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Thread: The Braist Study

  1. #16
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    They had to abandon the randomized design because parents had preferences.

    They do not claim it is still a randomized study. They claim it is, "a partially-randomized trial".

    It is a result already to see how many parents seem to have an idea of how to proceed when researchers themselves do not.

    This research is hard and this may be as good as it gets which is still far FAR better than a sharp stick in the eye.
    Sharon, mother of identical twin girls with scoliosis

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  2. #17
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    Moreover, even if it this study was truly randomized, it will still not answer a major open question of whether bracing only delays progression.

    It has been estimated that maybe 10% of folks who are braced appear to have avoided surgery at the end of puberty. But maybe this is the exact crowd that progresses in later life. Any curve >30* at maturity could progress to surgery and it would not be unusual to do as per at least one surgeon. I'm guessing a majority if not every patient who wore a brace comes out with at least a 30* curve so this question needs answering. Katz et al. can't help with this and neither can BrAIST.

    That is a truly difficult research problem.

    There is always going to be correct major criticism of studies in this field because it is intrinsically difficult. That won't go away.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

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    "We are all African."

  3. #18
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    Quote Originally Posted by Pooka1 View Post
    And I'm still waiting to know if the kids in Katz who wore their brace and didn't progress were all the lumbar and TL cases. The article is silent on that, perhaps for a reason.
    This information would be nice to know. However, there were only 8 TL or L curves out of their 100 patients to complete the study. The progression/non-progression split was 50/50. It's certainly possible that all 8 were in the non-progessive side. But it's also very possible, if not likely, that at least 2 or 3 were in the progression side.

  4. #19
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    Quote Originally Posted by Kevin_Mc View Post
    This information would be nice to know. However, there were only 8 TL or L curves out of their 100 patients to complete the study. The progression/non-progression split was 50/50. It's certainly possible that all 8 were in the non-progessive side. But it's also very possible, if not likely, that at least 2 or 3 were in the progression side.
    There were 12 kid who wore the brace the longest as I recall. Those kids had the least progression. This can be completely misinterpreted if all 8 L and TL cases were in that group. Maybe brace wear is more comfortable for curves lower down... easier to breath so they can make it tighter. Who knows.

    I just want to know if all 8 L and TL cases were in that group. It would weaken the paper considerably if that was the case. If it wasn't the case you would think they would have touted it. But they were silent.

    They had 100 data points. They could have plotted each one. Had they done so and not binned the data, the take home message would be that the scatter overwhelms the data and prediction of curve progression is impossible in any given case even given a prescribed number of hours of brace wear. But that isn't what they wanted to highlight obviously. That one graph being missing is significant to me at least.
    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."

  5. #20
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    BRAIST study published

    The Braist Study was just published in the New England Journal of Medicine. Here is an editorial published with it:

    http://www.nejm.org/doi/pdf/10.1056/NEJMe1310746

    The full-text article is available free online fron the New England Journal of Medicine. Here is a link that I think works. You have to tab down to the bottom and click to read full text article.

    http://www.nejm.org/doi/full/10.1056/NEJMoa1307337


    One point that jumped out at me was the authors state we are overtreating scoliosis significantly with bracing. They mentioned that at least 3 children had to be braced to prevent one surgery. The editorial lists something like 9 kids have to be braced to prevent one surgery. All concur that we are overtreating many kids with bracing, and that many kids do fine with being observed only.
    Last edited by leahdragonfly; 10-04-2013 at 08:29 AM.
    Gayle, age 50
    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)
    2010 VBS Dr Luhmann Shriners St Louis
    2017 curves stable/skeletely mature

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

  6. #21
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    Gayle, thanks for posting that.

    There is something funny about them stopping the study early. The results are substantially similar to Katz et al. (2010) and BrAIST wasn't stopped when that was published. That said, BrAiST is somewhat better than Katz et al. (2010) because they worked with less mature patients. Also they did a really good job matching showing the randomized and self-selected groups were similar as well as the braced and observed groups. There is no stacking of lumbar cases in the braced group like in previous studies.

    But the issues remain that a child with a 49* curve at maturity was a "success". I would like to see the final curve measurements on all "successful" cases and especially how many kids were >40* and >45*. This points up that the hypothesis was only how many kids can be keep below 50* at maturity, NOT how many kids avoid surgery for life. They did ask about what the risk reduction would be for a kid to agree to wear a brace but that was certainly misleading because the researchers meant at the point of maturity and the kids were probably thinking for life.

    Finally here is Dr. Hey who was in Lyon for the presentation and asked Weinstein and Dolan some questions... it seems the researchers themselves are somewhat skeptical of their claims.

    http://drlloydhey.blogspot.com/2013/...dolescent.html

    Also notice how Hey still says it's a decision for the kid and family and does not seem to now treat it like cancer wherein everyone gets the treatment because it's proven. That's because of the overtreatment and the fact that only a small percentage (~20% - ~30%) over and above the observed did not reach 50* at the point of maturity. In this regard it is similar to what was already surmised long about... only about 20% of kids are apparently helped by brace by the point of maturity. Not news. I have written that in this forum many, many times. That's another reason why there is something funny about them stopping the study early.

    Essentially, the child must be told they have about a 75% chance of not reaching 50* at maturity if they brace and about a 50% chance of not reaching 50* if they don't do a thing. And this is NO guarantee of avoiding surgery for life, only during adolescence to the point to maturity. Hmmmm.
    Last edited by Pooka1; 10-04-2013 at 10:32 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."

  7. #22
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    SRS Member Publishes Breakthrough Study on Bracing in Scoliosis

    This is the post on the Scoliosis Research Society's website;

    Dr. Stuart Weinstein recently reported the results of the NIH-funded Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) at the 48th Annual Meeting of the Scoliosis Research Society in Lyon, France. Simultaneously, the results were published online in the New England Journal of Medicine. Dr. Weinstein reported that bracing of adolescents with moderate scoliosis was effective treatment in the reduction of the number of patients who advance to the need for surgery. In addition, a dose response was found between the number of hours of brace wear and the success rate of bracing.

    Several medical centers worked together to perform the highest level of medical study, a randomized clinical trial, to answer the question of whether bracing is effective in growing children and adolescents with curves between 20 – 40 degrees. 242 patients participated in the study. Patients in the bracing group were assigned to wear a brace 18 hours per day (a typical bracing prescription). A special monitor was embedded in the brace to keep track of how long it was used per day. Patients in the observation-only group received no additional treatment. The end point of the study was “treatment failure” defined as progression of the scoliosis to ≥50 degrees or “treatment success” when skeletal maturity was reached without progression to 50 degrees.

    72% of brace wearers avoided surgical recommendations, but only 48% of patients in the observational group. Furthermore, the rate of success achieved by those patients who wore the brace for 13 hours or more was greater than 90%, showing that the amount of time the brace is worn is very important. The study provided strong evidence to the value of brace treatment for those adolescents at high risk of progression of surgery.

    In the past, the value of a screening examination for scoliosis has been debated due to inconclusive evidence of the success of non-operative treatment for scoliosis. This is no longer true as the evidence from the BrAIST study establishes the effectiveness of bracing as early, non-operative care. This may reduce the number of patients who progress to surgery and serve as a potential cost saving for the health care system and of great benefit to patients. Policy statements from professional organizations and governmental agencies regarding scoliosis screening in school programs and primary care settings will need to be reassessed in order to identify at-risk patients who will benefit from bracing for scoliosis.
    Best Regards,

    JOB

  8. #23
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    This is great news for the parents that are bracing their kids. My personal concern for these kids is that those with curves >40o<50o may likely progress as adults or have more complications from their scoliosis as adults when they may or may not have insurance. I guess in those cases, it would be up to the parents and providers to decide whether or not to proceed with surgery before the child "ages out".
    Be happy!
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  9. #24
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    Quote Originally Posted by rohrer01 View Post
    This is great news for the parents that are bracing their kids. My personal concern for these kids is that those with curves >40o<50o may likely progress as adults or have more complications from their scoliosis as adults when they may or may not have insurance. I guess in those cases, it would be up to the parents and providers to decide whether or not to proceed with surgery before the child "ages out".
    What if over half the "successes" were >40* at point of maturity? Would that still come under your definition of "great news for the parents"?

    What if kids between 30* and 40* largely didn't progress in both the braced and unbraced groups and only the kids >40* had their progression delayed to early adulthood by bracing as might turn out to be the case?

    I would like to see all the raw data from this study. I am guessing other papers with different conclusions could be written if we had that.
    Last edited by Pooka1; 10-04-2013 at 01:11 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."

  10. #25
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    I think once these papers are published that the researchers should be required to publish the raw data. I think there would be a lot less breathless statements of success if that happened.
    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."

  11. #26
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    They don't publish the curve characteristics at the end of treatment.... and that makes it in the NEJM.... I can not believe this....... They don't calculate any type of "curve-delta". If it's ok to do that because the success/failure classification is >50°, then why would it be necessary to include the curve sizes at baseline? Why publish any data at all? Why not just say, "Curves were <40° at the beginning and 75% were <50° at the end. Trust us."

    Well, on the plus side, the study probably wasn't that expensive or time consuming. So incomplete data really IS the way to go. You can always just do it again without too much trouble.

  12. #27
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    Quote Originally Posted by Kevin_Mc View Post
    They don't publish the curve characteristics at the end of treatment.... and that makes it in the NEJM.... I can not believe this....... They don't calculate any type of "curve-delta". If it's ok to do that because the success/failure classification is >50°, then why would it be necessary to include the curve sizes at baseline? Why publish any data at all? Why not just say, "Curves were <40° at the beginning and 75% were <50° at the end. Trust us."

    Well, on the plus side, the study probably wasn't that expensive or time consuming. So incomplete data really IS the way to go. You can always just do it again without too much trouble.
    As I said, there is something funny going on here. I think many of the "successes" were >40* and even >45*. That is one possible explanation why they didn't publish the bottom line data. It smells of politics. Stopping the study early at the point it was stopped for the reasons stated is objectively bizarre as far as I can tell.

    I fault the peer reviewers.
    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."

  13. #28
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    Quote Originally Posted by Pooka1 View Post
    As I said, there is something funny going on here. I think many of the "successes" were >40* and even >45*. That is one possible explanation why they didn't publish the bottom line data. It smells of politics. Stopping the study early at the point it was stopped for the reasons stated is objectively bizarre as far as I can tell.

    I fault the peer reviewers.
    This was stopped in January of this year?

    It's kind of en vogue to stop a study once you achieve a desired p-value or CI. Big huge studies will try to do it. It gives the statisticians something to do, i.e. regularly check the data and stop when you hit your target. Cost savings and whatnot.

    I side with you on this one. When you don't report data that is easily calculated and meaningful, there is a reason. ANY data from the endpoint concerning curve size is absent in the article and supplementary material.

  14. #29
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    Quote Originally Posted by Kevin_Mc View Post
    This was stopped in January of this year?
    I am not sure when it was stopped.

    It's kind of en vogue to stop a study once you achieve a desired p-value or CI. Big huge studies will try to do it. It gives the statisticians something to do, i.e. regularly check the data and stop when you hit your target. Cost savings and whatnot.
    Well I can understand doing that when you have everyone in the treatment arm living and everyone in the placebo arm dying. But these results are FAR from that.

    I side with you on this one. When you don't report data that is easily calculated and meaningful, there is a reason. ANY data from the endpoint concerning curve size is absent in the article and supplementary material.
    There is something funny here. The authors are going to be taken to task on this. I think there is some hint they are trying to be cautious in their comments to Dr. Hey. I hope someone files a FOIA to get the deltas. If most of the "successes" are >40* it will blow this study out of the water.
    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."

  15. #30
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    It occurred to me that Weinstein/Dolan/et al. might be planning more publications. They almost certainly are in my opinion. I am guessing that is almost certainly the case as the first publication is really just an extended abstract because they don't show the deltas. I hope subsequent publications show at least the following:

    1. Average and median of the final curve measurements in each of the treatment groups. Specifically how many of the "successes" ended up >40* and how many ended up >45*.

    2. Number of patients in each group. For example, we learn that ~90% of people who wore the brace >~13 hour were <50* at maturity. What if only 5 kids wore the brace that long? It is a result to know how many kids complied and at what levels.

    3. Clarity on acceptable levels of risk reduction for brace in terms of avoidance of surgery until point of maturity versus for life.

    I am hoping a political stink has not invaded this study. Subsequent pubs will clear that up. Absent subsequent pubs, that will never be cleared up and a rational person is invited to think there is some reason the deltas were not published that does NOT comport with the published conclusions.
    Last edited by Pooka1; 10-04-2013 at 09:24 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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