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Bayesian Analysis and the GUSTO Trial

Bayesian Analysis and the GUSTO Trial To the Editor. —Drs Brophy and Joseph1 suggest that GUSTO2 does not directly address which thrombolytic strategy is superior and that the large sample size used enabled a statistically significant but not clinically meaningful difference to be detected. Using a Bayesian analysis, they conclude that the clinical superiority of t-PA over SK remains uncertain. The rationale and interpretation of their Bayesian approach are greatly flawed for the following reasons: Thrombolytic treatment (vs placebo) has resulted in a 2.6% absolute reduction in mortality; an additional 1.0% achieved with a better thrombolytic strategy in GUSTO is impressive. This a priori definition of a clinically meaningful difference, which Brophy and Joseph label as "arbitrary," was also consistent with the design goals and sample sizes of the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI-2) trial3 and the Third International Study of Infarct Survival (ISIS-3) trial.4The three trials http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Bayesian Analysis and the GUSTO Trial

Goodman, Shaun; Langer, Anatoly
JAMA , Volume 274 (11) – Sep 20, 1995
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References (5)

Publisher
American Medical Association
Copyright
Copyright © 1995 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.1995.03530110035029
Publisher site
See Article on Publisher Site

Abstract

To the Editor. —Drs Brophy and Joseph1 suggest that GUSTO2 does not directly address which thrombolytic strategy is superior and that the large sample size used enabled a statistically significant but not clinically meaningful difference to be detected. Using a Bayesian analysis, they conclude that the clinical superiority of t-PA over SK remains uncertain. The rationale and interpretation of their Bayesian approach are greatly flawed for the following reasons: Thrombolytic treatment (vs placebo) has resulted in a 2.6% absolute reduction in mortality; an additional 1.0% achieved with a better thrombolytic strategy in GUSTO is impressive. This a priori definition of a clinically meaningful difference, which Brophy and Joseph label as "arbitrary," was also consistent with the design goals and sample sizes of the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI-2) trial3 and the Third International Study of Infarct Survival (ISIS-3) trial.4The three trials

Journal

JAMA – American Medical Association

Published: Sep 20, 1995

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