Growing pains

Just a question for Dr Hunt, this is not my field, but I have conducted studies with human/tissue subjects, in particular amputated limbs.
So, did the Ethics Committee that you submitted to for a trial on humans (juveniles) make any comment about the background Lit review, exclusion criteria, power of the study and more to the point were they happy about the progress report after (whatever the number of subjects) you/they elected?
The usual Mantra is Happy Ethics Committee, happy study. Therefore Mathew, you've justified all your hard work.
Regards
Ros

 

The original manuscript, 10K words, 42 pages long, complete with extensive hyperlinks to original articles that substituted for the bibliography, along with 45 minutes of patient interviews and approx 11 minutes of animation was sent to the reviewers and to PMM. Not sure if an Ethics Cmte was involved in the process. Perhaps Kevin can comment on that, a he has had numerous articles published by a similar fashion.

 

What a spectacular display of just how badly you understand the research process...

 

Perhaps...but I'm much more concerned about finding solutions then the "process", which seems to be what British and Aussie Pods are more concerned with. So be it. I find it interesting, however, that you and others would denigrate Dr. Valmassy and a Vascular Surgeon that reviewed my work, never once mentioning the lack of "process" as witnessed in the original manuscript. I'll be sure to forward your concerns to them.

You might be interested to note that the original manuscript had lots of jpegs attached of lateral and AP plain film radiographs that also demonstrated, quite adequately, patterns noted with these patients as a group. You might have learned something....then again, maybe not. But if it makes the article more palatable for you, then call it an opinion piece and not a research project. All we've ever asked is for practitioners to test the hypothesis. Better patient outcomes are the ultimate goal, and it takes seconds for anyone to test my "conjecture".

 

So let me get this right: you conducted a clinical trial on children in the absence of ethical committee clearance? Do you have any concept of what you have done? I would have been sacked for that. Rob

 

Really? You would've been sacked because you treated children? That's all I did...take X-Rays, take negative cast impressions, dispense orthotics and conducted patient/parent interviews afterwards. I'll forward your concerns to Dr. Valmassy.

 

It is now late - I am on the way to bed. I really cannot be arsed to deal with someone that has so little true understanding of the research process. Frankly, I find your approach scary. At sometime in the future, you may like to inform me as to why I have been reported to Valmassy - later will be fine. Rob

 

That?s what I have been trying to tell you for 2 months already, back when you were telling Dr Evans to get over herself.

What you wrote is your Opinion, you haven?t proved anything you need to do the research

:bang:

and by the way Drop the jingoistic attitude you might learn something

 

Not once did I read your dissent towards Angela Evans when she excoriated me for not mentioning osteomyelitis and cancer in my article, yet she never mentioned those differential diagnoses in either of hers. Double standard on her part? Hypocrisy on yours?

It appears that there's a rift between UK/Aussie and US Pods, because the Podiatrists over here are appreciative of my efforts, while those overseas continue to attack the process and means by which I conducted, submitted and had published the information. Not once did Dr. Valmassy mention what you, collectively have here. Neither did Dr. Hinton MD...neither did Dr. Scherer...neither did Dr. Rehm, (both of whom are on the Contributing Board at PMM), neither did Dr. Block, editor of PMM.

Now who's opinion should I value more...yours, or theirs? Boy...that's a tough call, eh?

 

who?s opinion ? or just liking what you hear from one side

and because I never really said anything more than the piece is your opinion and you need to prove it all the rest of the post is just strawman rubbish

 

Seriously?! I mean...

Seriously?

You think the ethics committee is involved after a study is carried out?

 

Trying to focus on the other stuff, but I'm admitting that I'm having a hard time dealing with the incredulity of somebody who aspires to be a researcher who does not know that you're supposed to get ethical approval before conducting medical research on children!!

Anyway.

Yes, yes. We all get it. You're a bigot with a problem with anybody who is not American and / or who does not agree with you.

Neither, come to that, does Mr Rothbart. His model is one of ascending motor patterns and a rather exaggerated version of kinetic chain theory. Never mind.

I struggle to put this in terms you will understand, but I remain open minded on the subject. The evidence for bone density is quite compelling, but so is the evidence for successful care with muscle stretching and orthoses. I mistrust the idea that is is psychosomatic, and the fact that we've found no association with foot posture makes that seem suspect. I believe that its probably a hetrogenous condition, the variation in presentation suggests to me we are dealing with a syndrome rather than a discrete disease process.

So I tell my patients that we don't know for certain what causes it, but we suspect that it's an overuse syndrome of some sort, which stretching orthoses seems to help. And I introduce my students to the range of opinions and evidence and let them decide for themselves.

The truth is, there is no slam dunk evidence for any one model. That's why your confident assertion that "GP is X" is so bizarre. Such clear cut and confident conclusions are rare, and require extraordinary evidence to support them. Your evidence, such as it was, does not even make the grade for ordinary.

You mean this?

All that means the presenting pain is not usually in a joint. As he says, shins, calves or thighs is most common, although I've had a few present with pain in the knees. Never in the STJ that I remember. Seems simple enough. He's commenting on where it presents, the clinical characteristics, not the aetiology. In fact he is at pains to say.

Anyway.

,

Really? Which one of your 4 plus hypotheses would that be for? And do you realise how weak anecdotal evidence is? That's why AE followed it up with a proper study, which showed her anecdotal evidence to be flawed.

And nope. Lots of nope.

Lets pretend for a second that palpating the sinus tarsi / STJ for pain in small children was a clinically validated measure. Lets pretend further that you can be sure that we do not have to worry about subconscious bias on the part of the tester, or subconscious compliance on the part of the child. Lets pretend we're also testing a control group.

What that would show, if all of that were given, would be a CORRELATION between tenderness in the STJ capsule and pain at night. It would still not indicate a CAUSAL link. You understand the difference between correlation and causality?

A thought occurs. If (one of) your hypotheses is that GP in the legs is referred from the STJ, why do you imagine it does not ALSO hurt in the STJ (unless you prod it)? I'm struggling to think of another type of radicular pain which always hurts in a remote location and never in the original location.

 

Podiatry is different in the US than elsewhere. Podiatrists here are allowed to perform surgery, take X-Rays and prescribe medications. No ethics cmte approval is required to treat patients. In fact, we can treat patients under the age of 18 without a signed informed consent from the parent if the treatment is conservative. If surgery is required, then an informed consent is required from the parent.

In the case of this pilot program, however, the parent submitted to having the child treated conservatively and was videotape interviewed along with the patient, which is above and beyond what is required. No breech of ethics...therefore, no ethics cmte approval was necessary. I can tell you this also...the parents and the patients were THRILLED to participate, as they realized they were part of something significant. They were even happier that the pain had resolved.

Yep...you're more concerned with the process than the information. Typical. Can I quote you in my upcoming presentation to nurses, docs and patients? It would be helpful.

 

Isaacs wrote: "I struggle to put this in terms you will understand, but I remain open minded on the subject. The evidence for bone density is quite compelling, but so is the evidence for successful care with muscle stretching and orthoses."

So how do you discern between stretching and orthotics when assessing efficacy? Do you eliminate stretching and just use orthotics, or vice versa? How do you know both are needed if you don't discriminate effectiveness between the two...or are you just hedging your bets? And if stretching does, indeed, seem to work, then are you suggesting the triceps surae is the problem here...or are you having the patient stretch other muscles as well? You stated that you remain open minded. Could've fooled me. One that is open minded would test, no matter how briefly, or on perhaps a minimal number of patients, new ideas and concepts that they might be able to incorporate into their own practices. You appear as one that is anything but open minded, because you're more concerned about the presentation of material than the content itself. The efficacy of orthotics is, as you've previously stated, well known. But as to how they may work is not understood...at least until now. You can dismiss this statement, as others here already have. But if better patient outcomes is your main concern, than perhaps a different tact may be in order.

You wrote: "So I tell my patients that we don't know for certain what causes it, but we suspect that it's an overuse syndrome of some sort, which stretching orthoses seems to help. And I introduce my students to the range of opinions and evidence and let them decide for themselves."

I'll give you the same quote I gave Kirby, and you're welcome to use it, as it is original: "Life is an overuse syndrome". So go ahead...take the plunge...test my hypothesis on your patients...it's easy, simple and takes just a seconds. You'd be surprised how appreciative the patient and the parent will be when you not only solve their problem, but describe in your own terms what "may" be causing the problem. You don't even have to give me credit. Their successful treatment and your epiphany is quite enough....even if I never know about it.

Cheers!

 

Redundant post

 

The Galileo gambit:

http://www.skepticalraptor.com/skep...l-fallacies/galileo-gambit-logical-fallacies/

https://en.wikipedia.org/wiki/Association_fallacy#Galileo_Gambit

http://rationalwiki.org/wiki/Galileo_gambit

 

LOL! I'll forward your thoughts to those that reviewed the article.

 

Matt, this is not a rift between US podiarists and the rest of the World. Protection of Human subjects for research has become a much bigger deal since you graduated.

http://history.nih.gov/research/downloads/helsinki.pdf

To get published in an actual medical journal (not a magazine) you need have approval from a human subjects review board when you do research on human subjects. We here in the states aren't up to date with the rest of the world because we don't have PhD. podiatrists. We don't have to done research to teach here.

Eric

 

Eric-thanks for the link. But according to Sec. II: Medical Research Combined with Clinical Care (Clinical Research)...

I abided by all the criteria set forth...even though I wasn't aware of the changes made. It's called...good medicine, crossing the "T's" and dotting the "I's". Perhaps performing surgery has taught me well the necessity of doing so. No one I offered this material to in its entirety, discussed what many of the Brit and Aussie contrarians here have offered...not one. And there's some fairly prestigious Docs that did just that...review the material. If this matter is a real concern to you, I suggest you contact them and offer your grievances. Until then...

Cheers!

 

I find that hard to believe. Seriously, nobody said "ah, you ought to state your hypothesis as such", "maybe you could describe your orthotic protocol" or "statistics are fun, hey you could do some"? Or words to that effect?

Really? Nobody?

I ask because I've read a lot of really excellent work from non UK / Oz authors. Indeed I would not have opined that there was any difference based on nationality. , I'm afraid I just don't buy that slapdash writing is broadly accepted over there.

Oh and seriously? Contact people and comment on our view of your report of what they said?! "Dear Dr valmassey, this guy said you said his research was good and it's not, what gives?". Really?

Is this really your last argument? That we should take your word that someone respected said nice things, and thus should disregard the gaping holes here? At least have the gumption to make your own arguments. Standing on the shoulders of giants is one thing. Hiding behind them is another.

 

Anyway. If you wanted to talk about your actual theory, rather than pouting about how mean everyone is for not accepting it, I wonder if you might address this point.

 

Just read of post#133, obviously you are entirely correct on the issue of consent in that context.
However, in the context of a research project there are a few things to bear in mind. All subjects must sign a document that outlines the background and purpose of the trial, it should contain and explain adverse reactions to the intervention and state quite clearly that the subject can withdraw from the trial any time without any prejudice. Without this there are legal implications.
Also the heading of the document implies that the Institution named (though whatever their protocol is) is aware of that trial. There would be disciplinary issues should those protocols be circumvented.
Ethics can be somewhat daunting in their complexity so that is why there are Ethics Committees, they are there to help, not to hinder. Of course they are there primarily to protect the patient.
Regards
Ros

 

What concerns me most in this whole exchange, is a sad, actually sad is not a strong enough word, lack of understanding about research methods, their use and abuse, and ethics, that had been agreed worldwide. Just lose UK/Ozz vs US arguments - they are bollocks. My advice, Mathew, is to go to Google, and look up two phrases 1) Helsinki agreement, to find out what the modern basis for ethics is, and 2) Tuskegee experiment to find out about probably the biggest abuse of this. If you are not aware of these issues, your education is sadly lacking - my advice is to deal with it.

 

"I'm only interested in helping patients not ticking boxes you un-American scum" argument in 5, 4, 3, 2....

 

Not that this post helps the whole process

Ps hows thing Rob long time no rant and stuff

Me having a break, then you

 

Yeah, been a while. Good to see you buddy.

 

Eric-clinical and observational trials in the US are governed by the National Institute for Health. Further, informed consent is required for those that participate in such study.

https://clinicaltrials.gov/ct2/about-studies/learn#WhoCanParticipate

The question of whether, or not, one can conduct these studies is based upon whether the study itself is federally funded, and if the medical device is FDA regulated.

"Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by the FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document."

Considering that orthotics are not regulated by the FDA, it appears that my clinical trial was totally within the boundaries of appropriate protocol, especially considering that I delivered informed consent prior to inclusion. The patients' participation in the videotaped interviews further verifies this fact.

As a side note, I have discussed this topic with a number of docs and my own patients that were not a part of the clinical trial, but are appreciative of the information I have provided them and are looking for relief. Without exception, they all believe that this debate here is a consequence of "professional jealousy". I would not like to believe that any of the Podiatrists here in the US would stoop that low, but we already have read the effect that this article has had here at PA with the foreign contingent. First...it was the method of study, then it was the lack of a placebo orthotic, then it morphed into a lack of references and now it is in re to not obtaining ethics review clearance, even though it is not required.

A prominent Podopediatrician recently told me that I should view the criticism as a sign that I'm actually DOING something. I'm comfortable with that.

Cheers!

 

hahhaa what a load of Bullsh!t and God bless aMerica once again

you need to get over yourself , all of those points are valid as are the questions re your opinion on the causes of Growing pain " the referred pain "

Now I am not really helping the process

best I be off then

 

5 pages and nearly 150 posts later.... We are getting a bit repetitive here.

We get it. The original manuscript was bigger. (How many pages was it again?) Doesn't automatically make it better. Why don't you upload it for us to read instead of just telling us all about it. It's very easy to promise something is a game changer when you are never going to show it to anyone!

So no less than 8 mentions for Dr Valmassy and at least 4 for "someone prominent". Bravo. Interesting that they have not come on here to provide support - I presume you have told them about this thread?

Matt; the above quotes highlight that you aren't even engaging in discussion here. If you really want people to take you seriously then stop repeating yourself and make a better argument!

 

Yeah, I'll be interested in that bit.

 

Griff-were you the one that originally dismissed the pilot study because I failed to use a placebo orthotic? Even if you aren't, could you please explain to this audience what is a placebo orthotic? Perhaps you should contact Dr. Valmassy yourself...and/or the licensing Board here in California in re to my supposed breach of informed consent. If you need further instruction on how to accomplish this, contact blinda as she has a history of doing just that.

 

Alright, buy that, although I do not agree with you. What refereed journal were you published in?

 

Laugh out loud all you want...doesn't really matter to me. The conjecture of other Podiatrists here in the States and my patients that I have discussed this with, are consistent with each other. I stand by my statements, here and in that pilot study. If better patient outcomes are important to you, then dismissal of the information offered is, IMO, placing personalities before principles while millions of patients await relief. Hope this helps.

 

Any change I might take your mind on the question of referred pain?

 

Refereed? Please contact Dr. Block and forward your concerns to him and his editorial staff. Then, please forward your concerns to aforementioned docs that reviewed the material. Who is Ros Kidd?

 

Haven`t the faintest idea to what you are referring to, Matthew. Care to elaborate?

 

So your response to my post suggesting you change your approach and stop repeating yourself is to not change your approach and to just repeat yourself?? (Chalk up number 9 for Valmassy mentions now). You really don't get it do you Matt. THIS IS NOT A VALID ARGUMENT. Your ability to commit logical fallacies may be even greater than your terrible understanding of the research process.

You are ducking and diving discussion/debate sir. Not even being clever about evading it either - just saying the same things over and over which are as invalid as they were the first time you said them. I am glad this thread is in the public domain so that educated people can read through it and make their own minds up.

 

Were you the one that mentioned placebo orthotics? I don't have the time to wade back through the posts here at the moment...nonetheless...Simple question. So...what is a placebo orthotic?

If the article is covering too much territory for you, and/or the pilot study wasn't conducted the way YOU like...in the final analysis, does that really matter? It takes just a second to prove me right, or wrong with your patients...adolescents with GP's or adults with RLS....just a second of your time. Perhaps it is too much to ask. Carry on.

 

I am sorry, I had thought I was talking to a tertiary educated person. This research - where was it published? That is a simple enough question.

Ros Kidd, I share her bed. However, do not ever think her opinions and mine are from the same place.

 

Nope. Not me. Nice try.

It has nothing to do with being the way I would like it. Minimum standards for research are reasonably well agreed upon worldwide. Read a book. We probably shouldn't even call what you have done 'research'. That's an insult to those who actually do it.

Research is not about proving people right or wrong (dial down the ego a smidge old boy). It is about answering questions as best we can. It is about designing protocols to answer these questions, and doing so in the best possible way (whilst understanding and embracing the limitations of all research). Again, read a book.

What you don't seem to understand is that no matter the result of me taking a few seconds in my clinic to "test your theory" it doesn't actually answer any questions. Read a book.

Matt: would you like me to recommend you a good research methods book that is aimed at undergraduate students?