Evaluation of a national digital pre-implantation biopsy service for deceased-donor kidney transplantation in the UK (Pithia trial); a stepped-wedge cluster randomised registry trial.

ABSTRACT:

Background

Pre-implantation biopsy may help select kidneys retrieved from elderly deceased donors for transplantation, but concerns persist that it may cause unnecessary discard of kidneys that would have provided acceptable transplant function. The PITHIA trial tested the hypothesis that introduction of a National Digital Pathology Service (NDPS) would increase the proportion of kidneys transplanted from elderly donors and/or improve their function.

Methods

A stepped-wedge cluster randomised controlled registry trial delivered the NDPS to 22 UK kidney transplant centres (clusters) in 5 sequences at four-monthly intervals, using a restricted randomisation technique to ensure similar cluster sizes in the intervention and control status. Upon access to the intervention, centre

SUBMITTER: Summers DM 

PROVIDER: S-EPMC12304751 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature