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Lisa Wruck

Associate Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
Durham Center, DUMC #3850, 300 West Morgan Street, Suite 800, Durham, NC 27701
P. O. Box 17969, 300 West Morgan Street, Suite 800, Durham, NC 27715

Selected Publications


Age and Aspirin Dosing in Secondary Prevention of Atherosclerotic Cardiovascular Disease.

Journal Article J Am Heart Assoc · February 20, 2024 BACKGROUND: In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to a ... Full text Link to item Cite

Principal stratification analysis of noncompliance with time-to-event outcomes.

Journal Article Biometrics · January 29, 2024 Post-randomization events, also known as intercurrent events, such as treatment noncompliance and censoring due to a terminal event, are common in clinical trials. Principal stratification is a framework for causal inference in the presence of intercurrent ... Full text Link to item Cite

Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.

Journal Article JAMA Cardiol · November 1, 2023 IMPORTANCE: Clinicians recommend enteric-coated aspirin to decrease gastrointestinal bleeding in secondary prevention of coronary artery disease even though studies suggest platelet inhibition is decreased with enteric-coated vs uncoated aspirin formulatio ... Full text Link to item Cite

Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors.

Journal Article J Am Heart Assoc · October 17, 2023 Background The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high- versus low-dose aspirin for secondary prevention of ... Full text Link to item Cite

Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE.

Journal Article Am Heart J · October 2023 BACKGROUND: Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTA ... Full text Link to item Cite

Examining COVID-19 testing and vaccination behaviors by heritage and linguistic preferences among Hispanic, Latino, or Spanish RADx-UP participants.

Journal Article Prev Med Rep · October 2023 The Hispanic, Latino, or Spanish (hereafter, "Hispanic") populations in the U.S. bear a disproportionate burden of COVID-19-related outcomes, including disease incidence and mortality. Developing culturally appropriate national public health services for H ... Full text Link to item Cite

Electronic health record characterization and outcomes of heart failure with preserved ejection fraction.

Conference Am Heart J · September 2023 BACKGROUND: Electronic health record (EHR)-based identification of heart failure with preserved ejection fraction (HFpEF) in the clinical setting may facilitate screening for clinical trials by improving the understanding of its epidemiology and outcomes; ... Full text Link to item Cite

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources.

Journal Article Am J Respir Crit Care Med · September 1, 2023 Rationale: Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease for which novel therapies are needed. External controls (ECs) could enhance IPF trial efficiency, but the direct comparability of ECs versus concurrent controls is unknown. Object ... Full text Link to item Cite

Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study.

Journal Article Journal of the American Heart Association · June 2023 Background Internet-based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and nonint ... Full text Cite

Outcomes among patients with peripheral artery disease in the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study.

Journal Article Vascular medicine (London, England) · April 2023 BackgroundWe aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial.MethodsIn a subanalysis of the Aspirin Dos ... Full text Cite

Looking for opportunities to co-enroll: The DISCOVERY study experience.

Journal Article J Stroke Cerebrovasc Dis · December 2022 BACKGROUND: Conducting high-quality stroke trials is complex and costly. Often these trials compete for the attention of researchers and the availability of patients. Enrolling patients in more than one study concurrently has the potential to accelerate re ... Full text Link to item Cite

Increasing access and uptake of SARS-CoV-2 at-home tests using a community-engaged approach.

Journal Article Prev Med Rep · October 2022 Inequalities around COVID-19 testing and vaccination persist in the U.S. health system. We investigated whether a community-engaged approach could be used to distribute free, at-home, rapid SARS-CoV-2 tests to underserved populations. Between November 18-D ... Full text Open Access Link to item Cite

Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies.

Journal Article Adv Ther · October 2022 Real-world evidence (RWE) is increasingly used to complement clinical trial data for regulatory decision-making and in certain cases utilized to establish the clinical effectiveness of a therapy. However, the use of RWE is not applicable for all regulatory ... Full text Link to item Cite

Standardizing, harmonizing, and protecting data collection to broaden the impact of COVID-19 research: the rapid acceleration of diagnostics-underserved populations (RADx-UP) initiative.

Journal Article J Am Med Inform Assoc · August 16, 2022 OBJECTIVE: The Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program is a consortium of community-engaged research projects with the goal of increasing access to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tests in un ... Full text Link to item Cite

Iterative approaches to the use of electronic health records data for large pragmatic studies.

Journal Article Contemp Clin Trials · June 2022 Randomized controlled trials (RCT) are the gold standard for evaluating the effectiveness and safety of interventions and treatments, yet traditional clinical trials have relied on cumbersome and redundant processes such as electronic data entry which invo ... Full text Link to item Cite

Association of Ischemic Stroke Incidence, Severity, and Recurrence With Dementia in the Atherosclerosis Risk in Communities Cohort Study.

Journal Article JAMA Neurol · March 1, 2022 IMPORTANCE: Ischemic stroke is associated with increased risk of dementia, but the association of stroke severity and recurrence with risk of impaired cognition is not well known. OBJECTIVE: To examine the risk of dementia after incident ischemic stroke an ... Full text Link to item Cite

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

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

Validation of Cardiovascular End Points Ascertainment Leveraging Multisource Electronic Health Records Harmonized Into a Common Data Model in the ADAPTABLE Randomized Clinical Trial.

Journal Article Circulation. Cardiovascular quality and outcomes · December 2021 BackgroundThe ADAPTABLE trial (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) is the first randomized trial conducted within the National Patient-Centered Clinical Research Network to use the electronic hea ... Full text Cite

Age and Aspirin Dosing in Secondary Prevention of Atherosclerotic Cardiovascular Disease.

Journal Article J Am Heart Assoc · February 20, 2024 BACKGROUND: In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to a ... Full text Link to item Cite

Principal stratification analysis of noncompliance with time-to-event outcomes.

Journal Article Biometrics · January 29, 2024 Post-randomization events, also known as intercurrent events, such as treatment noncompliance and censoring due to a terminal event, are common in clinical trials. Principal stratification is a framework for causal inference in the presence of intercurrent ... Full text Link to item Cite

Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.

Journal Article JAMA Cardiol · November 1, 2023 IMPORTANCE: Clinicians recommend enteric-coated aspirin to decrease gastrointestinal bleeding in secondary prevention of coronary artery disease even though studies suggest platelet inhibition is decreased with enteric-coated vs uncoated aspirin formulatio ... Full text Link to item Cite

Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors.

Journal Article J Am Heart Assoc · October 17, 2023 Background The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high- versus low-dose aspirin for secondary prevention of ... Full text Link to item Cite

Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE.

Journal Article Am Heart J · October 2023 BACKGROUND: Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTA ... Full text Link to item Cite

Examining COVID-19 testing and vaccination behaviors by heritage and linguistic preferences among Hispanic, Latino, or Spanish RADx-UP participants.

Journal Article Prev Med Rep · October 2023 The Hispanic, Latino, or Spanish (hereafter, "Hispanic") populations in the U.S. bear a disproportionate burden of COVID-19-related outcomes, including disease incidence and mortality. Developing culturally appropriate national public health services for H ... Full text Link to item Cite

Electronic health record characterization and outcomes of heart failure with preserved ejection fraction.

Conference Am Heart J · September 2023 BACKGROUND: Electronic health record (EHR)-based identification of heart failure with preserved ejection fraction (HFpEF) in the clinical setting may facilitate screening for clinical trials by improving the understanding of its epidemiology and outcomes; ... Full text Link to item Cite

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources.

Journal Article Am J Respir Crit Care Med · September 1, 2023 Rationale: Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease for which novel therapies are needed. External controls (ECs) could enhance IPF trial efficiency, but the direct comparability of ECs versus concurrent controls is unknown. Object ... Full text Link to item Cite

Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study.

Journal Article Journal of the American Heart Association · June 2023 Background Internet-based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and nonint ... Full text Cite

Outcomes among patients with peripheral artery disease in the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study.

Journal Article Vascular medicine (London, England) · April 2023 BackgroundWe aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial.MethodsIn a subanalysis of the Aspirin Dos ... Full text Cite

Looking for opportunities to co-enroll: The DISCOVERY study experience.

Journal Article J Stroke Cerebrovasc Dis · December 2022 BACKGROUND: Conducting high-quality stroke trials is complex and costly. Often these trials compete for the attention of researchers and the availability of patients. Enrolling patients in more than one study concurrently has the potential to accelerate re ... Full text Link to item Cite

Increasing access and uptake of SARS-CoV-2 at-home tests using a community-engaged approach.

Journal Article Prev Med Rep · October 2022 Inequalities around COVID-19 testing and vaccination persist in the U.S. health system. We investigated whether a community-engaged approach could be used to distribute free, at-home, rapid SARS-CoV-2 tests to underserved populations. Between November 18-D ... Full text Open Access Link to item Cite

Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies.

Journal Article Adv Ther · October 2022 Real-world evidence (RWE) is increasingly used to complement clinical trial data for regulatory decision-making and in certain cases utilized to establish the clinical effectiveness of a therapy. However, the use of RWE is not applicable for all regulatory ... Full text Link to item Cite

Standardizing, harmonizing, and protecting data collection to broaden the impact of COVID-19 research: the rapid acceleration of diagnostics-underserved populations (RADx-UP) initiative.

Journal Article J Am Med Inform Assoc · August 16, 2022 OBJECTIVE: The Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program is a consortium of community-engaged research projects with the goal of increasing access to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tests in un ... Full text Link to item Cite

Iterative approaches to the use of electronic health records data for large pragmatic studies.

Journal Article Contemp Clin Trials · June 2022 Randomized controlled trials (RCT) are the gold standard for evaluating the effectiveness and safety of interventions and treatments, yet traditional clinical trials have relied on cumbersome and redundant processes such as electronic data entry which invo ... Full text Link to item Cite

Association of Ischemic Stroke Incidence, Severity, and Recurrence With Dementia in the Atherosclerosis Risk in Communities Cohort Study.

Journal Article JAMA Neurol · March 1, 2022 IMPORTANCE: Ischemic stroke is associated with increased risk of dementia, but the association of stroke severity and recurrence with risk of impaired cognition is not well known. OBJECTIVE: To examine the risk of dementia after incident ischemic stroke an ... Full text Link to item Cite

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

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

Validation of Cardiovascular End Points Ascertainment Leveraging Multisource Electronic Health Records Harmonized Into a Common Data Model in the ADAPTABLE Randomized Clinical Trial.

Journal Article Circulation. Cardiovascular quality and outcomes · December 2021 BackgroundThe ADAPTABLE trial (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) is the first randomized trial conducted within the National Patient-Centered Clinical Research Network to use the electronic hea ... Full text Cite

Aspirin Dosing in Cardiovascular Disease. Reply.

Journal Article N Engl J Med · August 19, 2021 Full text Link to item Cite

Cognitive Impairment and Dementia After Stroke: Design and Rationale for the DISCOVERY Study.

Journal Article Stroke · August 2021 Stroke is a leading cause of the adult disability epidemic in the United States, with a major contribution from poststroke cognitive impairment and dementia (PSCID), the rates of which are disproportionally high among the health disparity populations. Desp ... 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

Predictors of Mortality by Sex and Race in Heart Failure With Preserved Ejection Fraction: ARIC Community Surveillance Study.

Journal Article J Am Heart Assoc · October 20, 2020 Background Heart failure with preserved ejection fraction (HFpEF) accounts for half of heart failure hospitalizations, with limited data on predictors of mortality by sex and race. We evaluated for differences in predictors of all-cause mortality by sex an ... Full text Link to item Cite

Methods for training collaborative biostatisticians.

Journal Article J Clin Transl Sci · August 4, 2020 The emphasis on team science in clinical and translational research increases the importance of collaborative biostatisticians (CBs) in healthcare. Adequate training and development of CBs ensure appropriate conduct of robust and meaningful research and, t ... Full text Link to item Cite

Plasma phospholipid very-long-chain SFAs in midlife and 20-year cognitive change in the Atherosclerosis Risk in Communities (ARIC): a cohort study.

Journal Article Am J Clin Nutr · June 1, 2020 BACKGROUND: Very-long-chain SFAs (VLSFAs) have recently gained considerable attention as having beneficial effects on health and aging. OBJECTIVES: The objective of this study was to assess the associations of plasma phospholipid VLSFAs [arachidic acid (20 ... Full text Link to item Cite

Survival advantage of cohort participation attenuates over time: results from three long-standing community-based studies.

Journal Article Ann Epidemiol · May 2020 PURPOSE: Cohort participants usually have lower mortality rates than nonparticipants, but it is unclear if this survival advantage decreases or increases as cohort studies age. METHODS: We used a 1975 private census of Washington County, Maryland, to compa ... Full text Link to item Cite

Gastrointestinal bleeding in patients with atrial fibrillation treated with Apixaban or warfarin: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.

Journal Article Am Heart J · March 2020 OBJECTIVES: A history of gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) may impact decisions about anticoagulation treatment. We sought to determine whether prior GIB in patients with AF taking anticoagulants was associated with ... Full text Link to item Cite

Age, knowledge, preferences, and risk tolerance for invasive cardiac care.

Journal Article Am Heart J · January 2020 BACKGROUND/OBJECTIVES: The extent to which individual knowledge, preferences, and priorities explain lower use of invasive cardiac care among older vs. younger adults presenting with acute coronary syndrome (ACS) is unknown. We directly surveyed a group of ... 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

The prevalence of atrial fibrillation on 48-hour ambulatory electrocardiography in African Americans compared to Whites: The Atherosclerosis Risk in Communities (ARIC) study.

Journal Article Am Heart J · October 2019 BACKGROUND: A lower prevalence of atrial fibrillation (AF), but paradoxically higher burden of cardiovascular disease risk factors, has been observed among African Americans compared to Whites in studies of AF identified by mostly 12-lead electrocardiogram ... Full text Link to item Cite

Temporal trends in validated ischaemic stroke hospitalizations in the USA.

Journal Article Int J Epidemiol · June 1, 2019 BACKGROUND: Accurate assessment of the burden of stroke, a major cause of disability and death, is crucial. We aimed to estimate rates of validated ischaemic stroke hospitalizations in the USA during 1998-2011. METHODS: We used the Atherosclerosis Risk in ... Full text Link to item Cite

Health-Related Quality of Life in Children and Young Adults with Marfan Syndrome.

Journal Article J Pediatr · January 2019 OBJECTIVE: To assess health-related quality of life (HRQOL) in a large multicenter cohort of children and young adults with Marfan syndrome participating in the Pediatric Heart Network Marfan Trial. STUDY DESIGN: The Pediatric Quality of Life Inventory (Pe ... Full text Link to item Cite

Predictors of Rapid Aortic Root Dilation and Referral for Aortic Surgery in Marfan Syndrome.

Journal Article Pediatr Cardiol · October 2018 Few data exist regarding predictors of rapid aortic root dilation and referral for aortic surgery in Marfan syndrome (MFS). To identify independent predictors of the rate of aortic root (AoR) dilation and referral for aortic surgery, we investigated the da ... Full text Link to item Cite

Heart Failure and Cognitive Impairment in the Atherosclerosis Risk in Communities (ARIC) Study.

Journal Article J Gen Intern Med · October 2018 BACKGROUND: Previous studies suggest that heart failure (HF) is an independent risk factor for cognitive decline. A better understanding of the relationship between HF, cognitive status, and cognitive decline in a community-based sample may help clinicians ... Full text Link to item Cite

Trends in Hospitalizations and Survival of Acute Decompensated Heart Failure in Four US Communities (2005-2014): ARIC Study Community Surveillance.

Journal Article Circulation · July 3, 2018 BACKGROUND: Community trends of acute decompensated heart failure (ADHF) in diverse populations may differ by race and sex. METHODS: The ARIC study (Atherosclerosis Risk in Communities) sampled heart failure-related hospitalizations (≥55 years of age) in 4 ... Full text Link to item Cite

Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial.

Journal Article Am Heart J · May 2018 BACKGROUND: Despite more than 200 years of clinical experience and a pivotal trial, recently published research has called into question the safety and efficacy of digoxin therapy in heart failure (HF). METHODS: HF-ACTION (ClinicalTrials.gov Number: NCT000 ... Full text Link to item Cite

Frequency of Care and Mortality Following an Incident Diagnosis of Peripheral Artery Disease in the Inpatient or Outpatient Setting: The ARIC (Atherosclerosis Risk in Communities) Study.

Journal Article J Am Heart Assoc · April 13, 2018 BACKGROUND: Available health services data for individuals with peripheral artery disease (PAD) are often from studies of those eligible for or undergoing intervention. Knowledge of the frequency of care and mortality following an initial PAD diagnosis by ... Full text Link to item Cite

Cognitive impairment and intracranial atherosclerotic stenosis in general population.

Journal Article Neurology · April 3, 2018 OBJECTIVE: To investigate the association between asymptomatic intracranial atherosclerosis and cognitive impairment in the Atherosclerosis Risk in Communities (ARIC) cohort. METHODS: ARIC participants underwent high-resolution 3T magnetic resonance angiog ... Full text Link to item Cite

Predicting Risk in Patients Hospitalized for Acute Decompensated Heart Failure and Preserved Ejection Fraction: The Atherosclerosis Risk in Communities Study Heart Failure Community Surveillance.

Journal Article Circ Heart Fail · December 2017 BACKGROUND: Risk-prediction models specifically for hospitalized heart failure with preserved ejection fraction are lacking. METHODS AND RESULTS: We analyzed data from the ARIC (Atherosclerosis Risk in Communities) Study Heart Failure Community Surveillanc ... Full text Link to item Cite

Accuracy of Self-Reported Heart Failure. The Atherosclerosis Risk in Communities (ARIC) Study.

Journal Article J Card Fail · November 2017 OBJECTIVE: The aim of this work was to estimate agreement of self-reported heart failure (HF) with physician-diagnosed HF and compare the prevalence of HF according to method of ascertainment. METHODS AND RESULTS: ARIC cohort members (60-83 years of age) w ... Full text Link to item Cite

Associations Between Midlife Vascular Risk Factors and 25-Year Incident Dementia in the Atherosclerosis Risk in Communities (ARIC) Cohort.

Journal Article JAMA Neurol · October 1, 2017 IMPORTANCE: Vascular risk factors have been associated with cognitive decline. Midlife exposure to these factors may be most important in conferring late-life risk of cognitive impairment. OBJECTIVES: To examine Atherosclerosis Risk in Communities (ARIC) p ... Full text Link to item Cite

Metabolomics and cognition in African American adults in midlife: the atherosclerosis risk in communities study.

Journal Article Transl Psychiatry · July 18, 2017 Clinical studies have shown alterations in metabolic profiles when patients with mild cognitive impairment and Alzheimer's disease dementia were compared to cognitively normal subjects. Associations between 204 serum metabolites measured at baseline (1987- ... Full text Link to item Cite

Repeatability of ectopic beats from 48-hr ambulatory electrocardiography: The Atherosclerosis Risk in Communities (ARIC) Study.

Journal Article Ann Noninvasive Electrocardiol · July 2017 BACKGROUND: The purpose of this study was to characterize the repeatability of ectopic beats, defined by premature atrial contractions (PACs) and premature ventricular contractions (PVCs), on ambulatory electrocardiogram (aECG) monitoring and evaluate the ... Full text Link to item Cite

Mind the Gap: Hospitalizations from Multiple Sources in a Longitudinal Study.

Journal Article Value Health · June 2017 BACKGROUND: Medicare claims and prospective studies with self-reported utilization are important sources of hospitalization data for epidemiologic and outcomes research. OBJECTIVES: To assess the concordance of Medicare claims merged with interview-based s ... Full text Link to item Cite

Peripheral Artery Disease Prevalence and Incidence Estimated From Both Outpatient and Inpatient Settings Among Medicare Fee-for-Service Beneficiaries in the Atherosclerosis Risk in Communities (ARIC) Study.

Journal Article J Am Heart Assoc · May 3, 2017 BACKGROUND: Outpatient ascertainment of peripheral artery disease (PAD) is rarely considered in the measurement of PAD clinical burden; therefore, the clinical burden of PAD likely has been underestimated while contributing to a decreased awareness of PAD ... Full text Link to item Cite

Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection.

Journal Article J Am Heart Assoc · April 24, 2017 BACKGROUND: End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trial ... Full text Link to item Cite

BNP and obesity in acute decompensated heart failure with preserved vs. reduced ejection fraction: The Atherosclerosis Risk in Communities Surveillance Study.

Journal Article Int J Cardiol · April 15, 2017 BACKGROUND: Levels of B-type natriuretic peptide (BNP), a prognostic marker in patients with heart failure (HF), are lower among HF patients with obesity or preserved Left Ventricular Ejection Fraction (LVEF). We examined the distribution and prognostic va ... Full text Link to item Cite

Genetic variants associated with risk of Alzheimer's disease contribute to cognitive change in midlife: The Atherosclerosis Risk in Communities Study.

Journal Article Am J Med Genet B Neuropsychiatr Genet · April 2017 Alzheimer's disease (AD) is the most common form of dementia and is characterized by impairment in memory, behavioral changes, and gradual loss of autonomy. Since there is a long latent period prior to diagnosis, the aim of this study was to determine whet ... Full text Link to item Cite

Community burden and prognostic impact of reduced kidney function among patients hospitalized with acute decompensated heart failure: The Atherosclerosis Risk in Communities (ARIC) Study Community Surveillance.

Journal Article PLoS One · 2017 BACKGROUND: Kidney dysfunction is prevalent and impacts prognosis in patients with acute decompensated heart failure (ADHF). However, most previous reports were from a single hospital, limiting their generalizability. Also, contemporary data using new equa ... Full text Link to item Cite

Prospective associations of plasma phospholipids and mild cognitive impairment/dementia among African Americans in the ARIC Neurocognitive Study

Journal Article Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring · January 1, 2017 Introduction The objective of this study was to investigate whether 10 phospholipids/metabolites previously identified as prospectively predictive of mild cognitive impairment (MCI) or dementia in whites would also be predictive in a mostly African-America ... Full text Cite

Multiple imputation of cognitive performance as a repeatedly measured outcome.

Journal Article Eur J Epidemiol · January 2017 Longitudinal studies of cognitive performance are sensitive to dropout, as participants experiencing cognitive deficits are less likely to attend study visits, which may bias estimated associations between exposures of interest and cognitive decline. Multi ... Full text Link to item Cite

Life-course blood pressure in relation to brain volumes.

Journal Article Alzheimers Dement · August 2016 INTRODUCTION: The impact of blood pressure on brain volumes may be time-dependent or pattern-dependent. METHODS: Of 1678 participants from the Atherosclerosis Risk in Communities Neurocognitive Study, we quantified the association between measures and patt ... Full text Link to item Cite

Iterative Outlier Removal: A Method for Identifying Outliers in Laboratory Recalibration Studies.

Journal Article Clin Chem · July 2016 BACKGROUND: Extreme values that arise for any reason, including those through nonlaboratory measurement procedure-related processes (inadequate mixing, evaporation, mislabeling), lead to outliers and inflate errors in recalibration studies. We present an a ... Full text Link to item Cite

Diabetes and Prediabetes and Risk of Hospitalization: The Atherosclerosis Risk in Communities (ARIC) Study.

Journal Article Diabetes Care · May 2016 OBJECTIVE: To examine the magnitude and types of hospitalizations among persons with prediabetes, undiagnosed diabetes, and diagnosed diabetes. RESEARCH DESIGN AND METHODS: This study included 13,522 participants in the Atherosclerosis Risk in Communities ... Full text Link to item Cite

Temporal Trends in Hospitalization for Acute Decompensated Heart Failure in the United States, 1998-2011.

Journal Article Am J Epidemiol · March 1, 2016 Estimates of the numbers and rates of acute decompensated heart failure (ADHF) hospitalization are central to understanding health-care utilization and efforts to improve patient care. We comprehensively estimated the frequency, rate, and trends of ADHF ho ... Full text Link to item Cite

Obstructive Sleep Apnea and 15-Year Cognitive Decline: The Atherosclerosis Risk in Communities (ARIC) Study.

Journal Article Sleep · February 1, 2016 STUDY OBJECTIVES: Prospective data evaluating abnormal sleep quality and quantity with cognitive decline are limited because most studies used subjective data and/or had short follow-up. We hypothesized that, over 15 y of follow-up, participants with objec ... Full text Link to item Cite

Plasma phospholipids and prevalence of mild cognitive impairment and/or dementia in the ARIC Neurocognitive Study (ARIC-NCS)

Journal Article Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring · January 1, 2016 Introduction: Phospholipids are altered in brains of patients with dementia and some studies suggest their plasma levels may be useful in the detection of mild cognitive impairment (MCI) and dementia. Methods: We measured 188 plasma metabolites in particip ... Full text Cite

Mild cognitive impairment and dementia prevalence: The Atherosclerosis Risk in Communities Neurocognitive Study

Journal Article Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring · January 1, 2016 Introduction: We examined prevalence of mild cognitive impairment (MCI) and dementia in the Atherosclerosis Risk in Communities (ARIC) Neurocognitive study. Methods: Beginning in June, 2011, we invited all surviving ARIC participants to undergo cognitive, ... Full text Cite

Perceived discrimination and cancer screening behaviors in US Hispanics: the Hispanic Community Health Study/Study of Latinos Sociocultural Ancillary Study.

Journal Article Cancer Causes Control · January 2016 PURPOSE: Perceived discrimination has been associated with lower adherence to cancer screening guidelines. We examined whether perceived discrimination was associated with adherence to breast, cervical, colorectal, and prostate cancer screening guidelines ... Full text Link to item Cite

Identification of Heart Failure Events in Medicare Claims: The Atherosclerosis Risk in Communities (ARIC) Study.

Journal Article J Card Fail · January 2016 BACKGROUND: We examined the accuracy of Medicare heart failure (HF) diagnostic codes in the identification of acute decompensated (ADHF and chronic stable (CSHF) HF. METHODS AND RESULTS: Hospitalizations were identified from medical discharge records for A ... Full text Link to item Cite

Application of Latent Variable Methods to the Study of Cognitive Decline When Tests Change over Time.

Journal Article Epidemiology · November 2015 BACKGROUND: The way a construct is measured can differ across cohort study visits, complicating longitudinal comparisons. We demonstrated the use of factor analysis to link differing cognitive test batteries over visits to common metrics representing gener ... Full text Link to item Cite

Midlife Alcohol Consumption and the Risk of Stroke in the Atherosclerosis Risk in Communities Study.

Journal Article Stroke · November 2015 BACKGROUND AND PURPOSE: Alcohol consumption is common in the United States and may confer beneficial cardiovascular effects at light-to-moderate doses. The alcohol-stroke relationship remains debated. We estimated the relationship between midlife, self-rep ... Full text Link to item Cite

High Cholesterol Awareness, Treatment, and Control Among Hispanic/Latinos: Results From the Hispanic Community Health Study/Study of Latinos.

Journal Article J Am Heart Assoc · June 24, 2015 BACKGROUND: We assessed high cholesterol (HC) awareness, treatment, and control rates among US Hispanic/Latino adults and describe factors associated with HC awareness and management. METHODS AND RESULTS: Baseline data (collected 2008-2011) from a multisit ... Full text Link to item Cite

Hearing impairment and cognitive decline: a pilot study conducted within the atherosclerosis risk in communities neurocognitive study.

Journal Article Am J Epidemiol · May 1, 2015 Hearing impairment (HI) is prevalent, is modifiable, and has been associated with cognitive decline. We tested the hypothesis that audiometric HI measured in 2013 is associated with poorer cognitive function in 253 men and women from Washington County, Mar ... Full text Link to item Cite

Vascular imaging abnormalities and cognition: mediation by cortical volume in nondemented individuals: atherosclerosis risk in communities-neurocognitive study.

Journal Article Stroke · February 2015 BACKGROUND AND PURPOSE: The relationships between cerebrovascular lesions visible on imaging and cognition are complex. We explored the possibility that the cerebral cortical volume mediated these relationships. METHODS: Total of 1906 nondemented participa ... Full text Link to item Cite

Tooth loss, periodontal disease, and cognitive decline in the Atherosclerosis Risk in Communities (ARIC) study.

Journal Article Community Dent Oral Epidemiol · February 2015 OBJECTIVE: The purpose of this prospective study was to investigate whether poor oral health predicted 8-year cognitive function change in predominantly late middle adults in the Atherosclerosis Risk in Communities (ARIC) study. METHODS: Participants inclu ... Full text Link to item Cite

Normative data for 8 neuropsychological tests in older blacks and whites from the atherosclerosis risk in communities (ARIC) study.

Journal Article Alzheimer Dis Assoc Disord · 2015 Accurate assessment of cognitive impairment requires comparison of cognitive performance in individuals to performance in a comparable healthy normative population. Few prior studies have included a large number of black participants and few have excluded ... Full text Link to item Cite

Pre-morbid body mass index and mortality after incident heart failure: the ARIC Study.

Journal Article J Am Coll Cardiol · December 30, 2014 BACKGROUND: Although obesity is an independent risk factor for heart failure (HF), once HF is established, obesity is associated with lower mortality. It is unclear if the weight loss due to advanced HF leads to this paradoxical finding. OBJECTIVES: This s ... Full text Link to item Cite

Outcomes of patients with anemia and acute decompensated heart failure with preserved versus reduced ejection fraction (from the ARIC study community surveillance).

Journal Article Am J Cardiol · December 15, 2014 Anemia is associated with poor prognosis in patients hospitalized with acute decompensated heart failure (ADHF). Whether the impact of anemia differs by heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction ... Full text Link to item Cite

Characteristics and outcomes of patients with acute decompensated heart failure developing after hospital admission.

Journal Article Am J Cardiol · November 15, 2014 There are limited data on acute decompensated heart failure (ADHF) that develops after hospital admission. This study sought to compare patient characteristics, co-morbidities, mortality, and length of stay by timing of ADHF onset. The surveillance compone ... Full text Link to item Cite

Validity of hospital discharge diagnosis codes for stroke: the Atherosclerosis Risk in Communities Study.

Conference Stroke · November 2014 BACKGROUND AND PURPOSE: Characterizing International Classification of Disease 9th Revision, Clinical Modification (ICD-9-CM) code validity is essential given widespread use of hospital discharge databases in research. Using the Atherosclerosis Risk in Com ... Full text Link to item Cite

Impact of atrial fibrillation on healthcare utilization in the community: the Atherosclerosis Risk in Communities study.

Journal Article J Am Heart Assoc · October 30, 2014 BACKGROUND: Atrial fibrillation (AF) is associated with increased risk of hospitalization. Little is known about the impact of AF on utilization of noninpatient health care or about sex or race differences in AF-related utilization. We examined rates of in ... Full text Link to item Cite

Heart failure risk across the spectrum of ankle-brachial index: the ARIC study (Atherosclerosis Risk In Communities).

Journal Article JACC Heart Fail · October 2014 OBJECTIVES: The aim of this study was to describe the relationship between ankle brachial index (ABI) and the risk for heart failure (HF). BACKGROUND: The ABI is a simple, noninvasive measure associated with atherosclerotic cardiovascular disease and death ... Full text Link to item Cite

Midlife hypertension and 20-year cognitive change: the atherosclerosis risk in communities neurocognitive study.

Journal Article JAMA Neurol · October 2014 IMPORTANCE: Hypertension is a treatable potential cause of cognitive decline and dementia, but its greatest influence on cognition may occur in middle age. OBJECTIVE: To evaluate the association between midlife (48-67 years of age) hypertension and the 20- ... Full text Link to item Cite

Identification of incident CKD stage 3 in research studies.

Journal Article Am J Kidney Dis · August 2014 BACKGROUND: In epidemiologic research, incident chronic kidney disease (CKD) commonly is determined by laboratory tests performed at planned study visits. Given the morbidity and mortality associated with CKD, persons with incident disease may be less like ... Full text Link to item Cite

Findings of universal cystoscopy at incontinence surgery and their sequelae.

Journal Article Am J Obstet Gynecol · May 2014 OBJECTIVE: The purpose of this study was to report the frequency of abnormal cystoscopy at incontinence surgery and to identify risk factors and sequelae of injury. STUDY DESIGN: Findings of cystoscopy were collected prospectively in 3 multicenter surgical ... Full text Link to item Cite

Impact of differential attrition on the association of education with cognitive change over 20 years of follow-up: the ARIC neurocognitive study.

Journal Article Am J Epidemiol · April 15, 2014 Studies of long-term cognitive change should account for the potential effects of education on the outcome, since some studies have demonstrated an association of education with dementia risk. Evaluating cognitive change is more ideal than evaluating cogni ... Full text Link to item Cite

Incidence and survival of hospitalized acute decompensated heart failure in four US communities (from the Atherosclerosis Risk in Communities Study).

Journal Article Am J Cardiol · February 1, 2014 Most population-based estimates of incident hospitalized heart failure (HF) have not differentiated acute decompensated heart failure (ADHF) from chronic stable HF nor included racially diverse populations. The Atherosclerosis Risk in Communities Study con ... Full text Link to item Cite

Comparable ascertainment of newly-diagnosed atrial fibrillation using active cohort follow-up versus surveillance of centers for medicare and medicaid services in the atherosclerosis risk in communities study.

Journal Article PLoS One · 2014 OBJECTIVE: Increasingly, epidemiologic studies use administrative data to identify atrial fibrillation (AF). Capture of incident AF is not well documented. We examined incidence rates and concordance of AF diagnosis based on active cohort follow-up versus ... Full text Link to item Cite

Trends in myocardial infarction rates and case fatality by anatomical location in four United States communities, 1987 to 2008 (from the Atherosclerosis Risk in Communities Study).

Journal Article Am J Cardiol · December 1, 2013 Although the incidence of and mortality after ST-segment elevation myocardial infarction (STEMI) is decreasing, time trends in anatomical location of STEMI and associated short-term prognosis have not been examined in a population-based community study. We ... Full text Link to item Cite

Classification of acute decompensated heart failure: an automated algorithm compared with a physician reviewer panel: the Atherosclerosis Risk in Communities study.

Journal Article Circ Heart Fail · July 2013 BACKGROUND: An algorithm to classify heart failure (HF) end points inclusive of contemporary measures of biomarkers and echocardiography was recently proposed by an international expert panel. Our objective was to assess agreement of HF classification by t ... Full text Link to item Cite

Comparative proteomic profiling of patients with atopic dermatitis based on history of eczema herpeticum infection and Staphylococcus aureus colonization

Journal Article Journal of Allergy and Clinical Immunology · January 1, 2011 Background: Atopic dermatitis (AD) is the most common inflammatory skin disorder in the general population worldwide, and the majority of patients are colonized with Staphylococcus aureus. Eczema herpeticum is a disseminated herpes simplex virus infection ... Full text Cite

Comparison of echocardiographic and cardiac magnetic resonance imaging measurements of functional single ventricular volumes, mass, and ejection fraction (from the Pediatric Heart Network Fontan Cross-Sectional Study).

Journal Article Am J Cardiol · August 1, 2009 Assessment of the size and function of a functional single ventricle (FSV) is a key element in the management of patients after the Fontan procedure. Measurement variability of ventricular mass, volume, and ejection fraction (EF) among observers by echocar ... Full text Link to item Cite

Design and rationale of a randomized trial comparing the Blalock-Taussig and right ventricle-pulmonary artery shunts in the Norwood procedure.

Journal Article J Thorac Cardiovasc Surg · October 2008 OBJECTIVE: The initial palliative procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood procedure, remains among the highest risk procedures in congenital heart surgery. The classic Norwo ... Full text Link to item Cite

How to interpret figures in reports of clinical trials.

Journal Article BMJ · May 24, 2008 A picture may be worth a thousand words but in medical research, caution Stuart Pocock, Thomas Travison, and Lisa Wruck, it is important to understand exactly what you are looking at ... Full text Link to item Cite

How to interpret figures in reports of clinical trials

Journal Article Clinical Otolaryngology · January 1, 2008 Full text Cite

Figures in clinical trial reports: Current practice & scope for improvement

Journal Article Trials · November 19, 2007 Background: Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. Purpose: To evaluate the current use of figures in Trial reports, and to make constructive suggestions for fu ... Full text Cite

Rationale and design of a randomized clinical trial of beta-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome.

Journal Article Am Heart J · October 2007 BACKGROUND: Cardiovascular disease, including aortic root dilation, dissection, and rupture, is the leading cause of mortality in patients with Marfan syndrome (MFS). The maximal aortic root diameter at the sinuses of Valsalva is considered the best predic ... Full text Link to item Cite

Burch colposuspension versus fascial sling to reduce urinary stress incontinence.

Journal Article N Engl J Med · May 24, 2007 BACKGROUND: Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations. METHODS: We performed a multicenter, randomized clinical ... Full text Link to item Cite

The relationships among measures of incontinence severity in women undergoing surgery for stress urinary incontinence.

Journal Article J Urol · May 2007 PURPOSE: We assessed the relationships among severity measures of urinary incontinence in women with stress predominant symptoms enrolled in a randomized clinical trial comparing 2 surgical techniques (Burch colposuspension vs pubovaginal sling) for stress ... Full text Link to item Cite

Reference urodynamic values for stress incontinent women.

Journal Article Neurourol Urodyn · 2007 OBJECTIVE: To determine reference urodynamic values for preoperative urodynamic studies in women undergoing surgery for pure or predominant stress urinary incontinence (SUI). MATERIALS AND METHODS: Six hundred fifty-five women with pure or predominant SUI ... Full text Link to item Cite

A sequential design to estimate sensitivity and specificity of a diagnostic or screening test.

Journal Article Stat Med · October 30, 2006 We consider efficient study designs to estimate sensitivity and specificity of a candidate diagnostic or screening test. Our focus is the setting in which the candidate test is inexpensive to administer compared to evaluation of disease status, and the tes ... Full text Link to item Cite