On behalf of the SONG-HD (Standardized Outcomes in Nephrology-Hemodialysis) initiative, Ju and colleagues report a systematic review published in AJKD of outcome measures for fatigue in hemodialysis patients in order to find the best metrics to assess this important complication.
The authors reviewed 140 studies representing more than 24,800 participants in 18 (13%) randomized-controlled trials, 24 (17%) non-randomized trials, and 98 (70%) observational studies.
Their results suggest a great need to improve the assessment of this problem. Overall, among the 140 studies, they found 45 different measures of fatigue with substantial heterogeneity in design and validation. 24 measures (53%) were developed specifically for the hemodialysis population while 17 measures (40%) were validated in other populations and 2 measures (4%) in CKD populations. Only 21% of the measures used to report fatigue in dialysis patients were validated in prior studies.
In seeking other aspects of “fatigue”, the authors identified 3 measures in at least one-third of studies: level of energy 19 (44%), tiredness 15 (35%), and life participation 14 (33%). Further, the authors identified 4 measurement dimensions to quantify these symptoms: severity 34 (79%), frequency 10 (23%), duration 4 (9%), and change 1 (2%). No single measure assessed all dimensions. Table 2 demonstrates the breadth and variability of fatigue dimensions, and also shows how difficult this outcome is to measure.
Using the COSMIN-COMET (Consensus-Based Standards for the Selection of Health Measurement Instruments-Core Outcome Measures in Effectiveness Trials) guidelines, Ju et al found that the measures were woefully lacking in validation. Even for those measures that had been validated, none were validated on more than 3 of 8 psychometric properties.
This study highlights a growing movement toward more emphasis on the perspectives of patients and developing well-validated and reproducible patient-reported outcomes. To date, the body of literature on fatigue does not capture the patient experience for a symptom consistently rated in the top 5 patient-reported concerns, outstripping even fear of death.
The SONG-HD is an international collaborative initiative founded in 2014. Its goal is to develop a core set of rigorously validated patient-oriented outcomes for use in clinical trials with the ultimate goal of improving health and quality-of-life for patients on hemodialysis. Fatigue is an important patient-related outcome that is extremely important in dialysis patients. The authors have to be applauded in identifying the deficiencies in quantifying subjective symptoms such as fatigue in patients undergoing hemodialysis.
Title: Patient-Reported Outcome Measures for Fatigue in Patients on Hemodialysis: A Systematic Review
Authors: A. Ju, M.L. Unruh, S.N. Davison, J. Dapueto, M.A. Dew, R. Fluck, M. Germain, S.V.Jassal, G. Obrador, D. O’Donoghue, P. Tugwell, J.C. Craig, A.F. Ralph, M. Howell, and A. Tong