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Observational Study
. 2023 May 22;13(5):e067386.
doi: 10.1136/bmjopen-2022-067386.

Prevalence of undiagnosed stage 3 chronic kidney disease in France, Germany, Italy, Japan and the USA: results from the multinational observational REVEAL-CKD study

Navdeep Tangri  1 , Toshiki Moriyama  2 , Markus P Schneider  3 , Jean Blaise Virgitti  4 , Luca De Nicola  5 , Matthew Arnold  6 , Salvatore Barone  7 , Emily Peach  8 , Eric Wittbrodt  9 , Hungta Chen  10 , Krister Järbrink  11 , Pamela Kushner  12
Affiliations
Observational Study

Prevalence of undiagnosed stage 3 chronic kidney disease in France, Germany, Italy, Japan and the USA: results from the multinational observational REVEAL-CKD study

Navdeep Tangri et al. BMJ Open. .

Abstract

Objectives: REVEAL-CKD aims to estimate the prevalence of, and factors associated with, undiagnosed stage 3 chronic kidney disease (CKD).

Design: Multinational, observational study.

Setting: Data from six country-specific electronic medical records and/or insurance claims databases from five countries (France, Germany, Italy, Japan and the USA [two databases]).

Participants: Eligible participants (≥18 years old) had ≥2 consecutive estimated glomerular filtration rate (eGFR) measurements (calculated from serum creatinine values, sex and age) taken from 2015 onwards that were indicative of stage 3 CKD (≥30 and <60 mL/min/1.73 m2). Undiagnosed cases lacked an International Classification of Diseases 9/10 diagnosis code for CKD (any stage) any time before, and up to 6 months after, the second qualifying eGFR measurement (study index).

Main outcome measures: The primary outcome was point prevalence of undiagnosed stage 3 CKD. Time to diagnosis was assessed using the Kaplan-Meier approach. Factors associated with lacking a CKD diagnosis and risk of diagnostic delay were assessed using logistic regression adjusted for baseline covariates.

Results: The prevalence of undiagnosed stage 3 CKD was 95.5% (19 120/20 012 patients) in France, 84.3% (22 557/26 767) in Germany, 77.0% (50 547/65 676) in Italy, 92.1% (83 693/90 902) in Japan, 61.6% (13 845/22 470) in the US Explorys Linked Claims and Electronic Medical Records Data database and 64.3% (161 254/250 879) in the US TriNetX database. The prevalence of undiagnosed CKD increased with age. Factors associated with undiagnosed CKD were female sex (vs male, range of odds ratios across countries: 1.29-1.77), stage 3a CKD (vs 3b, 1.81-3.66), no medical history (vs a history) of diabetes (1.26-2.77) or hypertension (1.35-1.78).

Conclusions: There are substantial opportunities to improve stage 3 CKD diagnosis, particularly in female patients and older patients. The low diagnosis rates in patients with comorbidities that put them at risk of disease progression and complications require attention.

Trial registration: NCT04847531.

Keywords: Adult nephrology; Chronic renal failure; EPIDEMIOLOGY; NEPHROLOGY.

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Conflict of interest statement

Competing interests: SB, EP, HC, KJ, and EW are employees of AstraZeneca and hold stock options. MA is an employee of AstraZeneca. NT has received grants from AstraZeneca, Boehringer 21 Ingelheim/Eli Lilly and Company, Janssen Pharmaceuticals, Otsuka Pharmaceutical Co, Ltd and Tricida, has received honoraria from AstraZeneca, Boehringer Ingelheim/Eli Lilly and Company, Janssen Pharmaceuticals, Otsuka Pharmaceutical and Tricida and holds stock options from Mesentech, Rénibus Therapeutics, pulseData and Tricida. MPS has received advisory board fees and honoraria from AstraZeneca, Bayer AG, Vifor Pharma Group and Boehringer Ingelheim/Eli Lilly and Company. LDN has received fees for scientific consultation and/or lectures by Astellas Pharma, AstraZeneca, Mundipharma and Vifor Pharma Group. PK has received speaker’s bureau and advisory board fees from AstraZeneca, Eli Lilly and Company and Novo Nordisk A/S, speaker’s fees from Bayer AG and honoraria from AstraZeneca and Eli Lilly and Company. TM and JBV have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Cohort selection. CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ICD, International Classification of Diseases; LCED, Explorys Linked Claims and Electronic Medical Records Data; LPD, Longitudinal Patient Database; RWD, Real World Data; THIN, The Health Improvement Network.
Figure 2
Figure 2
Prevalence of undiagnosed stage 3 CKD according to country and database (A) overall and (B) by sex. Undiagnosed cases are those that lack a diagnosis code for CKD (any stage), any time before and up to 6 months after study index. CKD, chronic kidney disease; LCED, Explorys Linked Claims and Electronic Medical Records Data.
Figure 3
Figure 3
Prevalence of undiagnosed stage 3 CKD according to the presence of comorbidities at study index, by country and database. Established CVD includes patients with a history of myocardial infarction, unstable angina, stroke, transient ischaemic attack, coronary artery bypass graft and percutaneous coronary intervention. Study index is defined as the date of a patient’s second qualifying eGFR measurement. *Owing to a lack of granularity for ICD-9 diagnostic codes in the database used, type of diabetes could not be determined in patients from Italy. †Owing to a lack of granularity for ICD-9 codes in the database used, established CVD does not include coronary artery bypass graft and percutaneous coronary intervention in patients from Italy. CKD, chronic kidney disease; CVD, cardiovascular disease; eGFR, estimated glomerular filtration rate; ICD-9, International Classification of Diseases 9; LCED, Explorys Linked Claims and Electronic Medical Records Data.
Figure 4
Figure 4
Kaplan-Meier estimates of time to CKD diagnosis according to country and database in patients undiagnosed at index, overall and by CKD stage (3a/3b). Shaded areas represent 95% confidence intervals. CKD, chronic kidney disease; LCED, Explorys Linked Claims and Electronic Medical Records Data.
See this image and copyright information in PMC

References

    1. Levey AS, Atkins R, Coresh J, et al. . Chronic kidney disease as a global public health problem: approaches and initiatives – a position statement from Kidney Disease: Improving Global Outcomes. Kidney Int 2007;72:247–59. 10.1038/sj.ki.5002343 - DOI - PubMed
    1. Bikbov B, Purcell CA, Levey AS, et al. . Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet 2020;395:709–33. 10.1016/S0140-6736(20)30045-3 - DOI - PMC - PubMed
    1. Xie Y, Bowe B, Mokdad AH, et al. . Analysis of the global burden of disease study highlights the global, regional, and national trends of chronic kidney disease epidemiology from 1990 to 2016. Kidney Int 2018;94:567–81. 10.1016/j.kint.2018.04.011 - DOI - PubMed
    1. Gansevoort RT, Correa-Rotter R, Hemmelgarn BR, et al. . Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention. Lancet 2013;382:339–52. 10.1016/S0140-6736(13)60595-4 - DOI - PubMed
    1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD work group . KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl 2013;3:1–150.

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