Lesley H Curtis

• Duke University

BACKGROUND Socioeconomic disadvantage is associated with greater risks of hospital readmission and mortality among patients with heart failure (HF). However, it is less clear whether socioeconomic disadvantage has an immediate and lasting impact on the risk of admissions after the diagnosis of HF. METHODS We used electronic health record data of p...

Importance Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied. Objective To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-rep...

Several years ago, the US News and World Report changed their risk-adjustment methodology, now relying almost exclusively on chronic conditions for risk adjustment. The impacts of adding selected acute conditions like pneumonia, sepsis, and electrolyte disorders (“augmented”) to their current risk models (“base”) for 4 specialties—cardiology, neuro...

While the Coronavirus Disease 2019 (COVID-19) pandemic continues to present global challenges, sufficient time has passed to reflect on lessons learned and use those insights to inform policy and approaches to prepare for the next pandemic. In May 2022, the Duke Clinical Research Institute (DCRI) convened a Think Tank with thought-leaders from acad...

Introduction: Pragmatic randomized controlled trials (RCT) often use multiple data sources to examine clinical events, but the relative contribution of data sources (patient-reported, electronic health records (EHR), private/public claims data) to clinical endpoint rates is often not examined. Hypothesis: We hypothesized that claims data would cont...

Importance Patient-reported health data can facilitate clinical event capture in pragmatic clinical trials. However, few data are available on the fitness for use of patient-reported data in large-scale health research. Objective To evaluate the concordance of a set of variables reported by patients and available in the electronic health record as...

Background Despite the extensive use of real-world data for retrospective, observational clinical research, our understanding of how real-world data might increase the efficiency of data collection in patient-level randomized clinical trials is largely unknown. The structure of real-world data is inherently heterogeneous, with each source electroni...

Background The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at high risk of disruption due to the dual impacts on the conduct of both care and research. Methods...

Background Improving diversity in clinical trials is essential in order to produce generalizable results. Although the importance of representation has become increasingly recognized, identifying strategies to approach this work remains elusive. This article reviews the proceedings of a multi-stakeholder conference about the current state of divers...

Objective To empirically explore how pragmatic clinical trials (PCTs) that used real-world data (RWD) assessed study-specific fitness-for-use. Methods We conducted interviews and surveys with PCT teams who used electronic health record (EHR) data to ascertain endpoints. The survey cataloged key concerns about RWD, activities used to assess data fi...

The Sentinel System is a major component of the United States Food and Drug Administration’s (FDA) approach to active medical product safety surveillance. While Sentinel has historically relied on large quantities of health insurance claims data, leveraging longitudinal electronic health records (EHRs) that contain more detailed clinical informatio...

Background: Understanding the relationship between patterns of peripheral artery disease patterns and outcomes is an essential step towards improving care and outcomes. We hypothesized that clinician specialty would be associated with occurrence of major adverse vascular events (MAVE). Methods: Patients with at least 1 peripheral artery disease-...

Background Sacubitril/Valsartan has been highly efficacious in randomized trials of heart failure with reduced ejection fraction (HFrEF). However, the effectiveness of sacubitril/valsartan in older patients hospitalized for HFrEF in real‐world US practice is unclear. Methods and Results This study included Medicare beneficiaries age ≥65 years who...

Introduction In the 2016 U.S. Presidential election, voters in communities with recent stagnation or decline in life expectancy were more likely to vote for the Republican candidate than in prior Presidential elections. We aimed to assess the association between change in life expectancy and voting patterns in the 2020 Presidential election. Metho...

Background : PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known. Methods : Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and M...

Introduction In the 2016 U.S. Presidential election, voters in communities with recent stagnation or decline in life expectancy were more likely to vote for the Republican candidate than in prior Presidential elections. We aimed to assess the association between change in life expectancy and voting patterns in 2018 U.S. House of Representative elec...

Every year, hospitals are ranked or rated by public and private organizations that aim to identify centers that provide high-quality health care. Although the reports are intended to help guide consumers in determining where to seek care, these ranking systems often yield conflicting information or, worse, misinformation for patients and their clin...

In late 2018, the Food and Drug Administration (FDA) outlined a framework for evaluating the possible use of real-world evidence (RWE) to support regulatory decision-making. This framework was created to facilitate studies that would generate high-quality RWE, including pragmatic clinical trials (PCTs), which are randomized trials designed to infor...

Purpose Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling complication of many chemotherapies. We investigated the feasibility of using health plan claims and administrative data to identify CIPN occurrence by comparing patients who received neurotoxic and non-neurotoxic chemotherapies. Methods The sample included over 53,000,000 pa...

Background Many large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitme...

Background: Peripheral artery disease (PAD) affects 8-10 million Americans, who face significantly elevated risks of both mortality and major limb events (such as amputation). Unfortunately, PAD is relatively under-diagnosed, under-treated, and under-researched, leading to wide variations in treatment patterns and outcomes. Efforts to improve PAD...

BACKGROUND Peripheral artery disease (PAD) affects 8 to 10 million Americans, who face significantly elevated risks of both mortality and major limb events such as amputation. Unfortunately, PAD is relatively underdiagnosed, undertreated, and underresearched, leading to wide variations in treatment patterns and outcomes. Efforts to improve PAD care...

Objectives: Evaluate the association of physical activity (PA) level and longitudinal PA trajectory with a composite heart failure hospitalization and mortality endpoint over a 5-year follow-up period following implantation. Background: Low device measured PA early after implantation of an implantable cardioverter-defibrillator (ICD) or cardiac...

Stakeholders in the clinical research enterprise are aligned around the need to make clinical research in general, and randomized controlled trials in particular, more meaningful and efficient. To that end, we have built distributed research networks (DRNs) for the Sentinel System, the National Institutes of Health (NIH) Collaboratory, and the Nati...

Background Data from randomized controlled trials and observational studies on older adults who take statins for primary prevention of atherosclerotic cardiovascular disease are limited. To determine the incidence of statin use in older adults with and without cardiovascular disease (CVD) and/or diabetes (DM), we conducted a descriptive observation...

Background Sacubitril/valsartan has been highly efficacious in randomized clinical trials of patients with HFrEF. However, the effectiveness of sacubitril/valsartan in routine US clinical practice is unclear. Methods This study included patients age ≥65 years who were hospitalized for HFrEF (ejection fraction ≤40%), were eligible for sacubitril/va...

Objectives: This study sought to describe clinical outcomes among patients with atrial fibrillation (AF) and contraindications to oral anticoagulation (OAC). Background: Treatment with OAC prevents stroke and death in patients with AF, but may be contraindicated among patients at high bleeding risk. Methods: This was an observational, longitud...

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 committee (+CEC) adjudication of cardiovascular outcomes. Methods: We performed a retrospective stu...

Background: Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies. Methods and results: Medicare claims were...

Congestion is associated with adverse outcomes in heart failure (HF) patients. We characterized congestion in patients hospitalized for HF and examined the association between congestion severity at admission and postdischarge outcomes. Using the OPTIMIZE-HF registry linked to Medicare claims, we analyzed patients ≥65 years old hospitalized for HF...

Background: Older adults with cardiometabolic conditions are typically seen by multiple providers. Management by multiple providers may compromise care continuity and increase health expenditures for older adults, which may partly explain the inverse association between continuity and Medicare expenditures found in prior studies. This study sought...

Importance In response to rapidly growing interest in population health, academic medical centers are launching department-level initiatives that focus on this evolving discipline. This trend, with its potential to extend the scope of academic medicine, has not been well characterized. Objective To describe the emergence of departments of populati...

Background: Emerging data suggest that neck circumference (NC) is associated with cardiometabolic risk factors. Limited research is available regarding the association between NC and cardiovascular outcomes in African Americans. Methods: Using data from the Jackson Heart Study, we included participants with recorded NC measurements at baseline (...

Background The 2013 American College of Cardiology/American Heart Association Cholesterol Treatment Guideline increased the number of primary prevention patients eligible for statin therapy, yet uptake of these guidelines has been modest. Little is known of how primary care provider (PCP) beliefs influence statin prescription. Methods and Results...

Background The angiotensin‐receptor/neprilysin inhibitor (ARNI) sacubitril/valsartan reduces hospitalization and mortality for patients with heart failure with reduced ejection fraction. However, adoption of ARNI into clinical practice has been slow. Factors influencing use of ARNI have not been fully elucidated. Using data from the Get With The Gu...

Table S1. Baseline Characteristics by ARNI Prescription at Discharge Table S2. Unadjusted and Adjusted Odds Ratios for the Association Between Patient‐Level Factors and Angiotensin‐Receptor/Neprilysin Inhibitor (ARNI) Prescription at Discharge

Data S1. Survey of Primary Care Clinician Beliefs and Approaches to Statin Therapy.

Introduction Advanced imaging can inform prognosis and may be a mechanism to de-escalate unnecessary end-of-life care in patients with cancer. Associations between greater use of advanced imaging and less-aggressive end-of-life care in real-world practice has not been examined. Methods We conducted a retrospective analysis of SEER-Medicare data on...

BACKGROUND Atrial fibrillation (AF) is an important public health problem across race/ethnic groups. Data from US cohort studies initiated in the 1980s suggest higher prevalence of AF risk factors among African Americans (AAs) than whites, but lower AF incidence. The Jackson Heart Study (JHS) is a community‐based study of 5,306 AAs recruited starti...

Background: Linking clinical registries to administrative claims data enables researchers to capitalize on the specific strengths of each data source with respect to the depth, breadth, and completeness of information. The objectives of this study were to link a health-system-based orthopaedic surgery registry to U.S. Medicare claims data without...

Background: Surveys of patients with cardiovascular disease have suggested that "home-time"-being alive and out of any health care institution-is a prioritized outcome. This novel measure has not been studied among patients with heart failure (HF). Objectives: This study sought to characterize home-time following hospitalization for HF and asses...

Introduction Distributed research networks (DRNs) are critical components of the strategic roadmaps for the National Institutes of Health and the Food and Drug Administration as they work to move toward large-scale systems of evidence generation. The National Patient-Centered Clinical Research Network (PCORnet®) is one of the first DRNs to incorpor...

Conflicting data exist regarding the associations of early repolarization (ER) with electrocardiogram (ECG) and clinical outcomes in blacks. We examined the association of ER defined by JPE and all-cause mortality as well as heart failure (HF) hospitalization in Blacks in the Jackson Heart Study (JHS) cohort. We included JHS participants with ECGs...

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide ran...

Background Non-adherence to medications is common and leads to suboptimal outcomes. Non-adherence can be intentional (e.g., deciding to skip dosages) or unintentional (e.g., forgetting), yet few studies have distinguished these reasons. An improved understanding of the reasons for non-adherence could inform the development of effective intervention...

Background Atrial fibrillation is increasingly prevalent as the US population ages and is associated with significant morbidity and mortality. Care for patients with atrial fibrillation can be costly, US health care costs are comparatively high, and there are few cost estimates available that incorporate detailed measurement of comorbidities and th...

Background Many older adults have multiple conditions and see multiple providers, which may impact their use of essential medications. Objective We examined whether the number of prescribers of these medications was associated with the availability of medications, a surrogate for adherence, to manage diabetes, hypertension or dyslipidemia. Method...

Background On May 20, 2016, US professional organizations in cardiology published joint treatment guidelines recommending the use of angiotensin-receptor neprilysin inhibitor (ARNI) for eligible patients with heart failure with reduced ejection fraction (HFrEF). Using data from the Get With The Guidelines–Heart Failure registry, we evaluated the ea...

Background Heart failure with preserved ejection fraction may be associated with chronotropic incompetence, but little is known about the incidence and prevalence of permanent pacemaker use in this population or factors associated with its use. Methods We analyzed patients with heart failure with preserved ejection fraction (ie, left ventricular e...

Background: Prior studies have reported higher in-hospital survival with prompt defibrillation and epinephrine treatment in patients with in-hospital cardiac arrest (IHCA). Whether this survival benefit persists after discharge is unknown. Methods: We linked data from a national IHCA registry with Medicare files and identified 36 961 patients ≥6...

Aims: Type 2 diabetes mellitus imposes significant burdens on patients and health care systems. Population-level interventions are being implemented to reach large numbers of patients at risk of or diagnosed with diabetes. We describe a population-based evaluation of the Southeastern Diabetes Initiative (SEDI) from the perspective of a payer, the...

Several in vitro and animal studies have showed that inflammatory markers play a role in bone remodeling and pathogenesis of osteoporosis. Additionally, some human longitudinal studies showed suggestive associations between elevated inflammatory markers and increased risk of non-traumatic fractures. We examined several inflammatory markers and mult...

Background: Deintensification of diabetic therapy is often clinically appropriate for older adults, because the benefit of aggressive diabetes treatment declines with age, while the risks increase. Objective: We examined rates of overtreatment and deintensification of therapy for older adults with diabetes, and whether these rates differed by me...

Table S1. Baseline Participant Characteristics Stratified by Field Center

Background Prior studies have demonstrated a link between the metabolic syndrome and increased risk of cardiovascular mortality. Whether the metabolic syndrome is associated with sudden cardiac death is uncertain. Methods and Results We characterized the relationship between sudden cardiac death and metabolic syndrome status among participants of...

Objectives Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. Background Modifications in rei...

Methods: Patients with functional and degenerative MR at high surgical risk in the EVEREST II High-Risk Registry and REALISM Continued-Access Study were linked to Medicare data. Pre- and post-MitraClip all-cause death, stroke, myocardial infarction, heart failure (HF), and bleeding hospitalizations were identified. Inpatient costs, adjusted to 201...

Background: The Jackson Heart Study (JHS) assesses cardiovascular disease risk factors among African Americans in Jackson, Mississippi. Whether characteristics of JHS participants differ from those of a broader African American population are unknown. Methods: In a retrospective observational analysis, we compared characteristics and outcomes of...

Objective: To determine whether greater pericardial fat volume would be associated with increased risk of incident atrial fibrillation (AF). Methods: In the Multi-Ethnic Study of Atherosclerosis and Jackson Heart Study, pericardial fat volume was quantified by computed tomography. Incident AF was identified from discharge diagnosis codes, study...

The learning healthcare system uses health information technology and the health data infrastructure to apply scientific evidence at the point of clinical care while simultaneously collecting insights from that care to promote innovation in optimal healthcare delivery and to fuel new scientific discovery. To achieve these goals, the learning health...

Background: Prior studies have reported higher in-hospital survival with prompt defibrillation and epinephrine treatment in patients presenting with in-hospital cardiac arrest (IHCA). Whether this survival benefit persists after discharge is unknown. Methods: We linked data from a national IHCA registry with Medicare files and identified 37,042 pat...

Ventricular tachycardia (VT) is common in cardiomyopathy patients with an implantable cardioverter-defibrillator. This analysis evaluated antiarrhythmic medication use and change in use over time in patients with VT and structural heart disease. Query of Medicare claims identified patients with an implantable cardioverter-defibrillator and VT. Pati...

Background: Apparent treatment-resistant hypertension (aTRH) is associated with an increased risk of adverse cardiovascular outcomes. We studied the frequency and intensity of care for aTRH among participants aged 65 years and older in the US-based REGARDS study linked with Medicare claims. Methods: Blood pressure (BP) was measured twice and ave...

Background: Heart failure guidelines recommend routine monitoring of serum potassium, and renal function in patients treated with a mineralocorticoid receptor antagonist (MRA). How these recommendations are implemented in high-risk patients or according to setting of drug initiation is poorly characterized. Methods and results: We conducted a re...

Background In 2014, new hypertension guidelines liberalized blood pressure goals for persons 60 years and older. Little is known about the implications for blacks. Methods and Results Using data from 2000 through 2011 for 5280 participants in the Jackson Heart Study, a community‐based black cohort in Jackson, Mississippi, we examined whether highe...

Background: Despite the persistence of significant disparities, few evaluations examine disparities in laboratory testing by race/ethnicity, age, sex, Medicaid eligibility, and number of chronic conditions for Medicare fee-for-service beneficiaries' newly prescribed medications. In Medicare beneficiaries initiating diuretics or digoxin, this study...

Importance: Therapeutic hypothermia is used for patients following both out-of-hospital and in-hospital cardiac arrest. However, randomized trials on its efficacy for the in-hospital setting do not exist, and comparative effectiveness data are limited. Objective: To evaluate the association between therapeutic hypothermia and survival after in-h...

Background: Medicare beneficiaries with multiple chronic conditions are typically seen by multiple providers, particularly specialists. Clinically appropriate referrals to multiple specialists may compromise the continuity of care for multiple chronic condition beneficiaries and create care plans that patients may find challenging to reconcile, wh...

Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovasc...

Importance Increased resting heart rate is associated with worse outcomes in studies of mostly white populations, but its significance is not well established in African Americans persons whose cardiac comorbidities and structural abnormalities differ. Objective To study the prognostic utility of heart rate in a community-based African American co...

Background: Diabetes mellitus, heart failure (HF), and chronic kidney disease are common comorbidities, but overall use and safety of antihyperglycemic medications (AHMs) among patients with these comorbidities are poorly understood. Methods and results: Using Get With the Guidelines-Heart Failure and linked Medicare Part D data, we assessed AHM...