Research-grade data in the real world: challenges and opportunities in data quality from a pragmatic trial in community-based practices

Abstract

Randomized controlled trials face cost, logistic, and generalizability limitations, including difficulty engaging racial/ethnic minorities. Real-world data (RWD) from pragmatic trials, including electronic health record (EHR) data, may produce intervention evaluation findings generalizable to diverse populations. This case study of Project IMPACT describes unique barriers and facilitators of optimizing RWD to improve health outcomes and advance health equity in small immigrant-serving community-based practices. Project IMPACT tested the effect of an EHR-based health information technology intervention on hypertension control among small urban practices serving South Asian patients. Challenges in acquiring accurate RWD included EHR field availability and registry capabilities, cross-sector communication, and financial, personnel, and space resources. Although using RWD from community-based practices can inform health equity initiatives, it requires multidisciplinary collaborations, clinic support, procedures for data input (including social determinants), and standardized field logic/rules across EHR platforms.

Keywords: data quality; health equity; health information technology; immigrants; pragmatic trials; real world data.

Figure 1.

Collaborative partners and associated roles. Abbreviations: CDC, Centers for Disease Control and Prevention; EHR, electronic health record.

Figure 2.

BP value assessed on 12/31/2018 using 2 methods (custom data query vs built-in registry report) to identify patients with uncontrolled HTN between 1/1/18 and 6/30/18. Abbreviations: BP, blood pressure; HTN, hypertension.