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Minimum Core Data E...
Minimum Core Data Elements for Evaluation of TAVR : A Scientific Statement by PASSION CV, HVC, and TVT Registry
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- Simonato, Matheus (författare)
- Yale Sch Med, New Haven, CT USA
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- Vemulapalli, Sreekanth (författare)
- Duke Clin Res Inst, Box 3126, Durham, NC 27710 USA
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- Ben-Yehuda, Ori (författare)
- Univ Calif San Diego, San Diego, CA 92103 USA.;Cardiovasc Res Fdn, New York, NY USA
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- Wu, Changfu (författare)
- US FDA, Silver Spring, MD USA
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- Wood, Larry (författare)
- Edwards Lifesci, Irvine, CA USA
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- Popma, Jeff (författare)
- Medtron, Minneapolis, MN USA
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- Feldman, Ted (författare)
- Edwards Lifesci, Irvine, CA USA
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- Krohn, Carole (författare)
- Soc Thorac Surg, Chicago, IL USA
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- Hardy, Karen M. (författare)
- Common Spirit Hlth, Chicago, IL USA
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- Guibone, Kimberly (författare)
- Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
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- Christensen, Barbara (författare)
- Amer Coll Cardiol, Washington, DC USA
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- Alu, Maria C. (författare)
- Cardiovasc Res Fdn, New York, NY USA
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- Chen, Shmuel (författare)
- Columbia Univ, Irving Sch Med, New York, NY USA
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- Ng, Vivian G. (författare)
- Columbia Univ, Irving Sch Med, New York, NY USA
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- Chau, Katherine H. (författare)
- Columbia Univ, Irving Sch Med, New York, NY USA
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- Shahim, Bahira (författare)
- Karolinska Institutet
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- Vincent, Flavien (författare)
- Cardiovasc Res Fdn, New York, NY USA
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- MacMahon, John (författare)
- Mitre Med Corp, Morgan Hill, CA USA
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- James, Stefan, 1964- (författare)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Institutionen för medicinska vetenskaper
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- Mack, Michael (författare)
- Baylor Scott & White Hlth, Dallas, TX USA
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- Leon, Martin B. (författare)
- Columbia Univ, Irving Sch Med, New York, NY USA
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- Thourani, Vinod H. (författare)
- Piedmont Heart & Vasc Inst, Atlanta, GA USA
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- Carroll, John (författare)
- Univ Colorado, Sch Med, Denver, CO USA
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- Krucoff, Mitchell (författare)
- Duke Clin Res Inst, Box 3126, Durham, NC 27710 USA
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(creator_code:org_t)
- Elsevier, 2022
- 2022
- Engelska.
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Ingår i: Academic pediatrics. - : Elsevier. - 1876-2859 .- 1876-2867. ; 22:3, s. 685-697
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- transcatheter aortic valve replacement
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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Simonato, Matheu ...
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Vemulapalli, Sre ...
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Ben-Yehuda, Ori
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Wu, Changfu
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Wood, Larry
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Popma, Jeff
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visa fler...
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Feldman, Ted
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Krohn, Carole
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Hardy, Karen M.
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Guibone, Kimberl ...
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Christensen, Bar ...
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Alu, Maria C.
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Chen, Shmuel
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Ng, Vivian G.
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Chau, Katherine ...
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Shahim, Bahira
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Vincent, Flavien
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MacMahon, John
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James, Stefan, 1 ...
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Mack, Michael
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Leon, Martin B.
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Thourani, Vinod ...
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Carroll, John
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Krucoff, Mitchel ...
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kardiologi
- Artiklar i publikationen
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Academic pediatr ...
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JACC: Cardiovasc ...
- Av lärosätet
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Uppsala universitet
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Karolinska Institutet