This is a joint agency project involving the Food and Drug Administration (FDA) and National Institutes of Health/ National Library of Medicine (NIH/NLM) that addresses the Patient-Centered Outcomes Research (PCOR) priority to expand data capacity or data infrastructure for conducting research that informs decisions about the effectiveness of health interventions used in the Medicaid and Children's Health Insurance Programs.
This project aims to develop and publish open source code to format Transformed Medicaid Statistical Information System (T-MSIS) Research Identifiable Files (RIFs) to the Sentinel Common Data Model (CDM) in tandem with NLM’s formatting of the T-MSIS RIFs to the Observational Medical Outcomes Partnership (OMOP) CDM. Data quality will be characterized using a harmonized Data Quality Assessment Framework for electronic healthcare data that was developed in a previously-funded OS-Patient-Centered Outcomes Research Trust Fund (OS-PCORTF) project. To illustrate the benefits of CDM transformation, open source tools will be used to conduct several studies of public health importance, such studies of maternal mortality and adherence to clinical guidelines for perinatal testing. Lastly, the project will assess the feasibility of using Fast Healthcare Interoperability Resources (FHIR) APIs (Application Programming Interfaces) to link Electronic Health Record (EHR) data to T-MSIS claims data.
This project covers several major task areas:
Task 1: Develop Open Source Code to Format the T-MSIS data into the Sentinel Common Data Model
Task 2: Leverage the ASPE funded Data Quality Metrics Model to Characterize Data Quality
Task 3: Develop Open Source Code to Create a Mother-Infant Linkage in the Sentinel CDM
Task 4: Patient Centered Outcomes Research Demonstration Project
Task 5: Evaluate the feasibility of implementing FHIR APIs to link T-MSIS data with EHR data
Task 6: Develop a training webinar series to train Medicaid researchers on the new data transformation tools and disseminate major findings
Judith C. Maro, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
David Money, RPh., PMH; Efe Eworuke, Ph.D., MSc; Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD;
Sarah Dutcher, PhD, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland
Patricia Bright, MSPH, PhD; Jamila Mwidau, RN, BSN, MPH; Sanae Cherkaoui, MS, MPH, CPH; Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD
Brad Hammill, DrPh; Steven J. Lippmann, PhD; Michael Stagner; Jessica E. Pritchard, PhD Department of Population Health Sciences, Duke University School of Medicine, Durham, NC
Christine Halbig, MPH; Laura Shockro, Katie Shapiro, Malcolm Rucker, MS; Lauren Zichittella, MS Alexander Mai; Daniel Kiernan; Suzanne Carter, PhD, MS, MBA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Robert Rosofsky, MA; Health Information Systems Consulting LLC, Milton, MA