How can we design a trial to test efficacy of the surgery?

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Postby frodo » Thu May 13, 2010 3:52 pm

CureIous wrote:
That's precisely how Stanford is proposing to structure their study. The patient won't know if the balloon was fully inflated or not. All patients post-study that were in the "non-inflated" category will then have the option of getting the real deal. Simple and eloquent.
Mark


That is not better than to use restenosis as controls. How would you know if somebody gets a restenosis one day after treatment? You will have to wait a pre-defined period or until he request a new test to find the restenosis, and then he should be removed from the "treatement arm".

Then, why not treat everybody and just compare the de-stenosed and the restenosis groups? We only need to prove that blood flow affects the health of MS patients.
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Postby NZer1 » Thu May 13, 2010 4:12 pm

I agree with frodo, there is too much risk of confusing the purpose of CCSVI treatment and clouding the chances of people being treated.
The study of what the treatment specifically achieves is in the future. Get the treatment safety sorted first and start treating. Yes there is a huge learning curve and the more experience gained and challenges overcome, techniques evolving, testing improved will occur naturally.
The outcomes for people treated in time may be better than the initial people but most importantly progress will begin, especially for those in high need now for treatment that will effect their MS whether there is links is not important at this early stage.
Quality of life is the outcome!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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Postby CureIous » Thu May 13, 2010 9:37 pm

NZer1 wrote:I agree with frodo, there is too much risk of confusing the purpose of CCSVI treatment and clouding the chances of people being treated.
The study of what the treatment specifically achieves is in the future. Get the treatment safety sorted first and start treating. Yes there is a huge learning curve and the more experience gained and challenges overcome, techniques evolving, testing improved will occur naturally.
The outcomes for people treated in time may be better than the initial people but most importantly progress will begin, especially for those in high need now for treatment that will effect their MS whether there is links is not important at this early stage.
Quality of life is the outcome!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!


I doubt a couple months is going to make a drastic difference either way.
Without double blinding, forget about achieving any scientific legitimacy, and this stays fringe for the foreseeable future. It will be categorically written off as placebo, anectdotal. Studies won't begin to touch the numbers that need treatment immediately, so if someone is in those straits already, waiting on a study is a hail mary pass to begin with.
RRMS Dx'd 2007, first episode 2004. Bilateral stent placement, 3 on left, 1 stent on right, at Stanford August 2009. Watch my operation video: http://www.youtube.com/watch?v=cwc6QlLVtko, Virtually symptom free since, no relap
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Postby fogdweller » Fri May 14, 2010 9:03 am

CureIous wrote:That's precisely how Stanford is proposing to structure their study. The patient won't know if the balloon was fully inflated or not. All patients post-study that were in the "non-inflated" category will then have the option of getting the real deal. Simple and eloquent.
Mark


Sounds good. I guess informed consent is good enough given the low risk of sedation and angioplasty.

When do they start?!!
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Keep trials simple please

Postby MarkW » Sat May 15, 2010 4:31 am

Some thoughts:
-I recommend that all trials are kept as simple as possible.
-Immediate changes after CCSVI therapy (eg purple feet) are very important but it is not essential that everyone with MS has that symptom.
-general anaethesia is unlikely to get approval to blind a study.
Kind regards,
MarkW
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Postby Billmeik » Sat May 15, 2010 6:18 am

general anaesthesia is totally likely to get approved to blind a study.

As long as the patient consents there are no real ethical issues.

Let's get this done so this blockage can move
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Postby fogdweller » Sat May 15, 2010 11:19 am

Billmeik wrote:general anaesthesia is totally likely to get approved to blind a study.

As long as the patient consents there are no real ethical issues.


I'm with Mark, plus it sounds like he has been involved in trying to get studies approved. Just because paient's say they are willing to take the risk, it is unlikely that IRB's will agree to allow general anesthesia for everyone in a study.

I hate to say this, but you have to think like a hospital administrator in fear of lawyers; if someone dies from anesthesia and were in the placebo arm of the study, a dependant, spouse or parent might sue claiming the desperate patient would have consented to anything, no matter how unreasonable and since they were subjected to this risk with no chance of any improvement (they were in the untreated, placebo group) the consent was unreasonable.

Sorry, that is how it goes the risk averse system we have.

Sedation is such low risk, however, I guess itr is acceptable.
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Re: Keep trials simple please

Postby fogdweller » Sat May 15, 2010 11:22 am

MarkW wrote:Some thoughts:
-I recommend that all trials are kept as simple as possible.
-Immediate changes after CCSVI therapy (eg purple feet) are very important but it is not essential that everyone with MS has that symptom.
-general anaethesia is unlikely to get approval to blind a study.
Kind regards,
MarkW


I agree about anesthesia. I agree about keeping it simple. However, because MS is so varied, I think the patient in order to fulfill the inclusion criteria must have the symptom that is going to be measured. Otherwise if there will be no change to the sypmtom whether or not the treatment works.

I don't have fatigue. Why include me in a study to check if the treatment relieves fatigue?
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Postby Cece » Sat May 15, 2010 12:06 pm

fogdweller, I like that last part. It can be a study of "MS patients with fatigue scores of X," not just universal MS patients.

Whoever it was that said there will be a thousand research papers done on CCSVI in the next ten years, I agree...there is more than enough meat on this bone...

As for general anesthesia to do a procedure that can be done under limited anesthesia, that was the one possibility Dr. Sclafani suggested, then said it would be unethical and not likely to pass IRB.

I think Dr. Dake's idea for having the control group have a not-fully-inflated balloon seems close enough. Not perfect, but close enough, and if he's doing the study already, then full speed ahead...
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Postby NZer1 » Sat May 15, 2010 1:44 pm

Can the next group of people that receive treatment be grouped by their symptoms, eg 1.cog fog,2. purple feet,3.something else. Then there will be more ground and options covered as well as the possibility of more volume of people treated under the umbrella of multiple trails! The multiple trials would be to use each group to see if they have specific results on their type of symptom. Then more people in total, each with their bracket of symptoms can be treated in the trial. And one more group for compassion and urgency that are grouped by a multi list?, and they get to have their treatment sooner than any trial would allow.

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Last edited by NZer1 on Sat May 15, 2010 9:15 pm, edited 2 times in total.
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Postby Billmeik » Sat May 15, 2010 2:01 pm

I dont think people are really thinking about generals like they are trivial enough. People get them at the dentist now because it's boring being awake.

Anyways if its an issue a simple curtain so the patient cant see the monitor might be enough...And ya just dont inflate on placebo group
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Postby Cece » Sat May 15, 2010 2:48 pm

NZer1 wrote:Can the next group of people that receive treatment be grouped by their symptoms, eg 1.cog fog,2. purple feet,3.something else.

I think you can also cross-analyze the data like this after the study has been done. Like how Zivadinov in the Buffalo study can give us the total results and then separate it out based on subgroups (PPMS, RRMS, CIS, etc.).
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Postby Billmeik » Sun May 16, 2010 6:38 am

really the best way to bring flakyness into in is to talk about symptoms. All tstudies should be comparison of mri's over time seeking disease activity..
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Postby belsadie » Sun May 16, 2010 3:09 pm

I've been reading the clinical trials debate/debacle? and I'm beginning to get a major headache. I have always held the belief that being a participant in the "I'm not really being treated" group is fundamentally unethical. If I sign up, I want the treatment, whatever it might be, and I've been a participant in clinical trials..... The placebo effect is real, I've seen it and even experienced it. When there's already so much evidence out there. let's stop the ridiculous rationalizing and jumping through the hoops set out there to distract us, and join the ranks of people who are intelligent enough to do their own research and decide on their own treatment. My Lord! How many scientists/physicians are needed to validate the reality of a possible solution to a MiSerable condition!? OK, yeah, possible. This approach is in its infancy but maybe it's time to change the paradigm of acceptable research techniques. WHY is the present model the ONLY model? Think of the MRF's model. Before they proposed this change. scientists didn't share/collaborate with one another and now...and how successful are they being!?
It's time to stop guarding the perimeter of your own,narrow discipline,Doc! There just might be someone out there with a better idea. Perhaps they should remember how they were told to share and not be mean spirited by their Moms.[/i]
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Postby thisisalex » Mon May 17, 2010 12:25 pm

still dont get it why do we need placebo kontrolled trial... and by the way: what is placebo, how long is it called placebo? what if they fake the treatment for me, and the placebo works for decades for me? :)

Zamboni did a trial regarding venous stenosis and chronic fatigue:

http://www.ncbi.nlm.nih.gov/pubmed/20351673

There was 31 CCSVI patients, they got treatment. all of them.
all of them had much lesser fatigue, even after 12 months!
Is this placebo? for 12 months? i dont think so.

then why do we need placebo kontrolled trials?
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