Human Versus Computer-based Predictions of Long Allograft Survival

Completed

• Conditions: Kidney Transplant Failure

• Registration Number: NCT04918199
• Lead Sponsor: Paris Translational Research Center for Organ Transplantation

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-08
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• transplant evaluation available at one year post-transplant

Exclusion Criteria

• no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death censored allograft failure seven years after risk assessment	7 years	Predictions performances to predict allograft failure defined as a patient's definitive return to dialysis or preemptive kidney retransplantation after risk assessment.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the parameters' importance in the prediction for physicians	7 years	Mean decrease in accuracy from a random survival forest from each physician will be used to determine the relative importance of the first ten parameters that led to their predictions.
Inter-rater agreement	7 years	Fleiss kappa will be used to measure inter-rater agreement between each physician's ranking

Trial Locations

Locations (1)

Paris Translational Centre for Organ Transplantation; 🇫🇷 Paris, Île-de-France, France