 |
|
Study Power in the SORT OUT II Trial—Reply
|
|
| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
|
|
|
In Reply: Dr Kaneda is correct. In the original version of the SORT OUT II study protocol, we hypothesized major adverse cardiac event (MACE) rates of 20% over 5 years and selected a 25% relative reduction of MACE rates as the minimal relevant difference, which required randomization of 1800 patients (2-sided P < .05; study power, 0.80). The protocol also prespecified an interim analysis after 9 months. At this earlier time point, the event rate must be smaller than after 5 years. The event curves were expected to be curvilinear with an initial steep rise in events followed by a smaller slope, and we assumed a 9-month MACE rate of 10.0% and a relative difference of 25% (ie, 7.5% vs 10%), assumptions that would have required randomization of 4006 patients to achieve the same power.
This sample size was not feasible, and we therefore considered either omitting the interim analysis and . . . [Full Text of this Article]
Anders Michael Galløe, MD
anders@galloe.dk
Niels Bligaard, MD;
Peter Riis Hansen, MD
Department of Cardiology
Gentofte University Hospital
Copenhagen, Denmark
RELATED ARTICLE
Comparison of Paclitaxel- and Sirolimus-Eluting Stents in Everyday Clinical Practice: The SORT OUT II Randomized Trial
Anders M. Galløe, Leif Thuesen, Henning Kelbæk, Per Thayssen, Klaus Rasmussen, Peter R. Hansen, Niels Bligaard, Kari Saunamäki, Anders Junker, Jens Aarøe, Ulrik Abildgaard, Jan Ravkilde, Thomas Engstrøm, Jan S. Jensen, Henning R. Andersen, Hans E. Bøtker, Søren Galatius, Steen D. Kristensen, Jan K. Madsen, Lars R. Krusell, Steen Z. Abildstrøm, Ghita B. Stephansen, Jens F. Lassen, and for the SORT OUT II Investigators
JAMA. 2008;299(4):409-416.
ABSTRACT
| FULL TEXT
RELATED LETTER
Study Power in the SORT OUT II Trial
Hideaki Kaneda
JAMA. 2008;299(17):2021-2022.
EXTRACT
| FULL TEXT
|
