Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

Официальное название

Validation of Diagnostic Codes for Identifying Chlamydial Infections From TriNetX Electronic Health Record Data in the United States

Обзор

This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database in the US is an appropriate real-world data (RWD) source for conducting chlamydia-related research to support the chlamydia trachomatis (CT) messenger Ribonucleic acid (mRNA) vaccine program. There are two primary objectives for this study: 1. To determine the validity of ICD, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes to identify patients with chlamydial infections using TriNetX EHR data in the US 2. To describe screening or diagnostic testing and treatment patterns in patients with chlamydia using TriNetX EHR data in the US There are also two secondary objectives for this study: 1. To explore the feasibility of developing a modified algorithm for identifying patients with chlamydia applicable for Merative MarketScan Commercial Claims and Encounters (CCAE) database based on the findings from the primary objectives 2. To compare patient characteristics, use of screening or diagnostic testing, and treatment patterns among patients with chlamydia between TriNetX EHR data and the MarketScan CCAE data in the US

Первичные конечные точки

• Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections [Срок оценки: From year 2016 through year 2024]
• Descriptive analyses of chlamydia patients [Срок оценки: From year 2016 through year 2024]

Вторичные конечные точки (2)

• Validity of CCAE Database for Chlamydial Infections [Срок оценки: From year 2016 through year 2023]
• Comparison of chlamydia patient characteristics between EHR and claims RWD sources in the US [Срок оценки: From year 2016 through year 2024]

Критерии участия

Inclusion Criteria for Primary Objectives:

• Patients with an ICD-10-CM diagnosis of chlamydia documented in their EHR OR patients with a nucleic acid amplification test (NAAT) result for chlamydia (either positive or negative) during the study period. The index date is the date of the first-recorded diagnosis code, or the date of the first-recorded NAAT result when no diagnosis code for chlamydia exists.
• Patients with at least one visit within 30 days both before and after their index date.

Exclusion Criteria for Primary Objectives:

• Patients with no documented ICD-10-CM diagnosis for chlamydia who possessed unknown laboratory test results for chlamydia during the study period (removed from ICD validation assessment in primary analysis).
• Patients with an ICD-10-CM diagnosis without a corresponding laboratory test (removed from ICD validation assessment in primary analysis).

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Massachusetts Medical School — Worcester

Идентификаторы

NCT: NCT07094373 · VAV19180 · U1111-1322-6372

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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