Approaches to protocol standardization and data harmonization in the ECHO-wide cohort study

Abstract

The United States (U.S.) National Institutes of Health-funded Environmental influences on Child Health Outcomes (ECHO)-wide Cohort was established to conduct high impact, transdisciplinary science to improve child health and development. The cohort is a collaborative research design in which both extant and new data are contributed by over 57,000 children across 69 cohorts. In this review article, we focus on two key challenging issues in the ECHO-wide Cohort: data collection standardization and data harmonization. Data standardization using a Common Data Model and derived analytical variables based on a team science approach should facilitate timely analyses and reduce errors due to data misuse. However, given the complexity of collaborative research designs, such as the ECHO-wide Cohort, dedicated time is needed for harmonization and derivation of analytic variables. These activities need to be done methodically and with transparency to enhance research reproducibility. IMPACT: Many collaborative research studies require data harmonization either prior to analyses or in the analyses of compiled data. The Environmental influences on Child Health Outcomes (ECHO) Cohort pools extant data with new data collection from over 57,000 children in 69 cohorts to conduct high-impact, transdisciplinary science to improve child health and development, and to provide a national database and biorepository for use by the scientific community at-large. We describe the tools, systems, and approaches we employed to facilitate harmonized data for impactful analyses of child health outcomes.

Fig. 1. Demonstration of how the Cohort Measurement Identification Tool was used for collecting and reporting metadata about planned data collection.

a shows, in select screenshots, how the cohort used the tool to identify the relevant life stage, select the measures that will be used to collect data on Child Sleep Health (an outcome), and on Caregiver Stressful Life Events (an exposures). b is an excerpt from the Cohort Measurement Identification Tool summary report template that demonstrates how the Caregiver Stressful Life Events measures selected by the cohorts were summarized by frequencies across life stages.

Fig. 2

Collaborative uses of the Cohort Measurement Identification Tool (CMIT).

Fig. 3

Data systems managed by the Data Analysis Center (DAC).

Fig. 4

Central data harmonization processes following receipt of data files from the cohorts.