Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
ConditionChlamydial Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-44
SponsorSanofi
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
For the primary objectives, the study population will include patients aged 14 to 44 years old identified between 1 January 2016 and 31 October 2024 in TriNetX USA Network. Patients are eligible if they have at least one ICD-10-CM diagnosis code for chlamydia or a known Nucleic Acid Amplification Test (NAAT) result. For the secondary objectives, the study population includes 1.) patients aged 14 to 44 years with at least one ICD-10-CM diagnosis code for chlamydia between 1 February 2016 and 30 November 2023 in the MarketScan CCAE database and 2.) patients aged 14 to 44 years with an ICD-10-CM diagnosis code for chlamydia or a positive NAAT result for chlamydia between 1 January 2016 and 31 October 2024 in TriNetX Dataworks USA.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
533,000 Participants
are grouped into 3 trial groupsGroup A: Cohort 1 (primary objective)
Group B: Cohort 2 (secondary objective)
Group C: Cohort 3 (secondary objective)
Trial outcomes
Primary outcomes
1
Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections
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
Time frame
From year 2016 through year 20242
Descriptive analyses of chlamydia patients
Describe demographic characteristics, laboratory testing, and treatment patterns among true positive and false negative chlamydia patients
Time frame
From year 2016 through year 2024Secondary outcomes
1
Validity of CCAE Database for Chlamydial Infections
Detect chlamydia cases using a mix of diagnostic codes, lab test codes, treatments, to detect/confirm chlamydia infection
Time frame
From year 2016 through year 20232
Comparison of chlamydia patient characteristics between EHR and claims RWD sources in the US
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
Time frame
From year 2016 through year 2024 Source ClinicalTrials.gov