Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jan 10;6(1):ooac108.
doi: 10.1093/jamiaopen/ooac108. eCollection 2023 Apr.

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation

Yue Yu  1 , Guoqian Jiang  2 , Eric Brandt  3 , Tom Forsyth  3 , Sanket S Dhruva  4 , Shumin Zhang  5 , Jiajing Chen  3 , Peter A Noseworthy  6 , Amit A Doshi  7 , Kimberly Collison-Farr  3 , Dure Kim  8 , Joseph S Ross  9 , Paul M Coplan  5   10 , Joseph P Drozda Jr  3
Affiliations

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation

Yue Yu et al. JAMIA Open. .

Abstract

The objective of this study is to describe application of the Observational Medical Outcomes Partnership (OMOP) common data model (CDM) to support medical device real-world evaluation in a National Evaluation System for health Technology Coordinating Center (NESTcc) Test-Case involving 2 healthcare systems, Mercy Health and Mayo Clinic. CDM implementation was coordinated across 2 healthcare systems with multiple hospitals to aggregate both medical device data from supply chain databases and patient outcomes and covariates from electronic health record data. Several data quality assurance (QA) analyses were implemented on the OMOP CDM to validate the data extraction, transformation, and load (ETL) process. OMOP CDM-based data of relevant patient encounters were successfully established to support studies for FDA regulatory submissions. QA analyses verified that the data transformation was robust between data sources and OMOP CDM. Our efforts provided useful insights in real-world data integration using OMOP CDM for medical device evaluation coordinated across multiple healthcare systems.

Keywords: OMOP CDM; UDI; medical data standardization; medical device.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Data Integration model at Mercy and Mayo Clinic.
Figure 2.
Figure 2.
OMOP CDM statistics for tables used. CDM: common data model; OMOP: Observational Medical Outcomes Partnership.
Figure 3.
Figure 3.
Concept set statistics by different analysis usage categories. *The codes in the “safety outcome” set are used to identify charts for review for potential safety events. All safety outcomes were identified by physician chart review.
See this image and copyright information in PMC

References

    1. Krucoff MW, Sedrakyan A, Normand SL.. Bridging nnmet medical device ecosystem needs with strategically coordinated registries networks. JAMA 2015; 314 (16): 1691–2. - PubMed
    1. Center for Devices and Radiological Health, US Food and Drug Administration. Strengthening our national system for medical device postmarket surveillance. 2013. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProd.... Accessed July 29, 2022.
    1. US Food and Drug Administration. 2018-2020 Strategic Priorities. Center for Devices and Radiological Health. 2018. https://www.fda.gov/media/110478/download. Accessed July 29, 2022.
    1. Drozda JP Jr, Roach J, Forsyth T, et al.Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration. J Am Med Inform Assoc 2018; 25 (2): 111–20. - PMC - PubMed
    1. Dhalluin T, Fakhiri S, Bouzillé G, et al.Role of real-world digital data for orthopedic implant automated surveillance: a systematic review. Expert Rev Med Devices 2021; 18 (8): 799–810. - PubMed

LinkOut - more resources