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Thread: The Braist Study

  1. #1
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    The Braist Study (& Scolios Research Funding)

    The purpose of the Braist Study is: to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.

    Concluding data should be available for analysis in August 2010. The study is limited to the TSLO type bracing method. If I am reading the information about this study correctly, it appears that compliance will involve some pretty amazing monitoring (Wear time measured using a temperature monitor).

    Anyway ... the official government web link below offers a lot of information about all this (including email contacts) for us to monitor as time goes by.

    Principal Investigator: Stuart L. Weinstein, MD University of Iowa
    Study Director: Lori A. Dolan, PhD University of Iowa

    http://clinicaltrials.gov/ct2/show/NCT00448448
    Last edited by mamamax; 11-26-2009 at 09:09 AM.

  2. #2
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    Grant Money for Scoliosis Research/Study

    While looking through the web site above, which is a registry of federally and privately supported clinical trials conducted in the United States and around the world, I found 42 studies devoted to scoliosis. http://www.clinicaltrials.gov/ct2/re...scoliosis&pg=1

    So, I think it is good to see that so much is going on. One completed study (1/09) caught my eye: An Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis http://www.clinicaltrials.gov/ct2/sh...liosis&rank=11

    While the study was completed in January of this year, there are no posted results as of this date. Maybe it takes another year to analyze data, I don't know but I sure would be interested in the results of that one.

    Have to say I often find myself questioning why studies dealing with Schroth exercises seem so limited in number and largely obtainable only outside this country under German publication. Maybe it is because there are few government grants available for such things here in the US, forcing such studies into a self funded or privately funded category. I don't know, but when I searched for available grant money available for scoliosis studies - I couldn't find any. There was an award ceiling for $125,000,000 in 2004 for studies related to HIV/AIDS care programs. But I'll be darned if I can find any grant money available for Scoliosis studies.

    Is it just me and my lack of searching skills? Here is the Advanced search link: http://www.grants.gov/search/advance...0H!-1163459943




  3. #3
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    Quote Originally Posted by mamamax View Post
    Concluding data should be available for analysis in August 2010.
    The POSNA presentation by Lori Dolan states that they have not randomized as many patients as they were predicting and therefore don't think they will have 384 randomized patients until August 2011.

    I personally can't imagine making a decision on whether to brace patients or not based off of 384 patients, half of them not wearing a brace, with many different variable physical attributes, but, whatever.....that's what the statistics say, so it must be valid.

  4. #4
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    Quote Originally Posted by Ballet Mom View Post
    I personally can't imagine making a decision on whether to brace patients or not based off of 384 patients, half of them not wearing a brace, with many different variable physical attributes, but, whatever.....that's what the statistics say, so it must be valid.
    I agree. Who will not be bracing and who will make that decision? I think ideally, the decision should be with the parents. However, how many parents are going to be willing to just watch and wait? I wasn't aware of the 2011 update - thanks!

  5. #5
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    Finding & Following the Funding

    The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The work of HHS is conducted by the Office of the Secretary and 11 agencies. http://www.hhs.gov/about/

    Of these eleven agencies - it is the National Institutes of Health (NIH) that is the primary federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people's health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 institutes and centers, the NIH provides leadership and financial support to researchers in all fifty states and throughout the world. http://clinicalresearch.nih.gov/about.html

    NIAMS is one component of the National Institutes of Health (NIH), they research diseases of the bones, joints, muscles, and skin. This is the agency sponsoring the Briast study (looks like through HHS funding).

    All 27 institutes and centers under NIH can be found here: http://www.nih.gov/icd/index.html

    If you read through this listing you will see there is no agency established specifically for scoliosis. Should there be? A few departments within it could be dedicated to the research of conservative methods.

    Want to know how much funding is available, where it has been & where it is going? http://report.nih.gov/rcdc/categories/

  6. #6
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    An Update

    Thanks to the efforts of those at SSO, Lori Dolan (Braist Study Director) has posted some interesting information in their forum. Her comments can be found here:

    http://www.scoliosis-support.org/sho...863#post118863
    http://www.scoliosis-support.org/showthread.php?t=6954

    I've invited Lori to join this thread and hope her schedule will permit some input here.

    I have a few questions.

    The first concerns how subjects will be followed. I wonder how often they will be seen and how often their braces will be checked for any necessary adjustments. Also, is the temperature monitor designed to resolve all compliance issues? Seems there may be several TSLO type braces used - will subjects be monitored by those who are well experienced in the application of each?

    My second question concerns US funding of scoliosis research through NIH (under HSS). I searched the government web site
    http://www.grants.gov/search/advance...0H!-1163459943 to see what was available for scoliosis research and found nothing. I wonder if Lori has any input regarding future funding.
    Last edited by mamamax; 11-26-2009 at 09:34 AM.

  7. #7
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    Smile Message from Lori Dolan

    I received a very nice letter from Lori Dolan today. She is experiencing some problems logging in to our forum and has written Joe O'Brien about it - so hopefully she will be able to join us shortly.

    In the mean time she gave me permission to post her replies to my questions. Lori has graciously taken time from her I'm sure hectic schedule to join our forum and has expressed an openness to our questions here.

    Thank you Lori and hope to see you here soon!

    My questions, previously posted are below - Lori's answers (verbatim) are indented and follow each question.


    __________________________________________________ _________________________________

    I have a few questions. The first concerns how subjects will be followed. I wonder how often they will be seen and how often their braces will be checked for any necessary adjustments.
    Subjects are seen every 6 months for a clinical exam, x-rays and to complete questionnaires about their health and well-being. Those in the bracing arm are seen every 6 months AND as often as needed to maintain brace comfort and maximize correction/balance. The orthotist/MD team have free reign to see the subjects at any time in between their scheduled six month visits. We call each subject every month to see if they have any questions/concerns. All are encouraged to contact us at any time.

    Also, is the temperature monitor designed to resolve all compliance issues?
    The temperature monitor will tell us with some degree of certainty what the dose of bracing was. We will not know how tightly the brace was applied, but we will know the date, day of the week, and times the brace was on and off. Then we can check whether there's a particularly effective amount of weartime, if the brace needs to be worn everyday, if daytime wear is better than nighttime, and if patients with different curves, Cobb angles, and/or degrees of skeletal maturity require different doses to prevent curve progression.

    Seems there may be several TSLO type braces used - will subjects be monitored by those who are well experienced in the application of each?
    Each orthotist/MD team is using the type of brace they routinely prescribe in regular practice. This should ensure that they are comfortable with measurement, construction, fit and maintenance of the brace. Most are using customized Boston braces, du Pont uses the Wilmington brace, and here at Iowa we use the Rosenberger brace. Some orthotists are including some features of Cheneau braces.

    My second question concerns US funding of scoliosis research through NIH (under HSS). I searched the government web site
    http://www.grants.gov/search/advance...0H!-1163459943 to see what was available for scoliosis research and found nothing. I wonder if Lori has any input regarding future funding.

    I don't have any knowledge about future funding - Dr. Weinstein is the head of the American Academy of Orthopaedic Surgeons and he is constantly in Washington DC and at the NIH speaking to staff members and Congressmen about the need for increased funding for orthopaedic research. As far as I know, there has never been a call from NIH specifically for proposals concerning scoliosis, however, there are funds available for clinical trials and genetics work in general. We feel it is very important that BrAIST is well-run and produces results with a high level of credibility and integrity. BrAIST is the largest NIH funded clinical trial in pediatric orthopaedic history and our success will hopefully pave the way for future funding. I also want to acknowledge the incredible support we have received from the Shiners Hospital system. Without their co-funding, and that of the Canadian Institutes of Health Research, we would not be able to do this work.

    I would also like to take this opportunity to announce that BrAIST is now a partially-randomized preference trial. That means that families who decline randomization can still participate by choosing either bracing or observation. Other than this change in the way treatments are assigned, the protocol will remain the same. As we anticipated, the majority of families want to be free to choose their own treatment and so we are now including this as an option.

    Thank you for this opportunity.

    Sincerely, Lori Dolan, PhD
    Project Director, BrAIST"




  8. #8
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    Thanks again Lori for your responses!

    How long is this study expected to take, and is there any consideration being given to the inclusion of Spinecor?

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    I would also like to take this opportunity to announce that BrAIST is now a partially-randomized preference trial. That means that families who decline randomization can still participate by choosing either bracing or observation. Other than this change in the way treatments are assigned, the protocol will remain the same. As we anticipated, the majority of families want to be free to choose their own treatment and so we are now including this as an option.

    Thank you for this opportunity.

    Sincerely, Lori Dolan, PhD
    Project Director, BrAIST
    That is absolutely WONDERFUL news that they are going to allow patients and their families to choose their treatment! What a great decision on these researchers' part. Perhaps now they can actually get some statistically significant numbers of brace wearers to determine the traits that allow for successful bracing! Kudos to them for changing the study to accomodate these parents that wish to brace their children.

    Thanks Mamamax for contacting Lori Dolan, good for you!

  10. #10
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    What ever happened to BRAIST?

    Have there been any updates from BRAIST since 2009? I did see that study participants are no longer being enrolled.

    Just curious...
    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

  11. #11
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    They are probably still collecting and(or) crunching data. I would hope every one of the study subjects is past maturity at the time of data crunching or the results should not be publishable.

    If they have some preliminary results, I suppose Dolan or a coauthor will be presenting it at meetings ahead of a publication.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

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  12. #12
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    http://clinicaltrials.gov/ct2/show/NCT00448448

    Estimated Enrollment: 500
    Study Start Date: February 2007
    Estimated Study Completion Date: August 2012
    Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
    They probably got their 500 subjects and that is why they are no longer enrolling. They are still collecting data based on this timeline.
    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."

  13. #13
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    There was an update last week at the SRS meeting.

    To BrAIST or not to BrAIST: Self-Selection in the Bracing in Adolescent Idiopathic Scoliosis Trial
    Lori A. Dolan, PhD; Stuart L. Weinstein, MD
    USA

    Summary: Without random selection and random assignment to treatment, the results and conclusions of clinical trials can be subject to selection bias . Selection bias may prevent the generalization of findings to patients outside the trial, and more seriously, may prevent researchers from knowing whether the treatment effect is due to the treatment itself or due to the non-equivalence of the arms at baseline . This study indicates that the BrAIST sample is representative of the target population and the bracing and observation arms are equivalent in terms of known risk factors for curve progression .

    Introduction: BrAIST is a partially-randomized trial comparing the outcomes of bracing and observation in children with adolescent idiopathic scoliosis . The purpose of this study is to evaluate two sources of selection bias: self-selection into the study and self-selection of treatment arm . Specifically we asked 1) is the BrAIST sample representative of the target population and 2) are the treatment arms equivalent in terms of risk factors for curve progression?

    Methods: We addressed these questions by comparing baseline demographic, radiographic and psychosocial characteristics between the patients who enrolled in BrAIST and those who declined; and between the bracing and observation arms .

    Results: Since April 2007, 1131 patients met eligibility criteria; 360 (32%) agreed to participate . There were no statistically significant differences between those who declined and those who agreed to participate in terms of largest Cobb angle, curve type, gender, or age . Blacks/African-Americans were more likely to participate (50%) than other racial groups (p<0 .01) .

    Of the 360 participants, 219 (61%) entered into the bracing arm . Prior to treat- ment, there were no statistically significant differences in demographics, curve characteristics (Cobb angle, curve type, rotation, flexibility, kyphosis, lordosis), skeletal maturity (Risser and digital skeletal age), general health, back pain or psychosocial characteristics including body image and quality of life . However, those who were very dissatisfied with their current back condition were more likely to choose a brace than to be observed (73 vs . 51%, p<0 .01) .

    Conclusion: BrAIST is still open to enrollment and these results are preliminary . The lack of difference between those who said “yes” and those who said “no” provides evidence that the sample is representative of the target population of high-risk adolescents . Likewise, lack of difference between the bracing and observation arms at baseline indicates any differences in outcome at the end of the study can be attributed to treatment and not to inbalance related to self-selection.

    Significance: This study creates confidence that the final results and conclusions from BrAIST will be free from significant selection bias .
    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Dilbert
    I'm sarcastic... what's your super power? --Unknown
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  14. #14
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    There was also an E-poster:

    Does 25° and Risser 0-2 Still Constitute Reasonable Bracing Criteria? Decisions using Traditional Criteria Compared to the Digital Maturity Stage System
    Lori A. Dolan, PhD; Karim Z. Masrouha, MD; Stuart L. Weinstein, MD; James O. Sanders, MD

    Summary: While Risser grade has the status of tradition and familiarity, the recently-studied digital skeletal maturity staging (DMS) is more specific during the long Risser 0 phase with the potential to accurately target patients at high risk for curve progression .

    Introduction: Standard bracing criteria are Risser 0-2 with a curve of 25+ degrees or 20° with documented 5° progression . However, recent studies found maturity staging using hand radiographs are more closely tied to peak height velocity and curve changes over time than the Risser grade . (Sanders et al . 2007) Additionally, the combination of digital maturity stages (DMS) and Cobb angle was highly predictive of eventual curve progression to surgical indications . (Sanders et al ., 2008) We evaluated the correspondence between Risser and DMS in an independent sample, and then examined how using the DMS would change decisions to brace relative to the Risser-based method .

    Methods: We used data from 327 subjects enrolled in the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) . Risser grade and DMS were compared using the Spearman correlation . Each subject was “indicated” for bracing using the traditional Risser/Cobb angle criteria and the criteria suggested by Sanders et al . of 20° at DMS 2 and 30° at DMS 3 . Agreement between indications was calculated using the kappa statistic .

    Results: DMS ranged from 1-8 and Risser from 0-5 . Risser and DMS were moderately related (Spearman r=0 .55) . 98% of subjects at DMS 2 were Risser 0 or 1, but subjects at Risser 0 had DMS ranging from 2 to 6 . Conversely, DMS 3, corresponding to the timing of the PHV, occurred during Risser 0 11%, and Risser 1 87% of the time .
    Agreement between the decision systems was low (kappa = 0 .20) . 241 subjects (74%) met Risser criteria compared to 135 (41%) who met the DMS criteria .

    Conclusion: The correlation between Risser and DMS is moderate, but when combined with the Cobb angle to select patients at high-risk of curve progression, the two decision systems frequently result in different treatment plans . Using curve magnitude with DMS would reduce the incidence of bracing by 33% .
    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Dilbert
    I'm sarcastic... what's your super power? --Unknown
    ---------------------------------------------------------------------------------------------------------------------------------------------------
    Surgery 2/10/93 A/P fusion T4-L3
    Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation
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    If you've signed up and are having trouble posting, please check your spam folder. An email was sent to the email address which you subscribed. You have to follow the instructions in that email. Done that and still having trouble posting? Contact Joe O'Brien at jpobrien@scoliosis.org.

  15. #15
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    Hey Linda, thanks for posting those abstracts.

    I'm relieved to see the partial self-selection into treatment arms didnt' screw up their study. They took a chance there and won.

    The poster is some evidence for what was previously suspected... many kids are braced needlessly based on relation to peak height velocity. Then they are going to have to determine if there is a second group within that group (of maturity plus Cobb) who still don't need to be braced.

    And finally, hopefully they will get a number on brace efficacy to compare to the Katz et. al 2010 study. That will be pretty interesting. My guess is that within curve types (T versus L), they will see a slight relation between brace wear and lack of progression that is meaningless in terms of predicting what any new case will do just as Katz was. 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.
    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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