Research Interests
I believe that we can and should leverage electronic health data for clinical research and quality assessment. While not the answer to all questions, real-world data (RWD) like health care claims data and electronic health record (EHR) data contain a wealth of information.
I’m currently working to bring RWD to many different projects:
- FDA Sentinel Initiative: I am responsible for the team that transforms and manages the 100% Medicare and 100% Medicaid claims data, within the CMS Virtual Research Data Center (VRDC), for the Sentinel distributed database. FDA uses this database to monitor its regulated medical products.
- Pragmatic Clinical Trials: I am working with the Data Coordinating Centers for multiple trials to obtain and incorporate RWD for participants into clinical trial databases. This is one way we hope to make trials more pragmatic and lower cost. Good examples of this work include the ADAPTABLE [ClinicalTrials.gov Identifier: NCT02697916] and PREVENTABLE [NCT04262206] trials. Both are pragmatic mega-trials relying on RWD for outcomes. Other trials leveraging real-world data that I am or have been involved with include HARMONY [NCT02465515], CEPIO-D [NCT03749629], and PRECIDENTD.
- NIH Cohort Studies: I have partnered with multiple investigators at other universities who run cohort studies sponsored by the National Heart, Lung, and Blood Institute to link Medicare claims data for their study participants. These studies include the Framingham Heart Study, the Strong Heart Study, the Jackson Heart Study, the Cardiovascular Health Study (CHS), and MESA (Multi-Ethnic Study of Atherosclerosis).
- Health System Performance: I am working closely with Duke University Health System quality leadership to explore and benchmark performance using the same claims data that CMS, US News & World Report, and other ratings groups rely on. We have a keen interest in understanding the potential role of neighborhood deprivation on clinical outcomes and how this may affect hospital performance estimates.
Of course, for healthcare research, it is not easy to extract value out of RWD. Meaningful, actionable results require rigorous study design, a deep knowledge of data provenance, and appropriate statistical methods. I have a commitment to quality in all of these areas.
I’m currently working to bring RWD to many different projects:
- FDA Sentinel Initiative: I am responsible for the team that transforms and manages the 100% Medicare and 100% Medicaid claims data, within the CMS Virtual Research Data Center (VRDC), for the Sentinel distributed database. FDA uses this database to monitor its regulated medical products.
- Pragmatic Clinical Trials: I am working with the Data Coordinating Centers for multiple trials to obtain and incorporate RWD for participants into clinical trial databases. This is one way we hope to make trials more pragmatic and lower cost. Good examples of this work include the ADAPTABLE [ClinicalTrials.gov Identifier: NCT02697916] and PREVENTABLE [NCT04262206] trials. Both are pragmatic mega-trials relying on RWD for outcomes. Other trials leveraging real-world data that I am or have been involved with include HARMONY [NCT02465515], CEPIO-D [NCT03749629], and PRECIDENTD.
- NIH Cohort Studies: I have partnered with multiple investigators at other universities who run cohort studies sponsored by the National Heart, Lung, and Blood Institute to link Medicare claims data for their study participants. These studies include the Framingham Heart Study, the Strong Heart Study, the Jackson Heart Study, the Cardiovascular Health Study (CHS), and MESA (Multi-Ethnic Study of Atherosclerosis).
- Health System Performance: I am working closely with Duke University Health System quality leadership to explore and benchmark performance using the same claims data that CMS, US News & World Report, and other ratings groups rely on. We have a keen interest in understanding the potential role of neighborhood deprivation on clinical outcomes and how this may affect hospital performance estimates.
Of course, for healthcare research, it is not easy to extract value out of RWD. Meaningful, actionable results require rigorous study design, a deep knowledge of data provenance, and appropriate statistical methods. I have a commitment to quality in all of these areas.
Selected Grants
UrogynCREST Program
ResearchCourse Faculty · Awarded by National Institutes of Health · 2019 - 2029PDUFA VII: Task 1, Project 1, Signal Detection - Pregnancy registries versus electronic healthcare database studies (MAX Data Incorporation)
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2024 - 2027The REHAB-HFpEF Trial - Year 2
ResearchCo Investigator · Awarded by Wake Forest University · 2022 - 2027HOME RUN HITTER - Blue Button
ResearchPrincipal Investigator · Awarded by Vanderbilt University Medical Center · 2023 - 2027A Life Course Approach to Identify Risks of Hospitalization in Older Adults with Heart Failure
ResearchCo Investigator · Awarded by National Institutes of Health · 2022 - 2027The Path to Improving Diabetic Retinopathy Outcomes: Evaluating Neighborhood Characteristics and Healthcare Quality
ResearchCo-Principal Investigator · Awarded by National Institutes of Health · 2024 - 2026Strong Heart Study Coordinating Center
ResearchPrincipal Investigator · Awarded by The University of Oklahoma Health Sciences Center · 2019 - 2026Jackson Heart Study Cardiovascular Disease Working Group and Medicare Data Linkage
ResearchCo Investigator · Awarded by University of Mississippi Medical Center · 2023 - 2025Use and Effectiveness of Outpatient Intravenous Diuretic Therapy as Treatment for Worsening Heart Failure
ResearchMentor · Awarded by American Heart Association · 2022 - 2025Framingham Heart Study
ResearchPrincipal Investigator · Awarded by Boston University · 2019 - 2025Sentinel Year 10 (OY2024) Querying Work Order Activity 1: ARIA
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2023 - 2024Sentinel Year 10 (OY2024) Infrastructure
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2023 - 2024SCDM 8.2.0 Implementation
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2023 - 2024Sentinel Year 10 (OY2024) Querying Work Order Activity 2: COVID ARIA
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2023 - 2024Data Expansion: Integration of T-MSIS Medicaid Data for Sentinel Routine Querying
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2021 - 2024COPD, Asthma, And Respiratory Disease Effectiveness (CARE) For 21st Century Cures
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2019 - 2024FDA-Catalyst alignment with the CMS linkage to the PCORI RELIANCE trial
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2019 - 2024Sentinel WO2016 Mod #8: Approaches to handling partially observed confounder data from (EHR) in NRS of MC
ResearchCo Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2022 - 2024Framingham Heart Study
ResearchPrincipal Investigator · Awarded by Boston University · 2023 - 2024Strong Heart Study Coordinating Center
ResearchPrincipal Investigator · Awarded by The University of Oklahoma Health Sciences Center · 2023 - 2024Sentinel WO 1036-5 Mod #11Feasibility assessment of using FHIR APIs to link EHR data from healthcare delivery organizations with T-MSIS claims data to improve the interoperability of EHR data
ResearchCo Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2022 - 2024Examining Medicare Reliance after Implementation of Medicare Payment Reform and the ACA Marketplace
ResearchCo Investigator · Awarded by Robert Wood Johnson Foundation · 2021 - 2023Sentinel Year 9 (OY2023) Querying Work Order - CMS and ASMD (Activity 1)
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2022 - 2023Sentinel Year 9 (OY2023) Infrastructure
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2022 - 2023Sentinel Year 9 (OY2023) Querying Work Order - CMS and ASMD (Activity 2)
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2022 - 2023Jackson Heart Study Cardiovascular Disease (CVD) Working Group and Medicare Data Linkage
ResearchCo Investigator · Awarded by University of Mississippi Medical Center · 2022 - 2023ADAPTABLE Supplement
Clinical TrialProgram Director · Awarded by Patient-Centered Outcomes Research Institute · 2015 - 2023SCDM 8.1.0 Implementation
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2022 - 2023Strong Heart Study Coordinating Center
ResearchPrincipal Investigator · Awarded by The University of Oklahoma Health Sciences Center · 2022 - 2023Comparative Effectiveness of Pharmacogenomics for Treatment of Depression (CEPIO-D)
ResearchPrincipal Investigator · Awarded by Massachusetts General Hospital · 2020 - 2023Evaluating fitness-for-use of Electronic Health Records in Clinical Research
ResearchCo Investigator · Awarded by Food and Drug Administration · 2019 - 2022Sentinel Year 8 (OY2022) Infrastructure
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2021 - 2022Sentinel Year 8 (OY2022) Querying
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2021 - 2022Jackson Heart Study Cardiovascular Disease (CVD) Working Group and Medicare Data Linkage
ResearchCo Investigator · Awarded by University of Mississippi Medical Center · 2021 - 2022Framingham Heart Study
ResearchPrincipal Investigator · Awarded by Boston University · 2021 - 2022Strong Heart Study Coordinating Center
ResearchPrincipal Investigator · Awarded by The University of Oklahoma Health Sciences Center · 2021 - 2022Administrative Claims-based Efficiencies for the Advancement of Regulatory Sciences
ResearchSenior Statistician · Awarded by Burroughs Wellcome Fund · 2014 - 2021Sentinel Year 7 (OY2021) Infrastructure
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2020 - 2021Sentinel Year 7 (OY2021) Querying - Duke University (for Medicare FFS)
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2020 - 2021Jackson Heart Study Cardiovascular Disease (CVD) Working Group and Medicare Data Linkage
ResearchCo Investigator · Awarded by University of Mississippi Medical Center · 2020 - 2021Characterizing Health Disparities in the Shift to North Carolina Medicaid Managed Care
ResearchInvestigator · Awarded by Kate B. Reynolds Charitable Trust · 2020 - 2021SCDM 8.0.0 Implementation: Addition of a Prescribing table, Addition of code types for Dispensing, Diagnosis, and Procedure tables, and Enhancements for Provider and Facility Identification
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2020 - 2021Strong Heart Study Coordinating Center
ResearchPrincipal Investigator · Awarded by The University of Oklahoma Health Sciences Center · 2020 - 2021Sentinel Year 6 (OY2020) Infrastructure
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2019 - 2020Fitness-for-Use of Electronic Health Records as Source Data for Clinical Research Option Period 3
ResearchCo Investigator · Awarded by Food and Drug Administration · 2019 - 2020Fitness-for-Use of Electronic Health Records as Source Data for Clinical Research- Option 1
ResearchCo Investigator · Awarded by Food and Drug Administration · 2016 - 2020Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)
Clinical TrialInvestigator · Awarded by Patient-Centered Outcomes Research Institute · 2015 - 2020Jackson Heart Study Cardiovascular Disease (CVD) Working Group and Medicare Data Linkage
ResearchCo Investigator · Awarded by University of Mississippi Medical Center · 2019 - 2020Framingham Heart Study
ResearchPrincipal Investigator · Awarded by Boston University · 2019 - 2020Linking Medicare Claims and the SJM Patient Database
ResearchPrincipal Investigator · Awarded by St. Jude Medical Inc. · 2017 - 2019Opioid Utilization and Treatment in North Carolina
ResearchInvestigator · Awarded by Laura and John Arnold Foundation · 2018 - 2019Center for Medicare & Medicaid Services (CMS) Available Data Evaluation
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2019 - 2019Methodology for Linking Clinical and Administrative Databases
ResearchSenior Statistician · Awarded by Patient-Centered Outcomes Research Institute · 2014 - 2019Fitness-for-Use of Electronic Health Records as Source Data for Clinical Research- Option 2
ResearchCo Investigator · Awarded by Food and Drug Administration · 2018 - 2019Enriching Center for Medicare & Medicaid Services (CMS) data source: fresher pharmacy data exploration and inclusion of NDI segment of the Master Beneficiary File
ResearchPrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2018 - 2018Task Order S08: 2018 Data Partner Summit
ConferencePrincipal Investigator · Awarded by Harvard Pilgrim Health Care, Inc. · 2018 - 2018Jackson Heart Study
ResearchPrincipal Investigator · Awarded by University of Mississippi Medical Center · 2013 - 2018A Collaboration for Improving Outcomes of African Americans with Heart Failure
ResearchCo Investigator · Awarded by National Institutes of Health · 2013 - 2018Trends in Outpatient Heart Failure Management over time
ResearchPrincipal Investigator · Awarded by Amgen, Inc. · 2017 - 2018Improving Data Completeness and Expanding Available Data Elements in the TVT Registry through the use of Electronic Health Record Based Data: Linking the TVT Registry and PCORnet
ResearchCo Investigator · Awarded by Mayo Clinic · 2016 - 2018CMS Linkage in Distributed Data Research Networks - Pilot Project
ResearchPrincipal Investigator · Awarded by Patient-Centered Outcomes Research Institute · 2015 - 2018HO-15-16139: Clinical, Epidemiological, and Health Economic Characteristics of Acute Decompensated Heart Failure Patients with Varying Degrees of Respiratory Involvement
ResearchPrincipal Investigator · Awarded by GlaxoSmithKline · 2016 - 2018Fitness-for-Use of Electronic Health Records as Source Data for Clinical Research
ResearchCo Investigator · Awarded by Food and Drug Administration · 2016 - 2018Increasing Patient and System Value with Community Based Palliative Care
ResearchStatistician · Awarded by Four Seasons · 2014 - 2017Urinary Dysfunction in the Elderly: Informing Accountable Urologic Care
ResearchSenior Statistician · Awarded by National Institutes of Health · 2014 - 2017Fragmentation of Medication Management in Medicare
ResearchCo Investigator · Awarded by Agency for Healthcare Research and Quality · 2014 - 2016Increasing Patient and System Value with Community Based Palliative Care
ResearchStatistician · Awarded by Four Seasons · 2014 - 2015MESA
ResearchPrincipal Investigator · Awarded by University of Washington · 2009 - 2015MESA
ResearchBiostatistician · Awarded by University of Washington · 2009 - 2015CHS
ResearchBiostatistician · Awarded by University of Washington · 2012 - 2015Jackson Heart Study
ResearchPrincipal Investigator · Awarded by University of Mississippi Medical Center · 2013 - 2015Framingham Study - Amendment 3
ResearchStatistical Programmer · Awarded by Boston University · 2014 - 2015CHS
ResearchBiostatistician · Awarded by University of Washington · 2009 - 2014Patterns of Health Care Use, Treatment & Outcomes in Atrial Fibrillation: PATH-AF
ResearchStatistician · Awarded by National Institutes of Health · 2010 - 2014ICD Therapy in Patients with Congestive Heart Failure
ResearchSenior Statistician · Awarded by National Institutes of Health · 2009 - 2014Comparative Effectiveness of Therapies for Heart Failure
ResearchBiostatistician · Awarded by Agency for Healthcare Research and Quality · 2010 - 2013DEcIDE DES TO4 W3
ResearchStatistician · Awarded by Agency for Healthcare Research and Quality · 2009 - 2012Novel Group Parent Training Program for Anorexia Nervosa
ResearchStatistician · Awarded by National Institutes of Health · 2005 - 2010Fatigue in HIV Positive People
ResearchStatistician · Awarded by National Institutes of Health · 2004 - 2010DEcIDE Health Outcomes of Carotid Artery Disease
ResearchStatistical Programmer · Awarded by Agency for Healthcare Research and Quality · 2007 - 2010Heart Failure : Epidemiology & Outcomes in the Elderly
ResearchStatistical Programmer · Awarded by National Institutes of Health · 2006 - 2009DCRI Research Center for CERTs
ResearchStatistical Programmer · Awarded by Agency for Healthcare Research and Quality · 1999 - 2008DCRI CERT for Cardiovascular Therapies
ResearchStatistician · Awarded by National Institutes of Health · 1999 - 2002External Relationships
- JAMA Network Open
- National Institute of Mental Health
This faculty member (or a member of their immediate family) has reported outside activities with the companies, institutions, or organizations listed above. This information is available to institutional leadership and, when appropriate, management plans are in place to address potential conflicts of interest.