The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration.

In the CONVINCE trial, the primary analysis demonstrated a survival benefit for patients receiving high-dose hemodiafiltration (HDF) as compared with high-flux hemodialysis (HD). A secondary objective was to evaluate effects on health-related quality of life (HRQoL); assessed in eight domains (physical function, cognitive function, fatigue, sleep disturbance, anxiety, depression, pain interference, social participation) applying instruments from the Patient-Reported Outcome Measurement Information System (PROMIS) before randomization and every three months thereafter. In total 1360 adults with dialysis-dependent chronic kidney disease, eligible to receive high-flux HDF (23 liters or more), were randomized (1:1); 84% response rate to all questionnaires. Both groups reported a continuous deterioration in all HRQoL domains. Overall, raw score changes from baseline were more favorable in the HDF group, resulting in a significant omnibus test after a median observation period of 30 months. Most relevant single raw score differences were reported for cognitive function. Patients receiving HDF reported a decline of -0.95 units (95% confidence interval - 2.23 to +0.34) whereas HD treated patients declined by -3.90 units (-5.28 to - 2.52). A joint model, adjusted for mortality differences, utilizing all quarterly assessments, identified a significantly slower HRQoL decline in physical function, cognitive function, pain interference, and social participation for the HDF group. Their physical health summary score declined -0.46 units/year slower compared to the HD group. Thus, the CONVINCE trial showed a beneficial effect of high-dose hemodiafiltration for survival as well as a moderate positive effect on patients' quality of life, most pronounced with respect to their cognitive function. REGISTRATION: NTR7138 on the International Clinical Trials Registry Platform.

Psychosocial Determinants for Self-Reported Health Status in Hemodialysis Patients: A Cohort Analysis of the CONVINCE Randomized Trial.

BACKGROUND: We investigated whether psychosocial determinants self-efficacy and social support are associated with Health-Related Quality of Life in hemodialysis patients enrolled in the CONVINCE trial. METHODS: We used baseline data from the cohort of patients involved in the CONVINCE randomized trial of hemodiafiltration versus hemodialysis. Measures included age, gender, relationship status, children, housing, education, employment, comorbidities, dialysis schedules, time of first dialysis, residual kidney function, general self-efficacy and social support scores, and PROMIS measurements for health-related quality of life. Associations were analyzed using hierarchical regression. RESULTS: One thousand three hundred and sixty patients from CONVINCE were the cohort of interest. Mean age was 62±13.5 years (range 20-92), and 66.9% were men. Self-efficacy was a significant predictor for all health-related quality of life domains: depression (ß = -0.36, p < 0.001), anxiety (ß = -0.35, p < 0.001), social participation (ß = 0.32, p < 0.001), cognition (ß = 0.29, p < 0.001), fatigue (ß = -0.29, p < 0.001), physical function (ß = 0.27, p < 0.001), sleep disturbance (ß = -0.23, p < 0.001), pain interference (ß = 0.21, p < 0.001), pain intensity (ß = -0.17, p < 0.001), interdialytic symptoms (ß = -0.14, p = 0.002) and intradialytic symptoms (ß = -0.14, p = 0.002). Social support was a significant predictor for cognition (ß = 0.21, p < 0.001), sleep disturbance (ß = -0.11, p = 0.017) and intradialytic symptoms (ß =- 0.11, p = 0.02). CONCLUSIONS: Higher general self-efficacy scale scores are associated with improvements in cognition, depression, anxiety, social participation, fatigue, physical function, sleep disturbance, pain interference, interdialytic symptoms, pain intensity and intradialytic symptoms. Associations for self-efficacy are larger than those for social support and stronger than previously reported. It is plausible that targeted psychosocial interventions may improve health outcomes in people on hemodialysis.