Men's Health Foundation, Los Angeles, CA, USA.
Epividian, Inc., Durham, NC, USA.
HIV Med. 2020 May;21(5):299-308. doi: 10.1111/hiv.12826. Epub 2020 Jan 27.
The aim of the study was to assess the validity of an easy-to-calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA.
PLWH (2002-2016) without prior exposure to potentially nephrotoxic antiretroviral agents and with at least three estimated glomerular filtration rate (eGFR) test results were identified in the Observational Pharmaco-Epidemiology Research and Analysis (OPERA ) cohort. Three samples were drawn independently using the same eligibility criteria but each using a different eGFR equation, specifically the Cockcroft-Gault (C-G), Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR estimation method. Full and short D:A:D risk scores were applied. CKD was defined as a confirmed decrease in eGFR to < 60 mL/min/1.73 m (stages 3-5). Poisson models estimated the association between CKD incidence and a one-point increase in the continuous risk score. The incidence rate ratio (IRR), adjusted IRR (aIRR), and Harrell's discrimination statistic were used to assess validity.
There were 19 444, 22 727 and 22 748 PLWH in the OPERA C-G, CKD-EPI and MDRD samples, respectively. The median (minimum-maximum) follow-up duration was 6.1 (0.3-9.1) years in the D:A:D cohort and ranged from 3.2 to 3.5 (0.2-15.5) years in the OPERA validation samples. The observation time for the majority of PLWH in the D:A:D cohort began prior to 2006, in stark contrast to the OPERA validation samples, where the majority of PLWH were observed after 2011. The CKD incidence ranged from 7.3 per 1000 person-years [95% confidence interval (CI) 6.8, 7.9 per 1000 person-years] in OPERA C-G to 11.0 (95% CI 10.4, 11.6 per 1000 person-years) in OPERA MDRD. In OPERA samples, IRRs by risk group and adjusted IRRs (full risk score) were similar to those in the D:A:D derivation cohort (adjusted IRR 1.3; 95% CI 1.3, 1.3). Harrell's c-statistic ranged from 0.87 to 0.92 in the OPERA samples, comparable to that in the derivation cohort (0.92). Results for short scores were similar.
The findings support the validity of the D:A:D risk scoring method for assessing CKD (stages 3-5) probability in an exclusively USA-based sample regardless of eGFR method.
本研究旨在评估 Data Collection on Adverse Events of Anti-HIV Drugs（D:A:D）组开发的易于计算的慢性肾脏病（CKD）风险评分在一项美国 HIV 感染者（PLWH）的纵向观察研究中的有效性。
在 Observational Pharmaco-Epidemiology Research and Analysis（OPERA）队列中，确定了 2002-2016 年期间没有接触过潜在肾毒性抗逆转录病毒药物且至少有 3 次估计肾小球滤过率（eGFR）检测结果的 PLWH。使用相同的纳入标准，独立抽取了 3 个样本，但每个样本都使用了不同的 eGFR 方程，具体为 Cockcroft-Gault（C-G）、改良肾脏病饮食研究（MDRD）或慢性肾脏病流行病学合作研究（CKD-EPI）eGFR 估计方法。应用了完整和简化的 D:A:D 风险评分。CKD 定义为经确认的 eGFR 下降至<60 mL/min/1.73 m（3-5 期）。泊松模型估计了 CKD 发病率与连续风险评分增加一个点之间的关联。使用发病率比（IRR）、调整后发病率比（aIRR）和 Harrell 的判别统计量来评估有效性。
在 OPERA C-G、CKD-EPI 和 MDRD 样本中，PLWH 的数量分别为 19444、22727 和 22748。D:A:D 队列的中位（最小-最大）随访时间为 6.1（0.3-9.1）年，而在 OPERA 验证样本中，范围为 3.2-3.5（0.2-15.5）年。D:A:D 队列中大多数 PLWH 的观察时间始于 2006 年之前，与 OPERA 验证样本形成鲜明对比，后者中大多数 PLWH 的观察时间都在 2011 年之后。CKD 的发病率范围从 OPERA C-G 的 7.3/1000 人年（95%CI 6.8，7.9/1000 人年）到 OPERA MDRD 的 11.0（95%CI 10.4，11.6/1000 人年）。在 OPERA 样本中，风险组的发病率比（IRR）和调整后的发病率比（完整风险评分）与 D:A:D 推导队列相似（调整后发病率比 1.3；95%CI 1.3，1.3）。Harrell 的 c 统计量在 OPERA 样本中的范围为 0.87-0.92，与推导队列相当（0.92）。简化评分的结果相似。
无论 eGFR 方法如何，本研究结果支持 D:A:D 风险评分方法在评估美国特定人群 CKD（3-5 期）概率中的有效性。
