Displaying items by tag: Scoliosis bracing

Scoliosis has been part of the recorded medical history for the last 3,500 years and our understanding of it is obviously much improved since then, but still poorly understood overall.  The newest research and understanding of the condition points to it being primarily a neuro-hormonal cause and the spinal curve (the scoliosis) is a reaction/ primary symptom.  
 
Scoliosis bracing and scoliosis surgery are based on the old philosophy that scoliosis is soley a spine disease, not primarily a neuro-hormonal condition that causes a spine disease, so their methodology is based on a "treat the spine only" mentality and this is reflected in the poor results each methodoloy displays in long-term research studies.  Essentially, scoliosis brace treatment is worthless and scoliosis surgery may be worse than doing nothing at all in many cases.
 
Here is where our scoliosis treatment system/methodology comes into the mix.  We recognize that scoliosis is primarily a neuro-hormonal condition and the spinal curve is merely a symptom of the underlying disease, which is why our program/product and message is so refreashing and unique.....and hopefully appealing and accepted.


Patients/parents are entering the scoliosis treatment process at different points and at very different levels of experience with scoliosis treatment.  The biggest difference isn't education about scoliosis or financial restraints, but rather sense of urgency.
 
The current scoliosis treatment model uniformally follows the guidelines of curves 0-25* are observed only/ no treatment; curves 25*-40* are recommended for some sort of bracing; and curves 40* and larger are recommended for scoliosis surgery, which is not medically necessary and primarily indicated for cosmetic improvement of the spinal/toso deformity.  Keep in mind that some of the long-term scoliosis surgery studies indicate failure rates as high as 40% only 17 years post op.
 
So the mother who googles "scoliosis treatment" after learning her 12 year old daughter has a mild scoliosis curvature and the ortho doctor has told her it's not big deal and we will just re-evaluate it again in 6 months has a low sense of urgency, but enough concern to go out on the internet and do some checking around for her own piece of mind.  While the mother with a 14 year old daughter with a scoliosis spine of 45* and the orthopedic surgeon is pushing her hard (usually via guild or fear) to schedule her daughter for scoliosis surgery ASAP is coming into the scoliosis treatment process with a high sense of ugency and anxiety sense of urgency.  The mother's with daughters in scoliosis braces are generally already in the process, but at their wits end, because their kid refuses to wear the brace or it isn't working, so the are left with a sense of frustration and defeat, instead of a sense of urgency.

 

We understand the scoliosis treatment process is confusing and frustrating.  Many consider it out-dated and techologically obselete in many ways.  We agree that we need a better way and that is the goal of creating a scoliosis exercise based treatment approach that permanently re-trains the brain to learn how to hold the scoliosis spine in a straighter position automatically.  We know it sounds too good be true to many, but some times the good things are true.  We need a better way and we hope you agree that future scoliosis treatments must make the transition towards minimally invasive, exercises for scoliosis based approachs that target the neuro-hormonal causes of the scoliosis condition and not just the scoliosis curve.

My Motivation and About Me

By Maggie Victoria

 

I am writing this article, in the hope that you the reader will understand, my journey as a Mom of a scoliosis child, and I, a post scoliosis surgery patient. It is my hope that you will find insight, and knowledge in my journey and experience with my Life after scoliosis surgery, and now my daughters journey through her challenge to stabilize and treat her scoliosis against the norms, of the scoliosis treatment protocol, which is “wait and watch”, “scoliosis bracing”, progression and ultimately, the last choice scenario of scoliosis surgery.

 

Her diagnosis of scoliosis was a devastating blow to me. I realized then that I could not allow my experience to become hers and I would not allow her to sit and wait until she reached surgical levels. It is her diagnosis that has led me to become a passionate advocate of CLEAR scoliosis treatment methods, and non-surgical scoliosis treatment of her scoliosis during the normal surgical protocol of wait and watch. C.L.E.A.R. stands for "Chiropractic Leadership, Educational Advancement, & Research"

I came upon the CLEAR Institute through my research on the web and contacted them. What I found surprised me, delighted me, and excited me. These professionals are devoted to the non-surgical scoliosis treatment of our children and they are highly educated in scoliosis and its anomalies. They are quietly, revolutionizing, and bettering the health of the scoliosis child without surgery. With just one visit to a certified CLEAR doctor, I knew we were in the right place, and such a stark contrast to the experience we had at the scoliosis surgery clinic.  

 

I want to share my experience and my journey with you, the reader, in hopes, that you too, will seek the truth, about scoliosis treatments, about the controversy that is now surrounding scoliosis surgery i.e. its benefits vs. its long term outcomes and risks.

 

I hope it will provoke questions, and thought and further research, so you the parent, will make the best decision possible, without pressure, or haste fort the benefit of your child and your child’s health. Scoliosis treatment with the CLEAR Institute methods does no harm and creates no pain.  Unlike scoliosis surgery, which is life altering and permanent. Once your scoliosis spine is surgically fused, you are forever, now limited going forward in your ability to take advantage of the new, promising treatments and research advances that will be available. I am not willing to close that door for my daughter.

Be well, and best Wishes.

~Maggie

 

Life after Scoliosis Surgery

Please note, the following content is not to degrade or bash the scoliosis surgeon who has devoted their life to the surgical treatment of our community. It is rather, to raise awareness, of the options that we now have available to us for non-surgical scoliosis intervention. I think this next decade, has exciting times ahead for us, as we journey through, to find the better way.

There are millions of individuals diagnosed with scoliosis world-wide.  Many of these children will undergo invasive and life altering spinal fusion scoliosis surgery. Most often the parents and the families are told that scoliosis fusion scoliosis surgery is the only way to treat the scoliosis patient once the curve progresses above a pre-determined threshold. I have spoken and dialoged with many scoliosis surgical patients, who were told that without  scoliosis surgery they would be dead, as their heart and lungs would be crushed. Upon challenging this very ideal, I am met with great resistance, and this notion just is not true. Research indicates that the disease of scoliosis is not life threatening. In fact, many insurance companies are beginning to review these scoliosis surgeries, for the benefits vs. the costs of the scoliosis surgery itself. If you are told that there is no choice, and surgery is a must, and must be done immediately, please pause, please ask questions, and please do not rush to scoliosis fusion surgery.

There has been vast progress in the non-invasive, non-surgical approach to scoliosis treatment. There are options available that have shown to stabilize, decrease, or reverse the scoliosis while keeping the mind, body and spirit, intact and whole. Currently, there are somewhere in the range of about 800,000 people in America with scoliosis.

 

We continue to rely on antiquated treatment methods, that do very little to address the root cause of the curve. Standard treatment protocol for the scoliosis patients is “wait and watch”, “scoliosis brace” and scoliosis surgery. This leaves parents and children very few options, but scoliosis fusion surgery as the scoliosis curve progresses and rotates.

 

The Pre-conceived Notions about Scoliosis and Its Treatment

Doctors, the scoliosis community and even the published media continually indoctrinate those newly diagnosed that nothing but surgical correction of scoliosis, can address the condition of scoliosis. What is not conveyed to each new patient is that generally scoliosis bracing does not hold the spine stable, and does nothing to reverse the scoliosis, and the wait and watch protocol, is largely a ticking time bomb that ultimately can lead to scoliosis surgery, for those who are sure to progress without non-surgical scoliosis intervention.

 

Scoliosis surgery, is brute force lateral curve correction, with spinal fusion, and metal instrumentation introduced to the body that will have long term outcomes that are not favorable and can lead to patients becoming permanently disabled, living with severe debilitating chronic pain at a time in their lives when they least expect it.

 

Scoliosis surgeries are not to be taken lightly. These scoliosis surgeries are complex, and they are not without risk of short and long term complications. When complications arise, long term, there is no standard treatment protocol to address the complications and no one individual will have the same issues as the next. Complications, of premature wear above and below the instrumentation and fusion levels can occur, degenerative disc disease (DDD), stenosis (narrowing that causes pinching of the nerves or spinal cord), facet joint arthropathy (joint disease), bone spur formation, osteoarthritis, spondylitis, spondylolesthesis, loss of correction, flat back syndrome, instrumentation failure and surgical failure etc.

 

The patient, with failed scoliosis surgery syndrome, quickly gets caught up, in a vicious circle of medical professionals, they are largely dismissed, some are even referred to psychiatrists for emotional issues, that are diagnosed as a result of the so called treatment team not being able to identify why this patient is failing to thrive. Most of these scoliosis patients end up finding peace, support, and guidance on online forums, and groups for folks that suffer just as they are. They are further victimized by the health care system as they are tossed from surgeon to surgeon and prescribed inadequate treatments that are meant to pacify rather than fix the root cause. These patients do not have the courage and have a voice until they find out through online forums that they are one of many others suffering just the same. The only answer for these patients is more surgery, surgery that is far more complex and dangerous then the first scoliosis surgery. To add further insult to injury most of these patients have to fight to get any government disability income what so ever. Many of them are turned down several times, and end up needing a lawyer to fight for what is rightfully theirs. The question in my mind, is who is accountable for these failed surgeries, who is accountable for the generations of people who are now in failure, who have lost their abilities, their quality of lives, their ability to earn an income that far exceeds what any individual would receive on SSI disability benefits. We have lost generations of productive contributing adults who are now living in chronic pain.

 

We must begin to question, why scoliosis surgeries are on the rise in America and why it is being promoted as the only treatment that must be performed to address the lateral curve of the scoliosis patients. We must become skeptics in our own healthcare as these surgeries are presented as “life and death” scenarios that must be performed immediately once the patient advances to perceived surgical levels. We must also begin to question the very elements that are used to determine the severity of the scoliosis Cobb angle. We know that the measurement of the Cobb angle only addresses the scoliosis curvature from a two dimensional perspective and this is flawed from the onset as scoliosis is more than two dimensional. We must begin to question, to research to find a better way.

The medical community as an entity must better service its scoliosis community of patients by making parents aware of these non-surgical treatments developed by the CLEAR Institute for the sake and the well-being of the patient.

 

We are being told after all this time, that the only way to improve, to relieve (non-existent symptoms of pain) is to open the body up, chip away at bone from hips and ribs for harvest to the spinal vertebrae, to take the mobile, flexible spine and to fuse it to a solid, immobile structure that will become rigid, and instrument the spine, with large and invasive pieces of metal. The body, and its natural mechanics now permanently altered and the long term outcomes unknown.

We must begin to change mindset, to think progressively, and put aside the traditional treatment modalities to advance and to a better way of non-surgical, non-invasive treatment approaches for long term health benefits.

 

We as a community and as a parent must do our research, stay mindful of the advances in non-surgical scoliosis treatments and challenge the status quo for the best of our children.

Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT.

 

Idiopathic scoliosis of spine is a unique and rather confusing condition. Adolescent children (mainly girls) whom appear to have perfectly normal and healthy spines all of a sudden develop an unexplained scoliosis spine; often in only a few months. They didn't start to do anything differently, they didn't start eating anything differently, and perhaps most the weird part is that despite their scoliosis spine being crooked, they are still generally healthy.


Of course, not "knowing" the cause of the condition certainly makes the task of scoliosis treatment quite challenging; especially when one considers that researchers have yet to find anything actually broken or wrong with the scoliosis spine itself ......it's simply just crooked. In the early stage idiopathic scoliosis patients the discs appear to normal, the muscles appear to be normal, the vertebrae appear to be normal, the ligaments appear to be normal; the scoliosis spine just is crooked for no apparent reason.


This lack of evidence is what has lead to most idiopathic scoliosis researchers to begin looking for a neurological cause for scoliosis of spine, and they are collected a lot of compelling data/evidence to support a neurological under-development in the postural control centers of the brain stem as a root cause component (a combination of genetic and environmental influences) of the scoliosis of spine condition.


Armed with this knowledge, it is pretty easy to see why "mainstream" scoliosis treatment (scoliosis brace treatment and scoliosis surgery) have very poor outcomes and are basically obsolete at this point. As it turns out, process matters in scoliosis treatment.


I always like to use the "making bread" analogy when discussing the Mix/Fix/Set protocol developed by the CLEAR Institute. Throw eggs, flour, yeast, oil, ect into a bowl and toss it in the oven and you won't get bread.....you'll get warm goo. However, if you knead the ingredients into dough, let it rise in the fridge, cook it in a pre-heated oven for the prescribed amount of time you will most likely get bread. Same ingredients, different protocols, dramatically different outcomes.


The successful scoliosis treatment programs for scoliosis of spine in the future will primarily focus on the neuro-muscular component of the scoliosis spine and not just the curvature itself. It will begin as a pro-active scoliosis spine rehab program in the earliest stages of idiopathic scoliosis. And perhaps most importantly, it will focus on the elimination of the environmental influences that combine with the genetic pre-disposition that actually causes scoliosis of spine and will (hopefully) lead to a cure for idiopathic scoliosis.

Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT.

 

 

I have co-coordinated treatment with many orthopedic scoliosis specialists in the past and time and time again I see mothers and daughters get completely rail-roaded into the myth of an immediate medically necessary "need" for scoliosis surgery. Often in conversations that last under a minute before a decision is made and without any independent investigation of less invasive alternatives.....or if the patient would be better off doing nothing at all. After all, the primary indication for scoliosis surgery in adolescent idiopathic scoliosis patients is for cosmetic improvement.

 

Often after years of observation or failed scoliosis brace treatment attempts, the doctor turns to the mother and says "If you love your daugher you'll schedule her for scoliosis surgery right away"....As if there is some some sort of life threatening emergency. There is no consultation of alternatives, no discussion about the short, intermediate, and long-term risks/benefits of the procedure, and generally no mention that this highly invasive procedure isn't even medically necessary from an organic health point of view.....Adolescent idopathic scoliosis (AIS) isn't going to kill you as an adolescent....period. So what is the rush to surgery?

"The current trend for management of these curves is early surgical intervention, the rationale being the ineffectiveness of bracing in preventing the progression of such a large curve and the difficulty in obtaining satisfactory correction by postponing scoliosis surgery to a later date. On the basis of our results, we propose a conservative line of management for these curves, in contrast with current views, rather than to rush into a major spine surgery, expecting a favorable outcome with a well-supervised bracing program. If the curve progresses, scoliosis surgery can always be considered later, keeping in mind the excellent correction obtained with the pedicle screw systems even for large curves of 70 to 100 degrees."


~ A large adolescent idiopathic scoliosis curve in a skeletally immature patient: is early surgery the correct approach? Overview of available evidence.
Telang SS, Suh SW, Song HR, Vaidya SV. Department of orthopedics, Korea University, Guro Hospital, Guro-Dong, Guro-Gu, Seoul, Korea.
J Spinal Disord Tech. 2006 Oct;19(7):534-40.

 

Many people have made the arguement that scoliosis surgery as a teenager will halt progression in adulthood....which is simply not accurate..........

 

"Initial average loss of spinal correction post-surgery is 3.2 degrees in the first year and 6.5 after two years with continued loss of 1.0 degrees per year throughout life."

 

........Keep in mind that the average adulthood progression is 1-3 degrees per year.

 

Some say, "What about the use of scoliosis surgery patients to provide a better quality of life for them in adulthood." This would hold significant value if it were true......unfortunately for a large percentage of them it is not........

 

“40% of operated treated patients with idiopathic scoliosis were legally defined as severely handicapped persons”
~Gotze C, Slomka A, Gotze HG, Potzl W, Liljenqvist U, Steinbeck J. Long-term results of quality of life in patients with idiopathic scoliosis after Harrington instrmentation and their relevance for expert evidence. Z Orthop Ihre Grenzgeb 2002 Sep-Oct;140(5):492-8

 

Others have made the case for "protecting" the patients lung volume.....again, this is a strawman arguement because the there is virtually no coorelation between Cobb angle and lung volume, which varies greatly from case to case......and is not improved post operatively anyway....

 

"The correlation between the change in Cobb angle and the thoracic volume change was poor for both groups."


~Scoliosis curve correction, thoracic volume changes, and thoracic diameters in scoliotic patients after anterior and posterior instrumentation. Int Orthop 2001;25(2):66-0

 

The final position many scoliosis surgery supporters take is impact not surgically treating the adolescent patient would have on them psychologically. Unfortunately, that position/assumption is again false.....

 

“The psychological health status is significantly impaired.”
~Quality of Life and Back Pain: Outcome 16.7 Years After Harrington Instrumentation
Spine 2002 Jul 1;27 (13) :1456-63 Gotze et al, Dept. of O Surg, Hamm,Germany

 

Can someone please show me where I'm going wrong here or has the world of scoliosis treatment just become "too quick to cut" in terms of Idiopathic Scoliosis in adolescent patients.

Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT.

 

There are many symptoms associated with idiopathic scoliosis which range from spine/body deformity, pain, restricted breathing, depression to decreased social functioning, limited physical activity, and lower quality of life.  How every there is one symptom which is often over looked and left out entirely.

 

What if the Cobb angle is really just a "symptom" of the unseen neurological condition that is outwardly and physically manifested as idiopathic scoliosis?  I mean, scoliosis is a multi-factorial condition caused by the combination of genetic pre-disposition and environmental influences, so wouldn't anything else be considered a "symptom"?

 

It is kind of like watching the wind out a window. You can't see the wind, but you can see the effects of the wind on the trees, grass, ect....What if the same is true with scoliosis?...you can't see the neurological condition, but you can see it's effects on the spine.

 

So scoliosis bracing and scoliosis surgery would only be treating the symptom, not the condition itself.

Deep huh?

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• The current system of idiopathic scoliosis detection, evaluation, early intervention, treatment schedule, and treatment methods need to be completely over-hauled from the ground up. The current system is too patch-worked and broken to be fixed…..It needs to be replaced.


• Adam’s positions (the bending over and looking for rib cage asymmetry test) isn’t sensitive enough to detect scoliosis in its early stages…..it is often referred to as “the too late test”.


• Cobb’s angle was developed in 1948 by Dr. Cobb (modest fellow) and is a completely obsolete system of analysis. Attempting to describe a condition as complex as scoliosis purely by the means radiographic lateral flexion is the equivalent to attempting to describe all the features of your new luxury car by only its color. I feel that the continued use of cobb’s angle as the sole system of analysis is the single greatest obstacle blocking further understanding of the true nature of scoliosis. There is so much more to this condition than just a cobb angle.


• The current treatment schedule for scoliosis (10 degree diagnosis, 25 degree bracing, 40 degree surgery) is a scam. It was accepted entirely on one article in 1977, by one doctor who openly admits the numbers are arbitrary and based on a cost based analysis to fit a particular healthcare system. It is not based off science, and more importantly, not based off the patient’s best interests.


• Observation only is not treatment…..it is simply doing nothing…..an aggressive, non-invasive early stage scoliosis intervention program should be employed during this time. An adolescent child’s best hope of beating scoliosis is reduction and stabilization of the curvature while it is still flexible and before it gets a biomechanical advantage.


• scoliosis bracing should be abolished. It has no clinical value and only serves to psychologically scar our children whom already have enough hurdles to overcome. Scoliosis is a 3 dimensional deformity of the spine and some of the latest CT “in brace” imaging indicates rigid bracing increases the rotation component…..especially the rib cage rotation.


• Scoliosis surgery has been proven and accepted to provide NO clinical value to the patient in terms of organic health measures (pulmonary function, cardiac output, elimination of pain, ect). The research on this is clear, the vast majority of orthopedic doctors agree on the subject, and may patients assume it is “medically necessary” and don’t even ask. The orthopedic doctor should make this very clear when discussing the procedure, but they don’t have an obligation to do so. Every patient must be their own advocate….and that goes for every healthcare procedure. Given the high rate of complications, long recovery, and poor long-term outcomes……I feel asking a desperate parent and/or patient to trade deformity for dysfunction is unfair and borderline unethical. Just my opinion and I know many of you will disagree. You are free to do so.

 

I’m not claiming a conspiracy theory in respect to the orthopedic community, but what real motivation would an orthopedic surgeon have to create a non-surgical solution? Every doctor (even me) is bias towards their treatment option, but asking the orthopedic community to re-work the entire problem is likely to receive a disingenuous effort due to financial conflicts of interest alone.


 I hope many of you can come to the realization that the current system of treatment is broken and it needs to be fixed if we are truly going to offer a solution filled with hope to future scoliosis sufferers.

 

Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.

 

This is an interesting article that highlights the controversy surrounding the continued use of brace treatment for scoliosis.  I don't believe that the future of scoliosis treatment will include the continued use of bracing for scoliosis.

 

Professional Opinion Concerning the Effectiveness

of Bracing Relative to Observation in Adolescent

Idiopathic Scoliosis

Lori A. Dolan, PhD,* Melanie J. Donnelly, MD,Þ Kevin F. Spratt, PhD,Þ and Stuart L. Weinstein, MD*

 

Objective: To determine if community equipoise exists concerning

the effectiveness of bracing in adolescent idiopathic scoliosis.

 

Background Data: Bracing is the standard of care for adolescent

idiopathic scoliosis despite the lack of strong reasearch evidence

concerning its effectiveness. Thus, some researchers support the idea

of a randomized trial, whereas others think that randomization in the

face of a standard of care would be unethical.

 

Methods: A random of Scoliosis Research Society and Pediatric

Orthopaedic Society of North America members were asked to

consider 12 clinical profiles and to give their opinion concerning the

radiographic outcomes after observation and bracing.

 

Results: An expert panel was created from the respondents. They

expressed a wide array of opinions concerning the percentage of

patients within each scenario who would benefit from bracing.

Agreement was noted concerning the risk due to bracing for postmenarchal

patients only.

 

Conclusions: This study found a high degree of variability in

opinion among clinicians concerning the effectiveness of bracing,

suggesting that a randomized trial of bracing would be ethical.

 

Key Words: adolescent idiopathic scoliosis, bracing, concensus,

effectiveness, standard of care

(J Pediatr Orthop 2007;27:270Y276)

 

Bracing was adopted as the standard of care for nonoperative

treatment of adolescent idiopathic scoliosis

(AIS) long before the application of the current standards of

scientific evidence. It is questionable whether a new

technology would enjoy such widespread use if it was based

on a literature with limitations similar to those noted in

bracing: of the multiple published studies of bracing

effectiveness, the overwhelming majority are level IV case

series, with only a few level III case-control or retrospective

cohort studies, and only 1 level II prospective cohort study.

Another important limitation of the literature is the paucity

of evidence concerning the effect of bracing on surgical rates

despite the suggestion that the progression to surgery

indicates the ultimate failure of bracing treatment.1 To our

knowledge, only 2 studies2,3 have quantified (relative to

observation) the risk reduction (RR) in surgical rates due

to bracing.

The science of bracing has been hampered, ironically,

by the publication of uncontrolled studies to support bracing

as the standard of care. Consequently, researchers have

hesitated to conduct a randomized trial, stating that it would

be unethical to deny treatment (not brace) when bracing is

considered an effective therapy that has Bstood the test of

time[4 even when that test has been less than rigorous. To the

proponents of bracing, this may not be bothersome; however,

to those who are unconvinced by the evidence, following the

standard of care and prescribing a brace can itself be an

ethical battle.

More than 50 pediatric orthopaedic surgeons volunteered

to participate in a recent randomized trial proposed to

compare bracing with the observation on AIS.5 However,

several of those approached to participate declined on ethical

grounds. Concerned about this objection, we decided to test

the validity of the conclusion that a randomized study comparing

bracing with observation is unethical using the criteria

of clinical equipoise.6 Clinical equipoise has been defined as

Bthe state of honest, professional disagreement in the

community of expert practitioners as to the preferred treatment

6[. Other similar definitions of equipoise include the

state of uncertainty on the part of the pertinent community,

the opinion that no one arm of the trial is known to offer

greater harm or benefit,7 and the lack of consensus within the

expert community about the comparative merits of the

treatments being tested. Random assignment of treatments,

under the condition of equipoise, is not then a default on the

obligation to give the most appropriate treatment because this

is unknown.8

Judgments concerning the presence or absence of equipoise

can come from 3 sources of information: (1) informal

information from the opinions of local clinicians; (2)

semiformal information from evidence of different practices

across physicians or localities or from differing opinions in

the literature; and (3) formal information derived from the

specific measurement of expert opinion.8 In the literature,

only 2 published natural history studies report a rate of

surgery: Bunnell,9 in 1986, reported an overall surgery rate of

16% in curves diagnosed as having an angle of between 16

and 96 degrees, whereas Goldberg et al4 reported a 28%

surgery rate in curves with angle ranging from 10 to greater

than 60 degrees. Table 1 summarizes the results of bracing

outcome studies. Several uncontrolled retrospective case

series of braced patients have been published; those reporting

surgical rates demonstrate widely varying outcomes ranging

from 7% to 43%.10Y22 Two studies have simultaneously compared

untreated and braced curves.2,3 Fernandez-Feliberti et al2

reported a 26% surgery rate in the braced cases compared with

38% in the observed cases. Miller et al,3 in their case-control

study of small curves, found a 2% surgical rate in untreated

curves compared with 5% in the braced group. These

variations in outcomes are likely caused by different inclusion

criteria, including Cobb angle and sex. The literature on

surgical rates, then, is extremely variable and does not support

the superiority of bracing over observation with any certainty.

This variability provides some evidence of equipoise;

however, the evidence for a medical intervention does not

always equal the degree to which clinicians endorse the

intervention or agree on its outcomes.

We therefore sought another source of information, a

formal survey of expert opinion concerning the effect of

bracing relative to observation on cases of AIS. Sufficient

variability and lack of consensus in these estimates would

provide additional evidence of community equipoise and

would therefore support the ethics of randomization in a trial

of bracing on cases of AIS.

 

METHODS

Expert Panel

With institutional review board approval, we used the

membership rosters of the Scoliosis Research Society (SRS)

and the Pediatric Orthopaedic Society of North America as

the sampling frame for this study. Most members of both

societies are practicing physicians, although both include

small numbers of nurses, scientists, and other allied health

professionals involved in the care of children with orthopaedic

conditions. Both societies have official publications that

regularly publish research concerning the natural history and

treatment outcomes of AIS and include such articles and

posters at their national meetings. A sample of 423 members

was randomly selected. The responses were anonymous and

no attempt was made to follow up the nonresponders. All

responses were returned within 3 months after they were

mailed.

The members were also asked to supply information

concerning the following professional characteristics: number

of years in practice, specialty, whether they completed a

fellowship in that specialty, percentage of practice devoted to

AIS, and a self-rating of their familiarity with the literature

concerning bracing and AIS on a scale ranging from 1 to 3.

Surveys

The surveys were designed to gather the opinion of the

respondents concerning the radiographic outcomes of bracing

and the observation at the endpoint of skeletal maturity.

Skeletal maturity was chosen as the endpoint because the risk

of continued progression drops significantly after this point is

reached.23 The 45-degree-angle outcome was chosen as a

proxy for surgical indication, as in the studies by Little et al17

and Upadhyay et al.20

Each member received instructions and examples on

how to complete the surveys. The members were asked to

imagine patients between the ages of 10 and 15 years with

differing clinical profiles who present to their practice for

initial evaluation of AIS. The profiles included combinations

of 3 curve types (thoracic, thoracolumbar/lumbar, and double

major), the presence or absence of menarche, and the size of

the Cobb angle (25Y34 degrees or 35Y45 degrees).

The survey was structured as 6 decision trees, each

presenting (1) a treatment (bracing or observation); (2)

branches for the clinical profiles; and (3) branches for 2

radiographic outcomes (e45 or >45 degrees). Examples of

the decision trees are given in Figures 1A and B. The

members were also asked to estimate the percentage of

patients from their practice presenting with each clinical

profile. These estimates of practice mix were not used in the

analysis but were elicited to help the respondents concentrate

on each separate profile. Then, they were asked to

estimate the percentage of patients in whom they would

expect to achieve a curve with an angle less than 45 degrees

(success) of 45 degrees or greater (failure) at skeletal

maturity after both an observation (natural history) and a full

course of bracing. The members were instructed to use their

knowledge of the AIS literature and their experience to make

these estimates.

 

Statistical Analysis

Descriptive statistics were calculated for the (1) percentage

of patients defined as successes after bracing and after

observation, (2) the RR due to bracing (the percentage of

failure under observation minus the percentage of failure after

bracing), and (3) the number of profiles where the respondents

agreed on the RR. Agreement was defined similar to the

previous work of Wright et al24 and Dunn et al.25 Agreement

was present if greater than 80% of the respondents_ RR

estimates were within a given range (low, 0%Y39% RR;

moderate, 40%Y69% RR; and high, 70%Y100% RR). The

influence of curve type and profile on the outcomes was quantified

using analysis of variance and W2 tests of association.

 

RESULTS

Sample

A total of 423 surveys were mailed and 92 responses

were received. Of these, 10 were from clinicians who declined

to participate, and 4 responses were deemed invalid

because of bracing failure rates that were uniformly higher

than observation failure rates. Therefore, usable data was

obtained from 78 respondents (19%). Considering the low

response rate and, therefore, the questionable generalizability

across all clinicians, we decided instead to use an expert panel

approach similar to that used by Latthe et al26 and Lilford27 in

their studies of clinical equipoise. From the 78 respondents,

we chose an expert panel of those who reportedly devote

more than 25% of their practice to AIS and who also consider

themselves very familiar with the AIS and bracing literature.

Of these 29 experts, 20 (69%) listed pediatric orthopaedics as

their subspecialty; 3 (10%), spine; and 4, pediatric spine. On

average, the panel had spent 22.55 years in their specialty

(range, 6Y45 years) and 24 (83%) had completed a fellowship

in that specialty. The average percentage of practice devoted

to AIS was 49% (range, 28%Y100%).

 

Outcome Estimates

Table 2 summarizes the success estimates (percentage

of curves progressing to a Cobb angle less than 45 degrees)

FIGURE 1. Examples of survey. A, Estimates of observation outcomes. B, Estimates of bracing outcomes.

Dolan et al J Pediatr Orthop & Volume 27, Number 3, April/May 2007

272 * 2007 Lippincott Williams & Wilkins

Copyr ight © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

for each of the profiles and the treatments (bracing or

observation). Although the average estimates indicate that the

group felt that bracing demonstrates an advantage over

observation in the risk of surgery, the estimates for both

bracing and observation varied widely. For example, the

panel estimated that anywhere from 20% to 80% of small

thoracic curves in immature patients would succeed without

treatment. For the same group of curves, the success rates

after bracing ranged from 49% to 90%. The type of curve

alone had no significant effect on the estimates, but the

estimates were higher or lower depending on the profile

(a statistical interaction of curve size and menarcheal

status; P G 0.0001). This interaction is illustrated by the

estimates for thoracic curves. The average success estimate

for small thoracic curves in premenarcheal patients without

treatment was 44.87% compared with 77.22% for small

curves in postmenarcheal patients (difference of approximately

22%), whereas the average success estimate for large

thoracic curves was 20.39% in premenarcheal patients and

55.85% in postmenarcheal patients (difference of approximately

35%). Figure 2 summarizes these relationships.

Table 3 summarizes the RR estimates for each clinical

profile. The RR estimates were obtained by subtracting the

bracing failure rates from the observation failure rates. Like

the raw success rate estimates, there was wide variation in the

RR estimates. The minimum RR was 0% for all profiles, and

the maximum ranged from 55% (small curves in postmenarcheal

patients with thoracolumbar/lumbar curves) to 75%

(small thoracic curves in postmenarcheal patients and large

thoracic curves in premenarcheal patients). Another way to

demonstrate the variability between the raters is to look at the

median estimates. For example, the median RR for postmenarcheal

patients with large thoracic curves was 30%;

therefore, one half of the panel thought that the RR due to

bracing was 0% to 30%, whereas the other half thought that it

was 30% to 75%.

The RR estimates did not significantly differ across

curve types, but they were significantly different between

profiles (P G 0.0001). This is expected considering the

interaction observed for the raw success estimates. The

interaction suggests that on average, the panel thought that

the impact of bracing was dependent on both the curve size

and the menarcheal status of the patient. Consistently,

however, the RR estimates for premenarcheal patients were

greater than those for the postmenarcheal patients. Thus, the

panel responses suggest that bracing has a greater positive

impact for premenarcheal patients than for postmenarcheal

patients. Boxplots summarizing the RR estimates are

provided in Figure 3.

Agreement

We divided the range of RR estimates into 3 intervals:

small effect (0%Y39% fewer failures with bracing), medium

effect (40%Y69% fewer failures with bracing), and large

effect (70%Y100% fewer failures with bracing). Clinical

agreement was present if more than 80% of the experts_

estimates were within 1 of the 3 intervals. We evaluated

whether there was clinical agreement on the outcomes of each

of the 12 profiles.

According to this definition, there was clinical agreement

on only 4 of the 12 profiles, all of which proposed a

small RR due to bracing in postmenarcheal patients. These

agreements are highlighted in Table 4. More than 80% of

the experts indicated that bracing would have a small

effect on postmenarcheal patients with thoracic curves (for

both small and large curves), postmenarcheal patients with

small thoracolumbar/lumbar curves, and postmenarcheal

patients with small double major curves. The respondents

were very close to agreement (77% and 79%) that bracing

would have only a small effect on postmenarcheal patients

with either large thoracolumbar/lumber curves or double

major curves.

 

DISCUSSION

This study used the experts_ opinion of radiographic

outcomes to estimate the surgical rates after observation and

bracing for cases of AIS. These rates varied widely within the

panel for both treatments, as did the consequent RR due to

bracing. The reported RR ratios indicate a wide spectrum of

opinion, from substantial benefit from brace use to no benefit

at all. Agreement, defined as greater than 80% endorsement,

existed in about one third of the profiles. These data

demonstrate significant uncertainty within this expert group

concerning the outcomes of observation and bracing.

Consequently, we think that there is evidence of community

equipoise for most clinical profiles contained in this survey

and that the equipoise requirement for an ethical randomized

trial has been met.

The method of expert group input has been widely used

in other health research applications, including technology

assessment, education and training, priorities and information,

and development of clinical practice.28 The design used

here allowed a panel of geographically dispersed experts to be

surveyed efficiently and confidentially.29 All clinicians

reviewed exactly the same material, with no uncertainty

concerning Cobb angle measurement or other evaluations that

might occur in actual practice. In addition, because these

estimates reflect the initial clinical judgments in the absence

of knowledge of the estimates of other clinicians, they

provide an indication of the extent of interclinician variation

that might occur in actual practice. Some might argue that the

contrived situation of this research design does not reflect

clinical practice. However, would the outcomes be any less

variable if it was a parent, rather than a researcher, asking BOf

children like mine, how many will need surgery without

treatment? How many will need surgery after treatment?[ It

seems very unlikely that the results of this exercise overestimate

the extent of interclinician variation in predicting the

effectiveness of bracing in this population.

Several recent articles have reported on the clinical

agreement concerning the indications and the outcomes of

medical treatment for other purposes in addition to clinical

trial planning.24Y26,30,31 Two of these papers involve

orthopaedics and each defined agreement similarly to this

paper. Wright et al24 demonstrated disagreement similar to

that shown in this article in their survey concerning the

indications and the outcomes of total knee replacement.

For example, their respondents indicated that anywhere

from 1% to 95% of patients would require a revision

within 10 years of their primary replacement. Dunn et al25

also found a significant variation in decision making and a

lack of clinical agreement concerning the indications for

rotator cuff surgery.

To our knowledge, there have been only 3 published

reports measuring community equipoise to specifically assess

the ethics and the feasibility of conducting randomized

clinical trials. Young et al32 mailed surveys to all members of

a vascular surgery professional organization and asked the

members to rate several common clinical scenarios describing

2 alternative treatments for the same condition. The

respondents showed great variability in their responses, and

each treatment was endorsed to some degree in all of the

scenarios. There were only 1 in 6 scenarios where more than

70% of the respondents agreed that the same treatment was

preferable. The authors conclude that this variation indicates

equipoise within the membership and, therefore, that

randomized clinical trials would be ethically justified.

Lilford27 surveyed the expectations of a 10-member expert

panel concerning the probable relative risk of morbidity

resulting from immediate or delayed delivery in scenarios

involving at-risk fetuses. For each scenario the average result

was no relative RR, but the range in estimates for each

scenarios was large. In 1 scenario, the estimates ranged from

a 75% decrease to a 25% increase in the risk to a fetus

delivered early. Lambert et al33 investigated the perceptions

of the parents and the members of the Pediatric Ophthalmology

and Strabismus Society concerning the treatment

for infants with congenital cataracts. On a scale ranging from

1 to 10, with 1 strongly favoring an intraocular implant and

10 strongly favoring a contact lens, the median score of the

respondents was 7.5. This range of opinions also manifested

itself as a support for randomized controlled trials because

61% of the respondents indicated that they would be willing

to randomize children to one of these 2 treatments.

These studies indicate that clinical disagreement is a

reality across specialties and interventions. Three possible

explanations for clinical disagreement demonstrated by

studies such as these include the limitations of available

knowledge, the controversy within the research literature, and

the inadequate dissemination or adoption of available information.

24 A recent article by the SRS Bracing Committee34

addresses these issues by calling for completeness and

uniformity in the subjects, endpoints, and outcomes of

bracing studies to maximize the likelihood of developing a

coherent, accepted body of knowledge concerning this

disease. If future articles adopt this approach, disagreements

may diminish.

It has been suggested that progression to surgery

indicates the ultimate failure of bracing treatment.1 The key

question of any future study of bracing, randomized or not,

must be BHow many patients avoided surgery because of

bracing treatment?[ This study found a high degree of

variability in opinion among experts concerning the effectiveness

of bracing. Yet, bracing is the standard of care for

AIS, and all 362 respondents to a recent survey from the

SRS35 indicated that they advocate its use. This implies a

major disconnect between opinions of effectiveness and

endorsement of bracing by the community. Patients considering

their treatment options need to be aware of this

disconnect; instead of considering bracing as the only option,

they should take this variation into account along with

their personal goals and tolerance for risk. In addition, these

results indicate that a randomized trial of bracing would not

only be ethical but also necessary.

 

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