United Kingdom catheter study- protocol synopsis

BACKGROUND: High-quality peritoneal dialysis (PD) catheter insertion pathways are essential for optimal access to the therapy. Dialysis outcomes are influenced by a range of patient and center-related factors, and there is a need to better understand these so that catheter insertion pathways can be better matched to individual circumstances. OBJECTIVES: To examine how patient- and center-related factors influence the choice of catheter insertion pathways for a PD patient, and the impact of such factors and pathways on patient outcomes, and specifically, to compare the occurrence of and recovery from PD catheter-related adverse events and mortality in individuals who had surgical catheter insertion with those who had medical catheter insertion, and evaluate health economics. STUDY DESIGN: A prospective multi-center cohort study of incident PD patients at catheter insertion. This is an ancillary study nested within the International Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). METHODS: Patients will be recruited during a 30-month recruitment period at 45 United Kingdom (UK) renal facilities, with a minimum 12-month follow-up. A graphical Markov model will be fitted to describe the associations between patient demographics, comorbidities, and catheter insertion pathways that are not explained by center practices and their impact on the occurrence of catheter-related adverse events, and patient-reported outcomes. The model will also explore the extent to which the catheter insertion pathway is determined by the center practice patterns, accounting for patient mix. Multi-state models will compare the rate of occurrence of a PD catheter-related adverse event, recovery from this, and mortality in individuals who had surgical catheter insertion compared with those who had medical catheter insertion, accounting for competing events, and adjusting for patient and center factors. A health economics evaluation will establish which, if any, catheter insertion pathway is superior in terms of cost effectiveness. DISCUSSION: The study will provide information on which catheter insertion pathways are better according to individual characteristics and whether it is acceptable for dialysis units to rely on a single catheter insertion technique or whether they should invest in developing flexible pathways that incorporate both medical and surgical PD catheter insertion techniques.