A growing population of adults living with severe, chronic childhood-onset health conditions has created a need for specialized health care delivered by providers who have expertise both in adult medicine and in those conditions. Optimal care of these patients requires systematic approaches to healthcare transition (HCT). Guidelines for HCT exist, but gaps in care occur, and there are limited data on outcomes of HCT processes.

The Single Disease Workgroup of the Lifespan Domain Task Force of the National Center for Advancing Translational Sciences Clinical and Translational Science Award programs convened a group to review the current state of HCT and to identify gaps in research and practice. Using cystic fibrosis and sickle cell disease as models, key themes were developed. A literature search identified general and disease-specific articles. We summarized key findings.

We identified literature characterizing patient, parent and healthcare provider perspectives, recommendations for transition care, and barriers to effective transition.

With increased survival of patients with severe childhood onset diseases, ongoing study of effective transition practices is essential as survival increases for severe childhood onset diseases. We propose pragmatic methods to enhance transition research to improve health and key outcomes.

The final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.

Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.

The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.

Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

We developed a service to identify potential study participants through electronic medical records and deliver study invitations through patient portals.

The service was piloted in a cohort study that used multiple recruitment methods.

Patient portal messages were sent to 1303 individuals and the enrollment rate was 10% (n=127). The patient portal enrollment rate was significantly higher than email and post mail (4%) strategies.

Patient portal messaging was an effective recruitment strategy.

Community engagement is deemed as critical to the success of the CTSA program. In 2009, to improve research engagement and build capacity for community-engaged research across the translational spectrum, the Center for Clinical and Translational Science at the University of Illinois at Chicago created a Community Engagement Advisory Board (CEAB). Here, we report results of our ongoing evaluation efforts.

CEAB activities are evaluated using mixed methods. Annual CEAB evaluation surveys were completed from 2010 to 2016 (n=106 respondents). In 2014, two 90-minute focus groups were conducted with a subset of recent CEAB members (n=19).

Survey data suggest respondents perceive their consultations to be helpful in improving the capacity of researchers (90%) and the quality of research projects (80%). Further, CEAB members perceive themselves to have personally benefitted from their involvement including obtaining new knowledge (84%), expansion of their networks (76%), and forming new community linkages (51%). Results of the qualitative data were consistent with survey data.

Our CEAB has improved research engagement and developed institutional capacity to conduct community-engaged research in several ways. Our findings can inform the establishment or enhancement of community engagement services for CTSA-affiliated researchers and community partners.

The lack of diversity in health research participation has serious consequences for science as well as ethics. While there is growing interest in solving the problem, much of the work to date focuses on attitudes of distrust among members of underrepresented communities. However, there is also a pressing need to understand existing barriers within the cultural and structural context of researchers and research staff.

This study adopted a sequential exploratory mixed-methods design to allow for a focused examination of barriers to inclusive research recruitment among researchers and staff. Barriers first identified from an initial quantitative investigation (web-based survey; n = 279) were further explored through qualitative methods (key informant interviews; n = 26). Participants were investigators and research team members in both phases of the study.

The survey revealed a paradoxical disconnect between participants’ reported belief in the abstract value of diversity in research participation (87.1% important/extremely important) and belief in it as an important goal in their own specific research (38.3% important/extremely important). Interviews reveal that researchers and staff perceive many barriers to the recruitment of members of underrepresented groups and hold a general view of diversity in research as an impractical, even unattainable, goal.

It is crucial that principal investigators not only understand the consequences of the continued exclusion of marginalized groups from research but also implement strategies to reverse this trend and communicate with research staff on the issue. While individual bias does play a role (ex: a priori assumptions about the willingness or ability of members of underrepresented groups to participate), these behaviors are part of a larger context of systemic racism.

It is not clear how to effectively recruit healthy research volunteers.

We developed an electronic health record (EHR)-based algorithm to identify healthy subjects, who were randomly assigned to receive an invitation to join a research registry via the EHR’s patient portal, letters, or phone calls. A follow-up survey assessed contact preferences.

The EHR algorithm accurately identified 858 healthy subjects. Recruitment rates were low, but occurred more quickly via the EHR patient portal than letters or phone calls (2.7 vs. 19.3 or 10.4 d). Effort and costs per enrolled subject were lower for the EHR patient portal (3.0 vs. 17.3 or 13.6 h, $113 vs. $559 or $435). Most healthy subjects indicated a preference for contact via electronic methods.

Healthy subjects can be accurately identified from EHR data, and it is faster and more cost-effective to recruit healthy research volunteers using an EHR patient portal.

Although the science of team science is no longer a new field, the measurement of team science and its standardization remain in relatively early stages of development. To describe the current state of team science assessment, we conducted an integrative review of measures of research collaboration quality and outcomes.

Collaboration measures were identified using both a literature review based on specific keywords and an environmental scan. Raters abstracted details about the measures using a standard tool. Measures related to collaborations with clinical care, education, and program delivery were excluded from this review.

We identified 44 measures of research collaboration quality, which included 35 measures with reliability and some form of statistical validity reported. Most scales focused on group dynamics. We identified 89 measures of research collaboration outcomes; 16 had reliability and 15 had a validity statistic. Outcome measures often only included simple counts of products; publications rarely defined how counts were delimited, obtained, or assessed for reliability. Most measures were tested in only one venue.

Although models of collaboration have been developed, in general, strong, reliable, and valid measurements of such collaborations have not been conducted or accepted into practice. This limitation makes it difficult to compare the characteristics and impacts of research teams across studies or to identify the most important areas for intervention. To advance the science of team science, we provide recommendations regarding the development and psychometric testing of measures of collaboration quality and outcomes that can be replicated and broadly applied across studies.

Ensuring equitable access to health care is a widely agreed-upon goal in medicine, yet access to care is a multidimensional concept that is difficult to measure. Although frameworks exist to evaluate access to care generally, the concept of “access to genomic medicine” is largely unexplored and a clear framework for studying and addressing major dimensions is lacking.

Comprised of seven clinical genomic research projects, the Clinical Sequencing Evidence-Generating Research consortium (CSER) presented opportunities to examine access to genomic medicine across diverse contexts. CSER emphasized engaging historically underrepresented and/or underserved populations. We used descriptive analysis of CSER participant survey data and qualitative case studies to explore anticipated and encountered access barriers and interventions to address them.

CSER’s enrolled population was largely lower income and racially and ethnically diverse, with many Spanish-preferring individuals. In surveys, less than a fifth (18.7%) of participants reported experiencing barriers to care. However, CSER project case studies revealed a more nuanced picture that highlighted the blurred boundary between access to genomic research and clinical care. Drawing on insights from CSER, we build on an existing framework to characterize the concept and dimensions of access to genomic medicine along with associated measures and improvement strategies.

Our findings support adopting a broad conceptualization of access to care encompassing multiple dimensions, using mixed methods to study access issues, and investing in innovative improvement strategies. This conceptualization may inform clinical translation of other cutting-edge technologies and contribute to the promotion of equitable, effective, and efficient access to genomic medicine.

A feedforward pathological signaling loop generated by TNFα and IFN-γ synergy in the inflamed lung, driving CXCL-10 (IP-10) and CXCL-9 chemokine-mediated activated T-cell and monocyte/macrophage tissue recruitment, may define the inflammatory biology of lethal COVID-19 respiratory failure.

To assess TNFα-antagonist therapy, 18 hospitalized adults with hypoxic respiratory failure and COVID-19 pneumonia received single-dose infliximab-abda therapy 5 mg/kg intravenously between April and December 2020. The primary endpoint was time to increase in oxygen saturation to fraction of inspired oxygen ratio (SpO2/FiO2) by ≥50 compared to baseline and sustained for 48 h. Secondary endpoints included 28-day mortality, dynamic cytokine profiles, secondary infections, duration of supplemental oxygen support, and hospitalization.

Patients were predominantly in critical respiratory failure (15/18, 83%), male (14/18, 78%), above 60 years (median 63 years, range 31–80), race-ethnic minorities (13/18, 72%), lymphopenic (13/18, 72%), steroid-treated (17/18, 94%), with a median ferritin of 1953 ng/ml. Sixteen patients (89%) met the primary endpoint within a median of 4 days; 14/18 (78%) were discharged in a median of 8 days and were alive at 28-day follow-up. Three deaths were attributed to secondary lung infection. Mean plasma IP-10 levels declined sharply from 9183 to 483 pg/ml at Day 3 and 146 pg/ml at Day 14/discharge. Significant Day 3 declines in IFN- $\gamma $ , TNFα, IL-27, CRP, and ferritin occurred. IP-10 and CXCL-9 declines were strongly correlated among patients with lymphopenia reversal (Day 3, Pearson r: 0.98, P-value 0.0006).

Infliximab-abda may rapidly abrogate pathological inflammatory signaling to facilitate clinical recovery in severe and critical COVID-19.

Community engagement (CE) has become more prevalent among academic health centers (AHCs), with significant diversity in practices and language. The array of approaches to CE contributes to confusion among practitioners.

We have reviewed multiple models of CE utilized by AHCs, Clinical and Translational Science Awards, and higher education institutions overall. Taking these models into consideration, we propose a comprehensive model of CE that encompasses a broader spectrum of activities and programs.

The CE Components Practical Model includes 5 components: Community Outreach and Service, Education, Clinical Care, Research, and Policy and Advocacy. The components are supported by the foundational elements within administrative functions and infrastructure.

This model will accomplish the following: (1) reduce confusion about CE; (2) provide a broader understanding of CE; and (3) increase the ability of CE practitioners to interact with each other through this common reference and engage in advancing CE scholarship.

NIH Clinical and Translational Science Awards (CTSAs) include KL2 mentored career development awards for faculty commencing clinical and translational research. A survey of KL2 leaders revealed program practices, curricular elements and compelling data about scholar characteristics and outcomes.

We conducted a literature review, framed the survey construct, and obtained input from across the CTSA consortium. A REDCap survey was emailed in fall 2016 to 61 active programs.

Fifty-five programs (90.2%) responded. Respondents had been funded from 3 to 11 years, including 22 “mature” hubs funded for ≥8 years. Program cohort sizes were 56% “small”, 22% “medium”, and 22% “large.” Hubs offer extensive competency-aligned training opportunities relevant to clinical and translational research, including graduate degrees, mentorship, and grant-writing. Seventy-two percent of hubs report parallel “KL2-equivalent” career development programs. All hubs share their training and facilitate intermingling with other early stage investigators. A total of 1,517 KL2 scholars were funded. KL2 awardees are diverse in their disciplines, research projects, and representation; 54% are female and 12% self-identified as underrepresented in biomedical research. Eighty-seven percent of scholars have 2–3 mentors and are currently supported for 2–3 years. Seventy-eight percent of alumni remain at CTSA institutions in translational science. The most common form of NIH support following scholars’ KL2 award is an individual career development award.

The KL2 is a unique career development award, shaped by competency-aligned training opportunities and interdisciplinary mentorship that inform translational research pathways. Tracking both traditional and novel outcomes of KL2 scholars is essential to capture their career trajectories and impact on health.

A pilot study by 6 Clinical and Translational Science Awards (CTSAs) explored how bibliometrics can be used to assess research influence.

Evaluators from 6 institutions shared data on publications (4202 total) they supported, and conducted a combined analysis with state-of-the-art tools. This paper presents selected results based on the tools from 2 widely used vendors for bibliometrics: Thomson Reuters and Elsevier.

Both vendors located a high percentage of publications within their proprietary databases (>90%) and provided similar but not equivalent bibliometrics for estimating productivity (number of publications) and influence (citation rates, percentage of papers in the top 10% of citations, observed citations relative to expected citations). A recently available bibliometric from the National Institutes of Health Office of Portfolio Analysis, examined after the initial analysis, showed tremendous potential for use in the CTSA context.

Despite challenges in making cross-CTSA comparisons, bibliometrics can enhance our understanding of the value of CTSA-supported clinical and translational research.