Colorado Immersion Training in Community Engagement: Ten years of learning and doing.

The Colorado Immersion Training in Community Engagement (CIT) program supports a change in the research trajectory of junior faculty, early career researchers, and doctoral students toward Community-Based Participatory Research (CBPR). CIT is within the Community Engagement and Health Equity Core (CEHE) at the Colorado Clinical and Translational Sciences Institute (CCTSI), an NIH-funded Clinical and Translational Science award. This Translational Science Case Study reports on CIT's impacts from 2010 to 2019.

Team science competencies across the career life course for translational science teams.

Introduction: Translational science (TS) teams develop and conduct translational research. Academic TS teams can be categorized under three constituency groups: trainees and faculty, clinical research professionals (CRP), and community partners. Our study objectives were to define individual and team competencies of these three constituency groups during their career life course and determine relative importance and the level of mastery of each of the competencies needed at different stages of their life course.

A national unmet needs assessment for CTSA-affiliated electronic health record data networks: A customer discovery approach.

Introduction: The expansion of electronic health record (EHR) data networks over the last two decades has significantly improved the accessibility and processes around data sharing. However, there lies a gap in meeting the needs of Clinical and Translational Science Award (CTSA) hubs, particularly related to real-world data (RWD) and real-world evidence (RWE).

Methods: We adopted a mixed-methods approach to construct a comprehensive needs assessment that included: (1) A Landscape Context analysis to understand the competitive environment; and (2) Customer Discovery to identify stakeholders and the value proposition related to EHR data networks.

A Machine Learning Method for Allocating Scarce COVID-19 Monoclonal Antibodies.

Importance: During the COVID-19 pandemic, the effective distribution of limited treatments became a crucial policy goal. Yet, limited research exists using electronic health record data and machine learning techniques, such as policy learning trees (PLTs), to optimize the distribution of scarce therapeutics.

Objective: To evaluate whether a machine learning PLT-based method of scarce resource allocation optimizes the treatment benefit of COVID-19 neutralizing monoclonal antibodies (mAbs) during periods of resource constraint.

Real-world evaluation of early remdesivir in high-risk COVID-19 outpatients during Omicron including BQ.1/BQ.1.1/XBB.1.5.

Background: A trial performed among unvaccinated, high-risk outpatients with COVID-19 during the delta period showed remdesivir reduced hospitalization. We used our real-world data platform to determine the effectiveness of remdesivir on reducing 28-day hospitalization among outpatients with mild-moderate COVID-19 during an Omicron period including BQ.1/BQ.

Factors in COVID-19 vaccine uptake in five racial/ethnic Colorado communities: A report from the Colorado CEAL project.

Purpose: To understand motivators, concerns, and factors associated with COVID-19 vaccine initiation for adults in five racial/ethnic communities across Colorado.

Methods: Community-based data collectors surveyed participants from five Colorado communities (urban and rural Latina/o/x, urban Black, rural African American immigrant, and urban American Indian) about vaccine attitudes, intentions, and uptake from September to December 2021. Bivariate and multivariable logistic regression models were used to examine factors associated with the primary outcome of COVID-19 vaccine "initiation.

Association between monoclonal antibody therapy, vaccination, and longer-term symptom resolution after acute COVID-19.

Effective therapies for reducing post-acute sequelae of COVID-19 (PASC) symptoms are lacking. Evaluate the association between monoclonal antibody (mAb) treatment or COVID-19 vaccination with symptom recovery in COVID-19 participants. The longitudinal survey-based cohort study was conducted from April 2021 to January 2022 across a multihospital Colorado health system.

Effectiveness of subcutaneous monoclonal antibody treatment in emergency department outpatients with COVID-19.

Objectives: To evaluate whether subcutaneous neutralizing monoclonal antibody (mAb) treatment given in the emergency department (ED) setting was associated with reduced hospitalizations, mortality, and severity of disease when compared to nontreatment among mAb-eligible patients with coronavirus disease 2019 (COVID-19).

Methods: This retrospective observational cohort study of ED patients utilized a propensity score-matched analysis to compare patients who received subcutaneous casirivimab and imdevimab mAb to nontreated COVID-19 control patients in November-December 2021. The primary outcome was all-cause hospitalization within 28 days, and secondary outcomes were 90-day hospitalization, 28- and 90-day mortality, and ED length of stay (LOS).

Rapid Community Translation in the Colorado CEAL (CO-CEAL) Program: Transcreating Messaging to Promote COVID-19 Vaccination.

Providing communities with COVID-19 vaccination information is essential for optimizing equitable vaccine uptake. Using rapid community translation, adapted from Boot Camp Translation, five community teams transcreated COVID-19 vaccination campaigns. Transcreated messaging incorporated community attitudes, culture, and experiences.

Occult right ventricular dysfunction and right ventricular-vascular uncoupling in left ventricular assist device recipients.

Background: Detecting right heart failure post left ventricular assist device (LVAD) is challenging. Sensitive pressure-volume loop assessments of right ventricle (RV) contractility may improve our appreciation of post-LVAD RV dysfunction.

Methods: Thirteen LVAD patients and 20 reference (non-LVAD) subjects underwent comparison of echocardiographic, right heart cath hemodynamic, and pressure-volume loop-derived assessments of RV contractility using end-systolic elastance (Ees), RV afterload by effective arterial elastance (Ea), and RV-pulmonary arterial coupling (ratio of Ees/Ea).

The Evolve to Next-Gen ACT Network: An evolving open-access, real-world data resource primed for real-world evidence research across the Clinical and Translational Science Award Consortium.

The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become "Evolve to Next-Gen ACT" (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products.

Multi-omic approach identifies hypoxic tumor-associated myeloid cells that drive immunobiology of high-risk pediatric ependymoma.

Ependymoma (EPN) is a devastating childhood brain tumor. Single-cell analyses have illustrated the cellular heterogeneity of EPN tumors, identifying multiple neoplastic cell states including a mesenchymal-differentiated subpopulation which characterizes the PFA1 subtype. Here, we characterize the EPN immune environment, in the context of both tumor subtypes and tumor cell subpopulations using single-cell sequencing (scRNAseq, n = 27), deconvolution of bulk tumor gene expression (n = 299), spatial proteomics (n = 54), and single-cell cytokine release assays (n = 12).

I2N: image to nutrients, a sensor guided semi-automated tool for annotation of images for nutrition analysis of eating episodes.

Introduction: Dietary assessment is important for understanding nutritional status. Traditional methods of monitoring food intake through self-report such as diet diaries, 24-hour dietary recall, and food frequency questionnaires may be subject to errors and can be time-consuming for the user.

Methods: This paper presents a semi-automatic dietary assessment tool we developed - a desktop application called Image to Nutrients (I2N) - to process sensor-detected eating events and images captured during these eating events by a wearable sensor.

Outcomes of a Career Development Award (Pre-K) Mock Review Program for Postdoctoral Fellows and Early-Career Faculty.

Purpose: Securing research funding for early-career investigators remains challenging. The authors present the results of a presubmission career development award (Pre-K) review program for postdoctoral fellows and early-career faculty.

Method: The Pre-K program is designed to help mentored postdoctoral fellows and early-career faculty write successful career development awards by assigning expert reviewers to score each application and provide written and oral critiques before a mock study section.

The spectrum of eating environments encountered in free living adults documented using a passive capture food intake wearable device.

Introduction: The aim of this feasibility and proof-of-concept study was to examine the use of a novel wearable device for automatic food intake detection to capture the full range of free-living eating environments of adults with overweight and obesity. In this paper, we document eating environments of individuals that have not been thoroughly described previously in nutrition software as current practices rely on participant self-report and methods with limited eating environment options.

Methods: Data from 25 participants and 116 total days (7 men, 18 women, M = 44 ± 12 years, BMI 34.

Development and validation of a multivariable preoperative prediction model for postoperative length of stay in a broad inpatient surgical population.

Background: Postoperative length of stay is a meaningful patient-centered outcome and an important determinant of healthcare costs. The Surgical Risk Preoperative Assessment System preoperatively predicts 12 postoperative adverse events using 8 preoperative variables, but its ability to predict postoperative length of stay has not been assessed. We aimed to determine whether the Surgical Risk Preoperative Assessment System variables could accurately predict postoperative length of stay up to 30 days in a broad inpatient surgical population.

Real-world evaluation of bebtelovimab effectiveness during the period of COVID-19 Omicron variants, including BA.4/BA.5.

Objectives: Bebtelovimab is an anti-SARS-CoV-2 monoclonal antibody active against Omicron lineage variants authorized to treat high-risk outpatients with COVID-19. We sought to determine the real-world effectiveness of bebtelovimab during the Omicron phases BA.2/BA2.

Addressing leadership communication, parenting demands and mental health challenges: a mixed-methods case study of clinical and translational scientists during COVID-19.

Background: In March 2020, academic research centres in Colorado were closed to prevent the spread of COVID-19. Scientists and research staff were required to continue their work remotely with little time to prepare for the transition.

Methods: This survey study used an explanatory sequential mixed-method design to explore clinical and translational researcher and staff experiences of the transition to remote work during the first 6 weeks of the COVID-19 pandemic.

Real-world use of nirmatrelvir-ritonavir in outpatients with COVID-19 during the era of omicron variants including BA.4 and BA.5 in Colorado, USA: a retrospective cohort study.

Background: Nirmatrelvir is a protease inhibitor with in-vitro activity against SARS-CoV-2, and ritonavir-boosted nirmatrelvir can reduce the risk of progression to severe COVID-19 among individuals at high risk infected with delta and early omicron variants. However, less is known about the effectiveness of nirmatrelvir-ritonavir during more recent BA.2, BA2.

Preoperative Prediction of Unplanned Reoperation in a Broad Surgical Population.

Introduction: Unplanned reoperation is an undesirable outcome with considerable risks and an increasingly assessed quality of care metric. There are no preoperative prediction models for reoperation after an index surgery in a broad surgical population in the literature. The Surgical Risk Preoperative Assessment System (SURPAS) preoperatively predicts 12 postoperative adverse events using 8 preoperative variables, but its ability to predict unplanned reoperation has not been assessed.

RANTES (CCL5) in Patients With Geographic Atrophy Age-Related Macular Degeneration.

Purpose: A previous study from our research group showed significantly lower levels of RANTES (Regulated upon Activation, Normal T Cell Expressed and Secreted) in patients with intermediate age-related macular degeneration (AMD) compared to control patients with no AMD. The primary aim of this study was to assess levels of RANTES in a cohort of patients with a more advanced form of the disease, geographic atrophy (GA), in comparison with controls.

Methods: The study was conducted on a cohort of patients with GA recruited into a Colorado AMD registry.