Biography and Research Information
Metrics
- h-index: 24
- Publications: 121
- Citations: 4,387
Positions
-
Associate DirectorUS Food and Drug Administration White Oak Campus Office of Clinical Evidence and Analysis ORCID
-
Associate DirectorUniversity of Arkansas for Medical Sciences ORCID
Selected Publications
-
A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks (2024)
-
Using propensity scores to estimate effects of treatment initiation decisions: State of the science (2024)
-
Data sources and applied methods for paclitaxel safety signal discernment (2024)
-
RWD139 Enhancing Public Health Through Timely Detection: Assessing the Value of Real-World Evidence With a Cardiovascular Defibrillator Leads Case Study (2024)
-
Developing a Coordinated Registry Network for devices used for acute ischemic stroke intervention: basilar artery occlusion quality assessment pilot (2024)
-
Validation of algorithms in studies based on routinely collected health data: general principles (2024)
-
Determining the value of the abdominal core health quality collaborative to support regulatory decisions (2024)
-
Data sources and applied methods for paclitaxel safety signal discernment (2024)
-
The association of major adverse limb events and combination stent and atherectomy in patients undergoing revascularization for lower extremity peripheral artery disease (2023)
-
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices (2023)
-
Building the foundation for a modern patient-partnered infrastructure to study temporomandibular disorders (2023)
-
A Quantitative Framework to Identify and Prioritize Opportunities in Biomedical Product Innovation (2023)
-
Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network (2023)
-
Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies (2023)
-
Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN) (2022)
Collaboration Network
Top Collaborators
- IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage
- The International Consortium of Orthopaedic Registries: Overview and Summary
- Association Between Endoscopic vs Open Vein-Graft Harvesting and Mortality, Wound Complications, and Cardiovascular Events in Patients Undergoing CABG Surgery
- Sex and Risk of Hip Implant Failure
- The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices
Showing 5 of 50 shared publications
- Registry-Based Prospective, Active Surveillance of Medical-Device Safety
- A Framework for Evidence Evaluation and Methodological Issues in Implantable Device Studies
- Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices
- Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence
- Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing
Showing 5 of 20 shared publications
- Association of Sex With Risk of 2-Year Revision Among Patients Undergoing Total Hip Arthroplasty
- Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies
- A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks
- Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies
- Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network
Showing 5 of 18 shared publications
- Real-World Evidence — What Is It and What Can It Tell Us?
- Association Between Endoscopic vs Open Vein-Graft Harvesting and Mortality, Wound Complications, and Cardiovascular Events in Patients Undergoing CABG Surgery
- Sex and Risk of Hip Implant Failure
- Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices
- Risk of Revision for Fixed Versus Mobile-Bearing Primary Total Knee Replacements
Showing 5 of 15 shared publications
- Registry-Based Prospective, Active Surveillance of Medical-Device Safety
- Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices
- Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing
- Elevated B-Type Natriuretic Peptide Is Associated With Increased In-Hospital Mortality or Cardiac Arrest in Patients Undergoing Implantable Cardioverter-Defibrillator Implantation
- Selection of prosthetic aortic valves in the United States among elderly Medicare patients from 2006 to 2015
Showing 5 of 14 shared publications
- Registry-Based Prospective, Active Surveillance of Medical-Device Safety
- Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices
- Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks
- Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing
- Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment
Showing 5 of 12 shared publications
- Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: A Cardiac Safety Research Consortium “Incubator” Think Tank
- Disproportionality analysis for signal detection of implantable cardioverter–defibrillator‐related adverse events in the Food and Drug Administration Medical Device Reporting System
- Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: A Review of the Literature
- Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
- Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: FDA Patient-Level Meta-Analysis of Premarket Clinical Trials
Showing 5 of 11 shared publications
- Association Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes
- Contemporary incidence, outcomes, and survival associated with endovascular aortic aneurysm repair conversion to open repair among Medicare beneficiaries
- Association of Sex With Risk of 2-Year Revision Among Patients Undergoing Total Hip Arthroplasty
- Editor's Choice – Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention
- Two-Year Revision Rates in Total Ankle Replacement Versus Ankle Arthrodesis
Showing 5 of 11 shared publications
- The International Consortium of Orthopaedic Registries: Overview and Summary
- Sex and Risk of Hip Implant Failure
- National and International Postmarket Research and Surveillance Implementation
- Risk of Revision for Fixed Versus Mobile-Bearing Primary Total Knee Replacements
- Stages and Tools for Multinational Collaboration: The Perspective from the Coordinating Center of the International Consortium of Orthopaedic Registries (ICOR)
Showing 5 of 10 shared publications
- The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices
- Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks
- Contemporary incidence, outcomes, and survival associated with endovascular aortic aneurysm repair conversion to open repair among Medicare beneficiaries
- Editor's Choice – Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention
- Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions
Showing 5 of 10 shared publications
- Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: A Cardiac Safety Research Consortium “Incubator” Think Tank
- Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies
- Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: A Cardiac Safety Research Consortium “Incubator” Think Tank
- Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank
- Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Showing 5 of 9 shared publications
- Registry-Based Prospective, Active Surveillance of Medical-Device Safety
- Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks
- Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies
- Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank
- Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet)
Showing 5 of 8 shared publications
- Editorial: Arthroplasty Devices: Registries and Beyond
- An in silico framework for integrating epidemiologic and genetic evidence with health care applications: ventilation-related pneumothorax as a case illustration
- Abstract 26: Comparison of Medicare Claims with Clinical Trial Outcomes for Follow-up of Older Individuals with Acute Coronary Syndrome
- Opportunities and Challenges of Retrieval Analysis: The Role of Standardized Periprosthetic Tissue and Fluid Analysis for Assessing an Aggravated Host Response
- Data sources and applied methods for paclitaxel safety signal discernment
Showing 5 of 8 shared publications
- The STS-ACC Transcatheter Valve Therapy National Registry
- Association Between Endoscopic vs Open Vein-Graft Harvesting and Mortality, Wound Complications, and Cardiovascular Events in Patients Undergoing CABG Surgery
- Association Between Endoscopic vs Open Vein-Graft Harvesting and Mortality, Wound Complications, and Cardiovascular Events in Patients Undergoing CABG Surgery
- Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
- Long-Term Outcomes After Transmyocardial Revascularization
Showing 5 of 7 shared publications
- A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty
- Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Hip Arthroplasty
- Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: A Cardiac Safety Research Consortium “Incubator” Think Tank
- Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: A Cardiac Safety Research Consortium “Incubator” Think Tank
- Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Showing 5 of 7 shared publications