Meera J. Patel, Xuan Wang, Baylor Scott, White Health Teodoro Bottiglieri, Baylor Scott & White Health Heather Kitzman
OBJECTIVES/GOALS: Chronic kidney disease (CKD) impacts 15% of US adults and African American (AA) persons are disproportionately affected with more than 3 times higher risk of kidney failure when compared to Caucasian persons. This study evaluated the physiological and metabolomic effects of increased fruits and vegetables (F&V) on cardio-renal risk factors. METHODS/STUDY POPULATION: This pilot trial used a prospective, 2-group, randomized study design to evaluate a F&V intervention (N=46), where participants received a prescribed amount of fresh, base-producing F&V compared to a wait-list control (WL) condition (N=45). All participants were African American adults (≥18 years), had self-reported hypertension, and had CKD (Stage 1-3) on screening spot-urine microalbumin test. Participants were measured at baseline and 6 weeks post-intervention. Clinical data (i.e., systolic and diastolic blood pressure, lipid panel, hemoglobin A1C, BMI [body mass index], and albumin to creatinine ratio) were collected. Targeted metabolomic quantitative analysis was performed followed by LC-MS/MS and FIA-MS/MS. Linear mixed models evaluated analyte expression and clinical data. RESULTS/ANTICIPATED RESULTS: AA participants (N=91) were aged 58 ± 10.2 years, 66% female, and 54% had incomes ≤$50,000. T-tests compared change scores (baseline to 6-weeks) between groups. The F&V group demonstrated a significant reduction in BMI of -4.7 ± 10.5 kg/m² compared to a 1.9 ± 8.3 kg/m² increase in the WL group, p<.01. Further, the F&V group demonstrated a reduction in total cholesterol of -15.4 ± 58.8 mg/dL compared to a 17.7 ± 68.8 mg/dL increase in the WL group, p<.05. Non-significant reductions in hemoglobin A1c were found in the F&V versus the WL group. Metabolomic analysis indicated significant variation with an increase of suggestive key biomarkers for worse CKD in the WL versus F&V groups at 6-weeks. DISCUSSION/SIGNIFICANCE: Consumption of only 2 cups of F&V via a community-based intervention reduced CVD risk factors in AA adults with CKD and HTN and resulted in molecular/biochemical changes which may improve long-term kidney health. Further investigation may lead to development of cost-effective dietary intervention models to improve CKD outcomes in AA persons.
{"title":"499 Physiological and Metabolomic Effects of a Community-Based Cardiorenal Protective Diet Intervention in African Americans with Chronic Kidney Disease and Hypertension","authors":"Meera J. Patel, Xuan Wang, Baylor Scott, White Health Teodoro Bottiglieri, Baylor Scott & White Health Heather Kitzman","doi":"10.1017/cts.2024.423","DOIUrl":"https://doi.org/10.1017/cts.2024.423","url":null,"abstract":"<p>OBJECTIVES/GOALS: Chronic kidney disease (CKD) impacts 15% of US adults and African American (AA) persons are disproportionately affected with more than 3 times higher risk of kidney failure when compared to Caucasian persons. This study evaluated the physiological and metabolomic effects of increased fruits and vegetables (F&V) on cardio-renal risk factors. METHODS/STUDY POPULATION: This pilot trial used a prospective, 2-group, randomized study design to evaluate a F&V intervention (N=46), where participants received a prescribed amount of fresh, base-producing F&V compared to a wait-list control (WL) condition (N=45). All participants were African American adults (≥18 years), had self-reported hypertension, and had CKD (Stage 1-3) on screening spot-urine microalbumin test. Participants were measured at baseline and 6 weeks post-intervention. Clinical data (i.e., systolic and diastolic blood pressure, lipid panel, hemoglobin A1C, BMI [body mass index], and albumin to creatinine ratio) were collected. Targeted metabolomic quantitative analysis was performed followed by LC-MS/MS and FIA-MS/MS. Linear mixed models evaluated analyte expression and clinical data. RESULTS/ANTICIPATED RESULTS: AA participants (N=91) were aged 58 ± 10.2 years, 66% female, and 54% had incomes ≤$50,000. T-tests compared change scores (baseline to 6-weeks) between groups. The F&V group demonstrated a significant reduction in BMI of -4.7 ± 10.5 kg/m² compared to a 1.9 ± 8.3 kg/m² increase in the WL group, p<.01. Further, the F&V group demonstrated a reduction in total cholesterol of -15.4 ± 58.8 mg/dL compared to a 17.7 ± 68.8 mg/dL increase in the WL group, p<.05. Non-significant reductions in hemoglobin A1c were found in the F&V versus the WL group. Metabolomic analysis indicated significant variation with an increase of suggestive key biomarkers for worse CKD in the WL versus F&V groups at 6-weeks. DISCUSSION/SIGNIFICANCE: Consumption of only 2 cups of F&V via a community-based intervention reduced CVD risk factors in AA adults with CKD and HTN and resulted in molecular/biochemical changes which may improve long-term kidney health. Further investigation may lead to development of cost-effective dietary intervention models to improve CKD outcomes in AA persons.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"45 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dusti Jones, Lindsey N. Potter, Cho Y. Lam, David W. Wetter
OBJECTIVES/GOALS: Negative emotions (NE) play a pivotal role in addiction-related processes, including tobacco lapse during a quit attempt. Some NEs (e.g., shame, guilt) are posited to lead to a spiraling effect, whereby lapse predicts increased NEs leading to further lapse. This study goal is to examine associations between NEs and lapse. METHODS/STUDY POPULATION: This study examined associations between tobacco lapse and 13 distinct NEs among people who use tobacco and are trying to quit in two tobacco cessation studies. In Study 1, 220 adult (ages 18-74) cigarette users who identified as Black (50% female) participated in a 14-day study where ecological momentary assessment (with assessments approximately every 4 hours) was used to assess emotions and lapse in real-time and real-world settings. In Study 2, 288 adult (ages 18-71) cigarette users who were low socioeconomic status (51% White, 14% Black, 10% Hispanic, 49% female) participated in a 14-day study with the same study protocol as Study 1. Between and lagged within-person associations testing links between distinct NEs and lapse were examined with multilevel modeling with logistic links for binary outcomes. RESULTS/ANTICIPATED RESULTS: Results from Study 1 suggested that at the between-person level, disgust (OR =1.22, CI: 1.05, 1.42), nervousness (OR=1.23, CI:1.05,1.43), guilt (OR=1.40, CI: 1.16,1.69), and sadness (OR=1.18, CI:1.02,1.36) were predictive of higher odds of lapse, and at the within-person level, shame (OR=1.23, CI:1.04,1.45) was associated with higher odds of lapse. Results from Study 2 were similar and suggested that at the between-person level, disgust (OR=1.35, CI: 1.16, 1.56) and guilt (OR=1.88, CI:1.07,3.30), and at the within-person level, shame (OR =1.31, CI:1.10,1.55), were associated with higher odds of lapse. DISCUSSION/SIGNIFICANCE: The present study uses real-time, real-world data to demonstrate the role of distinct NEs on momentary tobacco lapse and helps elucidate specific NE that hinder the ability to abstain from tobacco use during a quit attempt. Results suggest that disgust, guilt, and shame play consistent roles in predicting lapse among diverse samples of tobacco users.
{"title":"362 Examining Temporal Links Between Distinct Negative Emotions and Tobacco Lapse During A Cessation Attempt","authors":"Dusti Jones, Lindsey N. Potter, Cho Y. Lam, David W. Wetter","doi":"10.1017/cts.2024.321","DOIUrl":"https://doi.org/10.1017/cts.2024.321","url":null,"abstract":"OBJECTIVES/GOALS: Negative emotions (NE) play a pivotal role in addiction-related processes, including tobacco lapse during a quit attempt. Some NEs (e.g., shame, guilt) are posited to lead to a spiraling effect, whereby lapse predicts increased NEs leading to further lapse. This study goal is to examine associations between NEs and lapse. METHODS/STUDY POPULATION: This study examined associations between tobacco lapse and 13 distinct NEs among people who use tobacco and are trying to quit in two tobacco cessation studies. In Study 1, 220 adult (ages 18-74) cigarette users who identified as Black (50% female) participated in a 14-day study where ecological momentary assessment (with assessments approximately every 4 hours) was used to assess emotions and lapse in real-time and real-world settings. In Study 2, 288 adult (ages 18-71) cigarette users who were low socioeconomic status (51% White, 14% Black, 10% Hispanic, 49% female) participated in a 14-day study with the same study protocol as Study 1. Between and lagged within-person associations testing links between distinct NEs and lapse were examined with multilevel modeling with logistic links for binary outcomes. RESULTS/ANTICIPATED RESULTS: Results from Study 1 suggested that at the between-person level, disgust (OR =1.22, CI: 1.05, 1.42), nervousness (OR=1.23, CI:1.05,1.43), guilt (OR=1.40, CI: 1.16,1.69), and sadness (OR=1.18, CI:1.02,1.36) were predictive of higher odds of lapse, and at the within-person level, shame (OR=1.23, CI:1.04,1.45) was associated with higher odds of lapse. Results from Study 2 were similar and suggested that at the between-person level, disgust (OR=1.35, CI: 1.16, 1.56) and guilt (OR=1.88, CI:1.07,3.30), and at the within-person level, shame (OR =1.31, CI:1.10,1.55), were associated with higher odds of lapse. DISCUSSION/SIGNIFICANCE: The present study uses real-time, real-world data to demonstrate the role of distinct NEs on momentary tobacco lapse and helps elucidate specific NE that hinder the ability to abstain from tobacco use during a quit attempt. Results suggest that disgust, guilt, and shame play consistent roles in predicting lapse among diverse samples of tobacco users.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"46 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kitt Swartz, Matt Honoré, Kimberly Cook, Heidi Funderburgh, Cynthia Morris, David Ellison
OBJECTIVES/GOALS: The Oregon Clinical and Translational Research Institute (OCTRI) Clinical Research Navigator program provides a single point of entry for clinical and translational research services, support, advice and guidance. We provide data to illustrate the Navigator model at OHSU and examine continued opportunities to optimize research resources. METHODS/STUDY POPULATION: Requests and activities performed by the OCTRI Navigator program, staffed by 3 FTE (2 Assistant Navigators and 1 Assistant Director) were analyzed. Navigator receives requests through multiple methods: a digital form (REDCap®), email, phone calls. Requests for services and support include focused need for a core or a broad request for multiple services for start-up: informatics, the clinical and translational research center, regulatory knowledge and support, recruitment, qualitative methods, community research, biostatistics or broad consultations. Requests are tracked in SPARCRequest. Navigator also supports wayfinding to institutional resources outside of the CTSA, matchmaking for sponsors seeking investigators, and serves as a connector and facilitator across programs. RESULTS/ANTICIPATED RESULTS: OCTRI Clinical Research Navigator triaged an average of 964 research requests for 613 projects with 388 unique investigators annually between 2018-2022. Navigator also fields more than 80 calls each year that are unrelated to CTSA projects. Project requests are examined to illustrate trends in projects requesting multiple services and display how Navigator simplifies project intake and connects researchers to resources they may have not recognized they needed. Project attributes including funding type and funding status are included in this review. DISCUSSION/SIGNIFICANCE: CTSA resources are essential to the infrastructure available to researchers. While absolute numbers of requests provide little insight into the impact each CTSA hub may have, the timing and clustering trends of projects with multiple program requests shows how a combination of technology and experienced staff can efficiently support researchers.
{"title":"524 Navigator: Providing a foundation for cross team collaboration and custom research service through the CTSA Hub","authors":"Kitt Swartz, Matt Honoré, Kimberly Cook, Heidi Funderburgh, Cynthia Morris, David Ellison","doi":"10.1017/cts.2024.446","DOIUrl":"https://doi.org/10.1017/cts.2024.446","url":null,"abstract":"OBJECTIVES/GOALS: The Oregon Clinical and Translational Research Institute (OCTRI) Clinical Research Navigator program provides a single point of entry for clinical and translational research services, support, advice and guidance. We provide data to illustrate the Navigator model at OHSU and examine continued opportunities to optimize research resources. METHODS/STUDY POPULATION: Requests and activities performed by the OCTRI Navigator program, staffed by 3 FTE (2 Assistant Navigators and 1 Assistant Director) were analyzed. Navigator receives requests through multiple methods: a digital form (REDCap®), email, phone calls. Requests for services and support include focused need for a core or a broad request for multiple services for start-up: informatics, the clinical and translational research center, regulatory knowledge and support, recruitment, qualitative methods, community research, biostatistics or broad consultations. Requests are tracked in SPARCRequest. Navigator also supports wayfinding to institutional resources outside of the CTSA, matchmaking for sponsors seeking investigators, and serves as a connector and facilitator across programs. RESULTS/ANTICIPATED RESULTS: OCTRI Clinical Research Navigator triaged an average of 964 research requests for 613 projects with 388 unique investigators annually between 2018-2022. Navigator also fields more than 80 calls each year that are unrelated to CTSA projects. Project requests are examined to illustrate trends in projects requesting multiple services and display how Navigator simplifies project intake and connects researchers to resources they may have not recognized they needed. Project attributes including funding type and funding status are included in this review. DISCUSSION/SIGNIFICANCE: CTSA resources are essential to the infrastructure available to researchers. While absolute numbers of requests provide little insight into the impact each CTSA hub may have, the timing and clustering trends of projects with multiple program requests shows how a combination of technology and experienced staff can efficiently support researchers.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"66 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Siyu Chen, Sarah K. Brewer, Robert Sege, Aviva Must, Nadia Prokofieva, Thomas W. Concannon, Alice Rushforth, Lisa Welch
OBJECTIVES/GOALS: Community and other stakeholder engagement (CSE) is critical for relevant and equitable clinical research, yet implementation poses challenges. This study delineates the perspectives of scientists and diverse stakeholders regarding facilitators and challenges in CSE, its perceived value, and their recommendations for successful CSE. METHODS/STUDY POPULATION: The Tufts CTSI Pilot Studies Program requires applicants to propose a plan for CSE while implementing the award, including which stakeholders (SHs)—community members, clinicians, and others affected by the research--will be involved and at what stages. This qualitative study assessed the experiences of both Principal Investigators (PIs) and SHs engaged in pilot projects from three cohorts of awardees (2019-21). Recruitment targeted one PI and one SH per project. Semi-structured interviews explored their CSE experiences, including facilitators, challenges, meaningfulness, perceived impact, intent to participate in CSE in future studies, as well as recommendations for funders, research support organizations, and investigators. Inductive consensus-based coding and thematic analysis was employed. RESULTS/ANTICIPATED RESULTS: Fourteen PIs from different pilot projects and a SH from five of these projects participated. Almost all PIs (92%) had over six years of experience, but two-thirds (67%) had little or no experience with CSE. Four SHs self-identified as representatives of community organizations and one as a clinician scientist. CSE was a “win-win” for both PIs and SHs, and all PIs intended to involve SHs in other research studies. Three facilitators were identified as fostering effective CSE (e.g., PI access to CSE expertise while conducting the project), while four challenges hindered it (e.g., limits on SH capacity and CSE funding). SHs advised scientists to build authentic, sustained relationships, and PIs and SHs provided three actionable recommendations for funders and research support organizations to deepen and expand CSE. DISCUSSION/SIGNIFICANCE: Perspectives of scientists and SHs engaged in research projects are vital for expanding and sustaining effective CSE in research. Funders and research support organizations can enhance their strategies for CSE integration in clinical and translational research by incorporating these diverse views to ensure the research achieves maximal impact.
{"title":"281 Catalyzing Community and Stakeholder Engagement (CSE) in Research: Perspectives from Scientist and Stakeholder Experience","authors":"Siyu Chen, Sarah K. Brewer, Robert Sege, Aviva Must, Nadia Prokofieva, Thomas W. Concannon, Alice Rushforth, Lisa Welch","doi":"10.1017/cts.2024.257","DOIUrl":"https://doi.org/10.1017/cts.2024.257","url":null,"abstract":"<p>OBJECTIVES/GOALS: Community and other stakeholder engagement (CSE) is critical for relevant and equitable clinical research, yet implementation poses challenges. This study delineates the perspectives of scientists and diverse stakeholders regarding facilitators and challenges in CSE, its perceived value, and their recommendations for successful CSE. METHODS/STUDY POPULATION: The Tufts CTSI Pilot Studies Program requires applicants to propose a plan for CSE while implementing the award, including which stakeholders (SHs)—community members, clinicians, and others affected by the research--will be involved and at what stages. This qualitative study assessed the experiences of both Principal Investigators (PIs) and SHs engaged in pilot projects from three cohorts of awardees (2019-21). Recruitment targeted one PI and one SH per project. Semi-structured interviews explored their CSE experiences, including facilitators, challenges, meaningfulness, perceived impact, intent to participate in CSE in future studies, as well as recommendations for funders, research support organizations, and investigators. Inductive consensus-based coding and thematic analysis was employed. RESULTS/ANTICIPATED RESULTS: Fourteen PIs from different pilot projects and a SH from five of these projects participated. Almost all PIs (92%) had over six years of experience, but two-thirds (67%) had little or no experience with CSE. Four SHs self-identified as representatives of community organizations and one as a clinician scientist. CSE was a “win-win” for both PIs and SHs, and all PIs intended to involve SHs in other research studies. Three facilitators were identified as fostering effective CSE (e.g., PI access to CSE expertise while conducting the project), while four challenges hindered it (e.g., limits on SH capacity and CSE funding). SHs advised scientists to build authentic, sustained relationships, and PIs and SHs provided three actionable recommendations for funders and research support organizations to deepen and expand CSE. DISCUSSION/SIGNIFICANCE: Perspectives of scientists and SHs engaged in research projects are vital for expanding and sustaining effective CSE in research. Funders and research support organizations can enhance their strategies for CSE integration in clinical and translational research by incorporating these diverse views to ensure the research achieves maximal impact.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"4 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVES/GOALS: The objectives of this workshop were to: (1) provide learners with a space to become aware of and discuss the history of the LGBTQ+ community in medical and public health research; (2) apply frameworks for LGBTQ+ inclusivity in research, inspired by lived experience and multimedia; and (3) assess LGBTQ+ research inclusivity best practices. METHODS/STUDY POPULATION: The CTSC provided the LGBT Community Center of Greater Cleveland (Center) with access to academic resources via an affiliate account and insights on the clinical and translational science research process. Members of the CTSC Research Equity, Accessibility, Diversity, and Inclusion team met regularly with the education and programming team at the Center to review research findings for workshop segments, ideate and provide feedback on activities, and strategize to ensure a psychologically safe virtual environment for learners. Zoom registration was used for workshop registration. An evaluation survey, created by the LGBT Community Center of Greater Cleveland (Center), was deployed by the CTSC to learners after the workshop. Respondents reported that the LGBTQ+ terminology focus was most valuable. RESULTS/ANTICIPATED RESULTS: To maximize investment in and scale theLGBTQ+ Inclusivity For Researchers workshop, the LGBT Community Center of Greater Cleveland offered a shortened version to their Youth Participatory Action Research group and will continue to offer the workshop in their suite of program/educational offerings. The CTSC plans to offer opportunities to co-host the workshop at its hospital system partner institutions, with room to tailor content based on internal LGBT resources (e.g., gender care offered at the institution). We hope to see a remarkable increase in LGBTQ+ identifying researchers, LGBTQ+ participation in research studies and clinical trials, and LGBTQ+ research topics/ideas/questions in response to CTSC pilots, local, national, and global funding opportunities. DISCUSSION/SIGNIFICANCE: LGBTQ+ people are less likely to have a regular health care provider—impeding screening, diagnosis, and treatment. This is reflected in health research where clinical research participation may follow a diagnosis. By providing tools for LGBTQ+ research inclusion, we will catalyze more research with LGBTQ+ people—as researchers and participants.
{"title":"110 Answering the Call for Greater LGBTQ+ Research Inclusivity by Co-Developing A Workshop for Researchers","authors":"Gelise Thomas, Lizzie Bjork, Zina Hempstead, Gulnar Feerasta","doi":"10.1017/cts.2024.108","DOIUrl":"https://doi.org/10.1017/cts.2024.108","url":null,"abstract":"<p>OBJECTIVES/GOALS: The objectives of this workshop were to: (1) provide learners with a space to become aware of and discuss the history of the LGBTQ+ community in medical and public health research; (2) apply frameworks for LGBTQ+ inclusivity in research, inspired by lived experience and multimedia; and (3) assess LGBTQ+ research inclusivity best practices. METHODS/STUDY POPULATION: The CTSC provided the LGBT Community Center of Greater Cleveland (Center) with access to academic resources via an affiliate account and insights on the clinical and translational science research process. Members of the CTSC Research Equity, Accessibility, Diversity, and Inclusion team met regularly with the education and programming team at the Center to review research findings for workshop segments, ideate and provide feedback on activities, and strategize to ensure a psychologically safe virtual environment for learners. Zoom registration was used for workshop registration. An evaluation survey, created by the LGBT Community Center of Greater Cleveland (Center), was deployed by the CTSC to learners after the workshop. Respondents reported that the LGBTQ+ terminology focus was most valuable. RESULTS/ANTICIPATED RESULTS: To maximize investment in and scale theLGBTQ+ Inclusivity For Researchers workshop, the LGBT Community Center of Greater Cleveland offered a shortened version to their Youth Participatory Action Research group and will continue to offer the workshop in their suite of program/educational offerings. The CTSC plans to offer opportunities to co-host the workshop at its hospital system partner institutions, with room to tailor content based on internal LGBT resources (e.g., gender care offered at the institution). We hope to see a remarkable increase in LGBTQ+ identifying researchers, LGBTQ+ participation in research studies and clinical trials, and LGBTQ+ research topics/ideas/questions in response to CTSC pilots, local, national, and global funding opportunities. DISCUSSION/SIGNIFICANCE: LGBTQ+ people are less likely to have a regular health care provider—impeding screening, diagnosis, and treatment. This is reflected in health research where clinical research participation may follow a diagnosis. By providing tools for LGBTQ+ research inclusion, we will catalyze more research with LGBTQ+ people—as researchers and participants.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"43 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annabelle N. Brinkerhoff, Jigar Gosalia, Juan J. Qiu, James A. Pawelczyk, David N. Proctor
OBJECTIVES/GOALS: ICD-10 coding inconsistencies hinder timely recognition and treatment of metabolic syndrome (MetS), posing a significant risk for cardiometabolic disease progression. This study employed a digital phenotype for MetS and compared odds for medication and lifestyle intervention compared to those coded for MetS. METHODS/STUDY POPULATION: MetS is a cluster of cardiometabolic risk factors that increase risk for numerous adverse clinical outcomes. Patients with MetS were identified through electronic medical records on TriNetX LLC using the standard ICD-10 code or through a digital phenotype, involving grouping codes for the individual components. Percentage of patients with MetS not captured with the standard code was identified. In addition, disparities in blood pressure, glucose, lipid-lowering medication, and lifestyle intervention between the coding schemas were assessed, shedding light on healthcare inequities and informing targeted interventions. Odds ratios (RR) were presented for all outcomes. RESULTS/ANTICIPATED RESULTS: Patient demographics and lab values were similar between the standard code and digital phenotype cohorts. Of the 4.3 million individuals aged 50 to 80 identified as having MetS using the digital phenotype in the TriNetX research network, only 1.78% of participants shared the standard code. Individuals with the digital phenotype for MetS were at lower odds in receiving glucose lowering medication (OR: 2.11, 95% CI: 1.98–2.13, p <0.001) and exercise or nutrition-based intervention advice (OR: 1.76, 95% CI: 1.55–1.96, p <0.001) after controlling for demographics and lab values for each MetS component. DISCUSSION/SIGNIFICANCE: This project utilized TriNetX to create a digital phenotype for MetS, and suggests most patients are not coded for it using the standard ICD-10 system. This is troublesome given those with the standard code are less likely to receive certain interventions.
{"title":"15 Discrepancies in Medication Usage and Lifestyle Modification Referrals in Metabolic Syndrome is Dependent on how the Syndrome is Coded: A TriNetX Study","authors":"Annabelle N. Brinkerhoff, Jigar Gosalia, Juan J. Qiu, James A. Pawelczyk, David N. Proctor","doi":"10.1017/cts.2024.36","DOIUrl":"https://doi.org/10.1017/cts.2024.36","url":null,"abstract":"OBJECTIVES/GOALS: ICD-10 coding inconsistencies hinder timely recognition and treatment of metabolic syndrome (MetS), posing a significant risk for cardiometabolic disease progression. This study employed a digital phenotype for MetS and compared odds for medication and lifestyle intervention compared to those coded for MetS. METHODS/STUDY POPULATION: MetS is a cluster of cardiometabolic risk factors that increase risk for numerous adverse clinical outcomes. Patients with MetS were identified through electronic medical records on TriNetX LLC using the standard ICD-10 code or through a digital phenotype, involving grouping codes for the individual components. Percentage of patients with MetS not captured with the standard code was identified. In addition, disparities in blood pressure, glucose, lipid-lowering medication, and lifestyle intervention between the coding schemas were assessed, shedding light on healthcare inequities and informing targeted interventions. Odds ratios (RR) were presented for all outcomes. RESULTS/ANTICIPATED RESULTS: Patient demographics and lab values were similar between the standard code and digital phenotype cohorts. Of the 4.3 million individuals aged 50 to 80 identified as having MetS using the digital phenotype in the TriNetX research network, only 1.78% of participants shared the standard code. Individuals with the digital phenotype for MetS were at lower odds in receiving glucose lowering medication (OR: 2.11, 95% CI: 1.98–2.13, p <0.001) and exercise or nutrition-based intervention advice (OR: 1.76, 95% CI: 1.55–1.96, p <0.001) after controlling for demographics and lab values for each MetS component. DISCUSSION/SIGNIFICANCE: This project utilized TriNetX to create a digital phenotype for MetS, and suggests most patients are not coded for it using the standard ICD-10 system. This is troublesome given those with the standard code are less likely to receive certain interventions.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"19 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Derek J. Bays, Hannah P. Savage, Connor Tiffany, Mariela A. F. Gonzalez, Eli. J. Bejarano, Henry Nguyen, Hugo L. P. Masson, Thaynara P. Carvalho, Renato L. Santos, Andrew Tritt, Suzanne M. Noble, George R. Thompson, Andreas J. Bäumler
OBJECTIVES/GOALS: Antibiotic treatment sets the stage for intestinal domination by Candida albicanswhich is necessary for development of invasive disease, but the resources driving this bloom remain poorly defined. We sought to determine these factors in order to design novel prophylaxis strategies for reducing gastrointestinal (GI) colonization. METHODS/STUDY POPULATION: We initially developed a generalizable framework, termed metabolic footprinting to determine the metabolites C. albicanspreferentially uses in the mouse GI tract. After identifying the metabolites C. albicansutilizes, we usedin vitro growth assays in the presence and absence of oxygen to validate out metabolomics findings. We next determined if a probiotic E. coli that utilizes oxygen would reduce C. albicanscolonization compared to a mutant E. coli that could not respire oxygen. Finding that oxygen was a necessary resource, we utilized germ-free mice to determine if Clostridiaspp. known to reduce GI oxygen would prevent C. albicanscolonization. Lastly, we sought to see if 5-aminosalicylic acid (5-ASA) could prevent C. albicanscolonization. RESULTS/ANTICIPATED RESULTS: We found that C. albicans preferentially utilizes simple carbohydrates including fructo-oligosaccharides (e.g., 1-kestose), disaccharides (e.g., β-gentiobiose), and alcoholic sugars (e.g., sorbitol) and is able to grow in vitro on minimal media supplemented with either of these nutrients. However, in the hypoxic environment that is found in the “healthy” colon, C. albicans cannot utilize these nutrients. We next found that pre-colonization in a mouse model with a probiotic E. coli significantly reduced C. albicanscolonization, but the mutant E. coli had no effect on colonization. We next showed that Clostridia supplementation restored GI hypoxia and reduced C. albicanscolonization. Remarkably, we found that 5-ASA significantly reduced GI colonization of C. albicans. DISCUSSION/SIGNIFICANCE: We have shown that C. albicans requires oxygen to colonize the GI tract. Importantly, we found that 5-ASA can prevent an antibiotic mediated bloom of C. albicans by restoring GI hypoxia, which warrants additional studies to determine if 5-ASA can be used as an adjunctive prophylactic treatment in high risk patients.
{"title":"403 Epithelial hypoxia maintains colonization resistance against Candida albicans","authors":"Derek J. Bays, Hannah P. Savage, Connor Tiffany, Mariela A. F. Gonzalez, Eli. J. Bejarano, Henry Nguyen, Hugo L. P. Masson, Thaynara P. Carvalho, Renato L. Santos, Andrew Tritt, Suzanne M. Noble, George R. Thompson, Andreas J. Bäumler","doi":"10.1017/cts.2024.350","DOIUrl":"https://doi.org/10.1017/cts.2024.350","url":null,"abstract":"OBJECTIVES/GOALS: Antibiotic treatment sets the stage for intestinal domination by Candida albicanswhich is necessary for development of invasive disease, but the resources driving this bloom remain poorly defined. We sought to determine these factors in order to design novel prophylaxis strategies for reducing gastrointestinal (GI) colonization. METHODS/STUDY POPULATION: We initially developed a generalizable framework, termed metabolic footprinting to determine the metabolites C. albicanspreferentially uses in the mouse GI tract. After identifying the metabolites C. albicansutilizes, we usedin vitro growth assays in the presence and absence of oxygen to validate out metabolomics findings. We next determined if a probiotic E. coli that utilizes oxygen would reduce C. albicanscolonization compared to a mutant E. coli that could not respire oxygen. Finding that oxygen was a necessary resource, we utilized germ-free mice to determine if Clostridiaspp. known to reduce GI oxygen would prevent C. albicanscolonization. Lastly, we sought to see if 5-aminosalicylic acid (5-ASA) could prevent C. albicanscolonization. RESULTS/ANTICIPATED RESULTS: We found that C. albicans preferentially utilizes simple carbohydrates including fructo-oligosaccharides (e.g., 1-kestose), disaccharides (e.g., β-gentiobiose), and alcoholic sugars (e.g., sorbitol) and is able to grow in vitro on minimal media supplemented with either of these nutrients. However, in the hypoxic environment that is found in the “healthy” colon, C. albicans cannot utilize these nutrients. We next found that pre-colonization in a mouse model with a probiotic E. coli significantly reduced C. albicanscolonization, but the mutant E. coli had no effect on colonization. We next showed that Clostridia supplementation restored GI hypoxia and reduced C. albicanscolonization. Remarkably, we found that 5-ASA significantly reduced GI colonization of C. albicans. DISCUSSION/SIGNIFICANCE: We have shown that C. albicans requires oxygen to colonize the GI tract. Importantly, we found that 5-ASA can prevent an antibiotic mediated bloom of C. albicans by restoring GI hypoxia, which warrants additional studies to determine if 5-ASA can be used as an adjunctive prophylactic treatment in high risk patients.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"35 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVES/GOALS: Our study aims to 1) examine the link between engagement in CLR Academy and youth diabetes risk factors—physical activity, nutrition, mental health, and weight status; 2) examine CLR’s role in moderating the relationship between perceived discrimination and these risk factors. Includes a program evaluation of CLR & interviews of members. METHODS/STUDY POPULATION: Youth-onset diabetes is rising in American minority communities. Youth sports programs like the Community Leadership Revolution (CLR) Academy in Washtenaw County, MI are emerging responses to this issue. CLR targets diabetes risk factors through team sports by promoting mindfulness and healthy habits. Employing a mixed-methods, pretest-posttest approach, our study focuses on how the frequency of engagement in CLR impacts CLR’s effect on youth’s diabetes risk factors. Considering the discrimination minority youth experience, we also aim to see if CLR potentially buffers the impact of perceived discrimination on diabetes risk factors. A posttest program evaluation of CLR will also include semi-structured interviews with CLR staff and participants. RESULTS/ANTICIPATED RESULTS: There is potential that youth with high engagement in CLR Academy may see enhanced benefits in managing diabetes risk factors compared to less active participants. This may be particularly true for youth experiencing high perceived discrimination, with potential marked improvements in mental health, like reduced anxiety and depression. Additionally, through a program evaluation and semi-structured interviews, our study aims to uncover the factors contributing to CLR’s success as a community-led intervention while also identifying areas for enhancement. Post-study, CLR will receive financial support to integrate these insights into their program, furthering their effectiveness in youth diabetes prevention and overall well-being. DISCUSSION/SIGNIFICANCE: This study may provide significant insights into the relationship between sports participation, diabetes risk factors, and perceived discrimination. The findings could help CLR improve its program and guide more effective diabetes prevention strategies in minority youth through other youth sports programs.
{"title":"230 Assessing the Role of Youth Sports in Diabetes Prevention and Perceived Discrimination","authors":"Leesi George-Komi, Leah Robinson","doi":"10.1017/cts.2024.212","DOIUrl":"https://doi.org/10.1017/cts.2024.212","url":null,"abstract":"OBJECTIVES/GOALS: Our study aims to 1) examine the link between engagement in CLR Academy and youth diabetes risk factors—physical activity, nutrition, mental health, and weight status; 2) examine CLR’s role in moderating the relationship between perceived discrimination and these risk factors. Includes a program evaluation of CLR & interviews of members. METHODS/STUDY POPULATION: Youth-onset diabetes is rising in American minority communities. Youth sports programs like the Community Leadership Revolution (CLR) Academy in Washtenaw County, MI are emerging responses to this issue. CLR targets diabetes risk factors through team sports by promoting mindfulness and healthy habits. Employing a mixed-methods, pretest-posttest approach, our study focuses on how the frequency of engagement in CLR impacts CLR’s effect on youth’s diabetes risk factors. Considering the discrimination minority youth experience, we also aim to see if CLR potentially buffers the impact of perceived discrimination on diabetes risk factors. A posttest program evaluation of CLR will also include semi-structured interviews with CLR staff and participants. RESULTS/ANTICIPATED RESULTS: There is potential that youth with high engagement in CLR Academy may see enhanced benefits in managing diabetes risk factors compared to less active participants. This may be particularly true for youth experiencing high perceived discrimination, with potential marked improvements in mental health, like reduced anxiety and depression. Additionally, through a program evaluation and semi-structured interviews, our study aims to uncover the factors contributing to CLR’s success as a community-led intervention while also identifying areas for enhancement. Post-study, CLR will receive financial support to integrate these insights into their program, furthering their effectiveness in youth diabetes prevention and overall well-being. DISCUSSION/SIGNIFICANCE: This study may provide significant insights into the relationship between sports participation, diabetes risk factors, and perceived discrimination. The findings could help CLR improve its program and guide more effective diabetes prevention strategies in minority youth through other youth sports programs.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"59 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Casey R. Dorr, Weihua Guan W, Guillaume Onyeaghala G, William S Oetting, Roslyn B Mannon, Gaurav Agarwal, Jonathan Maltzman, Arthur Matas, Pamala A Jacobson, Ajay K Israni, for DeKAF Genomics
OBJECTIVES/GOALS: Assess molecular and cellular mechanisms of allograft loss in kidney biopsies using digital spatial profiling and clinical outcomes data. METHODS/STUDY POPULATION: Patients with chronic allograft dysfunction (CGD), enrolled in the Deterioration of Kidney Allograft Function (DeKAF) study, with or without eventual allograft loss, were included. CGD was defined as a >25% increase in creatinine over 3 months relative to a baseline. Kidney biopsy tissue was assessed by Nanostring GeoMX digital spatial profiling (DSP) after staining with anti-pan-cytokeratin, anti-CD45, anti-CD68, Syto-13, to identify specific cell populations, and Nanostring’s Whole Transcriptome Atlas (WTA), to quantify the distribution of transcripts across the biopsy. Up to 14 regions of interest (ROIs) were selected, with or without glomerulus. CIBERSORT was used to perform cell deconvolution. Clinical and outcomes data were from the DeKAF study and United States Renal Data System. RESULTS/ANTICIPATED RESULTS: Macrophage (M1) cell population abundance was significantly different in ROIs with glomerulus between graft loss and no graft loss. Principle component analysis of differentially expressed genes resulted in transcriptomes in ROIs that cluster together by clinical outcome of graft loss or no graft loss. There were 203 DEGs in ROIs with glomerulus that were different by graft loss or no graft loss. By pathway analysis, these 203 DEGS were enriched in the T-cell activation, integrin signaling and inflammation pathways. DISCUSSION/SIGNIFICANCE: DSP of kidney allograft biopsies allows for the identification and quantification of specific cell types, such as macrophages and molecular transcripts as potential drug targets. This data can be used to understand mechanisms of kidney allograft loss and may lead to improved immune suppression in kidney transplant recipients.
目的/目标:利用数字空间图谱和临床结果数据评估肾活检中异体移植物损失的分子和细胞机制。方法/研究对象:纳入慢性同种异体移植功能障碍(CGD)患者,这些患者参加了肾脏同种异体移植功能恶化(DeKAF)研究,无论最终是否出现同种异体移植损失。CGD的定义是3个月内肌酐相对于基线上升25%。肾活检组织经抗泛角蛋白、抗CD45、抗CD68和Syto-13染色后,用Nanostring GeoMX数字空间图谱(DSP)进行评估,以确定特定的细胞群,并用Nanostring的全转录组图谱(WTA)量化活检组织中的转录本分布。在有或没有肾小球的情况下,最多可选择 14 个感兴趣区(ROI)。CIBERSORT用于进行细胞去卷积。临床和结果数据来自 DeKAF 研究和美国肾脏数据系统。结果/预期结果:在有肾小球的 ROI 中,巨噬细胞(M1)群的丰度在移植物丢失和无移植物丢失之间存在显著差异。对差异表达基因进行主成分分析后发现,ROI 中的转录组按照移植物缺失或无移植物缺失的临床结果聚类在一起。在有肾小球的 ROI 中,有 203 个 DEGs 因移植物缺失或无移植物缺失而不同。通过通路分析,这203个DEGS富集在T细胞活化、整合素信号转导和炎症通路中。讨论/意义:肾脏移植活组织的 DSP 可以识别和量化特定的细胞类型,如巨噬细胞和作为潜在药物靶点的分子转录本。这些数据可用于了解肾脏异体移植损失的机制,并可改善肾移植受者的免疫抑制。
{"title":"487 Digital Spatial Profiling of Allograft Loss in Kidney Biopsies with Chronic Allograft Dysfunction","authors":"Casey R. Dorr, Weihua Guan W, Guillaume Onyeaghala G, William S Oetting, Roslyn B Mannon, Gaurav Agarwal, Jonathan Maltzman, Arthur Matas, Pamala A Jacobson, Ajay K Israni, for DeKAF Genomics","doi":"10.1017/cts.2024.413","DOIUrl":"https://doi.org/10.1017/cts.2024.413","url":null,"abstract":"<p>OBJECTIVES/GOALS: Assess molecular and cellular mechanisms of allograft loss in kidney biopsies using digital spatial profiling and clinical outcomes data. METHODS/STUDY POPULATION: Patients with chronic allograft dysfunction (CGD), enrolled in the Deterioration of Kidney Allograft Function (DeKAF) study, with or without eventual allograft loss, were included. CGD was defined as a >25% increase in creatinine over 3 months relative to a baseline. Kidney biopsy tissue was assessed by Nanostring GeoMX digital spatial profiling (DSP) after staining with anti-pan-cytokeratin, anti-CD45, anti-CD68, Syto-13, to identify specific cell populations, and Nanostring’s Whole Transcriptome Atlas (WTA), to quantify the distribution of transcripts across the biopsy. Up to 14 regions of interest (ROIs) were selected, with or without glomerulus. CIBERSORT was used to perform cell deconvolution. Clinical and outcomes data were from the DeKAF study and United States Renal Data System. RESULTS/ANTICIPATED RESULTS: Macrophage (M1) cell population abundance was significantly different in ROIs with glomerulus between graft loss and no graft loss. Principle component analysis of differentially expressed genes resulted in transcriptomes in ROIs that cluster together by clinical outcome of graft loss or no graft loss. There were 203 DEGs in ROIs with glomerulus that were different by graft loss or no graft loss. By pathway analysis, these 203 DEGS were enriched in the T-cell activation, integrin signaling and inflammation pathways. DISCUSSION/SIGNIFICANCE: DSP of kidney allograft biopsies allows for the identification and quantification of specific cell types, such as macrophages and molecular transcripts as potential drug targets. This data can be used to understand mechanisms of kidney allograft loss and may lead to improved immune suppression in kidney transplant recipients.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"37 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVES/GOALS: Endovascular peripheral vascular interventions (PVIs) are increasingly utilized for the treatment of peripheral artery disease (PAD). We aimed to assess characteristics of patients receiving PVI at ambulatory surgical centers and office-based labs (ASC/OBL) versus the outpatient hospital (hospital) site of service. METHODS/STUDY POPULATION: We performed a retrospective analysis using 100% Medicare fee-for-service claims data between January 1, 2017 and December 31, 2022. We used Current Procedural Terminology (CPT) codes to identify patients undergoing angioplasty, stenting, or atherectomy. Patient demographics were collected from the Medicare Master Beneficiary Summary File and associated comorbidities and PVI indications were identified using International Classification of Disease (ICD)-10 codes. We used patient ZIP codes to determine patients’ residence densities and regions. We used site of service codes to determine whether PVI were performed in the ASC/OBL versus hospital. Results were analyzed with descriptive statistics. RESULTS/ANTICIPATED RESULTS: Of 817,241 patients undergoing PVI for PAD, 461,068 (56.4%) were treated in an ASC/OBL. Compared to patients treated in the hospital, patients receiving PVI at ASC/OBLs were more likely to be older, female, non-white race, with fewer comorbidities (end stage renal disease, diabetes, hypertension, and any history of tobacco use) (all, P<0.001). Patients treated in ASC/OBLs more frequently resided in urban (vs. rural) locations, and in the South and West (both, P<0.001). Indication for PVI was predominately chronic limb-threatening ischemia, and clinically similar between groups (77.1% vs. 76.2%). There was a significant change in site of service over time: a minority (47.6%) of PVIs were performed in the ASC/OBL in 2017, whereas the majority (64.7%) of PVIs were performed in the ASC/OBL in 2022 (P<0.001). DISCUSSION/SIGNIFICANCE: Patients treated in ASC/OBLs were less medically complex compared to those treated in the outpatient hospital setting. Further study is needed to examine whether differences in patient characteristics versus other factors (e.g. reimbursement) are driving the increase in PVIs performed in the ASC/OBL over time.
{"title":"20 Characteristics of Medicare patients receiving peripheral vascular interventions for peripheral artery disease differ by outpatient site of service","authors":"Terrence Tsou, Chen Dun, Caitlin Hicks","doi":"10.1017/cts.2024.39","DOIUrl":"https://doi.org/10.1017/cts.2024.39","url":null,"abstract":"OBJECTIVES/GOALS: Endovascular peripheral vascular interventions (PVIs) are increasingly utilized for the treatment of peripheral artery disease (PAD). We aimed to assess characteristics of patients receiving PVI at ambulatory surgical centers and office-based labs (ASC/OBL) versus the outpatient hospital (hospital) site of service. METHODS/STUDY POPULATION: We performed a retrospective analysis using 100% Medicare fee-for-service claims data between January 1, 2017 and December 31, 2022. We used Current Procedural Terminology (CPT) codes to identify patients undergoing angioplasty, stenting, or atherectomy. Patient demographics were collected from the Medicare Master Beneficiary Summary File and associated comorbidities and PVI indications were identified using International Classification of Disease (ICD)-10 codes. We used patient ZIP codes to determine patients’ residence densities and regions. We used site of service codes to determine whether PVI were performed in the ASC/OBL versus hospital. Results were analyzed with descriptive statistics. RESULTS/ANTICIPATED RESULTS: Of 817,241 patients undergoing PVI for PAD, 461,068 (56.4%) were treated in an ASC/OBL. Compared to patients treated in the hospital, patients receiving PVI at ASC/OBLs were more likely to be older, female, non-white race, with fewer comorbidities (end stage renal disease, diabetes, hypertension, and any history of tobacco use) (all, P<0.001). Patients treated in ASC/OBLs more frequently resided in urban (vs. rural) locations, and in the South and West (both, P<0.001). Indication for PVI was predominately chronic limb-threatening ischemia, and clinically similar between groups (77.1% vs. 76.2%). There was a significant change in site of service over time: a minority (47.6%) of PVIs were performed in the ASC/OBL in 2017, whereas the majority (64.7%) of PVIs were performed in the ASC/OBL in 2022 (P<0.001). DISCUSSION/SIGNIFICANCE: Patients treated in ASC/OBLs were less medically complex compared to those treated in the outpatient hospital setting. Further study is needed to examine whether differences in patient characteristics versus other factors (e.g. reimbursement) are driving the increase in PVIs performed in the ASC/OBL over time.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"46 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}