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Early-stage chronic kidney disease (CKD) is usually asymptomatic and often results in delayed diagnosis, which is associated with increased risks of disease progression and comorbidities. However, data for epidemiological and clinical characteristics of undiagnosed, early-stage CKD in China is still lacking.
REVEAL-CKD is a retrospective, multinational, observational study using real-world data (e.g., claims and/or electronic medical records) across selected countries. The present study analysed de-identified patient data from 20 hospitals extracted from the China Renal Data System (CRDS). Patients aged ≥18 years and with two consecutive estimated glomerular filtration rate (eGFR) measurements ≥30 and <60 mL/min/1.73m2 (indicating stage 3 CKD) recorded >90 and ≤730 days apart from 2015 to 2020 were included. The date of the second qualifying eGFR measurement was considered as the index date. All eligible patients must also have ≥12 months of continuous medical records in CRDS before the first qualifying eGFR. The primary outcome is the rate of undiagnosed stage 3 CKD (defined as those without a CKD-related diagnostic code [ICD-10CN]) during the baseline period (defined as from ≥12 months prior to the first qualifying eGFR to 6 months after the index date). Distributions of key patient characteristics during the baseline period among the undiagnosed and the diagnosed patients were summarized. For statistical comparison between the undiagnosed and diagnosed patients, Wilcoxon rank sum tests were applied for continuous variables and chi-square tests were applied for categorical variables.
A total of 35,222 adult patients with stage 3 CKD were included. The median (interquartile range [IQR]) age was 74.1 (64.2, 81.6) years; 56.1% were males; and the median (IQR) eGFR was 49.0 (41.6–54.8) mL/min/1.73 m2. Overall, only 10,008 (28.4%) patients were diagnosed at or within 6 months after the index date. Among 25,214 (71.6%) patients with undiagnosed CKD, 2,344 (9.2%) had a delayed diagnosis, of which the median (IQR) time to diagnosis from the index date was 9.4 (6.9–15.6) months. The rest of the patients continued without a diagnosis. Characteristics of the study population stratified by the status of CKD diagnosis during the baseline period are presented in the Table 1–3. Compared with the diagnosed CKD patients, the undiagnosed patients had higher proportions of elderly (≥65 years old, P<0.001) and female patients (P<0.001), and lower proportions of patients with type 2 diabetes (P<0.001), hypertension (P<0.001) and atherosclerotic cardiovascular disease (ASCVD) (P<0.001).
Consistent with data observed in other countries in the multinational REVEAL-CKD study, real-world data from hospital setting in China demonstrated that there is an urgent need to raise awareness of CKD among patients and healthcare providers globally. Among patients from the CRDS, more than 70% of patients with stage 3 CKD were found to be undiagnosed. Multiple factors may have contributed to the delayed diagnosis (or lack thereof), and these need to be further explored.