About

Lisa Wruck is a Professor of Biostatistics and Bioinformatics at Duke University. She is also a member of the Duke Clinical Research Institute. Her academic role involves research and teaching within the Division of Biostatistics at Duke. Her work focuses on biostatistics and bioinformatics, contributing to the academic and research community at Duke University. She is based in Durham, North Carolina, and is associated with the Duke Department of Biostatistics and Bioinformatics.

Research topics

• Medicine
• Internal medicine
• Political Science
• Physical therapy
• Intensive care medicine
• Mathematics
• Pathology
• Virology
• Statistics
• Environmental health
• Gerontology

Selected publications

• Multiply robust estimation for causal survival analysis with treatment noncompliance

  The Annals of Applied Statistics · 2026-03-01

  article

  Comparative effectiveness research frequently addresses a time-to-event outcome and can require unique considerations in the presence of treatment noncompliance. Motivated by the challenges in addressing noncompliance in the ADAPTABLE pragmatic clinical trial, we develop a multiply robust estimator to estimate the principal survival causal effects under the principal ignorability and monotonicity. The multiply robust estimator is consistent, even if one, and sometimes two, of the required models are misspecified. We apply the multiply robust method in the ADAPTABLE trial to evaluate the effect of low- vs. high-dose aspirin assignment on patients’ death and hospitalization from cardiovascular diseases. We find that, comparing to low-dose assignment, assignment to the high-dose leads to differential effects among always high-dose takers, compliers, and always low-dose takers. Such treatment effect heterogeneity contributes to the null intention-to-treatment effect. We further perform a formal sensitivity analysis for investigating the robustness of our causal conclusions under violation of two identification assumptions specific to noncompliance.

  PublisherDOI

• Prevalence of pre-stroke and stroke-related vision impairments and their association with mild cognitive impairment and dementia.

  UNC Libraries · 2026-03-17

  articleOpen accessSenior author

  Background: Vision impairment is a risk factor for mild cognitive impairment (MCI) among stroke survivors, but it is unclear if this association is driven by vision impairment present before or due to the stroke, and if similar associations exist with dementia. Objective: To (1) characterize the prevalence of pre-stroke and stroke-related vision impairment(s) among stroke survivors, and (2) quantify associations of vision impairment with dementia and cognitive impairment (MCI/dementia). Methods: Using participants from the Atherosclerosis Risk in Communities (ARIC) dataset with adjudicated incident strokes, we gathered descriptive statistics on the cohort, assessed if vision impairment was present at the time of incident stroke, and classified the impairments as pre-stroke or stroke-related. Multivariable logistic regression was used to estimate the association between these types of vision impairment and post-stroke cognitive impairment. Results: Among 233 incident stroke survivors (mean = 69 years old and 50.2% female sex), 23.2% with pre-stroke vision impairment and 18.9% with stroke-related vision impairment, there were 124 (53%) cases of cognitive impairment (n = 76 MCI, n = 48 dementia). Stroke-related vision impairment was significantly associated with higher odds of dementia (ref = normal/MCI) (adjusted odds ratio (aOR) = 2.32, 95% confidence interval (CI) = 1.08-4.92, p = 0.029), but not any cognitive impairment (ref = normal) (aOR = 1.33 95% CI = 0.67-2.70, p = 0.425). Further adjusting for stroke severity score attenuated the association of stroke-related vision impairment with dementia (aOR = 2.0, 95% CI = 0.90, 4.32, p = 0.08). Conclusions: Stroke-related vision impairment, but not pre-stroke vision impairment, was associated with higher odds of dementia. There is evidence that stroke severity could, at least partially, explain the observed association.

  PublisherDOI

• The power, potential of real-world data in randomized controlled trials: proceedings from a multistakeholder think tank

  Trials · 2026-04-11

  articleOpen accessCorresponding

  Randomized controlled trials (RCTs) remain the gold standard for evaluating medical interventions, but they often face challenges related to patient recruitment, cost, and efficiency. Real-world data (RWD) has emerged as a valuable tool to enhance trial design, improve patient identification, and support regulatory decision-making. However, integrating RWD into RCTs presents methodological, regulatory, and operational challenges. To address these issues, a think tank was convened in May 2024 at the Duke Clinical Research Institute, bringing together experts from academia, industry, healthcare systems, regulatory agencies, and patient advocacy groups. Discussions focused on three key areas: optimizing patient identification and outcome assessment, leveraging RWD for safety assessments, and using RWD in RCTs supporting regulatory approval. RWD has the potential to simplify eligibility criteria, enhance recruitment through artificial intelligence, and provide practical endpoints for evaluating treatment effects. The think tank underscored the need for collaboration across stakeholders to address challenges, such as data inconsistencies, privacy concerns, and infrastructure limitations. The event concluded with actionable recommendations, including the following: (1) standardizing RWD sources to ensure consistency and improve interoperability across healthcare systems, (2) developing regulatory frameworks that define acceptable use cases for RWD in clinical trials, (3) enhancing data quality through robust validation methodologies and real-time monitoring, (4) investing in artificial intelligence-driven patient identification tools to streamline recruitment, and (5) fostering multi-stakeholder collaboration to align expectations and share best practices. Moving forward, implementing these strategies will be critical to fully harness the potential of RWD in clinical research and improve trial efficiency.

  PublisherDOI

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

  UNC Libraries · 2025-02-06

  articleOpen access1st authorCorresponding
  PublisherDOI

• Antifibrotic Dose Reductions and Clinical Outcomes in Patients With Idiopathic Pulmonary Fibrosis in Real-World Data Sources

  American Journal of Respiratory and Critical Care Medicine · 2025-05-01 · 1 citations

  articleSenior author

  Abstract Rationale: Clinical trials of antifibrotic therapies, nintedanib and pirfenidone, demonstrate a reduction in lung function decline in patients with idiopathic pulmonary fibrosis (IPF). However, both medications are often poorly tolerated at full dose due to side effects, leading to dose reductions in clinical practice. We evaluated the comparability of clinical outcomes in patients treated with full dose, reduced dose, or discontinuation of antifibrotic therapies using 2 real-world data sources. Methods: Patients with IPF who initiated antifibrotic therapy were identified in 1) multicenter Pulmonary Fibrosis Foundation Patient Registry (Registry) and 2) Duke University Health System electronic health records (EHR). Dosing groups were defined over 1 year after antifibrotic initiation as: full dose (total daily dose [TDD] 300 mg nintedanib or 2403 mg pirfenidone), reduced dose (TDD <300 mg nintedanib or <2403 mg pirfenidone for ≥90 days) or stopped therapy for ≥90 days. Cox proportional hazards models landmarked at 1 year were fit to evaluate the association between dosing group and IPF progression, defined as ≥10% decline in FVC % predicted, hospitalization, lung transplant, or death. Mixed effects models were fit to evaluate differences in the rate of FVC decline after 1 year. Analyses were adjusted for demographics and lung function. Results: The analysis included 455 Registry patients and 577 EHR patients, of whom 309 (67.9%) and 393 (68.1%), respectively, remained on full antifibrotic dose at 12 months; 106 (23.3%) and 164 (28.4%) were treated with reduced dose; and 40 (8.8%) and 20 (3.5%) stopped therapy. Compared with patients on full doses, patients who stopped or reduced their antifibrotic dose did not have a significantly increased risk of progression in either the Registry (HR, 1.45 [95% CI, 0.98-2.14], HR, 1.15 [95% CI, 0.86-1.54], respectively) or EHR (HR, 1.01 [95% CI, 0.49-2.06], HR, 0.95 [95% CI 0.70-1.28], respectively). Patients on full dose had a numerically slower yearly rate of decline in FVC % predicted in both the Registry (-2.61% vs -3.57%) and EHR (-1.55% vs -2.21%) compared with those on reduced dose, but these differences were not statistically significant (-0.96% [95% CI, -2.17 to 0.25], -0.66% [95% CI, -2.18 to 0.86], respectively). Conclusion: Among patients with IPF, dose reduction and discontinuation of antifibrotics was frequently observed, likely due to poor drug tolerability. Clinical outcomes did not significantly differ based on antifibrotic dose, which can inform clinical decision making in the treatment of patients with IPF who experience side effects with antifibrotic therapy.

  PublisherDOI

• Association of race, ethnicity, and housing stability with COVID-19 testing method by investigators in underserved populations 2020–2023

  UNC Libraries · 2025-10-10

  articleOpen access

  Background Expanding SARS-CoV-2 testing was a critical part of community-based health efforts during the COVID-19 pandemic. In the RADx-UP consortium, a large NIH-funded network of community-engaged researchers in the United States, investigators were able to choose between PCR- and antigen-based testing strategies in community-based research settings. Data analyzing how COVID-19 diagnostics are chosen and utilized in research of vulnerable and underserved populations is limited. Objectives To examine the association of race, ethnicity, and housing stability with a PCR- or antigen-based testing strategy within COVID-19 testing projects in the RADx-UP consortium. Methods Testing protocols and investigator survey data describing target populations for community-engaged research projects were analyzed for association between race, ethnicity, and housing stability with SARS-CoV-2 test type. Community-engaged research projects were included if they were funded and approved to use PCR- and/or antigen-based COVID-19 testing by the RADx-UP testing core between 2020 and 2023. Multivariable adjustment to assess for confounding was then performed using rurality, project size, pandemic phase, and census region.ResultsSixty-seven projects (representing 479,410 participants) were included in the analysis. Overall, 24 (36%) projects chose an antigen-only testing strategy compared to 43 (64%) that chose a PCR-based strategy. No significant differences in distribution were seen in inclusion of PCR-testing by race (16 of 21 for Black race versus 27 of 46 for non-Black race, p = 0.198), ethnicity (22 of 33 for Hispanic ethnicity versus 21 of 34 for non-Hispanic ethnicity, p = 0.765), or housing stability (10 of 17 for unstable housing versus 33 of 50 for stable housing, p = 0.728) within intended population. Conclusion Race, ethnicity, and housing stability of an underlying vulnerable population was not significantly associated with the decision by community investigators regarding which COVID-19 testing strategy was most appropriate. Future research efforts should remain vigilant to offer emerging diagnostic technologies in the most equitable and appropriate ways.

  PublisherDOI

• The relationship between living in poverty and youth COVID-19 testing in underserved populations

  Annals of Epidemiology · 2025-06-14

  article
  PublisherDOI

• Investigating stroke-related vision impairments and time to incident dementia diagnosis

  Journal of Stroke and Cerebrovascular Diseases · 2025-10-30

  articleOpen access

  Vision loss is a risk factor for dementia, but it is unknown whether stroke-related vision impairment is linked to dementia risk in stroke survivors. This secondary analysis aimed to quantify the association between stroke-related vision impairment and time to incident dementia diagnosis, from time of stroke, using the Arthrosclerosis Risk in Communities study dataset. We included participants who sustained a non-fatal probable or definite ischemic, incident stroke captured from hospital surveillance during the study period and excluded those who were diagnosed with incident dementia prior to or less than half a year after the incident stroke. The association between stroke-related vision impairment (binary) and time from incident stroke to dementia diagnosis was analyzed using a Fine-Gray survival model to account for the competing risk of death, adjusting for age at incident stroke, stroke severity, biological sex, education and race-center. Among 787 stroke survivors, 31 % were diagnosed with dementia during the follow-up period and 19.5 % had stroke-related vision impairment. The presence of stroke-related vision impairment was not significantly associated with dementia diagnosis (HR = 1.18; 95 % CI 0.85, 1.63; p = 0.32). While results suggest that stroke-related vision impairment corresponds to a higher cumulative incidence of dementia, the association was not statistically significant.

  PublisherDOI

• Association of study visit interval length with follow-up completeness and adherence to assigned study drug dose: A randomized comparison of participants in the ADAPTABLE trial

  Contemporary Clinical Trials · 2025-07-25

  article
  PublisherDOI

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

  UNC Libraries · 2025-09-19

  articleOpen access

  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-American cohort. METHODS: We repeatedly measured 188 phospholipids/metabolites in plasma samples of 221 participants of the Atherosclerosis Risk in Communities study, 97% African American, who were followed between 2004-2006 and 2011-2013. RESULTS: After a mean follow-up of 7.3 years, 77 were classified as having MCI and 18 as having dementia. Our study failed to replicate previous findings in this mostly African American cohort, in that the 10 phospholipids/metabolites only achieved a C statistic/AUC of 0.609 in predicting development of MCI or dementia (compared to 0.96) and 0.607 in distinguishing normal from MCI or dementia at the follow-up visit. CONCLUSION: A panel of 10 phospholipids/metabolites previously associated with incident dementia was not predictive of MCI or dementia in an independent cohort.

  PublisherDOI

Recent grants

• ARIC Neurocognitive Study (ARIC-NCS) Renewal UNC 4 of 5

  NIH · $7.5M · 2010–2020

• RADx-UP CDCC

  NIH · $116.7M · 2020–2025

Frequent coauthors

• Wayne D. Rosamond

  University of North Carolina at Chapel Hill

  161 shared

• Rebecca F. Gottesman

  143 shared

• Laura R. Loehr

  University of North Carolina at Chapel Hill

  107 shared

• Sunil Agarwal

  101 shared

• Eyal Shahar

  97 shared

• Scott D. Solomon

  Harvard University

  94 shared

• Álvaro Alonso

  Emory University

  83 shared

• Gerardo Heiss

  Baylor College of Medicine

  74 shared