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

Matthias Rose; Felix H Fischer; Gregor Liegl; Giovanni F M Strippoli; Carina Hockham; Robin W M Vernooij; Claudia Barth; Bernard Canaud; Adrian Covic; Krister Cromm; Andrea M Cucui; Andrew Davenport; Kathrin I Fischer; Jörgen Hegbrant; Hanna Jaha; Anna Schappert; Marietta Török; Mark Woodward; Michiel L Bots; Peter J Blankestijn; CONVINCE Scientific Committee and CONVINCE Investigators

doi:10.1016/j.kint.2024.07.014

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

Kidney Int. 2024 Nov;106(5):961-971. doi: 10.1016/j.kint.2024.07.014. Epub 2024 Jul 30.

Authors

Matthias Rose¹, Felix H Fischer², Gregor Liegl³, Giovanni F M Strippoli⁴, Carina Hockham⁵, Robin W M Vernooij⁶, Claudia Barth⁷, Bernard Canaud⁸, Adrian Covic⁹, Krister Cromm¹⁰, Andrea M Cucui¹¹, Andrew Davenport¹², Kathrin I Fischer³, Jörgen Hegbrant¹³, Hanna Jaha³, Anna Schappert¹, Marietta Török¹⁴, Mark Woodward¹⁵, Michiel L Bots¹⁶, Peter J Blankestijn¹⁷; CONVINCE Scientific Committee and CONVINCE Investigators

Affiliations

¹ Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany; German Center for Mental Health (DZPG), Berlin, Germany.
² Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany; German Center for Mental Health (DZPG), Berlin, Germany. Electronic address: felix.fischer@charite.de.
³ Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany.
⁴ Department of Precision and Regenerative Medicine and Ionian Area (DIMEPRE-J), University of Bari, Bari, Italy; School of Public Health, University of Sydney, Sydney, Australia.
⁵ The George Institute for Global Health, School of Public Health, Imperial College London, London, UK.
⁶ Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
⁷ B. Braun Avitum AG, Medical Scientific Affairs, Melsungen, Germany.
⁸ Montpellier University, School of Medicine, Montpellier, France.
⁹ Department of Nephrology, University of Medicine "Grigore T. Popa", Iasi, Romania; Fresenius Nephrocare, Iasi, Romania.
¹⁰ Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany; Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg, Germany.
¹¹ Fresenius Nephrocare Dialysis Center, Bucharest, Romania.
¹² Department of Renal Medicine, Royal Free Hospital, Division of Medicine, University College London, London, UK.
¹³ Division of Nephrology, Department of Clinical Sciences, Lund University, Lund, Sweden.
¹⁴ Corporate Medical Office Diaverum, Malmö, Sweden.
¹⁵ School of Public Health, University of Sydney, Sydney, Australia; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
¹⁶ Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
¹⁷ Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.

PMID: 39089577
DOI: 10.1016/j.kint.2024.07.014

Abstract

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.

Keywords: health-related quality of life; hemodiafiltration; hemodialysis; patient-reported outcomes; quality of life; randomized controlled trial.

Publication types

Randomized Controlled Trial
Multicenter Study

MeSH terms

Aged
Cognition*
Female
Hemodiafiltration* / adverse effects
Hemodiafiltration* / methods
Humans
Male
Middle Aged
Patient Reported Outcome Measures
Quality of Life*
Renal Insufficiency, Chronic* / physiopathology
Renal Insufficiency, Chronic* / psychology
Renal Insufficiency, Chronic* / therapy
Social Participation
Treatment Outcome