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J Thorac Cardiovasc Surg 1997;114:146-147
© 1997 Mosby, Inc.
LETTERS TO THE EDITOR |
The Bristol Heart Instituteb
To the Editor:
We agree happily with virtually all of Professor Treasure's commentary following our paper.
1 Indeed, our agreement is already explicit in the text. We planned and executed a randomized controlled study within pre-recognized externally applied constraints on numbers. We considered the available outcome measures and concluded that none would provide sufficient power to detect differences of any interesting size with the numbers available. We welcome the consensus of experts that has taken place since our study was planned and completed, but know that the consensus is as much a way of sharing responsibility for error as a guaranteed pathway to truth. With the information available at the time, we made a prospective choice of an outcome measure that should logically have been more sensitive than existing ones and declared it to be our primary measure. No pilot data were available on this measure that could have informed prospective power calculations. It proved, in any case, to have enough power to detect an interesting difference with 95% confidence, although we made no secret of our doubt as to the clinical meaning of the difference. We identified the further analysis as being subsidiary, to inform further studies on the problems of this nature.
Nowhere did we use our results to draw inferences about stroke rate. Nowhere did we draw any conclusions about safety. Our concluding sentence remarked that our results, and the absence of any separate demonstration of benefit, provided little incentive to recommend the routine use of normothermic systemic perfusion (instead of the more established hypothermic conditions that in any case tend to come about by default). We completed our ongoing study of the effects of normothermic systemic perfusion on other organ systems 2-5 but no longer use it routinely.
The best "comic operas" need an element of tragedy. It often lies in the fact that the protagonists do not know whether and how much they agree.
References
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