Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform

Front Public Health. 2024 Jul 8:12:1379973. doi: 10.3389/fpubh.2024.1379973. eCollection 2024.

Abstract

Introduction: This study is part of the U.S. Food and Drug Administration (FDA)'s Biologics Effectiveness and Safety (BEST) initiative, which aims to improve the FDA's postmarket surveillance capabilities by using real-world data (RWD). In the United States, using RWD for postmarket surveillance has been hindered by the inability to exchange clinical data between healthcare providers and public health organizations in an interoperable format. However, the Office of the National Coordinator for Health Information Technology (ONC) has recently enacted regulation requiring all healthcare providers to support seamless access, exchange, and use of electronic health information through the interoperable HL7 Fast Healthcare Interoperability Resources (FHIR) standard. To leverage the recent ONC changes, BEST designed a pilot platform to query and receive the clinical information necessary to analyze suspected AEs. This study assessed the feasibility of using the RWD received through the data exchange of FHIR resources to study post-vaccination AE cases by evaluating the data volume, query response time, and data quality.

Materials and methods: The study used RWD from 283 post-vaccination AE cases, which were received through the platform. We used descriptive statistics to report results and apply 322 data quality tests based on a data quality framework for EHR.

Results: The volume analysis indicated the average clinical resources for a post-vaccination AE case was 983.9 for the median partner. The query response time analysis indicated that cases could be received by the platform at a median of 3 min and 30 s. The quality analysis indicated that most of the data elements and conformance requirements useful for postmarket surveillance were met.

Discussion: This study describes the platform's data volume, data query response time, and data quality results from the queried postvaccination adverse event cases and identified updates to current standards to close data quality gaps.

Keywords: adverse event (AE); data quality; electronic health record (EHR); fast healthcare interoperability resources (FHIR); health information technology; interoperability; public health; real-world data (RWD).

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems / standards
  • Data Accuracy*
  • Electronic Health Records / standards
  • Electronic Health Records / statistics & numerical data
  • Female
  • Health Information Exchange / standards
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Product Surveillance, Postmarketing / standards
  • Product Surveillance, Postmarketing / statistics & numerical data
  • Time Factors
  • United States
  • United States Food and Drug Administration*
  • Vaccination / adverse effects

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This research was funded through the FDA CBER BEST Initiative. Several co-authors hold commercial affiliations with IBM Consulting and Cedars-Sinai Health System. IBM Consulting (MD, BG, AS, AP and LJ), and Cedars-Sinai Health System (RD) provided support in the form of salaries for authors, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.