Susanne Ljungman1, Jørgen E Jensen2, Dag Paulsen3, Aivars Petersons4, Mai Ots-Rosenberg5, Heikki Saha6, Dirk G Struijk7, Martin Wilkie8, Olof Heimbürger9, Bernd Stegmayr10, Thomas Elung-Jensen11, Ann-Cathrine Johansson12, Margareta Rydström13, Helga Gudmundsdottir14, Max Petzold15. 1. Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden. 2. Department of Nephrology, Odense University Hospital, Denmark. 3. Department of Medicine, Innlandet Hospital HF, Lillehammer, Norway. 4. Nephrology Center, Department of Medicine, P. Stradins Clinical University Hospital, Riga, Latvia. 5. Department of Internal Medicine, University Hospital of Tartu, Estonia. 6. Department of Internal Medicine, Tampere University Hospital, Finland. 7. Medisch Centrum, University of Amsterdam, the Netherlands. 8. Renal Unit, Department of Nephrology, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, UK. 9. Patient Area Endocrinology and Nephrology, Karolinska University Hospital and Department of Clinical Science, Intervention, and Technology, Karolinska Institute, Stockholm, Sweden. 10. Department of Nephrology, Public Health, and Clinical Medicine, Umeå University, Sweden. 11. Department of Nephrology, Rigshospitalet University Hospital, Copenhagen, Denmark. 12. Department of Nephrology, Skane University Hospital, Malmö, Sweden. 13. Department of Nephrology, Skaraborg Hospital, Skövde, Sweden. 14. Department of Nephrology, Oslo University Hospital Ullevål, Norway. 15. Health Metrics Unit, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
Abstract
BACKGROUND: Peritonitis is more common in peritoneal dialysis (PD) patients nonadherent to the PD exchange protocol procedures than in compliant patients. We therefore investigated whether regular testing of PD knowledge with focus on infection prophylaxis could increase the time to first peritonitis (primary outcome) and reduce the peritonitis rate in new PD patients. METHODS: This physician-initiated, open-label, parallel group trial took place at 57 centers in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom from 2010 to 2015. New peritonitis-free PD patients were randomized using computer-generated numbers 1 month after the start of PD either to a control group (n = 331) treated according to center routines or to a retraining group (n = 340), which underwent testing of PD knowledge and skills at 1, 3, 6, 12, 18, 24, 30, and 36 months after PD start, followed by retraining if the goals were not achieved. RESULTS: In all, 74% of the controls and 80% of the retraining patients discontinued the study. The groups did not differ significantly regarding cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death; hazard ratio 0.84; 95% confidence interval (CI) 0.65-1.09) nor regarding peritonitis rate per patient year (relative risk 0.93; 95% CI 0.75-1.16). CONCLUSIONS: In this randomized controlled trial, we were unable to demonstrate that regular, targeted testing and retraining of new PD patients increased the time to first peritonitis or reduced the rate of peritonitis, as the study comprised patients with a low risk of peritonitis, was underpowered, open to type 1 statistical error, and contamination between groups.
RCT Entities:
BACKGROUND:Peritonitis is more common in peritoneal dialysis (PD) patients nonadherent to the PD exchange protocol procedures than in compliant patients. We therefore investigated whether regular testing of PD knowledge with focus on infection prophylaxis could increase the time to first peritonitis (primary outcome) and reduce the peritonitis rate in new PD patients. METHODS: This physician-initiated, open-label, parallel group trial took place at 57 centers in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom from 2010 to 2015. New peritonitis-free PD patients were randomized using computer-generated numbers 1 month after the start of PD either to a control group (n = 331) treated according to center routines or to a retraining group (n = 340), which underwent testing of PD knowledge and skills at 1, 3, 6, 12, 18, 24, 30, and 36 months after PD start, followed by retraining if the goals were not achieved. RESULTS: In all, 74% of the controls and 80% of the retraining patients discontinued the study. The groups did not differ significantly regarding cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death; hazard ratio 0.84; 95% confidence interval (CI) 0.65-1.09) nor regarding peritonitis rate per patient year (relative risk 0.93; 95% CI 0.75-1.16). CONCLUSIONS: In this randomized controlled trial, we were unable to demonstrate that regular, targeted testing and retraining of new PD patients increased the time to first peritonitis or reduced the rate of peritonitis, as the study comprised patients with a low risk of peritonitis, was underpowered, open to type 1 statistical error, and contamination between groups.