Digital Commons Network^™

Patient-Centered Approach To Surgical Prevention Of Ovarian Cancer: A Nonrandomized Clinical Trial, Karen H Lu, Andrea R Hagemann, Et Al.

2020-Current year OA Pubs

IMPORTANCE: Risk-reducing salpingo-oophorectomy (RRSO) is an effective option to prevent ovarian cancer in high-risk individuals, but adverse effects from premature menopause are a barrier to uptake. Interval salpingectomy with delayed oophorectomy (ISDO) may be an effective alternative.

OBJECTIVE: To evaluate the association of ISDO vs RRSO and sexual function and menopausal symptoms.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, multicenter, nonrandomized (patient preference) clinical trial was performed among Women Choosing Surgical Prevention participants with a pathogenic or likely pathogenic germline variant conferring an increased risk for ovarian cancer. Patients from 9 US centers were enrolled from June 2, 2016, to October …

Donor-Derived Cell-Free Dna As A Prognostic Biomarker After Heart Transplantation: The Define-Ht Study, Palak Shah, Paul J. Kim, Kelly H. Schlendorf, David A. Baran, Monica M. Colvin, Adam D. Devore, Howard Eisen, Kambiz Ghafourian, Michael M. Givertz, Eileen Hsich, Jaime L. W. Kennedy, Evan P. Kransdorf, Jose N. Nativi-Nicolau, Jignesh Patel, Eleni Tseliou, Omar Wever-Pinzon, Andrew Doud, Michelle S. Bloom, Sandra A. Carey, Navchetan Kaur, D Giovanni Biagini, Kyle E. Marshall, Michael Olympios, Mandeep R. Mehra, Josef Stehlik

Department of Medicine Faculty Papers

BACKGROUND: Measurement of donor-derived cell-free DNA fraction (dd-cfDNA%) and donor quantity score (DQS) is a noninvasive biomarker of acute rejection in heart transplantation (HT). Its prognostic value beyond histopathology remains uncertain.

OBJECTIVES: This study sought to evaluate associations between donor-derived cell-free DNA (dd-cfDNA) and clinically meaningful outcomes using a composite endpoint of treated rejection, graft dysfunction, retransplantation, or death within 1 year post-HT.

METHODS: The DEFINE-HT (Development of Noninvasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation) was a prospective, observational study following adult HT recipients at 10 U.S. centers for 1-year post-HT; blood was collected for dd-cfDNA testing …

Insurance Type And Menopausal Hormone Therapy Use Among Us Women, Arina Chesnokova, Sunni Mumford, Allison Schachter, Rebecca Hamm, Scott Lorch, Matthew Klebanoff, Sarah Lindley, Erika Harness, Makeba Williams, Marilyn Schapira

Student Papers, Posters & Projects

IMPORTANCE: Access to menopausal hormone therapy (MHT) in the US remains low. Understanding whether insurance type is associated with MHT underuse and racial disparities in menopausal care is critical for designing interventions that increase evidence-based and equitable menopause care.

OBJECTIVE: To examine whether Medicaid compared with private insurance is associated with lower MHT use among US women. A secondary objective explored the degree that payer type is associated with observed racial differences in MHT use.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used the 2013-2014, 2015-2016, and 2017-2020 cycles of the National Health and Nutrition Examination Survey (NHANES) to identify …

Arrhythmia Burden And Clinical Responses Under Continuous Monitoring In Heart Failure: Observations From The Alleviate-Hf Trial., Rami Kahwash, Javed Butler, Muhammad Shahzeb Khan, David Zhang, Jonathan Dukes, Madhu Reddy, Rachel M Kaplan, Anish Amin, Rahul Kanwar, Shantanu Sarkar, Verla Laager, Jennifer Wehking, Brian Van Dorn, Bart Gerritse, Nirav Patel, Aimee Laechelt, Michael R Zile, Alleviate-Hf Investigators

OhioHealth Research Institute Articles

BACKGROUND: Arrhythmia burden in ambulatory patients with symptomatic heart failure (HF) without cardiac implantable electronic devices (CIEDs) is not well defined, and it remains uncertain whether device-guided remote congestion management modifies arrhythmia occurrence.

OBJECTIVES: The goal was to assess whether arrhythmia burden differed between randomized congestion-management strategies and characterize the occurrences and associations of insertable cardiac monitor (ICM)-detected arrhythmias with therapeutic actions and clinical events.

METHODS: In ALLEVIATE-HF, patients with NYHA functional class II-III HF with any ejection fraction (EF) and a recent HF event, without prior CIEDs, underwent ICM implantation and were randomized to ICM-guided, physician-directed, nurse-facilitated congestion management …

Risk-Based Nurse-Managed Personalized Heart Failure Interventions: The Alleviate-Hf Trial., Javed Butler, Rami Kahwash, Muhammad Shahzeb Khan, David Zhang, Jonathan W Dukes, Madhu Reddy, Anupam Basuray, Elie Gharib, Bart Gerritse, Aimee Laechelt, Jennifer Wehking, Shantanu Sarkar, Brian Van Dorn, Nirav Patel, Verla Laager, Michael R Zile, Alleviate-Hf Investigators

Heart and Vascular Articles

BACKGROUND: Early identification of worsening heart failure (HF) may improve outcomes.

OBJECTIVES: This study aims to assess if insertable cardiac monitor (ICM)-based high-risk detection combined with centrally managed, nurse-facilitated, individually protocolized diuretic interventions is safe and improves HF outcomes.

METHODS: A Reveal LINQ (Medtronic) ICM with an investigational HF risk-status software was implanted in participants with HF who were randomized 1:1 to an intervention arm (high-risk HF alert triggering protocolized diuretic regimen) or an observation arm (standard care). The primary safety endpoint was intervention-related serious adverse events and the primary efficacy endpoint was a 5-component hierarchical composite including cardiovascular death …

Fractionated Stereotactic Radiotherapy (Fsrt) For Symptomatic Who Grade 1 Cavernous Sinus Meningiomas: Long-Term Local Control, Clinical Response, And Toxicity Outcomes, Ryan Shah, Shray Jain, Nilanjan Haldar, Lauren A. Holt, Robert Walker, Christopher J Farrell, Md, Debanjan Haldar, James J. Evans, Gregory S. Alexander, Wenyin Shi

Department of Radiation Oncology Faculty Papers

PURPOSE: Cavernous sinus meningiomas represent a significant clinical challenge, given the high prevalence of neurological deficits and limited surgical options. Radiation therapy is often the preferred treatment. This study evaluates the effectiveness of fractionated stereotactic radiation therapy (fSRT) in achieving local control and symptomatic relief in patients with cavernous sinus meningiomas.

METHODS: This is a single-institution retrospective analysis of patients with symptomatic presumed WHO grade 1 cavernous sinus meningiomas treated with fSRT (1.8-2 Gy per fraction). Clinical data were collected by chart review. Kaplan-Meier curves were generated to assess local control. Clinical responses were evaluated for symptom improvement, stability, or …

Obesity And Keratoconus: A Mediation Study Based On The Chinese Keratoconus Cohort, Kaili Yang, Anqi Chang, Runqi Tu, Liyan Xu, Yuwei Gu, Qi Fan, Shanshan Yin, Yi Yuan, Yifan Wang, Chenchen Yin, Yonghao Zang, Changxiu Li, Chenjiu Pang, Daniela Oehring, Yibin Hao, Shengwei Ren

School of Health Professions

Purpose: Growing evidence indicates a strong association between obesity and keratoconus (KC), although the potential mediating factors remain largely unknown. This study aimed to explore the potential pathways through which corneal biomechanical and topographic parameters might link obesity and KC using structural equation modeling (SEM). Methods: This case-control study included 759 participants (363 patients with KC and 396 controls) from the Chinese Keratoconus (CKC) Cohort Study. Associations among body mass index (BMI), corneal biomechanical parameters, topographic parameters, and KC were analyzed using generalized linear regression models. SEM was used to construct latent variables for corneal biomechanical and topographic parameters. Three …

Non-Tobacco Nicotine Dependence Is Associated With Increased Complications Following Clavicle Open Reduction Internal Fixation, Akin A. Adio, Rahul K. Goyal, Abby Skiena, Mohammad Daher, John G. Horneff, Hafiz F. Kassam, Brian W. Hill, Joseph A. Abboud

Rothman Institute Papers

BACKGROUND: Tobacco dependence is well established to impair bone healing and increase postoperative complications. However, the independent effects of nicotine, separate from combustion-related factors, remain unclear. This study aimed to evaluate the impact of non-tobacco nicotine dependence (NTND) following open reduction and internal fixation (ORIF) of clavicle fractures, including midshaft and lateral fracture subtypes.

METHODS: A retrospective cohort study was performed using a large national database. Patients undergoing ORIF of clavicle fractures were identified using procedural and diagnostic codes. Patients with non-tobacco nicotine dependence (e.g., vaping, patches, or gum) were identified and propensity score matched to (1) patients without nicotine …

Sputum Lautropia Is Decreased In Rheumatoid Arthritis-Associated Pulmonary Fibrosis, Timothy M. Wilson, Brendan Allen, J. Kirk Harris, Kristine A. Kuhn, Kevin D. Deane, Stephen M. Humphries, Joyce S. Lee, Joshua J. Solomon, M. Kristen Demoruelle

Division of Rheumatology Faculty Papers

OBJECTIVE: To investigate whether lung microbial composition differs between individuals with rheumatoid arthritis and pulmonary fibrosis (RA-PF) compared to those without fibrosis (RA-no-PF).

METHODS: We enrolled 54 RA patients (22 RA-PF, 32 RA-no-PF) from rheumatology and pulmonary clinics. PF was defined by high-resolution computed tomography (HRCT) findings. Induced sputum was analyzed using 16 S rRNA sequencing to identify the relative abundance of sputum bacteria. Taxonomic differences between groups were evaluated using three independent analytic approaches: Mann-Whitney U, DESeq2, and EdgeR, with false discovery rate correction. Logistic regression examined associations between Lautropia abundance and clinical variables.

RESULTS: Individuals with RA-PF were …

Electronic Health Record Alerts To Improve Lipid Lowering After A Recent Myocardial Infarction, Dean G. Karalis, Benjamin Richter, Scott Hessen, Patrick Moeller, Laney K. Jones

Division of Cardiology Faculty Papers

BACKGROUND: This observational, quality initiative evaluated the impact of changing from a passive (dismissible) to an active (nondismissible without action) electronic health record alert on guideline-recommended lipid-lowering therapy (LLT) prescriptions in patients with recent myocardial infarction at risk for secondary events.

METHODS: We sequentially recruited a retrospective passive-alert (February 2018-July 2019; n=733) and a prospective active-alert (August 2020-January 2022; n=587) cohort of patients who triggered an alert to intensify LLT or order a low-density lipoprotein-cholesterol (LDL-C) test if they had a recent myocardial infarction (within 12 months) and elevated (≥70 mg/dL) or missing LDL-C. Prescribed LLTs and cumulative percentages of …

Community Optometrist–Led Monitoring Of Quiescent Neovascular Age-Related Macular Degeneration: The Fenetre Randomized Clinical Trial, Anitta Sharma, Aljazy Jaber, Bishwanath Pal, John G. Lawrenson, Robert A. Harper, Adnan Tufail, Annastazia E. Learoyd, Emily Robinson, Abdel Douiri, Rachel Burman, Ashleigh Kernohan, Sofia Vougioukalou, Simon Read, Judit Csontos, Aled Jones, Sajjad Mahmood, Martin Mckibbin, Janet L. Peacock, Richard Gale, Praveen J. Patel, Pearse A. Keane, Robin Hamilton, Luke Vale, Catey Bunce, Konstantinos Balaskas

School of Nursing and Midwifery

Importance Hospital-based ophthalmology faces increasing demand for long-term monitoring of neovascular age-related macular degeneration (nAMD). Safe redistribution of routine monitoring to community clinicians is relevant to integrated community (primary)–secondary care models.   Objective To examine whether community optometrist–led monitoring of nAMD is noninferior to hospital-based monitoring for detecting disease activity requiring treatment.   Design, Setting, and Participants This multicenter, noninferiority randomized clinical trial was conducted from October 8, 2019, to January 31, 2024, at secondary centers (17 hospitals) and primary centers (60 community optometry practices) with 12-month follow-up. Statisticians were masked to patient grouping. Adults 55 years or older with quiescent AMD …

Apolipoprotein B100 Predicts Cardiovascular And Limb Events In Type 2 Diabetes Patients With Chronic Limb-Threatening Ischemia, Federico Biscetti, Maria Margherita Rando, Maria Anna Nicolazzi, Flavia Angelini, Roberto Iezzi, Luis H. Eraso, Paul J. Dimuzio, Dario Pitocco, Massimo Massetti, Antonio Gasbarrini, Andrea Flex

Department of Surgery Faculty Papers

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) and chronic limb-threatening ischemia (CLTI) undergoing lower extremity revascularization (LER) face high risks of major adverse cardiovascular events (MACE) and major adverse limb events (MALE), despite guideline-directed lipid-lowering therapy. Apolipoprotein B100 (ApoB100), reflecting total atherogenic particle number, may identify residual risk beyond LDL-cholesterol (LDL-C). Therefore, we investigated whether baseline ApoB100 levels independently predict MACE and MALE beyond conventional risk factors in this high-risk population.

METHODS: In this prospective cohort study, 167 T2DM patients with CLTI undergoing LER were followed for 12 months with visits at 1, 3, 6, and 12 months post-procedure. …

Identifying Social Determinants Of Health Subgroups And Their Associations With Health Outcomes In A Prospective Us Adult Covid-19 Cohort: An Analysis Of The Inspire Registry, Yohali Burrola-Mendez, Eugene Lin, Canada Parrish, Chialing Hsu, Mandy J. Hill, Michael Gottlieb, Kristin L. Rising, Lauren E. Wisk, Nicole L. Gentile, Rachel E. Geyer, Robert A. Weinstein, Michelle Santangelo, Kristyn Gatling, Jonathan W. Dyal, Joann G. Elmore, Robert M. Rodriguez, Phillip Watts, Ji Chen, Zihan Diao, Erica S. Spatz, Kwun Cg Chan, K A. Stephens, Kelli N. O'Laughlin, Inspire Group

Department of Emergency Medicine Faculty Papers

OBJECTIVE: To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.

DESIGN: Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.

SETTING: Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and …

Long Term Evaluation Of The Safety And Efficacy Of Local Cooling Anesthesia During Intravitreal Injections: The Cool-2 Trial, Arshad M. Khanani, Samir N. Patel, Charles C. Wykoff, Gun-Ho Kim, Ajay E. Kuriyan

Wills Eye Hospital Papers

BACKGROUND/OBJECTIVE: To evaluate the safety and effectiveness of a medical device providing cooling anesthesia to the eye as local anesthesia for intravitreal (IVT) injections.

SUBJECTS/METHODS: As a multicenter, open label, dose escalation clinical trial, subjects receiving at least 3 IVT injections in the study eye were recruited to participate. All patients received subconjunctival lidocaine as their anesthesia for previous IVT injections. Subjects receiving IVT injections were assigned (non-randomized) to four groups in which the cooling device was applied to the conjunctiva at the location of the intravitreal injection: Group 1: -10˚C for 20 seconds; Group 2: -15˚C for 10 seconds; …

The Effect Of Hunger On The Likelihood Of Glucose Excursions In Adults With Overweight Or Obesity: Continuous Glucose Monitoring And Ecological Momentary Assessment Observational Study, Byunggul Lim, Phrashiah Githinji, Yue Liao, Jacob Szeszulski, Alexandra L Macmillan Uribe, Rebecca A Seguin-Fowler, Jane Anderson, Chad D Rethorst

Faculty, Staff and Students Publications

Background: Maintaining stable glucose levels is important for metabolic health. Glucose excursions (GEs), which are marked increases in glucose following food intake, have been associated with a higher risk for cardiovascular disease and metabolic dysfunction. Individuals with overweight or obesity who do not have diabetes may still show impaired glucose regulation, as reflected in increased glucose variability. Hunger, as a real-time physiological cue, may be associated with subsequent glucose changes and represents a potential target for just-in-time adaptive interventions.

Objective: This study aimed to investigate the temporal relationship between self-reported hunger and subsequent glucose dynamics, including the likelihood of GE …

Development And Preliminary Validation Of Orca-Pd, An Online Rapid Cognitive Assessment For Parkinson Disease: Mixed Methods Study, Avigail Lithwick Algon, Sarah Brisman, Chi-Ying R Lin, William Saban

Faculty, Staff and Students Publications

Background: Traditional in-person neuropsychological tests for Parkinson disease (PD) lack accessibility, scalability, and PD specificity. Mobility impairments hinder access to in-person assessments, and long waiting times for expert evaluation limit scalability. Common tools for cognitive screening, such as the Montreal Cognitive Assessment, are generic and not specific to PD.

Objective: The goal of this study was to address these challenges by leveraging the internet. This study aimed to develop a sensitive tool to detect cognitive impairments in early- to mid-stage PD in an accessible and scalable manner.

Methods: We developed the Online Rapid Cognitive Assessment for Parkinson's Disease (ORCA-PD), a …

Relationship Between Sleep And Meal Timing With Glycemia Parameters In Individuals With Obesity Participating In A Randomized Time-Restricted Eating Study., Sirimon Reutrakul, Stacey L. Simon, Qi Wang, Emily N C Manoogian, Satchindananda Panda, Suryeon Ryu, Zan Gao, Caleb Griffiths, Erika Helgeson, Douglas G. Mashek, Niki Oldenburg, Lisa Senye Chow

Manuscripts, Articles, Book Chapters and Other Papers

Background/Objectives: Circadian misalignment, including mistimed sleep or eating, is associated with altered glucose metabolism. The importance of eating window timing for time-restricted eating (TRE) is increasingly recognized. This secondary analysis examined associations between meal to sleep timing intervals and glycemic parameters in individuals with obesity across three dietary interventions [TRE, CR: caloric restriction, and UE: unrestricted eating]. Methods: Participants aged 18-65 years with obesity were randomized to a 12-week intervention: TRE (8 h eating window), CR (15% reduction in daily caloric intake), or UE (usual eating habits). CGM and actigraphy were assessed over two weeks at baseline and end-intervention. Mixed …

The Relationship Between Psychological Stress And Sars-Cov-2 Nucleocapsid-Antibody Response Following Natural Infection: Longitudinal Findings From The Aegis Study, Erika T Beidelman, Ashley Judge, David B Allison, Stephanie Dickinson, Lilian Golzarri Arroyo, Anna L M Macagno, Michael J Ricciardi, Jon Macy, Stanley Perlman, Christina Ludema, Kevin C Maki, Molly Rosenberg

Faculty, Staff and Students Publications

Psychological stress can cause diminished immune response to infectious challenges. The extent this holds true during severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the modifying effect of vaccination status is untested. We explored these relationships in a non-random sample standardized to the US adult population. Across 2178 participants in the Aegis study (2021-2022), we identified 507 eligible laboratory-confirmed SARS-CoV-2 infections. We estimated the natural log of nucleocapsid-binding antibody absorbance (N-antibody) at study visits up to 225 days following a positive SARS-CoV-2 test. Linear mixed effects models were fit to estimate the association of baseline perceived stress and, separately, …

Body Mass Index, Clinical Outcomes, And Mortality In Heart Failure: A Mendelian Randomization Study, Nicholas Sunderland, Douglas L Mann, Et Al.

2020-Current year OA Pubs

BACKGROUND: Excess adiposity, most commonly indexed through body mass index (BMI), is strongly associated with the development of heart failure (HF). Weight loss therapies improve outcomes in patients with obesity and HF with preserved left ventricular ejection fraction (LVEF), but their effects in HF with reduced LVEF remain unclear.

OBJECTIVES: The aim of this work is to determine whether higher BMI is associated with adverse clinical outcomes in patients with HF and whether there is effect modification by LVEF subgroup.

METHODS: Two-sample Mendelian randomization (MR) was used, with genome-wide significant loci associated with BMI as instrumental variables and outcome data …

A Cross-Sectional Analysis Of The Vaginal Microenvironment In Rheumatoid Arthritis, Marlyd E Mejia, Savannah Bowman, Jessica Lee, Ali El-Halwagi, Keshia Ferguson, Maryjo Maliekel, Yixuan Zhou, Camille Serchejian, Clare M Robertson, Mallory B Ballard, Lee B Lu, Sobia Khan, Olubunmi O Oladunjoye, Shixia Huang, Sandeep K Agarwal, Kathryn A Patras

Faculty, Staff and Students Publications

The human microbiota is implicated in the development and progression of rheumatoid arthritis (RA). Given the increased RA burden in women and well-known correlations between the vaginal microbiota and local inflammation, we seek to understand the vaginal microenvironment in the context of RA pathology. Self-collected vaginal swabs and questionnaires on dietary, menstrual, and health information were obtained from 36 RA and 50 demographically-matched control women, 18–63 years of age. Medication regimen, along with disease activity and severity, was captured for the RA cohort. Vaginal swabs were subjected to long-read 16S rRNA gene sequencing, multiplex cytokine analyses, and quantification of rheumatoid …

Liver Injury From Medications Used For Treating Inflammatory Bowel Disease: The Drug-Induced Liver Injury Network Experience, Harish Gopalakrishna, Jiezhun Gu, Yi-Ju Li, Huiman Barnhart, Dina Halegoua-De Marzio, Herbert L. Bonkovsky, A. Sidney Barritt, Jean P. Molleston, Naga P. Chalasani, Marwan Ghabril

Division of Gastroenterology and Hepatology Faculty Papers

BACKGROUND: We aimed to investigate and characterise DILI due to approved therapies for inflammatory bowel disease (IBD).

METHODS: Using the Drug-Induced Liver Injury Network (DILIN) prospective study, we evaluated definite, highly likely, or probable DILI attributed to IBD therapies, including use for non-IBD indications (but excluding corticosteroids). HLA allele associations were investigated.

RESULTS: Among 1806 participants, 81 (4.5%) had IBD-agent DILI: 31 biologics (27 infliximab), 35 immunomodulators (31 azathioprine/mercaptopurine), 14 aminosalicylates (11 sulfasalazine) and 1 small molecule (tofacitinib). Median age was 45 years with 75% female and 78% White. Patients with biologic-DILI were younger, had longer latency (median 124 days), …

Adjunctive Psychosocial Interventions And Opioid Abstinence Among Patients Receiving Buprenorphine: A Randomized Clinical Trial., Michelle R. Lent, Emily E Hurstak, Kevin G Lynch, Emily Loscalzo, Kimberly Mazur, Helen L Lugo, Karen L Dugosh

PCOM Scholarly Works

IMPORTANCE: Adjunctive psychosocial treatments are recommended for many using medications for opioid use disorder (MOUD), but it is unclear which approaches can best enhance treatment outcomes.

OBJECTIVES: To evaluate the comparative effectiveness of 2 psychosocial treatments, peer recovery support (PRS) and cognitive-behavioral therapy (CBT), on opioid abstinence when used as adjunctive therapies to office-based buprenorphine treatment in adults with opioid use disorder (OUD).

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included US adults diagnosed with OUD referred for care at 5 federally qualified health centers with office-based addiction treatment programs by their clinicians from 2020 to 2024. Participants were …

Trastuzumab Deruxtecan In Hormone Receptor-Positive, Her2-Low/-Ultralow Metastatic Breast Cancer (Destiny-Breast06): Outcome Analyses By Time To Progression On Prior First-Line Endocrine Therapy With Cdk4/6 Inhibitor And Baseline Burden Of Disease, G Curigliano, N A Bagegni, Et Al.

2020-Current year OA Pubs

BACKGROUND: In DESTINY-Breast06, trastuzumab deruxtecan (T-DXd) improved progression-free survival (PFS) versus physician's choice of chemotherapy (TPC) for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low/-ultralow metastatic breast cancer (mBC), without new safety signals. We report additional analyses exploring outcomes for patients with characteristics that affect prognosis.

PATIENTS AND METHODS: Patients were randomly assigned 1 : 1 to receive T-DXd (5.4 mg/kg) once every 3 weeks or TPC. Subgroups were specified post hoc from the intent-to-treat population (N = 866). Outcomes were PFS, objective response rate (ORR), and duration of response (DOR) by blinded independent central review …

Cabozantinib Plus Nivolumab And Ipilimumab In Previously Untreated, Advanced Renal Cell Carcinoma: Final Results And Biomarker Analyses From The Phase Iii Cosmic-313 Study, R J Motzer, M A Reimers, Et Al.

2020-Current year OA Pubs

BACKGROUND: Primary results from COSMIC-313 demonstrated significantly longer progression-free survival (PFS) with first-line cabozantinib plus nivolumab and ipilimumab versus placebo plus nivolumab and ipilimumab in patients with advanced renal cell carcinoma. Final efficacy and safety results, as well as data from exploratory biomarker analyses, are reported here.

PATIENTS AND METHODS: The design, participants, and primary-endpoint PFS outcomes have been reported previously for this phase III, double-blind, randomized (1 : 1) study of cabozantinib or placebo plus nivolumab and ipilimumab in adults with previously untreated, advanced clear cell renal cell carcinoma. The secondary endpoint was overall survival (OS) in the intention-to-treat …

Alcohol Consumption And Molecular Subtypes Of Colorectal Cancer: Pooled Observational And Mendelian Randomization Analyses, Christos V Chalitsios, Yin Cao, Et Al.

2020-Current year OA Pubs

BACKGROUND: Alcohol consumption is associated with colorectal cancer (CRC) risk, yet its association with distinct molecular subtypes remains unclear. Clarifying this could reveal insights into alcohol's carcinogenic mechanisms.

OBJECTIVES: We examined the association between alcohol consumption and the risk of CRC subtypes defined by individual tumor markers (and marker combinations), namely microsatellite instability (MSI) status, CpG island methylator phenotype (CIMP) status, BRAF, and KRAS mutations.

METHODS: Pooled observational (n

RESULTS: Among drinkers, each additional 14 g/d of alcohol was associated with a 10% higher CRC risk [odds ratio (OR) = 1.10; 95% confidence interval (CI): 1.07, 1.13], but this association …

Use Of Wearable Sensors To Measure Improvements In Real World Upper Extremity Activity After Brachial Plexus Reconstruction, Arakua N Welbeck, Catherine E Lang, David M Brogan, Christopher J Dy

2020-Current year OA Pubs

PURPOSE: Current functional assessments after brachial plexus (BP) reconstruction, including surgeon-graded active range of motion and strength scores, and patient-reported outcomes (PROs), have limitations. This study evaluated the feasibility of wearable sensors to quantify recovery and functional outcomes following BP reconstruction. We hypothesized that sensor-derived measures of daily upper-extremity use would correlate with PROs and that real-world upper-extremity use would improve.

METHODS: Traumatic BP injury patients wore bilateral wrist accelerometers for 7-day periods at 3- to 6-month intervals. Data were grouped relative to timing of reconstruction. Duration and magnitude of upper-extremity activity were expressed as ratios of injured to uninjured …

Genetic Ancestry-Concordant Ceramide Metabolism And Response To Androgen Receptor Pathway Inhibition In Metastatic Castration-Resistant Prostate Cancer, Sean Piwarski, Lauren Howard, Morgan Paul, Nick Bachelder, Bonnie Lacroix, Angela Clayton, Donna Allen, Julie Kephart, Andrew Armstrong, Steven Patierno, Daniel George, Terry Hyslop, Jennifer Freedman

Department of Pharmacology, Physiology, and Cancer Biology Faculty Papers

BACKGROUND: The authors observed differences in response between Black and White patients with metastatic castration-resistant prostate cancer (mCRPC) who were treated prospectively with androgen receptor pathway inhibition (ARPI) in the Abi Race and PANTHER studies. In addition, genetic ancestry-related single nucleotide variants in ceramide metabolism genes were associated with the time to prostate-specific antigen progression in the Abi Race study. For this report, the authors analyzed ceramide metabolites and their association with response to ARPI treatment in the Abi Race and PANTHER studies.

METHODS: Fasting serum levels were obtained from 22 Black patients and 22 White patients in the Abi …

Silk Vista Baby Versus Pipeline Embolization Device For Unruptured Distal Anterior Cerebral Artery Aneurysms: A Multicenter Propensity-Weighted Comparative Study., Valerio Da Ros, Frédéric Clarençon, Adam A. Dmytriw, Pascal Jabbour Md, Marios Psychogios, Peter Sporns, Ajit S. Puri, Ameer E. Hassan, Oktay Algin, Markus A. Möhlenbruch, Mauro Bergui, Oded Goren, Gregoire Boulouis, Takeshi Morimoto, Raoul Pop, Joanna Wk Ho, Virginia Pujol Lereis, Jared Cooper, Giancarlo Salsano, Alessandro Sgreccia, Arturo Consoli, Eytan Raz, Julien Burel, Khawaja Muhammad Baqir Hassan, Zhe Ji, Riitta Rautio, Maria Ruggiero, Federico Sabuzi, Stefania Proietti, Joseph Domenico Gabrieli, Michael Levitt, Antonio Armando Caragliano, Christophe Cognard, Gaultier Marnat, Nicola Limbucci, Mariangela Piano, Alexis Guedon, Andrea Romi, Fortunato Di Caterino, Mykola Vyval, Adrien Guenego, Mohamad Abdalkader, Thanh Nguyen, Vitor Mendes Pereira, Ocilio Ribeiro Goncalves, Erwah Kalsoum, Alessandro Pedicelli, Andrea M Alexandre, Luca Scarcia

Department of Neurosurgery Faculty Papers

BACKGROUND: Flow diversion is effective for unruptured distal anterior cerebral artery (DACA) aneurysms, yet comparative data between the Silk Vista Baby (SVB) and Pipeline Embolization Device (PED) in this challenging territory remain scarce.

METHODS: We conducted a retrospective multicenter study using the CRETA Registry, including consecutive patients with unruptured DACA aneurysms treated with SVB or PED. The primary endpoint was complete angiographic occlusion (O'Kelly-Marotta grade D). Secondary outcomes included procedural characteristics, clinical outcome (modified Rankin Scale), and complications. Overlap weighting was applied to account for non-randomized treatment allocation. Predictors of occlusion were explored using penalized logistic regression. A sensitivity analysis …

Exploring Racial And Ethnic Diversity Trajectories And Diabetes Prevalence In The United States, Jiue-An Yang, Calvin P Tribby, Anna Dmowska, Qian Xiao, Marta M Jankowska

Faculty, Staff and Student Publications

This study investigates whether long-term changes in neighborhood racial and ethnic diversity are associated with adult diabetes prevalence across the contiguous United States. We calculated diversity indexes for US census tracts (n = 72,033) using decennial census data from 1990 to 2020. Five diversity trajectory clusters were identified using K-means clustering. Diabetes prevalence in 2019 was obtained from the CDC's PLACES dataset. Linear mixed models (LMMs) assessed global associations between diversity trajectories and diabetes prevalence, adjusting for age, sex, poverty, marital status, and public insurance. Geographically weighted regression (GWR) examined local variations in these associations. Compared to the reference group …

Dental Care Utilization Among Sexual And Gender Minority Individuals, Ishita Singh, Oladipo Afolayan, Sarah S Jackson, Irene Tamí-Maury

Faculty, Staff and Student Publications

Objectives: Sexual and gender minority (SGM) individuals can experience notable health disparities, including higher HIV prevalence, social isolation, substance abuse, lack of culturally competent providers, and poorer health outcomes compared to heterosexuals due to stigma and discrimination. This study aims to identify predictors of dental care utilization across sexual minorities using the 2023 TEXAS PRIDE Survey.

Methods: We analyzed data from 517 SGM individuals, assessing sociodemographic characteristics, health behaviors, and recent medical and dental visits. Multivariable logistic regression identified predictors of dental care utilization (i.e., a dental visit in the past year).

Results: Among sexual orientation groups, reported dental care …