The IeDEA Data Exchange Standard: a common data model for global HIV cohort collaboration

Abstract

Objective To describe content domains and applications of the IeDEA Data Exchange Standard, its development history, governance structure, and relationships to other established data models, as well as to share open source, reusable, scalable, and adaptable implementation tools with the informatics community. Methods In 2012, the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration began development of a data exchange standard, the IeDEA DES, to support collaborative global HIV epidemiology research. With the HIV Cohorts Data Exchange Protocol as a template, a global group of data managers, statisticians, clinicians, informaticians, and epidemiologists reviewed existing data schemas and clinic data procedures to develop the HIV data exchange model. The model received a substantial update in 2017, with annual updates thereafter. Findings The resulting IeDEA DES is a patient-centric common data model designed for HIV research that has been informed by established data models from US-based electronic health records, broad experience in data collection in resource-limited settings, and informatics best practices. The IeDEA DES is inherently flexible and continues to grow based on the ongoing stewardship of the IeDEA Data Harmonization Working Group with input from external collaborators. Use of the IeDEA DES has improved multiregional collaboration within and beyond IeDEA, expediting over 95 multiregional research projects using data from more than 400 HIV care and treatment sites across seven global regions. A detailed data model specification and REDCap data entry templates that implement the IeDEA DES are publicly available on GitHub. Conclusions The IeDEA common data model and related resources are powerful tools to foster collaboration and accelerate science across research networks. While currently directed towards observational HIV research and data from resource-limited settings, this model is flexible and extendable to other areas of health research.

Effects of National Adoption of Treat-All Guidelines on Pre-Antiretroviral Therapy (ART) CD4 Testing and Viral Load Monitoring After ART initiation: A Regression Discontinuity Analysis

“…The IeDEA consortium pools observational clinical data on approximately 1.7 million PLWH ever enrolling in care at approximately 400 care and treatment sites in 46 countries [ 19 ]—sites whose practices reflect national and local treatment guidelines. De-identified data were approved for use by local research ethics committees and were standardized in accordance with IeDEA data definitions [ 20 ].…”

Long-term HIV care outcomes under universal HIV treatment guidelines: A retrospective cohort study in 25 countries

“…Our study population was drawn from IeDEA’s cohorts in the Asia-Pacific, Central Africa, East Africa, the Caribbean, Central and South America, and North America regions, which agreed to the use of their data for this retrospective cohort study, based on a concept proposal approved by IeDEA’s executive committee. Deidentified patient data from participating IeDEA cohorts were standardized in accordance with IeDEA data definitions [ 18 ]. The research was approved by the City University of New York (CUNY) University Institutional Review Board (#2018–0809).…”

“…For each country in participating regional cohorts, we identified the date universal ART eligibility was extended to all adult patients, based on policy documents, literature, and inputs from in-country experts, as described elsewhere [ 19 ]. Patients were eligible if they were at least 15 years of age and ART naïve at the time of enrollment in HIV care at an IeDEA site, enrolled in care in the 24 months immediately before national adoption of universal treatment guidelines or in the first 12 months thereafter, and enrolled in care at least 12 months before database closure (i.e., submission of data to IeDEA’s regional data centers for processing in accordance with IeDEA’s data exchange standards [ 18 ]). For cohorts that deidentify patient data by shifting patient encounter dates by <30 days, we excluded all patients enrolling in care within +/− 30 days of the date of guideline adoption.…”

Lessons learned from over a decade of data audits in international observational HIV cohorts in Latin America and East Africa

“…Although a small number of sites have left the networks over time (e.g., due to funding challenges, changes in leadership, reduced capacity for research, and inadequate data gathering), the variables gathered and harmonized have remained consistent. To support data harmonization across regions, database structures for both regional cohorts are modeled after the HIV Cohorts Data Exchange Protocol and the IeDEA Data Exchange Standard [ 34 , 35 ]. Clinical source documents at participating HIV clinics include both paper-based patient charts and EHR systems.…”