This Is MS Multiple Sclerosis Community: Knowledge & Support

[MegansMom]

I am wondering if trial outcomes ever get corrected?

I have heard that several people that were in studies were " undertreated" or deemed " no CCSVI" and subsequently correctly diagnosed and treated, usually by another center.

At first I thought that it was just an oddity and rare but over time it seems to me that I am hearing about more and more.

This doesn't bode well for CCSVI research accuracy. Especially when it involves different sites .
Do these patients ( or their correcting IRs ) ever contact the initial trial ?
Does the data ever get corrected? Do the statistics ever get recalculated?

I really do not blame the initial centers, I am sure that their failure to assess correctly was the limitations of their lack of experience. I will refrain from
listing the Trial centers that I know have miss diagnosed CCSVI, but I sure hope that the information gets conveyed and amended and republished.

Does anyone know?

[MegansMom]

Today I see that 110 views of my opening post and no replies. So I am assuming no one knows the answer?

[Cece]

I was one of those views! My guess is no. Any testing or treatment done for CCSVI at some other facility would have different methods. To change the data for one patient wouldn't be very controlled.

[MarkW]

The answer to this question depends on what you mean by "trials".
I use trials to mean new chemical entity (drug) testing by tha pharma industry. Here data is published in journals after a registration submission is made. Answer is No. If different data is discovered this is usually submitted to the registration authorities by the pharma company before it is formally released.
All of the tests performed for CCSVI are performed to support the researchers opinion. Therories and counter theories are argued in learned journals but this happens very slowly. Answer is Yes.

I know this does not answer your question. Medical science is like this - the answer depends on the exact words in the question.

That why I use Prof Zamboni's term CCSVI syndrome. It is precise.

MarkW

[MegansMom]

So if a number of people W/MS are tested for CCSVI via Doppler or MRV and deemed NOT to have CCSVI and they subsequently go to another center and test positive, via any method including venogram and they are then treated, this data never gets recorded?

Seems weird.

If a drug study has it's results published and later a whole lot of folks have grave side effects or big improvement then this gets amended and published right? Why not the same for diagnosis and procedural studies?

[Cece]

If the healthy controls are not also examined by the other center, than the new info from the MS patients from the other center isn't useful.

It is frustrating that there have been several patients with missed diagnoses from studies who have gone on to be treated for CCSVI.

[MarkW]

Cat (MegansMum) posted:
So if a number of people W/MS are tested for CCSVI via Doppler or MRV and deemed NOT to have CCSVI and they subsequently go to another center and test positive, via any method including venogram and they are then treated, this data never gets recorded?
Seems weird.

The data is recorded by the second centre but it is seldom published. The debate usually centres on the method used by the first centre. This is why Prof Zamboni wrote to AoN explaining the defects in interpreting the results of the German study published in AoN.
Also remember that Dr S reported that the saw a vein valve problem with an IVUS which was not observed with a catheter venogram, so you need both of full diagnosis. Diagnosing and treating CCSVI syndrome is 'in development', which is difficult to comprehend after reading some posts on this site and on facebook.

Cat asks:
If a drug study has it's results published and later a whole lot of folks have grave side effects or big improvement then this gets amended and published right? Why not the same for diagnosis and procedural studies?

My expertise is pharmaceuticals. Doctors use drugs for non approved diseases called 'off label' prescribing. I equate the use of arterial balloons in veins as an 'off label' procedure. Ask an interventionalist or surgeon for an expert answer.

MarkW