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How do you do the box around someone else's text?

I really don't understand the point of treating healthy people? Maybe venography to compare the actual status of their veins but I don't know how many people are going to sign up for that test. Are they making it so uncomfortable for healthy people that there won't be any volunteers so no trials?
I had high hopes for the Sask gov't proposal for trials but that's on hold now and I had high hopes for Manitoba but I fear we are going the same route as Sask.

munchkin wrote:How do you do the box around someone else's text?

Click on quote in the upper right hand corner of the post you're replying to.

I really don't understand the point of treating healthy people? Maybe venography to compare the actual status of their veins but I don't know how many people are going to sign up for that test. Are they making it so uncomfortable for healthy people that there won't be any volunteers so no trials?
I had high hopes for the Sask gov't proposal for trials but that's on hold now and I had high hopes for Manitoba but I fear we are going the same route as Sask.

I agree. Seems like a sham already. Let's hope we're wrong.

Thanks for the help.

I agree with you and hope they prove that we had nothing to fear.

In Buffalo they called it phase 1 when they had 10 MS patients getting the procedure, fully knowing they were getting it, to check for safety. Then phase 2 was another 20 patients randomized so that there was a sham group and an actually treated group. No need to treat healthy volunteers! Especially when MS patients go wanting.

Cece wrote:In Buffalo they called it phase 1 when they had 10 MS patients getting the procedure, fully knowing they were getting it, to check for safety. Then phase 2 was another 20 patients randomized so that there was a sham group and an actually treated group. No need to treat healthy volunteers! Especially when MS patients go wanting.

Now, that approach makes sense! I'm willing to be the first in line to test the safety. Except for MS, I'm perfectly healthy. I know 75,000 other Canadians also want to be first. Let's do the safety testing on someone with MS.

Clinical trials of CCSVI venoplasty procedures:

1. Health:
Healthy volunteers would be needed to test prevalence. What is needed here is a reliable diagnosis of CCSVI. If the IR or Vascular surgeon has been trained in Ferrara, or has a pedigree that is traceable to Ferrara, that should be no problem. Failing that, diagnosis could happen once the procedure is underway, assuming a high (8 or 9/10) rate, and informed consent has been obtained from definite MS sufferers.

Diagnosis of MS will have to be accepted, even though there is a high rate of misdiagnosis.

2. Sham Procedure Controls:
Testing for efficacy requires a sham procedure. Since the wound is slight, it should be possible to do a sham procedure without even entering a blood vessel if the subject is sufficiently sedated. The service of a good anesthesiologist should make it possible to make a small cut and bandage it, keeping subjects under sedation for a time which is randomly chosen between 45 minutes and 1.25 hours. The difference to a patient who was not conscious during the procedure will be limited to the effect on symptoms.

3. Placebo/sham termination:
Consensus should be reached in advance on a length of time Tr for results to appear. Whether and how to treat re-occurrence of symptoms should be left to the patient-doctor conversation. However, after the time Tr, having been consensually agreed upon between neurologists, vascular surgeons and interventional radiologists, the sham patients should be offered real venoplasty. Longer terms of efficacy should be tested without benefit of a sham cohort, since time is of the essence in treating progressive disease, MS has progression even before it is symptomatic, and it is never progression-free even during remission.

4. Substitute controls in longer trials:
If necessary, age, time-since-diagnosis, and/or disability matched controls can be substituted for sham patients who have been treated, to control for longer-term efficacy, as long as information has been collected over the time since the beginning of the trial, about relapse and/or progression of those matched controls.

That means a rigorous collection of this control information should have been done, starting now for any patients who intend to make themselves available as trial subjects. It should continue at appropriate intervals, until these patients either withdraw from candidacy, or are treated outside of a CCSVI trial, regardless of whether or when they enter one. It might be appropriate for the pertinent professions to come to some consensus on the nature, and schedule for collection of this data, as soon as possible. It should include as much as possible of the data collected in trials. Standards would be useful, such as EDSS and MSFC scores.

5. Placebo limits:
There is a limited time beyond which placebo is either ineffective or should be considered to have no more possibility of confounding the result. This time limit should be agreed in advance as well.