Assoc Prof Clinical Medicine
M_MED-VAMC-CARD
Publications
What Observational Research Contributes and What It Requires: The Devil Is in the Design.
Journal of the American College of Cardiology
An Unfinished ANTHEM: Ethics, Evidence, and Early Trial Termination.
Journal of the American College of Cardiology
Cardiovascular Regulatory Science: Accelerating the Path from Bench to Bedside.
American heart journal
A Standardized Statistical Framework for Population Surveillance Using the National Health Interview Survey.
JACC. Advances
Dietary Quality by Sex, Age, and Race/Ethnicity: A JACC Data Report on Trends in the United States, 1999-2020.
Journal of the American College of Cardiology
Exercise by Atherosclerotic Cardiovascular Disease Status: A JACC Data Report on Trends in the United States, 2020-2024.
Journal of the American College of Cardiology
Health Care Access by Atherosclerotic Cardiovascular Disease Status: A JACC Data Report on Trends in the United States, 2019-2024.
Journal of the American College of Cardiology
Health Care Affordability by Atherosclerotic Cardiovascular Disease Status: A JACC Data Report on Trends in the United States, 2019-2024.
Journal of the American College of Cardiology
Health Care Utilization by Atherosclerotic Cardiovascular Disease Status: A JACC Data Report on Trends in the United States, 2019-2024.
Journal of the American College of Cardiology
Out-of-Pocket Costs and Financial Burden Among Working-Age Adults With Cardiovascular Conditions: A JACC Data Report on Trends in the United States, 2007-2022.
Journal of the American College of Cardiology
Sleep Duration by Atherosclerotic Cardiovascular Disease Status: A JACC Data Report on Trends in the United States, 2020-2024.
Journal of the American College of Cardiology
Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support.
Medical devices (Auckland, N.Z.)
When the System Works-and Why it so Often Does Not: Building a Learning Infrastructure for High-Risk Medical Devices.
Journal of the American College of Cardiology
Shared Decision-Making and Patient Decision Aids for Percutaneous Left Atrial Appendage Occlusion.
JAMA network open
The Food and Drug Administration's role in supporting therapeutic development to address unmet needs: the National Academies report and beyond.
Health affairs scholar
Artificial Intelligence to Propel Evidence Generation.
Journal of the American College of Cardiology
Cardiovascular Statistics in the United States, 2026: JACC Stats.
Journal of the American College of Cardiology
Automatic Medicare Coverage for New Medical Technologies - Here We Go Again.
The New England journal of medicine
Correlates of Nocturnal Hypertension in a Real-World Cohort.
American journal of hypertension
Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support.
medRxiv : the preprint server for health sciences
Postmarket Data-Real World Safety Evaluation of Pulsed Field Ablation-and Beyond.
Journal of the American College of Cardiology
Hospital Acquisition Costs for Breakthrough-Designated Devices Awarded Supplemental Medicare Reimbursement.
JAMA health forum
Blood Pressure Control and Maintenance in U.S. Veterans: Roles of Sex, Race, Ethnicity, and Deprivation.
JACC. Advances
Insurer Coverage of Invasive Coronary Angiography and Percutaneous Coronary Intervention for Stable Coronary Artery Disease in the United States Compared With Guidelines and Landmark Trials.
Circulation. Cardiovascular quality and outcomes
Evaluation of Payer Policies to Reduce Low-Value Medical Device-Based Procedure Use.
JAMA health forum
Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation.
Academic medicine : journal of the Association of American Medical Colleges
The Role of Clinicians in Advancing Cardiovascular Device Safety.
Journal of the American College of Cardiology
Phenome-Wide Risk Evaluation of GLP-1 Receptor Agonist Use in Type 2 Diabetes with Real-World Data Across Multiple Healthcare Systems.
medRxiv : the preprint server for health sciences
Outcomes associated with remote monitoring without in-person evaluations for patients with cardiovascular implantable electronic devices.
Heart rhythm O2
FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program.
JAMA internal medicine
Sex differences and the role of anemia in contrast-associated acute kidney injury after percutaneous coronary intervention.
The Journal of invasive cardiology
Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry.
American heart journal
JACC Data Report: Cardiovascular Disease Mortality Trends in the United States (1999-2023).
Journal of the American College of Cardiology
The Potential Role of Early Left Ventricular Unloading in ST-Segment Elevation Myocardial Infarction-Related Cardiogenic Shock.
Journal of the American College of Cardiology
Towards a dynamic model to estimate evolving risk of major bleeding after percutaneous coronary intervention.
PLOS digital health
Mechanical Circulatory Support in Acute Myocardial Infarction-Cardiogenic Shock: 2025 Acute Coronary Syndrome Guideline in Context.
Journal of the American College of Cardiology
Understanding Transient Left Ventricular Ejection Fraction Reduction During Atrial Fibrillation With Artificial Intelligence.
Journal of the American Heart Association
Complications Associated With Safety Mode Initiation in Recalled Boston Scientific Pacemakers.
Journal of the American College of Cardiology
Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices.
JAMA network open
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study.
BMJ (Clinical research ed.)
Supporting the Development of Drugs for Rare Diseases - The Importance of Regulatory Transparency.
The New England journal of medicine
Characterization of studies considered and required under Medicare's coverage with evidence development program.
Clinical trials (London, England)
Ten-Year Medicare Use and Spending on the 10 Drugs Selected for Negotiation Under the Inflation Reduction Act.
Journal of the American Heart Association
Tracking and Failure Analysis of Explanted Neuromodulation Devices.
Neuromodulation : journal of the International Neuromodulation Society
Services and payments associated with the medicare new technology add-on payment program.
Health affairs scholar
Medicare Payment for Calcium Modification Technologies Among Patients Undergoing Percutaneous Coronary Intervention, 2021-2022.
medRxiv : the preprint server for health sciences
Assessing Medicare's Coverage With Evidence Development Program.
Health affairs (Project Hope)
Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices.
Medical decision making : an international journal of the Society for Medical Decision Making
Representativeness of Studies Required Under Medicare's Coverage With Evidence Development Program.
JAMA
Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications.
Health affairs (Project Hope)
Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.
Annals of internal medicine
Quality of Life and Quality of Evidence for Subcutaneous Versus Transvenous Implantable Cardioverter-Defibrillators.
Circulation. Cardiovascular quality and outcomes
Medical Devices Applying for Outpatient Medicare Supplemental Payments.
JAMA health forum
Advances in Transcatheter Tricuspid Valve Interventions: Implications for Health Policy.
Journal of the American College of Cardiology
Implementation of a Cardiovascular Implantable Electronic Device Heart Failure Prediction Tool-Guided Management Pathway.
The American journal of cardiology
Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
Annals of internal medicine
If We Measure, We Can Improve.
Journal of the American College of Cardiology
Use of electronic health records to characterize patients with uncontrolled hypertension in two large health system networks.
BMC cardiovascular disorders
Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
Annals of internal medicine
Industry Payments to Cardiology Fellows and Early-Career Cardiologists.
JAMA internal medicine
Decreasing unnecessary use of continuous cardiac monitoring (telemetry) in hospitalised patients.
BMJ (Clinical research ed.)
Prescription Digital Therapeutics: The Authors Reply.
Health affairs (Project Hope)
Funding of evidence included within public comments submitted to inform Medicare national coverage determinations.
Health affairs scholar
Utilization of Fixed-Dose Combination Treatment for Hypertension in Medicare and Medicaid From 2016 to 2020.
Circulation. Cardiovascular quality and outcomes
Medicare Coverage and Patient Out-of-Pocket Costs for Cardiovascular-Kidney-Metabolic Medications.
JAMA network open
Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014-2022.
Medical devices (Auckland, N.Z.)
Blood Pressure Control and Maintenance in a Prospective Cohort of Younger Veterans: Roles of Sex, Race, Ethnicity, and Social Determinants of Health.
medRxiv : the preprint server for health sciences
Hospital Prices for Physician-Administered Drugs. Reply.
The New England journal of medicine
Prices and complications in hospital-based and freestanding surgery centers.
The American journal of managed care
Informational letters or postcards to initiate remote monitoring among veterans with pacemakers and implantable cardioverter-defibrillators: A randomized, controlled trial.
Pacing and clinical electrophysiology : PACE
Monitoring of Remotely Reprogrammable Implantable Loop Recorders With Algorithms to Reduce False-Positive Alerts.
Journal of the American Heart Association
Use of Electronic Health Records to Characterize Patients with Uncontrolled Hypertension in Two Large Health System Networks.
Research square
Hospital Prices for Physician-Administered Drugs for Patients with Private Insurance.
The New England journal of medicine
Informational Postcards Increase Engagement with Remote Monitoring Among Veterans with Pacemakers and Implantable Cardioverter-Defibrillators: a Stepped-Wedge Randomized Controlled Trial.
Journal of general internal medicine
Physicians' Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey.
Health affairs (Project Hope)
Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program.
JAMA cardiology
Deep Learning of Electrocardiograms in Sinus Rhythm From US Veterans to Predict Atrial Fibrillation.
JAMA cardiology
Cardiac coronary tomography angiography (CCTA) use across geographical regions in the USA and the UK: a cross-sectional study.
BMJ surgery, interventions, & health technologies
Strategies to enhance remote monitoring adherence among patients with cardiovascular implantable electronic devices.
Heart rhythm O2
Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity.
Health affairs (Project Hope)
Systematic reprogramming of implantable cardioverter-defibrillators to match the 2019 consensus recommendations.
Heart rhythm
The Need for Randomized Clinical Trials Demonstrating Reduction in All-Cause Mortality With Blood Tests for Cancer Screening.
JAMA internal medicine
Unique Device Identifiers for Medical Devices at 10 Years.
JAMA internal medicine
Medical device risk (re)classification: lessons from the FDA's 515 Program Initiative.
BMJ surgery, interventions, & health technologies
Clinical Phenotyping with an Outcomes-driven Mixture of Experts for Patient Matching and Risk Estimation.
ACM transactions on computing for healthcare
Reply: The Challenge of Minimizing Unnecessary ICD Shocks While Also Preventing Syncope.
JACC. Clinical electrophysiology
Payer-Negotiated Prices for Cardiac Electrophysiology Procedures at 2022-2023 Top 100 US News & World Report for Cardiology and Heart Surgery Hospitals.
Circulation. Arrhythmia and electrophysiology
Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials.
Clinical trials (London, England)
Use of Electronic Health Records to Characterize Patients with Uncontrolled Hypertension in Two Large Health System Networks.
medRxiv : the preprint server for health sciences
Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022.
JAMA internal medicine
Physician Perspectives on the Food and Drug Administration's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease.
Clinical pharmacology and therapeutics
Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study.
Medical devices (Auckland, N.Z.)
Challenges and solutions to advancing health equity with medical devices.
Nature biotechnology
Physician responses to apple watch-detected irregular rhythm alerts.
American heart journal
Trends in Spending and Claims for P2Y12 Inhibitors by Medicare and Medicaid From 2015 to 2020.
Journal of the American Heart Association
Medical Device Modifications Through Premarket Approval Supplements-Ensuring Patient Safety.
JAMA network open
Identifying treatment heterogeneity in atrial fibrillation using a novel causal machine learning method.
American heart journal
Trends in FDA Adverse Events Reporting for Inferior Vena Cava Filters and Estimated Insertions in the US, 2016 to 2020.
JAMA internal medicine
Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.
BMJ surgery, interventions, & health technologies
Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia.
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
Ventricular arrhythmia detection for contemporary Biotronik and Abbott implantable cardioverter defibrillators with markedly prolonged detection in Biotronik devices.
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.
BMJ surgery, interventions, & health technologies
Traumatic Syncope Caused by Prolonged Ventricular Arrhythmias With a Defibrillator Programmed to 2019 Consensus Recommendations.
JACC. Clinical electrophysiology
Adding device identifiers to claims forms-a key step to advance medical device safety.
BMJ (Clinical research ed.)
A Policy Approach to Reducing Low-Value Device-Based Procedure Use.
The Milbank quarterly
Characterization of multi-domain postoperative recovery trajectories after cardiac surgery using a digital platform.
NPJ digital medicine
Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.
BMJ surgery, interventions, & health technologies
Medicare's National Coverage Determination for Aducanumab - A One-Off or a Pragmatic Path Forward?
The New England journal of medicine
Quantification of Device-Related Event Reports Associated With the CardioMEMS Heart Failure System.
Circulation. Cardiovascular quality and outcomes
Analysis of Patient-Focused Information About Left Atrial Appendage Occlusion on US Hospital Web Pages.
JAMA internal medicine
Emulating the GRADE trial using real world data: retrospective comparative effectiveness study.
BMJ (Clinical research ed.)
Gender Differences in Guideline-Directed Medical Therapy for Cardiovascular Disease Among Young Veterans.
Journal of general internal medicine
Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice.
JAMA network open
Diffusion of Percutaneous Ventricular Assist Devices in US Markets.
Circulation. Cardiovascular interventions
Implantable cardioverter-defibrillator placement among patients with left ventricular ejection fraction ≤35 % at least 40 days after acute myocardial infarction.
American heart journal plus : cardiology research and practice
Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure.
Journal of the American College of Cardiology
Medical Device User Fee Reauthorization - Back to Basics or Looking Ahead?
The New England journal of medicine
US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019.
JAMA internal medicine
Factors associated with remote monitoring adherence for cardiovascular implantable electronic devices.
Heart rhythm
Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel.
Clinical pharmacology and therapeutics
Evaluation of cardiovascular implantable electronic device leads post implant: ElectroPhysiology Predictable And SuStainable Implementation Of National Registries (EP PASSION).
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.
Journal of general internal medicine
2021 Update on Pediatric Overuse.
Pediatrics
Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019.
JAMA internal medicine
A 510(k) ancestry of robotic surgical systems.
International journal of surgery (London, England)
Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center.
BMJ surgery, interventions, & health technologies
Coverage of Transvenous Pulmonary Embolectomy - Medicare's Missed Opportunity for Evidence Generation.
The New England journal of medicine
Resource Utilization Following Coronary Computed Tomographic Angiography and Stress Echocardiography in Patients Presenting to the Emergency Department With Chest Pain.
The American journal of cardiology
Clinical studies sponsored by digital health companies participating in the FDA's Precertification Pilot Program: A cross-sectional analysis.
Clinical trials (London, England)
Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020.
JAMA internal medicine
Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment.
JAMA network open
Reply to the Editor-Denominator neglect in meta-analysis: electrical abnormalities in St. Jude/Abbott pacing leads.
Heart rhythm
Feasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: A fit-for-purpose informatics analysis report.
Journal of the American Medical Informatics Association : JAMIA
Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.
JAMA internal medicine
Electrical abnormalities with St. Jude/Abbott pacing leads: A systematic review and meta-analysis.
Heart rhythm
Trajectories of Pain After Cardiac Surgery: Implications for Measurement, Reporting, and Individualized Treatment.
Circulation. Cardiovascular quality and outcomes
Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices.
Cardiovascular digital health journal
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
Clinical trials (London, England)
Changing FDA Approval Standards: Ethical Implications for Patient Consent.
Journal of general internal medicine
Medicare's New Device-Coverage Pathway - Breakthrough or Breakdown?
The New England journal of medicine
Media Portrayals of Extracorporeal Membrane Oxygenation: The Unforeseen Harm of Unfounded Optimism.
JAMA internal medicine
GLASS(Y) Half-Full: Moving Towards Greater Pragmatism in Outcome Ascertainment for Clinical Trials.
Circulation. Cardiovascular quality and outcomes
Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019.
JAMA internal medicine
Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock.
JAMA network open
Trends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020.
JAMA network open
Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology.
BMJ surgery, interventions, & health technologies
Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019.
JAMA internal medicine
Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products.
Mayo Clinic proceedings
Early experience with the FDA's Breakthrough Devices program.
Nature biotechnology
Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices.
Gastrointestinal endoscopy
Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform.
NPJ digital medicine
The Art of the Deal: Negotiating Consult Conflict.
The American journal of medicine
Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures.
Circulation. Cardiovascular quality and outcomes
Commentary on Bertagnolli et al.: Leveraging electronic health record data for clinical trials-a brave new world.
Clinical trials (London, England)
2019 Update on Pediatric Medical Overuse: A Systematic Review.
JAMA pediatrics
A Successful but Underused Strategy for Reducing Low-Value Care: Stop Paying for It.
JAMA internal medicine
Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals.
LGBT health
Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017.
Journal of managed care & specialty pharmacy
Medicare beneficiaries' out-of-pocket costs for commonly used generic drugs, 2009-2017.
The American journal of managed care
Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data.
Journal of the American Heart Association
Physician and Patient Adjustment to Reference Pricing for Drugs.
JAMA network open
Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews.
Clinical trials (London, England)
2019 Update on Medical Overuse: A Review.
JAMA internal medicine
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Journal of managed care & specialty pharmacy
Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies.
Journal of general internal medicine
Age-treatment subgroup analyses in Cochrane intervention reviews: a meta-epidemiological study.
BMC medicine
Medicare Formulary Coverage of Brand-Name Drugs and Therapeutically Interchangeable Generics.
Journal of general internal medicine
Use of Mechanical Cardiopulmonary Resuscitation Devices for Out-of-Hospital Cardiac Arrest, 2010-2016.
JAMA network open
Evolution of Medicare Formulary Coverage Changes for Antithrombotic Therapies After Guideline Updates.
Circulation
Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10-Year Assessment.
Journal of the American Heart Association
Disparities in Socioeconomic Context and Association With Blood Pressure Control and Cardiovascular Outcomes in ALLHAT.
Journal of the American Heart Association
Controversies in Diagnostic Imaging of Patients With Suspected Stable and Acute Chest Pain Syndromes.
JACC. Cardiovascular imaging
Evaluation of technologies approved for supplemental payments in the United States.
BMJ (Clinical research ed.)
Clinical Interpretation of High-Sensitivity Troponin Testing-Reply.
JAMA internal medicine
2018 Update on Pediatric Medical Overuse: A Review.
JAMA pediatrics
Medicare Formulary Coverage and Restrictions for Opioid Potentiators from 2013 to 2017.
Journal of general internal medicine
2018 Update on Medical Overuse.
JAMA internal medicine
Implementation of an EConsult System with Patient Navigation.
Journal of health care for the poor and underserved
Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval.
Journal of managed care & specialty pharmacy
Alirocumab's Price Reduction.
Circulation
Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program.
JAMA internal medicine
Age of Data at the Time of Publication of Contemporary Clinical Trials.
JAMA network open
Real-World Evidence: Promise and Peril For Medical Product Evaluation.
P & T : a peer-reviewed journal for formulary management
Medicare Beneficiary Out-of-Pocket Costs for Generic Cardiovascular Medications Available Through $4 Generic Drug Discount Programs.
Annals of internal medicine
Continuing to Improve Appropriateness of Continuous Electrocardiographic Monitoring (Telemetry).
JAMA internal medicine
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.
Pharmacoepidemiology and drug safety
Fulfilling the Promise of Unique Device Identifiers.
Annals of internal medicine
Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.
BMJ (Clinical research ed.)
2017 Update on Pediatric Medical Overuse: A Review.
JAMA pediatrics
Medicare Spending and Potential Savings on Brand-Name Drugs With Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015.
JAMA internal medicine
Medical Overuse of Prostate-Specific Antigen Testing and Overprescription of Antibiotics-Reply.
JAMA internal medicine
2017 Update on Medical Overuse: A Systematic Review.
JAMA internal medicine
New and incremental FDA black box warnings from 2008 to 2015.
Expert opinion on drug safety
Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results.
Journal of the American Heart Association
Coronary Computed Tomography Angiography vs Functional Stress Testing for Patients With Suspected Coronary Artery Disease: A Systematic Review and Meta-analysis.
JAMA internal medicine
Requiem for a Scaffold.
Annals of internal medicine
Medicare Formulary Coverage Restrictions for Prescription Opioids, 2006 to 2015.
Annals of internal medicine
Merits of Data Sharing: The Digitalis Investigation Group Trial.
Journal of the American College of Cardiology
The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Journal of managed care & specialty pharmacy
Association between FDA black box warnings and Medicare formulary coverage changes.
The American journal of managed care
Author's Response.
Pediatrics
Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices.
JAMA internal medicine
Heterogeneity in Early Responses in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial).
Hypertension (Dallas, Tex. : 1979)
FDA Drug Trials Snapshots-A Clearer Picture.
JAMA internal medicine
Real-World Data on Heart Failure Readmission Reduction: Real or Real Uncertain?
Journal of the American College of Cardiology
Transcatheter Aortic Valve Replacement in Younger Individuals.
JAMA internal medicine
Medicare Formulary Changes After the 2013 American College of Cardiology/American Heart Association Cholesterol Guideline.
Journal of the American College of Cardiology
Update on Pediatric Overuse.
Pediatrics
2016 Update on Medical Overuse: A Systematic Review.
JAMA internal medicine
For the Patient with "Low-risk Chest Pain"-How Low Is Low?
Academic radiology
Sex-Specific Data for the Subcutaneous Implantable Cardioverter-Defibrillator.
Journal of the American College of Cardiology
Championing Effectiveness Before Cost-Effectiveness.
JACC. Heart failure
The Core Value of Cost-Effectiveness Analyses.
Journal of the American College of Cardiology
Update on Medical Practices That Should Be Questioned in 2015.
JAMA internal medicine
Revisiting Essure--Toward Safe and Effective Sterilization.
The New England journal of medicine
Setting a research agenda for medical overuse.
BMJ (Clinical research ed.)
Here Today, Gone Tomorrow.
The American journal of medicine
Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.
BMJ (Clinical research ed.)
Evidence And Medicare's Coverage Of Interventions.
Health affairs (Project Hope)
Update on medical overuse.
JAMA internal medicine
Presumed safe no more: lessons from the Wingspan saga on regulation of devices.
BMJ (Clinical research ed.)
A double-edged sword.
Journal of hospital medicine
FDA regulation of cardiovascular devices and opportunities for improvement.
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
Medical device regulation: time to improve performance.
PLoS medicine
Withdrawing unsafe drugs from the market.
Health affairs (Project Hope)
Sex-specific outcomes for HeartMate II.
Journal of the American College of Cardiology
Transcatheter aortic-valve replacement.
The New England journal of medicine
Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.
Circulation. Cardiovascular quality and outcomes
Medical device recalls: get it right the first time: Comment on "Medical device recalls and the FDA approval process".
Archives of internal medicine
Inclusion of training patients in US Food and Drug Administration premarket approval cardiovascular device studies.
Archives of internal medicine
The need for sex-specific data prior to food and drug administration approval.
Journal of the American College of Cardiology
Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.
JAMA
CMS's landmark decision on CT colonography--examining the relevant data.
The New England journal of medicine