research in haemodialysis vary widely in the dimensions assessed; and the importance of these dimensions to patients and health professionals is unknown. This study aimed to identify the most important dimensions of fatigue to assess in patients on haemodialysis participating in trials. Methods: In an international survey, patients/caregivers and health professionals rated the absolute and relative importance of content and measurement dimensions to include in a core outcome measure of fatigue. A 9-point Likert scale (7-9 indicating critical importance) was used to assess absolute importance and best-worst scale was used to assess importance of each dimension compared to others. © 2019 Asian Pacific Society of Nephrology.

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The ASCEND-NHQ randomized trial found positive effects of daprodustat on hemoglobin and quality of life in patients with non-dialysis chronic kidney disease

2023 , Johansen, Kirsten L. , Cobitz, Alexander R. , Singh, Ajay K. , Macdougall, Iain C. , Lopes, Renato D. , Obrador, Gregorio , Kovesdy, Csaba P. , Israni, Rubeen , Jha, Vivekanand , Okoro, Tony , Sprys, Mike , Jolly, Shivinder , Lindsay, Alistair C. , Bhatt, Purav , Refoios Camejo, Rodrigo , Keeley, Tom , Cizman, Borut , Wheeler, David C.

The ASCEND-NHQ trial evaluated the effects of daprodustat on hemoglobin and the Medical Outcomes Study 36-item Short Form Survey (SF-36) Vitality score (fatigue) in a multicenter, randomized, double-blind, placebo-controlled trial. Adults with chronic kidney disease (CKD) stages 3-5, hemoglobin 8.5-10.0 g/dl, transferrin saturation 15% or more, and ferritin 50 ng/ml or more without recent erythropoiesis-stimulating agent use were randomized (1:1) to oral daprodustat or placebo to achieve and maintain target hemoglobin of 11-12 g/dl over 28 weeks. The primary endpoint was the mean change in hemoglobin between baseline and the evaluation period (Weeks 24-28). Principal secondary endpoints were proportion of participants with a 1 g/dl or more increase in hemoglobin and mean change in the Vitality score between baseline and Week 28. Outcome superiority was tested (1-sided alpha level of 0.025). Overall, 614 participants with non-dialysis-dependent CKD were randomized. The adjusted mean change in hemoglobin from baseline to the evaluation period was greater with daprodustat (1.58 vs 0.19 g/dl). The adjusted mean treatment difference (AMD) was significant at 1.40 g/dl (95% confidence interval 1.23, 1.56). A significantly greater proportion of participants receiving daprodustat showed a 1 g/dl or greater increase in hemoglobin from baseline (77% vs 18%). The mean SF-36 Vitality score increased by 7.3 and 1.9 points with daprodustat and placebo, respectively; a clinically and statistically significant 5.4 point Week 28 AMD increase. Adverse event rates were similar (69% vs 71%); relative risk 0.98, (95% confidence interval 0.88, 1.09). Thus, in participants with CKD stages 3-5, daprodustat resulted in a significant increase in hemoglobin and improvement in fatigue without an increase in the overall frequency of adverse events. Copyright © 2023 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

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Management of Anemia in Nondialysis Chronic Kidney Disease: Current Recommendations, Real-World Practice, and Patient Perspectives

2020 , Guedes, Murilo , Robinson, Bruce M. , Obrador, Gregorio , Tong, Allison , Pisoni, Ronald L. , Pecoits-Filho, Roberto

In nondialysis CKD (ND-CKD), anemia is a multifactorial and complex condition in which several dysfunctions dynamically contribute to a reduction in circulating hemoglobin (Hb) levels in red blood cells. Anemia is common in CKD and represents an important and modifiable risk factor for poor clinical outcomes. Importantly, symptoms related to anemia, including reduced physical functioning and fatigue, have been identified as high priorities by patients with CKD. The current management of anemia in ND-CKD (i.e., parameters to initiate treatment, Hb and iron indexes targets, choice of therapies, and effect of treatment on clinical and patient-reported outcomes) remains controversial. In this review article, we explore the epidemiology of anemia in ND-CKD and revise current recommendations and controversies in its management. Exploring data from real-world clinical practices, particularly from the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps), we highlight the current challenges to translating current recommendations to clinical practice, providing patients' perspectives of anemia and how it affects their quality of life. Finally, we summarize recent advances in the field of anemia that may change the way this condition will be managed in the future. Copyright © 2020 by the American Society of Nephrology.

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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.