PMID: 12757998May 22, 2003Paper

Do arrhythmia patients improve survival by participating in randomized clinical trials? Observations from the Cardiac Arrhythmia Suppression Trial (CAST)and the Antiarrhythmics Versus Implantable Defibrillators Trial (AVID)

Controlled Clinical Trials
A P HallstromAVID Investigators

Abstract

It is debatable whether patients benefit directly from participation in a randomized clinical trial. We attempt to address this question for participants in the Cardiac Arrhythmia Suppression Trial (CAST) and the Antiarrhythmics Versus Implantable Defibrillators (AVID) studies. Survival rates were compared between eligible patients who enrolled in the trials and eligible patients who did not enroll, adjusting for baseline covariates. In CAST, despite that the active therapy was found to confer an almost threefold increased risk of death, survival was similar between the 3163 enrolled and the 1363 nonenrolled eligible patients. However, when patients were under study management, their risk of death was approximately 20% lower than when they left study management. In AVID, overall survival was similar between the 1016 enrolled and the 1246 nonenrolled eligible patients. However, mortality was substantially higher among patients not enrolled because the referring physician mandated the type of therapy. Overall these observational analyses suggest a net improvement in survival for the participants in these two trials.

References

Jul 23, 1992·The New England Journal of Medicine·UNKNOWN Cardiac Arrhythmia Suppression Trial II Investigators
Aug 10, 1989·The New England Journal of Medicine·UNKNOWN Cardiac Arrhythmia Suppression Trial (CAST) Investigators
Jun 1, 1985·Controlled Clinical Trials·M E MattsonR McArdle
Feb 1, 1993·British Journal of Clinical Pharmacology·E G BevanG T McInnes
Dec 31, 1997·The New England Journal of Medicine·UNKNOWN Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators
Dec 3, 1998·International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care·F W VerheggenG J Kok
Feb 27, 2001·Journal of Clinical Epidemiology·D A BraunholtzR J Lilford
Mar 1, 2002·The New England Journal of Medicine·Robert Steinbrook

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Citations

Nov 22, 2013·The American Journal of Bioethics : AJOB·John D Lantos
Sep 21, 2011·QJM : Monthly Journal of the Association of Physicians·C D ChueC J Ferro
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