Moving the goalposts into unblinded territory: lessons of DEFER and FAME 2 and their implications for shifting end points in ISCHEMIA
Author(s)
Rajkumar, Christopher A
Nijjer, Sukhjinder S
Cole, Graham D
Al-Lamee, Rasha
Francis, Darrel P
Type
Journal Article
Abstract
At its conception, a randomized controlled trial is carefully designed to detect a significant effect of an intervention on a prespecified primary end point. Each aspect of a trial is deliberately constructed to allow it to answer this principal question. From the moment the first patient is recruited, the primary end point is fixed, and all other outcomes are considered secondary.
Date Issued
2018-03-01
Date Acceptance
2018-03-01
Citation
Circulation: Cardiovascular Quality and Outcomes, 2018, 11 (3)
ISSN
1941-7705
Publisher
American Heart Association
Journal / Book Title
Circulation: Cardiovascular Quality and Outcomes
Volume
11
Issue
3
Copyright Statement
© 2018 American Heart Association, Inc. This is a non-final version of an article published in final form in Circulation: Cardiovascular Quality and Outcomes at https://dx.doi.org/10.1161/CIRCOUTCOMES.118.004665
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
bias
coronary artery disease
clinical trials
percutaneous coronary intervention
FRACTIONAL FLOW RESERVE
MEDICAL THERAPY
GUIDED PCI
DISEASE
MODERATE
Publication Status
Published
Article Number
e004665
Date Publish Online
2018-03-12