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LindaRacine
12-09-2008, 03:23 PM
SALT LAKE CITY, Dec. 9 /PRNewswire/ -- Axial Biotech, Inc. announced today the commercial launch of a new DNA-based test that indicates the likelihood of progression to a severe curve for children diagnosed with Adolescent Idiopathic Scoliosis (AIS). This new molecular diagnostic tool marks a major advancement in which medical treatments can be personalized to patients diagnosed with this deforming disease. The test will be marketed under the name of ScoliScore(TM) AIS Prognostic Test.


Scoliosis is an abnormal curvature of the spine that affects two to three percent of the population, or an estimated 7 million people in the United States. Most often scoliosis is identified during school or sport screenings. Girls are eight times more likely than boys to have a curve progress to a point that treatment is required.


Currently, to determine whether or not a curve will progress patients are observed over a period of several years with the uncertainty of not knowing what the long-term outcome is likely to be. If the curve does continue to progress, the most widely accepted treatments are spinal bracing or ultimately spinal fusion surgery.


"For decades, spine surgeons have been looking for ways to determine which patients may progress and which may not," stated Ken Ward, M.D., Chief Scientific Officer for Axial Biotech. "Currently, most patients diagnosed with scoliosis have spinal x-rays repeated over several years because of the lack of precise clinical indicators or markers that can identify the likelihood of severe curve progression. This lack of predictive information is very inefficient and can cause adolescents to be given years of unnecessary radiation exposure."


ScoliScore(TM) was developed by utilizing a genome wide association study that identified a panel of 53 genetic markers associated with severe curve progression. This scoliosis research involved collecting DNA samples from over 9,500 patients from 85 clinical sites throughout the world. The test was then further validated in two separate clinical trials.


John Climaco, CEO and President of Axial Biotech, said that the launch of ScoliScore(TM) illustrates the company's commitment to making critical information from molecular diagnostic tests more broadly available to spinal surgeons, patients, and their family members. "Our long-term vision is to utilize the knowledge and capabilities gained from the development of this test and apply it to other spinal diseases," said Mr. Climaco.


The initial launch of the ScoliScore(TM) test will be to a small group of physicians in the U.S. The test will be processed solely at Axial's CLIA certified laboratory, which meets all applicable state and federal guidelines. It will be made commercially available to physicians nationwide in 2009. Axial Biotech has signed an agreement with DePuy Spine, Inc. to sell and market ScoliScore(TM).


For more information on the ScoliScore(TM) test, please contact Axial Biotech Customer Service at 877-AXIAL98 (877-294-2598) or visit the company's website at www.axialbiotech.com

flowerpower
12-10-2008, 01:35 PM
Thanks for posting Linda, I was wondering when it would start being put to use. Our ortho dr. said he was going to start utilizing this test soon and I am eagerly anticipating this for my 10 yr. old.

Renee

flowerpower
12-19-2008, 09:24 AM
Well, we saw our dr. this week for my older son's 3 yr. post op checkup and was able to ask about the ScoliScore testing for my 10 y.o. We were told that the testing should begin soon sometime after the first of the year BUT they will initially only be offering the test to girls between 9-13 y.o. with an initial scoliosis diagnosis of 16-25 deg. I'm bummed, my son falls perfectly w/in that range.

Renee

nate03
12-19-2008, 03:02 PM
Yes, I just got the same type of disappointing news. My older son, just turned 14 and was diagnosed with a 22 degree curve last week, but he also is not eligible for the test. We were given the possible option of having him participate in the next trial, which we will gladly do to help others..........but it won't benefit him any personally. My daughter has been told she has mild scoli, and she is age 11, so I may try to have her tested. But, it is offered at very few hospitals right now and with it being so narrow I honestly don't know if I would find it very meaningful at this point anyhow.

At least they are getting a step closer to some answers.........but it definitely has a long way to go!

-Cara

Rayknox
12-20-2008, 02:24 PM
If this test is accurate, does this mean that they will recommend spinal surgery for any child that qualifies irrespective of the degree of curvature at the time of testing.

Pooka1
12-20-2008, 02:32 PM
If this test is accurate, does this mean that they will recommend spinal surgery for any child that qualifies irrespective of the degree of curvature at the time of testing.

:confused:

I think the main outcomes will be to:

1. avoid bracing kids who will not progress to surgery territory, and

2. avoid bracing kids who are going to progress to surgery territory absent some robust evidence bracing works.

leahdragonfly
12-20-2008, 07:45 PM
The idea of the test also is to guide follow-up care. If a curve has a low risk for progression they would space out the doctor's visits and x-rays to reduce radiation exposure. And of course they are not going to recommend surgery for a kid based on the results irregardless of curve! Only kids with curves large enough for surgery will receive surgery recommendations. The genetic test will just be one more piece of information.

ecnw
12-25-2008, 05:27 PM
It's too bad that they're only testing on girls, and at age 9. I would think most parents who would be interested in having it done would be those who have a family history, in which case it can start much younger than that.
Emily

txmarinemom
12-28-2008, 07:26 AM
I've been wondering when this would become a huge revelation ... that really isn't.

Also would LOVE to hear what weight the SRS doctors place on this. Surely it will be a big topic (or ... not) in San Antonio for the 2009 conference (I am SO not missing this one! ;-).

Yes, it's a start ... but I also believe the efficacy (and applicable group of patients) is overrated. Your mileage may vary, as always ... but my JIS curve was ±35° when diagnosed at age 10. Beyond the parameters (even as a female) others have mentioned.

And, LMAO they signed with Depuy - and a "small group of physicians in the U.S." will initially be afforded the tools to launch. Makes you wonder where the organizations interests lie.

From the press release:

"ScoliScore(TM) was developed by utilizing a genome wide association study that identified a panel of 53 genetic markers associated with severe curve progression. This scoliosis research involved collecting DNA samples from over 9,500 patients from 85 clinical sites throughout the world. The test was then further validated in two separate clinical trials.

John Climaco, CEO and President of Axial Biotech, said that the launch of ScoliScore(TM) illustrates the company's commitment to making critical information from molecular diagnostic tests more broadly available to spinal surgeons, patients, and their family members. "Our long-term vision is to utilize the knowledge and capabilities gained from the development of this test and apply it to other spinal diseases," said Mr. Climaco."

9,500 patients from 85 clinical sites throughout the world isn't enough to prove it out? And what OTHER spine diseases when they can't even say it's effective for scoli prediction??

Pam

concerned dad
12-30-2008, 08:55 AM
Well, it would be a great medical breakthrough if it worked.
I looked at their website to try to see some information about accuracy/ reliabality. They really dont have too much in their "publications" portion. It looks like a few poster sessions and presentations.
I would think a physician would want to see the basis of proof of just how and why this test works. Heck, a parent would want to see the same.
Of course, since the test does no harm (unless medical decisions are made based on results) I guess it doesnt hurt to try it.
The 13 year old cut off seems random. Does DNA change as you age?

I saw two things that were pretty interesting from their website (although not directly related to the DNA test discussion).

One of the presentations was given last year at the SRS meeting in Utah. I looked at the program here (http://www.srs.org/professionals/meetings/am08/Prelim.pdf) The talk was only 4 minutes long. Many of the talks were just 4 minutes. Is that usual for these medical conferences?
8:30 - 8:34 am Predicting Brace-Resistant Adolescent
Paper #6 Idiopathic Scoliosis (I dont suppose anyone here has a copy of the proceedings)
It looks like the talks were in rapid fire progression and they finished that day at noon. Perhaps physicians are used to processing information rapidly, but that seemed odd to me.

the other thing I was amused to see was from the axialbiotech website where they were talking about how great it was to do DNA work in Utah. They said:
Known Paternity: Fewer errors occur when studying extended families in Utah because the incidence of “non-paternity” (unknown or incorrectly attributed fathers) is lower. (<1% among Utah residents verses approximately 10% for the rest of the U.S. )

10%? wow.

Maybe I should get off the computer and spend more time with my dear wife.

Pooka1
12-30-2008, 09:13 AM
the other thing I was amused to see was from the axialbiotech website where they were talking about how great it was to do DNA work in Utah. They said:
Known Paternity: Fewer errors occur when studying extended families in Utah because the incidence of “non-paternity” (unknown or incorrectly attributed fathers) is lower. (<1% among Utah residents verses approximately 10% for the rest of the U.S. )

10%? wow.

Maybe I should get off the computer and spend more time with my dear wife.

That could be explained easily if only about 5 guys fathered most of the kids in the state. :cool:

LindaRacine
12-31-2008, 11:08 PM
One of the presentations was given last year at the SRS meeting in Utah. I looked at the program here (http://www.srs.org/professionals/meetings/am08/Prelim.pdf) The talk was only 4 minutes long. Many of the talks were just 4 minutes. Is that usual for these medical conferences?

I think it's different for every conference. SRS papers are 5 minutes long. They're pretty strict about it.

--Linda

nate03
02-06-2009, 06:59 AM
Hi,
I recently came across this powerpoint presentation posted on the web regarding the genetic testing:


http://www.vinzenzgruppe.at/vinzenzgruppe/media/pdf/03Ogilivie.pdf/



I do not know much about the accuracy or validity of this presentation - the company who posted it is in Austria I think.........but I thought it might be interesting reading for those following the genetic testing progress.

Pooka1
02-06-2009, 07:43 AM
Thanks for posting that, Cara!

Very interesting.

I note that their ideal future doesn't include bracing.

This is consistent with the literature on the efficacy of bracing in my opinion.

(I further note the ideal future doesn't include woo-woo "treatments" but I won't dwell on that.)

Evidence-based medicine... more than just a good idea.

sharon

PNUTTRO
02-09-2009, 07:03 PM
Hi,
I recently came across this powerpoint presentation posted on the web regarding the genetic testing:


http://www.vinzenzgruppe.at/vinzenzgruppe/media/pdf/03Ogilivie.pdf/



I do not know much about the accuracy or validity of this presentation - the company who posted it is in Austria I think.........but I thought it might be interesting reading for those following the genetic testing progress.



Cara, this was authored by the same people in SLC, Utah--James Ogilvie

PNUTTRO
02-09-2009, 07:23 PM
I really hate this test. 53 markers! are you out of your living mind?!

The first paper from Axial on the subject is from 2006, which ruled out a founder effect in related families. That is, there is not a single gene responsible. This isn't surprising given the variability of penetrence in families. It is neither dominant nor recessive trait.

The search for idiopathic scoliosis genes.
Ogilvie JW, Braun J, Argyle V, Nelson L, Meade M, Ward K.
Spine. 2006 Mar 15;31(6):679-81.

There are no subsequent publications of the larger study. Only the presentation at the SRS meeting. The power point presentation that Cara posted previously as well as the abstract and press release have inconsistent statements.

The power point states that all of their scoliosis patients are related. I find that quite peculiar.

The larger study that includes "1,200 unrelated Caucasian" patients. I don't see how this helps anyone of a different ethnicity.

The press release and the power point indicate 53 different markers. The abstract says 30. There is no public description of those markers because they are proprietary. But if their patent is in place, surely they could let us know some of them. Maybe they are related to previously identified genes. It would at least give Axial some validation.

Anyway. I don't know why I felt like I had to put in my two cents, but there it is. I guess I am just a pessimist about companies that will have a press release before publishing their results. Abstracts don't count--usually conference presentations are about incomplete or cutting edge data. Axial presented zero details. The abstract contains 2 figures that are proof of principle diagrams, not data.

p

PNUTTRO
02-11-2009, 01:47 PM
http://www.axialbiotech.com/files/fda_approval.pdf

concerned dad
02-12-2009, 01:23 PM
Above on Dec 30th I said
"They really dont have too much in their "publications" portion. It looks like a few poster sessions and presentations. "

I was suprised to see PNUTTRO discuss a paper in SPINE. I could swear that wasnt in their publications section 6 weeks ago. It certainly is there now. Maybe my mind is failing, I dont know. I went to look on the internet archive (Wayback machine) to see if their website was updated and when. They (Wayback) lags about 6 months so I'll have to wait and see if I'm loosing my mind.

PNUTTRO
02-13-2009, 01:14 PM
I was suprised to see PNUTTRO discuss a paper in SPINE. I could swear that wasnt in their publications section 6 weeks ago. It certainly is there now. Maybe my mind is failing, I dont know. I went to look on the internet archive (Wayback machine) to see if their website was updated and when. They (Wayback) lags about 6 months so I'll have to wait and see if I'm loosing my mind.

I don't know about their website, but the publication in SPINE doesn't discuss data for this test anyway. It was a genetic study to see if they could ascertain a single mutation in their study population. They found none. Wishful thinking I suppose.

I wouldn't worry too much about losing your mind. You likely have a lot on your mind anyway.

p

PNUTTRO
03-28-2009, 07:22 PM
Does anyone know if Axial provides genetic counseling with their DNA test, or do they give you the risk score and say see ya' later?


p

debbei
03-29-2009, 08:00 PM
I asked my 9 year old's scoliosis doctor about this test a few weeks ago, and I was disappointed when he described the whole thing as a money-making venture that wasn't worth anything. :(

concerned dad
03-30-2009, 08:09 AM
IMO, there is nothing wrong with a venture out to make money. In a weird way we are fortunate there are so many potential patients. An obscure illness would not necessarily draw the attention of the people with the money, skills and knowledge to investigate it.
But because of the money involved, discernment and oversight is necessary.

I wonder why your doctor thinks the test has no merit. It is my understanding that it is still in an alpha testing stage.

LindaRacine
04-29-2009, 04:58 PM
http://www.orlandosentinel.com/news/local/orl-new-scoliosis-saliva-test-043009,0,6348003.story

Saliva test can predict scoliosis risk

By Robyn Shelton | Sentinel Staff Writer
April 29, 2009


Carly Bosse, 13, with her mom Maurie Bosse, holds her brace that she wears at night. She is benefiting from a new DNA test to determine the severity of scioliosis, or curvature of the spine. Carly was diagnosed with scioliosis at 11. (George Skene, Orlando Sentinel / March 18, 2009)

Doctors have learned more about the curve in Carly Bosse's spine from her genes than her X-rays.

A DNA screening that is being tested in Orlando shows the teen's scoliosis – an abnormal curving of the spine – probably will not need surgery.

The test, called ScoliScore, identifies patients at risk of severe curves, said Dr. Raymond Knapp, a pediatric orthopedic surgeon at Arnold Palmer Hospital for Children. It also indicates when youngsters are in little danger.

"We know when we have to treat someone aggressively, and when we can reassure parents that it's not going to get much worse," Knapp said. "This will basically change the way we treat scoliosis."

In Carly's case, the genetic profile puts her in an intermediate risk category, said her mother Maurie Bosse of Oviedo. That's good news because the curve is not bad enough to warrant an operation. But it's also fair warning to the 13-year-old, who wears a brace overnight.

"I know that she must keep wearing that brace every single night without fail," Bosse said. "She cannot go one night without it."

As many as three in 10 people suffer from some form of scoliosis, though many don't have noticeable problems from it. The side-to-side curve often is detected during routine exams, when a child bends at the waist with arms dangling and one shoulder appears higher than the other. Measurements and X-rays can be done to make a formal diagnosis.

Doctors typically follow patients with X-rays every six months to track the curve's progression, said Dr. Richard E. McCarthy, president-elect of the Scoliosis Research Society. Physicians will continue to watch patients closely, but the test helps them do so with more confidence.

"It's not something that replaces anything that we're currently doing, but it enhances what we're doing," said McCarthy from the University of Arkansas for Medical Sciences.

ScoliScore is based on 53 different stretches of DNA that have been linked to scoliosis. To take the test, patients spit into a cup to provide a saliva sample that contains their DNA. The sample is evaluated by ScoliScore's maker, Utah-based Axial Biotech.

The analysis is complicated, measuring genes that provide protection from scoliosis versus those that have been found to exacerbate the problem. Patients get a score from 0 to 200 – 40 and below is considered low risk; 41 to 180 is intermediate; and 181 to 200 is high.

"We're not diagnosing whether or not someone has the disease," said Eric Olson, a spokesman for Axial Biotech. "We're actually diagnosing something much more complex, which is how it will progress."

ScoliScore is being used on a limited basis for now at about 35 locations nationwide, including Arnold Palmer hospital, which has been involved in its initial testing. The screening costs nearly $3,000, but it is being given for free in the short-term, because most insurance companies do not currently pay for it. Olson expects health plans to cover the test as it becomes more widely used.

leahdragonfly
04-29-2009, 10:34 PM
I asked my 9 year old's scoliosis doctor about this test a few weeks ago, and I was disappointed when he described the whole thing as a money-making venture that wasn't worth anything. :(



Hi Debbe,

I'm just wondering, did your daughter's doctor elaborate about his opinion of the ScoliScore? I know some Shriner's Hospitals are using the test, along with some other prominent scoliosis surgeons. My daughter doesn't fit the test criteria since she has JIS, but I would certainly be curious about it if she was eligible.

Take care,

debbei
04-30-2009, 05:00 AM
Hi Debbe,

I'm just wondering, did your daughter's doctor elaborate about his opinion of the ScoliScore? I know some Shriner's Hospitals are using the test, along with some other prominent scoliosis surgeons. My daughter doesn't fit the test criteria since she has JIS, but I would certainly be curious about it if she was eligible.

Take care,


No he didn't. AFter I read the article last night his whole attitude just bothers me and I don't know what I want to do about it. :(

txmarinemom
04-30-2009, 07:16 PM
As many as three in 10 people suffer from some form of scoliosis, though many don't have noticeable problems from it.

How did they arrive at a 30% figure, I wonder, vs. the standard 2-3% of the population?

PNUTTRO
05-01-2009, 10:13 AM
http://www.orlandosentinel.com/news/local/orl-new-scoliosis-saliva-test-043009,0,6348003.story

Saliva test can predict scoliosis risk

By Robyn Shelton | Sentinel Staff Writer
April 29, 2009



"We know when we have to treat someone aggressively, and when we can reassure parents that it's not going to get much worse," Knapp said. "This will basically change the way we treat scoliosis."

In Carly's case, the genetic profile puts her in an intermediate risk category, said her mother Maurie Bosse of Oviedo. That's good news because the curve is not bad enough to warrant an operation. But it's also fair warning to the 13-year-old, who wears a brace overnight.

"I know that she must keep wearing that brace every single night without fail," Bosse said. "She cannot go one night without it."


I love this article. The kid has a genetic test done. She already wears a brace. She has to continue wearing the brace and be monitored. If she does progress anyway--this is a risk assessment, not a fact--she will have surgery.

How does this "change the way we treat scoliosis"?

Dingo
05-04-2009, 10:06 AM
It's certainly possible that children with particular genes have a greater risk of curve progression. By comparison buildings constructed under different standards can be more or less earthquake resistant.

But regardless of construction methods buildings don't usually topple unless they are hit by an earthquake or some other destructive force. The Scoliometer isn't designed to tell us what that force is. The Scoliometer tells us the likelihood that a child's spine can withstand the force. Every teenage girl could take the Scoliometer and get a curve progression risk. Obviously the results which range from high risk to low risk would only be important to those few girls with the disease.

PNUTTRO said something that I think deserves a comment.

The first paper from Axial on the subject is from 2006, which ruled out a founder effect in related families. That is, there is not a single gene responsible. This isn't surprising given the variability of penetrence in families. It is neither dominant nor recessive trait.

The idea that a very common, worldwide childhood disease like Scoliosis could be due to founder effect (http://en.wikipedia.org/wiki/Founder_effect) is silly. I don't mean it's wrong because a lot of good ideas turn out to be wrong. I mean that hypothesis is silly. Did the scientists at Axial think that Scoliosis genes spread from one village in Britain to all of Britan to every nation around the globe at around a 2% or 3% frequency? Whoever came up with that hypothess probably shouldn't be working in science.

leahdragonfly
05-04-2009, 10:16 PM
Dingo,

You have your terminology mixed up! The Scoliometer is also called the inclinometer and is a non-invasive measure of spinal rotation. It is used in school screening programs among other uses. You can purchase one from the NSF for about $55 I believe.

The new genetic test is called the ScoliScore, and I think that is what you are referring to.

BTW, I am personally not ready to throw out the idea of a genetic basis for scoliosis. My father has mild scoliosis, I was braced for moderate scoliosis and still have a 36 degree lumbar curve, my sister has a very mild curve, and now my young daighter has JIS. The jury is still out for my 4 y/o son, but his spine is definitely not quite straight either.

Dingo
05-05-2009, 09:47 AM
Scolimeter - Scoliscore

DOH!

Thanks Leah! I have my terms mixed up. :eek:

I wouldn't absolutely discount genetics for every case of Scoliosis.

Your family might share a new, genetic mutation that causes spine disorders. Natural selection tends to be tough on these types of genes so in all likelihood it's new and very rare. These types of genetic disorders usually hit one child in thousands or even tens of thousands.

Maybe you guys share a genetic susceptability to an environmental trigger that leads to Scoliosis. This trigger could be a particular medicine, pollution or even a common virus like RSV.

Reyes syndrome (http://www.reyessyndrome.org/) works something like that. If you give the wrong kid Aspirin he is in big trouble.

Microbes tend to be far deadlier and more prolific. Flu virus appears to trigger Autism and Schizophrenia (http://www.sciencedaily.com/releases/2007/10/071016090135.htm) in kids with a particular genetic susceptability.

Endocardial Fibroelastosis (http://emedicine.medscape.com/article/896375-overview) was a fatal heart disorder that hit 1 child in about 5,000. Scientists noticed that it hit some families harder than others which suggested some kind of susceptability. They also noticed a correlation with mumps. When mumps vaccinations became widespread this heart condition completely disappeared.

My money is on something like that. Children with Scoliosis probably have a genetic susceptability to something. We just don't know what that is.

Scoliosis only has a 13% identical twin concordance rate (http://www.scoliosis.org/forum/showthread.php?t=8480). For most children environment is playing a huge part.

txmarinemom
05-07-2009, 12:12 AM
Reyes syndrome (http://www.reyessyndrome.org/) works something like that. If you give the wrong kid Aspirin he is in big trouble.

Dingo, the use of aspirin - and risk of Reyes - has been well documented since the *late 70's*.

Don't tout it like it's something new.

concerned dad
05-07-2009, 09:01 AM
Don't tout it like it's something new.

ummm, I missed the part where he suggested/ implied/ hinted/ alluded to (our understanding of) the relationship between Reyes and Aspirin being something new.
:confused:

concerned dad
05-26-2009, 03:46 PM
I found an interesting paper this afternoon while looking for something else (I was trying to find out about the "International Scoliosis Society" as mentioned by DT in another thread – no luck)

The paper I did find was:

A History of Bracing for Idiopathic Scoliosis in North America
Reginald S. Fayssoux MD, Robert H. Cho MD, Martin J. Herman MD
Clin Orthop Relat Res
Published online May 22, 2009


(Dingo will appreciate the timeliness of the information.)

They went throught he history of bracing, starting with Hippocrates.

Their reasoning for the historical perspective is:
‘‘If you would understand anything, observe its beginning and its development.’’—Aristotle

They gave a discussion of all the braces we've talked about here from the Milwaukee to the SpineCor.

In the discussion section they talked about one of my favorite topics, assessing skeletal maturity by ways other than Risser. They then go on to discuss the genetic testing (hence, a posting in this thread);

Advances in genetic research have been the most exciting developments to date. James W. Ogilvie and colleagues have identified genetic markers, two major genetic loci and 12 minor loci, related to the development of scoliosis [41]. They found 95% of patients with idiopathic curves greater than 40* had these genetic markers. Using a simple genetic test, it may be possible to identify individuals at highest risk of developing severe scoliosis at the time of initial diagnosis. Armed with this information, followup care and treatment considerations can be individualized. Early bracing or minimally invasive surgical procedures may be recommended for those with a positive screen for severe scoliosis, whereas those at low risk based on DNA analysis may be spared unnecessary treatment.

Then they discuss internal bracing and fusionless procedures which I take to be VBS techniques.

All in all, an interesting paper.

Here is the link to the Abstract (http://www.ncbi.nlm.nih.gov/pubmed/19462214?dopt=Abstract)

leahdragonfly
05-27-2009, 10:28 PM
Hi CD,

Thanks for the link to the abstract--it looks like a very interesting article, and I just e-mailed my friendly medical librarian to ask if she can get me the complete article. If I can maybe I can figure out how to place a hot link to it here (no idea how--haha).

Take care,

Ballet Mom
05-28-2009, 11:54 AM
Wow, this looks like a very interesting article. Seems to touch on all the things we've been discussing on this forum. I would love to read it. If anyone does get access to it, please post if you're able. Thanks!

leahdragonfly
05-28-2009, 07:49 PM
I have the entire History of Bracing article and it is very interesting. If someone can please tell me how, I will post it or a link to it--it is 11 pages long. Anyone out there who knows how to do this? I have it in PDF form.

LindaRacine
05-28-2009, 08:02 PM
Hi Leah...

If you picked up the PDF on the internet, you can simply copy the link location by right clicking on the link that you used to get to the PDF. If not, I think all you have to do is attach the file to a message (see Additional Options below the Reply to Thread box).

Regards,
Linda

leahdragonfly
05-28-2009, 09:07 PM
Ok Linda, I followed your instructions but the file limit for attaching PDF's is 100 kb, and the article is 364 kb. CD, are you out there? You're good at attaching files and links, any tips?

concerned dad
05-29-2009, 08:58 AM
Sorry, been out of town for a couple of days.

Leah, the issue isnt so much attaching the file (we could work around that by breaking the PDF into 100K chunks and posting in pieces). The issue is copyright infringement.
Papers published in Scoliosis Journal (SOSORT) are posted online. There is no problem linking to them.
Some SpineCor papers are posted online (presumably after having received permission).
But I believe this paper is protected by copyright. I do not know the specifics of the law. I have shared, via email, certain papers with other members here and at least my conscious was fine as it was between parent and parent (our intent is to help our kids, not open a commercial enterprise).

If memory serves me correctly, it is OK to post extracts (I think the limit is 10% of the text) so long as it is attributed.

I could be wrong on this and if anyone has any details or workarounds it would be great if all of us could share the literature openly. But, until then, I think we're going to be limited to sharing relevant papers via email.

concerned dad
05-29-2009, 03:39 PM
In another thread in research I mentioned this paper (http://www.sosort-lyon.net/pdf/saa1.pdf)by the Axial Biotech guys that was presented at SOSORT last week.

I was hoping it might be a topic of interest, and perhaps it is more appropriate to post it here.

They have a graph at the bottom of the Abstract comparing the calculated risk of progression for two groups of kids. One is braced and the other is not. This is a whole new way of looking at the issue of bracing and I think it is fascinating.

It took me a while to figure out just what they were plotting but I think I have it. To get a data point for the two groups at, say, Scolioscore 100, they take all the kids with that Scolioscore and present the percent of those who progressed to 50 degrees. (it looks to me like 25% of the observation group and 35% of the braced group with scolioscores of 100 progressed).

If bracing had a positive effect, we would expect to see a significant divergence of the curves. (They didnt see that, in fact, they saw the opposite which would suggest, if you had a scolioscore of 100 your risk of progression would be decreased if you did NOT wear a brace).

Now, they didnt go on to make any major conclusions about bracing efficacy. I would love to see the actual data points on their curves to see just how scattered things are but I am betting it is proprietary.

The conclusion they did make was that in designing bracing studiies, not only do researches need to consider all the usual stuff (curve type, age, maturity, etc) but they also need to consider genotype homogeneity. You can't compare bracing efficacy between, say, two 11 year old girls, Risser 0, 30 degree curves with one having a "scolioscore" of 25 and the other having a "scolioscore" of 150.

But I thought this was an interesting way to use the data they collected. I wonder if they have enough detail to break it down and analyze other differences between the kids (besides braced vs no braced, maybe by geographic latitude (to look at Dingo's Melatonin thing) or by brace type or by use of an excercise therapy.

Comments anyone?

LindaRacine
05-29-2009, 10:15 PM
Ok Linda, I followed your instructions but the file limit for attaching PDF's is 100 kb, and the article is 364 kb. CD, are you out there? You're good at attaching files and links, any tips?
Leah...

Would you mind sending the PDF to me in an email? (linda@scoliosislinks.com).

--Linda

LindaRacine
05-29-2009, 10:25 PM
CD...

That's pretty interesting. As always, however, we don't know how good the braces were (did they all get at least 50% in brace correction?). And, we don't really know how compliant the kids were (the study says compliant, but I'm sure that's self reported at best).

Regards,
Linda

Ballet Mom
05-30-2009, 01:55 AM
Hi CD,

I guess after looking at that chart by the Axial Biotech guys, I just don't believe it. It makes me think there's something wrong with the Scolioscore, not with bracing. Or, as Linda pointed out, something wrong with the bracing used in this study. Of course, I'm sure they're a lot smarter than me and I don't have any of the info, but just on the face of it, don't you think that if bracing caused a greater risk of progression than not bracing, that all these very intelligent orthopedic surgeons would have continued to brace in the face of years of evidence? I just don't buy it. And especially with the results my daughter has had....surely she is not the only patient out there who has been successful with bracing. (Yes, yes, I know that she could continue to progress once she stops bracing, but I'm thrilled to have that roll of the dice, nothing is guaranteed for anyone in this scoliosis world I'm afraid).

Are the Scolioscore guys sure they're pinpointing the risk of scoliosis progression itself and not something else like the tendency towards double-jointedness in people, which seems to be a possible indicator for potential scoliosis? I could see genes being detected by the test that reflect double-jointedness and then there could be an additional trigger that causes the progression of scoliosis (like Dingo's hypotheses) that would not be being shown with the DNA test, which make the results not useful in my thought process.

Anyhow, for what it's worth, their study just doesn't make logical sense to me .

concerned dad
05-30-2009, 08:14 AM
Hi CD,


Are the Scolioscore guys sure they're pinpointing the risk of scoliosis progression itself and not something else like the tendency towards double-jointedness in people, which seems to be a possible indicator for potential scoliosis? .

Well, whatever they are pinpointing they sure think it is related to scoliosis.

A risk of progression score was calculated using 53 genetic markers with utility for calculating the risk of AIS curve progression from <25° to >40° before skeletal maturity or >50° at maturity (1-200).

I would likke to know just strong the predictive capabality of the test is.


They calculate a "risk". Qualitatively, a higher scolioscore yields a higher risk. But, say you have a scolioscore of 100 which equates roughly to a risk of 35% that you will progress to either greater than 40* (before maturity) or greater than 50* (at maturity), it still doesnt tell you "for sure" anything. It just tells you you have a 35% chance of that happening.

The greater utility (in my mind at least) is for comparisons of groups like they did in this study. You would have expected different outcomes for the same genotype with bracing and observation, and they didnt see it (with a fairly large sample size).

It would be nice to see a full paper discussing this rather that a brief abstract. Maybe one will be out soon.

Pooka1
05-30-2009, 08:36 AM
Several good points being made by folks.

First, I agree the bracing efficacy could be artificially low due to many factors:

1. non-perfect compliance
2. not weeding out connective tissue cases from AIS
3. improperly fitted braces
4. etc.

These issues and others make the bracing literature a mess which also means there could be a cohort out there who do respond to bracing and can avoid surgery in their life. We may never know because it is so hard to do a study and because the treatment is not benign.

It is interesting that this isn't the first reference we have seen to bracing being LESS effective to stop progression that observation. Maybe there is a cohort out there whose scoliosis does get worse with muscle atrophy from brace wear. (Note I don't think this applies to part-time, night-time bracing if the kid is exercising during the day.) As I have suggested, bracing and PT work in opposite fashions so they likely both can't work for keeping a person sub-surgical their entire life. But if true, that means there is something to the muscle tone theory which I trashed just yesterday. :D

In re Scoliscore, they may be pin-pointing other things like double-jointedness also but they are definitely pin-pointing the risk of progression in scoliosis also. It's the only thing they measured (or at least showed on that graph) so it has to be what they are pin-pointing. Now if they don't have enough subjects or they otherwise have holes in their method then it is still a false conclusion.

Also, I am suspicious of graphs without error bars. In this case, though, they are not trying to tease out a nuance between the two curves so it seems okay to say they are the same curve.

PNUTTRO
05-30-2009, 06:29 PM
It would be nice to see a full paper discussing this rather that a brief abstract. Maybe one will be out soon.

Yeah, you'll never see that paper. This has been one of my biggest complaints about this group.

The problem with the chart is that it is a self fulfilling prophecy. They plot ScolioScore against Risk of Curve progression. Isn't that what the scolioscore is supposed to predict? If they showed actual curve progression then it would validate the scolioscore--but they don't show that. It would be nice some actual numbers. I haven't been able to find any numbers in any publication. They cover it by saying the data is proprietary.

Let us know if you can find any real data.

I checked the references in the paper that you linked to, regarding genetics data.

James W. Ogilvie and colleagues have identified genetic markers, two major genetic loci and 12 minor loci, related to the development of scoliosis [41].
The above statement is not supported by data in the paper (ref 41). They say that there is a founder effect for 2 different genetic loci, but there is no linkage data to support it and no mention of 12 other minor loci. They don't even say what those 2 major loci are. Granted, I only spent a little time on it, but I am pretty sure its not there.

p

Pooka1
05-30-2009, 08:34 PM
Yeah, you'll never see that paper. This has been one of my biggest complaints about this group.

The problem with the chart is that it is a self fulfilling prophecy. They plot ScolioScore against Risk of Curve progression. Isn't that what the scolioscore is supposed to predict? If they showed actual curve progression then it would validate the scolioscore--but they don't show that. It would be nice some actual numbers. I haven't been able to find any numbers in any publication. They cover it by saying the data is proprietary.

Let us know if you can find any real data.

Wait a minute. They are calibrating the Scoliscore with the known outcomes (percentage/risk of progression seen for each patient in which a scoliscore of a given magnitude was determined).

That is a calibration curve, not a self-fulfilling prophecy as I understand what they are doing. I could be wrong. It is interesting how certain ranges of Scolisores yield the same risk.

Having so many markers reminds me of the guys who try to fit curves empirically with high order polynomials rather than work for a determinisitic solution from known physical principles. So they just keep adding terms to improve the fit but other problems ensue. I don't know the specifics.

PNUTTRO
06-02-2009, 08:59 AM
Having so many markers reminds me of the guys who try to fit curves empirically with high order polynomials rather than work for a determinisitic solution from known physical principles. So they just keep adding terms to improve the fit but other problems ensue. I don't know the specifics.


I'm not sure I really understand their graph, but your right, it just seems a little too perfect.

Pooka1
06-02-2009, 06:05 PM
I'm not sure I really understand their graph, but your right, it just seems a little too perfect.

I know why you are suspicious of the graph... it can easily seem "cooked" which is what I think you were picking up on.

I had to ponder it for a long time but I think both the x-axis and the y-axis are actual data.

The independent variable (x-axis) is the suite of markers that go into generating a "scoliscore." These markers were identified from a population of kids with scoliosis with known outcomes, perhaps the same set of kids that they calculated progression risk from. Now that sounds circular and "self fulfilling" but I don't think it actually matters if the same population of kids that was used to generate the marker suite is used for the dependent variable (y-axis) because they are only calibrating at the moment.

The Y-axis is generated by knowing the outcome of each patient and generating the risk of progression just from knowing the outcome. They then calibrate that with the scoliscore.

It sounds fishy because there are really three things here... scoliscore, risk of progression, and calculating scoliscore using risk of progression. It's like hindcasting I believe which is done with data in hand where you know the answer ahead of time. It's okay to calibrate only. But I think once they calibrate their scoliscore, it can then be used as advertised... to predict the risk of progression based on the suite of markers that go into the scoliscore.

That's what I think is going on and I certainly could be wrong. I wonder if they will ever get this stuff out in a peer-reviewed format. And I hope the journal gets some math guys to look it over.

Pooka1
06-02-2009, 06:30 PM
Had another thought...

What bothered me at first is that they don't tell us how they calculate the scoliscore. At some point, that has to be the dependent variable, not the independent variable like the graph shows.

What I think they did was determine the marker suites of patients with known outcomes by having a graph of risk (%) on the x-axis as the independent variable versus VARIOUSLY CALCULATED scoliscores on the y-axis (i.e., opposite to the graph they show). Then they picked the one that yielded the best curve (highest slope maybe).

Then they took the optimized scoliscore and calibrated it against the risk, making the scoliscore the independent variable which is how it has to be if they want to use it the way they do.

I wish we had a math guy on the group. Maybe Ti Ed, as an engineer, could comment.

Pooka1
06-02-2009, 06:48 PM
There's a problem that I just noticed here...

The text states,

"There was little statistical difference in the curves representing risk of progression versus curve severity when the two groups were compared. Graph 1"

But the graph is labeled (at least) risk of curve progression (%) versus scoiliscore.

It is impossible to know what they mean but my best guess is that is their calibration curve.

rohrer01
04-13-2010, 08:43 PM
the other thing I was amused to see was from the axialbiotech website where they were talking about how great it was to do DNA work in Utah. They said:
Known Paternity: Fewer errors occur when studying extended families in Utah because the incidence of “non-paternity” (unknown or incorrectly attributed fathers) is lower. (<1% among Utah residents verses approximately 10% for the rest of the U.S. )


That is funny, considering if this is the same test that me and my family contributed our DNA to, and I'm pretty sure it is, we are not from Utah. My father is "Mormon" but I am not. Maybe they used the LDS geneological records to choose candidates. That would be the only way they could have tracked me down. Now how did they find out I had scoliosis? Hmmmmm..... It's a scary world out there! LOL :eek::DCan they do that?

debbei
04-13-2010, 08:57 PM
the other thing I was amused to see was from the axialbiotech website where they were talking about how great it was to do DNA work in Utah. They said:
Known Paternity: Fewer errors occur when studying extended families in Utah because the incidence of “non-paternity” (unknown or incorrectly attributed fathers) is lower. (<1% among Utah residents verses approximately 10% for the rest of the U.S. )


That is funny, considering if this is the same test that me and my family contributed our DNA to, and I'm pretty sure it is, we are not from Utah. My father is "Mormon" but I am not. Maybe they used the LDS geneological records to choose candidates. That would be the only way they could have tracked me down. Now how did they find out I had scoliosis? Hmmmmm..... It's a scary world out there! LOL :eek::DCan they do that?

I was referred by a friend, and all 3 of my children and I participated. We are not Mormon, and I know who my kids' father is. :) Axial has sent a letter for the second time asking for more DNA from son#2.

I think I'll be getting my daughter's test results tomorrow.

rohrer01
04-13-2010, 10:42 PM
They never gave us any personal results. Just updates on the progress of the study. It is very encouraging, at least maybe my grandchildren will benefit from it. After talking to more of my family members, scoliosis is way more prevalent than I knew. I never knew ANYONE in my family has it. As it turns out I have a paternal grandmother, maternal aunt, and a neice. My daughter also developed a very mild case. And of course, myself. Definitely sounds genetic to me! Axial Biotech doesn't have all that history on me because I found out AFTER me and my parents sent in our DNA. I would like to know if it recessive, dominant, or a combination type gene, or many genes contributing. I was hoping they would send me this information at least, but nothing. :(

debbei
04-14-2010, 06:17 AM
They never gave us any personal results. Just updates on the progress of the study. It is very encouraging, at least maybe my grandchildren will benefit from it. After talking to more of my family members, scoliosis is way more prevalent than I knew. I never knew ANYONE in my family has it. As it turns out I have a paternal grandmother, maternal aunt, and a neice. My daughter also developed a very mild case. And of course, myself. Definitely sounds genetic to me! Axial Biotech doesn't have all that history on me because I found out AFTER me and my parents sent in our DNA. I would like to know if it recessive, dominant, or a combination type gene, or many genes contributing. I was hoping they would send me this information at least, but nothing. :(

No, we were part of the study but didn't get any personal results either. About a month ago, my daughter took the test that is now on the market which resulted from the study. That's the one we're getting results on.

rohrer01
04-14-2010, 11:06 PM
No, we were part of the study but didn't get any personal results either. About a month ago, my daughter took the test that is now on the market which resulted from the study. That's the one we're getting results on.


It will be very interesting to hear the results of this test, if you are willing to share. Maybe they only needed a second sample of your son's DNA because a labby dropped it, it got contaminated, or it didn't turn out in the PCR machine, or they left the gel running too long and lost it all? Could have been many things gone wrong with his sample. I'm sure it's nothing to be too concerned about.
My daughter is too old to be in the study sample, she is 20. She won't even get another x-ray unless she has pain. She doesn't want to be exposed to the radiation, can't say that I blame her, though. There are risks with everything.
Something kind of interesting though, is my son has such a slight curvature that it's not considered "scoliosis" but he does have spina bifida occulta, which I also have. I wonder if there is a correlation there. Maybe a different study is being conducted on that. I'm not up on all the current studies, my life has been going in a completely different direction until recently.
I also wonder if there is a correlation to the gene/s connected with Marfan's syndrome, as scoliosis is very common in people with Marfan's. I have a nephew with Marfan's. My personal opinion is that it is that not one single gene is involved. And if a person gets a "good" copy of a gene and a "bad" copy of the same gene, there can still be enough bad protein (gene product) floating around that the good stuff isn't enough to completely suppress the disease. That would explain why my daughter has a very mild case.
In conclusion to this, all I can say is I need to read the reasearch that's been done. Something I have obviously neglected to do. I feel priviledged to have been part of the study and hope some good comes from it.
I look forward to hearing from you. I hope I wasn't confusing or too off topic.
:o

debbei
04-15-2010, 05:23 AM
It will be very interesting to hear the results of this test, if you are willing to share. Maybe they only needed a second sample of your son's DNA because a labby dropped it, it got contaminated, or it didn't turn out in the PCR machine, or they left the gel running too long and lost it all? Could have been many things gone wrong with his sample. I'm sure it's nothing to be too concerned about.
My daughter is too old to be in the study sample, she is 20. She won't even get another x-ray unless she has pain. She doesn't want to be exposed to the radiation, can't say that I blame her, though. There are risks with everything.
Something kind of interesting though, is my son has such a slight curvature that it's not considered "scoliosis" but he does have spina bifida occulta, which I also have. I wonder if there is a correlation there. Maybe a different study is being conducted on that. I'm not up on all the current studies, my life has been going in a completely different direction until recently.
I also wonder if there is a correlation to the gene/s connected with Marfan's syndrome, as scoliosis is very common in people with Marfan's. I have a nephew with Marfan's. My personal opinion is that it is that not one single gene is involved. And if a person gets a "good" copy of a gene and a "bad" copy of the same gene, there can still be enough bad protein (gene product) floating around that the good stuff isn't enough to completely suppress the disease. That would explain why my daughter has a very mild case.
In conclusion to this, all I can say is I need to read the reasearch that's been done. Something I have obviously neglected to do. I feel priviledged to have been part of the study and hope some good comes from it.
I look forward to hearing from you. I hope I wasn't confusing or too off topic.
:o

Sure, I'll let you know when I find out. Apparently, the results are into the Dr's office, but my daughter's ortho doesn't want to 'interpret the results for us'. Instead, he wants this Axial representative who he works with to give us the info. My daughter is one of the first in his office to have the test, so I guess they're trying to work out their process.

As for my son, this is the 3rd sample he is sending in. They told us on the 2nd sample that there was someting exciting with his DNA, and they even sent him a gift card as compensation for the 2nd sample. He's sending it in for free this time. :) I don't know--it just makes me want to watch him carefully as he gets older. He turns 18 this fall, so maybe I'll bring him back to the ortho one more time for a look over.

I'll keep you posted,

rohrer01
04-15-2010, 01:01 PM
Wow! I wonder what exciting thing they found? Does he have scoliosis?

debbei
04-23-2010, 06:38 PM
Wow! I wonder what exciting thing they found? Does he have scoliosis?

Hi,
yes the son who they've requested extra DNA twice does have a mild case of scoliosis.

LindaRacine
06-05-2012, 07:00 PM
http://www.ncbi.nlm.nih.gov/pubmed/22614798

Does ScoliScore™ Provide More Information Than Traditional Clinical Estimates Of Curve Progression?
Roye BD, Wright ML, Williams BA, Matsumoto H, Corona J, Hyman JE, Roye DP Jr, Vitale MG.
Source

1Department of Orthopaedic Surgery - Columbia University Medical Center, New York, NY. 2Division of Orthopaedics - Southern Illinois University - School of Medicine - Springfield, IL.
Abstract

STRUCTURED ABSTRACT: Study Design. Retrospective study comparing ScoliScore and clinical risk estimatesObjective. The purpose of this study is to compare risk stratification between ScoliScore and traditional clinical estimates to determine if ScoliScore provides unique information.Summary of Background Data. ScoliScore™ is a genetic prognostic test designed to evaluate the risk of curve progression in skeletally immature Adolescent Idiopathic Scoliosis patients with Cobb angles of 10°-25°. Clinicians are currently trying to better understand the role this test may play in guiding clinical decision making as current standards of curve progression are largely based on radiographic markers such as curve magnitude and bone age.Methods. Ninety-one patients who received ScoliScore testing at our center and met study inclusion criteria were identified. Patients were given a "clinical risk" level using their Risser sign and Cobb angle. Assigned clinical risk levels were compared to the ScoliScore risk levels reported by the manufacturer's scoring algorithm.Results. ScoliScore risk distribution in our population was 36%-low risk, 55%-intermediate risk, and 9%-high risk. This compares with 2%, 51%, and 47%, respectively for comparable clinical risk groupings. Only 25% of patients were in the same risk category for both systems. There were no significant correlations between ScoliScore and age, race, menarchal status, Risser sign or gender. There was a positive correlation between the Cobb angle and the ScoliScore (r = .581, p<0.001). Cobb angle remained significant in the multivariate regression model (p<0.001) and Cobb angle was found to account for 33.3% of ScoliScore's variance.Conclusion. Only Cobb angle showed significant correlation with ScoliScore among the socioclinical variables studied. The risk distribution of the two risk estimation systems examined differed markedly: ScoliScore predicted nearly 16x more low risk patients and over 5x fewer high risk patients. This demonstrates that ScoliScore provides unique information to traditional predictors of curve progression, advancing our understanding of the role of ScoliScore in the clinical setting.

Pooka1
06-05-2012, 07:33 PM
That's pretty interesting.

At least 34% of those kids were spared wearing a brace needlessly. This comports with other estimates of needless bracewear though it is on the low end... I have seen estimates of 75% to about 90% being needless. If that group is representative, then that is potentially a lot less bracing which was one of the goals in the future that the Scoliscore developers envisioned.

Pooka1
06-05-2012, 07:41 PM
By the way, that really goes to show the clinical indicators really aren't so good after all these years for predicting at the ends of the risk spectrum. They tended to greatly underestimate the low risk kids and greatly overestimate the high risk kids.

I conclude the following are possible explanations:

1. Clinical observation outside of rigorous controlled studies clearly does NOT give these surgeons a firm clue about curve progression risk for about half their patients with smaller curves. This is actually a penetrating glimpse into the obvious though we still have folks here who think even years and years of clinical work substitutes for controlled studies.

2. These surgeons are bracing out of fear of being sued or being browbeaten by ignorant parents.

3. Both #1 and #2.

flerc
06-15-2012, 09:18 AM
Sorry if I’m asking something well known. That kind of test was tested in an objective way? That is, testing samples of 2 groups of adults: having and not having scoliosis. Of course the test should to be done without knowing which sample belongs to each group.

Pooka1
06-15-2012, 09:28 AM
Sorry if I’m asking something well known. That kind of test was tested in an objective way? That is, testing samples of 2 groups of adults: having and not having scoliosis. Of course the test should to be done without knowing which sample belongs to each group.

They need to calibrate the test with known outcomes. Then they apply the formula to unknown outcomes.

All tests need to be calibrated.

flerc
06-15-2012, 11:05 AM
They need to calibrate the test with known outcomes. Then they apply the formula to unknown outcomes.

All tests need to be calibrated.

Sorry, it seems I don’t have idea about what kind of test it this. I supposed it was an exclusively genetic test, that is, only genes would be needed to do it, so saliva samples would be the only one needed for this test.
As a blood test says about a disease evaluating virus founded or not in blood (without any kind of calibration as I know) the scolioscore says about a progressive scoliosis evaluating the state of some groups of genes. That’s what I believed but it seems I’m wrong.

Pooka1
06-15-2012, 11:25 AM
Okay I re-read the abstract.

They are simply comparing the distribution of low, medium, and high risk patients based on two approaches, traditional clinical measurement and Scolicore.

They showed the two approaches for labeling patients as low, medium, or high risk of progression produce different predictions. So either one or none are right.

They did not report on which approach was more accurate though the smart money is on Scoliscore if it continues to make accurate predictions.

The importance of this is to show that the traditional clinical assessment of risk is not accurate at the low and high risk ends. This should not be surprising because surgeons working in uncontrolled situations can't in principle tell what is going on. If they got it right it would be coincidence. In this case they are getting it wrong. For decades. And so many kids have worn the brace needlessly. Many surgeons probably suspected that braces weren't likely to be necessary but parents aren't always rational on this point. Just because a treatment exists doesn't mean it is necessary or effective. Braces typify this point in spades.

Pooka1
06-15-2012, 11:28 AM
And so many kids have worn the brace needlessly.

These are counted as brace successes by those who do not understand the need for controls. They are not successes, they are failures because they are unnecessary treatment. The doctor's oath is to first do no harm. They are missing that mark with much of brace wear for lack of controlled studies.

flerc
06-15-2012, 12:22 PM
I should to read all this thread, it seems I have nothing clear.. I thought that the scoliosicore was always presented as the extremely accurate test that parents need to does in order to take decissions..

rohrer01
06-15-2012, 12:24 PM
They need to calibrate the test with known outcomes. Then they apply the formula to unknown outcomes.

All tests need to be calibrated.

Yes, all tests need to be calibrated. The problem is, they took samples from adults, like me, with known outcomes. FALSE. My outcome is changing and the makers of this test aren't even aware of people like me. They go with what x-rays they were given at the time they collected our DNA and categorize according to that.

flerc
06-15-2012, 01:02 PM
SALT LAKE CITY ...? Is the same?? http://www.scoliosis.org/forum/showthread.php?10652-First-Genetic-Test-for-AIS

rohrer01
06-15-2012, 01:08 PM
I believe that is where these researchers are located.

flerc
06-15-2012, 01:21 PM
Would be true that about those 3 or 4 men??

rohrer01
06-15-2012, 01:28 PM
What 3 or 4 men? I'm sorry I didn't look at the link. Are you referring to the researchers? If so, at least some of them came from the Twin Cities Spine Center in Minneapolis, MN, USA. Dr. Ogillvie for sure.

flerc
06-15-2012, 02:13 PM
Rorher, I was referring to that



I think it has been shown that between 3 and 4 men fathered all the children in the Mormon church. :D

...

rohrer01
06-15-2012, 04:42 PM
The study I was in was not the one conducted among those in the Salt Lake City area. However, unbeknownst to the people at Axial Biotech I am of Mormon descent and my scoliosis came down through that side of the family. They didn't ask that question on the questionnaire. I didn't know it at the time, anyway. My father was a practicing Mormon and I was raised that way, although am no longer. I found out my whole lineage (because they do geneology) after I did the DNA swab. My dad went blind and was dying and he asked me to read a bunch of papers. It was all geneology and it went all the way back to the beginning of "The Church" which kind of weirded me out a little. I'm not putting down Mormon's, as I still have Mormon family. I just didn't realize that there was a Mormon "ethnicity" like there is a Jewish "ethnicity". You don't have to be Jewish to be Jewish. I hope you understand what I'm saying...

Pooka1
06-15-2012, 05:40 PM
Fer, that was a joke about 3 or 4 men fathered all the children in the Mormon church. I was talking about polygamy which the Mormon Church reluctantly gave up in exchange for Utah becoming a state. But there are still large groups of Mormon polygamists walking around loose. Warren Jeffs, a leader of one, is now doing jail time for child rape or something along those lines. He married young teenagers. If you want to be a pedophile, the fundamentalist Mormon church is the place to be.

flerc
06-18-2012, 11:33 AM
Yes Rorher, I understand what you say, certainly I should have realize that the Sharon’s joke not may be possible.. I know Mormons in my country (I had a good friend) and of course they cannot be descendents of those men. I was doubting about the quality of the sample to get the scolioscore, but anyway I’m thinking (even I accept that I may be missing something because I didn’t read yet all this thread), that surely is not a predictive score model (as thousands used for differential applications) as I thought.

That kind of models are also used in Risk Analysis and the concept is to determine the behavior of specifics entities, analyzing the history and determining in that way, the variables (which of those exactly, values, incidence..) leading to some specific behavior.
Then the predictive model is used to anticipate the behavior of every entity belonging to the universe studied, only knowing the variables determined, whose values would be the input required to obtain an outcome (score) telling about the expected behavior.
In this case, the entities would be people’s spine, the variables would be genes and the behavior the progression.

And of course, all predictive models are tested with the most recent data before use it, that is, some entities whose variables and behavior are known (and not forming part of the Data Base used to make the model) are evaluated under the model and then is known if the model was accurate about the outcome for those entities or not.
This kind of models, in some areas need to be constantly checked, because for example, new variables not involved before may have now some kind of incidence, some scenarios changes..

So if this would be the case of the scolioscore, it should have to be tested with samples (having and not scoliosis as I asked before) before use it. I don’t know what kind of calibration may need, but anyway, that kind of test should have to be done and constantly should to be tested.

rohrer01
06-18-2012, 11:44 PM
Yes, it is my understanding that the test is meant to be predictive. Testing people with scoliosis and people without scoliosis is useless. There could be someone without scoliosis that tests very high, but never develops scoliosis. It only works once the process of the scoliosis had begun. Then those particular genes play a part in progression. What is the trigger that starts progression? No one knows for sure. I'm pretty sure that they looked at outcomes and compared the most frequent DNA sequences with the severe outcomes. Let's say everyone with a curve of 40* or more always have certain segments of DNA show up (yes, they used 40* as "severe" because they wanted to predict who would reach that angle or greater at or before skeletal maturity). Then a child comes in with AIS and has a scoliscore. IF that child has most or all of the markers that usually show up in larger curves, they will score high, meaning they have a great risk for progression and surgery may be considered sooner. That's how I understand it anyway. Also, high scoring individuals will usually NOT respond to bracing, so that saves them years of agony just to end up with surgery anyway. I'm sure Sharon will chime in here if I'm wrong. She is much more read on the Scoliscore than I am.

flerc
06-19-2012, 09:11 AM
All predictive score models may and must to be tested with existent data (not forming part of the data base used to construct the model) whose behavior is already known, otherwise it would be only a matter of faith to trust in that model.
In this case, the sample to test the scolioscore should be done with adults with small and big curves so scoliosis process has begun in all of them. In people with few degrees stopped (the score should be low) and in others not until so many degrees where reached (the score should to be high).

rohrer01
06-19-2012, 09:55 AM
As far as I know, that is how it was constructed. In my case, no one thought mine would progress, or at least not much.

flerc
06-19-2012, 10:03 AM
It seems to be constructed in that way (old people should have to be selected), but how it was TESTED?

flerc
06-20-2012, 12:35 PM
|
All predictive score models may and must to be tested with existent data (not forming part of the data base used to construct the model) whose behavior is already known, otherwise it would be only a matter of faith to trust in that model.
In this case, the sample to test the scolioscore should be done with adults with small and big curves so scoliosis process has begun in all of them. In people with few degrees stopped (the score should be low) and in the others not until so many degrees where reached (the score should to be high).

I believe that if that test was not done for some serious and and impartial Organization, parents should to be advised. Is good to have faith in God, Saints, some Religion, but in a Company doing a great bussiness???

rohrer01
06-20-2012, 03:26 PM
It seems to be constructed in that way (old people should have to be selected), but how it was TESTED?

I don't agree. There should be young people with already severe curves that would be as useful, if not more useful than old people. Older people sometimes progress due to age related degeneration on an already crooked spine. So this progression may have nothing to do with the genetic component of this disease. I don't think this company has any ulterior motives, at least not any more than any other company. They research to create a useful and marketable product that helps in the management of scoliosis. If money is made, that is not a bad thing. Think of how much a brace costs... Money pays for the time of the researchers. It pays for the company to keep going. It doesn't make them unreliable monsters. If I took the time to get a Ph.D., then I would expect to get paid for my services, too, even though I would be researching the things I thought would be helpful in improving lives.

flerc
06-20-2012, 04:54 PM
I don't agree. There should be young people with already severe curves that would be as useful, if not more useful than old people. Older people sometimes progress due to age related degeneration on an already crooked spine. So this progression may have nothing to do with the genetic component of this disease.
May be but, as I interpreted you was suggesting, young people with small curves may be not the best.



I don't think this company has any ulterior motives, at least not any more than any other company. They research to create a useful and marketable product that helps in the management of scoliosis. If money is made, that is not a bad thing. Think of how much a brace costs... Money pays for the time of the researchers. It pays for the company to keep going. It doesn't make them unreliable monsters. If I took the time to get a Ph.D., then I would expect to get paid for my services, too, even though I would be researching the things I thought would be helpful in improving lives.

?????? Where I have said something like that??. What I'm saying is that ALL PREDICTIVE SCORE MODELS MUST TO BE TESTED!! Do you not agree? Otherwise trust in them would be only a matter of faith. They are receiving a pay to do it (nobody is saying is bad), enough reason to do it, so which would be the reason of that faith? I saw many predictive score models in my life and it would be the first time I heard something like that. How clients may trust in them if THEY ARE NOT CORRECTLY TESTED? Tell me, maybe is all a confusion because my lack of imagination.

LindaRacine
06-20-2012, 05:00 PM
Like any good study, they used half the database to build the model, then applied the model to the other half of the database, and found it to be in the high 90 percents in terms of accuracy.

flerc
06-20-2012, 05:02 PM
To the best of my knowledge, the only use of the Scoliscore test is to predict whether or not a child is likely to progress into the surgical range (40+ degrees) by maturity.

And why are you sure that works in that case? What kind of test was done to be sure about how accurate is? I'm missing something? A test as I suggested was done?

flerc
06-20-2012, 05:08 PM
Like any good study, they used half the database to build the model, then applied the model to the other half of the database, and found it to be in the high 90 percents in terms of accuracy.

That's what I was asking. I imagine it was done or supervised by some Organization and it's continuosly tested with known data.

rohrer01
06-20-2012, 05:18 PM
How do you know that it wasn't properly tested? I don't ever recall reading that young patients with small curves were used in collecting the DNA samples used in developing this test. I guess that's why I made the assumption that I did about ulterior motives (money making). It's my understanding that they did extensive testing before releasing the test for public use. Also, by trying the test out on the public, they continue to collect data that will either confirm or negate that accuracy of this test. By having a scolicore done, there is NO RISK to the patient except for the risks involved with any blood draw. Data is being collected on all kinds of medical devices and drugs even after release to the public.

Treatment is ultimately decided upon by a collaboration between the doctor, parent, and patient (hopefully) and not based solely on the results of this test. For example, if a patient tests really high for progression, the parent may still want to brace their child. The scoliscore may indicate that the patient's scoliosis will progress regardless of bracing, but that does not mean that the parents and doctors should do nothing. Exercise and diet are always good for everyone, so this should always be implemented in any treatment plan. Bracing may be used to try to hold a curve until the child has had enough growth time to gain most the their skeletal maturity before surgery instead of having surgery before growth is complete or near complete. Sometimes, surgery may not be avoidable in adolescents with very low risser if they are progressing very rapidly. Scoliscore is just a tool to help evaluate the risk of progression. It doesn't take the place of treatment.

On the other hand, if the patient test really low for possible progression, they should still be monitored. If they do progress, bracing may still be considered. BUT, if progression is very slow and the child never reaches, say 30* (for the sake of argument), why put them through the pain of a brace? This doesn't mean that the physician and parents can't choose bracing as an option. It just might mean that there may not be a need for it. There may not be a need for super frequent x-rays, saving them from exposure. If the parent isn't comfortable with that. They certainly can ask for more strict monitoring despite a low Scoliscore.

In the end, it's just a tool. It can be used in deciding treatment options, but doesn't have to be considered when deciding treatment.

debbei
06-20-2012, 05:31 PM
My 3 kids and I were all included in this study. My kids all have small curves, I had the gigantic ones :)

Jesse, my middle son, had such a great sample that the Alial people had him send additional DNA 2x. They wouldn't tell me what was so 'special' about his vs. 2 siblings, but they said it was very 'exciting.' The 2nd time they even sent him a gift card.

I've said this here before--maybe even on this thread--that I wonder if he has the genes that will make him progress due to their interest in his samples.

He's 19 yrs old now and I will continue to watch him.

flerc
06-20-2012, 05:46 PM
How do you know that it wasn't properly tested?

Did you read my first question in this thread?


Sorry if I’m asking something well known. That kind of test was tested in an objective way? That is, testing samples of 2 groups of adults: having and not having scoliosis. Of course the test should to be done without knowing which sample belongs to each group.

Yes, it seems I was asking about something well known.
Read all what I post then, and say me when I said it wasn't properly tested. I was asking, not affirming. If you would have said me that
Like any good study, they used half the database to build the model, then applied the model to the other half of the database, and found it to be in the high 90 percents in terms of accuracy. (I suppose is exactly the test I was saying) I was not continuing asking the same.. in any case I would have asked about the Organization supervising that test, periodic test and so on, but not about if the right test was done or not.

Pooka1
06-20-2012, 06:35 PM
By having a scolicore done, there is NO RISK to the patient except for the risks involved with any blood draw.

It's a spit test.

Pooka1
06-20-2012, 06:52 PM
in any case I would have asked about the Organization supervising that test, periodic test and so on, but not about if the right test was done or not.

Scientific fraud is relatively rare. Scientists are the good guys and traffic in intellectual honesty as a rule.

flerc
06-20-2012, 08:25 PM
Scientific fraud is relatively rare. Scientists are the good guys and traffic in intellectual honesty as a rule.

Science and moral are not the same. There not exists such thing as elites. Mengele as I know was a scientist, and of course private companies should to be controlled. Test should to be for every kind of products regardless if scientists were working on it or not.

mariaf
06-20-2012, 09:46 PM
How do you know that it wasn't properly tested? I don't ever recall reading that young patients with small curves were used in collecting the DNA samples used in developing this test. I guess that's why I made the assumption that I did about ulterior motives (money making). It's my understanding that they did extensive testing before releasing the test for public use. Also, by trying the test out on the public, they continue to collect data that will either confirm or negate that accuracy of this test. By having a scolicore done, there is NO RISK to the patient except for the risks involved with any blood draw. Data is being collected on all kinds of medical devices and drugs even after release to the public.

Treatment is ultimately decided upon by a collaboration between the doctor, parent, and patient (hopefully) and not based solely on the results of this test. For example, if a patient tests really high for progression, the parent may still want to brace their child. The scoliscore may indicate that the patient's scoliosis will progress regardless of bracing, but that does not mean that the parents and doctors should do nothing. Exercise and diet are always good for everyone, so this should always be implemented in any treatment plan. Bracing may be used to try to hold a curve until the child has had enough growth time to gain most the their skeletal maturity before surgery instead of having surgery before growth is complete or near complete. Sometimes, surgery may not be avoidable in adolescents with very low risser if they are progressing very rapidly. Scoliscore is just a tool to help evaluate the risk of progression. It doesn't take the place of treatment.

On the other hand, if the patient test really low for possible progression, they should still be monitored. If they do progress, bracing may still be considered. BUT, if progression is very slow and the child never reaches, say 30* (for the sake of argument), why put them through the pain of a brace? This doesn't mean that the physician and parents can't choose bracing as an option. It just might mean that there may not be a need for it. There may not be a need for super frequent x-rays, saving them from exposure. If the parent isn't comfortable with that. They certainly can ask for more strict monitoring despite a low Scoliscore.

In the end, it's just a tool. It can be used in deciding treatment options, but doesn't have to be considered when deciding treatment.

Well said, rohrer01. Nobody is (hopefully) using this test as their sole deciding factor when it comes to surgery, bracing or any other treatment. So it is hard to imagine these folks could have a vested interest in any one particular outcome. I would also imagine that if one only wanted to get rich, they could find a much more lucrative way to do it. As Linda explained, they used pretty standard models when compiling their database. I see no red flags here.

flerc
06-21-2012, 01:16 AM
Asking for the kind of test used to measure the reliability of this product (as I did and nobody was replying), or about the Organism supervising that test (why not?) or about any other procedure used in other predictive score models on other areas, has nothing to do with what you are saying. Try to understand better before comment about what others said.

rohrer01
06-21-2012, 03:29 AM
It's a spit test.

I should have known, since my family and I gave them spit and not blood. =) ...That's a duh moment on my part!

rohrer01
06-21-2012, 03:33 AM
My 3 kids and I were all included in this study. My kids all have small curves, I had the gigantic ones :)

Jesse, my middle son, had such a great sample that the Alial people had him send additional DNA 2x. They wouldn't tell me what was so 'special' about his vs. 2 siblings, but they said it was very 'exciting.' The 2nd time they even sent him a gift card.

I've said this here before--maybe even on this thread--that I wonder if he has the genes that will make him progress due to their interest in his samples.

He's 19 yrs old now and I will continue to watch him.

That's interesting. I wonder if they would have wanted my daughter's DNA for the study had she been seen by an SRS doctor? She has a small curve and is grown now, but not at the time.

rohrer01
06-21-2012, 03:37 AM
Asking for the kind of test used to measure the reliability of this product (as I did and nobody was replying), or about the Organism supervising that test (why not?) or about any other procedure used in other predictive score models on other areas, has nothing to do with what you are saying. Try to understand better before comment about what others said.

I'm not sure what regulatory agency oversees the test. Maybe Linda knows. I would guess it would be the AMA (American Medical Association), but I could be wrong. I think maybe you are getting frustrated with our answers because, at least for myself, we are not crystal clear on what exactly you are asking.

rohrer01
06-21-2012, 03:42 AM
Scientific fraud is relatively rare. Scientists are the good guys and traffic in intellectual honesty as a rule.

I don't know if I agree there. I've heard of cover-ups, especially in pharmaceuticals. People are still people and scientists aren't immune to greed and dishonesty because they have Ph.D. or M.D. behind their names. I don't have any reason to doubt THESE people, though. They have nothing to gain by putting out a faulty test.

rohrer01
06-21-2012, 03:49 AM
So if this would be the case of the scolioscore, it should have to be tested with samples (having and not scoliosis as I asked before) before use it. I don’t know what kind of calibration may need, but anyway, that kind of test should have to be done and constantly should to be tested.

Linda answered the question you asked before. I believe I answered this one about why people without scoliosis would not be a good "control" for this type of study. I'm trying really hard to figure out what it is that you want to know that I am missing. It may be a language barrier.

mariaf
06-21-2012, 08:11 AM
Try to understand better before comment about what others said.

I was actually commenting on what rohrer said, which I understood perfectly. I'm not trying to attack you, flerc - I hope you don't read that tone into my posts - I think as someone said, there may be a bit of a language barrier which I think we are all, yourself included, trying to work around as best we can. However, nobody here seems to understand exactly what you are asking and maybe that's why our answers are not addressing your concerns.

mariaf
06-21-2012, 08:21 AM
I don't know if I agree there. I've heard of cover-ups, especially in pharmaceuticals. People are still people and scientists aren't immune to greed and dishonesty because they have Ph.D. or M.D. behind their names. I don't have any reason to doubt THESE people, though. They have nothing to gain by putting out a faulty test.

I agree on both points. First, that in this case there doesn't seem to be anything to be gained by these folks by putting out a faulty test. And second, I generally trust doctors, surgeons and other medical professionals a lot more than those in pharmaceuticals, whom I really don't trust much at all.

flerc
06-21-2012, 12:54 PM
I was actually commenting on what rohrer said, which I understood perfectly. I'm not trying to attack you, flerc - I hope you don't read that tone into my posts - I think as someone said, there may be a bit of a language barrier which I think we are all, yourself included, trying to work around as best we can. However, nobody here seems to understand exactly what you are asking and maybe that's why our answers are not addressing your concerns.

Ok Mariaf, I said that because you approved what Rorhrer was saying to me and I really don’t agreed with her reply, because as I said then, I was not criticizing anything or affirming anything, I was only asking to know about the approval procedures around the scolioscore. Surely it was a misunderstanding, maybe because a bit of a language barrier or because I was not expressing the concepts in the right way.

Certainly I have never paid before so much attention to the scolioscore history, only about the change that would imply in the scoliosis treatment, so I was not sure about anything related with it. When it begun to be clear for me that effectively it is a predictive score model, I wanted to know if the steps required to use such kind of models were satisfied and if the kind of data was the same as I was thinking should to be.
Rorhrer corrected me when she said that the samples must to be conformed with people having all of them scoliosis. So then I asked if effectively, the same kind of data used to constructed it, was used for test it, as it occurs in every predictive model.. this test is the way to be sure about how much reliable is the model, that is, how much sure may be someone about the outcome that the model may give for each sample. It seems I was not clear enough doing that question.
When Linda answered it, it was clear for me that A.B. declared to have complied with those (basic) steps required.

But when someone is thinking in acquire a predictive score model, before buy or approve their use, they should to be sure about how good it is. Nobody as I know refuse to does a test to know that, because in the construction of the model were involved recognized or prestigious people, as may be the people of that Company.
So I was asking what kind of test did the Government before approving the use of the scolioscore. It might have done for me in 2 ways: If people of Goverment were involved in some way in the Project, having access to the data used, they could have corroborated the validity of the test done.
Otherwise they should to do another test, with other data (but of the same kind). If that was the case, was the reliability (percentages of correct outcomes) the same as the determined by the Company? How many samples were used?

Well, that’s were the kind of questions I wanted to do about the scolioscore.. and I have more, but I don’t know if 'm being now clear enough. Please, let me know if not.

flerc
06-21-2012, 01:10 PM
Linda answered the question you asked before. I believe I answered this one about why people without scoliosis would not be a good "control" for this type of study. I'm trying really hard to figure out what it is that you want to know that I am missing. It may be a language barrier.

Yes Rorher, as I said recently to Mariaf, I understood both answers. I hope you may understand now what I said.

rohrer01
06-21-2012, 04:55 PM
Flerc,
If you want accurate information it is always best to go to the source rather than asking others. Here's the web address for Axial Biotech. Maybe you can direct some of your questions to them if they aren't directly answered on their website.

http://www.axialbiotech.com/

flerc
06-22-2012, 11:04 AM
Flerc,

I don't believe the government validates the efficacy of medical tests (or devices, btw). The only arm of the government involved in this kind of oversight, the FDA, only approves drugs. Again, to the best of my knowledge.

There's whatever efficacy is reported by the test maker would only be coming from the test maker.

FDA might not be the governmental organism for this, but should to be another available to test this product. I suppose they could not have any problem in collecting hundreds or thousands of samples of adults with small or big curves not belonging to the AB data base. It would be something extremely simple to do that test. How much could be the cost? Surely insignificant for something so important.

Pooka1
06-22-2012, 11:29 AM
FDA might not be the governmental organism for this, but should to be another available to test this product. I suppose they could not have any problem in collecting hundreds or thousands of samples of adults with small or big curves not belonging to the AB data base. It would be something extremely simple to do that test. How much could be the cost? Surely insignificant for something so important.

Here is the paper. Any scientist is invited to replicate the study.

http://www.ncbi.nlm.nih.gov/pubmed/21102273.1

This stuff (molecular biology) is extremely expensive to do. Scoliosis, while not an orphan disease, is close to that. It is important to you and us but in the grand scheme of medical research, IS etiology is barely on the radar as far as I can tell. There are no more than two or three major groups studying it IN THE ENTIRE WORLD. Now compare and contrast that with cancer research where the number of major groups studying that is probably in the hundreds if not thousands.

Perspective always.

flerc
06-22-2012, 07:53 PM
Here is the paper. Any scientist is invited to replicate the study.

http://www.ncbi.nlm.nih.gov/pubmed/21102273.1

This stuff (molecular biology) is extremely expensive to do. Scoliosis, while not an orphan disease, is close to that. It is important to you and us but in the grand scheme of medical research, IS etiology is barely on the radar as far as I can tell. There are no more than two or three major groups studying it IN THE ENTIRE WORLD. Now compare and contrast that with cancer research where the number of major groups studying that is probably in the hundreds if not thousands.

Perspective always.

I'm not saying to do any kind of study but to test the scolioscore. I understand it could not be any complication in doing that test.
How much expensive is to test a sample with that model? How much could be the cost for the Goverment to test some hundreds of samples? Certainly AB should to take charge of a considerable part of the cost, I believe.

rohrer01
06-22-2012, 08:22 PM
I think the ultimate "test" of the Scoliscore will come with time and the collection of data from those who are being tested as a part of their workup by their physicians. This information will almost certainly be passed along to Axial Biotech through physician reporting.

flerc
06-22-2012, 09:07 PM
I think the ultimate "test" of the Scoliscore will come with time and the collection of data from those who are being tested as a part of their workup by their physicians. This information will almost certainly be passed along to Axial Biotech through physician reporting.

Why to wait so many years if it may be done now? What if then is discovered that the reliability of that model was so lesser that the declared by the Company? And people taking fusion early? There would not way to know if the test was right or not.

Pooka1
06-22-2012, 09:38 PM
And people taking fusion early?

How do you know this? It sounds wrong.

flerc
06-22-2012, 09:43 PM
How do you know this? It sounds wrong.

Ok, I believe I have read something like this but surely I'm wrong.

LindaRacine
06-22-2012, 10:02 PM
This thread gets more bizarre by the moment. What, exactly, would the government test? A bunch of people's spit?

Axial Biotech has tens of millions of dollars invested in ScoliScore. They expect to never make a profit. Individual families rarely, if ever, have to pay anything for this test. First, most insurance companies are picking up the cost. American insurance companies apparently believe the research, or they wouldn't reimburse for it. If for some reason, the insurance company doesn't pay, the amount a patient's family has to pay is based on the family income. The family has to earn something like $450,000 per year to have to pay outright for the test.

If you want to find a company that is far more likely to be bilking the public, Fierc, you need only look at the companies and products of the dozens of threads you've started.

flerc
06-22-2012, 10:20 PM
If you want to find a company that is far more likely to be bilking the public, Fierc, you need only look at the companies and products of the dozens of threads you've started.

I have not any interest in that kind of discussions.

Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Dilber

Thanks for the advice!

flerc
06-22-2012, 10:21 PM
I should know this, because I used to be in Public Health, but I don't think the government actually tests any of these things - not even drugs. They ask drug manufacturers to run tests, but the federal government does not validate these things themselves (and, again, I don't think they even require that medical test manufacturers validate them, but I'm not sure).

And drugs are the bright spot in federal government oversight. If you get a medical device put in your body, like the pedicle screws used in scoliosis surgery, *no one* is responsible for vetting those. If there's a problem, the government can step in afterwards and ban them, but no one is ensuring that these things are safe/effective/etc before they go into you.

I think people believe that these things are under greater oversight then they actually are. But, it's really pretty wild west-y in the medical field.

I believe that if in fact, this is also the case with the scolioscore, surgeons should to remarks this fact when they recommends (they does?) the scolioscore to parents. Much people may trust so much in Goverment Organism and not so much in private companies and they are in their all right to think in that way.

flerc
06-22-2012, 10:50 PM
I'm not so sure they trust that much in government organisms either :)

What Rohrer and Maria are saying is right. No doctor is going to rely solely on the results of this test to recommend a treatment. Doctors tend to be very conservative - they do things the way they've always done them. If a doctor has a hunch or an intuition, based on experience, that a curve is going to progress, they're likely to go with their hunch rather then with the results of the test. If, over time, they feel that the test is more reliable then their hunches, then they'll start to depend on the test. But no doctor worth their salt is going to instantly start relying on a test which they have no experience with. That's just not how medicine works.

But they not give the score to parents?

flerc
06-22-2012, 10:56 PM
I believe that if in fact, this is also the case with the scolioscore, surgeons should to remarks this fact when they recommends (they does?) the scolioscore to parents. Much people may trust so much in Goverment Organism and not so much in private companies and they are in their all right to think in that way.

Hudger, in ultimate instance who decide are parents, or not? Then surgeons should to give all the information leading they to recommend what they recommend. So I not see what is wrong in what I said.

rohrer01
06-23-2012, 12:13 AM
Flerc,
Science and research are NOT usually overseen by a government agency in this country. I don't know what you keep asking about that for. Maybe in your country it is different, but here in the U.S. that is the way things are done. The federal government will give grants (money) for research, but that's as far as it usually goes, execpt for the FDA overseeing drugs. I would guess that this is because the development of new drugs has much more potential for dishonesty for monetary gain and could kill people. Medical tests harm no one, so why should there be governmental oversight? Do doctors need governmental oversight to test someone's blood for disease? No, they don't. There are agencies in place like the American Medical Association and the different medical licensing agencies that take care of quack doctors and can pull their license to practice medicine if they are hurting people. There is absolutely no harm that could come from getting a Scoliscore test. It is simply a tool to help give a doctor more information about the patient. If he bases his decisions strictly on that test, then he is inept and shouldn't be allowed to practice medicine. There is, in fact, a large pool of adults with known outcomes in the Axial Biotech database. Any other research organization, or individual, would be welcome to repeat AB's study. It is encouraged in science. But because there is medical reporting, why do they need to? That is what peer review is for. Scientists oversee other scientists. If the test proves inaccurate over time, people will quit using it. It's that simple. I gave you the web address to Axial Biotech. You can ask them these questions and I'll bet you'll get the same answers. I think you are beating a dead horse here. We've given you as much information as we can. I'm sorry that you don't find the answers satisfactory, but it is what it is. Sorry we can't come up with what you are looking for. It just doesn't exist, unless we are still misunderstanding you.

flerc
06-23-2012, 02:30 AM
The federal government will give grants (money) for research, but that's as far as it usually goes, execpt for the FDA overseeing drugs. I would guess that this is because the development of new drugs has much more potential for dishonesty for monetary gain and could kill people. Medical tests harm no one, so why should there be governmental oversight?


I don’t agree. A bad decision leading to something harmful may be taken believing in the test. The test is done to takes decisions although sometimes (as may occurs with the scolioscore) it may not the only the only source of information for that.
Do you really believe that a bad testing product saying about the existence or not of cancer may not be harmful????




Do doctors need governmental oversight to test someone's blood for disease? No, they don't. There are agencies in place like the American Medical Association and the different medical licensing agencies that take care of quack doctors and can pull their license to practice medicine if they are hurting people.

This is something absolutely different. I never suggested to oversight the doctor’s work, but the product they use.



There is absolutely no harm that could come from getting a Scoliscore test. It is simply a tool to help give a doctor more information about the patient.


Again I absolutely disagree because the same reason.



If he bases his decisions strictly on that test, then he is inept and shouldn't be allowed to practice medicine.


His decision may be different trusting in the test than don’t doing it. Otherwise which could be sense in doing that test???



There is, in fact, a large pool of adults with known outcomes in the Axial Biotech database. Any other research organization, or individual, would be welcome to repeat AB's study. It is encouraged in science. But because there is medical reporting, why do they need to?


What do you means about AB’s study? The construction of the scolioscore or the test of the scolioscore? If you means the first, I have never suggested that. If you suggest the last, I believe is a way to control this product, as FDA control drugs, that is, another kind of product. What is so bad in thinking that would be good to have a similar kind of control also in this case? Really I don’t understand. If it is impossible, ok is impossible, but nobody may say that would not have sense.



If the test proves inaccurate over time, people will quit using it. It's that simple.


I not see it so simple. I don’ t believe that any parent may see it so simple. I believe they prefer to know now if it’s inaccurate or not. So I believe they'd prefer to have the best guarantee that is a good product, so I believe that if the goverment gives such kind of guarantee (for example doing the simple test I said) they would see it as a more reliable product. But ok, I may be wrong and for all parents, the guarantee of the Company would be absolutely enough and they not need any more.



I think you are beating a dead horse here. We've given you as much information as we can. I'm sorry that you don't find the answers satisfactory, but it is what it is. Sorry we can't come up with what you are looking for.


No, I don’t believe that



It just doesn't exist, unless we are still misunderstanding you.



I believe Hdugger understand me what I was asking and saying and I perfectly understood her response. Then I was commenting what I believe about that.. and then we may agree or not with our comments .. nothing else. And of course nothing bad is in thinking different.. I try to believe..

Thanks for your interest in clarifying my doubts

flerc
06-23-2012, 03:26 AM
I'm not sure if they should or not (or if they could or not), but they don't. Parents will likely get a few numbers (a Cobb angle, maybe a Riser score, and a scoliscore test, if it's given), but they aren't expected to make a decision based on that information. They couldn't, I don't think. They're supposed to trust the doctor to make a recommendation based on those few numbers and lots more information that the doctor likely couldn't put into words.

I've been on the forum, pretty actively reading about scoliosis for several years now. I couldn't tell you if my son should have surgery or not if you held a gun to my head. I doubt I'd ever have enough information to make that decision. All I can do is get enough information from a site like this to figure out who a good doctor is, and trust them to parse the information enough to allow me to reach a decision. The last time I saw my son's surgeon, he did not recommend surgery. So, we didn't get surgery. If he does recommend it when we go again in December, and if someone else I respect concurs, my son would likely get surgery. It's really that simple.

So, a number on a scoliscore test one way or another isn't really going to matter to me. If my surgeon feels like it's a good predictor or feels like it's a poor predictor, then I have to trust his judgement. There's just no good way I could reach a sound decision on the topic.

Certainly is not the point if only Dr. may decide or not. As I said to Rorhrer, Dr's decision may be different trusting in the outcome of the test than don’t doing it. Otherwise which could be sense in doing that test??? So it would be good to count with a good predictive model. So it would be good to have the best guarantees.. so..

mariaf
06-23-2012, 06:18 AM
But they not give the score to parents?

flerc,

If you are asking if parents receive their child's score from the scoliscore, yes they do. I have talked to several parents who repeated what their child's numerical score was - they also knew the interpretation of the score (i.e., low risk of progression, etc.). Hope this helps.

mariaf
06-23-2012, 06:29 AM
I'm not sure if they should or not (or if they could or not), but they don't. Parents will likely get a few numbers (a Cobb angle, maybe a Riser score, and a scoliscore test, if it's given), but they aren't expected to make a decision based on that information. They couldn't, I don't think. They're supposed to trust the doctor to make a recommendation based on those few numbers and lots more information that the doctor likely couldn't put into words.

I've been on the forum, pretty actively reading about scoliosis for several years now. I couldn't tell you if my son should have surgery or not if you held a gun to my head. I doubt I'd ever have enough information to make that decision. All I can do is get enough information from a site like this to figure out who a good doctor is, and trust them to parse the information enough to allow me to reach a decision. The last time I saw my son's surgeon, he did not recommend surgery. So, we didn't get surgery. If he does recommend it when we go again in December, and if someone else I respect concurs, my son would likely get surgery. It's really that simple.

So, a number on a scoliscore test one way or another isn't really going to matter to me. If my surgeon feels like it's a good predictor or feels like it's a poor predictor, then I have to trust his judgement. There's just no good way I could reach a sound decision on the topic.

So much good stuff in this post. My son was originally diagnosed about a decade ago. During that time I, too, have done tons of reading and research, actively read scoliosis forums, started my own forum/website on VBS and other fusionless alternatives with another mom, talked to numerous doctors, hundreds of parents, etc., etc.

That said, the only one I would ever trust to decide on the course of my son's treatment is his doctor - in our case, Dr. Betz, whom I trust completely (otherwise, IMO, we should have another doctor). If you have a good doctor whom you trust, who has treated hundreds (maybe thousands) of patients for scoliosis over decades, who has access to all sorts of medical data (particularly in teaching hospitals like Shriners), and has analyzed that data year after year, consulted with other top colleagues in the field, attended conferences where these colleagues share the latest information with each other, etc. - how could I possibly put my limited knowledge against his?

I am NOT saying that anyone is suggesting that parents make these decisions alone or take decisions out of the doctors' hands (that would be nuts) - I'm just pointing out that at the end of the day, hopefully we have found what we feel are the very best doctors in the field to treat our children and we must trust them - in my view, it's in our kids' best interest to do so.

mariaf
06-23-2012, 06:54 AM
His decision may be different trusting in the test than don’t doing it. Otherwise which could be sense in doing that test???


I don't necessarily agree with this, flerc. I talk to lots of parents - many whose kids have taken this test - and I haven't gotten the impression from any of them that, for example, surgery - or any other method of treatment - was ever recommended (or not recommended) by their childs' doctor because of the scolisore.

I suppose the sense in doing the test is to learn. I do think the doctors are very interested in watching the test results roll in, and seeing if those results match actual patient outcomes, something that could take several years.

I'm sure there are guidelines for the current test criteria (i.e., reasons that AB believe it works) but as time goes on, and more and more results are examined, the test will become more reliable and more widely accepted and used - or the opposite could happen if those results are not favorable.

mariaf
06-23-2012, 06:57 AM
Doctors tend to be very conservative - they do things the way they've always done them.

I have found this to be true as well.

Pooka1
06-23-2012, 07:38 AM
I have found this to be true as well.

This (doctors being conservative and not wanting to change) arguably needs to change. Kids are being tortured with bracing for no reason. That one paper I posted documented a huge overtreatment with bracing which was known or suspected from other studies. One study estimated that 9 kids are treated with bracing for one that actually might have benefited. That is outrageous in terms of suffering an cost.

One study so far documented that surgeons are OVERestimating the progression potential and underestimating the low risk group size. This result merely shows the obvious... there is a reason even decades of clinical work can't in principle substitute for controlled studies or accurate genetic tests in this case. Surgeons just see that a majority of kids wearing braces don't progress to surgery but what they can't know is that most of those kids wouldn't have progressed to surgery without the brace. It is impossible for them to distinguish this in practice so they are conservative.

If Scoliscore stands, it deserves the Nobel for saving kids from harsh and unnecessary treatment.

flerc
06-23-2012, 10:24 AM
Mariaf, I know you are not saying exactly that, but I don’t agree that everyone MUST to leave always the decision in Dr’s hands, regardless he may be the best or the worst. Is great you are happy to have done what your surgeons said you, but would you be so happy to have done what he said if you would see now your son suffering a lot or in a bad condition? And that may happen depending on the particular case even with the best Dr. of the world. When you are confronted with terrible choices, is not so simple to lead the decision in other hands. But even if we want to leave all in Dr’s hands, they should to give all the information about why they recommends what they recommend and the risk in doing that. At least it may be useful to trust in him or decide to know another opinion.

So, as they must to inform about the Cobb angle, the Risser and statistics about progression and the genetic score (as you said they are informing) when it was done, they should to explain the reliability of this test. Of course, if they only does the test to learn and watching the test results, they not need to explain that.
And of course, even if he are taking into account the score, if for every parent, the guarantee of a private company is absolutely enough, they also not need to say anything about that.

rohrer01
06-23-2012, 11:19 AM
Flerc,
I'm going to address some of these things since I believe you are misunderstanding what I am trying to say.
I don’t agree. A bad decision leading to something harmful may be taken believing in the test. The test is done to takes decisions although sometimes (as may occurs with the scolioscore) it may not the only the only source of information for that.
Do you really believe that a bad testing product saying about the existence or not of cancer may not be harmful????
Rarely, if ever, do doctors rely on one test before beginning a treatment. If they did, they would be bad doctors. Cancer is a good example of that. For instance, I was screened with mammography that suggested that I may have breast cancer. The doctor's did not rely on that one test and schedule me for a mastectomy. They did a magnified mammogram (which was also wrong and the error rate here is 90%) and then a biopsy to confirm whether or not I really did have cancer. As it turned out I did not have cancer, so was spared a mastectomy. So in this instance, the initial mammogram told them more information, but they did not rely solely on that information. Does that mean that we should do away with mammography as a bad test since it is usually WRONG about cancer? When I say that, I mean on an initial mammogram that looks suspicious for cancer, LESS THAN 1% of those suspicious mammograms end up being cancer. I don't believe we should do away with that SCREENING test because it is usually wrong. It is wrong over 99% of the time but still has the potential to save the lives of the <1% of people screened that actually do have cancer.

Now compare that to Scoliscore. I would say that MOST scores do not tell the doctor anything because they are neither really high nor really low. But for the few that fall into one of these categories, it can help the doctor determine what other tests should be done and how frequent they need to have x-rays. This could save thousands of kids with low scores from being over radiated. For the very few with very high scores, having more frequent x-rays could save them from not being diagnosed with very rapid progression. It's good to intervene if the progression becomes very rapid, as the more severe the scoliosis, the more dangerous the surgery. This doesn't mean that they will operate on kids with 20* curves just because they scored very high. That would be insane.




This is something absolutely different. I never suggested to oversight the doctor’s work, but the product they use.
If you limit the tests available to doctors by strict governmental oversight, you are in essence tying their hands. They should be able to use whatever test they want so long as they know the test limitations.
An example here is the standard test for Lyme's disease. The standard test misses many, many cases of Lyme's disease. Does that mean that this test should be banned? No, because it catches "some" cases. For the one's that it misses there is another test that is more expensive, but more accurate. It also misses some of the cases of Lyme's. Should it be thrown out also? No, because it catches more cases than the first test. But because it is more expensive it is not the first choice in testing for Lyme's. Ultimately, some cases of Lyme's have to be diagnosed purely by symptoms. That's where a doctor should be very discerning.

It's the same with Scoliscore. The doctors need to be discerning and rely on their judgement for most of the kids that have meaningless scores. For those that have meaningful scores, they must be watched either more or less aggressively. This DOES NOT HARM the child.



His decision may be different trusting in the test than don’t doing it. Otherwise which could be sense in doing that test???
It is used as a screening tool, not as a diagnostic tool. It's like the difference between the low magnification mammogram and the high magnification mammogram and the biopsy and the ultimate mastectomy. I would compare it to the original low magnification mammogram. It tells something, but not everything.




What do you means about AB’s study? The construction of the scolioscore or the test of the scolioscore? If you means the first, I have never suggested that. If you suggest the last, I believe is a way to control this product, as FDA control drugs, that is, another kind of product. What is so bad in thinking that would be good to have a similar kind of control also in this case? Really I don’t understand. If it is impossible, ok is impossible, but nobody may say that would not have sense.
I believe that the very nature of the construction of this test has everything to do with the test itself. People with larger curves posses certain DNA segments (genes if you prefer) that people with smaller curves do not. They were able to see this as they looked at the DNA of all of the individuals they tested when they compared DNA of those with larger curve magnitudes with DNA of people with smaller curves. So basically if you see it enough in randomly chosen "test subjects", you know what to look for in the rest of the population. As far as I know, they contacted SRS doctors and asked their patients permission to look at x-rays and give DNA samples. So, if my DNA was looked at to see which "progression genes" I posess, what makes the fact that I may have certain genes any different than your daughter, who was not part of the study, if she posesses some of the same genes? If your daughter were tested, they would be looking for the same genes that show up in other people with 40* or larger curves. It's not really any different, except they have, by looking at many sets of DNA, narrowed the common progression genes down. If your daughter posessed them, the same as me, it doesn't make any difference whether she was part of the study or just took the test. It's the same process of isolating DNA and looking to see what shows up. It's not a tell all. It's a look at what genes someone posesses. You have to take into consideration the unknown factors that start progression. Again, that's why the test is useless for people without scoliosis. Because these other factors are unknown, the test could never be 100% reliable. MOST medical screening tests are not even close to 100% reliable.



I not see it so simple. I don’ t believe that any parent may see it so simple. I believe they prefer to know now if it’s inaccurate or not. So I believe they'd prefer to have the best guarantee that is a good product, so I believe that if the goverment gives such kind of guarantee (for example doing the simple test I said) they would see it as a more reliable product. But ok, I may be wrong and for all parents, the guarantee of the Company would be absolutely enough and they not need any more.
The U.S. government does not regulate these things. I can give you a much more serious example. There was a hip prosthesis used in hip replacement surgeries made by a certain company. It was the artificial DuPuy hip. These artificial hips WERE faulty and many people were injured by having this faulty hip transplant. Now hip transplant is one of the few surgeries along with scoliosis surgery that is a "big one". The government wasn't the one intervening as far as I know. Because of medical reporting, the company that made these issued a recall. Now how do you recall implants that are already in people? The people sue the company for any damages, pain and suffering, and medical costs involved in replacing the faulty hip implants. The company has to pay a LOT of money to these people for producing a faulty product. Now this isn't something that these companies want to happen. So they try their hardest to extensively test the products before they release them for use in live people. This company lost a LOT of money. If someone was not healthy enough to have a faulty hip replaced, then they had to live with it. Medicine is not a perfect art. I'm sure there must be some regulatory agency looking over these things, but I could be wrong. I'm pretty sure it's not the government. I am not aware of any government agency except the FDA. The FDA basically only regulates things we consume such as food and drugs.

They do have a Surgeon General in the government, but I don't really know how much power they have. I know that cigarrettes and other tobacco products, for example, by government mandate, have a Surgeon General's warning about the risks of tobacco use on the label of every tobacco product. The FDA mandates that foods be labelled for content and that drugs list adverse reactions and potential problems and contraindications in their leaflets that come with the original packaging and that it be made available to consumers upon request. I just don't think that the same holds true for diagnostic tests. The legal system is set up to handle that. If someone is injured, they sue the company that issued the test or in some way caused harm. That's why doctor's have to have malpractice insurance, too. If they make a mistake, they can be sued for a LOT of money and can have their medical license revoked by a medical licensing board, not the government. Companies, too, can be sued. In large cases they call them "class action suits". People don't like to be sued, so that is what regulates a lot of what goes on here in this country. I should probably know more about the regulatory agencies in my own country, but they only require so much in school. They can't cover everything.

There is absolutely NO offense taken. I just feel that you are saying that Scoliscore should be regulated by the government for its reliability. That is not wrong. I just don't think things work that way here. Science self-regulates by peer review and challenges by other scientists, even in the medical field.

rohrer01
06-23-2012, 11:31 AM
If Scoliscore stands, it deserves the Nobel for saving kids from harsh and unnecessary treatment.

I 100% agree!

Pooka1
06-23-2012, 03:07 PM
I would say that MOST scores do not tell the doctor anything because they are neither really high nor really low.

Actually, I think in one calibration set, about 75% were in the low risk group, 24% were in the medium risk, and 1% were in the high risk. I think the perceived goal of the work was to avoid bracing the low risk kids and get the high risk kids into VBS or something. The 24% medium risk are still at risk for being treated, perhaps uselessly either because the bracing won't work or they never needed bracing. Some may be helped by bracing, at least for the a few years.


The doctors need to be discerning and rely on their judgement for most of the kids that have meaningless scores.

About 75% have meaningful scores. Only 25% still have a question mark hanging over them.

rohrer01
06-23-2012, 03:17 PM
Thank you for the correction, Sharon. However, medium risk, at least in my opinion, is meaningless in the sense that you don't know which way it will go. Really low scores and really high scores are the most meaningful. It was my understanding from other posts that really low and really high scores are rare. I stand corrected. I would much rather subject my child to VBS or tethering than fusion. I realize that they are both surgery, but they leave some flexibility. There are still criteria for these procedures other than the Scoliscore and would still be done despite having this extra tool to help in prognosis. My point to Flerc was that this test isn't causing harm to kids even "if" it turns out to be unreliable, which I don't believe is the case. The other point was that scientists keep themselves "in check" by peer review and the ability to challenge the study by trying to repeat it. I don't believe Scoliscore needs to be repeated, as it is self-repeating in nature by physician reporting.

Pooka1
06-23-2012, 03:26 PM
Thank you for the correction, Sharon. However, medium risk, at least in my opinion, is meaningless in the sense that you don't know which way it will go.

I agree. Luckily it will be only about 25% of the kids who won't have an answer from Scoliscore.


I would much rather subject my child to VBS or tethering than fusion.

Completely agree. If my kid scored in high risk I would immediately seek out VBS or tethering. If medium risk, I would watch it closely and them think about VBS or tethering.


My point to Flerc was that this test isn't causing harm to kids even "if" it turns out to be unreliable, which I don't believe is the case. The other point was that scientists keep themselves "in check" by peer review and the ability to challenge the study by trying to repeat it. I don't believe Scoliscore needs to be repeated, as it is self-repeating in nature by physician reporting.

Good points. Agreed.

The beauty of Scoliscore, if it stands, is that about 75% will have some kind of hard idea what will happen with their curve. The one unknown is that some of the low risk kids will end up with curves >30* but <40* and so although are not surgical at maturity might be so at some point later in life.

rohrer01
06-23-2012, 03:31 PM
The one unknown is that some of the low risk kids will end up with curves >30* but <40* and so although are not surgical at maturity might be so at some point later in life.

Don't I know the truth in that. I only wish they had Scoliscore when I was a kid. At least I could have known which category. At that time, of course they didn't have VBS or tethering. I would still rather have been fused a few vertebrae way back then, than be enduring what I am today.

Pooka1
06-23-2012, 03:41 PM
Don't I know the truth in that. I only wish they had Scoliscore when I was a kid. At least I could have known which category. At that time, of course they didn't have VBS or tethering. I would still rather have been fused a few vertebrae way back then, than be enduring what I am today.

Yeah there seems to be a group of kids, of which you were probably included, who might have or even arguably would have benefited from fusion despite being below the normal trigger angle. While your cases is somewhat murky, the kids with TL curves seem to clearly constitute a case for operating below the trigger angle to save levels.

They just don't know what is better for unusual curves like you have. There probably is not enough of a case load to figure out the best way forward. In other cases, maybe fusing a few levels at very low angles will solve the problem. We may never know because surgery always carried risks. What Scoliscore can do is help people better assess all risks so they can balance them out more accurately. Maybe high risk kids will opt to try to fuse a few levels at the apex in an effort to avoid both VBS/tethering and very long fusions. Your curve is very high and tight. Maybe that is the kind that would respond to an early tiny fusion at the apex. Who knows what the future holds.

flerc
06-23-2012, 04:36 PM
Flerc,
I'm going to address some of these things since I believe you are misunderstanding what I am trying to say.
Rarely, if ever, do doctors rely on one test before beginning a treatment. If they did, they would be bad doctors. Cancer is a good example of that. For instance, I was screened with mammography that suggested that I may have breast cancer. The doctor's did not rely on that one test and schedule me for a mastectomy. They did a magnified mammogram (which was also wrong and the error rate here is 90%) and then a biopsy to confirm whether or not I really did have cancer. As it turned out I did not have cancer, so was spared a mastectomy. So in this instance, the initial mammogram told them more information, but they did not rely solely on that information. Does that mean that we should do away with mammography as a bad test since it is usually WRONG about cancer? When I say that, I mean on an initial mammogram that looks suspicious for cancer, LESS THAN 1% of those suspicious mammograms end up being cancer. I don't believe we should do away with that SCREENING test because it is usually wrong. It is wrong over 99% of the time but still has the potential to save the lives of the <1% of people screened that actually do have cancer.


Rorhrer, in every case the reliability of the test (screening or predictive) should to be tested and known. What if they supposed that mammogram is much more reliable than it is in fact? It might not suggest any problem in women having cancer and if they believe is so much accurate they might not do any other test and cancer might advance. Or suppose biopsy would be something harmful. How many women may be hurt unnecessary?



Now compare that to Scoliscore. I would say that MOST scores do not tell the doctor anything because they are neither really high nor really low. But for the few that fall into one of these categories, it can help the doctor determine what other tests should be done and how frequent they need to have x-rays. This could save thousands of kids with low scores from being over radiated. For the very few with very high scores, having more frequent x-rays could save them from not being diagnosed with very rapid progression. It's good to intervene if the progression becomes very rapid, as the more severe the scoliosis, the more dangerous the surgery. This doesn't mean that they will operate on kids with 20* curves just because they scored very high. That would be insane.


In order to allow what you say, it would to be a reliable product. I believe that enough proofs of that reliability should to be done in order to use it as are you are saying. Otherwise it could be of course a dangerous procedure.



If you limit the tests available to doctors by strict governmental oversight, you are in essence tying their hands. They should be able to use whatever test they want so long as they know the test limitations.
An example here is the standard test for Lyme's disease. The standard test misses many, many cases of Lyme's disease. Does that mean that this test should be banned? No, because it catches "some" cases. For the one's that it misses there is another test that is more expensive, but more accurate. It also misses some of the cases of Lyme's. Should it be thrown out also? No, because it catches more cases than the first test. But because it is more expensive it is not the first choice in testing for Lyme's. Ultimately, some cases of Lyme's have to be diagnosed purely by symptoms. That's where a doctor should be very discerning.


I have never suggested something like that. I only said that government should to give guarantees of the reliability of this product and not only believe in what any Company may say about the test they did, because they assumed they are the good guys and so much competents. I never said they are not. But this is not the way that the client –consumer model works. I have seen many giant companies billing dozens, hundreds.. of times more than AB, with so many scientist and genious of every kind working for them, proving that their products really works as they says in order that clients may be interested in acquiring it. They not feel offended when clients requires to does or supervise a test of their products.

In this case the clients would be the people and the Government should to represent them, so they should had supervised the AB test or done another one (as I was saying with adults having scoliosis). Maybe they have done yet something in this sense and all this discussion has not any sense, I simply was asking, not affirming anything.
And anyway is just only my point of view. . maybe that if your Government is just only trusting in that Company, all people believe they are doing the right and nothing more is necessary. . and probably they are right. Many people in the world would works more relaxed if nobody tests their products before acquiring them and just only trust in their word and expertise.



It is used as a screening tool, not as a diagnostic tool. It's like the difference between the low magnification mammogram and the high magnification mammogram and the biopsy and the ultimate mastectomy. I would compare it to the original low magnification mammogram. It tells something, but not everything.


Yes, and it might be harmful if is not reliable.



I believe that the very nature of the construction of this test has everything to do with the test itself. People with larger curves posses certain DNA segments (genes if you prefer) that people with smaller curves do not. They were able to see this as they looked at the DNA of all of the individuals they tested when they compared DNA of those with larger curve magnitudes with DNA of people with smaller curves. So basically if you see it enough in randomly chosen "test subjects", you know what to look for in the rest of the population. As far as I know, they contacted SRS doctors and asked their patients permission to look at x-rays and give DNA samples. So, if my DNA was looked at to see which "progression genes" I posess, what makes the fact that I may have certain genes any different than your daughter, who was not part of the study, if she posesses some of the same genes? If your daughter were tested, they would be looking for the same genes that show up in other people with 40* or larger curves. It's not really any different, except they have, by looking at many sets of DNA, narrowed the common progression genes down. If your daughter posessed them, the same as me, it doesn't make any difference whether she was part of the study or just took the test. It's the same process of isolating DNA and looking to see what shows up. It's not a tell all. It's a look at what genes someone posesses. You have to take into consideration the unknown factors that start progression. Again, that's why the test is useless for people without scoliosis. Because these other factors are unknown, the test could never be 100% reliable. MOST medical screening tests are not even close to 100% reliable.


So if the test is done in 100 adults with so much and few degrees, those genes should to be or not founded in at least 90 cases (giving high or low scores).



The U.S. government does not regulate these things. I can give you a much more serious example. There was a hip prosthesis used in hip replacement surgeries made by a certain company. It was the artificial DuPuy hip. These artificial hips WERE faulty and many people were injured by having this faulty hip transplant. Now hip transplant is one of the few surgeries along with scoliosis surgery that is a "big one". The government wasn't the one intervening as far as I know...


Yes, surely is as you say.



There is absolutely NO offense taken. I just feel that you are saying that Scoliscore should be regulated by the government for its reliability. That is not wrong. I just don't think things work that way here. Science self-regulates by peer review and challenges by other scientists, even in the medical field.

Yes, I think that Government should to be sure about the reliability of every kind of test used in medicine, but certainly I have never worked with any Health Organization/Institute, even in my country I don’t know how the guarantees in this sense are given.
And of course, not offense taken. Is good to talk even in the absolute disagreement when there are not attacks and nobody tries to convince the other about their thoughts.

mariaf
06-23-2012, 10:35 PM
Mariaf, I know you are not saying exactly that, but I don’t agree that everyone MUST to leave always the decision in Dr’s hands, regardless he may be the best or the worst. Is great you are happy to have done what your surgeons said you, but would you be so happy to have done what he said if you would see now your son suffering a lot or in a bad condition? And that may happen depending on the particular case even with the best Dr. of the world. When you are confronted with terrible choices, is not so simple to lead the decision in other hands. But even if we want to leave all in Dr’s hands, they should to give all the information about why they recommends what they recommend and the risk in doing that. At least it may be useful to trust in him or decide to know another opinion.


I agree with you, flerc that I would want to know what the doctor is recommending and why he is recommending it regarding the treatment of my son. And, believe me, I have never been afraid to ask every question that was on my mind. I guess at the end of the day, it's a partnership between parent and doctor when deciding on treatment, but I do believe that if I had the best doctor in the world as you say, or one of the best, his or her knowledge would far outweigh mine so as long as their course of action made sense to me, I would go along with it because I would feel it was in my son's best interest to do so. But I do think parents should be informed and should fully understand all aspects of their child's care and never be afraid to question what they don't understand.

mariaf
06-23-2012, 10:43 PM
This (doctors being conservative and not wanting to change) arguably needs to change. Kids are being tortured with bracing for no reason. That one paper I posted documented a huge overtreatment with bracing which was known or suspected from other studies. One study estimated that 9 kids are treated with bracing for one that actually might have benefited. That is outrageous in terms of suffering an cost.

I completely agree.

Bracing is a good example of why it needs to change. I would also include the fact that there are not nearly enough doctors performing VBS and tethering for that VERY reason, that they want to stick with things they are familiar with and do things the way they have always done them. Many of these doctors will refer patients to a doctor who DOES perform VBS, for example, but will say they are not yet performing it themselves. I'd like to know what the heck they are waiting for since they obviously feel the procedure is reasonably safe and effective - otherwise they would not be referring patients to other doctors for a consult.

rohrer01
06-24-2012, 04:01 AM
Flerc,
It is not a matter of disagreeing. I agree that there should be some oversight of any kind of medical tests. But who should do it? Do you really trust a government with your health? Some would say yes, others no. That's a matter of politics. I'm pretty sure there ARE checks and balances in place, but I don't know what they are. If they aren't in place, then they should be. We agree on that.

flerc
06-24-2012, 08:59 AM
I agree with you, flerc that I would want to know what the doctor is recommending and why he is recommending it regarding the treatment of my son. And, believe me, I have never been afraid to ask every question that was on my mind. I guess at the end of the day, it's a partnership between parent and doctor when deciding on treatment, but I do believe that if I had the best doctor in the world as you say, or one of the best, his or her knowledge would far outweigh mine so as long as their course of action made sense to me, I would go along with it because I would feel it was in my son's best interest to do so. But I do think parents should be informed and should fully understand all aspects of their child's care and never be afraid to question what they don't understand.

Mariaf, I understand and I respect what you say but I believe that sometimes is not clear which could the right decision. If you know that you’ll make a terrify and irreversible damage to your son doing what the best doctor say, because he believes that the chances of a worst damage in the future are high, I think that is not a simple decision. Mainly if nobody may assure that a Dr of the XXII century might believe that the chances of something worst in your particular case are not so high and he know that because he has a knowledge not acquired yet for Drs of our age.. and who knows if also he would not recommend you something known in your age. .

So in some cases, Drs of our century may be wrong in their recommendations as we know they were in some cases Drs of gone centuries and you may do something terrible to your son trusting in them. And of course you might do something worst not doing what they recommend. It’s not a simple decision.
There are areas where the knowledge of our Drs we may say is enough and of course it would be a madness to doubt in does what they say. If your son would have appendicitis and you refuse the surgery, there would not be any doubt about your wrong and unacceptable action. This problem is well known and surely none Dr of the future would doubt that the current Drs’s solution would be the best option for your son in your century.

But if the problem of your son, even is known for Drs since centuries ago, remains being a mystery for them and they only has old and bad solution for your case, guaranteeing irreversible damages, I believe that nobody may say that is clear what to do.

leahdragonfly
06-24-2012, 10:48 AM
I think that Government should to be sure about the reliability of every kind of test used in medicine

I agree that some sort of oversight somewhere would be good, but I think it is extremely idealistic to expect the government to guarantee the reliability of EVERY medical test offered. The expense of that to the government would be absolutely staggering. And it's not like the government has a great track record for efficiency or integrity. I think it is more the role of the physician to evaluate the legitimacy of the test and decide if he/she wants to offer it in their practice. Physicians are trained in medicine, but the government is not. At some point every patient or parent has to find a doctor they trust, who they believe is the best and most qualified choice for them, and trust that person's judgement and training, as Maria said.

On a side note, my two kids and I just sent in spit DNA samples to Axial Biotech and we are participating in their research study, hopefully aimed at genetic testing/predictive tests for progression in JIS. We are a good family to study with all three of us having scoliosis.

flerc
06-24-2012, 01:02 PM
Rohrer, Leahdragonfly, certainly I not trust a priori in any Government. I have seen in my life few good governments and so much of the worst of the worst. But is their responsibility to assure that things work as they should to works. This is the role of the State and governments should to execute the action needed to grant the right function of the State.
The health of course is some of the most important issues and the State should to assure that controls are done as they should.
Dr’s knowledge of course is limited even for the best, specially in some areas and of course they need the best tools, mainly since some decades ago, when something as a ‘study oriented decision’ have begun. It seems that now they almost not need to see the patient, to touch it.. as was some decades ago. Now they mainly see the outcomes of studies as images or tests. So the State should to assure us that the sufficient proofs were done in order to trust in those tests as the scolioscore. and if them were not done yet, I believe the cost to do it could not be so big. I don’t know if hundreds or thousands of adults would be needed to being tested with the scolioscore.. but certainly if the cost would be estimated they says something as.. about how many cases of people with this pathology we are talking this test would be very important? Only the 1%.. waste the money in something more important!
But maybe Axial Biotech is a disinterested company only thinking in our welfare as some here said (I’m not being ironic) and they agree to affront some part of the costs.

flerc
06-24-2012, 01:33 PM
Physicians are trained in medicine, but the government is not.

The State should to contract people with the expertise required for doing or supervising such kind of controls.

leahdragonfly
06-24-2012, 02:03 PM
Flerc,

Why the government though? They have no medical training. They can barely manage most country's finances. Leave the medical issues to the experts, the doctors and researchers. The government can not do everything for everyone and should not be expected to.

Pooka1
06-24-2012, 03:26 PM
But if the problem of your son, even is known for Drs since centuries ago, remains being a mystery for them and they only has old and bad solution for your case, guaranteeing irreversible damages, I believe that nobody may say that is clear what to do.

Yes. We don't have all the answers. Some people are in impossible situations. Life is unfair. What can you do?

rohrer01
06-24-2012, 04:17 PM
On a side note, my two kids and I just sent in spit DNA samples to Axial Biotech and we are participating in their research study, hopefully aimed at genetic testing/predictive tests for progression in JIS. We are a good family to study with all three of us having scoliosis.

I didn't know you also have scoliosis. I didn't know you have another child with it, either. Yes, you are a good family to study. Is there any scoliosis on your wife's side of the family?

leahdragonfly
06-24-2012, 06:00 PM
Hi rorher,

that was me (Gayle) who posted about my 2 kids with JIS, as well as myself with scoliosis (braced in jr high, progressed after age 40). My 7 y/o son was diagnosed in April with an 18-degree thoracic curve which we are currently observing. My father apparently has a very mild curve. No known scoliosis on my husband's side of the family.

My son is actually the perfect example of a child in which the Axial test could be very helpful in deciding on treatment. He's young with tons of growing left to do, with a mild curve now but a strong family history. Will he progress, nobody knows at this point. Although it is quite likely that he will, maybe he will get lucky. If he doesn't get lucky and does progress we will have him evaluated for possible VBS or tethering. Unfortunately he is currently outside of the established criteria for the Scoliscore test, which is why we wanted to participate in the research. Hopefully someday soon there will be more answers for families like ours.

flerc
06-24-2012, 08:16 PM
Yes. We don't have all the answers. Some people are in impossible situations. Life is unfair. What can you do?

I wish to know that. It remembers me an old chapter of Star Trek (the greatest Tv serie of all the times) when Mr. Spok was in a little spaceship in an hostile planet full of monster and if they try to leave the planet the spaceship (I don’t remember if it was exactly like I say) would goes to the sun and they would die burned in few minutes, but they cannot defeat the monsters who were trying to enter to the spaceship.

Of course all they prefer to died fighting than dying burned in the sun, but Spok realized that his belief system and logic was absolutely useless, so he decided to do the most crazy and absurd that would be done in this situation, that is, choosing the option that seems to be worst and they went towards the sun and they began to burn.. and something that even Spok could never imagine happened, so of course he choose the best option. . I miss so much that series.

Pooka1
06-24-2012, 08:37 PM
I wish to know that. It remembers me an old chapter of Star Trek (the greatest Tv serie of all the times) when Mr. Spok was in a little spaceship in an hostile planet full of monster and if they try to leave the planet the spaceship (I don’t remember if it was exactly like I say) would goes to the sun and they would die burned in few minutes, but they cannot defeat the monsters who were trying to enter to the spaceship.

Of course all they prefer to died fighting than dying burned in the sun, but Spok realized that his belief system and logic was absolutely useless, so he decided to do the most crazy and absurd that would be done in this situation, that is, choosing the option that seems to be worst and they went towards the sun and they began to burn.. and something that even Spok could never imagine happened, so of course he choose the best option. . I miss so much that series.

Excellent post!

Post of the month nomination!

flerc
06-24-2012, 09:02 PM
I glad you like it.

rohrer01
06-24-2012, 10:00 PM
Hi rorher,

that was me (Gayle) who posted about my 2 kids with JIS, as well as myself with scoliosis (braced in jr high, progressed after age 40). My 7 y/o son was diagnosed in April with an 18-degree thoracic curve which we are currently observing. My father apparently has a very mild curve. No known scoliosis on my husband's side of the family.



LOL...I'm so sorry! I though it was Flerc!!!

rohrer01
06-24-2012, 10:03 PM
I wish to know that. It remembers me an old chapter of Star Trek (the greatest Tv serie of all the times) when Mr. Spok was in a little spaceship in an hostile planet full of monster and if they try to leave the planet the spaceship (I don’t remember if it was exactly like I say) would goes to the sun and they would die burned in few minutes, but they cannot defeat the monsters who were trying to enter to the spaceship.

Of course all they prefer to died fighting than dying burned in the sun, but Spok realized that his belief system and logic was absolutely useless, so he decided to do the most crazy and absurd that would be done in this situation, that is, choosing the option that seems to be worst and they went towards the sun and they began to burn.. and something that even Spok could never imagine happened, so of course he choose the best option. . I miss so much that series.

Yet another Trekky!!! LOL ...I liked the original when I was a kid much better, but Next Generation eventually grew on me. Data, the new "Spock" character, always searching for emotion.

flerc
06-25-2012, 11:30 AM
What lucky! I believe are very different and not only in the kind of the arguments.. I see 0 charisma in all those empty personages.. maybe Captain Picard the only exception but anyway.. never more as an Enterprise with Captain Kirk, Spoke, Dr. Mc Coy.. we would need people of those times..

flerc
06-25-2012, 12:11 PM
I absolutely get that. There is no good solution. We're so desensitized to the options after awhile that we can sit around and rationally talk about fusing a spine or wearing a brace, but, really, these are solutions out of some bygone medical era. They might as well be pounding holes in skulls to let the demons escape.

I know I've quoted it a few times, but Lewis Thomas really nails where we are in scoliosis treatment. What he says, in a nutshell, is that until medicine actually understands a disorder, they have these incredibly expensive, intrusive, archaic methods of dealing with the symptoms which in no way cure the disorder. Once they understand a disorder, the solution is elegant and cheap and actually fixes the problem.

We are definitely in the "don't understand the first thing about it" phase, because the available treatments for scoliosis are just about the most expensive, intrusive, archaic medical treatments around.

But, what are you going to do?


Hdugger, certainly this Lewis Thomas was a wise man.
May we do something? I believe that as in other situations, people affected may do something but unfortunately only jointly.

flerc
06-25-2012, 09:25 PM
Flerc,

Why the government though? They have no medical training. They can barely manage most country's finances. Leave the medical issues to the experts, the doctors and researchers. The government can not do everything for everyone and should not be expected to.

Certainly some governments may be good an others bad, so is difficult to trust in governments. But someone is needed to do the controls. . More of something as civil power is needed.

I only may trust in scientist’s works, but if there are developed inside scientific environments such as Universities or some special Institutes. But when the scientists works in Companies, in something that will give great profits to the company, not always the scientific environment has something to do. Also we may say that there is something as a grey zone in some products which are not clearly scientific or clearly technical..

I have not any doubt that the Fermat theorem was finally demonstrated and as some complex encryption algorithms based on that famous theorem. But I’m not a priori so much sure of the reliability of some Security Systems using those algorithms. I should to test it or trust in who tested it before.

So many things used in medicine not necessarily emerge from a Scientific environment, as we may say about a device. Even products as some predictive score models may be done for professionals as engineers with enough concepts about statistics and Data Mining.

I’m not sure yet about the test done to the scoliscore. I’m still reading this link posted by Kevin_Mc some time ago. . it seems to talk about this. www.axialbiotech.com/files/fda_approval.pdf

flerc
06-26-2012, 03:20 PM
FDA believes that clinical laboratories that develop such tests are acting as manufacturers of medical devices and are subject to FDA jurisdiction under the act. However, FDA recognizes that the use of in-house developed tests has contributed to enhanced standards of medical care in many circumstances and that significant regulatory changes in this area could have negative effects on the public health.

Certainly I not see which could have been the negative effect (except spending some dollars) if FDA would have supervised the test or doing another one. If we were talking about drugs, the tests surely may be not so simple, and probably not so much reliable anyway (it seems that the real test is done in consumers).. but in this case, if AB used n adults to do that test and the reliability obtained was about the 99%, the FDA also might find n adults with similar curves and pay for the scolioscore test for all of them and measure the reliability to know if it was the same.

leahdragonfly
06-26-2012, 06:56 PM
Flerc,

I guess I am confused--you seem to have some objection to the Scoliscore, as you have posted over and over that it should be checked, etc, so may I ask, what is your concern here? One could make the same objections about bracing for example.

Pooka1
06-26-2012, 07:03 PM
Flerc,

I guess I am confused--you seem to have some objection to the Scoliscore, as you have posted over and over that it should be checked, etc, so may I ask, what is your concern here? One could make the same objections about bracing for example.

Actually, there is more high quality data about Scoliscore than there is for bracing despite the decades of research on the latter.

leahdragonfly
06-26-2012, 09:33 PM
Very true Sharon!

I think the Scoliscore is a very important addition to the physician's toolkit for scoliosis. The more predictive data they have for risk of progression, the better in my opinion. I would have my son tested in a hot second if he fell within the testing guidelines. Unfortunately he does not.

rohrer01
06-26-2012, 09:42 PM
Very true Sharon!

I think the Scoliscore is a very important addition to the physician's toolkit for scoliosis. The more predictive data they have for risk of progression, the better in my opinion.

I wholeheartedly concur!

flerc
06-27-2012, 12:21 AM
Flerc,

I guess I am confused--you seem to have some objection to the Scoliscore, as you have posted over and over that it should be checked, etc, so may I ask, what is your concern here? One could make the same objections about bracing for example.

Yes leahdragonfly, of course you may ask me that.
Certainly I also made some objections about braces, but not about the test (not so simple and quick to do), but about how they are used.

My first interest about the scolioscore was when I have read some time ago about the way that it would change the scoliosis treatment. I participated so much in this thread http://www.scoliosis.org/forum/showthread.php?11620-Changes-in-scoliosis-treatment-due-to-Scoliscore that I visited again yesterday and saw the last post and the AB article.

But regardless the change that may does or not, I believe that would be really great to know which genes are failing provoking the curve. And I believe that would be good for everyone, not only kids or teens, although of course the biggest aid would be for them. One of the first questions I did in this forum was if genes only are a cause until growth finish or may remain as a cause also then. I’m not sure about that and even if genes may not be modified, if we know the kind of impact they are provoking, maybe some actions may be taken to counterattack the effect of that failure. But of course we need to be sure about what genes really are guilty.

If I have posted over and over as you said (in fact at first I was asking about how it was) that it should be checked in a more credible (and also fast) way, it was mainly because it seemed it was not clear what I was saying or why I was saying that. If we would have the same perspectives about what is needed to assure a good test, surely I would have found a more brief way to well found what I said, also about the risks of using a model with a reliability different that wich seems to have, although I hope it would not be the case. And I not see ilogic that people absolutely trust in this test.. I think is something really arguable what anyone may believe.. and certainly, I hope a low score for your son.

mariaf
06-27-2012, 08:58 AM
I think the Scoliscore is a very important addition to the physician's toolkit for scoliosis. The more predictive data they have for risk of progression, the better in my opinion.

As rohrer01 said, I wholeheartedly concur as well!

Pooka1
06-27-2012, 09:31 AM
My first interest about the scolioscore was when I have read some time ago about the way that it would change the scoliosis treatment. I participated so much in this thread http://www.scoliosis.org/forum/showthread.php?11620-Changes-in-scoliosis-treatment-due-to-Scoliscore that I visited again yesterday and saw the last post and the AB article.

The first post on that thread is stem to stern paranoid conspiracy theory and misinformation.

You might just ignore it if you want to get the real story.

flerc
06-27-2012, 10:44 AM
The first post on that thread is stem to stern paranoid conspiracy theory and misinformation.

You might just ignore it if you want to get the real story.

My posts in that thread and in this was only based on what I (at least believed to) know or inferred by myself when I was affirming something, or asking when I was not sure about something. My interest in this thread in knowing the real story was only because I wanted to know how much credible is the reliability declared and I believe I know now all what I need to know in order to do a right evaluation and of course, my criteria to evaluate this may be different for you, for me.. everyone may have different criterias for that and I was not trying to changing that fact.

Pooka1
06-27-2012, 10:59 AM
My posts in that thread and in this was only based on what I (at least believed to) know or inferred by myself when I was affirming something, or asking when I was not sure about something. My interest in this thread in knowing the real story was only because I wanted to know how much credible is the reliability declared and I believe I know now all what I need to know in order to do a right evaluation and of course, my criteria to evaluate this may be different for you, for me.. everyone may have different criterias for that and I was not trying to changing that fact.

People are entitled to their own criteria/opinions. They are NOT entitled to their own facts. That thread is a symphony of misinformation and paranoid conspiracy as a matter of FACT. Not that I am saying you need to worry about facts if you don't want to. You don't have to care about reality. Many people clearly do not.

Kevin_Mc
06-27-2012, 11:27 AM
Read through the recent posts here as well as the article Linda posted. You all are correct, that the scoliscore is only meant to be used as a tool for doctors to use. It's a risk assessment for kids who already have scoliosis. In the article Linda posted and the original article it is intended to reduce the amount of x-rays and doctor's visits for kids with a low score, i.e. <50. For kids with a score 50-180, continued monitoring will be important. For kids >180, close monitoring is definitely indicated and some doctors/families might want to look seriously at bracing/stapling/etc... This is the same thing that most prediction tools are trying to do. The article Linda posted compares the scoliscore to the most common method of Lonstein. To date, it was the largest and 'best' study to predict progression and uses risser, cobb, and age at detection (I think). We used it in our TR study to assess risk. But like what has already been mentioned, it is only predicting the likelihood of progressing >40° by skeletal maturity. And we all know that kids with scoliosis become adults with scoliosis. Nonetheless, the scoliscore paper and company mission overall seems very sincere.

Flerc, you make a good point about the genes. This is one HUGE thing the scoliscore test discovered. We now have a list of 37 (or was it 51) genes to look at. It still doesn't give any indication of a trigger. But it does provide some insight into some things that might drive the curve. The next step is to track those genes and find out what proteins they are (or are not) making. What is the expression of those genes. There is a tool on pubmed where you can look up genes and find out what is known. From a muscle point of view, I think I remember there being a calcium transporter gene in there and other somewhat related genes. But overall, nothing was really standing out to me from the quick search I did a while back.

Looking back at the recent article, they show that the scoliscore and Lonstein method for progression risk come out with different results. However, they don't show the accuracy of either method. This is weird because it is a retrospective study. Presenting the accuracy would be extremely important to include. Maybe this data is buried somewhere in the discussion. If I had reviewed this paper, this is information I would have wanted to see.

Pooka1
06-27-2012, 11:38 AM
Looking back at the recent article, they show that the scoliscore and Lonstein method for progression risk come out with different results. However, they don't show the accuracy of either method. This is weird because it is a retrospective study. Presenting the accuracy would be extremely important to include. Maybe this data is buried somewhere in the discussion. If I had reviewed this paper, this is information I would have wanted to see.

I suspect it will come out as a separate paper when all the patents have unequivocally reached maturity.

It continues to floor me how someone can look at the Scoliscore effort and not conclude those guys are saints. I blame the pervasive war on sceince that is constantly being conducted in the US that ranges from evolution denial to old earth denial to climate change denial and includes denial of any fact that folks simply don't want to accept for emotional reasons. We are the laughing stock of the world. Of thirty some countries, only Turkey has a more ignorant populace on the fact of evolution. We are losing out prominent place in science on the world stage and looking like idiots.

flerc
06-27-2012, 11:44 AM
I might agree that thread is a symphony of misinformation and conspiracy but for other different reasons than you. But I just said all I had to say about that in that thread, as I asked and comment all I wanted in this


Not that I am saying you need to worry about facts if you don't want to. You don't have to care about reality. Many people clearly do not.

If you are saying me that because what said in that thread, you perfectly know what I think about that. You and I were the main participants (more posts) and if you have interest in say something about that, you should to do it in this thread. I see out off topic to do that here. If I mentioned it was because Leahdragonfly not understood my interest in this thread.

But if you are saying me that because I was saying in this thread, tell me which are the facts I’m refusing to see. It’s something in order to improve the criteria for trusting in the reliability of the scolioscore?. Maybe I missed something. I heard you and I’m not being ironic.
Leahdragonfly. I hope you realize now why I not stop to post in this thread.

rohrer01
06-27-2012, 11:48 AM
Now that we have established progression probablilty with the Scoliscore, what I would be most interested in next is the trigger. This intrigues me from a molecular biologic point of view because a person with a perfectly healthy spine can carry these same "defective" genes, if you will, and never develop scoliosis. Is there a "trigger gene"? If I were fortunate enough to be on this team of researchers, I would be looking for a group of genes or single gene or stretch of DNA that ONLY shows up in people with scoliosis. I would want to know if the trigger is genetic, epigenetic, strictly environmental or the like. I would like to be able to administer this test to kids as a routine screening BEFORE they develop scoliosis. But, unfortunately, we are not at that point, ...yet.

flerc
06-27-2012, 12:03 PM
I suspect it will come out as a separate paper when all the patents have unequivocally reached maturity.

It continues to floor me how someone can look at the Scoliscore effort and not conclude those guys are saints. I blame the pervasive war on sceince that is constantly being conducted in the US that ranges from evolution denial to old earth denial to climate change denial and includes denial of any fact that folks simply don't want to accept for emotional reasons. We are the laughing stock of the world. Of thirty some countries, only Turkey has a more ignorant populace on the fact of evolution. We are losing out prominent place in science on the world stage and looking like idiots.

It continues to floor me how someone may deny the importance of right procedures in test products.. even if they are done by saints. That seems to happen here, because if you know that they were right done instead of criticize who thinks in that way, you have should to showed the proofs about that and you didn’t. And say what you think in the face instead of talking about 'someone, people folks..'.

Kevin_Mc
06-27-2012, 12:11 PM
I suspect it will come out as a separate paper when all the patents have unequivocally reached maturity.


Hopefully. They do discuss the accuracy. Or rather, acknowledge that they aren't reporting the accuracy but showing how the test might be used clinically, i.e. risk classification. Their concern with Lonstein is that they classify more kids as moderate to high risk than the scoliscore which increases the kid's/parent's stress level. However, and they mention this in the text, the Lonstein paper is meant to predict progression of >5° from the time of detection. So these two tests are measuring two very different things. It's possible that accuracy for both tests is high. A high Lonstein risk but low scoliscore says 'you will progress >5° but you probably won't go >40°'. Accordingly, I disagree with the title of the article that scoliscore provides MORE information THAN traditional estimates of curve progression. First, "traditional estimates", to me, implies several methods. They use 1, albeit I think it IS considered the 'gold standard'. As well, "More information than" suggests that they'll give the same information and then-some. I'd say scoliscore provides more reliable information for certain patients (based on current data sets), so perhaps that can be interpreted as 'more'. It's a semantics issue for me.

What would be great is to increase the accuracy of the Lonstein (or similar method) and combine that with the scoliscore. This way an 11 year old risser 0 with a 20° and scoliscore of 60, can be told, you will progress >5° from now (relative measure), but won't progress beyond >40° (absolute measure) by skeletal maturity. And then adjust treatment goals from there.

flerc
06-27-2012, 12:20 PM
[QUOTE=Kevin_Mc;140824]
Flerc, you make a good point about the genes. This is one HUGE thing the scoliscore test discovered. We now have a list of 37 (or was it 51) genes to look at. It still doesn't give any indication of a trigger. But it does provide some insight into some things that might drive the curve. The next step is to track those genes and find out what proteins they are (or are not) making. What is the expression of those genes. There is a tool on pubmed where you can look up genes and find out what is known. From a muscle point of view, I think I remember there being a calcium transporter gene in there and other somewhat related genes. But overall, nothing was really standing out to me from the quick search I did a while back.
QUOTE]

Kevin!!! As always the best pleasure for me to read your posts!. I’m happy to know they are in that path. I hope you may give me some links.
Thanks!!

Kevin_Mc
06-27-2012, 12:28 PM
Now that we have established progression probablilty with the Scoliscore, what I would be most interested in next is the trigger. This intrigues me from a molecular biologic point of view because a person with a perfectly healthy spine can carry these same "defective" genes, if you will, and never develop scoliosis. Is there a "trigger gene"?


I think an interesting report would be to look at the scoliscore of non-scolitic people. I understand why they developed the model the way they did (and did a nice job of it). But to find possible triggers, comparing high scoliscore subjects, with and without scoliosis would be potentially very interesting. A prospective study using 5-8 year olds. Who has a high score? Who develops scoliosis? etc... A longitudinal study within a school district. It would probably only cost elebenty-million dollars. Plus one grad student. Because that's not too much for one grad student to do right? :>

Pooka1
06-27-2012, 07:38 PM
Hopefully. They do discuss the accuracy. Or rather, acknowledge that they aren't reporting the accuracy but showing how the test might be used clinically, i.e. risk classification. Their concern with Lonstein is that they classify more kids as moderate to high risk than the scoliscore which increases the kid's/parent's stress level. However, and they mention this in the text, the Lonstein paper is meant to predict progression of >5° from the time of detection. So these two tests are measuring two very different things. It's possible that accuracy for both tests is high. A high Lonstein risk but low scoliscore says 'you will progress >5° but you probably won't go >40°'. Accordingly, I disagree with the title of the article that scoliscore provides MORE information THAN traditional estimates of curve progression. First, "traditional estimates", to me, implies several methods. They use 1, albeit I think it IS considered the 'gold standard'. As well, "More information than" suggests that they'll give the same information and then-some. I'd say scoliscore provides more reliable information for certain patients (based on current data sets), so perhaps that can be interpreted as 'more'. It's a semantics issue for me.

What would be great is to increase the accuracy of the Lonstein (or similar method) and combine that with the scoliscore. This way an 11 year old risser 0 with a 20° and scoliscore of 60, can be told, you will progress >5° from now (relative measure), but won't progress beyond >40° (absolute measure) by skeletal maturity. And then adjust treatment goals from there.

I think the issue is that patients don't really care if they progress >5* per se if it isn't rigorously linked to eventually needing surgery. That is where Lonstein and Carlson fail the patient. It is a number and you can measure it but it is not especially relevant to the patient's interests.

Here's what AB has on their website about L & C...


Lonstein and Carlson

For the past 25 years, Lonstein and Carlson’s4 study of 727 patients has been the basis for physicians’ estimates of probability of curve progression. While the study was in many ways forward thinking;

Its outcome only predicted progression of 5º – 10º.
The accompanying progression factor formula and nomogram were only valid for curves between 20º -29°.
The predictive value for a patient with a curve of less than 20° was invalid.


(emphasis added)


Lonstein-Carlson 1984 Study

Today’s management of the AIS patient is quite similar to what it has been for the past 25 years. Since Lonstein and Carlson published their criteria for predicting curve progression in 1984, no other research built on their original work has ever been published in a peer reviewed journal. Surgeons however, have taken what Lonstein and Carlson proposed and liberally applied these criteria, expanding the interpretation of the data beyond the 20 – 29° Cobb angle and beyond just 5 – 10° of progression, to encompass lesser curve magnitudes and subsequent progression much greater than 10°.

Though Lonstein-Carlson criteria for progression of an AIS curve represented interesting observations with respect to understanding the disease of AIS at the time, its use as a prognostic tool has the same reported limits today as it did in 1984. Because the criteria are based solely on observational parameters that have already occurred (age, Risser sign, Cobb angle), the criteria have less predictive value.

Lonstein-CarlsonThe progression factor equation and resulting graph were reported to be valid only for curves of 20 – 29° and could be used to estimate further risk of progression of 5 – 10°. This very narrow predictive capability does not approach the curve magnitude generally accepted as a reasonable point at which instrumented correction would be considered.

Given these extensive limitations, use of Lonstein-Carlson criteria to predict curve progression is just slightly better than the random chance of assessing progression by flipping a coin.

mariaf
06-27-2012, 09:05 PM
I think the issue is that patients don't really care if they progress >5* per se if it isn't rigorously linked to eventually needing surgery. That is where Lonstein and Carlson fail the patient. It is a number and you can measure it but it is not especially relevant to the patient's interests.


Good point, Sharon. If progression is to the point where surgery is eventually needed that is one thing. Otherwise, as you say it's just a number.

My hope for David has always been that when he is done growing he has not progressed to the point of needing fusion. I've never really thought of a 'number' that I would like him to end up at - I suppose because it's really not relevant. If he's not to the point of needing surgery (fusion), then that will mean - whatever the number is - his dcotors feel that he'll do OK without any further treatment at that point - and that's what IS relevant.

Pooka1
06-27-2012, 09:10 PM
Good point, Sharon. If progression is to the point where surgery is eventually needed that is one thing. Otherwise, as you say it's just a number.

My hope for David has always been that when he is done growing he has not progressed to the point of needing fusion. I've never really thought of a 'number' that I would like him to end up at - I suppose because it's really not relevant. If he's not to the point of needing surgery (fusion), then that will mean - whatever the number is - his dcotors feel that he'll do OK without any further treatment at that point - and that's what IS relevant.

Yes very well put, Maria.

It's really all a game of fusion surgery avoidance. Will fusion surgery be required in their lifetime or not? The rest is just commentary.

Kevin_Mc
06-28-2012, 11:32 AM
I think the issue is that patients don't really care if they progress >5* per se if it isn't rigorously linked to eventually needing surgery.


Based on my interactions with patients and families, I don't agree with that assertion. As well, I'd say that the final number, i.e. curve size at skeletal maturity, has been inappropriately ignored for decades. There are real differences in the life of a curve into adulthood depending on if it's 20°, 30° or 40°.

No doubt, though, that the Lonstein method doesn't have great reliability. But, if improved (assuming that's possible), this type of prediction would have very important clinical implications.

Pooka1
06-28-2012, 11:40 AM
Based on my interactions with patients and families, I don't agree with that assertion. As well, I'd say that the final number, i.e. curve size at skeletal maturity, has been inappropriately ignored for decades. There are real differences in the life of a curve into adulthood depending on if it's 20°, 30° or 40°.

For those parents who KNOW that 30* appears to be an important threshold then they would be interested in whether the progression will land them north of 30*. This is a small minority as far as I can tell. For parents not hip to that, they are just interested in surgery avoidance in my opinion.


No doubt, though, that the Lonstein method doesn't have great reliability. But, if improved (assuming that's possible), this type of prediction would have very important clinical implications.

If it could have beem improved it would have been by now in my opinion. Sometimes, the variability is just inherently deep and not graspable.

Kevin_Mc
06-28-2012, 11:52 AM
For those parents who KNOW that 30* appears to be an important threshold then they would be interested in whether the progression will land them north of 30*. This is a small minority as far as I can tell. For parents not hip to that, they are just interested in surgery avoidance in my opinion.

And here lies the problem. Clinicians (and researchers) are not informing their patients and families about the life of the curve. Partly because this information has been slow to confirm. But, OTOH, the intense focus on surgery avoidance during adolescence has ignored the long-term implications of curves >25°. Even now that much more is known about these curves in adults, the focus remains on skeletal maturity. Parents don't care about the 'final' number because many clinicians don't care about the 'final' number.




If it could have beem improved it would have been by now in my opinion. Sometimes, the variability is just inherently deep and not graspable.

No doubt.

Pooka1
06-29-2012, 08:29 AM
And here lies the problem. Clinicians (and researchers) are not informing their patients and families about the life of the curve. Partly because this information has been slow to confirm. But, OTOH, the intense focus on surgery avoidance during adolescence has ignored the long-term implications of curves >25°. Even now that much more is known about these curves in adults, the focus remains on skeletal maturity. Parents don't care about the 'final' number because many clinicians don't care about the 'final' number.

I certainly agree that pediatric surgeons do not appear to be mentioning the 30* threshold to parents. If they did, parents would damn well care about whether the final number is greater than or less than 30*. I think the reason surgeons don't mention it is because it is at odds with the standard of care of bracing to 40*. The reason as far as I know for NOT bracing curves >40* is because the game is likely lost in the long term if not at maturity. So bracing would just be cruel theatrics for the parents. If it turns out that the game is lost north of 30* at maturity for many folks then that should ramify to the standard of care for bracing 30* - 40* curves unless and until it is shown to protect patients for life from surgery.

Just my opinion. I wish surgeons would address the issue and ramifications.

LindaRacine
06-29-2012, 04:52 PM
I think it's because most of the curve progression studies have been done by physicians who treat only kids <18yo. It's been difficult for anyone to find a large cohort of patients with radiographs that span the necessary 4+ decades. There has been talk about a centralized scoliosis registry, but I'm not sure that will ever get off the drawing board.

rohrer01
06-30-2012, 02:06 AM
I think an interesting report would be to look at the scoliscore of non-scolitic people. I understand why they developed the model the way they did (and did a nice job of it). But to find possible triggers, comparing high scoliscore subjects, with and without scoliosis would be potentially very interesting. A prospective study using 5-8 year olds. Who has a high score? Who develops scoliosis? etc... A longitudinal study within a school district. It would probably only cost elebenty-million dollars. Plus one grad student. Because that's not too much for one grad student to do right? :>

Unfortunately, it usually boils down to $$$ and grants aren't easy to get. That's the 'why' in why research teams often team up with bigger companies that hope to turn a profit.

But IF you could compare the scores of scoliotics with non-scoliotics, which I believe Axial Biotech did in some respects, then we may be closer to knowing the trigger. The reason I say that they did do some comparison, or at least have the potential to do so, is because they took DNA from BOTH of my non-scoliotic parents along with my DNA. I'm wondering if they found a difference on a large scale and if so, why didn't they publish it? Maybe they just don't have enough collective data? It makes me curious if it isn't a specific gene combination that triggers the scoliosis to begin with. One parent has one and the other parent has the other. I'm not talking as in recessive inheritance. I'm referring to two or more different nonmatching loci, one set coming from each parent to form the awful combination that leads to progression. That would be difficult to figure out, but they do have collective data on non-scoliotics already. But like I said, maybe it's not enough to determine this. It could be that no one thought of it, which I find hard to believe. These guys know what they are doing. So that leaves us with a big "WHY?" Is there really nothing there to be found?

rohrer01
06-30-2012, 02:17 AM
I think it's because most of the curve progression studies have been done by physicians who treat only kids <18yo. It's been difficult for anyone to find a large cohort of patients with radiographs that span the necessary 4+ decades. There has been talk about a centralized scoliosis registry, but I'm not sure that will ever get off the drawing board.

It would help if they didn't destroy our initial radiographs. That's the most ignorant policy I've ever heard of with people with scoliosis. I could see throwing away a film of someone's broken foot, but these films are very important and useful. I was VERY upset when I found out my original films were destroyed. Now there's absoluely NOTHING to compare. Otherwise, I'm sure they'd be able to get many people at 4+ decades. It's hard to believe the ignorance of hospitals sometimes. I think another problem here, though, is that older people (>40 years) may progress simply due to the start and rapid progression of degenerative changes. I can't imagine that the wear and tear of a normal spine would compare to that of a scoliotic one. There's just too much stress on the apices of the curves over time. So I don't know how useful adult curve progression studies would be. I'm sure you'll correct me if I'm wrong. I say this based on what makes sense to me.

Dingo
10-15-2014, 10:52 PM
The Axial Biotech Scoliscore test was sold to a company called Transgenomic for pennies on the dollar after Axial was liquidated and shut down.

If you look at Transgenomic's stock chart it doesn't appear to be doing much better.

Transgenomic Inc. (TBIO) (http://finance.yahoo.com/echarts?s=TBIO+Interactive#symbol=TBIO;range=6m)

What will happen to Scoliscore if Transgenomic is liquidated is anybodies guess.

flerc
10-17-2014, 08:47 AM
If the scolioscore really works, they should not refuse to does the test in everyone. Which could be the problem in doing it not only in kids with scoliosis, but also in adults, with scoliosis or not and also without knowing anything about the owner of the spit. If someone wants to know if is pregnant, nobody asks to fulfill any kind of requirement in order to buy the test.. even a man may do it.. the sellers of pregnancy test are very much sure about what they are selling.. it seems to not be happening the same with the scolioscore sellers..