Why I decided to brace my daughter with the SpineCor

[Pooka1]

The little thread that could!

Dr. Dolan's response was very similar to what I mentioned... do NOT expect to see anything from a PowerPoint conference talk in a published article. One is peer-reviewed and one is not.

Moreover, those are old data that are still not in print in that form. I think they are interim angles measured in brace which would explain why they haven't been published.

[Pooka1]

If I was Coillard, I would pick a surgery indication angle of 5,690*. The brace would look pretty successful.

[concerned dad]

I wonder what the stats would be if they picked a real world surgery trigger angle.

oh come on. I admit I dont know what is considered "real world" but isnt this close? in fact, i thought the 45 was low (not that I really know).

General indication for fusion in all patients was progression of primary curve of more than 60° in thoracic region and 45° in thoracolumbar and lumbar region.

And what would the stats be? In accordance with the SRS guidelines, they report what the number of patients who progressed to 45 degrees was as follows:

Percentage of patients who progressed beyond 45°at maturity. Seven patients out of the 298 patients who had a definite outcome (2.3%) had documented progression of curve beyond 45° at maturity. Surgery was required for 3 of these patients.

So, I dont think they are jigging the data with their indications for surgery. Maybe that is what the canadian health system dictates. Who knows.
But they are at least reporting the data as suggested (by the SRS).

[Pooka1]

Is this paper online somewhere? I'd like to look at it.

[concerned dad]

Is this paper online somewhere? I'd like to look at it.

Not yet, but it is virtually identical to the European Spine Journal paper, just more/updated results.

But guess what I found ...... the entire SRS Bracing Criteria paper
SRS paper on Bracing studies

[Pooka1]

But guess what I found ...... the entire SRS Bracing Criteria paper
SRS paper on Bracing studies

Note they suggest >45* as a possible need for surgery.

Not 60*.

Not 5,690*.

[concerned dad]

Note they suggest >45* as a possible need for surgery.

Not 60*.

Not 5,690*.

What the SRS want to see reported is:

b. The percentage of patients who have had surgery recommended/undergone before skeletal maturity (i.e., the time when the orthosis would normally have been discontinued). The surgical indications must be documented.

c. The percentage of patients who progress beyond 45°, indicating the possible need for surgery.

They ask for these numbers so that someone cant be accused of misrepresenting surgery rates by using a high COBB angle recomendation for surgery.

Coillard is the first and only (opps, lets not forget Janicki a few pages before her) researcher to report their results in accordance with these criteria.

I have two thiings on my to do list some weekend. I want to compare Janicki and Coillard results (since they both reported using consistent SRS guidelines, it should be straight forward).
and
Since Dr Dolan noted that the Danielson paper (the one "salvaging" the large SRS Bracing study by Nachemson) wasnt published when she wrote her paper, it would be interesting to look at her results including the Danielson data.

[Pooka1]

What the SRS want to see reported is:

[COLOR="Blue"]b. The percentage of patients who have had surgery recommended/undergone before skeletal maturity (i.e., the time when the orthosis would normally have been discontinued). The surgical indications must be documented.

I'd like to hear a rational defense of this criterion from the SRS or anyone for that matter.

It seems like a proxy for "high rate of curvature." Why not just ask about the rate of curvature instead of layering on a confounder about variation in individual surgeon's opinions about when to pull the surgical trigger?

Coillard is the first and only (opps, lets not forget Janicki a few pages before her) researcher to report their results in accordance with these criteria.

I have never met anyone who did not refer to two articles published in the same issue as "simultaneous publication."

Moreover, as we've seen, adherence to those criteria does not guarantee a quality publication.

[txmarinemom]

Fuzzy AIS/JIS lines ...

As I'm sure we've discussed before, the distinction between AIS and JIS is sometimes a bit fuzzy. For the purposes of studies Immi is classes as AIS as she was braced a week before her tenth birthday.

However, we know that she is really a JIS case as her curve has been around (and apparently progressing) since she was 7/8...

That's exactly how my curve was, Laura. I was classed AIS because JIS wasn't broken out into its own category in 1978.

In adulthood, I was classed JIS because, as you said, I had an established curve (somewhere in the ±35° range if I remember correctly) a few months before my 10th birthday.

Regards,
Pam

[concerned dad]

I'd like to hear a rational defense of this criterion from the SRS or anyone for that matter.

It seems like a proxy for "high rate of curvature." Why not just ask about the rate of curvature instead of layering on a confounder about variation in individual surgeon's opinions about when to pull the surgical trigger?

Rate of curvature is a hard thing to measure. To get a rate (as you know) requires two measurements (accurate measurements BTW and COBB angles aren’t inherently accurate to measure – and then you have the inbrace and out of brace thing going on).

Surgery is pretty easy. Either you had it or you didn’t.

And, it makes sense to throw in indications for surgery too.

And, to round things out, throw in the number of patients who progressed beyond 45 degrees (just to rule out any trickery or deception).

The INTENT of these numbers is to assess brace effectiveness. I think these reporting criteria are easier to measure and more meaningful than “rate of curvature”.

Dr. Dolan makes the case that rate of surgery is the only meaningful assessment of bracing effectiveness. So meaningful in fact, that her systematic review excluded the Nachemson study (“failed” 1995 SRS Bracing Study) because it did not include surgical rates. (Yes, there may be other problems with Nachemson, but the surgery thing is why she did not include it).

I have never met anyone who did not refer to two articles published in the same issue as "simultaneous publication."

I know, I forgot to include the wink

Moreover, as we've seen, adherence to those criteria does not guarantee a quality publication.

Well, it may not guarantee a quality publication, but it does guarantee comprarable results. At least we are comparing apples with apples.

About the quality publication thing, last night I read an interesting paper discussing archiving research data, the scientific method and making public policy decisions based on "refereed" literature.
Here is a link if anyone is interested.
due diligence

And yeah, the whole AIS, JIS thing seems gray. I wonder why they make the distinction. Must have a good reason I suppose.

[Pooka1]

Rate of curvature is a hard thing to measure. To get a rate (as you know) requires two measurements (accurate measurements BTW and COBB angles aren’t inherently accurate to measure – and then you have the inbrace and out of brace thing going on).

Surgery is pretty easy. Either you had it or you didn’t.

When you don't have the the protocol of not doing out of brace radiographs, rate of curvature is FAR FAR FAR more robust than whether or not someone has had surgery. This is a self-inflicted problem and is a penetrating glimpse into the obvious.

I don't mean to keep repeating myself but I will... just in this little group we have folks pulling the trigger with a single curve below 50* and folks with double 60+* curves who have had a surgeon suggest they don't need surgery.

If at this point anyone thinks recommendation for, or having, surgery isn't an obvious confound then either you or I am missing some major piece of understanding.

And, to round things out, throw in the number of patients who progressed beyond 45 degrees (just to rule out any trickery or deception).

This is really the only robust criterion among the ones being discussed in this subpart of the thread.

The INTENT of these numbers is to assess brace effectiveness. I think these reporting criteria are easier to measure and more meaningful than “rate of curvature”.

Completely disagree.

Dr. Dolan makes the case that rate of surgery is the only meaningful assessment of bracing effectiveness. So meaningful in fact, that her systematic review excluded the Nachemson study (“failed” 1995 SRS Bracing Study) because it did not include surgical rates. (Yes, there may be other problems with Nachemson, but the surgery thing is why she did not include it).

Does she defend that in print?

[concerned dad]

Does she defend that in print?

Yes, Dolan does. I dont have the paper in front of me but I'll try to quote it.
She says "who the heck cares if the curve progresses beyond a number. What people really care about is will bracing prevent surgery".

Not sure if that is a totally accurate quote but I'll amend it tomorrow if necessary.

She discusses at some length WHY the indication for surgery is important in assessing bracing efficacy. Heck, look at the title of her paper.

Regarding the robustness of "rate of curvature". Just how many xrays do you think it would take to determine the variation in that rate?

[Pooka1]

Yes, Dolan does. I dont have the paper in front of me but I'll try to quote it.
She says "who the heck cares if the curve progresses beyond a number. What people really care about is will bracing prevent surgery".

Not sure if that is a totally accurate quote but I'll amend it tomorrow if necessary.

Yes but how valuable is that information if there is no objective standard for surgery? How do you explain the wide range in angles that trigger surgery?

She discusses at some length WHY the indication for surgery is important in assessing bracing efficacy. Heck, look at the title of her paper.

I'd like to see how she fields the issues I brought up. Maybe I'm missing something. This is her field, not mine.

Regarding the robustness of "rate of curvature". Just how many xrays do you think it would take to determine the variation in that rate?

AFAIK, a common protocol is twice a year. Isn't Spinecor three times a year?

That would be enough or at least far, far, far better than the number of folks who had surgery, some of whom had a single 50* curve and some of whom had double 70* curves. I consider the percentage who have surgery a worthless statistic unless all surgeons are using the identical standard which we know a priori just from this little group they are not.

[concerned dad]

OK, maybe my quote above wasnt entirely verbatim. Funny, she doesnt use the word 'heck' anywhere.

Here is what Dolan has to say about it in her 2007 Spine paper.

Patients and families don’t generally fear curve progression; they fear curve progression to the point where surgery is the only option to improve or maintain an acceptable level of cosmesis. Therefore, it is not surprising that many opt for orthotic treatment without seriously considering the approach of watchful waiting advocated by Dickson and Weinstein in England56 and Goldberg et al57 in Ireland. Unfortunately, orthotic treatment is not necessarily benign in terms of the psychosocial and body image concerns it causes for many families.

Therefore, we think that such a treatment decision should be based on the best evidence available concerning the rate of surgery with and without treatment, including the patient and treatment characteristics that contribute to higher rates of surgery. This evidence is an integral part of informed choice and should be available to clinicians, patients, and their parents as they contemplate bracing. To date, no systematic review has synthesized this evidence.

The objective of this review is to develop a pooled estimate of the incidence of surgery in untreated patients (treated by observation only) and in brace-treated patients with AIS, as well as for specific risk factors that may significantly affect the prevalence of surgery. Ultimately, the objective of this review is to help clinicians, patients, and parents make informed choices concerning treatment for AIS.

I said earlier that this paper was used to demonstrate that there was not a difference between bracing and observation wrt surgery rates and that this evidence was then used in support of the RCT. This paper was not intended to investigate if bracing affected the curve size. It just looked at whether or not the curve progressed to surgery.

Maybe I'm wrong, but I think if a similar systematic review was performed to assess if bracing affected curve SIZE then the results would have been YES.

So, if Sharon is correct when she says surgery is a poor measure of bracing efficacy, does that mean that the BrAIST RCT is proceeding on weak grounds?

[concerned dad]

So, if Sharon is correct when she says surgery is a poor measure of bracing efficacy, does that mean that the BrAIST RCT is proceeding on weak grounds?

Here is an interesting viewpoint that I agree with. A fellow made the following post here about 6 years ago.

The early detection and treatment of scoliosis is essential to minimize the affects of this condition and provide patients with healthcare options that are less expensive, less painful and less invasive. Most scoliosis spine specialists agree that surgery should be a last resort and efforts should be taken to keep the curve from reaching 45 degrees.

We need a much more aggressive standard however. It is in the best interest of our adolescent patients to replace the generally accepted wait and see approach with an effective non-operative treatment intervention plan. While there are many unknowns and questions about the effect of, and treatment for, scoliosis there certainly is no evidence to suggest that there is a benefit to a curve getting larger. Furthermore, if bony vertebral deformity begins to develop around 30 degrees, and the probability of continued curve progression in adulthood begins to rise at this level as well, then our focus should be on minimizing the magnitude of the curve in the early stages with a goal of keeping it as much below 30 degrees as possible. In order to achieve this goal however we need significantly more multidisciplinary research and coordination to develop and validate a more effective early intervention treatment plan.
__________________
Best Regards,

JOB

This post (from our host Joe O'Brien) would seem to counter the logic of using Dolans paper as support for BrAIST. Should the goal of intervention be escaping surgery or should the goal be stabilizing (or perhaps w/SpineCor, reducing) curve amplitude?