Establishing a core outcome measure for cancer in trials in kidney transplantation: a standardized outcomes in nephrology-kidney transplantation consensus workshop report

Cancer is a critically important outcome for kidney transplant recipients that inconsistently and infrequently reported in trials. We convened a consensus workshop to establish a core outcome measure for cancer for trials in kidney transplant recipients. Workshop attendees included 21 transplant recipients, 2 caregivers and 46 health professionals from 12 countries. Transcripts were analyzed thematically. Three themes were identified. “ Fear of cancer occurrence due to immunosuppression ” reflected the psychological burden and uncertainties when balancing suppression with long-term cancer risk. “ Capturing the details of type, stage and recurrence ”, encompassed recognizing the differential consequences of cancer types, delineating the stage of cancer to convey severity, and distinguishing recurrent from de novo cancer. “ Recognizing the challenges of capturing cancer events ” included under-reporting and incomplete documentation of longer-term outcomes, variability in cancer screening practices, and absence of coordinated trial networks to support harmonization and aggregation of cancer outcomes across studies. Participants agreed that occurrence, with stratification by cancer type, stage, and recurrence, where possible, would be a practical and meaningful core outcome measure for cancer. Consistent reporting of cancer using a standardized core outcome measure may help to improve the consistency and relevance of trial findings and assist in shared decision-making in kidney transplantation.