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

Background: 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. Objectives: To validate a core patient-reported outcome measure (PROM) for fatigue in hemodialysis. Design: A longitudinal cohort study was conducted to assess the validity and reliability of a new fatigue measure (SONG-HD Fatigue).Eligible and consenting patients completed the measure at three time points: baseline, a week later and twelve days following the second time point. Cronbach’s α and Intraclass correlation coefficient were calculated to assess internal consistency and Spearman’s rho was used to assess convergent validity. Confirmatory factor analysis was also conducted.Setting: Hemodialysis units in the United Kingdom, Australia and Romania participated in this study.Participants: Adult patients aged 18 years and over, English-Speaking, and receiving maintenance hemodialysis were eligible to participate.Measurements: SONG-HD Fatigue, visual analogue scale for fatigue, 12-Item Short Form survey, 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 the SONG-HD Fatigue is internally consistent (Cronbach’s α =0.81- 0.86) and stable over a one-week period (Intraclass correlation coefficient =0.68-74). The measure demonstrated convergence with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and had moderate correlations with other measures that assessed related but not the same concept (12-Item Short Form Survey and Visual Analogue Scale). Confirmatory factor analysis supported the one-factor model. Conclusions: The SONG-HD Fatigue appears to be a reliable and valid measure to be used in trials involving patients receiving hemodialysis. </div

Diabetes Management in Chronic Kidney Disease: Synopsis of the KDIGO 2022 Clinical Practice Guideline Update.

Description: The KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease is an update of the 2020 guideline from Kidney Disease: Improving Global Outcomes (KDIGO). Methods: The KDIGO Work Group updated the guideline, which included reviewing and grading new evidence that was identified and summarized. As in the previous guideline, the Work Group used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to appraise evidence and rate the strength of recommendations and expert judgment to develop consensus practice points. New evidence led to updating of recommendations in the chapters Comprehensive Care in Patients With Diabetes and CKD (Chapter 1) and Glucose-Lowering Therapies in Patients With T2D and CKD (Chapter 4). New evidence did not change recommendations in the chapters Glycemic Monitoring and Targets in Patients With Diabetes and CKD (Chapter 2), Lifestyle Interventions in Patients With Diabetes and CKD (Chapter 3), and Approaches to Management of Patients With Diabetes and CKD (Chapter 5). Recommendations: The updated guideline includes 13 recommendations and 52 practice points for clinicians caring for patients with diabetes and chronic kidney disease (CKD). A focus on preserving kidney function and maintaining well-being is recommended using a layered approach to care, starting with a foundation of lifestyle interventions, self-management, and first-line pharmacotherapy (such as sodium–glucose cotransporter-2 inhibitors) demonstrated to improve clinical outcomes. To this are added additional drugs with heart and kidney protection, such as glucagon-like peptide-1 receptor agonists and nonsteroidal mineralocorticoid receptor antagonists, and interventions to control risk factors for CKD progression and cardiovascular events, such as blood pressure, glycemia, and lipids. In light of the emergence of new high-quality evidence, the KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (1) update follows only 2 years after the original 2020 guideline (2). The overall scope and systematic literature search for the update were unchanged from the original guideline and addressed both type 1 diabetes (T1D) and type 2 diabetes (T2D), all stages of chronic kidney disease (CKD), and patients who had a kidney transplant or those treated with hemodialysis or peritoneal dialysis (2). High-quality evidence on patient care, specifically from randomized controlled trials, was evaluated. This led to revision of recommendations on what constitutes comprehensive care, use of sodium–glucose cotransporter-2 (SGLT2) inhibitors, and use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), as well as the introduction of a new section on use of mineralocorticoid receptor antagonists (MRAs).</p

A Core Outcome Set for Trials in Glomerular Disease

Background and objectives Outcomes reported in trials in adults with glomerular disease are often selected with minimal patient input, are heterogeneous, and may not be relevant for clinical decision making. The Standardized Outcomes in Nephrology–Glomerular Disease (SONG-GD) initiative aimed to establish a core outcome set to help ensure that outcomes of critical importance to patients, care partners, and clinicians are consistently reported.Design, setting, participants, and measurements We convened two 1.5-hour workshops in Melbourne, Australia, and Washington, DC, United States. Attendees were identified purposively with 50 patients/care partners and 88 health professionals from 19 countries; 51% were female. Patients and care partners were from the United States, Australia, and Canada, and had experience of a glomerular disease with systemic features (n=9), kidney-limited nephrotic disease (n=9), or other kidney-limited glomerular disease (n=8). Attendees reviewed the results of the SONG-GD Delphi survey and aims of the workshop and then discussed potential core outcomes and their implementation in trials among moderated breakout groups of eight to 12 people from diverse backgrounds. Transcripts of discussions were analyzed thematically.Results Three themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance (i.e., applicable across diverse populations and settings). The fourth theme, preparedness for implementation, included engaging with funders and regulators, establishing reliable and validated measures, and leveraging existing endorsements for patient-reported outcomes.Conclusions Workshop themes demonstrated support for kidney function, disease activity, death, life participation, and cardiovascular disease, and these were established as the core outcomes for trials in adults with glomerular disease. Future work is needed to establish the core measures for each domain, with funders and regulators central to the uptake of the core outcome set in trials.</div