Pub Date : 2024-04-23eCollection Date: 2024-01-01DOI: 10.1017/cts.2024.523
Amanda Piring, Jim Morrison, Noah Federman, Laurie Shaker-Irwin, Sam Duong-Brett
[This corrects the article DOI: 10.1017/cts.2024.117.].
[此处更正了文章 DOI：10.1017/cts.2024.117.]。
{"title":"Erratum: 120 Impact of Undergraduate Clinical Research Experience: Highlighting the UCLA Clinical and Translational Science Institute Research Associates Program (CTSI-RAP) - CORRIGENDUM.","authors":"Amanda Piring, Jim Morrison, Noah Federman, Laurie Shaker-Irwin, Sam Duong-Brett","doi":"10.1017/cts.2024.523","DOIUrl":"https://doi.org/10.1017/cts.2024.523","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2024.117.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140855159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-23eCollection Date: 2024-01-01DOI: 10.1017/cts.2024.522
Roselyne Tchoua, Kate Karam, Kelly McCabe
[This corrects the article DOI: 10.1017/cts.2024.284.].
[此处更正了文章 DOI：10.1017/cts.2024.284.]。
{"title":"Erratum: 313 Data-Driven Evaluation of Community Health Worker Program - CORRIGENDUM.","authors":"Roselyne Tchoua, Kate Karam, Kelly McCabe","doi":"10.1017/cts.2024.522","DOIUrl":"https://doi.org/10.1017/cts.2024.522","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2024.284.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058572/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140863971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-23eCollection Date: 2024-01-01DOI: 10.1017/cts.2024.520
Daniel Andrew Lichlyter, Myles Joshua T Tan, Alfredo B Satriya, Weston J Schrock, Shaira L Kee, Michael Aaron G Sy, Mayra B Silva, Trevor L Schrock
[This corrects the article DOI: 10.1017/cts.2024.462.].
[此处更正了文章 DOI：10.1017/cts.2024.462]。
{"title":"Erratum: 541 A Framework for Multicultural and Multidisciplinary Near-Peer Mentoring for Artificial Intelligence in Healthcare Education: A University of Florida Friend Group - CORRIGENDUM.","authors":"Daniel Andrew Lichlyter, Myles Joshua T Tan, Alfredo B Satriya, Weston J Schrock, Shaira L Kee, Michael Aaron G Sy, Mayra B Silva, Trevor L Schrock","doi":"10.1017/cts.2024.520","DOIUrl":"https://doi.org/10.1017/cts.2024.520","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2024.462.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140865109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lesli Skolarus, Tamara Sutton, Darius Tandon, Josefina Serrato
OBJECTIVES/GOALS: We describe the transition of ShAred Resource Panels (ShARPs) within the Center for Community Health (CCH) at Northwestern University’s Clinical and Translational Sciences (NUCATS) Institute to virtual sessions and explore ongoing practices. METHODS/STUDY POPULATION: Restrictions placed during the COVID-19 pandemic led to changes in community-engaged health equity research, such as the transition of community and partner-engaged panels from in-person to virtual. ShARPs have occurred since December 2015. The model includes research team members, community members, community co-facilitator, and CCH staff. These custom panels bring together 8-10 community members familiar with a research topic or community of focus, offering feedback on adaptations that can improve research relevance and feasibility. Until the COVID-19 pandemic, all ShARPs were conducted in person. From March 2020 to January 2023, panels occurred virtually. From 2023, the option of virtual or in-person ShARPs has been available. Count data and informal interview data were reviewed. RESULTS/ANTICIPATED RESULTS: The number of ShARPs peaked in 2019 and has remained stable. The first virtual ShARP occurred on April 22, 2020, and all subsequent sessions have been virtual. As of October 2023, 6 ShARPs have occurred, with no research teams pursuing an in-person session despite its availability. Participants described virtual ShARPs as convenient and accessible. Academic teams cited concern about low community member participation should they opt for an in-person session. DISCUSSION/SIGNIFICANCE: It is feasible to conduct ShARPs virtually and is the current preferred modality. Whether virtual ShARPs enhance, neutralize, or detract from the effectiveness of the session is unknown and guides our future work. More research is needed, including discussion, and learning from our CTSA colleagues.
{"title":"247 Virtual community and partner-engaged panels - We can do them, but should we?","authors":"Lesli Skolarus, Tamara Sutton, Darius Tandon, Josefina Serrato","doi":"10.1017/cts.2024.227","DOIUrl":"https://doi.org/10.1017/cts.2024.227","url":null,"abstract":"OBJECTIVES/GOALS: We describe the transition of ShAred Resource Panels (ShARPs) within the Center for Community Health (CCH) at Northwestern University’s Clinical and Translational Sciences (NUCATS) Institute to virtual sessions and explore ongoing practices. METHODS/STUDY POPULATION: Restrictions placed during the COVID-19 pandemic led to changes in community-engaged health equity research, such as the transition of community and partner-engaged panels from in-person to virtual. ShARPs have occurred since December 2015. The model includes research team members, community members, community co-facilitator, and CCH staff. These custom panels bring together 8-10 community members familiar with a research topic or community of focus, offering feedback on adaptations that can improve research relevance and feasibility. Until the COVID-19 pandemic, all ShARPs were conducted in person. From March 2020 to January 2023, panels occurred virtually. From 2023, the option of virtual or in-person ShARPs has been available. Count data and informal interview data were reviewed. RESULTS/ANTICIPATED RESULTS: The number of ShARPs peaked in 2019 and has remained stable. The first virtual ShARP occurred on April 22, 2020, and all subsequent sessions have been virtual. As of October 2023, 6 ShARPs have occurred, with no research teams pursuing an in-person session despite its availability. Participants described virtual ShARPs as convenient and accessible. Academic teams cited concern about low community member participation should they opt for an in-person session. DISCUSSION/SIGNIFICANCE: It is feasible to conduct ShARPs virtually and is the current preferred modality. Whether virtual ShARPs enhance, neutralize, or detract from the effectiveness of the session is unknown and guides our future work. More research is needed, including discussion, and learning from our CTSA colleagues.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581337","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}
Kathryn Fiorella, Eric Teplitz, Rodman Getchell, Grace E. Gonzalez
OBJECTIVES/GOALS: This project adopts a multifaceted approach to improving aquaculture management practices in Kenya’s Lake Victoria region by identifying fish pathogens, measuring algal toxin levels in commonly consumed fish, surveying fish farming practices, and educating the public. METHODS/STUDY POPULATION: Limited existing data on the state of floating cage culture in Kenya influenced our decision to begin this portion of the project with a brief literature review of potential Nile tilapia pathogens. Databases were screened for mention of disease in either wild or caged Nile tilapia, with emphasis given to those in Lake Victoria. Results were compiled into a spreadsheet and analyzed for frequently occurring pathogens. The next portion involved creating an interview style survey to assess current cage culture management practices in the region. Editing was done to ensure questions remained unbiased, non-leading, culturally sensitive, multilingual and relevant to the situation. Data went through a quality control screening and analysis was conducted through the R programming language. RESULTS/ANTICIPATED RESULTS: Beginning with mortality, of the 93 farms surveyed, data analysis revealed that there is a higher probability that farms will have a mortality of approximately 20%, over the course of a production cycle. For biosecurity and fish health practices, data shows that 97% of farms do not disinfect scooping nets or other fish handling materials when moving from one cage to another. During the 2022-2023 production cycle, 44% of farms experienced fish kills of over 50 fish. 73% of the 93 farms do not contact any organization when a fish kill occurs. In a qualitative answer, it also appears that many farm workers dispose of their dead fish within the lake, feed it to livestock or dogs, or eat it. Algae blooms have been experienced at 80% of the farms surveyed and 43% of farms say they have seen fish gasping at the surface for air. DISCUSSION/SIGNIFICANCE: While farms are implementing good management practices in the areas of cage design, stocking, and feeding practices, there is room for improvement in fish health, biosecurity, and managing algal blooms. The findings provide insight into the areas that should be considered when taking action to improve the welfare of the region.
{"title":"61 A Multifaceted Approach to Improving Fish Farming in Kenya’s Lake Victoria Region","authors":"Kathryn Fiorella, Eric Teplitz, Rodman Getchell, Grace E. Gonzalez","doi":"10.1017/cts.2024.67","DOIUrl":"https://doi.org/10.1017/cts.2024.67","url":null,"abstract":"OBJECTIVES/GOALS: This project adopts a multifaceted approach to improving aquaculture management practices in Kenya’s Lake Victoria region by identifying fish pathogens, measuring algal toxin levels in commonly consumed fish, surveying fish farming practices, and educating the public. METHODS/STUDY POPULATION: Limited existing data on the state of floating cage culture in Kenya influenced our decision to begin this portion of the project with a brief literature review of potential Nile tilapia pathogens. Databases were screened for mention of disease in either wild or caged Nile tilapia, with emphasis given to those in Lake Victoria. Results were compiled into a spreadsheet and analyzed for frequently occurring pathogens. The next portion involved creating an interview style survey to assess current cage culture management practices in the region. Editing was done to ensure questions remained unbiased, non-leading, culturally sensitive, multilingual and relevant to the situation. Data went through a quality control screening and analysis was conducted through the R programming language. RESULTS/ANTICIPATED RESULTS: Beginning with mortality, of the 93 farms surveyed, data analysis revealed that there is a higher probability that farms will have a mortality of approximately 20%, over the course of a production cycle. For biosecurity and fish health practices, data shows that 97% of farms do not disinfect scooping nets or other fish handling materials when moving from one cage to another. During the 2022-2023 production cycle, 44% of farms experienced fish kills of over 50 fish. 73% of the 93 farms do not contact any organization when a fish kill occurs. In a qualitative answer, it also appears that many farm workers dispose of their dead fish within the lake, feed it to livestock or dogs, or eat it. Algae blooms have been experienced at 80% of the farms surveyed and 43% of farms say they have seen fish gasping at the surface for air. DISCUSSION/SIGNIFICANCE: While farms are implementing good management practices in the areas of cage design, stocking, and feeding practices, there is room for improvement in fish health, biosecurity, and managing algal blooms. The findings provide insight into the areas that should be considered when taking action to improve the welfare of the region.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581343","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}
Tingting Zhao, Xiaolin Chang, Subrata Biswas, Jeremy Balsbaugh, Jennifer Liddle, Ming-hui Chen, Adam Matson, Xiaomei Cong
OBJECTIVES/GOALS: Early life pain/stress impacts infants’ neurodevelopmental outcomes. Mitochondrial dysfunction may interface between infants’ stress and neurodevelopment. The study aims to investigate the associations between pain/stress, proteins associated with mitochondrial dysfunction, and neurobehavioral responses in preterm infants. METHODS/STUDY POPULATION: A prospective cohort study was conducted with 33 preterm infants enrolled between September 2017 and July 2022 at two affiliated NICUs in Hartford and Farmington, CT. Daily pain/stress experienced during NICU was documented. At 36-38 weeks post-menstrual age (PMA), neurobehavioral outcomes were evaluated using the NICU Network Neurobehavioral Scale (NNNS) and buccal swabs for Mass spectrometry-based proteomics analysis. Lasso statistical methods were conducted to study the association between protein abundance and infants’ NNNS summary scores. Multiple linear regression and Gene Ontology (GO) enrichment analyses were performed to examine how clinical characteristics and neurodevelopmental outcomes may be associated with protein levels and underlying molecular pathways. RESULTS/ANTICIPATED RESULTS: During NICU hospitalization, preterm premature rupture of membrane (PPROM) was negatively associated with neurobehavioral outcomes. The protein functions, including leptin receptor binding activity, glutathione disulfide oxidoreductase activity, and response to oxidative stress, lipid metabolism, phosphate, and proton transmembrane transporter activity, were negatively associated with neurobehavioral outcomes. In contrast, cytoskeletal regulation, epithelial barrier, and protection function were found to be positively associated with neurodevelopmental outcomes. In addition, mitochondrial dysfunction-related proteins (SPRR2A, PAIP1, S100A3, MT-CO2, PiC, GLRX, PHB2, and BNIPL-2, ABLIM1, UNC45A, Keratins, MUC1, and CYB5B) were found to be associated with neurobehavioral outcomes. DISCUSSION/SIGNIFICANCE: Mitochondrial dysfunction-related proteins were observed to be associated with early life pain/stress and neurodevelopmental outcomes in infants. Buccal proteins could be used to predict potential neurobehavioral outcomes. In addition, individualized skin integrity protection should be provided to preterm infants during their NICU stay.
{"title":"98 The Crosstalk between Mitochondrial Dysfunction and Neurodevelopmental Outcomes in Preterm Infants with Pain/Stress in the NICU","authors":"Tingting Zhao, Xiaolin Chang, Subrata Biswas, Jeremy Balsbaugh, Jennifer Liddle, Ming-hui Chen, Adam Matson, Xiaomei Cong","doi":"10.1017/cts.2024.96","DOIUrl":"https://doi.org/10.1017/cts.2024.96","url":null,"abstract":"<p>OBJECTIVES/GOALS: Early life pain/stress impacts infants’ neurodevelopmental outcomes. Mitochondrial dysfunction may interface between infants’ stress and neurodevelopment. The study aims to investigate the associations between pain/stress, proteins associated with mitochondrial dysfunction, and neurobehavioral responses in preterm infants. METHODS/STUDY POPULATION: A prospective cohort study was conducted with 33 preterm infants enrolled between September 2017 and July 2022 at two affiliated NICUs in Hartford and Farmington, CT. Daily pain/stress experienced during NICU was documented. At 36-38 weeks post-menstrual age (PMA), neurobehavioral outcomes were evaluated using the NICU Network Neurobehavioral Scale (NNNS) and buccal swabs for Mass spectrometry-based proteomics analysis. Lasso statistical methods were conducted to study the association between protein abundance and infants’ NNNS summary scores. Multiple linear regression and Gene Ontology (GO) enrichment analyses were performed to examine how clinical characteristics and neurodevelopmental outcomes may be associated with protein levels and underlying molecular pathways. RESULTS/ANTICIPATED RESULTS: During NICU hospitalization, preterm premature rupture of membrane (PPROM) was negatively associated with neurobehavioral outcomes. The protein functions, including leptin receptor binding activity, glutathione disulfide oxidoreductase activity, and response to oxidative stress, lipid metabolism, phosphate, and proton transmembrane transporter activity, were negatively associated with neurobehavioral outcomes. In contrast, cytoskeletal regulation, epithelial barrier, and protection function were found to be positively associated with neurodevelopmental outcomes. In addition, mitochondrial dysfunction-related proteins (SPRR2A, PAIP1, S100A3, MT-CO2, PiC, GLRX, PHB2, and BNIPL-2, ABLIM1, UNC45A, Keratins, MUC1, and CYB5B) were found to be associated with neurobehavioral outcomes. DISCUSSION/SIGNIFICANCE: Mitochondrial dysfunction-related proteins were observed to be associated with early life pain/stress and neurodevelopmental outcomes in infants. Buccal proteins could be used to predict potential neurobehavioral outcomes. In addition, individualized skin integrity protection should be provided to preterm infants during their NICU stay.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581357","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: This study explored personal recovery support, including social determinants of health and psychosocial needs to understand factors for sustaining recovery among parenting and pregnant women with opioid use disorder. METHODS/STUDY POPULATION: This study used a mixed method quantitative/qualitative design and recruited women from residential/transitional facilities in an urban area. We used the Accountable Health Communities Health-Related Social Needs tool to assess social determinants of health factors, level of physical activity, family/community support, and mental health (stress). Through focus groups, we interviewed women to describe challenges to recovery and to resources including access to providers, housing, childcare, and food assistance from lived experiences. RESULTS/ANTICIPATED RESULTS: Survey analysis showed social determinants of health factors such as food and transportation were partially mitigated by residential living; however, parenting and pregnant women with opioid use disorder remained concerned about housing and finances; and encountered low levels of physical activity and significant stress. Preliminary results from the focus groups revealed a theme of positive recovery and retention experiences from residential living. DISCUSSION/SIGNIFICANCE: Evidence from studies suggests focused interventions for recovering women to reduce relapse risk factors and adverse maternal outcomes. Opportunities for improving personal recovery capital are accessible in residential facilities, however, further exploration of unmet social determinants of health factors are needed for recovery retention.
{"title":"203 Assessing social determinants of health and psychosocial factors critical to sustaining recovery among pregnant and parenting women with opioid use disorder","authors":"Doris Titus-Glover","doi":"10.1017/cts.2024.194","DOIUrl":"https://doi.org/10.1017/cts.2024.194","url":null,"abstract":"OBJECTIVES/GOALS: This study explored personal recovery support, including social determinants of health and psychosocial needs to understand factors for sustaining recovery among parenting and pregnant women with opioid use disorder. METHODS/STUDY POPULATION: This study used a mixed method quantitative/qualitative design and recruited women from residential/transitional facilities in an urban area. We used the Accountable Health Communities Health-Related Social Needs tool to assess social determinants of health factors, level of physical activity, family/community support, and mental health (stress). Through focus groups, we interviewed women to describe challenges to recovery and to resources including access to providers, housing, childcare, and food assistance from lived experiences. RESULTS/ANTICIPATED RESULTS: Survey analysis showed social determinants of health factors such as food and transportation were partially mitigated by residential living; however, parenting and pregnant women with opioid use disorder remained concerned about housing and finances; and encountered low levels of physical activity and significant stress. Preliminary results from the focus groups revealed a theme of positive recovery and retention experiences from residential living. DISCUSSION/SIGNIFICANCE: Evidence from studies suggests focused interventions for recovering women to reduce relapse risk factors and adverse maternal outcomes. Opportunities for improving personal recovery capital are accessible in residential facilities, however, further exploration of unmet social determinants of health factors are needed for recovery retention.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581358","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 primary purpose of the QA/QC Project Manager (PM), appointed under the NCATS UL1 administrative supplement award, is to facilitate quality and timely NCATS prior approval submissions preventing study start delays. Other goals include supporting these projects’ IRB applications and monitoring to ensure data quality and compliance. METHODS/STUDY POPULATION: At the Indiana CTSI, the QA/QC PM is assigned to the Regulatory Knowledge and Support program (RKS) and functions as a unique regulatory service provider. Through monitoring, auditing, and personalized consultations, the IN CTSI QA/QC PM provides study teams with regulatory, GCP, and other compliant study conduct insights while managing NCATS prior approval and RPPR submission quality and timeliness. In contrast to many CTSAs, this role is uniquely situated within RKS and provides QA/QC support through a regulatory lens. The Indiana CTSI QA/QC PM serves on the CTSA QA/QC Lead Team collaborating with NCATS and other CTSA QA/QC personnel. The Lead Team engages with NCATS to host monthly/quarterly meetings and participate in a discussion forum of NCATS and other CTSA QA/QC personnel. RESULTS/ANTICIPATED RESULTS: Not all CTSAs employ the QA/QC PM as regulatory support and the role and skill sets at each CTSA vary, yet the collaborative nature of these individuals across the CTSAs facilitates sharing of resources and knowledge. While prior approval and RPPR submissions vary widely, the QA/QC PMs can rely on their counterparts for guidance complying with the same regulations and policies within unique research settings and institutional nuances. The IN CTSI QA/QC PM, in collaboration with the QA/QC Lead Team, provided quality assurance revisions to the NCATS prior approval instructions which were adopted and published by NCATS January 2022 for implementation at all CTSAs. Ongoing, quality control efforts are accomplished through education, monitoring, and regulatory consultations. DISCUSSION/SIGNIFICANCE: As the research environment evolves, the QA/QC PM responsibilities shift in response to needs within RKS and NCATS. The versatility of the position enables QA/QC to occur at all stages of a study. QA/QC strategies aim to facilitate communication, quality NCATS prior approval and RPPR submissions, and compliance with proposed study conduct.
{"title":"509 Regulatory Lens of a QA/QC Project Manager","authors":"Rachel Bennett, Christine Sego Caldwell","doi":"10.1017/cts.2024.433","DOIUrl":"https://doi.org/10.1017/cts.2024.433","url":null,"abstract":"OBJECTIVES/GOALS: The primary purpose of the QA/QC Project Manager (PM), appointed under the NCATS UL1 administrative supplement award, is to facilitate quality and timely NCATS prior approval submissions preventing study start delays. Other goals include supporting these projects’ IRB applications and monitoring to ensure data quality and compliance. METHODS/STUDY POPULATION: At the Indiana CTSI, the QA/QC PM is assigned to the Regulatory Knowledge and Support program (RKS) and functions as a unique regulatory service provider. Through monitoring, auditing, and personalized consultations, the IN CTSI QA/QC PM provides study teams with regulatory, GCP, and other compliant study conduct insights while managing NCATS prior approval and RPPR submission quality and timeliness. In contrast to many CTSAs, this role is uniquely situated within RKS and provides QA/QC support through a regulatory lens. The Indiana CTSI QA/QC PM serves on the CTSA QA/QC Lead Team collaborating with NCATS and other CTSA QA/QC personnel. The Lead Team engages with NCATS to host monthly/quarterly meetings and participate in a discussion forum of NCATS and other CTSA QA/QC personnel. RESULTS/ANTICIPATED RESULTS: Not all CTSAs employ the QA/QC PM as regulatory support and the role and skill sets at each CTSA vary, yet the collaborative nature of these individuals across the CTSAs facilitates sharing of resources and knowledge. While prior approval and RPPR submissions vary widely, the QA/QC PMs can rely on their counterparts for guidance complying with the same regulations and policies within unique research settings and institutional nuances. The IN CTSI QA/QC PM, in collaboration with the QA/QC Lead Team, provided quality assurance revisions to the NCATS prior approval instructions which were adopted and published by NCATS January 2022 for implementation at all CTSAs. Ongoing, quality control efforts are accomplished through education, monitoring, and regulatory consultations. DISCUSSION/SIGNIFICANCE: As the research environment evolves, the QA/QC PM responsibilities shift in response to needs within RKS and NCATS. The versatility of the position enables QA/QC to occur at all stages of a study. QA/QC strategies aim to facilitate communication, quality NCATS prior approval and RPPR submissions, and compliance with proposed study conduct.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581363","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: Thiswork is an evidential study that demonstrates the positive impactof integrating Community Health Workers (CHWs) and SocialDeterminants of Health on an important health outcome, notably in decreasing the 30-day unplanned hospital ED readmissions at Sinai Health Systems. METHODS/STUDY POPULATION: Using datafrom the Sinai Urban Health Institute (SUHI), we compare predictingthe readmissions of patients with and without data pertainingto Social Determinants of Health (SDoH). We thoroughly describe the data cleaning and data pre-processing, done in collaboration with experts in community health. We use a fundamental and ubiquitous classifier in Random Forest for its feature characterization capability in order to translate models results into insights and recommendations for the CHW program. RESULTS/ANTICIPATED RESULTS: We show that when patients are simply engaged byCHWs, regardless of the content of those conversations, we canincrease the predictive accuracy of our classifier by 5%. We usethis result to make recommendations for improving patient careand discuss limitations and future work. Importantly our workpoints directly to the human connection between patients andCHWs as an important feature in the readmission rate. DISCUSSION/SIGNIFICANCE: Our work shows that the predictive capabilities of the classifier increases with CHW logs and SDoH survey data, highlighting the benefit of collecting this information. This is the first step in early identification of such patients so that CHWs are focusing on and providing resources to patients who will most benefit from the program.
{"title":"313 Identification of novel plasma protein of Community Health Worker Program","authors":"Roselyne Tchoua, Kate Karam, Kelly McCabe","doi":"10.1017/cts.2024.284","DOIUrl":"https://doi.org/10.1017/cts.2024.284","url":null,"abstract":"OBJECTIVES/GOALS: Thiswork is an evidential study that demonstrates the positive impactof integrating Community Health Workers (CHWs) and SocialDeterminants of Health on an important health outcome, notably in decreasing the 30-day unplanned hospital ED readmissions at Sinai Health Systems. METHODS/STUDY POPULATION: Using datafrom the Sinai Urban Health Institute (SUHI), we compare predictingthe readmissions of patients with and without data pertainingto Social Determinants of Health (SDoH). We thoroughly describe the data cleaning and data pre-processing, done in collaboration with experts in community health. We use a fundamental and ubiquitous classifier in Random Forest for its feature characterization capability in order to translate models results into insights and recommendations for the CHW program. RESULTS/ANTICIPATED RESULTS: We show that when patients are simply engaged byCHWs, regardless of the content of those conversations, we canincrease the predictive accuracy of our classifier by 5%. We usethis result to make recommendations for improving patient careand discuss limitations and future work. Importantly our workpoints directly to the human connection between patients andCHWs as an important feature in the readmission rate. DISCUSSION/SIGNIFICANCE: Our work shows that the predictive capabilities of the classifier increases with CHW logs and SDoH survey data, highlighting the benefit of collecting this information. This is the first step in early identification of such patients so that CHWs are focusing on and providing resources to patients who will most benefit from the program.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581152","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}
Rhonda Kost, Ranee Chatterjee, Ann Dozier, Daniel Ford, Joseph Andrews, Nancy Green, Paul A. Harris, Alex Cheng
OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a 6-CTSA Rockefeller-led collaboration to developcustom REDCap infrastructure to collect participant feedback using the validated Research Participant Perception Survey (RPPS), demonstrate its value in use cases, and disseminate it for broad adoption. METHODS/STUDY POPULATION: The EPV team developed data and survey implementation standards, and specifications for the dashboard and multi-lingual RPPS/REDCap project XML file. The VUMC built a custom At-a-Glance Dashboard external module that displays Top Box scores (percent best answer), with conditional formatting to aid analysis, and response/completion rates. Results populate site dashboards, and aggregate to a multi-site dashboard for benchmarking. Results can be filtered by participant/study characteristics. Sites developed individual use cases, leveraging local infrastructure, initiatives and stakeholder input. Infrastructure and guides were designed for dissemination through public websites. RESULTS/ANTICIPATED RESULTS: Five sites sent 23,797surveys via email, patient portal or SMS. 4,133 (19%) participants diverse in age, race, and ethnicity, returned responses. Sites analyzed their data and acted on selected findings, improving recruitment, communication and feeling valued. Aggregate scores for feeling listened to and respected were hight (>90%%); scores for feeling prepared by the consent process were lower (57-77%) and require action. Some groups experiences were better than others. Sites differed significantly in some scores. Dissemination of EPV is underway. Infrastructure and guides are downloadable free of charge, with advice from the EPV team. In 2023, a sixth site began piloting a lower literacy survey version and syncing data to the consortium dashboard. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to collect participant feedback, identify actionable findings and benchmark with peers. Stakeholders and collaborators designed and tested local initiatives to increase responses and diversity, address disparities, and discover better practices.
{"title":"177 Placing Participant Experiences at the Center of Improving Research by Empowering the Participant Voice","authors":"Rhonda Kost, Ranee Chatterjee, Ann Dozier, Daniel Ford, Joseph Andrews, Nancy Green, Paul A. Harris, Alex Cheng","doi":"10.1017/cts.2024.168","DOIUrl":"https://doi.org/10.1017/cts.2024.168","url":null,"abstract":"OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a 6-CTSA Rockefeller-led collaboration to developcustom REDCap infrastructure to collect participant feedback using the validated Research Participant Perception Survey (RPPS), demonstrate its value in use cases, and disseminate it for broad adoption. METHODS/STUDY POPULATION: The EPV team developed data and survey implementation standards, and specifications for the dashboard and multi-lingual RPPS/REDCap project XML file. The VUMC built a custom At-a-Glance Dashboard external module that displays Top Box scores (percent best answer), with conditional formatting to aid analysis, and response/completion rates. Results populate site dashboards, and aggregate to a multi-site dashboard for benchmarking. Results can be filtered by participant/study characteristics. Sites developed individual use cases, leveraging local infrastructure, initiatives and stakeholder input. Infrastructure and guides were designed for dissemination through public websites. RESULTS/ANTICIPATED RESULTS: Five sites sent 23,797surveys via email, patient portal or SMS. 4,133 (19%) participants diverse in age, race, and ethnicity, returned responses. Sites analyzed their data and acted on selected findings, improving recruitment, communication and feeling valued. Aggregate scores for feeling listened to and respected were hight (>90%%); scores for feeling prepared by the consent process were lower (57-77%) and require action. Some groups experiences were better than others. Sites differed significantly in some scores. Dissemination of EPV is underway. Infrastructure and guides are downloadable free of charge, with advice from the EPV team. In 2023, a sixth site began piloting a lower literacy survey version and syncing data to the consortium dashboard. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to collect participant feedback, identify actionable findings and benchmark with peers. Stakeholders and collaborators designed and tested local initiatives to increase responses and diversity, address disparities, and discover better practices.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140581204","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：