TSRH research shows that bracing IS effective!

[flerc]

That's true in general, with the one exception that there is extra caution taken when it appears that participants are possibly endangering children by advocating that they ignore their doctor's advice. The general policy, to the best of my understanding, is that such advocating is not permitted, and threads are locked down when that policy is breached. I believe that's why there's such caution on the Spinecor threads to emphasize that the advice is for adults only.

I am strongly suggesting that the same care be taken in these bracing threads.

Itīs right what you are doing, because not exists such warnings.
At least I donīt see any warning in the feet of every section,.. posts (even news) of this forum, like here: http://escoliosis.org/escoforo/index.php?board=6.0 (Debes saber, en general, que los mensajes son opiniones de ...)

[Pooka1]

I ever thought it was unnecessary such kind of warnings, because I was mistaken in my assumption that its exists in all sections, all threads, all posts.., like in the Spain Forum, where we could read that: 'You must to know, in general, the messages are opinions mainly of people affected by scoliosis, kyphosis, lordosis ... to share experience, support and information. Before taking any decision, you should always consult a spine specialist'.
It should to be the same here, no?

Yes that is true but I think the situation in the research section is out of hand and has resisted being brought under control. The research section should be masked or deleted or something.

Different people have identified different dangers and threats but they mostly concern the research section. People don't know what they don't know and it's scary to read some of these things. Everyone is a lay person here except McIntire in his field of expertise.

But the main problem in my opinion is people think the journal articles are better than they are. That is the single most dangerous aspect here in my opinion by far. If we could know people are approaching everything with skepticism, it wouldn't such a concern but that is hardly ever the case with anything, not just scoliosis research. If we could count on skepticism, people wouldn't have to bang on an on about worrying about innocent parents and children. But we can't. That's why I would advocate for masking the research section.

[skevimc]

Wow.. Quite the little pressure cooker we have here.

One really difficult thing I've noticed with scoliosis research is finding appropriate treatment groups as well as appropriate controls. As has been mentioned, stacking, inadvertently, treatment groups with certain types of curves used to not be that big of a deal. Or rather, it wasn't really understood how big of a deal it really is. That is, it has been shown in several different types of articles that there are different progression risks for nearly every category imaginable. risser, skeletal maturity, chronological age, curve magnitude, vertebral rotation, curve type, and on and on and on. Having two perfectly matched groups will be nearly impossible. Doesn't mean it shouldn't be attempted and certainly doesn't mean that this shouldn't come out very clearly in the discussion. But it does paint a very grim picture for the relative success of any treatment study that isn't well funded or doesn't have a very progressive clinic that is willing to forgo some 'profit' in order to move the field forward. Like the current study. Those who received the Boston brace were given the brace free of charge. I'm not sure how that worked because it was said that the study didn't cost extra.

At any rate, based on what we now know about progression risk, just about any study published in the last 5 years could be completely negated or at least heavily footnoted. Nothing will ever work 100% of the time and nothing will ever completely outline the full risk for progression. I would love to be proven wrong about that. There are just simply too many variables to completely control for. And once we control for those, another study will be published showing that hair color affects progression risk thus negating all previous work that didn't control for hair color.

Patients, families, doctors, researchers, therapists, orthotists, lay, expert, etc... will ultimately pick something they like and will probably stick with it. Changing their minds is incredibly difficult despite what studies say. And nearly everyone will have a scientific leg to stand on because every study will have some type of variable that is not controlled. Being purely objective is probably as difficult as designing a flawless study. I see it happen all the time. It really is enough to drive you crazy. In fact, I'm reminded of what Dr. Asher always told me. "Don't go into scoliosis research. It will drive you crazy". I would amend that to say "Don't go into 'clinical' research. It will drive you crazy".

[flerc]

Yes that is true but I think the situation in the research section is out of hand and has resisted being brought under control. The research section should be masked or deleted or something.

Different people have identified different dangers and threats but they mostly concern the research section. People don't know what they don't know and it's scary to read some of these things. Everyone is a lay person here except McIntire in his field of expertise.

But the main problem in my opinion is people think the journal articles are better than they are. That is the single most dangerous aspect here in my opinion by far. If we could know people are approaching everything with skepticism, it wouldn't such a concern but that is hardly ever the case with anything, not just scoliosis research. If we could count on skepticism, people wouldn't have to bang on an on about worrying about innocent parents and children. But we can't. That's why I would advocate for masking the research section.

I understand your point, but I disagree about what it should to be done.
You are contemplating only the negative side, but the positive side should not to be vanished.
The problem in fact is that someone could take a wrong desision based over something read in this forum. This could happens with all sections, even the surgical section, so, if research section should to be closed, then all this forum should to be closed too.
It would be really a more honest dession of the owners of this forum, instead to continues allowing that only one kind of information can be shared.

[bbrian35]

Just curious Brian... were you braced as a child?

I assumed that it wasn't traumatic when I first started my support group, but after talking to enough adults who were braced as kids, I can tell you that it is traumatic for many kids.

--Linda

No, not me personally, but my dd as well as many others in a support group we regularly attend are. I wish I could quote many of the wonderful young ladies in the group, all of whom wear braces on an average on 18-22 hours a day. All will admit it was a difficult adjustment, but none feel as it negatively impacts them to the point of being traumatized based on their group input. The group is moderated by a therapist specializing in working with these girls. There are problems, most of them regard dressing or dealing with hot weather, and other things that don't sound as if they have a traumatic impact from what is routinely discussed. There are also many satirical comments made where the girls all giggle. They spend most of the meeting laughing and joking. Unless this is a way with dealing with post traumatic stress, I don't see a huge, negative impact. I see girls dealing with and accepting this as part of their life in a positive manner. I'm sure there are time that are worse than others that I may not see, but they all seem to accept this as something they need to do right now. They are quite inspiring. If they profess that it's not so bad, who am I to suggest they are wrong. Maybe the Milwaukee brace used in the past which was much more obvious could be part of what caused many adults to feel so bad about brace wearing. I do know that my kid's group of friends is supportive and wonderful in helping my daughter with things in school. It's like it's drawn them closer together. They have named her brace Captain Disaster. I don't have a sampling of 100's of people, only about 15, but none of the girls describe their life as problematic or traumatic due to the bracing. Maybe take a poll on the forum for kids in braces.

[Pooka1]

Letter to the editor and author response

http://www.ejbjs.org/cgi/eletters/92/6/1343#11803

Interesting.

[Ballet Mom]

http://www.ejbjs.org/cgi/eletters/92/6/1343#11803

Interesting.

That is interesting...thanks for sharing.

Best quote:

Dr. Price notes that bracing is not benign, and we agree completely. The successful patients in the study wore their braces for more than 12 hours per day averaged over 18 months; no small task. We in no way imply that bracing is easy, just that it is effective. At least now when we encourage a patient to wear the brace, we have evidence that it is worth the effort, and we have some concept of the required daily hours of wear.

John A. Herring, MD, http://www.tsrhc.org/staff-directory-orthopedic.htm
Orthopedic Surgeon
Texas Scottish Rite Hospital for Children, Dallas, Texas,
Donald Katz, BS, CO, Richard Browne, PhD, Derek Kelly, MD, and John Birch, MD

[Pooka1]

more data

http://www.ejbjs.org/cgi/data/92/6/1343/DC1/1

The first graph needs confidence intervals. It's possible those are all the same curve within the precision.

Given the complete overlap in the (one sigma?) error bars, I don't see how they can say the brace wear time effect on Cobb was different between the three groups. In my field, when I see bar graphs like that with complete error bar overlap I say there is no difference between treatments.

So if those are one sigma bars, looking at the last set of bars (Final)...

1. for >12 hours wear, the average ~33* and 68% of the time the angle will fall between ~22* and ~44*.

2. for <7 hours wear, the average ~44* and 68% of the time the angle will fall between 34* and ~54*.

So 37% of the time (more than a third of the time) the angle will fall outside those ranges. Plus it becomes somewhat one-tailed at some point because you get into very small angles that wouldn't be braced at all. Thus there is a huge overlap in the dependent variable making it hard to predict the final angle from hours of wear.

There is some tendency towards a smaller average angle at the final point but it is hard to justify 12 versus 7 hours of wear with that amount of variability.

So the averages are different but the variability is such that it is hard to make any comment other than the different treatments are so variable that the outcomes overlap. I think this was mentioned earlier by Pnuttro when she stated the range in brace wear for the curves that progressed was huge and nearly completely overlapped the range in brace wear for curves that didn't progress.

This would be cleaner I think if they at least broke out the curve types. And at that point it might be that some of these groups have only a few kids. There were only 100 total and 50 progressed and 50 didn't.

[Pooka1]

Commentary

http://www.ejbjs.org/Comments/2010/c...0_aronsson.dtl

[Pooka1]

This point is from the commentary...

There are some methodological aspects of note. While substantial attention is given to accurate measurement of brace wear, the Cobb angle, which is the dependent variable, remains a potential Achilles heel of the study. The Cobb angle must be measured with great care from a given radiograph to achieve the study's threshold precision, indicating a 6° change. The patient's spinal shape in any one radiograph depends on several factors, including posture, time of day5, and patient positioning for the radiograph. Because the spine is flexible, the Cobb angle is a "moving target" that does not distinguish between the vertebral and disc components of the scoliosis deformity.

Now if each of these Cobb angle measurements (hundreds of times considering all the patients over time) is not one number for each measurement but instead a range of numbers as this paragraph is indicating (and as we know anyway). When you carry this plus or minus "error" through, it's going to muddy the picture even more. If they formally included a +/- range in the line and bar graphs it would have the effect of making the error bars even wider and making it more difficult than it was already to predict a Cobb angle from brace wear with any confidence.

The other thing is that the commentary and McIntire both mentioned the complexity of the data analysis. That is consistent with many variables, interacting in perhaps different ways (additive, multiplicative, etc.), are determining the final Cobb angle or that if there is one main variable, it wasn't one of the things they studied. It suggests that a clear relation between any one of the variables (say chrono age) is not straight-forwardly linked to progression risk and you have to parse the data in various ways to get a significant relation. And what they ended up with was a huge variation in angle although the central tendencies of the various sub groups were different.

Hypo numbers that characterize the trend follow...

It's like saying the progression risk of wearing the brace 12 hours is 50% +/- 5% versus saying the risk is 50% +/- 100%. Both ranges have the same average but the predictive capability of the first is far better than the second.

It's like telling a kid if they wear the brace for 12 or more hours they have a 40% chance of progression but if they wear it only 7 hours they have a 50% or 60% chance of progression. Nobody can parse that in real life.

Also, I notice the top category is 12 hours (or more). That is very interesting given that some kids were told to wear the brace 23 hours (or something like that). This might mean one of two things... 12 hours is really all that is needed and kids should never be told to wear a brace more than that. Alternatively, it might mean they had too few kids wearing the brace much more than 12 hours to make any statement about efficacy. Both results would be interesting. If someone has the paper, can you see if they address that?

Last, I don't understand how they didn't break out the data for curve type. Maybe they did and it didn't show a pattern. Or maybe they didn't and missed if the T curves behaved one way and the double majors behaved another. I just find it amazing if they didn't address that at all.

OR NOT TO ALL OF WHAT I WROTE! (disclaimer to satisfy hdugger).

[skevimc]

Given the complete overlap in the (one sigma?) error bars, I don't see how they can say the brace wear time effect on Cobb was different between the three groups. In my field, when I see bar graphs like that with complete error bar overlap I say there is no difference between treatments.

So if those are one sigma bars, looking at the last set of bars (Final)...

1. for >12 hours wear, the average ~33* and 68% of the time the angle will fall between ~22* and ~44*.

2. for <7 hours wear, the average ~44* and 68% of the time the angle will fall between 34* and ~54*.

I see what you are saying. The statistical test was most likely a repeated measures. Therefore the variance between groups wouldn't be between the groups at the individual time points but rather the difference between the time points for each group. If you ran a basic t-test at each time point there probably wouldn't be a difference.

[Pooka1]

I see what you are saying. The statistical test was most likely a repeated measures. Therefore the variance between groups wouldn't be between the groups at the individual time points but rather the difference between the time points for each group. If you ran a basic t-test at each time point there probably wouldn't be a difference.

Yes I agree it is what I highlighted in your comment.

And I think it is actually misleading if not wrong to lump things that you have evidence shouldn't be lumped like different curve types as in that bar graph. You don't know if the averages are being skewed away from a real central tendency if you broke out according to curve type. I mean you can physically do it and crunch out a number and it looks meaningful but it may not be.

Hopefully a medical statistician reviewed that and any paper with "complex" analyses.

And the bottom line is how are surgeons supposed to use this in what they tell patients? These are small differences in central tendency that are swamped out by the variability. It is hard to use these results.

What surgeons cannot do with this is tell patients that if they wear their brace for X hours they will not progress or if they don't wear their brace for X hours they will progress. The huge variability prevents them from saying that. Plus you add the known difference between T and L curves to these results and then the surgeon might say that although the average is slightly lower for 12 hours for 7 hours, that was developed by lumping curves. Your curve is an L so you would expect a lower risk of progression. Or your curve is T so your risk might more resemble the risk for people who wear the brace for 7 hours even if you wear it for 12.

Basically, I would say this study might (if it stands) provide some support for the surgeons who say they feel bracing is effective. But they have to translate that into something concrete for patients and parents and I don't think this study will help much in that regard.

I hate complex statistical analyses because it is very easy to fool yourself. When I design an experiment, if an answer doesn't come out cleanly one way or another, I redesign the experiment. For that bar graph, I would say the final results are not obviously different and move on. Some of my colleagues would run stats on the data until they eke out a small result. That is how I think this paper went.

And I am not blaming the authors in any way. I think this subject is inherently complex and there will be no clean answers with any study design. If there were clean answers we would have some indication of it by now after ~60 years of bracing.

The last thing is something that the commentary mentioned that is very bothersome... 60% of the girls were beyond the growth spurt. If you are testing something (bracing) with a mechanism that is supposed to be active during the growth spurt, you need to separate those two groups in the analysis or abandon the hypothesis that bracing works only during the growth spurt. Can't have both.

How did the kids do who were before or in the growth spurt versus past it? Isn't that a key question? And if there is no difference don't you have to abandon the hypothesis of how braces work? I am saying it is not enough to tease out differences. It is also important if the results don't support their original hypotheses if that is what happened. For example if the results don't show that kids braced through the entire growth spurt and didn't have a better outcome than kids who were braced after the growth spurt then something is wrong either with how people think bracing works or the data.

I still haven't found the paper but if they didn't find significant differences between subgroups for which we have some evidence there should be a difference and ended up creating sub groups in ways that may just maximize the difference between groups then it might just be a statistical anomaly with too few patients. The curve type mix of the patients does not resemble that of the general population (more double majors compared to T curves) and I hope they addressed that as it affects their conclusions and extrapolations to the general population.

[Pooka1]

And by the way, with so few L curves in the study, I think it might be fair to say NONE of these results apply to L curves. None.

It may not apply to T curves if they are lost in the variabilty (or causing some of it).

It may apply mainly if not mostly to double major curves in skeletally mature patients.

[PNUTTRO]

Sharon.
I think they didn't break it down more because the groups would be too small to be of any significance. It all could have been attributed to chance.

Also, even if the spread was significantly overlapped, it would have been nice to see the means. The mean probably would have shifted in favor of wearing the brace, but then again probably not significant because of the small sample size.

Keep in mind that all of these result pertain to a population. I think that bracing might help some kids, especially those that have a lot of growing to do. Every kid is different, and I think that trying the brace and getting good compliance is better than doing nothing, even if you end up going to surgery later. You never know where you will fall in the spectrum. Do you want to take the chance?

p

[Pooka1]

Sharon.
I think they didn't break it down more because the groups would be too small to be of any significance. It all could have been attributed to chance.

Yes I bet you are correct. But then we have to ask what do these numbers mean if they are known to represent a mixed bag? Then chance comes in as to exactly how mixed that bag is and how the bag is mixed. I can calculate any number of numbers for my data but I know for a fact some do NOT mean anything. I can still calcualte them though.

Also, even if the spread was significantly overlapped, it would have been nice to see the means. The mean probably would have shifted in favor of wearing the brace, but then again probably not significant because of the small sample size.

Yes I again agree. But the goal here for patients and parents I think is the ability to predict outcome from brace compliance. When the small changes in means are swamped by the variabilty, the ability to predict is not significanly enhanced by this study, especially for L curves and possibly for all skeletally immature curves.

Keep in mind that all of these result pertain to a population. I think that bracing might help some kids, especially those that have a lot of growing to do.

And yet a majority of the study subjects were past the growth spurt.

Every kid is different, and I think that trying the brace and getting good compliance is better than doing nothing, even if you end up going to surgery later. You never know where you will fall in the spectrum. Do you want to take the chance?

p

Well, with the huge variability seen in this study, I'm tempted to say what I say about winning the lottery... the chances of winning are about the same whether you buy a ticket or not.

Now it's not quite that bad with this study but I just wonder what surgeons will say to patients now versus before on the basis of this study.

Did they try to determine how many patients would not have progressed anyway (no bracing)?