Roy Louise, Zappitelli Michael, White-Guay Brian, Lafrance Jean-Philippe, Dorais Marc, Perreault Sylvie
Faculty of Medicine, University of Montreal, University of Montreal Hospital Center, QC, Canada.
Faculty of Medicine, Department of Pediatrics, Pediatric Nephrology, Toronto Hospital for Sick Children, University of Toronto, ON, Canada.
Can J Kidney Health Dis. 2020 Oct 10;7:2054358120959908. doi: 10.1177/2054358120959908. eCollection 2020.
Chronic kidney disease (CKD) is a major health issue and cardiovascular risk factor. Validity assessment of administrative data for the detection of CKD in research for drug benefit and risk using real-world data is important. Existing algorithms have limitations and we need to develop new algorithms using administrative data, giving the importance of drug benefit/risk ratio in real world.
The aim of this study was to validate a predictive algorithm for CKD GFR category 4-5 (eGFR < 30 mL/min/1.73 m but not receiving dialysis or CKD G4-5ND) using the administrative databases of the province of Quebec relative to estimated glomerular filtration rate (eGFR) as a reference standard.
This is a retrospective cohort study using chart collection and administrative databases.
The study was conducted in a community outpatient medical clinic and pre-dialysis outpatient clinic in downtown Montreal and rural area.
Patient medical files with at least 2 serum creatinine measures (up to 1 year apart) between September 1, 2013, and June 30, 2015, were reviewed consecutively (going back in time from the day we started the study). We excluded patients with end-stage renal disease on dialysis. The study was started in September 2013.
Glomerular filtration rate was estimated using the CKD Epidemiological Collaboration (CKD-EPI) from each patient's file. Several algorithms were developed using 3 administrative databases with different combinations of physician claims (diagnostics and number of visits) and hospital discharge data in the 5 years prior to the cohort entry, as well as specific drug use and medical intervention in preparation for dialysis in the 2 years prior to the cohort entry.
Chart data were used to assess eGFR. The validity of various algorithms for detection of CKD groups was assessed with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
A total of 434 medical files were reviewed; mean age of patients was 74.2 ± 10.6 years, and 83% were older than 65 years. Sensitivity of algorithm #3 (diagnosis within 2-5 years and/or specific drug use within 2 years and nephrologist visit ≥4 within 2-5 years) in identification of CKD G4-5ND ranged from 82.5% to 89.0%, specificity from 97.1% to 98.9% with PPV and NPV ranging from 94.5% to 97.7% and 91.1% to 94.2%, respectively. The subsequent subgroup analysis (diabetes, hypertension, and <65 and ≥65 years) and also the comparisons of predicted prevalence in a cohort of older adults relative to published data emphasized the accuracy of our algorithm for patients with severe CKD (CKD G4-5ND).
Our cohort comprised mostly older adults, and results may not be generalizable to all adults. Participants with CKD without 2 serum creatinine measurements up to 1 year apart were excluded.
The case definition of severe CKD G4-5ND derived from an algorithm using diagnosis code, drug use, and nephrologist visits from administrative databases is a valid algorithm compared with medical chart reviews in older adults.
慢性肾脏病(CKD)是一个主要的健康问题和心血管危险因素。在利用真实世界数据进行药物获益和风险研究中,对行政数据检测CKD的有效性评估很重要。现有算法存在局限性,鉴于药物获益/风险比在现实世界中的重要性,我们需要利用行政数据开发新算法。
本研究的目的是使用魁北克省的行政数据库,以估计肾小球滤过率(eGFR)作为参考标准,验证一种用于CKD GFR 4-5期(eGFR<30 mL/min/1.73 m²但未接受透析或CKD G4-5ND)的预测算法。
这是一项使用病历收集和行政数据库的回顾性队列研究。
该研究在蒙特利尔市中心和农村地区的社区门诊医疗诊所和透析前门诊诊所进行。
对2013年9月1日至2015年6月30日期间至少有2次血清肌酐测量值(间隔最多1年)的患者医疗档案进行连续回顾(从我们开始研究的那天开始追溯)。我们排除了接受透析的终末期肾病患者。该研究于2013年9月开始。
使用CKD流行病学协作组(CKD-EPI)公式从每位患者的档案中估算肾小球滤过率。利用3个行政数据库开发了几种算法,这些数据库包含队列入组前5年内科医生诊疗信息(诊断和就诊次数)与医院出院数据的不同组合,以及队列入组前2年为准备透析的特定药物使用和医疗干预情况。
使用病历数据评估eGFR。通过敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)评估检测CKD组的各种算法的有效性。
共审查了434份医疗档案;患者的平均年龄为74.2±10.6岁,83%的患者年龄超过65岁。算法3(2至5年内诊断和/或2年内特定药物使用以及2至5年内肾病专家就诊≥4次)识别CKD G4-5ND的敏感性范围为82.5%至89.0%,特异性范围为97.1%至98.9%,PPV和NPV分别为94.5%至97.7%和91.1%至94.2%。随后的亚组分析(糖尿病、高血压以及年龄<65岁和≥≥65岁)以及相对于已发表数据的老年人群队列中预测患病率的比较强调了我们的算法对重度CKD(CKD G4-5ND)患者的准确性。
我们的队列主要由老年人组成,结果可能无法推广到所有成年人。排除了间隔1年未进行2次血清肌酐测量的CKD参与者。
与老年人群的病历审查相比,使用行政数据库中的诊断代码、药物使用和肾病专家就诊情况得出的重度CKD G4-5ND病例定义是一种有效的算法。