Michael J Pencina

Journal Article Arterioscler Thromb Vasc Biol · August 15, 2024 BACKGROUND: Recent observational and Mendelian randomization analyses have reported significant effects of very-low-density lipoprotein cholesterol (VLDL-C) on risk that is independent of ApoB. OBJECTIVES: To determine the independent association of VLDL-C ... Full text Link to item Cite

A Federated Registration System for Artificial Intelligence in Health.

Journal Article JAMA · August 12, 2024 Full text Link to item Cite

Empowering nurses to champion Health equity & BE FAIR: Bias elimination for fair and responsible AI in healthcare.

Journal Article J Nurs Scholarsh · July 29, 2024 BACKGROUND: The concept of health equity by design encompasses a multifaceted approach that integrates actions aimed at eliminating biased, unjust, and correctable differences among groups of people as a fundamental element in the design of algorithms. As ... Full text Link to item Cite

The Influence of Hybrid Comprehensive Telerehabilitation on Anxiety in Heart Failure Patients: The TELEREH-HF Randomized Clinical Trial.

Journal Article Journal of clinical psychology in medical settings · June 2024 Telerehabilitation for heart failure (HF) patients is beneficial for physical functioning, prognosis, and psychological status. The study aimed at evaluating the influence of hybrid comprehensive telerehabilitation (HCTR) on the level of anxiety in compari ... Full text Cite

Adaptive Discretization for Event PredicTion (ADEPT).

Journal Article Proc Mach Learn Res · May 2024 Recently developed survival analysis methods improve upon existing approaches by predicting the probability of event occurrence in each of a number pre-specified (discrete) time intervals. By avoiding placing strong parametric assumptions on the event dens ... Link to item Cite

Identifying a stable and generalizable factor structure of major depressive disorder across three large longitudinal cohorts.

Journal Article Psychiatry Res · March 2024 The Patient Health Questionnaire 9 (PHQ-9) is the current standard outpatient screening tool for measuring and tracking the nine symptoms of major depressive disorder (MDD). While the PHQ-9 was originally conceptualized as a unidimensional measure, it has ... Full text Link to item Cite

The Causal-Benefit Model to Prevent Cardiovascular Events

Journal Article JACC: Advances · March 1, 2024 Selecting individuals for preventive lipid-lowering therapy is presently governed by the 10-year risk model. Once a prespecified level of cardiovascular disease risk is equaled or exceeded, individuals become eligible for preventive lipid-lowering therapy. ... Full text Cite

Translating ethical and quality principles for the effective, safe and fair development, deployment and use of artificial intelligence technologies in healthcare.

Journal Article J Am Med Inform Assoc · February 16, 2024 OBJECTIVE: The complexity and rapid pace of development of algorithmic technologies pose challenges for their regulation and oversight in healthcare settings. We sought to improve our institution's approach to evaluation and governance of algorithmic techn ... Full text Link to item Cite

Development and Validation of the American Heart Association's PREVENT Equations.

Journal Article Circulation · February 6, 2024 BACKGROUND: Multivariable equations are recommended by primary prevention guidelines to assess absolute risk of cardiovascular disease (CVD). However, current equations have several limitations. Therefore, we developed and validated the American Heart Asso ... Full text Link to item Cite

A Nationwide Network of Health AI Assurance Laboratories.

Journal Article JAMA · January 16, 2024 IMPORTANCE: Given the importance of rigorous development and evaluation standards needed of artificial intelligence (AI) models used in health care, nationwide accepted procedures to provide assurance that the use of AI is fair, appropriate, valid, effecti ... Full text Link to item Cite

Trans-Balance: Reducing demographic disparity for prediction models in the presence of class imbalance.

Journal Article J Biomed Inform · January 2024 INTRODUCTION: Risk prediction, including early disease detection, prevention, and intervention, is essential to precision medicine. However, systematic bias in risk estimation caused by heterogeneity across different demographic groups can lead to inapprop ... Full text Link to item Cite

The Crucial Role of Academic Medical Centers in Preparing for the Future of Health AI

Journal Article North Carolina Medical Journal · January 1, 2024 Full text Cite

Novel Prediction Equations for Absolute Risk Assessment of Total Cardiovascular Disease Incorporating Cardiovascular-Kidney-Metabolic Health: A Scientific Statement From the American Heart Association.

Journal Article Circulation · December 12, 2023 Cardiovascular-kidney-metabolic (CKM) syndrome is a novel construct recently defined by the American Heart Association in response to the high prevalence of metabolic and kidney disease. Epidemiological data demonstrate higher absolute risk of both atheros ... Full text Link to item Cite

Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions.

Journal Article NPJ Digit Med · November 25, 2023 The integration of Quality Management System (QMS) principles into the life cycle of development, deployment, and utilization of machine learning (ML) and artificial intelligence (AI) technologies within healthcare settings holds the potential to close the ... Full text Link to item Cite

Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association.

Journal Article Circulation · November 14, 2023 Cardiovascular-kidney-metabolic health reflects the interplay among metabolic risk factors, chronic kidney disease, and the cardiovascular system and has profound impacts on morbidity and mortality. There are multisystem consequences of poor cardiovascular ... Full text Link to item Cite

A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association.

Journal Article Circulation · November 14, 2023 A growing appreciation of the pathophysiological interrelatedness of metabolic risk factors such as obesity and diabetes, chronic kidney disease, and cardiovascular disease has led to the conceptualization of cardiovascular-kidney-metabolic syndrome. The c ... Full text Link to item Cite

Concordance/discordance between serum apolipoprotein B, low density lipoprotein cholesterol and non-high density lipoprotein cholesterol in NATPOL 2011 participants - An epidemiological perspective.

Journal Article Int J Cardiol · November 1, 2023 BACKGROUND: The study compared the distribution of serum LDL-C, non-HDL-C, and apolipoprotein B (apoB) among participants of the NATPOL 2011 survey and analysed concordance/discordance of results in the context of the risk for atherosclerotic cardiovascula ... Full text Link to item Cite

External validation of AI models in health should be replaced with recurring local validation.

Journal Article Nat Med · November 2023 Full text Link to item Cite

Facilitating Harmonization of Variables in Framingham, MESA, ARIC, and REGARDS Studies Through a Metadata Repository.

Journal Article Circ Cardiovasc Qual Outcomes · November 2023 BACKGROUND: High-quality research in cardiovascular prevention, as in other fields, requires inclusion of a broad range of data sets from different sources. Integrating and harmonizing different data sources are essential to increase generalizability, samp ... Full text Link to item Cite

Reply: Origins and Previous Applications of Causal-Benefit Models

Journal Article JACC: Advances · September 1, 2024 Full text Cite

Discordance Analysis of VLDL-C and ApoB in UK Biobank and Framingham Study: A Prospective Observational Study.

A Federated Registration System for Artificial Intelligence in Health.

Journal Article JAMA · August 12, 2024 Full text Link to item Cite

Empowering nurses to champion Health equity & BE FAIR: Bias elimination for fair and responsible AI in healthcare.

The Influence of Hybrid Comprehensive Telerehabilitation on Anxiety in Heart Failure Patients: The TELEREH-HF Randomized Clinical Trial.

Adaptive Discretization for Event PredicTion (ADEPT).

Identifying a stable and generalizable factor structure of major depressive disorder across three large longitudinal cohorts.

The Causal-Benefit Model to Prevent Cardiovascular Events

Translating ethical and quality principles for the effective, safe and fair development, deployment and use of artificial intelligence technologies in healthcare.

Development and Validation of the American Heart Association's PREVENT Equations.

A Nationwide Network of Health AI Assurance Laboratories.

Trans-Balance: Reducing demographic disparity for prediction models in the presence of class imbalance.

The Crucial Role of Academic Medical Centers in Preparing for the Future of Health AI

Journal Article North Carolina Medical Journal · January 1, 2024 Full text Cite

Novel Prediction Equations for Absolute Risk Assessment of Total Cardiovascular Disease Incorporating Cardiovascular-Kidney-Metabolic Health: A Scientific Statement From the American Heart Association.

Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions.

Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association.

A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association.

Concordance/discordance between serum apolipoprotein B, low density lipoprotein cholesterol and non-high density lipoprotein cholesterol in NATPOL 2011 participants - An epidemiological perspective.

External validation of AI models in health should be replaced with recurring local validation.

Journal Article Nat Med · November 2023 Full text Link to item Cite

Facilitating Harmonization of Variables in Framingham, MESA, ARIC, and REGARDS Studies Through a Metadata Repository.

Mitigating Racial And Ethnic Bias And Advancing Health Equity In Clinical Algorithms: A Scoping Review.

Journal Article Health Aff (Millwood) · October 2023 In August 2022 the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking prohibiting covered entities, which include health care providers and health plans, from discriminating against individuals when using clinical algorith ... Full text Link to item Cite

Life expectancy associated with different ages at diagnosis of type 2 diabetes in high-income countries: 23 million person-years of observation.

Journal Article Lancet Diabetes Endocrinol · October 2023 BACKGROUND: The prevalence of type 2 diabetes is increasing rapidly, particularly among younger age groups. Estimates suggest that people with diabetes die, on average, 6 years earlier than people without diabetes. We aimed to provide reliable estimates of ... Full text Link to item Cite

Needles in a Haystack: Finding Qualitative and Quantitative Collaborators in Academic Medical Centers.

Journal Article Acad Med · August 1, 2023 Translational research is a data-driven process that involves transforming scientific laboratory- and clinic-based discoveries into products and activities with real-world impact to improve individual and population health. Successful execution of translat ... Full text Link to item Cite

Semi-supervised calibration of noisy event risk (SCANER) with electronic health records.

Journal Article Journal of biomedical informatics · August 2023 ObjectiveElectronic health records (EHR), containing detailed longitudinal clinical information on a large number of patients and covering broad patient populations, open opportunities for comprehensive predictive modeling of disease progression a ... Full text Cite

Cardiovascular Disease Risk Assessment Using Traditional Risk Factors and Polygenic Risk Scores in the Million Veteran Program.

Journal Article JAMA Cardiol · June 1, 2023 IMPORTANCE: Primary prevention of atherosclerotic cardiovascular disease (ASCVD) relies on risk stratification. Genome-wide polygenic risk scores (PRSs) are proposed to improve ASCVD risk estimation. OBJECTIVE: To determine whether genome-wide PRSs for cor ... Full text Link to item Cite

Calibration and Uncertainty in Neural Time-to-Event Modeling.

Journal Article IEEE Trans Neural Netw Learn Syst · April 2023 Models for predicting the time of a future event are crucial for risk assessment, across a diverse range of applications. Existing time-to-event (survival) models have focused primarily on preserving pairwise ordering of estimated event times (i.e., relati ... Full text Link to item Cite

Cardiovascular Disease Risk Prediction in Young Adults-The Next Frontier.

Journal Article JAMA Cardiol · February 1, 2023 Full text Link to item Cite

Predictive Accuracy of Stroke Risk Prediction Models Across Black and White Race, Sex, and Age Groups.

Journal Article JAMA · January 24, 2023 IMPORTANCE: Stroke is the fifth-highest cause of death in the US and a leading cause of serious long-term disability with particularly high risk in Black individuals. Quality risk prediction algorithms, free of bias, are key for comprehensive prevention st ... Full text Link to item Cite

Interplay of Atherogenic Particle Number and Particle Size and the Risk of Coronary Heart Disease.

Journal Article Clin Chem · January 4, 2023 BACKGROUND: We examined the interplay of apolipoprotein B (apoB) and LDL particle size, approximated by the LDL-cholesterol (LDL-C)/apoB ratio, on the risk of new-onset coronary heart disease (CHD). METHODS: Participants without cardiovascular disease from ... Full text Link to item Cite

Is hypertriglyceridemia a reliable indicator of cholesterol-depleted Apo B particles?

Journal Article J Clin Lipidol · 2023 OBJECTIVES: Because cholesterol-depleted Apo B particles are thought to be a hallmark of hypertriglyceridemia, American, Canadian and European Lipid Guidelines suggest screening for Apo B only in patients with hypertriglyceridemia. Accordingly, this study ... Full text Link to item Cite

Predictors of long-term prognosis based on clinical status and measurements obtained in heart failure patients after 9-week hybrid comprehensive telerehabilitation: A subanalysis of the TELEREH-HF randomized clinical trial.

Journal Article Kardiol Pol · 2023 BACKGROUND: Assessing prognosis in heart failure (HF) is of major importance. AIMS: The study aimed to define predictors influencing long-term cardiovascular mortality or HF hospitalization ("composite outcome") based on clinical status and measurements ob ... Full text Link to item Cite

Relationship between physical capacity and depression in heart failure patients undergoing hybrid comprehensive telerehabilitation vs. usual care: subanalysis from the TELEREH-HF Randomized Clinical Trial.

Journal Article Eur J Cardiovasc Nurs · August 29, 2022 AIMS: The hybrid comprehensive telerehabilitation (HCTR) consisting of telecare (with psychological telesupport), telerehabilitation, and remote monitoring of cardiovascular implantable electronic devices might be an option to improve both physical capacit ... Full text Link to item Cite

Predictive Utility of a Validated Polygenic Risk Score for Long-Term Risk of Coronary Heart Disease in Young and Middle-Aged Adults.

Journal Article Circulation · August 23, 2022 BACKGROUND: Understanding the predictive utility of previously derived polygenic risk scores (PRSs) for long-term risk of coronary heart disease (CHD) and its additive value beyond traditional risk factors can inform prevention strategies. METHODS: Data fr ... Full text Link to item Cite

A framework for the oversight and local deployment of safe and high-quality prediction models.

Journal Article J Am Med Inform Assoc · August 16, 2022 Artificial intelligence/machine learning models are being rapidly developed and used in clinical practice. However, many models are deployed without a clear understanding of clinical or operational impact and frequently lack monitoring plans that can detec ... Full text Link to item Cite

Time to Revisit Using 10-Year Risk to Guide Statin Therapy.

Journal Article JAMA Cardiol · August 1, 2022 Full text Link to item Cite

Clinical Trials in the 21st Century - Promising Avenues for Better Studies.

Journal Article NEJM Evid · June 2022 Innovation in Clinical Trials in the 21st CenturyMedical evidence is rooted in randomized controlled trials but there is a pressing need for innovative designs. Pencina and Thompson introduce a new series that reviews the most promising innovations in tria ... Full text Link to item Cite

An adverse lipoprotein phenotype-hypertriglyceridaemic hyperapolipoprotein B-and the long-term risk of type 2 diabetes: a prospective, longitudinal, observational cohort study.

Journal Article Lancet Healthy Longev · May 2022 BACKGROUND: This study examines the risk of new-onset diabetes in patients with hypertriglyceridaemic hyperapolipoprotein B (high triglycerides, high apolipoprotein B [apoB], low LDL cholesterol to apoB ratio, and low HDL cholesterol). The aim was to estab ... Full text Link to item Cite

Observability and its impact on differential bias for clinical prediction models.

Journal Article J Am Med Inform Assoc · April 13, 2022 OBJECTIVE: Electronic health records have incomplete capture of patient outcomes. We consider the case when observability is differential across a predictor. Including such a predictor (sensitive variable) can lead to algorithmic bias, potentially exacerba ... Full text Link to item Cite

A proposal for developing a platform that evaluates algorithmic equity and accuracy.

Journal Article BMJ Health Care Inform · April 2022 We are at a pivotal moment in the development of healthcare artificial intelligence (AI), a point at which enthusiasm for machine learning has not caught up with the scientific evidence to support the equity and accuracy of diagnostic and therapeutic algor ... Full text Link to item Cite

Prognostic Impact of Hybrid Comprehensive Telerehabilitation Regarding Diastolic Dysfunction in Patients with Heart Failure with Reduced Ejection Fraction-Subanalysis of the TELEREH-HF Randomized Clinical Trial.

Journal Article J Clin Med · March 26, 2022 AIMS: The objective of the study was to evaluate the effects of individually prescribed hybrid comprehensive telerehabilitation (HCTR) implemented at patients' homes on left ventricular (LV) diastolic function in heart failure (HF) patients. METHODS AND RE ... Full text Link to item Cite

Managing Atherosclerotic Cardiovascular Risk in Young Adults: JACC State-of-the-Art Review.

Journal Article J Am Coll Cardiol · March 1, 2022 There is a need to identify high-risk features that predict early-onset atherosclerotic cardiovascular disease (ASCVD). The authors provide insights to help clinicians identify and address high-risk conditions in the 20- to 39-year age range (young adults) ... Full text Link to item Cite

Heart Failure Patients’ Adherence to Hybrid Comprehensive Telerehabilitation and Its Impact on Prognosis Based on Data from TELEREH-HF Randomized Clinical Trial

Journal Article Applied Sciences (Switzerland) · March 1, 2022 (1) Background Adherence to treatment guidelines in heart failure (HF) patients is of major prognostic importance, but thorough implementation of guidelines in routine care remains insufficient. Introducing hybrid comprehensive telerehabilitation (HCTR) co ... Full text Cite

Antiarrhythmic effect of 9-week hybrid comprehensive telerehabilitation and its influence on cardiovascular mortality in long-term follow-up - subanalysis of the TELEREHabilitation in Heart Failure Patients randomized clinical trial.

Journal Article Arch Med Sci · 2022 INTRODUCTION: Cardiac rehabilitation is a component of heart failure (HF) management, but its effect on ventricular arrhythmias is not well understood. We analyzed the antiarrhythmic effect of a 9-week hybrid comprehensive telerehabilitation (HCTR) program ... Full text Link to item Cite

Predictors of proarrhythmic effect in heart failure patients after 9-week hybrid comprehensive telerehabilitation and their influence on cardiovascular mortality in long-term follow-up: Subanalysis of the TELEREH-HF randomized clinical trial.

Journal Article J Electrocardiol · 2022 BACKGROUND: Regular exercise training is beneficial in heart failure (HF) patients. However, its potential proarrhythmic effect is possible but has not been sufficiently investigated. OBJECTIVE: To identify patients at risk for proarrhythmic effect after t ... Full text Link to item Cite

Extrapolating Survival From Randomized Clinical Trial Data-Possibilities and Caution.

Journal Article JAMA Cardiol · November 1, 2021 Full text Link to item Cite

Assessment of ECG during hybrid comprehensive telerehabilitation in heart failure patients-Subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) randomized clinical trial.

Journal Article Ann Noninvasive Electrocardiol · November 2021 BACKGROUND: Exercise training in heart failure (HF) patients should be monitored to ensure patients' safety. Electrocardiographic (ECG) telemonitoring was used to assess the safety of hybrid comprehensive telerehabilitation (HCTR). OBJECTIVE: Analysis of E ... Full text Link to item Cite

Competing Risks, Treatment Switching, and Informative Censoring.

Journal Article JAMA Cardiol · August 1, 2021 Full text Link to item Cite

Impact of train/test sample regimen on performance estimate stability of machine learning in cardiovascular imaging.

Journal Article Sci Rep · July 14, 2021 As machine learning research in the field of cardiovascular imaging continues to grow, obtaining reliable model performance estimates is critical to develop reliable baselines and compare different algorithms. While the machine learning community has gener ... Full text Link to item Cite

Incremental Benefits of Machine Learning-When Do We Need a Better Mousetrap?

Journal Article JAMA Cardiol · June 1, 2021 Full text Link to item Cite

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease.

Journal Article N Engl J Med · May 27, 2021 BACKGROUND: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS: Using an open ... Full text Link to item Cite

Effects of hybrid comprehensive telerehabilitation on cardiopulmonary capacity in heart failure patients depending on diabetes mellitus: subanalysis of the TELEREH-HF randomized clinical trial.

Journal Article Cardiovasc Diabetol · May 13, 2021 BACKGROUND: Type 2 diabetes mellitus (DM) is one of the most common comorbidities among patients with heart failure (HF) with reduced ejection fraction (HFrEF). There are limited data regarding efficacy of hybrid comprehensive telerehabilitation (HCTR) on ... Full text Link to item Cite

Enabling counterfactual survival analysis with balanced representations

Conference ACM CHIL 2021 - Proceedings of the 2021 ACM Conference on Health, Inference, and Learning · April 8, 2021 Balanced representation learning methods have been applied successfully to counterfactual inference from observational data. However, approaches that account for survival outcomes are relatively limited. Survival data are frequently encountered across dive ... Full text Cite

An aetiology-based subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial.

Journal Article ESC Heart Fail · April 2021 AIMS: The aim of our study was to analyse the benefits of a 9 week hybrid comprehensive telerehabilitation (HCTR) programme in heart failure (HF) patients according to aetiology, as a subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH ... Full text Link to item Cite

Impact of the COVID-19 pandemic on patterns of outpatient cardiovascular care.

Journal Article Am Heart J · January 2021 BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic brought about abrupt changes in the way health care is delivered, and the impact of transitioning outpatient clinic visits to telehealth visits on processes of care and outcomes is unclear. METHO ... Full text Link to item Cite

The Dose-Response Relationship Between Physical Activity and Cardiometabolic Health in Adolescents.

Journal Article Am J Prev Med · January 2021 INTRODUCTION: This study examines the dose-response relationship between moderate-to-vigorous physical activity and cardiometabolic measures in adolescents. METHODS: Cross-sectional spline analyses were performed using 2003-2016 National Health and Nutriti ... Full text Link to item Cite

Clinical reasoning and prevention of cardiovascular disease.

Journal Article J Clin Lipidol · 2021 All the major lipid prevention guidelines agree that the 10-year risk of a cardiovascular event should be the primary method to select individuals for statin prevention of a cardiovascular event. They also all rely on LDL cholesterol (LDL-C) as the primary ... Full text Link to item Cite

Prediction of Incident Atherosclerotic Cardiovascular Disease Using Traditional and Polygenic Risk Score Modeling: The Million Veteran Program Experience

Conference CIRCULATION · 2021 Cite

Testing Clinical Prediction Models.

Journal Article JAMA · November 17, 2020 Full text Link to item Cite

Remote Monitoring of Cardiac Implantable Electronic Devices in Patients Undergoing Hybrid Comprehensive Telerehabilitation in Comparison to the Usual Care. Subanalysis from Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomised Clinical Trial.

Journal Article Journal of clinical medicine · November 2020 BackgroundThe impact of cardiac rehabilitation on the number of alerts in patients with remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is unknown. We compared alerts in RM and outcomes in patients with CIEDs undergoing hy ... Full text Cite

The Expected 30-Year Benefits of Early Versus Delayed Primary Prevention of Cardiovascular Disease by Lipid Lowering.

Journal Article Circulation · September 2020 BACKGROUND: Lipid-lowering recommendations for prevention of atherosclerotic cardiovascular disease rely principally on estimated 10-year risk. We sought to determine the optimal time for initiation of lipid lowering in younger adults as a function of expe ... Full text Link to item Cite

Understanding Observational Treatment Comparisons in the Setting of Coronavirus Disease 2019 (COVID-19).

Journal Article JAMA Cardiol · September 1, 2020 Full text Link to item Cite

Prevention of cardiovascular disease: time for a course correction.

Journal Article Eur Heart J · August 14, 2020 Full text Link to item Cite

The Dose-Response Relationship Between Physical Activity and Cardiometabolic Health in Young Adults.

Journal Article J Adolesc Health · August 2020 PURPOSE: Guidelines recommend 150 minutes of weekly moderate-to-vigorous physical activity (MVPA) for all adults, although physical activity level correlation with cardiometabolic health is not well characterized for young adults. We determined the dose-re ... Full text Link to item Cite

Federal judge invalidates icosapent ethyl patents - but on the basis of a common statistical mistake.

Journal Article Nat Biotechnol · August 2020 Full text Link to item Cite

Overlap Weighting: A Propensity Score Method That Mimics Attributes of a Randomized Clinical Trial.

Journal Article JAMA · June 16, 2020 Full text Link to item Cite

Understanding Observational Treatment Comparisons in the Setting of Coronavirus Disease 2019 (COVID-19).

Journal Article JAMA Cardiol · May 5, 2020 Full text Link to item Cite

Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study.

Journal Article Ann Allergy Asthma Immunol · May 2020 BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exa ... Full text Link to item Cite

Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial.

Journal Article JAMA Cardiol · May 1, 2020 IMPORTANCE: Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question. OBJECTIVE: To report the rationale and design for a randomized clinica ... Full text Link to item Cite

Prediction Models - Development, Evaluation, and Clinical Application.

Journal Article N Engl J Med · April 23, 2020 Full text Link to item Cite

Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial.

Journal Article JAMA Cardiol · March 1, 2020 IMPORTANCE: Guidelines recommend exercise training as a component of heart failure management. There are large disparities in access to rehabilitation, and introducing hybrid comprehensive telerehabilitation (HCTR) consisting of remote monitoring of traini ... Full text Link to item Cite

Using Propensity Score Methods to Create Target Populations in Observational Clinical Research.

Journal Article JAMA · February 4, 2020 Full text Link to item Cite

The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement.

Journal Article Ann Intern Med · January 7, 2020 Heterogeneity of treatment effect (HTE) refers to the nonrandom variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), ... Full text Link to item Cite

The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration.

Journal Article Ann Intern Med · January 7, 2020 The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed to promote the conduct of, and provide guidance for, predictive analyses of heterogeneity of treatment effects (HTE) in clinical trials. The goal of predictive HTE a ... Full text Link to item Cite

The Project Baseline Health Study: a step towards a broader mission to map human health.

Journal Article NPJ Digit Med · 2020 The Project Baseline Health Study (PBHS) was launched to map human health through a comprehensive understanding of both the health of an individual and how it relates to the broader population. The study will contribute to the creation of a biomedical info ... Full text Open Access Link to item Cite

Survival Analysis meets Counterfactual Inference.

Journal Article CoRR · 2020 Cite

Letter by Sniderman et al Regarding Article, "Comparison of Conventional Lipoprotein Tests and Apolipoproteins in the Prediction of Cardiovascular Disease".

Journal Article Circulation · December 10, 2019 Full text Link to item Cite

Single Measurements of Carboxy-Terminal Fibroblast Growth Factor 23 and Clinical Risk Prediction of Adverse Outcomes in CKD.

Journal Article American journal of kidney diseases : the official journal of the National Kidney Foundation · December 2019 Rationale & objectiveAn elevated fibroblast growth factor 23 (FGF-23) level is independently associated with adverse outcomes in populations with chronic kidney disease, but it is unknown whether FGF-23 testing can improve clinical risk prediction ... Full text Cite

Apolipoprotein B Particles and Cardiovascular Disease: A Narrative Review.

Journal Article JAMA Cardiol · December 1, 2019 IMPORTANCE: The conventional model of atherosclerosis presumes that the mass of cholesterol within very low-density lipoprotein particles, low-density lipoprotein particles, chylomicron, and lipoprotein (a) particles in plasma is the principal determinant ... Full text Link to item Cite

Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.

Journal Article Am Heart J · December 2019 BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committe ... Full text Link to item Cite

Cardiovascular risk factor profiles in familial hypercholesterolemia patients with and without genetic mutation compared to a nationally representative sample of adults in a high-risk European country.

Journal Article Am Heart J · December 2019 BACKGROUND: There is a paucity of data on the distribution of cardiovascular risk factors in patients with familial hypercholesterolemia (FH) as compared to the general population. The aim of the study was to compare cardiovascular risk factors in a cohort ... Full text Link to item Cite

Hybrid comprehensive telerehabilitation in heart failure patients (TELEREH-HF): A randomized, multicenter, prospective, open-label, parallel group controlled trial-Study design and description of the intervention.

Journal Article Am Heart J · November 2019 UNLABELLED: Guidelines recommend exercise training as a component of heart failure (HF) management. There are large disparities in access to rehabilitation and introducing hybrid comprehensive telerehabilitation (TR) consisting of remote monitoring of trai ... Full text Link to item Cite

Clinical Effectiveness of Direct Oral Anticoagulants vs Warfarin in Older Patients With Atrial Fibrillation and Ischemic Stroke: Findings From the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study.

Journal Article JAMA Neurol · October 1, 2019 IMPORTANCE: Current guidelines recommend direct oral anticoagulants (DOACs) over warfarin for stroke prevention in patients with atrial fibrillation (AF) who are at high risk. Despite demonstrated efficacy in clinical trials, real-world data of DOACs vs wa ... Full text Open Access Link to item Cite

Cost-effectiveness of Low-density Lipoprotein Cholesterol Level-Guided Statin Treatment in Patients With Borderline Cardiovascular Risk.

Journal Article JAMA Cardiol · October 1, 2019 IMPORTANCE: American College of Cardiology/American Heart Association cholesterol guidelines prioritize primary prevention statin therapy based on 10-year absolute risk (AR10) of atherosclerotic cardiovascular disease (ASCVD). However, given the same AR10, ... Full text Link to item Cite

Measures for evaluation of prognostic improvement under multivariate normality for nested and nonnested models.

Journal Article Stat Med · September 10, 2019 When comparing performances of two risk prediction models, several metrics exist to quantify prognostic improvement, including the change in the area under the Receiver Operating Characteristic curve, the Integrated Discrimination Improvement, the Net Recl ... Full text Link to item Cite

Egg Consumption and Risk of Total and Cause-Specific Mortality: An Individual-Based Cohort Study and Pooling Prospective Studies on Behalf of the Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group.

Journal Article J Am Coll Nutr · August 2019 The associations of egg consumption with total, coronary heart disease (CHD), and stroke mortality are poorly understood. We prospectively evaluated the link between total, CHD, and stroke mortality with egg consumption using a randomly selected sample of ... Full text Open Access Link to item Cite

Trajectories of Non-HDL Cholesterol Across Midlife: Implications for Cardiovascular Prevention.

Journal Article J Am Coll Cardiol · July 9, 2019 BACKGROUND: Extended elevations of non-high-density lipoprotein cholesterol (non-HDL-C) across a lifespan are associated with increased risk of cardiovascular disease (CVD). However, optimal testing intervals to identify individuals with high lipid-related ... Full text Link to item Cite

Application of net reclassification index to non-nested and point-based risk prediction models: a review.

Journal Article Eur Heart J · June 14, 2019 Much of medical risk prediction involves externally derived prediction equations, nomograms, and point-based risk scores. These settings are vulnerable to misleading findings of incremental value based on versions of the net reclassification index (NRI) in ... Full text Link to item Cite

Statistical methods for building better biomarkers of chronic kidney disease.

Journal Article Stat Med · May 20, 2019 The last two decades have witnessed an explosion in research focused on the development and assessment of novel biomarkers for improved prognosis of diseases. As a result, best practice standards guiding biomarker research have undergone extensive developm ... Full text Link to item Cite

ApoB.

Journal Article Circ Res · May 10, 2019 Full text Link to item Cite

An outcome model approach to transporting a randomized controlled trial results to a target population.

Journal Article J Am Med Inform Assoc · May 1, 2019 OBJECTIVE: Participants enrolled into randomized controlled trials (RCTs) often do not reflect real-world populations. Previous research in how best to transport RCT results to target populations has focused on weighting RCT data to look like the target da ... Full text Link to item Cite

Evaluation of Mortality Data From the Social Security Administration Death Master File for Clinical Research.

Journal Article JAMA Cardiol · April 1, 2019 IMPORTANCE: Despite its documented undercapture of mortality data, the US Social Security Administration Death Master File (SSDMF) is still often used to provide mortality end points in retrospective clinical studies. Changes in death data reporting to SSD ... Full text Link to item Cite

Quantifying Importance of Major Risk Factors for Coronary Heart Disease.

Journal Article Circulation · March 26, 2019 BACKGROUND: To optimize preventive strategies for coronary heart disease (CHD), it is essential to understand and appropriately quantify the contribution of its key risk factors. Our objective was to compare the associations of key modifiable CHD risk fact ... Full text Link to item Cite

Equalization of four cardiovascular risk algorithms after systematic recalibration: individual-participant meta-analysis of 86 prospective studies.

Journal Article Eur Heart J · February 14, 2019 AIMS: There is debate about the optimum algorithm for cardiovascular disease (CVD) risk estimation. We conducted head-to-head comparisons of four algorithms recommended by primary prevention guidelines, before and after 'recalibration', a method that adapt ... Full text Open Access Link to item Cite

Single-number summary and decision analytic measures can happily coexist.

Journal Article Stat Med · February 10, 2019 Full text Link to item Cite

Incremental prognostic value of renal function for stroke prediction in atrial fibrillation.

Journal Article Int J Cardiol · January 1, 2019 BACKGROUND: Renal function has been associated with an increased stroke risk in patients with atrial fibrillation (AF). However, whether renal function incrementally adds to risk prediction in both anticoagulated and non-anticoagulated patients with AF is ... Full text Link to item Cite

Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk: The CARMELINA Randomized Clinical Trial.

Journal Article JAMA · January 1, 2019 IMPORTANCE: Type 2 diabetes is associated with increased cardiovascular (CV) risk. Prior trials have demonstrated CV safety of 3 dipeptidyl peptidase 4 (DPP-4) inhibitors but have included limited numbers of patients with high CV risk and chronic kidney di ... Full text Link to item Cite

Informatics-Enabled Learning Health Systems: Strategies for Success from Four Academic Medical Centers.

Conference AMIA · 2019 Cite

A Long-term Benefit Approach vs Standard Risk-Based Approaches for Statin Eligibility in Primary Prevention.

Journal Article JAMA Cardiol · November 1, 2018 IMPORTANCE: A 10-year benefit-based approach to statin therapy in primary prevention includes younger individuals with higher low-density lipoprotein cholesterol (LDL-C) and prevents more cardiovascular events than a risk-based approach. However, a 10-year ... Full text Link to item Cite

Eradicating the Burden of Atherosclerotic Cardiovascular Disease by Lowering Apolipoprotein B Lipoproteins Earlier in Life.

Journal Article J Am Heart Assoc · October 16, 2018 Full text Link to item Cite

Statins at Dialysis Transition-Supportive but Not Sufficient.

Journal Article JAMA Netw Open · October 5, 2018 Full text Link to item Cite

Placebo Response as a Latent Characteristic: Application to Analysis of Sequential Parallel Comparison Design Studies

Journal Article Journal of the American Statistical Association · October 2, 2018 In clinical trials, placebo response can affect the inference about efficacy of the studied treatment. It is important to have a robust way to classify trial subjects with respect to their response to placebo. Simple, criterion-based classification may lea ... Full text Cite

Sick Individuals and Sick Populations by Geoffrey Rose: Cardiovascular Prevention Updated.

Journal Article J Am Heart Assoc · October 2, 2018 Full text Link to item Cite

Nonparametric estimation and inference for polytomous discrimination index.

Journal Article Stat Methods Med Res · October 2018 Polytomous discrimination index is a novel and important diagnostic accuracy measure for multi-category classification. After reconstructing its probabilistic definition, we propose a nonparametric approach to the estimation of polytomous discrimination in ... Full text Link to item Cite

High-sensitivity C-reactive protein elevation in patients with prior myocardial infarction in the United States.

Journal Article Am Heart J · October 2018 IMPORTANCE: The extent to which levels of high-sensitivity C-reactive protein (hs-CRP), a known marker of increased cardiovascular risk, are elevated and are associated with standard cardiovascular risk factors in patients with a history of myocardial infa ... Full text Link to item Cite

Microsimulation model to predict incremental value of biomarkers added to prognostic models.

Journal Article J Am Med Inform Assoc · October 1, 2018 It is unclear to what extent simulated versions of real data can be used to assess potential value of new biomarkers added to prognostic risk models. Using data on 4522 women and 3969 men who contributed information to the Framingham CVD risk prediction to ... Full text Link to item Cite

Deriving Real-World Insights From Real-World Data: Biostatistics to the Rescue.

Journal Article Ann Intern Med · September 18, 2018 Full text Open Access Link to item Cite

On Deep Learning for Medical Image Analysis.

Journal Article JAMA · September 18, 2018 Full text Link to item Cite

Improving patient risk communication: Translating cardiovascular risk into standardized risk percentiles.

Journal Article Am Heart J · April 2018 BACKGROUND: Current cholesterol guidelines recommend using 10-year risk of atherosclerotic cardiovascular disease (ASCVD) to guide informed decisions regarding statin therapy, yet patients may have difficulty conceptualizing absolute risk estimates. Peer c ... Full text Link to item Cite

Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk.

Journal Article Cardiovasc Diabetol · March 14, 2018 BACKGROUND: Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA® trial aims to evaluate the effects o ... Full text Open Access Link to item Cite

Absolute vs Additive Net Reclassification Index.

Journal Article JAMA · February 13, 2018 Full text Link to item Cite

Longitudinal FGF23 Trajectories and Mortality in Patients with CKD.

Journal Article J Am Soc Nephrol · February 2018 Elevated fibroblast growth factor 23 (FGF23) levels, measured at a single time, are strongly associated with increased risk of mortality in patients with CKD. There are minimal data on serial FGF23 measurements in CKD. In a prospective case-cohort study of ... Full text Link to item Cite

Adherence to Adding ICS to Rescue Therapy in a Pragmatic Trial with Adults with Asthma– a Pilot Study

Conference Journal of Allergy and Clinical Immunology · February 2018 Full text Cite

The Duke Health Data Science Internship Program: Integrating the Educational Mission into Real-World Research.

Conference AMIA · 2018 Cite

Net reclassification index at event rate: properties and relationships.

Journal Article Stat Med · December 10, 2017 The net reclassification improvement (NRI) is an attractively simple summary measure quantifying improvement in performance because of addition of new risk marker(s) to a prediction model. Originally proposed for settings with well-established classificati ... Full text Link to item Cite

Discrimination slope and integrated discrimination improvement - properties, relationships and impact of calibration.

Journal Article Stat Med · December 10, 2017 Discrimination slope, defined as the slope of a linear regression of predicted probabilities of event derived from a prognostic model on the binary event status, has recently gained popularity as a measure of model performance. It is as a building block fo ... Full text Link to item Cite

Authors' response to comments.

Journal Article Stat Med · December 10, 2017 Full text Link to item Cite

Impact of Heart Outcomes Prevention Evaluation Trial on Statin Eligibility for the Primary Prevention of Cardiovascular Disease: Insights from the National Health and Nutrition Examination Survey.

Journal Article Circulation · November 7, 2017 Full text Link to item Cite

The Benefit Model for Prevention of Cardiovascular Disease: An Opportunity to Harmonize Guidelines.

Journal Article JAMA Cardiol · November 1, 2017 Full text Link to item Cite

Asymptotic distribution of ∆AUC, NRIs, and IDI based on theory of U-statistics.

Journal Article Stat Med · September 20, 2017 The change in area under the curve (∆AUC), the integrated discrimination improvement (IDI), and net reclassification index (NRI) are commonly used measures of risk prediction model performance. Some authors have reported good validity of associated methods ... Full text Link to item Cite

Guideline Recommendations for Statin Therapy-Reply.

Journal Article JAMA · September 12, 2017 Full text Link to item Cite

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.

Journal Article Clin Trials · August 2017 Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for ... Full text Link to item Cite

Efficacy and Safety of Alternate-Day Versus Daily Dosing of Statins: a Systematic Review and Meta-Analysis.

Journal Article Cardiovasc Drugs Ther · August 2017 PURPOSE: We conducted a meta-analysis of randomized controlled trials (RCTs) and quasi-RCTs to synthesize evidence about the efficacy and safety of alternate-day vs daily dosing of statins. METHODS: We searched selected databases through January 2, 2017 to ... Full text Link to item Cite

A comparison of risk prediction methods using repeated observations: an application to electronic health records for hemodialysis.

Journal Article Stat Med · July 30, 2017 An increasingly important data source for the development of clinical risk prediction models is electronic health records (EHRs). One of their key advantages is that they contain data on many individuals collected over time. This allows one to incorporate ... Full text Link to item Cite

Transcatheter Versus Surgical Aortic Valve Replacement: Propensity-Matched Comparison.

Journal Article J Am Coll Cardiol · July 25, 2017 BACKGROUND: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. ... Full text Link to item Cite

Multi-category diagnostic accuracy based on logistic regression

Journal Article Statistical Theory and Related Fields · July 3, 2017 We provide a detailed review for the statistical analysis of diagnostic accuracy in a multi-category classification task. For qualitative response variables with more than two categories, many traditional accuracy measures such as sensitivity, specificity ... Full text Cite

Seasonal and circadian variations of acute myocardial infarction: Findings from the Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program.

Journal Article Am Heart J · July 2017 BACKGROUND: Seasonal variation with winter preponderance of myocardial infarction incidence has been described decades ago, but only a few small studies have classified myocardial infarction based on ST-segment elevation. It is unclear whether seasonal and ... Full text Link to item Cite

Prognostic Value of Noninvasive Cardiovascular Testing in Patients With Stable Chest Pain: Insights From the PROMISE Trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain).

Journal Article Circulation · June 13, 2017 BACKGROUND: Optimal management of patients with stable chest pain relies on the prognostic information provided by noninvasive cardiovascular testing, but there are limited data from randomized trials comparing anatomic with functional testing. METHODS: In ... Full text Link to item Cite

CARMELINA (R) Trial Baseline Characteristics: A Cardiovascular and Renal Microvascular Outcome Trial with Linagliptin in Patients with Type 2 Diabetes at High Vascular Risk

Conference DIABETES · June 1, 2017 Link to item Cite

Comparison of Recommended Eligibility for Primary Prevention Statin Therapy Based on the US Preventive Services Task Force Recommendations vs the ACC/AHA Guidelines.

Journal Article JAMA · April 18, 2017 IMPORTANCE: There are important differences among guideline recommendations for using statin therapy in primary prevention. New recommendations from the US Preventive Services Task Force (USPSTF) emphasize therapy based on the presence of 1 or more cardiov ... Full text Link to item Cite

Assessing electronic health record phenotypes against gold-standard diagnostic criteria for diabetes mellitus.

Journal Article J Am Med Inform Assoc · April 1, 2017 OBJECTIVE: We assessed the sensitivity and specificity of 8 electronic health record (EHR)-based phenotypes for diabetes mellitus against gold-standard American Diabetes Association (ADA) diagnostic criteria via chart review by clinical experts. MATERIALS ... Full text Link to item Cite

Rejoinder.

Journal Article Clin Trials · April 2017 Full text Link to item Cite

Data monitoring committees: Promoting best practices to address emerging challenges.

Journal Article Clin Trials · April 2017 BACKGROUND AND PURPOSE: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investig ... Full text Link to item Cite

Association of Preceding Antithrombotic Treatment With Acute Ischemic Stroke Severity and In-Hospital Outcomes Among Patients With Atrial Fibrillation.

Journal Article JAMA · March 14, 2017 IMPORTANCE: Antithrombotic therapies are known to prevent stroke for patients with atrial fibrillation (AF) but are often underused in community practice. OBJECTIVES: To examine the prevalence of patients with acute ischemic stroke with known history of AF ... Full text Open Access Link to item Cite

Low-density lipoprotein cholesterol and survival in pulmonary arterial hypertension.

Journal Article Sci Rep · February 15, 2017 Low-density lipoprotein cholesterol(LDL-C) is a well established metabolic marker of cardiovascular risk, however, its role in pulmonary arterial hypertension (PAH) has not been determined. Therefore we assessed whether LDL-C levels are altered in PAH pati ... Full text Open Access Link to item Cite

Opportunities and challenges in developing risk prediction models with electronic health records data: a systematic review.

Journal Article J Am Med Inform Assoc · January 2017 OBJECTIVE: Electronic health records (EHRs) are an increasingly common data source for clinical risk prediction, presenting both unique analytic opportunities and challenges. We sought to evaluate the current state of EHR based risk prediction modeling thr ... Full text Link to item Cite

Predicting mortality over different time horizons: which data elements are needed?

Journal Article J Am Med Inform Assoc · January 2017 OBJECTIVE: Electronic health records (EHRs) are a resource for "big data" analytics, containing a variety of data elements. We investigate how different categories of information contribute to prediction of mortality over different time horizons among pati ... Full text Link to item Cite

Combining clinical and angiographic variables for estimating risk of target lesion revascularization after drug eluting stent placement.

Journal Article Cardiovasc Revasc Med · 2017 BACKGROUND: Drug-eluting stents (DES) reduce restenosis but require prolonged antiplatelet therapy, when compared with bare metal stents. Ideally, the patient should be involved in this risk:benefit assessment prior to selecting DES, to maximize the benefi ... Full text Link to item Cite

Scientific, societal, and economic consequences of releasing interim data from clinical trials.

Journal Article Eur Heart J Qual Care Clin Outcomes · January 1, 2017 Full text Link to item Cite

Developing a framework for a comprehensive data sharing program.

Conference AMIA · 2017 Cite

Erratum to: Methods for evaluating medical tests and biomarkers.

Journal Article Diagn Progn Res · 2017 [This corrects the article DOI: 10.1186/s41512-016-0001-y.]. ... Full text Open Access Link to item Cite

Determining When to Add Nonstatin Therapy: A Quantitative Approach.

Journal Article J Am Coll Cardiol · December 6, 2016 BACKGROUND: Costs and uncertainty about the benefits of nonstatin therapies limit their use. OBJECTIVES: The authors sought to identify patients who might benefit from the addition of a nonstatin to background statin therapy. METHODS: We performed systemat ... Full text Link to item Cite

Estimation of Risk for Initial Atherosclerotic Cardiovascular Disease Events: Taking Stock and Moving Forward.

Journal Article Circulation · December 6, 2016 Full text Link to item Cite

Choice of agreement indices for assessing and improving measurement reproducibility in a core laboratory setting.

Journal Article Stat Methods Med Res · December 2016 Clinical core laboratories, such as Echocardiography core laboratories, are increasingly used in clinical studies with imaging outcomes as primary, secondary, or surrogate endpoints. While many factors contribute to the quality of measurements of imaging v ... Full text Link to item Cite

Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.

Journal Article J Am Soc Echocardiogr · December 2016 BACKGROUND: There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results. METHODS: Twe ... Full text Open Access Link to item Cite

Risk Prediction With Electronic Health Records: The Importance of Model Validation and Clinical Context.

Journal Article JAMA Cardiol · December 1, 2016 Full text Link to item Cite

Association of 30-Day Readmission Metric for Heart Failure Under the Hospital Readmissions Reduction Program With Quality of Care and Outcomes.

Journal Article JACC Heart Fail · December 2016 OBJECTIVES: This study sought to determine whether processes of care and long-term clinical outcomes for heart failure (HF) admissions across Get With The Guidelines-Heart Failure (GWTG-HF) program participating centers differ according to HF-specific risk ... Full text Link to item Cite

Controlling for Informed Presence Bias Due to the Number of Health Encounters in an Electronic Health Record.

Journal Article Am J Epidemiol · December 1, 2016 Electronic health records (EHRs) are an increasingly utilized resource for clinical research. While their size allows for many analytical opportunities, as with most observational data there is also the potential for bias. One of the key sources of bias in ... Full text Link to item Cite

Do Not Over (P) Value Your Research Article.

Journal Article JAMA Cardiol · December 1, 2016 Full text Link to item Cite

Temporal Changes in the Association Between Modifiable Risk Factors and Coronary Heart Disease Incidence.

Journal Article JAMA · November 15, 2016 Full text Link to item Cite

A comparison of time dependent Cox regression, pooled logistic regression and cross sectional pooling with simulations and an application to the Framingham Heart Study.

Journal Article BMC Med Res Methodol · November 3, 2016 BACKGROUND: Typical survival studies follow individuals to an event and measure explanatory variables for that event, sometimes repeatedly over the course of follow up. The Cox regression model has been used widely in the analyses of time to diagnosis or d ... Full text Link to item Cite

A comparison of time dependent Cox regression, pooled logistic regression and cross sectional pooling with simulations and an application to the Framingham Heart Study

Journal Article BMC medical research methodology · November 3, 2016 BACKGROUND: Typical survival studies follow individuals to an event and measure explanatory variables for that event, sometimes repeatedly over the course of follow up. The Cox regression model has been used widely in the analyses of time to diagnosis or d ... Cite

Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates.

Journal Article J Pediatr · November 2016 OBJECTIVE: To evaluate the relationship between ampicillin dosing, exposure, and seizures. STUDY DESIGN: This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure pr ... Full text Link to item Cite

Assessing Cardiovascular Risk to Guide Hypertension Diagnosis and Treatment.

Journal Article JAMA Cardiol · November 1, 2016 IMPORTANCE: The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated the benefit of lowering systolic blood pressure (SBP) to 120 mm Hg, yet other trials, such as Heart Outcomes Prevention Evaluation-3 (HOPE-3), did not find consistent benefit. ... Full text Link to item Cite

Age and Cardiovascular Risk Attributable to Apolipoprotein B, Low-Density Lipoprotein Cholesterol or Non-High-Density Lipoprotein Cholesterol.

Journal Article J Am Heart Assoc · October 13, 2016 BACKGROUND: Higher concentrations of the apolipoprotein B (apoB) lipoproteins increase the risk of cardiovascular disease. However, whether the risk associated with apoB lipoproteins varies with age has not been well examined. METHODS AND RESULTS: We deter ... Full text Link to item Cite

Hospital Variation in Home-Time After Acute Ischemic Stroke: Insights From the PROSPER Study (Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research).

Journal Article Stroke · October 2016 BACKGROUND AND PURPOSE: Stroke survivors identify home-time as a high-priority outcome; there are limited data on factors influencing home-time and home-time variability among discharging hospitals. METHODS: We ascertained home-time (ie, time alive out of ... Full text Link to item Cite

Impact of statin therapy on plasma adiponectin concentrations: A systematic review and meta-analysis of 43 randomized controlled trial arms.

Journal Article Atherosclerosis · October 2016 BACKGROUND AND AIMS: The effect of statin therapy on plasma adiponectin levels has not been conclusively studied. Therefore, we aimed to evaluate this effect through a systematic review and meta-analysis of available randomized controlled trials (RCTs). ME ... Full text Link to item Cite

Population Effect of Differences in Cholesterol Guidelines in Eastern Europe and the United States.

Journal Article JAMA Cardiol · September 1, 2016 IMPORTANCE: The American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of blood cholesterol and the current European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines differ in how they i ... Full text Link to item Cite

Open Access Platforms for Sharing Clinical Trial Data--Reply.

Journal Article JAMA · August 9, 2016 Full text Link to item Cite

Statin Utilization and Recommendations Among HIV- and HCV-infected Veterans: A Cohort Study.

Journal Article Clin Infect Dis · August 1, 2016 BACKGROUND: Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections are associated with increased risk of cardiovascular disease (CVD). The potential impact of recently updated cholesterol guidelines on treatment of HIV- and HCV-infected ... Full text Link to item Cite

Risk of Premature Cardiovascular Disease vs the Number of Premature Cardiovascular Events.

Journal Article JAMA Cardiol · July 1, 2016 Full text Link to item Cite

Comparison of clinical outcomes between bioresorbable vascular stents versus conventional drug-eluting and metallic stents: a systematic review and meta-analysis.

Journal Article EuroIntervention · June 12, 2016 AIMS: Several studies have suggested good procedural and similar clinical outcomes between everolimus-eluting Absorb bioresorbable stents (BRS) versus conventional drug-eluting stents (DES), but the evidence is not definitive. Our aim was to perform a syst ... Full text Link to item Cite

A calibration hierarchy for risk models was defined: from utopia to empirical data.

Journal Article J Clin Epidemiol · June 2016 OBJECTIVE: Calibrated risk models are vital for valid decision support. We define four levels of calibration and describe implications for model development and external validation of predictions. STUDY DESIGN AND SETTING: We present results based on simul ... Full text Link to item Cite

Assessment of Administrative Data to Identify Acute Myocardial Infarction in Electronic Health Records.

Journal Article J Am Coll Cardiol · May 24, 2016 Full text Link to item Cite

Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Clinical Trial.

Journal Article JAMA Cardiol · May 1, 2016 IMPORTANCE: Previous trial results have suggested that dipeptidyl peptidase 4 inhibitor (DPP4i) use might increase heart failure (HF) risk in type 2 diabetes mellitus (T2DM). The DPP4i sitagliptin has been shown to be noninferior to placebo with regard to ... Full text Link to item Cite

The Enigma of Glucose and Lipid Metabolism.

Journal Article JAMA Cardiol · May 1, 2016 Full text Link to item Cite

Moving From Clinical Trials to Precision Medicine: The Role for Predictive Modeling.

Journal Article JAMA · April 26, 2016 Full text Link to item Cite

Individualized Statin Benefit for Determining Statin Eligibility in the Primary Prevention of Cardiovascular Disease.

Journal Article Circulation · April 19, 2016 BACKGROUND: Current guidelines recommend statins in the primary prevention of cardiovascular disease on the basis of predicted cardiovascular risk without directly considering the expected benefits of statin therapy based on the available randomized, contr ... Full text Link to item Cite

Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

Journal Article Am Heart J · April 2016 Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXena ... Full text Link to item Cite

Rationale and design of the Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR trial): A randomized multicenter controlled event-driven trial.

Journal Article Am Heart J · April 2016 Aortic valve replacement (AVR) therapy is an obvious choice for symptomatic severe aortic stenosis (AS) patients as it improves symptoms, left ventricular function, and survival. The treatment decisions and indication for AVR in asymptomatic patients with ... Full text Link to item Cite

Development and Validation of Risk Prediction Models for Cardiovascular Events in Black Adults: The Jackson Heart Study Cohort.

Journal Article JAMA Cardiol · April 1, 2016 IMPORTANCE: Cardiovascular risk assessment is a fundamental component of prevention of cardiovascular disease (CVD). However, commonly used prediction models have been formulated in primarily or exclusively white populations. Whether risk assessment in bla ... Full text Link to item Cite

Use of Open Access Platforms for Clinical Trial Data.

Journal Article JAMA · March 22, 2016 Full text Link to item Cite

Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

Journal Article Am Heart J · February 2016 There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researcher ... Full text Link to item Cite

Head-to-head comparison of statins versus fibrates in reducing plasma fibrinogen concentrations: A systematic review and meta-analysis.

Journal Article Pharmacol Res · January 2016 BACKGROUND: Several studies suggest differences between fibrates and statins in lowering plasma fibrinogen (Fib) concentrations, but the evidence is not definitive. Therefore, the aim of this meta-analysis of head-to-head randomized trials was to compare t ... Full text Link to item Cite

Prevalence of lipid abnormalities in Poland. The NATPOL 2011 survey.

Journal Article Kardiol Pol · 2016 BACKGROUND: Poland represents a country of high cardiovascular (CV) risk. The association between lipid abnormalities and increased CV risk is well established. Therefore, it is important to monitor the prevalence and control of dyslipidaemia. AIM: To eval ... Full text Link to item Cite

A Systematic Review of Using Electronic Heath Records to Predict Clinical Events: Assessment of Opportunities and Challenges.

Conference CRI · 2016 Cite

The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation.

Journal Article Eur Heart J · December 7, 2015 BACKGROUND: Therapeutic decisions in atrial fibrillation (AF) are often influenced by assessment of bleeding risk. However, existing bleeding risk scores have limitations. OBJECTIVES: We sought to develop and validate a novel bleeding risk score using rout ... Full text Open Access Link to item Cite

The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation

Journal Article European heart journal · December 7, 2015 BACKGROUND: Therapeutic decisions in atrial fibrillation (AF) are often influenced by assessment of bleeding risk. However, existing bleeding risk scores have limitations. ... Full text Cite

Association of obesity and inflammatory marker levels on treatment outcome: results from a double-blind, randomized study of adjunctive L-methylfolate calcium in patients with MDD who are inadequate responders to SSRIs.

Journal Article J Clin Psychiatry · December 2015 OBJECTIVE: Adjunctive treatment with L-methylfolate calcium significantly improved treatment outcomes in patients with major depressive disorder (MDD) and an inadequate response to antidepressants. This post hoc exploratory analysis evaluated baseline conc ... Full text Link to item Cite

Risk Prediction for Individuals--Reply.

Journal Article JAMA · November 3, 2015 Full text Link to item Cite

Substance use and mental diagnoses among adults with and without type 2 diabetes: Results from electronic health records data.

Journal Article Drug Alcohol Depend · November 1, 2015 BACKGROUND: Comorbid diabetes and substance use diagnoses (SUD) represent a hazardous combination, both in terms of healthcare cost and morbidity. To date, there is limited information about the association of SUD and related mental disorders with type 2 d ... Full text Open Access Link to item Cite

Anticholinergic vs Long-Acting β-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial.

Journal Article JAMA · October 27, 2015 IMPORTANCE: The efficacy and safety of long-acting β-agonists (LABAs) have been questioned. Black populations may be disproportionately affected by LABA risks. OBJECTIVE: To compare the effectiveness and safety of tiotropium vs LABAs, when used with inhale ... Full text Link to item Cite

Response to Letter Regarding Article, "Hyperlipidemia in Early Adulthood Increases Long-Term Risk of Coronary Heart Disease".

Journal Article Circulation · October 20, 2015 Full text Link to item Cite

Clinical Effectiveness of Statin Therapy After Ischemic Stroke: Primary Results From the Statin Therapeutic Area of the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study.

Journal Article Circulation · October 13, 2015 BACKGROUND: In patients with ischemic stroke, data on the real-world effectiveness of statin therapy for clinical and patient-centered outcomes are needed to better inform shared decision making. METHODS AND RESULTS: Patient-Centered Research Into Outcomes ... Full text Link to item Cite

Apolipoprotein B improves risk assessment of future coronary heart disease in the Framingham Heart Study beyond LDL-C and non-HDL-C.

Journal Article Eur J Prev Cardiol · October 2015 AIMS: Analyses using conventional statistical methodologies have yielded conflicting results as to whether low-density lipoprotein cholesterol (LDL-C) or non-high-density lipoprotein cholesterol (non-HDL-C) or apolipoprotein B (apoB) is the best marker of ... Full text Link to item Cite

Risk scores and biomarkers for the prediction of 1-year outcome after transcatheter aortic valve replacement.

Journal Article Am Heart J · October 2015 BACKGROUND: Up to 50% of the patients still die or have to be rehospitalized during the first year after transcatheter aortic valve replacement (TAVR). This emphasizes the need for more strategic patient selection. The aim of this prospective observational ... Full text Link to item Cite

Evaluating Discrimination of Risk Prediction Models: The C Statistic.

Journal Article JAMA · September 8, 2015 Full text Link to item Cite

Applicability and potential clinical effects of 2013 cholesterol guidelines on major cardiovascular events.

Journal Article Am Heart J · September 2015 BACKGROUND: The applicability to different race/ethnic groups and effects on cardiovascular disease (CVD) outcomes of the 2013 American College of Cardiology and American Heart Association (ACC/AHA) guidelines for cholesterol management remain to be determ ... Full text Link to item Cite

Genetic variants primarily associated with type 2 diabetes are related to coronary artery disease risk.

Journal Article Atherosclerosis · August 2015 BACKGROUND: The mechanisms underlying the association between diabetes and coronary artery disease (CAD) risk are unclear. We aimed to assess this association by studying genetic variants that have been shown to associate with type 2 diabetes (T2DM). If th ... Full text Link to item Cite

On the quantitative assessment of predictive biomarkers.

Journal Article J Natl Cancer Inst · August 2015 Full text Link to item Cite

Medical history for prognostic risk assessment and diagnosis of stable patients with suspected coronary artery disease.

Journal Article Am J Med · August 2015 OBJECTIVE: To develop a clinical cardiac risk algorithm for stable patients with suspected coronary artery disease based upon angina typicality and coronary artery disease risk factors. METHODS: Between 2004 and 2011, 14,004 adults with suspected coronary ... Full text Link to item Cite

Real world effectiveness of warfarin among ischemic stroke patients with atrial fibrillation: observational analysis from Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) study.

Journal Article BMJ · July 31, 2015 OBJECTIVE: To examine the association between warfarin treatment and longitudinal outcomes after ischemic stroke in patients with atrial fibrillation in community practice. DESIGN: Observational study. SETTING: Hospitals (n = 1487) participating in the Get ... Full text Open Access Link to item Cite

ACP Journal Club. In adults without CV disease, most prediction scores overestimated risk for atherosclerotic CV events.

Journal Article Ann Intern Med · July 21, 2015 Full text Link to item Cite

Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.

Journal Article N Engl J Med · July 16, 2015 BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind st ... Full text Link to item Cite

Placebo non-response measure in sequential parallel comparison design studies.

Journal Article Stat Med · July 10, 2015 The Sequential Parallel Comparison Design (SPCD) is one of the novel approaches addressing placebo response. The analysis of SPCD data typically classifies subjects as 'placebo responders' or 'placebo non-responders'. Most current methods employed for anal ... Full text Link to item Cite

The Role of Physicians in the Era of Predictive Analytics.

Journal Article JAMA · July 7, 2015 Full text Link to item Cite

Calibration and Discrimination Among Multiple Cardiovascular Risk Scores in a Modern Multiethnic Cohort.

Journal Article Ann Intern Med · July 7, 2015 Full text Link to item Cite

Graphical assessment of incremental value of novel markers in prediction models: From statistical to decision analytical perspectives.

Journal Article Biom J · July 2015 New markers may improve prediction of diagnostic and prognostic outcomes. We aimed to review options for graphical display and summary measures to assess the predictive value of markers over standard, readily available predictors. We illustrated various ap ... Full text Link to item Cite

Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research: Implementing the patient-driven research paradigm to aid decision making in stroke care.

Journal Article Am Heart J · July 2015 BACKGROUND: Stroke is common and costly, annually depriving the lives and well-being of 800,000 Americans. Despite demonstrated efficacy in clinical trials, questions remain about the safety and clinical effectiveness of various treatment options given pat ... Full text Link to item Cite

Limitations in the conventional assessment of the incremental value of predictors of cardiovascular risk.

Journal Article Curr Opin Lipidol · June 2015 PURPOSE OF REVIEW: Whether a factor significantly increases the area under the curve (AUC) of a receiver operating characteristic analysis has become the standard test of its utility. Thus, in many studies, apolipoprotein B and LDL particle number have not ... Full text Link to item Cite

Association of Obesity and Levels of Inflammatory Markers on Treatment Outcome with Adjunctive (6S)-5-methyl-5,6,7,8-tetrahydropteroyl-L-glutamic Acid (CH3-FH4) in MDD Patients Who are Inadequate Responders to SSRIs

Conference BIOLOGICAL PSYCHIATRY · May 1, 2015 Link to item Cite

Using age- and sex-specific risk thresholds to guide statin therapy: one size may not fit all.

Journal Article J Am Coll Cardiol · April 28, 2015 BACKGROUND: New cholesterol guidelines emphasize 10-year risk of cardiovascular disease (CVD) to identify adults eligible for statin therapy as primary prevention. Whether these CVD risk thresholds should be individualized by age and sex has not been explo ... Full text Link to item Cite

A victory for statins or a defeat for diet policies? Cholesterol falls in Poland in the past decade: A modeling study.

Journal Article Int J Cardiol · April 15, 2015 AIM: The present study is aimed to examine whether recent changes in population total cholesterol (TC) levels in Poland might be attributed to increased use statins. METHODS: Two independent, nationally representative cross-sectional studies were conducted ... Full text Link to item Cite

A confidence ellipse for the Net Reclassification Improvement.

Journal Article Eur J Epidemiol · April 2015 The Net Reclassification Improvement (NRI) has become a popular metric for evaluating improvement in disease prediction models through the past years. The concept is relatively straightforward but usage and interpretation has been different across studies. ... Full text Link to item Cite

Trends in diabetes incidence: the Framingham Heart Study.

Journal Article Diabetes Care · March 2015 OBJECTIVE: Obesity and type 2 diabetes continue to increase in prevalence in the U.S. Whether diabetes incidence continues to increase in recent times is less well documented. We examined trends in diabetes incidence over the previous four decades. RESEARC ... Full text Link to item Cite

Hyperlipidemia in early adulthood increases long-term risk of coronary heart disease.

Journal Article Circulation · February 3, 2015 BACKGROUND: Many young adults with moderate hyperlipidemia do not meet statin treatment criteria under the new American Heart Association/American College of Cardiology cholesterol guidelines because they focus on 10-year cardiovascular risk. We evaluated ... Full text Link to item Cite

Clinical Effectiveness of Anticoagulation with Warfarin among Ischemic Stroke Patients with Atrial Fibrillation: Findings from the Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study

Conference STROKE · February 1, 2015 Link to item Cite

High vs. Moderate-intensity Statin Therapy After Ischemic Stroke: Findings from PROSPER

Conference STROKE · February 1, 2015 Link to item Cite

Clinical Effectiveness of Statin Therapy after Ischemic Stroke: Primary Results from the PROSPER Study

Conference STROKE · February 1, 2015 Link to item Cite

RE: net risk reclassification P Values: valid or misleading?

Journal Article J Natl Cancer Inst · January 2015 Full text Link to item Cite

P-wave indices and atrial fibrillation: cross-cohort assessments from the Framingham Heart Study (FHS) and Atherosclerosis Risk in Communities (ARIC) study.

Journal Article Am Heart J · January 2015 BACKGROUND: Atrial fibrillation (AF) is associated with increased morbidity. P-wave indices (PWIs) measure atrial electrical function and are associated with AF. Study of PWI has been limited to single-cohort investigations, and their contributions to risk ... Full text Link to item Cite

Serial measurements of N-terminal pro-brain natriuretic peptide in patients with coronary heart disease.

Journal Article PLoS One · 2015 OBJECTIVE: To assess the prognostic value of 12-months N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) levels on adverse cardiovascular events in patients with stable coronary heart disease. METHODS: NT-proBNP concentrations were measured at baseline ... Full text Link to item Cite

Inference for reclassification statistics under nested and non-nested models for biomarker evaluation.

Journal Article Biomarkers · 2015 The Net Reclassification Improvement (NRI) and the Integrated Discrimination Improvement (IDI) are used to evaluate the diagnostic accuracy improvement for biomarkers in a wide range of applications. Most applications for these reclassification metrics are ... Full text Link to item Cite

What to expect from net reclassification improvement with three categories.

Journal Article Stat Med · December 10, 2014 The net reclassification improvement (NRI) has become a popular measure of incremental usefulness of markers added to risk prediction models. However, the expected magnitude of the three-category NRI is not well understood, leading researchers to rely on s ... Full text Link to item Cite

Prevalence of diabetes and impaired fasting glucose in Poland--the NATPOL 2011 Study.

Journal Article Diabet Med · December 2014 AIMS: The aim of the analysis was to assess the prevalence of diabetes and impaired fasting glucose in Poland. METHODS: A questionnaire survey on a representative sample of 2411 Polish adults, complemented by blood pressure, anthropometric and fasting plas ... Full text Link to item Cite

Predicted long-term cardiovascular risk among young adults in the national longitudinal study of adolescent health.

Journal Article Am J Public Health · December 2014 OBJECTIVES: We estimated the distribution of predicted long-term cardiovascular disease (CVD) risk among young adults in the United States. METHODS: Our data were derived from National Longitudinal Study of Adolescent Health participants (n = 14 333; avera ... Full text Link to item Cite

Future Risk of Cardiovascular Disease in Adults with Prolonged Exposure to High Blood Pressure

Conference CIRCULATION · November 25, 2014 Link to item Cite

European and American Blood Cholesterol Guidelines Result in Similar Rates of Statin Recommendations when Applied to a Country with High Cardiovascular Disease Risk

Conference CIRCULATION · November 25, 2014 Link to item Cite

Clinical implications of chronic heart failure phenotypes defined by cluster analysis.

Journal Article J Am Coll Cardiol · October 28, 2014 BACKGROUND: Classification of chronic heart failure (HF) is on the basis of criteria that may not adequately capture disease heterogeneity. Improved phenotyping may help inform research and therapeutic strategies. OBJECTIVES: This study used cluster analys ... Full text Link to item Cite

Charting a roadmap for heart failure biomarker studies.

Journal Article JACC Heart Fail · October 2014 Heart failure is a syndrome with a pathophysiological basis that can be traced to dysfunction in several interconnected molecular pathways. Identification of biomarkers of heart failure that allow measurement of the disease on a molecular level has resulte ... Full text Link to item Cite

B-type natriuretic peptide and C-reactive protein in the prediction of atrial fibrillation risk: the CHARGE-AF Consortium of community-based cohort studies.

Journal Article Europace · October 2014 AIMS: B-type natriuretic peptide (BNP) and C-reactive protein (CRP) predict atrial fibrillation (AF) risk. However, their risk stratification abilities in the broad community remain uncertain. We sought to improve risk stratification for AF using biomarker ... Full text Link to item Cite

Model for End-Stage Liver Disease score predicts mortality in critically ill cirrhotic patients.

Journal Article J Crit Care · October 2014 PURPOSE: Cirrhosis is a common condition that complicates the management of patients who require critical care. There is interest in identifying scoring systems that may be used to predict outcome because of the poor odds for recovery despite high-intensit ... Full text Link to item Cite

How to interpret a small increase in AUC with an additional risk prediction marker: decision analysis comes through.

Journal Article Stat Med · September 28, 2014 An important question in the evaluation of an additional risk prediction marker is how to interpret a small increase in the area under the receiver operating characteristic curve (AUC). Many researchers believe that a change in AUC is a poor metric because ... Full text Link to item Cite

Net reclassification improvement and integrated discrimination improvement require calibrated models: relevance from a marker and model perspective.

Journal Article Stat Med · August 30, 2014 Full text Link to item Cite

Patients affected by changes to hypertension guideline--reply.

Journal Article JAMA · August 27, 2014 Full text Link to item Cite

Prognostic value of quantitative contrast-enhanced cardiovascular magnetic resonance for the evaluation of sudden death risk in patients with hypertrophic cardiomyopathy.

Journal Article Circulation · August 5, 2014 BACKGROUND: Hypertrophic cardiomyopathy (HCM) is the most common cause of sudden death in the young, although not all patients eligible for sudden death prevention with an implantable cardioverter-defibrillator are identified. Contrast-enhanced cardiovascu ... Full text Link to item Cite

Quantifying cardiometabolic risk using modifiable non-self-reported risk factors.

Journal Article Am J Prev Med · August 2014 BACKGROUND: Sensitive general cardiometabolic risk assessment tools of modifiable risk factors would be helpful and practical in a range of primary prevention interventions or for preventive health maintenance. PURPOSE: To develop and validate a cumulative ... Full text Link to item Cite

Independent data monitoring committees: preparing a path for the future.

Journal Article Am Heart J · August 2014 Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities ... Full text Link to item Cite

Assessing the incremental predictive performance of novel biomarkers over standard predictors.

Journal Article Stat Med · July 10, 2014 It is unclear to what extent the incremental predictive performance of a novel biomarker is impacted by the method used to control for standard predictors. We investigated whether adding a biomarker to a model with a published risk score overestimates its ... Full text Link to item Cite

Application of the new cholesterol guidelines.

Journal Article N Engl J Med · July 3, 2014 Full text Link to item Cite

Risk assessment to predict arterial and venous events in patients undergoing percutaneous coronary intervention.

Journal Article Clin Appl Thromb Hemost · July 2014 Atherosclerosis and venous thromboembolism (VTE) share common risk factors. We set to assess the strength of the association between atherosclerosis risk factors and disease manifestation, and VTE, in patients with coronary artery disease undergoing percut ... Full text Link to item Cite

Prognostic value of Rb-82 positron emission tomography myocardial perfusion imaging in coronary artery bypass patients.

Journal Article Eur Heart J Cardiovasc Imaging · July 2014 AIMS: We sought to determine the prognostic value of positron emission tomography (PET) myocardial perfusion imaging (MPI) in patients with prior coronary artery bypass graft (CABG) surgery. PET MPI has recently been shown to provide incremental risk strat ... Full text Link to item Cite

Influence of exercise training on T-wave alternans assessed during exercise test in heart failure patients.

Journal Article Int J Cardiol · July 1, 2014 Full text Link to item Cite

The knowledge and awareness of hypertension among patients with hypertension in central Poland: a pilot registry.

Journal Article Angiology · July 2014 We assessed the differences in the knowledge and level of awareness of hypertension among patients with hypertension from Central Poland; 248 (57.6% females) patients diagnosed with hypertension completed a questionnaire. Most (79%) of the patients were un ... Full text Link to item Cite

Heparin monotherapy or bivalirudin during percutaneous coronary intervention in patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease: results from the Evaluation of Drug-Eluting Stents and Ischemic Events registry.

Journal Article Circ Cardiovasc Interv · June 2014 BACKGROUND: The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined. METHODS AND RESULTS: The study population consisted of patients enrolled in the Evaluation of D ... Full text Link to item Cite

Biomarkers of myocardial stress and fibrosis as predictors of mode of death in patients with chronic heart failure.

Journal Article JACC Heart Fail · June 2014 OBJECTIVES: The aim of this study was to determine whether biomarkers of myocardial stress and fibrosis improve prediction of the mode of death in patients with chronic heart failure. BACKGROUND: The 2 most common modes of death in patients with chronic he ... Full text Link to item Cite

Taking a longer term view of cardiovascular risk: the causal exposure paradigm.

Journal Article BMJ · May 21, 2014 Full text Link to item Cite

Sensitivity and specificity can change in opposite directions when new predictive markers are added to risk models.

Journal Article Med Decis Making · May 2014 When comparing prediction models, it is essential to estimate the magnitude of change in performance rather than rely solely on statistical significance. In this paper we investigate measures that estimate change in classification performance, assuming 2-g ... Full text Link to item Cite

Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis and critical examination of current methodologies.

Journal Article Catheter Cardiovasc Interv · May 1, 2014 BACKGROUND: The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective ... Full text Link to item Cite

Application of new cholesterol guidelines to a population-based sample.

Journal Article N Engl J Med · April 10, 2014 BACKGROUND: The 2013 guidelines of the American College of Cardiology and the American Heart Association (ACC-AHA) for the treatment of cholesterol expand the indications for statin therapy for the prevention of cardiovascular disease. METHODS: Using data ... Full text Link to item Cite

Proportion of US adults potentially affected by the 2014 hypertension guideline.

Journal Article JAMA · April 9, 2014 IMPORTANCE: The new 2014 blood pressure (BP) guideline released by the panel members appointed to the Eighth Joint National Committee (JNC 8; 2014 BP guideline) proposed less restrictive BP targets for adults aged 60 years or older and for those with diabe ... Full text Link to item Cite

Prognostic value of PET myocardial perfusion imaging in obese patients.

Journal Article JACC Cardiovasc Imaging · March 2014 OBJECTIVES: This study sought to determine and compare the prognostic and incremental value of positron emission tomography (PET) in normal, overweight, and obese patients. BACKGROUND: Cardiac rubidium 82 (Rb-82) PET is increasingly being used for myocardi ... Full text Link to item Cite

Doppler-detected valve movement in aortic stenosis: a predictor of adverse outcome.

Journal Article Clin Cardiol · March 2014 BACKGROUND: The absence of auscultatory aortic valve closure sound is associated with severe aortic stenosis. The absence of Doppler-derived aortic opening (Aop ) or closing (Acl ) may be a sign of advanced severe aortic stenosis. HYPOTHESIS: Absent Dopple ... Full text Link to item Cite

Trends in the association of parental history of obesity over 60 years.

Journal Article Obesity (Silver Spring) · March 2014 OBJECTIVE: The association of familial as compared to genetic factors in the current obesogenic environment, compared with earlier, leaner time periods, is uncertain. METHODS: Participants from the Framingham Heart Study were classified according to parent ... Full text Link to item Cite

Correction to How to interpret a small increase in AUC with an additional risk prediction marker: Decision analysis comes through [Statist. Med. (2015) 33, 22, 3946-3959] DOI: 10.1002/sim.6195

Journal Article Statistics in Medicine · February 28, 2014 Full text Cite

Net reclassification improvement: computation, interpretation, and controversies: a literature review and clinician's guide.

Journal Article Ann Intern Med · January 21, 2014 The net reclassification improvement (NRI) is an increasingly popular measure for evaluating improvements in risk predictions. This article details a review of 67 publications in high-impact general clinical journals that considered the NRI. Incomplete rep ... Full text Link to item Cite

Admission cell free DNA levels predict 28-day mortality in patients with severe sepsis in intensive care.

Journal Article PLoS One · 2014 AIM: The aim of the current study is to assess the mortality prediction accuracy of circulating cell-free DNA (CFD) level at admission measured by a new simplified method. MATERIALS AND METHODS: CFD levels were measured by a direct fluorescence assay in se ... Full text Link to item Cite

General medical burden in bipolar disorder: findings from the LiTMUS comparative effectiveness trial.

Journal Article Acta Psychiatr Scand · January 2014 OBJECTIVE: This study examined general medical illnesses and their association with clinical features of bipolar disorder. METHOD: Data were cross-sectional and derived from the Lithium Treatment - Moderate Dose Use Study (LiTMUS), which randomized symptom ... Full text Link to item Cite

Left ventricular hypertrophy patterns and incidence of heart failure with preserved versus reduced ejection fraction.

Journal Article Am J Cardiol · January 1, 2014 Higher left ventricular (LV) mass, wall thickness, and internal dimension are associated with increased heart failure (HF) risk. Whether different LV hypertrophy patterns vary with respect to rates and types of HF incidence is unclear. In this study, 4,768 ... Full text Link to item Cite

Long-term efficacy and safety of Zotarolimus-eluting stent in patients with diabetes mellitus: pooled 5-year results from the ENDEAVOR III and IV trials.

Journal Article Catheter Cardiovasc Interv · December 1, 2013 OBJECTIVE: To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM). BACKGROUND: Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compare ... Full text Link to item Cite

Prognostic implications of procedural vs spontaneous myocardial infarction: results from the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry.

Journal Article Am Heart J · December 2013 BACKGROUND: In randomized clinical trials, procedural myocardial infarction (MI) or spontaneous MI is often weighted equally as a component of a composite clinical end point. An underlying assumption of this approach is that procedural and spontaneous MIs ... Full text Link to item Cite

Impact of correlation on predictive ability of biomarkers.

Journal Article Stat Med · October 30, 2013 In this paper, we investigate how the correlation structure of independent variables affects the discrimination of risk prediction model. Using multivariate normal data and binary outcome, we prove that zero correlation among predictors is often detrimenta ... Full text Link to item Cite

A meta-analysis of the role of statins on renal outcomes in patients with chronic kidney disease. Is the duration of therapy important?

Journal Article Int J Cardiol · October 15, 2013 INTRODUCTION: The efficacy of statin treatment in chronic kidney disease (CKD) patients remains controversial. Therefore, we performed a meta-analysis to investigate whether statins modulate renal function in patients with CKD. METHODS: Data from Scopus, P ... Full text Link to item Cite

The effects of statins on blood pressure in normotensive or hypertensive subjects--a meta-analysis of randomized controlled trials.

Journal Article Int J Cardiol · October 3, 2013 OBJECTIVE: The aim of this meta-analysis was to investigate whether statin therapy is associated with blood pressure (BP)-lowering in patients with or without hypertension. BACKGROUND: The beneficial effects of statins on the cardiovascular system may in p ... Full text Link to item Cite

Incremental prognostic value of biomarkers beyond the GRACE (Global Registry of Acute Coronary Events) score and high-sensitivity cardiac troponin T in non-ST-elevation acute coronary syndrome.

Journal Article Clin Chem · October 2013 BACKGROUND: Guidelines recommend the use of validated risk scores and a high-sensitivity cardiac troponin assay for risk assessment in non-ST-elevation acute coronary syndrome (NSTE-ACS). The incremental prognostic value of biomarkers in this context is un ... Full text Link to item Cite

Repeat bone mineral density screening and prediction of hip and major osteoporotic fracture.

Journal Article JAMA · September 25, 2013 IMPORTANCE: Screening for osteoporosis with bone mineral density (BMD) is recommended for older adults. It is unclear whether repeating a BMD screening test improves fracture risk assessment. OBJECTIVES: To determine whether changes in BMD after 4 years pr ... Full text Link to item Cite

Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community.

Journal Article J Am Heart Assoc · September 3, 2013 BACKGROUND: Atrial fibrillation (AF) patterns and their relations with long-term prognosis are uncertain, partly because pattern definitions are challenging to implement in longitudinal data sets. We developed a novel AF classification algorithm and examin ... Full text Link to item Cite

Prostate-specific antigen velocity: new methods, same results, still no evidence of clinical utility.

Journal Article Eur Urol · September 2013 Full text Link to item Cite

Predictive models in heart failure: who cares?

Journal Article Circ Heart Fail · September 1, 2013 Full text Link to item Cite

The effects of aripiprazole on the subscales of the Kellner Symptom Questionnaire in treatment resistant depression.

Journal Article Int Clin Psychopharmacol · September 2013 We have recently examined the efficacy of low-dose aripiprazole augmentation for major depressive disorder (MDD), with modest nonsignificant benefit found. In a secondary investigation, we examined whether aripiprazole resulted in improvement in four subsc ... Full text Link to item Cite

Stress cardiac magnetic resonance imaging provides effective cardiac risk reclassification in patients with known or suspected stable coronary artery disease.

Journal Article Circulation · August 6, 2013 BACKGROUND: A recent large-scale clinical trial found that an initial invasive strategy does not improve cardiac outcomes beyond optimized medical therapy in patients with stable coronary artery disease. Novel methods to stratify at-risk patients may refin ... Full text Link to item Cite

Risk assessment for incident heart failure in individuals with atrial fibrillation.

Journal Article Eur J Heart Fail · August 2013 BACKGROUND: Atrial fibrillation (AF) is a strong risk factor for heart failure (HF); HF onset in patients with AF is associated with increased morbidity and mortality. Risk factors that predict HF in individuals with AF in the community are not well establ ... Full text Link to item Cite

A repeated measures model for analysis of continuous outcomes in sequential parallel comparison design studies.

Journal Article Stat Med · July 20, 2013 Previous authors have proposed the sequential parallel comparison design (SPCD) to address the issue of high placebo response rate in clinical trials. The original use of SPCD focused on binary outcomes, but recent use has since been extended to continuous ... Full text Link to item Cite

Statins decrease all-cause mortality only in CKD patients not requiring dialysis therapy--a meta-analysis of 11 randomized controlled trials involving 21,295 participants.

Journal Article Pharmacol Res · June 2013 The available studies have reported the benefits of statins on all-cause and cardiovascular mortality in chronic kidney disease (CKD) patients. However studies in end-stage renal disease patients on dialysis yielded conflicting results. Therefore, we perfo ... Full text Link to item Cite

Early-adulthood cardiovascular disease risk factor profiles among individuals with and without diabetes in the Framingham Heart Study.

Journal Article Diabetes Care · June 2013 OBJECTIVE: Many studies of diabetes have examined risk factors at the time of diabetes diagnosis instead of considering the lifetime burden of adverse risk factor levels. We examined the 30-year cardiovascular disease (CVD) risk factor burden that particip ... Full text Link to item Cite

Age trends in estradiol and estrone levels measured using liquid chromatography tandem mass spectrometry in community-dwelling men of the Framingham Heart Study.

Journal Article J Gerontol A Biol Sci Med Sci · June 2013 BACKGROUND: Age trends in estradiol and estrone levels in men and how lifestyle factors, comorbid conditions, testosterone, and sex hormone-binding globulin affect these age trends remain poorly understood, and were examined in men of the Framingham Heart ... Full text Link to item Cite

Comparison of operating characteristics of commonly used sample size re-estimation procedures in a two-stage design

Journal Article Communications in Statistics: Simulation and Computation · May 1, 2013 In group sequential clinical trials, there are several sample size re-estimation methods proposed in the literature that allow for change of sample size at the interim analysis. Most of these methods are based on either the conditional error function or th ... Full text Cite

Genetic predisposition to higher blood pressure increases coronary artery disease risk.

Journal Article Hypertension · May 2013 Hypertension is a risk factor for coronary artery disease. Recent genome-wide association studies have identified 30 genetic variants associated with higher blood pressure at genome-wide significance (P<5 × 10(-8)). If elevated blood pressure is a causativ ... Full text Link to item Cite

Effects of statins on lipid profile in chronic kidney disease patients: a meta-analysis of randomized controlled trials.

Journal Article Curr Med Res Opin · May 2013 OBJECTIVE: The available data on statin effects in chronic kidney disease (CKD) patients are still conflicting. We investigated the impact of short- and long-term statin therapy on lipid profiles in CKD patients requiring or not requiring dialysis. RESEARC ... Full text Link to item Cite

Lack of interaction of beta-cell-function-associated variants with hypertension on change in fasting glucose and diabetes risk: the Framingham Offspring Study.

Journal Article J Hypertens · May 2013 OBJECTIVE: To test whether pancreatic beta-cell genetic frailty and hypertension (HTN) interact in their associations with change over time in fasting glucose (ΔFG) or type 2 diabetes mellitus (T2D) risk. METHODS AND RESULTS: We pooled data from 3471 Frami ... Full text Link to item Cite

Evaluation of markers and risk prediction models: overview of relationships between NRI and decision-analytic measures.

Journal Article Med Decis Making · May 2013 BACKGROUND: For the evaluation and comparison of markers and risk prediction models, various novel measures have recently been introduced as alternatives to the commonly used difference in the area under the receiver operating characteristic (ROC) curve (Δ ... Full text Link to item Cite

Understanding increments in model performance metrics.

Journal Article Lifetime Data Anal · April 2013 The area under the receiver operating characteristic curve (AUC) is the most commonly reported measure of discrimination for prediction models with binary outcomes. However, recently it has been criticized for its inability to increase when important risk ... Full text Link to item Cite

The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles.

Journal Article Am Heart J · April 2013 BACKGROUND: Left ventricle (LV) remodeling after anterior wall myocardial infarction leads to increased LV volumes, myocardial stress, and, ultimately, heart failure (HF). Patients have high morbidity and mortality risk, and treatment remains limited. Perc ... Full text Link to item Cite

Simple risk model predicts incidence of atrial fibrillation in a racially and geographically diverse population: the CHARGE-AF consortium.

Journal Article J Am Heart Assoc · March 18, 2013 BACKGROUND: Tools for the prediction of atrial fibrillation (AF) may identify high-risk individuals more likely to benefit from preventive interventions and serve as a benchmark to test novel putative risk factors. METHODS AND RESULTS: Individual-level dat ... Full text Link to item Cite

Association of smoking cessation and weight change with cardiovascular disease among adults with and without diabetes.

Journal Article JAMA · March 13, 2013 IMPORTANCE: Smoking cessation reduces the risks of cardiovascular disease (CVD), but weight gain that follows quitting smoking may weaken the CVD benefit of quitting. OBJECTIVE: To test the hypothesis that weight gain following smoking cessation does not a ... Full text Link to item Cite

Validation of a breast cancer risk prediction model developed for Black women.

Journal Article J Natl Cancer Inst · March 6, 2013 BACKGROUND: A breast cancer risk prediction model for black women, developed from data in the Women's Contraceptive and Reproductive Experiences (CARE) study, has been validated in women aged 50 years or older but not among younger women or for specific br ... Full text Link to item Cite

Cardiovascular Disease Risk Assessment: Insights from Framingham.

Journal Article Glob Heart · March 2013 Cardiovascular disease (CVD) is among the leading causes of death and disability worldwide. Since its beginning, the Framingham study has been a leader in identifying CVD risk factors. Clinical trials have demonstrated that when the modifiable risk factors ... Full text Link to item Cite

Sex-specific differences in the predictive value of cholesterol homeostasis markers and 10-year cardiovascular disease event rate in Framingham Offspring Study participants.

Journal Article J Am Heart Assoc · February 19, 2013 BACKGROUND: Available data are inconsistent regarding factors influencing plasma cholesterol homeostasis marker concentrations and their value in predicting subsequent cardiovascular disease (CVD) events. METHODS AND RESULTS: To address this issue, the rel ... Full text Link to item Cite

Prognostic value of stress myocardial perfusion positron emission tomography: results from a multicenter observational registry.

Journal Article J Am Coll Cardiol · January 15, 2013 OBJECTIVES: The primary objective of this multicenter registry was to study the prognostic value of positron emission tomography (PET) myocardial perfusion imaging (MPI) and the improved classification of risk in a large cohort of patients with suspected o ... Full text Link to item Cite

Relation of circulating liver transaminase concentrations to risk of new-onset atrial fibrillation.

Journal Article Am J Cardiol · January 15, 2013 Heart failure, a strong risk factor for atrial fibrillation (AF), is often accompanied by elevated liver transaminases. The aim of this study was to test the hypothesis that elevated transaminases are associated with the risk for incident AF in the communi ... Full text Link to item Cite

The age-specific quantitative effects of metabolic risk factors on cardiovascular diseases and diabetes: a pooled analysis.

Journal Article PLoS One · 2013 BACKGROUND: The effects of systolic blood pressure (SBP), serum total cholesterol (TC), fasting plasma glucose (FPG), and body mass index (BMI) on the risk of cardiovascular diseases (CVD) have been established in epidemiological studies, but consistent es ... Full text Link to item Cite

Neck circumference and the development of cardiovascular disease risk factors in the Framingham Heart Study.

Journal Article Diabetes Care · January 2013 Full text Link to item Cite

Incremental value of rare genetic variants for the prediction of multifactorial diseases.

Journal Article Genome Med · 2013 BACKGROUND: It is often assumed that rare genetic variants will improve available risk prediction scores. We aimed to estimate the added predictive ability of rare variants for risk prediction of common diseases in hypothetical scenarios. METHODS: In simul ... Full text Link to item Cite

Risk of type 2 diabetes and cumulative excess weight exposure in the Framingham Offspring Study.

Journal Article J Diabetes Complications · 2013 AIM: Mid-life obesity is associated with T2D risk. However, less is known about the cumulative effect of obesity during adulthood. METHODS: Framingham Offspring Study participants who had an examination at 35±2 years and were initially free of T2D were inc ... Full text Link to item Cite

Prevalence and control of cardiovascular risk factors in Poland. Assumptions and objectives of the NATPOL 2011 Survey.

Journal Article Kardiol Pol · 2013 BACKGROUND: Cardiovascular diseases (CVD) have been the main cause of death in Poland for the last five decades. In 2010, CVD caused 46.0% of all deaths in Poland. An analysis performed using the IMPACT model, have shown that the reduction in mortality due ... Full text Link to item Cite

Lithium treatment moderate-dose use study (LiTMUS) for bipolar disorder: a randomized comparative effectiveness trial of optimized personalized treatment with and without lithium.

Journal Article Am J Psychiatry · January 2013 OBJECTIVE: Lithium salts, once the mainstay of therapy for bipolar disorder, have tolerability issues at a higher dosage that often limit adherence. The authors investigated the comparative effectiveness of more tolerable dosages of lithium as part of opti ... Full text Link to item Cite

Red cell distribution width is a predictor of mortality in patients undergoing percutaneous coronary intervention.

Journal Article J Thromb Thrombolysis · January 2013 Red cell distribution width (RDW), a measure of the variability in size of circulating erythrocytes, is an independent predictor of mortality in patients with cardiovascular disease. We hypothesized that RDW is a prognostic marker of death, myocardial infa ... Full text Link to item Cite

Repeat revascularization after contemporary percutaneous coronary intervention: an evaluation of staged, target lesion, and other unplanned revascularization procedures during the first year.

Journal Article Circ Cardiovasc Interv · December 2012 BACKGROUND: Although drug-eluting stents and intensive secondary prevention have contributed to improved outcomes after percutaneous coronary intervention (PCI), repeat revascularization remains relatively common in contemporary practice. We used data from ... Full text Link to item Cite

L-methylfolate as adjunctive therapy for SSRI-resistant major depression: results of two randomized, double-blind, parallel-sequential trials.

Journal Article Am J Psychiatry · December 2012 OBJECTIVE: The authors conducted two multicenter sequential parallel comparison design trials to investigate the effect of L-methylfolate augmentation in the treatment of major depressive disorder in patients who had a partial response or no response to se ... Full text Link to item Cite

Genotype prediction of adult type 2 diabetes from adolescence in a multiracial population.

Journal Article Pediatrics · November 2012 BACKGROUND: Understanding the risk for type 2 diabetes (T2D) early in the life course is important for prevention. Whether genetic information improves prediction models for diabetes from adolescence into adulthood is unknown. METHODS: With the use of data ... Full text Link to item Cite

Evaluating treatment efficacy by multiple end points in phase II acute heart failure clinical trials: analyzing data using a global method.

Journal Article Circ Heart Fail · November 2012 BACKGROUND: To assess concomitant simultaneous effects on multiple end points using global statistical methods in phase II acute heart failure studies. METHODS AND RESULTS: Using simulations we have assessed different statistical methods to evaluate concom ... Full text Link to item Cite

Misuse of DeLong test to compare AUCs for nested models.

Journal Article Stat Med · October 15, 2012 The area under the receiver operating characteristics curve (AUC of ROC) is a widely used measure of discrimination in risk prediction models. Routinely, the Mann-Whitney statistics is used as an estimator of AUC, while the change in AUC is tested by the D ... Full text Link to item Cite

C-reactive protein, fibrinogen, and cardiovascular disease prediction.

Journal Article N Engl J Med · October 4, 2012 BACKGROUND: There is debate about the value of assessing levels of C-reactive protein (CRP) and other biomarkers of inflammation for the prediction of first cardiovascular events. METHODS: We analyzed data from 52 prospective studies that included 246,669 ... Full text Open Access Link to item Cite

Galectin-3, a marker of cardiac fibrosis, predicts incident heart failure in the community.

Journal Article J Am Coll Cardiol · October 2, 2012 OBJECTIVES: The aim of this study was to examine the relation of galectin-3 (Gal-3), a marker of cardiac fibrosis, with incident heart failure (HF) in the community. BACKGROUND: Gal-3 is an emerging prognostic biomarker in HF, and experimental studies sugg ... Full text Link to item Cite

Adult height and the risk of cause-specific death and vascular morbidity in 1 million people: individual participant meta-analysis.

Journal Article Int J Epidemiol · October 2012 BACKGROUND: The extent to which adult height, a biomarker of the interplay of genetic endowment and early-life experiences, is related to risk of chronic diseases in adulthood is uncertain. METHODS: We calculated hazard ratios (HRs) for height, assessed in ... Full text Link to item Cite

Discriminative ability, reclassification and net benefit: Research methodology No. 7: The predictive value of biomarkers

Journal Article Nederlands Tijdschrift voor Geneeskunde · October 1, 2012 Cite

Diagnostic accuracy of fractional flow reserve from anatomic CT angiography.

Journal Article JAMA · September 26, 2012 CONTEXT: Coronary computed tomographic (CT) angiography is a noninvasive anatomic test for diagnosis of coronary stenosis that does not determine whether a stenosis causes ischemia. In contrast, fractional flow reserve (FFR) is a physiologic measure of cor ... Full text Link to item Cite

Pencina et al. respond to "The incremental value of new markers" and "Clinically relevant measures? A note of caution".

Journal Article Am J Epidemiol · September 15, 2012 Full text Link to item Cite

Interpreting incremental value of markers added to risk prediction models.

Journal Article Am J Epidemiol · September 15, 2012 The discrimination of a risk prediction model measures that model's ability to distinguish between subjects with and without events. The area under the receiver operating characteristic curve (AUC) is a popular measure of discrimination. However, the AUC h ... Full text Link to item Cite

Variations in common carotid artery intima-media thickness during the cardiac cycle: implications for cardiovascular risk assessment.

Journal Article J Am Soc Echocardiogr · September 2012 BACKGROUND: Common carotid artery intima-media thickness (IMT), a measure of atherosclerosis, varies between peak systole and end-diastole. This difference might affect cardiovascular risk assessment. METHODS: IMT measurements of the right and left common ... Full text Link to item Cite

A genetic risk score based on direct associations with coronary heart disease improves coronary heart disease risk prediction in the Atherosclerosis Risk in Communities (ARIC), but not in the Rotterdam and Framingham Offspring, Studies.

Journal Article Atherosclerosis · August 2012 OBJECTIVE: Multiple studies have identified single-nucleotide polymorphisms (SNPs) that are associated with coronary heart disease (CHD). We examined whether SNPs selected based on predefined criteria will improve CHD risk prediction when added to traditio ... Full text Link to item Cite

Invited commentary: Clinical usefulness of the Framingham cardiovascular risk profile beyond its statistical performance.

Journal Article Am J Epidemiol · August 1, 2012 Framingham risk functions (FRFs) have been developed for over 50 years. There have been numerous applications of them and within the last few decades they have been used in drug treatment guidelines. The Adult Treatment Panel III explicitly used a coronary ... Full text Link to item Cite

Caution is needed in the interpretation of added value of biomarkers analyzed in matched case control studies.

Journal Article Clin Chem · August 2012 Full text Link to item Cite

Impact of drug eluting stent length on outcomes of percutaneous coronary intervention (from the EVENT registry).

Journal Article Am J Cardiol · August 1, 2012 In randomized trials, longer drug-eluting stent (DES) length has been associated with adverse clinical events. We used data from the EVENT registry to examine the impact of DES length on outcomes in routine clinical practice. We identified 5,425 unselected ... Full text Link to item Cite

Coronary computed tomographic angiography and risk of all-cause mortality and nonfatal myocardial infarction in subjects without chest pain syndrome from the CONFIRM Registry (coronary CT angiography evaluation for clinical outcomes: an international multicenter registry).

Journal Article Circulation · July 17, 2012 BACKGROUND: The predictive value of coronary computed tomographic angiography (cCTA) in subjects without chest pain syndrome (CPS) has not been established. We investigated the prognostic value of coronary artery disease detection by cCTA and determined th ... Full text Link to item Cite

Quantifying discrimination of Framingham risk functions with different survival C statistics.

Journal Article Stat Med · July 10, 2012 Cardiovascular risk prediction functions offer an important diagnostic tool for clinicians and patients themselves. They are usually constructed with the use of parametric or semi-parametric survival regression models. It is essential to be able to evaluat ... Full text Link to item Cite

An international model to predict recurrent cardiovascular disease.

Journal Article Am J Med · July 2012 BACKGROUND: Prediction models for cardiovascular events and cardiovascular death in patients with established cardiovascular disease are not generally available. METHODS: Participants from the prospective REduction of Atherothrombosis for Continued Health ... Full text Link to item Cite

Discriminating clinical features of heart failure with preserved vs. reduced ejection fraction in the community.

Journal Article Eur Heart J · July 2012 AIMS: Heart failure (HF) is a major public health burden worldwide. Of patients presenting with HF, 30-55% have a preserved ejection fraction (HFPEF) rather than a reduced ejection fraction (HFREF). Our objective was to examine discriminating clinical feat ... Full text Link to item Cite

A double-blind, placebo-controlled study of aripiprazole adjunctive to antidepressant therapy among depressed outpatients with inadequate response to prior antidepressant therapy (ADAPT-A study):(Psychotherapy and Psychosomatics (2012) 81, (87-97))

Journal Article Psychotherapy and Psychosomatics · June 1, 2012 Full text Cite

Comparative value of coronary artery calcium and multiple blood biomarkers for prognostication of cardiovascular events.

Journal Article Am J Cardiol · May 15, 2012 The value of coronary artery calcium (CAC) scoring versus multiple biomarkers in increasing risk prediction for cardiovascular disease (CVD) remains unknown. The study group consisted of 1,286 asymptomatic participants (mean ± SD 59 ± 8 years old) with no ... Full text Link to item Cite

Adjustment of the GRACE score by growth differentiation factor 15 enables a more accurate appreciation of risk in non-ST-elevation acute coronary syndrome.

Journal Article Eur Heart J · May 2012 AIMS: The aim of the study was to evaluate whether knowledge of the circulating concentration of growth differentiation factor 15 (GDF-15) adds predictive information to the Global Registry of Acute Coronary Events (GRACE) score, a validated scoring system ... Full text Link to item Cite

Thoroughly modern risk prediction?

Journal Article Sci Transl Med · April 25, 2012 Researchers use a data-driven technique called statistical learning to fashion risk prediction algorithms for clinical situations with low event rates. ... Full text Link to item Cite

Abstract LB-327: Validation of a breast cancer risk prediction model in African American women

Journal Article Cancer Research · April 15, 2012 AbstractExisting breast cancer risk prediction models, such as the Breast Cancer Risk Assessment Tool (BCRAT), are less reliable for predicting risk in African American women than they are in white women. Ga ... Full text Cite

Troponin criteria for myocardial infarction after percutaneous coronary intervention.

Journal Article Arch Intern Med · March 26, 2012 BACKGROUND: The universal definition of myocardial infarction specifies creatine kinase-MB fraction (CKMB) or troponin values more than 3 times the 99th percentile of the upper reference limit as diagnostic after percutaneous coronary intervention, with a ... Full text Link to item Cite

Parental intermittent claudication as risk factor for claudication in adults.

Journal Article Am J Cardiol · March 1, 2012 Little is known about the familial aggregation of intermittent claudication (IC). Our objective was to examine whether parental IC increased the risk of IC in adult offspring, independent of the established cardiovascular risk factors. We evaluated the Off ... Full text Link to item Cite

Efficacy of dose increase among nonresponders to low-dose aripiprazole augmentation in patients with inadequate response to antidepressant treatment: a randomized, double-blind, placebo-controlled, efficacy trial.

Journal Article J Clin Psychiatry · March 2012 OBJECTIVE: To examine the efficacy of a dose increase of aripiprazole to 5 mg/d in subjects with major depressive disorder (MDD) who did not respond to 4 weeks of treatment with aripiprazole 2 mg/d in a randomized, double-blind, placebo-controlled, parent ... Full text Link to item Cite

A genetic risk score is associated with incident cardiovascular disease and coronary artery calcium: the Framingham Heart Study.

Journal Article Circ Cardiovasc Genet · February 1, 2012 BACKGROUND: Limited data exist regarding the use of a genetic risk score (GRS) for predicting risk of incident cardiovascular disease (CVD) in US-based samples. METHODS AND RESULTS: By using findings from recent genome-wide association studies, we construc ... Full text Link to item Cite

Comparison of academic and nonacademic sites in multi-center clinical trials.

Journal Article J Clin Psychopharmacol · February 2012 The selection of appropriate subjects is a critical element of successful clinical trials. Failure to properly identify, select, and retain subjects in clinical trials of antidepressant medications may affect the ability to show separation from placebo. Li ... Full text Link to item Cite

Assessing the incremental value of diagnostic and prognostic markers: a review and illustration.

Journal Article Eur J Clin Invest · February 2012 BACKGROUND: New markers may improve prediction of diagnostic and prognostic outcomes. We review various measures to quantify the incremental value of markers over standard, readily available characteristics. METHODS: Widely used traditional measures includ ... Full text Link to item Cite

A framework for quantifying net benefits of alternative prognostic models.

Journal Article Stat Med · January 30, 2012 New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantify ... Full text Link to item Cite

Novel metrics for evaluating improvement in discrimination: net reclassification and integrated discrimination improvement for normal variables and nested models.

Journal Article Stat Med · January 30, 2012 Net reclassification and integrated discrimination improvements have been proposed as alternatives to the increase in the area under the curve for evaluating improvement in the performance of risk assessment algorithms introduced by the addition of new phe ... Full text Link to item Cite

Authors' reply

Journal Article Statistics in Medicine · January 13, 2012 Full text Cite

[Discriminative ability, reclassification and net benefit: the predictive value of biomarkers].

Journal Article Ned Tijdschr Geneeskd · 2012 More and more biomarkers are becoming available to predict the risk of disease. Several performance measures are used to express the predictive value of a biomarker. In this article we use as an example the Framingham risk score with and without the HDL ch ... Link to item Cite

Measuring carotid artery intima-media thickness: simplicity versus complexity?

Journal Article J Am Soc Echocardiogr · January 2012 Full text Link to item Cite

Ankle-brachial index and cardiovascular risk prediction: an analysis of 11,594 individuals with 10-year follow-up.

Journal Article Atherosclerosis · January 2012 BACKGROUND: Low ankle-brachial index (ABI) is associated with increased risk of subsequent cardiovascular disease events, independent of Framingham risk factors, but its ability to improve risk prediction prospectively has not been examined. METHODS: We co ... Full text Link to item Cite

Discriminative ability, reclassification and net benefit: Research methodology No. 7: The predictive value of biomarkers

Journal Article Nederlands Tijdschrift voor Geneeskunde · 2012 Cite

A double-blind, placebo-controlled study of aripiprazole adjunctive to antidepressant therapy among depressed outpatients with inadequate response to prior antidepressant therapy (ADAPT-A Study).

Journal Article Psychother Psychosom · 2012 BACKGROUND: We assessed the efficacy of low-dose aripiprazole added to antidepressant therapy (ADT) in major depressive disorder (MDD) patients with inadequate response to prior ADT. METHODS: As per the sequential parallel comparison design, 225 MDD subjec ... Full text Link to item Cite

[Discriminative ability, reclassification and net benefit: the predictive value of biomarkers].

Journal Article Nederlands tijdschrift voor geneeskunde · January 1, 2012 More and more biomarkers are becoming available to predict the risk of disease. Several performance measures are used to express the predictive value of a biomarker. In this article we use as an example the Framingham risk score with and without the HDL ch ... Cite

Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease.

Journal Article JAMA · November 23, 2011 CONTEXT: Variants in the CYP2C19 gene influence the pharmacologic and clinical response to the standard 75-mg daily maintenance dose of the antiplatelet drug clopidogrel. OBJECTIVE: To test whether higher doses (up to 300 mg daily) improve the response to ... Full text Link to item Cite

Incident Congestive Heart Failure and Common Carotid Artery Diameter: The Framingham Offspring Study

Conference CIRCULATION · November 22, 2011 Link to item Cite

Prevalent Cardiovascular Disease and Progression of Carotid Intima-Media Thickness

Conference CIRCULATION · November 22, 2011 Link to item Cite

Improved cardiac risk assessment with noninvasive measures of coronary flow reserve.

Journal Article Circulation · November 15, 2011 BACKGROUND: Impaired vasodilator function is an early manifestation of coronary artery disease and may precede angiographic stenosis. It is unknown whether noninvasive assessment of coronary vasodilator function in patients with suspected or known coronary ... Full text Link to item Cite

Common carotid artery intima-media thickness progression as a predictor of stroke in multi-ethnic study of atherosclerosis.

Journal Article Stroke · November 2011 BACKGROUND AND PURPOSE: Carotid artery intima-media thickness (IMT) is a marker of cardiovascular disease associated with incident stroke. We studied whether IMT rate of change is associated with stroke. METHODS: We studied 5028 participants of the Multi-E ... Full text Link to item Cite

Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site.

Journal Article Am Heart J · November 2011 BACKGROUND: Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcom ... Full text Link to item Cite

Sex hormone-binding globulin, but not testosterone, is associated prospectively and independently with incident metabolic syndrome in men: the framingham heart study.

Journal Article Diabetes Care · November 2011 OBJECTIVE: The association between total testosterone and metabolic syndrome has prompted speculation that low testosterone contributes to the pathophysiology of metabolic syndrome in men. We determined whether testosterone or sex hormone-binding globulin ... Full text Link to item Cite

Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis.

Journal Article Catheter Cardiovasc Interv · November 1, 2011 OBJECTIVE: To provide safety and performance goals for prospective single-arm trials of bare metal renal artery stenting in patients with resistant hypertension associated with high grade atherosclerotic renal artery stenosis. BACKGROUND: To date, there ha ... Full text Link to item Cite

Carotid Intima-Media Thickness and Cardiovascular Events REPLY

Journal Article NEW ENGLAND JOURNAL OF MEDICINE · October 27, 2011 Link to item Cite

The authors reply

Journal Article New England Journal of Medicine · October 27, 2011 Cite

Bleeding risk comparing targeted low-dose heparin with bivalirudin in patients undergoing percutaneous coronary intervention: results from a propensity score-matched analysis of the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry.

Journal Article Circ Cardiovasc Interv · October 1, 2011 BACKGROUND: Prior randomized trials have shown reduced bleeding with bivalirudin compared with unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI). However, it is not known if this benefit is also present when UFH d ... Full text Link to item Cite

Prognostic implications of creatine kinase-MB elevation after percutaneous coronary intervention: results from the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry.

Journal Article Circ Cardiovasc Interv · October 1, 2011 BACKGROUND: Creatine kinase-MB (CK-MB) elevation after percutaneous coronary intervention (PCI) has been associated with increased risk for mortality. Although most studies have defined periprocedural myocardial infarction (pMI) as an elevation in CK-MB >3 ... Full text Link to item Cite

[Performance measures for prediction models and markers: evaluation of predictions and classifications].

Journal Article Rev Esp Cardiol · September 2011 Prediction models are becoming more and more important in medicine and cardiology. Nowadays, specific interest focuses on ways in which models can be improved using new prognostic markers. We aim to describe the similarities and differences between perform ... Full text Link to item Cite

Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration.

Journal Article Eur J Clin Invest · September 2011 • The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice. • The number of studies assessing the predictive ability is steadil ... Full text Link to item Cite

Clinical and economic outcomes of liberal versus selective drug-eluting stent use: insights from temporal analysis of the multicenter Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry.

Journal Article Circulation · August 30, 2011 BACKGROUND: Although the benefits of drug-eluting stents (DES) for reducing restenosis after percutaneous coronary intervention are well established, the impact of alternative rates of DES use on population-level outcomes is unknown. METHODS AND RESULTS: W ... Full text Link to item Cite

Higher aldosterone and lower N-terminal proatrial natriuretic peptide as biomarkers of salt sensitivity in the community.

Journal Article Eur J Cardiovasc Prev Rehabil · August 2011 BACKGROUND: Salt sensitivity, a trait characterized by a pressor blood pressure response to increased dietary salt intake, has been associated with higher rates of cardiovascular target organ damage and cardiovascular disease events. Recent experimental st ... Full text Link to item Cite

Strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS): explanation and elaboration.

Journal Article J Clin Epidemiol · August 2011 The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily in ... Full text Link to item Cite

Reference ranges for testosterone in men generated using liquid chromatography tandem mass spectrometry in a community-based sample of healthy nonobese young men in the Framingham Heart Study and applied to three geographically distinct cohorts.

Journal Article J Clin Endocrinol Metab · August 2011 CONTEXT: Reference ranges are essential for partitioning testosterone levels into low or normal and making the diagnosis of androgen deficiency. We established reference ranges for total testosterone (TT) and free testosterone (FT) in a community-based sam ... Full text Link to item Cite

Carotid-wall intima-media thickness and cardiovascular events.

Journal Article N Engl J Med · July 21, 2011 BACKGROUND: Intima-media thickness of the walls of the common carotid artery and internal carotid artery may add to the Framingham risk score for predicting cardiovascular events. METHODS: We measured the mean intima-media thickness of the common carotid a ... Full text Link to item Cite

Associations of edge-detected and manual-traced common carotid intima-media thickness measurements with Framingham risk factors: the multi-ethnic study of atherosclerosis.

Journal Article Stroke · July 2011 BACKGROUND AND PURPOSE: Carotid intima-media thickness (IMT) is a marker of cardiovascular disease derived from ultrasound images of the carotid artery. In most outcome studies, human readers identify and trace the key IMT interfaces. We evaluate an altern ... Full text Link to item Cite

Effect of clopidogrel pretreatment on ischemic complications of percutaneous coronary intervention among bivalirudin-treated patients (from the EVENT registry).

Journal Article Am J Cardiol · June 15, 2011 Although clopidogrel pretreatment benefits patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes, these benefits are less well established among patients undergoing elective PCI--in particular, when they are treated with ... Full text Link to item Cite

Performance of current guidelines for coronary heart disease prevention: optimal use of the Framingham-based risk assessment.

Journal Article Atherosclerosis · June 2011 BACKGROUND: There is a strong positive association between Framingham Risk Scores (FRS) in a population and incidence of hard coronary heart disease (hCHD) events. Under current Adult Treatment Panel III guidelines, individuals with FRS that indicate ≥20% ... Full text Link to item Cite

Equivalence of improvement in area under ROC curve and linear discriminant analysis coefficient under assumption of normality.

Journal Article Stat Med · May 30, 2011 In this paper we investigate the addition of new variables to an existing risk prediction model and the subsequent impact on discrimination quantified by the area under the receiver operating characteristics curve (AUC of ROC). Based on practical experienc ... Full text Link to item Cite

On the C-statistics for evaluating overall adequacy of risk prediction procedures with censored survival data.

Journal Article Stat Med · May 10, 2011 For modern evidence-based medicine, a well thought-out risk scoring system for predicting the occurrence of a clinical event plays an important role in selecting prevention and treatment strategies. Such an index system is often established based on the su ... Full text Link to item Cite

Circulating plasma cholesteryl ester transfer protein activity and blood pressure tracking in the community.

Journal Article J Hypertens · May 2011 OBJECTIVE: Clinical trials using cholesteryl ester transfer protein (CETP) inhibitors to raise high-density lipoprotein cholesterol (HDL-C) concentrations reported an 'off-target' blood pressure (BP) raising effect. We evaluated the relations of baseline p ... Full text Link to item Cite

Prevalence of low ankle-brachial index, elevated plasma fibrinogen and CRP across Framingham risk categories: data from the National Health and Nutrition Examination Survey (NHANES) 1999-2004.

Journal Article Atherosclerosis · May 2011 OBJECTIVE: 60-80% of heart attacks or coronary-related deaths occur in individuals identified as non-high-risk per the conventional risk assessment algorithms. Abnormal ankle-brachial index (ABI), plasma fibrinogen and plasma C-reactive protein (CRP) have ... Full text Link to item Cite

Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration.

Journal Article Eur J Hum Genet · May 2011 The rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily inc ... Full text Link to item Cite

Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration.

Journal Article European journal of human genetics : EJHG · May 1, 2011 The rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily inc ... Cite

Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration.

Journal Article Eur J Epidemiol · April 2011 The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily in ... Full text Link to item Cite

Separate and combined associations of body-mass index and abdominal adiposity with cardiovascular disease: collaborative analysis of 58 prospective studies.

Journal Article Lancet · March 26, 2011 BACKGROUND: Guidelines differ about the value of assessment of adiposity measures for cardiovascular disease risk prediction when information is available for other risk factors. We studied the separate and combined associations of body-mass index (BMI), w ... Full text Link to item Cite

Incidence and clinical outcome of minor surgery in the year after drug-eluting stent implantation: results from the Evaluation of Drug-Eluting Stents and Ischemic Events Registry.

Journal Article Am Heart J · February 2011 BACKGROUND: The aim of the study was to describe the incidence and consequences of minor surgery after drug-eluting stent (DES) implantation. METHODS: The Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) Registry prospectively enrolled unselec ... Full text Link to item Cite

Extensions of net reclassification improvement calculations to measure usefulness of new biomarkers.

Journal Article Stat Med · January 15, 2011 Appropriate quantification of added usefulness offered by new markers included in risk prediction algorithms is a problem of active research and debate. Standard methods, including statistical significance and c statistic are useful but not sufficient. Net ... Full text Link to item Cite

Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry.

Journal Article J Cardiovasc Comput Tomogr · 2011 BACKGROUND: Coronary computed tomographic angiography (CCTA) of 64-detector rows or greater represents a novel noninvasive anatomic method for evaluation of patients with suspected coronary artery disease (CAD). Early studies suggest a potential for progno ... Full text Link to item Cite

Genetic risk reclassification for type 2 diabetes by age below or above 50 years using 40 type 2 diabetes risk single nucleotide polymorphisms.

Journal Article Diabetes Care · January 2011 OBJECTIVE: To test if knowledge of type 2 diabetes genetic variants improves disease prediction. RESEARCH DESIGN AND METHODS: We tested 40 single nucleotide polymorphisms (SNPs) associated with diabetes in 3,471 Framingham Offspring Study subjects followed ... Full text Link to item Cite

Segment-specific association between plasma homocysteine level and carotid artery intima-media thickness in the Framingham Offspring Study.

Journal Article J Stroke Cerebrovasc Dis · 2011 Elevated plasma total homocysteine (tHcy) level is an established risk factor for cardiovascular disease. The relationship between tHcy and carotid artery intima-media thickness (IMT) at the internal carotid artery (ICA)/bulb-IMT and common carotid artery ... Full text Link to item Cite

Sample size calculation for poisson endpoint using the exact distribution of difference between two poisson random variables

Journal Article Statistics in Biopharmaceutical Research · January 1, 2011 We propose a method that compares Poisson distributed outcomes. Our method uses the exact distribution of the difference between two Poisson variables to calculate the sample size required to detect a given difference with prespecified power. When the true ... Full text Cite

Associations of carotid artery intima-media thickness (IMT) with risk factors and prevalent cardiovascular disease: comparison of mean common carotid artery IMT with maximum internal carotid artery IMT.

Journal Article J Ultrasound Med · December 2010 OBJECTIVE: The goal of this study was to compare internal carotid artery (ICA) intima-media thickness (IMT) with common carotid artery (CCA) IMT as global markers of cardiovascular disease (CVD). METHODS: Cross-sectional measurements of the mean CCA IMT an ... Full text Link to item Cite

Familial aggregation of left ventricular geometry and association with parental heart failure: the Framingham Heart Study.

Journal Article Circ Cardiovasc Genet · December 2010 BACKGROUND: Data regarding the familial aggregation of left ventricular (LV) geometry and its relations to parental heart failure (HF) are limited. METHODS AND RESULTS: We evaluated concordance of LV geometry within 1093 nuclear families in 5758 participan ... Full text Link to item Cite

Statistical methods for assessment of added usefulness of new biomarkers.

Journal Article Clin Chem Lab Med · December 2010 The discovery and development of new biomarkers continues to be an exciting and promising field. Improvement in prediction of risk of developing disease is one of the key motivations in these pursuits. Appropriate statistical measures are necessary for dra ... Full text Link to item Cite

Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions.

Journal Article Am Heart J · December 2010 BACKGROUND: Dual antiplatelet therapy with aspirin and thienopyridines (clopidogrel or prasugrel) is required after placement of coronary stents to prevent thrombotic complications. Although current clinical practice guidelines recommend 12-month treatment ... Full text Link to item Cite

Association between familial atrial fibrillation and risk of new-onset atrial fibrillation.

Journal Article JAMA · November 24, 2010 CONTEXT: Although the heritability of atrial fibrillation (AF) is established, the contribution of familial AF to predicting new-onset AF remains unknown. OBJECTIVE: To determine whether familial occurrence of AF is associated with new-onset AF beyond esta ... Full text Link to item Cite

Lifecourse Analysis Reveals Adverse Cardiovascular Disease Risk Factor Profiles up to 30 Years Prior to the Diagnosis of Diabetes

Conference CIRCULATION · November 23, 2010 Link to item Cite

Clinical Predictors of Heart Failure with Preserved vs Reduced Ejection Fraction: Data from the Framingham Heart Study

Conference CIRCULATION · November 23, 2010 Link to item Cite

Carotid Plaque Improves Discrimination and Reclassification of Cardiovascular Risk Prediction Models

Conference CIRCULATION · November 23, 2010 Link to item Cite

Validation of an atrial fibrillation risk algorithm in whites and African Americans.

Journal Article Arch Intern Med · November 22, 2010 BACKGROUND: We sought to validate a recently published risk algorithm for incident atrial fibrillation (AF) in independent cohorts and other racial groups. METHODS: We evaluated the performance of a Framingham Heart Study (FHS)-derived risk algorithm modif ... Full text Link to item Cite

Response to letters regarding article, arterial stiffness and cardiovascular events: The framingham heart study

Journal Article Circulation · November 9, 2010 Full text Cite

Circulating Plasma CETP Activity and Blood Pressure Tracking in the Community

Conference HYPERTENSION · November 1, 2010 Link to item Cite

Statistical methods for the time-to-event analysis of individual participant data from multiple epidemiological studies.

Journal Article Int J Epidemiol · October 2010 BACKGROUND: Meta-analysis of individual participant time-to-event data from multiple prospective epidemiological studies enables detailed investigation of exposure-risk relationships, but involves a number of analytical challenges. METHODS: This article de ... Full text Link to item Cite

Rapid adoption of drug-eluting stents: clinical practices and outcomes from the early drug-eluting stent era.

Journal Article Am Heart J · October 2010 OBJECTIVES: We sought to evaluate the early drug-eluting stent (DES) era, characterized by widespread device use. BACKGROUND: Contemporary clinical practice incorporating more selective DES use can only be assessed by understanding the early DES era. METHO ... Full text Link to item Cite

Effect of coronary target lesion revascularization on late cardiac events after insertion of sirolimus-eluting or bare metal stents.

Journal Article Am J Cardiol · September 15, 2010 Restenosis is associated with acute myocardial infarction (MI) either at presentation or related to complications of target lesion revascularization (TLR). The cumulative late effect of TLR after drug-eluting or bare metal stent placement on cardiac death ... Full text Link to item Cite

Frequency of major noncardiac surgery and subsequent adverse events in the year after drug-eluting stent placement results from the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) Registry.

Journal Article JACC Cardiovasc Interv · September 2010 OBJECTIVES: This study sought to determine the frequency of noncardiac surgery and adverse post-operative events among patients who recently received a drug-eluting stent (DES) following noncardiac surgery. BACKGROUND: Little is known about frequency of an ... Full text Link to item Cite

Routine laboratory results and thirty day and one-year mortality risk following hospitalization with acute decompensated heart failure.

Journal Article PLoS One · August 17, 2010 INTRODUCTION: Several blood tests are performed uniformly in patients hospitalized with acute decompensated heart failure and are predictive of the outcomes: complete blood count, electrolytes, renal function, glucose, albumin and uric acid. We sought to e ... Full text Link to item Cite

Response to letter regarding article, "association of circulating cholesteryl ester transfer protein activity with incidence of cardiovascular disease in the community"

Journal Article Circulation · August 10, 2010 Full text Cite

Predicting restenosis of drug-eluting stents placed in real-world clinical practice: derivation and validation of a risk model from the EVENT registry.

Journal Article Circ Cardiovasc Interv · August 2010 BACKGROUND: Prediction of restenosis after percutaneous coronary intervention (PCI) remains challenging, and existing risk assessment algorithms were developed before the widespread adoption of drug-eluting stents (DES). METHODS AND RESULTS: We used data f ... Full text Link to item Cite

Diet quality, physical activity, smoking status, and weight fluctuation are associated with weight change in women and men.

Journal Article J Nutr · July 2010 The effect of diet quality on weight change, relative to other body weight determinants, is insufficiently understood. Furthermore, research on long-term weight change in U.S. adults is limited. We evaluated prospectively patterns and predictors of weight ... Full text Link to item Cite

Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies.

Journal Article Lancet · June 26, 2010 BACKGROUND: Uncertainties persist about the magnitude of associations of diabetes mellitus and fasting glucose concentration with risk of coronary heart disease and major stroke subtypes. We aimed to quantify these associations for a wide range of circumst ... Full text Link to item Cite

Free testosterone levels are associated with mobility limitation and physical performance in community-dwelling men: the Framingham Offspring Study.

Journal Article J Clin Endocrinol Metab · June 2010 CONTEXT: Mobility limitation is associated with increased morbidity and mortality. The relationship between circulating testosterone and mobility limitation and physical performance is incompletely understood. OBJECTIVE: Our objective was to examine cross- ... Full text Link to item Cite

Iatrogenic gastric acid suppression and the risk of nosocomial Clostridium difficile infection.

Journal Article Arch Intern Med · May 10, 2010 BACKGROUND: The incidence and severity of Clostridium difficile infections are increasing. Acid-suppressive therapy has been suggested as a risk factor for C difficile, but this remains controversial. METHODS: We conducted a pharmacoepidemiologic cohort st ... Full text Link to item Cite

Triglyceride-mediated pathways and coronary disease: collaborative analysis of 101 studies.

Journal Article Lancet · May 8, 2010 BACKGROUND: Whether triglyceride-mediated pathways are causally relevant to coronary heart disease is uncertain. We studied a genetic variant that regulates triglyceride concentration to help judge likelihood of causality. METHODS: We assessed the -1131T>C ... Full text Link to item Cite

Cross-sectional relations of lipid concentrations to left ventricular structural attributes.

Journal Article Am J Cardiol · May 1, 2010 Although previous investigations reported on the associations of lipid concentrations with left ventricular remodeling in specific subpopulations, few data exist on these associations in a community-based sample of subjects without cardiovascular disease. ... Full text Link to item Cite

Diet quality and obesity in women: the Framingham Nutrition Studies.

Journal Article Br J Nutr · April 2010 Obesity affects one in three American adult women and is associated with overall mortality and major morbidities. A composite diet index to evaluate total diet quality may better assess the complex relationship between diet and obesity, providing insights ... Full text Link to item Cite

Reclassification calculations for persons with incomplete follow-up.

Journal Article Ann Intern Med · February 2, 2010 Full text Link to item Cite

Arterial stiffness and cardiovascular events: the Framingham Heart Study.

Journal Article Circulation · February 2, 2010 BACKGROUND: Various measures of arterial stiffness and wave reflection have been proposed as cardiovascular risk markers. Prior studies have not assessed relations of a comprehensive panel of stiffness measures to prognosis in the community. METHODS AND RE ... Full text Link to item Cite

Improvement of cardiovascular risk prediction: time to review current knowledge, debates, and fundamentals on how to assess test characteristics.

Journal Article Eur J Cardiovasc Prev Rehabil · February 2010 Cardiovascular risk assessment might be improved with the addition of emerging, new tests derived from atherosclerosis imaging, laboratory tests or functional tests. This article reviews relative risk, odds ratios, receiver-operating curves, posttest risk ... Full text Link to item Cite

A cost-minimization analysis of dexmedetomidine compared with midazolam for long-term sedation in the intensive care unit.

Journal Article Crit Care Med · February 2010 OBJECTIVE: To compare the intensive care unit costs and determine factors influencing these costs in mechanically ventilated patients randomized to dexmedetomidine or midazolam by continuous infusion. DESIGN: Cost minimization analysis of a double-blind, m ... Full text Link to item Cite

Relations of biomarkers of distinct pathophysiological pathways and atrial fibrillation incidence in the community.

Journal Article Circulation · January 19, 2010 BACKGROUND: Biomarkers of multiple pathophysiological pathways have been related to incident atrial fibrillation (AF), but their predictive ability remains controversial. METHODS AND RESULTS: In 3120 Framingham cohort participants (mean age 58.4+/-9.7 year ... Full text Link to item Cite

Separating the mechanism-based and off-target actions of cholesteryl ester transfer protein inhibitors with CETP gene polymorphisms.

Journal Article Circulation · January 5, 2010 BACKGROUND: Cholesteryl ester transfer protein (CETP) inhibitors raise high-density lipoprotein (HDL) cholesterol, but torcetrapib, the first-in-class inhibitor tested in a large outcome trial, caused an unexpected blood pressure elevation and increased ca ... Full text Link to item Cite

An obesity dietary quality index predicts abdominal obesity in women: potential opportunity for new prevention and treatment paradigms.

Journal Article J Obes · 2010 Background. Links between dietary quality and abdominal obesity are poorly understood. Objective. To examine the association between an obesity-specific dietary quality index and abdominal obesity risk in women. Methods. Over 12 years, we followed 288 Fram ... Full text Link to item Cite

Assessing the performance of prediction models: a framework for traditional and novel measures.

Journal Article Epidemiology · January 2010 The performance of prediction models can be assessed using a variety of methods and metrics. Traditional measures for binary and survival outcomes include the Brier score to indicate overall model performance, the concordance (or c) statistic for discrimin ... Full text Link to item Cite

Association of circulating cholesteryl ester transfer protein activity with incidence of cardiovascular disease in the community.

Journal Article Circulation · December 15, 2009 BACKGROUND: Plasma high-density lipoprotein cholesterol concentration is related inversely to the risk of cardiovascular disease (CVD). Inhibiting cholesteryl ester transfer protein (CETP) activity raises high-density lipoprotein cholesterol and may be car ... Full text Link to item Cite

Major lipids, apolipoproteins, and risk of vascular disease.

Journal Article JAMA · November 11, 2009 CONTEXT: Associations of major lipids and apolipoproteins with the risk of vascular disease have not been reliably quantified. OBJECTIVE: To assess major lipids and apolipoproteins in vascular risk. DESIGN, SETTING, AND PARTICIPANTS: Individual records wer ... Full text Link to item Cite