Background: Identifying functional biomarkers related to treatment success can aid in optimizing therapy and provide a better understanding of the neural mechanisms of treatment-resistant depression (TRD) and subcallosal cingulate deep brain stimulation (SCC-DBS). Methods: Magnetoencephalography data were obtained from 16 individuals with SCC-DBS for TRD and 25 healthy subjects. We identified region-specific oscillatory modulations that both (i) discriminate individuals with TRD (SCC-DBS OFF) from healthy controls and (ii) discriminate responders from non-responders (SCC-DBS ON). The effects of stimulation intensity and frequency were also explored. Results: Discriminative regions that differentiated responders from non-responders based on modulations of increased alpha (8-12 Hz) and decreased gamma (32-116 Hz) power included nodes of the default mode, central executive, and somatomotor networks, Broca’s area, and lingual gyrus. Furthermore, low stimulation frequency had stronger effects on oscillatory modulation. Conclusions: The identified functional biomarkers implicate modulations of TRD-related activity in brain regions involved in emotional control/processing, motor control, and interactions between speech, vision, and memory – all implicated in depression. These electrophysiological biomarkers have the potential to be used as functional proxies for therapy optimization. Additional stimulation parameter analyses revealed that oscillatory modulations are strengthened by increasing stimulation intensity or reducing frequency, which may benefit SCC-DBS non-responders.

This article presents a landscape assessment of the findings from the 2021 Clinical and Translational Science Award (CTSA) Evaluators Survey. This survey was the most recent iteration of a well established, national, peer-led systematic snapshot of the CTSA evaluators, their skillsets, listed evaluation resources, preferred methods, and identified best practices. Three questions guided our study: who are the CTSA evaluators, what competencies do they share and how is their work used within hubs. We describe our survey process (logistics of development, deployment, and differences in historical context with prior instruments); and present its main findings. We provide specific recommendations for evaluation practice in two main categories (National vs Group-level) including, among others, the need for a national, strategic plan for evaluation as well as enhanced mentoring and training of the next generation of evaluators. Although based on the challenges and opportunities currently within the CTSA Consortium, takeaways from this study constitute important lessons with potential for application in other large evaluation consortia. To our knowledge, this is the first time 2021 survey findings are disseminated widely, to increase transparency of the CTSA evaluators' work and to motivate conversations within hub and beyond, as to how best to leverage existent evaluative capacity.

OBJECTIVES/GOALS: A new mandate for Clinical & Translational Science Award (CTSA) Programs is for pilot grant funding to support clinical and translational science (CTS) projects that study challenges in the translational research pipeline. This pivot requires new structures and supports to help investigators design and implement high-quality CTS projects. METHODS/STUDY POPULATION: The Michigan Institute for Clinical & Health Research (MICHR) at the University of Michigan (U-M) has launched two rounds of pilot funding since March 2023. Faculty and staff across U-M’s three campuses, community members, and those at collaborating institutions and hospitals were eligible to apply. New pre-award supports included a CTS project framework; a recorded webinar that educated about CTS and the funding opportunity; office hours to provide tailored project feedback; a letter of intent to screen for alignment with CTS; and reviewer training for academic and community reviewers. Funded projects operate like 'mini cooperative agreements”, with MICHR experts partnering with awardees to refine evaluation plans, prepare work products, advise on dissemination, and navigate emergent challenges. RESULTS/ANTICIPATED RESULTS: The first round of funding was launched in the absence of pre-award supports; ten applications we received from faculty proposing translational research rather than CTS. We quickly re-released the FOA, expanding eligibility to staff. We received nine applications, ultimately funding four staff and one faculty studying operational challenges in translation and helping them create robust evaluation plans. We piloted the pre-award supports in our second round, with 40 individuals viewing our webinar and 11 attending office hours. Those who watched the webinar before attending office hours better understood how to embed CTS questions within their programs of research. We recently received 19 letters of intent, addressing both operational and scientific challenges, with 16 eligible to submit applications. DISCUSSION/SIGNIFICANCE: Education and personalized feedback seem to elicit a higher yield of CTS projects. Staff are already adept at solving operational challenges, so the pre-award supports were most critical for faculty accustomed to writing traditional translational research proposals. Staff have most benefited from guidance in evaluation and dissemination.

OBJECTIVES/GOALS: The objective of this initiative was to promote MICHR staff’s production of Clinical and Translational Science publications. MICHR leadership approved this initiative, including an evaluation plan with measurable outcomes goals, and contracted with an experienced scientific writing coach with over 20 years of experience working with CTSAs. METHODS/STUDY POPULATION: A sequential mixed methods program evaluation designs was used. Pre- and post-surveys were used to measure participating staff’s gain in skill, understanding & satisfaction. An interview with the instructor was then conducted to characterize staff performance, and identify possible areas of programmatic improvement. This initial phase of the program evaluation was conducted in the Summer of 2023. The results were used to inform an expansion of the program to include more staff in the the Fall of 2023. Pre- and post-program surveys of the participants were conducted and interviews with each program participant were conducted. Finally, interviews with non-participating staff were conducted to assess their need for writing support and the challenges and facilitators of their scientific writing. RESULTS/ANTICIPATED RESULTS: Preliminary evaluation results obtained in the summer of 2023 were positive. All participants completed the course, and spent an average of 3.3 hours working between sessions. Six manuscripts were developed, five of which are being readied for submission and one submitted as of August 2023. Analysis of the pre-and post-program surveys indicated that all participants gained writing skill and authorship knowledge. Specifically, they gained confidence in 7 writing skills and 6 first-author roles evaluated during the course. All participants were satisfied with their experience and recommended the course to their colleagues, and the course instructor was also satisfied with the course. However, the participants noted that competing work demands and variable preparation hindered their work in the course. DISCUSSION/SIGNIFICANCE: With the increasing focus on Clinical and Translational Science taking place across the CTSA Consortium it is important to involve research staff in paper writing teams, including in first-author roles. Professional development in scientific writing can support Clinical and Translational Research staff contributing to this emerging science.

OBJECTIVES/GOALS: There is broad recognition that interdisciplinary research teams are uniquely suited to address complex research questions. At the Michigan Institute for Clinical & Health Research, we recognized a significant gap in support services at the University of Michigan for coordinating interdisciplinary teams to advance translational research. METHODS/STUDY POPULATION: The initial team science challenge we tackled was how to bring together cross-disciplinary groups, for the first time, to engage meaningfully and collaboratively with a ‘wicked’ problem of interest and create a shared vision. To address this, we developed Ideation Jams, which are facilitated experiences that help new groups build community, identify and prioritize research opportunities, determine how individual interests and other potential partners align with opportunities, and commit to next steps that will advance collaborative efforts. Ideation Jams leverage the methods and mindsets of design thinking, including divergence and convergence; making information visual; amplifying diversity; horizontal distribution of responsibility; and bias towards action. RESULTS/ANTICIPATED RESULTS: We have facilitated 11 Ideation Jams with 255 participants, including faculty, staff, health practitioners, and community members, who brought diverse expertise and insight to the research problems. Participant feedback has been overwhelmingly positive, with Ideation Jams fostering shared vision and innovation, and positively impacting various measures related to team performance. Participants have reported that Ideation Jams catalyzed various outcomes, including submission and award of grants, the introduction of new and specialized clinical offerings, and development of an interdisciplinary research agenda for their field of interest. Most recently, we trained representatives from five Clinical & Translational Science Award hubs to implement Ideation Jams at their universities. DISCUSSION/SIGNIFICANCE: Ideation Jams are ideal for mobilizing new groups around complex research problems, moving them from blue-sky thinking to action planning in three hours. Ideation Jams will be integrated into a suite of facilitated experiences, trainings, and grant development services to provide iterative support as teams advance their research priorities.

OBJECTIVES/GOALS: In line with NCATS funding requirements, the Michigan Institute for Clinical and Health Research (MICHR) established a continuous quality improvement (CQI) process and used the process to guide the implementation of a benchmarking project to evaluate and set goals for MICHR’s production of Clinical and Translational Science manuscripts. METHODS/STUDY POPULATION: We aimed to increase the number of Clinical and Translational Science papers MICHR produces and to set a reasonable goal for improvement. Benchmarking was used to obtain a baseline and inform the identification of a reasonable goal for improvement. 11 Peer institutions were identified with similar funding levels. 1,225 Publications from 2022 for all 12 CTSAs were obtained from NIH Reporter. All publications were reviewed by title to identify probable CTS content. Two staff reviewers confirmed a total of 108 CTS publications across all CTSAs, and coded each paper to characterize the theoretical approach, method (quantitative and/or qualitative), analytic method and topic. All publications that were selected for benchmarking were also tracked and compared using Altmetrics for Institutions and Overton platforms. RESULTS/ANTICIPATED RESULTS: A total of 108 CTS publications were produced by 12 benchmarked CTSAs in 2022; of those, 70% (77) regarded research infrastructure, 37% (41) regarded research methods, and 15% (16) regarded clinical care. Over half, 53% (58), of the benchmarked papers are empirical research papers; of those, 67% (39) used quantitative methods, 28% (16) used qualitative methods, and 5% (3) used mixed methods. A clear majority of the benchmarked papers, 70% (76), provided only descriptive analyses, 18% (19) provided inferential analyses, and 12% (13) provided predictive analyses. We identified an opportunity to produce more manuscripts with descriptive analyses of research infrastructure. In the long-term, we saw an opportunity to produce predictive analyses of translational initiatives designed to impact clinical care. DISCUSSION/SIGNIFICANCE: The benchmarking results helped MICHR identify goals for its production of Clinical and Translational Science to fill gaps in the field. Expanding the scope of this benchmarking project might achieve greater interrater reliability using larger representative sets of publications drawn from institutions across the CTSA Consortium.

The University of Michigan created the Practice-Oriented Research Training (PORT) program and implemented it between 2008 and 2018. The PORT program provided research training and funding opportunities for allied healthcare professionals. The program consisted of weekly didactics and group discussion related to topics relevant to developing specific research ideas into projects and funding for a mentored research project for those who submitted a competitive grant application. The goal of this evaluation was to assess the long-term impact of the PORT program on the research careers of the participants. Ninety-two participants (74 staff and 18 faculty) participated in both phases of the program. A mixed-methods approach to evaluation was used; 25 participants who received funding for their research completed surveys, and semi-structured interviews were conducted with eight program participants. In addition, data were collected on participants’ publication history. Fifteen out of the 74 staff participants published 31 first-authored papers after participating in PORT. Twelve out of 15 staff participants who published first-authored papers did so for the first time after participating in the PORT program. Results of quantitative and qualitative analyses suggest that the PORT program had positive impacts on both participants and the research community.

Clinical and translational research relies on a well-trained workforce, but mentorship programs designed expressly for this workforce are lacking. This paper presents the development of a mentoring program for research staff and identifies key programmatic outcomes. Research staff participating in this program were matched with a senior mentor. Focus groups were conducted to identify key program outcomes. Surveys were administered throughout the program period to assess participants’ experience, gains in skill, and subsequent careers. Analysis of the resultant qualitative and quantitative data are used to characterize the implementation and impact of the program. A total of 47 mentees and 30 mentors participated in program between 2018 and 2023. A comprehensive logic model of short-, intermediate- and long-term outcomes was developed. Participants reported positive valuations of every programmatic outcome assessed including their program experience, learning and research careers. The pool of available mentors also grew as new mentors were successfully recruited for each cohort. This mentorship program developed and implemented by senior research staff successfully provided junior research staff with professional development support, mentorship, and professional development opportunities. Junior and senior health research staff built mentoring relationships that advanced their clinical and translational research careers.

OBJECTIVES/GOALS: To improve early career faculty members’ NIH grant writing skills, Clinical and Translational Science Awards (CTSA) hubs have developed a variety of workshop-style programs. However, few articles have evaluated the impact of grant writing workshops on NIH grant submission and award rates. METHODS/STUDY POPULATION: The K Writing program was developed by the Michigan Institute for Clinical and Health Research (MICHR) at the University of Michigan. Since 2012, 435 scholars have participated in the program. The MICHR K Writing program is a three-part workshop series that prepares scholars by providing them with guidelines to write all sections of a career development grant application. Each session focuses on different sections of the K award proposal. During the workshop sessions, participants break into small groups and exchange drafts of their proposal sections and receive peer critique and feedback from senior faculty facilitators who have experience with NIH study sections. RESULTS/ANTICIPATED RESULTS: Between 2012-2018, 273 scholars participated and 57% were female. Our two primary outcomes of interest are submission rates and success rates (the number of grants awarded divided by the number of applications). We plan to examine the effects of several characteristics, including number of sessions attended, cohort year, and faculty vs. postdoctoral status. We will also examine whether there were differences in submission and success rates between female and male researchers and between underrepresented minority scholars and those who identified as white or Asian. Lastly, we will report submission and success rates for each grant mechanism and compare them to the national averages. DISCUSSION/SIGNIFICANCE: Obtaining external research funding is an important part of a faculty career, especially at its early stages. This research has important implications for the design of similar programs intended to increase submission and success rates for federal grant applications.

OBJECTIVES/GOALS: There are few training programs for health research staff and clinicians like The Practice-Oriented Research Training program, that include opportunities to conduct funded clinical and translational research. The goal of this study is to evaluate the long-term impact of this program on participants professional development and advancement. METHODS/STUDY POPULATION: The Practice-Oriented Research Training program for health research staff and clinicians was operated by the Michigan Institute for Clinical and Health Research from 2008 through 2018. Participants received training and formed teams that received financial support to conduct a clinical or translational study with a faculty mentor. Eleven cohorts comprising 111 individuals participated. The long-term impact of the program was evaluated using sequential mixed methods. All participants were invited to evaluate the program via an online survey in 2021. Respondents were invited to participate in interviews in 2022. Secondary records of the participants’ publications, grants, and professional advancement were collected. RESULTS/ANTICIPATED RESULTS: 68 participants in the PORT program published 345 papers in peer-reviewed scientific journals following the program, averaging over 5 publications per participant. These publications have been cited over 4000 times with an average of over 13 citations per paper. Large proportion of program participants have continued contributing to health research; the vast majority of program participation chose to continue at the University of Michigan. Survey results indicate participants’ belief that the program had wide-ranging and enduring impacts on key aspects of their careers, including their application of research to practice. Interviews confirmed that the program helped many participants make substantial advancement in their careers. DISCUSSION/SIGNIFICANCE: Training programs for health research staff and clinicians can have a substantial and enduring impact on their professional development and advancement. The need for programs like PORT will increase as the health research workforce grows. These results inform recommendations for translational scientists.

OBJECTIVES/GOALS: This study evaluates the impact of an updated and expanded training for social and behavioral health researchers. Participants’ experience with training modules focused on community engagement is a focus of this evaluation as is the application of this training by participants in teams. METHODS/STUDY POPULATION: The Social and Behavioral Research training series for health researchers and team members was first created by faculty and staff of the Michigan Institute for Clinical and Health Research in 2018. This training was updated and expanded in 2021 with support from the National Institutes of Health to include new material regarding community-engaged health research as well as updates concerning technology and new federal regulations. Past participants of the training were invited to retake the training, as were clinical and translational researchers at University of Michigan who were new to the training. Surveys were sent to all participants after completing the training and a focus group of research staff was conducted to identify how they utilized the training in support of their teams. RESULTS/ANTICIPATED RESULTS: It is anticipated that at least 100 individuals will participate in the evaluation of the Social and Behavioral Research training between October 2022 and February 2023. Data extracted from U-M’s learning management platform will demonstrate how well participants performed on key knowledge checks embedded in the modules and how quickly they progressed through the sections of the training. These results will be compared to benchmarks derived from evaluations of the prior course which were conducted in 2018. A focus group of at least 10 individuals will demonstrate how health research staff utilized the training and associated resources to advance the scientific work of their study teams. DISCUSSION/SIGNIFICANCE: Comprehensive training programs for research best practices in social and behavioral health need to have tailored and up-to-date information for this group of researchers and staff. The results of this evaluation will demonstrate how this program contributed to the professional development of the health research workforce.

OBJECTIVES/GOALS: There is a critical need to provide quality training for study teams. Materials need to be flexible and available at the learner’s preferred time and format. DIAMOND was developed to provide nimble education offerings that respond to the changing landscape of clinical and translational research. METHODS/STUDY POPULATION: In 2018 four CTSA institutions (the University of Michigan, the Ohio State University, Rochester University, and Tufts University) collaborated to launch the DIAMOND portal. Developed as a CTSA-wide web-based platform, DIAMOND allows members of clinical and translational research teams to widely share and access training and education resources. In 2022 a MICHR-led update of DIAMOND used principles of user centered design to improve the platform. New features include updated search functions to quickly find and sort training materials, tagging training materials to the characteristics of a translational scientist, and development of user controlled customized playlists. RESULTS/ANTICIPATED RESULTS: DIAMOND currently includes 217 training resources developed by 30 CTSA hubs and private industry. The platform has over 600 page views per day from users across the U.S. and internationally. DIAMOND includes an easy-to-use form to upload new materials to the platform. Contributors are asked to include key words and select competency domains and characteristics of a translational scientist that apply to their materials. Other new features include tagging materials to streamline and improve search results, the ability to sort materials by competency domain or characteristics of a translational scientist, and the ability for users to create and share customized, personalized playlists. DISCUSSION/SIGNIFICANCE: DIAMOND is an important tool to support workforce development for study teams. Updates to the flexible digital platform meet the needs and preferences of adult learners and busy health professionals. Lessons learned from the design process and future plans for the platform will be explored.

COVID-19 reinforced the need for effective leadership and administration within Clinical and Translational Science Award (CTSA) program hubs in response to a public health crisis. The speed, scale, and persistent evolution of the pandemic forced CTSA hubs to act quickly and remain nimble. The switch to virtual environments paired with supporting program operations, while ensuring the safety and well-being of their team, highlight the critical support role provided by leadership and administration. The pandemic also illustrated the value of emergency planning in supporting organizations’ ability to quickly pivot and adapt. Lessons learned from the pandemic and from other cases of adaptive capacity and preparedness can aid program hubs in promoting and sustaining the overall capabilities of their organizations to prepare for future events.

Retrospective case studies of initiatives supported by the National Institutes of Health’s Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to changing FDA guidance issued in 2020 to support clinicians’ treatment of COVID-19 patients in Michigan. We studied how this program changed throughout the pandemic to support physicians’ requests for remdesivir, convalescent plasma, and other uses of unapproved drugs and novel medical devices. A protocol for retrospective translational science case studies of health interventions developed by CTSA evaluators was used for this case study. Data collection methods included seven interviews and a review of institutional data, peer-reviewed publications, news stories, and other public records. The barriers identified include evolving guidance, misalignment of organizational operations, and the complexity of the research infrastructure. The facilitators of translation include collaboration between research and care teams, increasing engagement with a broad network of supporters, and ongoing professional development for research staff. The findings of this case study can be used to inform future investigations of the principles underlying the translational process.