The Braist Study

[Pooka1]

Are Dr. McIntire's comments ad hominem attacks also or just mine? Just curious.

What you are missing is this is not falsifying data or a false reading of the data. The data are what they are. That's your misunderstanding of my comments. Anyone working with data will tell you that it can be presented in various ways. The researchers chose one way. Everyone usually chooses one way.

Dr. McIntire, working it this field stated: (emphasis added).. the first comment appears to address the per review in part...

They don't publish the curve characteristics at the end of treatment.... and that makes it in the NEJM.... I can not believe this....... They don't calculate any type of "curve-delta". If it's ok to do that because the success/failure classification is >50°, then why would it be necessary to include the curve sizes at baseline? Why publish any data at all? Why not just say, "Curves were <40° at the beginning and 75% were <50° at the end. Trust us."

I side with you (Pooka) on this one. When you don't report data that is easily calculated and meaningful, there is a reason. ANY data from the endpoint concerning curve size is absent in the article and supplementary material.

The baseline data has plenty of detail. There is a maturity scale as well as different curve types and whatnot. Either in the paper or in the supplementary info. MY critique is primarily with the end point data. The average curve at baseline was ~35° in all groups (IIRC). The end point curve size would be good to know, although I don't think average is the best measure for curve size. Median is probably better unless the data are REALLY normally distributed.

Again, what you (hdugger) are missing is this is not falsifying data or a false reading of the data. The data are what they are. That's your misunderstanding of my comments. Anyone working with data will tell you that it can be presented in various ways. The researchers chose one way. Everyone usually chooses one way.

Here is my best explanation for not including critical data in the publication:

It occurred to me that Weinstein/Dolan/et al. might be planning more publications. They almost certainly are in my opinion. I am guessing that is almost certainly the case as the first publication is really just an extended abstract because they don't show the deltas.

Here is Dr. McIntire again which I never disagreed with... (emphasis added)

As far as any kind of nefarious motives, I tend to side with the scientists and give them the benefit of the doubt. It's not that I doubt their data as much as I question how meaningful it is if "success" is determined as <50°. If the pre-treatment group is 33° and the "success" group is 48°, well then I'm not sure I'd consider that to be a great outcome. The brace group had fewer surgeries than the observation group, and I think that is real. I like the creativity they used to randomize or to self select the treatment. I like the stratification of brace wearers to time in brace. I think they did an amazing amount of work to do a serious study and to control for a BUNCH of things are have been traditionally difficult, if not impossible, to do. They might have had a very strict limit on the amount of tables and figures they could have, which is why they probably had the supplemental info. So I WANT to say they left out the end point data as somewhat of an oversight because they had a bunch of other stuff to report. But, having published, the scientist knows their data better than anyone. To not mention anything about the end point other than success/failure percentage.... makes it tough to believe it was an oversight and probably means it brings the results into question/doubt. It would be great if I were wrong.

And I'll point out that publishing the average end points would add ONE LINE to the table but would require at least one paragraph to explain. So maybe there is a space limitation but I would think they would drop something else out before that. Not my field, their call.

Finally, you CONTINUE to make this about me using tenuous, if not completely ridiculous examples. Your breathless accusations to avoid responding to my points are not getting you anywhere. I could go back and make a list of points you have avoided. I will continue to point this out as long as you continue to do this.

[hdugger]

What you are missing is this is not falsifying data or a false reading of the data. The data are what they are. That's your misunderstanding of my comments. Anyone working with data will tell you that it can be presented in various ways. The researchers chose one way. Everyone usually chooses one way.

I've stopped boring myself for the moment, so I'll say a little more about this.

Yes, of course, one has to choose how to present data. That part is not in question. Making a choice which leads the reader to reach a conclusion which is in clear contrast to what the raw data itself would suggest is a pretty serious mistake, at best. Publishing that misleading conclusion, not as a mistake, but as a calculated move to bow to political pressure, as you suggest, is unsavory. In summary, what you are suggesting is that the raw data would show that bracing is not effective. Or that it is just barely effective - leaving braced children with just-pre-surgical-curves.. And that the authors are failing to show the ineffective-bracing data and are, instead, suggesting that their study showed that bracing is effective.

Again, that's a pretty serious claim. That's not just "oh, I had two ways to show the data and I chose this one." Instead, it's "I chose not to publish what the data clearly suggested - that bracing was ineffective or just barely effective - and I let myself be pressured into instead publishing a paper which claimed that bracing *is* effective." If that is honestly what you believe happened in this case, that's worth approaching an ethical body about, IMO.

BTW, this is my second go-round defending fellow MPH-er Dolan from charges of bowing to political pressure. In my first year here, I had to convince Ballet Mom that Dolan was not some shill for the insurance company whose charge it was to prove bracing ineffective in order to save money. Now that her paper has found bracing effective, I find myself defending her against charges that she's bowed to pressure to make bracing seem effective. Really, I think the woman should at least send me a thank you note I suspect the charges and counter charges of bowing to political pressure have less to do with anything she's done and more to do with people's need for the results to be one thing or the other. Either that or the woman is the cleverest counter-agent who ever lived.

I honestly do not believe she's anyone's shill, and I do not believe that the data, when shown, will clearly reveal that bracing leaves children just pre surgical. Although there have not been good randomized studies of bracing vs. non-bracing, there are studies that follow braced kids for 10 to 20 years, and it's only a small percentage of them who go on to have surgery in that time frame. In general, in the one dual study I saw comparing the two populations, they do about the same as kids who went through surgery. There's no reason to think that the long term results from this study will be radically different.

And I'll point out that publishing the average end points would add ONE LINE to the table but would require at least one paragraph to explain. So maybe there is a space limitation but I would think they would drop something else out before that. Not my field, their call.

What would that one line be?

I mean that seriously - what number would they use? When they assigned the children to the bracing and control arms, those children were all the same. It made sense to average all their curve numbers together in each arm and put it in the table as a single line - brace vs. control.

Once they'd started bracing, the bracing arm fractured into several groups. The two top quartiles may be equivalent - you might be able to merge those together. But are you going to merge the results from a kid who had 0 hours in a brace per day with one who had 17 hours per day? And, if you felt brave enough to do that, what, exactly, would that number tell you? Again, you're not averaging across a treatment group, really, because some of these kids didn't really have any treatment at all.

Is that number - the one where you average the kid who had 0 hours in a brace, total, with a kid who had 12000 hours in a brace over several year - is that a meaningful number? Does it more clearly represent the data over just not presenting it at all? How many paragraphs of text, how many tables, would you need to make sense of that merged number?

I don't have any reason to suspect that these researchers willfully withheld a line or two of data which would have completely clarified their data. I think they were prepared to answer one question with their study - is bracing effective in keeping kids from surgery - and they published the data which had the most bearing on that question - the question they were funded to answer.

That they failed to answer the question you were *hoping* they would ask is not really a useful criticism. They never planned to answer the questions you're posing now. They're not dodging the question - it was never in their study to begin with. But, they do have lots of data, and they've said they'll go on publishing from it, so it's possible that one of the studies they publish will be the one you hoped this one would be.

OK, now I am boring myself and I have some complicated Danish TV show to watch which is far more interesting that anything I've written recently.

[Pooka1]

Are Dr. McIntire's comments ad hominem attacks also or just mine? Just curious.

I've stopped boring myself for the moment, so I'll say a little more about this.

Yes, of course, one has to choose how to present data. That part is not in question. Making a choice which leads the reader to reach a conclusion which is in clear contrast to what the raw data itself would suggest is a pretty serious mistake, at best. Publishing that misleading conclusion, not as a mistake, but as a calculated move to bow to political pressure, as you suggest, is unsavory. In summary, what you are suggesting is that the raw data would show that bracing is not effective. Or that it is just barely effective - leaving braced children with just-pre-surgical-curves.. And that the authors are failing to show the ineffective-bracing data and are, instead, suggesting that their study showed that bracing is effective.

Again, that's a pretty serious claim. That's not just "oh, I had two ways to show the data and I chose this one." Instead, it's "I chose not to publish what the data clearly suggested - that bracing was ineffective or just barely effective - and I let myself be pressured into instead publishing a paper which claimed that bracing *is* effective." If that is honestly what you believe happened in this case, that's worth approaching an ethical body about, IMO.

BTW, this is my second go-round defending fellow MPH-er Dolan from charges of bowing to political pressure. In my first year here, I had to convince Ballet Mom that Dolan was not some shill for the insurance company whose charge it was to prove bracing ineffective in order to save money. Now that her paper has found bracing effective, I find myself defending her against charges that she's bowed to pressure to make bracing seem effective. Really, I think the woman should at least send me a thank you note I suspect the charges and counter charges of bowing to political pressure have less to do with anything she's done and more to do with people's need for the results to be one thing or the other. Either that or the woman is the cleverest counter-agent who ever lived.

I honestly do not believe she's anyone's shill, and I do not believe that the data, when shown, will clearly reveal that bracing leaves children just pre surgical. Although there have not been good randomized studies of bracing vs. non-bracing, there are studies that follow braced kids for 10 to 20 years, and it's only a small percentage of them who go on to have surgery in that time frame. In general, in the one dual study I saw comparing the two populations, they do about the same as kids who went through surgery. There's no reason to think that the long term results from this study will be radically different.



What would that one line be?

I mean that seriously - what number would they use? When they assigned the children to the bracing and control arms, those children were all the same. It made sense to average all their curve numbers together in each arm and put it in the table as a single line - brace vs. control.

Once they'd started bracing, the bracing arm fractured into several groups. The two top quartiles may be equivalent - you might be able to merge those together. But are you going to merge the results from a kid who had 0 hours in a brace per day with one who had 17 hours per day? And, if you felt brave enough to do that, what, exactly, would that number tell you? Again, you're not averaging across a treatment group, really, because some of these kids didn't really have any treatment at all.

Is that number - the one where you average the kid who had 0 hours in a brace, total, with a kid who had 12000 hours in a brace over several year - is that a meaningful number? Does it more clearly represent the data over just not presenting it at all? How many paragraphs of text, how many tables, would you need to make sense of that merged number?

I don't have any reason to suspect that these researchers willfully withheld a line or two of data which would have completely clarified their data. I think they were prepared to answer one question with their study - is bracing effective in keeping kids from surgery - and they published the data which had the most bearing on that question - the question they were funded to answer.

That they failed to answer the question you were *hoping* they would ask is not really a useful criticism. They never planned to answer the questions you're posing now. They're not dodging the question - it was never in their study to begin with. But, they do have lots of data, and they've said they'll go on publishing from it, so it's possible that one of the studies they publish will be the one you hoped this one would be.

OK, now I am boring myself and I have some complicated Danish TV show to watch which is far more interesting that anything I've written recently.

[flerc]

Hdugger, good to see you again. I’m thinking in what may parents believe seeing 15 pages up to now discussing if this Braist study is a proof or not about brace effectiveness. More long and confussing the discussion is, more effective is the work done here in order to convince parents to discard braces as an option. Certainly I feel I’m contributing to that evil purpose helping to add tons of posts that of course is difficult to believe might be read for those worry parents. It could be good if we could force to answer what we ask, but we cannot.. See what I asked her many posts ago:

tell me in what way I may not see this

'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.'

as a statistical 'proof' about the effectiveness of braces as researchers says, believing of course it is a serious study.
Do you believe in the existence of an unknow factor stronger than brace? But if it was the case, why it was so uneven among braced/not braced cases? Do you know about studies where observed cases were more succesful than braced cases? How many?

Of course everyone with enough Statistics concepts is able to calculate how much significant is this outcome among 146 braced cases and 96 observed cases.

Do you believe she gave some answer? To just only saying that it would be better to give more information or better information or quoting other not similar studies which needed to be repited or what Kevin may said about previous studies, is not a demonstration of course. Just only in ones of her last posts, she quoted some surgeons talking about probable differences between not randomized and randomized treatment selection groups, but I understand mainly remarking which kind of curves are more or less able to be corrected with braces.

She must to prove that this study is not given a statistical reason to be enough sure that braces are more effectives that just only eating dessert almost every night or taking a bath every day. How many times I asked her for such proof? And my request was allways literally buried with tons of posts not demonstrating anything. So certainly has not any sense to continue with this ‘discussion’. There are more than enough evidence about what kind of forum is this and anything we may do here can change it.

[hdugger]

Just curious.

As is your right. Mine is to choose not to fall into rat hole discussion where every word I write is a boring rehash.

Was it George Bernard Shaw who had that great line about "are you enjoying yourself at this party." "Yes, and that's the only thing I'm enjoying."

When I can't even enjoy my own writing - well, really, what's the point.

Flerc, I'm in agreement that it would be extremely hard for anyone considering bracing their child to make any sense of the study based on this discussion. I don't have much control over that. I try to repeat what seems like a balanced summary of the study as often as I can, correct obvious errors, and try to stay on the main track instead of following conversational threads where ever they might lead. Beyond that, there's not much that I can do. The study I posted earlier about how people perceive studies based on comments they read is pretty disheartening. Negative comments overpower everything else. So, really, what does one do about that? Honestly, it just beats the hell out of me.

[Pooka1]

As is your right. Mine is to choose not to fall into rat hole discussion where every word I write is a boring rehash.

Coward. Not intellectually honest.

None of these comments are ad hom. You are not following along if you think any of them are ad hom.

You accuse me of ad hom but my comments are no different than others yet you cowardly refuse to call them ad hom. You don't have the backbone to say those other comments are the same.

Either they are ALL ad hom or NONE are ad hom. And you know it. And you obviously refuse to acknowledge it.

How do you live with yourself? Forget being honest with others... how do you live with not being honest with yourself? I could not do that. Intellectual honesty is all we have.

[Pooka1]

As is your right. Mine is to choose not to fall into rat hole discussion where every word I write is a boring rehash.

If you can't defend what you are saying then you might as well be singing. Why are you participating if you are openly dishonest? How is that useful?

[hdugger]

Why are you participating?

For one reason and one reason only - because there are parents trying to decide whether or not to brace their child to try and avoid surgery, and the undertones of this discussion - not the facts, not evidence, not things that can rationally be measured in the cold light - but undertones and conjectures and all kinds of things that influence in a way that can't really be rationally measured out and balanced - are affecting that decision.

If I thought that poring through every comment in this discussion and deciding whether it was an ad hominem attack or simply uncharitable would help those parents, I'd do it. But I don't, and I don't really care how you or anyone assess that decision.

Those parents deserve something better than what this discussion is offering them. They deserve not to be treated as pariahs for trying to keep their child off the operating table and they deserve not to encounter a discussion on a support forum that feels like entering the most political spin room in the world. Before Flerc entered the discussion, I don't think anyone following along would have known that the results of the research was that bracing was effective in keeping kids from surgery. The first flurry of posts I saw only mentioned the overtreatment statistic and not the effectivness statistic, and even that was inflated from what the study found (treat 3 (or 2 if over 13 hours a day) to save one). One participant offered up that the effectiveness was good news for bracing parents, and was immediately greeted with the response that they wouldn't say that if all of the braced kids' curves were over 40 degrees - again, a number that had absolutely nothing to do with the research being discussed. And then the political motives of the researchers started being discussed.

*That's* what's important to me, and the rest of the back and forth is really no nevermind (except the side discussion about mocking parents in a support forum, which I think is part and parcel of the treatment of bracing/exercise/etc. participants in general.) Somewhere out there actual parents/children are trying to reach an informed decision on a critical topic. Lives are being changed. And there's a whole lot of heat and not much light being generated here by people who aren't facing the consequences of that decision.

For those parents, here are the facts as best I can discern them:

* Bracing research in the past has suggested that bracing is effective, but, like most medical research, has not been able to solidly say just how many kids were kept from surgery by bracing and how many were braced unnecessarily.
* Randomized studies answer that question by randomly assigning patients to one treatment or the other
* This is the first (and, likely, the last) randomized study of bracing, so it's the best evidence we have to date and may not ever be superseded by better evidence.
* The study found that bracing 0 to 6 hours a day didn't change the risks of having surgery, bracing 6 to 12 decreased the risk by 50%, and bracing more than 12 hours decreased the risk by 80%
* The study also found that 50% of the children who *weren't* braced did not progress to surgery
* The endpoint of the study was >50 degrees/surgery by maturity. It did not follow the patients beyond that point and did not, therefore, measure the lifetime risk of surgery.

If you're considering bracing, then:

* You have a 50% of *not* progressing, even if you don't wear the brace, and you likewise have a 50% chance of progressing to surgery if you do nothing at all
* If you do wear a brace more than 6 hours a day, you have a 25% chance of progressing to surgery
* If you do wear a brace more than 12 hours a day, you have a 10% chance of progressing to surgery

So, bracing doesn't guarantee that you won't need surgery, and not bracing doesn't guarantee that you will. Bracing is tough, surgery is tough. There's nothing in the numbers that suggests that you're a better or worse parent by choosing to or not to brace. It's a purely personal decision based on how you assess the odds and how you and your child feel.

Information past maturity is unfortunately not all that plentiful. Some braced kids will progress to surgery as an adult, and some surgical kids will need more surgery. But, in general, these kids do fine regardless of which treatment you choose.

[Pooka1]

How do Dr. McIntire's comments differ from what I said? Were they libelous/slanderous?

blah blah blah -

[Pooka1]

, and the rest of the back and forth is really no nevermind

Then why accuse me of ad hom?

[Pooka1]

This is only the second or third time in all the years I have been posting that I am asking for a moderator to do something. So it is significant in my mind at least!

I am asking the posts that hdugger wrote that accuse me of ad hom be removed because she will not stand by them thereby revealing her hypocrisy. They are merely ad hom themselves.

Thanks in advance.

Or we could just wait until the next post deleting binge from hdugger herself. I'm willing to do that also. There is a pattern of not standing by posts with her such that she will delete them.

[hdugger]

Here, you can locate your contention that the researchers have suppressed certain data because succumbed to political pressure on the chart by yourself:

http://upload.wikimedia.org/wikipedi...ement1.svg.png

IMO, it's less than name calling but more than responding to tone. It does not engage the *facts* of the study in any way. It notes the absence of certain data (engaging with fact) and then zooms right to 1) assuming that the researchers are hiding something by not including this data; 2) stating that they're hiding it because they've succumed to political pressure. At this point, we're miles away from the research and trying to ascertain the researchers motives for performing certain unsavory acts, none of which there's actually anything but conjectural evidence to support.

Dr. McIntire defends the researchers against the second accusation, saying that he doesn't believe that anything nefarious is going on, but does support the first idea that they're deliberately not publshing data because it would call their conclusion into question. I don't think that goes all the way to ad hominen, but I'd consider it uncharitable.

There's 10 minutes of my life that I'll never get back.

[Pooka1]

Sometimes, in a debate, all you have to do is underline what the other person says. Consider me doing that. This is NOT going away.

Here, you can locate your contention that the researchers have suppressed certain data because succumbed to political pressure on the chart by yourself:

http://upload.wikimedia.org/wikipedi...ement1.svg.png

IMO, it's less than name calling but more than responding to tone. It does not engage the *facts* of the study in any way. It notes the absence of certain data (engaging with fact) and then zooms right to 1) assuming that the researchers are hiding something by not including this data; 2) stating that they're hiding it because they've succumed to political pressure. At this point, we're miles away from the research and trying to ascertain the researchers motives for performing certain unsavory acts, none of which there's actually anything but conjectural evidence to support.

Dr. McIntire defends the researchers against the second accusation, saying that he doesn't believe that anything nefarious is going on, but does support the first idea that they're deliberately not publshing data because it would call their conclusion into question. I don't think that goes all the way to ad hominen, but I'd consider it uncharitable.

There's 10 minutes of my life that I'll never get back.

[Pooka1]

IMO,

Good for you. Why delete your posts if not because you can't defend them?

[Pooka1]

You need to STOP putting words in my mouth. You have done little else. This is not going away.

Here, you can locate your contention that the researchers have suppressed certain data because succumbed to political pressure on the chart by yourself:

http://upload.wikimedia.org/wikipedi...ement1.svg.png

IMO, it's less than name calling but more than responding to tone. It does not engage the *facts* of the study in any way. It notes the absence of certain data (engaging with fact) and then zooms right to 1) assuming that the researchers are hiding something by not including this data; 2) stating that they're hiding it because they've succumed to political pressure. At this point, we're miles away from the research and trying to ascertain the researchers motives for performing certain unsavory acts, none of which there's actually anything but conjectural evidence to support.

Dr. McIntire defends the researchers against the second accusation, saying that he doesn't believe that anything nefarious is going on, but does support the first idea that they're deliberately not publshing data because it would call their conclusion into question. I don't think that goes all the way to ad hominen, but I'd consider it uncharitable.

There's 10 minutes of my life that I'll never get back.