spinecor

[jillw]

MJB, Although Dr. Rivard may feel that there isn't a need for an out of brace xray, he is in agreement with the other doctors that when an out of brace xray is taken, that the child should be out of brace for at least 24 hours prior. Well, caveat - he hasn't told me that directly, because we haven't had the out of brace xray discussion yet, but he had told others who had posted that here.

Sharon, I believe you are right...they have been gathering data and they have to decide on a protocol. They would say that the data they have (that looks very promising) is based upon not being out of brace for more than 2 hours at any one time (although to clarify, 2 out of brace periods are allowed per day as long as the brace is worn in between...i.e. a couple hours out of brace in the morning and a couple hours out of brace in the late afternoon for a total of 4 hours out of brace). I imagine they'd say that at this point they don't have any data to indicate whether the brace has the same success rates if somebody goes 4 straight hours out of brace on a REGULAR basis or spends 6 hours out of brace or whatever. I saw a similar evolution with the TLSOs....while people have been wearing them for decades, it was more recently (relatively) that studies were done to see whether wearing a tlso for 18 hours a day was really any worse than 23 hours a day. First they have to come up with a baseline, and then when the results of the baseline are well established they can start to tweak various controls (i.e. time in brace). Nonetheless, I'd be shocked if they said occasional exceptions are likely to be harmful.

[Pooka1]

Nonetheless, I'd be shocked if they said occasional exceptions are likely to be harmful.

I suggest any rational person would be shocked.

Every parent is trying to do their best for their kid. But not every parent understands every aspect of what doctors tell patients/parents and especially WHY these doctors say what they say. Sticking to two two-hour out-of-brace periods without exception like it was life or death is simply ignorant of the circumstances in this case.

I am a researcher and I understand the need for high-quality, highly controlled data to advance this field. But I don't think that goal is more important than my kid going to a water park for an afternoon out of brace if I were in that situation. The outcome won't change but the kid will be happier. Win-win. YMMV.

[MJB]

But I don't think that goal is more important than my kid going to a water park for an afternoon out of brace if I were in that situation. The outcome won't change but the kid will be happier. Win-win. YMMV.

I do agree with you on that, that is why I personally make exceptions when we are out swimming, although not every time we go... For a waterpark, which we went to one last week I made an exception but really in total with a lunch break in between (in brace) she only had about 4 hours at the most out of the brace, then I did not let her have one in the evening, which was fine because we left the park at just after 4 anyway. Although that week because I was off work a few days and we went swimming every day, I did not allow this every day, the days that we just went to the pool I followed her 2 hour breaks.

As for my H, I have no clue why he is so stuck on being so strict about it, trust me he knows I don't agree with him and we have discussed it but nothing comes of it.

[MJB]

I suggest any rational person would be shocked.

Sticking to two two-hour out-of-brace periods without exception like it was life or death is simply ignorant of the circumstances in this case.

.

Even though I agree with you on what I posted above, I do not consider my H to be ignorant though, he is just doing what HE thinks is best as a parent, where as I choose to do what I think is best... he is a great parent and isn't trying to make our daughters life miserable, she is a very happy little girl...

Some may think it's great that he sticks to it so well because then we wont get into slacking with it and being TOO easy with it and others may think he's being too hard on her with it.

[Pooka1]

I think you are in a very dicey situation.

Even though you realize the arbitrary nature of Rivard's advice, if you follow through on occasional longer out-of-brace periods and your daughter eventually does need fusion, your husband might incorrectly blame the failure of the approach on those occasional longer out of brace periods even though that isn't rational.

I have no basis to relate to your situation. I took the lead, if you will, on the scoliosis situation with my daughters and my husband trusts me to research the options and explain it to him. I do not have all the answers and brought him up to speed so he can help make decisions. He keeps me logical and rational and I keep him logical and rational to the best of our abilities... it's never going to be 100% because frankly, I find this business with both my girls having scoliosis, though having different trajectories, maddening. But we try.

But I have absolutely no experience with my husband misunderstanding about something that is arbitrary. He has a science background also and understands about data, research protocols, clinical trials, etc.. He has yet to take an irrational position w.r.t. our decisions about helping our girls with scoliosis. I suppose if he did, I would be obliged to ignore it. My kids come first. But it would be dicey.

[emarismom]

There have been many times that due to our schedules and life in general that we have not followed the 2 two hours out of brace rule. Sometimes we have done 3 hours and then 1 hour later. Sometimes we have done 1 three and a half hour break.

This happens because maybe we go out and she leaves the brace at home. If we take a few extra minutes here or there, she's out of it too long. Or she will be watching TV and not notice the time, so we have to adjust things around. Marlowe, as time goes by you will see that it is impossible to make sure that every single day Hallle is in the brace the specified amount of time.

Life keeps on going even though a child is in the brace. It is impossible and impractical to think that we can monitor every moment of our children's daily schedule so closely. We as parents are human and we will have days where we are thinking about something other than the brace or we are just to busy to pay attention to it. Of course, in the beginning it is ALL CONSUMING.

[leahdragonfly]

To Emily's Mom,

(sorry I don't know your name). Your post above is so well-said, and I agree with your philosophy about brace-wearing fitting in to the grand scheme of family life. My daughter is in a boston brace, not spinecor, but I just had to comment.

[RugbyLaura]

It's a tough one though isn't it?

We all want the best for our kids; The best life, to be happy, the best possible childhood and the best scoliosis outcome. Perhaps it's not possible to have it all? Just putting my thoughts down here - not intending to make any judgements!

Although bracing has been around for many decades and spinecor for ?15? years or so there is still relatively little data. I'm no expert but I would imagine that, to get reliable results, studies would need to follow children in different groups using the brace for different amounts of time. And some would need to be the control sample Given the fact that our childrens curves vary considerably by size, age, direction, position, etc it would take an enormous amount of children participating to get anything near meaningful results.

It would also mean that parents would have to stick rigidly to their child's prescription. And be totally honest! (given that some will not be honest for one reason or another, can the results ever be reliable unless children are watched 20 hrs a day by an outsider?? Ridiculous! But valid??).

Perhaps by being flexible with inbrace hours we are delaying meaningful results. By choosing to follow the medical advice (that we have sought) only up to the point that it stops suiting us, are we helping? Are we being selfish? By delaying this data (if we are) are we preventing our granchildren from having a chance of successful treatment?

I am not directing this at anyone (other than myself), it is a discussion I often have in my own head!


Regarding the idea that treatment should be free of charge for those "participating" in studies. Wouldn't that be great! But quite impossible, although I imagine that the Drs wish it could be. I truely believe that most doctors want to do good. (Ok, they need to earn a living too). Maybe I'm being naive, but does it really matter whether their motives are altruistic or monetary if the studies are rigorously evaluated and the results are reliable?

Laura

[Pooka1]

Perhaps by being flexible with inbrace hours we are delaying meaningful results. By choosing to follow the medical advice (that we have sought) only up to the point that it stops suiting us, are we helping? Are we being selfish? By delaying this data (if we are) are we preventing our granchildren from having a chance of successful treatment?

The data will always be delayed. I don't see how anyone can stick with a protocol like it's life and death absent hard data. And until they start paying folks to participate in these studies rather than charging them an arm and a leg, it's going to be tough going getting hard data. I, for one, would feel no obligation to stick to the protocol absent data if it meant sacrificing my child's comfort and happiness. It's not even a close call. But that's the kind of hair pin I am. YMMV.

Regarding the idea that treatment should be free of charge for those "participating" in studies. Wouldn't that be great! But quite impossible,

Don't you have sponsored clinical trials in the U.K.? It's not only possible but relatively easy to find a study. For example, my father was dying of myelodysplasia secondary to years of chemo for lymphoma. I found a clinical trial for him that would have been free.

The problem with bracing is that nobody appears to want to sponsor a clinical trial for bracing because there is not enough money in the end to do so, not because a clinical trial is impossible in principle. It's not obvious that this would be the case but there you go. Or maybe I'm misunderstanding you?

although I imagine that the Drs wish it could be. I truely believe that most doctors want to do good. (Ok, they need to earn a living too). Maybe I'm being naive, but does it really matter whether their motives are altruistic or monetary if the studies are rigorously evaluated and the results are reliable?

Well, I'll just say that it is hard to be totally objective when you have invented a device. I'm not saying that there is some funny business with the data so far on Spinecor because I don't know that. I AM saying at least one surgeon has questioned the published results as being "overly rosy." I don't know the basis of that comment but I can say there are fine lines sometimes between various ways of looking at data, massaging data, selecting data, etc.

In the bracing data, I note they often only look at a subset of the initial group for one reason or another. That is data selection and may or may not be justified. In my field, if I were reviewing a paper that engaged in overt and seemingly targeted data selection, I would stop reviewing it and send it back with a recommendation to reject. Same with QA/QC. I recently recommended rejecting a paper for lack of adequate QA/QC. You have no idea of the quality of your data if you don't monitor the quality. It may be good or it may be crap. And any study without a control group can be filed in the circular file from the get-go as you yourself stated above.

[emarismom]

Laura,

You have voiced many of the concerns I've been having lately. When our children are diagnosed, we go in with guns drawn, ready to take on the world, and we believe we will defeat the diagnosis. But as time goes on, the reality sets in, that this diagnosis IS ongoing. WE will not "defeat" it in a month, a year, or even five years. It will run its course in ours and our childrens life. It will not end until our children reach maturity. For some of us, this is a very long road.

As far as the data goes on bracing , there is really noway to be sure that any of the research studies that have been conducted are even valid. There are just to many variables and too many unknowns. (Which brace works the best?, How many hours a day? Who is a good candidate for bracing? , For how long should the brace be worn?, Is it worth the effort?).

I can say that we are delaying meaningful data, because if we are the the ones Spinecor is actually basing their data on, then obviously their data is flawed, because as a few of us have said, we don't follow protocol to the letter.

When the question of doctors motives comes up, I have a really big issue. My daughter is more valuable to her orthopedic if she progresses. That is a fact. The doctors know that they have a treatment (surgery), that can cure the scoliosis. They know there won't be any long term damage done by letting the child progress to surgery. So what is the real reason for the lack of good, solid research on bracing? Is it that it is almost impossible to conduct or is it that it is not financially beneficial?

Is the current trend away from bracing a result of "the lack of good data on the benefits of it" or is this trend related to $$ to be made when these children progress.

Michelle

[RugbyLaura]

Originally Posted by Pooka1
The problem with bracing is that nobody appears to want to sponsor a clinical trial for bracing because there is not enough money in the end to do so.

Yep, you've hit the nail on the head again. A study is obviously not impossible, a poor choice of word on my part. But it may be difficult given the variables. The main problem is the lack of funding.

Originally Posted by Pooka1
I, for one, would feel no obligation to stick to the protocol absent data if it meant sacrificing my child's comfort and happiness.

And I. However, I do have occasional feelings of guilt. Is there ever going to be any data if we don't stick to the protocol? Catch 22?

[emarismom]

Pooka,

We must have posted at the exact same time. I'm sure that MANY orthopedics have questioned the reliability of the published data on Spinecor. My orthopedic has been VERY clear to point out to me that all of the data conducted has been conducted by the inventors of the brace. Of course, they would have no reason to biased would they?

[Pooka1]

Is the current trend away from bracing a result of "the lack of good data on the benefits of it" or is this trend related to $$ to be made when these children progress.

Well, I have noted the OPPOSITE trend with both our orthopod and our surgeon. They never braced to my knowledge UNTIL the night-time brace came out with some promising data.

Both of them are surgeons and yet they went to bracing in the recent past based on the data as far as I know.

[emarismom]

Pooka,

What nighttime brace is your daughter wearing? Maybe I need to investigate this as an option in the future.

[Pooka1]

Pooka,

What nighttime brace is your daughter wearing? Maybe I need to investigate this as an option in the future.

It's a Charleston but I don't know why the Providence brace wouldn't work the same. They are both night-time bending braces.