Dr. Behfar Ehdaie

So it was very clear to us that reducing the burden at the time of consent actually created more informed consent, less anxiety, and increase our enrollment into clinical trials. And so that was the next pearl, which was to really take the concept of the standard randomized controlled trial discussion and modify it to this integrated trial if you're comparing it to a standard of care procedure.

Yeah. I mean, the second consent is a full consent conversation, but directed at the actual intervention without really... clouding that with the information from standard of care. So you can now even imagine not just looking at, let's say in this case was a mindfulness approach. You can consent all biopsy patients in your institution.

Yeah. I mean, the second consent is a full consent conversation, but directed at the actual intervention without really... clouding that with the information from standard of care. So you can now even imagine not just looking at, let's say in this case was a mindfulness approach. You can consent all biopsy patients in your institution.

Yeah. I mean, the second consent is a full consent conversation, but directed at the actual intervention without really... clouding that with the information from standard of care. So you can now even imagine not just looking at, let's say in this case was a mindfulness approach. You can consent all biopsy patients in your institution.

And now instead of just having a mindfulness intervention, let's say you want to compare Flomax versus no Flomax for all patients. So that could be a secondary randomization that's also occurring in the background. So you can approach a patient and say, Oh, by the way, there's two things that we think may benefit you. The first is we'll put this tape on and you listen to it during the procedure.

And now instead of just having a mindfulness intervention, let's say you want to compare Flomax versus no Flomax for all patients. So that could be a secondary randomization that's also occurring in the background. So you can approach a patient and say, Oh, by the way, there's two things that we think may benefit you. The first is we'll put this tape on and you listen to it during the procedure.

And now instead of just having a mindfulness intervention, let's say you want to compare Flomax versus no Flomax for all patients. So that could be a secondary randomization that's also occurring in the background. So you can approach a patient and say, Oh, by the way, there's two things that we think may benefit you. The first is we'll put this tape on and you listen to it during the procedure.

And the other one is this medication that we would put you on afterwards to see if it reduces your risk of urinary retention. The point being is each one of those are separate outcomes. One's looking at pain, one's looking at urinary retention rates. They're separate. They're not going to interact with one another.

And the other one is this medication that we would put you on afterwards to see if it reduces your risk of urinary retention. The point being is each one of those are separate outcomes. One's looking at pain, one's looking at urinary retention rates. They're separate. They're not going to interact with one another.

And the other one is this medication that we would put you on afterwards to see if it reduces your risk of urinary retention. The point being is each one of those are separate outcomes. One's looking at pain, one's looking at urinary retention rates. They're separate. They're not going to interact with one another.

Now you have multiple randomizations occurring, and your standard of care group is still the standard of care. So that's your control group. So you're basically, in many ways, creating multiple trials within a large cohort. This was initially described by Dr. Rawlings years ago called multiple trials and cohorts trials. The problem was is that... It was still randomized trials.

Now you have multiple randomizations occurring, and your standard of care group is still the standard of care. So that's your control group. So you're basically, in many ways, creating multiple trials within a large cohort. This was initially described by Dr. Rawlings years ago called multiple trials and cohorts trials. The problem was is that... It was still randomized trials.

Now you have multiple randomizations occurring, and your standard of care group is still the standard of care. So that's your control group. So you're basically, in many ways, creating multiple trials within a large cohort. This was initially described by Dr. Rawlings years ago called multiple trials and cohorts trials. The problem was is that... It was still randomized trials.

You still had the regulatory features, the clutteredness of follow-up. But what we decided was we will do this two-stage consent and combine it with our clinically integrated trials, meaning we're still collecting this patient's data and information outcomes as part of routine care anyway. So there's no incremental cost after that initial setup of all these measurements for each additional patient.

You still had the regulatory features, the clutteredness of follow-up. But what we decided was we will do this two-stage consent and combine it with our clinically integrated trials, meaning we're still collecting this patient's data and information outcomes as part of routine care anyway. So there's no incremental cost after that initial setup of all these measurements for each additional patient.

You still had the regulatory features, the clutteredness of follow-up. But what we decided was we will do this two-stage consent and combine it with our clinically integrated trials, meaning we're still collecting this patient's data and information outcomes as part of routine care anyway. So there's no incremental cost after that initial setup of all these measurements for each additional patient.

So we were able to run the secondary trial of the headphone study. We enrolled 280 patients in one year, published that data recently. And again, the cost was just the cost of getting the trial up and running. Everything else was part of our standard of care. This was a randomized control trial. For your information, it did not show a benefit in mindfulness for patients.

So we were able to run the secondary trial of the headphone study. We enrolled 280 patients in one year, published that data recently. And again, the cost was just the cost of getting the trial up and running. Everything else was part of our standard of care. This was a randomized control trial. For your information, it did not show a benefit in mindfulness for patients.

So we were able to run the secondary trial of the headphone study. We enrolled 280 patients in one year, published that data recently. And again, the cost was just the cost of getting the trial up and running. Everything else was part of our standard of care. This was a randomized control trial. For your information, it did not show a benefit in mindfulness for patients.

I think the discomfort was still uncomfortable. Of course, we transitioned to transperineal biopsies in clinic now, which are its own challenge. But the point is, we were able to run a trial again, low cost, greater cruel. And remember, when you talk about a cruel, I don't think of just about a cruel for a trial. I think of it as from the perspective of access.