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  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"




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