Human Versus Computer-based Predictions of Long Allograft Survival (iBox vs Human)

Paris Translational Research Center for Organ Transplantation

Status: Completed

Conditions: Kidney Transplant Failure

Treatments: Other: Physician assessement; Device: Computer based assessment (iBox)

Study type: Observational

Funder types: Other

Identifiers

NCT04918199

iBoxvsHuman

Details and patient eligibility

About

The clinical decision-making after kidney transplantation is mainly driven by patient individual assessment. However, this task remains difficult and uncertain due to the integration of complex and numerous parameters. We aim to evaluate and compare the ability of transplant physicians to predict long term allograft survival compared with a computer-based survival prediction algorithm (iBox system).

Full description

400 kidney transplant recipients among the cohort of 4,000 patients from the Paris Transplant Group prospective kidney transplant cohort (NCT03474003) were randomly selected. We generated an anonymized electronic health record for each included patient including a total of 60 classical kidney transplant prognostic parameters comprising baseline transplant and recipient characteristics, together with post-transplant parameters including allograft function, proteinuria, histology, diagnoses, and immunological profile collected during the first-year post-transplant. The time of risk evaluation for the human and the iBox system were at 1-year post transplant and the death censored allograft survival predictions made at 7 years after risk assessment. We enrolled transplant physicians at various stages of their careers (residents, fellows and seniors) to assign death censored graft survival probabilities at 7 years post risk assessment. The physicians were blinded to the actual patient outcome (allograft failure) and the iBox predictions. The physicians-based predictions will then be compared with the iBox system, a validated computer-based kidney survival prediction system.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• transplant evaluation available at one year post-transplant

Exclusion criteria

• no

Trial design

400 participants in 1 patient group

Paris Transplant Group cohort

Description:

400 (10%) of the patients were randomly selected from 4,000 consecutive patients over 18 years of age prospectively enrolled at the time of kidney transplantation from a living or deceased donor at Necker Hospital, Saint-Louis Hospital, Foch Hospital, and Toulouse Hospital between January 1, 2005, and January 1, 2014, in France.

Treatment:

Device: Computer based assessment (iBox)

Other: Physician assessement