Kaitlyn Bejar, Richard R. Drake, Peggi M Angel, Teresa Johnson‐Pais, Robin Leach
OBJECTIVES/GOALS: Distinguishing indolent from aggressive prostate cancer and early identification of men at risk of developing aggressive, metastatic disease is of great importance. We aim to explore the relationship between N-glycan and collagen composition in prostate tumor tissue and the long-term outcome of the disease. METHODS/STUDY POPULATION: Matrix assisted laser desorption/ionization mass spectrometry can be utilized to characterize N-glycan profiles in formalin fixed paraffin embedded tissues. Collagen may also be characterized using ECM-targeted collagenase MALDI imaging. These approaches were used to analyze prostatectomy samples with different clinical outcomes. Tissue microarrays containing tissues from 75 non-progressors (no evidence of disease; NED) and 50 metastatic cases (MET) were examined. From a combined list of 90 N-glycans and 500 collagenase peptides, the average AUC intensity value for each glycan and collagen peptide was extracted and assessed as a predictor of metastatic progression. Ancestral informative markers were analyzed and polygenic hazard risk scores were generated for samples as well. RESULTS/ANTICIPATED RESULTS: Three N-glycans and three collagen peptides were found to discriminate between NED and MET cases with statistical significance. The best performing N-glycan was Hex6HexNAc6Fuc1 with an AUC of 0.77 (p<0.001). While the best performing collagen peptide was COL1A2 with an AUC of C 0.77 (p<0.001). DISCUSSION/SIGNIFICANCE: Both a collagen peptide and N-glycan were discovered as promising biomarkers to predict metastasis. Future validation studies are needed to confirm biomarker potential and to determine if the addition of these biomarkers can strengthen current genomic classifier’s ability to predict metastatic prostate cancer.
{"title":"386 The Analysis of N-glycans and Collagen to Predict Prostate Adenocarcinoma Outcome","authors":"Kaitlyn Bejar, Richard R. Drake, Peggi M Angel, Teresa Johnson‐Pais, Robin Leach","doi":"10.1017/cts.2024.337","DOIUrl":"https://doi.org/10.1017/cts.2024.337","url":null,"abstract":"OBJECTIVES/GOALS: Distinguishing indolent from aggressive prostate cancer and early identification of men at risk of developing aggressive, metastatic disease is of great importance. We aim to explore the relationship between N-glycan and collagen composition in prostate tumor tissue and the long-term outcome of the disease. METHODS/STUDY POPULATION: Matrix assisted laser desorption/ionization mass spectrometry can be utilized to characterize N-glycan profiles in formalin fixed paraffin embedded tissues. Collagen may also be characterized using ECM-targeted collagenase MALDI imaging. These approaches were used to analyze prostatectomy samples with different clinical outcomes. Tissue microarrays containing tissues from 75 non-progressors (no evidence of disease; NED) and 50 metastatic cases (MET) were examined. From a combined list of 90 N-glycans and 500 collagenase peptides, the average AUC intensity value for each glycan and collagen peptide was extracted and assessed as a predictor of metastatic progression. Ancestral informative markers were analyzed and polygenic hazard risk scores were generated for samples as well. RESULTS/ANTICIPATED RESULTS: Three N-glycans and three collagen peptides were found to discriminate between NED and MET cases with statistical significance. The best performing N-glycan was Hex6HexNAc6Fuc1 with an AUC of 0.77 (p<0.001). While the best performing collagen peptide was COL1A2 with an AUC of C 0.77 (p<0.001). DISCUSSION/SIGNIFICANCE: Both a collagen peptide and N-glycan were discovered as promising biomarkers to predict metastasis. Future validation studies are needed to confirm biomarker potential and to determine if the addition of these biomarkers can strengthen current genomic classifier’s ability to predict metastatic prostate cancer.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"248 ","pages":"115 - 115"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140776264","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}
Michelle Jenkerson, S. Freel, Anthony Keyes, Jessica Cranfill, Rachel Cody
OBJECTIVES/GOALS: 1. Standardize pathways, training and evaluations 2. Expose apprentices to a variety of research experiences 3. Remove barriers to hiring early talent 4. Expand opportunities for underrepresented minority applicants to obtain clinical research professional positions METHODS/STUDY POPULATION: Collaborators connected by the Clinical Research Professional Taskforce ACTS SIG conducted a landscape analysis survey to identify aspects of CRP Apprentice models and formed a Subgroup. Members will share plans for multiple apprenticeship programs, including specific training modalities and skill sets used to prepare apprentices for a successful clinical research professional career. Methods across institutions include: • Increasing awareness of the profession • Facilitating talent identification for managers • Making the business case for funding and staffing • Implementing work-based learning for fundamental competency development Survey results from CRP institutions demonstrated apprenticeships are value added to teaching how to conduct research. RESULTS/ANTICIPATED RESULTS: The landscape survey of Apprentice programs revealed multiple models in use. The newly formed Apprentice subgroup is engaging in analysis and actively working to build a standardized repository of competency-aligned, research courses and experiences for apprentices. Results will help make the business case for starting or growing programs. Subgroup members have focused on a shared goal of expanding opportunities for underrepresented minority applicants, with current outreach efforts that are extending awareness of the CRP profession. We anticipate a continuous strengthening of connections between institutions to share a variety of models to implement, develop shared tools (e.g., proficiency tests), and share existing tools to standardize pathways and training for CRP apprenticeships. #_msoanchor_1 DISCUSSION/SIGNIFICANCE: Academic Medical Centers (AMCs) need novel strategies to support clinical research portfolios.Innovative Apprenticeship Models improve efficiency and sustainability of the clinical research professional (CRP) workforce to train the next generation of CRPs in an effective and timely way.
{"title":"114 Reimagining Entryways: Innovative Apprenticeship Models for New Clinical Research Professionals","authors":"Michelle Jenkerson, S. Freel, Anthony Keyes, Jessica Cranfill, Rachel Cody","doi":"10.1017/cts.2024.112","DOIUrl":"https://doi.org/10.1017/cts.2024.112","url":null,"abstract":"OBJECTIVES/GOALS: 1. Standardize pathways, training and evaluations 2. Expose apprentices to a variety of research experiences 3. Remove barriers to hiring early talent 4. Expand opportunities for underrepresented minority applicants to obtain clinical research professional positions METHODS/STUDY POPULATION: Collaborators connected by the Clinical Research Professional Taskforce ACTS SIG conducted a landscape analysis survey to identify aspects of CRP Apprentice models and formed a Subgroup. Members will share plans for multiple apprenticeship programs, including specific training modalities and skill sets used to prepare apprentices for a successful clinical research professional career. Methods across institutions include: • Increasing awareness of the profession • Facilitating talent identification for managers • Making the business case for funding and staffing • Implementing work-based learning for fundamental competency development Survey results from CRP institutions demonstrated apprenticeships are value added to teaching how to conduct research. RESULTS/ANTICIPATED RESULTS: The landscape survey of Apprentice programs revealed multiple models in use. The newly formed Apprentice subgroup is engaging in analysis and actively working to build a standardized repository of competency-aligned, research courses and experiences for apprentices. Results will help make the business case for starting or growing programs. Subgroup members have focused on a shared goal of expanding opportunities for underrepresented minority applicants, with current outreach efforts that are extending awareness of the CRP profession. We anticipate a continuous strengthening of connections between institutions to share a variety of models to implement, develop shared tools (e.g., proficiency tests), and share existing tools to standardize pathways and training for CRP apprenticeships. #_msoanchor_1 DISCUSSION/SIGNIFICANCE: Academic Medical Centers (AMCs) need novel strategies to support clinical research portfolios.Innovative Apprenticeship Models improve efficiency and sustainability of the clinical research professional (CRP) workforce to train the next generation of CRPs in an effective and timely way.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"86 ","pages":"33 - 33"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140755874","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}
Iram Ahmad, Peter K Moon, Kristina M Ward, Taseer F Din, Sara Saki, Alan Cheng, K. Yeom
OBJECTIVES/GOALS: Early diagnosis of congenital sensorineural hearing loss (SNHL) is of paramount importance in preventing speech and language impairment.Diffusion tensor imaging (DTI) MRI can identify brain microstructural changes that may potentially contribute towards prognosticating rehabilitation. METHODS/STUDY POPULATION: We retrospectively reviewed pediatric patients with SNHL who obtained DTI MRI between 2011 and 2019, identifying 16 pediatric patients (age <18 years) with at least moderate asymmetric/bilateral SNHL., and gender-matched controlswithout neurological, developmental, or MRI-based brain macrostructural abnormalities. The following brainstem regions and tracts of the auditory pathway were assessed: superior olivary nucleus (SON), inferior colliculus (IC), ipsilateral tracts between the inferior colliculus and superior olivary nucleus (IC-SON). Diffusion values for bilateral regions and tracts were generated, then averaged to calculate a mean value for fractional anisotropy (FA) and mean diffusivity (MD) for each subject. RESULTS/ANTICIPATED RESULTS: Significant differences were identified in FA values of the SON between the SNHL cohort and controls (0.377±0.056 vs 0.422±0.052; p=0.009). No other FA or MD values were significantly different. In children £5 years, MD was significantly decreased in the SNHL cohort compared to controls in the IC (0.918±0.051 vs 1.120±0.142; p<0.001). In children >5 years, there were no significant differences in MD (1.124±0.198 vs 0.997±0.103; p = 0.119). There were no significant differences in MD or FA in the white matter fibers of the IC-SON tract [applewebdata%3A//720AAF0C-C4CF-459C-A42A-6BAA56C4E4CA#_msocom_2]. DISCUSSION/SIGNIFICANCE: This is the first study to assess microstructural changes in brainstem auditory pathway regions among children with SNHL. Longitudinal studies are warranted to assess the predictive value of DTI imaging for long-term outcomes and prognosticating intervention.
目的/目标：先天性感音神经性听力损失（SNHL）的早期诊断对于预防言语和语言障碍至关重要。弥散张量成像（DTI）MRI可以识别大脑微结构变化，可能有助于预后康复。方法/研究对象：我们回顾性研究了2011年至2019年期间接受DTI MRI检查的SNHL儿科患者，确定了16名儿科患者（5岁，MD无显著差异（1.124±0.198 vs 0.997±0.103；P = 0.119）。IC-SON束白质纤维的MD或FA没有明显差异[applewebdata%3A//720AAF0C-C4CF-459C-A42A-6BAA56C4E4CA#_msocom_2]。讨论/意义：这是第一项评估 SNHL 儿童脑干听觉通路区域微结构变化的研究。有必要进行纵向研究，以评估 DTI 成像对长期结果和预后干预的预测价值。
{"title":"483 Radiographic Changes in the Auditory Pathway to Predict Outcomes of Children with Hearing Loss","authors":"Iram Ahmad, Peter K Moon, Kristina M Ward, Taseer F Din, Sara Saki, Alan Cheng, K. Yeom","doi":"10.1017/cts.2024.409","DOIUrl":"https://doi.org/10.1017/cts.2024.409","url":null,"abstract":"OBJECTIVES/GOALS: Early diagnosis of congenital sensorineural hearing loss (SNHL) is of paramount importance in preventing speech and language impairment.Diffusion tensor imaging (DTI) MRI can identify brain microstructural changes that may potentially contribute towards prognosticating rehabilitation. METHODS/STUDY POPULATION: We retrospectively reviewed pediatric patients with SNHL who obtained DTI MRI between 2011 and 2019, identifying 16 pediatric patients (age <18 years) with at least moderate asymmetric/bilateral SNHL., and gender-matched controlswithout neurological, developmental, or MRI-based brain macrostructural abnormalities. The following brainstem regions and tracts of the auditory pathway were assessed: superior olivary nucleus (SON), inferior colliculus (IC), ipsilateral tracts between the inferior colliculus and superior olivary nucleus (IC-SON). Diffusion values for bilateral regions and tracts were generated, then averaged to calculate a mean value for fractional anisotropy (FA) and mean diffusivity (MD) for each subject. RESULTS/ANTICIPATED RESULTS: Significant differences were identified in FA values of the SON between the SNHL cohort and controls (0.377±0.056 vs 0.422±0.052; p=0.009). No other FA or MD values were significantly different. In children £5 years, MD was significantly decreased in the SNHL cohort compared to controls in the IC (0.918±0.051 vs 1.120±0.142; p<0.001). In children >5 years, there were no significant differences in MD (1.124±0.198 vs 0.997±0.103; p = 0.119). There were no significant differences in MD or FA in the white matter fibers of the IC-SON tract [applewebdata%3A//720AAF0C-C4CF-459C-A42A-6BAA56C4E4CA#_msocom_2]. DISCUSSION/SIGNIFICANCE: This is the first study to assess microstructural changes in brainstem auditory pathway regions among children with SNHL. Longitudinal studies are warranted to assess the predictive value of DTI imaging for long-term outcomes and prognosticating intervention.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"55 ","pages":"142 - 143"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140768450","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: Globally, diabetes affects 537 million people and 15-25% will develop a foot ulcer in their lifetime. Diabetic foot ulcers (DFU) tend to be chronic and non-healing due to the poor wound healing environment, leading to infection or amputation. Our study aims to develop a method to predict and prevent DFU formation. METHODS/STUDY POPULATION: Our preliminary plan is to develop a method to detect high plantar pressures, coupled with the ability to automatically adjust an orthotic device to offload excess pressure. Our current aim is to create a “smart orthotic” which will link with foot mapping technology to automatically offload high pressure areas, reducing the need for a separate clinic visit for orthotic adjustment. We aim to prove that our device will normalize plantar pressure distribution, which will prevent callus and subsequent DFU formation. The current target population includes those with diagnosed diabetes and are ambulatory. RESULTS/ANTICIPATED RESULTS: With our technology, we anticipate normalization of plantar pressure distribution in a more frequent fashion than is currently done. Because annual orthotic fittings, which is current standard of care, do not provide regular enough adjustments to match the rate of diabetic foot structural changes and peak plantar pressure redistribution, our device will address two gaps in management. One, patients will receive near-instantaneous changes in plantar pressure offloading, allowing for near continuous orthotic customization. Secondly, our device would reduce the clinical appointment burden, which would be especially important for patients with multiple medical comorbidities or experience other barriers to accessing healthcare. DISCUSSION/SIGNIFICANCE: While DFUs are commonplace and their complications are well recognized, there still exists a gap in ulcer prevention. Our proposed solution will redistribute pathologic plantar pressures, allow for more frequent monitoring, automatic therapy, and aid in the management of high ulcer risk patients.
{"title":"349 Addressing the Gaps in Diabetic Foot Ulcer Management: Prediction and Prevention","authors":"Shirley Lin, Ronald Sherman","doi":"10.1017/cts.2024.311","DOIUrl":"https://doi.org/10.1017/cts.2024.311","url":null,"abstract":"OBJECTIVES/GOALS: Globally, diabetes affects 537 million people and 15-25% will develop a foot ulcer in their lifetime. Diabetic foot ulcers (DFU) tend to be chronic and non-healing due to the poor wound healing environment, leading to infection or amputation. Our study aims to develop a method to predict and prevent DFU formation. METHODS/STUDY POPULATION: Our preliminary plan is to develop a method to detect high plantar pressures, coupled with the ability to automatically adjust an orthotic device to offload excess pressure. Our current aim is to create a “smart orthotic” which will link with foot mapping technology to automatically offload high pressure areas, reducing the need for a separate clinic visit for orthotic adjustment. We aim to prove that our device will normalize plantar pressure distribution, which will prevent callus and subsequent DFU formation. The current target population includes those with diagnosed diabetes and are ambulatory. RESULTS/ANTICIPATED RESULTS: With our technology, we anticipate normalization of plantar pressure distribution in a more frequent fashion than is currently done. Because annual orthotic fittings, which is current standard of care, do not provide regular enough adjustments to match the rate of diabetic foot structural changes and peak plantar pressure redistribution, our device will address two gaps in management. One, patients will receive near-instantaneous changes in plantar pressure offloading, allowing for near continuous orthotic customization. Secondly, our device would reduce the clinical appointment burden, which would be especially important for patients with multiple medical comorbidities or experience other barriers to accessing healthcare. DISCUSSION/SIGNIFICANCE: While DFUs are commonplace and their complications are well recognized, there still exists a gap in ulcer prevention. Our proposed solution will redistribute pathologic plantar pressures, allow for more frequent monitoring, automatic therapy, and aid in the management of high ulcer risk patients.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"424 5","pages":"106 - 106"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140780501","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 long-term goal of our lab is to develop clinical and intra-operative methods to aid in assessment of compressive and traumatic peripheral neuropathies. The overall objective of this project is toidentify the potential of serum neurofilament light chain as a diagnostic biomarker for nerve injury. METHODS/STUDY POPULATION: The objective of this prospective study is to obtain data on serum NfL levels in patients with cubital tunnel syndrome and traumatic nerve injuries. Serum NfL from patients with cubital tunnel and traumatic nerve injuries will be compared to serum NfL of asymptomatic, sex and aged matched controls. Pre-operative and post-operative serum levels will be measured and compared topatient’s pre-operative physical exam findings, motor and sensory function testing, electrodiagnostic studies, ultrasound, presence of intraneural vascularity, and post-operative patient reported outcome measures for cubital tunnel patients. For patients with traumatic nerve injury, acute phase and a subsequent serum NfL measurement will be used to assess temporal changes in NfL. RESULTS/ANTICIPATED RESULTS: The central hypothesis of this study is that symptomatic compression of the ulnar nerve or traumatic injury to the brachial plexus leading to axonotmesis will result in measurable increases in serum NfL proportional to the degree of nerve injury. This hypothesis has been formulated based on clinical experience and published studies demonstrating increased expression of serum NfL levels with axonal injury secondary to varying forms of peripheral neuropathy. DISCUSSION/SIGNIFICANCE: The significance of this project is that characterization of the relationship of clinical symptoms, non-invasive imaging and expression of NfL will lead to better diagnostic and prognostic algorithms in the treatment of compressive and traumatic peripheral neuropathies.
{"title":"486 Quantification of serum neurofilament light chain (NfL) in cubital tunnel","authors":"Amanda Faust, Christopher Dy, David M. Brogan","doi":"10.1017/cts.2024.412","DOIUrl":"https://doi.org/10.1017/cts.2024.412","url":null,"abstract":"OBJECTIVES/GOALS: The long-term goal of our lab is to develop clinical and intra-operative methods to aid in assessment of compressive and traumatic peripheral neuropathies. The overall objective of this project is toidentify the potential of serum neurofilament light chain as a diagnostic biomarker for nerve injury. METHODS/STUDY POPULATION: The objective of this prospective study is to obtain data on serum NfL levels in patients with cubital tunnel syndrome and traumatic nerve injuries. Serum NfL from patients with cubital tunnel and traumatic nerve injuries will be compared to serum NfL of asymptomatic, sex and aged matched controls. Pre-operative and post-operative serum levels will be measured and compared topatient’s pre-operative physical exam findings, motor and sensory function testing, electrodiagnostic studies, ultrasound, presence of intraneural vascularity, and post-operative patient reported outcome measures for cubital tunnel patients. For patients with traumatic nerve injury, acute phase and a subsequent serum NfL measurement will be used to assess temporal changes in NfL. RESULTS/ANTICIPATED RESULTS: The central hypothesis of this study is that symptomatic compression of the ulnar nerve or traumatic injury to the brachial plexus leading to axonotmesis will result in measurable increases in serum NfL proportional to the degree of nerve injury. This hypothesis has been formulated based on clinical experience and published studies demonstrating increased expression of serum NfL levels with axonal injury secondary to varying forms of peripheral neuropathy. DISCUSSION/SIGNIFICANCE: The significance of this project is that characterization of the relationship of clinical symptoms, non-invasive imaging and expression of NfL will lead to better diagnostic and prognostic algorithms in the treatment of compressive and traumatic peripheral neuropathies.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"1218 25","pages":"143 - 144"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140774160","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: Penn State CTSI supports KL2 career development awards for faculty seeking to become leaders in clinical and translational research. CTSAs can benefit from a better understanding of KL2 applicant profiles and trainee outcomes. Predictive modeling of KL2 records provides insights into institutional processes and continuous improvement goals. METHODS/STUDY POPULATION: Collecting KL2 application records at Penn State CTSI from 2017 to 2023, comprising both accepted and not accepted candidate profiles, this study used a generalized logistic mixed model with binomial distribution to understand the factors predictive of KL2 trainee acceptance, (n=47). The following factors were modeled as potentially predictive of scholars’ acceptance: Institution-specific Processes—Campus; Terminal Degree Type; College of Residency, Applicant Demographics and Portfolio—Minoritized or Protected Groups; Mean Application Score; Rurality Focus; Gender, and Outcomes—Post-Program h-index. RESULTS/ANTICIPATED RESULTS: Only Campus and Degree were significant factors predictive of trainee acceptance (r<.0001), with a particular campus and the MD degree-designation both exerting selectional pressures on acceptance rates. Applicant demographics were not significant historical factors in selection despite the most recent trainee cohort comprised of all women. Similarly, while our CTSA focuses on rural inequality and accessibility, a research proposal focused on rurality was not a significant factor for acceptance. Notably, NIH-scaled application scores and post-program h-indices were not significant for accepted and non-accepted applicants. DISCUSSION/SIGNIFICANCE: The absence of applicant-focused selectional pressure is striking—Penn State CTSI does not significantly select for gender, URM, or URP status. Administration is now empowered to intentionally engage, recruit, and retain from our other affiliated campuses and colleges.
目标/目的：宾夕法尼亚州立大学临床与转化研究中心（Penn State CTSI）为希望成为临床与转化研究领军人物的教师提供 KL2 职业发展奖励。更好地了解 KL2 申请者的情况和受训者的成果，将使 CTSAs 受益匪浅。对 KL2 记录进行预测建模，可以深入了解机构流程和持续改进目标。方法/研究对象：本研究收集了宾夕法尼亚州立大学 CTSI 从 2017 年到 2023 年的 KL2 申请记录，包括被录取和未被录取的候选人资料，使用二项分布的广义逻辑混合模型来了解 KL2 受训人员录取的预测因素（n=47）。以下因素被认为是预测学者被录取的潜在因素：机构特定流程--校园；最终学位类型；居住学院、申请人人口统计学和作品集--少数群体或受保护群体；平均申请得分；关注农村地区；性别和结果--项目结束后的 h 指数。结果/预期结果：只有校区和学位是预测受训者录取率的重要因素（r<.0001），特定校区和医学博士学位对录取率都有选择压力。尽管最近一批受训人员全部为女性，但申请者的人口统计学特征并不是影响选择的重要历史因素。同样，虽然我们的 CTSA 重点关注农村的不平等和可及性，但以农村为重点的研究提案并不是录取的重要因素。值得注意的是，美国国立卫生研究院（NIH）的申请评分和项目结束后的 h 指数对被录取和未被录取的申请者没有显著影响。讨论/意义：宾夕法尼亚州立大学的 CTSI 项目并没有明显地针对申请人的性别、少数民族或少数民族学生身份进行选择，这一点令人震惊。行政部门现在有权有意识地从我们的其他附属校区和学院吸引、招聘和留住学生。
{"title":"165 Predicting Success: A Mixed Model of KL2 Trainee Profiles and Outcomes","authors":"Alyson Eggleston, Jessica Petrie","doi":"10.1017/cts.2024.158","DOIUrl":"https://doi.org/10.1017/cts.2024.158","url":null,"abstract":"OBJECTIVES/GOALS: Penn State CTSI supports KL2 career development awards for faculty seeking to become leaders in clinical and translational research. CTSAs can benefit from a better understanding of KL2 applicant profiles and trainee outcomes. Predictive modeling of KL2 records provides insights into institutional processes and continuous improvement goals. METHODS/STUDY POPULATION: Collecting KL2 application records at Penn State CTSI from 2017 to 2023, comprising both accepted and not accepted candidate profiles, this study used a generalized logistic mixed model with binomial distribution to understand the factors predictive of KL2 trainee acceptance, (n=47). The following factors were modeled as potentially predictive of scholars’ acceptance: Institution-specific Processes—Campus; Terminal Degree Type; College of Residency, Applicant Demographics and Portfolio—Minoritized or Protected Groups; Mean Application Score; Rurality Focus; Gender, and Outcomes—Post-Program h-index. RESULTS/ANTICIPATED RESULTS: Only Campus and Degree were significant factors predictive of trainee acceptance (r<.0001), with a particular campus and the MD degree-designation both exerting selectional pressures on acceptance rates. Applicant demographics were not significant historical factors in selection despite the most recent trainee cohort comprised of all women. Similarly, while our CTSA focuses on rural inequality and accessibility, a research proposal focused on rurality was not a significant factor for acceptance. Notably, NIH-scaled application scores and post-program h-indices were not significant for accepted and non-accepted applicants. DISCUSSION/SIGNIFICANCE: The absence of applicant-focused selectional pressure is striking—Penn State CTSI does not significantly select for gender, URM, or URP status. Administration is now empowered to intentionally engage, recruit, and retain from our other affiliated campuses and colleges.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"197 2","pages":"49 - 50"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140776088","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}
Simona Kwon, Amanda Bunting, Helen Panageas, Joan Margiotta, Kimberly Diaz, Gregory Laynor, James Holahan, SUsan Andersen
OBJECTIVES/GOALS: In a 2022 NASEM Report, “… successful inclusion of underrepresented populations in research is investing in diverse research teams to enhance congruence and to optimize recruitment and retention success.” Thus, academic research institutions must provide safe, respectful and inclusive work environments to support diverse research teams. METHODS/STUDY POPULATION: Resources, policies and protocols related to disruptive research participants have not been well articulated at our institution. Given this dearth of information, we launched a new initiative across our CTSA, IRB, Office of General Counsel and Department of Population Health. The multipronged approach includes: 1) Conduct a scoping review of published and gray literature to identify best practices, trainings and resources to mitigate discrimination, harassment of research team members; 2) Co-develop new institutional policies and procedures to ensure safety and respect for both research staff and participants; 3) Develop an online training on research team field and workplace safety; and 4) Widely disseminate policies and resources to address the overall gap in academic research. RESULTS/ANTICIPATED RESULTS: Our ongoing scoping review has shown that here is an overall lack of information on bias, discrimination and harassment perpetrated by research participants towards research teams. Based on our activities, new Human Research Protection policies were launched. These include defining what disruptive participant behavior in research is, the introduction of a Statement on the Conduct of Participants in Research Studies, and steps study teams may implement to manage disruptive behavior initiated by a research participate. Next steps include the development of training resources for study teams on the new policies and to introduce de-escalation and situational awareness strategies and trainings. DISCUSSION/SIGNIFICANCE: As research teams become increasingly diverse, there is a need to better support them and ensure that the research field and work settings are safe, inclusive environments with articulated policies that mitigate/prevent discrimination, bias and harassment perpetrated by study participants.
{"title":"517 The Development of New Institutional Policies on Mitigating Unacceptable Behavior and Managing Disruptive Research Participants","authors":"Simona Kwon, Amanda Bunting, Helen Panageas, Joan Margiotta, Kimberly Diaz, Gregory Laynor, James Holahan, SUsan Andersen","doi":"10.1017/cts.2024.440","DOIUrl":"https://doi.org/10.1017/cts.2024.440","url":null,"abstract":"OBJECTIVES/GOALS: In a 2022 NASEM Report, “… successful inclusion of underrepresented populations in research is investing in diverse research teams to enhance congruence and to optimize recruitment and retention success.” Thus, academic research institutions must provide safe, respectful and inclusive work environments to support diverse research teams. METHODS/STUDY POPULATION: Resources, policies and protocols related to disruptive research participants have not been well articulated at our institution. Given this dearth of information, we launched a new initiative across our CTSA, IRB, Office of General Counsel and Department of Population Health. The multipronged approach includes: 1) Conduct a scoping review of published and gray literature to identify best practices, trainings and resources to mitigate discrimination, harassment of research team members; 2) Co-develop new institutional policies and procedures to ensure safety and respect for both research staff and participants; 3) Develop an online training on research team field and workplace safety; and 4) Widely disseminate policies and resources to address the overall gap in academic research. RESULTS/ANTICIPATED RESULTS: Our ongoing scoping review has shown that here is an overall lack of information on bias, discrimination and harassment perpetrated by research participants towards research teams. Based on our activities, new Human Research Protection policies were launched. These include defining what disruptive participant behavior in research is, the introduction of a Statement on the Conduct of Participants in Research Studies, and steps study teams may implement to manage disruptive behavior initiated by a research participate. Next steps include the development of training resources for study teams on the new policies and to introduce de-escalation and situational awareness strategies and trainings. DISCUSSION/SIGNIFICANCE: As research teams become increasingly diverse, there is a need to better support them and ensure that the research field and work settings are safe, inclusive environments with articulated policies that mitigate/prevent discrimination, bias and harassment perpetrated by study participants.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"334 1","pages":"153 - 154"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140781957","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: Susceptible mucocutaneous membranes of the eye and nasal cavity are easily infected by viruses leading to pink eye or respiratory infections whose direct cost has been estimated as $16 billion annually in the United States. We have developed a novel and effective barrier that will be agnostic to variants enveloped viruses like coronaviruses. METHODS/STUDY POPULATION: We evaluated the efficacy of hydroxypropyl cyclodextrin barrier in preventing respiratory coronavirus infections using 25 humanized angiotensin converting enzyme-2 receptor (hACE-2) mice under a BSL3 laboratory setting. We have shown the barrier is safe and efficacious in preventing coronavirus infections in in vitro respiratory cell lines. We instilled 10 uL aliquot of the barrier into the nostril of the mouse 30 minutes before exposing them to a 10uL titer containing 10,000 plaque forming units of the SARS-CoV-2 delta variant. The control mice received the SARS-CoV-2 infection but not the barrier. The mice were observed for 5 days after which they were sacrificed. We analyzed the lungs and nasal palates for viral load using reverse transcription-polymerase chain reaction. RESULTS/ANTICIPATED RESULTS: We observed our barrier to be effective in preventing SARS-CoV-2 delta variant infection in hACE2 mice models. The lungs and nasal secretions of treated mice were less infectious with lower viral load than the control mice. The lungs of treated mice showed decrease in IFN gene expression and many cytokines and chemokines that regulate virally induced inflammatory responses such as IL-1b, IL-8, CXCL9, CXCL10, and the CCLs. We observed the plasma Angiotensin I and Angiotensin II decreased with barrier treatment, correlating with the viral load observed in the lungs. These peptides may be useful biomarkers for monitoring viral load within the lungs of virally infected individuals. DISCUSSION/SIGNIFICANCE: This supports the barrier’s efficacy to reduce transmission and prevent infections of SARS-CoV-2. This easy to use barrier can augment the mucocutaneous layers of the eye and nasal cavity. Our agnostic barrier will reduce the economic and public health burden of seasonal respiratory and eye viral infections and their related deaths amongst the public.
{"title":"378 Hydroxypropyl beta cyclodextrin barrier prevents respiratory and eye viral infections","authors":"I. Asante, Angela Lu, M. Humayun, Stan Louie","doi":"10.1017/cts.2024.332","DOIUrl":"https://doi.org/10.1017/cts.2024.332","url":null,"abstract":"OBJECTIVES/GOALS: Susceptible mucocutaneous membranes of the eye and nasal cavity are easily infected by viruses leading to pink eye or respiratory infections whose direct cost has been estimated as $16 billion annually in the United States. We have developed a novel and effective barrier that will be agnostic to variants enveloped viruses like coronaviruses. METHODS/STUDY POPULATION: We evaluated the efficacy of hydroxypropyl cyclodextrin barrier in preventing respiratory coronavirus infections using 25 humanized angiotensin converting enzyme-2 receptor (hACE-2) mice under a BSL3 laboratory setting. We have shown the barrier is safe and efficacious in preventing coronavirus infections in in vitro respiratory cell lines. We instilled 10 uL aliquot of the barrier into the nostril of the mouse 30 minutes before exposing them to a 10uL titer containing 10,000 plaque forming units of the SARS-CoV-2 delta variant. The control mice received the SARS-CoV-2 infection but not the barrier. The mice were observed for 5 days after which they were sacrificed. We analyzed the lungs and nasal palates for viral load using reverse transcription-polymerase chain reaction. RESULTS/ANTICIPATED RESULTS: We observed our barrier to be effective in preventing SARS-CoV-2 delta variant infection in hACE2 mice models. The lungs and nasal secretions of treated mice were less infectious with lower viral load than the control mice. The lungs of treated mice showed decrease in IFN gene expression and many cytokines and chemokines that regulate virally induced inflammatory responses such as IL-1b, IL-8, CXCL9, CXCL10, and the CCLs. We observed the plasma Angiotensin I and Angiotensin II decreased with barrier treatment, correlating with the viral load observed in the lungs. These peptides may be useful biomarkers for monitoring viral load within the lungs of virally infected individuals. DISCUSSION/SIGNIFICANCE: This supports the barrier’s efficacy to reduce transmission and prevent infections of SARS-CoV-2. This easy to use barrier can augment the mucocutaneous layers of the eye and nasal cavity. Our agnostic barrier will reduce the economic and public health burden of seasonal respiratory and eye viral infections and their related deaths amongst the public.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"27 ","pages":"113 - 113"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140789854","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}
Edgardo L. Rosado-Santiago, J. C. Soto-Santiago, Edgardo L. Rosado-Santiago, Lizbelle De Jesús-Ojeda
OBJECTIVES/GOALS: The Title V project team is offering an elective course to teach the historical development of CTR, make a compelling scientific presentation, and use bibliographic databases. In addition, students learn: to write the research question, design a career development plan, protect human subjects in research, and the mentor-mentee relationship. METHODS/STUDY POPULATION: The course includes a variety of educational strategies and activities that allow the student to increase their knowledge and initiate their interest in the field of CTR. Both academic semesters (August to December and January to May) are offered remotely in two-hour synchronous sessions on Fridays from 3:00 p.m. to 5:00 p.m. through videoconferences, in addition to asynchronous activities. Invited expert lecturers and faculty reinforce the course content in each topic they address. In addition, course coordinators assign guided tasks where the students perform the work. Then, they present or send their work to the course coordinators for evaluation. RESULTS/ANTICIPATED RESULTS: The course began in January 2020 and has had six offerings, including one in the current academic semester (August to December 2023). Its first offering was in the semester from January to May, and due to the interest generated in students in August 2022, it is now available in both semesters. From its beginning to the present, the course has included students from the University of Puerto Rico (UPR) Bayamon, Cayey, Humacao, Mayagüez, and Rio Piedras campuses, impacting all geographic areas of Puerto Rico. The course has also represented an opportunity for graduate faculty to teach CTR to undergraduate students. Until 2023, 56 students have enrolled. DISCUSSION/SIGNIFICANCE: Upon completing six-course offerings, the evaluation carried out by the students demonstrates satisfaction with the learning obtained. The knowledge and skills achieved have led them to participate in CTR with the mentoring of collaborating course professors and starting a new professional development opportunity for undergraduate students.
{"title":"119 Academic Innovation through the interdisciplinary (elective) course Introduction to Clinical and Translational Research (CTR) to increase the number of undergraduate students in Puerto Rico with the knowledge, skills, abilities, and opportunities in CTR","authors":"Edgardo L. Rosado-Santiago, J. C. Soto-Santiago, Edgardo L. Rosado-Santiago, Lizbelle De Jesús-Ojeda","doi":"10.1017/cts.2024.116","DOIUrl":"https://doi.org/10.1017/cts.2024.116","url":null,"abstract":"OBJECTIVES/GOALS: The Title V project team is offering an elective course to teach the historical development of CTR, make a compelling scientific presentation, and use bibliographic databases. In addition, students learn: to write the research question, design a career development plan, protect human subjects in research, and the mentor-mentee relationship. METHODS/STUDY POPULATION: The course includes a variety of educational strategies and activities that allow the student to increase their knowledge and initiate their interest in the field of CTR. Both academic semesters (August to December and January to May) are offered remotely in two-hour synchronous sessions on Fridays from 3:00 p.m. to 5:00 p.m. through videoconferences, in addition to asynchronous activities. Invited expert lecturers and faculty reinforce the course content in each topic they address. In addition, course coordinators assign guided tasks where the students perform the work. Then, they present or send their work to the course coordinators for evaluation. RESULTS/ANTICIPATED RESULTS: The course began in January 2020 and has had six offerings, including one in the current academic semester (August to December 2023). Its first offering was in the semester from January to May, and due to the interest generated in students in August 2022, it is now available in both semesters. From its beginning to the present, the course has included students from the University of Puerto Rico (UPR) Bayamon, Cayey, Humacao, Mayagüez, and Rio Piedras campuses, impacting all geographic areas of Puerto Rico. The course has also represented an opportunity for graduate faculty to teach CTR to undergraduate students. Until 2023, 56 students have enrolled. DISCUSSION/SIGNIFICANCE: Upon completing six-course offerings, the evaluation carried out by the students demonstrates satisfaction with the learning obtained. The knowledge and skills achieved have led them to participate in CTR with the mentoring of collaborating course professors and starting a new professional development opportunity for undergraduate students.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"134 ","pages":"34 - 34"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140763543","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}
D. Wolf, Thomas Keller, Matt Honoré, Shandee Dixon, Cynthia Morris
OBJECTIVES/GOALS: To truly improve health equity and accessibility, we must develop a diverse and inclusive workforce. The BUILD EXITO program developed as a collaboration between a network of undergraduate programs and a CTSA hub and now has become a sustainable resource that will outlive NIH funding. We will disseminate our successful model. METHODS/STUDY POPULATION: The BUILD EXITO program has completed 10 years of NIH funding, a partnership between OCTRI and Portland State University (PSU), to create a new model of research training for underrepresented and disadvantaged students. This model provides an opportunity to learn about clinical and translational research academic careers; participate in a research enhancement and professional development curriculum;have a long-term authentic research experience; and receive enhanced mentorship. BUILD EXITO includes PSU, and local and 3 US Pacific territory 2-year colleges. We have developed a sustainable plan that includes these core elements after NIH support for the program ends. We have tracked long-term student outcomes for entry into graduate programs and the research workforce. RESULTS/ANTICIPATED RESULTS: We will describe the experimental model and the network of university and community colleges in BUILD EXITO, including PSU, U of Alaska, and colleges in US territories of Guam, Northern Mariana Islands, and American Samoa. All these universities and colleges have high proportions of underrepresented and disadvantaged students. We will present data on characteristics of the >600 students who have participated in BUILD EXITO to demonstrate the diversity of the cohort. We will also describe 4-year degree completion, engagement in the research workforce, and entry into graduate or professional programs. We will show how this has positively affected faculty inclusion of students in research, institutional policies at the 2-year and 4-year programs, and how this model has become sustainable. DISCUSSION/SIGNIFICANCE: The BUILD EXITO program developed as a collaboration of the CTSA hub at OHSU and a highly diverse undergraduate programs. We have developed a successful model for training a diverse research workforce and will disseminate this sustainable model.
{"title":"97 BUILD EXITO: a successful collaborative training program for STEM undergraduates to improve workforce diversity","authors":"D. Wolf, Thomas Keller, Matt Honoré, Shandee Dixon, Cynthia Morris","doi":"10.1017/cts.2024.95","DOIUrl":"https://doi.org/10.1017/cts.2024.95","url":null,"abstract":"OBJECTIVES/GOALS: To truly improve health equity and accessibility, we must develop a diverse and inclusive workforce. The BUILD EXITO program developed as a collaboration between a network of undergraduate programs and a CTSA hub and now has become a sustainable resource that will outlive NIH funding. We will disseminate our successful model. METHODS/STUDY POPULATION: The BUILD EXITO program has completed 10 years of NIH funding, a partnership between OCTRI and Portland State University (PSU), to create a new model of research training for underrepresented and disadvantaged students. This model provides an opportunity to learn about clinical and translational research academic careers; participate in a research enhancement and professional development curriculum;have a long-term authentic research experience; and receive enhanced mentorship. BUILD EXITO includes PSU, and local and 3 US Pacific territory 2-year colleges. We have developed a sustainable plan that includes these core elements after NIH support for the program ends. We have tracked long-term student outcomes for entry into graduate programs and the research workforce. RESULTS/ANTICIPATED RESULTS: We will describe the experimental model and the network of university and community colleges in BUILD EXITO, including PSU, U of Alaska, and colleges in US territories of Guam, Northern Mariana Islands, and American Samoa. All these universities and colleges have high proportions of underrepresented and disadvantaged students. We will present data on characteristics of the >600 students who have participated in BUILD EXITO to demonstrate the diversity of the cohort. We will also describe 4-year degree completion, engagement in the research workforce, and entry into graduate or professional programs. We will show how this has positively affected faculty inclusion of students in research, institutional policies at the 2-year and 4-year programs, and how this model has become sustainable. DISCUSSION/SIGNIFICANCE: The BUILD EXITO program developed as a collaboration of the CTSA hub at OHSU and a highly diverse undergraduate programs. We have developed a successful model for training a diverse research workforce and will disseminate this sustainable model.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"114 3","pages":"26 - 27"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140767899","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}
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