OBJECTIVES/GOALS: The goal of this project was to assess the scientific impact of Miami CTSI’s Mentored Career Development (KL2) Program using bibliometric tools and network visualization in addition to the traditional metrics used to provide a comprehensive evaluation. METHODS/STUDY POPULATION: Scholarly productivity of KL2 scholars were tracked using REDCap. For bibliometric data analysis and visualization, publications were queried using iCite (NIH Office of Portfolio Analysis) and Web of Science database. A total of 173 publications produced by eight KL2 scholars from 2013-2018 were analyzed and categorized into pre-award, during award, and post-award periods. iCite was used to assess scientific influence and translation. Scientific networks and collaboration were visualized using VOSviewer (Centre for Science and Technology Studies, Leiden University). CTSA Common Metrics were tracked using the Results Based Accountability framework. RESULTS/ANTICIPATED RESULTS: Albeit of modest size, the Miami CTSI’s KL2 Program had significant scientific productivity and impact in its first five years. Our KL2 scholars’ publications were cited twice as frequently as other papers in their fields. Further, 48% of publications post KL2 award were above the NIH 50th percentile and had higher citation impact compared to the average NIH-funded paper; 11% were in the top 10% NIH citation ranking. In contrast, only 20% of the publications pre-KL2 award were above the NIH 50th percentile. The program also promoted research collaboration; network visualizations indicate larger co-authorship and organization networks of KL2 scholars post-award. DISCUSSION/SIGNIFICANCE OF IMPACT: Bibliometric and data visualization approaches helped us better identify trends and gauge effectiveness of the KL2 program. These findings provided useful insight into the scientific influence and impact of our scholars’ work.

OBJECTIVES/GOALS: We describe here the implementation of a pilot Quality Improvement (QI) program in clinical research processes in order to facilitate translation from bench to community. This presentation will also discuss challenges encountered by the research teams during the implementation of QI activities. METHODS/STUDY POPULATION: Miami CTSI collaborated with University of Kansas’ CTSA to test the implementation of a QI program for clinical research processes. The program has a duration of 1 year and consists of multi-modal training and coaching sessions with different research teams. Six teams comprising of Principal investigators, clinical coordinators, and regulatory specialists participated in the program based in applied clinical microsystem theory science. Team coaches and teams worked together to assess current processes, test new and improved processes, and standardize and disseminate applicable best practices of the QI program. RESULTS/ANTICIPATED RESULTS: The implementation of QI activities in large clinical research settings poses numerous challenges for the research team. We will present survey results from the coaching sessions and follow on feedback from the different teams involved in the program to implement the QI activities. We will describe the modifications and adjustments made to the original conceptual framework of QI program in order for it to be applicable and feasible for the settings of the University of Miami. We will provide recommendations for other academic clinical research centers that are considering implementing a QI program. DISCUSSION/SIGNIFICANCE OF IMPACT: The successful adaptation of a QI process to implement in academic clinical research settings relies on early engagement of the institution leadership, careful selection of team members, as well as developing communication skills to enhance team dynamics as a clinical research unit.

OBJECTIVES/GOALS: The objectives of this presentation are to discuss 1) the implementation of Consent to Contact at an Academic Medical Center; 2) the access to lists of potential participants by study teams; and 3) the challenges and adjustments made to the initial conceptualized process. METHODS/STUDY POPULATION: Participant recruitment is critical to the success of all research studies. It is particularly challenging when investigators do not have a patient population from which to recruit. Thus, the University of Miami launched the CTC initiative in 2016 to facilitate study recruitment. Study investigators can request access to a registry of participants who agreed to be contacted and meet the initial study eligibility criteria. A multidisciplinary Operational Committee provides oversight and regulates access to the CTC registry. RESULTS/ANTICIPATED RESULTS: The registry has over 110K patients who have agreed to be contacted for eligible research studies. The demographic distribution of the patients in the registry mirrors the diversity of the UHealth population. As of January 2018, when the registry became available to the research community, 25 study teams from different departments, including the All of Us Research Program, have requested potential participant lists. The process of requesting access to patient lists is adapted to studies’ needs, with particular reference to sensitive populations, such as HIV/AIDS, substance abuse, etc. Results on utilization and satisfaction of the CTC initiative are being collected and will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: The CTC initiative allows UHealth patients to opt-in to the registry for research studies. The Operational Committee continues to monitor the successful consent of patients to participate in individual research studies and improving the request process.

OBJECTIVES/GOALS: The goal of this project was to a) evaluate the first five years of Miami CTSI’s Pilot Translational and Clinical Studies Program using outcome measures that quantify research productivity augmented by the CTSA Common Metrics; and b) use the results to shape future program management. METHODS/STUDY POPULATION: Pilot Program applicant and awardee demographic data were collected during the first 5-year cycle of the Miami CTSI grant. Projects were categorized into the translation spectrum based on type of research using published guidelines. Research productivity from funded pilot projects were tracked annually using internal institutional grant award databases and external databases such as PubMed and NIH Reporter. CTSA Common Metrics were tracked using the Results Based Accountability framework. Relative Citation Ratio (RCR), NIH percentile and translation impact of pilot project publications were determined using the iCite tool (NIH Office of Portfolio Analysis). RESULTS/ANTICIPATED RESULTS: The Miami CTSI’s Pilot Award Program demonstrated notable success in its first five years. Of the twenty-two projects that were funded during that time period, 45% led to follow-on funding for a total of $17.2M—a strong return on investment of 15:1. Further, 77% of awardees had at least one publication. A total of four patents and 43 publications resulted directly from the funded projects. The mean RCR for all publications was 2.7, weighted RCR was 99.87, and nine papers were been cited by clinical documents. Overall, 63% of the projects were classified as T1/T2 (pre-clinical/clinical research) and 37% as T3/T4 (post-clinical translational research/public health). DISCUSSION/SIGNIFICANCE OF IMPACT: Miami CTSI’s Pilot Award Program demonstrated success in scholarly output, follow on funding, and scientific impact. These results will serve as benchmarks going forward and will allow the CTSI to leverage program strengths in collaborating with other institutional internal award mechanisms.

Objectives: To test the hypothesis that brain arterial diameters are associated with cognitive performance, particularly in arteries supplying domain-specific territories. Methods: Stroke-free participants in the Northern Manhattan Study were invited to have a brain MRI from 2003–2008. The luminal diameters of 13 intracranial arterial segments were obtained using time-of-flight magnetic resonance angiogram (MRA), and then averaged and normalized into a global score and region-specific arterial diameters. Z-Scores for executive function, semantic memory, episodic memory and processing speed were obtained at MRI and during follow-up. Adjusted generalized additive models were used to assess for associations. Results: Among the 1034 participants with neurocognitive testing and brain MRI, there were non-linear relationships between left anterior (ACA) and middle cerebral artery (MCA) diameter and semantic memory Z-scores (χ2=10.00; DF=3; p=.019), and left posterior cerebral artery (PCA) and posterior communicating artery (Pcomm) mean diameter and episodic memory Z-scores (χ2=9.88; DF=3; p=.020). Among the 745 participants who returned for 2nd neuropsychological testing, on average 5.0±0.4 years after their MRI, semantic memory change was associated non-linearly with the left PCA/Pcomm mean diameter (χ2=13.09; DF=3; p=.004) and with the right MCA/ACA mean diameter (χ2=8.43; DF=3; p=.03). In both cross-sectional and longitudinal analyses, participants with the larger brain arterial diameters had more consistently lower Z-scores and greater decline than the rest of the participants. Conclusions: Brain arterial diameters may have downstream effects in brain function presenting as poorer cognition. Identifying the mechanisms and the directionality of such interactions may increase the understanding of the vascular contribution to cognitive impairment and dementia. (JINS, 2018, 24, 335–346)

Metabolic syndrome (MetS) is a clustering of vascular risk factors and is associated with increased risk of cardiovascular disease. Less is known about the relationship between MetS and cognition. We examined component vascular risk factors of MetS as correlates of different cognitive domains. The Northern Manhattan Study (NOMAS) includes 1290 stroke-free participants from a largely Hispanic multi-ethnic urban community. We used structural equation modeling (SEM) to model latent variables of MetS, assessed at baseline and an average of 10 years later, at which time participants also underwent a full cognitive battery. The two four-factor models, of the metabolic syndrome (blood pressure, lipid levels, obesity, and fasting glucose) and of cognition (language, executive function, psychomotor, and memory), were each well supported (CFI=0.97 and CFI=0.95, respectively). When the two models were combined, the correlation between metabolic syndrome and cognition was −.31. Among the metabolic syndrome components, only blood pressure uniquely predicted all four cognitive domains. After adjusting for age, gender, race/ethnicity, education, smoking, alcohol, and risk factor treatment variables, blood pressure remained a significant correlate of all domains except memory. In this stroke-free race/ethnically diverse community-based cohort, MetS was associated with cognitive function suggesting that MetS and its components may be important predictors of cognitive outcomes. After adjusting for sociodemographic and vascular risk factors, blood pressure was the strongest correlate of cognitive performance. Findings suggest MetS, and in particular blood pressure, may represent markers of vascular or neurodegenerative damage in aging populations. (JINS, 2014, 20, 1–10)

The meanings of several target neuropsychological variables, including measures of executive functioning, were examined using contextual analysis across a sample of English-speakers and a sample of Spanish-speakers. Results of the contextual analysis, which examined the contributions of the latent constructs of memory, psychomotor speed, visual spatial ability, and knowledge and comprehension, to the target neuropsychological variables indicate that each of the target variables likely reflects the unique contribution of several reference abilities. These findings provide evidence that the neuropsychological variables are multi-dimensional. The patterns of relations were similar across the samples of English and Spanish speakers. (JINS, 2012, 18, 223–233)

Cognitive reserve is a hypothetical construct that has been used to inform models of cognitive aging and is presumed to be indicative of life experiences that may mitigate the effects of brain pathology. The purpose of this study was to evaluate the construct validity of cognitive reserve by examining both its convergent and its discriminant validity across three different samples of participants using structural equation modeling. The cognitive reserve variables were found to correlate highly with one another (thereby providing evidence of convergent validity), but demanding tests of discriminant validity indicated that, in two of the samples, the cognitive reserve construct was highly related to an executive functioning construct. (JINS, 2009, 15, 558–569.)