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Thread: TSRH research shows that bracing IS effective!

  1. #46
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    Quote Originally Posted by Pooka1 View Post
    And if these patients go back 10 years, how did they choose a mere 100 out of all of them? They have to worry about data selection which I'm guessing can be inadvertent also. That is, they inadvertently used a criterion that was correlated with a certain outcome... something like the inadvertent stacking of T curves in the non-braced group versus L curves in the braced group of that other study which I'm blanking on the name of.
    It's a prospective study so the time for recruitment was 1998-2000, i.e. they didn't have 10 years of patients from which to chose. In that recruitment window there were 260 patients prescribed a Boston brace. 134 didn't meet the inclusion criteria, non-AIS, previous orthotic treatment, risser 3 or more, curve too big and 1 declined.

    Quote Originally Posted by Pooka1 View Post
    And speaking of T versus L curves, I hope they indicated which compliance group had which curve types. It would invalidate the results to some extent if the L group was over-represented in the compliant group and(or) the T group was over-represented in the less compliant group.
    They didn't report in this way and I wish they had. There might be some nuggets buried in the text though. It would be easy to email them and ask.

    At any rate, there were 62 double major, 26 single T, 8 T/L or L, 3 double T, 1 triple. So the majority were a higher risk.

    Quote Originally Posted by Pooka1 View Post
    I also question the 68% figure for chance of progression between 20* and 29* at low Risser. I think that comes from a table where there are no errors bars if I'm remembering correctly. If they showed the error bars, that number might appear less hard let's say than it appears.
    That number is correct. It does come from a table and is mentioned in the text. It's just 68% of the curves with risser 0 or 1 and 20-29 (deg) progressed.

    Quote Originally Posted by LindaRacine View Post
    Hi Kevin...

    The real natural history of the cohort won't be known until they reach at least the age of 35, when a lot of curves seem to start causing trouble. If bracing doesn't keep most of the patients out of the O.R., then it's going to be judged pretty worthless, because there's a big cost, both monetarily and in terms of the additional pain and disability of adult scoliosis surgery vs. adolescent scoliosis surgery.

    At this point, it would be reasonable to say that bracing might work, but no one yet knows for certain.
    I agree that the long-term results are still in question. But the results through skeletal maturation seem to be fairly solid. But I see your point and can see how problematic it is for any form of treatment/management that does not follow the patient until 35 and beyond.

  2. #47
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    Quote Originally Posted by skevimc View Post
    It's a prospective study so the time for recruitment was 1998-2000, i.e. they didn't have 10 years of patients from which to chose. In that recruitment window there were 260 patients prescribed a Boston brace. 134 didn't meet the inclusion criteria, non-AIS, previous orthotic treatment, risser 3 or more, curve too big and 1 declined.
    Oh wow. Does that means they have data as long as about 8-10 years out. That would be very important. Or does it mean they just collected the last in-brace radiograph from patients who were recruited as far back as 1998 with nothing since for any of them?

    They didn't report in this way and I wish they had. There might be some nuggets buried in the text though. It would be easy to email them and ask.

    At any rate, there were 62 double major, 26 single T, 8 T/L or L, 3 double T, 1 triple. So the majority were a higher risk.
    I agree. Unless close to all 26 T were in the non compliant group and close to all 8 T/L or L were in the compliant group simultaneously, I think the data might be okay from the standpoint of that issue. But since there is something known about this issue, I don't know why the peer reviewers don't insist on clear statements upfront on this. We do have some data on this.

    That number is correct. It does come from a table and is mentioned in the text. It's just 68% of the curves with risser 0 or 1 and 20-29 (deg) progressed.
    What if it is 68% +/- 100%? What is it is 68% +/- 300%? Is there a point at which it would matter in your mind? You can average a very rangy set of numbers and get an average but what does it mean if the variability is so high? I think this is how we can have a surgeon tell a woman who was in the low 30* at maturity that it isn't unusual for someone like that to reach surgical range as a young adult. That statement continues to floor me and I think some bracing decisions might be different if parents knew that.

    I agree that the long-term results are still in question. But the results through skeletal maturation seem to be fairly solid. But I see your point and can see how problematic it is for any form of treatment/management that does not follow the patient until 35 and beyond.
    I'm glad I am not in this field. It looks very dicey from here. I wish bracing wasn't such a hard treatment. Life is short.
    Sharon, mother of identical twin girls with scoliosis

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  3. #48
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    Quote Originally Posted by Pooka1 View Post
    Oh wow. Does that means they have data as long as about 8-10 years out. That would be very important. Or does it mean they just collected the last in-brace radiograph from patients who were recruited as far back as 1998 with nothing since for any of them?
    They probably do have quite a bit of follow-up data. But this was my original point that they might not have IRB approval to report on that data. IRB's can be quite strict when it comes to data collection on patients. If it wasn't in their original consent form that they would/could collect follow-up data they have to go through IRB again. Some IRB's can be very easy to work with and others, not so much.

    Quote Originally Posted by Pooka1 View Post
    What if it is 68% +/- 100%? What is it is 68% +/- 300%? Is there a point at which it would matter in your mind? You can average a very rangy set of numbers and get an average but what does it mean if the variability is so high?
    I'm not sure what you're saying here. Out of their patients who fit in that category, 68% progressed. This is an absolute number. I'm unclear how this could be a range, unless this is some math trick of which I'm unaware. Which definitely happens.

    Quote Originally Posted by Pooka1 View Post
    I'm glad I am not in this field. It looks very dicey from here. I wish bracing wasn't such a hard treatment. Life is short.
    From my point of view, it's not the 'treatment' that is hard (easy for me to say right??). It's the follow-up. Scoliosis can get lumped into the other diseases that are life long conditions. Regardless of what happens until skeletal maturity there will still be an adult with scoliosis. If the success or acceptance of any treatment is tied to the long-term success of that adult, the patients will simply outlive the researchers.

    Ian Stokes and his collaborator (Aronnson ???) published a commentary on this article and made a good point about their research design. To me it seems the project was set up such that they simply tied their results to their clinical practice. That is, everyone who is treated there gets enrolled. They alluded to this by saying that 'the research design was unique and did not require additional funds to complete'. (Or something like that). I might be misinterpreting what that means though.

  4. #49
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    Quote Originally Posted by skevimc View Post
    As I read the article, it seems to be a new study i.e. patient population. However, the patients were recruited between 1998 and 2000. If this group published on the same data I can't find it and they don't refer to that in the introduction. The whole group published a paper in 1997 comparing Boston to Charleston and the lead author (Katz) published something in 2001 but that was a retrospective study.

    All patients were risser 2 or less and between 25 and 45. X-rays taken every 4 months out of brace. All patients were followed until skeletal maturity. Failure was >6 progression or progression to surgery.

    They do a fairly complex analysis linking brace wear to progression and stratifying by tri-radiate cartilage, risser, time of day the brace is worn, compliance and total number of hours of brace wear.

    Of the 100 patients, 50 progressed and 50 did not. Of the 50 that did progress, 28 had surgery. The non-sugical group had a significantly higher number of daily brace wear (10.6 v 7.2), total number of braced hours (5002 v 2552), and percent compliance (42.4 v 24.4). These numbers include the non-progression group as well, i.e. 28 had surgery and 72 did not and 22 of the 72 with no surgery had progression. It would be interesting to see the analysis of the surgical v non-surgical in the progressing group.

    The group that had the highest number of progressions was the risser 0 group. The risser 0 non-progressive group had a significantly higher number of daily brace wear than the progressive group (9.9 v 5.2).

    The article goes on and on. Lots of statistics but the data seems to be fairly clearly presented, that is, they don't seem to be massaging the data too much. There are a lot of more detailed results in the text, but requires careful reading. Of interest.



    The latest follow-up date isn't mentioned, but the patients were recruited at least 10 years ago. So it's not a huge jump to say these have remained stable after brace treatment. However, I do wish they would present that data. But it's possible they didn't have IRB approval for that.
    Thank you for an intelligent and informed review of the article.

  5. #50
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    For anyone doubting the validity of this study because of all the extraneous double talk on this thread, US News just named TSRH #2 best orthopedic hospital in the nation.

    http://health.usnews.com/best-hospit...gs/orthopedics

  6. #51
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    Quote Originally Posted by skevimc View Post
    I'm not sure what you're saying here. Out of their patients who fit in that category, 68% progressed. This is an absolute number. I'm unclear how this could be a range, unless this is some math trick of which I'm unaware. Which definitely happens.
    Oh sorry. I was referring to the table of historical risks for each combination of curve magnitude and Risser. The data they compared their data to (bad sentence!). That needs error bars and I don't think it has them especially since I don't think many patients were used to develop the percentage. On the other hand, the fact that this study found the identical percentage is consistent with small error bars.

    Ian Stokes and his collaborator (Aronnson ???) published a commentary on this article and made a good point about their research design. To me it seems the project was set up such that they simply tied their results to their clinical practice. That is, everyone who is treated there gets enrolled. They alluded to this by saying that 'the research design was unique and did not require additional funds to complete'. (Or something like that). I might be misinterpreting what that means though.
    If you are correct, that is a very robust design in my opinion. But I wonder if it can be right given the distribution of curve types doesn't seem to match that in the population (i.e., the majority were double majors whereas the majority of all curves is T as far as I know. ). If that is correct then this particular sample patient population may not reflect the general population. Who knows.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

  7. #52
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    Quote Originally Posted by Pooka1 View Post
    Oh sorry. I was referring to the table of historical risks for each combination of curve magnitude and Risser. The data they compared their data to (bad sentence!). That needs error bars and I don't think it has them especially since I don't think many patients were used to develop the percentage. On the other hand, the fact that this study found the identical percentage is consistent with small error bars.
    Not to belabor the point. But I was referring to the historical data as well. The 68% number is explicitly stated in a table and the text for curves 20-29 and risser 0 or 1 in the Lonstein and Carlson 1984 article. I'm not sure how this would have error bars.

    Quote Originally Posted by Pooka1 View Post
    If you are correct, that is a very robust design in my opinion. But I wonder if it can be right given the distribution of curve types doesn't seem to match that in the population (i.e., the majority were double majors whereas the majority of all curves is T as far as I know. ). If that is correct then this particular sample patient population may not reflect the general population. Who knows.
    It was set-up as an "intent-to-treat" design. So anyone who was prescribed a Boston brace in that time would be asked to participate in the study. So the curve demographics would heavily favor those curves for which a Boston would be most appropriate. My assumption is that other patients were prescribed other brace types and thus were not approached to be in the study. In the discussion they mention that a weakness of the study is they looked at only one brace type. And in the future they would include additional types now that the heat sensors are easier to apply and so compliance can be recorded.

  8. #53
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    Quote Originally Posted by skevimc View Post
    Not to belabor the point. But I was referring to the historical data as well. The 68% number is explicitly stated in a table and the text for curves 20-29 and risser 0 or 1 in the Lonstein and Carlson 1984 article. I'm not sure how this would have error bars.
    Assume that 68% figure was determined from a group of 10 people. (ETA: Can't be 10, let's say 13 or something like that.) Would you obtain that 68% on the next group of 12 people? What about any new group of 50 people? Or an other group of 50 people.

    I am not claiming the group was necessarily too small. I'm saying that the variability of this condition is so high that it it hard to imagine that 68% would be repeated if the figure was calculated for another small(ish?) group.

    Or I might be completely wrong! I don't do this type of study.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
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    "We are all African."

  9. #54
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    I second Sherie's appreciation for Kevin's input. I don't think we can be reminded of the real constraints of medical research often enough.

    It's *very* easy, when you're not actually doing research in this field, to fall into the trap of comparing the studies which are done to "the idea study," and to see incompetence/trickery in designs which don't match that ideal.

    Studies in medical research simply are not ideal, often through no fault of the researchers involved. It's very difficult to ethically treat people and do great research at the same time, and it's equally difficult to get the money/participants/consent for the kind of ideal study I think we'd all like to see.

  10. #55
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    Quote Originally Posted by LindaRacine View Post
    Hi Sherie...

    The studies found that bracing works. However, since that time many specialists have agreed with Sharon, that since there is no control, they cannot tell for certain whether the braced kids might not have progressed without any treatment.

    With that said, if I had a skeletally immature child with a curve between 25-40 degrees, I'd push them to wear a brace as much as possible.

    Regards,
    Linda
    Thanks for saying this. My DD is two weeks into wearing her RSC brace and I really can't imagine doing "nothing" but waiting for her curves to get large enough to require surgery. Yes, that may happen anyway, but we're going to give this brace thing a try.

    Granted, she's only 11 and is pretty self-confident. She even says that she "hardly notices" the brace anymore. Kudos to her.

  11. #56
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    Another compliance study

    http://www.scoliosis.org/forum/showthread.php?t=9741

    This is different group and they split the results into two articles, one very short for some reason.

    It turns out to be an in-brace study.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
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    "We are all African."

  12. #57
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    Thanks for the nice review skevimc! I don't understand what's so difficult to understand about 68% though. Seems fairly straight forward unless you are trying to make it something it isn't or trying to unmake what it is. I agree with Linda. I feel bracing for certain curves at low Risser is the choice I would make (and have made). Having my kid do it, it is not as traumatic and problematic as some may think.

  13. #58
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    Quote Originally Posted by bbrian35 View Post
    it is not as traumatic and problematic as some may think.
    Just curious Brian... were you braced as a child?

    I assumed that it wasn't traumatic when I first started my support group, but after talking to enough adults who were braced as kids, I can tell you that it is traumatic for many kids.

    --Linda

  14. #59
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    Quote Originally Posted by Pooka1 View Post
    http://www.scoliosis.org/forum/showthread.php?t=9741

    This is different group and they split the results into two articles, one very short for some reason.

    It turns out to be an in-brace study.

    Hi to all my old friends! Just checking in and I see an old post of mine has been brought up.

    I took a couple of seconds to google the name of the research paper and came up with the actual study mentioned above (The Association Between Brace Compliance and Outcome for Patients With Idiopathic Scoliosis), as I hate disinformation.

    Here's the actual study's verbiage:


    The curve magnitude was measured by Cobb angle in
    a whole-spine posteroanterior radiograph taken every 4 to 6
    months out of the brace.

    And here’s the link to the Journal of Pediatric Orthopedics in case anyone would like to read it for themselves. The quote comes from the second page of the document, which is actually page 421 in the Journal itself, second paragraph.

    http://early-onset-scoliosis.com/Doc...Compliance.pdf


    I am not going to try to find the old studies that I posted many moons ago that showed that most moderate curves that were braced did not progress in adulthood, but instead tended to move towards the size of the Cobb angle at diagnosis and not greater. I’m sure you can find them for yourselves if you look for them.

    For those who are interested, my daughter is doing very well, she’s still wearing a nighttime brace as she is still only Risser 2. At last month’s orthopedic appt, her Cobb angle of her thoracic curve was measured at 29 degrees and her compensatory curve had basically disappeared. Her doctor said that although they never say that curves are improved, hers looked really good. I certainly agreed. For those who don’t know, she was diagnosed with a 35 degree thoracic curve and a 21 degree compensatory curve at Risser 0 and twelve years of age. She is now fifteen. She had “grown” one inch from her last six month visit, although I believe some of that was due to the disappearance of her compensatory curve (which may be due to a powerful drug she was taking, not the brace, who knows?)

    For those parents who wish to brace and the child will accept the brace, there is every reason to give your child a chance at bracing. I truly believe that. Good luck to all who are bracing.
    Last edited by Ballet Mom; 07-16-2010 at 11:46 PM.

  15. #60
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    Quote Originally Posted by bbrian35 View Post
    Thanks for the nice review skevimc! I don't understand what's so difficult to understand about 68% though. Seems fairly straight forward unless you are trying to make it something it isn't or trying to unmake what it is.
    Many things that seem straight forward are not.

    T and L curves are known to have a different progression risk. If you are dealing with small groups of patients and one group is stacked with L curves and the other is stacked with T curves, you would not expect to calculate the same risk of progression for each group with what is known.

    This issue of inadvertently stacking T and L curves in various study cohorts is recognized as having invalidated other studies. Thus it is considered a very serious issue as far as I can tell.

    You can't have one progression risk with a given Risser range and Cobb range without talking about the mix of T and L curves. I mean you can but it might not mean anything if the patients were inadvertently stacked in the historical and present paper.
    Last edited by Pooka1; 07-17-2010 at 06:32 AM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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