advanced sonological protocol from Italian study

[Cece]

http://www.sciencedirect.com/science/ar ... 8X12000848

Italian multicenter study on venous hemodynamics in multiple sclerosis: Advanced Sonological Protocol

Introduction: Because of the recent hypothesis of involvement of the venous hemodynamics in multiple sclerosis (MS), and because of the pitfalls of these studies, there is the need to achieve a definite conclusion from a large sample of subjects by using a strict and controlled neurosonological protocol. The aim of the advanced protocol, designed for a subgroup of the FISM study, is to analyze several items of the venous hemodynamics in order to obtain more pathophysiological data on venous circulation. Advanced Ultrasound Protocol: This is a multicenter, observational study. From a pool of about 1200 adults with MS, 400 healthy subjects and 400 subjects with other neurodegenerative disorders (2000 subjects in total) will be selected a population able to be examined by the advanced protocol. The examiner will always be blind on the clinical diagnosis, and the exams will be performed according to a standard protocol, whose measurements are mandatory for all participating centers. The advanced protocol is on a voluntary basis and it is optional. It includes, besides the basic one, measurements of blood flow volumes in carotid and vertebral arteries and in jugular and vertebral veins (inflow and outflow), with the definition of the drainage pattern. The ultrasound examination at each clinical site will be followed by a second centralized blinded evaluation. The prevalence of CCSVI in MS will be estimated, with confidence intervals at 95%, and compared with the prevalence in other groups. Moreover, multiple analysis will be done comparing venous hemodynamics in the three different groups.

The article is available in full, with images, but I haven't had a chance to read it.

[1eye]

This is multi-centre. As such, its numbers will probably assume statistical significance, for those who care about such things. The study is also being run by mostly Italian neurologists. Any judgement I may still possess is reserved for later, but it could be the makings of a Good Thing.

[MarkW]

After a quick scan of this paper my comment is BEWARE. My guess is that the Neuros who collected this data are trying to show that Prof Zamboni's criteria are not good science. Let's go back to the simple mantra that gold standard diagnosis of CCSVI syndrome requires an invasive procedure using catheter venography and intravascular ultrasound.
MarkW

[1eye]

...Let's go back to the simple mantra that gold standard diagnosis of CCSVI syndrome requires an invasive procedure using catheter venography and intravascular ultrasound.
MarkW

Yep, and why would you run a multi-centre study on a screening tool? If they wanted to test IVUS, I would sit up and take notice. But then they'd have to a) pay money and b) talk fast.

[Cece]

They're also looking at inflow, despite CCSVI being a matter of outflow obstructions. They're looking at blood flow volume in the outflow veins and at the "drainage pattern." It's not mentioned in the introduction if they are looking at blood flow stasis, retrograde flow, or visible valvular obstructions. I still have to read the article.

It should be noted that, for the vertebral artery and carotid artery measurements being taken, the gold standard is MR phase-contrast quantification, and not sonological data at all. http://www.ajnr.org/content/27/2/363.full

[masci]

Baracchini & Al are known v CCSVI. Their studies have often been criticized by prof. Zamboni.
In previous studies, has been matched CCSVI / MS = 0