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Minimum Core Data E...
Minimum Core Data Elements for Transcatheter Mitral Therapies : Scientific Statement by PASSION CV, HVC, and TVTR
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- Vemulapalli, Sreekanth (författare)
- Duke Univ Hlth, Duke Clin Res Inst, Durham, NC USA.
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- Simonato, Matheus (författare)
- Yale Sch Med, New Haven, CT USA.
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- Ben Yehuda, Ori (författare)
- Univ Calif San Diego, San Diego, CA 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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- Feldman, Ted (författare)
- Edwards Lifesci, Irvine, CA USA.
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- Popma, Jeffrey J. (författare)
- Medtronic Inc, Minneapolis, MN USA.
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- Sundareswaren, Kartik (författare)
- Abbott Vasc, St Rosa, 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 Deaconness Med Ctr, Boston, MA 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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- Ng, Vivian G. (författare)
- Columbia Univ, Irving Med Ctr, New York, NY USA.
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- Chau, Katherine H. (författare)
- Columbia Univ, Irving Med Ctr, New York, NY USA.
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- Chen, Shmuel (författare)
- New York Presbyterian, Cornell Weill Med Ctr, 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,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
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- Mack, Michael (författare)
- Baylor Scott & White, Plano, TX USA.
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- Leon, Martin B. (författare)
- Columbia Univ, Irving Med Ctr, 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 W. (författare)
- Duke Univ Hlth, Duke Clin Res Inst, Durham, NC USA.
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Duke Univ Hlth, Duke Clin Res Inst, Durham, NC USA Yale Sch Med, New Haven, CT USA. (creator_code:org_t)
- Elsevier, 2023
- 2023
- Engelska.
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Ingår i: JACC. - : Elsevier. - 1936-8798 .- 1876-7605. ; 16:12, s. 1437-1447
- Relaterad länk:
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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
- Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/ American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, 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
- core data elements
- harmonization
- transcatheter mitral valve repair
- transcatheter mitral valve replacement
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- Av författaren/redakt...
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Vemulapalli, Sre ...
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Simonato, Matheu ...
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Ben Yehuda, Ori
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Wu, Changfu
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Feldman, Ted
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Popma, Jeffrey J ...
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Sundareswaren, K ...
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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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Ng, Vivian G.
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Chau, Katherine ...
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Chen, Shmuel
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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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- MEDICIN OCH HÄLSOVETENSKAP
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och Klinisk medicin
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och Kardiologi
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JACC
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Uppsala universitet
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Karolinska Institutet