Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
- Conditions
- Chlamydial Infections
- Registration Number
- NCT07094373
- Lead Sponsor
- Sanofi
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 533000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections From year 2016 through year 2024 Diagnostic performance of ICD-10-CM codes for chlamydial infections, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), compared to Nucleic Acid Amplification Test (NAAT) results for chlamydial infections
Descriptive analyses of chlamydia patients From year 2016 through year 2024 Describe demographic characteristics, laboratory testing, and treatment patterns among true positive and false negative chlamydia patients
- Secondary Outcome Measures
Name Time Method Validity of CCAE Database for Chlamydial Infections From year 2016 through year 2023 Detect chlamydia cases using a mix of diagnostic codes, lab test codes, treatments, to detect/confirm chlamydia infection
Comparison of chlamydia patient characteristics between EHR and claims RWD sources in the US From year 2016 through year 2024 Compare demographics and clinical features (e.g., age, sex, treatment history, comorbidities) of chlamydia patients as seen in EHRs which contain clinical notes, lab results, and detailed medical histories and claims data
Trial Locations
- Locations (1)
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
University of Massachusetts Medical School🇺🇸Worcester, Massachusetts, United States