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Your search keyword '"Marinac‐Dabic, Danica"' showing total 236 results
Start Over Author "Marinac‐Dabic, Danica" Publication Type Academic Journals
236 results on '"Marinac‐Dabic, Danica"'

2. Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks

Author

Sedrakyan, Art, Marinac-Dabic, Danica, Campbell, Bruce, Aryal, Suvekshya, Baird, Courtney E, Goodney, Philip, Cronenwett, Jack L, Beck, Adam W, Paxton, Elizabeth W, Hu, Jim, Brindis, Ralph, Baskin, Kevin, Cowley, Terrie, Levy, Jeffery, Liebeskind, David S, Poulose, Benjamin K, Rardin, Charles R, Resnic, Frederic S, Tcheng, James, Fisher, Benjamin, Viviano, Charles, Devlin, Vincent, Sheldon, Murray, Eldrup-Jorgensen, Jens, Berlin, Jesse A, Drozda, Joseph, Matheny, Michael E, Dhruva, Sanket S, Feeney, Timothy, Mitchell, Kristi, and Pappas, Gregory

Subjects
Information and Computing Sciences, Health Services and Systems, Health Sciences, Generic health relevance, device safety, device surveillance, health care quality, access, and evaluation, health technology, real world evidence
Abstract

ObjectivesGenerating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding.Design setting and participantsWe invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020.Main outcome measuresConsensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity.ResultsOf 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains.ConclusionsWe have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

Published
2022

5. Validation of algorithms in studies based on routinely collected health data: general principles.

Author

Ehrenstein, Vera, Hellfritzsch, Maja, Kahlert, Johnny, Langan, Sinéad M, Urushihara, Hisashi, Marinac-Dabic, Danica, Lund, Jennifer L, Sørensen, Henrik Toft, and Benchimol, Eric I

Subjects
DATABASES, PROFESSIONAL practice, RESEARCH evaluation, DECISION making, ACQUISITION of data, RESEARCH methodology, EVIDENCE-based medicine, ALGORITHMS, EPIDEMIOLOGICAL research
Abstract

Clinicians, researchers, regulators, and other decision-makers increasingly rely on evidence from real-world data (RWD), including data routinely accumulating in health and administrative databases. RWD studies often rely on algorithms to operationalize variable definitions. An algorithm is a combination of codes or concepts used to identify persons with a specific health condition or characteristic. Establishing the validity of algorithms is a prerequisite for generating valid study findings that can ultimately inform evidence-based health care. In this paper, we aim to systematize terminology, methods, and practical considerations relevant to the conduct of validation studies of RWD-based algorithms. We discuss measures of algorithm accuracy, gold/reference standards, study size, prioritization of accuracy measures, algorithm portability, and implications for interpretation. Information bias is common in epidemiologic studies, underscoring the importance of transparency in decisions regarding choice and prioritizing measures of algorithm validity. The validity of an algorithm should be judged in the context of a data source, and one size does not fit all. Prioritizing validity measures within a given data source depends on the role of a given variable in the analysis (eligibility criterion, exposure, outcome, or covariate). Validation work should be part of routine maintenance of RWD sources. This article is part of a Special Collection on Pharmacoepidemiology. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials

Author

Brennan, J. Matthew, Wruck, Lisa, Pencina, Michael J., Clare, Robert M., Lopes, Renato D., Alexander, John H., O'Brien, Sean, Krucoff, Mitchell, Rao, Sunil V., Wang, Tracy Y., Curtis, Lesley H., Newby, L. Kristin, Granger, Christopher B., Patel, Manesh, Mahaffey, Kenneth, Ross, Joseph S., Normand, Sharon-Lise, Eloff, Benjamin C., Caños, Daniel A., Lokhnygina, Yuliya V., Roe, Matthew T., Califf, Robert M., Marinac-Dabic, Danica, and Peterson, Eric D.

Published
2019
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15. Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies

Author

Golan, Ron, Bernstein, Adrien, Sedrakyan, Art, Daskivich, Timothy J., Du, Dongyi T., Ehdaie, Behfar, Fisher, Benjamin, Gorin, Michael A., Grunberger, Ivan, Hunt, Bradley, Jiang, Hongying H., Kim, Hyung L., Marinac-Dabic, Danica, Marks, Leonard S., McClure, Timothy D., Montgomery, Jeffrey S., Parekh, Dipen J., Punnen, Sanoj, Scionti, Stephen, Viviano, Charles J., Wei, John T., Wenske, Sven, Wysock, James S., Rewcastle, John, Carol, Mark, Oczachowski, Marc, and Hu, Jim C.

Published
2018
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20. Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set

Author

Spronk, Pauline E. R., Begum, Husna, Vishwanath, Swarna, Crosbie, Andy, Earnest, Arul, Elder, Elisabeth, Lumenta, David B., Marinac-Dabic, Danica, Moore, Colin C. M., Mureau, Marc A. M., Perks, Graeme, Pusic, Andrea L., Stark, Birgit, von Fritschen, Uwe, Klein, Howard, Cooter, Rodney D., Rakhorst, Hinne A., and Hopper, Ingrid

Published
2020
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22. Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet)

Author

Zeitler, Emily P., Al-Khatib, Sana M., Drozda, Joseph P., Jr., Kessler, Larry G., Kirtane, Ajay J., Kong, David F., Laschinger, John, Marinac-Dabic, Danica, Morice, Marie-Claude, Reed, Terrie, Sedrakyan, Art, Stein, Kenneth M., Tcheng, James, and Krucoff, Mitchell W.

Published
2016
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28. Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies.

Author

Nieuwenhuijse, Marc J., Randsborg, Per-Henrik, Hyde, Jensen H., Wenna Xi, Franklin, Patricia, Limin Sun, Xinyan Zheng, Banerjee, Samprit, Mao, Jialin, Aryal, Suvekshya, Chan, Priscilla, Chen, Amanda, Liebeskind, Alexander, Bonangelino, Pablo, Voorhorst, Paul, Gressler, Laura E., Devlin, Vincent, Peat, Raquel, Marinac-Dabic, Danica, and Paxton, Elizabeth

Abstract

Background: Objective performance criteria (OPC) is a novel method to provide minimum performance standards and improve the regulated introduction of original or incremental device innovations in order to prevent patients from being exposed to potentially inferior designs whilst allowing timely access to improvements. We developed 2-year safety and effectiveness OPC for total hip and knee replacement (THR and TKR). Methods: Analyses of large databases were conducted using various data sources: a systematic literature review; a direct data analysis from The Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement and Quality Improvement Registry (FORCE-TJR) and the Kaiser Permanente Implant Registry (KPIR); and claims data analyses from longitudinal discharge data in New York and California states. The literature review included U.S. patients (≥ 18 years) who received THR or TKR for primary end-stage osteoarthritis and prospectively collected data on patient-reported outcome measures (PROMs) from at least 100 subjects and/or 2-year implant survival for at least 250 implants. Random effects models were used for meta-analysis. Results: Data were available from a total of 951 100 patients. After screening of 7979 abstracts, 294 studies underwent full-text review and 31 studies contributed to the evidence synthesis (333 995 implants). Direct data analysis of FORCE-TJR contributed 9223 joint replacement patients to the construction of OPC for effectiveness; KPIR contributed 262 044 patients for the construction of OPC for safety. Claims database analysis contributed 345 838 patients to the construction of safety OPC. OPC for safety were constructed for cumulative incidences of 2-year all-cause and septic revision (THR/TKR 2.0%/1.6% and 0.6%/0.7%), and OPC for effectiveness were constructed based on four disease-specific and three general health-related quality of life PROMs (HOOS/KOOS 87.1/80.6; HSS/KSS function 94.4/90.6; SF-12/SF-36, PCS 46.5/41.9, EQ-5D 0.88/0.84). Conclusion: This study is the first to construct a 2-year OPC for the safety and effectiveness of THR and TKR based on U.S. real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for a regulated and safe introduction to the (commercial) market. [ABSTRACT FROM AUTHOR]

Published
2023
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34. Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: A Cardiac Safety Research Consortium “Incubator” Think Tank

Author

Al-Khatib, Sana M., Calkins, Hugh, Eloff, Benjamin C., Kowey, Peter, Hammill, Stephen C., Ellenbogen, Kenneth A., Marinac-Dabic, Danica, Waldo, Albert L., Brindis, Ralph G., Wilbur, David J., Jackman, Warren M., Yaross, Marcia S., Russo, Andrea M., Prystowsky, Eric, Varosy, Paul D., Gross, Thomas, Pinnow, Ellen, Turakhia, Mintu P., and Krucoff, Mitchell W.

Published
2010
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35. Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: A Cardiac Safety Research Consortium “Incubator” Think Tank

Author

Al-Khatib, Sana M., Calkins, Hugh, Eloff, Benjamin C., Packer, Douglas L., Ellenbogen, Kenneth A., Hammill, Stephen C., Natale, Andrea, Page, Richard L., Prystowsky, Eric, Jackman, Warren M., Stevenson, William G., Waldo, Albert L., Wilber, David, Kowey, Peter, Yaross, Marcia S., Mark, Daniel B., Reiffel, James, Finkle, John K., Marinac-Dabic, Danica, Pinnow, Ellen, Sager, Phillip, Sedrakyan, Art, Canos, Daniel, Gross, Thomas, Berliner, Elise, and Krucoff, Mitchell W.

Published
2010
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37. Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network.

Author

Iorga, Andrea, Velezis, Marti J, Marinac-Dabic, Danica, Lario, Robert F, Huff, Stanley M, Gore, Beth, Mermel, Leonard A, Bailey, L Charles, Skapik, Julia, Willis, Debi, Lee, Robert E, Hurst, Frank P, Gressler, Laura E, Reed, Terrie L, Towbin, Richard, and Baskin, Kevin M

Subjects
CENTRAL venous catheters, ELECTRONIC health records, MEDICAL equipment, MEDICAL care costs, INFRASTRUCTURE (Economics)
Abstract

There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device–related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices

Author

Resnic, Frederic S., Gross, Thomas P., Marinac-Dabic, Danica, Loyo-Berrios, Nilsa, Donnelly, Sharon, Normand, Sharon-Lise T., and Matheny, Michael E.

Subjects
Automatic testing equipment -- Usage, Cardiovascular diseases -- Care and treatment, Cardiovascular equipment -- Complications and side effects, Cardiovascular equipment -- Safety and security measures
Abstract

Several cohort analyses are conducted to determine the effectiveness of the automated safety surveillance which is used to detect the postprocedure safety signals of approved cardiovascular devices. The surveillance is shown to be extremely feasible and accurate.

Published
2010

49. Association Between Endoscopic vs Open Vein-Graft Harvesting and Mortality, Wound Complications, and Cardiovascular Events in Patients Undergoing CABG Surgery

Author

Williams, Judson B., Peterson, Eric D., Brennan, J. Matthew, Sedrakyan, Art, Tavris, Dale, Alexander, John H., Lopes, Renato D., Dokholyan, Rachel S., Zhao, Yue, O’Brien, Sean M., Michler, Robert E., Thourani, Vinod H., Edwards, Fred H., Duggirala, Hesha, Gross, Thomas, Marinac-Dabic, Danica, and Smith, Peter K.

Published
2012
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