More Good Evidence Bracing Works in AIS

[Ballet Mom]

Here is a video presented by Dr. William Shaughnessy at the Mayo Clinic from the last POSNA meeting. The results of the Mayo Clinic changing their ineffective scoliosis bracing program with a new program had dramatic results in their bracing success in AIS.

Here are their conclusions:

-Effective bracing changes the natural history of AIS

-Changes in brace program significantly improved results

-Brace program changes led to significantly less progression AND less surgery

-Poor compliance is the single most important determinant of brace failure

-We now assume progression is due to poor compliance until proven otherwise. (Remember they're talking about AIS, not congenital or other types).

-Psychological co-morbidity has significant negative impact on compliance and success.

-In this series there was NO progression to surgery if:

-initial curve magnitude was less than 40 degrees and
-bracewear greater than fifteen hours per day

The study states that the psychological co-morbidity of brace failure they discovered was due to ADHD, anxiety disorder, oppositional defiance disorder, or depression being treated with medication.


Click on the May 13th presentation link "Bracing for Adolescent Idiopathic Scoliosis: Determinants of Success" presented by William J. Shaughnessy, MD


http://posna.gmetonline.com/Presenta...onpackageid=84

[Ballet Mom]

Hi hdugger,

Yes, I believe that if someone is interested in bracing their child, they definitely need to look into which orthopedists actively support bracing beforehand.

Apparently the Mayo Clinic had a bracing program that ten years ago i.e. 2000, was very similar to the natural history...i.e. not doing anything effective and the surgeons, patients and parents were quite dissatisfied.

40% of brace patients required surgery!

60% of patients showed progression greater than 5 degrees.

So Mayo revamped their bracing program and went with a custom molded TLSO, orthotist retraining with a Risser casting frame with aggressive manual manipulation of the mold requiring a 50% correction or they'd change the brace that day, constantly emphasizing compliance and they added nurse practitioners for counseling, education and followup.

[Ballet Mom]

What I find most interesting is this:

In this series there was NO progression to surgery if:

-initial curve magnitude was less than 40 degrees and
-bracewear greater than fifteen hours per day


How does Scoliscore work into this? According to them there are people with high Scoliscores that are completely resistant to bracing. So does that mean that over the course of ten years, no one with a high Scoliscore was seen at Mayo Clinic or somehow all fell into the non-compliant group? Highly unlikely.

[LindaRacine]

Revised Link

If necessary, navigate to the 2011 Annual Meeting, presentations from 5/13/11

The one thing that I have some concern about is that it appears that they cherry picked the patients in the "good" group. So, if the child has no psychological issues and will wear their brace >14 hours a day, they have a good outcome, at least at 3M following treatment.

To really know if it works, however, they're going to have to find out in 50 years, how many of those patients didn't eventually need surgery. While I still think I'd consider putting my child into a brace if all the planets aligned perfectly, I honestly don't think we'll know if bracing is a potentially successful treatment until we know their COMPLETE natural history. I know this is the same old debate we've been having for years, but everyone who is going to have to go through the turmoil of bracing a child, needs to understand that they may just be putting the necessity to have a scoliosis fusion off for 20, 30, 40, or 50+ years. While the parents may not be around for that eventuality, we need to consider if the braced kids have a better quality of life in the end, than the non-braced kids.

[jrnyc]

i agree with you completely, Linda...
the only way to know for sure is to check again in 50 years...

jess

[rohrer01]

I must have missed something about scoliscore. I don't recall ever reading that people with high scores are resistant to bracing. I thought it just indicated that the curve was likely to progress to surgical stage. My question is, do they mean surgical stage before skeletal maturity or just sometime in that persons life? Bracing and scoliscore are both highly debated and HOT topics on the forum. I see plenty of people on the forum that were braced for years as kids and told they were out of the woods, so to speak, only to have surgery later on as middle aged or older adults. So what is considered successful bracing? Getting them to 18 years old with a subsurgical curve or keeping them subsurgical for life? I'm not for or against bracing. I think that is an individuals choice to make for their own children. But, whatever the root cause of scoliosis is, which we still don't know, will likely still be present in adulthood. It's easier for kids to recover than older folks. On the other hand, I can understand as a parent myself, that no parent WANTS their child to have surgery. Sometimes it just boils down to surgery now or surgery later. There's just no clear cut way to determine that because each individual is unique.

[mamamax]

Very informative posting - thank you Ballet Mom!

[Pooka1]

This is a five minute talk. A five minute NON-peer-reviewed talk. I could be unfair and launch several criticisms, some along the lines of the criticisms of Katz et. al. (2010), another study purporting to show brace wear is effective under certain circumstances. But that would be unfair. I am quite glad I didn't get criticism on some talks I gave because the published, peer-reviewed paper was different.

One thing is unless they used heat sensors, the patient reported brace wear times is very likely inflated (i.e., nonsense). We know this from other studies. So if brace wear works, the magic number is lower than 15 hours almost for sure. In Katz et al. (2010) I think it was 12 hours (on average of course).

The only reason Katz et al. (2010) was barely publishable without identifying where the 9 non-T and non-double majors curves were was because it was only 9 out of 100. But we still don't know if those lumbars made up the majority of the non-progressive cases because the authors chose not to share that information, perhaps for a reason. If the breakdown of curve type is not reported in this new study then it is nonsense given what is known about the difference propensities of different curves to progress. And that is especially true given the small study population which apparently was far from random and cherry-picked on certain grounds.

This is a small group that appears to differ from the larger groups studied in some ways. That might matter. Also they should quantify the number of patients who wore the brace unnecessarily. This by all other accounts will be the majority of the patients in any reasonably sized group. And this is especially important as the braces here would seem more uncomfortable that other braces because they changed them until them got the 50% correction. That is another reason to doubt any self-reported brace wear times. I am reminded of the anecdote that some teenagers with Type I diabetes never get with the program and die. They just don't want to do so and can't be made to do so. So if there are kids who will die over not following a treatment then I suspect there will be more who will be willing to face surgery over not following a treatment. Brace wear is hard and there will be ethical considerations even if/when it is shown to be effective in some circumstances. It's never as easy as it seems.

The elephant in the room is what has been mentioned... there are any number of people on this site and others that have been sent home after brace wear and told they were out of the wood for life and to move on. It could be this very group who were apparently held to subsurgical range during growth but nevertheless when on to surgery even as young adults. All the collapsing spine cases may fall into this category. Who knows. That braces may only delay surgery as opposed to avoid it is still on the table given all the studies as far as I know.

I could go on but not over a five minute non-peer-reviewed talk.

For now the take home for the bunnies is that neither Katz et al. (2010) nor this study halted BrAIST on ethical grounds That is, it is STILL considered ethical to randomize kids to a "no-brace" group and so say the experienced pediatric orthopedic surgeons at 26 medical centers. Non-actions like that speak louder than words.

[Pooka1]

ps. Look at the error bars. Like Katz et al. (2010), any signal that might be there is swamped out by the noise making prediction in any particular case is impossible.

So it is to be expected that there will be some cases that follow the rules, follow directions and STILL are surgical prior to maturity. It's just too variable to predict. In fact what Katz et al. (2010) and this study (if it is published in the peer-reviewed literrature) does document is the variability. I consider that one of the stronger results in terms of evidence presented. But of course it is a penetrating glimpse into the obvious that AIS is highly variable.

Someone needs to study the bitterness quotient of wearing a brace as directed and also needing surgery.

[Kevin_Mc]

How does Scoliscore work into this? According to them there are people with high Scoliscores that are completely resistant to bracing. So does that mean that over the course of ten years, no one with a high Scoliscore was seen at Mayo Clinic or somehow all fell into the non-compliant group? Highly unlikely.

I must have missed something about scoliscore. I don't recall ever reading that people with high scores are resistant to bracing.

In the Scoliscore paper (Ward 2010), of the 183 patients with a score of >190, 178 progressed to surgery ~47% of which reported being compliant with their brace protocol. But, as has been pointed out, reported compliance and actual compliance can be/are two very different things.

I can't load the video here at work so I don't know what the numbers are for the study in question. How the current study measured compliance would be pretty important. And did enrollment last over 10 years? You all are saying that the numbers of the study are small and/or cherry-picked. If the numbers are small over 10 years then the type of patient enrolled is definitely very specific. Or is it a retrospective study?

[Ballet Mom]

The one thing that I have some concern about is that it appears that they cherry picked the patients in the "good" group. So, if the child has no psychological issues and will wear their brace >14 hours a day, they have a good outcome, at least at 3M following treatment.

To really know if it works, however, they're going to have to find out in 50 years, how many of those patients didn't eventually need surgery. While I still think I'd consider putting my child into a brace if all the planets aligned perfectly, I honestly don't think we'll know if bracing is a potentially successful treatment until we know their COMPLETE natural history. I know this is the same old debate we've been having for years, but everyone who is going to have to go through the turmoil of bracing a child, needs to understand that they may just be putting the necessity to have a scoliosis fusion off for 20, 30, 40, or 50+ years. While the parents may not be around for that eventuality, we need to consider if the braced kids have a better quality of life in the end, than the non-braced kids.

The study isn't cherry picked, it's simply where the patients ended up in results of the study. If I were a doctor or a parent, I would certainly seriously consider doing something different, such as vertebral stapling rather than bracing, if my patient or child had one of the pscyhological co-morbidities.

I would certainly take my chances with bracing versus early surgery as there is plenty of longterm experience that most curves don't progress until fifty degrees. I don't think these surgeons are making up that number for nothing, at least in the thoracic curves. And I'd guess it's probably better not to fuse lumbar curves early, even if they do eventually progress. And there are many surgeries without a completely great outcome, so those complications are avoided in the process.

In terms of longterm studies, I would think they could start compiling the longterm data on the Harrington Rods soon. :-) There is a good video on that same POSNA meeting site by Dr. Colin Moseley and if you watch the first few minutes he states that the problem with longterm outcomes is that the patient outlives the surgeons by a whole generation. So really, all these surgical procedures have less information regarding longterm outcomes than the bracing. ("Evidence Based Medicine Not A Slam Dunk" from day one of the meeting 5/11/2011).

[Ballet Mom]

Also they should quantify the number of patients who wore the brace unnecessarily. This by all other accounts will be the majority of the patients in any reasonably sized group. And this is especially important as the braces here would seem more uncomfortable that other braces because they changed them until them got the 50% correction. That is another reason to doubt any self-reported brace wear times. I am reminded of the anecdote that some teenagers with Type I diabetes never get with the program and die. They just don't want to do so and can't be made to do so. So if there are kids who will die over not following a treatment then I suspect there will be more who will be willing to face surgery over not following a treatment. Brace wear is hard and there will be ethical considerations even if/when it is shown to be effective in some circumstances. It's never as easy as it seems..

Exactly who is wearing the brace unnecessarily? I presume all of them were progressing curves of a certain size that needed to be braced or they'd continue to increase in size and deformity. I don't understand why you think keeping a curve smaller and a back less deformed is a bad thing.

The elephant in the room is what has been mentioned... there are any number of people on this site and others that have been sent home after brace wear and told they were out of the wood for life and to move on. It could be this very group who were apparently held to subsurgical range during growth but nevertheless when on to surgery even as young adults. All the collapsing spine cases may fall into this category. Who knows. That braces may only delay surgery as opposed to avoid it is still on the table given all the studies as far as I know..

The orthopedists would know if most peoples braced spines were collapsing later on in life. They're not dumb. I'm not sure why you continue to deny the generally accepted progression standards according to curve size.

There are also studies showing that having a fused spine in the thoracic curve can lead to problems in the lower spine later on. Why do you ignore that information? Or the study that shows that patients with fused spines have less function than those not fused? Or that they participate in sports less?

For now the take home for the bunnies is that neither Katz et al. (2010) nor this study halted BrAIST on ethical grounds That is, it is STILL considered ethical to randomize kids to a "no-brace" group and so say the experienced pediatric orthopedic surgeons at 26 medical centers. Non-actions like that speak louder than words.

I think if the three studies from DuPont, Texas Scottish Rite, and the Mayo Clinic had been available, the surgeons may have come to a different conclusion.

[Ballet Mom]

Very informative posting - thank you Ballet Mom!

Mamamax! It's so nice to hear from you! I hope you and your sister are doing well. :-)

[Ballet Mom]

In the Scoliscore paper (Ward 2010), of the 183 patients with a score of >190, 178 progressed to surgery ~47% of which reported being compliant with their brace protocol. But, as has been pointed out, reported compliance and actual compliance can be/are two very different things.

I can't load the video here at work so I don't know what the numbers are for the study in question. How the current study measured compliance would be pretty important. And did enrollment last over 10 years? You all are saying that the numbers of the study are small and/or cherry-picked. If the numbers are small over 10 years then the type of patient enrolled is definitely very specific. Or is it a retrospective study?

I found this article which discusses apparently the same study that must have been done in 2007. The patient numbers are a little smaller so I think Dr. Shaughnessy must have updated this study with the new patients they've had for the current presentation. They also state that they're looking to place sensors in the braces for routine wear when they're available. So I assume most of the data is without the sensors and possibly the newer data might have sensor data.

The specific criteria for inclusion is on the video, but I really don't know why they don't have more scoli kids coming through their doors. Dr. Shaughnessy does state that zero patients not progressing to surgery has actually held for ten years if they were less than 40 degrees and wore their brace for fifteen hours minimum.

http://www.oandpbusinessnews.com/view.aspx?rid=58855

[LindaRacine]

The study isn't cherry picked, it's simply where the patients ended up in results of the study. If I were a doctor or a parent, I would certainly seriously consider doing something different, such as vertebral stapling rather than bracing, if my patient or child had one of the pscyhological co-morbidities.

They started out the study with more patients than they ended up with, by removing some patients who had psychological issues and removing at least some of the kids who wore the brace less than 13 hours.

In terms of longterm studies, I would think they could start compiling the longterm data on the Harrington Rods soon.

•Spinal range of motion, muscle endurance, and back pain and function at least 20 years after fusion or brace treatment for AIS
•Back pain and function 23 years after fusion for AIS
•Childbearing, curve progression, and sexual function in women 22 years after treatment for AIS
•Radiologic findings and curve progression 22 years after treatment for AIS: comparison of brace and surgical treatment with matching control group of straight individuals
•Long-term results of the Harrington operation. Apropos of a series of 200 cases (1964-1986)