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I found that 0 of 63 patients responded to an alternative therapy, but when I submitted the paper for publication, they said I needed a statistical test. Why do I need a statistical test for this, and what is the best way to respond to the reviewers?

The bigger question, if you are meaning to address questions of relative efficacy, is what is your control group? Data from a single-arm trial are not useful for establishing efficacy or lack thereof unless results from the comparator are known to a high degree of precision and you have faith that the patients entering your study are very similar to those in the comparator studies. But I sense however that you are only trying to establish that the alternative therapy is not looking good by itself in the types of patients treated. Then a statistical test is not called for but a confidence interval is. Here the 3/N rule comes into play because of the zero. The upper 95% confidence limit for the probability of response is close to 3/63 = 0.048. The Wilson (a method that is generally more accurate than the so -called "exact" binomial method) confidence limits are [0, 0.057] which in this case happens to equal the "exact" limits. You can be, loosely speaking, be 95% confident that the unknown probability of response to alternative therapy in the types of patients you studied is <= than 0.057.

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Topic revision: r2 - 05 Aug 2011 - 10:28:35 - MaryBanach

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