Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, and retention (ER&R) training programs for Clinical Research Professionals (CRPs) often focus on policies and regulations. Although some training on the importance of diversity and inclusion in clinical research participation has recently been developed, there remains a need for training that couples critical equity, diversity, and inclusion (EDI) concepts with skill development in effective recruitment and retention strategies, regulations, and best practices.

We developed the ER&R Certificate program as a holistic approach to provide Duke University CRPs the opportunity to build competency in gap areas and to increase comfort in championing equitable partnerships with clinical research participants. The thirteen core and elective courses include blended learning elements, such as e-learning and wiki journaling prompts, to facilitate meaningful discussions. Pre- and post-assessments administered to CRP program participants and their managers assessed program impact on CRP skills in ER&R tasks and comfort in equitable, diverse, and inclusive engagement of clinical research participants.

Results from the first two cohorts indicate that CRPs perceived growth in their own comfort with program learning objectives, especially those centered on participant partnership and EDI principles, and most managers witnessed growth in competence and responsibility for ER&R-related tasks. Results suggest value in offering CRPs robust training programs that integrate EDI and ER&R training.

Socially assistive robots (SARs) are a promising tool to manage children’s pain and distress related to medical procedures, but current options lack autonomous adaptability. The aim of this study was to understand children’s and caregivers' perceptions surrounding the use of an artificial intelligence (AI)-enhanced SAR to provide personalized procedural support to children during intravenous insertion (IVI) to inform the design of such a system following a user-centric approach.

This study presents a descriptive qualitative needs assessment of children and caregivers. Data were collected via semi-structured individual interviews and focus groups. Participants were recruited from two Canadian pediatric emergency departments (EDs) between April 2021 and January 2022.

Eleven caregivers and 19 children completed 27 individual interviews and one focus group. Three main themes were identified: A. Experience in the clinical setting, B. Acceptance of and concerns surrounding SARs, and C. Features that support child engagement with SARs. Most participants expressed comfort with robot technology, however, concerns were raised about sharing personal information, photographing/videotaping, and the possibility of technical failure. Suggestions for feature enhancements included increasing movement to engage a child’s attention and tailoring language to developmental age. To enhance the overall ED experience, participants also identified a role for the SAR in the waiting room.

Artificial intelligence-enhanced SARs were perceived by children and caregivers as a promising tool for distraction during IVIs and to enhance the overall ED experience. Insights collected will be used to inform the design of an AI-enhanced SAR.

Clinical trials are a critical step in the meaningful translation of biomedical discoveries into effective diagnostic and therapeutic interventions. Quality by design (QbD) is a framework for embedding quality into the design, conduct, and monitoring of clinical trials. Here we report the feasibility and acceptability of a process for implementing QbD in clinical research at an academic health center via multidisciplinary design studios aimed at identifying and prioritizing critical to quality (CTQ) factors.

The Clinical Trial Transformation Initiative’s Principles Document served as a guide to identify and categorize key CTQ factors, defined as elements of a clinical trial that are critical to patient safety and data integrity. Individual trials were reviewed in CTQ design studios (CTQ-DS) and the feasibility and acceptability of this intervention was examined through post-meeting interviews and surveys.

Eight clinical research protocols underwent the QbD evaluation process. The protocols ranged from multicenter randomized clinical trials to nonrandomized investigator-initiated studies. A developmental evaluation informed the iterative refinement of the CTQ-DS process, and post-meeting surveys revealed that CTQ-DS were highly valued by principal investigators (PIs) and resulted in multiple protocol changes.

The present study demonstrated that QbD principles can be implemented to inform the design and conduct of clinical research at an academic health center using multidisciplinary design studios aimed at identifying and prioritizing CTQ elements. This approach was well received by the participants including study PIs. Future research will need to evaluate the effectiveness of this approach in improving the quality of clinical research.

Although the involvement of citizen scientists in research can contribute to scientific benefits, much remains unknown about participants’ lived experiences in research. Thus, the purpose of this study was to explore how citizen scientists describe their role in, motivation for, and communication with researchers.

In-depth interviews (N = 9) were conducted with citizen scientists at a translational health research center.

Key results include that citizen scientists were invested in learning researchers’ discipline-specific language and viewed small group sizes as conducive to their active participation.

Programs can apply these findings in an effort to improve citizen scientists’ long-term engagement in research.

Transdisciplinary (TD) research and community-based participatory research (CBPR) represent promising investigative approaches to ameliorate health disparities. Public investments in team-based TD research to address multifactorial public health problems have increased over the last two decades. Similarly, recognition that community participation in research and social action is essential to promoting health equity is reflected in increased prioritization of community engagement in research and practice. Yet, models that describe and guide the combined TD and CBPR approach are lacking.

We utilized a qualitative, convergent parallel case study design that included document reviews and one-on-one interviews to assess how investigators from the Centers for Population Health and Health Disparities (CPHHD) initiative integrated TD team science and CBPR in their work, and what they perceived as the impact of that work on health equity.

Twenty-five CPHHD investigators and National Institutes of Health program staff participated in a one-on-one interview. Document and interview data informed the development of an iterative conceptual model of TD CBPR comprising five domains: problem focus, contexts, collaboration and partnership, outcomes, and societal impact of TD CBPR.

TD team science and CBPR are integrally related; combining principles of both can facilitate more efficient, equitable progress toward team outcomes, improved population health, and increased health equity. This model could assist researchers and public health practitioners in designing community-relevant, scientifically rigorous research with practical implications for improving health and quality of life among marginalized populations.

The COVID-19 pandemic created an unprecedented need for population-level clinical trials focused on the discovery of life-saving therapies and treatments. However, there is limited information on perception of research participation among perinatal populations, a population of particular interest during the pandemic.

Eligible respondents were 18 years or older, were currently pregnant or had an infant (≤12 months old), and lived in Florida within 50 miles of sites participating in the OneFlorida Clinical Research Consortium. Respondents were recruited via Qualtrics panels between April and September 2020. Respondents completed survey items about barriers and facilitators to participation and answered sociodemographic questions.

Of 533 respondents, most were between 25 and 34 years of age (n = 259, 49%) and identified as White (n = 303, 47%) and non-Hispanic (n = 344, 65%). Facebook was the most popular social media platform among our respondents. The most common barriers to research participation included poor explanation of study goals, discomforts to the infant, and time commitment. Recruitment through healthcare providers was perceived as the best way to learn about clinical research studies. When considering research participation, "myself" had the greatest influence, followed by familial ties. Noninvasive biological samples were highly acceptable. Hispanics had higher positive perspectives on willingness to participate in a randomized study (p = 0.009). Education (p = 0.007) had significant effects on willingness to release personal health information.

When recruiting women during the pregnancy and postpartum periods for perinatal studies, investigators should consider protocols that account for common barriers and preferred study information sources. Social media-based recruitment is worthy of adoption.

Hyperbilirubinemia is common in the neonatal period; however, delayed diagnosis or inadequate treatment can cause irreparable damage to the neonates. We aimed to evaluate the efficacy of oral fenofibrate for hyperbilirubinemia in term neonates.

This single-blind randomized controlled trial included 86 term neonates aged 3–7 days, with birth weight ≥2500 g, admitted to Bandar Abbas Children’s Hospital, Bandar Abbas Iran, from July 23, 2019, to July 22, 2020. The fenofibrate group received 10 mg/kg oral fenofibrate and phototherapy, while controls only received phototherapy. Serum total bilirubin was measured at 24 and 48 h and at the time of discharge. Hospital length of stay was also noted.

The two study groups were comparable regarding age, gender, gestational age, birth weight, and baseline total serum bilirubin levels. Serum total bilirubin levels at 48 h (P < 0.001) and at discharge (P < 0.001) were significantly lower in the fenofibrate group compared to controls. Although hospital length of stay was lower in the fenofibrate group compared to controls, the difference was not statistically significant (P = 0.612). Fenofibrate was more effective on the reduction of serum bilirubin in neonates aged 3–4.5 days starting at the 24th hour. Moreover, it was more effective in female neonates compared to males starting at the 48th hour.

A single dose of oral fenofibrate reduced total serum bilirubin in term neonates with hyperbilirubinemia without any side effects; however, this effect was more prominent after 48 h.

The Clinical and Translational Science Award (CTSA) institutions are increasing development of training programs in community-engaged research (CEnR) to support translational science.

This study sampled posters at CTSA national meetings to identify CEnR training approaches, topics, and outcomes.

Qualitative analysis of 30 posters revealed training topics and outcomes focused primarily on CEnR capacity building, overcoming barriers, systems change, and sustainability.

Further research should focus on development and results of CTSA CEnR training program metrics.

The Great CTSA Team Science Contest (GTSC) was developed to discover how Clinical and Translational Science Award (CTSA) hubs promote and support team science [1]. The purpose of this study was a secondary qualitative analysis of the GTSC submissions to better understand the diversity of team science initiatives across the CTSA consortium.

Secondary qualitative analysis of the GTSC data addressed the following research questions, which defined the top-level coding: (1) What CTSA component sponsored it? (2) Who was the team doing the work? (3) Who were the intended beneficiaries? (4) What was the intended outcome? (5) What strategies did they use? (6) What translational science (TS) stage was addressed? (7) How do they align with the NCATS team science strategic goals? (8) How do the CTSA’s team science efforts align with the National Academies Research Council (NRC) recommendations for enhancing the effectiveness of team science?

The GTSC received 170 submissions from 45 unique CTSA hubs. Qualitative analysis revealed a great variety of team science strategies for virtually all team science stakeholders. In addition to strategies to promote team science, results show successful examples that focus on outcomes and illustrate ways of measuring success.

The GTSC shows that the CTSA consortium is involved in an extremely diverse array of team science activities, which align well with both the NRC recommendations for enhancing the effectiveness of team science and the NCATS strategic goals for team science. Future research should evaluate the efficacy of team science strategies.

Arkansans have some of the worst breast cancer mortality to incidence ratios in the United States (5th for Blacks, 4th for Whites, 7th overall). Screening mammography allows for early detection and significant reductions in mortality, yet not all women have access to these life-saving services. Utilization in Arkansas is well below the national average, and the number of FDA-approved screening facilities has decreased by 38% since 2001. Spatial accessibility plays an important role in whether women receive screenings.

We use constrained optimization models within a geographic information system (GIS) to probabilistically allocate women to nearby screening facilities, accounting for facility capacity and patient travel time. We examine accessibility results by rurality derived from rural–urban commuting area (RUCA) codes.

Under most models, screening capacity is insufficient to meet theoretical demand given travel constraints. Approximately 80% of Arkansan women live within 30 minutes of a screening facility, most of which are located in urban and suburban areas. The majority of unallocated demand was in Small towns and Rural areas.

Geographic disparities in screening mammography accessibility exist across Arkansas, but women living in Rural areas have particularly poor spatial access. Mobile mammography clinics can remove patient travel time constraints to help meet rural demand. More broadly, optimization models and GIS can be applied to many studies of healthcare accessibility in rural populations.

SPARK launched in 2016 to build a US cohort of autistic individuals and their family members. Enrollment includes online consent to share data and optional consent to provide saliva for genomic analysis. SPARK’s recruitment strategies include social media and support of a nation-wide network of clinical sites. This study evaluates SPARK’s recruitment strategies to enroll a core study population.

Individuals who joined between January 31, 2018, and May 29, 2019 were included in the analysis. Data include sociodemographic characteristics, clinical site referral, the website URL used to join, how the participant heard about SPARK, enrollment completion (online registration, study consents, and returning saliva sample), and completion of the baseline questionnaire. Logistic regressions were performed to evaluate the odds of core participant status (completing enrollment and baseline questionnaire) by recruitment strategy.

In total, 31,715 individuals joined during the study period, including 40% through a clinical site. Overall, 88% completed online registration, 46% returned saliva, and 38% were core participants. Those referred by a clinical site were almost twice as likely to be core participants. Those who directly visited the SPARK website or performed a Google search were more likely to be core participants than those who joined through social media.

Being a core participant may be associated with the “personal” connection and support provided by a clinical site and/or site staff, as well as greater motivation to seek research opportunities. Findings from this study underscore the value of adopting a multimodal recruitment approach that combines social media and a physical presence.

In order to fully participate in informed consent, patients must understand what it is that they are agreeing, or not agreeing, to. In most cases, patients look to their clinicians to help develop the appropriate understanding required to give informed consent. Often the quality of the information available as well as the delivery methods are not optimal.

Using a visual aid as an adjunct to risk communication in a stressful setting as the Emergency Department has a clear potential in facilitating the communication process. To support more accurate and consistent presentation of risk, we formed a team with implementation scientists, patient education specialists, nurses, physicians, and professional designers to transform the information available into a 6th grade reading level visual aid tool. We applied a DMAIC (Define, Measure, Analyze, Improve and Control) process to design the tool. We measured and analyzed its effectiveness through feedback from providers, patients, and caregivers. This cycle happened 3 times until we reached the final version of the visual aid.

We utilized a DMAIC methodology as well as modified Delphi method to create and refine a visual aid tool. Several rounds of end-user feedback along with DMAIC allowed us to create a tool that was consistently better with each round of development, analysis and feedback. After arriving at the final version of the tool, we surveyed physicians in our Emergency Department. We measured the difficulty to understand the information, whether doctors think the visual aid will help patients to understand the data, and the appropriateness of the tool’s length and the amount of information in it.

We believe that our experience can be replicated by other researchers and clinicians in the endeavor of translating the evidence into clinical practice. An effort should be made to fully translate research findings until the end of the research to practice continuum in order to better translate knowledge into a useful and useable form for informed consent decisions in busy clinical practice.

A Health Equity Task Force (HETF) of members from seven Centers funded by the National Cancer Institute’s (NCI) Implementation Science in Cancer Control Centers (ISC3) network sought to identify case examples of how Centers were applying a focus on health equity in implementation science to inform future research and capacity-building efforts.

HETF members at each ISC3 collected information on how health equity was conceptualized, operationalized, and addressed in initial research and capacity-building efforts across the seven ISC3 Centers funded in 2019–2020. Each Center completed a questionnaire assessing five health equity domains central to implementation science (e.g., community engagement; implementation science theories, models, and frameworks (TMFs); and engaging underrepresented scholars). Data generated illustrative examples from these five domains.

Centers reported a range of approaches focusing on health equity in implementation research and capacity-building efforts, including (1) engaging diverse community partners/settings in making decisions about research priorities and projects; (2) applying health equity within a single TMF applied across projects or various TMFs used in specific projects; (3) evaluating health equity in operationalizing and measuring health and implementation outcomes; (4) building capacity for health equity-focused implementation science among trainees, early career scholars, and partnering organizations; and (5) leveraging varying levels of institutional resources and efforts to engage, include, and support underrepresented scholars.

Examples of approaches to integrating health equity across the ISC3 network can inform other investigators and centers’ efforts to build capacity and infrastructure to support growth and expansion of health equity-focused implementation science.