The Braist Study

[flerc]

I recall you said the same thing about my (factual) comments about MAGEC. Called it libel/slander and suggested someone report me to the company so I can be sued.

Of course you should to be sued but mainly this forum, and not because just only that post of course. I remember I was not the only one asking you to give a justification about what you said against Magec and you didn’t. Anyway in a court I believe the most important fact is the clear intention to confuse everything. Something evident just only seeing this thread. What could a parent think reading it? What are these people talking about? Could it be clear for someone? The very much good comments of The New York Times note about the study (and the study itself) which shows something really interesting and important as confirmed brace effectiveness is, was absolutely buried manyy posts ago. You know worries parents has not time to live in this forum as you do and cannot be reading all the discussion generated by you, to say what? That there is not evidence showing without any doubt that all the successful braced cases will be out of surgery need, because just only being under 50° is not a guarantee? How many words took me to say that? Of course is extremely obvious the way you use to confuse saying things as ‘just only other braist study’, ‘they will never arrive to a consensus’, ‘it’s full of slants’, ‘‘it should be considered the propagation error’, ‘they uses averages instead of medians’, ‘not so much significant successful cases’, ‘the distribution of a possible X factor causing the success was not so much uneven’, etc, etc,,,,,,,etc,,,,etc,,,,, etc. Sorry if were not exactly your words, I have not time to quoting all what you say (and reread all) that obviously hides the important and confuse people trying to get information from the most visited scoliosis forum of the world.

[flerc]

For (specially new here) parents thinking in braces, here is the note with the link to the last Braist study we were talking about:

http://www.nytimes.com/2013/09/20/he...ent.html?_r=2&
'In the analysis that included both groups, the rate of treatment success was 72 percent among children with bracing, compared with 48 percent among those under observation. The benefit increased the longer bracing was worn. More than 90 percent of the children who were successfully treated wore their braces more than 13 hours a day.'

Surely the moderator will delete this post, or would be buried under various ‘wise’ and 'brilliant' criticisms again.

This forum cannot be changed from inside!

[Pooka1]

Here's my guess as to what the next publication will be...

Using the final curve measurements and modeling the likelihood of the observation group and the successful bracing group that might eventually reach 50*. Were the final curve measurements in the successful observation group different than those in the successful bracing group?

http://jbjs.org/article.aspx?articleid=18804

http://www.scoliosis.org/forum/showt...quot-scoliosis (N.B. this thread had posts removed by the post authors after responses were made.)

I think they could write a few more articles with their data on:
- whether or not curve type matters in progression as has been seen in other studies
- rigorously isolating bracing dose as the main factor in progression <50* at maturity given subgroup size and looking for correlation of amount of progression and bracing dose
- more on the patients' perceptions of risk reduction needed to consider bracing and comparison with parents' perceptions (if they did that)

OR! Something completely different because it's their field not mine! Those are just the ones I think they have the data to write about and that I would like to see.

[LindaRacine]

This thread has gotten way out of control. Let's get it 100% back on topic.

[sjmcphee]

I removed my off topic comments from the thread.. But not because anything I said wasn't true..
You all know what I advocate is a full understanding of individual scoliosis curve patterns based on logic..
And that I'm not trying to sell anything.. I want real understanding.. Not a trial and error based system..
Anything less than that is unacceptable..

[flerc]

..it's their field not mine!

Good! Of course this is definitely very far to be out of topic. It would be better if you put it in your signature. Parents are in their right in knowing all about who is saying every time in the most visited Scoliosis Forum around the world, how much unethical the brace practice is, seeming to talk in the name of science as use to do in every non surgical thread.. even talking about a science war. They should to know about you!.
If they want to know about people talking in favor of braces, after analyzing that Braist study, as for instance all those talking in the NY Times note, they can, they are not hiding that kind of information about their self and parents may confirm it.
So what about you? What data about your self will you give them in order to be possible for them to assign a right weight too to all what they are hearing against braces?

[Pooka1]

Infomrative post on Jerry Coyne's site

Jerry Coyne is a prominent biological researcher at the University of Chicago. A blurb in here... http://jerrycoyne.uchicago.edu/about.html

I have been banging on about how a majority of medical research (and I don't know why it would be limited to that field) is false as shown by John P. A. Ioannidis. I am not claiming BrAIST is false and I certainly am not alleging nefarious motives. I am saying it needs to be replicated at least once and probably more for reasons explained below.

http://whyevolutionistrue.wordpress....-in-bad-shape/

Science is in bad shape

There are two pieces in the latest Economist that are must-reads not just for scientists, but for science-friendly laypeople. Both paint a dire picture of how credible scientific claims are, and how weak our system is for adjudicating them before publication. One piece is called “How science goes wrong“; the other is “Trouble at the lab.” Both are free online, and both, as is the custom with The Economist, are written anonymously.

The main lesson of these pieces is that we shouldn’t trust a scientific result unless it’s been independently replicated—preferably more than once. That’s something we should already know, but what we don’t know is how many findings—and the articles deal largely with biomedical research—haven’t been replicable, how many others haven’t even been subject to replication, and how shoddy the reviewing process is, so that even a published result may be dubious.

For those who consider this first BrAIST article a landmark publication, Dr. Coyne writes:

If you read the Economist pieces, all of these are mentioned save #4 (peculiarity of one’s material). And the findings are disturbing. Here are just a few, quoted from the articles:

Last year researchers at one biotech firm, Amgen, found they could reproduce just six of 53 “landmark” studies in cancer research. Earlier, a group at Bayer, a drug company, managed to repeat just a quarter of 67 similarly important papers. A leading computer scientist frets that three-quarters of papers in his subfield are bunk. In 2000-10 roughly 80,000 patients took part in clinical trials based on research that was later retracted because of mistakes or improprieties.

. . . consider 1,000 hypotheses being tested of which just 100 are true (see chart). Studies with a power of 0.8 will find 80 of them, missing 20 because of false negatives. Of the 900 hypotheses that are wrong, 5%—that is, 45 of them—will look right because of type I errors. Add the false positives to the 80 true positives and you have 125 positive results, fully a third of which are specious. If you dropped the statistical power from 0.8 to 0.4, which would seem realistic for many fields, you would still have 45 false positives but only 40 true positives. More than half your positive results would be wrong.

John Bohannon, a biologist at Harvard, recently submitted a pseudonymous paper on the effects of a chemical derived from lichen on cancer cells to 304 journals describing themselves as using peer review. An unusual move; but it was an unusual paper, concocted wholesale and stuffed with clangers in study design, analysis and interpretation of results. Receiving this dog’s dinner from a fictitious researcher at a made up university, 157 of the journals accepted it for publication.Dr Bohannon’s sting was directed at the lower tier of academic journals. But in a classic 1998 study Fiona Godlee, editor of the prestigious British Medical Journal, sent an article containing eight deliberate mistakes in study design, analysis and interpretation to more than 200 of the BMJ’s regular reviewers. Not one picked out all the mistakes. On average, they reported fewer than two; some did not spot any.

The journal recommends several ways to fix these problems, including mandatory sharing of data and getting reviewers to work harder, reanalyzing the data in a reviewed paper from the ground up. The former is a good suggestion: many people in my own field, for example, refuse to send flies to other workers, even though they’ve published data from those flies. But reanalyzing other people’s data is almost impossible. We’re all busy, and it’s enormously time-consuming to redo a full data analysis.

I don't think the BrAIST researchers should share their raw data until all the publications come out. But once they are out they should make is all available.

[sjmcphee]

I know I should keep my mouth shut.. but I just cant.
I don't know why I am the only one that sees it.
Why cant you people see 'The Big Picture'.
The improvements in scoliosis treatment aren't based on an complete understanding of curve pattern biomechanics.
The improvements have come from a system based on trial and error.
Researchers don't understand the exact biomechanics of scoliosis and this is the ultimate reason why surgeries and bracing are only ever going to be somewhat effective.
I think its been about 100yrs now since the first scoliosis surgery btw..
They waste all their research time on studies that only serve the trial and error system.
We could all come up with a million new ideas in how to treat scoliosis.
But then we'd need a million researchers to spent months / years testing those ideas.
When we really need them to study SCOLIOSIS itself.
And its all a waste of time, I am sick of all these studies and comparisons that don't really go anywhere or really help anything.
Lets get REAL ok, there are two aspects to scoliosis.
Spinal curvature phase - what causes that? There's that area of research.
Which leads to point where the condition becomes more complicated by biomechanical factors.
Scoliosis Phase - altered biomechanics / asymmetrical loading / curve patterns. There's that area of research.
You can do all the comparisons you want, collect all the data you can muster but it isn't going to get us any closer to figuring this thing out.
That's not how this problem is. That's not how they are going to learn about scoliosis. - At least be true to the condition.
Researchers need to STOP being SCIENTISTS and start being INVESTIGATORS and using logic.
Without understanding the biomechanics of individual curve patterns we are always going to be trapped in a trial and error based treatment system.
Is there a way to figure it out?
Until recently its not been possible to create detailed models of scoliosis progression, but with todays computer technology it now is possible.
The years of trial an error are not applicable anymore.
Is there a weak link in understanding scoliosis?
Yes - its in curve patterns.
And then you start going down the whole path of LOGIC that I put forward.
Look at everything I have tried to put forward.
We don't need to mutilate animals or do clinical trials or compare 100 of this to 100 of that.
It's yesterdays thinking.. They need to get with the program.
We need them to sit down and look at the problem for what it is.
Altered biomechanics - Asymmetrical Loading - Curve Patterns
Put these components together and there is no other logical explanation other than the one I have previously suggested.
That there is a biomechanical basis to scoliosis curve patterns and that the path of progression can be calculated... Not predicted.
Researchers need to use that computer modelling technology to its full potential and completely simulate the path of individual curve patterns.
I may not be a researcher but I know logic and I know that this is the only thing that will change things for us.

What if cancer researchers said to cancer patients 'we know of something that might help but we don't want to spend time researching it because its too hard'.

And you can all say and think whatever you want about me, but it doesn't change that what I'm saying is true, and you all know it.

I hate the trial and error based system that has sees us patients only as labrats or cattle for them to test new ideas on.
I want something real. Study Scoliosis for what it is.

This guy's website looked dubious from the get go advertising patients case studies was it??
What do you expect??

'The Big Picture' - people

[flerc]

Scott, parents who have read this

For (specially new here) parents thinking in braces, here is the note with the link to the last Braist study we were talking about:

http://www.nytimes.com/2013/09/20/he...ent.html?_r=2&
'In the analysis that included both groups, the rate of treatment success was 72 percent among children with bracing, compared with 48 percent among those under observation. The benefit increased the longer bracing was worn. More than 90 percent of the children who were successfully treated wore their braces more than 13 hours a day.'


Surely the moderator will delete this post, or would be buried under various ‘wise’ and 'brilliant' criticisms again.

This forum cannot be changed from inside!

may believe you are helping Pooka1 to hide that important data for them. Just only her large post and yours was enough to buried it again and also the question I did her then, that of course she don’t want to reply. Why do you believe they didn’t delete your out off topic post and she stopped to talk about evolution and everything having nothing to do with that important proof about brace effectiveness? Because you are not (at least explicity) talking in favour of braces of course!.
In other thread I might talk about Biomechanics but I would be the only one. This forum doesn’t want anybody talking about non surgical options! And it cannot be changed form inside.

[Pooka1]

Do you consider this first BrAIST paper to be a landmark study?

Does anyone think it doesn't need to be repeated?

What percentage of people who are in no danger of ever having to wear a brace think it doesn't need to be repeated?

Would the conclusions change if the medians versus the averages were shown?

Would it need to be repeated if the bracing "successes" were expected to progress over time given their magnitude at maturity?

This is the best study to date as far as we known now no matter what the results. That doesn't mean it doesn't need to be repeated to have confidence in the results as the history of this field has shown. This is a tough game and it's a tough treatment. Breathlessness is not warranted in my opinion when we are talking 23/7 hard bracing for years.

[Pooka1]

I think the BrAIST researchers could confirm/deny the conclusions in this study using the BrAIST data.

http://www.ncbi.nlm.nih.gov/pubmed/19333102

I assume they would sort by curve type which is also something I hope the BrAIST researchers try to address in future publications.

Spine (Phila Pa 1976). 2009 Apr 1;34(7):697-700. doi: 10.1097/BRS.0b013e31819c9431.
Curve progression in idiopathic scoliosis: follow-up study to skeletal maturity.
Tan KJ, Moe MM, Vaithinathan R, Wong HK.
Source

Department of Orthopaedic Surgery, National University Hospital, National University of Singapore, 5 Lower Kent Ridge Road, Singapore. jinmi@pacific.net.sg
Abstract
STUDY DESIGN:

This is a follow-up study to skeletal maturity on a cohort of students screened for a 1-year prospective epidemiological prevalence study for scoliosis.
OBJECTIVES:

This study aims to identify the prognostic factors for curve progression to a magnitude of 30 degrees at skeletal maturity in skeletally immature patients with adolescent idiopathic scoliosis.
SUMMARY OF BACKGROUND DATA:

The natural history of idiopathic scoliosis is not well understood. Previous reports have focused on the characteristics of curve progression where progression has been predefined at specific angles of 5 degrees to 6 degrees. However, the absolute curve magnitude at skeletal maturity is more predictive of long-term curve behavior rather than curve progression of a defined magnitude over shorter periods of skeletal growth. It is generally agreed that curves less than 30 degrees are highly unlikely to progress after skeletal maturity. Hence, defining the factors that influence curve progression to an absolute magnitude of more than 30 degrees at skeletal maturity would more significantly aid clinical practice.
METHODS:

One hundred eighty-six patients who fulfilled the study criteria were selected from an initial 279 patients with idiopathic scoliosis detected by school screening, and who were followed-up till skeletal maturity. The initial age, gender, pubertal status, and initial curve magnitude were used as risk factors to predict the probability of curve progression to more than 30 degrees at skeletal maturity.
RESULTS:

Curve magnitude at first presentation was the most important predictive factor for curve progression to a magnitude of more than 30 degrees at skeletal maturity. An initial Cobb angle of 25 degrees had the best receiver-operating characteristic of 0.80 with a positive predictive value of 68.4% and a negative predictive value of 91.9% for curve progression to 30 degrees or more at skeletal maturity.
CONCLUSION:

Initial Cobb angle magnitude is the most important predictor of long-term curve progression and behavior past skeletal maturity. We suggest an initial Cobb angle of 25 degrees as an important threshold magnitude for long-term curve progression. Initial age, gender, and pubertal status were less important prognostic factors in our study.

PMID:
19333102
[PubMed - indexed for MEDLINE]

[Pooka1]

Emphasis added.

http://journals.lww.com/spinejournal...pathic.16.aspx

CHD7 Gene Polymorphisms and Familial Idiopathic Scoliosis

Tilley, Mera K. PhD*; Justice, Cristina M. PhD*; Swindle, Kandice BS†; Marosy, Beth MS‡; Wilson, Alexander F. PhD*; Miller, Nancy H. MD†
Collapse Box
Abstract

Study Design. Model-independent linkage analysis and tests of association were performed for 22 single nucleotide polymorphisms in the CHD7 gene in 244 families of European descent with familial idiopathic scoliosis (FIS).

Objective. To replicate an association between FIS and the CHD7 gene on 8q12.2 in an independent sample of families of European descent.

Summary of Background Data. The CHD7 gene on chromosome 8, responsible for the CHARGE syndrome, was previously associated with FIS in an independent study that included 52 families of European descent.

Methods. Model-independent linkage analysis and intrafamilial tests of association were performed on the degree of lateral curvature considered as a qualitative trait (with thresholds of ≥10°, ≥15°, ≥20°, and ≥30°) and as a quantitative trait (degree of lateral curvature). Results from the tests of associations from this study and the previous study were combined in a weighted meta-analysis.

Results. No significant results (P < 0.01) were found for linkage analysis or tests of association between genetic variants of the CHD7 and FIS in this study, failing to replicate the findings from the previous study. Furthermore, no significant results (P < 0.01) were found from meta-analysis of the results from the tests of association from this sample and from the previous sample.

Conclusion. No association between the 22 genotyped single nucleotide polymorphisms in the CHD7 gene and FIS within this study sample was found, failing to replicate the earlier findings. Further investigation of the CHD7 gene and its potential association to FIS may be required.

Level of Evidence: N/A

[sjmcphee]

Could you guys post the link to the actual research paper again, I went back through the posts and couldn't find it.
And also a link to the guys website, I want to have a look at that again.

I know youse two are at it again.. lol

Now for one, If my kid had scoliosis, I'd probably be willing to put my kid in a brace for a chance at saving them from surgery.
Even if I had to see the discomfort and distress on their face..
And even if there was a chance the scoliosis wasn't going to progress anyway.
I wouldn't enjoy doing it, but its the 'being creul to be kind' clause.
But Id probably be wanting to have a look at that Torsion Rotation therapy as well.
And actively seeking out whatever else I can find as well.

But on the face value of it Flerc, I think the others have a right to be sceptical or dubious given that they haven't released all the data.
And that brings me to the question 'What do they have to hide?' - Even though that might sound a little paranoid.
On the face value of it I generally agree with the things Pooka has alluded to.
I might have ideas that may seem crazy to others but I do advocate towards logic and evidence.

But that doesn't mean I am against bracing, I am just a realist.

I think parents have a right to want more conclusive data on the effectiveness of braces.
And basic information as well.

What braces work best for what curves - etc.

But me, I just want an end to the Trial and Error treatment regime.
And in some ways I feel like I could not be bothered with anything that serves this system.
I feel like its all a waste of time with the blind leading the blind, and that there's bigger fish to fry.

But as I said before I probably would brace my kid, even if I knew there was a chance it wouldn't matter either way.

The real question to me isn't data on the effectiveness of braces.
Lets say we found a brace that worked - then the question would be -
How did it work?

Some braces are really simple.
Nothing more than a hard bandage wrapped around the torso while the patient is laying in the correct position.

I advocate a REAL understanding of scoliosis 'Over and Above' the Trial and Error regime.
And I also advocate for better more easily accessible info for scoliosis on the internet.

Improve the face of scoliosis on the internet, improve fundraising opportunities, and get the money to figure out the biomechanics of the condition.

Short of exposing the whole sad state of affairs of scoliosis, I am thinking about offering a $10,000 bounty to any researcher than can successfully replicate the transition from normal biomechanical function to altered biomechanical function in a fully functional spine model with the input info I will provide.

Also for me (and you guys too) good news...
After all these years I've found a surgeon who has agreed to review my research, if you can call it that.
So for the next few weeks I am going to have to spend some time making sure I am putting everything across on my webpage the best I can.
I am honestly not sure if any other researcher has put the 3 factors of altered biomechanics, asymmetrical loading and curve patterns together in a way that makes logical sense like I have. I don't understand why no-one pays any attention to me..
Well there's a few reasons I am aware of - shoddy attitude being one of them... lol

Anyhow I guess I kind of understand / agree with both of you.
You don't want to see the bracing concept run into the ground or see parents turn away from bracing (am I correct?), and Pooka wants more reliable info.

Neither of your concerns are wrong or unfounded - that is if I get what you are arguing about properly.

- Scott

[sjmcphee]

I assume they would sort by curve type which is also something I hope the BrAIST researchers try to address in future publications.

I second that motion.. The criteria seemed a little broad.. I would want all the data otherwise there's no point in it.
Maybe the good news is that now they can build on what they started in future studies..
But we are all looking at years of studies just waiting for peoples scoliosis to progress..
That's the truth of it..

I just get mad at the state of things. If it were up to me the exact biomechanics of individual curve patterns would have been known 10years ago.

And all this trial and error stuff can become landfill for all I care.
You guys tell me - I know you have all dug through the literature way more than me.
Has anyone ever proposed a more logical explanation of the three components of altered biomechanics, asymmetrical loading and curve patterns better than I have???
Seriously.. If anyone ever has, I want to know..

And Flerc I certainly don't have an issue whatsoever with anyone discussing AND applying non - surgical options.
I think its actually good that people investigate things for themselves and have as much info on hand to do that.
So technically I am for anything that can prevent surgery..
We need to be pro-active and figure things out for ourselves if researchers wont..

N yeah I would be the only one who cares about biomechanics..
And the logic of the whole thing.. Its kind of sad..
Its like I'm giving away $100 notes and you're all fighting over the handful of shrapnel that was thrown on the ground first..
But its ok.. I always knew this was my battle.. And I will soon bring it to the attention of the people that matter..
They wont have a choice..

I'm sorry I push my issue onto other threads, but what I am saying really does affect diagnosis, bracing, surgery and everything in between.
I'm not always completely off topic, and I only want what's best for all of us..
We've all got our own different views and positions and parts to play..
And I'll always be on the side of whatever's best for the patient..

[Pooka1]

I wrote this on 25 Sept 2011. It is STILL true even after the first BrAIST publication. This game is hard though not as hard as brace treatment.

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

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

That is a truly difficult research problem.

There is always going to be correct major criticism of studies in this field because it is intrinsically difficult. That won't go away.