Medicine and Health Sciences Commons^™

An Allele-Agnostic Mutant-Kras Inhibitor Suppresses Tumor Maintenance Signals And Reprograms Tumor Immunity In Pancreatic Cancer, Kathleen M Mcandrews, Francesca Paradiso, Clint A Stalnecker, Benson S Chellakkan, Fredrik I Thege, David H Peng, Barbara A Moreno Diaz, Hikaru Sugimoto, Sarah I Patel, Krishnan K Mahadevan, Michelle L Kirtley, Danielle Wills, Amari M Sockwell, Andre Luis F Fonseca, Yunhe Liu, Kimal I Rajapakshe, Nathaniel G Yee, Phuong Thao Tran, Huda Alchikh Omar, Antonio Tedeschi, Fiorella Schischlik-Siegl, Andrew S Boghossian, Matthew G Rees, Melissa M Ronan, Jennifer A Roth, Dorothea Rudolph, Martin Aichinger, Florian Ebner, Artem V Artemov, Jesse Lipp, Laura Pisarsky, Valerie Laura Herrmann, John Park, Jörg F Rippmann, Otmar Schaaf, Vanessa Chandler, Mariah Williams, Charles E Deckard, Linghua Wang, Channing J Der, Christopher Vellano, Paola A Guerrero, Timothy P Heffernan, Raghu Kalluri, Anirban Maitra

Faculty, Staff and Student Publications

KRAS is among the most frequently mutated oncogenes in cancer, and for decades, efforts at pharmacological blockade of its function in solid cancers have been unsuccessful. A notable advance in this endeavor is the recent development of small molecule KRAS inhibitors, which enable direct targeting of the mutant oncoprotein. Here, we comprehensively evaluate the pre-clinical efficacy of BI-2493 a panKRASi, a first-in-class allele agnostic mutant KRAS inhibitor, in pancreatic ductal adenocarcinoma (PDAC). We report effective tumor growth suppression across a broad range of models, including cell lines, patient-derived xenografts (PDXs), syngeneic orthotopic models, and prolonged survival in genetically engineered mouse …

Dietary And Consumer Behaviors In Individuals Currently Using Substances: A Cross-Sectional Study Based On Nhanes (2013 - 2018), A Sarah Cohen, Marylou Cardenas-Turanzas, Audrey Lopez, Tiffany Champagne-Langabeer

Faculty, Staff and Student Publications

Background: Substance use disorders (SUD) are associated with metabolic dysregulation and nutritional deficiencies. Studies show that incorporating nutrition interventions into treatment may improve physical and psychological health. This study sought to explore dietary and consumer behavior in individuals currently using substances.

Methods: Data from the 2013 - 2018 National Health and Nutrition Examination Survey were used for this cross-sectional study. Individuals 18 - 69 who were currently using marijuana, cocaine, heroin, methamphetamines, or injected unprescribed drugs were compared with individuals not using substances. Dietary and consumer behavior, including alcohol consumption was assessed. Analyses were performed using Stata I/C version 15. …

Sociodemographic Determinants Of Telehealth Visits: A Comparison Of Mental Health And Substance Use Disorders With Other Services, Stanley Nkemjika, Orman Trent Hall, Jeanette Tetrault, Ayana Jordan

Department of Psychiatry and Human Behavior Faculty Papers

BACKGROUND/OBJECTIVES: Discrimination has wide-ranging implications, affecting patients' trust in healthcare professionals and their intentions to seek care. It can cause barriers that can affect access to care, especially among racial and ethnic minority groups in mental healthcare settings. Hence, we aim to examine the relationship between racial discrimination and reasons for using telehealth services.

METHOD: Using the 2022 Health Information National Trends Survey (HINTS-6), we isolated 6017 participants who reported on discrimination inquiry. The primary dependent variable in this study is self-reported discrimination in healthcare, while the main independent variable is the reason for the most recent telehealth visit, and …

An Isoform-Specific Runx1c-Btg2 Axis Governs Aml Quiescence And Chemoresistance, Cuijuan Han, Zhiping Zhang, Edie I Crosse, Sogand Sajedi, Bin Lu, Xiyue Wang, Sadik Karma, Mitch Kostich, Sakthi Harini Rajendran, Dylan B Udy, Steven Chen, Alexander Arnuk, Abimbola Eunice Lawal, Kayla R Koenig, Meryl Mckenna, Patrick K Reville, Hussein A Abbas, Omar Abdel-Wahab, Pedro Miura, Robert K Bradley, Eric Wang

Faculty, Staff and Student Publications

Aberrant levels or structures of RNA isoforms are a hallmark of many cancers, including acute myeloid leukemia (AML), yet their role in AML chemoresistance remains unclear. We conducted a paired analysis of RNA isoform changes in patients with AML before therapy and at relapse after chemotherapy and identified intragenic DNA methylation at the proximal promoter of the transcription factor RUNX1, which resulted in elevated expression of the long-isoform RUNX1C through its alternative distal promoter. The unique N-terminal region of RUNX1C orchestrated an isoform-specific transcriptional program that promoted chemoresistance, with its direct target BTG2 playing a role in chemotherapy resistance. …

Amoxicillin Vs Ceftriaxone To Treat Pneumonia Caused By Amoxicillin-Non-Susceptible Streptococcus Pneumoniae, Daniel M Musher

Faculty, Staff and Students Publications

Although the article by J Càmara, I Grau, A González-Díaz, N Santos, et al. (Antimicrob Agents Chemother 69:e00237-25, 2025, https://doi.org/10.1128/aac.00237-25) suggests that ceftriaxone is greatly superior to amoxicillin in treating pneumonia due to pneumococci with an MIC > 2 mg/L, much of the difference in efficacy of the two drugs may have been due to dosage, route, and times of administration of the amoxicillin.

Development Of A Clinical Practice Guideline To Improve Appointment Adherence Among Adults With Depression In An Outpatient Setting Using The Agree Ii Framework, Udenma Okafor-Bryden

Walden Dissertations and Doctoral Studies

This Doctor of Nursing Practice (DNP) project was designed to develop a clinical practice guideline (CPG) to enhance appointment adherence among adults with depression in an outpatient mental health clinic, thereby improving outcomes. The practice-focused question was Will a CPG utilizing a multimodal reminder system improve appointment adherence? Missed appointments in outpatient mental health care contribute to delayed treatment, increased symptom severity, and higher rates of emergency care utilization. These disruptions not only compromise clinical outcomes but also financially burden healthcare systems and disrupt continuity of care. The CPG was developed using the Johns Hopkins evidence-based practice model and a …

Nebulization Of An Mrna-Encoded Monoclonal Antibody For Passive Immunization Of Foals Against Rhodococcus Equi, Rebecca M Legere, Jeannine A Ott, Cristina Poveda, Daryll Vanover, Karin E R Borba, Jae Yeon Joo, Cameron L Martin, Bibiana P Da Silveira, Jocelyne M Bray, Kerstin Landrock, Gus A Wright, J Chistensen Blazier, Andrew E Hillhouse, Ashley L Benham-Duret, Brandon Mistretta, Rafaela L Klein, Sarah M Thompson, Amelia R Woolums, Michael F Criscitiello, Luc R Berghman, Angela I Bordin, Philip J Santangelo, Jeroen Pollet, Noah D Cohen

Faculty, Staff and Students Publications

Inhalation of Rhodococcus equi causes severe pneumonia in humans and animals worldwide, most commonly affecting horse foals. The standard for preventing R. equi pneumonia in foals is transfusion of hyperimmune plasma, which is expensive and carries the risk of adverse effects. Our goal was to passively immunize foals against R. equi by nebulizing mRNA encoding an equine monoclonal antibody (mAb) against the virulence-associated protein A (VapA) directly into the lungs. VapA-specific memory B cells from an immunized horse were used to identify and select the sequence for an equine immunoglobulin (Ig)G1 mAb. In vitro-transcribed mRNA encoding this sequence expressed …

Persistent Na+ Current Couples Spreading Depolarization To Seizures In Scn8a Gain-Of-Function Mice, Isamu Aiba, Yao Ning, Jeffrey L Noebels

Faculty, Staff and Students Publications

Spreading depolarization (SD) is a slowly propagating wave of massive cellular depolarization that transiently impairs the function of affected brain regions. Although SD typically arises as an isolated hemispheric event, we previously reported that reducing M-type potassium current (IKM) by ablation of Kcnq2 in forebrain excitatory neurons results in tightly coupled spontaneous bilateral seizure–SD complexes in the awake mouse cortex.

Here we find that enhanced persistent Na+ current attributable to gain-of-function mutations in Scn8a (N1768D/+, hereafter D/+) produces a similar compound cortical excitability phenotype. Chronic direct-current (DC)-band EEG recording detected spontaneous bilateral seizure–SD complexes accompanied by seizures with …

Neonatal Striatal Volume Is Associated With Infant Anhedonia, Melissa Nevarez-Brewster, Catherine H. Demers, Jessica L. Irwin, Laura M. Glynn, Martin A. Styner, Mercedes Hoeflich Haase, M. Camille Hoffman, Diego A. Pizzagalli, Benjamin L. Hankin, Elysia Poggi Davis

Psychology: Faculty Scholarship

Anhedonia is increasingly recognized as a transdiagnostic risk factor for psychopathology. New evidence demonstrates that anhedonia is present in infancy and early childhood. Structural variability in striatal regions involved in reward processing and pleasure seeking is concurrently linked to anhedonia, yet few studies have examined whether striatal differences presage anhedonia, and none have examined prospective associations before middle childhood. The present study examined whether neuroanatomical markers that confer risk for anhedonia can be detected as early as the neonatal period. Specifically, we tested whether the volume of striatal regions in neonates predicted the emergence of infant anhedonic behaviors at six …

Handling Hemolytic Blood Samples From High-Risk Clinical Areas: A Call To Action, Alan H B Wu, Jerrold H Levy, W Franklin Peacock, Ramzy Rimawi, Manuel Sanchez Luna, Christopher Farnsworth, Hugo Stiegler, Robert H Christenson

2020-Current year OA Pubs

BACKGROUND: Spectrophotometric testing to detect sample hemolysis is available from central laboratory chemistry analyzers. While the cause and preventative measures are known, hemolysis continues to be a common preanalytical error, especially for specimens collected from the emergency department (ED) and intensive care units (ICUs) where point-of-care analyzers are commonly used for whole blood electrolyte testing. Recently, these analyzers have employed technology to detect hemolysis directly on whole blood samples.

METHODS: Experienced laboratorians and physicians from the clinical laboratory, ED, adult and neonatal ICUs provide a summary of the medical importance of in vitro hemolysis. Causes for in vivo hemolysis are …

Reliability Of T2-Weighted Mri Volumetric Measurements For Knee Effusion Assessment Following Acl Injury: An Intra-Rater And Inter-Rater Study, Reginald Chinweze, Neal Weldon, Matthew A. Tao, Melissa Manzer, Elizabeth Wellsandt

Posters and Presentations: Physical Therapy

Purpose: Knee effusion after anterior cruciate ligament (ACL) injury and reconstruction is associated with quadriceps dysfunction and may contribute to early osteoarthritis development. This study was subsequently designed to determine the intra-rater and inter-rater reliability of our method for volumetric quantitative measurements of knee effusion using T2-weighted magnetic resonance imaging (MRI) after ACL injury and reconstruction.

Methods: MRIs of 10 ACL-injured knees and 10 uninjured knees from participants aged 15-35 years old were included. Exclusion criteria included previous knee injury/surgery, inflammatory disease, BMI >30 kg/m2, and concomitant grade III ligament tears. Two independent raters analyzed effusion volumes using custom MATLAB …

Use Of Eagala Model–Based Psychotherapy For Youth Psychological Disorders, Kimberley D. Ryan, Tammy L.B. Mckenzie

People and Animals: The International Journal of Research and Practice

Global youth psychological disorder prevalence has increased exponentially. Therefore, a drastic increase in mental health care utilization is expected. Since traditional approaches to the treatment of adult psychological disorders are ineffective with youth, alternative approaches to treatment of youth psychological disorders must be considered. One such approach is equine assisted psychotherapy (EAP), a person-centered, experiential approach using horses during the treatment of psychological disorders and the basis of the Equine Assisted Growth and Learning Association (Eagala) model–based programming. This article presents the quantitative research findings of a study investigating the effectiveness of the Eagala model–based EAP programming in the treatment …

Introducing Therapy Dog Programs Within Organizational Settings: A Scoping Review Of Implementation Processes And Practices, Laura Mundy, Carlie Driscoll, Janette Young

People and Animals: The International Journal of Research and Practice

Organizations are introducing therapy dog programs at a growing rate. Standards and guidelines for including therapy dogs in programs with people are also being developed and made available to those implementing such programs. How organizations are implementing programs, how they are aligning with available standards, and the presence of any barriers and facilitators to their implementation has been largely unexplored. Therefore, the aim of our review was to summarize the literature available on the implementation of therapy dog programs within organizational settings. Furthermore, we aimed to summarize available descriptions of program practices and their alignment with best practice guidelines, and …

Novel Percutaneous Repair Of Femoral Pseudoaneurysms Using Perclose Proglide™: A Case Series, Ryan Mancoll, Emily Burnett, Nicholas Bandy, Benjamin Samberg, Thomas Cook, Jacob Hoffman, Christopher Murter, Matthew Rossi, David Dexter, Hosam El Sayed, Animesh Rathore Md

Cardiovascular Research Symposium

BACKGROUND - This case series details the novel use of the Perclose ProGlide closure device to successfully repair three separate cases of iatrogenic femoral pseudoaneurysms (PSAs) without attempting other modalities first. Conventional treatment methods of ultrasound-guided compression, duplex-directed thrombin injection (DDTI), or open surgical repair were contraindicated in these patients due to unique anatomy or advanced comorbidities.

METHODS – Details were gathered via a retrospective chart review.

RESULTS - In the first case, a 73-year-old female had an access site PSA off the superficial femoral artery (SFA) with concomitant arteriovenous fistula (AVF) and advanced cardiac disease. The ProGlide device was …

A Diagnostic Dilemma Due To A Large Chiari Network, Kyle Admire, Xian Qiao

Cardiovascular Research Symposium

INTRODUCTION: Chiari networks are reticulated networks of fibers that result from incomplete reabsorption of the right valve of the sinus venosus. While the true clinical significance of these is currently unknown, there are associations with dysrhythmias, paradoxical emboli, and thrombi formation. Here, we describe a large, incidentally found Chiari network which encompasses most of the right atrium.

CASE: A 42-year-old female with a past medical history of obesity (BMI 58) and well-controlled asthma presented to the emergency department in respiratory distress with hypercapnia and hypoxemia. Computed tomography (CT) with angiography of the chest was performed and did not show a …

Challenging Case: Acute Type A Aortic Dissection With Multi-Organ Malperfusion, Rishab Agarwal, Allebelle Bradshaw Md, Jennifer S. Lawton Md

Cardiovascular Research Symposium

Description of case: A 57-year-old male with hypertension and obesity presented with acute, severe chest pain. He developed a cold, numb right leg with motor deficits. He was hypotensive with a lactate of 7.4. CT imaging revealed an acute Type A aortic dissection (TAAD) with malperfusion involving the right internal carotid, right subclavian, and right coronary arteries, as well as the superior mesenteric artery, and right iliac artery (Fig 1A/B). He was transferred to our tertiary center for emergent surgery.

Five hours after presentation, he underwent emergent ascending aortic replacement, deep hypothermic circulatory arrest, and retrograde cerebral perfusion. The …

Emergent Aorto-Bi-Iliac Bypass For Collapsed Gore Excluder Endograft, Ryan Mancoll, Khushie Martharoo, Emidio Germano Md, David Dexter Md, Animesh Rathore Md

Cardiovascular Research Symposium

No abstract provided.

Peri-Graft Sheath Anchor Technique For Target Vessel Cannulation In Fenestrated Aortic Repair, Ryan Mancoll, Khushie Martharoo, Emidio Germano Md, David Dexter Md, Animesh Rathore Md

Cardiovascular Research Symposium

No abstract provided.

Association Between Cardiovascular Risk And Kidney Function In A Real-World Peruvian Cohort, Juan Munoz-Moreno, Gina Sanchez, Johanna Contreras

Cardiovascular Research Symposium

Background: Cardiovascular risk and kidney function are interrelated, with variations by sex and age. Middle-aged women often have slightly lower kidney function than men, increasing susceptibility to early renal effects of elevated cardiovascular risk, but data from Latin America remain limited.

Methods: Cross-sectional study of adults aged 40-79 years evaluated at a tertiary hospital in Peru between January and June 2024. We excluded individuals with established cardiovascular disease, statin use, LDL >190 mg/dL, or incomplete ASCVD risk data. Ten-year ASCVD risk was estimated using the 2013 Pooled Cohort Equations with race set as “Other” and classified as low, borderline, intermediate, …

Six-Year Survival Following Liver Transplant In Val30met Hereditary Transthyretin Amyloidosis, Juan Munoz-Moreno, Johanna Contreras

Cardiovascular Research Symposium

Background: Hereditary transthyretin amyloidosis (ATTRv) is a progressive, multisystem disorder caused by pathogenic TTR mutations affecting the heart and peripheral nerves. While disease-modifying agents such as tafamidis are available, liver transplantation (LTx) remains an option in selected genotypes, with over 50% of Val30Met carriers surviving up to 20 years post-transplant.

Case: A 53-year-old male with a permanent pacemaker for complete atrioventricular block presented with NYHA class II dyspnea, syncope, and lower extremity paresthesias. ECG showed atrial fibrillation. Transthoracic echocardiography revealed preserved ejection fraction, biventricular wall thickening with granular appearance, moderate left atrial dilation, and moderate mitral regurgitation. Speckle-tracking echocardiography demonstrated …

Mechanical Circulatory Support As A Bridge To Early Recovery Of Left Ventricular Function In Fulminant Myocarditis, Juan Munoz-Moreno, Gina Sanchez, Johanna Contreras

Cardiovascular Research Symposium

Background: Fulminant myocarditis (FM) is a rare cause of acute heart failure that can lead to a rapid left ventricular ejection fraction (LVEF) decline within four weeks. With in-hospital mortality up to 18.2%, timely mechanical circulatory support (MCS) is essential to stabilize hemodynamics and bridge to recovery or transplantation.

Case: A 49-year-old Japanese man with hypertension and diabetes presented with two weeks of dyspnea and angina after a flu-like illness. On admission, he developed ventricular fibrillation requiring advanced CPR. Physical exam revealed pulmonary congestion. ECG showed repolarization abnormalities. TTE demonstrated severe biventricular dysfunction (LVEF 9%, RVFAC 9%). Labs showed elevated …

Inferior Vena Cava Thrombosis In Nephrotic Syndrome: Two Cases Managed With Endovascular Thrombectomy, Rishab Agarwal, Benjamin Samberg, David Dexter Md

Cardiovascular Research Symposium

Background: Nephrotic syndrome (NS) confers a hypercoagulable state that can precipitate venous thromboembolism (VTE), rarely involving the inferior vena cava (IVC).

Cases: We describe two patients with NS who developed IVC thrombosis. One underwent mechanical thrombectomy using the ClotTriever®/Protrieve™ system (Inari Medical, Irvine, CA, USA); the other underwent aspiration thrombectomy using the AngioVac® system (AngioDynamics, Latham, NY, USA), with adjunct balloon maneuvers for renal vein thrombus.

Outcomes: Both patients achieved immediate IVC recanalization with symptom improvement and patent IVC on short‑term duplex follow‑up.

Conclusions: In NS‑associated IVC thrombosis, device‑based endovascular thrombectomy can be performed safely with restoration of caval patency. …

Cardiopulmonary Bypass Facilitates Emergent Tavr And Bifurcation Pci In A Highly Comorbid 72-Year-Old Female With Acute Valvular Shock, Omar Sale Bs, Nicholas Valle Do, Matthew Rossi Md, Joshua Cohen Md, Paul Lavigne Md, Matthew Summers Md

Cardiovascular Research Symposium

Title:

Cardiopulmonary Bypass Facilitates Emergent TAVR and Bifurcation PCI in a Highly Comorbid 72-year-old Female with Acute Valvular Shock

Introduction:

Transcatheter aortic valve replacement (TAVR) has emerged as a critical minimally invasive option for patients with severe AS who present in valvular shock, particularly those at prohibitive surgical risk. Multicenter registry data demonstrate that emergent TAVR in this population is associated with promising procedural success, significant improvements in functional status, and lower short- and long-term mortality compared to medical management or balloon aortic valvuloplasty, with outcomes approaching those of surgical aortic valve replacement in selected patients [1] [2]. We present …

Acute Valve Syndrome And 1-Year All-Cause Mortality Post-Avr: A Retrospective Cohort Study, Omar Sale Bs, Nicholas Valle Do, Israa Saleh, Omar Jafar Md, Matthew Summers Md

Cardiovascular Research Symposium

Background: Acute Valve Syndrome (AVS) identifies a high-risk cohort of aortic stenosis (AS) patients with poor outcomes following aortic valve replacement (AVR), but the spectrum of risk within this group has yet to be fully explored. We sought to evaluate whether admission markers facilitated risk stratification of 1-year mortality in an AVS cohort.

Methods: In a retrospective cohort study (MIMIC-IV v3.1), we identified 2,380 adults who underwent AVR between 2008–2019. Patients were classified as AVS or progressive valvular disease (PVD). AVS was defined by criteria of acute decompensation, including advanced heart failure symptoms, cardiogenic shock, or significant hyperlactatemia. The AVS …

President's Message, Gregory P. Guerra D.D.S.

New Orleans Dental Association News

Monthly update from Dr. Greg Guerra, D.D.S. with details of recent events, upcoming activities and news from the association.

Noda News September 2025

New Orleans Dental Association News

New Orleans Dental Association (NODA) News includes regular columns with regional news impacting the New Orleans membership including: columns from the President and Executive Director, feature articles relating to the field of dentistry, association events and upcoming activities, component news, continuing education opportunities, and classifieds.

The Physiological Impacts Of Nano-Ceramic Window Films In Hot-Climate Architecture: Theoretical Biological Study, Lina M. Shaker, Shahab Abdulla, Ralela Makline

AUIQ Complementary Biological System

This research explores the integration of nano-ceramic window films as a passive architectural strategy to improve both energy performance and occupant biological well-being in commercial buildings. The biological objective centers on enhancing health, comfort, and physiological stability by regulating thermal, optical, and radiative indoor conditions. Simulations on a three-story, 2,000 m² building demonstrated that high-performance films reduced indoor temperatures by up to 3.5°C, lowering thermal stress and core body heat load. Ultraviolet (UV) transmission was curtailed to as low as 1%, significantly decreasing skin damage doses below 0.2 MED/day. Select films maintained optimal Equivalent Melanopic Lux (EML) levels (up to …

The Best Cut: Evaluating Block, Sliced, And Diced Cartilage In Dorsal Augmentation Rhinoplasty, Trimartani Koento, Mirta Hediyati Reksodiputro, Mikhael Yosia

AUIQ Complementary Biological System

Rhinoplasty is a surgical procedure aimed at improving the nasal shape and function, with dorsal augmentation playing a crucial role in nasal reconstruction. Autologous cartilage grafts, particularly from the rib, are widely used due to their structural integrity but pose challenges such as postoperative warping, graft shifting, and resorption. The evolution of cartilage grafting techniques has progressed from block to sliced and diced cartilage to enhance long-term stability and aesthetic outcomes. Block cartilage provides excellent structural support but is prone to warping due to intrinsic stress. Sliced cartilage reduces warping risk while offering greater flexibility, whereas diced cartilage allows for …

Enhancing The Care Of Patients With Bone And Joint Infections Through Educational Interventions, Neel B. Shah, Jessica Seidelman, Katherine Belden, Elizabeth Thottacherry, Allison Lastinger, Priya Nori, Ronald M. Beaulieu, Don Bambino Geno Tai

Division of Infectious Diseases and Environmental Medicine Faculty Papers

Musculoskeletal infections represent a significant proportion of the clinical workload for infectious diseases (ID) providers, often presenting complex diagnostic and therapeutic challenges. Many providers may feel inadequately prepared to manage these conditions, which require a nuanced understanding of microbiology, musculoskeletal anatomy, surgical intervention, and orthopedic hardware. We implemented a pair of educational interventions including an online library of high-yield musculoskeletal ID literature and an educational podcast. © The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

How Life-Cycle Real-World Evidence Can Bridge Evidentiary Gaps In Precision Oncology, Emanuel Krebs, Deirdre Weymann, Tania M. Bubela, Dean A. Regier

Office of the Provost

Precision oncology uses omics-based diagnostic technologies to inform histology-agnostic cancer treatment. To date, health system implementation remains limited owing to high uncertainty in regulatory and reimbursement evidence submissions. In this perspective, we describe a life-cycle approach to the evaluation of precision oncology technologies that addresses evidentiary uncertainty and is grounded in real-world evidence (RWE) derived using data routinely collected by healthcare systems. We consider the role for RWE in international regulatory and reimbursement decision-making, review common biases for observational precision oncology evaluations, make specific recommendations for RWE study design and analysis, and specify healthcare system requirements for data collection. We …