The study was designed to give us some confidence that the observations we're making are reproducible. Remember it was designed before we had any prospective data and before we knew the quantitative effect on CPSI of the prostatectomy.
With this in mind, we wanted to some extent "homogenize" the patient population. So for example, we are excluding men who speak only Russian. Why? Because among other things we do not have Russian speaking staff that can give informed consent. Likewise, we do not have a validated Russian version of the CPSI and would have no confidence that their reports are on the same questions the English speaking patients are answering.
Remember that we had no idea about the theoretical association of age with treatment effect. So if some age cohorts were less responsive than others, this might have weakened our ability to make a statistically significant observation. We know today that the effect is actually substantial, but we didn't know it them.
There is another consideration about age, which has to do not only with maturity but also fertility. We want to be slow to remove prostates from men of child bearing ages. This is obviously a somewhat random selection. I think many of us would agree that we should not be doing prostatectomy for teebagers. Somewhere between age 18 and old age is a "reasonable" minimal age. In any event, I advise all patients that prostatectomy causes infertility and remind those who still may want children that they absolutely must bank some sperm first.
Finally, you do not have to be in the study to be treated. So a Russian speaker and a 29-year old English speaker can still have treatment. It's just that we will not include them in the study and we will not include their reports in the pooled analysis that the study will report.
Please let me know if you have any questions.
Thank you again.
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