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Registry-based randomised clinical trial : Efficient evaluation of generic pharmacotherapies in the contemporary era

Yndigegn, Troels LU ; Hofmann, Robin ; Jernberg, Tomas and Gale, Chris P. (2018) In Heart 104(19). p.1562-1567
Abstract

Randomised clinical trials are the gold standard for testing the effectiveness of clinical interventions. However, increasing complexity and associated costs may limit their application in the investigation of key cardiovascular knowledge gaps such as the re-evaluation of generic pharmacotherapies. The registry-based randomised clinical trial (RRCT) leverages data sampling from nationwide quality registries to facilitate high participant inclusion rates at comparably low costs and, therefore, may offer a mechanism by which such clinical questions may be answered. To date, a number of studies have been conducted using such trial designs, but uncritical use of the RRCT design may lead to erroneous conclusions. The current review provides... (More)

Randomised clinical trials are the gold standard for testing the effectiveness of clinical interventions. However, increasing complexity and associated costs may limit their application in the investigation of key cardiovascular knowledge gaps such as the re-evaluation of generic pharmacotherapies. The registry-based randomised clinical trial (RRCT) leverages data sampling from nationwide quality registries to facilitate high participant inclusion rates at comparably low costs and, therefore, may offer a mechanism by which such clinical questions may be answered. To date, a number of studies have been conducted using such trial designs, but uncritical use of the RRCT design may lead to erroneous conclusions. The current review provides insights into the strengths and weaknesses of the RRCT, as well as provides an exploratory example of how a trial may be designed to test the long-term effectiveness of beta blockers in patients with myocardial infarction who have preserved left ventricular systolic function.

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author
; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Acute Myocardial Infarction, Electronic Medical Records, Pharmacology, Study Design
in
Heart
volume
104
issue
19
pages
1562 - 1567
publisher
BMJ Publishing Group
external identifiers
  • scopus:85049152888
  • pmid:29666176
ISSN
1355-6037
DOI
10.1136/heartjnl-2017-312322
language
English
LU publication?
yes
id
c49536e1-3272-4b84-8300-1deb88681ea1
date added to LUP
2018-07-17 10:02:30
date last changed
2020-09-23 07:08:08
@article{c49536e1-3272-4b84-8300-1deb88681ea1,
  abstract     = {<p>Randomised clinical trials are the gold standard for testing the effectiveness of clinical interventions. However, increasing complexity and associated costs may limit their application in the investigation of key cardiovascular knowledge gaps such as the re-evaluation of generic pharmacotherapies. The registry-based randomised clinical trial (RRCT) leverages data sampling from nationwide quality registries to facilitate high participant inclusion rates at comparably low costs and, therefore, may offer a mechanism by which such clinical questions may be answered. To date, a number of studies have been conducted using such trial designs, but uncritical use of the RRCT design may lead to erroneous conclusions. The current review provides insights into the strengths and weaknesses of the RRCT, as well as provides an exploratory example of how a trial may be designed to test the long-term effectiveness of beta blockers in patients with myocardial infarction who have preserved left ventricular systolic function.</p>},
  author       = {Yndigegn, Troels and Hofmann, Robin and Jernberg, Tomas and Gale, Chris P.},
  issn         = {1355-6037},
  language     = {eng},
  month        = {04},
  number       = {19},
  pages        = {1562--1567},
  publisher    = {BMJ Publishing Group},
  series       = {Heart},
  title        = {Registry-based randomised clinical trial : Efficient evaluation of generic pharmacotherapies in the contemporary era},
  url          = {http://dx.doi.org/10.1136/heartjnl-2017-312322},
  doi          = {10.1136/heartjnl-2017-312322},
  volume       = {104},
  year         = {2018},
}