In Reply: As we noted, we stopped our study
after enrollment of 50% of the planned sample size because there was a negligible
likelihood of showing a benefit to weekly courses of corticosteroids in our
sample. Based on our findings after evaluation of 308 women (relative risk
[RR], 0.98; 95% confidence interval [CI], 0.67-1.44) and also 502 women (RR,
0.80; 95% CI, 0.59-1.10), there was only a 7% probability that we would observe
a significant difference in composite morbidity rates, if we recruited our
planned sample size. We do not agree with Dr Jenkins and colleagues that our
event rates were changing dramatically over time or that our assumptions in
performing our conditional power analysis were false. Our trend analysis,
based on cohorts of 100 patients each, is presented in Table 1. No clear pattern emerged. Jenkins et al emphasize the uncertainty
surrounding the use of inferential statistics in a population sample. However,
with a larger sample, preliminary trends suggesting a benefit might have been
reversed. We agree that our decision to prematurely terminate the study resulted
in decreased statistical power to determine the effect of weekly courses.
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