The Axial Biotech Test is Here

[mariaf]

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]

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]

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]

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]

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]

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]

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]

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

I 100% agree!

[Pooka1]

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]

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]

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]

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]

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]

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]

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.