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Thread: Brace Study Concerns

  1. #1
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    Brace Study Concerns

    Quote Originally Posted by AMom View Post
    Sharon,

    My daughter was initially put in the no-brace group in this experiment and I was livid. It is highly un-ethical to put anyone in a randomized trial without their knowledge. Informed consent should be the foundation of medical treatment--anything less is malpractice. I actually read the forms I sign and make written modifications to them regarding use of her records i.e. they may only be used for HER treatment, they may not be used for education or shared in any form. I NEVER GAVE CONSENT FOR HER TO PARTICIPATE IN ANY TRIALS.
    This doesn't comport with how they say they are running BrAIST. It sounds unethical and illegal. Are you absolutely certain it was a study and the study was BrAIST? The reason I ask is when dealing with patients and telling them which group they were randomized to, some people objected. So they went to a semi-randomized design. So obviously everyone knew they were in the study and that there were randomized. That's why I don't think it is that BrAIST study.

    Is the medical center where you went listed on the BrAIST site? Did they tell you it was BrAIST?

    If you are sure it is BrAIST, you should write to Lori Dolan at Iowa and demand answers. Then write to the newspaper.

    Was your daughter's curve over 25* when this all went down?
    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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    Quote Originally Posted by AMom View Post
    I am extremely offended that anyone would think it appropriate for doctors would take it upon themselves to withhold treatment for their own purposes. Didn’t the medical profession learn anything about ethics from the syphilis trials run in the mid 1900’s?
    I certainly understand your offense. But bracing, despite being a standard of care, is not a proven treatment. It is still experimental as we are seeing with these journal articles. I didn't appreciate my daughter being given an experimental treatment just because it is the standard of care. And I especially didn't appreciate not being told it was experimental. Talk about the syphilis experiments... there you go. All experimental treatments should strictly require explanation of the experimental nature, the state of the data, and then consent. Had I known the abject poverty of evidence for bracing, I would have turned it down had not my daughter wanted to try it. That literature is not a literature. It's nonsense. In no other field can you get away with decades of no controls. That, in a nutshell, is why they are still at square one with bracing. It's a tough field as is PT research.

    It is uncanny how an experimental treatment like bracing is the standard of care and I am not the first to comment on that. It's just that people want an effective conservative treatment to avoid surgery and they don't like watch and wait. That is why some surgeons claim bracing is for the parents.

    Bracing maybe some day be shown to work for certain classes of patients. But until then, there is a high degree of overtreatment which may not be ethical given the difficulty of the treatment. And there is the failure rate which might be largely accounted for by noncompliance but I'm skeptical.

    Did you do Scoliscore with your daughter? Can't you get a brace for her now?
    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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    Quote Originally Posted by AMom View Post
    Sharon,

    My daughter was initially put in the no-brace group in this experiment and I was livid. It is highly un-ethical to put anyone in a randomized trial without their knowledge. Informed consent should be the foundation of medical treatment--anything less is malpractice. I actually read the forms I sign and make written modifications to them regarding use of her records i.e. they may only be used for HER treatment, they may not be used for education or shared in any form. I NEVER GAVE CONSENT FOR HER TO PARTICIPATE IN ANY TRIALS.

    Before we went to see the ortho, I asked via telephone if he braced children and he replied, "Yes." Then, during the first visit, I reiterated the brace question and he again said, "Yes." When we went back 6 months later and her curve had progressed again, I asked him at what degree would he brace her and what type of brace would he use and he made lots of noises, but refused to answer my questions. I was persistent and becoming very suspicious about his behavior. He walked out of the room refusing to answer so I requested the head of his department.

    Someone took me aside and explained what was going on with regard to the trials they were running at the hospital. No matter the degree of curve/ age/ rate of progression/ what the parents requested NONE of the children would be braced at that site.

    I am extremely offended that anyone would think it appropriate for doctors would take it upon themselves to withhold treatment for their own purposes. Didn’t the medical profession learn anything about ethics from the syphilis trials run in the mid 1900’s?

    I will stop my story here.

    A Mom
    Where are you located? If you are in the U.S., you should contact the Committee on Human Research at the facility where your daughter was treated. (There may also be a similar organization in Canada, but I don't know anything about it.) If you truly didn't sign a consent, it's highly likely that all research for at least the spine department at the facility, will get shut down. A Google search of the facility and CHR or Committee on Human Research, should bring up the department's contact information. You can also contact Lori Dolan at lori-dolan@uiowa.edu. She is the Study Director.

    It's bizarre to me that everyone at the facility where your daughter was treated was randomized into the non-treatment arm. I don't recall ever reading anything like that. Did you actually talk to the surgeon over the phone prior to your appointment? ("Before we went to see the ortho, I asked via telephone if he braced children and he replied, "Yes.") I wanted to clarify that "he replied" refers to the surgeon.

    Regards,
    Linda
    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
    ---------------------------------------------------------------------------------------------------------------------------------------------------
    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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    Quote Originally Posted by LindaRacine View Post
    Where are you located? If you are in the U.S., you should contact the Committee on Human Research at the facility where your daughter was treated. (There may also be a similar organization in Canada, but I don't know anything about it.) If you truly didn't sign a consent, it's highly likely that all research for at least the spine department at the facility, will get shut down. A Google search of the facility and CHR or Committee on Human Research, should bring up the department's contact information. You can also contact Lori Dolan at lori-dolan@uiowa.edu. She is the Study Director.

    It's bizarre to me that everyone at the facility where your daughter was treated was randomized into the non-treatment arm. I don't recall ever reading anything like that. Did you actually talk to the surgeon over the phone prior to your appointment? ("Before we went to see the ortho, I asked via telephone if he braced children and he replied, "Yes.") I wanted to clarify that "he replied" refers to the surgeon.

    Regards,
    Linda
    That testimonial is very bizarre and doesn't really fit with what I have read about how BrAIST is operating. I think this will turn out to be a misunderstanding but because I consider AMom to be entirely rational, I am holding a completely open mind.

    If this turns out to be BrAIST, I will send the thread to Dolan and ask her to respond here. And I will never again mention BrAIST without mentioning this event.

    Whatever study it is, some people clearly need to lose their jobs if the facts are as reported. There are enough folks who are at war with science due to ignorance, intelectual dishonesty, and moral turpitude. We don't need to be creating situations where more do so.
    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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    Please move this to a new thread

    [QUOTE=Pooka1;136726]Gupta is a top guy as far as I know. I bet you will get a great result.

    Hi Folks,

    I've been away from the site for a couple of days. Linda, I'm not sure how it works, but will you please move my comment, & yours and Sharon’s questions regarding the brace study and the things that happened with our family to a new thread I will start named, "Brace Study Concerns" so I can share what I learn as I obtain answers without interrupting Annm's thread? Sorry for disrupting your post.

    Thank you for your assistance!

    A Mom

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    Brace Study Concerns

    Hi Folks,

    I've been away from the site for a couple of days. Linda, I'm not sure how it works, but will you please move my comment, & yours and Sharon’s questions regarding the brace study and the things that happened with our family to this new thread I started named, "Brace Study Concerns" so I can share what I learn as I obtain answers without interrupting Annm's thread?

    I will look up the BrAIST study to see if the hospital is part of their study. (Sharon seems fairly certain this entity would not have acted in this manner.) I will also contact the hospitals' Committee on Human Research to discuss what occurred. When I know more, I will share what I learn.

    A few notes: I live in the USA; I was not told the name of the study; I did speak directly with the ortho--no question about the disconnect between the initial information received, the avoidance of info later, or the final info received; My daughter's curve was 22° at the time, I was seeking info for near-future care; I chose another city/ ortho to provide care for my daughter's scoliosis; The new ortho did offer a brace when her curve progressed, but we had begun PT/ core torso rotation w/ back extensions and decided to give it 4 months to see if it would "hold" her curve so she was not braced (it did not progress for 8 months); Her next x-ray is in four weeks so we will soon learn if her curve has progressed over the last six months; and I will answer any other questions as they arise.

    A Mom

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    The hospital is part of the study discussed

    Sharon,

    I just checked the site you suggested and am sorry to report the HOSPITAL I was discussing is part of the study you mentioned. I will check the exact date, but the year (2007) is also a match. I sent an email to Lori Dolan to see if my daughter's ortho was participating in the study. Let's hope he wasn't. People like him make me so tired.

    A Mom
    Last edited by AMom; 03-15-2012 at 01:31 AM.

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    AMom,

    Thank you very much for doing all that!!!

    There are enough imaginary reasons why people feel they need to be at war with science. We don't need to add real ones like you have relayed.

    If it turns out to be BrAIST and Dolan does not repudiate the tactics then it won't go unmentioned in the future in this site. It sounds illegal what they did.
    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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    Unethical Behavior

    Quote Originally Posted by AMom View Post
    I realized I can (cut and paste) move my comment to this thread. A Mom

    Originally Posted by Pooka1
    Hi and welcome.

    Deep breaths. :-)

    ....

    Do NOT beat yourself or your daughter up over the brace wear issue. There is a large trial going on now where kids are randomized to a no-brace group and surgeons agree that is ethical. So don't beat yourself up. Please. The jury is obviously still out on bracing.

    ....

    Deep breaths.

    Best regards,
    Sharon

    Sharon,

    My daughter was initially put in the no-brace group in an experiment and I was livid. It is highly un-ethical to put anyone in a trial without their knowledge. Informed consent should be the foundation of medical treatment--anything less is malpractice. I actually read the forms I sign and make written modifications to them regarding use of her records i.e. they may only be used for HER treatment, they may not be used for education or shared in any form. I NEVER GAVE CONSENT FOR HER TO PARTICIPATE IN ANY TRIALS.

    Before we went to see the ortho, I asked via telephone if he braced children and he replied, "Yes." Then, during the first visit, I reiterated the brace question and he again said, "Yes." When we went back 6 months later and her curve had progressed I asked him at what degree would he brace her and what type of brace would he use and he made lots of noises, but refused to answer my questions. I was persistent and becoming very uncomfortable with his behavior. He walked out of the room refusing to answer so I requested the head of his department.

    Someone took me aside and explained what was going on with regard to the trials they were running at the hospital. No matter the degree of curve/ age/ rate of progression/ what the parents requested NONE of the children would be braced at that site.

    I am extremely offended that anyone would think it appropriate for doctors would take it upon themselves to withhold treatment for their own purposes. Didn’t the medical profession learn anything about ethics from the syphilis trials run in the mid 1900’s?

    I will stop my story here.

    A Mom

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    Lmtcb

    I left a message with the hospital’s Records Department. The reports will give me the DOS as well as the ortho's name. I also spoke with the hospital's Patient Representative and she is looking for the contact person for their IRB team. They do not have an Ethic's Department or Committee on Human Research listed on their site. (I'm not in a place where I can go through my own records.)

    This incident had a large impact on how I perceive the medical profession with regard to treating my children, but I keep hoping I will come across something that proves we were not part of the study.

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    Quote Originally Posted by AMom View Post
    This incident had a large impact on how I perceive the medical profession with regard to treating my children, but I keep hoping I will come across something that proves we were not part of the study.
    I think at 22* you could not have been in the study because that is outside of the treatment window.

    Someone correct me if I'm wrong. Please.

    So technically if you were not in the study then they don't need to inform you. Presumably you would have been informed had you been in the study.

    But there is still the isue of how BrAIST is operating, specifically:

    1. are they having entire instituions in only one study arm,

    2. how is the semi-randomization working which includes patient preference and when did it start, and

    3. is anyone ever enrolled in the study without their knowledge?
    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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    Found one report

    One of the forms was located, 1st x-ray was taken 11/30/2006, read as 14° or 17° "in the mid and lower thoracic spine...mild rotational component...no anomalies are noted...." That makes sense, because 6 months later it had increased somewhat which prompted my persistent bracing questions. The form is dated 01/19/2007.

    The study seems to have begun in February-March so maybe she wasn't actually enrolled in the study because her next x-ray would have been in May and they had no way of knowing her curve would have been large enough to be included in the study. (According the BrAIST site I read, I believe 20° may have been the minimum curve size to be included in the study)

    Because I know you'll ask Sharon, the NOTES from the actual visit report 17 and the REPORT says 14 degrees. It is typical to have a disparity between what the ortho reads during the visit and what he writes in the report. As long as the figures are similar, I don't worry about the discrepancy.

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    Info cut & pasted from BrAIST info

    Quote Originally Posted by Pooka1 View Post
    I think at 22* you could not have been in the study because that is outside of the treatment window.

    Someone correct me if I'm wrong. Please.

    So technically if you were not in the study then they don't need to inform you. Presumably you would have been informed had you been in the study.
    ....


    Eligibility


    Ages Eligible for Study:

    10 Years to 15 Years

    Genders Eligible for Study:

    Both

    Accepts Healthy Volunteers:

    No

    Criteria

    Inclusion Criteria:
    •Diagnosis of AIS
    •Skeletally immature (Risser grade 0, 1, or 2)
    •Pre-menarchal or post-menarchal by no more than 1 year
    •Primary Cobb angle between 20 and 40 degrees
    •Curve apex caudal to T7 vertebrae
    •Physical and mental ability to adhere to bracing protocol
    •Ability to read and understand English, Spanish, or French
    •Documented insurance coverage and/or personal willingness to pay for treatment

    Exclusion Criteria:
    •Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
    •History of previous surgical or orthotic treatment for AIS

    SHE COULD NOT HAVE BEEN PART OF THE STUDY BECAUSE SHE WAS TOO YOUNG. She was 8yro when her curve was large enough to allow her inclusion. Maybe the ortho confused her with another patient? Or maybe he was treating all patients as though they were part of the study to avoid a mistake? Or maybe he simply did not believe in the usefulness of bracing and now had a vehicle to carry his belief? I don't know what he was thinking; I can only report what he was saying and doing/ not doing.

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    BrAIST Response/ Letter

    Quote Originally Posted by AMom View Post
    Sharon,

    I just checked the site you suggested and am sorry to report the HOSPITAL I was discussing is part of the study you mentioned. I will check the exact date, but the year (2007) is also a match. I sent an email to Lori Dolan to see if my daughter's ortho was participating in the study. Let's hope he wasn't. People like him make me so tired.

    A Mom
    Hello XXXX –

    Thank you for your email and for bringing your concerns to my attention and please know that I am taking this very seriously.

    I cannot comment on what you heard/experienced at XXX’s Hospital since I was not present.

    What I can comment on are the procedures and human subject research protections built into BrAIST.

    1) All physicians participating in BrAIST were chosen because they felt more research was needed to provide evidence about the appropriate use of braces. All attested to having an open mind; this is called clinical equipoise.
    2) The purpose of BrAIST is NOT to prove that braces don't work. The trial was designed to detect both positive and negative outcomes of bracing and of observation. The main outcome of the study is based upon the Cobb angle, which is determined by two readers, both of whom are blinded to whether the subject was braced or observed. Neither reader is an orthopaedic surgeon, which provides assurance that they have nothing to gain professionally from the results of the study.
    3) The study and procedures were thoroughly reviewed and approved by the National Institutes of Health, the Canadian Institutes of Health Research, the Shriners Hospital system and human subjects research boards at each of the participating sites. Research at the study sites is governed by the local human subjects research board whose responsibility it is to assure that the process for attaining fully informed and voluntary consent is in accord with Federal regulations and Good Clinical Practice (GCP) guidelines. Each site is required to have approval for the study renewed on a yearly; we track these renewals very closely at Iowa. If, for any reason, approval lapses then I personally inform the NIH, and the University of Iowa Division of Sponsored Programs, and all research activity is stopped at that site until approval is renewed.
    4) The regulations and GCP guidelines prohibit the start of study procedures until AFTER written consent for participation is given by the parent or legal guardian of the patient, and written assent is given by the patient.
    5) The right to change treatment arms is written into the BrAIST protocol. We respect the autonomy of the family to make treatment decisions. Several subjects have opted for observation after a course of bracing, and several have decided to start bracing after an initial period of observation. The protocol does request that the study staff do not suggest change in treatment; but certainly allows the family to request and receive a change in treatment.
    6) All subject data are monitored by either myself or the lead clinical coordinator at Iowa. This includes an onsite examination of each and every consent and assent form to assure that proper procedures have been followed and documented.
    7) The study is monitored yearly by an independent Data Safety Monitoring Board which was appointed by the NIH. The board reviews the progress of the trial as well as all adverse events and major protocol deviations.
    8) Concerning your specific comments about bracing at the XXX ' s Hospital. This site enrolled 12 subjects; the first 8 were randomized to a treatment. Randomization involves a 50:50 chance (across the entire study) of being placed in either the bracing or observation arm. Randomization was performed via a computer program at Iowa and was not subject to control by any individual study team member. In August of 2007, at XXX's, a subject who was randomized to observation requested and received a brace. Of the 4 subjects who entered the trial under the preference arm, 3 chose and received brace treatment. Overall, 6 subjects were initially braced and 6 were observed.
    9) We have documented during yearly monitoring visits that all subjects (at ALL BrAIST sites) for whom we have received study data have signed appropriate consent and assent forms.
    9) I am including here snapshots from the BrAIST Manual of Operations and Procedures so you can see what assurances are in place.

    3. Informed Consent

    After eligibility is confirmed, PI should begin the conversation with the patient concerning the trial.He/she should emphasize that we are offering this trial because we do not know with any certainty whether bracing or observation is the correct treatment for AIS.After this conversation, if the patient is interested, the study coordinator will then present the BRAIST Education MODULE . This module will be used at all sites and with all patients.This module presents information specific to AIS and why we are conducting a trial comparing bracing and watchful waiting.If the patient/family requests more time to review the material and/or to make a decision, the coordinator should give them information on how to access the BRAIST Education Module from home.The local coordinator is responsible for obtaining informed consent prior to randomization or any study procedures

    4. Randomization Procedure

    Once the subject has been enrolled and the consent forms signed, the coordinator will log onto the DMC Web system http://www.braist.org/ to receive the treatment assignment for that subject:either thoracolumbosacral orthosis (TLSO) or watchful waiting.Randomization occurs after the information on the SCREENING/ENROLLMENT FORM is entered onto the Web page.The subject is defined as randomized when the treatment is assigned.Because intention-to-treat analyses will be employed, every subject who is assigned a treatment must be included in the final analysis.Therefore, patients should not be randomized unless the coordinator is certain that they are fully informed about the trial and committed to proceeding and complying with the assigned treatment.

    d.Non-compliance and Cross-over

    Patients do not always comply with brace wear: they either wear their braces fewer hours per day than prescribed, or do not wear them at all.Subjects should be encouraged to fully comply with the treatment in order to obtain the best results possible.Non-compliance will be documented through the brace temperature monitors.Subjects will not be dropped from the study for non-compliance.It is also possible that subjects randomized to the observation arm will at some time request bracing treatment.All attempts will be made to encourage the subject to continue with observation, however, it is the subjects’ right to request and obtain a brace if they wish.This request will be complied with by the research team. The subject will then be fit with a brace and followed using the bracing protocol.The DMC should be notified of observation subjects who begin bracing.Subjects will not be dropped from the study for crossing over to bracing treatment.

    I am very sorry that you had this experience. I hope that I have assured you that BrAIST procedures are in place to protect the rights of patients and research subjects, to respect the autonomy of families to determine treatment, and to provide a fair evaluation of bracing and observation. It is our sincere desire to provide research information to help patients and families make the best treatment choice.

    I would appreciate it if you could post my response on the forum so other readers have access to this information.

    Please address any specific concerns about your treatment at XXX to Dr. XXX personally.

    Thank you.

    Lori Dolan
    Lori A. Dolan, PhD
    Trial Director, BrAIST
    University of Iowa Health Care
    Department of Orthopaedics and Rehabilitation
    01079 JPP
    200 Hawkins Drive
    Iowa City, IA 52242
    phone 319-356-1075
    fax 319-353-7919
    lori-dolan@uiowa.edu
    Last edited by AMom; 03-15-2012 at 02:50 PM. Reason: insert "snapshot" referenced in #9

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    A Mom's Response to BrAIST Letter

    Hi Lori,

    Thank you very much for explaining the procedures and protections built into the study. I am relieved to see the small number of patients enrolled at the XXX hospital, this means it was unlikely our family was ever involved in the study and "lost" within the mass of participants. After reading numbers 1 - 9, 3. Informed Consent, 4. Randomization Procedure, and subsection D. Non-Compliance & Crossover, it appears there was never any intent to place children in the study without parental consent.

    ….

    I am happy to copy your letter onto the NSF site, but will remove the hospital name as well as my own name before placing it on the web site. (Mine for privacy reasons and the hospital's because they generally do a good job taking care of families and don't need their reputation damaged because of one unprofessional individual who no longer works there.)

    Finally, I have already placed a call this morning to speak directly with the hospital administration regarding my concern. I wish I had been able to address the issue fully in 2007, but it was not possible. At least I will be able to state my concerns and then move forward.

    Thank you again for your prompt response.

    XXX XXX

    Note: Highlighted areas to be replaced by X's.

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