Feasibility of Identifying Demographic and Clinical Insights for Patients with Chronic Kidney Disease from Real-World Data

Author(s)

Madaj K1, Brauneis J2, Menon J3, Vossen C4
1Syneos Health, UNIONTOWN, OH, USA, 2Syneos Health, Morrisville, NC, USA, 3Syneos Health, Aarhus, 82, Denmark, 4Syneos Health, Amsterdam, NH, Netherlands

Presentation Documents

OBJECTIVES: Studies assessing disease burden related to chronic kidney disease (CKD) are limited. Due to large sample sizes, real-world data (RWD) have the potential to provide insight into CKD patients. This study aimed to assess the availability and completeness of demographics, clinical characteristics, and outcomes in adult patients with stage 4 or 5 CKD using two RWD sources (a United States [US] claims database, and a global electronic medical record [EMR] network).

METHODS: Adult patients ≥18 years with diagnostic evidence of stage 4 or 5 CKD were queried using ICD-10-CM diagnosis codes (N18.4, N18.5, I12.0, I13.11, I13.2, Z49, Z99.2) from two RWD sources between 01 January 2018 to 15 February 2023. Documented diagnosis codes with associated dates were the minimum requirement for data inclusion. Unique patient counts, demographics, clinical characteristics, laboratory information, comorbidities, treatment-related adverse events (AE), and major adverse cardiovascular events (MACE) availability were assessed across both RWD sources. Data completeness were also assessed, where available.

RESULTS: 4,513,897 patients were identified in the US claims database, and 698,078 in the EMR network. Age and gender data were available in both RWD sources, with a completeness of >99%. Additional demographic data available from both sources included race and ethnicity data, with the EMR network having a completeness of 86% and 75%, respectively. Both RWD sources had clinical characteristics, comorbidities, concomitant medications, laboratory results, and outcome data (AE, MACE; without causality) readily available. Completeness was low for treatment-related AEs and MACE in both the US claims database and the EMR network.

CONCLUSIONS: We were able to determine availability of demographic and clinical insights to CKD patients across two RWD sources, with availability and completeness varying by source. Despite limitations for assessing treatment outcomes, it is feasible for RWD to provide insight into CKD disease burden, which may aid in drug development.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)

Code

RWD180

Topic

Study Approaches

Topic Subcategory

Electronic Medical & Health Records

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Urinary/Kidney Disorders

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