Lyon wrote:Have a surgeon or group of surgeons perform the operation/sham and then remove them from farther participation in the trial....DON'T use stents as they would show up on imaging and ruin the blind.
Will someone who really knows weigh in? I don't think sham surgery can ever be done ethically. Surgery, especially if it involves anesthesia, always has some risk, and if there is guaranteed no benefit because the surgery is sham, then it is unethical to subject the patient to that risk, however minor.
In a company where I was recently on Sr. staff, we conducted a surgical trial to determine the efficacy of a catheter treatment, similar to a stent. Here is how we did the double blind type studyl to get scientifically valid data: We enrolled the patients in the study. They read and signed the informed consent. Then an envelope was chose at random that had either treatment or non-treatment arm in the sealed envelope. Half (or some percentage) of the patients enrolled were in the treatment arm, and the rest were in the non-treatment arm. At the end of the study the results were compared to see if the treatment resulted in a significant improvement.
This way the patients were segregated at random, and the results were compared.
This could be done here as follows: MS patients would be informed of the details of the study, and would agree to participate. (This would include an agreement NOT to get treatment if their envelope was a non-treatment envelope). They would then be tested for CCSVI. If they had it, half (or some percentage) would be designated at random to be in the treatment arm, and the rest would be designated to be in the noin-treatment arm. After the study, the results would be compared. I can imagine the primary endpoint could be.... relapses over a one year period. (this would mean a one year study) New lesions over the one year perioud (again a one year period) or progression (this would either have to be over a longer period or involve a very large number of participants.) Statistician can determine going in how many participants you need depending on the thing to be measured and the length of time of the study to get to statistical significance. The more frequent or dramatic the event to be measured and the more participants, the shorter the study can be.