Reporting of “dialysis adequacy” as an outcome in randomised trials conducted in adults on haemodialysis

Abstract

BackgroundClinical trials are most informative for evidence-based decision-making when they consistently measure and report outcomes of relevance to stakeholders, especially patients, clinicians, and policy makers. However, sometimes terminology used is interpreted differently by different stakeholders, which might lead to confusion during shared decision making. The construct dialysis adequacy is frequently used, suggesting it is an important outcome both for health care professionals as for patients.ObjectiveTo assess the scope and consistency of the construct dialysis adequacy as reported in randomised controlled trials in hemodialysis, and evaluate whether these align to the insights and understanding of this construct by patients.MethodsTo assess scope and consistency of dialysis adequacy by professionals, we performed a systematic review searching the Cochrane Central Register of Controlled Trials (CENTRAL) up to July 2017. We identified all randomised controlled trails (RCT) including patients on hemodialysis and reporting dialysis adequacy, adequacy or adequacy of dialysis and extracted and classified all reported outcomes. To explore interpretation and meaning of the construct of adequacy by patients, we conducted 11 semi-structured interviews with HD patients using thematic analysis. Belgian registration number B670201731001.FindingsFrom the 31 included trials, we extracted and classified 98 outcome measures defined by the authors as adequacy of dialysis, of which 94 (95%) were biochemical, 3 (3%) non-biochemical surrogate and 2 (2%) patient-relevant. The three most commonly reported measures were all biochemical. None of the studies defined adequacy of dialysis as a patient relevant outcome such as survival or quality of life. Patients had a substantially different understanding of the construct dialysis adequacy than the biochemical interpretation reported in the literature. Being alive, time spent while being on dialysis, fatigue and friendliness of staff were the most prominent themes that patients linked to the construct of dialysis adequacy.ConclusionAdequacy of dialysis as reported in the literature refers to biochemical outcome measures, most of which are not related with patient relevant outcomes. For patients, adequate dialysis is a dialysis that enables them to spend as much quality time in their life as possible.

Patients’ experiences of transitioning between different renal replacement therapy modalities: A qualitative study

“…While there is a vast body of research on dialysis outcomes, 15 –19 our findings are novel in their focus on the transitioning experience when changing KRT modality. To our knowledge, this is the first study to use a truly inductive method to understand the process of transitioning between the different KRT modalities.…”

Does Adequate Hemodialysis Prevent Symptoms?: A National Cross-Sectional Survey

“…The reason is that Kt/V and URR alone are not sufficient to evaluate dialysis adequacy. Querying the well-being and quality of life of the patient is therefore extremely important in the evaluation of dialysis adequacy (Steyaert et al, 2019).…”

“…The Kt/V values of patients experiencing muscle cramps were interestingly found to be statistically significantly higher than the others in our study. An interview conducted by Steyaert et al (2019) with 11 patients revealed that only one patient described dialysis adequacy as removal of toxic products from the blood while the others thought their actual survival was due to adequate dialysis. Two patients attributed muscle cramping to high ultrafiltration and emphasized that this could be prevented by strict fluid control while good dialysis could be provided with low ultrafiltration.…”

Composite Uremic Load and Physical Performance in Hemodialysis Patients: A Cross-Sectional Study

“…The need to use patient relevant rather than biochemical surrogates as outcomes of clinical studies has recently gained a lot of attention [4,5]. Various studies aimed to identify a gold quantifier of uremic burden that is associated with hard endpoints such as Quality of Life (QoL), morbidity, and mortality [8].…”

“…By using these models, a conceptual association between composite uremic load and other outcomes can be examined. Second, several initiatives have emerged pointing to the necessity to use patient relevant rather than pure surrogate (biochemical) markers as outcomes in studies [4,5]. Survival is of course important, but it does not allow to assess the impact of alternative strategies in a short time frame.…”