Scholars@Duke
Samuel Broderick

Samuel Broderick

Biostatistician, Senior
Duke Clinical Research Institute
samuel.broderick@duke.edu
North Pavilion, DUMC # 3850, Location # 4523, Durham, NC 27715
200 Morris Street, 5300-D, Durham, NC 27701

Scholarly Works

Additive prognostic value of functional performance to coronary artery anatomy: the ISCHEMIA trial.

Journal article Eur Heart J Cardiovasc Imaging · April 30, 2026 AIMS: To assess whether baseline functional performance assessed by exercise treadmill stress testing (EST) has additive value to coronary computed tomography angiography (CCTA) for risk stratification among patients with chronic coronary disease (CCD) and ... Full text Link to item Cite

Comparative Prognosis by Stress ECG and Stress Imaging: Results From the ISCHEMIA Trial.

Journal article JACC Cardiovasc Imaging · September 2025 BACKGROUND: Limited contemporary evidence exists on risk prediction by stress imaging and exercise electrocardiography (ECG) among patients with chronic coronary syndromes (CCS). Objectives From the ISCHEMIA (International Study of Comparative Health Effec ... Full text Link to item Cite

Safety Outcomes from a Long-Term, Prospective Study of Sertraline Use in Children and Adolescents: The Sertraline Pediatric Registry for the Evaluation of Safety.

Journal article J Child Adolesc Psychopharmacol · August 2025 Objectives: To describe the Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) safety results, including adverse events (AEs) (serious and nonserious, including suicide-related events) following long-term treatment with sertraline in chil ... Full text Link to item Cite

Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial.

Journal article BMJ Open · March 26, 2025 INTRODUCTION: Low back pain (LBP) is a key source of medical costs and disability, impacting over 31 million Americans at any given time and resulting in US$100-US$200 billion per year in total healthcare costs. LBP is one of the leading causes of ambulato ... Full text Link to item Cite

Factors Associated With Coronary Angiography Performed Within 6 Months of Randomization to the Conservative Strategy in the ISCHEMIA Trial.

Journal article Circ Cardiovasc Interv · June 2024 BACKGROUND: ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coron ... Full text Link to item Cite

Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES).

Journal article J Child Adolesc Psychopharmacol · February 2023 Objective: To describe the results of the Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES) outcome measures of cognitive, emotional, and physical development following long-term treatment with sertraline (for up to 3 years) in children ... Full text Link to item Cite

Survival After Invasive or Conservative Management of Stable Coronary Disease.

Journal article Circulation · January 3, 2023 BACKGROUND: The ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) compared an initial invasive versus an initial conservative management strategy for patients with chronic coronary disease and mod ... Full text Link to item Cite

At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study.

Journal article BMC Public Health · December 4, 2021 BACKGROUND: The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve as a global health crisis. Although highly effective vaccines have been developed, non-pharmaceutical interventions remain crit ... Full text Link to item Cite

Sertraline Pediatric Registry for the Evaluation of Safety: Design and Clinical Characteristics of Pediatric Patients Prescribed Sertraline.

Journal article J Child Adolesc Psychopharmacol · August 2021 Objectives: To describe the study design and clinical characteristics of patients in the Sertraline Pediatric RegIstry for The Evaluation of Safety (SPRITES). Methods: SPRITES is an open-label postmarketing study of development and safety outcomes in patie ... Full text Link to item Cite

Management of Coronary Disease in Patients with Advanced Kidney Disease.

Journal article N Engl J Med · April 23, 2020 BACKGROUND: Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease. METHODS: We randomly assigned 777 patients with advanced kidney dise ... Full text Link to item Cite

Initial Invasive or Conservative Strategy for Stable Coronary Disease.

Journal article N Engl J Med · April 9, 2020 BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. M ... Full text Link to item Cite

Comparison of Clinical Characteristics and Outcomes of Patients With Versus Without Diabetes Mellitus and With Versus Without Angina Pectoris (from the Duke Databank for Cardiovascular Disease).

Journal article Am J Cardiol · June 1, 2017 Angina pectoris (AP) has different prognostic implications in various populations. Patients with diabetes mellitus (DM) may experience neuropathy such that AP may not be perceived in the setting of coronary artery disease (CAD). The prognostic utility of A ... Full text Link to item Cite

Race and Sex Differences in QRS Interval and Associated Outcome Among Patients with Left Ventricular Systolic Dysfunction.

Journal article J Am Heart Assoc · March 20, 2017 BACKGROUND: Prolonged QRS duration is associated with increased mortality among heart failure patients, but race or sex differences in QRS duration and associated effect on outcomes are unknown. METHODS AND RESULTS: We investigated QRS duration and morphol ... Full text Open Access Link to item Cite

What is the best ST-segment recovery parameter to predict clinical outcome and myocardial infarct size? Amplitude, speed, and completeness of ST-segment recovery after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

Journal article J Electrocardiol · 2017 AIMS: ST-segment recovery (STR) is a strong mechanistic correlate of infarct size (IS) and outcome in ST-segment elevation myocardial infarction (STEMI). Characterizing measures of speed, amplitude, and completeness of STR may extend the use of this noninv ... Full text Link to item Cite

Antianginal medications and long-term outcomes after elective catheterization in patients with coronary artery disease.

Journal article Clin Cardiol · December 2016 BACKGROUND: Antianginal medications are a class I recommendation by the American College of Cardiology/American Heart Association guidelines for stable ischemic heart disease. We sought to better understand guidance in drug selection and real-life outcomes ... Full text Link to item Cite

Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial.

Journal article Lancet Oncol · March 2016 BACKGROUND: Non-clear cell renal cell carcinomas are histologically and genetically diverse kidney cancers with variable prognoses, and their optimum initial treatment is unknown. We aimed to compare the mTOR inhibitor everolimus and the VEGF receptor inhi ... Full text Link to item Cite

Clinical outcome as a function of the PR-interval-there is virtue in moderation: data from the Duke Databank for cardiovascular disease.

Journal article Europace · June 2015 AIMS: Recently, a U-shaped association between PR-interval and the risk of developing atrial fibrillation was described, with higher risk in patients with long and short PR-intervals. Little is known regarding the association of PR-interval duration and mo ... Full text Link to item Cite

Predictors of long-term clinical endpoints in patients with refractory angina.

Journal article J Am Heart Assoc · January 30, 2015 BACKGROUND: Clinical outcomes in patients with refractory angina (RA) are poorly characterized and variably described. Using the Duke Database for Cardiovascular Disease (DDCD), we explored characteristics that drive clinical endpoints in patients with cla ... Full text Link to item Cite

Use of antiarrhythmic drug therapy and clinical outcomes in older patients with concomitant atrial fibrillation and coronary artery disease.

Journal article Europace · September 2014 AIMS: Atrial fibrillation (AF) and coronary artery disease (CAD) are common in older patients. We aimed to describe the use of antiarrhythmic drug (AAD) therapy and clinical outcomes in these patients. METHODS AND RESULTS: We analysed AAD therapy and outco ... Full text Link to item Cite

Phase I study of capecitabine, oxaliplatin, bevacizumab, and everolimus in advanced solid tumors.

Journal article Invest New Drugs · August 2014 PURPOSE: To define maximum tolerated dose (MTD), toxicities, and pharmacodynamics of capecitabine, oxaliplatin, bevacizumab, and everolimus in advanced solid tumor patients. DESIGN: This was a standard "3 + 3" dose-escalation trial. All subjects received b ... Full text Link to item Cite

Persistent angina pectoris in ischaemic cardiomyopathy: increased rehospitalization and major adverse cardiac events.

Journal article Eur J Heart Fail · August 2014 AIMS: The impact of refractory angina pectoris (AP) in patients with ischaemic cardiomyopathy (ICM) is unknown. We investigated the characteristics and outcomes of ICM patients with persistent AP following cardiac catheterization. METHODS AND RESULTS: Pati ... Full text Link to item Cite

Heart failure with preserved ejection fraction: comparison of patients with and without angina pectoris (from the Duke Databank for Cardiovascular Disease).

Journal article J Am Coll Cardiol · January 28, 2014 OBJECTIVES: This study investigated the characteristics and outcomes of patients with heart failure with preserved ejection fraction (HFpEF) and angina pectoris (AP). BACKGROUND: AP is a predictor of adverse events in patients with heart failure with reduc ... Full text Link to item Cite

Quality of anticoagulation with warfarin in patients with nonvalvular atrial fibrillation in the community setting.

Journal article J Electrocardiol · 2013 BACKGROUND: The benefit of oral anticoagulation therapy with warfarin for stroke prevention in atrial fibrillation (AF) is directly dependent on the quality of anticoagulation (QoA), which in the US is provided predominantly in the community setting. With ... Full text Link to item Cite

Antithrombotic therapy for atrial fibrillation and coronary artery disease in older patients.

Journal article Am Heart J · October 2012 BACKGROUND: Older patients with atrial fibrillation (AF) and coronary artery disease (CAD) face high risk of stroke and bleeding with antithrombotic therapy. Balancing safe and effective use of aspirin, clopidogrel, and warfarin in this population is impor ... Full text Link to item Cite

Race and gender variation in the QT interval and its association with mortality in patients with coronary artery disease: results from the Duke Databank for Cardiovascular Disease (DDCD).

Journal article Am Heart J · September 2012 BACKGROUND: In several studies, prolongation of the corrected QT (QTc) interval has been associated with an increased risk of cardiac events. However, data on race and gender variation in the QTc and its associated risk of death are lacking. METHODS: We pr ... Full text Link to item Cite

Pharmacokinetic and pharmacodynamic effects of elinogrel: results of the platelet function substudy from the intravenous and oral administration of elinogrel to evaluate tolerability and efficacy in nonurgent percutaneous coronary intervention patients (INNOVATE-PCI) trial.

Journal article Circ Cardiovasc Interv · June 2012 BACKGROUND: Elinogrel is the only selective, competitive and reversible platelet P2Y(12) inhibitor available in both intravenous (IV) and oral formulations. METHODS AND RESULTS: This substudy of the Intravenous and Oral Administration of Elinogrel to Evalu ... Full text Link to item Cite

Relation among body mass index, exercise training, and outcomes in chronic systolic heart failure.

Journal article The American journal of cardiology · December 2011 Exercise training (ET) in patients with heart failure (HF), as demonstrated in the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION), was associated with improved exercise tolerance and health status and a trend towa ... Full text Cite

Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery.

Journal article JAMA · February 9, 2011 CONTEXT: Several small studies have suggested that cardiac enzyme elevation in the 24 hours following coronary artery bypass graft (CABG) surgery is associated with worse prognosis, but a definitive study is not available. Also, the long-term prognostic im ... Full text Link to item Cite

Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2 evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) Trial.

Journal article Circulation · April 20, 2010 BACKGROUND: Factor Xa and factor IIa (thrombin) play roles in thrombotic complications after percutaneous coronary intervention. M118 is a novel low-molecular-weight heparin that has been rationally designed to capture the desired attributes of unfractiona ... Full text Link to item Cite

Long-term morbidity and mortality among medically managed patients with angina and multivessel coronary artery disease.

Journal article Am Heart J · December 2009 BACKGROUND: There are little data regarding outcomes in patients with angina and severe coronary artery disease (CAD) treated with medical management. Using the Duke Databank of Cardiovascular Disease, we describe the prevalence and long-term outcomes of p ... Full text Link to item Cite

Design and rationale of the Evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) trial.

Journal article Am Heart J · November 2009 BACKGROUND: Currently recommended anticoagulant agents used in the setting of percutaneous coronary intervention (PCI) inhibit, with varying degrees of intensity, 2 critical targets (factor Xa and/or IIa) of the coagulation cascade, yet they carry signific ... Full text Link to item Cite