drsclafani wrote:I made four major points
3. I argued that demands for a randomized trial were very premature if needed at all. i showed them the diagnostic challenges, the laack of clarity about the type, size, duration of balloon angioplasty, the unclear role of doppler, MRV, venography etc made it very unclear what represented best practice. without that knowledge we cannot compare liberation to durgs or to sham, etc. I gave countless examples of the confusing issues and numerous examples of bizarre veins
Dr. S. several months ago you were suggesting that anyone getting treatment, if at all possible, should do so only in a study. Have you changed tht view?
I thnk I agree with you. Several of us in this forum have tried to figure out how to structure a study to obtain meaningful data, and with the variety of the conditions and the difficulty and variability of the condition, and the fact tht this is a surgical, mechanical intervention not a drug, that has been almost impossible, not to mention the difficulty in blinding the study. Do you have any suggetions for the structure of a study at this time?
No, I have not changed my mind. All patients should contribute to the furthering of this concept
step 1: proof of concept
step 2 open label cohort studies
step 3 small trials, registries
step 4 randomized prospective trials, possibly with placebo control
I think that patients should be part of studies, not necessarily that they need to be part of a randomized trial . First we have to figure out what is best practice