Training T-shaped translational scientists.

Unlabelled: To evaluate the design of I-Corps@NCATS as a translational scientist training program, we mapped specific elements of the program's content and pedagogy to the characteristics of a translational scientist, as first defined by Gilliland et al. []: systems thinker, process innovator, boundary spanner, team player, and skilled communicator. Using a mixed-methods evaluation, we examined how the I-Corps@NCATS training program, delivered across twenty-two Clinical and Translational Science Award Hubs, impacted the development of these key translational scientist characteristics.

Dynamics of SARS-CoV-2 Seroprevalence in a Large US population Over a Period of 12 Months.

Due to a combination of asymptomatic or undiagnosed infections, the proportion of the United States population infected with SARS-CoV-2 was unclear from the beginning of the pandemic. We previously established a platform to screen for SARS-CoV-2 positivity across a representative proportion of the US population, from which we reported that almost 17 million Americans were estimated to have had undocumented infections in the Spring of 2020. Since then, vaccine rollout and prevalence of different SARS-CoV-2 variants have further altered seropositivity trends within the United States population.

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.

Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC).

Harmonized Multisite MRI-Based Quantification of Human Liver Fat and Stiffness: A Pilot Study.

Background: Nonalcoholic fatty liver disease (NAFLD) is a leading cause of end-stage liver disease. NAFLD diagnosis and follow-up relies on a combination of clinical data, liver imaging, and/or liver biopsy. However, intersite imaging differences impede diagnostic consistency and reduce the repeatability of the multisite clinical trials necessary to develop effective treatments.

Percutaneous arteriovenous fistula creation in the management of severe Hemophilia A and end-stage kidney disease needing hemodialysis access, and beyond.

With the contemporary KDOQI, a patient-focused approach in vascular access care is emphasized more than ever when planning RRT. Nevertheless, functional vascular access continues to be the Achilles' heel for successful hemodialysis in specific patient sub-groups, such as the Hemophilia-A population. The newer percutaneous endovascular approach is a safer alternative when conventional surgical AVF poses high bleeding risks perioperatively, which subsequently prevents ESKD patients to have desired permanent dialysis access.

The Pittman Scholar Program for junior faculty recognition at the University of Alabama at Birmingham Heersink School of Medicine.

The University of Alabama at Birmingham Heersink School of Medicine established the Pittman Scholars Program in 2015 to elevate scientific impact and to support the recruitment and retention of highly competitive junior faculty. The authors examined the impact of this program on research productivity and on faculty retention. The authors evaluated publications and extramural grant awards and available demographic data for the Pittman Scholars compared to all junior faculty in the Heersink School of Medicine.

Leveraging CTSA hubs for rapid, large-scale, high-impact research: A case study during a global public health emergency.

As the COVID-19 pandemic took hold in the USA in early 2020, it became clear that knowledge of the prevalence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among asymptomatic individuals could inform public health policy decisions and provide insight into the impact of the infection on vulnerable populations. Two Clinical and Translational Science Award (CTSA) Hubs and the National Institutes of Health (NIH) set forth to conduct a national seroprevalence survey to assess the infection's rate of spread. This partnership was able to quickly design and launch the project by leveraging established research capacities, prior experiences in large-scale, multisite studies and a highly skilled workforce of CTSA hubs and unique experimental capabilities at the NIH to conduct a diverse prospective, longitudinal observational cohort of 11,382 participants who provided biospecimens and participant-reported health and behavior data.

Letter to the Editor Response: Exploring COVID-19 Vaccine Hesitancy Among Stakeholders in African American and Latinx Communities in the Deep South Through the Lens of the Health Belief Model.

The purpose of this submission to respond to a Letter to the Editor recently submitted regarding our manuscript, "Exploring COVID-19 Vaccine Hesitancy among Stakeholders in African American and Latinx Communities in the Deep South through the Lens of the Health Belief Model" published in the American Journal of Health Promotion in February, 2022. The manuscript reported on a study that had as its purpose to qualitatively explore perceptions related to COVID-19 vaccination intention among African American and Latinx participants and suggest potential intervention strategies.

Multi-ancestry genome-wide association analyses identify novel genetic mechanisms in rheumatoid arthritis.

Rheumatoid arthritis (RA) is a highly heritable complex disease with unknown etiology. Multi-ancestry genetic research of RA promises to improve power to detect genetic signals, fine-mapping resolution and performances of polygenic risk scores (PRS). Here, we present a large-scale genome-wide association study (GWAS) of RA, which includes 276,020 samples from five ancestral groups.

Exploring COVID-19 Vaccine Hesitancy Among Stakeholders in African American and Latinx Communities in the Deep South Through the Lens of the Health Belief Model.

Purpose: The purpose of this study was to qualitatively explore perceptions related to COVID-19 vaccination intention among African American and Latinx participants and suggest intervention strategies.

Approach: Ninety minute virtual focus groups (N = 8), segmented by county, race and ethnicity were conducted with stakeholders from 3 vulnerable Alabama counties.

Participants: Participants (N = 67) were primarily African American and Latinx, at least 19 years, and residents or stakeholders in Jefferson, Mobile, and Dallas counties.

Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics.

The 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation. There was simultaneously a need to expand research to obtain crucial data about disease prognosis and therapy and enormous limitations on conducting research as localities and institutions limited travel and person-to-person contact. These imperatives resulted in major changes in the way research was conducted, including expediting Institutional Review Board review, shifting to remote interactions with participants, centralizing decision-making in prioritizing research protocols, establishing biobanks, adopting novel informatics platforms, and distributing study drugs in unconventional ways.

Building biorepositories in the midst of a pandemic.

Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention. They rely on the complex integration of scientific need, regulatory oversight, quality control in collection, processing and tracking, and linkage to robust phenotype information. The COVID-19 pandemic amplified many of these considerations and illuminated new challenges, all while academic health centers were trying to adapt to unprecedented clinical demands and heightened research constraints not witnessed in over 100 years.

Undiagnosed SARS-CoV-2 seropositivity during the first 6 months of the COVID-19 pandemic in the United States.

Asymptomatic SARS-CoV-2 infection and delayed implementation of diagnostics have led to poorly defined viral prevalence rates in the United States and elsewhere. To address this, we analyzed seropositivity in 9089 adults in the United States who had not been diagnosed previously with COVID-19. Individuals with characteristics that reflected the U.

Fine-mapping, trans-ancestral and genomic analyses identify causal variants, cells, genes and drug targets for type 1 diabetes.

We report the largest and most diverse genetic study of type 1 diabetes (T1D) to date (61,427 participants), yielding 78 genome-wide-significant (P < 5 × 10) regions, including 36 that are new. We define credible sets of T1D-associated variants and show that they are enriched in immune-cell accessible chromatin, particularly CD4 effector T cells. Using chromatin-accessibility profiling of CD4 T cells from 115 individuals, we map chromatin-accessibility quantitative trait loci and identify five regions where T1D risk variants co-localize with chromatin-accessibility quantitative trait loci.

Returning to Growth: One Academic Medical Center's Successful Five-Step Approach to Change Management.

The University of Alabama at Birmingham academic medical center (UAB AMC) had achieved great success and growth during the 50 years since its founding. However, the challenging and more competitive environment of the 2000s left the UAB AMC on a downward trajectory. The UAB AMC had to overcome difficult internal cultural and structural barriers that stood in the way of the transformational change needed to remain competitive.

Mapping a Pandemic: SARS-CoV-2 Seropositivity in the United States.

Asymptomatic SARS-CoV-2 infection and delayed implementation of diagnostics have led to poorly defined viral prevalence rates. To address this, we analyzed seropositivity in US adults who have not previously been diagnosed with COVID-19. Individuals with characteristics that reflect the US population ( = 11,382) and who had not previously been diagnosed with COVID-19 were selected by quota sampling from 241,424 volunteers (ClinicalTrials.

Skewed allelic expression on X chromosome associated with aberrant expression of XIST on systemic lupus erythematosus lymphocytes.

A common feature of autoimmune diseases, including systemic lupus erythematosus (SLE), is an increased prevalence in women. However, the molecular basis for sex disparity in SLE remains poorly understood. To examine the role of X-linked transcription in SLE adaptive immune cells, we performed RNA-seq in T cell and B cell subsets from either healthy donors or patients with SLE.

Complement genes contribute sex-biased vulnerability in diverse disorders.

Many common illnesses, for reasons that have not been identified, differentially affect men and women. For instance, the autoimmune diseases systemic lupus erythematosus (SLE) and Sjögren's syndrome affect nine times more women than men, whereas schizophrenia affects men with greater frequency and severity relative to women. All three illnesses have their strongest common genetic associations in the major histocompatibility complex (MHC) locus, an association that in SLE and Sjögren's syndrome has long been thought to arise from alleles of the human leukocyte antigen (HLA) genes at that locus.

Translational Research-For the Individual and the Community.

The potential for translational research to improve human health is unprecedented, as the integration of genetic health risks with other data influencing health provides substantial opportunities for improvement. However, how integrating these data sources in a fair, unbiased and appropriate way without reinforcing pre-existing assumptions requires thoughtful implementation. Furthermore, integration of new technologies requires assessment of needs and benefits for the individual balanced with community needs and goals.

Population-Specific Patterns of Epigenetic Defects in the B Cell Lineage in Patients With Systemic Lupus Erythematosus.

Objective: To determine the stage of B cell development at which a systemic lupus erythematosus (SLE)-associated DNA methylation signature originates in African American (AA) and European American (EA) subjects, and to assess whether epigenetic defects in B cell development patterns could be predictive of SLE status in individual and mixed immune cell populations.

Methods: B cells from AA patients (n = 31) and EA patients (n = 49) with or without SLE were sorted using fluorescence-activated cell sorting into 5 B cell subsets. DNA methylation, measured at ~460,000 CpG sites, was interrogated in each subset.

Come from away: Best practices in mini-sabbaticals for the development of young investigators: a White Paper by the SEQUIN (mini-Sabbatical Evaluation and QUality ImprovemeNt) Group.

Mini-sabbaticals are formal short-term training and educational experiences away from an investigator's home research unit. These may include rotations with other research units and externships at government research or regulatory agencies, industry and non-profit programs, and training and/or intensive educational programs. The National Institutes of Health have been encouraging training institutions to consider offering mini-sabbaticals, but given the newness of the concept, limited data are available to guide the implementation of mini-sabbatical programs.