RT Journal Article
SR Electronic
T1 Registry-based randomised clinical trial: efficient evaluation of generic pharmacotherapies in the contemporary era
JF Heart
JO Heart
FD BMJ Publishing Group Ltd and British Cardiovascular Society
SP 1562
OP 1567
DO 10.1136/heartjnl-2017-312322
VO 104
IS 19
A1 Troels Yndigegn
A1 Robin Hofmann
A1 Tomas Jernberg
A1 Chris P Gale
YR 2018
UL http://heart.bmj.com/content/104/19/1562.abstract
AB 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.