Digital Commons Network^™

Volumetric Buccal Bone Alterations At Immediate Implant Sites With Or Without Soft Tissue Augmentation: A 6-Month Assessment, Mary Jung, Duong Tran, Chi-Ching Chang, Sung K Kim, Yosuke Tsukiboshi, Seiko Min, Srinivas Ayilavarapu, Chun-Teh Lee

Faculty, Staff and Student Publications

Background: This study is part of a randomized controlled trial investigating the impact of soft tissue augmentation (STA) using subepithelial connective tissue graft (SCTG) (immediate implant with subepithelial connective tissue graft [ICT] group) or acellular dermal matrix (ADM) (immediate implant with acellular dermal matrix [IAD] group) versus no STA (control) on the clinical outcomes following immediate implant placement (IIP). This study aimed to investigate volumetric buccal bone dimensional changes at immediate implant sites 6 months after the surgery.

Methods: Forty-five patients requiring extraction of a maxillary anterior tooth or premolar and randomly assigned to one of the three groups were …

Investigation Of Teratogenic Concerns In The Coronavirus Disease Of 2019 Era, Kate Richardson, Emily C Daykin, Kathleen Shields, S Shahrukh Hashmi, Lorrie Harris-Sagaribay, Molly Daniels, Myla Ashfaq

Faculty, Staff and Student Publications

Background: MotherToBaby (MTB) is a teratogen information service that provides information about exposures during pregnancy and breastfeeding to the public and healthcare providers. During the Coronavirus Disease of 2019 (COVID-19) pandemic, MTB received an influx of queries regarding the teratogenicity of the virus and the vaccine. The purpose of this study was to assess the frequency and type of exposures asked about prior to the onset of the COVID-19 pandemic through March 2022 and to evaluate the demographics of individuals who made inquiries.

Methods: Data from MTB contacts (2018-2022) were accessed through a data-sharing agreement. The data were cleaned and …

Transcriptomics And Metabolomics Analysis Reveal Cell Subpopulations Of Trophoblast Cells Associated With Preeclampsia, Xiaojun Zhu, Ying Jiang, Lilin Wang, Peiyue Jiang, Zixing Zhong, Hetong Li, Caihong Zheng, Lujiao Chen, Juan Wei, Xishi Lin, Peng Ding, Zehua Dong, Xiaosheng Wang, Qiong Luo

Faculty, Staff and Student Publications

Placental abnormalities are central to preeclampsia (PE), yet the cellular and molecular mechanisms underlying this dysfunction remain unclear. We applied a multi-layered, integrative approach to investigate placental tissue from patients with PE and matched controls. Single-cell RNA sequencing (scRNA-seq; GSE173193) and bulk RNA sequencing (bulk RNA-seq; GSE203507) datasets were obtained from the Gene Expression Omnibus. The scRNA-seq dataset included two PE and two control samples, whereas the bulk RNA-seq dataset focused on eight early-onset PE and five uncomplicated term births. Trophoblast subpopulations were identified via scRNA-seq, and pseudotime analysis was used to trace differentiation trajectories. Differential expression and pathway enrichment …

Striatum Volume And Affective Symptomatology Are Associated With Sleep In Schizophrenia, Alia R Warner, Xiaoming Du, Yizhou Ma, Kyle R Noll, Si Gao, Bhim Adhikari, Bruno Kluwe-Schiavon, Alina Siatka, Anya Savransky, Peter Kochunov, L Elliot Hong

Faculty, Staff and Student Publications

Sleep dysfunction is common among individuals with schizophrenia spectrum disorders (SSD). Sleep duration and other sleep quality metrics are associated with worse patient clinical and social outcomes. We examined if accumulative stress, gray matter structural volume measured with high-resolution structural brain MRI, diffusion tensor imaging measures of white matter microstructure, and psychopathology (for the schizophrenia group) may act as predictors of sleep quality and compared individuals with SSD (N = 101) and healthy controls (N = 86). We created an adjusted Pittsburgh Sleep Quality Index (PSQI-A) score to measure sleep quality and account for abnormally long sleep duration as dysfunctional. …

Antenatal Prediction Of Early Cord Clamping Among Infants Born Extremely Preterm, Anup C Katheria, Rebecca A Dorner, William A Grobman, Matthew A Rysavy, Jenny Koo, Myra H Wyckoff, Grecio Sandoval, Sara B Demauro, Abhik Das, Henry C Lee, Michael Cotten, Laura Calvo, Shampa Saha

Faculty, Staff and Student Publications

Objective: To identify prenatal risk factors associated with early cord clamping (ECC) in infants born extremely preterm (22-28 weeks) and to use these factors to predict which infants have the highest risk of ECC.

Study design: Stepwise logistic regression and classification and regression tree analysis were performed to identify variables most associated with ECC and to build a parsimonious model to identify infants born preterm who are at the highest risk of ECC.

Results: There were 12 622 infants eligible for analysis (ECC, n = 8465 vs deferred cord clamping [DCC], n = 4157). In the classification and regression tree …

Outcomes Of Witnessed Versus Unwitnessed Patients With Stroke After Endovascular Therapy In The Extended Time Window, Liisa Tomppo, Nicolas Martinez-Majander, Muhammad M Qureshi, Thanh N Nguyen, Raul G Nogueira, Simon Nagel, Jelle Demeestere, Volker Puetz, Hilde Henon, Marta Olive-Gadea, João Pedro Marto, Anne Dusart, Peter A Ringleb, Osama O Zaidat, Diogo C Haussen, Mahmoud H Mohammaden, Mohamad Abdalkader, Jean Raymond, Santiago Ortega-Gutierrez, Sunil A Sheth, Hiroshi Yamagami, João Nuno Ramos, Francois Caparros, Daniel P O Kaiser, Marc Ribo, Sergio Salazar-Marioni, Kanta Tanaka, Pekka Virtanen, Ajit S Puri, James E Siegler, Syed F Zaidi, Mouhammad Jumaa, Eugene Lin, Jordi Mayol, Rita Ventura, Simon Winzer, Piers Klein, Flavio Bellante, Jorge Cespedes, Anke Wouters, Hesham E Masoud, Liqi Shu, Alicia C Castonguay, Christian Herweh, Monica Cheng, Wei Hu, Daniel Roy, Shadi Yaghi, Robin Lemmens, Charlotte Cordonnier, Markus A Möhlenbruch, Daniel Strbian

Faculty, Staff and Student Publications

Background: It remains unclear whether outcomes of patients treated with endovascular thrombectomy with large-vessel occlusion and unwitnessed onset of stroke differ from those with witnessed onset in the extended time window.

Methods: We enrolled patients with anterior circulation large-vessel occlusion (internal carotid artery, M1, or M2 segment of the middle cerebral artery) undergoing endovascular thrombectomy within 6 to 24 hours from the time last seen well, from 2014 to 2022, at 66 sites in Europe, North America, and Asia. Patients with a prestroke modified Rankin Scale score of >3 or age < 18 were excluded. We categorized patients by onset mode as witnessed or unwitnessed. The primary outcome was the modified Rankin Scale shift at 90 days. Secondary outcomes were functional independence, a composite of functional independence or return of Rankin to prestroke level, symptomatic intracranial hemorrhage, mortality, and a composite of severe disability or mortality at 90 days. We applied inverse probability of treatment weighting to compare outcomes between the groups.

Results: Of 5098 patients assessed for eligibility, we included …

Sleep-Disordered Breathing In Newborns After Myelomeningocele Repair, Renée A Shellhaas, Fauziya Hassan, Thornton A Mason, Jagruti Anadkat, Ellen Bendel-Stenzel, Stephanie Eyerly-Webb, Cindy K Jon, Robin M Lloyd, Julie S Moldenhauer, Ramesha Papanna, John E Pascoe, Stefanie Riddle, Regina Reynolds, Brandon G Rocque, Narong Simakajornboon, Marjorie C Treadwell, R Bradley Troxler, Lydia S Youmans, Niko A Kaciroti, Harlan Mccaffery, Hemant A Parmar, Lora Merley, Stephanie Md Rau, Ronald D Chervin, John D E Barks

Faculty, Staff and Student Publications

Background & objective: Sleep-disordered breathing (SDB) may be a remediable contributor to abnormal cognitive outcomes for children with myelomeningocele. We investigated the frequency of SDB among neonates with fetal vs postnatal myelomeningocele repair.

Methods: In this nine-center, prospective, observational study, neonates with myelomeningocele born at more than 30 weeks gestational age underwent a 10-hour bedside polysomnogram at at least 35 weeks postmenstrual age, before hospital discharge. The primary outcome was SDB severity, reflected by the apnea-hypopnea index (AHI; number of respiratory events per hour of sleep). Decisions regarding surgical timing (fetal vs postnatal), technique (open fetal vs fetoscopic approach), and …

Bayesian Posthoc Trial Analysis Of Cerclage Management In Preterm Prelabor Rupture Of The Membranes, Beth L Pineles, Kyung Hyun Lee, Baha M Sibai

Faculty, Staff and Student Publications

Background: There is inadequate evidence on whether to retain or remove a cervical cerclage after preterm prelabor rupture of the membranes (PPROM). The PROMCerclage trial was the only study to randomize patients to cerclage retention or immediate cerclage removal after PPROM. The trial was terminated early, and results were not statistically significant but the cerclage retention group had shorter latency and more chorioamnionitis. Bayesian post-hoc trial analysis maximizes available clinical trial data by formally integrating information from preexisting studies or prior beliefs into statistical modeling to estimate the probability of a treatment effect.

Objective: To re-analyze published results of the …

Stimulated Cytokine Production, Attachment, And Emotional Well-Being In Dementia Spousal Caregivers, Daniel L Argueta, Sarah Roberts, Kelly N Brice, E Lydia Wu-Chung, Vincent D Lai, Jensine Paoletti-Hatcher, Bryan T Denny, Charles Green, Samantha Henry, Luis D Medina, Paul E Schulz, Jennifer Stinson, Cobi Heijnen, Christopher P Fagundes

Faculty, Staff and Student Publications

Background: Proinflammatory cytokine production may be related to poor emotional adjustment in dementia spousal caregivers. People who display attachment insecurity may be at increased risk for adverse caregiving experiences and poor psychosocial outcomes.

Objective: This study aimed to understand whether proinflammatory cytokine production was associated with anticipatory grief, caregiver burden, and depressive symptoms and whether those relationships were stronger for caregivers higher on attachment anxiety or avoidance.

Method: A sample of 103 dementia spousal caregivers provided self-report data on demographics, health information, and psychosocial outcomes. We also determined lipopolysaccharide-induced whole-blood interleukin-6, interleukin-1β, tumor necrosis factor-α, and interleukin-10 production and combined …

Cardiometabolic Parameter Change By Weight Regain On Tirzepatide Withdrawal In Adults With Obesity: A Post Hoc Analysis Of The Surmount-4 Trial, Deborah B Horn, Bruno Linetzky, Melanie J Davies, Luke J Laffin, Hui Wang, Madhumita A Murphy, Sarah Zimner-Rapuch, Eva Lau, Avigdor D Arad, Clare J Lee

Faculty, Staff and Student Publications

Importance: In the SURMOUNT-4 trial, most adults with obesity who had tirzepatide withdrawn following a 36-week treatment regained weight. The association between the degree of weight regain and cardiometabolic parameters after tirzepatide withdrawal is unknown.

Objective: To assess changes in cardiometabolic parameters by degree of weight regain after withdrawal of tirzepatide.

Design, setting, and participants: This post hoc analysis of the SURMOUNT-4 trial included tirzepatide-treated participants with 10% or greater weight reduction at week 36 initially randomized to placebo. Data were collected from March 2021 to May 2023, and data were analyzed from February 2024 to March 2025.

Interventions: After …

Role Of Childhood Trauma In Interoception And Alexithymia In Schizophrenia, Samantha Narvaez, Krista Wisner, Alina Siatka, L Elliot Hong, Joshua Chiappelli

Faculty, Staff and Student Publications

Childhood trauma (CT) is a notable risk factor for schizophrenia. Separately, CT has been associated with alexithymia, referring to difficulties in identifying and describing one's own feelings, as well as disturbed interoception, referring to difficulties sensing and responding to signals that originate from within the body. Both self-perception impairments have been observed in schizophrenia; however, the role of CT in these observations in schizophrenia is unclear. To address this gap, interoception was assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), alexithymia was assessed using the Toronto Alexithymia Scale (TAS-20), and CT was measured using the Childhood Trauma Questionnaire (CTQ) …

Cultural Influences On Camouflaging And Autistic Burnout: Examining The Experiences Of Latino Autistic Young Adults, Antonio F Pagán, Katherine A Loveland, Ron Acierno

Faculty, Staff and Student Publications

The present study explored the relationship between camouflaging, autistic burnout, and cultural factors in Latino young adults with autism spectrum disorder (ASD). While autistic burnout and camouflaging have been widely studied in general ASD populations, limited research has focused on Latino individuals, who may experience unique pressures due to cultural values such as collectivism, familism, and traditional gender roles. Participants (N = 56) from the ¡Iniciando! la Adultez therapy program completed measures assessing burnout, camouflaging, acculturation, and cultural values. Results indicate that participants reported moderate to high levels of autistic burnout, with the highest levels observed in heightened self-awareness …

Convolutional Neural Networks For Automatic Tuber Segmentation And Quantification Of Tuber Burden In Tuberous Sclerosis Complex, Iván Sánchez Fernández, Matheus D Soldatelli, Gillian N Miller, Catharina F Gout, Ellen C Broekhuizen, Iris C J Den Hertog, Daan A Pijs, Errol Apostolopoulos, Prabhjot Kaur, Abdelhakim Ouaalam, Martina E Bebin, Hope Northrup, Darcy A Krueger, Joyce Y Wu, Alexander L Cohen, Mustafa Sahin, Davood Karimi, Simon K Warfield, Jurriaan M Peters

Faculty, Staff and Student Publications

Objective: This study was undertaken to develop a fully automated algorithm for tuber segmentation and quantification of tuber volume that performs similarly to the gold standard human neuroradiologist.

Methods: We used brain magnetic resonance imaging (MRI) from patients with tuberous sclerosis complex (TSC) to train and validate a convolutional neural network (CNN), which was evaluated on segmentation with the Dice-Sørensen similarity coefficient (DSSC) and on tuber burden quantification with Spearman correlation coefficient against a neuroradiologist's gold standard in the test set.

Results: We collected 263 MRIs from 196 patients (57% males) with median (25th percentile-75th percentile) age of 4.3 (3.0-10.1) …

Presenilin L166p Mutation, A Model Of Familial Alzheimer's Disease, Leads To Early Onset Bone Loss, Vidyani Suryadevara, Connor J Krehbial, Anuradha K Valiya, Melinda Vang, Julian Balanta-Melo, Pierre P Eleniste, Sumana Posritong, Jung Min Hong, Katie Chester, Gabriel M Pagnotti, Teresita Bellido, Monte S Willis, Angela Bruzzaniti

Faculty, Staff and Student Publications

Accelerated bone loss has been reported in the early stages of Alzheimer's disease (AD) as indicated by reduced bone mineral density and increased fracture risk in these patients, compared to healthy individuals. In the present study, we investigated bone loss in mouse models of familial Alzheimer's disease harboring the Presenilin 1 (L166P) knock-in mutation (PSEN1 KI), with or without the human amyloid precursor protein transgene (hAPP Tg+) known to induce brain amyloid pathology by 6 months. Female and not male 12-month PSEN1/hAPP Tg+ mice exhibited reduced whole-body bone mineral density and bone mineral content, compared to sex-matched controls. Consistent with …

Retrospective Analysis Of Cutaneous Immune-Related Adverse Events Following Checkpoint Inhibitor Therapy In Melanoma Patients Reveals Increased Risk Associated With The Hla-B*51:01 Allele, Mckenzie Dileo, Samantha Oglesby, Cheuk Hong Leung, Kristen E Pauken, Sahira Farooq, Lauren E Haydu, Shelby L Kubicki, Rebeca Martinez, Macartney Welborn, Sana Zahiruddin, Jun Zou, Kai Cao, Anisha B Patel

Faculty, Staff and Student Publications

Background: While immune checkpoint inhibitors (ICIs) have shown significant efficacy, a common side effect is cutaneous immune-related adverse events (irAEs). This study focuses on exploring the association between specific human leukocyte antigen (HLA) alleles and the development of cutaneous irAEs in melanoma patients undergoing ICI monotherapy and combination therapy. As certain HLA types are indicative of susceptibility to autoimmune diseases, it was hypothesized that HLA typing could serve as a potential screening tool for identifying patients at increased risk for developing irAEs.

Methods: A retrospective chart review was performed of 515 patients with melanoma who underwent ICI therapy, either as …

Cardiometabolic Indicators Of Cognitive Impairment In The Cameron County Hispanic Cohort, Fadi I Musfee, Seema Agarwal, Vahed Maroufy, Chelsea Liu, Joseph B Mccormick, Susan Fisher-Hoch, Sean I Savitz

Faculty, Staff and Student Publications

Background

Objective

Methods

Hypoglossal Neuropathy In The Pathogenesis Of Fibrosis-Related Late-Radiation Associated Dysphagia: A Correlative Analysis Utilizing Electromyography To Explore The Frequency Of Clinical And Subclinical Neuropathy In A Pilot Dysphagia Trial, Holly Mcmillan, Christine Okoro, Sheila Buoy, Karin Woodman, Nicolaas Anderson, Clifton Fuller, Stephen Y Lai, Katherine Hutcheson

Faculty, Staff and Student Publications

Background: Late radiation-associated dysphagia (late-RAD) commonly presents in patients with signs of hypoglossal neuropathy, with hallmark clinical features including lingual atrophy, deviation, and fasciculation. Gold-standard electromyography (EMG) has not been used to explore the frequency of hypoglossal neuropathy in patients with late-RAD.

Methods: Exploratory post hoc secondary analysis of MANTLE trial (NCT03612531) was completed. The presence of cranial nerve XII (CN XII) neuropathy was classified by (1) features of clinical assessment as well as (2) intramuscular genioglossus EMG pre-MANTLE intervention in disease-free HNC survivors ≥ 2 years post-radiotherapy (RT) with grade ≥ 2 fibrosis and dysphagia.

Results: All …

Impact Of Treatment Interruption On Outcomes In Head And Neck Cancer: Nrg/Rtog Secondary Analysis, Laila A Gharzai, Emily Morris, Matthew J Schipper, Kelley M Kidwell, Phuc Felix Nguyen-Tân, David I Rosenthal, Maura L Gillison, Richard C Jordan, Adam S Garden, Shlomo A Koyfman, Jimmy J Caudell, Dukagjin M Blakaj, Neal E Dunlap, Greg A Krempl, John M Longo, Christopher U Jones, Michael F Gensheimer, Thomas J Galloway, Lyudmila Demora, Quynh-Thu Le, Jennifer L Shah, Krithika Suresh, Michelle Mierzwa

Faculty, Staff and Student Publications

Importance: Historical evidence demonstrated that delays or interruptions in radiotherapy (RT) are associated with poorer oncologic outcomes in head and neck squamous cell carcinoma (HNSCC). Substantial concerns arose during the COVID-19 pandemic, when treatment schedules were frequently disrupted.

Objective: To determine the association of RT interruptions with locoregional failure (LRF) and overall survival (OS).

Design, setting, and participants: This retrospective review and secondary analysis of 3 randomized clinical trials (NRG/RTOG 0129, 0522, and 1016) included patients enrolled in the trials who were treated with RT. Patients with HNSCC were grouped as (1) p16-positive oropharynx (p16+ OPSCC) and (2) p16-negative oropharynx …

Melody: Mediation Analysis In Logistic Regression For High-Dimensional Mediators And A Binary Outcome, Sunyi Chi, Xingyu Li, Peng Wei, Xuelin Huang

Faculty, Staff and Student Publications

Mediation analysis is a pivotal tool for elucidating the indirect effect of an environmental factor or treatment on disease through potentially high‐dimensional omics data, such as gene expression profiles. However, traditional mediation analysis methods tailored for binary outcomes often rely on the rare disease assumption in logistic regression and provide inadequate measures of total mediation effect when multiple mediators have effects in different directions. In this paper, we develop a MEdiation analysis framework in LOgistic regression for high‐Dimensional mediators and a binarY outcome (MELODY). It leverages a second‐moment‐based measure analogous to the ��2 for linear models to quantify the total …

Acta2 Pathogenic Variants Activating Heat Shock Factor 1 And Increasing Cholesterol Biosynthesis In Smooth Muscle Cells Predispose To Early Onset Atherosclerosis, Maura L Boerio, Abhijnan Chattopadhyay, Xue-Yan Duan, Aamuktha Karla, Ernesto Calderon Martinez, Amelie Pinard, Andrew K Morse, Darshan Reddy, Sree Dharma, Walter Velasco-Torrez, Julien Marcadier, Siddharth K Prakash, Sherene Shalhub, Julie De Backer, Richmond Jeremy, Shaine A Morris, Anji T Yetman, Alan C Braverman, Dianna M Milewicz

Faculty, Staff and Student Publications

Background: ACTA2 pathogenic variants predispose to thoracic aortic disease, and a subset of variants lead to early onset atherosclerotic cardiovascular disease (ASCVD). The molecular pathway linking misfolded SMA (α-smooth muscle actin) monomers to augmented atherosclerosis-associated smooth muscle cell phenotypic modulation can be modeled in vitro by stably expressing the ACTA2 p.R149C variant in Acta2-/- smooth muscle cells.

Methods: The Montalcino Aortic Consortium patient registry was used to identify cases with ACTA2 pathogenic/likely pathogenic missense variants. These patients were surveyed, and medical records were reviewed, to identify cases with early onset ASCVD. The variants for these cases, as well as …

Visit-Level Quality Measurement Reveals Missed Opportunities And Overuse In Preventive Oral Health Care, Bunmi Tokede, Suhasini Bangar, Swaroop Gantela, Ryan Brandon, Alfa Yansane, Donald B Rindal, Don Worley, Joel White, Joanna Mullins, Ana Neumann, Todd Johnson, Nicholas Skourtes, Gregory Olson, Janelle Urata, Heather Weidner, Katie Lamberger, Aaron Truong, Heiko Spallek, Elsbeth Kalenderian, Muhammad F Walji

Faculty, Staff and Student Publications

Background: Traditional annual dental quality measures fail to capture real-time care delivery and can mask critical gaps in patient-specific treatment. The authors developed and implemented visit-level adaptations of established caries quality measures to enable actionable, point-of-care assessment.

Methods: The authors conducted a retrospective analysis of 1.09 million dental visits across 400,000 patients (2021-2023) at 4 US institutions using axiUm (Henry Schein Corp) or Epic (Epic Systems) electronic health records. The authors transformed 2 annual measures involving caries risk assessment and risk-based preventive treatment into visit-level metrics using a 2 × 2 matrix framework: action due and performed, due and not …

Circulating Fatty Acid Binding Protein 4 (Fabp-4) Concentrations And Mortality In Individuals With Colorectal Cancer In The European Prospective Investigation Into Cancer And Nutrition Study, Thu Thi Pham, Katharina Nimptsch, Krasimira Aleksandrova, Mazda Jenab, Veronika Fedirko, Anja Olsen, Anne Tjønneland, Claire Cadeau, Gianluca Severi, Matthias B Schulze, Renée Turzanski Fortner, Verena Katzke, Claudia Agnoli, Carlotta Sacerdote, Rosario Tumino, Simona Signoriello, Camino Trobajo-Sanmartín, Jesús-Humberto Gómez, María-Dolores Chirlaque, Maria-Jose Sánchez, Marta Crous-Bou, Anne May, Alicia Heath, Dagfinn Aune, Elisabete Weiderpass, Tobias Pischon

Faculty, Staff and Student Publications

Human fatty acid binding protein‐4 (FABP‐4), a protein elevated in obesity that promotes colon cancer cell invasiveness and metastasis, may be associated with higher mortality in individuals with colorectal cancer (CRC) and may serve as a mediator of the obesity–mortality association in these individuals. We used a causal diagram to inform covariate selection and applied Cox proportional hazards models to estimate hazard ratios (HRs) for CRC‐specific, non‐CRC‐specific, and all‐cause mortality by FABP‐4 levels measured in baseline blood samples from 1371 incident CRC cases from the European Prospective Investigation into Cancer and Nutrition cohort. Competing risk analyses were adapted for CRC …

Prospective Evaluation Of The European Society Of Cardiology 0/1h-Algorithm’S Safety And Efficacy For Triage Of Patients With Suspected Myocardial Infarction (Presc1se-Mi): Rationale And Design Of A Prospective International Multicenter Stepped-Wedge Cluster Randomized Controlled Trial, Jasper Boeddinghaus, Paolo Bima, Luca Crisanti, Dagmar I Keller, Ksenija Slankamenac, Michael Christ, Philipp Schuetz, Andrea Wiencierz, Ivo Strebel, Julia Reinhardt, Iryna Vyshnevska, Tzu-Ying Tsao, Felix Mahfoud, Maria Pia Ruggieri, Stephan Steuer, Òscar Miró, Veli-Pekka Harjola, Fulvio Morello, Peiman Nazerian, Dominik Roth, José Luis Zamorano, Deborah Erica Gannon, Jason Pott, Mohammed Oa Abubakr, Hyun Suk Yang, Joe Young, Richina Bicette, Andreea Cuculici, Héctor Bueno, Juan Sanchis, Christian Mueller

Faculty, Staff and Students Publications

Background: International practice guidelines recommend the more rapid European Society of Cardiology (ESC) 0/1h-algorithm for the triage of patients with suspected myocardial infarction (MI) as the preferred option and consider the ESC 0/3h-algorithm as an alternative. However, many centers worldwide have not yet adopted the ESC 0/1h-algorithm in clinical practice due to uncertainty which approach best balances safety and efficacy.

Methods: PRESC1SE-MI (PRospective Evaluation of the European Society of Cardiology 0/1h-algorithm`s Safety and Efficacy for Triage of Patients with Suspected Myocardial Infarction) is an international, investigator-initiated multicenter, stepped-wedge, cluster randomized controlled trial. At least 52,156 consecutive adult patients with nontraumatic …

Baseline Characteristics In The Synchronize™-2 Randomized Phase 3 Trial Of Survodutide, A Glucagon Receptor/Glp-1 Receptor Dual Agonist, For Obesity In People With Type 2 Diabetes, Sean Wharton, Carel W Le Roux, Biykem Bozkurt, Elke Platz, Gabriele Bleckert, Samina Ajaz Hussain, Martina Brueckmann, Elena Startseva, Isabel M Kloer, Lee M Kaplan

Faculty, Staff and Students Publications

Aims: Survodutide is an investigational glucagon receptor/glucagon-like peptide-1 receptor dual agonist that has shown promise for treating obesity and its complications in Phase 2 trials. Two double-blind, randomized, global Phase 3 trials are designed to assess the efficacy and safety of survodutide for treatment of obesity-SYNCHRONIZE™-1 in people with obesity without type 2 diabetes (T2D) and SYNCHRONIZE™-2 in people with obesity and T2D. This paper describes the baseline characteristics of participants in SYNCHRONIZE-2 (ClinicalTrials.gov identifier NCT06066528).

Materials and methods: Participants aged ≥18 years with a body mass index (BMI) ≥27 kg/m2 and T2D were randomized 1:1:1 to weekly subcutaneous …

Maternal Myo-Inositol Intake And Congenital Heart Defects In Offspring: A Population-Based Case-Control Study, Ruiqi Cen, L Joseph Su, Jun Ying, Mohammed S Orloff, Elijah H Bolin, Xiangyang Lou, Lynn M Almli, Lorenzo D Botto, Marilyn L Browne, Richard H Finnell, Mary M Jenkins, Eirini Nestoridi, Andrew F Olshan, Paul A Romitti, Gary M Shaw, Wendy N Nembhard

Faculty, Staff and Students Publications

Objective: To investigate associations between maternal periconceptional (three months prior through the third pregnancy month) myo-inositol intake and the odds of selected congenital heart defects in offspring.

Design: A population-based case-control study using the National Birth Defects Prevention Study (NBDPS) database.

Setting: United States.

Population or sample: Women with singleton live births without major birth defects (controls) and women with singleton live births, stillbirths, or terminations with selected nonsyndromic congenital heart defects (CHD; cases).

Methods: Descriptive analyses, logistic regression models, ascertainment of myo-inositol intake from supplements and food using a shortened food frequency questionnaire and survey.

Main outcome measures: Odds …

Participant Retention In A Prospective Multicenter Cohort Of Participants With Pancreatitis And Factors Associated With Attrition, Radmila Choate, Jun Xu, Jeffrey J Easler, Samuel Han, Anna E Phillips, Melena D Bellin, William E Fisher, Evan L Fogel, Chris Forsmark, Phil A Hart, Stephen J Pandol, Walter G Park, Jose Serrano, Stephen K Van Den Eeden, Santhi Swaroop Vege, Liang Li, Darwin L Conwell, Dhiraj Yadav

Faculty, Staff and Students Publications

Objectives: Participant retention is essential in prospective studies to minimize bias and maintain validity. This study aimed to estimate retention rates and identify factors influencing attrition in a multicenter cohort (PROCEED) of US adults with acute/recurrent acute pancreatitis (AP/RAP) and chronic pancreatitis (CP).

Methods: Participants from the PROCEED study with AP/RAP or CP eligible for follow-up within the designated visit window were included. Retention was defined as completing at least one follow-up visit during the observation period. Retention was analyzed by follow-up mode (in-person and/or medical record review) and disease type (AP/RAP and CP). Retention factors were assessed using univariate …

An Examination Of Racial Bias In Scoring The Autism Diagnostic Observation Schedule (Ados) Module 3: An Item Response Theory Analysis, Yuen Yvonne Yu, Austin Wyman, Calliana J Faulk, Lizzy J Fulop, Rebecca L Greenberg, Rachel M Benecke, Lauren K Steinbeck, Jessica Foy, Caitlyn Kim, George O Emory, Eric A Storch, Casey J Zampella, Benjamin E Yerys, Robert T Schultz, Julia Parish-Morris, John D Herrington, Caitlin C Clements

Faculty, Staff and Students Publications

Given the rising prevalence of autism among racial minority children in the United States, but persistent service use disparities, this study examines potential bias in specific items from the autism diagnostic observation schedule (ADOS), a highly regarded autism evaluation. We leveraged unidimensional item response theory graded response models and a sample of 735 children to analyze the differential item functioning (DIF) of items within ADOS Module 3. Three items showed significant signs of racial bias: A1 (overall language level), A5 (offers information), and D5 (compulsions and rituals). On these items, Black/African American and Asian children were usually more likely to …

"He Just Wants Someone To Hear Him And Listen To Him": Barriers And Facilitators To Autistic Youth With Anxiety Receiving Quality Mental Healthcare, Daylin Delgado, Shannon C Lapoint, Grace Lee Simmons, Julia M Heinly, Whitney S Shepherd De, Bridgett Kiernan, Lauren Brookman-Frazee, Eric A Storch, Brenna B Maddox

Faculty, Staff and Students Publications

About half of autistic youth present with clinically interfering anxiety. Psychotherapies with exposure-focused elements are effective in academic clinical settings and controlled trials. However, there is relatively less research examining the implementation of modified interventions for autistic youth with anxiety in community mental health settings. The current study explores community members' perceptions of barriers and facilitators that impact autistic youth with anxiety's receipt of quality mental health services in their community. Semi-structured interviews were conducted with 15 autistic youth, 15 caregivers of autistic youth, 11 community mental health clinicians, and 8 community mental health clinic leaders. Interviews were analyzed thematically. …

Evaluating The Genetic Overlap Between Congenital Heart Disease And Neuroblastoma Risk., Ji Yun Tark, Alexander Renwick, Yao Yu, Aniko Sabo, Andrew F Olshan, Sharon E Plon, Chad D Huff, Philip J Lupo

Faculty, Staff and Students Publications

Children with congenital heart disease (CHD) have elevated neuroblastoma (NB) risk, potentially due to shared neural crest origins. We analyzed rare exonic de novo single-nucleotide variants in 702 CHD and 454 NB trios from the Neuroblastoma Epidemiology in North America Study, Gabriella Miller Kids First Program, and a published cohort. Seven genes, including CHD risk genes POGZ and LZTR1 (linked to Noonan syndrome and Schwannomatosis), showed nominal (p < 0.05) enrichment in both cohorts. CIC, IREB2, POGZ, and PCDHG cluster are associated with neurodevelopmental disorders, supporting shared developmental mechanisms. Findings warrant investigation of pathways linking congenital anomalies and childhood cancer.

Aladdin: A Machine Learning Approach To Enhance The Prediction Of Significant Fibrosis Or Higher In Metabolic Dysfunction-Associated Steatotic Liver Disease, Naim Alkhouri, Terry Cheuk-Fung Yip, Laurent Castera, Marina Takawy, Leon A Adams, Nipun Verma, Juan Pablo Arab, Syed-Mohammed Jafri, Bihui Zhong, Julie Dubourg, Vincent L Chen, Ashwani K Singal, Luis Antonio Díaz, Nicholas Dunn, Rida Nadeem, Vincent Wai-Sun Wong, Manal F Abdelmalek, Zhengyi Wang, Ajay Duseja, Yousef Almahanna, Haya A Omeish, Junzhao Ye, Stephen A Harrison, Jessica Cristiu, Marco Arrese, Sage Robert, Grace Lai-Hung Wong, Amani Bajunayd, Congxiang Shao, Matthew Kubina, Winston Dunn

Faculty, Staff and Students Publications

Introduction: The recent US Food and Drug Administration approval of resmetirom for treating metabolic dysfunction-associated steatohepatitis in patients necessitates patient selection for significant fibrosis or higher (≥F2). No existing vibration-controlled transient elastography (VCTE) algorithm targets ≥F2.

Methods: The mAchine Learning ADvanceD fibrosis and rIsk metabolic dysfunction-associated steatohepatitis Novel predictor (ALADDIN) study addressed this gap by introducing a machine-learning-based web calculator that estimates the likelihood of significant fibrosis using routine laboratory parameters with and without VCTE. Our study included a training set of 827 patients, a testing set of 504 patients with biopsy-confirmed metabolic dysfunction-associated steatotic liver disease from 6 centers, …