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Understanding the u...
Understanding the use of observational and randomized data in cardiovascular medicine
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- Bowman, Louise (author)
- Univ Oxford, Nuffield Dept Populat Hlth, Oxford, England.
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- Baras, Aris (author)
- Regeneron Pharmaceut, Tarrytown, NY USA.
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- Bombien, Rene (author)
- TUV SUD, Munich, Germany.
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- Califf, Robert M. (author)
- Duke Univ, Div Cardiol, Sch Med, Durham, NC USA.
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- Chen, Zhengmin (author)
- Univ Oxford, Nuffield Dept Populat Hlth, Oxford, England.
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- Gale, Chris P. (author)
- Univ Leeds, Leeds Inst Cardiovasc & Metab Med, Leeds, W Yorkshire, England.
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- Gaziano, J. Michael (author)
- Harvard Med Sch, Brigham & Womens Hosp, Dept Med, VA Boston Healthcare Syst, Boston, MA 02115 USA.
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- Grobbee, Diederick E. (author)
- Univ Med Ctr Utrecht, Div Julius Ctr, Dept Epidemiol, Utrecht, Netherlands.
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- Maggioni, Aldo P. (author)
- European Soc Cardiol, EURObservat Res Programme, Paris, France.;ANMCO Res Ctr, Florence, Italy.
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- Muse, Evan D. (author)
- Scripps Clin, Scripps Res Translat Inst, San Diego, CA USA.
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- Roden, Dan M. (author)
- Vanderbilt Univ, Med Ctr, Dept Med, Nashville, TN USA.;Vanderbilt Univ, Med Ctr, Dept Pharmacol, Nashville, TN 37232 USA.;Vanderbilt Univ, Med Ctr, Dept Biomed Informat, Nashville, TN USA.
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- Schroeder, Stefan (author)
- Bayer AG, Pharmaceut, Berlin, Germany.
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- Wallentin, Lars, 1943- (author)
- Uppsala universitet,Kardiologi
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- Casadei, Barbara (author)
- John Radcliffe Hosp, Radcliffe Dept Med, Div Cardiovasc Med, Level 6,West Wing, Oxford OX3 9DU, England.
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Univ Oxford, Nuffield Dept Populat Hlth, Oxford, England Regeneron Pharmaceut, Tarrytown, NY USA. (creator_code:org_t)
- 2020-02-04
- 2020
- English.
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In: European Heart Journal. - : OXFORD UNIV PRESS. - 0195-668X .- 1522-9645. ; 41:27, s. 2571-2578
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https://academic.oup...
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https://urn.kb.se/re...
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Abstract
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- The availability of large datasets from multiple sources [e.g. registries, biobanks, electronic health records (EHRs), claims or billing databases, implantable devices, wearable sensors, and mobile apps], coupled with advances in computing and analytic technologies, have provided new opportunities for conducting innovative health research. Equally, improved digital access to health information has facilitated the conduct of efficient randomized controlled trials (RCTs) upon which clinical management decisions can be based, for instance, by permitting the identification of eligible patients for recruitment and/or linkage for follow-up via their EHRs. Given these advances in cardiovascular data science and the complexities they behold, it is important that health professionals have clarity on the appropriate use and interpretation of observational, so-called 'real-world', and randomized data in cardiovascular medicine. The Cardiovascular Roundtable of the European Society of Cardiology (ESC) held a workshop to explore the future of RCTs and the current and emerging opportunities for gathering and exploiting complex observational datasets in cardiovascular research. The aim of this article is to provide a perspective on the appropriate use of randomized and observational data and to outline the ESC plans for supporting the collection and availability of clinical data to monitor and improve the quality of care of patients with cardiovascular disease in Europe and provide an infrastructure for undertaking pragmatic RCTs. Moreover, the ESC continues to campaign for greater engagement amongst regulators, industry, patients, and health professionals in the development and application of a more efficient regulatory framework that is able to take maximal advantage of new opportunities for improving the design and efficiency of observational studies and RCT in patients with cardiovascular disease.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Observational studies
- Big data
- Randomized clinical trials
- Electronic health records
- Large prospective cohorts
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Bowman, Louise
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Baras, Aris
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Bombien, Rene
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Califf, Robert M ...
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Chen, Zhengmin
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Gale, Chris P.
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Gaziano, J. Mich ...
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Grobbee, Diederi ...
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Maggioni, Aldo P ...
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Muse, Evan D.
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Roden, Dan M.
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Schroeder, Stefa ...
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Wallentin, Lars, ...
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Casadei, Barbara
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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European Heart J ...
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Uppsala University