Digital Commons Network^™

Phase 2 Study Of Zilovertamab Vedotin In Participants With Metastatic Solid Tumors, Funda Meric-Bernstam, Martin Gutierrez, Enrique Sanz-Garcia, Diego Villa, Jun Zhang, Jennifer Friedmann, Fengting Yan, Mark A Socinski, John Sarantopoulos, Luis E Raez, Quincy S Chu, Maxime Chénard-Poirier, Manash Chatterjee, Hong Ren, Qi Liu, Douglas A Levine, Komal L Jhaveri

Faculty, Staff and Student Publications

Purpose: Zilovertamab vedotin, an antibody‒drug conjugate targeting receptor tyrosine kinase‒like orphan receptor 1 (ROR1), had manageable safety and promising antitumor activity in participants with relapsed or refractory non-Hodgkin lymphomas. We evaluated zilovertamab vedotin in participants with previously-treated metastatic solid tumors.

Methods: This phase 2, open-label, nonrandomized study (NCT04504916) enrolled participants with metastatic triple-negative breast cancer, hormone receptor‒positive (HR+) breast cancer, nonsquamous non‒small-cell lung cancer, platinum-resistant ovarian cancer, or pancreatic cancer. Participants received zilovertamab vedotin ≤2.5 mg/kg once every 3 weeks (Q1/3W) or < 1.75 mg/kg twice every 3 weeks (Q2/3W). Primary endpoint was objective response rate (ORR) per RECIST v1.1 by blinded independent central review. ROR1 protein expression was correlated with clinical outcomes.

Results: 102 participants were enrolled (Q1/3W, n=70; Q2/3W, n=32). ORR was 1% (95% CI, 0%‒8%) with …

Interactive 3d Segmentation For Primary Gross Tumor Volume In Oropharyngeal Cancer, Mikko Saukkoriipi, Jaakko Sahlsten, Joel Jaskari, Lotta Orsmaa, Jari Kangas, Nastaran Rasouli, Roope Raisamo, Jussi Hirvonen, Helena Mehtonen, Jorma Järnstedt, Antti Mäkitie, Mohamed Naser, Clifton Fuller, Benjamin Kann, Kimmo Kaski

Faculty, Staff and Student Publications

Radiotherapy is the main treatment modality of oropharyngeal cancer (OPC), in which an accurate segmentation of primary gross tumor volume (GTVt) is essential but also challenging due to significant interobserver variability and the time consumed in manual tumor delineation. For such a challenge an interactive deep learning (DL) based approach offers the advantage of automatic high-performance segmentation with the flexibility for user correction when necessary. In this study, we investigate an interactive DL for GTVt segmentation in OPC by introducing a novel two-stage Interactive Click Refinement (2S-ICR) framework and implementing state-of-the-art algorithms. Using the 2021 HEad and neCK TumOR dataset …

Three Things We Can Do Now To Reduce The Risk Of Avian Influenza Spillovers, Kenneth B Yeh, William P Bahnfleth, Elaine Bradford, Carol Cardona, Kristen K Coleman, Peter J Hudson, Bernadeta Dadonaite, Rebecca J Hutchins, Anthony Maresso, C Raina Macintyre, Matthew Scotch

Faculty, Staff and Students Publications

No abstract provided.

Grade Concept Paper 9: Rationale And Process For Creating A Grade Ontology, Paul Whaley, Brian Alper, Joanne Dehnbostel, Carlos Alva-Diaz, Stavros Antoniou, Antonio Bognanni, Javier Bracchiglione, Therese Kristine Dalsbø, Sean Grant, Jennifer Hunter, Alfonso Iorio, Malgorzata Lagisz, Harold Lehmann, Sheyu Li, Joerg Meerpohl, Saphia Mokrane, Cauê Monaco, Ignacio Neumann, Kevin Pottie, Shahab Sayfi, Nigar Sekercioglu, Jasvinder Singh, Bernardo Sousa-Pinto, Janice Tufte, Lenny Thinagaran Vasanthan, Li Wang, Jun Xia, Xiaomei Yao, Holger Schünemann

Faculty, Staff and Students Publications

Context: As the rate of research production accelerates, the ability to efficiently and unambiguously communicate judgments relating to the synthesis, evaluation, and use of scientific information becomes paramount.

Perspective: Scientific information can be viewed as a "layered infrastructure" of data, evidence, knowledge, and use. The GRADE approach serves as a de facto data standard for this infrastructure, supporting movement between layers by reducing ambiguity in claims to knowledge (in the form of judgements of certainty in the evidence when answering research questions) and level of commitment to possible solutions to problems (in the form of strength of recommendations for interventions). …

Survival To Hospital Discharge In The Fetus With Moderate To Severe Mitral Regurgitation Either In Isolation Or In Combination With Aortic Valve Stenosis Or Atresia, A Fetal Heart Society Collaborative Study, Betul Yilmaz Furtun, Kavitha Pundi, Anita Moon-Grady, Nicole Cresalia, Asela Nieuwsma, Sarah K Gelehrter, Bhawna Arya, Mary T Donofrio, Christopher Statile, Ann Kavanaugh-Mchugh, Lindsay Freud, Elijah Bolin, Megan Warner, Sowmya Balasubramanian, James Strainic, Carol Wittlieb-Weber, Nelangi M Pinto, Lisa Hornberger, Shaine A Morris

Faculty, Staff and Students Publications

Background: Case series report high mortality after fetal diagnosis of moderate to severe mitral regurgitation in combination with left atrial dilation, hydrops, or restrictive atrial septum. However, overall outcomes and specific high-risk features remain unclear.

Methods: We performed a multicenter retrospective cohort study of fetuses with ≥moderate mitral regurgitation and normal cardiac connections evaluated January 1, 2005 to January 31, 2016. Fetuses undergoing fetal cardiac intervention (FCI) were described separately. We assessed associations between fetal echocardiographic features and discharge mortality using mixed logistic regression and classification and regression tree modeling, stratified by studies performed < 28 and ≥28 weeks gestational age (GA).

Results: Of 67 fetuses, 96% had …

Twelve Tips To Help Junior Faculty Review Medical Education Literature With Confidence, Abagayle Bierowski, Casey Morrone, Ridhima Ghei, Michael Pasirstein, Dimitrios Papanagnou

Department of Emergency Medicine Faculty Papers

Peer reviews play a critical role in maintaining the quality, credibility, and advancement of medical education scholarships. While many early career faculty members are eager to contribute to the peer review process, there are few formal resources available to guide them in how to approach this work effectively. This article offers 12 practical tips tailored specifically for junior faculty who are new to reviewing medical education manuscripts. These tips cover key aspects of the review process, including how to structure feedback, evaluate methodological rigor, assess alignment with journal aims, and communicate constructively with authors and editors. The guide also emphasizes …

The Effect Of Hcv On Methadone Dose During Pregnancy, Sarah Boudova, Neel S. Iyer, Danielle M. Tholey, Jonathan M. Fenkel, Rupsa C. Boelig

Department of Obstetrics and Gynecology Faculty Papers

Pregnancy is a time of high patient motivation to initiate treatment for opioid use disorder (OUD). Hepatic drug metabolism can be altered by pregnancy and hepatitis C virus (HCV) infection. We aimed to examine the impact of HCV during pregnancy on methadone dosing. Retrospective chart review of all pregnant patients with OUD admitted for initiation of methadone from 1/2020-6/2022. Associations were examined using Student's T-tests, chi-squared tests, Fisher's exact tests and univariate and multivariate linear regression. We identified 191 pregnancies initiated on methadone, of which 188 were screened for HCV. 111 (59.0%) were HCV Antibody (Ab)+, of whom 108 were …

Comparative Outcomes Of Coil Embolization And Surgical Clipping In Elderly Patients With Subarachnoid Hemorrhage: A Systematic Review And Meta-Analysis, Yohanna Idsabella Rossi, Gabriel Bolner, Jonathan Costa Dall'acqua, Fabiana Dolovitsch De Oliveira, Lucas V. Zacaria, Taís L. Denicol, Michel Frudit, Natália Vasconcellos De Oliveira Souza

Department of Neurology Faculty Papers

BACKGROUND AND OBJECTIVES: Elderly patients with subarachnoid hemorrhage (SAH) face a disproportionately high burden of morbidity and mortality. While endovascular coiling is often favored in this population, direct comparisons with surgical clipping are limited. We conducted a meta-analysis to compare outcomes of clipping versus coiling in SAH patients aged ≥ 60 years.

METHODS: A systematic search of PubMed, Embase, and Cochrane databases identified studies comparing the two treatments in this age group. The primary outcome was a composite of unfavorable outcomes (modified Rankin Scale [mRS] > 2 and mortality). Secondary outcomes included mortality, favorable outcome (mRS 0-2), rebleeding, and hospital length …

Hemispherotomy For Drug-Resistant Epilepsy In Bilateral Sturge-Weber Syndrome: Illustrative Cases, Eveline Teresa Hidalgo, Eric A Grin, Yosef Dastagirzada, Nealen Laxpati, Judith Bluvstein, Julia R Schneider, Daniel Miles, Michal Tzadok, James Riviello, Howard L Weiner

Faculty, Staff and Students Publications

Background: Sturge-Weber syndrome (SWS) is a congenital neurocutaneous disorder characterized by angiomas of the face, choroid, and leptomeninges. Seizures in these children often present within the first 2 years of life. SWS is typically unilateral, but bilateral SWS occurs in approximately 15% of cases. Bilateral SWS is associated with earlier seizure onset and poorer cognitive, developmental, and functional outcomes. More than half of children with SWS develop drug-resistant epilepsy requiring surgical intervention. Hemispherotomy has been established as a successful treatment for unilateral SWS, but resective surgery has traditionally not been considered a treatment option for patients with bilateral disease.

Observations: …

Evaluation Of Mrcat As A Surrogate For Traditional Ct Simulation In Proton Prostate Radiotherapy Planning, Karen Weeks

Masters Projects

Purpose:

This study evaluated whether Philips MRCAT-generated synthetic CT (sCT) can serve as a clinically viable substitute for traditional CT (CT) simulation in proton therapy planning for prostate radiotherapy using a double-scatter technique.

Methods:

Ten prostate cancer patients treated with proton therapy between 2024 and 2025 were retrospectively analyzed. Each patient underwent both CT and MRI in the treatment position. MRCAT sCT images were generated using atlas-based and segmentation algorithms. The original proton treatment plan was transferred onto the MRCAT dataset. Dosimetric parameters, target coverage, organ-at-risk (OAR) doses, and Hounsfield Unit (HU) values were compared. The sign(M) test …

Factors Informing Referral Of Adult Patients To Palliative Care Services In A Tertiary Facility In Kenya: Physicians' Perspective, Donnah A. Opiyo

Master of Medicine in Family Medicine

Background The growing burden of chronic diseases underscores the urgent need for palliative care integration into healthcare systems worldwide. Despite its benefits, palliative care remains underutilized due to various barriers, including health system limitations, institutional challenges, infrastructure gaps, and individual provider factors. However, limited research has explored the specific factors influencing physicians' decisions to refer patients to palliative care. This study sought to fill that gap by examining the key determinants shaping referral practices in a tertiary facility in Kenya.

Design and Methods This exploratory qualitative study examined 22 physician specialists from five departments at Aga Khan University Hospital, Nairobi. …

Incidence Of Peripheral Intravenous Cannula Complications And Associated Factors Among Paediatric Patients At A Tertiary-Care Referral Hospital, Vanessa Minsari Ogega

Master of Medicine in Paediatrics and Child Health

Introduction: Peripheral intravenous catheters (PIVCs) are widely used in clinical practice and are a major source of procedure-related pain in children. Their use is associated with complications including occlusion, dislodgement, infiltration, extravasation, phlebitis, and, rarely, bloodstream infections.

Objectives: To determine the incidence and risk factors associated with PIVC complications among paediatric patients aged 1 day to 18 years at Aga Khan University Hospital, Nairobi. The study also assessed the average survival time of PIVCs.

Methods: A prospective cohort study was conducted on 320 PIVCs among 192 children admitted between August and October 2024. Data collected included patient demographics, clinical characteristics, …

Cbl Regulation Of C-Met Signaling In Corneal Epithelial Cells., Kate Elise Tarvestad Laise

Electronic Theses and Dissertations

The cornea is the most anterior portion of the eye and permits light passage through to retina, allowing formation of a clear image as long as it remains healthy. If the cornea sustains damage, it creates and entrance for foreign body invasion, infection, and ultimately blindness in the immunocompromised eye. Healing the corneal tissue is critical for vision restoration and pain alleviation, as it is the most densely innervated tissue in the body. Growth factors and their cognate receptors are currently under investigation as tools to restore proper corneal physiology. We hypothesize that manipulating the hepatocyte growth factor (HGF) /c-Met …

Exploring The Effect Of Social Determinants Of Health (Sdoh) Factors On The Time To Kidney Transplant Evaluation Completion For African American End Stage Renal Disease (Esrd) Patients, Kesha Levesque

MUSC Theses and Dissertations

Purpose – The purpose of this dissertation is to investigate the relationship between demographics and Social Determinants of Health (SDOH) variables on diagnostic testing time completion in patients being evaluated for kidney transplant waitlisting.

Aims - Compared to White Americans, African Americans who are eligible to receive a kidney transplant are less likely to complete the required testing in order to be placed on the kidney transplant waiting list which puts African Americans at risk for morbidity and mortality due to prolonged exposure to dialysis. The COVID-19 pandemic was directly associated with a decrease in the number of patients placed …

Resonant Disruptions: Understanding Canadian Nurses’ Practice With Youth Survivors Of Sexual Exploitation, Danielle E. Giebelhaus, Andrew Estefan Phd, Rpn

Dignity: A Journal of Analysis of Exploitation and Violence

The sexual exploitation of youth is a global concern. Youth survivors of sexual exploitation present to and require healthcare services, but most nurses do not feel effectively equipped to care for this population. There is currently little nursing literature to guide nurses in their practice with youth survivors. In this article, we report on a qualitative, hermeneutic study undertaken to explore nursing practice with youth survivors of sexual exploitation. Hermeneutics is concerned with understanding, and is a helpful way to conduct research when little is known about a topic. In this study, we asked the research question, “How might we …

Strength Beyond Cancer: An Occupational Therapy Guidebook For African American Breast Cancer Survivors, Taihia A. Wilson

Student Capstone Papers

This capstone project aims to explore the nuanced and often underrepresented experiences of African American women (AAW) who have survived breast cancer (BC), with a specific focus on the recovery phase. By examining the physical, cognitive, and psychosocial obstacles encountered during survivorship, the project seeks to highlight significant gaps in care and support. The primary goal of this project is to develop an accessible and culturally responsive guidebook that provides healthy strategies to enhance quality of life (QoL), promote occupational wellbeing, and empower AAW to manage their overall health beyond treatment. This paper will begin by presenting the background and …

Intention To Take Pre-Exposure Prophylaxis (Prep) As An Hiv Preventive Medication: An Application Of The Health Belief Model And Theory Planned Behavior, Besuthu Nakekelwa Nkambule

Graduate Theses and Dissertations

South Africa (SA) has 7.7 million citizens (12.6% of its 2023 population) living with human immunodeficiency virus (HIV). The use of pre-exposure prophylaxis (PrEP) as an antiretroviral medication for HIV-negative individuals is a promising HIV prevention strategy in SA that can help the attainment of an HIV free generation. PrEP offers greater than 90% protection against HIV acquisition. Despite SA’s efforts in increasing PrEP coverage for its citizens, primarily to those at substantial risk, its adoption remains relatively low. Structural barriers related to access, costs, lack of awareness, and, more recently, US funding cuts exacerbate the challenges of PrEP’s potential …

Perception And Experiences With Telemedicine Among Caregivers Of Children Requiring Outpatient Chronic Care, Maureen Wambui Kigara

Master of Medicine in Paediatrics and Child Health

Introduction Telemedicine is an expanding healthcare modality with potential to enhance access to paediatric specialist care, reduce healthcare costs, and minimize school and work disruptions. However, little is known about caregiver perceptions and experiences with telemedicine in low- and middle-income countries, especially in the context of chronic paediatric care.

Objectives This study explored how caregivers of children with chronic health conditions perceive and experience telemedicine, and what factors influence its adoption. The findings aim to inform the design of patient-centered paediatric telemedicine services.

Methodology A cross-sectional qualitative study was conducted at the Paediatric Specialist Clinics of Aga Khan University Hospital. …

Work Impairment And Financial Outcomes Among Adults With Vs Without Long Covid, Michael Gottlieb, Ji Chen, Huihui Yu, Michelle Santangelo, Erica S. Spatz, Nicole L. Gentile, Rachel E. Geyer, Caitlin Malicki, Kristyn Gatling, Kelli N. O'Laughlin, Kari A. Stephens, Joann G. Elmore, Lauren E. Wisk, Michelle L'Hommedieu, Robert Rodriguez, Juan Carlos C. Montoy, Ralph C. Wang, Kristin L. Rising, Efrat Kean, Jonathan W. Dyal, Mandy J. Hill, Arjun K. Venkatesh, Robert A. Weinstein

Department of Emergency Medicine Faculty Papers

IMPORTANCE: While much of the focus on long COVID (LC; defined as developing new, persistent symptoms lasting 3 months or longer after SARS-CoV-2 infection) has been on health status and quality of life, the impact on individual work productivity and financial distress are less well established.

OBJECTIVES: To assess differences in work and financial outcomes among individuals with current, resolved, and no LC up to 3 years after initial infection.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, multisite, longitudinal cohort study enrolled adult participants (age ≥18 years) with at least 1 reported SARS-CoV-2 infection from December 7, 2020, to August 29, …

Applications Of Preclinical Magnetic Resonance Imaging In The Treatment Of Traumatic Brain Injury And Understanding Carotid Artery Atherosclerosis, Evan Timothy Curtis

Dissertations and Doctoral Documents, University of Nebraska-Lincoln, 2023–

Advances in magnetic resonance imaging (MRI) provide the opportunity to investigate research questions that have been left unanswered. In the cases of traumatic brain injury (TBI) and carotid artery atherosclerosis, MRI is a resource for non-invasively viewing the phenomena taking place. Additionally, potential interventions and treatments can be observed without harm to the subject. This dissertation expands the understanding of two preclinical applications of MRI: traumatic brain injury and carotid artery atherosclerosis in mouse models.

TBI is a leading cause of death and disability for individuals between 15–45 years of age and effective pharmaceutical interventions for treating the secondary damage …

Development And Implementation Of An Ob/L&D Sbar Framework To Enhance Communication Between Obstetric Nurses And Anesthesia Providers: A Quality Improvement Initiative, Jenna E. Bigam, Laina J. Uzarski

Doctor of Nurse Anesthesia Practice (DNAP) Manuscripts

Effective communication between obstetric (OB) nurses and anesthesia providers is critical to ensure patient safety during epidural placements in labor and delivery (L&D) settings. At a large teaching hospital, communication gaps were identified when OB nurses requested anesthesia for epidural placements without consistently providing vital patient information. The lack of structured communication can result in important details being overlooked, which may lead to delays in care and potential patient harm. To address this, the SBAR (Situation, Background, Assessment, Recommendation) communication framework was implemented to standardize and improve information exchange. This Doctorate of Nurse Anesthesia Practice (DNAP) project aimed to enhance …

Microbial Metabolite Regulation Of Microglial Ahr Signaling In Alzheimer’S Disease, Ghalya E. Alrousan

Dissertations and Theses (Open Access)

Introduction: Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by amyloid-β plaque accumulation, neuroinflammation, and cognitive decline. Recent evidence suggests that systemic factors, particularly the gut microbiota and its metabolites, play a significant role in shaping brain immune responses, including microglial activation. However, the mechanisms linking gut dysbiosis to microglial dysfunction in AD are poorly understood. The aryl hydrocarbon receptor (AHR), a ligand-activated transcription factor responsive to tryptophan metabolites, has recently gained attention as a key regulator of neuroinflammation and microglial function. I hypothesize that the loss of beneficial microbial AHR ligands, specifically indole derivatives, during aging and AD …

Emotional Safety In Pediatrics: The Impact Of Child Life Services On Healthcare Professionals’ Perceptions Of Their Own, Patients’, And Families’ Outpatient Experiences, Jenni Davis

All Dissertations

Medical visits, regardless of setting, are stressful for children and their families. Care that focuses on the emotional safety of children and families can help reduce this stress. However, not all staff feel prepared to provide emotionally safe care. Child life specialists (CLSs) are specifically trained to support emotional needs during healthcare encounters. Their presence may help staff stress as well, not just stress for children and families.

This study used three surveys to understand stress among healthcare staff working in pediatric outpatient clinics and surgery settings, and how support from a CLS affects staff, children, and families. All staff …

Exploring Behavioural Motivations Of Treatment Refusal In Cancer: A Q-Methodological Approach, Ruby Koyllor A. Gleeson, Nicolas H. Hart, Darren Haywood, Frank D. Baughman

Research outputs 2022 to 2026

Background: Cancer treatment refusal is known to lower survival rates and increase cancer symptoms in individuals with cancer. Behavioural motivations of treatment refusal need to be elucidated for better cancer care. Using Q-methodology, a mixed methods research approach, we explored behavioural motivations of treatment refusal in individuals diagnosed with cancer. Method: Thirty-nine individuals (n = 39; age = 49.2 ± 12.2 years) were recruited from Australia, the UK, and the USA, who had refused cancer treatment within the past decade. Participants completed an online demographic questionnaire and a Q-sort activity which required the organisation and ranking of 44 statements on …

Sugar Functionalized Collagen Material For Local Modulation Of Innate Immunity, Francesca Taraballi, Claudia Corbo, Julia Enterria-Rosales, John Otto Martinez, Silvia Minardi, Laura Pandolfi, Xing Wang, Ennio Tasciotti, Kavindra V Singh, Cesar A Arias, Bruna Corradetti

Faculty, Staff and Students Publications

Small alterations during the early stages of the innate immune response to an implant can drive large changes in adaptive immunity. Biomaterials for regenerative purposes can be engineered to modulate this immune response in beneficial ways. This study presents an innovative patch designed and functionalized to target the innate immunity at the implant site. Mannose moieties are incorporated into collagen patches, resulting in a technology called Local Immunotuning Patch (LIP), designed to directly interact with antigen presenting cells through their mannose receptor. In vitro, LIP shows anti-inflammatory effects on bone marrow-derived macrophages and inhibitory properties even on methicillin-resistant bacterial strains. …

Privacy In Perspective: Research Participants’ Priorities And Concerns Related To Sharing Data Generated In Human Neuroscience Studies, Christi J Guerrini, Jill O Robinson, Norah L Crossnohere, Mary A Majumder, Kathryn Maxson Jones, Whitney Bash Brooks, Sameer A Sheth, Amy L Mcguire

Faculty, Staff and Students Publications

The societal benefits from sharing and reusing data collected in human neuroscience studies are widely appreciated. However, there are persistent barriers to data sharing as well as privacy concerns related to unauthorized access, misuse, and reidentification of deidentified data. Thus far, few studies have been conducted with neuroscience research participants to understand their data sharing priorities and concerns. We conducted a survey utilizing an experimental design with N=52 participants in neuroscience studies funded by the U.S. National Institutes of Health representing diverse neurotechnologies and health conditions. Respondents prioritized sharing practices that maximize reuse of data to benefit patients and reduce …

Contextualization Of Harmonized Cognitive Assessment Protocol (Hcap) In An Aging Population In Rural Low-Resource Settings In Africa: Experiences And Strategies Adopted To Optimize Effective Adaption Of Cognitive Tests In Kenya, Roselyter Riang’A, Eunice Muthoni, Niranjani Nagarajan, Felix Agoi, Patrick Mwangala, Alden Gross, Jean Ikanga, Kenneth Langa, Edward Miguel, Anthony Ngugi

Population Health, East Africa

Cross-cultural adaptation of cognitive assessments is crucial for detecting Alzheimer's disease (AD) and related dementias (ADRD) in aging populations. This study documents the adaptation of the Harmonized Cognitive Assessment Protocol (HCAP) for a pilot study on the Longitudinal Study of Health and Aging in Kenya (LOSHAK) in rural Kilifi County, Kenya, highlighting challenges and strategies for optimizing outcomes. As part of the LOSHAK feasibility phase, cognitive tests including: the Swahili Mental State Examination, 10-word recall, animal naming, story recall, clock drawing, and making change, were administered to 202 participants (≥45 years) from the Kaloleni/Rabai Health and Demographic Surveillance System (KRHDSS). …

Bridging The Capacity Building Gap For Antimicrobial Stewardship Implementation: Evidence From Virtual Communities Of Practice In Kenya, Ghana, And Malawi, Ana De Lima, Kwame Buabeng, Mavis Sakyi, Hope Chadwala, Nicole Devereaux, Collins Mitambo, Christine Mugo-Sitati, Jennifer Njuhigu, Gunturu Revathi, Emmanuel Tanui

Pathology, East Africa

Background/Objectives: Strengthening antimicrobial stewardship (AMS) programs is an invaluable intervention in the ongoing efforts to contain the threat of antimicrobial resistance (AMR), particularly in low-resource settings. This study evaluates the impact of the Telementoring, Education, and Advocacy Collaboration initiative for Health through Antimicrobial Stewardship (TEACH AMS), which uses the virtual Extension for Community Healthcare Outcomes (ECHO) learning model to enhance AMS capacity in Kenya, Ghana, and Malawi. Methods: A mixed-methods approach was used, which included attendance data collection, facility-level assessments, post-session and follow-up surveys, as well as focus group discussions. Results: Between September 2023 and February 2025, 77 virtual learning …

Efficacy And Safety Of Oral Decitabine/Cedazuridine In The Chronic Myelomonocytic Leukaemia Subpopulations From Phase 2 And 3 Studies, Michael R Savona, Olatoyosi Odenike, Gail J Roboz, Harshad Amin, Amy E Dezern, Elizabeth A Griffiths, Kim-Hien Dao, Amer M Zeidan, Bhavana Bhatnagar, Rena Buckstein, Brian Leber, Mary-Margaret Keating, Somedeb Ball, Aram Oganesian, Yuri Sano, Harold N Keer, Guillermo Garcia-Manero

Faculty, Staff and Student Publications

DNA methyltransferase inhibitors (DNMTis) are commonly used in treating chronic myelomonocytic leukaemia (CMML); however, data from prospective studies of DNMTis in CMML are limited. The present analysis evaluated the efficacy, safety and pharmacodynamics of the oral DNMTi decitabine/cedazuridine in the subset of patients with CMML from the phase 2 and 3 trials, which led to the approval of this agent for myelodysplastic syndromes and CMML in the United States and Canada. Potential prognostic factors also were analysed. In all, 34 patients with CMML were screened and 33 were treated. Most patients (76% [n = 25]) had myelodysplastic type-CMML and 77% …

Patient, Physician, And Assessor Blinding In Phase Iii Randomized Trials In Oncology: A Meta-Epidemiological Analysis, Gabrielle Brown, Pavlos Msaouel, Avital M Miller, Ramez Kouzy, Timothy A Lin, Joseph Abi Jaoude, Ethan B Ludmir, Alexander D Sherry

Faculty, Staff and Student Publications

Background: Blinding mitigates bias in randomized trials and may be especially crucial for surrogate endpoints, such as progression-free survival (PFS). Here, we characterize utilization of and factors associated with blinding in Phase III oncology trials with PFS primary endpoints.

Methods: Two-arm, superiority-design trials investigating systemic therapy were identified in May 2024 from ClinicalTrials.gov with no date limitation. Trials were required to have a PFS primary endpoint. The study outcomes were the presence of double-blind designs and blinded independent central review (BICR) for the primary endpoint. Ninety-five percent credible intervals for binary outcomes were estimated from beta distributions, and multivariable logistic …