Fatigue is one of the most common symptoms reported by patients on dialysis, but there is little data to guide clinicians about how to manage it. A new initiative aims to change that by helping researchers routinely and consistently measure fatigue in their studies of dialysis-related care.
The Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) project was created to establish a standard set of measures that should be used in all studies enrolling patients receiving dialysis. Having such a standard set of measures used across clinical trials makes it easier to compare the results of different studies, explained Angela Ju, BSc, of the University of Sydney in Australia. To identify which measures were most important to patients and clinicians, SONG-HD did a rigorous, three-round online survey of patients and clinicians.
“Fatigue was the top patient-reported outcome that health professionals and patients both picked,” said Ju, who is the project coordinator of the SONG-HD fatigue project. So, Ju and her colleagues began assessing how fatigue is currently measured in clinical trials, with the hope of identifying an existing questionnaire they could recommend for use across trials. Their results were published in a review that found many different measures were being used ranging from 20 questions to only 4 questions, Ju noted. Some questions ask only about physical fatigue while other questions address other dimensions of fatigue, for example, how it affects mental capacity.
“There’s a whole lot out there, but it became clear that it wasn’t really standardized,” Ju said.
Shared values
To assess what is most important to patients and other stakeholders when measuring fatigue, Mark Unruh, MD, professor of medicine at the University of New Mexico and chair of the SONG-HD fatigue project, led a workshop in Chicago in November 2016. The workshop brought together 15 patients or caregivers and 42 other stakeholders, including clinicians, researchers, policymakers, and industry representatives.
The participants confirmed that fatigue is seen as a key measure that should be measured consistently across studies.
“The patients and stakeholders felt that fatigue was important enough to include as a measure in basically every trial looking at dialysis outcomes,” Unruh said.
For patients, the most important aspect of dialysis-related fatigue was how it affected their day-to-day life. One patient participant said: “When I got off [dialysis] I was wasted. I couldn’t do anything. It was hard to walk a block to get to my car.”
In discussions with patients, Ju learned that such crippling fatigue was manageable if patients could go home and sleep, but it becomes a serious problem when it prevents patients from completing essential tasks like working or picking up their children from school or activities. “That’s when it becomes important,” Ju said.
The workshop also provided valuable insights regarding how patients and physicians feel about talking about fatigue during visits.
Some patients expressed concern about wasting their physician’s time by asking about their fatigue, Ju said. One patient she spoke with told Ju that she and her fellow patients often discuss symptoms like fatigue in the waiting room rather than talking with their physician.
Patients also suggested physicians place more “emphasis on how the patient is feeling, less on what the doctor thinks,” by asking the patient their views on how to best manage fatigue. But clinicians noted they were worried about burdening patients with repetitive questions.
“They don’t want to tire them out by asking them the same questions all the time,” Ju said.
Researchers on the project also expressed a need for short, meaningful questionnaires that can fit into the workload of research teams.
A better measure
The workshop and surveys by the SONG-HD team revealed three key dimensions of fatigue that should be measured: fatigue’s impact on the patient’s life, patient’s energy level, and their degree of tiredness. None of the existing measures Ju and her colleagues identified in her review looked at all three of these dimensions.
“There wasn’t one measure that maps out these dimensions that we could just take and validate,” Ju said.
So, they created a short questionnaire of their own that addresses these three dimensions, and they have already begun the process of validating it.
Once that process is complete, Unruh said he hopes this new measure will become a tool that is used routinely in studies in the same way that estimated glomerular filtration rate is used as a routine measure of kidney function. This will allow researchers to track how the treatments they are studying affect fatigue, even if reducing fatigue is not the primary goal of the treatment being studied, Unruh explained.
“We all kind of know what fatigue is, but being able to measure it and reproduce it is what has been missing because everybody kind of chooses their own fatigue questionnaire,” Unruh said. “Measuring fatigue in a careful way and being able to reproduce that I think would be helpful toward improving that outcome.”
Ju Angela , et al.. Patient-reported outcome measures for fatigue in patients on hemodialysis: A systematic review. Am J Kidney Dis 2018. DOI https://doi.org/10.1053/j.ajkd.2017.08.019.
