As clinical trials adopt remote methodologies, there is need to optimize efficiency of remote enrollment. Within a remote clinical trial, we aim to (1) assess if sociodemographic factors differ among those consenting via mail vs. technology-based procedures (e-consent), (2) determine if, among those consenting via mail, a small unconditional monetary reward ($5) increases likelihood of subsequent enrollment, (3) economically evaluate additional cost per additional participant enrolled with $5 reward.

In the parent nationwide randomized clinical trial of adult smokers (N = 638), participants could enroll via mail or e-consent. Logistic regression models assessed relationships between sociodemographics and enrollment via mail (vs e-consent). Mailed consent packets were randomized (1:4) to include $5 unconditional reward or not, and logistic regression modeling examined impact of reward on subsequent enrollment, allowing for a randomized study within a study. Incremental cost-effectiveness ratio analysis estimated additional cost per additional participant enrolled with $5 incentive.

Older age, less education, lower income, and female sex predicted enrolling via mail vs e-consent (p < .05’s). In adjusted model, older age (AOR = 1.02, p = .016) and less education (AOR = 2.23, p < .001) remained predictive of mail enrollment. The $5 incentive (vs none) increased enrollment rate by 9% (AOR = 1.64, p = .007), with estimated cost of additional $59 per additional participant enrolled.

As e-consent methods become more common, they have potential to reach many individuals but with perhaps diminished inclusion across all sociodemographic groups. Provision of an unconditional monetary incentive is possibly a cost-effective mechanism to increase recruitment efficiency for studies employing mail-based consenting procedures.

Consenting donors for remnant clinical biospecimen donation is critical for scaling research biorepositories. Opt-in, low-cost, self-consenting for donations that solely relied on clinical staff and printed materials was recently shown to yield ∼30% consent rate. We hypothesized that adding an educational video to this process would improve consent rates.

Randomized patients (by clinic day) in a Cardiology clinic received either printed materials (control) or the same materials plus an educational video on donations (intervention) while waiting to be seen. Engaged patients were surveyed at the clinic checkout for an “opt-in” or “opt-out” response. The decision was documented digitally in the electronic medical record. The primary outcome of this study was the consent rate.

Thirty-five clinic days were randomized to intervention (18) or control (17). Three hundred and fifty-five patients were engaged, 217 in the intervention and 158 in the control. No significant demographic differences were noted between treatment groups. Following an intention-to-treat analysis, the rate of opt-in for remnant biospecimen donation was 53% for the intervention and 41% for the control group (p-value = 0.03). This represents a 62% increase in the odds of consenting (OR = 1.62, 95% CI = 1.05–2.5).

This is the first randomized trial showing that an educational video is superior to printed materials alone when patients are self-consenting for remnant biospecimen donation. This result adds to the evidence that efficient and effective consenting processes can be integrated into clinical workflows to advance universal consenting in medical research.

Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of “informativeness,” highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise.

Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies.

We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.

Midcareer research faculty are a vital part of the advancement of science in U.S. medical schools, but there are troubling trends in recruitment, retention, and burnout rates.

The primary sampling frame for this online survey was recipients of a single R01 or equivalent and/or K-award from 2013 to 2019. Inclusion criteria were 3–14 years at a U.S. medical school and rank of associate professor or two or more years as assistant professor. Forty physician investigators and Ph.D. scientists volunteered for a faculty development program, and 106 were propensity-matched controls. Survey items covered self-efficacy in career, research, work-life; vitality/burnout; relationships, inclusion, trust; diversity; and intention to leave academic medicine.

The majority (52%) reported receiving poor mentoring; 40% experienced high burnout and 41% low vitality, which, in turn, predicted leaving intention (P < 0.0005). Women were more likely to report high burnout (P = 0.01) and low self-efficacy managing work and personal life (P = 0.01) and to be seriously considering leaving academic medicine than men (P = 0.003). Mentoring quality (P < 0.0005) and poor relationships, inclusion, and trust (P < 0.0005) predicted leaving intention. Non-underrepresented men were very likely to report low identity self-awareness (65%) and valuing differences (24%) versus underrepresented men (25% and 0%; P < 0.0005). Ph.D.s had lower career advancement self-efficacy than M.D.s (P < .0005).

Midcareer Ph.D. and physician investigators faced significant career challenges. Experiences diverged by underrepresentation, gender, and degree. Poor quality mentoring was an issue for most. Effective mentoring could address the concerns of this vital component of the biomedical workforce.

Computerized-adaptive testing (CAT) may increase reliability or reduce respondent burden for assessing patient-reported outcomes compared with static short forms (SFs). We compared CAT versus SF administration of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric measures in pediatric inflammatory bowel disease (IBD).

Participants completed 4-item CAT, 5- or 6-item CAT, and 4-item SF versions of the PROMIS Pediatric measures. We compared average T-scores, intra-class correlations (ICCs), floor and ceiling effects, and standard error of measurement (SEM) across forms, along with mean effect sizes between active versus quiescent IBD disease activity groups.

Average PROMIS T-scores across forms were <3 points (minimally important difference) of each other. All forms correlated highly with each other (ICCs ≥0.90) and had similar ceiling effects, but the CAT-5/6 had lower floor effects. The CAT-5/6 had lower SEM than the CAT-4 and SF-4, and the CAT-4 had a lower SEM than the SF-4. Mean effect sizes were similar across forms when contrasting disease activity groups.

The CAT and SF forms produced similar score results, but the CAT had better precision and lower floor effects. Researchers should consider PROMIS pediatric CAT if they anticipate that their sample will skew toward symptom extremes.

Recruiting underrepresented people and communities in research is essential for generalizable findings. Ensuring representative participants can be particularly challenging for practice-level dissemination and implementation trials. Novel use of real-world data about practices and the communities they serve could promote more equitable and inclusive recruitment.

We used a comprehensive primary care clinician and practice database, the Virginia All-Payers Claims Database, and the HealthLandscape Virginia mapping tool with community-level socio-ecological information to prospectively inform practice recruitment for a study to help primary care better screen and counsel for unhealthy alcohol use. Throughout recruitment, we measured how similar study practices were to primary care on average, mapped where practices’ patients lived, and iteratively adapted our recruitment strategies.

In response to practice and community data, we adapted our recruitment strategy three times; first leveraging relationships with residency graduates, then a health system and professional organization approach, followed by a community-targeted approach, and a concluding approach using all three approaches. We enrolled 76 practices whose patients live in 97.3% (1844 of 1907) of Virginia’s census tracts. Our overall patient sample had similar demographics to the state for race (21.7% vs 20.0% Black), ethnicity (9.5% vs 10.2% Hispanic), insurance status (6.4% vs 8.0% uninsured), and education (26.0% vs 32.5% high school graduate or less). Each practice recruitment approach uniquely included different communities and patients.

Data about primary care practices and the communities they serve can prospectively inform research recruitment of practices to yield more representative and inclusive patient cohorts for participation.

Leadership is recognized as an essential competency across healthcare and science. The LEAD (Leadership Emerging in Academic Departments) program at the Icahn School of Medicine at Mount Sinai (ISMMS) is a structured 12-month blended learning program that catalyzes personal and professional leadership skills, behaviors, and capacity.

Utilizing a post-program survey design, the Leadership Program Outcome Measure (LPOM) explored self-reported impact of the LEAD program on leadership knowledge and skills in relation to personal and organizational leadership constructs. Application of leadership skills to practice was tracked via completion of a leadership-focused capstone project.

Over 3 cohorts, 76 participants graduated and 50 completed the LPOM survey (68% response rate). Participants self-reported an increase in leadership skills, conveyed plans to use acquired skills in current and future leadership positions, and noted improved leadership skills across the personal and organizational domains. Comparatively less change was detected at the community level. Tracking of capstone projects found that 64% of participants were able to successfully implement their project in practice.

LEAD was successful in promoting the development of personal and organizational leadership practices. The LPOM evaluation provided a valuable lens through which to assess the individual, interpersonal, and organizational impact of a multidimensional leadership training program.

The University of Illinois at Chicago (UIC), along with many academic institutions worldwide, made significant efforts to address the many challenges presented during the COVID-19 pandemic by developing clinical staging and predictive models. Data from patients with a clinical encounter at UIC from July 1, 2019 to March 30, 2022 were abstracted from the electronic health record and stored in the UIC Center for Clinical and Translational Science Clinical Research Data Warehouse, prior to data analysis. While we saw some success, there were many failures along the way. For this paper, we wanted to discuss some of these obstacles and many of the lessons learned from the journey.

Principle investigators, research staff, and other project team members were invited to complete an anonymous Qualtrics survey to reflect on the project. The survey included open-ended questions centering on participants’ opinions about the project, including whether project goals were met, project successes, project failures, and areas that could have been improved. We then identified themes among the results.

Nine project team members (out of 30 members contacted) completed the survey. The responders were anonymous. The survey responses were grouped into four key themes: Collaboration, Infrastructure, Data Acquisition/Validation, and Model Building.

Through our COVID-19 research efforts, the team learned about our strengths and deficiencies. We continue to work to improve our research and data translation capabilities.

Many diseases are highly prevalent in older adults, yet older adults are often underrepresented in corresponding trials. Our objectives were to (1) determine alignment between Institutional Review Board (IRB) protocol age ranges and enrollment demographics to disease demographics pre- and post-implementation of the 2019 National Institutes of Health (NIH) Lifespan Policy and (2) raise awareness about inclusive recruitment to principal investigators (PIs).

This was a pre-post study. We reviewed investigator-initiated studies meeting eligibility criteria at Oregon Health & Science University from 2017 to 2018 to determine baseline alignment. Alignment was defined by the level of matching between protocol/enrollment age and disease demographics: 2 points for full match, 1 point for partial match, and 0 points for mismatch. After the NIH policy implementation, we reviewed new studies for alignment. When a mismatch was determined, we contacted PIs (either at initial IRB protocol submission or during ongoing recruitment) to raise awareness and provide strategies to expand inclusion of older adults in their trials.

Studies that matched IRB protocol ages to disease demographics significantly improved from 78% pre-implementation to 91.2% post-implementation. Similarly, study enrollment ages matching disease demographics increased by 13.4% following the implementation (74.5%–87.9%). Out of 18 post-implementation mismatched studies, 7 PIs accepted a meeting and 3 subsequently changed their protocol age ranges.

This study highlights strategies that translational institutes and academic institutions could use to identify research studies whose participants do not align with disease demographics, offering opportunities for researcher awareness and training to enhance inclusion.

The COVID-19 pandemic had an abrupt impact on patient-oriented research early in the pandemic. CTSA Clinical Research Centers (CRCs) rapidly adapted to this challenge, but the continued impact of later phases of the pandemic on CRC operations is not clear.

An online REDCap survey of CTSA CRCs was developed that covered the first 2 years of the pandemic. The survey focused on impact on CRC functions, mitigation strategies, recovery of CRC activities, CRC contributions to COVID-related research, and potential lessons for future public health emergencies. The survey was sent to CRC directors at 61 CTSA Hubs in May 2022.

Twenty-seven Hubs (44%) responded to the survey. Most CRCs reported greater than 50% declines in inpatient census in the first year of the pandemic, with less severe impacts on outpatient census. CRCs pivoted to support COVID-related research and adopted innovative technology-driven approaches to support clinical research. Census improved in the second year of the pandemic in most CRCs but often remained below pre-pandemic levels, and greater than half of CRCs reported decreased revenue.

CTSA-supported CRCs faced unprecedented challenges at the onset of the COVID-19 pandemic and responded rapidly to support COVID-related research and implement innovative approaches that allowed patient-oriented research activities to resume. However, many CRCs continued to report decreased research activities in the second year of the pandemic, and the long-term effects on CRC operations on finances are not clear. CRCs will likely need to evolve to provide support in nontraditional ways.

Research participation during undergraduate years has a powerful influence on career selection and attitudes toward scientific research. Most undergraduate research programs in academic health centers are oriented toward basic research or address a particular disease focus or research discipline. Undergraduate research programs that expose students to clinical and translational research may alter student perceptions about research and influence career selection.

We developed an undergraduate summer research curriculum, anchored upon a clinical and translational research study developed to address a common unmet needs in neonatal nurseries (e.g., assessment of neonatal opioid withdrawal syndrome). Program topics reflected the cross-disciplinary expertise that contributed to the development of this “bedside to bench” study, including opioid addiction, vulnerable populations, research ethics, statistics, data collection and management, assay development, analytical laboratory analysis, and pharmacokinetics. The curriculum was delivered through three offerings over 12 months, using Zoom video-conferencing due to restrictions imposed by the COVID-19 pandemic.

Nine students participated in the program. Two-thirds reported the course enhanced their understanding of clinical and translational research. Over three-quarters reported the curriculum topics were very good or excellent. In open-ended questions, students reported that the cross-disciplinary nature of the curriculum was the strongest aspect of the program.

The curriculum could be readily adapted by other Clinical and Translational Science Award programs seeking to provide clinical and translational research-oriented programs to undergraduate students. Application of cross-disciplinary research approaches to a specific clinical and translational research question provides students with relevant examples of translational research and translational science.

Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test’s performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.

This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported.

A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide.

The digital site-less approach employed in the “Test Us At Home” study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.

Early diagnosis of sepsis is essential for a favorable disease outcome. The aim of this study was to evaluate the association of initial and subsequent presepsin concentrations with sepsis outcomes.

One hundred sepsis patients were enrolled in the study from two different university centers. Four times during study, concentrations of presepsin, procalcitonin (PCT), and C-reactive protein (CRP) were measured, and Sequential Organ Failure Assessment (SOFA) score and Acute Physiology and Chronic Health Evaluation (APACHE II) score were calculated. Patients were grouped into survivors and nonsurvivors. A sandwich ELISA kit was used to measure presepsin concentrations. To test the changes in biomarkers concentrations and SOFA score and APACHE II score during the disease course and to estimate the differences between outcome groups, generalized linear mixed effects model was used. Receiver operating characteristic curve analysis was performed to determine the prognostic value of presepsin concentrations.

Initial values of presepsin, SOFA score, and APACHE II score were significantly higher in nonsurvivors compared to survivors. Concentrations of PCT and CRP did not differ significantly between outcome groups. ROC curve analyses show a greater predictive ability of initial presepsin concentrations for predicting mortality compared to subsequent measurements of presepsin concentrations.

Presepsin has a good ability to predict mortality. Initial presepsin concentrations better reflects poor disease outcome compared to presepsin concentrations 24 and 72 hours after admission.