Abstract
This collection consists of an article, the Statistical Analysis Plan v1.2, and the Statistical Analysis Plan (SAP) checklist.
Background: Peritoneal dialysis (PD) is one of the most effective kidney replacement therapies for patients with kidney failure. Despite its advantages – e.g., home-based, relatively simple, cost-effective – the uptake of PD remains modest, primarily due to concerns about infection risk and catheter-related complications. Training of patients (and clinicians) is essential for preventing complications; however, evidence supporting its effectiveness remains limited. This study compared the effect of training curriculum targeting PD patients and trainers with standard care, in a pragmatic, multi-centre (at Australian and New Zealand sites), superiority, cluster-randomised, controlled trial (TEACH-PD).
Methods: TEACH-PD was designed to enrol 1,500 adult participants in 44 clusters with kidney failure receiving PD as a new treatment. Clinical outcomes routinely collected by the ANZDATA Registry were utilised. PD-related infection (exit site, tunnel, peritonitis), infection-associated catheter removal, haemodialysis transfer, hospitalisation, mortality, quality of life, healthcare use and cost-effectiveness were compared between clusters randomised to TEACH-PD training curriculum compared to clusters randomised to usual care. The primary outcome (risk of PD-related infection) will be modelled as clustered survival data with competing risks (death, treatment change) using a marginal, multi-state, Cox model with a robust sandwich variance estimator. The Statistical Analysis Plan (SAP) provided as supplementary content details the methods of analysis and reporting.
Conclusions: The SAP described here resulted from an iterative, collaborative effort among statisticians and the clinician leads of the trial. Specification of statistical methods prior to trial completion will contribute to unbiased analyses of the collected data.
Trial registration: https://clinicaltrials.gov/study/NCT03816111