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Leveraging electron...
Leveraging electronic health records to streamline the conduct of cardiovascular clinical trials
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- Khan, Muhammad Shahzeb (författare)
- Duke Univ, Div Cardiol, Sch Med, 2301 Erwin Rd, Durham, NC 27705 USA.
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- Usman, Muhammad Shariq (författare)
- Univ Mississippi, Dept Med, Med Ctr, 2500 N State St, Jackson, MS 39216 USA.
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- Talha, Khawaja M. (författare)
- Univ Mississippi, Dept Med, Med Ctr, 2500 N State St, Jackson, MS 39216 USA.
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- Van Spall, Harriette G. C. (författare)
- McMaster Univ, Dept Med, Hamilton, ON, Canada.;McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada.;Populat Hlth Res Inst, Hamilton, ON, Canada.
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- Greene, Stephen J. (författare)
- Duke Univ, Div Cardiol, Sch Med, 2301 Erwin Rd, Durham, NC 27705 USA.;Duke Clin Res Inst, Durham, NC USA.
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- Vaduganathan, Muthiah (författare)
- Harvard Med Sch, Brigham & Womens Hosp, Cardiovasc Div, Boston, MA USA.
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- Khan, Sadiya S. (författare)
- Northwestern Univ, Dept Prevent Med, Feinberg Sch Med, Chicago, IL USA.
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- Mills, Nicholas L. (författare)
- Univ Edinburgh, Royal Infirm Edinburgh, BHF Ctr Cardiovasc Sci, Chancellors Bldg, Edinburgh, Scotland.;Univ Edinburgh, Usher Inst, Edinburgh, Scotland.
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- Ali, Ziad A. (författare)
- St Francis Hosp & Heart Ctr, DeMatteis Cardiovasc Inst, Roslyn, NY USA.
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- Mentz, Robert J. (författare)
- Duke Univ, Div Cardiol, Sch Med, 2301 Erwin Rd, Durham, NC 27705 USA.;Duke Clin Res Inst, Durham, NC USA.
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- Fonarow, Gregg C. (författare)
- Univ Calif Los Angeles, Div Cardiol, Los Angeles, CA USA.
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- Rao, Sunil, V (författare)
- NYU, Div Cardiol, Langone Hlth Syst, New York, NY USA.
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- Spertus, John A. (författare)
- St Lukes Mid Amer Heart Inst, Dept Cardiol, Kansas City, MO USA.;Univ Missouri, Kansas Citys Healthcare Inst Innovat Qual, Kansas City, MO USA.
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- Roe, Matthew T. (författare)
- Duke Univ, Div Cardiol, Sch Med, 2301 Erwin Rd, Durham, NC 27705 USA.;Duke Clin Res Inst, Durham, NC USA.
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- Anker, Stefan D. (författare)
- Charite, Berlin Inst Hlth Ctr Regenerat Therapies BCRT, Dept Cardiol CVK, Berlin, Germany.;Charite, German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany.
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- James, Stefan, 1964- (författare)
- Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
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- Butler, Javed (författare)
- Univ Mississippi, Dept Med, Med Ctr, 2500 N State St, Jackson, MS 39216 USA.;Baylor Scott & White Res Inst, Dallas, TX USA.
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- McGuire, Darren K. (författare)
- UT Southwestern Med Ctr & Parkland Hlth & Hosp Sy, Dept Internal Med, Div Cardiol, Dallas, TX USA.
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Duke Univ, Div Cardiol, Sch Med, 2301 Erwin Rd, Durham, NC 27705 USA Univ Mississippi, Dept Med, Med Ctr, 2500 N State St, Jackson, MS 39216 USA. (creator_code:org_t)
- Oxford University Press, 2023
- 2023
- Engelska.
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Ingår i: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 44:21, s. 1890-1909
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Conventional randomized controlled trials (RCTs) can be expensive, time intensive, and complex to conduct. Trial recruitment, participation, and data collection can burden participants and research personnel. In the past two decades, there have been rapid technological advances and an exponential growth in digitized healthcare data. Embedding RCTs, including cardiovascular outcome trials, into electronic health record systems or registries may streamline screening, consent, randomization, follow-up visits, and outcome adjudication. Moreover, wearable sensors (i.e. health and fitness trackers) provide an opportunity to collect data on cardiovascular health and risk factors in unprecedented detail and scale, while growing internet connectivity supports the collection of patient-reported outcomes. There is a pressing need to develop robust mechanisms that facilitate data capture from diverse databases and guidance to standardize data definitions. Importantly, the data collection infrastructure should be reusable to support multiple cardiovascular RCTs over time. Systems, processes, and policies will need to have sufficient flexibility to allow interoperability between different sources of data acquisition. Clinical research guidelines, ethics oversight, and regulatory requirements also need to evolve. This review highlights recent progress towards the use of routinely generated data to conduct RCTs and discusses potential solutions for ongoing barriers. There is a particular focus on methods to utilize routinely generated data for trials while complying with regional data protection laws. The discussion is supported with examples of cardiovascular outcome trials that have successfully leveraged the electronic health record, web-enabled devices or administrative databases to conduct randomized trials.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- Registry
- Electronic health record
- Digitization
- Wearable
- RCT
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- Av författaren/redakt...
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Khan, Muhammad S ...
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Usman, Muhammad ...
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Talha, Khawaja M ...
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Van Spall, Harri ...
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Greene, Stephen ...
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Vaduganathan, Mu ...
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visa fler...
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Khan, Sadiya S.
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Mills, Nicholas ...
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Ali, Ziad A.
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Mentz, Robert J.
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Fonarow, Gregg C ...
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Rao, Sunil, V
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Spertus, John A.
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Roe, Matthew T.
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Anker, Stefan D.
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James, Stefan, 1 ...
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Butler, Javed
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McGuire, Darren ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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European Heart J ...
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Uppsala universitet