How well chlamydia diagnosis codes in US electronic health records match lab results

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

We will test whether diagnosis codes in a large US electronic health record database match laboratory test results for people with chlamydia.

Quick facts

• Study type: Observational
• Enrollment: 533000 (estimated)
• Ages: 14 Years to 44 Years
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Locations: 1 site (Worcester, Massachusetts)
• Trial ID: NCT07094373 on ClinicalTrials.gov

What this trial studies

This project uses de-identified US electronic health record data from the TriNetX network to compare ICD-10-CM diagnostic codes for chlamydia with nucleic acid amplification test (NAAT) results. Researchers will identify patients with either a chlamydia diagnosis code or a NAAT result and use the first-recorded code or test as the index date, requiring at least one clinical visit within 30 days before and after that date. The primary analyses will validate ICD-10-CM code accuracy and describe testing and treatment patterns; a secondary aim will explore adapting the identification algorithm for commercial claims datasets. All work uses existing records and does not involve new patient visits or interventions.

Who should consider this trial

Good fit: Ideal candidates are people whose medical records in the TriNetX US network include either an ICD-10-CM code for chlamydia or a recorded NAAT result and at least one visit within 30 days before and after that record.

Not a fit: People without recorded lab results or diagnosis codes in the TriNetX network, or whose records lack visits near the index date, are unlikely to contribute to or benefit from this validation.

Why it matters

Potential benefit: If successful, this could make research using routine EHR data more reliable, helping guide chlamydia prevention and vaccine development.

How similar studies have performed: Previous code-validation work for infectious diseases has shown mixed accuracy depending on the condition and dataset, so this application to chlamydia in TriNetX is important but not yet established.

Eligibility criteria

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.

Where this trial is running

Worcester, Massachusetts

• University of Massachusetts Medical School — Worcester, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Chlamydial Infections