The Clinical and Translational Science Awards (CTSA) Program supports a national network of medical research institutions working to expedite the development of treatments and interventions. High-performing translational teams (TTs) involving inter-institutional collaborations are critical for advancing these evidence-based approaches. However, management of these complex teams can be difficult, and tailored project management may help TTs overcome the unique challenges they face.

We conducted qualitative interviews with 14 dedicated project managers (PMs) from six CTSAs to learn more about their experiences with TTs. Information derived from the thematic analysis of the data was used to identify barriers and facilitators for effective project management.

Barriers included a lack of institutional support, communication issues, pushback, role confusion, and a need for agility. Facilitators included transparent communication, supportive team environments, shared leadership with autonomy, and opportunities for professional development. The PMs interviewed for this study provided descriptions of their work that depicted a more expansive view of project management than the more traditional approach focused on meeting deadlines and managing deliverables.

Our findings have been used to inform development, training, and guidance for an innovative project management resource, the Project Management Innovation Center of Excellence (PROMICE) recently launched at the UW-Madison Institute for Clinical and Translational Research (ICTR). Through the development of a dedicated career path, PROMICE recognizes the value that PMs bring to translational science and provides the support that they need to be innovative, leading their teams to success.

While providing compensation for participation in research studies is common, there is an ongoing debate surrounding compensation models and how they can be equitably applied. This work attempts to better understand the landscape of research compensation by evaluating factors associated with compensation of research study participants across instiutional review board (IRB)-approved studies at a single academic institution in California.

We extracted all IRB applications for social, behavioral, educational, and public policy research studies between January 1, 2019, and December 31, 2021, at the University of California, San Francisco. Compensation amounts, time estimates for participation, and location of study activities (hybrid, remote, in-person) were extracted from free text entries in the IRB application and reorganized into discrete variables. Multivariable logistic regression was used to assess factors associated with receiving payment after adjusting for time.

We analyzed 403 unique IRB applications. Studies held at public hospitals and clinics were more likely to provide compensation to study participants, whereas studies held at the university hospitals and clinics were less likely to provide compensation. Unfunded studies also were less likely to provide compensation to research study participants. While participants that were classified as “economically/educationally disadvantaged” and “unable to read, speak, or understand English” within the institution’s IRB application were more likely to receive compensation, those that had “diminished capacity to consent” were less likely to receive compensation.

While there are multiple frameworks for compensation, there is still significant variability in compensation strategies. Institutions should center equity in considering standardized approaches to compensation for research participation.

Decentralized research has many advantages; however, little is known about the representativeness of a source population in decentralized studies. We recruited participants aged 18-64 years from four states from June to December 2022 for a prospective cohort study to assess viral epidemiology. Our aim was to determine the association between age, gender, race/ethnicity, rurality, and socioeconomic status (SES) on study participation in a decentralized prospective cohort study.

We consented 9,286 participants from 231,099 (4.0%) adults with the mean age of 45.6 years (±12.0). We used an electronic decentralized approach for recruitment. Consented participants were more likely to be non-Hispanic White, female, older, urban residents, have more health conditions, and possessed higher socioeconomic status (SES) compared to those non-consented.

We observed an interaction between SES and race-ethnicity on the odds of consent (P = 0.006). Specifically, SES did not affect non-Hispanic white participation rates(OR 1.24 95% CI 1.16 – 1.32] for the highest SES quartile compared to those with the lowest SES quartile) as much as it did participants combined across the other races (OR 1.73; 95% CI 1.45 – 2.98])

The relationship between SES and consent rates might be disproportionately greater in historically disadvantaged groups, compared to non-Hispanic White. It suggests that instead of focusing on enrollment of specific minority groups in research, there is value in future research exploring and addressing the diversity of barriers to trials within minority groups. Our study highlights that decentralized studies need to address social determinants of health, especially in under-resourced populations.

Insufficient sample sizes threatened the fidelity of the primary research trials. Even if the research group recruits a sufficient sample size, the sample may lack diversity, reducing the generalizability of the results of the study. Evaluating the effectiveness of online advertising platforms (e.g., Facebook & Google Ads) versus traditional recruitment methods (e.g., flyers, clinical participation) is essential.

Patients were recruited through email, electronic direct message, paper advertisements, and word-of-mouth advertisement (traditional) or through Google Ads and Facebook Ads (advertising) for a longitudinal study on monitoring COVID-19 using wearable devices. Participants were asked to wear a smart watch-like wearable device for ∼ 24 hours per day and complete daily surveys.

The initiation conversion rate (ICR, impressions to pre-screen ratio) was better for traditional recruitment (24.14) than for Google Ads, 28.47 ([0.80, 0.88]; p << 0.001). The consent conversion rate (CCR, impressions to consent ratio) was also higher for traditional recruitment (66.54) than for Google Ads, 2961.20 ([0.015, 0.030]; p << 0.001). Participants recruited through recommendations or by paper flier were more likely to participate initially (Χ2 = 23.65; p < 0.005). Clinical recruitment led to more self-reporting white participants, while other methods yielded great diversity (Χ2 = 231.47; p << 0.001).

While Google Ads target users based on keywords, they do not necessarily improve participation. However, our findings are based on a single study with specific recruitment strategies and participant demographics. Further research is needed to assess the generalizability of these findings across different study designs and populations.

Integrating scientific research across multiple disciplines to advance breakthroughs is at the heart of clinical-translational science (CTS); among competencies that have been identified as essential for progress, skillful communication is critical. Few tools are available to address the social dynamics of the multidimensional diversity characteristics of CTS. We created the “Building a Diverse Biomedical Workforce Through Communication Across Difference (CAD)” workshop intervention. Based on principles of intercultural communication, CAD taught novel situationally-based communication skills to dyads of near-peer mentors and their undergraduate mentees. This study reports on the effectiveness of the operative mechanisms employed in CAD workshops for helping participants navigate highly diverse research environments.

Participant data were collected from multiple sources, including workshop artifacts as well as focus groups conducted post-workshop. Data were organized, individually coded, and then iteratively and collectively into pre-defined and emergent themes.

Responses indicated that the content and activities resonated strongly with participants and illuminated their understanding of challenges (both their own and others’) related to belonging, confidence, and connectedness to the research environment; several participants shared that they planned to use or had successfully used the skills. Focus group comments revealed that participants recognized the potential of the skills to include significant opportunities for non-instrumental interaction, contributing to a psychologically healthier workplace.

A brief intervention to develop communication skills across a variety of differences characteristic of clinical-translational settings improves communication between mentors and mentees and with peers and increases sense of belonging in the workplace, with potential benefits to wellbeing.

Anxiety and depression in epilepsy are common and impactful. Screening with validated measures at every epilepsy visit is a quality measure, yet screening remains limited due to time constraints.

This study aimed to develop an implementation strategy for anxiety and depression screening at an epilepsy center and evaluate it in a pre-post design with RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Guided by the Capability, Opportunity, Motivation-Behavior behavior change wheel framework, the strategy incorporated electronic health record tools and support staff activation of electronic screeners during visit check-in. Outcomes were evaluated over five months post-implementation and compared with two 3-month pre-implementation timeframes.

Post-implementation, 29.2% of 943 visits met the anxiety and depression screening quality measure, a significant increase from 12.6% immediately pre-implementation (p < 0.0001) and 6.28% before any screening interventions (p < 0.0001). Patients who completed electronic screeners post-implementation were younger than non-completers (mean 39.3 vs. 43.4 years, p = 0.001) and more likely to be white than other race/ethnicity categories (p = 0.002). There was substantial variability in screening rates among clinic staff (0–80% for support staff, 10.1–55.3% for providers), with higher screening among neurology support staff than temporary staff. Only 0.23% of post-implementation visits had screeners initiated but left incomplete. A shift to virtual visits during COVID-19 complicated Maintenance.

This framework-based implementation strategy effectively increased screening rates by epilepsy specialists, though challenges remain, including variability across clinic team members and lower reach among older and non-white patients. This study describes a feasible strategy for epilepsy centers to use for improved performance on an American Academy of Neurology quality measure (depression and anxiety screening for patients with epilepsy).

Underrepresentation of diverse populations in medical research undermines generalizability, exacerbates health disparities, and erodes trust in research institutions. This study aimed to identify a suitable survey instrument to measure trust in medical research among Black and Latino communities in Baltimore, Maryland.

Based on a literature review, a committee selected two validated instruments for community evaluation: Perceptions of Research Trustworthiness (PoRT) and Trust in Medical Researchers (TiMRs). Both were translated into Spanish through a standardized process. Thirty-four individuals participated in four focus groups (two in English, two in Spanish). Participants reviewed and provided feedback on the instruments’ relevance and clarity. Discussions were recorded, transcribed, and analyzed thematically.

Initial reactions to the instruments were mixed. While 68% found TiMR easier to complete, 74% preferred PoRT. Key discussion themes included the relevance of the instrument for measuring trust, clarity of the questions, and concerns about reinforcing negative perceptions of research. Participants felt that PoRT better aligned with the research goal of measuring community trust in research, though TiMR was seen as easier to understand. Despite PoRT’s lower reading level, some items were found to be more confusing than TiMR items.

Community feedback highlighted the need to differentiate trust in medical research, researchers, and institutions. While PoRT and TiMR are acceptable instruments for measuring trust in medical research, refinement of both may be beneficial. Development and validation of instruments in multiple languages is needed to assess community trust in research and inform strategies to improve diverse participation in research.

Community engagement in research (CEnR) is fundamental to recruitment and retention in research studies. CEnR study closure, with a view to promote subsequent interactions with participants, can foster long-term relationships between research teams and participants. We detail the principles, procedures and outcomes of respectful closure in a study focused on scaling-up tools to measure DNA integrity in population samples.

The study incorporated CEnR principles and practices, engaging a Community Advisory Board (CAB) to guide most study procedures. The CAB-designed closure protocol included 1) attempts at one-on-one contact via telephone, followed by a letter, if no contact was established; 2) provision of a study closure packet; 3) periodic mailing of study updates; and 4) a request for sustained interaction with the Community Engagement Team (CE Team), including participants’ approval to receive invitations for future projects. Items 3 and 4 were framed as choices to further interaction and its extent.

Among 191 participants enrolled, 119 were contacted at closure (62% retention rate). Most frequently (97.5%), contacted participants agreed to receive information about new research projects, while 90.8% agreed to receive ongoing information about the DNA integrity study. Subsequently, the CE Team implemented two study update mailings and two CEnR studies, enrolling 18 participants in a consultative role and four in a collaborative role.

Respectful study closure offers avenues for sustained interaction between CEnR teams and study participants, beyond the discrete boundaries of specific research projects. It can support the long-term connections that enable the positive outcomes of CEnR.

Cognitive decline and sleep concerns are significant health issues among older adults. Nonpharmacological treatments to address these concerns are needed, particularly for older adults who are more likely to be prescribed multiple medications and experience adverse effects of additional drugs. The aim of the current qualitative study was to understand and document the experiences of older adults with subjective memory decline participating in prolonged nightly fasting (PNF) intervention.

This single-group pilot study was conducted as a fully remote, 8-week, pre/postintervention. Postintervention, 16 participants (≥65 years) participated in semistructured qualitative exit interviews about their experiences with the PNF intervention. Interviews lasted approximately 20–30 minutes, were conducted by trained study staff, and then analyzed by the team to understand relevant themes.

Two major themes that emerged from the data were engagement with and perceived effects of the PNF intervention. Within these two themes, nine subthemes emerged: accountability; use of days off; feasibility; intervention tools; behavioral strategies; timing/routine; awareness; self-efficacy; and perceived health-related outcomes. Overall, interviews suggested strong engagement with the PNF intervention as well as a number of positive perceived effects of the intervention.

These findings contribute to a broad field of intermittent fasting by exploring and understanding the direct experiences of older adults participating in PNF. Some participants identified challenges of participation, yet this qualitative approach can guide future PNF implementation with older adults. Notably, responses support the quantitative data suggesting that PNF is a feasible and acceptable intervention for older adults.

Guideline-based tobacco treatment is infrequently offered. Electronic health record-enabled patient-generated health data (PGHD) has the potential to increase patient treatment engagement and satisfaction.

We evaluated outcomes of a strategy to enable PGHD in a medical oncology clinic from July 1, 2021 to December 31, 2022. Among 12,777 patients, 82.1% received a tobacco screener about use and interest in treatment as part of eCheck-in via the patient portal.

We attained a broad reach (82.1%) and moderate response rate (30.9%) for this low-burden PGHD strategy. Patients reporting current smoking (n = 240) expressed interest in smoking cessation medication (47.9%) and counseling (35.8%). As a result of patient requests via PGHD, most tobacco treatment requests by patients were addressed by their providers (40.6–80.3%). Among patients with active smoking, those who received/answered the screener (n = 309 ) were more likely to receive tobacco treatment compared with usual care patients who did not have the patient portal (n = 323) (OR = 2.72, 95% CI = 1.93–3.82, P < 0.0001) using propensity scores to adjust for the effect of age, sex, race, insurance, and comorbidity. Patients who received yet ignored the screener (n = 1024) compared with usual care were also more likely to receive tobacco treatment, but to a lesser extent (OR = 2.20, 95% CI = 1.68–2.86, P < 0.0001). We mapped observed and potential benefits to the Translational Science Benefits Model (TSBM).

PGHD via patient portal appears to be a feasible, acceptable, scalable, and cost-effective approach to promote patient-centered care and tobacco treatment in cancer patients. Importantly, the PGHD approach serves as a real world example of cancer prevention leveraging the TSBM.