SOSORT paper with discussion of Dolan's metanalysis

[Pooka1]

At face value, that SOSORT paper shows a much lower surgery rate after bracing than the ones Dr Dolan included. Wonder why? Maybe their proxy for surgery was 90 degrees. Maybe they braced 16 year old kids who were done growing. Maybe they braced 10 degree curves. I dunno, but I want to find out.

I suggest your guesses are likely to be correct and largely explain their data.

Dr Dolan mentioned in her paper that her confidence in the braced surgical rate was high. These SOSORT guys seem to disagree.

Either there is or isn't a commonly accepted trigger angle for surgery. If one exists, I think it's ~50.*

Now if everyone was framing their discussion around the rate at which folks hit 50*, that would be valuable I think.

If the angles can be found in these studies, and if everyone can agree on 50* as a surgical trigger, I don't think there would be any disagreement whatsoever on "surgical rates" between Dolan and the SOSORT types.

And last, I think the SOSORT surgical trigger is not 90* but 9000*.

[Dingo]

my nonscientific reply

Here is my not entirely scientific 2 cents on bracing

1) There are studies that indicate bracing works, marginally works or doesn't work at all.
Analysis: Bracing just barely comes out ahead on this one.

2) Bracing lowers Calmodulin levels which are the prime mover in curve progression.
Analysis: Clear evidence that bracing could work.

3) I've read at least 100 posts that give me anecdotal evidence that bracing works.
Analysis: Not scientifically strong but still believable evidence that bracing works for some kids.

Add it all up and I say bracing works.

It would take a half dozen good studies to prove this or disprove it so until then I have to go with my gut.

[concerned dad]

Sorry Dingo, not exactly what I was after.

I wanted to explore what we know from the literature and the ethical implications. (not that I dont value your 2 cents, it's just that we already have two diametrically opposing assertions)

Dolan says we dont know if bracing works to reduce the incidence of surgery.
SOSORT says bracing and excercise works to reduce the incidence of surgery.

Dolan says a RCT is ethical.
SOSORT says a RCT is unethical.

I would think this topic would garner more discussion.
I'm not much help because I seem to flip flop all over the place on the issue.
We really need someone to dig through the SOSORT references and look at how valid the studies were relative to things like

Maybe their proxy for surgery was 90 degrees. Maybe they braced 16 year old kids who were done growing. Maybe they braced 10 degree curves.

[concerned dad]

Dickson does a better job at discussing the stratification issue in the Nachemson paper.

From a 1999 paper by Dickson in Spine discussing Nachemson.....

One hundred and eleven braced patients were compared to 129 observed and 46 electrically stimulated. The failure rate was an increase in Cobb angle by 6°. On this basis 36% of the braced, 52% of the observed, and 63% of the stimulated failed and these differences achieved statistical significance. The next paper in the same journal looked at factors that affect natural history and one of the most compelling features was that thoracic curves had a much worse prognosis than thoracolumbar curves. Looking now at the proportions of the more progressive thoracic curves in the three trial groups, 89% were thoracic in the stimulated group, 81% in the observed group, and a mere 68% in the braced group. Meanwhile, in the paper originating in Puerto Rico, 70% of the untreated group had thoracic curves and 46% of the treated group. It would be difficult to stack the odds better.

Of course, by recognizing that "the next paper in the same journal" revealed the issue of stratification, Dickson is not suggesting malfeasance. How could anyone have known before hand. It must have been a heartbreaking revealation to the folks working on the research.

[PNUTTRO]

Dolan says a RCT is ethical.
SOSORT says a RCT is unethical.

RCT? randomized clinical trial?

Can you comment on the ethical question? In what way is it unethical?

[Dingo]

To brace or not to brace

concerned dad

I would bet that the more a scientist digs into previous studies the more problems they'll find.

Even though many of these (or all of these) studies contain flaws they taught us a lot about Scoliosis in general.

Somebody needs to take this info, use a large sample and compare apples to apples.

100 twelve year old girls with a 20ish degree Thorocolumbar curve in a Providence brace for 1 year versus the same type of girls in a nonbraced group. Oh yeah and put a chip in the brace to make sure it's being used.

It's the only way to end the debate once and for all.

[LindaRacine]

Dingo...

Yes, RCT = Randomized Controlled Trial.

All I know for certain about the RCT debate is that I personally wouldn't want my child to end up in the control group, at least assuming that s/he was in a curve range/Risser that would put her at risk. Having gone through surgery, it's not something I would wish my child to go through, if there was a chance it could be avoided.

I honestly think we're not far from knowing which children (genetically) are at risk. Perhaps we could take a cohort of these children who are genetically at risk, prescribe a brace at the appropriate time (cobb angle/Risser value), monitor compliance, and evaluate results by compliance range.

No matter what we do, I think we're still a long way away from knowing the truth. In the time being, should our kids be braced or not? There are pros and cons for both sides of this debate, so I guess each parent has to make their own informed decision.

Regards,
Linda

[PNUTTRO]

I think that a trial could be ethical but not random. Since there are those that choose not to brace and those that don't comply, researcher should be able to find a good control group.

A problem may arise when a clinician influences the decision after inclusion in the trial.

Additionally, there are those that opt not to have surgery (for various reasons) even after it is recommended.

It would have to be longitudinal cohort study.

Is the Braist study really randomized?

[Pooka1]

I would not let my kid participate in a RCT at this point because there is no good evidence bracing works.

It's my daughter's decision to try the Charleston, not mine.

That said, I think RCTs are ethical even though bracing is a very difficult treatment compared to surgery.

[Pooka1]

And one other thing...

If it is true that virtually all adults develop other problems simply from having scoliosis for years then bracing will become obviously unethical if it works to delay surgery rather than avoid it.

As of now, though, because there is no good evidence bracing works and because nobody who knows what they are talking about ever says longstanding scoliosis causes all these other problems that ofter trigger surgery, I think RCTs can be considered ethical. But I think the days are numbered when it can be so considered for several reasons.

[LindaRacine]

If it is true that virtually all adults develop other problems simply from having scoliosis for years then bracing will become obviously unethical if it works to delay surgery rather than avoid it.

Hi Sharon....

I doubt that all people with scoliosis will develop other problems as they age. I know of dozens of people in their 30s and 40s, who were braced as kids, but who have no problems with their spines now.

That being said, they have a significant chance of problems later in life anyway. I've seen several references over the last 10-20 years, that show that something like 85% of the general adult population will have one or more instances of back pain in their lifetimes.

Additionally, a significant number of people who have normal spines to start with, will have some degree of scoliosis in later years:

http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

Regards,
Linda

[Pooka1]

Hi Sharon....

I doubt that all people with scoliosis will develop other problems as they age. I know of dozens of people in their 30s and 40s, who were braced as kids, but who have no problems with their spines now.

That being said, they have a significant chance of problems later in life anyway. I've seen several references over the last 10-20 years, that show that something like 85% of the general adult population will have one or more instances of back pain in their lifetimes.

Additionally, a significant number of people who have normal spines to start with, will have some degree of scoliosis in later years:

http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

Regards,
Linda

Okay that's really interesting. I knew a majority of (non-fused) people develop back problems if they live long enough but I didn't know it was 85%!

I'm just putting various statements our surgeon made into some logical framework.

I asked why the big difference in recovery between kids and adults and he said adults almost never just have a curve... they almost always have other issues which complicates the recovery. Now I see that it's going to be dicey to sort out which problems may be attributable to the scoliosis and which to just being older because as you say, most adults will eventually have back problems. I don't know.

[concerned dad]

Can you comment on the ethical question? In what way is it unethical?

We touched on the ethical issue starting at about post 12 of this thread

If you take a close look at Figure 1 in the paper linked at the front of this thread you see Dolan shows no difference between surgery rates of braced and unbraced kids.

Note: There is only one bar there showing unbraced results.

Then you look at the results reported by the SOSORT guys (the Top Bars), they show a marked difference between their braced results and the ones reported by Dolan.

If a doctor believes a better treatment is available, it is unethical to withold it for research purposes. Dolan doesnt think that we know a better treatment is available, SOSORT believes that there is a better treatment (bracing).

And Pnuttro, you are absolutely correct about the possibility of designing a trial that is ethical but not random. That is precisely what they did in the big (failed) 1995 SRS Nachemson bracing study. They got around the ethics by noticing the different "standards of care" at different institutions. Some didnt brace. They felt it didnt work. They were the control. It was, however, not random.

the Braist Trial is indeed Random. If you agree to participate, they essentially flip a coin and put you in a brace or watch till you hit 50 degrees. (Some of the participating centers in the 1995 studies watched for 6 degrees and then wrote watching off as a failure for that patient and then braced)

I dont know, I find the whole thing really interesting to explore the ethics and the scientific method and the science. The fact that it is relevant to my daughter helps too, for sure. I think all the researchers invo9lved are doing the darndest to get the right answers in an ethical and scientifically correct fashion.

And Dingo

100 twelve year old girls with a 20ish degree Thorocolumbar curve in a Providence brace for 1 year versus the same type of girls in a nonbraced group. Oh yeah and put a chip in the brace to make sure it's being used.

it's not as easy as all that. Dolan reports on the other website that they only have 100 girls so far in their study across all curve types and all amplitudes.
And, I dont know if I would brace my 12 year old with only a 20 degree curve. I would be inclined (now) to wait to see if it is an advancing curve.
All it takes is to live with a kid for a couple of months (or even review the posting in the bracing forum) to discover that bracing is no small inconvienence, it is a pretty dramatic change in their lives (albeit, hopefully short lived and only till skeletal maturity). A parent looks to see if there is evidence that it will "work", both in the literature (highly variable results reported) and in your particular case (decent in brace correction).
If it were as simple as taking a pill or turning off a night lite, well, then yes, the treatment would be worth the chance even if there is no good evidence it works. But bracing is not trivial. It has to be a bummer to have surgery, but even more of a bummer to wear a brace for 2 years and then still have surgery.
As surgery methods improve, it makes the decision harder (or, in a strange way easier perhaps).
In my opinion anyway

And just to recap my daughters situation - we are not bracing her 38 degree curve. That decision was based on lots of things, but largely on the indications that she is almost skeletally mature and she did not obtain a good inbrace correction when we tried bracing. And we never would have come to that decision without this forum and ALL the participants as a resource.

[Pooka1]

(snip good points)

And just to recap my daughters situation - we are not bracing her 38 degree curve.

My daughter hit and passed 38* and bracing was never discussed at any point by either our referring surgeon or the surgeon who did the fusion. I'm guessing they knew through experience that a curve that is moving that fast and twisting up that earlier is not likely to respond. She was spared a brace and luckily had a relatively easy time with the surgery.

Because of the quick/smooth recovery, she has said she was glad to have the surgery and was glad not to have to wear a brace after seeing just the Charleston on her sister. I can only imagine how grateful she would be to not have to wear a 23/7 hard brace.

[Dingo]

bracing

concerned dad

Dolan reports on the other website that they only have 100 girls so far in their study across all curve types and all amplitudes.

Hmmm... interesting. Until technology advances research might not be able to give us a definitive answer on bracing. Ironically by the time science advances far enough to give is an accurate answer Scoliosis might be cured or treated with drugs.

All it takes is to live with a kid for a couple of months (or even review the posting in the bracing forum) to discover that bracing is no small inconvienence

I am under no illusions about bracing. It breaks my heart to think of my son in a brace. But if his curve progresses I don't see another option. To me 23/7 bracing sounds at least 10 times more difficult than night bracing.