Dataset Information

DIALysis or not: Outcomes in older kidney patients with GerIatriC Assessment (DIALOGICA): rationale and design.

ABSTRACT:

Background

The incidence and prevalence of older patients with kidney failure who are dependent on dialysis is increasing. However, observational studies showed limited or no benefit of dialysis on mortality in subgroups of these patients when compared to conservative care. As the focus is shifting towards health-related quality of life (HRQoL), current evidence of effects of conservative care or dialysis on HRQoL in older patients is both limited and biased. Dialysis comes with both high treatment burden for patients and high costs for society; better identification of patients who might not benefit from dialysis could result in significant cost savings. The aim of this prospective study is to compare HRQoL, clinical outcomes, and costs between conservative care and dialysis in older patients.

Methods

The DIALysis or not: Outcomes in older kidney patients with GerIatriC Assessment (DIALOGICA) study is a prospective, observational cohort study that started in February 2020. It aims to include 1500 patients from 25 Dutch and Belgian centres. Patients aged ≥70 years with an eGFR of 10-15 mL/min/1.73m² are enrolled in the first stage of the study. When dialysis is initiated or eGFR drops to 10 mL/min/1.73m² or lower, the second stage of the study commences. In both stages nephrogeriatric assessments will be performed annually, consisting of questionnaires and tests to assess most common geriatric domains, i.e. functional, psychological, somatic, and social status. The primary outcome is HRQoL, measured with the Twelve-item Short-Form Health Survey. Secondary outcomes are clinical outcomes (mortality, hospitalisation, functional status, cognitive functioning, frailty), cost-effectiveness, and decisional regret. All outcomes are (repeated) measures during the first year of the second stage. The total follow-up will be a maximum of 4 years with a minimum of 1 year in the second stage.

Discussion

By generating more insight in the effects of conservative care and dialysis on HRQoL, clinical outcomes, and costs, findings of this study will help patients and physicians make a shared decision on the best individual treatment option for kidney failure.

Trial registration

The study was registered in the Netherlands Trial Register ( NL-8352 ) on 5 February 2020.

SUBMITTER: van Oevelen M

PROVIDER: S-EPMC7825220 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Maximal conservative management (MCM) may be an appropriate alternative option for dialysis in some elderly patients with end-stage kidney disease (ESKD). Evidence about the impact of dialysis or MCM on quality of life (QoL) in older patients is sparse. In the GOLD (Geriatric assessment in OLder patients starting Dialysis) Study the trajectory of QoL was assessed in patients starting dialysis or MCM. METHODS:Patients ≥65 years old were included just prior to dialysis initiation or after decision for MCM. Baseline data included demographics, frailty as measured with a geriatric assessment, comorbidity (CIRS-G) and QoL, measured with the EQ-5D-3 L (EQ-5D Index and overall self-rated health). Six months follow-up data included QoL, hospitalizations and mortality. Change of QoL was assed with paired t-tests. Cox-regression was used to assess survival of MCM and dialysis patients. RESULTS:The cohort comprised 192 dialysis and 89 MCM patients. The MCM patients were older (mean age 82 ± 6 vs. 75 ± 7 years, p < 0.01) and mean kidney function was better (eGFR 11.5 ± 4.0 vs. 8.0 ± 2.9 ml/min/1.73m2, p < 0.01). Baseline QoL did not differ significantly between the groups. After six months, EQ-5D Index did not improve significantly in the dialysis group with mean ± standard error (SE) 0.026 ± 0.014 (p = 0.10; not clinically relevant), but a small but clinically relevant decline was seen in the conservative group: 0.047 ± 0.022 (p < 0.01; between group difference p < 0.01). Hospitalization occurred in 50% of dialysis patients vs. 24% of conservative patients (p < 0.01). In patients over 80 years old, no survival benefit could be found for dialysis patients starting dialysis vs. MCM. CONCLUSION:A small decline of QoL was found for conservative patients, while QoL did not change in dialysis patients. However, hospitalization rate was higher in patients starting dialysis. In patients over 80 years, no survival benefit was found.