TY - JOUR
T1 - 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)
AU - Hallstrom, Al
AU - Friedman, Lawrence
AU - Denes, Pablo
AU - Rizo-Patron, Carlos
AU - Morris, Mary
N1 - Funding Information:
This work was supported in part by contracts (NO1-HC-25117 and NO1-HC-65042) with the National Heart, Lung, and Blood Institute, Bethesda, Maryland.
PY - 2003/6
Y1 - 2003/6
N2 - 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.
AB - 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.
KW - Enrollees and nonenrollees
KW - Patient participants
KW - Randomized clinical trials
KW - Trial participants
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U2 - 10.1016/S0197-2456(03)00002-3
DO - 10.1016/S0197-2456(03)00002-3
M3 - Article
C2 - 12757998
AN - SCOPUS:0038030987
SN - 0197-2456
VL - 24
SP - 341
EP - 352
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
IS - 3
ER -