Use of the BIOGROUP® French laboratories database to conduct CKD observational studies: a pilot EPI-CKD1 study
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Claire Visseaux
, Cécile Conte
Abstract
Objectives
Medical biology is essential for diagnosing and monitoring cardio-reno-metabolic diseases. The EPI-CKD1 study utilizes data from Biogroup® French laboratories to examine the burden of chronic kidney disease (CKD) and the effect of heart failure, and diabetes in an outpatient setting in order to address gaps in national databases that lack biological data.
Methods
All adults (≥18 years) with at least one blood creatinine test between January 1st of 2021, and June 30th of 2022 were included. Key biomarkers measured included serum creatinine, estimated glomerular filtration rate (eGFR), hemoglobin A1c, B-type natriuretic peptide (BNP), NT-Pro BNP, and urinary albumin/creatinine ratio (uACR).
Results
Among a total of 4,061,208 adults with at least one blood creatinine test, 465,225 (11.5 %) had altered kidney function. Their mean age was 57.9 years (SD 18.8), with 56.7 % women. Diabetes was present in 8.3 %, and heart failure in 1.4 %. Altered kidney function standardized prevalence was estimated to 8.06 %, with an incidence of 5.10 %. Patients with end-stage CKD had an average of 7.9 eGFR measurements, compared to 2 for those with eGFR >60 mL/min/1.73 m2. Older age, diabetes, and heart failure were associated with an increased risk of eGFR <60 mL/min/1.73 m2.
Conclusions
The EPI-CKD1 study demonstrates the utility of Biogroup® data for large-scale observational studies, offering precise, medically relevant insights on patients at cardio-renal risk. Future studies should focus on data enrichment and long-term follow-up to deepen understanding.
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Research ethics: The study was conducted in accordance with the principles of the declaration of Helsinki. In compliance with the French regulations, the study has been approved by the Health Data Hub (approval number: F20221206154319).
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Informed consent: Patients were provided with comprehensive non-individual information about the objectives of the study and were notified about their right to object at any time to the use of collected data. A waiver was obtained for individual written informed consent. All data were fully anonymized before analyses.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: The data from this study cannot be publicly shared. Due to the real-world nature of the study, which relies on laboratory data, disclosing this information could compromise the confidentiality of results and internal processes. Therefore, for data protection and confidentiality reasons, no data sharing will be possible.
References
1. Benchimol, EI, Smeeth, L, Guttmann, A, Harron, K, Moher, D, Petersen, I, et al.. The REporting of studies conducted using observational routinely-collected health data (RECORD) statement. PLoS Med 2015;12:e1001885.10.1371/journal.pmed.1001885Search in Google Scholar PubMed PubMed Central
2. BIOGROUP – Laboratoire de biologie médicale [Internet]. Biogroup. [cited 2024 Jul 25]. Available from: https://biogroup.fr/.Search in Google Scholar
3. Hill, NR, Fatoba, ST, Oke, JL, Hirst, JA, O’Callaghan, CA, Lasserson, DS, et al.. Global prevalence of chronic kidney disease – a systematic review and meta-analysis. PLoS One 2016;11:e0158765.10.1371/journal.pone.0158765Search in Google Scholar PubMed PubMed Central
4. GBD Chronic Kidney Disease Collaboration. 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.Search in Google Scholar
5. Olié, V, Cheddani, L, Stengel, B, Gabet, A, Grave, C, Blacher, J, et al.. [Prevalence of chronic kidney disease in France, Esteban study 2014-2016]. Nephrol Ther 2021;17:526–31.10.1016/j.nephro.2021.05.006Search in Google Scholar PubMed
6. Ortiz, A, Mattace-Raso, F, Soler, MJ, Fouque, D. Ageing meets kidney disease. Nephrol Dial Transplant 2022;38:523–6.10.1093/ndt/gfac199Search in Google Scholar PubMed PubMed Central
7. Evans, M, Lewis, RD, Morgan, AR, Whyte, MB, Hanif, W, Bain, SC, et al.. A narrative review of chronic kidney disease in clinical practice: current challenges and future perspectives. Adv Ther 2022;39:33–43.10.1007/s12325-021-01927-zSearch in Google Scholar PubMed PubMed Central
8. Whitman, IR, Feldman, HI, Deo, R. CKD and sudden cardiac death: epidemiology, mechanisms, and therapeutic approaches. J Am Soc Nephrol 2012;23:1929–39.10.1681/ASN.2012010037Search in Google Scholar PubMed PubMed Central
9. Issad, B, Galland, R, Merle, V, Lobbedez, T, Lassalle, M. Prevalence of end stage kidney disease and distribution of treatment modalities. Nephrol Ther 2022;18:18/5S–e15-18/5S-e20.10.1016/S1769-7255(22)00563-6Search in Google Scholar PubMed
10. Levey, AS, Stevens, LA, Schmid, CH, Zhang, Y (Lucy), Castro, AF, Feldman, HI, et al.. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150:604–12.10.7326/0003-4819-150-9-200905050-00006Search in Google Scholar PubMed PubMed Central
11. Cavalier, E, Zima, T, Datta, P, Makris, K, Schaeffner, E, Langlois, M, et al.. Recommendations for European laboratories based on the KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease. Clin Chem Lab Med 2024;63:525–34.10.1515/cclm-2024-1082Search in Google Scholar PubMed
12. Mueller, C, McDonald, K, de Boer, RA, Maisel, A, Cleland, JGF, Kozhuharov, N, et al.. Heart Failure Association of the European Society of Cardiology practical guidance on the use of natriuretic peptide concentrations. Eur J Heart Fail 2019;21:715–31.10.1002/ejhf.1494Search in Google Scholar PubMed
13. Li, L, Semenov, AG, Feygina, EE, Yang, C, Wang, N, Chen, C, et al.. Diagnostic utility of total NT-proBNP testing by immunoassay based on antibodies targeting glycosylation-free regions of NT-proBNP. Clin Chem Lab Med 2023;61:485–93.10.1515/cclm-2022-1194Search in Google Scholar PubMed
14. Collège de la Haute Autorité de Santé. Guide de parcours de soins - Diabète de type 2 de l’adulte. Le Parcours de Soin Saint-Denis, France: Haute Autorité de Santé; 2014.Search in Google Scholar
15. Institut National de la Statistique et des Etudes Economiques (INSEE). Estimations de population (2022) [Internet]. https://www.insee.fr/.2023 [cited 2023 Mar 15]. Available from: https://www.insee.fr/.Search in Google Scholar
16. Guide du parcours de soins – Maladie rénale chronique de l’adulte (MRC) [Internet]. Haute Autorité de Santé. [cited 2023 Jun 23]. Available from: https://www.has-sante.fr/jcms/p_3288950/fr/guide-du-parcours-de-soins-maladie-renale-chronique-de-l-adulte-mrc.Search in Google Scholar
17. Bongard, V, Dallongeville, J, Arveiler, D, Ruidavets, J-B, Cottel, D, Wagner, A, et al.. Estimation et caractérisation de l’insuffisance rénale chronique en France. Ann Cardiol Angeiol 2012;61:239–44.10.1016/j.ancard.2012.03.003Search in Google Scholar PubMed
18. Banerjee, S, Panas, R. Diabetes and cardiorenal syndrome: understanding the “triple threat”. Hellenic J Cardiol 2017;58:342–7.10.1016/j.hjc.2017.01.003Search in Google Scholar PubMed
19. Ronco, C, House, AA, Haapio, M. Cardiorenal syndrome: refining the definition of a complex symbiosis gone wrong. Intensive Care Med 2008;34:957–62.10.1007/s00134-008-1017-8Search in Google Scholar PubMed
20. Inker, LA, Astor, BC, Fox, CH, Isakova, T, Lash, JP, Peralta, CA, et al.. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis 2014;63:713–35.10.1053/j.ajkd.2014.01.416Search in Google Scholar PubMed
21. Akbari, A, Clase, CM, Acott, P, Battistella, M, Bello, A, Feltmate, P, et al.. Canadian society of nephrology commentary on the KDIGO clinical practice guideline for CKD evaluation and management. Am J Kidney Dis 2015;65:177–205.10.1053/j.ajkd.2014.10.013Search in Google Scholar PubMed
22. Johnson, DW, Atai, E, Chan, M, Phoon, RK, Scott, C, Toussaint, ND, et al.. KHA-CARI Guideline: early chronic kidney disease: detection, prevention and management. Nephrology 2013;18:340–50.10.1111/nep.12052Search in Google Scholar PubMed
23. R.E.I.N. (Réseau Epidémiologique et Information en (…)) - Agence de la biomédecine [Internet]. 2023 [cited 2024 Oct 1]. Available from: https://www.agence-biomedecine.fr/R-E-I-N-Reseau-Epidemiologique-et-Information-en-Nephrologie.Search in Google Scholar
24. CKD-REIN | France cohortes [Internet]. 2024 [cited 2024 Oct 1]. Available from: https://francecohortes.org/cohortes/annuaire-des-cohortes/CKD-REIN.Search in Google Scholar
25. Dienemann, T, Fujii, N, Orlandi, P, Nessel, L, Furth, SL, Hoy, WE, et al.. International Network of Chronic Kidney Disease cohort studies (iNET-CKD): a global network of chronic kidney disease cohorts. BMC Nephrol 2016;17:121.10.1186/s12882-016-0335-2Search in Google Scholar PubMed PubMed Central
26. Raffray, M, Bayat, S, Lassalle, M, Couchoud, C. Linking disease registries and nationwide healthcare administrative databases: the French renal epidemiology and information network (REIN) insight. BMC Nephrol 2020;21:25.10.1186/s12882-020-1692-4Search in Google Scholar PubMed PubMed Central
27. Scailteux, L-M, Droitcourt, C, Balusson, F, Nowak, E, Kerbrat, S, Dupuy, A, et al.. French administrative health care database (SNDS): the value of its enrichment. Therapie (Paris) 2019;74:215–23.10.1016/j.therap.2018.09.072Search in Google Scholar PubMed
28. Neyazi, M, Bremer, JP, Knorr, MS, Gross, S, Brederecke, J, Schweingruber, N, et al.. Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community. Clin Chem Lab Med 2024;62:740–52.10.1515/cclm-2023-0743Search in Google Scholar PubMed
29. Delanaye, P, Glassock, RJ, Pottel, H, Rule, AD. An age-calibrated definition of chronic kidney disease: rationale and benefits. Clin Biochem Rev 2016;37:17–26.Search in Google Scholar
30. Farrington, K, Covic, A, Nistor, I, Aucella, F, Clyne, N, De Vos, L, et al.. Clinical Practice Guideline on management of older patients with chronic kidney disease stage 3b or higher (eGFR<45 mL/min/1.73 m2): a summary document from the European Renal Best Practice Group. Nephrol Dial Transplant 2017;32:9–16.10.1093/ndt/gfw411Search in Google Scholar PubMed
31. Inker, LA, Schmid, CH, Tighiouart, H, Eckfeldt, JH, Feldman, HI, Greene, T, et al.. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med 2012;367:20–9.10.1056/NEJMoa1114248Search in Google Scholar PubMed PubMed Central
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- Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics
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- Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database
- Clinical vs. statistical significance: considerations for clinical laboratories
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Articles in the same Issue
- Frontmatter
- Editorial
- Setting analytical performance specification by simulation (Milan model 1b)
- Reviews
- Unveiling the power of R: a comprehensive perspective for laboratory medicine data analysis
- Clostebol detection after transdermal and transmucosal contact. A systematic review
- Opinion Papers
- A value-based score for clinical laboratories: promoting the work of the new EFLM committee
- Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics
- Perspectives
- Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database
- Clinical vs. statistical significance: considerations for clinical laboratories
- Genetics and Molecular Diagnostics
- Reliable detection of sex chromosome abnormalities by quantitative fluorescence polymerase chain reaction
- Targeted proteomics of serum IGF-I, -II, IGFBP-2, -3, -4, -5, -6 and ALS
- Candidate Reference Measurement Procedures and Materials
- Liquid chromatography tandem mass spectrometry (LC-MS/MS) candidate reference measurement procedure for urine albumin
- General Clinical Chemistry and Laboratory Medicine
- Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results
- Exploring the extent of post-analytical errors, with a focus on transcription errors – an intervention within the VIPVIZA study
- A survey on measurement and reporting of total testosterone, sex hormone-binding globulin and free testosterone in clinical laboratories in Europe
- Quality indicators in laboratory medicine: a 2020–2023 experience in a Chinese province
- Impact of delayed centrifugation on the stability of 32 biochemical analytes in blood samples collected in serum gel tubes and stored at room temperature
- Concordance between the updated Elecsys cerebrospinal fluid immunoassays and amyloid positron emission tomography for Alzheimer’s disease assessment: findings from the Apollo study
- Novel protocol for metabolomics data normalization and biomarker discovery in human tears
- Use of the BIOGROUP® French laboratories database to conduct CKD observational studies: a pilot EPI-CKD1 study
- Reference Values and Biological Variations
- Consensus instability equations for routine coagulation tests
- Hematology and Coagulation
- Flow-cytometric lymphocyte subsets enumeration: comparison of single/dual-platform method in clinical laboratory with dual-platform extended PanLeucogating method in reference laboratory
- Cardiovascular Diseases
- Novel Mindray high sensitivity cardiac troponin I assay for single sample and 0/2-hour rule out of myocardial infarction: MERITnI study
- Infectious Diseases
- Cell population data for early detection of sepsis in patients with suspected infection in the emergency department
- Letters to the Editor
- Lab Error Finder: A call for collaboration
- Cascading referencing of terms and definitions
- Strengthening international cooperation and confidence in the field of laboratory medicine by ISO standardization
- Determining the minimum blood volume required for laboratory testing in newborns
- Performance evaluation of large language models with chain-of-thought reasoning ability in clinical laboratory case interpretation
- Vancomycin assay interference: low-level IgM paraprotein disrupts Siemens Atellica® CH VANC assay
- Dr. Morley Donald Hollenberg. An extraordinary scientist, teacher and mentor