Validation of Diagnostic Codes for Identifying Chlamydial Infections From TriNetX Electronic Health Record Data in the United States
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sanofi
- Enrollment
- 533,000
- Locations
- 1
- Primary Endpoint
- Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections
Study Overview
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:
- 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
- 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:
- 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
- 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 14 Years to 44 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
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
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
Outcomes
Primary Outcomes
Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections
Time Frame: 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
Time Frame: From year 2016 through year 2024
Describe demographic characteristics, laboratory testing, and treatment patterns among true positive and false negative chlamydia patients
Secondary Outcomes
- Validity of CCAE Database for Chlamydial Infections(From year 2016 through year 2023)
- Comparison of chlamydia patient characteristics between EHR and claims RWD sources in the US(From year 2016 through year 2024)