In this study, we identified a high prevalence of self-reported fatigue at 72.1% and important stress at 39.3% for CKD patients treated with hemodialysis. To our knowledge, this study was the first of its kind conducted in France with questionnaires filled at the healthcare facility via a tablet on describing the use of ePROMs.
Fatigue was the most prevalent symptom identified in our study, in comparison to the other symptoms assessed. The prevalence of 72.1% of patients was consistent with the range of previous published literature, which presented a figure from 60–97%. These results were additionally similar to the weighted mean prevalence of 71% estimated in a systematic review [17, 18]. These results did not differ between centers even though patient characteristics and comorbidities differed.
Items collected from a patient were with a simple binary question and visual analog scale instead of a dedicated measure and thus may not have reflected the specificity of fatigue from patients under hemodialysis. Such specific questionnaire was not available at the time of protocol definition and therefore a generic questionnaire was used. In future studies, items may be collected via the recently published measure SONG-HD questionnaire specifically designed for patients treated with hemodialysis . This innovative tool designed through an international study included several components of fatigue including tiredness, lack of energy and inability to participate in social situations . This tool, however, did not distinguish between interdialytic fatigue and post-dialysis fatigue .
In our study, the post-dialysis fatigue through the after-session delay recovery time in hours was chosen to be assessed as expressed by the patient. The recovery time inferior to 6 hours found in the study for 75.1% of patients were similar compared to an international study where 73% of patients declared the same timing, as well as a recovery time of more than 12 hours declared by 11.6% of patients from our study compared to 10% in the international DOPPS study . Increased fatigue and higher levels of perceived stress were associated in the multivariate analysis indicating the potential interrelation between these two symptoms.
The stress assessment through the perceived stress score seemed to be more informative than the visual analog scale (VAS) to assess its intensity as it allowed to better discriminate patient groups with different stress levels. The two scales are different as the VAS describe the stress at the time of the questionnaire while the PSS includes the stress felt in the past week. Additionally, the analog scale may reflect the stress level more at the time of the questionnaire while the PSS findings may reflect the stress tendency over the past weeks more and thus may be a better estimation of the patient stress level at home.
On the other hand, results on sleep quality were different to those reported in the literature. While we found only 14.5% of patients with reported altered sleep, sleep disturbance was reported at weighted mean prevalence of 44% with a range of 20–83% [12, 23, 24] in various countries. The observed difference may be due to the questionnaire used to assess the sleep quality in our study. The questionnaire in our study focused on the sleep quality the night before the dialysis session in comparison to the previous nights, to assess the potential impact of pre-dialysis anxiety on sleep quality. Additionally, these results may be in favor of a limited impact of the dialysis on sleep quality. The difference in results compared with literature is thus explained as those results concerning the disturbance in overall sleep quality for patients treated by hemodialysis in comparison to their situation before the dialysis initiation .
The main strengths of this study relied on the cross-sectional and multicenter design from various HD center settings and the use of simple questionnaires to collect data from patients through a tablet directly at patient side. The collection of data from patients during a consultation or HD session through a tablet device also allowed to not have missing data that could have weaken the interpretation of the results. On the other hand, the answers provided by patients may as well have been influenced by the settings in which they were to reply.
Despite significant differences in patient characteristics from the three centers including age, comorbidities or type of dialysis, no differences were found on the prevalence of the various PROMs, in favor of internally coherent results. The study population was not matching with the population profile of the French Renal Epidemiology and Information Network (REIN) [26, 27, 26] and consequently, in terms of comorbidities, coronary artery disease, congestive heart failure and cancer comorbidities the prevalence were higher in our study population. Contrarily, prevalence of diabetes and cerebrovascular disease were lower compared to REIN. This difference may lead to a selection bias and therefore our results may not be applicable to all hemodialysis patients in France. The 3 centers in our study have different characteristics, and no statistical differences were observed between centres for the three e-PROMS.
The main limitations of this study included the observational design, limited number of patients included, and the absence of linkage of PROMs with clinical outcomes such as cardiovascular events, hospitalizations or mortality. However, the objective was to describe the symptoms of patients and not to explain these symptoms with their clinical situation or outcomes.
Nonetheless, meta-analysis of oncology trials identified baseline fatigue as an independent prognostic factor for overall survival above performance status and quality of life in oncology patients, recommending collecting this information in routine oncology care for patient stratification . Due to the clinical impact of fatigue on daily QoL of patients undergoing hemodialysis, it may be however relevant to consider the presence of reported fatigue in such patients to be a clinically relevant item to consider as itself, despite the need for further research in this area . Additionally, recent studies identified an association between fatigue and all-cause mortality in those patients as well as between frailty and worse health related QoL [22, 31, 32].
To improve daily routine care of CKD patients treated with HD, the collection and integration of ePROMs into the care plan could be promoted in a standardized approach. Such efforts are currently being conducted in various countries or regions such as in Ontario, Canada with the Edmonton Symptom Assessment System Revised for routine PROMs collection in hemodialysis routine care and should be encouraged as well in France33. In this regard, the French Society of Nephrology, Dialysis and Transplant (SFNDT) published in 2020 a new guideline recommending the use of EuroQol 5D and 12-Item Short Form Health Survey for outcome measures and e-Satis national public system for measuring patient satisfaction [34, 35].
Dedicated software linking patient registries in hemodialysis, collection of ePROMs for remote patient monitoring and measures of patient satisfaction may thus be used to ease and improve routine care as well as clinical and epidemiological research36.