BMJ open · 2025
Kidney failure risk equation to predict kidney transplant failure in individuals with an eGFR<30 mL/min/1.73 m2: a UK Renal Registry external validation and recalibration study.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Masoud Sherry, Bello Aisha, Santhakumaran Shalini, Casula Anna, Maher Francesa, Benoy-Deeney Fran, Medcalf James, Major Rupert, Nitsch Dorothea
Аннотация
OBJECTIVES: To externally validate and subsequently repurpose/recalibrate the easily accessible kidney failure risk equation (KFRE) for a prevalent transplant population with an estimated glomerular filtration rate (eGFR)<30 mL/min/1.73 m². It also aims to evaluate the recalibrated KFRE's potential to improve clinical practice with a clinical utility assessment.
DESIGN: Retrospective cohort study using UK Renal Registry data.
SETTING: 68 adult UK kidney centres.
PARTICIPANTS: 4092 patients with grafts at least 2 years old and eGFR<30 mL/min/1.73 m2 from 2009 to 2018.
PRIMARY OUTCOME MEASURE: Death-censored allograft failure at 2 years, defined as dialysis initiation, re-transplantation or, in the absence of the former two, the recorded date of transplant failure.
PROGNOSTIC MODEL VALIDATION: The KFRE was calculated at baseline using the 2-year, 8-variable non-North American KFRE, and performance was assessed using Harrell's C-statistic and calibration plots. The model was recalibrated using Cox Regression (2009-2013 cohort) and temporally validated using the 2014-2018 cohort. Clinical utility was assessed using decision-curve analysis, estimating per-100-patient gains in timely planning and reductions in unnecessary interventions compared with eGFR triggers.
RESULTS: The original KFRE had excellent discrimination but was miscalibrated, underpredicting graft failure. Temporal validation demonstrated that the performance of the recalibrated KFRE could be maintained across time periods (Harrell's C-index of 0.81 (95% CI 0.80 to 0.83); O/E (Observed/Expected events) ratio 1.00 (95% CI 0.93 to 1.07). It identified 9/100 more patients for timely intervention and 13/100 more for whom intervention could be delayed compared with a late clinical trigger of an eGFR<15 mL/min/1.73 m2.
CONCLUSIONS: While there are other prognostic models, this is the first study to focus on the understudied and clinically important cohort of patients with an eGFR<30 mL/min/1.73 m², offering more relevant 2-year predictions. For this underserved population, we present an easily accessible model that is robust to temporal and case-mix differences, demonstrates clinical utility and has the potential to improve daily clinical practice.
DESIGN: Retrospective cohort study using UK Renal Registry data.
SETTING: 68 adult UK kidney centres.
PARTICIPANTS: 4092 patients with grafts at least 2 years old and eGFR<30 mL/min/1.73 m2 from 2009 to 2018.
PRIMARY OUTCOME MEASURE: Death-censored allograft failure at 2 years, defined as dialysis initiation, re-transplantation or, in the absence of the former two, the recorded date of transplant failure.
PROGNOSTIC MODEL VALIDATION: The KFRE was calculated at baseline using the 2-year, 8-variable non-North American KFRE, and performance was assessed using Harrell's C-statistic and calibration plots. The model was recalibrated using Cox Regression (2009-2013 cohort) and temporally validated using the 2014-2018 cohort. Clinical utility was assessed using decision-curve analysis, estimating per-100-patient gains in timely planning and reductions in unnecessary interventions compared with eGFR triggers.
RESULTS: The original KFRE had excellent discrimination but was miscalibrated, underpredicting graft failure. Temporal validation demonstrated that the performance of the recalibrated KFRE could be maintained across time periods (Harrell's C-index of 0.81 (95% CI 0.80 to 0.83); O/E (Observed/Expected events) ratio 1.00 (95% CI 0.93 to 1.07). It identified 9/100 more patients for timely intervention and 13/100 more for whom intervention could be delayed compared with a late clinical trigger of an eGFR<15 mL/min/1.73 m2.
CONCLUSIONS: While there are other prognostic models, this is the first study to focus on the understudied and clinically important cohort of patients with an eGFR<30 mL/min/1.73 m², offering more relevant 2-year predictions. For this underserved population, we present an easily accessible model that is robust to temporal and case-mix differences, demonstrates clinical utility and has the potential to improve daily clinical practice.