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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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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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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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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.

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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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Resumen de las Guías de práctica clínica KDIGO sobre el cuidado del receptor de trasplante renal

2011 , Kasiske, Bertram L. , Zeier, Martin G. , Chapman, Jeremy R. , Craig, Jonathan C. , Ekberg, Henrik , Garvey, Catherine A. , Green, Michael D. , Jha, Vivekanand , Josephson, Michelle A. , Kiberd, Bryce A. , Kreis, Henri A. , McDonald, Ruth A. , Newmann, John M. , Obrador, Gregorio , Vincenti, Flavio G. , Cheung, Michael , Earley, Amy , Raman, Gowri , Abariga, Samuel , Wagner, Martin , Balk, Ethan M.

La guía de práctica clínica 2009 Enfermedad Renal: Mejorando los Resultados Globales (KDIGO, por sus siglas en inglés) sobre el control, manejo y tratamiento de receptores de un trasplante renal, está destinada a ayudar al cuidado médico de adultos y niños después de un trasplante renal. El proceso de desarrollo de la guía se ha hecho con un enfoque basado en la evidencia y las recomendaciones sobre manejo se fundamentan en revisiones sistemáticas de ensayos clínicos relevantes sobre el tratamiento. La valoración crítica de la calidad de la evidencia y la fuerza de las recomendaciones se basan en los Grados de Recomendación, Valoración, Desarrollo y Evaluación (GRADE, por sus siglas en inglés). La guía ofrece recomendaciones para la inmunosupresión y el monitoreo del injerto, así como para la prevención y el tratamiento de infecciones, enfermedades cardiovasculares, neoplasias y otras complicaciones frecuentes en el receptor de un trasplante renal, como los trastornos hematológicos y óseos. Se discuten las limitaciones de la evidencia, especialmente debidas a la falta de resultados definitivos en ensayos clínicos, y se proporcionan sugerencias para futuras investigaciones. Este resumen contiene una breve descripción de la metodología y de las recomendaciones completas de las guías, pero no contiene la justificación y las referencias de cada recomendación, las cuales han sido publicadas en otra revista. ©Revista de nefrología, diálisis y transplante, Sociedad Argentina de Nefrología Argentina.

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KDIGO clinical practice guideline for the care of kidney transplant recipients: a summary

2010 , Kasiske, Bertram L. , Zeier, Martin G. , Chapman, Jeremy R. , Craig, Jonathan C. , Ekberg, Henrik , Garvey, Catherine A. , Green, Michael D. , Jha, Vivekanand , Josephson, Michelle A. , Kiberd, Bryce A. , Kreis, Henri A. , McDonald, Ruth A. , Newmann, John M. , Obrador, Gregorio , Vincenti, Flavio G. , Cheung, Michael , Earley, Amy , Raman, Gowri , Abariga, Samuel , Wagner, Martin , Balk, Ethan M.

The 2009 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline on the monitoring, management, and treatment of kidney transplant recipients is intended to assist the practitioner caring for adults and children after kidney transplantation. The guideline development process followed an evidence-based approach, and management recommendations are based on systematic reviews of relevant treatment trials. Critical appraisal of the quality of the evidence and the strength of recommendations followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. The guideline makes recommendations for immunosuppression and graft monitoring, as well as prevention and treatment of infection, cardiovascular disease, malignancy, and other complications that are common in kidney transplant recipients, including hematological and bone disorders. Limitations of the evidence, especially the lack of definitive clinical outcome trials, are discussed and suggestions are provided for future research. This summary includes a brief description of methodology and the complete guideline recommendations but does not include the rationale and references for each recommendation, which are published elsewhere. © Kidney International

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A survey on the methodological processes and policies of renal guideline groups as a first step to harmonize renal guidelines

2014 , Haller, Maria C. , Veer, Sabine N. van der , Nagler, Evi V. , Tomson, Charlie , Lewington, Andrew , Hemmelgarn, Brenda R. , Gallagher, Martin , Rocco, Michael , Obrador, Gregorio , Vanholder, Raymond , Craig, Jonathan C. , Biesen, Wim van

Background: Worldwide, several bodies produce renal guidelines, potentially leading to duplication of effort while other topics may remain uncovered. A collaborative work plan could improve efficiency and impact, but requires a common approved methodology. The aim of this study was to identify organizational and methodological similarities and differences among seven major renal guideline bodies to identify methodological barriers to a collaborative effort. Methods: An electronic 62-item survey with questions based on the Institute of Medicine standards for guidelines was completed by representatives of seven major organizations producing renal guidelines: the Canadian Society of Nephrology (CSN), European Renal Best Practice (ERBP), Kidney Disease Improving Global Outcome (KDIGO), Kidney Health Australia-Caring for Australians with Renal Insufficiency (KHA-CARI), Kidney Disease Outcome Quality Initiative (KDOQI), Sociedad Latino-Americano de Nefrologia e Hipertension (SLANH) and United Kingdom Renal Association (UK-RA). © Nephrology Dialysis Transplantation