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Australian research not finding CCSVI in subjects

Posted: Mon Jul 04, 2011 8:36 pm
by Cece
http://www.msra.org.au/abnormal-venous- ... atients-ms
“To date we have studied 35 people with MS and 35 healthy control subjects, so we are just over one third of the way towards completion,” reports A/Prof Chambers. “Preliminary blinded analysis of the whole 70 cases, using the criteria proposed by Zamboni, indicates that CCSVI (chronic cerebrospinal venous insufficiency) is less prevalent than expected.” In fact, preliminary analysis has revealed that no subjects so far studied have CCSVI according to the criteria proposed by Zamboni. “Since our MS cohort are in the early stages of disease, this would imply that if CCSVI does occur in MS, it does not have a causal role, and it may only develop in more advanced MS,” explains A/Prof Chambers. “It is possible that CCSVI is mainly observed in advanced MS. This is supported by our observations in out-of-trial advanced MS patients.”
The investigators also plan to present these findings at ECTRIMS (Congress of the European Committee for Treatment and Research in Multiple Sclerosis) in Amsterdam, October 2011.
Well, we know what one of the studies presented at ECTRIMS this fall will say! Last year at ECTRIMS there were studies that found CCSVI and studies that didn't. More that did than that didn't, though. The year before, the only CCSVI at ECTRIMS was a poster by Dr. Zamboni. It's progress!

Posted: Mon Jul 04, 2011 9:41 pm
by MrSuccess
wonderful . Now their research methods and techniques can be evaluated . Trained by Dr. Dope ? Did I spell that right ? Doeppe ?

How to you pronounce that ..... Dopey ? :wink:

Be careful when you step into the spotlight ......... you better be able to sing and dance .......... :twisted:



Mr.Success

Posted: Mon Jul 04, 2011 10:50 pm
by se1956
They seem to have 0% in all subjects (pwMS and healthy)??

"....that no subjects so far studied have CCSVI according to the criteria proposed by Zamboni...."

Their analysis seems to be flawed.

R.

Posted: Tue Jul 05, 2011 1:13 am
by AMcG
It is not just the analysis that is flawed. This fool has just provided feedback to his sonographer(s) that they failed to find CCSVI in any subjects. To avoid a learning effect you have to keep your sonographers blinded to the end of the study. The sonographers are now going to be thinking 'did we do something wrong?' and potentially change their behaviour in subsequent testing.

Of course Chambers can say he instructed them to carry on testing in the same way but he cannot now say they they were totally blinded to their results.

Posted: Tue Jul 05, 2011 5:34 am
by cathyb
To date we have studied 35 people with MS and 35 healthy control subjects, so we are just over one third of the way towards completion,” reports A/Prof Chambers. “Preliminary blinded analysis of the whole 70 cases, using the criteria proposed by Zamboni, indicates that CCSVI (chronic cerebrospinal venous insufficiency) is less prevalent than expected.” In fact, preliminary analysis has revealed that no subjects so far studied have CCSVI according to the criteria proposed by Zamboni. “Since our MS cohort are in the early stages of disease, this would imply that if CCSVI does occur in MS, it does not have a causal role, and it may only develop in more advanced MS,” explains A/Prof Chambers. “It is possible that CCSVI is mainly observed in advanced MS. This is supported by our observations in out-of-trial advanced MS patients.”

Analysis of preliminary results, before the completion of a study, must always be interpreted with caution and final conclusions can only be drawn at study completion. The investigators will continue to recruit their planned sample size of 100 patients and control pairs. Discussions with international investigators, including Zamboni, at the recent

Australasian Phlebology College meeting in Melbourne indicated that others use broader ultrasound criteria for diagnosing CCSVI. However, as yet there are no standardised validated criteria.

“Our data set includes a number of ultrasound parameters not included in the Zamboni definitions,” explains A/Prof Chambers. “We intend to apply advanced statistical methods to determine which if any ultrasound variables are more prevalent in MS. Our results in healthy controls will also provide the best available venous ultrasound data to give a ‘normal range’ for comparison.”
Wow, that's messed up. So, they're using something more rigid than the Zamboni definitions and are finding nothing in anyone?

So, if I am trying to diagnose a broken arm the way to do it is to conclude the arm is broken if:
1. An x-ray shows the break
2. The patient has bad breath
3. The patient has at least one wart

Am I reading that right? How can they possibly draw conclusions at this point, and then they discuss that it's more prevalent in more advanced cases? Why are they drawing conclusions based on people that aren't in the study? OK, is this some kind of joke?

Posted: Tue Jul 05, 2011 6:09 am
by frodo
AMcG wrote:It is not just the analysis that is flawed. This fool has just provided feedback to his sonographer(s) that they failed to find CCSVI in any subjects. To avoid a learning effect you have to keep your sonographers blinded to the end of the study. The sonographers are now going to be thinking 'did we do something wrong?' and potentially change their behaviour in subsequent testing.

Of course Chambers can say he instructed them to carry on testing in the same way but he cannot now say they they were totally blinded to their results.
Great argument. Is it known if they intend to publish their results in any magazine? the director should be warned about these effects.

Posted: Tue Jul 05, 2011 6:22 am
by fernando
I do not understand this type of studies.

Whenever some technician needs to apply a new technique he/she must learn and practice it before.

US is a technique applied in a novel way to screen for a novel condition, so they are trying to accomplish several things at once, naive technicians to see something that they do not know if it even exists.

Recipe for disaster.

Posted: Tue Jul 05, 2011 6:34 am
by bil
se1956 wrote:They seem to have 0% in all subjects (pwMS and healthy)??

"....that no subjects so far studied have CCSVI according to the criteria proposed by Zamboni...."

Their analysis seems to be flawed.

R.
Or maybe they've just got good sonographers who don't press down too hard and therefore don't end up seeing things that aren't there?

Posted: Tue Jul 05, 2011 6:43 am
by Cece
Discussions with international investigators, including Zamboni, at the recent Australasian Phlebology College meeting in Melbourne indicated that others use broader ultrasound criteria for diagnosing CCSVI.
This is why I'm curious about if plethysmography is a better test, particularly if it can be more easily standardized and reproduced.

Posted: Tue Jul 05, 2011 8:08 am
by se1956
If you take venous problems in the legs, they typically start in the age of 20-30 (like MS).
At the onset I think the difference between healthy and ill is small too - but the cause of the progressive leg disease are the veins.

With a value of 0% they state, that the veins in the neck are always perfect.

With the experiences from Dr. S., BNAC …. the only conclusion can be, that their tests, parameters, analysis … are useless, because they have no sensitivity to different venous conditions in the neck.

R.

Posted: Tue Jul 05, 2011 8:48 am
by Cece
se1956 wrote:With a value of 0% they state, that the veins in the neck are always perfect.
!!
That's a good point.
It makes no sense to me that veins could go wrong in the legs or in the torso (liver, pulmonary) but not in the neck.

If it's in the human body, it can go wrong....

Posted: Tue Jul 05, 2011 9:23 am
by scorpion
MrSuccess wrote:wonderful . Now their research methods and techniques can be evaluated . Trained by Dr. Dope ? Did I spell that right ? Doeppe ?
How to you pronounce that ..... Dopey ? :wink:

Be careful when you step into the spotlight ......... you better be able to sing and dance .......... :twisted:



Mr.Success
But not to continue to make snide comments or insult. This would not be tolerated on the antibiotics or Revimmune forum. Nor should it be tolerated here.
cheer

Posted: Tue Jul 05, 2011 10:56 am
by Lanie
...“Our data set includes a number of ultrasound parameters not included in the Zamboni definitions,” explains A/Prof Chambers. “We intend to apply advanced statistical methods to determine which if any ultrasound variables are more prevalent in MS. Our results in healthy controls will also provide the best available venous ultrasound data to give a ‘normal range’ for comparison.”...

If their sonographer was trained in the Zamboni protocol they will find CCSVI - if it exists. Consistency and standardization in the protocol is what is needed for patients to get an accurate diagnosis. By changing or adding to the protocol based on their opinion only skews validity and ultimately affects patients getting treatment.

Posted: Tue Jul 05, 2011 11:09 am
by EJC
Finding 0% in all subjects is as spurious as finding 100% in all subjects.

Biology and natural variation would throw up at least one anomaly.

Posted: Tue Jul 05, 2011 11:39 am
by 1eye
I think probably some groups with axes to grind need to be allowed some years, first to hone their grinding technique, and then to make short work of their axes. There are going to be some puzzles posed by weird results and by those who work on them, until things shake out a little. :roll: