Human Versus Computer-based Predictions of Long Allograft Survival

Study Overview
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Brief Summary
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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
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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.

Official Title
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Computer Based, vs Human Based Assessment of Kidney Allograft Failure Prediction and Stratification

Conditions
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Kidney Transplant Failure

Intervention / Treatment
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* Device: Computer based assessment (iBox)
* Other: Physician assessement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: transplant evaluation available at one year post-transplant Exclusion Criteria: no

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paris Transplant Group cohort<br>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. | Device: Computer based assessment (iBox)<br>* Individual allograft survival probabilities of death censored allograft survival seven years after the time of risk evaluation, computed using the iBox (NCT03474003), a qualified prognostication system designed to predict long term allograft survival up to seven years after evaluation.<br>Other: Physician assessement<br>* Based on anonymized electronic health records, physicians have to determine a percentage of death censored allograft survival seven years after the time of risk evaluation,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death censored allograft failure seven years after risk assessment | Predictions performances to predict allograft failure defined as a patient's definitive return to dialysis or preemptive kidney retransplantation after risk assessment. | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the parameters' importance in the prediction for physicians | 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. | 7 years | 
| Inter-rater agreement | Fleiss kappa will be used to measure inter-rater agreement between each physician's ranking | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iBox, individual risk prediction, kidney transplantation, long-term allograft outcome