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Thread: "troublingly inconsistent or inconclusive studies of any level."

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    "troublingly inconsistent or inconclusive studies of any level."

    http://www.ncbi.nlm.nih.gov/pubmed/17728687?ordinalpos=1&itool=EntrezSystem2.PEntrez. Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.P ubmed_Discovery_RA&linkpos=5&log$=relatedreviews&l ogdbfrom=pubmed

    Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review.

    Dolan LA, Weinstein SL.

    Department of Orthopaedics and, Rehabilitation, University of Iowa Healthcare, Iowa City, IA, USA. lori-dolan@uiowa.edu

    STUDY DESIGN.: Systematic review of clinical studies. OBJECTIVES.: To develop a pooled estimate of the prevalence of surgery after observation and after brace treatment in patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA.: Critical analysis of the studies evaluating bracing in AIS yields limited evidence concerning the effect of TLSOs on curve progression, rate of surgery, and the burden of suffering associated with AIS. Many patients choose bracing without an evidence-based estimate of their risk of surgery relative to no treatment. Therefore, such an estimate is needed to promote informed decision-making. METHODS.: Multiple electronic databases were searched using the key words "adolescent idiopathic scoliosis," "observation," "orthotics," "surgery," and "bracing." The search was limited to the English language. Studies were included if observation or a TLSO was evaluated and if the sample closely matched the current indications for bracing (skeletal immaturity, age <15 years, Cobb angle between 20 degrees and 45 degrees ). One reviewer (L.A.D) selected the articles and abstracted the data, including research design, type of brace, minimum follow-up, and surgical rate. Additional data concerning inclusion criteria and risk factors for surgery included gender, Risser, age and Cobb angle at brace initiation, curve type, and dose (hours of recommended brace wear). RESULTS.: Eighteen studies were included (observation = 3, bracing = 15). All were Level III or IV clinical series. Despite some uniformity in surgical indications, the surgical rates were extremely variable, ranging from 1 surgery of 72 patients (1%) to 51 of 120 patients (43%) after bracing, and from 2 surgeries of 15 patients (13%) to 18 of 47 patients (28%) after observation. When pooled, the bracing surgical rate was 23% compared with 22% in the observation group. Pooled estimates for surgical rate by type of brace, curve type, Cobb angle, Risser sign, and dose were also calculated. CONCLUSION.: Comparing the pooled rates for these two interventions shows no clear advantage of either approach. Based on the evidence presented here, one cannot recommend one approach over the other to prevent the need for surgery in AIS. This recommendation carries a grade of D, indicating that the use of bracing relative to observation is supported by "troublingly inconsistent or inconclusive studies of any level." The decision to brace for AIS is often difficult for clinicians and families. An evidence-based estimate of the risk of surgery will provide additional information to use as they weigh the costs and benefits of bracing.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

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    Interesting, but I'd be curious about what the real brace experts think. There is a LOT of variation in bracing, based on the skill and experience of the MD and the orthotist. Many TLSO bracing studies were based on off-the-shelf braces as opposed to custom made orthotics.

    Lacking any other evidence, if I had a child who fit the profile of successfully braced patients (25-40 degrees with the appropriate Risser), I'd definitely want to give bracing a chance.

    --Linda

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    It's so interesting how different folks see data.

    I look at the same studies and would not put my child in a brace. My one braced daughter chose to try it. It is failing as I type. In hindsight at least, that wasn't the correct decision. I think the literature supports that outcome though.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

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    "We are all African."

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    I know a lot of kids who have been successfully braced and whom have avoided surgery, even in the long term. The best example is probably Joe O'Brien, President of the National Scoliosis Foundation, was not braced, and has had to have several surgeries for scoliosis. His brother was braced, and has avoided surgery well into adulthood. We both know, however, that anecdotal evidence is pretty useless.

    With that said, if I had a kid who was super rebellious about wearing the brace, I probably wouldn't push it.

    --Linda

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    How do you know the success in avoiding surgery was over and above the natural history without good controlled studies which apparently don't exist yet for the most part?
    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."

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    interesting article Sharon

    Hi Sharon,

    Thanks for the interesting article. It's even harder for parents like myself with a young JIS child to make informed decisions, since there are even fewer articles about treatment of JIS. In addition to Dr Betz we have seen two other pediatric spine specialists, one in particular who seemed very pro-bracing, and both told me clearly that "we don't even know if bracing works."

    I read one article about AIS recently that suggested that 70% of AIS patients who were braced wouldn't have progressed to surgical levels anyway, hence they were treated with a brace unnecessarily. That haunts me to no end, since I was personally braced and HATED it. If it were a benign treatment it would be different...
    Gayle, age 49
    Oct 2010 fusion T8-sacrum w/ pelvic fixation
    Feb 2012 lumbar revision for broken rods @ L2-3-4
    Sept 2015 major lumbar A/P revision for broken rods @ L5-S1


    mom of Leah, 15 y/o, Diagnosed '08 with 26* T JIS (age 6)
    5/10 VBS Dr Luhmann Shriners St Louis
    5/16 6 yrs post-op, 24*T/ 22* L, mild increase in curves, watching

    also mom of Torrey, 12 y/o son, 16* T, stable

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    Linda,

    You obviously haven't seen the results of the current bracing studies. Bracing is a crapshoot at best (sorry ... no matter *what* type of brace for initial onset JIS/AIS).

    I'm really surprised you haven't seen this same data. BTW ... who do you consider the "real brace experts"? LMAO ... THE brace experts in modern day are determining braces are iffy.

    Personally, like Gayle, having BEEN a braced child, I'd never consider it.
    Last edited by txmarinemom; 12-20-2008 at 12:33 AM.
    Fusion is NOT the end of the world.
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    Quote Originally Posted by leahdragonfly View Post
    Hi Sharon,

    Thanks for the interesting article. It's even harder for parents like myself with a young JIS child to make informed decisions, since there are even fewer articles about treatment of JIS. In addition to Dr Betz we have seen two other pediatric spine specialists, one in particular who seemed very pro-bracing, and both told me clearly that "we don't even know if bracing works."

    I read one article about AIS recently that suggested that 70% of AIS patients who were braced wouldn't have progressed to surgical levels anyway, hence they were treated with a brace unnecessarily. That haunts me to no end, since I was personally braced and HATED it. If it were a benign treatment it would be different...
    The situation with AIS is more straightforward in terms of waiting and then fusion.

    The situation with JIS is just harrowing as far as I can tell. It seems the best hope at the moment are the non-fusion surgical procedures like Ti ribs, growth rods, and stapling. That's what I would be looking at if I were in that situation.

    That appears to be the state of the art at the moment.

    In re bracing, it is rational to conclude most/all of the present studies suffer from fatal design flaws and are certainly well within the issue for most research results being false. That's why we have orthopods watching and waiting and not bracing. They are just being ethical.
    Last edited by Pooka1; 12-20-2008 at 08:31 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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    "Real" bracing experts?

    I don't really understand the reference to real brace experts. The closest thing we have to bracing experts are the orthopods publishing studies. As Pam stated, those are the ones pointing out the flaws in previous studies. The lack of a control group is the tip of the iceberg (though it is singly the hugest Achilles heel in the earlier studies).

    There are NON-experts when it comes to bracing. Listed in this column are:

    1. chiros
    2. orthothists

    Our orthotist claimed only 2 out of a few hundred patients he braced over several years ever went on to need surgery IIRC. Now I like the guy and I'm not saying he is lying. I AM saying he is misinformed or delusional as an absolute fact.

    And I doubt anyone is using off-the-shelf bracing as opposed to custom bracing for the later studies. What is the evidence for that claim? I don't think that can be the reason for lack of positive bracing results.
    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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    cognitive dissonance

    I am also very puzzled by Linda's comment about "the real bracing experts." Who do you mean Linda? The pro-bracing ortho I referenced above is the inventor of a mainstream night brace, and even he told me "we don't know if bracing works."

    I believe that cognitive dissonance plays a large part in the bracing debate. (Read up on it if you're not sure what it is). How could these orthotists and orthopedists live with themselves knowing they had subjected hundreds of children and teens to the misery of bracing, only to suspect that it doesn't work! Cognitive dissonance makes them too uncomfortable psychologically (even unconsciously) and so they come to believe that studies be damned, bracing MUST work!

    I find it just another thing about scoliosis that is so hard to deal with: we don't know how our child's situation will unfold, we don't have a strong body of valid scientific evidence, and we as parents are left to make terribly difficult decisions for our children. I know the only thing that keeps me sane in the event Leah has progression is the promise of VBS.
    Gayle, age 49
    Oct 2010 fusion T8-sacrum w/ pelvic fixation
    Feb 2012 lumbar revision for broken rods @ L2-3-4
    Sept 2015 major lumbar A/P revision for broken rods @ L5-S1


    mom of Leah, 15 y/o, Diagnosed '08 with 26* T JIS (age 6)
    5/10 VBS Dr Luhmann Shriners St Louis
    5/16 6 yrs post-op, 24*T/ 22* L, mild increase in curves, watching

    also mom of Torrey, 12 y/o son, 16* T, stable

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    I hear you Gayle.

    Although there aren't long-term studies, I think the surgical procedures are very promising. And they don't appear to be dangerous or risky over and above generic surgical concerns but I haven't researched them in depth.

    I predict all the present surgical interventions will eventually be shown to have a higher success rate for JIS than any brace.

    There, I'm on record.

    There is reason for hope here.

    sharon

    ps. I think you are correct about the cognitive dissonance. That explains a lot of things that go on in society (e.g., faith versus evidence), not just this aspect of medical research. It's one of the reasons why most published scientific results are false.
    Last edited by Pooka1; 12-20-2008 at 09:32 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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    This is a continuation of a related topic discussed in a thread titled "Scoliosis Specialists". other thread I think this thread is a more appropriate place to continue the chat.

    The Dolan paper (abstract posted at the beginning of this thread) is very interesting. It is a systematic review of a whole bunch of prior studies. The authors used strict criteria for selecting published papers on bracing and statistically analyzed the pooled results. Their conclusions can be summed up as follows

    Comparing the pooled rates for these two interventions shows no clear advantage of either approach. Based on the evidence presented here, one cannot recommend one approach over the other to prevent the need for surgery in AIS.

    As a father who has decided to brace his daughter, these conclusions are obviously troubling. So, I decided to dig into this paper and see what I could learn (I do NOT have a background in biology or medicine).
    The first thing that jumped out at me from the Dolan paper is the small sample size of UNBRACED patients. You add them ALL up and you come up with 139 kids. (As opposed to their BRACED pool which totaled 1814). The authors, in their discussion make the following comment:

    there is less evidence for the observation pooled rate since only 3 studies, representing just 2 institutions, were available for this review.

    Wow, just two institutions? Which ones? They are the ones in Puerto Rico and Ireland.
    OK, they go on to say:

    This lack of confidence is amplified by the fact that the rates differ greatly between the (observation pooled) studies.

    Well, so not only do they have a small sample size from just 3 studies, but the data “differ greatly”. Just how much do they differ?

    Without the Fernandez-Feliberti et al data, the observation surgical rate would be 13%, which is significantly lower than that following bracing. An obviously erroneous conclusion would be that
    bracing causes an excess risk of surgery.
    (Emphasis added is mine).

    Yep, that is troubling. They excluded just one study (The Puerto Rico study) and showed that bracing causes an excess risk of surgery. It makes you wonder about the other study. It sure would be nice to see what happens to the numbers if they excluded the other study (Ireland). Unfortunately they don’t provide the calculation but I can tell you it would sway it the other way (it would show that bracing causes a decreased risk). The abstracts for the Puerto Rico study and the Ireland study are both posted in the other thread.

    Also troubling, in the Dolan paper there is a table summarizing the previous research. In that table (Table 2) they say the following about the Puerto Rico Study. They (Dolan) claims that the main conclusion of the PR study was

    “Nonintervention is equivalent to bracing in surgical rate”

    Now, That is troubling because I read the abstract of the Puerto Rico paper and it concludes

    the control group had a threefold increase in the odds of ending with surgery compared to the treatment group (OR = 3.24, 95% CI, 1.09-9.60). The curve was more likely to progress >40 in the control group (OR = 2,83, 95% CI, 0.98-8.17)

    Just what paper were they reading? This makes NO sense – is it equivalent or is it 3 times more likely? The data from the only control group opposing the control data from Ireland is misinterpreted? EDIT after looking at this again, I think there was a problem with my PDF of the paper and this comment that they made was in reference to the Goldberg paper and not the PR paper.

    Sharon posted a link to a paper that claims that “most published research results are false”. (a very interesting paper we should discuss relative to the specifics of scoliosis bracing – but perhaps on a different thread)
    Isn’t it possible that here we have an example of a false result in the Dolan paper?

    And is this the paper that the “anti bracing “ folks are embracing to support their argument? (well, it’s not just this one, also cited is the Ireland paper, but we discussed the problems with that on the other thread).

    The call for a large randomized controlled study isn’t going to help us here and now. There are a lot of challenges (ethical and logistical) involved with doing a study like that. We have to look (with a discerning eye) at what data we have available now.

    Dolan in the above 2007 paper says

    The few studies that have compared bracing to observation have demonstrated some decreased risk of curve progression (generally defined as >5 change). Of these, the study by Nachemson and Peterson is the only prospective, multicenter controlled study (Level 2b).

    Dolan also says the Nachemson paper is the most rigorous to date”. What does the Nachemson paper conclude?

    Treatment with a brace was associated with a success rate of 74 percent at four years; observation only with a success rate of 34 percent.”

    Note that Dolan did not include the Nachemson data in their “systematic review” because it failed an “inclusion criteria” of providing information concerning surgical rates. And, just to put the Nachemson study in perspective, it was performed by the Brace Study group of the Scoliosis Research Society (it was a multicenter study).

    I don’t intend to sound harsh here. I am just trying to give a voice to the other viewpoint.
    There are a lot of brave kids out there diligently following their doctors and parents advice and wearing their brace. I would not want them to come to the conclusion after reading a thread like this that bracing is somehow scientifically shown to be a waste of time. Comments such as “I look at the same studies and would not put my child in a brace” and “Bracing is a crapshoot at best” from obviously very smart and respected posters warrant a response from an opposing view. And here you have it.

    All of the above is just my current opinion and subject to change.
    Last edited by concerned dad; 02-17-2009 at 03:56 PM. Reason: correct comment about table 2

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    Quote Originally Posted by concerned dad View Post
    As a father who has decided to brace his daughter, these conclusions are obviously troubling. So, I decided to dig into this paper and see what I could learn (I do NOT have a background in biology or medicine).
    I also have no background in biology or medicine (though I have had some college-level bio and some grad-level microbio). But that said, I am SO not a biologist.

    Quote Originally Posted by concerned dad View Post
    The first thing that jumped out at me from the Dolan paper is the small sample size of UNBRACED patients. You add them ALL up and you come up with 139 kids. (As opposed to their BRACED pool which totaled 1814). The authors, in their discussion make the following comment:

    there is less evidence for the observation pooled rate since only 3 studies, representing just 2 institutions, were available for this review.
    This is just reiterating the comment that there are few controlled bracing studies.

    Quote Originally Posted by concerned dad View Post
    Wow, just two institutions? Which ones? They are the ones in Puerto Rico and Ireland.
    OK, they go on to say:

    This lack of confidence is amplified by the fact that the rates differ greatly between the (observation pooled) studies.

    Well, so not only do they have a small sample size from just 3 studies, but the data “differ greatly”. Just how much do they differ?

    Without the Fernandez-Feliberti et al data, the observation surgical rate would be 13%, which is significantly lower than that following bracing. An obviously erroneous conclusion would be that
    bracing causes an excess risk of surgery.
    (Emphasis added is mine).
    Try to keep an open mind to all possibilities. This is not obviously erroneous if somehow the brace results in lost muscle tone that somehow accelerates or allows more curvature when the brace is removed. Now I'm not saying this explanation is likely. I think a more likely explanation is that bracing does not increase surgical rates and that the sample size is too small to say anything one way or the other.

    Quote Originally Posted by concerned dad View Post
    Yep, that is troubling. They excluded just one study (The Puerto Rico study) and showed that bracing causes an excess risk of surgery. It makes you wonder about the other study. It sure would be nice to see what happens to the numbers if they excluded the other study (Ireland). Unfortunately they don’t provide the calculation but I can tell you it would sway it the other way (it would show that bracing causes a decreased risk). The abstracts for the Puerto Rico study and the Ireland study are both posted in the other thread.
    I wouldn't sweat the meaning of considering one or the other of these studies. I think both are most likely flawed. We need higher quality studies going forward. I think the best we can say now is that bracing might be measurably efficacious over and above natural history but it has to be shown. I would characterize the bracing advocates as being in the category of, "Everybody knows it but nobody shows it" as a colleague of my says. Well, I'm waiting for someone to show it despite the case that some folks seem to know it.

    Quote Originally Posted by concerned dad View Post
    Also troubling, in the Dolan paper there is a table summarizing the previous research. In that table (Table 2) they say the following about the Puerto Rico Study. They (Dolan) claims that the main conclusion of the PR study was

    “Nonintervention is equivalent to bracing in surgical rate”

    Now, That is troubling because I read the abstract of the Puerto Rico paper and it concludes

    the control group had a threefold increase in the odds of ending with surgery compared to the treatment group (OR = 3.24, 95% CI, 1.09-9.60). The curve was more likely to progress >40 in the control group (OR = 2,83, 95% CI, 0.98-8.17)

    Just what paper were they reading? This makes NO sense – is it equivalent or is it 3 times more likely? The data from the only control group opposing the control data from Ireland is misinterpreted?
    It could just be a simple error that got by the reviewers. Or it could be that Dolan re-crunched the Puerto Rican data. Or it could be something else. Taking surgery as a criteria is clearly out to lunch anyway. And the sample size is too small to rule out non-random reasons for progression beyond 40* being related to brace or not.

    Either way, not enough there for me to get excited about either way.

    Quote Originally Posted by concerned dad View Post
    Sharon posted a link to a paper that claims that “most published research results are false”. (a very interesting paper we should discuss relative to the specifics of scoliosis bracing – but perhaps on a different thread)
    Isn’t it possible that here we have an example of a false result in the Dolan paper?
    No I think that's a simple error or a re-crunching using more robust criteria. The paper discussing why most published results are false is not referring to these types of errors but rather much more fundamental ones as far as I know. That is, the data presented in the papers are not made up and they can be interpreted in the way the authors do. But they are still wrong for many other reasons.

    Quote Originally Posted by concerned dad View Post
    And is this the paper that the “anti bracing “ folks are embracing to support their argument? (well, it’s not just this one, also cited is the Ireland paper, but we discussed the problems with that on the other thread).
    I think it goes far beyond any one paper. I think it's also years of personal experience bracing by orthopods and them noting the results though not publishing them necessarily. You get a sense if something is working or not if you brace kids and many still go on to surgery.

    Quote Originally Posted by concerned dad View Post
    The call for a large randomized controlled study isn’t going to help us here and now. There are a lot of challenges (ethical and logistical) involved with doing a study like that. We have to look (with a discerning eye) at what data we have available now.

    Dolan in the above 2007 paper says

    The few studies that have compared bracing to observation have demonstrated some decreased risk of curve progression (generally defined as >5 change). Of these, the study by Nachemson and Peterson is the only prospective, multicenter controlled study (Level 2b).

    Dolan also says the Nachemson paper is the most rigorous to date”. What does the Nachemson paper conclude?

    Treatment with a brace was associated with a success rate of 74 percent at four years; observation only with a success rate of 34 percent.”

    Note that Dolan did not include the Nachemson data in their “systematic review” because it failed an “inclusion criteria” of providing information concerning surgical rates. And, just to put the Nachemson study in perspective, it was performed by the Brace Study group of the Scoliosis Research Society (it was a multicenter study).
    I will await some more controlled studies.

    Quote Originally Posted by concerned dad View Post
    I don’t intend to sound harsh here. I am just trying to give a voice to the other viewpoint.
    There are a lot of brave kids out there diligently following their doctors and parents advice and wearing their brace. I would not want them to come to the conclusion after reading a thread like this that bracing is somehow scientifically shown to be a waste of time. Comments such as “I look at the same studies and would not put my child in a brace” and “Bracing is a crapshoot at best” from obviously very smart and respected posters warrant a response from an opposing view. And here you have it.

    All of the above is just my current opinion and subject to change.
    I don't think anyone has said bracing is a waste of time. I think it has been said, and is fair to say, bracing hasn't been shown to be particularly efficacious over and above watching and waiting.

    If folks want to take a shot with bracing then they should be able to do so.

    sharon
    Last edited by Pooka1; 12-26-2008 at 01:47 PM.
    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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    BrAIST study

    Hi Concerned Dad,

    I wanted to start by saying that I respect your choice in selecting a treatment for your daughter's scoliosis. I would never judge another parent for choosing to brace or not brace or opt for surgery. We all are trying to do what we think is best for our kids, of that I am sure!

    I have been following this thread (and the other one linked to it-thanks). I have some additional interest in the topic of bracing because I wore a Boston brace very miserably for two years, and I don't think I ever fully "got over it." It was incredibly difficult to say the least. My young daughter wore a brace for 5 months earlier this year and it was not a happy time for our family. Some other families are luckier I guess because some kids seems to tolerate bracing better than others. Not having a sound scientific base to guide treatment choices with is a huge concern for me. If bracing were a benign treatment it would be different and easier, I think.

    Anyway, enough rambling! Concerned Dad, the study that was mentioned but not named is the BrAIST Study. Here is a link:
    http://clinicaltrials.gov/ct2/show/NCT00448448

    It is a fully randomized trial. The participants do not get to self-select the treatment. You can find quite a bit about the study online.

    Best regards,
    Gayle, age 49
    Oct 2010 fusion T8-sacrum w/ pelvic fixation
    Feb 2012 lumbar revision for broken rods @ L2-3-4
    Sept 2015 major lumbar A/P revision for broken rods @ L5-S1


    mom of Leah, 15 y/o, Diagnosed '08 with 26* T JIS (age 6)
    5/10 VBS Dr Luhmann Shriners St Louis
    5/16 6 yrs post-op, 24*T/ 22* L, mild increase in curves, watching

    also mom of Torrey, 12 y/o son, 16* T, stable

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    First, thank you for summarizing those papers, I can never get through them (the one thing I don't have patience to do).
    I do think that the paper you mentioned has results that are skewed, major differences in sizes and different countries use different methods, as we have read on this forum. I'd be more interested in US studies.
    My personal opinion is to use any non-invasive method first, before one thinks of surgery. There seems to be more brace choices that are less showing than the older ones, that should be investigated.
    When it comes to the results of surgery after bracing, there are many factors that can lead to this. Such as for my daughter, we knew surgery would eventually be neccessary, we were just trying to prolong it. As for my son, we keep our fingers crossed that as he goes on major growth spurts the curve won't decide to increase. Of course in his case, during the summer when it is hot, it's uncomfortable to wear, right now it helps to keep him warm. The inconsistancy of wear might do him in.
    I don't know how the studies deal with those types of situations, or if they even mention it, but that would hold more standing for me.

    Emily

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