Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

Conditions

• Chlamydial Infections

Eligibility Criteria

Sex

ALL

Age

14 Years - 44 Years

Healthy Volunteers

Not accepted

Study Details

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

Key Dates

Start date

Jan 1, 2025

Status verified

Jan 2026

Primary completion

Jun 12, 2026

Completion

Jun 12, 2026

Study Design

Enrollment

533,000 participants (estimated)

Arms

• Arm: Cohort 1 (primary objective)
  Patients aged 14 to 44 years with an ICD-10-CM diagnosis of chlamydia documented in their EHR OR patients with a NAAT result for chlamydia (either positive or negative) during the study period (2016-2024) from the TriNetX USA Network
• Arm: Cohort 2 (secondary objective)
  Patients aged 14 to 44 years with ≥1 ICD-10-CM diagnosis code for chlamydia between 2016 - 2023 in the MarketScan Commercial Claims and Encounters (CCAE) database
• Arm: Cohort 3 (secondary objective)
  Patients aged 14 to 44 years with ≥1 ICD-10-CM diagnosis code for chlamydia or a positive NAAT result for chlamydia between 2016 -2024 in TriNetX Dataworks USA

Primary Outcome Measure

Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections [ Time Frame: From year 2016 through year 2024 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (1)

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