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4. Accrual to Clinical Trials (ACT): A Clinical and Translational Science Award Consortium Network

Author

Visweswaran, Shyam, Becich, Michael J, D’Itri, Vincent S, Sendro, Elaina R, MacFadden, Douglas, Anderson, Nicholas R, Allen, Karen A, Ranganathan, Dipti, Murphy, Shawn N, Morrato, Elaine H, Pincus, Harold A, Toto, Robert, Firestein, Gary S, Nadler, Lee M, and Reis, Steven E

Subjects
Health Services and Systems, Health Sciences, Clinical Trials and Supportive Activities, Clinical Research, clinical trials, accrual, cohort discovery, clinical data research network, electronic health records, Health services and systems
Abstract

The Accrual to Clinical Trials (ACT) network is a federated network of sites from the National Clinical and Translational Science Award (CTSA) Consortium that has been created to significantly increase participant accrual to multi-site clinical trials. The ACT network represents an unprecedented collaboration among diverse CTSA sites. The network has created governance and regulatory frameworks and a common data model to harmonize electronic health record (EHR) data, and deployed a set of Informatics for Integrating Biology and the Bedside (i2b2) data repositories that are linked by the Shared Health Research Information Network (SHRINE) platform. It provides investigators the ability to query the network in real time and to obtain aggregate counts of patients who meet clinical trial inclusion and exclusion criteria from sites across the United States. The ACT network infrastructure provides a basis for cohort discovery and for developing new informatics tools to identify and recruit participants for multi-site clinical trials.

Published
2018

9. The ENACT Network: An Evolving Open-Access, Real-World Data Resource Primed for RWE Research across the CTSA Consortium

Author

Morrato, Elaine H., primary, Lennox, Lindsay A., additional, Dearing, James W., additional, Coughlan, Anne T., additional, Gano, Elaina S., additional, McFadden, Doug, additional, Mora, Nallely, additional, Pincus, Harold Alan, additional, Firestein, Gary S., additional, Toto, Robert, additional, and Reis, Steven E., additional

Published
2023
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10. Gene-Centric Meta-Analysis of Lipid Traits in African, East Asian and Hispanic Populations

Author

Elbers, Clara C, Guo, Yiran, Tragante, Vinicius, van Iperen, Erik PA, Lanktree, Matthew B, Castillo, Berta Almoguera, Chen, Fang, Yanek, Lisa R, Wojczynski, Mary K, Li, Yun R, Ferwerda, Bart, Ballantyne, Christie M, Buxbaum, Sarah G, Chen, Yii-Der Ida, Chen, Wei-Min, Cupples, L Adrienne, Cushman, Mary, Duan, Yanan, Duggan, David, Evans, Michele K, Fernandes, Jyotika K, Fornage, Myriam, Garcia, Melissa, Garvey, W Timothy, Glazer, Nicole, Gomez, Felicia, Harris, Tamara B, Halder, Indrani, Howard, Virginia J, Keller, Margaux F, Kamboh, M Ilyas, Kooperberg, Charles, Kritchevsky, Stephen B, LaCroix, Andrea, Liu, Kiang, Liu, Yongmei, Musunuru, Kiran, Newman, Anne B, Onland-Moret, N Charlotte, Ordovas, Jose, Peter, Inga, Post, Wendy, Redline, Susan, Reis, Steven E, Saxena, Richa, Schreiner, Pamela J, Volcik, Kelly A, Wang, Xingbin, Yusuf, Salim, Zonderland, Alan B, Anand, Sonia S, Becker, Diane M, Psaty, Bruce, Rader, Daniel J, Reiner, Alex P, Rich, Stephen S, Rotter, Jerome I, Sale, Michèle M, Tsai, Michael Y, Borecki, Ingrid B, Hegele, Robert A, Kathiresan, Sekar, Nalls, Michael A, Taylor, Herman A, Hakonarson, Hakon, Sivapalaratnam, Suthesh, Asselbergs, Folkert W, Drenos, Fotios, Wilson, James G, and Keating, Brendan J

Subjects
Epidemiology, Biological Sciences, Health Sciences, Genetics, Clinical Research, Atherosclerosis, Aetiology, 2.1 Biological and endogenous factors, Alleles, Asian People, Black People, Cholesterol, Gene Frequency, Genetic Association Studies, Genetic Predisposition to Disease, Genotype, Hispanic or Latino, Humans, Lipoproteins, HDL, Lipoproteins, LDL, Polymorphism, Single Nucleotide, Triglycerides, genetic variants, loci, lipid, genotyping, CD36 deficiency, General Science & Technology
Abstract

Meta-analyses of European populations has successfully identified genetic variants in over 100 loci associated with lipid levels, but our knowledge in other ethnicities remains limited. To address this, we performed dense genotyping of ∼2,000 candidate genes in 7,657 African Americans, 1,315 Hispanics and 841 East Asians, using the IBC array, a custom ∼50,000 SNP genotyping array. Meta-analyses confirmed 16 lipid loci previously established in European populations at genome-wide significance level, and found multiple independent association signals within these lipid loci. Initial discovery and in silico follow-up in 7,000 additional African American samples, confirmed two novel loci: rs5030359 within ICAM1 is associated with total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) (p = 8.8×10(-7) and p = 1.5×10(-6) respectively) and a nonsense mutation rs3211938 within CD36 is associated with high-density lipoprotein cholesterol (HDL-C) levels (p = 13.5×10(-12)). The rs3211938-G allele, which is nearly absent in European and Asian populations, has been previously found to be associated with CD36 deficiency and shows a signature of selection in Africans and African Americans. Finally, we have evaluated the effect of SNPs established in European populations on lipid levels in multi-ethnic populations and show that most known lipid association signals span across ethnicities. However, differences between populations, especially differences in allele frequency, can be leveraged to identify novel signals, as shown by the discovery of ICAM1 and CD36 in the current report.

Published
2012

13. PERSISTENT CHEST PAIN AT 5 YEARS: PREDICTORS AND ASSOCIATED OUTCOMES AMONG WOMEN WITH AND WITHOUT OBSTRUCTIVE CORONARY ARTERY DISEASE IN THE WOMEN'S ISCHEMIA SYNDROME EVALUATION (WISE)

Author

Obrutu, Okezi, primary, Wei, Janet, additional, Gulati, Martha, additional, Reis, Steven E., additional, Bittner, Vera, additional, Handberg, Eileen M., additional, Cook-Wiens, Galen, additional, Pepine, Carl J., additional, and Merz, C. Noel Bairey, additional

Published
2023
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17. Long-Term Adverse Outcomes in Black Women With Ischemia and No Obstructive Coronary Artery Disease: A Study of the WISE (Women’s Ischemia Syndrome Evaluation) Cohort

Author

Luu, Judy M., primary, Malhotra, Pankaj, additional, Cook-Wiens, Galen, additional, Pepine, Carl J., additional, Handberg, Eileen M., additional, Reis, Steven E., additional, Reichek, Nathaniel, additional, Bittner, Vera, additional, Wei, Janet, additional, Kelsey, Sheryl F., additional, Sailaja Marpuri, Reddy, additional, Sopko, George, additional, and Bairey Merz, C. Noel, additional

Published
2023
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20. Leveraging CTSA hubs for rapid, large-scale, high-impact research: A case study during a global public health emergency

Author

Croker, Jennifer A., primary, Valenti, Shannon, additional, Baus, Holly Ann, additional, Ford, Eric W., additional, Mathias, David, additional, Yasko, Laurel, additional, McGaughey, Dan, additional, Smith, Tony, additional, Underwood, Katherine, additional, Avolio, Jennifer, additional, Sadtler, Kaitlyn, additional, Memoli, Matthew J., additional, Kimberly, Robert P., additional, and Reis, Steven E., additional

Published
2022
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27. DIET, ANGIOGRAPHIC CORONARY DISEASE, AND CARDIOVASCULAR OUTCOMES IN WOMEN

Author

Schwartz, Brandon, primary, Choi, So Yung, additional, Cook-Wiens, Galen, additional, Kelsey, Sheryl Foulke, additional, Malhotra, Pankaj, additional, Handberg, Eileen M., additional, Reis, Steven E., additional, Rogers, William J., additional, Sharaf, Barry L., additional, Sopko, George, additional, Matthews, Anne, additional, Taha, Yasmeen, additional, Aggarwal, Monica, additional, Pepine, Carl J., additional, and Merz, C. Noel Bairey, additional

Published
2022
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30. Leveraging CTSA hubs for rapid, large-scale, high-impact research: A case study during a global public health emergency.

Author

Croker, Jennifer A., Valenti, Shannon, Baus, Holly Ann, Ford, Eric W., Mathias, David, Yasko, Laurel, McGaughey, Dan, Smith, Tony, Underwood, Katherine, Avolio, Jennifer, Sadtler, Kaitlyn, Memoli, Matthew J., Kimberly, Robert P., and Reis, Steven E.

Abstract

As the COVID-19 pandemic took hold in the USA in early 2020, it became clear that knowledge of the prevalence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among asymptomatic individuals could inform public health policy decisions and provide insight into the impact of the infection on vulnerable populations. Two Clinical and Translational Science Award (CTSA) Hubs and the National Institutes of Health (NIH) set forth to conduct a national seroprevalence survey to assess the infection's rate of spread. This partnership was able to quickly design and launch the project by leveraging established research capacities, prior experiences in large-scale, multisite studies and a highly skilled workforce of CTSA hubs and unique experimental capabilities at the NIH to conduct a diverse prospective, longitudinal observational cohort of 11,382 participants who provided biospecimens and participant-reported health and behavior data. The study was completed in 16 months and benefitted from transdisciplinary teamwork, information technology innovations, multimodal communication strategies, and scientific partnership for rigor in design and analytic methods. The lessons learned by the rapid implementation and dissemination of this national study is valuable in guiding future multisite projects as well as preparation for other public health emergencies and pandemics. [ABSTRACT FROM AUTHOR]

Published
2023
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33. Risk factors for heart failure in women with ischemia and no obstructive coronary artery disease

Author

Leong, Derek, primary, Tjoe, Benita, additional, Zarrini, Parham, additional, Cook-Wiens, Galen, additional, Wei, Janet, additional, Shufelt, Chrisandra L., additional, Pepine, Carl J., additional, Handberg, Eileen M., additional, Reis, Steven E., additional, Reichek, Nathaniel, additional, Bittner, Vera, additional, Kelsey, Sheryl F., additional, Marpuri, Reddy Sailaja, additional, Sopko, George, additional, and Merz, C. Noel Bairey, additional

Published
2021
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34. Development of a Coronavirus Disease 2019 (COVID-19) Application Ontology for the Accrual to Clinical Trials (ACT) network

Author

Visweswaran, Shyam, primary, Samayamuthu, Malarkodi J, additional, Morris, Michele, additional, Weber, Griffin M, additional, MacFadden, Douglas, additional, Trevvett, Philip, additional, Klann, Jeffrey G, additional, Gainer, Vivian S, additional, Benoit, Barbara, additional, Murphy, Shawn N, additional, Patel, Lav, additional, Mirkovic, Nebojsa, additional, Borovskiy, Yuliya, additional, Johnson, Robert D, additional, Wyatt, Matthew C, additional, Wang, Amy Y, additional, Follett, Robert W, additional, Chau, Ngan, additional, Zhu, Wenhong, additional, Abajian, Mark, additional, Chuang, Amy, additional, Bahroos, Neil, additional, Reeder, Phillip, additional, Xie, Donglu, additional, Cai, Jennifer, additional, Sendro, Elaina R, additional, Toto, Robert D, additional, Firestein, Gary S, additional, Nadler, Lee M, additional, and Reis, Steven E, additional

Published
2021
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37. Association between the severity of angiographic coronary artery disease and paraoxonase gene polymorphisms in the National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE) study

Author

Chen, Qi, Reis, Steven E., Kammerer, Candace M., McNamara, Dennis M., Holubkov, Richard, Sharaf, Barry L., Sopko, George, Pauly, Daniel F., Merz, C. Noel Bairey, and Kamboh, M. Ilyas

Subjects
High density lipoproteins -- Physiological aspects, High density lipoproteins -- Genetic aspects, Coronary heart disease -- Physiological aspects, Coronary heart disease -- Genetic aspects, Ischemia -- Physiological aspects, Ischemia -- Genetic aspects, Polymorphism (Zoology) -- Physiological aspects, Polymorphism (Zoology) -- Genetic aspects, Biological sciences
Published
2003

38. An atomic approach to the design and implementation of a research data warehouse.

Author

Visweswaran, Shyam, McLay, Brian, Cappella, Nickie, Morris, Michele, Milnes, John T, Reis, Steven E, Silverstein, Jonathan C, and Becich, Michael J

Abstract

Objective: As a long-standing Clinical and Translational Science Awards (CTSA) Program hub, the University of Pittsburgh and the University of Pittsburgh Medical Center (UPMC) developed and implemented a modern research data warehouse (RDW) to efficiently provision electronic patient data for clinical and translational research.Materials and Methods: We designed and implemented an RDW named Neptune to serve the specific needs of our CTSA. Neptune uses an atomic design where data are stored at a high level of granularity as represented in source systems. Neptune contains robust patient identity management tailored for research; integrates patient data from multiple sources, including electronic health records (EHRs), health plans, and research studies; and includes knowledge for mapping to standard terminologies.Results: Neptune contains data for more than 5 million patients longitudinally organized as Health Insurance Portability and Accountability Act (HIPAA) Limited Data with dates and includes structured EHR data, clinical documents, health insurance claims, and research data. Neptune is used as a source for patient data for hundreds of institutional review board-approved research projects by local investigators and for national projects.Discussion: The design of Neptune was heavily influenced by the large size of UPMC, the varied data sources, and the rich partnership between the University and the healthcare system. It includes several unique aspects, including the physical warehouse straddling the University and UPMC networks and management under an HIPAA Business Associates Agreement.Conclusion: We describe the design and implementation of an RDW at a large academic healthcare system that uses a distinctive atomic design where data are stored at a high level of granularity. [ABSTRACT FROM AUTHOR]

Published
2022
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40. Scale-up of the Accrual to Clinical Trials (ACT) network across the Clinical and Translational Science Award Consortium: a mixed-methods evaluation of the first 18 months

Author

Morrato, Elaine H., primary, Lennox, Lindsay A., additional, Sendro, Elaina R., additional, Schuster, Anne L., additional, Pincus, Harold A., additional, Humensky, Jennifer, additional, Firestein, Gary S., additional, Nadler, Lee M., additional, Toto, Robert, additional, and Reis, Steven E., additional

Published
2020
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41. Predicted Versus Observed Major Adverse Cardiac Event Risk in Women With Evidence of Ischemia and No Obstructive Coronary Artery Disease: A Report From WISE (Women's Ischemia Syndrome Evaluation)

Author

Sedlak, Tara, primary, Herscovici, Romana, additional, Cook‐Wiens, Galen, additional, Handberg, Eileen, additional, Wei, Janet, additional, Shufelt, Chrisandra, additional, Bittner, Vera, additional, Reis, Steven E., additional, Reichek, Nathaniel, additional, Pepine, Carl, additional, and Bairey Merz, C. Noel, additional

Published
2020
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49. Postmenopausal Women with a History of Irregular Menses and Elevated Androgen Measurements at High Risk for Worsening Cardiovascular Event-Free Survival: Results from the National Institutes of Health—National Heart, Lung, and Blood Institute Sponsored Women’s Ischemia Syndrome Evaluation

Author

Shaw, Leslee J., Bairey Merz, C Noel, Azziz, Ricardo, Stanczyk, Frank Z., Sopko, George, Braunstein, Glenn D., Kelsey, Sheryl F., Kip, Kevin E., Cooper-DeHoff, Rhonda M., Johnson, B Delia, Vaccarino, Viola, Reis, Steven E., Bittner, Vera, Hodgson, T Keta, Rogers, William, and Pepine, Carl J.

Published
2008

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