Digital Commons Network^™

The Extracellular Contractile Injection System Is Enriched In Environmental Microbes And Associates With Numerous Toxins, Alexander Martin Geller, Inbal Pollin, David Zlotkin, Aleks Danov, Nimrod Nachmias, William B. Andreopoulos, Keren Shemesh, Asaf Levy

Faculty Research, Scholarly, and Creative Activity

The extracellular Contractile Injection System (eCIS) is a toxin-delivery particle that evolved from a bacteriophage tail. Four eCISs have previously been shown to mediate interactions between bacteria and their invertebrate hosts. Here, we identify eCIS loci in 1,249 bacterial and archaeal genomes and reveal an enrichment of these loci in environmental microbes and their apparent absence from mammalian pathogens. We show that 13 eCIS-associated toxin genes from diverse microbes can inhibit the growth of bacteria and/or yeast. We identify immunity genes that protect bacteria from self-intoxication, further supporting an antibacterial role for some eCISs. We also identify previously undescribed eCIS …

Community Norms Of The Muscle Dysmorphic Disorder Inventory (Mddi) Among Cisgender Sexual Minority Men And Women, Jason M. Nagata, Emilio J. Compte, Chloe J. Cattle, Jason M. Lavender, Tiffany A. Brown, Stuart B. Murray, Annesa Flentje, Matthew R. Capriotti, Micah E. Lubensky, Juno Obedin-Maliver, Mitchell R. Lunn

Faculty Research, Scholarly, and Creative Activity

Background: Representing the pathological extreme pursuit of muscularity, muscle dysmorphia (MD) is characterized by a pervasive belief or fear around insufficient muscularity and an elevated drive for muscularity. Despite evidence of elevated body image-related concerns among sexual minority populations, little is known about the degree of muscle dysmorphia (MD) symptoms among sexual minorities, particularly based on Muscle Dysmorphic Disorder Inventory (MDDI) scores. The objective of this study was to examine the nature and severity of MD symptoms in cisgender sexual minority men and women and provide community norms of the MDDI for these populations. Methods: Data from participants in The …

Species And Population Specific Gene Expression In Blood Transcriptomes Of Marine Turtles, Shreya M. Banerjee, Jamie Adkins Stoll, Camryn D. Allen, Jennifer M. Lynch, Heather S. Harris, Lauren Kenyon, Richard E. Connon, Eleanor J. Sterling, Eugenia Naro-Maciel, Kathryn Mcfadden, Margaret M. Lamont, James Benge, Nadia B. Fernandez, Jeffrey A. Seminoff, Scott R. Benson, Rebecca L. Lewison, Tomoharu Eguchi, For Full Author List, See Comments Below

Faculty Research, Scholarly, and Creative Activity

Background: Transcriptomic data has demonstrated utility to advance the study of physiological diversity and organisms’ responses to environmental stressors. However, a lack of genomic resources and challenges associated with collecting high-quality RNA can limit its application for many wild populations. Minimally invasive blood sampling combined with de novo transcriptomic approaches has great potential to alleviate these barriers. Here, we advance these goals for marine turtles by generating high quality de novo blood transcriptome assemblies to characterize functional diversity and compare global transcriptional profiles between tissues, species, and foraging aggregations. Results: We generated high quality blood transcriptome assemblies for hawksbill (Eretmochelys …

Hidden Markov Models Identify Major Movement Modes In Accelerometer And Magnetometer Data From Four Albatross Species, Melinda G. Conners, Théo Michelot, Eleanor I. Heywood, Rachael A. Orben, Richard A. Phillips, Alexei L. Vyssotski, Scott A. Shaffer, Lesley H. Thorne

Faculty Research, Scholarly, and Creative Activity

Background: Inertial measurement units (IMUs) with high-resolution sensors such as accelerometers are now used extensively to study fine-scale behavior in a wide range of marine and terrestrial animals. Robust and practical methods are required for the computationally-demanding analysis of the resulting large datasets, particularly for automating classification routines that construct behavioral time series and time-activity budgets. Magnetometers are used increasingly to study behavior, but it is not clear how these sensors contribute to the accuracy of behavioral classification methods. Development of effective classification methodology is key to understanding energetic and life-history implications of foraging and other behaviors. Methods: We deployed …

Potential Health And Economic Impacts Of Dexamethasone Treatment For Patients With Covid-19, Ricardo Águas, Adam Mahdi, Rima Shretta, Peter Horby, Martin Landray, Lisa White, Fatima Arifi, Chynar Zhumalieva, Inke N.D. Lubis, Antoninho Benjamin Monteiro, Ainura Moldokmatova, Siyu Chen, Aida Estebesova, Mofakhar Hussain, Dipti Lata, Emmanuel A. Bakare, Michael Klein, For Full Author List, See Comments Below

Faculty Research, Scholarly, and Creative Activity

Dexamethasone can reduce mortality in hospitalised COVID-19 patients needing oxygen and ventilation by 18% and 36%, respectively. Here, we estimate the potential number of lives saved and life years gained if this treatment were to be rolled out in the UK and globally, as well as the cost-effectiveness of implementing this intervention. Assuming SARS-CoV-2 exposure levels of 5% to 15%, we estimate that, for the UK, approximately 12,000 (4,250 - 27,000) lives could be saved between July and December 2020. Assuming that dexamethasone has a similar effect size in settings where access to oxygen therapies is limited, this would translate …

Impact Of The Who Surgical Safety Checklist Relative To Its Design And Intended Use: A Systematic Review And Meta-Meta-Analysis, Kenji T. Sotto, Barbara K. Burian, Mary E. Brindle

Faculty Research, Scholarly, and Creative Activity

Background
The aim of this study was to identify what parts of the World Health Organization Surgical Safety Checklist (WHO SSC) are working, what can be done to make it more effective, and to determine if it achieved its intended effect relative to its design and intended use.
Study Design
We conducted a qualitative thematic analysis and meta-meta-analyses of findings in WHO SSC systematic reviews following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.
Results
Twenty systematic reviews were included for qualitative thematic analysis. Narrative information was coded in 4 primary areas with a focus on impact of …

The Invisible Language: Unintentional Patronage And Missions Practice In Contemporary Thailand, Samuel Burton Jones

Electronic Theses and Dissertations

Patronage-clientelism is a current and important topic of discussion among the anthropological and missiological community. The effects of unintended patronage by Western missionaries in the context of Thai culture, however, are underexplored in academic research. In this study, I analyzed the effects of unintentional patronage among Western missionaries in a Thai cross-cultural ministry context. To do this I utilized a multiple case study method in which I compared four cases and analyzed for examples of how unintentional patronage is generated. I discovered that unintentional patronage was likely a result of insufficient missionary education regarding patronage-clientelism, as well as a lack …

The Impact Of Leadership And Institutional Priorities On Degree Completion Of Community College Students, Estelle L. Garza

Electronic Theses and Dissertations

This study explored student perceptions of leadership and the impact they believed it to have on their ability to complete a degree at a community college district. Community college degree completion is both a statewide and national problem as most students who start a degree program will drop out before reaching the requirements to finish their degree, which can hurt their career opportunities and the economy. The purpose of this study was to determine how students perceive factors like leadership and their satisfaction with institutional priority factors to impact degree completion. This study used action research and a mixed methods …

The Human Right To Water And Sanitation: Using Natural Language Processing To Uncover Patterns In Academic Publishing, Christopher Michael Faulkner, Joshua Earl Lambert, Bruce M. Wilson, Matthew Steven Faulkner

Faculty Research, Scholarly, and Creative Activity

After years of advocacy and international negotiation, the General Assembly of the United Nations voted to officially recognize a stand-alone human right to water and sanitation on 28 July 2010. Since, academic scholarship has continued to grow in an effort to understand the implications of the codification of this human right. Yet, with this growth, it has become impractical if not impossible for scholars to keep up with the advancement of academic knowledge or to make sense of it in a systematic way. In short, to date, we know very little about the trends in the literature as they have …

Punnett Squares Or Protein Production? The Expert–Novice Divide For Conceptions Of Genes And Gene Expression, Dina L. Newman, Aeowynn Coakley, Aidan Link, Korinne Mills, L. Kate Wright

Faculty Research, Scholarly, and Creative Activity

Concepts of molecular biology and genetics are difficult for many biology undergraduate students to master yet are crucial for deep understanding of how life works. By asking students to draw their ideas, we attempted to uncover the mental models about genes and gene expression held by biology students (n = 23) and experts (n = 18) using semistructured interviews. A large divide was identified between novice and expert conceptions. While experts typically drew box-and-line representations and thought about genes as regions of DNA that were used to encode products, students typically drew whole chromosomes rather than focusing on gene structure …

Drivers Of Understory Plant Communities In Sierra Nevada Mixed Conifer Forests With Pyrodiversity, Kate Wilkin, Lauren Ponisio, Danny L. Fry, Brandon M. Collins, Tadashi Moody, Scott L. Stephens

Faculty Research, Scholarly, and Creative Activity

Background: Fire suppression in western North America increased and homogenized overstory cover in conifer forests, which likely affected understory plant communities. We sought to characterize understory plant communities and their drivers using plot-based observations from two contemporary reference sites in the Sierra Nevada, USA. These sites had long-established natural fire programs, which have resulted in restored natural fire regimes. In this study, we investigated how pyrodiversity—the diversity of fire size, severity, season, and frequency—and other environment factors influenced species composition and cover of forest understory plant communities. Results: Understory plant communities were influenced by a combination of environmental, plot-scale recent …

Immunological And Hematological Outcomes Following Protracted Low Dose/Low Dose Rate Ionizing Radiation And Simulated Microgravity, Amber M. Paul, Eliah G. Overbey, Willian A. Da Silveira, Nathaniel Szewczyk, Nina C. Nishiyama, Michael J. Pecaut, Sulekha Anand, Jonathan M. Galazka, Xiao Wen Mao

Faculty Research, Scholarly, and Creative Activity

Using a ground-based model to simulate spaceflight [21-days of single-housed, hindlimb unloading (HLU) combined with continuous low-dose gamma irradiation (LDR, total dose of 0.04 Gy)], an in-depth survey of the immune and hematological systems of mice at 7-days post-exposure was performed. Collected blood was profiled with a hematology analyzer and spleens were analyzed by whole transcriptome shotgun sequencing (RNA-sequencing). The results revealed negligible differences in immune differentials. However, hematological system analyses of whole blood indicated large disparities in red blood cell differentials and morphology, suggestive of anemia. Murine Reactome networks indicated majority of spleen cells displayed differentially expressed genes (DEG) …

Adaptive Laboratory Evolution Of Β-Caryophyllene Producing Saccharomyces Cerevisiae, Avinash Godara, Katy C. Kao

Faculty Research, Scholarly, and Creative Activity

Background: β-Caryophyllene is a plant terpenoid with therapeutic and biofuel properties. Production of terpenoids through microbial cells is a potentially sustainable alternative for production. Adaptive laboratory evolution is a complementary technique to metabolic engineering for strain improvement, if the product-of-interest is coupled with growth. Here we use a combination of pathway engineering and adaptive laboratory evolution to improve the production of β-caryophyllene, an extracellular product, by leveraging the antioxidant potential of the compound. Results: Using oxidative stress as selective pressure, we developed an adaptive laboratory evolution that worked to evolve an engineered β-caryophyllene producing yeast strain for improved production within …

Fuel Load, Stand Structure, And Understory Species Composition Following Prescribed Fire In An Old-Growth Coast Redwood (Sequoia Sempervirens) Forest, David Cowman, Will Russell

Faculty Research, Scholarly, and Creative Activity

Background: With the prevalence of catastrophic wildfire increasing in response to widespread fire suppression and climate change, land managers have sought methods to increase the resiliency of landscapes to fire. The application of prescribed burning in ecosystems adapted to fire can reduce fuel load and fire potential while minimizing impacts to the ecosystem as a whole. Coast redwood forests have historically experienced fire from both natural and anthropogenic sources, and are likely to respond favorably to its reintroduction. Results: Random sampling was conducted in three burned sites and in three unburned sites, in an old-growth coast redwood (Sequoia sempervirens [D. …

How Should Medical Schools Foster Equity And Inclusion In Admissions?, Adela Valdez, Lala Forrest, Alessandra Jimenez, Kim-Thu Pham

School of Medicine Publications

This commentary in response to a case considers how merit and features of medical school applicants’ dossiers should be drawn upon in admissions processes to promote equity and inclusion in medicine. It is argued that medical schools should incentivize inclusion by redefining merit in their admissions goals and processes, promote meaningful inclusion, and show institutional leadership in addressing social justice.

The Landscape Of Renal Replacement Therapy In Veterans Affairs Medical Center Intensive Care Units, Chandan Vangala, Maulin Shah, Natasha N Dave, Layth Al Attar, Sankar D Navaneethan, Venkat Ramanathan, Susan Crowley, Wolfgang C Winkelmayer

Faculty, Staff and Students Publications

BACKGROUND: Outpatient dialysis is standardized with several evidence-based measures of adequacy and quality that providers aim to meet while providing treatment. By contrast, in the intensive care unit (ICU) there are different types of prolonged and continuous renal replacement therapies (PIRRT and CRRT, respectively) with varied strategies for addressing patient care and a dearth of nationally accepted quality parameters. To eventually describe appropriate quality measures for ICU-related renal replacement therapy (RRT), we first aimed to capture the variety and prevalence of basic strategies and equipment utilized in the ICUs of Veteran Affairs (VA) medical facilities with inpatient hemodialysis capabilities.

METHODS: …

The Bridwell Quill. Issues 39-40: The Mystic & The Muse, Anthony Elia

Bridwell Library Publications

No abstract provided.

Combined Amplification And Sound Therapy For Individuals With Tinnitus And Coexisting Hearing Loss: A Retrospective Cohort Study, Purushothaman Ganesan, Hansapani Rodrigo, Jason Schmiedge, Rob Reiter, Simham Swapna, Vinaya Manchaiah

School of Mathematical & Statistical Sciences Faculty Publications

BACKGROUND: The heterogeneity of tinnitus perception and its impact necessitates a tailor-made management approach in everyone. The current study examined the effects of residual inhibition in combined amplification and sound therapy in individuals with tinnitus and coexisting hearing loss.

METHODS: A retrospective analysis was performed on patients with tinnitus and coexisting hearing loss between 2016 and 2019. A total of 72 patients provided with combined amplification and sound therapy were divided into 3 groups based on residual inhibition: (i) complete residual inhibition, (ii) partial residual inhibition, and (iii) negative residual inhibition. Tinnitus severity was measured using the Tinnitus …

The Sun In Its Glory: The Diffusion Of Jonathan Dymond’S Works In The United States, 1831-1836, Jennifer Rycenga

Faculty Research, Scholarly, and Creative Activity

The English Quaker and linen-draper Jonathan Dymond (1796-1828) is best known for his strong philosophic articulation of the testimony against war. The first American edition of Dymond’s work, though, was published not by Quakers but by a small group of activist-thinkers in north-eastern Connecticut, the Windham County Peace Society, which issued a thousand copies of Dymond’s The Applicability of the Pacific Principles of the New Testament to the Conduct of States in the spring of 1832. Dymond’s systematic moral philosophy extended into many corners of the burgeoning philanthropic movements in New England, most notably among Immediate Abolitionists, within the Peace …

Bioabsorbable Metal Zinc Differentially Affects Mitochondria In Vascular Endothelial And Smooth Muscle Cells, Olivia R. M. Bagshaw, Fereshteh Moradi, Christopher S. Moffatt, Hillary A. Hettwer, Ping Liang, Jeremy Goldman, Jaroslaw Drelich, Jeffrey A. Stuart

Michigan Tech Publications, Part 1

Zinc is an essential trace element having various structural, catalytic and regulatory interactions with an estimated 3000 proteins. Zinc has drawn recent attention for its use, both as pure metal and alloyed, in arterial stents due to its biodegradability, biocompatibility, and low corrosion rates. Previous studies have demonstrated that zinc metal implants prevent the development of neointimal hyperplasia, which is a common cause of restenosis following coronary intervention. This suppression appears to be smooth muscle cell-specific, as reendothelization of the neointima is not inhibited. To better understand the basis of zinc's differential effects on rat aortic smooth muscle (RASMC) versus …

3d Printing In Cardiology: A Review Of Applications And Roles For Advanced Cardiac Imaging, Ellen M. Lindquist, Jordan M. Gosnell, Sana K. Khan, John L. Byl, Weihua Zhou, Jingfeng Jiang, Et. Al.

Michigan Tech Publications, Part 1

With the rate of cardiovascular diseases in the U.S increasing throughout the years, there is a need for developing more advanced treatment plans that can be tailored to specific patients and scenarios. The development of 3D printing is rapidly gaining acceptance into clinical cardiology.

In this review, key technologies used in 3D printing are briefly summarized, particularly, the use of artificial intelligence (AI), open-source tools like MeshLab and MeshMixer, and 3D printing techniques such as fused deposition molding (FDM) and polyjet are reviewed. The combination of 3D printing, multiple image integration, and augmented reality may greatly enhance data visualization …

Characterization Of Coupling Between Inertial Particles And Turbulent Wakes From Porous Disk Generators, Kristin N. Travis, Sarah E. Smith, Laure Vignal, Henda Djeridi, Mickael Bourgoin, Raul Bayoan Cal, Martin Obligado

Mechanical and Materials Engineering Faculty Publications and Presentations

This study presents the findings of a wind tunnel experiment investigating the behaviour of micrometric inertial particles with Stokes numbers around unity in the turbulent wake of a stationary porous disk. Various concentrations Φv ∈ ([6 − 19] × 10−6) of poly-disperse water droplets (average diameter 40–50μm) are compared with sub-inertial tracer particles. Hot-wire anemometry, phase Doppler interferometry and particle image velocimetry were implemented in the near- and far-wake regions to study the complex dynamics of such particles. Quadrant analysis is used to explore the shear effects of the particle wake interaction. Turbulence statistics and particle size distributions reveal distinct …

Models Versus Datasets: Reducing Bias Through Building A Comprehensive Ids Benchmark, Rasheed Ahmad, Izzat Alsmadi, Wasim Alhamdani, Lo'ai A. Tawalbeh

Computer Science Faculty Publications (Archived)

Today, deep learning approaches are widely used to build Intrusion Detection Systems for securing IoT environments. However, the models’ hidden and complex nature raises various concerns, such as trusting the model output and understanding why the model made certain decisions. Researchers generally publish their proposed model’s settings and performance results based on a specific dataset and a classification model but do not report the proposed model’s output and findings. Similarly, many researchers suggest an IDS solution by focusing only on a single benchmark dataset and classifier. Such solutions are prone to generating inaccurate and biased results. This paper overcomes these …

Achieving Excellence For California’S Freight System: Developing Competitiveness And Performance Metrics; Incorporating Sustainability, Resilience, And Workforce Development, Jian-Yu Ke, Fynnwin Prager, Jose Martinez, Chris Cagle

Mineta Transportation Institute

This study explores the question of whether California's freight system is staying competitive with other US regions. A novel analytical framework compares supply chain performance metrics across multiple US states and regions for seaports, airports, highways, freight rail service, and distribution centers by combining the Performance Evaluation Matrix (PEM), Competitive Position Matrix (CPM), and Business Process Management (BPM) approaches. Analysis of industry data and responses from structured interviews with 30 freight industry experts across 5 transportation sectors suggests that California's freight system is competitive for seaports, airports, and freight rail; however, highways and distribution centers have room for improvement with …

Prenatal Risk Factors And Neonatal Dna Methylation In Very Preterm Infants, Marie Camerota, Stefan Graw, Todd M. Everson, Elisabeth C. Mcgowan, Julie A. Hofheimer, T. Michael O’Shea, Brian S. Carter, Jennifer B. Helderman, Jennifer Check, Charles R. Neal, Steven L. Pastyrnak, Lynne M. Smith, Lynne M. Dansereau, Sheri A. Dellagrotta, Carmen J. Marsit, Barry M. Lester

Manuscripts, Articles, Book Chapters and Other Papers

Background: Prenatal risk factors are related to poor health and developmental outcomes for infants, potentially via epigenetic mechanisms. We tested associations between person-centered prenatal risk profiles, cumulative prenatal risk models, and epigenome-wide DNA methylation (DNAm) in very preterm neonates. Methods: We studied 542 infants from a multi-center study of infants born < 30 weeks postmenstrual age. We assessed 24 prenatal risk factors via maternal report and medical record review. Latent class analysis was used to define prenatal risk profiles. DNAm was quantified from neonatal buccal cells using the Illumina MethylationEPIC Beadarray. Results: We identified three latent profiles of women: a group with few risk factors (61%) and groups with elevated physical (26%) and psychological (13%) risk factors. Neonates born to women in higher risk subgroups had differential DNAm at 2 CpG sites. Higher cumulative prenatal risk was associated with methylation at 15 CpG sites, 12 of which were located in genes previously linked to physical and mental health and neurodevelopment. Conclusion: We observed associations between prenatal risk factors and DNAm in very preterm infants using both person-centered and cumulative risk approaches. Epigenetics offers a potential biological indicator of prenatal risk exposure.

Pfoa Loaded Gac Fall 2021 Report, Ramiro Nava

Water Resources Science and Technology Theses and Graduate Research Reports (Archived)

No abstract provided.

Diagnostic Yield Of Genetic Testing In 324 Infants With Hypotonia., Sonal Sharma, Elena Repnikova, Janelle R. Noel-Macdonnell Phd, Jean-Baptist Lepichon

Manuscripts, Articles, Book Chapters and Other Papers

This retrospective cohort study was designed to determine the yield of genetic tests in hypotonic infants and develop a diagnostic algorithm. Out of 496 patients identified by International Classification of Diseases (ICD) 9/10 coding, 324 patients met the inclusion criteria. Diagnostic yields were 32% for karyotype, 19% for microarray, 30% for targeted genetic tests, 38% for gene panels, and 31% for exome sequencing. In addition, we considered the diagnostic contribution of ancillary tests, including neuroimaging, metabolic tests, and so forth. The combination of microarray and exome sequencing gave the highest diagnostic yield. None of the other tests added significant value …

The Association Of Step-Based Metrics And Adiposity In The Hispanic Community Health Study/Study Of Latinos., Samantha Schilsky, Daniela Sotres-Alvarez, Wayne D. Rosamond, Gerardo Heiss, June Stevens, Nicole Butera, Jianwen Cai, Jordan A. Carlson, Carmen Cuthbertson, Martha Daviglus, Madison N. Lecroy, Amber Pirzada, Kelly R. Evenson

Manuscripts, Articles, Book Chapters and Other Papers

Objective: Examine cross-sectional and longitudinal associations of accelerometer measured step volume (steps/day) and cadence with adiposity and six-year changes in adiposity in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL).

Methods: HCHS/SOL's target population was 60% female with a mean age of 41 years. Cross-sectional (n = 12,353) and longitudinal analyses (n = 9,077) leveraged adjusted complex survey regression models to examine associations between steps/day, and cadence with weight (kg), waist circumference (cm) and body mass index (kg/m2). Effect measure modification by covariates was examined.

Results: Lower steps/day and intensity was associated with higher adiposity at baseline. Compared to those …

Multiplex Pcr Pathogen Detection In Acute Gastroenteritis Among Hospitalized Us Children Compared With Healthy Controls During 2011-2016 In The Post-Rotavirus Vaccine Era., Christopher J. Harrison, Ferdaus Hassan, Brian R. Lee, Julie Boom, Leila C. Sahni, Coreen Johnson, James Dunn, Daniel C. Payne, Mary E. Wikswo, Umesh Parashar, Rangaraj Selvarangan

Manuscripts, Articles, Book Chapters and Other Papers

Background: Despite vaccine-induced decreases in US rotavirus (RV) disease, acute gastroenteritis (AGE) remains relatively common. We evaluated AGE pathogen distribution in hospitalized US children in the post-RV vaccine era.

Methods: From December 2011 to June 2016, the New Vaccine Surveillance Network (NVSN) conducted prospective, active, population-based surveillance in hospitalized children with AGE. We tested stools from 2 NVSN sites (Kansas City, Houston) with Luminex x-TAG Gastrointestinal Pathogen Panels (Luminex GPP) and analyzed selected signs and symptoms.

Results: For 660 pediatric AGE inpatients and 624 age-matched healthy controls (HCs), overall organism detection was 51.2% and 20.6%, respectively (P < .001). Among AGE subjects, GPP polymerase chain reaction detected >1 virus …

Inter-Rater Reliability Of The Neonatal Adverse Event Severity Scale Using Real-World Neonatal Clinical Trial Data., Tamorah R. Lewis, Norma Terrin, Jonathan Davis, Kurt Michels, Thomas Salaets, Kelly Wade, International Neonatal Consortium

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: The Neonatal Adverse Event Severity Scale (NAESS) was developed to improve scoring of neonatal adverse events (AEs) and accelerate neonatal drug development. This is the first validation study of the novel tool.

STUDY DESIGN: Retrospective validation study assessing the inter-rater reliability (IRR) of the NAESS. Reviewers used real-world AE data from a neonatal trial. Intra-class correlation (ICC) statistical analysis was performed.

RESULT: Sixty AEs were randomly assigned to twelve reviewers for a total of 240 severity scores. Generic and AE-specific NAESS tables were assessed. The ICC was 0.63 (95% confidence interval 0.51 to 0.73). Percent variation due to reviewer …