PDA

View Full Version : The Braist Study



Pages : [1] 2

mamamax
11-24-2009, 10:58 AM
The purpose of the Braist Study is: to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.

Concluding data should be available for analysis in August 2010. The study is limited to the TSLO type bracing method. If I am reading the information about this study correctly, it appears that compliance will involve some pretty amazing monitoring (Wear time measured using a temperature monitor).

Anyway ... the official government web link below offers a lot of information about all this (including email contacts) for us to monitor as time goes by.

Principal Investigator: Stuart L. Weinstein, MD University of Iowa
Study Director: Lori A. Dolan, PhD University of Iowa

http://clinicaltrials.gov/ct2/show/NCT00448448

mamamax
11-24-2009, 02:35 PM
While looking through the web site above, which is a registry of federally and privately supported clinical trials conducted in the United States and around the world, I found 42 studies devoted to scoliosis. http://www.clinicaltrials.gov/ct2/results?term=scoliosis&pg=1

So, I think it is good to see that so much is going on. One completed study (1/09) caught my eye: An Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis http://www.clinicaltrials.gov/ct2/show/NCT00886652?term=scoliosis&rank=11

While the study was completed in January of this year, there are no posted results as of this date. Maybe it takes another year to analyze data, I don't know but I sure would be interested in the results of that one.

Have to say I often find myself questioning why studies dealing with Schroth exercises seem so limited in number and largely obtainable only outside this country under German publication. Maybe it is because there are few government grants available for such things here in the US, forcing such studies into a self funded or privately funded category. I don't know, but when I searched for available grant money available for scoliosis studies - I couldn't find any. There was an award ceiling for $125,000,000 in 2004 for studies related to HIV/AIDS care programs. But I'll be darned if I can find any grant money available for Scoliosis studies.

Is it just me and my lack of searching skills? Here is the Advanced search link: http://www.grants.gov/search/advanced.do;jsessionid=cxmbLM1K9f8LkdTPXsnnwhVphNt Tc2ZQdS6zX1Y2wlmCQf90wY0H!-1163459943

Ballet Mom
11-24-2009, 02:53 PM
Concluding data should be available for analysis in August 2010.


The POSNA presentation by Lori Dolan states that they have not randomized as many patients as they were predicting and therefore don't think they will have 384 randomized patients until August 2011.

I personally can't imagine making a decision on whether to brace patients or not based off of 384 patients, half of them not wearing a brace, with many different variable physical attributes, but, whatever.....that's what the statistics say, so it must be valid.

mamamax
11-24-2009, 03:00 PM
I personally can't imagine making a decision on whether to brace patients or not based off of 384 patients, half of them not wearing a brace, with many different variable physical attributes, but, whatever.....that's what the statistics say, so it must be valid.

I agree. Who will not be bracing and who will make that decision? I think ideally, the decision should be with the parents. However, how many parents are going to be willing to just watch and wait? I wasn't aware of the 2011 update - thanks!

mamamax
11-24-2009, 07:11 PM
The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The work of HHS is conducted by the Office of the Secretary and 11 agencies. http://www.hhs.gov/about/

Of these eleven agencies - it is the National Institutes of Health (NIH) that is the primary federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people's health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 institutes and centers, the NIH provides leadership and financial support to researchers in all fifty states and throughout the world. http://clinicalresearch.nih.gov/about.html

NIAMS is one component of the National Institutes of Health (NIH), they research diseases of the bones, joints, muscles, and skin. This is the agency sponsoring the Briast study (looks like through HHS funding).

All 27 institutes and centers under NIH can be found here: http://www.nih.gov/icd/index.html

If you read through this listing you will see there is no agency established specifically for scoliosis. Should there be? A few departments within it could be dedicated to the research of conservative methods.

Want to know how much funding is available, where it has been & where it is going? http://report.nih.gov/rcdc/categories/

mamamax
11-26-2009, 08:42 AM
Thanks to the efforts of those at SSO, Lori Dolan (Braist Study Director) has posted some interesting information in their forum. Her comments can be found here:

http://www.scoliosis-support.org/showthread.php?p=118863#post118863
http://www.scoliosis-support.org/showthread.php?t=6954

I've invited Lori to join this thread and hope her schedule will permit some input here.

I have a few questions.

The first concerns how subjects will be followed. I wonder how often they will be seen and how often their braces will be checked for any necessary adjustments. Also, is the temperature monitor designed to resolve all compliance issues? Seems there may be several TSLO type braces used - will subjects be monitored by those who are well experienced in the application of each?

My second question concerns US funding of scoliosis research through NIH (under HSS). I searched the government web site
http://www.grants.gov/search/advance...0H!-1163459943 to see what was available for scoliosis research and found nothing. I wonder if Lori has any input regarding future funding.

mamamax
12-02-2009, 06:15 PM
I received a very nice letter from Lori Dolan today. She is experiencing some problems logging in to our forum and has written Joe O'Brien about it - so hopefully she will be able to join us shortly.

In the mean time she gave me permission to post her replies to my questions. Lori has graciously taken time from her I'm sure hectic schedule to join our forum and has expressed an openness to our questions here.

Thank you Lori and hope to see you here soon!

My questions, previously posted are below - Lori's answers (verbatim) are indented and follow each question.

__________________________________________________ _________________________________

I have a few questions. The first concerns how subjects will be followed. I wonder how often they will be seen and how often their braces will be checked for any necessary adjustments.

Subjects are seen every 6 months for a clinical exam, x-rays and to complete questionnaires about their health and well-being. Those in the bracing arm are seen every 6 months AND as often as needed to maintain brace comfort and maximize correction/balance. The orthotist/MD team have free reign to see the subjects at any time in between their scheduled six month visits. We call each subject every month to see if they have any questions/concerns. All are encouraged to contact us at any time.
Also, is the temperature monitor designed to resolve all compliance issues?

The temperature monitor will tell us with some degree of certainty what the dose of bracing was. We will not know how tightly the brace was applied, but we will know the date, day of the week, and times the brace was on and off. Then we can check whether there's a particularly effective amount of weartime, if the brace needs to be worn everyday, if daytime wear is better than nighttime, and if patients with different curves, Cobb angles, and/or degrees of skeletal maturity require different doses to prevent curve progression.
Seems there may be several TSLO type braces used - will subjects be monitored by those who are well experienced in the application of each?

Each orthotist/MD team is using the type of brace they routinely prescribe in regular practice. This should ensure that they are comfortable with measurement, construction, fit and maintenance of the brace. Most are using customized Boston braces, du Pont uses the Wilmington brace, and here at Iowa we use the Rosenberger brace. Some orthotists are including some features of Cheneau braces.

My second question concerns US funding of scoliosis research through NIH (under HSS). I searched the government web site
http://www.grants.gov/search/advance...0H!-1163459943 to see what was available for scoliosis research and found nothing. I wonder if Lori has any input regarding future funding.

I don't have any knowledge about future funding - Dr. Weinstein is the head of the American Academy of Orthopaedic Surgeons and he is constantly in Washington DC and at the NIH speaking to staff members and Congressmen about the need for increased funding for orthopaedic research. As far as I know, there has never been a call from NIH specifically for proposals concerning scoliosis, however, there are funds available for clinical trials and genetics work in general. We feel it is very important that BrAIST is well-run and produces results with a high level of credibility and integrity. BrAIST is the largest NIH funded clinical trial in pediatric orthopaedic history and our success will hopefully pave the way for future funding. I also want to acknowledge the incredible support we have received from the Shiners Hospital system. Without their co-funding, and that of the Canadian Institutes of Health Research, we would not be able to do this work.

I would also like to take this opportunity to announce that BrAIST is now a partially-randomized preference trial. That means that families who decline randomization can still participate by choosing either bracing or observation. Other than this change in the way treatments are assigned, the protocol will remain the same. As we anticipated, the majority of families want to be free to choose their own treatment and so we are now including this as an option.

Thank you for this opportunity.


Sincerely, Lori Dolan, PhD
Project Director, BrAIST"

mamamax
12-02-2009, 06:29 PM
Thanks again Lori for your responses!

How long is this study expected to take, and is there any consideration being given to the inclusion of Spinecor?

Ballet Mom
12-02-2009, 06:50 PM
I would also like to take this opportunity to announce that BrAIST is now a partially-randomized preference trial. That means that families who decline randomization can still participate by choosing either bracing or observation. Other than this change in the way treatments are assigned, the protocol will remain the same. As we anticipated, the majority of families want to be free to choose their own treatment and so we are now including this as an option.

Thank you for this opportunity.


Sincerely, Lori Dolan, PhD
Project Director, BrAIST

That is absolutely WONDERFUL news that they are going to allow patients and their families to choose their treatment! What a great decision on these researchers' part. Perhaps now they can actually get some statistically significant numbers of brace wearers to determine the traits that allow for successful bracing! Kudos to them for changing the study to accomodate these parents that wish to brace their children. :)

Thanks Mamamax for contacting Lori Dolan, good for you!

leahdragonfly
09-24-2011, 08:59 PM
Have there been any updates from BRAIST since 2009? I did see that study participants are no longer being enrolled.

Just curious...

Pooka1
09-24-2011, 09:16 PM
They are probably still collecting and(or) crunching data. I would hope every one of the study subjects is past maturity at the time of data crunching or the results should not be publishable.

If they have some preliminary results, I suppose Dolan or a coauthor will be presenting it at meetings ahead of a publication.

Pooka1
09-24-2011, 09:20 PM
http://clinicaltrials.gov/ct2/show/NCT00448448


Estimated Enrollment: 500
Study Start Date: February 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

They probably got their 500 subjects and that is why they are no longer enrolling. They are still collecting data based on this timeline.

LindaRacine
09-24-2011, 11:39 PM
There was an update last week at the SRS meeting.

To BrAIST or not to BrAIST: Self-Selection in the Bracing in Adolescent Idiopathic Scoliosis Trial
Lori A. Dolan, PhD; Stuart L. Weinstein, MD
USA

Summary: Without random selection and random assignment to treatment, the results and conclusions of clinical trials can be subject to selection bias . Selection bias may prevent the generalization of findings to patients outside the trial, and more seriously, may prevent researchers from knowing whether the treatment effect is due to the treatment itself or due to the non-equivalence of the arms at baseline . This study indicates that the BrAIST sample is representative of the target population and the bracing and observation arms are equivalent in terms of known risk factors for curve progression .

Introduction: BrAIST is a partially-randomized trial comparing the outcomes of bracing and observation in children with adolescent idiopathic scoliosis . The purpose of this study is to evaluate two sources of selection bias: self-selection into the study and self-selection of treatment arm . Specifically we asked 1) is the BrAIST sample representative of the target population and 2) are the treatment arms equivalent in terms of risk factors for curve progression?

Methods: We addressed these questions by comparing baseline demographic, radiographic and psychosocial characteristics between the patients who enrolled in BrAIST and those who declined; and between the bracing and observation arms .

Results: Since April 2007, 1131 patients met eligibility criteria; 360 (32%) agreed to participate . There were no statistically significant differences between those who declined and those who agreed to participate in terms of largest Cobb angle, curve type, gender, or age . Blacks/African-Americans were more likely to participate (50%) than other racial groups (p<0 .01) .

Of the 360 participants, 219 (61%) entered into the bracing arm . Prior to treat- ment, there were no statistically significant differences in demographics, curve characteristics (Cobb angle, curve type, rotation, flexibility, kyphosis, lordosis), skeletal maturity (Risser and digital skeletal age), general health, back pain or psychosocial characteristics including body image and quality of life . However, those who were very dissatisfied with their current back condition were more likely to choose a brace than to be observed (73 vs . 51%, p<0 .01) .

Conclusion: BrAIST is still open to enrollment and these results are preliminary . The lack of difference between those who said “yes” and those who said “no” provides evidence that the sample is representative of the target population of high-risk adolescents . Likewise, lack of difference between the bracing and observation arms at baseline indicates any differences in outcome at the end of the study can be attributed to treatment and not to inbalance related to self-selection.

Significance: This study creates confidence that the final results and conclusions from BrAIST will be free from significant selection bias .

LindaRacine
09-24-2011, 11:42 PM
There was also an E-poster:

Does 25° and Risser 0-2 Still Constitute Reasonable Bracing Criteria? Decisions using Traditional Criteria Compared to the Digital Maturity Stage System
Lori A. Dolan, PhD; Karim Z. Masrouha, MD; Stuart L. Weinstein, MD; James O. Sanders, MD

Summary: While Risser grade has the status of tradition and familiarity, the recently-studied digital skeletal maturity staging (DMS) is more specific during the long Risser 0 phase with the potential to accurately target patients at high risk for curve progression .

Introduction: Standard bracing criteria are Risser 0-2 with a curve of 25+ degrees or 20° with documented 5° progression . However, recent studies found maturity staging using hand radiographs are more closely tied to peak height velocity and curve changes over time than the Risser grade . (Sanders et al . 2007) Additionally, the combination of digital maturity stages (DMS) and Cobb angle was highly predictive of eventual curve progression to surgical indications . (Sanders et al ., 2008) We evaluated the correspondence between Risser and DMS in an independent sample, and then examined how using the DMS would change decisions to brace relative to the Risser-based method .

Methods: We used data from 327 subjects enrolled in the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) . Risser grade and DMS were compared using the Spearman correlation . Each subject was “indicated” for bracing using the traditional Risser/Cobb angle criteria and the criteria suggested by Sanders et al . of 20° at DMS 2 and 30° at DMS 3 . Agreement between indications was calculated using the kappa statistic .

Results: DMS ranged from 1-8 and Risser from 0-5 . Risser and DMS were moderately related (Spearman r=0 .55) . 98% of subjects at DMS 2 were Risser 0 or 1, but subjects at Risser 0 had DMS ranging from 2 to 6 . Conversely, DMS 3, corresponding to the timing of the PHV, occurred during Risser 0 11%, and Risser 1 87% of the time .
Agreement between the decision systems was low (kappa = 0 .20) . 241 subjects (74%) met Risser criteria compared to 135 (41%) who met the DMS criteria .

Conclusion: The correlation between Risser and DMS is moderate, but when combined with the Cobb angle to select patients at high-risk of curve progression, the two decision systems frequently result in different treatment plans . Using curve magnitude with DMS would reduce the incidence of bracing by 33% .

Pooka1
09-25-2011, 07:27 AM
Hey Linda, thanks for posting those abstracts.

I'm relieved to see the partial self-selection into treatment arms didnt' screw up their study. They took a chance there and won.

The poster is some evidence for what was previously suspected... many kids are braced needlessly based on relation to peak height velocity. Then they are going to have to determine if there is a second group within that group (of maturity plus Cobb) who still don't need to be braced.

And finally, hopefully they will get a number on brace efficacy to compare to the Katz et. al 2010 study. That will be pretty interesting. My guess is that within curve types (T versus L), they will see a slight relation between brace wear and lack of progression that is meaningless in terms of predicting what any new case will do just as Katz was. And I'm still waiting to know if the kids in Katz who wore their brace and didn't progress were all the lumbar and TL cases. The article is silent on that, perhaps for a reason.

Pooka1
09-25-2011, 07:56 PM
They had to abandon the randomized design because parents had preferences.

They do not claim it is still a randomized study. They claim it is, "a partially-randomized trial".

It is a result already to see how many parents seem to have an idea of how to proceed when researchers themselves do not.

This research is hard and this may be as good as it gets which is still far FAR better than a sharp stick in the eye.

Pooka1
09-25-2011, 08:03 PM
Moreover, even if it this study was truly randomized, it will still not answer a major open question of whether bracing only delays progression.

It has been estimated that maybe 10% of folks who are braced appear to have avoided surgery at the end of puberty. But maybe this is the exact crowd that progresses in later life. Any curve >30* at maturity could progress to surgery and it would not be unusual to do as per at least one surgeon. I'm guessing a majority if not every patient who wore a brace comes out with at least a 30* curve so this question needs answering. Katz et al. can't help with this and neither can BrAIST.

That is a truly difficult research problem.

There is always going to be correct major criticism of studies in this field because it is intrinsically difficult. That won't go away.

Kevin_Mc
10-05-2011, 02:29 PM
And I'm still waiting to know if the kids in Katz who wore their brace and didn't progress were all the lumbar and TL cases. The article is silent on that, perhaps for a reason.

This information would be nice to know. However, there were only 8 TL or L curves out of their 100 patients to complete the study. The progression/non-progression split was 50/50. It's certainly possible that all 8 were in the non-progessive side. But it's also very possible, if not likely, that at least 2 or 3 were in the progression side.

Pooka1
10-05-2011, 02:38 PM
This information would be nice to know. However, there were only 8 TL or L curves out of their 100 patients to complete the study. The progression/non-progression split was 50/50. It's certainly possible that all 8 were in the non-progessive side. But it's also very possible, if not likely, that at least 2 or 3 were in the progression side.

There were 12 kid who wore the brace the longest as I recall. Those kids had the least progression. This can be completely misinterpreted if all 8 L and TL cases were in that group. Maybe brace wear is more comfortable for curves lower down... easier to breath so they can make it tighter. Who knows.

I just want to know if all 8 L and TL cases were in that group. It would weaken the paper considerably if that was the case. If it wasn't the case you would think they would have touted it. But they were silent.

They had 100 data points. They could have plotted each one. Had they done so and not binned the data, the take home message would be that the scatter overwhelms the data and prediction of curve progression is impossible in any given case even given a prescribed number of hours of brace wear. But that isn't what they wanted to highlight obviously. That one graph being missing is significant to me at least.

leahdragonfly
10-04-2013, 08:23 AM
The Braist Study was just published in the New England Journal of Medicine. Here is an editorial published with it:

http://www.nejm.org/doi/pdf/10.1056/NEJMe1310746

The full-text article is available free online fron the New England Journal of Medicine. Here is a link that I think works. You have to tab down to the bottom and click to read full text article.

http://www.nejm.org/doi/full/10.1056/NEJMoa1307337


One point that jumped out at me was the authors state we are overtreating scoliosis significantly with bracing. They mentioned that at least 3 children had to be braced to prevent one surgery. The editorial lists something like 9 kids have to be braced to prevent one surgery. All concur that we are overtreating many kids with bracing, and that many kids do fine with being observed only.

Pooka1
10-04-2013, 08:57 AM
Gayle, thanks for posting that.

There is something funny about them stopping the study early. The results are substantially similar to Katz et al. (2010) and BrAIST wasn't stopped when that was published. That said, BrAiST is somewhat better than Katz et al. (2010) because they worked with less mature patients. Also they did a really good job matching showing the randomized and self-selected groups were similar as well as the braced and observed groups. There is no stacking of lumbar cases in the braced group like in previous studies.

But the issues remain that a child with a 49* curve at maturity was a "success". I would like to see the final curve measurements on all "successful" cases and especially how many kids were >40* and >45*. This points up that the hypothesis was only how many kids can be keep below 50* at maturity, NOT how many kids avoid surgery for life. They did ask about what the risk reduction would be for a kid to agree to wear a brace but that was certainly misleading because the researchers meant at the point of maturity and the kids were probably thinking for life.

Finally here is Dr. Hey who was in Lyon for the presentation and asked Weinstein and Dolan some questions... it seems the researchers themselves are somewhat skeptical of their claims.

http://drlloydhey.blogspot.com/2013/09/are-scoliosis-braces-adolescent.html

Also notice how Hey still says it's a decision for the kid and family and does not seem to now treat it like cancer wherein everyone gets the treatment because it's proven. That's because of the overtreatment and the fact that only a small percentage (~20% - ~30%) over and above the observed did not reach 50* at the point of maturity. In this regard it is similar to what was already surmised long about... only about 20% of kids are apparently helped by brace by the point of maturity. Not news. I have written that in this forum many, many times. That's another reason why there is something funny about them stopping the study early.

Essentially, the child must be told they have about a 75% chance of not reaching 50* at maturity if they brace and about a 50% chance of not reaching 50* if they don't do a thing. And this is NO guarantee of avoiding surgery for life, only during adolescence to the point to maturity. Hmmmm.

Joe O'Brien
10-04-2013, 10:17 AM
This is the post on the Scoliosis Research Society's website;

Dr. Stuart Weinstein recently reported the results of the NIH-funded Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) at the 48th Annual Meeting of the Scoliosis Research Society in Lyon, France. Simultaneously, the results were published online in the New England Journal of Medicine. Dr. Weinstein reported that bracing of adolescents with moderate scoliosis was effective treatment in the reduction of the number of patients who advance to the need for surgery. In addition, a dose response was found between the number of hours of brace wear and the success rate of bracing.

Several medical centers worked together to perform the highest level of medical study, a randomized clinical trial, to answer the question of whether bracing is effective in growing children and adolescents with curves between 20 – 40 degrees. 242 patients participated in the study. Patients in the bracing group were assigned to wear a brace 18 hours per day (a typical bracing prescription). A special monitor was embedded in the brace to keep track of how long it was used per day. Patients in the observation-only group received no additional treatment. The end point of the study was “treatment failure” defined as progression of the scoliosis to ≥50 degrees or “treatment success” when skeletal maturity was reached without progression to 50 degrees.

72% of brace wearers avoided surgical recommendations, but only 48% of patients in the observational group. Furthermore, the rate of success achieved by those patients who wore the brace for 13 hours or more was greater than 90%, showing that the amount of time the brace is worn is very important. The study provided strong evidence to the value of brace treatment for those adolescents at high risk of progression of surgery.

In the past, the value of a screening examination for scoliosis has been debated due to inconclusive evidence of the success of non-operative treatment for scoliosis. This is no longer true as the evidence from the BrAIST study establishes the effectiveness of bracing as early, non-operative care. This may reduce the number of patients who progress to surgery and serve as a potential cost saving for the health care system and of great benefit to patients. Policy statements from professional organizations and governmental agencies regarding scoliosis screening in school programs and primary care settings will need to be reassessed in order to identify at-risk patients who will benefit from bracing for scoliosis.

rohrer01
10-04-2013, 12:35 PM
This is great news for the parents that are bracing their kids. My personal concern for these kids is that those with curves >40o<50o may likely progress as adults or have more complications from their scoliosis as adults when they may or may not have insurance. I guess in those cases, it would be up to the parents and providers to decide whether or not to proceed with surgery before the child "ages out".

Pooka1
10-04-2013, 01:05 PM
This is great news for the parents that are bracing their kids. My personal concern for these kids is that those with curves >40o<50o may likely progress as adults or have more complications from their scoliosis as adults when they may or may not have insurance. I guess in those cases, it would be up to the parents and providers to decide whether or not to proceed with surgery before the child "ages out".

What if over half the "successes" were >40* at point of maturity? Would that still come under your definition of "great news for the parents"?

What if kids between 30* and 40* largely didn't progress in both the braced and unbraced groups and only the kids >40* had their progression delayed to early adulthood by bracing as might turn out to be the case?

I would like to see all the raw data from this study. I am guessing other papers with different conclusions could be written if we had that.

Pooka1
10-04-2013, 01:12 PM
I think once these papers are published that the researchers should be required to publish the raw data. I think there would be a lot less breathless statements of success if that happened.

Kevin_Mc
10-04-2013, 02:24 PM
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."

Well, on the plus side, the study probably wasn't that expensive or time consuming. So incomplete data really IS the way to go. You can always just do it again without too much trouble.

Pooka1
10-04-2013, 02:32 PM
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."

Well, on the plus side, the study probably wasn't that expensive or time consuming. So incomplete data really IS the way to go. You can always just do it again without too much trouble.

As I said, there is something funny going on here. I think many of the "successes" were >40* and even >45*. That is one possible explanation why they didn't publish the bottom line data. It smells of politics. Stopping the study early at the point it was stopped for the reasons stated is objectively bizarre as far as I can tell.

I fault the peer reviewers.

Kevin_Mc
10-04-2013, 03:08 PM
As I said, there is something funny going on here. I think many of the "successes" were >40* and even >45*. That is one possible explanation why they didn't publish the bottom line data. It smells of politics. Stopping the study early at the point it was stopped for the reasons stated is objectively bizarre as far as I can tell.

I fault the peer reviewers.

This was stopped in January of this year?

It's kind of en vogue to stop a study once you achieve a desired p-value or CI. Big huge studies will try to do it. It gives the statisticians something to do, i.e. regularly check the data and stop when you hit your target. Cost savings and whatnot.

I side with you 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.

Pooka1
10-04-2013, 03:17 PM
This was stopped in January of this year?

I am not sure when it was stopped.


It's kind of en vogue to stop a study once you achieve a desired p-value or CI. Big huge studies will try to do it. It gives the statisticians something to do, i.e. regularly check the data and stop when you hit your target. Cost savings and whatnot.

Well I can understand doing that when you have everyone in the treatment arm living and everyone in the placebo arm dying. But these results are FAR from that.


I side with you 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.

There is something funny here. The authors are going to be taken to task on this. I think there is some hint they are trying to be cautious in their comments to Dr. Hey. I hope someone files a FOIA to get the deltas. If most of the "successes" are >40* it will blow this study out of the water.

Pooka1
10-04-2013, 09:21 PM
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. I hope subsequent publications show at least the following:

1. Average and median of the final curve measurements in each of the treatment groups. Specifically how many of the "successes" ended up >40* and how many ended up >45*.

2. Number of patients in each group. For example, we learn that ~90% of people who wore the brace >~13 hour were <50* at maturity. What if only 5 kids wore the brace that long? It is a result to know how many kids complied and at what levels.

3. Clarity on acceptable levels of risk reduction for brace in terms of avoidance of surgery until point of maturity versus for life.

I am hoping a political stink has not invaded this study. Subsequent pubs will clear that up. Absent subsequent pubs, that will never be cleared up and a rational person is invited to think there is some reason the deltas were not published that does NOT comport with the published conclusions.

Pooka1
10-05-2013, 01:10 AM
I have a fourth question... were they bracing kids with curves >40* at any point?

There is a reason the bracing protocol has an upper limit of 40*. I am guessing that reason is because bracing is known not to work on curves >40*. I therefore assume they pulled kids out of brace if they were >40* despite not being skeletally mature.

This is an ethical question that I hope is answered somewhere.

rohrer01
10-05-2013, 01:28 AM
My reply was for the parents that are bracing their kids. It's a hard call no matter what.

From MY training, ALL data are to be included in a published paper. I haven't read the paper, but assumed that they included it. It does bother me that there wasn't any curve typing. Again, I assumed a GOOD paper would contain that information. It's those kids that have curves >40o that, in my opinion, are most at risk as adults. I don't consider ending up between 40o and 50o "success".

I think we can do better by our kids than bracing. Although, I'm not recanting my statement for the fact that parents that brace early on may be heading off progression in less aggressive curves. Again, that's the big question, whether bracing does ANY good or not.

My 5y/o grandson is showing signs of early scoliotic development. I'm not quite sure how we'll handle it. I'd much rather go for stapling than bracing, personally.

leahdragonfly
10-05-2013, 10:07 AM
I need to go back and read through the inclusion criteria, but as I recall, awhile into the study, they started admitting post-menarchal girls as well as curves 20-25 degrees. As we all know these two groups do not carry the same risk of progression as the pre-menarchal girl with a 25-40 degree curve. I would like to know how many kids from the first two categories were included, because to me that would artificially inflate the "success" group.

I have to agree with Pooka that this is not what I expected from this study. I still have to go read Dr Hey's comments because now I am very curious!

It makes me furious to know that I suffered emotionally so much in my brace, as many kids do, only to hear that it was almost surely unnecessary. That's a very bitter pill.

Pooka1
10-05-2013, 10:11 AM
I need to go back and read through the inclusion criteria, but as I recall, awhile into the study, they started admitting post-menarchal girls as well as curves 20-25 degrees. As we all know these two groups do not carry the same risk of progression as the pre-menarchal girl with a 25-40 degree curve. I would like to know how many kids from the first two categories were included, because to me that would artificially inflate the "success" group.

I have to agree with Pooka that this is not what I expected from this study. I still have to go read Dr Hey's comments because now I am very curious!

It makes me furious to know that I suffered emotionally so much in my brace, as many kids do, only to hear that it was almost surely unnecessary. That's a very bitter pill.

Gayle, I am so glad you post on this forum. The perspective of an adult looking back on bracing is or should be valuable to patients and parents facing a bracing decision. It would matter to me if I was back at that point with a kid.

Thanks so much.

Sharon

Pooka1
10-05-2013, 10:14 AM
I need to go back and read through the inclusion criteria, but as I recall, awhile into the study, they started admitting post-menarchal girls as well as curves 20-25 degrees. As we all know these two groups do not carry the same risk of progression as the pre-menarchal girl with a 25-40 degree curve. I would like to know how many kids from the first two categories were included, because to me that would artificially inflate the "success" group.


Excellent point. And we are going to have to make DAMN SURE they weren't stacked in the braced group. Damn sure. Imagine the fall out if these two groups were overrepresented in the braced group? Would there be any credibility left whatsoever?

LindaRacine
10-05-2013, 10:38 AM
While I understand all of your observations, and in general agree, I think we have to ask ourselves if the authors had any motivation to "cheat" the data. I didn't read the full article yet, so didn't see the disclosures, but I doubt any of the authors stand to make any substantial money from the manufacture or sale of braces. Is it just the glory? For many years, Weinstein's chart of progression risk was considered the gold standard. That's no longer the case, so maybe he feels the need to be back in the limelight.

Pooka1
10-05-2013, 10:46 AM
While I understand all of your observations, and in general agree, I think we have to ask ourselves if the authors had any motivation to "cheat" the data. I didn't read the full article yet, so didn't see the disclosures, but I doubt any of the authors stand to make any substantial money from the manufacture or sale of braces. Is it just the glory? For many years, Weinstein's chart of progression risk was considered the gold standard. That's no longer the case, so maybe he feels the need to be back in the limelight.

If there is politics, I would not lay blame at the feet of the researchers necessarily. I think the author comments as related by Hey can be viewed as somewhat cautious w.r.t. the paper's conclusions. I would need more information starting with the ACTUAL STUDY DATA. That would be novel in this case.

Kevin_Mc
10-05-2013, 12:35 PM
Check the link posted earlier... The paper is free to view. And it's not that long.

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.

The study was stopped in January 2013.

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.

leahdragonfly
10-05-2013, 05:06 PM
While I understand all of your observations, and in general agree, I think we have to ask ourselves if the authors had any motivation to "cheat" the data. I didn't read the full article yet, so didn't see the disclosures, but I doubt any of the authors stand to make any substantial money from the manufacture or sale of braces. Is it just the glory? For many years, Weinstein's chart of progression risk was considered the gold standard. That's no longer the case, so maybe he feels the need to be back in the limelight.

Linda,

I doubt any of us who are currently discussing the study results think or suggest that the authors have a potential financial gain from promoting bracing. Clearly that is not the case. My theory is one of possible cognitive dissonance on the part of researchers, and/or fear of massively going against the tide of the medical profession. For many generations now bracing has been the standard of care. It was something orthos could offer to parents and kids instead of telling them there is no effective treatment other than watch and wait until possible surgery. Out "fix-it" attitude towards medical care causes people to expect doctors to be able to fix their child's problem. I think most people generally have heard of bracing for scoliosis, so to now be told that it is actually not very effective (even though we have been subjecting kids to it for years) is unacceptable. Physicians and researchers are human, too, and can not help but have some preconceived ideas about scoliosis and its treatment. Hence the cognitive dissonance...i.e...."Scoliosis is a disfiguring disease of children, there MUST be an effective non-surgical treatment for it by now." It gives parents and doctors something to "do" while observing the scoliosis, a sense of control over it. Not to mention it is a huge source of billable orthopedic visits.

Braist was supposed to be the be-all/end-all to the brace discussion, and now the results really aren't all that. The study was difficult to recruit for and took several years longer than planned due to this. The researchers apparently underestimated how much families want to choose their treatment...Imagine that! I think the majority of orthos out there want to be able to offer some non-surgical treatment to families, so there is a huge amount of pressure from the ortho community to maintain the status quo.

I personally am appalled that we are bracing 9 kids to prevent one surgery. This is an unimaginable burden on the child and family, not to mention economically. I truly hope that the take-home message from Braist is that we are bracing way too many kids unnecessarily. Hopefully the researchers are combing over their data to hone in on exactly which set of children actually benefit from bracing. That would be an admirable end result of the study.

LindaRacine
10-05-2013, 10:59 PM
Hopefully the researchers are combing over their data to hone in on exactly which set of children actually benefit from bracing. That would be an admirable end result of the study.

Amen!

--Linda

Pooka1
10-06-2013, 07:05 PM
Check the link posted earlier... The paper is free to view. And it's not that long.

Yes I read it.


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.

Yes I am referring to that lack of end point data also. They may be saving it for another pub. Also, I made the point upthread about wanting to see the median which never seems to be shown in these papers. I think there are some papers out there that would have different conclusions if they used the median rather than the average. In a highly heterogeneous condition like AIS, I would imagine the median should be shown alone or along with the average. I think if these paper showed both, the issue of different conclusions might become obvious if only because of the small number of cases in each data bin.

I agree with your other points.

sjmcphee
10-06-2013, 09:32 PM
Hey everyone,
Bracing isn't really my specific area of interest just yet, though in time it may be.
The best application for scoliosis biomechanics (my interest) is in bracing.. and hardware too I suppose..
In time, I will focus on bracing.

I see a future where EOS 2D/3D Imaging System is coupled with my knowledge of curve pattern biomechanics and 3D SLS printing.
So that a patient would get an EOS 3D X-Ray which would send that data to a processing and manufacturing facility.
A computer with patented software from my knowledge of scoliosis biomechanics would process that data and then it would be sent to a 3D SLS printer for manufacturing.
What you would have is a brace designed specifically to counter the progression from the curve pattern biomechanics and factors relating to growth, and designed as both a perfect fit and 100% effective for doing whatever it is meant to do, with minimum coverage. The brace would be manufactured and shipped to the patient or orthotist in under 48hrs.
Diagnosis (http://www.eos-imaging.com/) and Manufacturing (http://www.3dsystems.com/au/3d-printers/production/spro-230#.UlIYZdh-_IV) - Check out the videos on the Manufacturing site to see how it would be made.

Anyway, my futuristic innovative ideas aside, I note that you guys are upset or confused that the authors have not given enough info.
Now I don't want to state the obvious, but have you guys actually thought of emailing the authors and just asking for the extra info you want??
Why don't you just formulate a list of questions and email them and ask them??

Its easy enough to get surgeons and researchers contact email addresses..
I'm sure if you email them they will respond..
If you don't ask, you don't get..

- Scott

rohrer01
10-07-2013, 08:39 AM
Gayle, I am so glad you post on this forum. The perspective of an adult looking back on bracing is or should be valuable to patients and parents facing a bracing decision. It would matter to me if I was back at that point with a kid.

Thanks so much.

Sharon

Just an observation on this point. While Gayle would have NOT gone for the bracing had she known she would end up having surgery anyway, my DIL feels quite the opposite. I can't understand it. She feels that the brace basically ruined her adolescence and made her self-conscious, horribly uncomfortable, and unable to eat. But she still clings to the thought that she would have been worse off had she not worn the brace. I don't know if this was doctor induced jargon to make her feel better about ending up with surgery despite bracing, or whether she came up with the idea to rationalize and convince herself that the brace did some good and her curve would have been worse. It baffles me because the brace has such a HUGE negative impact on her self esteem. She still carries around the emotional scars of the bracing trauma. It's so sad. But the question remains: Would she have progressed more rapidly to a more severe and disfiguring curve? As it is, they were not able to eliminate her rib hump because there was so much rotation. She was basically spiraling around her spine. Yet, all the "professionals" could focus on was that stupid Cobb angle. It was really much worse than a typical 48o curve.

My heart breaks for these people. We really need to know IF bracing helps stave off a more rapid curve progression until the child is skeletally mature. Even IF these aggressive curves end up having surgical intervention, is the possibility there that the deformities would be so much larger that the surgery itself would be more complicated and dangerous? Is there even a way to test that?

If at the end, as I've stated before, a curve ends up between 40 and 50 degrees, that's a flat out failure. That range is large enough to cause quite a bit more damage than some might think. For instance, my heart is deformed from this range of curve. Not typical, I know. But they need to quit focusing on that stupid Cobb angle and LOOK at the person's curve, degree of rotation, amount of hyper/hypo-kyphosis etc. Then and only then will they be able to come up with really effective treatment plans. This study is a blanket study and not as useful, in my opinion, as many people may think it is. Although, the general consensus here seems to be that it's pretty useless from what I've read. I'm of the opinion that the "conclusions" of these guys may me more deleterious to kids in the sense that the orthos will read it and say to themselves, "Yep, my treatment plan for kids is just fine." with the end result being no change what-so-ever in the protocol for treating scoliosis.

flerc
10-09-2013, 11:28 AM
http://www.nytimes.com/2013/09/20/health/new-study-lends-conclusive-support-to-a-scoliosis-treatment.html?_r=2&

Pooka1
10-09-2013, 11:42 AM
A link to the actual article has been posted. Why post an article about the article??? Please think for yourself.

flerc
10-09-2013, 11:52 AM
Sorry if the actual article was posted before, I have not all the day to read all what is posted here as you. Please try to understand what thinking really means before giving that kind of nonsense advices.

Pooka1
10-09-2013, 11:53 AM
Sorry if the actual article was posted before, I have not all the day to read all what is posted here as you.

If you aren't going to follow along then why post at all? What are the chances you will post something relevant?

flerc
10-09-2013, 12:04 PM
The actual article as you said was posted before in this forum? That is the problem for you? Or do you are simply criticizing I posted that New York Times article instead the other one?

Pooka1
10-09-2013, 01:40 PM
Another BrAIST article... I think they will publish several before it's all said and done.


October 01, 2013 - Volume 38 - Issue 21
pp: i-i,1799-1903,E1291-E1360

Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Weinstein, Stuart L.; Dolan, Lori A.; Wright, James G.; More

Purchase Access
In Brief
Abstract
PDF
+ Favorites

Study Design. Descriptive.

Objective. To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

Summary of Background Data. Bracing has remained the standard of care for the nonoperative treatment of adolescent idiopathic scoliosis since the introduction of the Milwaukee brace in the late 1940s, but it has never been subjected to a rigorous evaluation of either its efficacy or its effectiveness. The BrAIST was designed to address the primary question: Do braces (specifically a thoracolumbosacral orthosis) lower the risk of curve progression to a surgical threshold (≥50°) in patients with adolescent idiopathic scoliosis relative to watchful waiting alone?

Methods. The authors describe the rationale for BrAIST, including the limitations of the current literature evaluating bracing for adolescent idiopathic scoliosis. Second, the authors describe the preliminary work, including the preparation of the National Institutes of Health clinical trials planning grant. Finally, the authors describe the trial design in detail.

Results. BrAIST was conducted in 25 sites in North America. Subjects were treated either with a thoracolumbosacral orthosis or watchful waiting and followed every 6 months until they reached skeletal maturity or the surgical threshold of 50° Cobb angle.

Conclusion. Clinical decision making will be improved by translation of the BrAIST results into evidence-based prognosis and estimates of how the prognosis, specifically the risk of progressing to surgery, may be altered by the use of bracing.

Level of Evidence: N/A

flerc
10-09-2013, 02:46 PM
Another BrAIST article... I think they will publish several before it's all said and done.

For those researchers, probably not all but very much seems to be already said:

'In conclusion, bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis. Longer hours of brace wear were associated with greater benefit.'

Pooka1
10-12-2013, 08:17 PM
Why it is important to know NOT just that these "successes" were <50* at maturity but what exactly the curves were at maturity... five will get you ten that kids are only willing to wear a brace if it avoids surgery for life, NOT if it avoids surgery until you are 15 ore 16. If it doesn't make sense then it probably isn't true.


Over the weekend, I've been in email contact with a 33 yo woman from Houston Texas who shared her story of curve progression from the 30's now into the 40's with her thoracolumbar curve now after pregnancy, where surgery has been recommended.

http://drlloydhey.blogspot.com/2013/10/can-i-get-good-correction-of-my.html

flerc
10-12-2013, 09:05 PM
Obviously, kids are not stupids. Who said that?. If NECESSARILY progression until surgery need should to happen to every kid using braces at 15, 16 or then, then parents/surgeons opting for/recomending braces would be insane. Do you believe that? If it doesn't make sense then it probably isn't true.

Pooka1
10-13-2013, 07:26 AM
These kids all probably think they are avoiding surgery for life if the brace is successful. That is clearly false.

It's isn't a matter of intelligence. It is a matter of having or not having specific knowledge.

flerc
10-13-2013, 08:03 AM
These kids all may trust that people saying them to have chances of avoiding surgery for life if the brace is successful has enough intelligence and specific knowledge in order to say that.

Pooka1
10-13-2013, 08:29 AM
That's a faith position, not a scientific one. What is the evidence they have a chance to avoid surgery for life? Virtually all these braced kids are >30* at maturity.

flerc
10-13-2013, 09:13 AM
Virtually all these braced kids are >30* at maturity.

Who said that? Is far to be according the cases I know. And not every people with >30* at maturity are sentenced to have surgery.

Pooka1
10-13-2013, 09:33 AM
Who said that? Is far to be according the cases I know. And not every people with >30* at maturity are sentenced to have surgery.

No but there is a reason that <30* is said to be protective against surgery. So the question is are these braced kids told that anything >30* is not protective against the possibility of surgery?

Kids need to see some stats on actual progression rates starting from various curve magnitudes. I note that Dr. Hey doesn't seem shocked when someone comes into his office who needs surgery when they are in the 30s* at maturity. If it was rare then he should be shocked and not have so many cases on his blog.

leahdragonfly
10-13-2013, 09:57 AM
I originally was diagnosed with a Thoracolumbar S curve, with curves of 35 and 36 degrees at age 13. I wore my brace and my x-rays some months after being done with bracing showed my curves in the low 20's at age 15. Somewhere between there and age 40 my lumbar curve returned to 30-35, and two years later the lumbar curve was 47. Curiously the thoracic curve stayed around 25 all those years.

So for me I ended up with relatively small curves at maturity but then had a huge, rapid progression after age 40. I know I am not the only one here with this type of story. Dr Hey talks about people similar to me all the time.

What gets me is the statistics strongly imply (at least 70% chance) that my curve would not have progressed without a brace. I was braced immediately based on cobb angle, I never had any documented progression. So it is impossible to say if I was one of the ones who was "saved" from surgery with the brace, or if I was one of the 3 children who are braced unnecessarily for every one child who is saved from surgery. Definitely something to think about.

flerc
10-13-2013, 10:02 AM
Who said that? Is far to be according the cases I know.

You didn't answer that.
Do you believe that everyone knowing to have >30* at maturity would prefer to have surgery anyway?

Pooka1
10-13-2013, 10:07 AM
You didn't answer that.
Do you believe that everyone knowing to have >30* at maturity would prefer to have surgery anyway?

Nobody prefers surgery. You seem to think that choosing not to brace is choosing surgery. Most cases do NOT progress to surgery so that makes no sense. Most braced kids are braced needlessly. BrAIST showed this yet again. This is not new.

I think kids should know that even if they wear their brace as prescribed, if they are >30* at maturity, there is no guarantee they can avoid reaching surgical range. The brace is NO GUARANTEE to avoid surgery and I wonder how many kids are clear on this point.

flerc
10-13-2013, 06:28 PM
Nobody prefers surgery. You seem to think that choosing not to brace is choosing surgery. Most cases do NOT progress to surgery so that makes no sense. Most braced kids are braced needlessly. BrAIST showed this yet again. This is not new.


BrAIST showed much more

'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.'

Why do you are so sure that all parents of the brace group took a wrong decision? Do you believe the cases with significative lower chances to have surgery because the use of brace are not significant?
Or do you believe the chances to avoid surgery in those cases, have not decreased in a significative way? Do you believe the same outcomes would have been obteined if instead of using braces, they would have only had a bath every day?



I think kids should know that even if they wear their brace as prescribed, if they are >30* at maturity, there is no guarantee they can avoid reaching surgical range. The brace is NO GUARANTEE to avoid surgery and I wonder how many kids are clear on this point.

Probably it should to be as you as you say, but also they should know that without the use of brace, probably they will need surgery and nobody may assure them to be free of complications/limitations and back problems for ever as surely everone wants.

Pooka1
10-13-2013, 07:12 PM
We need to know the final curve magnitudes to respond to your post. Ask yourself why they might not have been published with the original article.

If many of the "successes" ended up >40* and even >45*, would you consider those successes?

And when we do see the final curve magnitudes, I want to see the medians. There is much that isn't apparent if only publishing averages. Actually I want so see all the data if possible after the authors finish publishing all the articles they plan.

Pooka1
10-13-2013, 07:14 PM
"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."

Here's another slant...

What percentage of kids who wore the brace more than 13 hours a day were "successful"?

flerc
10-14-2013, 12:14 AM
We need to know the final curve magnitudes to respond to your post. Ask yourself why they might not have been published with the original article.

I asked myself and I don't believe what it seems you are believing



If many of the "successes" ended up >40* and even >45*, would you consider those successes?


All were <=50º. Thinking that the chances to ending >50º without the use of brace would have been greater, I see it as succesful cases.
I think they are right in remarking the fact that group using brace where more succesful.
As I don't believe what it seems you are believing, I don't believe many of succesful cases ended in 50º and many of the failure cases of the other group ended in 51º.
And also they are right in remarking that much more cases among the succesful ones wore their braces more than 13 hours a day. As I don't believe many of succesful cases ended in 50º and many of the failure cases of the observation group ended in 51º , I don't think failure cases wore their braces the same amount of hours a day.



And when we do see the final curve magnitudes, I want to see the medians. There is much that isn't apparent if only publishing averages. Actually I want so see all the data if possible after the authors finish publishing all the articles they plan.

Me too, but is not the first case I see doing that.

flerc
10-14-2013, 12:49 AM
They not said anything about reduction in brace and spine flexibility Probably were not good and seems that brace was not complemented with nothing more (as exercises) and anyway the brace group were more succesful..

Pooka1
10-14-2013, 09:06 AM
They not said anything about reduction in brace and spine flexibility Probably were not good and seems that brace was not complemented with nothing more (as exercises) and anyway the brace group were more succesful..

You keep mentioning this but what is the evidence for it? There was NO correlation between flexibility, percent correction in brace, and progression in everyone's favorite bracing study(TM), Katz et al. (2010).

p. 1351, left column, middle...

http://scanscoliosis.com/files/DOC075.pdf

Reduction in brace, flexibility, PT as relating to decreased progression are all faith positions at the moment, not science.

flerc
10-14-2013, 01:50 PM
You keep mentioning this

Of course, why do you believe braces may work in order to stop/reduce a curve? Just only because they are uncomfortable? It's an interesting factor, surely the main/only one behind K-Taping, but is dificult to believe to be the same in braces and I don't believe K-Tapping may have the same effectiveness by their own.



but what is the evidence for it?


Which is the evidence showing that reduction in brace, spine flexibility and something else has nothing to do?



There was NO correlation between flexibility, percent correction in brace, and progression in everyone's favorite bracing study(TM), Katz et al. (2010).

p. 1351, left column, middle...

http://scanscoliosis.com/files/DOC075.pdf

Sorry, what I'm reading in this page is not affirming that reduction in brace and flexibility has nothing to do (they saw the opposite in other studies), but may be not significant compared with hours per day use. Surely true when initial curves and Risser are lowest.. is not obvious for you why?
Also they are not talking about the same concept of flexibility I'm talking..it seems to be true since they meassure it in a very different way.



Reduction in brace, flexibility, PT as relating to decreased progression are all faith positions at the moment, not science.

You seems to have an extreme limited idea about what science is.

Pooka1
10-14-2013, 03:08 PM
One of the better bracing studies shows NO correlation with things you think are important to lack of progression. That suggests the previous studies which appeared to show some correlation might be flawed. Or likely flawed. This game is tough.

I should have said "no good evidence" which may equate with "no evidence" depending on how poorly done those other studies are that purport to show a correlation.

Pooka1
10-14-2013, 04:04 PM
You seems to have an extreme limited idea about what science is.

I have a standard idea. You, in contrast, tend towards magical thinking.

flerc
10-14-2013, 05:18 PM
One of the better bracing studies shows NO correlation with things you think are important to lack of progression. That suggests the previous studies which appeared to show some correlation might be flawed. Or likely flawed. This game is tough.

I should have said "no good evidence" which may equate with "no evidence" depending on how poorly done those other studies are that purport to show a correlation.

Sorry again, may you show me WHERE they shows no correlation? I want to know if it is not only/mainly in cases with lowest Risser and curve. Certainly if this would be the most serious study and the other showing the contrary would be so flawed as it would seems logic to think in a clear evidende about no correlation, some reason should to be, we should to analyze which could be. Science is not just only an intrincated and complex game to justify magic things.

sjmcphee
10-15-2013, 07:07 AM
Hey hey
On a lighter note.. Check this out.. EOS Scoliosis Image
1525

- Scott

flerc
10-15-2013, 08:55 AM
may you show me WHERE they shows no correlation?

I was asking where they concluded there is no correlation. All what I read is where they says that no correlation present in that study may be because hours in brace is a much stronger factor than reduction in brace. Obviously nobody expects that just only 4 hours in brace with 90% reduction would be more effective than 24 hours in brace without reduction.
And of course braces are not magic things, if is reasonable to be sure about their effectiveness as this study is showing, is because something.
If some serious study shows outcomes leading to the conclusion about no correlation between flexibility and reduction in brace vs effectiveness, I want to see it.

Pooka1
10-15-2013, 09:18 AM
All I said was there was no correlation (in that study). That's what they found. No correlation.

I did not make a sweeping truth clam about whether there is in fact never a correlation. I leave the sweeping truth claims to the folk scientists who can conclude things based on one patient and no real understanding of the issues.

This area of research is a tough game. That's the most relevant take home message for me. Almost anything that you can rigorously show is remarkable as it is damn near impossible to show anything rigorously.

I would bet $100 if I had the raw data to BrAIST I would likely be able to write a paper with somewhat different conclusions. Same data. This is what is not obvious to folks who don't work with data. Medians versus averages, how you bin the data, what to emphasize, propagation of errors (final angle minus initial angle - the error on that is the square root of the sum of the squares as far as I know... not the error just on one of those measurements), etc. etc.

I am coming to understand why an important criticism to Katz et al. (2010) was about the actual curve measurements. They should have standardized on time of day when they shoot the film although if it was all random the deviations should balance/cancel. That criticism applies to Weinstein et al. (2013) though this paper is better in terms of having all blind readings. Also, all measurements are either correct (maximal in terms of normal to the beam and at the end of the day) or NOT correct (less than true value - not normal to the beam, imaging in the morning, etc.). I think it is physically impossible to OVER estimate the curve measurement other than the+/- 3* (intra-) reading error. Thus nobody is ever hustled into surgery when they were not surgical as some have imagined.

jrnyc
10-15-2013, 09:49 AM
hi Sharon
i think a basic research course...like research 101...teaches that two
people can take the same info and reach different conclusions..
even the same person can take the same info and do that...

i believe in politics that is called "spin"...??

jess

Pooka1
10-15-2013, 10:41 AM
hi Sharon
i think a basic research course...like research 101...teaches that two
people can take the same info and reach different conclusions..
even the same person can take the same info and do that...

i believe in politics that is called "spin"...??

jess

Yes great point! Science is more constrained than politics but there is still some "spin" in terms of how you crunch the data and how you table/graph it.

flerc
10-15-2013, 12:14 PM
When I have read this:


One of the better bracing studies shows NO correlation with things you think are important to lack of progression. That suggests the previous studies which appeared to show some correlation might be flawed.

I suppose you had something important to said that and criticize what I said


They not said anything about reduction in brace and spine flexibility Probably were not good and seems that brace was not complemented with nothing more (as exercises) and anyway the brace group were more succesful..

In this way


You keep mentioning this but what is the evidence for it? There was NO correlation between flexibility, percent correction in brace, and progression in everyone's favorite bracing study(TM), Katz et al. (2010).

p. 1351, left column, middle...

http://scanscoliosis.com/files/DOC075.pdf

Reduction in brace, flexibility, PT as relating to decreased progression are all faith positions at the moment, not science.

But I forgot that in your limited idea about what science is, just only the testing analysis take place, so if we have not some evidence directly showing something, there is not any reason (as logical reasoning based over assumption with reasonable reliability) to believe that surely is true.

Pooka1
10-15-2013, 12:45 PM
But I forgot that in your limited idea about what science is, just only the testing analysis take place, so if we have not some evidence directly showing something, there is not any reason (as logical reasoning based over assumption with reasonable reliability) to believe that surely is true.

It may be right. But when one of the better brace studies that attempts to control for more factors does not find that result then there is less reason to think it is right. It might be that it is correct but is so overwhelmed by other factors that it would be impossible to show.

You can't just KNOW it. You have to SHOW it. That's what separates evidence from faith.

flerc
10-16-2013, 06:45 AM
It may be right.

What I think about reduction in brace or also about your limited idea about what science is? I may only show enough evidence about the last.



But when one of the better brace studies that attempts to control for more factors does not find that result then there is less reason to think it is right. It might be that it is correct but is so overwhelmed by other factors that it would be impossible to show.

This study was done to show the effectivenes of braces and if hours in brace was evaluated surely was because obviously should to have a (causal of course) correlation if braces are really effective as they are showing.
It only would have been surprising if no correlation would have been found among cases with same (and very much significative) hours in brace, but is not what they said. Are you sure it’s not what was done in the other studies? Anyway is not surprising that in some cases enough hours in brace may be enough to be efficient, but not happens the same with great reduction and few time in brace. Also Risser and degrees has to do. The distribution of fhese variables (also (real) flexibility) should not to be the same in every study. Anyway I think it's right because theory behind braces and there is not evidence showing is not right as I know.



You can't just KNOW it. You have to SHOW it. That's what separates evidence from faith.


In order to be absolutely sure of course you have to have a proof, but if you have to take a decision and you have not all the information needed to consider it a proof, you must to use your brain and think for yourself and try to arrive to the most reasonable conclusion with the insufficient resources you have. Is clear that you don't need to do that. Good for you!.

Pooka1
10-16-2013, 08:34 AM
In order to be absolutely sure of course you have to have a proof, but if you have to take a decision and you have not all the information needed to consider it a proof, you must to use your brain and think for yourself and try to arrive to the most reasonable conclusion with the insufficient resources you have. Is clear that you don't need to do that. Good for you!.

It's clear that you are NOT the one who would have to wear a tighter, more restrictive brace for little demonstrated purpose.

The clearest correlations in this game tend to be between more draconian bracing among those in no danger of ever having to wear a brace. Exceptions to this occur among people who actually wore braces as children of course... they tend NOT to be draconian.

Pooka1
10-16-2013, 09:17 AM
Here's another way to explain the lack of correlation between "success" and flexibility and in-brace correction...

There are likely other factors like hours of brace wear in addition to unquantified (and potentially unquantifiable*) amenability to bracing that might explain the lack of correlation. The ability to predict which curves progress and which don't attests to the fact that there is much left unknown even after decades of study. Known unknowns and unknown unknowns abound. It is unethical to make children more uncomfortable than they need be without damn good proof. It seems to always come back to, "some curves never progress doing nothing and some curves progress no matter what you do."

*potentially unquantifiable should not be confuses with not real. For example, the number of birds in flight over the entire world is a number but we can never know that number. If the biochemistry is complex enough, IS may be in this category. Evolution has been happening for ~3.5 billion years and humans are just one example of a later form that is still extant. Ninety-nine percent of all species over that 3.5 billions have gone extinct. Scoliosis isn't impacting our extinction rate despite being long-standing. There is nothing in this situation that "owes" us a quantifiable answer. I think people would struggle less with natural "evil" like disease if they could accept this reality.

flerc
10-16-2013, 12:27 PM
It is unethical to make children more uncomfortable than they need be without damn good proof.


If studies are showing that braces are unecessary used in a high percentage, they also shows greater chances to avoid surgery using it.
Both studies conclusions should to be taken into account for parents evaluating the convenience of using braces or not . What would be really unethical is to leave parents without this non surgical option to avoid surgery.
If what you want is a proof and not only evidence of succesful percentages, you should to expand your limited science version and think in principles, causes, effects, laws, reasonings.. in order to conform a solid theory DEMONSTRATING why braces works. Surely the only way to do a brace really different to those used thousands of years ago.



*potentially unquantifiable should not be confuses with not real. For example, the number of birds in flight over the entire world is a number but we can never know that number. If the biochemistry is complex enough, IS may be in this category. Evolution has been happening for ~3.5 billion years and humans are just one example of a later form that is still extant. Ninety-nine percent of all species over that 3.5 billions have gone extinct. Scoliosis isn't impacting our extinction rate despite being long-standing. There is nothing in this situation that "owes" us a quantifiable answer. I think people would struggle less with natural "evil" like disease if they could accept this reality.

Good for you again, who seems having not the need to think in these scoliosis issues in order to take decisions, but you should to think that ESTÄ MAL CONTAR LA PLATA DELANTE DE LOS POBRES.
Anyway if you have something important to say about reduction/time in brace, real (or not) flexibility, bone modeling/remodeling laws, antigravity effects, physical laws, geometry considerations, tissues properties.. I'm all ears

Pooka1
10-16-2013, 01:01 PM
ESTÄ MAL CONTAR LA PLATA DELANTE DE LOS POBRES.

ESTÄ MAL folk science.

flerc
10-16-2013, 03:17 PM
You may be sure that if I'm only doing 'folk science' as you say is just only because I have not enough money.. I'm interested in solve a personal problem, not in intelectual disquisitions, I have not time for that.
But do you are worry thinking that bracing is an unethical practice? Ok, if you prove that (even being so primitive as they are) there is not any logical reason to be reasonably sure that they increments the possibility to avoid surgery, I will also believe the same, at least about these current braces.
As we only may talk about known evidence and not about principles, 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?

leahdragonfly
10-16-2013, 03:44 PM
If studies are showing that braces are unecessary used in a high percentage, they also shows greater chances to avoid surgery using it.

Perhaps every child should be braced from age 10-15, just to make sure they don't get scoliosis. I mean, why not, right? Surely this would help decrease surgeries, and parents and children would be happy to comply because they would be decreasing their risk of needing surgery, however low their risk was to begin with. Isn't it worth anything to decrease the risk of surgery?

Pooka1
10-16-2013, 05:47 PM
You may be sure that if I'm only doing 'folk science' as you say is just only because I have not enough money..

It's not so much lack of money that distinguishes folk scientists... it the COMPLETE and TOTAL lack of any relevant training or understanding of the subject. It is no crime to NOT be an IS researcher when your child has IS. This point needs to be made. Google "scholars" who do a five minute google search, read (and misunderstand) a few abstracts, are not in a position to move the ball down the field. And that is not their fault. Unfortunately, the less they know the more they think they know. That train is heading the wrong way.


But if it was the case, why it was so uneven among braced/not braced cases?

First of all, it is only ~25% over and above the W&W group that were <50* at maturity. Not "so uneven". This number is not dissimilar to previous studies and so is not groundbreaking.

Second, there is a large over treatment with brace. Most kids who wore the brace did so needlessly.

Third, we don't know what the final curve measurements were and it is curious they did not publish those immediately if they looked supportive of the claim. Unless most were <30* (which few of them likely were), they have no real reason to think the bracing avoided surgery in their life. And it is questionable if any kid would wear a brace if it wasn't a guarantee to avoid surgery for life, not just until they were 15 years old.

flerc
10-16-2013, 09:46 PM
First of all, it is only ~25% over and above the W&W group that were <50* at maturity. Not "so uneven". This number is not dissimilar to previous studies and so is not groundbreaking.


And how explain your not only limited but also ignorant, as it seems to be, science version this difference, mainly when it is similar to other studies as you are saying? This is what I asked you

Pooka1
10-16-2013, 10:03 PM
And how explain your not only limited but also ignorant, as it seems to be, science version this difference, mainly when it is similar to other studies as you are saying? This is what I asked you

Do you understand the concept of having a control group? What do you think the ~50% "success" rate in the control group means?

flerc
10-16-2013, 10:15 PM
That this is ~ the chance without brace.
What do you think the ~75% "success" rate in the braced group means?

Pooka1
10-16-2013, 10:18 PM
http://chemistry.about.com/od/chemistryterminology/a/What-Is-A-Control-Group.htm

Pooka1
10-16-2013, 10:19 PM
Do you know what I mean by "~"?

flerc
10-16-2013, 10:27 PM
In your science version I don't know, in Maths aproximated.

Pooka1
10-16-2013, 10:36 PM
Are you bitter?

flerc
10-16-2013, 10:38 PM
http://chemistry.about.com/od/chemistryterminology/a/What-Is-A-Control-Group.htm

http://es.wikipedia.org/wiki/Grupo_de_control

El experimento divide a los sujetos de estudio en dos grupos. En uno de ellos ―el grupo experimental― se aplica el tratamiento o factor testeado. En el otro ―el grupo de control― no se aplica el factor testeado.1 Luego se comparan ambos resultados. If the proportion of desired results is higher in the experimental (75%) group than in the control group (50%), then the treatment (brace) is efficient. If equal, is inefficient. And if it is less, is counterproductive.

Do you know why they say that?

Pooka1
10-16-2013, 10:43 PM
What approximate percentage of the braced group was unnecessarily treated?

Is that percentage similar to past estimates of the approximate percentage of a braced group that appeared to be affected by the brace at least temporarily?

(Total = "unnecessarily braced" + "apparently affected at least temporarily" + "reached surgical range during treatment")

flerc
10-16-2013, 10:53 PM
What approximate percentage of the braced group was unnecessarily treated?

~ 50%



Is that percentage similar to past estimates of the approximate percentage of a braced group that appeared to be affected by the brace at least temporarily?

I don't know.

(Total = "unnecessarily braced" + "apparently affected at least temporarily" + "reached surgical range during treatment")[/QUOTE]

Right!

mariaf
10-17-2013, 09:41 AM
Perhaps every child should be braced from age 10-15, just to make sure they don't get scoliosis. I mean, why not, right? Surely this would help decrease surgeries, and parents and children would be happy to comply because they would be decreasing their risk of needing surgery, however low their risk was to begin with. Isn't it worth anything to decrease the risk of surgery?

Great post, Gayle. You make the point very well when you said "however low their risk was to begin with". I think that is the key phrase here, and seems to be a question that nobody can answer.

flerc
10-17-2013, 11:11 AM
What approximate percentage of the braced group was unnecessarily treated?

Is that percentage similar to past estimates of the approximate percentage of a braced group that appeared to be affected by the brace at least temporarily?

(Total = "unnecessarily braced" + "apparently affected at least temporarily" + "reached surgical range during treatment")

I have answered that, but I don’t see how it proves that researchers were wrong when they concluded about the effectiveness of braces.. it’s only a part of the demonstration? I’m interested in see it.

flerc
10-17-2013, 12:39 PM
This area of research is a tough game. That's the most relevant take home message for me. Almost anything that you can rigorously show is remarkable as it is damn near impossible to show anything rigorously.

I would bet $100 if I had the raw data to BrAIST I would likely be able to write a paper with somewhat different conclusions. Same data. This is what is not obvious to folks who don't work with data. Medians versus averages, how you bin the data, what to emphasize, propagation of errors (final angle minus initial angle - the error on that is the square root of the sum of the squares as far as I know... not the error just on one of those measurements), etc. etc.

In order to demonstrate the wrong conclusion of the researchers, you may suppose the raw data what you want, but fulfilling of course what was detailed in the study.

Pooka1
10-17-2013, 01:54 PM
Once we see the final curve measurements, this may be largely a moot point. The "successes" may not seem so successful.

leahdragonfly
10-17-2013, 08:12 PM
Flerc,

You keep flogging the point that Braist proves bracing is effective--we get that. What you don't seem to get is that many children are being braced when they do not need it AT ALL. So I just must know, how many kids is it ok to brace unnecessarily to save one surgery? Two? Five? How about 10? Or 20? At what point is it unethical to treat many kids unnecessarily to save one surgery?

What if the treatment we were discussing were chemotherapy? Or some type of surgical procedure? Would it be just as ok then to treat many kids unnecessarily just to save one from fusion or some other outcome? At some point there must be a value judgement about the treatment. The editorial that accompanied the Braist article concluded that approx 9 kids are treated unnecessarily to save one surgery. I am so curious what you consider ok in terms of unnecessary treatment percentages?

Pooka1
10-17-2013, 09:05 PM
You post is so well-stated, Gayle.


The editorial that accompanied the Braist article concluded that approx 9 kids are treated unnecessarily to save one surgery.

And that one surgery is only before maturity. Anyone north of 30* when the brace comes off has no real guarantee of avoiding surgery for life. And that is the vast majority of braced kids.

There is a disconnect between what BrAIST is calling success (<50* at maturity) and what the patients and parents themselves very likely mean by success (avoiding surgery for life). I think more honesty on this issue would see brace wear plummet.

I think there are some parents who would brace with only a 1% chance or a 0.1% chance or or a 0.001% chance or actually ANY chance even if it's one in a million of avoiding surgery. I am getting the impression that our friend flerc is in that group of trying bracing even with odds worse than winning the lottery. Of course people who think that tend not to be the ones having to wear the brace so there's that. Kids only have one childhood and it is valuable.

flerc
10-17-2013, 09:42 PM
Once we see the final curve measurements, this may be largely a moot point. The "successes" may not seem so successful.

Well.. it was fun while it lasted!
This was the begining of the discussion:



First of all, it is only ~25% over and above the W&W group that were <50* at maturity. Not "so uneven". This number is not dissimilar to previous studies and so is not groundbreaking.



And how explain your not only limited but also ignorant, as it seems to be, science version this difference, mainly when it is similar to other studies as you are saying? This is what I asked you

You seemed so sure to be able to explain that I have encouraged you, but of course you cannot.
So not pretend now to were not be talking about the non significant this difference was to your absurd science version, where real science have not place. You are simply a lay pretending to talk in the name of Science, trying to confuse people having not science background in order to do your work.
Worldwide Science Organizations should to know what are you doing here.

Pooka1
10-17-2013, 09:47 PM
I noticed you didn't address Leahdragonfly's direct question to you.

Me, I think I am just a brain in a vat dreaming all this...

mariaf
10-18-2013, 08:18 AM
I think once these papers are published that the researchers should be required to publish the raw data. I think there would be a lot less breathless statements of success if that happened.

Agreed.

And what would the down side be of publishing the raw data?

flerc
10-18-2013, 08:52 AM
I think there would be a lot less breathless statements of success if that happened.

As the non significant for you uneven distribution of the "succesful" (as you call them) cases in braced group. Suppose the raw data you want as I said you before. Maybe the fun seeing your asbsurd concepts in action not finished yet.

Pooka1
10-18-2013, 08:59 AM
As the non significant for you uneven distribution of the "succesful" (as you call them) cases in braced group. Suppose the raw data you want as I said you before. Maybe the fun seeing your asbsurd concepts in action not finished yet.

I notice you didn't respond to Leahdragonfly's direct question to you.

flerc
10-18-2013, 10:00 AM
Stop to using Leahdragonfly's post to hide your Statistics ignorance!
Worldwide Science Organizations should to know what you are saying here.

mariaf
10-18-2013, 11:03 AM
Flerc,

You keep flogging the point that Braist proves bracing is effective--we get that. What you don't seem to get is that many children are being braced when they do not need it AT ALL. So I just must know, how many kids is it ok to brace unnecessarily to save one surgery? Two? Five? How about 10? Or 20? At what point is it unethical to treat many kids unnecessarily to save one surgery?

What if the treatment we were discussing were chemotherapy? Or some type of surgical procedure? Would it be just as ok then to treat many kids unnecessarily just to save one from fusion or some other outcome? At some point there must be a value judgement about the treatment. The editorial that accompanied the Braist article concluded that approx 9 kids are treated unnecessarily to save one surgery. I am so curious what you consider ok in terms of unnecessary treatment percentages?

Flerc,

It's a valid question and one that deserves consideration. The medical field uses 'risk vs. benefit' analyses all the time to weigh treatment options. We are simply asking how many kids do you think it would be OK to brace unnecessarily to save one surgery? You are entitled to feel however you want - I'm not trying to attack you - but again it's a very valid question in terms of the current discussion. In fact, it's almost impossible to weigh the entire issue WITHOUT addressing this question.

Pooka1
10-18-2013, 11:09 AM
Flerc,

It's a valid question and one that deserves consideration. The medical field uses 'risk vs. benefit' analyses all the time to weigh treatment options. We are simply asking how many kids do you think it would be OK to brace unnecessarily to save one surgery? You are entitled to feel however you want - I'm not trying to attack you - but again it's a very valid question in terms of the current discussion. In fact, it's almost impossible to weigh the entire issue WITHOUT addressing this question.

Flerc, maybe you could just say whether the number is more or less than one million.

I am coming to realize that there are probably parents who would accept even the remotest chance that some non-surgical treatment might work if it could avoid surgery. That's fine for easy treatments. It is NOT fine for difficult ones.

flerc
10-18-2013, 02:10 PM
I still believe you are enough intelligent to understand how serious is what you said and (of course) you were unable to prove.
Worldwide Science Organizations MUST know about it.

Pooka1
10-18-2013, 02:15 PM
I still believe you are enough intelligent to understand how serious is what you said and (of course) you were unable to prove.
Worldwide Science Organizations MUST know about it.

I noticed you didn't answer either Leahdragonfly or Maria. I think there is a reason you won't answer.

flerc
10-18-2013, 03:50 PM
Even although I would agree with them, it would not clean in anyway what you said and (of course) not proved. There is already no way even deleting the entire thread or banning me.

I noticed you continue without finish your demonstrating. I know why.

Worldwide Science Organizations should to take actions!.

hdugger
10-18-2013, 04:00 PM
I'm not particularly pro-brace or particularly anti-surgery - my son likely would have tried either one, if offered and I have no idea how he would have fared with either one. I'm the sissy in the family - he's pretty tough.

The Braist study is all about odds, but making sense of those odds is purely personal.

The odds are - given what we know now, the odds are 50/50 that a "high risk" case will progress to surgery by maturity. Wear a brace for less than 6 hours a day and you leave those odds unchanged. Wear it for 6 to 12 and you cut the risk by half. Wear it for more than 12 hours and you reduce the risk to < 10%. (I don't know where the 'brace 9 for 1 numbers come from - I don't see them in the article or in the editorial. The worst odds I see are 3 for 1)

What do you do with that information? Well, it really depends on your personal circumstances. For one child, that 50% chance of progressing to surgery may seem completely awful, and they'll be willing to brace. For another, the brace is too awful, and they'll take the chance on surgery. No one other than the patient can decide. That surgery freaks me out doesn't mean someone else's kid has to brace - it's all personal. But this study at least tells you pretty clearly what the odds are, and you can work it out yourself from there.

One thing I would say - if the curve is in your lumbar spine, I'd err on the side of bracing. Once a lumbar curve hits a certain size in a teen NOTHING you do is going to keep you from a very significant chance of needing surgery as an adult. Fusing the curve as a teen isn't a fix for the lumbar spine - you're still very likely to need surgery later on to extend the fusion. I'd certainly throw that into the calculation if you're dealing with a lumbar curve. Likewise, surgery for kyphosis is pretty gnarly. If a brace will hold that curve and keep you off the operating table, then I'd try that. But, for those kids with curves just in the thoracic spine - it's a totally personal decision. Now they know the odds.

Pooka1
10-18-2013, 05:35 PM
Worldwide Science Organizations should to take actions!.

If you tell me who they are I will personally inform them of this thread. Do they ride in black helicopters?

flerc
10-18-2013, 06:50 PM
Of course you don't know that kind of Organizations as nothing having to do with science.
Laugh all what you want. Typical in a perfect fraud as you.
If I would be responsible of this forum I would not be very quit.

Pooka1
10-18-2013, 07:11 PM
I still believe you are enough intelligent to understand how serious is what you said and (of course) you were unable to prove.

What did I say and why is it so serious?

flerc
10-18-2013, 08:21 PM
It seems I should not continue believing that (first phrase)

Pooka1
10-18-2013, 08:38 PM
Pass.

.

.

leahdragonfly
10-18-2013, 08:55 PM
<snip>(I don't know where the 'brace 9 for 1 numbers come from - I don't see them in the article or in the editorial. The worst odds I see are 3 for 1)<snip>

Hi hdugger,

The 9 for 1 figure I quoted was from the full-test of the editorial when it was first published. Unfortunately it has now been changed to a 100-word free preview and you can not view the full-text editorial unless you want to pay $15.

A curious comment in the original Braist article that most people seem to miss is that 42% of the children in the brace group who never wore their brace were successful. These non-compliant kids were nontheless counted as bracing successes, since they counted all children in the brace group based on intent to treat, rather than focusing on those who actually wore the brace. So those 42% of the braced kids whose brace was under the bed or in the back of the closet were counted as bracing successes! How is that possible?

hdugger
10-18-2013, 09:17 PM
The 9 for 1 figure I quoted was from the full-test of the editorial when it was first published. Unfortunately it has now been changed to a 100-word free preview and you can not view the full-text editorial unless you want to pay $15.

Ah thanks. that explains it. I thought I was going blind. Can you recall what they based that number on? Is it that most kids who are braced are less high risk than this group? I just couldn't quite put it in context, since this study was coming up with a brace 3 to save one 1 ratio (or brace 2 to save 1 for more than 12 hours bracing a day)


A curious comment in the original Braist article that most people seem to miss is that 42% of the children in the brace group who never wore their brace were successful. These non-compliant kids were nontheless counted as bracing successes, since they counted all children in the brace group based on intent to treat, rather than focusing on those who actually wore the brace. So those 42% of the braced kids whose brace was under the bed or in the back of the closet were counted as bracing successes! How is that possible?

Yeah, I saw that too. But I think that would have the opposite effect - it would dilute the bracing group with people who weren't actually using the treatment making it seem *less* effective than it actually was in comparison to the control group. I think the overall effectiveness is slightly higher if you just focus on the kids who are actually wearing their brace, so tossing those kids out would have raised the success percentage.

So, I just ignored the overall numbers they reported, since it included all those kids who basically weren't wearing their brace, and focused only on the kids who were wearing it for 6 or more hours a day.

hdugger
10-18-2013, 09:43 PM
Googling back, I'm finding snippets from the editorial, but not any definite ratios. What I see is this:

"Thus, "the bracing indications described are probably too broad, resulting in what may be unnecessary treatment for many patients," Dr. Carragee and Dr. Lehman said. Although there do not appear to be physiological side effects to bracing in adolescent idiopathic scoliosis, "it carries financial, emotional, and social burdens that need to be considered."

"The challenge in the field going forward is to identify children who are most likely to benefit from bracing and those who are unlikely to benefit," they concluded."

which I think is absolutely true and the other main conclusion of the study. You'd like to see (well, not *like* to see) 100% progression in those offered but refused a brace an 0% progression in those braced. I'm hoping that, now that they're past wondering whether bracing works at all they can focus on who actually benefits and who doesn't. They've wasted a lot of years dithering around with this.

The thing that really surprised me about this study is just how effective braces were in the kids that wore them for a long time. I'd seen something from Dolan earlier talking about a review of the braces they did early in the study and how ill-fitting, etc some of them were. Can it really be true that you can wear even an ill-fitting brace for 12 hours a day and have it keep you from progressing to surgery? That just doesn't make any sense at all. Maybe as part of the study they made sure that the braces actually fit right? Or, maybe, knowing that they were being watched over, everyone really made sure that the braces were fitted right? I don't know, but 90-93% is *really* effective - much more than I expected.

And, how does this tie back to the whole Scoliscore thing? If bracing just does not work at all for a defined group of genetic patients, why is there a dose-response? Presumably, those kids are scattered throughout the different hours-of-wear groups and they'd fail bracing at a steady rate no matter how many hours a day they wore the brace. Or, maybe, they have to wear for 12 hours a day for it to work? Don't know. But this study is throwing a lot of what I thought I understood into question.

Pooka1
10-18-2013, 09:59 PM
Hi hdugger,

The 9 for 1 figure I quoted was from the full-test of the editorial when it was first published. Unfortunately it has now been changed to a 100-word free preview and you can not view the full-text editorial unless you want to pay $15.

This is the same over-treatment factor that Newton and his buddy calculated in their study.


A curious comment in the original Braist article that most people seem to miss is that 42% of the children in the brace group who never wore their brace were successful. These non-compliant kids were nontheless counted as bracing successes, since they counted all children in the brace group based on intent to treat, rather than focusing on those who actually wore the brace. So those 42% of the braced kids whose brace was under the bed or in the back of the closet were counted as bracing successes! How is that possible?

I hope they follow the "successes" out over time. I have surmised that braces may only delay surgery and this cohort would be good test of that. They should also follow the W&W group for later surgery. Anyone in either group who is north of 30* has no guarantee of avoiding progression, possibly to surgical range. In that sense, I wonder if there is a single true "success" in the braced group. I'd like to see an exit interview on the percentage of kids who think the bracing has let them dodge surgery for life. I bet it's most of them.

Pooka1
10-18-2013, 10:15 PM
I don't know, but 90-93% is *really* effective - much more than I expected.

Would it still be really effective if these kids in this "90-93%" had curves north of 40* and even north of 45* after bracing?

And just how many kids wore the brace that long and how many happened to be lumbar cases? It could be a handful. I'll see if I can reconstruct the numbers from the table data.

hdugger
10-18-2013, 10:15 PM
Googling back, I'm finding snippets from the editorial, but not any definite ratios. .

Ah, I see the review paper that it's based on. They say:

"The NNT (number needed to treat) for routine scoliosis bracing is about 9 patients for each surgery prevented. The NNT for patients highly compliant with bracing is about 4. "

But they then go on to say:

"We caution that these NNTs are derived from nonrandomized cohorts [they did a survey review of studies to date], and the true values from quality randomized controlled studies may be substantially different. "

The BRAist is that randomized controlled study. The figures from the Braist study - 3 NNT for 1 (for bracing > 6 hours) or 2 NNT for 1 (for bracing > 12 hours) is a more reliable figure than the 9 to 1.

hdugger
10-18-2013, 10:33 PM
Would it still be really effective if these kids had curves north of 40* and even north of 45* after bracing?

And just how many kids wore the brace that long and how many happened to be lumbar cases? It could be a handful. I'll see if I can reconstruct the numbers from the table data.

We could lay out any number of scenarios based on data which we simply do not have access to yet. If every braced child ended up at 49 degrees bracing would seem much less effective. If every unbraced child ended up at 49 degrees while the braced kids all stayed at 30, bracing would seem much more effective. And an infinity of points in-between. There's no point in evaluating that data until it's available.

They set out to study one thing, and that was "Does bracing keep kids from progressing to surgery." And they answered that question. The answer is a definitive yes. Right now, that is the only thing we know, and we have to guide ourselves with that one piece of information until they publish the rest of the data (which they're planning on doing). It's maddening, but that's just how it works.

So, if you want to increase your odds of keeping your kid off of the operating table, you'll brace, and you'll do it for more than 6 hours a day. If you'd rather not brace, you can gamble that your kid is the 1 out of 2 kids who won't progress to surgery. And if you're aiming for any other end point, you'll just keep waiting until the data is available. Welcome to the snail's pace of science.

Pooka1
10-18-2013, 10:40 PM
I think they will eventually publish the final curve measurements but it will be averages (not medians) and it will be binned in a certain way. We won't see the individual trajectories which would almost certainly show the same thing that Katz et al. (2010) showed, namely that you can't predict the outcome for any particular child no matter what they do or don't do. Kids agreeing to bracing probably don't get that.

And if the final curve measurements were stunningly in support of their conclusions, these measurements would have been in the first published paper in my opinion. Like Dr. McIntire says, we are asked to just trust them and it isn't clear why they published the beginning curves. Why bother? Just give the final percentage for "success".

hdugger
10-18-2013, 10:46 PM
I'm pretty sure that risk is measured by comparing the reduction in risk to the risk (and not adding to the non-risk).

So, if not bracing has 50% progressing to surgery and bracing has 75% not progressing to surgery, than bracing has reduced the risk by half (from 50% to 25%). I think that's the correct way to state it, and not that it's increased the chance of not progressing by a third.

It would make more sense if you did it with something where the numbers were less similar. So, if your lifetime chance of getting breast cancer is 10% (and, therefore, your chance of *not* getting it is 90%). Then something that reduces your lifetime risk to 5% has cut your risk in half (from 10 to 5). It hasn't just added 5% to your chance of not getting cancer. I mean, it has, but that's not how it's normally stated.

hdugger
10-18-2013, 10:58 PM
I think they will eventually . . . but it will be . . . and it will be . . . We won't see . . . which would almost certainly show . . .

And if . . ., these . . . would have been . . . in my opinion.

Hold on, Mildred, we're taking a sharp turn into conjecture alley!

I suppose any outcome is possible. I'm going to hold any further conclusions until I get some information to support them.

Pooka1
10-19-2013, 09:07 AM
I'm pretty sure that risk is measured by comparing the reduction in risk to the risk (and not adding to the non-risk).

So, if not bracing has 50% progressing to surgery and bracing has 75% not progressing to surgery, than bracing has reduced the risk by half (from 50% to 25%). I think that's the correct way to state it, and not that it's increased the chance of not progressing by a third.

I assume you are correct about how these types talk about risk (their field, they decide) but both statements are mathematically correct. The second is not "wrong" other than maybe in not using the terms that these guys use. In contrast, we have seen terminology where it is actually wrong to not use the correct terminology in the correct way ("environmental" factors in scoliosis). This isn't like that because it's math.


It would make more sense if you did it with something where the numbers were less similar. So, if your lifetime chance of getting breast cancer is 10% (and, therefore, your chance of *not* getting it is 90%). Then something that reduces your lifetime risk to 5% has cut your risk in half (from 10 to 5). It hasn't just added 5% to your chance of not getting cancer. I mean, it has, but that's not how it's normally stated.

I think you are right about how these things are commonly stated but the math is the math.

Here's how I look at it...

1. there's only about 25% of the braced group where we can say bracing affected the outcome of the study. That's because we know from the control group that half the braced group would not have hit 50* at maturity anyway no matter what they did or didn't do with the brace. And we know about 25% of the braced hit 50* before maturity but based on the dose-response curve, those kids were likely non-compliant and should not be considered "braced" in my opinion. Including them makes bracing look worse than it probably is as someone mentioned above. Also, including connective tissue cases also makes bracing look worse than it is apparently. Who knows what else is a "buzzkill" that should be excluded.

2. this 25% is probably in the sub-group who wore the brace the longest (dose-response curve). I would like to see every point in this smallish(?) group and see if the final measurements are that different from the unbraced group or the 50% of the braced group who were effectively unbraced (didn't wear the brace much if at all).

3. I hope they include the numbers of patients in each bin of final curve measurements. I'd like to know how many kids managed to wear the brace for each time bin. It is a result if only a handful managed it. That's why these guys publish intent to treat stats as far as I know.

I'm going to crunch some numbers on this.

Pooka1
10-19-2013, 09:42 AM
Hold on, Mildred, we're taking a sharp turn into conjecture alley!

I suppose any outcome is possible. I'm going to hold any further conclusions until I get some information to support them.

It is nerve-wracking to talk about another field of science that is not my own. I am hedging my words constantly because of this. I KNOW that I don't know.

In contrast, we have some "google scholars" with no sense of knowing that they don't know. These people google a topic for 5 minutes and claim to have found the answer to long-standing scientific questions. These are the people making the dramatic, definitive truth claims.

Because you have relevant training, I don't see you making wild truth claims like these people. The more relevant training someone has, the more they hedge on claims in a field that isn't theirs. That's my observation.

hdugger
10-19-2013, 10:02 AM
I assume you are correct about how these types talk about risk (their field, they decide)

It's not a technical term - when people talk casually about risk, like when they report it in the news, it's always reported this way. They always say something like "smoking doubles your chance of lung cancer" and not "smoking decreases your chance of not getting lung cancer by 2%". So, it's the way that risk is commonly (not just technically) understood.



I'm going to crunch some numbers on this.


I'm not sure it's necessary. This is at least the third report I've read that talks about keeping kids from surgery by following a certain protocol in bracing. Shaugnassey (phonetic spelling :)) at Mayo clinic I thought had the strongest argument. He used to see a bunch of kids progress to surgery even while braced, and then they changed the bracing protocol to a) make sure there was 50% correction in brace and b) make sure the kids wore it long enough (can't remember the time frame now) and suddenly no one was progressing to surgery. The people at Scottish Rites also saw a big decrease in the kids who followed the protocol.

Not that you can't crunch the numbers, of course, but I really think there's enough data in to make an informed decision. The open question has always been "are bracing experiments just so flawed that they make bracing appear to be effective when they're not." This study answers that question. Bracing really is effective in keeping kids from surgery.

With that nailed down, you can finally leave this question behind and move on to the other ones that have been woefully neglected while they dithered around with that one. What's the best protocol? What's the *minimum* number of hours you can have a kid wear a brace and still have it be 90% effective? Which kids benefit most from bracing? etc.

Once you get the data back on this study, you might be able to parse it out even more. How much did different groups of kids advance *in* brace? Were there differences in protocol/type of curve etc that might help you find a method that not only kept kids off the operating table, but really held their curve at exactly where it was when you put the brace on.

And so on and so on.

But, even without that information, for parents, this has been a really helpful study. Now they know (roughly) how likely their kid is to advance with and without bracing and they can use that information to make a decision. To me, that's huge.

flerc
10-19-2013, 10:12 AM
But, even without that information, for parents, this has been a really helpful study. Now they know (roughly) how likely their kid is to advance with and without bracing and they can use that information to make a decision. To me, that's huge.

Hdugger, you believe that because you have a science background, you know about statistical and Maths, but we all must to wait that Pooka1 finish the demosntration she began here:

Quote Originally Posted by flerc View Post
And how explain your not only limited but also ignorant, as it seems to be, science version this difference, mainly when it is similar to other studies as you are saying? This is what I asked you


Do you understand the concept of having a control group? What do you think the ~50% "success" rate in the control group means?

Maybe Maths is not what we believe it is.

Pooka1
10-19-2013, 10:29 AM
But, even without that information, for parents, this has been a really helpful study. Now they know (roughly) how likely their kid is to advance with and without bracing and they can use that information to make a decision. To me, that's huge.

This particular study is about reaching 50* at maturity, not avoiding surgery for life. That is why parents who take the percentages at face value and don't have the final curve measurements would be potentially fooling themselves.

Do you count the kids who are >40* and >45* at maturity as likely being "successful" in terms of avoiding surgery for life? Isn't that what patients and parents care about as opposed to 50* at maturity?

If all the successes were 49* would that be "successful"? I don't think they are but the published percentages would be entirely consistent and correct with this outcome.

hdugger
10-19-2013, 10:37 AM
In contrast, we have some "google scholars" with no sense of knowing that they don't know.

Is this a reference to Dingo? I've said it a few times before, but it's probably worth saying again. Dingo made the single biggest difference in my son's life of anyone we encountered on our scoliosis journey. His postings on the efficacy of exercise started us on our course of finding good PT/massage/etc, and that *completely* changed how my son looked and how he felt about himself. That's a huge gift for a kid with a stiff obvious curve and no great treatment options.

I appreciate Dingo's effort to help others, and I really marvel at the effort he's put into making his kid's life better. IMO, that makes him a stellar support forum participant. The rest of it - how he interprets studies, what he think about genetics vs. environment - is really no nevermind to me.

Pooka1
10-19-2013, 10:56 AM
The rest of it - how he interprets studies, what he think about genetics vs. environment - is really no nevermind to me.

Well I guess I am coming from a point of view where people study for years and dedicate their lives to helping sick kids and are pained to constantly identify what they don't know, not to overstep the data, having an appreciation for the limitations of their studies, etc. etc. In contrast, we are treated on a routine and on-going basis to being told these researchers are wasting their time, going down blind alleys, being stupid, etc. etc. because a lay person googed something in no time flat and didn't understand a damn thing they read.

The situation is so uncanny that it almost can't be parodied... whatever you might make up, the actual claims from the google scholars are even more bizarre.

hdugger
10-19-2013, 11:05 AM
This particular study is about reaching 50* at maturity, not avoiding surgery for life.

There has never been a scoliosis study about avoiding surgery for life, to the best of my knowledge. Not for bracing, not for surgery, not for anything. And, moreover, there will never be a randomized study that looks at this question, because you cannot assign children to non-bracing or non-surgery. So, that particular question will never be answered well. Parents will just have to deal with that.

Given that, this is the best information available for making a decision, and I don't see any better information coming down the pike.



Do you count the kids who are >40* and >45* at maturity as likely being "successful" in terms of avoiding surgery for life? Isn't that what patients and parents care about as opposed to 50* at maturity?

Now we're at the right question, IMO. No, the important thing has been and always will be avoiding surgery for life. But that would mean a total shift in thinking for pediatric orthopedic surgeons, because it means that the desired endpoint is not <50 degrees at maturity but less than <30 or even 20 degrees. What does that mean in terms of treatment? It means we dump the whole watch-and-wait thing while we watch curves creep up and up and really focus our research on keeping small curves as small as possible with as little cost (both emotional and financial) as possible. It means we actually start putting money into things like torso rotation studies etc. and seeing if there isn't an easy and cheap way to keep kids as straight as possible.

But none of that has anything to do with this study. This study is just following the status quo set by pediatric orthopedic surgeons. The fault in endpoint is not in the study but in how scoliosis in children is conceptualized, treated, and followed. If you want to change that, you have to start with the pediatric orthopedic surgeons.


If . . . were . . . would that . . .

We're heading back into conjecture alley. Let's put off analyzing that data until we actually have that data.

Pooka1
10-19-2013, 11:14 AM
There has never been a scoliosis study about avoiding surgery for life, to the best of my knowledge. Not for bracing, not for surgery, not for anything. And, moreover, there will never be a randomized study that looks at this question, because you cannot assign children to non-bracing or non-surgery. So, that particular question will never be answered well. Parents will just have to deal with that.

Given that, this is the best information available for making a decision, and I don't see any better information coming down the pike.

Wouldn't publishing the final curve measurements constitute "better information" for patients and parents than just the "success" percentages?


Now we're at the right question, IMO. No, the important thing has been and always will be avoiding surgery for life. But that would mean a total shift in thinking for pediatric orthopedic surgeons, because it means that the desired endpoint is not <50 degrees at maturity but less than <30 or even 20 degrees. What does that mean in terms of treatment? It means we dump the whole watch-and-wait thing while we watch curves creep up and up and really focus our research on keeping small curves as small as possible with as little cost (both emotional and financial) as possible. It means we actually start putting money into things like torso rotation studies etc. and seeing if there isn't an easy and cheap way to keep kids as straight as possible.

I agree with this.


But none of that has anything to do with this study. This study is just following the status quo set by pediatric orthopedic surgeons. The fault in endpoint is not in the study but in how scoliosis in children is conceptualized, treated, and followed. If you want to change that, you have to start with the pediatric orthopedic surgeons.


I would like to see a question o those questionnaires they did asking how many kids thought being <50* meant avoiding surgery for life and if that changed their approach to their treatment either way.


We're heading back into conjecture alley. Let's put off analyzing that data until we actually have that data.

The authors invited conjecture by not publishing obviously important data that has obvious bearing on the larger implications of their study. I am with Dr. McIntire on marveling that this is in a top shelf journal in the form it is in.

hdugger
10-19-2013, 11:16 AM
The situation is so uncanny that it almost can't be parodied.

That's just as well. I can't imagine any benefit in parodying patients or parents of patients on a support forum.

Dingo has a very young child with a very serious problem, and he's moving heaven and earth to make things right for his son. I have nothing but the highest admiration for him.

Pooka1
10-19-2013, 11:17 AM
Here's something that may or may not be important...

Within the intent to treat group, 60% of the observed group had a T or double major curve, the two curve types with the highest propensity to progress as far as I know. Yet the braced group only had 47% with these curve types.

Pooka1
10-19-2013, 11:20 AM
That's just as well. I can't imagine any benefit in parodying patients or parents of patients on a support forum.

Yes let's just let nonsense go unopposed. Damn the other readers who don't know the score and are just looking for help on the interwebs. Serves them right for not being scoliosis researchers.

Nobody starts out with wholesale criticism. It has gotten to that point over MANY YEARS in lock-step with the recalcitrance to reason and ration on display.

hdugger
10-19-2013, 11:49 AM
I would like to see a question o those questionnaires they did asking how many kids thought being <50* meant avoiding surgery for life and if that changed their approach to their treatment either way.

I'm going to note something which even I think is a little snippy, but I think it's also useful so I'll indulge.

When the Scoliscore study came out, I argued pretty hard that their endpoint of <40 degrees (I believe) by maturity was a bad one, because it sort of assumed that being 40 degrees at maturity was totally fine. You argued pretty hard *against* that position, felt that the test was useful even with that endpoint, felt that kids with low Scoliscors should be unbraced even if it meant that they might advance all the way to 40 degrees by maturity, actually felt that it was unethical *to* brace them even if it meant they might advance to 40 degrees, and so on.

Now, when we're discussing a bracing study, you're arguing that that same endpoint isn't acceptable and the only valuable data is how close these kids got to the endpoint.

I don't really have anything to say about that - I don't know why you felt like it was OK for kids to hit 40 degrees if they were left unbraced because they had a low Scoliscore while also feeling that it isn't OK for kids to hit 40 degrees in brace. I don't know, and I don't want to conjecture. It's really your business. But it does sometimes make it very hard to follow along with these arguments, because I feel like the sands keep shifting and what used to be down is the new up.

On the bracing study, I don't really have anything more to offer. In the big world of medical studies on scoliosis, this is one of the better ones, and I think it brings something new to the party. That's about as much as I can reasonably expect from any study in this area.

Pooka1
10-19-2013, 11:59 AM
The dose-response curve is for the braced kids within the intent to treat group only which is fine. It is only for the first 6 months of wear by the way. Not sure how to interpret that. It may mean that bracing success was underestimated if brace wear fell off after 6 months.

Those are quartiles so the boundaries are not chosen by the researchers. That also explains why they didn't need to put the "n" on each bin on the graph.

So there is a total of 75 kids depicted on that graph as far as I can tell which is less than Katz et al. (2010) which was 100 kids IIRC. No matter.

That means only 18.75 kids ( ;-) ) wore the brace >17.7 hours, the duration associated with >90% success. That's a result in itself. When the numbers get that low, I like to know what curve types, curve magnitudes, etc. they had compared to those of the other quartiles. If the numbers get low enough, it starts to matter if that group happened through no fault of the researchers to be stacked with curves that were smaller and/or lumbar and less likely to progress. If the groups were large this would not be an issue.

Pooka1
10-19-2013, 12:10 PM
I'm going to note something which even I think is a little snippy, but I think it's also useful so I'll indulge.

When the Scoliscore study came out, I argued pretty hard that their endpoint of <40 degrees (I believe) by maturity was a bad one, because it sort of assumed that being 40 degrees at maturity was totally fine. You argued pretty hard *against* that position, felt that the test was useful even with that endpoint, felt that kids with low Scoliscors should be unbraced even if it meant that they might advance all the way to 40 degrees by maturity, actually felt that it was unethical *to* brace them even if it meant they might advance to 40 degrees, and so on.

Now, when we're discussing a bracing study, you're arguing that that same endpoint isn't acceptable and the only valuable data is how close these kids got to the endpoint.

I don't really have anything to say about that - I don't know why you felt like it was OK for kids to hit 40 degrees if they were left unbraced because they had a low Scoliscore while also feeling that it isn't OK for kids to hit 40 degrees in brace. I don't know, and I don't want to conjecture. It's really your business. But it does sometimes make it very hard to follow along with these arguments, because I feel like the sands keep shifting and what used to be down is the new up.

On the bracing study, I don't really have anything more to offer. In the big world of medical studies on scoliosis, this is one of the better ones, and I think it brings something new to the party. That's about as much as I can reasonably expect from any study in this area.

Here's the critical difference... the Scoliscore population all had small curves. The test is only offered to kids with a "Mild Curve (10° - 25° Cobb angle)". Because most small curves do not progress, it can be reasonably inferred that most of those case outcomes were south of 40* were likely WAY south of 40*. I still think it is unethical to brace a low Scoliscore given the data because of this.

In BrAIST, they are starting with larger curves that are in the bracing range (25* to 40* though I think a few had curves <25*). The propensity to progress is greater. It can be reasonably inferred that some/many of the braced curves DID progress at least somewhat.

So basically the populations are very different between Scoliscore and BrAIST where one is not in the bracing window (less likely to progress) and one is (more likely to progress). Apples and oranges.

Pooka1
10-19-2013, 12:19 PM
Essentially only a literal handful of the low Scoliscore kids might be expected to progress to near 40* whereas at least some (many more than some) of the braced kids would be expected to progress to near 40*.

There is a reason W&W is ethical and remains ethical though that reason seems lost on many.

Pooka1
10-19-2013, 12:27 PM
Essentially, the NNT for the Scoliscore crowd would be way higher than the NNT for the braced crowd. Maybe a few orders of magnitude. That's where the ethics comes in.

hdugger
10-19-2013, 01:23 PM
Here's the critical difference... the Scoliscore population all had small curves . . .
In BrAIST, they are starting with larger curves that are in the bracing range (25* to 40* though I think a few had curves <25*).

So basically the populations are very different between Scoliscore and BrAIST where one is not in the bracing window (less likely to progress) and one is (more likely to progress). Apples and oranges.

No one ever talked about bracing kids who were not in the bracing window. We only talked about bracing kids who were. And we differed strongly on that topic.

While the Scoliscore kids are not in the bracing window when tested, they *are* in the bracing window when you decide whether or not to brace them. That was what our discussion was about. Your argument, if I remember the discussion title correctly, was "Is it unethical to brace a child with a low Scoliscore?" And you talked about being able to take these kids *not only in the bracing window but actually in braces* out of their braces since they wouldn't advance to surgery. So, we talking about kids in exactly the same curve magnitude and in exactly the same circumstances and with exactly the same endpoint in both cases. Apples and apples.

Your position in the first case - Scoliscore - was that bracing those kids to keep them from progressing to 40 degrees was *unethical.* The only endpoint that mattered was keeping them out of surgery - reaching 40 degrees was fine. Your opinion in the second case - Braist - is now that surgical/40 degree endpoint is *not* acceptable and you have to be assured that bracing can keep them well below that.

You really are welcome to believe whatever you want to believe. If you want to hold both conflicting opinions at the same time and argue each one fiercely, that's fine. I'm not the thought police. I'm just noting that it makes my head spin so fast that my brains are likely to come flying out my ears.

So, just to try and keep my head glued on, let me confirm that I'm now talking with the Pooka for whom a 40 degree curve at maturity is completely unacceptable and not the Pooka I talked with last year for whom bracing a child to *keep* them from reaching 40 degrees at maturity was completely unacceptable.

leahdragonfly
10-19-2013, 01:37 PM
Dingo has a very young child with a very serious problem, and he's moving heaven and earth to make things right for his son. I have nothing but the highest admiration for him.

Hi hdugger,

I will digress to comment on the above point for a moment. My son and Dingo's son are very similar in age, and they both had curves measured at almost 20 degrees at worst. Dingo has done a huge amount of exercise with his son, and I have allowed my son to eat dessert almost every night and wished fervently for his scoliosis to not get worse. Dingo's son currently has a curve still at 19 degrees. My son has a curve currently at 12 degrees. How do you explain this?

While I am extremely happy for Dingo and his son that his scoliosis has not gotten worse, his situation IN NO WAY proves anything at all about torso rotation, any more than my son's apparently regressing curve proves nothing AT ALL about daily dessert eating or fervent wishing. Dingo's situation does not make him any more of a hero than my son's situation does.

Now, back to our regular programming.

hdugger
10-19-2013, 02:05 PM
Essentially only a literal handful of the low Scoliscore kids might be expected to progress to near 40* whereas at least some (many more than some) of the braced kids would be expected to progress to near 40*.

You're sort of separating and clumping people where they ought not to be separated and clumped.

You're talking about the NNT for the entire group of low Scoliscore patients, and then sort of conflating it with NNT for a treatment (bracing) which would only be offered to a fraction of these kids. Yes, you would absolutely way overtreat if you stuck every low Scoliscore kid in brace, especially since a whole bunch of them are way below the bracing window. No one has ever suggested that - why would you brace a kid with a 12 degree curve? We're *only,* have been only, talking about kids with a low Scolioscore PLUS a curve that's in the bracing window. Those are the only kids anyone would ever discuss bracing.

So, the low scoliscore kids "who have a big enough curve to brace" are not separate from "the braced kids." It's just one group. The braced kids in the Braist study are made up of a subset of low Scoliscore kids plus a subset of the medium and high kids. And there's only one question for all of them - are you treating *just* to keep them from advancing to surgery? Or are you treating for some other endpoint, like 30 degrees at maturity. If it's the latter, then you shouldn't be taking *any* of them out of their brace, no matter what their Scoliscore is. If it's the former, then the Braist study tells you everything you need to know. But it can't be emphatically both things.

hdugger
10-19-2013, 02:13 PM
Now, back to our regular programming.

I'm glad your son is doing well. I was spared having to worry about my son until he was much older.

Heroic behavior isn't measured by success. If Dingo threw himself in front of a train to save his son, and failed or missed the tracks altogether, I'd still consider him a hero. He's doing everything in his power to make the best possible life for his son. That's all I can ask of anyone. I *hope* it all turns out well, but the results won't change my opinion of him one whit.

flerc
10-19-2013, 02:29 PM
Dingo's situation does not make him any more of a hero than my son's situation does.

The difference is that Dingo opted for a solution where logics has to do, although might not be yet enough effectiveness evidence. He believes in the standard Science version, but you seems to believe in the Pooka's Science version where logics has not much place and only solutions showing a clear evidence of working may be taken in account, and of course 'clear evidence' is different and seems to be based in a new Maths, which surely may prove that eat dessert almost every night is the same effective as something as Torso Rotation or even more. Probably this new Science version is better, it works for you, good for you and yor son!

flerc
10-19-2013, 03:14 PM
you seems to believe in the Pooka's Science version

Certainly the Nsf Forum Science version. Pooka1 is just only his official voice. Surely Worldwide Science Organizations will do it much better known.

Pooka1
10-19-2013, 04:02 PM
No one ever talked about bracing kids who were not in the bracing window. We only talked about bracing kids who were. And we differed strongly on that topic.

I don't remember things the way you do. I stand on my analysis then and now.

Pooka1
10-19-2013, 04:22 PM
Your position in the first case - Scoliscore - was that bracing those kids to keep them from progressing to 40 degrees was *unethical.* The only endpoint that mattered was keeping them out of surgery - reaching 40 degrees was fine. Your opinion in the second case - Braist - is now that surgical/40 degree endpoint is *not* acceptable and you have to be assured that bracing can keep them well below that.

Again, these populations are almost certainly different in terms of propensity to progress and, by association, amount of progression. You are mixing apples and oranges by conflating them.

It would help to know the percentage of the low Scoliscore kids who are in the bracing window >25* actually progressed >30*. I would bet it is a lower lower than the percentage of kids who are in the bracing window with unknown Scoliscores to progress >30* but I don't know that.

hdugger
10-19-2013, 04:30 PM
I don't remember things the way you do. I stand on my analysis then and now.

You don't have to recall - we converse in the written word and that word is still writ.

You:

Given how Dr. Lonner immediately took that girl out of her brace once the Scoliscore came back at <41, I am guessing that surgeons might think it is unethical to brace these children.

Me:

"The scolioscore only measures the chance of progressing to surgical territory as an adolescent, is my understanding. It says nothing about the chance of progressing to surgical territory as an adult, or of living with a painful curve that only reached 40 degrees as an adolescent.

So, if all you're concerned about is whether your child is going to have to have surgery before their 18th birthday, then, by all means, rely solely on the scolioscore.

OTOH, if what you're concerned about is their lifelong risk of requiring surgery, or the risk of having a painful presurgical curve all of their life, then the scolioscore isn't going to be of any help at all."

You:

By the way hdugger, are your saying it was unethical for Lonner to take that girl out of brace with a Scoliscore of <41?

Me

I think doctors are over-concerned with the magical surgical cutoff number for adolescents, and under-concerned with the life-long course of the disease.

You:

Now what would you have surgeons do in the situation with a kid with a Scoliscore of <41 given the bracing literature?

. . .

Also, what is out there to help with "life-long course of the disease" aspects irrespective of Scoiscore? Please be specific as in something a surgeon can actually and plausibly tell a kid in real life at this moment."

and so on and so on

I'm going to drop this, because it really isn't important in the larger scheme of things what you and I think (at least, not important to anyone other than ourselves), and this side discussion is starting to distract from the more important issues.

Again, your positions don't have to make sense to me - it's not some law or something. But it makes it hard for me to seriously discuss your positions when everything is fluid other than the end point - what matters changes, what we consider changes, what makes a good study changes, what's unethical changes. The only constant is that, in the end, bracing is bad. It's like getting into a political discussion with someone who isn't really willing to consider any position other than their own. It just makes the discussion kind of lifeless. Again, it's not your job to amuse me, but it's my job to stop chugging away when I'm not learning or saying anything new.

Pooka1
10-19-2013, 04:47 PM
hdugger

"The scolioscore only measures the chance of progressing to surgical territory as an adolescent, is my understanding. It says nothing about the chance of progressing to surgical territory as an adult, or of living with a painful curve that only reached 40 degrees as an adolescent.


No this is incorrect in one point.... surgical territory is >50* and Scoliscore low scores indicate a propensity to progress to <40*.

Again I say the percentage of low Scoliscore kids who reach near 40* is not going to be similar to the percentage of kids in BrAIST who make it there and beyond. The NNT among braced low Scoliscore kids is likely much higher than the NNT for BrAIST kids, even at the same angle I am guessing to the extent a low Scoliscore is protective against progression. Now there needs to be some more work on Scoliscore in my opinion after the prevalence of low, medium and high scores did not match that in the calibration set. I find that very troubling. But that is just about prevalence.

In that exchange you cited, you are tacitly arguing that some significantly large percentage of the Low Scoliscore kids will be near 40*. That does not comport with what is known about the prevalence of moderate curves like that compared to smaller curve.

Beyond that, I have never defended 40* as being protective against progression AFTER I saw that work showing the number is closer to 30*.

flerc
10-19-2013, 06:05 PM
But even if another was the factor explaying the difference,


First of all, it is only ~25% over and above the W&W group that were <50* at maturity. Not "so uneven". This number is not dissimilar to previous studies and so is not groundbreaking.


It was not so uneven the distribution in both groups. The difference, similar to previous studies not talk really about nothing significative in bracing practice or other factor.
Clearly those researchers unknown the NSFF science version when they did this study.

mariaf
10-20-2013, 08:30 AM
I'd still consider him a hero. He's doing everything in his power to make the best possible life for his son.

Not to minimize Dingo's efforts in any way, but I would add that ALL the parents on here are basically doing everything in their power to make the best possible life for their son or daughter, just not all in the same way. They are all heroes in my book.

mariaf
10-20-2013, 08:44 AM
There has never been a scoliosis study about avoiding surgery for life, to the best of my knowledge. Not for bracing, not for surgery, not for anything. And, moreover, there will never be a randomized study that looks at this question, because you cannot assign children to non-bracing or non-surgery. So, that particular question will never be answered well. Parents will just have to deal with that.

Given that, this is the best information available for making a decision, and I don't see any better information coming down the pike.


Right, parents will have to digest the data, flawed or not depending on one's view, and apply it to their particular situation. After this study came out, there were parents who e-mailed me (these were parents of kids who had either VBS or tethering, and we keep in touch) to basically say they don't care if data is released saying bracing is 100% effective, they would NEVER brace another child because bracing was such a nightmare for their family. A lot of these braced kids (not all) were teenage girls, and having a daughter myself, I believe it was as bad as they described to me at the time, if not worse.

I'm sure, on the other end of the spectrum, there are parents who feel equally as strong that no matter how small the chance of success of bracing was determined to be, they would try it in an effort to avoid surgery, and of course, they are not wrong to feel that way. That is their personal choice.

The only thing that has always stuck out to me is that in the one group of parents (not wanting to brace regardless), there always seems to be a lot of parents who were either braced themselves or had a child who wore a brace (or both), for whatever that's worth.

flerc
10-20-2013, 08:47 AM
we have some "google scholars" with no sense of knowing that they don't know. These people google a topic for 5 minutes and claim to have found the answer to long-standing scientific questions. These are the people making the dramatic, definitive truth claims.


CARADURA!!! I have never seen another case as yours before!
Do you are talking about google searchers?
Is evident for anyone with enough science background why you didn't finish your demonstration about the non significantly uneven distribution:



First of all, it is only ~25% over and above the W&W group that were <50* at maturity. Not "so uneven". This number is not dissimilar to previous studies and so is not groundbreaking.


As you haven't such bacground, it wasn't obvious for you how much significant was it even without the increment given with the obvious analysis you began to do, believing it would decrease the odds instead of increase as of course happens:


What approximate percentage of the braced group was unnecessarily treated?

Is that percentage similar to past estimates of the approximate percentage of a braced group that appeared to be affected by the brace at least temporarily?

(Total = "unnecessarily braced" + "apparently affected at least temporarily" + "reached surgical range during treatment")

Surely someone tell you how wrong you was and you stopped it.

Of course noone REAL member here, that is , someone affected for the scoliosis problem, must to have a science background and training. But since you are the voice of this forum, talking in the name of science and worry because 'the science war' you should.

Of course you'll never recognise this, dishonesty is other property of fakers. You fulfills all of them.
This dangerous and bad intontioned forum cannot be changed from inside. I have faith in REAL Science Organizations.

Pooka1
10-20-2013, 09:17 AM
The only thing that has always stuck out to me is that in the one group of parents (not wanting to brace regardless), there always seems to be a lot of parents who were either braced themselves or had a child who wore a brace (or both), for whatever that's worth.

Good point.

And then there is my night-time braced daughter who still needed fusion. So having gone through a fusion, she told me she still would never have worn a 23/7 under any circumstances. Actually, I suspect she might have if braces allowed kids to avoid surgery for life but that will never been the case so it is a moot point.

Pooka1
10-20-2013, 09:28 AM
I have faith in REAL Science Organizations.

Is there anyone on the forum who speaks from a "REAL" Science Organization in your opinion?

And let me take among swing at what I think you are complaining about. I am not sure but this is my best guess...

You don't like me characterizing 25% of the braced group as not being a "large" percentage. Is that right? So basically half the kids were braced unnecessarily and a quarter needed surgery. So that leaves one quarter who were apparently helped by bracing at least until the point of maturity. I consider that a horrifyingly small number given the difficulty of the treatment and the likelihood that some of these kids with larger curves will need surgery at some point. YMMV.

I have noticed that whether a person thinks a number is large or small tends to scale with whether they are ever in danger of actually having to wear a brace. There are exceptions... I am one of them. There are other exceptions on the group as Maria mentioned. I try to put myself in the shoes of these kids.

If that isn't your point then I don't know what you are trying to say.

hdugger
10-20-2013, 09:42 AM
Not to minimize Dingo's efforts in any way, but I would add that ALL the parents on here are basically doing everything in their power to make the best possible life for their son or daughter, just not all in the same way. They are all heroes in my book.

I wrote that in response to a post suggesting that he might be fair game for parody. When another parent on the forum is offered up for parody, I hope someone will likewise step up to defend them.

I'll note that I've had two people now try to correct/amend my assertion that I consider Dingo heroic, but no one else suggest that it might not be acceptable to parody him.

Pooka1
10-20-2013, 09:49 AM
I'll note that I've had two people now try to correct/amend my assertion that I consider Dingo heroic, but no one else suggest that it might not be acceptable to parody him.

Well it's a ridiculously small sample size and so doesn't prove anything.

But beyond that, why do you think that is? Recall you once told me you don't even read his biochem stuff. Why not? And why wouldn't any flaws in the thinking on that not carry over to his analysis of the PT literature (35 total patients for TRS, not uniformly effective, double publishing and lucrative(?) gym contracts for the developer, etc. etc. etc.)? And is any of it helping many parents?

hdugger
10-20-2013, 10:22 AM
You don't like me characterizing 25% of the braced group as not being a "large" percentage.

I believe the issue is your non-standard statement of risk. Bracing as a whole cuts the risk in half. Bracing more than 12 hours a day cuts the risk by something like 80%. Stating it that way allows other people to assess it in the same way as risk is normally assessed. Stating it the way you have runs the risk of confusing people about what the improvement actually is.

Again, you'd never describe a study where breast cancer was cut in half (from 10 to 5%) as "just increasing the non-risk risk by a small percentage of 5%" I mean, you could, but you wouldn't if you wanted to not confuse your listeners.



I have noticed that whether a person thinks a number is large or small tends to scale with whether they are ever in danger of actually having to wear a brace. ... I try to put myself in the shoes of these kids.

There is something insidiously unpleasant in this statement, and the many statements like it that I see scattered around the forum whenever the topic of bracing comes up. It troubled me enough that I wrote to the NSF and ended up leaving the forum because of the harm I feel that it does. I'm back on very limited terms, and on these terms, I'm participating *only* if I directly engage these kinds of statements when they come up. I don't imagine I'll be able to keep that up very long.

I will note that I have *never* seen a similar statement written about parents choosing surgery for their children. I have never seen someone suggest, as you have here, that parents are callously assessing the risk/benefit of surgery because they're not at risk of going under the knife.

Parents are faced with tough choices, no matter what treatment they choose for their child. And they are making those choices as best they can, with as much love, care, and understanding towards their children as they can. Whatever they choose, their child will suffer. And whatever they choose, their child will never be set back the way they were before they had scoliosis. There is no obvious right choice and no obvious right treatment.

Parents are not lovingly choosing surgery, but callously choosing bracing. They are loving choosing both. I would hope that both choices would be respected, and that both sets of parents would feel equally welcomed and supported.

Pooka1
10-20-2013, 10:36 AM
Bracing as a whole cuts the risk in half. Bracing more than 12 hours a day cuts the risk by something like 80%.

It cuts the risk AT THE POINT OF MATURITY. Leaving off that part is highly misleading because people will assume it means avoiding surgery for life. We can't suppose that until we see the final curve measurements. Note Dr. Hey's blog about "successful" brace cases who needs fusion, sometimes as early as young adults. I think everyone would agree that the "successes" that are >40* and greater than 45* may or may not be actual successes.


Again, you'd never describe a study where breast cancer was cut in half (from 10 to 5%) as "just increasing the non-risk risk by a small percentage of 5%" I mean, you could, but you wouldn't if you wanted to not confuse your listeners.

I would if the treatment was as hard as bracing.


I will note that I have *never* seen a similar statement written about parents choosing surgery for their children. I have never seen someone suggest, as you have here, that parents are callously assessing the risk/benefit of surgery because they're not at risk of going under the knife.

You say that like these parents have a choice. They do not. Bracing is a choice. That's something you never seem to acknowledge. It is cruel to lump the surgical decision which really isn't a decision in with an actual decision like whether to brace. These parents do NOT have the luxury of making a decision that those with kids in bracing range have. That is insensitive in the extreme.

Pooka1
10-20-2013, 10:38 AM
Essentially, that 25% can and will decrease over time. How much it decreases remains to be seen. How small does it need to get before you would admit only a small number were helped by bracing?

So essentially it is NOT 25% but something less.

And the NNT factor seems to always get short shrift.

leahdragonfly
10-20-2013, 10:49 AM
Hi hdugger,

I have never criticized a parent for choosing to brace their child. I am not sure why there is some automatic assumption that someone such as myself, who wore a brace as a teen AND also have a child who wore a brace, is criticizing parents for choosing to brace their kids. The bracing discourse here is not about personal choices of parents, whatever those choices may be (i.e. surgery, bracing, exercise, ice cream eating, etc). There are no easy choices with scoliosis. Nobody is more heroic for choosing one therapy over another, nor should any parent be criticized for trying to make the best choices for their child.

What I am trying to discuss is how bracing is presented to parents and kids by doctors. I believe that is also Pooka's intention. The majority of doctors do not tell parents and kids the current evidence for or against bracing. This is one reason why BRAIST had such a hard time meeting enrollment, and finally had to offer a treatment-choice arm rather than randomization. Some people choose to become very offended by our concern that bracing is seriously over-prescribed for many kids who apparently will not benefit from it. And I have to agree with Pooka that it is generally not the parents of kids who might need a brace or surgery. It is the rather holier-than-thou types (who have no danger of a brace entering their home) who suggest bracing is no big deal and why all the objection to bracing many kids who do not need it.

Anyone who has worn a brace themselves or had a child who had to wear a brace knows it is a very difficult treatment, period. You will not find one child or teen out there who loves their brace and is happy they got one. Some teens even end up with panic attacks or major depression because of their brace. Others appear to accept it but suffer quietly inside every day. This is why I advocate for strenuous and accurate research to pinpoint which exact kids will benefit from bracing, and spare all the rest from a difficult, unnecessary treatment. My participation in this discussion is not about personal choices, it is all about giving each parent accurate info so they can make their own informed decision. Every medical treatment choice should be based on a fully informed decision.

Pooka1
10-20-2013, 10:49 AM
Here is a mathematically accurate description of the published results of BrAIST...

I would honestly tell a child that the odds of not reaching 50* are the same as for reaching >50* and that the odds of wearing the brace needlessly are twice as high as both those other outcomes. Wearing the brace for no benefit is the most likely outcome BY FAR. Then I would explain the issue of final curve measurements when they are published and would help them guesstimate how much to reduce the 25% "success" rate to reflect that.

hdugger
10-20-2013, 10:51 AM
But beyond that, why do you think that is?

Why do I think that people are comfortable with the idea of parodying another parent in a support forum? Well, that's a question I've asked myself a lot.

Recall that I majored in biological psychology and not clinical, so I don't really have the appropriate background. But, based on my experience as a forum moderator along with my cursory reading of pop psychology, I'd say it was a kind of disinhibition and acculturation towards behaviors which people would normally find shocking or unpleasant.

Or, to put it more simply, if people are dropped into a situation where parodying of a parent is treated as normal and acceptable, they begin to feel and behave as is that behavior is OK, even though they would never consider behaving that way in any other situation. It's a kind of cultural norm, specific in this case to this forum and this parent.

But, even with the cultural norm, people still need to explain to themselves why it's OK to behave in a way that they would otherwise find unacceptable. And the normal way of doing that is to understand somehow that the victim brought it on themselves.

In this case, the commonly agreed upon explanation is "parent does not read scientific literature in a certain way" = "I do not have to treat them the way I think people should normally be treated."

In the realm of "the victim brought it on themselves" that's a pretty unique explanation, but it seems to work here.

Pooka1
10-20-2013, 11:00 AM
Gayle makes great points.

There is a space between an educated decision and an emotional decision. The size of that space should scale with the evidence in hand about the efficacy and difficulty of treatment options. I don't think it does at times and I am not going to criticize parents for having strong emotions. I am just saying kids have equally strong emotions and are on nearly equal footing with parents w.r.t. understanding the evidence simply because there isn't a lot of high quality evidence.

With every "marquee" bracing publication comes the declaration that the game is over and we can home home know and that bracing is effective. Remember that Shaunnessey (spelling?) that every loved and that hdugger mentioned upthread? It STILL hasn't been published last I checked. Perspective always. Remember Katz et al. (2010)? BrAIST wasn't halted when that came out. And even Nachemson who published some "definitive" work agreed to be on the panel for BrAIST. I am trying to make the point that scientists approach these things differently than lay people.

Pooka1
10-20-2013, 11:05 AM
Why do I think that people are comfortable with the idea of parodying another parent in a support forum? Well, that's a question I've asked myself a lot.

How outrageous would a parent have to get in their ignorant claims in order for you to no longer remain silent? I assume there is some point where you would not be quiet. You remain quiet about the biochem stuff because you personally don't care. But maybe others do care.

Isn't this just a matter of different interests and differnt bullcrap tolerance levels?

I intensely dislike the constant crapping on honest researchers but that doesn't bother you. Other things bother you that don't bother me. So what? What is the point of constantly pointing that out?

hdugger
10-20-2013, 11:17 AM
I have never criticized a parent for choosing to brace their child. I am not sure why there is some automatic assumption that someone such as myself, who wore a brace as a teen AND also have a child who wore a brace, is criticizing parents for choosing to brace their kids.

Here's a sample thread:

Dr. Hey deals with the fallout of parents lying about braces to kids -
http://www.scoliosis.org/forum/showthread.php?13696-Dr-Hey-deals-with-the-fallout-of-parents-lying-about-braces-to-kids

about a braced child who progressed to surgery. This isn't a response to a holier-than-thou outsider, it is a forum member accusing a parent of lying to their child because their child progressed to surgery after wearing a brace.

And this is just one topic about bracing - there are lots and lots of others.

Now, find me a similar topic about surgery. I can't tell you how many people I've seen come in here who believed that their surgery as a teen would protect them for life, only to face more surgery as an adult. Have you ever heard it suggested that their parents *lied* to them about their surgery?

Why is it acceptable to suggest that parents are *lying* to their child because bracing failed to hold their curve? Can you imagine coming into this forum for the first time after being prescribed a brace by your doctor and running across that discussion? How would you feel? Would you feel like this was the sort of place where you'd be welcomed and supported? Or would you, naturally, assume that you'd be blamed, BLAMED!, if your effort to protect your child failed?


It is the rather holier-than-thou types (who have no danger of a brace entering their home) who suggest bracing is no big deal and why all the objection to bracing many kids who do not need it.

You're going to have to find me a post where some holier-than-thou-type suggests that bracing is no big deal. I've never seen one myself.

flerc
10-20-2013, 11:19 AM
CARADURA!!! I have never seen another case as yours before!
Do you are talking about google searchers?
Is evident for anyone with enough science background why you didn't finish your demonstration about the non significantly uneven distribution:

Quote Originally Posted by Pooka1 View Post
First of all, it is only ~25% over and above the W&W group that were <50* at maturity. Not "so uneven". This number is not dissimilar to previous studies and so is not groundbreaking.
As you haven't such bacground, it wasn't obvious for you how much significant was it even without the increment given with the obvious analysis you began to do, believing it would decrease the odds instead of increase as of course happens:

Quote Originally Posted by Pooka1 View Post
What approximate percentage of the braced group was unnecessarily treated?

Is that percentage similar to past estimates of the approximate percentage of a braced group that appeared to be affected by the brace at least temporarily?

(Total = "unnecessarily braced" + "apparently affected at least temporarily" + "reached surgical range during treatment")
Surely someone tell you how wrong you was and you stopped it.

Of course noone REAL member here, that is , someone affected for the scoliosis problem, must to have a science background and training. But since you are the voice of this forum, talking in the name of science and worry because 'the science war' you should.

Of course you'll never recognise this, dishonesty is other property of fakers. You fulfills all of them.
This dangerous and bad intontioned forum cannot be changed from inside. I have faith in REAL Science Organizations.




Is there anyone on the forum who speaks from a "REAL" Science Organization in your opinion?

Specially new members may believe this is a Scientist forum. Is necessary explain why with all yours literally thousands of posts talking about why only people without science training may think in options different to surgery? Of course not.



And let me take among swing at what I think you are complaining about. I am not sure but this is my best guess...

You don't like me characterizing 25% of the braced group as not being a "large" percentage. Is that right? So basically half the kids were braced unnecessarily and a quarter needed surgery. So that leaves one quarter who were apparently helped by bracing at least until the point of maturity. I consider that a horrifyingly small number given the difficulty of the treatment and the likelihood that some of these kids with larger curves will need surgery at some point. YMMV.


If it like me or not,have not nothing to do. Is what it shows about your statistical background, but of course I expected some kind of explanation like this and I said why. But is enough obvious for everyone with enough Maths bacground what it shows, so continue giving other explanations like this if you want.
Just only one comment: If you may say is not my case is because we were noticed about her scoliosis when she was over 50º. Do you believe that if I was noticed when she was many degrees bellow, I was not at least considered the brace option if I would have the understanding (wright or wrong) I now have after these years analyzing the scoliosis issues?



If that isn't your point then I don't know what you are trying to say.

You don't understand what 'caradura' means? Sure you know about faker meaning..

Pooka1
10-20-2013, 11:26 AM
Now, find me a similar topic about surgery. I can't tell you how many people I've seen come in here who believed that their surgery as a teen would protect them for life, only to face more surgery as an adult. Have you ever heard it suggested that their parents *lied* to them about their surgery?

Once again, these parents do NOT have a choice. Nobody can decide not to have a surgery on the basis of possibly needing another down the road because that doesn't obviate the need for the first surgery. This is beyond obvious. And I have never seen a child say that their parent told them it was likely one-stop UNLESS the surgeon told them directly. Absent that, they are probably silent about the need for future surgery unless the surgeon mentions it. There is no way a parent can know one way or another unless the surgeon tells them or unless they understand the literature.

On the other hand, we can well imagine parents cajoling their kids into wearing a brace by scaring them with the possibly of surgery. And you will never find a surgeon scaring kids into wearing a brace by mentioning surgery. Or at least I hope not given the evidence.

That's the difference.

hdugger
10-20-2013, 11:39 AM
How outrageous would a parent have to get in their ignorant claims in order for you to no longer remain silent?

What would the parent of a sick young child have to do for me to find it acceptable to mock him in the support forum where he participates to discuss his child's problem? Wow, that's tough. Maybe if he started insulting my kid? That would probably set me off. I can't imagine that much else would.



I intensely dislike the constant crapping on honest researchers but that doesn't bother you.


Pooka on Dr. McIntyre

"Physical therapists are not trained in research. And as we have seen, even folks trained in research produce false results/conclusions a majority of the time. . . That paper is embarrassing. I am considering writing to the editors about it making the same points I made here. I'll report back if I do that and if I get a response. Exercise therapy might work but you wouldn't be able to determine that from that study design."

Pooka on (I think) Mooney but it could be McIntyre again

"I have not seen the entire report but at this point, this study appears to be among the worst that I have seen published in terms of extravagantly going beyond the results and wildly speculating without much if any ground to stand on. . . I am not trying to discourage you. I am saying the conclusions they reach in that study are obviously NOT supported by the data and I am floored it was published."

******

Again, it's hard to discuss things with you because up becomes down becomes up. In this case, constant crapping on honest researchers is so terrible that one parent must be laughed out of a support forum, and yet, at the same time, so totally acceptable that you routinely engage it in yourself. It makes it hard to seriously consider your strong positions, because I honestly have no idea what they are from minute to minute. The only thing I know, for sure, is that you believe bracing is bad and that Dingo is an idiot. Everything else is up for grabs.

Pooka1
10-20-2013, 11:54 AM
I wrote that in response to a post suggesting that he might be fair game for parody.

Actually I didn't say that. I said it was impossible to parody him. So no parody is possible even if one wanted to do so.

Pooka1
10-20-2013, 11:58 AM
Pooka on Dr. McIntyre

"Physical therapists are not trained in research. And as we have seen, even folks trained in research produce false results/conclusions a majority of the time. . . That paper is embarrassing. I am considering writing to the editors about it making the same points I made here. I'll report back if I do that and if I get a response. Exercise therapy might work but you wouldn't be able to determine that from that study design."

This was before I realized how hard it was do do a controlled study in this field. It is different. In fact Dr. McIntire's paper was singled out as one of the best in this field in many respects. ALso I am guessing I didn't know he had a PhD in that field at that point. That changes everything.



Pooka on (I think) Mooney but it could be McIntyre again

"I have not seen the entire report but at this point, this study appears to be among the worst that I have seen published in terms of extravagantly going beyond the results and wildly speculating without much if any ground to stand on. . . I am not trying to discourage you. I am saying the conclusions they reach in that study are obviously NOT supported by the data and I am floored it was published."

See above. I was blind-sided by the difficulty of doing a controlled study in this field. Perhaps you were born knowing that but I wasn't. Medical research is very different from other fields of research.

Pooka1
10-20-2013, 12:06 PM
Pooka on Dr. McIntyre

Count up every statement I made, whether or not I later corrected it, and compare it to the actual CONSTANT crapping on researchers that goes on here from other quarters.

What are the relative counts?

leahdragonfly
10-20-2013, 12:21 PM
If studies are showing that braces are unecessary used in a high percentage, they also shows greater chances to avoid surgery using it. Both studies conclusions should to be taken into account for parents evaluating the convenience of using braces or not . What would be really unethical is to leave parents without this non surgical option to avoid surgery.

Hdugger,

Here is one quick example in response to your request up-stream, this from flerc who is callous in suggesting wide-spread use of bracing even though the Braist researchers state their evidence shows that many kids are being braced unnecessarily.

Again I must point out that I never accused parents of lying to their kids. I object to doctors failing to give parents and kids full disclosure about the current state of bracing research, thus denying parents and kids the opportunity for truly informed consent. I do agree that many parents, probably out of fear and being underinformed, cajole or threaten their kids with the possibility of surgery if they don't wear their braces. This ends up being a huge mistake later on if the kids still progress to needing surgery, because by then the kids are terrified of the thought of surgery, due to their parents mistaken warnings.

hdugger
10-20-2013, 12:29 PM
Count up every statement I made, whether or not I later corrected it, and compare it to the actual CONSTANT crapping on researchers that goes on here from other quarters.

Really, I haven't got that kind of time. I'm just pointing out that crapping on researchers appears to be completely acceptable in some cases and completely unacceptable in others. Dingo was slammed for his reading of research at exactly the same time as you were attacking the torso rotations researchers. So, again, it had nothing to do *at the time* with a feeling that researchers should always be respected.

And then there's this, from you, in this very topic in just the last few weeks:

"As I said, there is something funny going on here. I think many of the "successes" were >40* and even >45*. That is one possible explanation why they didn't publish the bottom line data. It smells of politics. Stopping the study early at the point it was stopped for the reasons stated is objectively bizarre as far as I can tell.

I fault the peer reviewers."

So, researchers are skewing/hiding their data because of some kind of political pressure/decision, and, again, peer reviewers are not doing their job by allowing these papers to be published. Dingo hasn't posted in months about anything other than his son, and you're *still* slamming researchers in a field which you, admittedly, know nothing about for reasons which are conjectural at best.

So, again, what are the specific rules that one needs to follow when discussing research? Because, as best I can determine, the rules are that researchers who you disagree with are idiots/unethetical and anyone who publishes their research isn't doing their job, while researchers you agree with must be treated with absolute and utter respect or face mocking and parody.

Pooka1
10-20-2013, 12:35 PM
h? Because, as best I can determine, the rules are that researchers who you disagree with are idiots/unethetical and anyone who publishes their research isn't doing their job, while researchers you agree with must be treated with absolute and utter respect or face mocking and parody.

I stand on the record.

Pooka1
10-20-2013, 12:38 PM
crapping

We have very different definitions of "crapping on researchers", by the way. I also think you are avoiding the obvious point.

hdugger
10-20-2013, 12:49 PM
Here is one quick example in response to your request up-stream, this from flerc who is callous in suggesting wide-spread use of bracing even though the Braist researchers state their evidence shows that many kids are being braced unnecessarily.

I'm not trying to be thick, but you're really going to have to go through this sentence by sentence to show me how this is callous.

Let me parse through it:

"If studies are showing that braces are unecessary used in a high percentage, they also shows greater chances to avoid surgery using it."

That appears to just be a flat reading of the study. It acknowledges what the study also acknowledges - that braces are used unnecessarily in a high percentage of cases - while also acknowledging the other major conclusion of the study - that they greatly improve the chances of avoiding surgery.

Next sentence:

"Both studies conclusions should to be taken into account for parents evaluating the convenience of using braces or not."

That seems pretty reasonable to me. I think I said the exact same thing.

Is it this that you consider callous:

"What would be really unethical is to leave parents without this non surgical option to avoid surgery."

This is Flerc's opinion based on the study results, and he does use the word "unethical" which can be a little charged, but it doesn't seem callous to me. He's already acknowledged that braces are over-prescribed. He's saying that braces should be made available to patients who want to avoid surgery. Unless you feel that braces should not be made available, I don't quite see what's wrong with the statement. I will say that I, likewise, would consider it unethical to not allow patients to to choose bracing in order to avoid surgery.

So, again, I don't mean to be dense, but I'm not seeing the problem.

For the rest, I haven't had to talk my son through either bracing or surgery, but just from watching the forums I don't get the sense that parents are any better or worse informed about the risk/benefit of bracing then they are about any other treatment (watch and wait, surgery, etc). People show up on this forum after having been told the damndest things as teens about their chances of avoiding surgery as an adult. That's a problem in every treatment area - it's not something unique to bracing.

hdugger
10-20-2013, 01:01 PM
We have very different definitions of "crapping on researchers", by the way.

You're right. Your statement goes beyond crapping.

I can't imagine a more serious charge leveled against a researcher than that they are deliberately falsifying or at least encouraging a false reading of their data because of political motives, nor a more serious charge being leveled against their peers who are reviewing the study then that they are utterly abdicating their responsibility to science by allow such a study to be published. It's not just crapping - it's a serious allegation, possibly straying into slander/libel (can't recall which it is for the written word). If there is hard evidence to back up your charge, I strongly suggest you produce it. If you're slandering/libelling based on *conjecture* I'd just as strongly suggest you stop.

Pooka1
10-20-2013, 01:26 PM
You're right. Your statement goes beyond crapping.

I can't imagine a more serious charge leveled against a researcher than that they are deliberately falsifying or at least encouraging a false reading of their data because of political motives, nor a more serious charge being leveled against their peers who are reviewing the study then that they are utterly abdicating their responsibility to science by allow such a study to be published. It's not just crapping - it's a serious allegation, possibly straying into slander/libel (can't recall which it is for the written word). If there is hard evidence to back up your charge, I strongly suggest you produce it. If you're slandering/libelling based on *conjecture* I'd just as strongly suggest you stop.

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.

Pooka1
10-20-2013, 01:41 PM
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.


By the way I never faulted them on this (several publications) and never would. This was a very large study and I think they should get as many publications from it as possible.

There are several very strong points in this study and it is probably the best done to date. The subgroups are very well matched on many characteristics because they had largish groups. The issue is not the data. The issue is the meaning of the data. This is what hdugger is missing in her comments about my comments.

And I bet the researchers do want to keep track of all the patients and future outcomes. They want answers as do everyone else.

Pooka1
10-20-2013, 01:45 PM
it's a serious allegation, possibly straying into slander/libel (can't recall which it is for the written word).

I recall you said the same thing about my (factual) comments about MAGEC. Called it libel/slander and suggested someone report me to the company so I can be sued.

Is this new case more or less tight than that one? Just curious.

hdugger
10-20-2013, 02:20 PM
I recall you said the same thing about my (factual) comments about MAGEC. Called it libel/slander and suggested someone report me to the company so I can be sued..

I hardly remember discussing the MAGEC study, but I certainly could have.

I can pretty much guarantee that I didn't suggest someone "report you to the company so that you can be sued." I may well have suggested that you opened yourself up to such a charge. I'd say it again in this case - suggesting that someone has construed the data in a certain way or failed to include data which would change the conclusion of their study because they succumbed to political pressure is a serious charge.

I used to moderate forums, and I have a pretty good sense of the kinds of posts we were forced to delete because they opened us up to charges of slander/libel. This is that sort of claim.

I mention this not because you're going to be hauled into court, but because I want to stress that it's not just some nit-picking remark and that it rises to a higher level of seriousness then just assuming that you might know more then a researcher - which is the worst thing that Dingo is accused of.

None of this is the point, though and I'm boring myself again. My point was simply that I did not find mocking a parent in support forum acceptable behavior, and I did not accept your explanation that he'd somehow brought it on myself by breaking the completely inflexible rule that all forum members adhered to that they were not to say bad things about hard-working researchers. There is no such rule, and even if such a rule existed and was adhered to, it would not excuse the behavior.

Mocking parents in a support forum is not acceptable behavior, and your attempt to rationalize it fails to explain or excuse it. That's all I have to say on this topic.

Pooka1
10-20-2013, 02:33 PM
I'd say it again in this case - suggesting that someone has construed the data in a certain way or failed to include data which would change the conclusion of their study because they succumbed to political pressure is a serious charge.

First of all I never suggested most of that. I do stand by the politics comment.

Politics is not a serious claim unless the authors are making money. That isn't the case here. All data have to be presented one way or the other. All these medical articles are driven by some politics in my opinion. Most if not all these researchers are motivated to show the data in the way they honestly feel is most helpful. That is not bad per se. You are not understanding any of this.

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

There is an unfortunate coincidence between NOT publishing the final curve magnitudes and the fact that they concluded bracing is "successful." That is prime facie political in my opinion though obviously not unprofessional. It is successful according to their data and their definitions. But there is a larger meaning for successful that they are well aware of and I am certainly will address in future publications.

And despite the unfortunate coincidence, I do not think they are going to set themselves up to be shot down. The fact it came out this way actually suggests that maybe the final curve magnitudes are not that bad. They know they would be crucified if they were bad given the first publication. They aren't crazy.

Pooka1
10-20-2013, 02:49 PM
I hardly remember discussing the MAGEC study, but I certainly could have.

Your comment was in this thread before you deleted the post during one of you self-propelled post deletion binges. How many posts of yours did you delete in those episodes? I'm guessing upwards or 200.

http://www.scoliosis.org/forum/showthread.php?12835-Problems-identified-with-all-growing-rods-including-MAGEC

Or maybe you deleted the post as soon as I mentioned it. That's my guess.

hdugger
10-20-2013, 04:02 PM
Your comment was in this thread before you deleted the post during one of you self-propelled post deletion binges. How many posts of yours did you delete in those episodes? I'm guessing upwards or 200.

http://www.scoliosis.org/forum/showthread.php?12835-Problems-identified-with-all-growing-rods-including-MAGEC

Or maybe you deleted the post as soon as I mentioned it. That's my guess.

And conjecture alley opens up into the conjecture freeway, a place where people nefariously suppress data, delete posts, and otherwise try to befuddle and confuse the honest folk of NSF.

Actually, the mention of libel is Digno's in post #9 and then again in #14. He says that your statements could open the Eclipse company to damage, and that Linda might want to attend to such statements in her role as moderator. No one mentions that you ought to be reported to the company so that they can sue you, and I don't participate in the conversation at all, as best I can tell, and you respond to everyone who participates, so I'm pretty sure I was never there.

But, I don't mind being confused with Dingo, and I don't really care that you took such a sharp turn onto conjecture highway that you:

* conjectured what was said
* conjectured the person who said it
* conjectured the actions taken by said conjectured person to remove conjectured evidence which it appears never existed

I don't believe I've ever gone back and deleted a post of mine in order to win an argument. I don't much mind looking like an idiot. I *did* delete hundreds of posts in May (and would have deleted more, but some of the threads were locked). I did it for the reasons I stated above: Every time I fail to respond to a mis-statment or wild conjecture, every time I fail to defend against a cruelty or otherwise let stand things which I do not believe ought to be let stand, I appear to be condoning the behavior.

In my early time at NSF, I engaged every time one of these events happened. After awhile, it became too time consuming and, more importantly, eventually too heart-breaking to read the same things over and over again, so I put a large number of partiicipants, including you, on Ignore. That solved *my* problem, but I realize, in retrospect, that it made *the* problem much much worse. Now there were people saying all manner of untrue and hurtful things and *no one* was challenging it. Someone scanning through those discussion would feel as if everyone in the forum were in agreement with those statements, since no one stepped in to challenge them.

Flerc called me out on that, and he was right (hence the signature that I had for a long time). I'd protected myself but ended up harming people by doing so.

So, I went back and deleted every post that I could, and I wrote to NSF, and I participated in the long and uncomfortable thread where I really tried to call out what I saw going on, so that I said it once and in one place as clearly as I could in case no one at NSF responded and I had to leave the forum.

No one responded and I left and pretty much everyone pursuing any treatment other than surgery left. I have no interest in becoming a regular participant again, I assume to the utter relief of most. Simply, the forum does not feel safe, which is really the minimum requirement, for me, for a support forum.

I returned this weekend with the intent to make a few corrections to this thread, and then leave when the amount of "posts needing challenging" outstripped by ability to challenge. I've hit that point. It is lovely and sunny in Oregon today. My dogs are resting quietly. I'm going to go out and take pictures of birds, revel in the sunshine, and just accept that there's nothing more I can do here.

flerc
10-20-2013, 04:45 PM
How many posts of yours did you delete in those episodes? I'm guessing upwards or 200.

Excelent practice if we would be talking about you.. but about how many thousands should to be talking in order to clean this forum? But anyway what you did is done.

Hdugger don't waste your time taking this kind of discussions in this bad intentioned forum, specially with this faker. Remember it cannot be changed from inside. This thread was useful to show what it showed, endpoint

Pooka1
10-20-2013, 05:25 PM
And conjecture alley opens up into the conjecture freeway, a place where people nefariously suppress data, delete posts, and otherwise try to befuddle and confuse the honest folk of NSF.

Actually, the mention of libel is Digno's in post #9 and then again in #14.

You deleted your post on that issue.

It was something like how can they sue her if they don't know about it? You were egging them on to send the thread to the company because you are so sweet.

I remember it because it was similar in construction to what I say when I leave a place... "How can you miss me if I don't go away?"

hdugger
10-20-2013, 06:51 PM
You deleted your post on that issue.

It was something like how can they sue her if they don't know about it? You were egging them on to send the thread to the company because you are so sweet.

I remember it because it was similar in construction to what I say when I leave a place... "How can you miss me if I don't go away?"

I hate to see you racking your brain over this.

Might it have been this?

"I'm pretty sure UC Irvine was the party to license the technology to Ellipse Technologies, a privately held company located near UC Irvine facilities. Probably privately held with the parties involved. UC Irvine will know how to protect their investments and their faculty members' reputations if they become aware of it."

mariaf
10-21-2013, 08:40 AM
Anyone who has worn a brace themselves or had a child who had to wear a brace knows it is a very difficult treatment, period. You will not find one child or teen out there who loves their brace and is happy they got one. Some teens even end up with panic attacks or major depression because of their brace. Others appear to accept it but suffer quietly inside every day. This is why I advocate for strenuous and accurate research to pinpoint which exact kids will benefit from bracing, and spare all the rest from a difficult, unnecessary treatment.

I agree with this - and I think this is why some of us feel so strongly that bracing any number of kids unnecessarily is something to be taken very seriously. I had one mom tell me that she thanked the doctor who performed her daughter's tethering surgery (thus, making it no longer necessary for her to wear a brace) "for giving me my daughter back". She said her daughter went from being a happy, outgoing child before bracing, to being sullen, withdrawn and depressed once she had to wear the brace. There would be daily arguing, crying and it was putting a huge strain on the relationship between mother and daughter.

I can say for my own son, that had he been braced his entire childhood (as was being suggested at one time), I do not believe for one minute that he would be the happy-go-lucky kid who loves to play baseball, is outgoing and always making new friends. He was much younger when he wore a brace and still asked me one day 'why am I the only kid in kindergarten with one of these'? I was beginning to see it was something he was self-conscious about, and I can only imagine how much harder it would have become as he got older.

Heck, my daughter almost had a meltdown when she had to start high school with braces on her teeth! I think sometimes people forget just how difficult these years can be for kids without anything to make them feel different from their peers.

I almost neglected to mention that in addition to the social and emotional aspects of bracing, there are other issues to consider. Some children (my son included) have experienced digestive issues. At one point, we had to rmember not to give him a large meal within 2-3 hours of bedtime or he'd end up vomiting. I know of other children with related digestive issues - or as one kid told her mom, she just didn't enjoy eating anymore. In addition to any discomfort, there is the challenge of dealing with hot summer weather. I can't imagine a kid in Florida dealing with bracing in that climate. I had one father (a highway cop in Maryland, whose daughter had VBS) tell me he figured he had an idea of what bracing felt like from wearing a bulletproof vest in the summer and that he would not want his child to endure that.

Having said all this, like Gayle, I would never criticize a parent for choosing to brace their child, but it's not something I would ever want to do. And I must admit, sometimes my heart breaks for these kids.

flerc
10-21-2013, 01:41 PM
I recall you said the same thing about my (factual) comments about MAGEC. Called it libel/slander and suggested someone report me to the company so I can be sued.


Of course you should to be sued but mainly this forum, and not because just only that post of course. I remember I was not the only one asking you to give a justification about what you said against Magec and you didn’t. Anyway in a court I believe the most important fact is the clear intention to confuse everything. Something evident just only seeing this thread. What could a parent think reading it? What are these people talking about? Could it be clear for someone? The very much good comments of The New York Times note about the study (and the study itself) which shows something really interesting and important as confirmed brace effectiveness is, was absolutely buried manyy posts ago. You know worries parents has not time to live in this forum as you do and cannot be reading all the discussion generated by you, to say what? That there is not evidence showing without any doubt that all the successful braced cases will be out of surgery need, because just only being under 50° is not a guarantee? How many words took me to say that? Of course is extremely obvious the way you use to confuse saying things as ‘just only other braist study’, ‘they will never arrive to a consensus’, ‘it’s full of slants’, ‘‘it should be considered the propagation error’, ‘they uses averages instead of medians’, ‘not so much significant successful cases’, ‘the distribution of a possible X factor causing the success was not so much uneven’, etc, etc,,,,,,,etc,,,,etc,,,,, etc. Sorry if were not exactly your words, I have not time to quoting all what you say (and reread all) that obviously hides the important and confuse people trying to get information from the most visited scoliosis forum of the world.

flerc
10-21-2013, 05:03 PM
For (specially new here) parents thinking in braces, here is the note with the link to the last Braist study we were talking about:



http://www.nytimes.com/2013/09/20/health/new-study-lends-conclusive-support-to-a-scoliosis-treatment.html?_r=2&
'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.'



Surely the moderator will delete this post, or would be buried under various ‘wise’ and 'brilliant' criticisms again.

This forum cannot be changed from inside!

Pooka1
10-21-2013, 09:03 PM
Here's my guess as to what the next publication will be...

Using the final curve measurements and modeling the likelihood of the observation group and the successful bracing group that might eventually reach 50*. Were the final curve measurements in the successful observation group different than those in the successful bracing group?

http://jbjs.org/article.aspx?articleid=18804

http://www.scoliosis.org/forum/showthread.php?13727-Dr-Hey-has-seen-quot-countless-cases-quot-of-progression-in-quot-stable-quot-scoliosis (N.B. this thread had posts removed by the post authors after responses were made.)

I think they could write a few more articles with their data on:
- whether or not curve type matters in progression as has been seen in other studies
- rigorously isolating bracing dose as the main factor in progression <50* at maturity given subgroup size and looking for correlation of amount of progression and bracing dose
- more on the patients' perceptions of risk reduction needed to consider bracing and comparison with parents' perceptions (if they did that)

OR! Something completely different because it's their field not mine! Those are just the ones I think they have the data to write about and that I would like to see.

LindaRacine
10-21-2013, 10:50 PM
This thread has gotten way out of control. Let's get it 100% back on topic.

sjmcphee
10-22-2013, 01:05 AM
I removed my off topic comments from the thread.. But not because anything I said wasn't true..
You all know what I advocate is a full understanding of individual scoliosis curve patterns based on logic..
And that I'm not trying to sell anything.. I want real understanding.. Not a trial and error based system..
Anything less than that is unacceptable..

flerc
10-22-2013, 01:17 PM
..it's their field not mine!

Good! Of course this is definitely very far to be out of topic. It would be better if you put it in your signature. Parents are in their right in knowing all about who is saying every time in the most visited Scoliosis Forum around the world, how much unethical the brace practice is, seeming to talk in the name of science as use to do in every non surgical thread.. even talking about a science war. They should to know about you!.
If they want to know about people talking in favor of braces, after analyzing that Braist study, as for instance all those talking in the NY Times note, they can, they are not hiding that kind of information about their self and parents may confirm it.
So what about you? What data about your self will you give them in order to be possible for them to assign a right weight too to all what they are hearing against braces?

Pooka1
10-22-2013, 05:09 PM
Jerry Coyne is a prominent biological researcher at the University of Chicago. A blurb in here... http://jerrycoyne.uchicago.edu/about.html

I have been banging on about how a majority of medical research (and I don't know why it would be limited to that field) is false as shown by John P. A. Ioannidis. I am not claiming BrAIST is false and I certainly am not alleging nefarious motives. I am saying it needs to be replicated at least once and probably more for reasons explained below.

http://whyevolutionistrue.wordpress.com/2013/10/22/science-is-in-bad-shape/


Science is in bad shape

There are two pieces in the latest Economist that are must-reads not just for scientists, but for science-friendly laypeople. Both paint a dire picture of how credible scientific claims are, and how weak our system is for adjudicating them before publication. One piece is called “How science goes wrong“; the other is “Trouble at the lab.” Both are free online, and both, as is the custom with The Economist, are written anonymously.

The main lesson of these pieces is that we shouldn’t trust a scientific result unless it’s been independently replicated—preferably more than once. That’s something we should already know, but what we don’t know is how many findings—and the articles deal largely with biomedical research—haven’t been replicable, how many others haven’t even been subject to replication, and how shoddy the reviewing process is, so that even a published result may be dubious.

For those who consider this first BrAIST article a landmark publication, Dr. Coyne writes:


If you read the Economist pieces, all of these are mentioned save #4 (peculiarity of one’s material). And the findings are disturbing. Here are just a few, quoted from the articles:

Last year researchers at one biotech firm, Amgen, found they could reproduce just six of 53 “landmark” studies in cancer research. Earlier, a group at Bayer, a drug company, managed to repeat just a quarter of 67 similarly important papers. A leading computer scientist frets that three-quarters of papers in his subfield are bunk. In 2000-10 roughly 80,000 patients took part in clinical trials based on research that was later retracted because of mistakes or improprieties.




. . . consider 1,000 hypotheses being tested of which just 100 are true (see chart). Studies with a power of 0.8 will find 80 of them, missing 20 because of false negatives. Of the 900 hypotheses that are wrong, 5%—that is, 45 of them—will look right because of type I errors. Add the false positives to the 80 true positives and you have 125 positive results, fully a third of which are specious. If you dropped the statistical power from 0.8 to 0.4, which would seem realistic for many fields, you would still have 45 false positives but only 40 true positives. More than half your positive results would be wrong.


John Bohannon, a biologist at Harvard, recently submitted a pseudonymous paper on the effects of a chemical derived from lichen on cancer cells to 304 journals describing themselves as using peer review. An unusual move; but it was an unusual paper, concocted wholesale and stuffed with clangers in study design, analysis and interpretation of results. Receiving this dog’s dinner from a fictitious researcher at a made up university, 157 of the journals accepted it for publication.Dr Bohannon’s sting was directed at the lower tier of academic journals. But in a classic 1998 study Fiona Godlee, editor of the prestigious British Medical Journal, sent an article containing eight deliberate mistakes in study design, analysis and interpretation to more than 200 of the BMJ’s regular reviewers. Not one picked out all the mistakes. On average, they reported fewer than two; some did not spot any.

The journal recommends several ways to fix these problems, including mandatory sharing of data and getting reviewers to work harder, reanalyzing the data in a reviewed paper from the ground up. The former is a good suggestion: many people in my own field, for example, refuse to send flies to other workers, even though they’ve published data from those flies. But reanalyzing other people’s data is almost impossible. We’re all busy, and it’s enormously time-consuming to redo a full data analysis.


I don't think the BrAIST researchers should share their raw data until all the publications come out. But once they are out they should make is all available.

sjmcphee
10-22-2013, 07:39 PM
I know I should keep my mouth shut.. but I just cant.
I don't know why I am the only one that sees it.
Why cant you people see 'The Big Picture'.
The improvements in scoliosis treatment aren't based on an complete understanding of curve pattern biomechanics.
The improvements have come from a system based on trial and error.
Researchers don't understand the exact biomechanics of scoliosis and this is the ultimate reason why surgeries and bracing are only ever going to be somewhat effective.
I think its been about 100yrs now since the first scoliosis surgery btw..
They waste all their research time on studies that only serve the trial and error system.
We could all come up with a million new ideas in how to treat scoliosis.
But then we'd need a million researchers to spent months / years testing those ideas.
When we really need them to study SCOLIOSIS itself.
And its all a waste of time, I am sick of all these studies and comparisons that don't really go anywhere or really help anything.
Lets get REAL ok, there are two aspects to scoliosis.
Spinal curvature phase - what causes that? There's that area of research.
Which leads to point where the condition becomes more complicated by biomechanical factors.
Scoliosis Phase - altered biomechanics / asymmetrical loading / curve patterns. There's that area of research.
You can do all the comparisons you want, collect all the data you can muster but it isn't going to get us any closer to figuring this thing out.
That's not how this problem is. That's not how they are going to learn about scoliosis. - At least be true to the condition.
Researchers need to STOP being SCIENTISTS and start being INVESTIGATORS and using logic.
Without understanding the biomechanics of individual curve patterns we are always going to be trapped in a trial and error based treatment system.
Is there a way to figure it out?
Until recently its not been possible to create detailed models of scoliosis progression, but with todays computer technology it now is possible.
The years of trial an error are not applicable anymore.
Is there a weak link in understanding scoliosis?
Yes - its in curve patterns.
And then you start going down the whole path of LOGIC that I put forward.
Look at everything I have tried to put forward.
We don't need to mutilate animals or do clinical trials or compare 100 of this to 100 of that.
It's yesterdays thinking.. They need to get with the program.
We need them to sit down and look at the problem for what it is.
Altered biomechanics - Asymmetrical Loading - Curve Patterns
Put these components together and there is no other logical explanation other than the one I have previously suggested.
That there is a biomechanical basis to scoliosis curve patterns and that the path of progression can be calculated... Not predicted.
Researchers need to use that computer modelling technology to its full potential and completely simulate the path of individual curve patterns.
I may not be a researcher but I know logic and I know that this is the only thing that will change things for us.

What if cancer researchers said to cancer patients 'we know of something that might help but we don't want to spend time researching it because its too hard'.

And you can all say and think whatever you want about me, but it doesn't change that what I'm saying is true, and you all know it.

I hate the trial and error based system that has sees us patients only as labrats or cattle for them to test new ideas on.
I want something real. Study Scoliosis for what it is.

This guy's website looked dubious from the get go advertising patients case studies was it??
What do you expect??

'The Big Picture' - people

flerc
10-23-2013, 12:37 PM
Scott, parents who have read this

For (specially new here) parents thinking in braces, here is the note with the link to the last Braist study we were talking about:

http://www.nytimes.com/2013/09/20/health/new-study-lends-conclusive-support-to-a-scoliosis-treatment.html?_r=2&
'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.'


Surely the moderator will delete this post, or would be buried under various ‘wise’ and 'brilliant' criticisms again.

This forum cannot be changed from inside!

may believe you are helping Pooka1 to hide that important data for them. Just only her large post and yours was enough to buried it again and also the question I did her then, that of course she don’t want to reply. Why do you believe they didn’t delete your out off topic post and she stopped to talk about evolution and everything having nothing to do with that important proof about brace effectiveness? Because you are not (at least explicity) talking in favour of braces of course!.
In other thread I might talk about Biomechanics but I would be the only one. This forum doesn’t want anybody talking about non surgical options! And it cannot be changed form inside.

Pooka1
10-23-2013, 03:36 PM
Do you consider this first BrAIST paper to be a landmark study?

Does anyone think it doesn't need to be repeated?

What percentage of people who are in no danger of ever having to wear a brace think it doesn't need to be repeated?

Would the conclusions change if the medians versus the averages were shown?

Would it need to be repeated if the bracing "successes" were expected to progress over time given their magnitude at maturity?

This is the best study to date as far as we known now no matter what the results. That doesn't mean it doesn't need to be repeated to have confidence in the results as the history of this field has shown. This is a tough game and it's a tough treatment. Breathlessness is not warranted in my opinion when we are talking 23/7 hard bracing for years.

Pooka1
10-23-2013, 08:14 PM
I think the BrAIST researchers could confirm/deny the conclusions in this study using the BrAIST data.

http://www.ncbi.nlm.nih.gov/pubmed/19333102

I assume they would sort by curve type which is also something I hope the BrAIST researchers try to address in future publications.


Spine (Phila Pa 1976). 2009 Apr 1;34(7):697-700. doi: 10.1097/BRS.0b013e31819c9431.
Curve progression in idiopathic scoliosis: follow-up study to skeletal maturity.
Tan KJ, Moe MM, Vaithinathan R, Wong HK.
Source

Department of Orthopaedic Surgery, National University Hospital, National University of Singapore, 5 Lower Kent Ridge Road, Singapore. jinmi@pacific.net.sg
Abstract
STUDY DESIGN:

This is a follow-up study to skeletal maturity on a cohort of students screened for a 1-year prospective epidemiological prevalence study for scoliosis.
OBJECTIVES:

This study aims to identify the prognostic factors for curve progression to a magnitude of 30 degrees at skeletal maturity in skeletally immature patients with adolescent idiopathic scoliosis.
SUMMARY OF BACKGROUND DATA:

The natural history of idiopathic scoliosis is not well understood. Previous reports have focused on the characteristics of curve progression where progression has been predefined at specific angles of 5 degrees to 6 degrees. However, the absolute curve magnitude at skeletal maturity is more predictive of long-term curve behavior rather than curve progression of a defined magnitude over shorter periods of skeletal growth. It is generally agreed that curves less than 30 degrees are highly unlikely to progress after skeletal maturity. Hence, defining the factors that influence curve progression to an absolute magnitude of more than 30 degrees at skeletal maturity would more significantly aid clinical practice.
METHODS:

One hundred eighty-six patients who fulfilled the study criteria were selected from an initial 279 patients with idiopathic scoliosis detected by school screening, and who were followed-up till skeletal maturity. The initial age, gender, pubertal status, and initial curve magnitude were used as risk factors to predict the probability of curve progression to more than 30 degrees at skeletal maturity.
RESULTS:

Curve magnitude at first presentation was the most important predictive factor for curve progression to a magnitude of more than 30 degrees at skeletal maturity. An initial Cobb angle of 25 degrees had the best receiver-operating characteristic of 0.80 with a positive predictive value of 68.4% and a negative predictive value of 91.9% for curve progression to 30 degrees or more at skeletal maturity.
CONCLUSION:

Initial Cobb angle magnitude is the most important predictor of long-term curve progression and behavior past skeletal maturity. We suggest an initial Cobb angle of 25 degrees as an important threshold magnitude for long-term curve progression. Initial age, gender, and pubertal status were less important prognostic factors in our study.

PMID:
19333102
[PubMed - indexed for MEDLINE]

Pooka1
10-23-2013, 08:41 PM
Emphasis added.

http://journals.lww.com/spinejournal/Abstract/2013/10150/CHD7_Gene_Polymorphisms_and_Familial_Idiopathic.16 .aspx


CHD7 Gene Polymorphisms and Familial Idiopathic Scoliosis

Tilley, Mera K. PhD*; Justice, Cristina M. PhD*; Swindle, Kandice BS†; Marosy, Beth MS‡; Wilson, Alexander F. PhD*; Miller, Nancy H. MD†
Collapse Box
Abstract

Study Design. Model-independent linkage analysis and tests of association were performed for 22 single nucleotide polymorphisms in the CHD7 gene in 244 families of European descent with familial idiopathic scoliosis (FIS).

Objective. To replicate an association between FIS and the CHD7 gene on 8q12.2 in an independent sample of families of European descent.

Summary of Background Data. The CHD7 gene on chromosome 8, responsible for the CHARGE syndrome, was previously associated with FIS in an independent study that included 52 families of European descent.

Methods. Model-independent linkage analysis and intrafamilial tests of association were performed on the degree of lateral curvature considered as a qualitative trait (with thresholds of ≥10°, ≥15°, ≥20°, and ≥30°) and as a quantitative trait (degree of lateral curvature). Results from the tests of associations from this study and the previous study were combined in a weighted meta-analysis.

Results. No significant results (P < 0.01) were found for linkage analysis or tests of association between genetic variants of the CHD7 and FIS in this study, failing to replicate the findings from the previous study. Furthermore, no significant results (P < 0.01) were found from meta-analysis of the results from the tests of association from this sample and from the previous sample.

Conclusion. No association between the 22 genotyped single nucleotide polymorphisms in the CHD7 gene and FIS within this study sample was found, failing to replicate the earlier findings. Further investigation of the CHD7 gene and its potential association to FIS may be required.

Level of Evidence: N/A

sjmcphee
10-23-2013, 08:48 PM
Could you guys post the link to the actual research paper again, I went back through the posts and couldn't find it.
And also a link to the guys website, I want to have a look at that again.

I know youse two are at it again.. lol

Now for one, If my kid had scoliosis, I'd probably be willing to put my kid in a brace for a chance at saving them from surgery.
Even if I had to see the discomfort and distress on their face..
And even if there was a chance the scoliosis wasn't going to progress anyway.
I wouldn't enjoy doing it, but its the 'being creul to be kind' clause.
But Id probably be wanting to have a look at that Torsion Rotation therapy as well.
And actively seeking out whatever else I can find as well.

But on the face value of it Flerc, I think the others have a right to be sceptical or dubious given that they haven't released all the data.
And that brings me to the question 'What do they have to hide?' - Even though that might sound a little paranoid.
On the face value of it I generally agree with the things Pooka has alluded to.
I might have ideas that may seem crazy to others but I do advocate towards logic and evidence.

But that doesn't mean I am against bracing, I am just a realist.

I think parents have a right to want more conclusive data on the effectiveness of braces.
And basic information as well.

What braces work best for what curves - etc.

But me, I just want an end to the Trial and Error treatment regime.
And in some ways I feel like I could not be bothered with anything that serves this system.
I feel like its all a waste of time with the blind leading the blind, and that there's bigger fish to fry.

But as I said before I probably would brace my kid, even if I knew there was a chance it wouldn't matter either way.

The real question to me isn't data on the effectiveness of braces.
Lets say we found a brace that worked - then the question would be -
How did it work?

Some braces are really simple.
Nothing more than a hard bandage wrapped around the torso while the patient is laying in the correct position.

I advocate a REAL understanding of scoliosis 'Over and Above' the Trial and Error regime.
And I also advocate for better more easily accessible info for scoliosis on the internet.

Improve the face of scoliosis on the internet, improve fundraising opportunities, and get the money to figure out the biomechanics of the condition.

Short of exposing the whole sad state of affairs of scoliosis, I am thinking about offering a $10,000 bounty to any researcher than can successfully replicate the transition from normal biomechanical function to altered biomechanical function in a fully functional spine model with the input info I will provide.

Also for me (and you guys too) good news...
After all these years I've found a surgeon who has agreed to review my research, if you can call it that.
So for the next few weeks I am going to have to spend some time making sure I am putting everything across on my webpage the best I can.
I am honestly not sure if any other researcher has put the 3 factors of altered biomechanics, asymmetrical loading and curve patterns together in a way that makes logical sense like I have. I don't understand why no-one pays any attention to me..
Well there's a few reasons I am aware of - shoddy attitude being one of them... lol

Anyhow I guess I kind of understand / agree with both of you.
You don't want to see the bracing concept run into the ground or see parents turn away from bracing (am I correct?), and Pooka wants more reliable info.

Neither of your concerns are wrong or unfounded - that is if I get what you are arguing about properly.

- Scott

sjmcphee
10-23-2013, 09:09 PM
I assume they would sort by curve type which is also something I hope the BrAIST researchers try to address in future publications.

I second that motion.. The criteria seemed a little broad.. I would want all the data otherwise there's no point in it.
Maybe the good news is that now they can build on what they started in future studies..
But we are all looking at years of studies just waiting for peoples scoliosis to progress..
That's the truth of it..

I just get mad at the state of things. If it were up to me the exact biomechanics of individual curve patterns would have been known 10years ago.

And all this trial and error stuff can become landfill for all I care.
You guys tell me - I know you have all dug through the literature way more than me.
Has anyone ever proposed a more logical explanation of the three components of altered biomechanics, asymmetrical loading and curve patterns better than I have???
Seriously.. If anyone ever has, I want to know..

And Flerc I certainly don't have an issue whatsoever with anyone discussing AND applying non - surgical options.
I think its actually good that people investigate things for themselves and have as much info on hand to do that.
So technically I am for anything that can prevent surgery..
We need to be pro-active and figure things out for ourselves if researchers wont..

N yeah I would be the only one who cares about biomechanics..
And the logic of the whole thing.. Its kind of sad..
Its like I'm giving away $100 notes and you're all fighting over the handful of shrapnel that was thrown on the ground first..
But its ok.. I always knew this was my battle.. And I will soon bring it to the attention of the people that matter..
They wont have a choice..

I'm sorry I push my issue onto other threads, but what I am saying really does affect diagnosis, bracing, surgery and everything in between.
I'm not always completely off topic, and I only want what's best for all of us..
We've all got our own different views and positions and parts to play..
And I'll always be on the side of whatever's best for the patient..

Pooka1
10-24-2013, 06:08 AM
I wrote this on 25 Sept 2011. It is STILL true even after the first BrAIST publication. This game is hard though not as hard as brace treatment.


Moreover, even if it this study was truly randomized, it will still not answer a major open question of whether bracing only delays progression.

It has been estimated that maybe 10% of folks who are braced appear to have avoided surgery at the end of puberty. But maybe this is the exact crowd that progresses in later life. Any curve >30* at maturity could progress to surgery and it would not be unusual to do as per at least one surgeon. I'm guessing a majority if not every patient who wore a brace comes out with at least a 30* curve so this question needs answering. Katz et al. can't help with this and neither can BrAIST.

That is a truly difficult research problem.

There is always going to be correct major criticism of studies in this field because it is intrinsically difficult. That won't go away.

mariaf
10-24-2013, 08:29 AM
Now for one, If my kid had scoliosis, I'd probably be willing to put my kid in a brace for a chance at saving them from surgery.
Even if I had to see the discomfort and distress on their face..
And even if there was a chance the scoliosis wasn't going to progress anyway.

But as I said before I probably would brace my kid, even if I knew there was a chance it wouldn't matter either way.
- Scott

Hi Scott,

I can't help but be curious (sorry, I didn't have time to re-read old posts to see if you shared this personal info), but do you have children? If so, I can assume from your post that you have never had to brace any of them.

I'm NOT trying to attack you - so I hope it doesn't come across that was as that is not my intent, but I honestly and TRULY believe that people may think one way, but once in that particular situation, feel quite differently. I, myself, could have said the same thing as you BEFORE I actually knew what it was like to tell a child to wear a brace 22-23 hours a day and see firsthand all of the issues that could accompany it (none of them fun).

Now, it may very well be that you would do exactly as you say/think if you were in that situation and have your child wear the brace even though they might be miserable and even though, as you say, there's a chance it wouldn't matter either way. And even if you started to see that it was affecting their entire childhood.

Or maybe you'd surprise yourself and feel differently.

Just a thought to consider.

Take care,

jrnyc
10-24-2013, 12:02 PM
hi Maria
could not agree with you more...

as a kid, i would throw the night guard i was supposed to wear across
the room at nite, in my sleep, it hurt so much...
NO WAY i would have worn a brace if my scoli had been diagnosed as a kid...

i do not know how any young child can be convinced to wear a brace for the future of their spine...young kids have a hard time projecting into the future alot of the time...it seems so far away...
and to explain to them that they must suffer now for the future...
cruel, hard, tough thing to try to do...
especially when they could end up needing surgery anyway...
leading to lots of hours on a therapist's couch to deal with the
resulting anger and frustration!

jess...and Sparky

mariaf
10-24-2013, 01:25 PM
Hi Jess,

As a parent, I always remind myself that they only get one childhood.

I often tell the story of what my daughter (who was going on 13 at the time) said to me when I was lamenting on whether or not surgery (VBS) was the right thing for David. I knew in my heart that it was the right choice; nonetheless, it was a heavy weight to bear, basically making the decision for him, since he was in kindergarten. She said to me "Mom, I would probably be a little afraid of surgery, but I would want to have it rather than EVER wear a brace to school". She then informed me that NO WAY could I do that to her little brother either. Come to think of it, she's been a force to be reckoned with to this day - LOL!

Jackie says "WOOF" and Happy Halloween to Sparky!

jrnyc
10-24-2013, 02:31 PM
thanks...Sparky says "Boo, too"

how wonderful that your little boy has such a loving sister...
they will be such great friends...how super for her to have a
brother she is close with...
you are doing a great job, for them to be so loving and caring to
each other...

jess...and Sparky

mariaf
10-24-2013, 02:49 PM
Or maybe she just likes to tell me what to do - LOL :-))

Only kidding, she definitely looks out for her little bro!!!!

LindaRacine
10-24-2013, 03:45 PM
As a parent, I always remind myself that they only get one childhood.


I once heard Robert Winter, who was (and maybe still is) a bracing advocate, talk about bracing kids. He felt strongly that bracing was a good thing. He said something that has always stuck with me, and that was that he felt that while parents should encourage their kids to wear their brace, it wasn't worth ruining the parent/child relationship. I think that's really true. I've seen more than a few parent/kid relationships where the parents are very pushy about treatment (whether it's bracing, exercise, surgery or anything else). Most of those kids seem like they're very withdrawn, and I think they feel like they've had no power in terms of what is done to them.

Pooka1
10-24-2013, 05:44 PM
I've seen more than a few parent/kid relationships where the parents are very pushy about treatment (whether it's bracing, exercise, surgery or anything else). Most of those kids seem like they're very withdrawn, and I think they feel like they've had no power in terms of what is done to them.

Surgery is rarely, if ever, a choice for kids in range who are healthy enough for surgery. That's my understanding. It's not a choice and not in the same category as bracing and PT, neither of which have been shown to avoid surgery for life.

It's like saying my parents were "pushy" about my having to have my diseased, about to burst, appendix removed in a surgical procedure. Courts would step in on that and I hope on the fusion surgery for most kids who would benefit. You will NEVER see a court step in on bracing even after this first BrAIST article. Or PT. Can you even imagine.

Pooka1
10-24-2013, 09:42 PM
From Dr. Hey's blog (again, just for perspective)...


3) Lori [Dolan] agreed that we can't fully declare "success" with no surgery or curve less than 50 degrees at skeletal maturity, since some of those patients will continue to progress and/or have pain in adulthood and may eventually need surgery.


I liked Dr. Weinstein's comments in the blog above, but would probably be cautious about concluding that bracing prevents the need for surgery altogether, since the endpoint for their current study is only until skeletal maturity --- the game isn't over when you are done growing. In our natural history study that we are preparing for publication now, as many as 38-40% of patients with scoliosis as a teen continued to progress during adulthood. Lori did say that they are planning to do a 2 year follow-up on their cohort to see if there is any further progression. We both agreed that even long-term follow-up would be helpful -- even lifetime!! Certainly my hundreds and hundreds of adults over the years with progressive painful scoliosis would encourage us to consider such a long-term, full life approach.


In any case, it is a wonderful study and may encourage some of our guests to consider bracing, but it is a decision that requires dialogue with all parties -- especially the young lady or gentleman who needs to commit to wear the brace for at least 13 hours a day for possibly several years.

In re the last quote, notice how he is not treating bracing like perhaps chemotherapy for childhood leukemia wherein all patients get that and the vast majority beat cancer or at least 75% of childhood cancers are treatable per my understanding. Unlike chemo or radiation or whatever they do for childhood leukemias, he still says it's a "decision" requiring dialogue.

Note the distance between what surgeons like Dr. Hey and researchers like Dr. Dolan say on the one hand and what lay parents breathlessly conclude on fora on the other.

Also note that I don't think (or hope) you will find anyone who knows what they are talking about claim this study shows that a single kid has escaped surgery for life.

It is going to be so very interesting to see those final curve numbers. We might all be able to go home. Or not.

flerc
10-25-2013, 11:12 AM
Emphasis added.
CHD7 Gene Polymorphisms and Familial Idiopathic Scoliosis

Tilley, Mera K. PhD*; Justice, Cristina M. PhD*; Swindle, Kandice BS†; Marosy, Beth MS‡; Wilson, Alexander F. PhD*; Miller, Nancy H. MD†
Collapse Box
Abstract

Study Design. Model-independent linkage analysis and tests of association were performed for 22 single nucleotide polymorphisms in the CHD7 gene in 244 families of European descent with familial idiopathic scoliosis (FIS).

Objective. To replicate an association between FIS and the CHD7 gene on 8q12.2 in an independent sample of families of European descent.

Summary of Background Data. The CHD7 gene on chromosome 8, responsible for the CHARGE syndrome, was previously associated with FIS in an independent study that included 52 families of European descent.

Methods. Model-independent linkage analysis and intrafamilial tests of association were performed on the degree of lateral curvature considered as a qualitative trait (with thresholds of ≥10°, ≥15°, ≥20°, and ≥30°) and as a quantitative trait (degree of lateral curvature). Results from the tests of associations from this study and the previous study were combined in a weighted meta-analysis.

Results. No significant results (P < 0.01) were found for linkage analysis or tests of association between genetic variants of the CHD7 and FIS in this study, failing to replicate the findings from the previous study. Furthermore, no significant results (P < 0.01) were found from meta-analysis of the results from the tests of association from this sample and from the previous sample.

Conclusion. No association between the 22 genotyped single nucleotide polymorphisms in the CHD7 gene and FIS within this study sample was found, failing to replicate the earlier findings. Further investigation of the CHD7 gene and its potential association to FIS may be required.

Level of Evidence: N/A
http://journals.lww.com/spinejournal/Abstract/2013/10150/CHD7_Gene_Polymorphisms_and_Familial_Idiopathic.16 .aspx

Do you think that parents must to believe that is reasonable to expect something similar to what happened with that first CHD07 gene study, if that last braist study would be repeated? If this is your intention in posting this, did I miss some justification yours in other post? Or I should to wait for your justification as I’m waiting the end of your demonstration about the not so much uneven distribution of the X factor explaining it (not braces) the successful in the braced group.. as I’m also waiting for the raw data example (I asked for it to you many times) showing why the successful outcome in brace group don’t talk really about the brace effectiveness as Researchers said.. sure I’m forgetting something else.

If you want that parents hates braces so much as you do, you must first to give demonstrations about why they should to think that this outcome: ‘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’ is not showing a clear brace effectiveness, as Reserachesrs, Surgeons, Organizations are saying. Instead of trusting in them, it seems they must to trust in you, but of course you must to say them who you are. They should to know if you are a known Researcher or just only someone pretending in order to convince them to not consider braces as a way to avoid surgery.

Of course is unmoral what this forum does, not forcing you to do anything about that. I'm really veryyyy far to be the only one believing it.

LindaRacine
10-25-2013, 12:14 PM
Surgery is rarely, if ever, a choice for kids in range who are healthy enough for surgery. That's my understanding. It's not a choice and not in the same category as bracing and PT, neither of which have not been shown to avoid surgery for life.

It's like saying my parents were "pushy" about my having to have my diseased, about to burst, appendix removed in a surgical procedure. Courts would step in on that and I hope on the fusion surgery for most kids who would benefit. You will NEVER see a court step in on bracing even after this first BrAIST article. Or PT. Can you even imagine.

Nonetheless, it has not been unusual, even in posts on these forums, for kids to feel their parents made the surgery decision, against their will. I can't remember every story, but I think all or most of these people have had bad long-term outcomes.

I agree that if a kid absolutely needs surgery, it should be done, unfortunately regardless of how the kid feels. As I'm sure you already know, there are ways to soften the blow. Most kids are not going to go willingly into such a big surgery, so their parents have the responsibility of making an unpopular decision. I'm just saying that, sometimes, I've met people who blame their parents for making them have surgery, and who do not have a good relationship with their parents (either because of the decision, or because it was the decision that broke the camel's back).

--Linda

flerc
10-25-2013, 12:26 PM
They should to know if you are a known Researcher or just only someone pretending in order to convince them to not consider braces as a way to avoid surgery.


Of course I was just only referring to parents without enough science background .Certainly this not ending work done here, can confuse them very much.. they are really defenseless.

Pooka1
10-25-2013, 05:13 PM
Do you think that parents must to believe that is reasonable to expect something similar to what happened with that first CHD07 gene study, if that last braist study would be repeated? If this is your intention in posting this, did I miss some justification yours in other post? Or I should to wait for your justification as I’m waiting the end of your demonstration about the not so much uneven distribution of the X factor explaining it (not braces) the successful in the braced group.. as I’m also waiting for the raw data example (I asked for it to you many times) showing why the successful outcome in brace group don’t talk really about the brace effectiveness as Researchers said.. sure I’m forgetting something else.

If you want that parents hates braces so much as you do, you must first to give demonstrations about why they should to think that this outcome: ‘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’ is not showing a clear brace effectiveness, as Reserachesrs, Surgeons, Organizations are saying. Instead of trusting in them, it seems they must to trust in you, but of course you must to say them who you are. They should to know if you are a known Researcher or just only someone pretending in order to convince them to not consider braces as a way to avoid surgery.

Of course is unmoral what this forum does, not forcing you to do anything about that. I'm really veryyyy far to be the only one believing it.

How certain are you that you are interpreting these results correctly and not over-stating things?

From the Editorial in the NEJM that was published along with the first pub from the BrAIST study written by Eugene J. Carragee, M.D. and Ronald A. Lehman, Jr., M.D... (emphasis added)

September 19, 2013DOI: 10.1056/NEJMe1310746


Although the authors initially intended to conduct a strict randomized trial, in practice this was not possible. Strong treatment preferences limited enrollment in the randomized trial, so the investigators added observational patient-preference groups. Of 242 patients included in the analysis, 116 had received randomly assigned care and 126 received patient-directed care (71% of the patients in this group choosing brace treatment). Furthermore, very few patients wore the brace for the recommended 18 hours per day; 27% of the patients stopped using the brace completely (see the Supplementary Appendix of the article, available at NEJM.org).

The difficulties with enrollment and compliance must be considered in interpreting the results. Because much of the data were derived from a nonrandomized cohort, the magnitude of the associations between brace wear (and its duration) and good outcome may have been inadvertently magnified if patients whose curves were more likely to progress were correspondingly less inclined to wear a brace (e.g., if they had relatively stiff curves, which resist the corrective pressure of the brace, or rapidly progressing curves, which outgrow the mechanics of the brace). The intention-to-treat analysis showed the same general trend of treatment effectiveness but with much less statistical confidence.

The decision to commit a 12- or 13-year-old patient to several years of brace wear requires careful consideration of both the benefits and the downsides. Although brace wear in adolescent idiopathic scoliosis does not have the serious physiological side effects that are apparent in poliomyelitis-related scoliosis, it carries financial, emotional, and social burdens that need to be considered. Overall, the findings of the present trial confirm the general proposition that brace treatment confers benefits for some patients with adolescent idiopathic scoliosis, but an open question is the applicability of the findings to individual adolescents with idiopathic scoliosis. Patients with adolescent idiopathic scoliosis represent a heterogeneous group, and this study does not have adequate numbers to evaluate the treatment effect for specific structural types of adolescent idiopathic scoliosis or the efficacy according to relative correct-ability or relative discomfort of bracing that requires high forces to maintain correction. With improved flexibility, especially in the lumbar spine, the probability of success with bracing is likely to be greater.

As the authors appropriately point out, 48% of the untreated patients had a successful outcome, as did 41% of the patients in the bracing group who spent little time wearing the brace. In retrospect, the bracing indications described are probably too broad, resulting in what may be unnecessary treatment for many patients. We agree with the authors that the equally important finding of this study is that so many growing children with adolescent idiopathic scoliosis seem to do just fine with no treatment at all; the challenge for the field going forward is to identify children who are most likely to benefit from bracing and those who are unlikely to benefit.8,9


By the way, I earlier mis-stated that 75 kids were braced in the intent to treat arm. I was wrong... only 51 were braced in that arm. That means the quartiles in the dose-response curve each contain 51/4 = 12.75 kids. So 25.5 kids wore the brace for >12.9 hours (total in the two top quartiles). That is why the comments about the groups not being large enough for a heterogeneous condition. And we still don't know what their curve magnitudes were after the bracing. If they were north of 40* then we can go home on the dose-response curve in my opinion.

The other thing I wanted to say on this issue of not having enough patients is the study was stopped early before they could recruit enough patients. I don't think it's fair to gig the researchers on not having enough patients if you are going to stop their study. What am I missing? There are not enough patients but it is no fault of the researchers. It's almost like the panel didn't want a definitive answer and made sure the number of patients would be too low to settle the question.

I would have thought that once they showed that the two groups (intent-to-treat and as-treated) were similar enough they could just combine them. But apparently not. That is why the dose-response curve is ONLY for intent to treat and therefore has too few patients.

Pooka1
10-25-2013, 05:25 PM
Of course I was just only referring to parents without enough science background .Certainly this not ending work done here, can confuse them very much.. they are really defenseless.

Here are some more comments from a surgeon (Dr. William Taylor... http://neurosurgery.ucsd.edu/william-taylor-md/) and more from Dr. Carragee... (emphasis added)

http://www.medpagetoday.com/Orthopedics/Orthopedics/41732


While the study adds the "weight of the literature" in favor of bracing, Taylor noted that the patients might have been self-selected to have success, since about 65% of those screened and eligible did not take part in the study.

Indeed, the enrolment difficulties "must be considered in interpreting the results," commented Eugene Carragee, MD, of Stanford University School of Medicine in Stanford, Calif., and Ronald Lehman, MD, of the Walter Reed National Military Medical Center in Bethesda, Md.

In an accompanying editorial, they said that the associations between braces and treatment success might have been "inadvertently magnified" if participants whose curves were more likely to progress were less inclined to wear a brace -- something might have happened, for instance, if a patient had a relatively stiff curve that resisted the pressure of the brace.

Since the study also showed that some children did well without a brace, they concluded that "the challenge for the field going forward is to identify children who are most likely to benefit from bracing and those who are unlikely to benefit."

Pooka1
10-25-2013, 06:45 PM
You know, instead of averaging within quartiles, they COULD HAVE ALSO plotted all the 51 data points on the dose-response curve. Had they done that it would have been obvious that kids who wore the brace for many hours still were not <50* and that kids who wore the brace fewer hours were still <50* at maturity. The scatter would have been a take home message also.

And by the way, those 90%-93% of kids in the top quartile constitutes just under 12 kids. Call it 12. TWELVE KIDS. Once we know the curve magnitude of those 12, I don't think it will be too early to know if we can all go home.

hdugger
10-26-2013, 10:45 AM
By the way, I earlier mis-stated that 75 kids were braced in the intent to treat arm. I was wrong... only 51 were braced in that arm. That means the quartiles in the dose-response curve each contain 51/4 = 12.75 kids. So 25.5 kids wore the brace for >12.9 hours (total in the two top quartiles).

...
And by the way, those 90%-93% of kids in the top quartile constitutes just under 12 kids. Call it 12. TWELVE KIDS. Once we know the curve magnitude of those 12, I don't think it will be too early to know if we can all go home.

Jumping in for a few quick corrections,

Based on the discussion of Figure 2 in the report:

* 116 braced children were measured in the dose-response curve and I do not see any note of how they're broken down between randomized and unrandomized.
* The quartiles are divided by hours of wear, and not by numbers of children. You have no way of determining the number of children in each of the quartiles.
* The top two quartiles (not just the top one) are associated with roughly 90% success.
* The dose response was deemed significant "The quartile of duration of brace wear was positively associated with the rate of success (P<0.001)." Significance testing takes the number of subjects into account - whatever the number in each group, there were enough to make the dose response results significant.


The other thing I wanted to say on this issue of not having enough patients is the study was stopped early before they could recruit enough patients. I don't think it's fair to gig the researchers on not having enough patients if you are going to stop their study. What am I missing? There are not enough patients but it is no fault of the researchers. It's almost like the panel didn't want a definitive answer and made sure the number of patients would be too low to settle the question.

Hold on a second while I turn the world right side up. This, from the paper - "The trial was stopped early owing to the efficacy of bracing." So, more or less the exact opposite of what you state here. I believe the board called the study at either the point at which bracing was deemed effective enough that it would no longer be ethical to assign children to the non-bracing group, or at the point at which there was no reason to go on with the study because they had proved their conclusion. In either case, it was called due to proven effectiveness and not the reverse.

OK, that's enough for this weekend. There's lots more that could be corrected, but that's all I have time for.

hdugger
10-26-2013, 11:01 AM
This, from the paper - "The trial was stopped early owing to the efficacy of bracing." So, more or less the exact opposite of what you state here..

Here's Lori Dolan's explanation to Concerned Dad over on the Scoliosis Support forum back in 2009 about when and how they planned on stopping the study:

"Concerned Dad - We do have a set of formal stopping rules for BrAIST. After 1/3 of the required sample has reached an endpoint, we are required to present the data to the NIH and the Data Safety Monitoring Board. These data could show: 1) Bracing is so much better than observation we should stop the trial; 2) Observation is so much better than bracing we should stop the trial; 3) The outcomes are so similar between the two groups we'll never be able to find a significant difference so we should stop the trial; or 4) The outcomes are different and we should continue the trial. "

So, the endpoint turned out to be #1 - Bracing is so much better than observation we should stop the trial.

Pooka1
10-26-2013, 11:24 AM
Jumping in for a few quick corrections,

Based on the discussion of Figure 2 in the report:

* 116 braced children were measured in the dose-response curve and I do not see any note of how they're broken down between randomized and unrandomized.

This point is correct. I was mis-remembering. They combined the intent-to-treat and as-treated for the dose-response graph. They had previously tabled data from just the intent-to-treat but then jumped back to all braced patients for the graph.


* The quartiles are divided by hours of wear, and not by numbers of children. You have no way of determining the number of children in each of the quartiles.

This is NOT correct as far as I can tell. Each of the 116 patients wore the brace X number of hours on average during the six months. There are still 116/4 observations. one associated with each kid, in each quartile so the top quartile is 29 kids. The top two quartiles are 58 kids. Also note the error bars.

If they don't stick with just the intent-to-treat kids, the results will be further criticized. But if they lump both groups they will lose the randomization and they already have gotten gigged on that.

On the issue of stopping the study, yes I understand why they did. I am also pointing out that they are being criticized by people in their field for not having a large enough "n." Obviously the criteria they set before hand was too low if it going to result in too few patients to have confidence in the results that draws criticism from their research community.

Pooka1
10-26-2013, 11:56 AM
Here's Lori Dolan's explanation to Concerned Dad over on the Scoliosis Support forum back in 2009 about when and how they planned on stopping the study:

"Concerned Dad - We do have a set of formal stopping rules for BrAIST. After 1/3 of the required sample has reached an endpoint, we are required to present the data to the NIH and the Data Safety Monitoring Board. These data could show: 1) Bracing is so much better than observation we should stop the trial; 2) Observation is so much better than bracing we should stop the trial; 3) The outcomes are so similar between the two groups we'll never be able to find a significant difference so we should stop the trial; or 4) The outcomes are different and we should continue the trial. "

So, the endpoint turned out to be #1 - Bracing is so much better than observation we should stop the trial.

It sounds like the 1/3 criteria has come back to haunt them. Also, the hypothesis has to do with reaching 50* or not. They are not testing for surgery avoidance other than at the point of maturity. And even at that point, kids north of 45* are probably technically surgical if they are progressing even in brace.

Do you think this first BrAIST pub is a "landmark" pub?

Do you think there is no need to repeat it?

How many of the kids in the top two quartiles on the dose response curve would have to be north of 40* before you reject the connection between between being <50* at maturity and avoiding surgery for life? (I assume everyone here would outright reject all kids between 45* and 50* as likely NOT being successful in avoiding surgery... correct me if I'm wrong.)

Pooka1
10-26-2013, 12:29 PM
Here's another question... how mis-matched in terms of curve types would the quartiles have to be before you decide that the results on "success" can't be taken at face value? That is, what if the majority of the T and double major curves were in the lower wear hours quartiles by chance or for some other reason? At what point would that begin to matter?

Just asking.

hdugger
10-26-2013, 12:32 PM
Do you think there is no need to repeat it?

I don't believe it can be repeated in a randomized study. Ethically, they were only permitted to withhold bracing from patients in this study because there was no level 1 evidence of the efficacy. Now there is. You cannot ethically randomly assign children to *not* have an effective treatment.


. . .

There's not much point in covering the rest of this ground again. You're picking a set of conjectural endpoints out of the air and drawing conclusions/asking others to draw conclusions based on those conjectural endpoints. The standard in science is to draw conclusions based on the available, and not the conjectured, data. As more data come in, we can reassess our conclusions. Until then, it's pointless.

BTW, here's an interesting article to mull over - http://news.cnet.com/8301-1023_3-57604412-93/popular-science-silences-its-comments-section/

"In a post titled, "Why We're Shutting Off Our Comments," Popular Science's Online Content Director Suzanne LaBarre detailed how comments on the Internet can be bad for science at large. LaBarre cites a study led by University of Wisconsin-Madison Professor Dominique Brossard in which 1,183 Americans were given a fabricated story on nanotechnology and were asked how they felt about the subject, both before and after reading fake comments. By reading both civil and vile-trolling responses, the study found that people were swayed far more by negativity.
"Simply including an ad hominem attack in a reader comment was enough to make study participants think the downside of the reported technology was greater than they'd previously thought," wrote Brossard and coauthor Dietram A. Scheufele in an op-ed in The New York Times."

Pooka1
10-26-2013, 12:42 PM
I don't believe it can be repeated in a randomized study. Ethically, they were only permitted to withhold bracing from patients in this study because there was no level 1 evidence of the efficacy. Now there is. You cannot ethically randomly assign children to *not* have an effective treatment.

Given the dismally low repeatability of those other biomedical studies, how is it ethical to NOT repeat it? How did those other studies get repeated if you are correct that they never repeat studies like BrAIST?


There's not much point in covering the rest of this ground again. You're picking a set of conjectural endpoints out of the air and drawing conclusions/asking others to draw conclusions based on those conjectural endpoints. The standard in science is to draw conclusions based on the available, and not the conjectured, data. As more data come in, we can reassess our conclusions. Until then, it's pointless.

All good science is hypothesis driven. You are arguing against that and waiting until the results come in and then assessing it. That is one of the reasons why most published biomedical research is false.

Eventually we will learn the final curve measurements. I am asking people if they can decide on a threshold BEFORE that happens so they can honestly assess the results. If you do it after then you are probably being swayed by the results.

Pooka1
10-26-2013, 12:54 PM
BTW, here's an interesting article to mull over - http://news.cnet.com/8301-1023_3-57604412-93/popular-science-silences-its-comments-section/

"In a post titled, "Why We're Shutting Off Our Comments," Popular Science's Online Content Director Suzanne LaBarre detailed how comments on the Internet can be bad for science at large. LaBarre cites a study led by University of Wisconsin-Madison Professor Dominique Brossard in which 1,183 Americans were given a fabricated story on nanotechnology and were asked how they felt about the subject, both before and after reading fake comments. By reading both civil and vile-trolling responses, the study found that people were swayed far more by negativity.
"Simply including an ad hominem attack in a reader comment was enough to make study participants think the downside of the reported technology was greater than they'd previously thought," wrote Brossard and coauthor Dietram A. Scheufele in an op-ed in The New York Times."

There is a MUCH better reason to not have comment sections on technical matters... most/all people commenting have no relevant training or understanding to be commenting.

I have been banging on and on for years about how ridiculous it is for this forum to have a research section. There is exactly one person who has been on here who is known to have relevant training in this field. The only legitimate use of the research section would be to have that researcher posting stuff. One person. At that point, why bother?

What I have been doing is in the few general science areas, I can try to comment. That is MUCH easier than doing the research in this area. Anyone with science training can make the comments I make. In general, review is much easier than the actual research. But beyond those few general science issues that can be picked out, I quote actual authorities in the field. Of course those are conversation stoppers as we have seen until someone posts an opposing quote from another researcher which is extremely helpful to let people know the range of thought among researchers in a given field. That is valuable.

Pooka1
10-26-2013, 01:04 PM
And that is cancer which is much more likely to be life to death than scoliosis.

http://news.sciencemag.org/funding/2013/10/complete.-repeat-initiative-gets-1.3-million-try-replicate-cancer-studies


As several scientists told Science last year when the initiative got off the ground, Iorns is tackling a significant problem in biomedical research: the fact that many published studies can’t be repeated, and that many researchers aren’t enthusiastic about simply replicating what someone else has already done. As she stated earlier this week, the new funding will be critical in “helping to institutionalize scientific replication.”

Not repeating studies like BrAIST is a part of why most published research results are false. See articles mentioned upthread for why.

If BrAIST went the other way and showed no real difference between the observation and bracing, it STILL would need to be repeated. You have to grasp how hard it is to do this research.

hdugger
10-26-2013, 01:19 PM
I am asking people if they can decide on a threshold BEFORE that happens so they can honestly assess the results.

There are only two populations who need to decide on a threshold, and you and I are not in either.

Doctor's need to decide whether it makes sense to prescribe a brace, in a specific case, and families being offered braces need to decide whether or not to accept that treatment.

Everyone outside these two populations is just standing on the sidelines kibitzing. Which would be no nevermind except that, according to the research, their negative comments are unduly influencing at least one of the populations trying to make the decision.

hdugger
10-26-2013, 01:44 PM
This is NOT correct as far as I can tell. Each of the 116 patients wore the brace X number of hours on average during the six months. . . The top two quartiles are 58 kids.

I'd decided the other way because of my preconception that patients generally did not manage to wear their braces for that many hours a day. Apparently that's wrong, if half of the kids managed to wear them for over 13 hours a day for 6 months, and likewise managed to avoid surgery in 90% of the cases. So, only 1/4 wore them infrequently? That sort of surprises me, but I'm willing to accept it as so.



If BrAIST went the other way and showed no real difference between the observation and bracing, it STILL would need to be repeated.

Yes, they could repeat it if no real difference was found. Then it would not be considered unethical to withhold the treatment, since the treatment was not proven to be effective. It's only when a treatment is found to be effective that they can't simply randomize patients to not receive it.

Pooka1
10-26-2013, 01:45 PM
There are only two populations who need to decide on a threshold, and you and I are not in either.

Of course. We are lay people. This is obviously just for learning purposes.


Everyone outside these two populations is just standing on the sidelines kibitzing. Which would be no nevermind except that, according to the research, their negative comments are unduly influencing at least one of the populations trying to make the decision.

That's why I quoted several researchers in this field upthread. Their cautionary comments should probably be considered to be taken on board, yes?

Pooka1
10-26-2013, 01:46 PM
Wait a minute... are you including my pointing out that the final curve measurements are not known is a "negative" comment?

Pooka1
10-26-2013, 01:52 PM
Yes, they could repeat it if no real difference was found. Then it would not be considered unethical to withhold the treatment, since the treatment was not proven to be effective. It's only when a treatment is found to be effective that they can't simply randomize patients to not receive it.

But it is known that only a small percentage of these studies are able to get the same result when you repeat it. The conclusion can still be wrong. We are talking hard bracing. Why does Dr. Hey say bracing, UNlike chemotherapy for cancer, or appendix removal for appendicitis, is STILL a choice?

Another surgeon I quoted openly wondered if these results would change the treatment. Apparently at least some experts in this field are less persuaded by the study than lay people.

Pooka1
10-26-2013, 01:54 PM
I'd decided the other way because of my preconception that patients generally did not manage to wear their braces for that many hours a day. Apparently that's wrong, if half of the kids managed to wear them for over 13 hours a day for 6 months, and likewise managed to avoid surgery in 90% of the cases. So, only 1/4 wore them infrequently? That sort of surprises me, but I'm willing to accept it as so.

By the way, these types of graphs may be commonplace in the medical literature (I don't know) but I wonder if these results can be presented in a more straightforward fashion where lay people don't have to guess what is being shown.

hdugger
10-26-2013, 02:00 PM
""Simply including an ad hominem attack in a reader comment was enough to make study participants think the downside of the reported technology was greater than they'd previously thought," "

plus


There is something funny about them stopping the study early . . . That is one possible explanation why they didn't publish the bottom line data. It smells of politics. Stopping the study early at the point it was stopped for the reasons stated is objectively bizarre as far as I can tell. . . . There is something funny here. The authors are going to be taken to task on this. . . . I am hoping a political stink has not invaded this study . . . Imagine the fall out . . . Would there be any credibility left whatsoever?


= readers "thinking the downside of the reported . . . was greater than they'd previously thought"

Pooka1
10-26-2013, 02:02 PM
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
10-26-2013, 10:03 PM
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
10-26-2013, 10:17 PM
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
10-27-2013, 12:39 AM
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
10-27-2013, 01:52 AM
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
10-27-2013, 07:38 AM
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
10-27-2013, 07:39 AM
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
10-27-2013, 10:57 AM
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
10-27-2013, 11:05 AM
How do Dr. McIntire's comments differ from what I said? Were they libelous/slanderous?



blah blah blah -

Pooka1
10-27-2013, 11:09 AM
, and the rest of the back and forth is really no nevermind

Then why accuse me of ad hom?