Sammut-Powell Camilla, Sisk Rose, Vazquez-Mendez Estefania, Vasnawala Hardik, Goncalves Susana, Edge Mark, Cameron Rory
Gendius Limited, Alderley Edge, UK.
AstraZeneca, Cambridge, UK.
Kidney Int Rep. 2024 Apr 4;9(7):2047-2055. doi: 10.1016/j.ekir.2024.04.005. eCollection 2024 Jul.
A minimal-resource model for predicting reduced kidney function among people with type 2 diabetes and no diagnosis of chronic kidney disease (CKD) stages 3 to 5 was previously developed in a UK population to pre-screen for undiagnosed CKD. This study aims to evaluate the performance of the model on a global population and assess its adequacy with and without regional adjustment.
A retrospective observational study was performed using data collected from the iCaReMe global registry (NCT03549754) and the DISCOVER study (NCT02322762 and NCT02226822). Patients were grouped by their World Health Organization classified region. An estimated glomerular filtration rate (eGFR) <60 ml/min per 1.73 m was the marker of reduced kidney function. A regional-intercept recalibration was applied to adjust for regional variation. Discrimination and calibration were evaluated for the UK-developed and recalibrated models.
A total of 14,180 patients (46 countries, 6 regions) were identified with type 2 diabetes, no previous diagnosis of CKD stages 3 to 5, and had a serum creatinine measurement or eGFR recorded. The UK model underestimated risk when applied globally and was deemed inadequate. The model with regional adjustment achieved the target sensitivity (80.5%; 95% confidence interval [CI]: 78.8%-82.3%) and demonstrated a relative improvement of 51.5% (95% CI: 48.1%-55.1%) in the positive predictive value (PPV), compared to a screen-all approach.
The regional-adjusted model demonstrated adequate performance globally. Incorporating the model within practice could help clinicians to risk-stratify and prioritize patients at high risk. This could enable improved efficiency via risk-tailored screening, particularly in lower-middle-income countries (LMICs).
先前在英国人群中开发了一种低资源模型,用于预测2型糖尿病且未诊断为慢性肾脏病(CKD)3至5期患者的肾功能减退情况,以对未诊断的CKD进行预筛查。本研究旨在评估该模型在全球人群中的性能,并评估其在有无区域调整情况下的适用性。
使用从iCaReMe全球注册库(NCT03549754)和DISCOVER研究(NCT02322762和NCT02226822)收集的数据进行了一项回顾性观察研究。患者按世界卫生组织分类区域分组。估计肾小球滤过率(eGFR)<60 ml/(min·1.73 m²)是肾功能减退的标志。应用区域截距重新校准以调整区域差异。对英国开发的模型和重新校准的模型进行了鉴别力和校准评估。
共确定了14180例患者(来自46个国家,6个区域),患有2型糖尿病,既往未诊断为CKD 3至5期,且有血清肌酐测量值或记录的eGFR。英国模型在全球应用时低估了风险,被认为不适用。与全面筛查方法相比,经区域调整的模型达到了目标敏感性(80.5%;95%置信区间[CI]:78.8%-82.3%),阳性预测值(PPV)相对提高了51.5%(95% CI:48.1%-55.1%)。
经区域调整的模型在全球范围内表现出足够的性能。在实践中应用该模型可帮助临床医生对患者进行风险分层并确定高风险患者的优先级。这可以通过风险定制筛查提高效率,特别是在中低收入国家(LMICs)。