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Laura Qualls

Clinical Trials Project Leader III
Duke Clinical Research Institute
PO Box 17969, Durham, NC 27715

Scholarly Works


Evaluating fitness-for-use of electronic health records in ascertaining baseline characteristics and clinical outcomes in clinical trials: insights from the VESALIUS EHR demonstration project.

Journal article Trials · April 25, 2026 INTRODUCTION: A tremendous amount of clinical data is collected and stored in electronic health records (EHRs). Whether this data can be harnessed at scale to facilitate clinical trial conduct remains to be seen. METHODS: The Effect of Evolocumab in Patien ... Full text Link to item Cite

Assessing the harmonization of structured electronic health record data to reference terminologies and data completeness through data provenance.

Journal article Learn Health Syst · April 2025 INTRODUCTION: (1) Assess the harmonization of structured electronic health record data (laboratory results and medications) to reference terminologies and characterize the severity of issues. (2) Identify issues of data completeness by comparing complement ... Full text Link to item Cite

Assessing and improving research readiness in PCORnet®.

Journal article J Clin Transl Sci · 2025 PURPOSE: We describe the steps taken to assess and improve the research readiness of data within PCORnet®, specifically focusing on the results of the PCORnet data curation process between Cycle 7 (October 2019) and Cycle 16 (October 2024). MATERIAL AND ME ... Full text Open Access Link to item Cite

Optimizing data integration in trials that use EHR data: lessons learned from a multi-center randomized clinical trial.

Journal article Trials · September 1, 2023 BACKGROUND: Despite great promise, trials that ascertain patient clinical data from electronic health records (EHR), referred to here as "EHR-sourced" trials, are limited by uncertainty about how existing trial sites and infrastructure can be best used to ... Full text Link to item Cite

Mis-mappings between a producer's quantitative test codes and LOINC codes and an algorithm for correcting them.

Journal article J Am Med Inform Assoc · January 18, 2023 OBJECTIVES: To access the accuracy of the Logical Observation Identifiers Names and Codes (LOINC) mapping to local laboratory test codes that is crucial to data integration across time and healthcare systems. MATERIALS AND METHODS: We used software tools a ... 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

Evaluating Foundational Data Quality in the National Patient-Centered Clinical Research Network (PCORnet®).

Journal article EGEMS (Wash DC) · April 13, 2018 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 Nati ... Full text Link to item Cite

Medicare utilization, screening, and costs among participants in the Southeastern Diabetes Initiative: A population-based evaluation.

Journal article Prim Care Diabetes · April 2018 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 ev ... Full text Link to item Cite

The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

Journal article JACC Cardiovasc Interv · June 12, 2017 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 ... Full text Link to item Cite

Appropriate baseline laboratory testing following ACEI or ARB initiation by Medicare FFS beneficiaries.

Journal article Pharmacoepidemiol Drug Saf · September 2016 BACKGROUND: Laboratory testing to identify contraindications and adverse drug reactions is important for safety of patients initiating angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). Rates and predictors of appropria ... Full text Link to item Cite

Significant Morbidity and Mortality Among Hospitalized End-Stage Liver Disease Patients in Medicare.

Journal article J Pain Symptom Manage · September 2016 CONTEXT: For end-stage liver disease (ESLD) patients, care focuses on managing the life-threatening complications of portal hypertension, causing high resource utilization. OBJECTIVES: To describe the end-of-life trajectory of hospitalized ESLD patients in ... Full text Link to item Cite

Significant variation in P2Y12 inhibitor use after peripheral vascular intervention in Medicare beneficiaries.

Journal article Am Heart J · September 2016 UNLABELLED: There is no consensus regarding whether to use antithrombotic medications in patients with peripheral artery disease after lower-extremity peripheral vascular intervention. OBJECTIVES: The main hypothesis is that significant variation exists re ... Full text Link to item Cite

TRENDS IN THE CARE AND OUTCOMES OF MEDICARE BENEFICIARIES WITH TYPE 2 DIABETES, 2002-2011.

Journal article Endocr Pract · August 2016 OBJECTIVE: To summarize characteristics of Medicare beneficiaries with type 2 diabetes and to describe changing trends in care and outcomes. METHODS: We conducted a retrospective cohort study of a nationally representative 5% sample of fee-for-service Medi ... Full text Link to item Cite

Development and validation of a risk model for in-hospital worsening heart failure from the Acute Decompensated Heart Failure National Registry (ADHERE).

Journal article Am Heart J · August 2016 BACKGROUND: A subset of patients hospitalized with acute heart failure experiences in-hospital worsening heart failure, defined as persistent or worsening signs or symptoms requiring an escalation of therapy. METHODS: We analyzed data from the Acute Decomp ... Full text Link to item Cite

Low-density lipoprotein cholesterol level and statin use among Medicare beneficiaries with diabetes mellitus.

Journal article Diab Vasc Dis Res · May 2016 At the time of this study, guidelines recommended a primary goal of low-density lipoprotein cholesterol level less than 100 mg/dL for all patients, an optional goal of low-density lipoprotein cholesterol less than 70 mg/dL for patients with overt cardiovas ... Full text Link to item Cite

Linkage of Laboratory Results to Medicare Fee-for-Service Claims.

Journal article Med Care · November 2015 BACKGROUND: Medicare is the single largest purchaser of laboratory testing in the United States, yet test results associated with Medicare laboratory claims have historically not been available. OBJECTIVE: The purpose of this study was to describe both the ... Full text Link to item Cite

Trends in settings for peripheral vascular intervention and the effect of changes in the outpatient prospective payment system.

Journal article J Am Coll Cardiol · March 10, 2015 BACKGROUND: Peripheral vascular intervention (PVI) is an effective treatment option for patients with peripheral artery disease (PAD). In 2008, Medicare modified reimbursement rates to encourage more efficient outpatient use of PVI in the United States. OB ... Full text Link to item Cite

Relation of dyspnea severity on admission for acute heart failure with outcomes and costs.

Journal article Am J Cardiol · January 1, 2015 Hospitalization for heart failure (HF) is frequently related to dyspnea, yet associations among dyspnea severity, outcomes, and health care costs are unknown. The aim of this study was to describe the characteristics of patients hospitalized for acute HF b ... Full text Link to item Cite

Periprocedural imaging and outcomes after catheter ablation of atrial fibrillation.

Journal article Heart · December 2014 OBJECTIVE: Catheter ablation of atrial fibrillation (AF) has become an increasingly safe and effective therapy. This has been partly attributed to the use of adjunctive imaging modalities. We aimed to describe the use and associated outcomes of periprocedu ... Full text Link to item Cite

Predicting nursing home placement among home- and community-based services program participants.

Journal article Am J Manag Care · December 1, 2014 BACKGROUND: Several states offer publicly funded-care management programs to prevent long-term care placement of high-risk Medicaid beneficiaries. Understanding participant risk factors and services that may prevent long-term care placement can facilitate ... Link to item Cite

Clinical effectiveness of cardiac resynchronization therapy versus medical therapy alone among patients with heart failure: analysis of the ICD Registry and ADHERE.

Conference Circ Heart Fail · November 2014 BACKGROUND: Cardiac resynchronization therapy with defibrillator (CRT-D) reduces morbidity and mortality among selected patients with heart failure in clinical trials. The effectiveness of this therapy in clinical practice has not been well studied. METHOD ... Full text Link to item Cite

Anti-VEGF treatment patterns for neovascular age-related macular degeneration among medicare beneficiaries.

Journal article Am J Ophthalmol · September 2014 PURPOSE: To examine the use of anti-vascular endothelial growth factor (VEGF) therapy in clinical practice among patients with neovascular age-related macular degeneration (AMD). DESIGN: Retrospective cohort study. METHODS: Among 459 237 Medicare beneficia ... Full text Link to item Cite

Associations between anticoagulation therapy and risks of mortality and readmission among patients with heart failure and atrial fibrillation.

Journal article Circ Cardiovasc Qual Outcomes · September 2014 BACKGROUND: Patients with heart failure and atrial fibrillation are at higher risk of thromboembolic events than patients with heart failure alone. Yet, the use of anticoagulation therapy varies in clinical practice, especially among older patients, for wh ... Full text Link to item Cite

Cost analysis of periprocedural imaging in patients undergoing catheter ablation for atrial fibrillation.

Journal article Am J Cardiol · July 15, 2014 Cardiovascular imaging is an important part of procedural planning and safety for catheter ablation of atrial fibrillation (AF). However, the costs of imaging surrounding catheter ablation of AF have not been described. Medicare fee-for-service data were u ... Full text Link to item Cite

In-hospital worsening heart failure and associations with mortality, readmission, and healthcare utilization.

Journal article J Am Heart Assoc · July 11, 2014 BACKGROUND: A subset of patients hospitalized with acute heart failure experiences worsening clinical status and requires escalation of therapy. Worsening heart failure is an end point in many clinical trials, but little is known about its prevalence in cl ... Full text Link to item Cite

Comparative effectiveness of cardiac resynchronization therapy with an implantable cardioverter-defibrillator versus defibrillator therapy alone: a cohort study.

Journal article Ann Intern Med · May 6, 2014 BACKGROUND: Trials comparing implantable cardioverter-defibrillator (ICD) therapy with cardiac resynchronization therapy with a defibrillator (CRT-D) are limited to selected patients treated at centers with extensive experience. OBJECTIVE: To compare outco ... Full text Link to item Cite

Outcomes of medicare beneficiaries with heart failure and atrial fibrillation.

Journal article JACC Heart Fail · February 2014 OBJECTIVES: This study sought to examine the long-term outcomes of patients hospitalized with heart failure and atrial fibrillation. BACKGROUND: Atrial fibrillation is common among patients hospitalized with heart failure. Associations of pre-existing and ... Full text Link to item Cite

Adherence and persistence in the use of warfarin after hospital discharge among patients with heart failure and atrial fibrillation.

Journal article J Card Fail · January 2014 BACKGROUND: Postdischarge adherence and long-term persistence in the use of warfarin among patients with heart failure and atrial fibrillation without contraindications have not been fully described. METHODS AND RESULTS: We identified patients with heart f ... Full text Link to item Cite

Self-reported health parameters compared with clinician measurements: methods in practice-based research.

Journal article J Public Health Manag Pract · 2014 CONTEXT: Self-reported health data are used by health insurance companies to assess risk. Most studies show underreporting compared with clinical measurements. OBJECTIVE: To compare self-reported height, weight, blood pressure, waist circumference, and die ... Full text Link to item Cite

Postdischarge international normalized ratio testing and long-term clinical outcomes of patients with heart failure receiving warfarin: findings from the ADHERE registry linked to Medicare claims.

Journal article Clin Cardiol · December 2013 BACKGROUND: Effective warfarin thromboprophylaxis requires maintaining anticoagulation within the recommended international normalized ratio (INR) range. INR testing rates and associations between testing and outcomes are not well understood. HYPOTHESIS: I ... Full text Link to item Cite

QRS duration, bundle-branch block morphology, and outcomes among older patients with heart failure receiving cardiac resynchronization therapy.

Journal article JAMA · August 14, 2013 IMPORTANCE: The benefits of cardiac resynchronization therapy (CRT) in clinical trials were greater among patients with left bundle-branch block (LBBB) or longer QRS duration. OBJECTIVE: To measure associations between QRS duration and morphology and outco ... Full text Link to item Cite

Early intravenous heart failure therapy and outcomes among older patients hospitalized for acute decompensated heart failure: findings from the Acute Decompensated Heart Failure Registry Emergency Module (ADHERE-EM).

Journal article Am Heart J · August 2013 BACKGROUND: Timing of initial treatment for acute decompensated heart failure (ADHF) varies across hospitals and its impact on outcomes remains poorly defined. We examined the association between time to first intravenous (IV) heart failure (HF) therapy an ... Full text Link to item Cite

Transitional adherence and persistence in the use of aldosterone antagonist therapy in patients with heart failure.

Journal article Am Heart J · June 2013 BACKGROUND: Aldosterone antagonist therapy is recommended for selected patients with heart failure and reduced ejection fraction. Adherence to therapy in the transition from hospital to home is not well understood. METHODS: We identified patients with hear ... Full text Link to item Cite

Costs of newly diagnosed neovascular age-related macular degeneration among medicare beneficiaries, 2004-2008.

Journal article Retina · April 2013 PURPOSE: To examine associations between newly diagnosed neovascular age-related macular degeneration and direct medical costs. METHODS: This retrospective observational study matched 23,133 Medicare beneficiaries diagnosed with neovascular age-related mac ... Full text Link to item Cite

Follow-up of patients with new cardiovascular implantable electronic devices: are experts' recommendations implemented in routine clinical practice?

Journal article Circ Arrhythm Electrophysiol · February 2013 BACKGROUND: A 2008 expert consensus statement outlined the minimum frequency of follow-up of patients with cardiovascular implantable electronic devices (CIEDs). METHODS AND RESULTS: We studied 38 055 Medicare beneficiaries who received a new CIED between ... Full text Open Access Link to item Cite

The incremental value of medical nutrition therapy in weight management.

Journal article Manag Care · January 2013 OBJECTIVE: To evaluate the incremental cost of and health benefits attributable to medical nutrition therapy (MNT) for managed care members participating in an obesity-related health management program. DESIGN: Retrospective case-control. METHODOLOGY: Over ... Link to item Cite

Associations between aldosterone antagonist therapy and risks of mortality and readmission among patients with heart failure and reduced ejection fraction.

Journal article JAMA · November 28, 2012 CONTEXT: Aldosterone antagonist therapy for heart failure and reduced ejection fraction has been highly efficacious in randomized trials. However, questions remain regarding the effectiveness and safety of the therapy in clinical practice. OBJECTIVE: To ex ... Full text Link to item Cite

Treatment patterns for neovascular age-related macular degeneration: analysis of 284 380 medicare beneficiaries.

Journal article Am J Ophthalmol · June 2012 PURPOSE: To examine trends in the treatment of newly diagnosed neovascular age-related macular degeneration (AMD). DESIGN: Retrospective cohort study. METHODS: Among 284 380 Medicare beneficiaries with a new diagnosis between 2006 and 2008, we used the cum ... Full text Link to item Cite

Design and rationale of a retrospective clinical effectiveness study of aldosterone antagonist therapy in patients with heart failure.

Journal article Am Heart J · June 2012 BACKGROUND: Despite demonstrated efficacy in randomized trials, aldosterone antagonist therapy is not used in many eligible patients with heart failure. Questions remain about its clinical effectiveness and safety for patients who are underrepresented in r ... Full text Link to item Cite