This dichotomy keeps coming up here at Podiatry Arena and other places. Most recently in this thread:
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No evidence for foot orthoses in children (notice the questions by clinicians directed at the researchers about the type of foot orthotics used)
Previously it came up in this thread:
Effectiveness of Foot Orthoses to Treat Plantar Fasciitis (notice the really poor understanding by clinicians of just what is a randomised controlled trial)
In a post in this thread:
The 5 great FALLACIES of podiatric biomechanics, Kevin Kirby posted:Researchers often complain that clincians "just don't get it".
Clincians often complain that researchers "just don't get it".
I am a researcher and a clincian and I think "I get it".
What are we going to do about this?
How can researchers conduct clinical trials so that clinicians can "get it".
How can clinicians get researchers to see where they are coming from so they can "get it"
What say you?
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Last edited: Jul 13, 2007
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Dear Admin
Could it be that, to misquote Simon Spooer (from 5 Great fallacies), "scientific research deal in probabilities" and those probabilities can be subjective.
And so researchers often base their conclusions on the statistical significance
and clinicians base thier conclusions on clinical significance these two criteria are often not mutually conclusive.
Researchers may understand but very rarely indicate the limitations, errors and shortcomings of thier research. The clinician may have no idea about these limiting factors and so each disipline will have a different perception about the meaning of the stated results and conclusions.
Limitations and error have a very important role to play in data evaluation and in my opinion should be discussed more within a paper.
Cheers Dave Smith -
Craig and Dave:
Here are a few of the many problems with the researcher vs clinician lack of communication/understanding regarding foot orthosis research:
1. Most clinicians don't know much about research protocols, statistical methods and kinetic and kinematic analysis.
2. Most clinicians are not familiar with the existing literature on foot orthoses.
3. Most clinicians wouldn't know a good research project from a bad research project by reading the research paper.
4. Most researchers don't have a clue on how to examine a foot, or establish good foot orthosis prescription protocols for research.
5. Most researchers don't understand that foot orthoses can have a near infinite set of design parameters that will affect foot function and patient comfort.
6. Most researchers don't understand the importance of proper shoe design and fit along with the orthosis in order to optimize patient results.
There are more, but I need to get back to work. :eek: -
Me both clinician and researcher. I say:
VESTED INTEREST
On all sides....... -
Nice series of papers here (Sorry only abstracts- would be helpful to link to full papers if that's possible Craig?). As I recall, the last in this series explores the problems of clinical versus statistical significance
http://www.apodc.com.au/AJPM/Contents/Full text/Vol33/abstracts/Vol33 3 77-84abstract.pdf
http://www.apodc.com.au/AJPM/Contents/Full text/Vol34/abstracts/Vol34 1 5-14abstract.pdf
http://www.apodc.com.au/AJPM/Contents/Full text/Vol34/abstracts/Vol 34 4 125-131abstract.pdf -
I've said it before (most recently here:http://www.podiatry-arena.com/podiatry-forum/showthread.php?t=4116), and (unfortunately) I'll have to say it again... read the thread, I can't be bothered.
Here's an analogy to think about: if I reported on a drugs trial to treat syphilis where n =6000000, but each subject had received a different drug, what would your reactions be to my research design?
Lets go on a stage, lets say I found no positive outcomes:
should I conclude:
This study found no evidence to justify the use of drugs in the management of syphilis.
Or:
This study found no evidence to justify the specific drugs tested in the management of syphilis in the subjects that these individual drugs were tested in.
Or:
This study found no statistically significant differences in the outcomes measured in the subjects that these individual drugs were tested in.
????
Go ponder.
P.S. In the tabloid world in which we live, which of the above three conclusions appears the more "sensational" and likely to draw "fame" for the researcher?
Vested interest. Hmmmmmmmmm.Last edited: Jul 13, 2007 -
Simon
"VESTED INTEREST"
Agreed, bias can be very difficult to erradicate even if unintentional.
BTW I have a vested interest
I am very interested in Vests
In Vests I invested heavily
My bank account relies
primarily
That my investment in vestments are not
contrarily
viewed.
I thank you :p Danny -
QUOTE Simon Spooner
"Here's an analogy to think about: if I reported on a drugs trial to treat syphilis where n =6000000, but each subject had received a different drug, what would your reactions be to my research design?
No control, No statistical power, the inter and intra variability of each group (of one subject) could be attributable to chance or real effect but it would not be posible to show.
Lets go on a stage, lets say I found no positive outcomes:
should I conclude:
This study found no evidence to justify the use of drugs in the management of syphilis.
This conclusion cannot be extrapolated from the results
Or:
This study found no evidence to justify the specific drugs tested in the management of syphilis in the subjects that these individual drugs were tested in.
One could make this statement but the statistical evidence is very weak, Clinical eveidence may be stronger if there were a control and there was no significant diffrence between controls and experimental groups.
However the significance of any conclusions must be weak
Or:
This study found no statistically significant differences in the outcomes measured in the subjects that these individual drugs were tested in.
????
This is a true statement. Because the design was poor the statistical significance had to be low oe zero. It is not a very useful statement however even tho it is true and might appear sensational
Go ponder.
P.S. In the tabloid world in which we live, which of the above three conclusions appears the more "sensational" and likely to draw "fame" for the researcher?
Vested interest. Hmmmmmmmmm." -
I think the issues are deeper than statistical vs clinical significance. Take a look at the thread we had on Extracorporeal Shock Wave Therapy and the length that supporters of ESWT go to in an attempt to discredit the publications that show its not effective, yet are not prepared to hold the same publications that show it is effective up to the same standards of evaluation.
To those without a vested financial interest in ESWT, it is the studies that show it not to be effective that have the soundest methodologies.
We are all intelligent people with University degrees, why can be be so blind? -
I keep thinking of the "in my hands, this is really effective" argument. What we really need is clinician batting averages. Once that orthosis leaves your office how often does it really work. You can't go by the patient never came back. You could go by how often the patient asks for a second pair, but that's not enough. What we need is someone to pay to do the research on success rates for those who pay attention to their protocols versus those take a cast and use lab "discretion" on their prescription.
Kevin's point about orthotic modifications is a good one. There are a lot of times where the patient comes back and a simple modification to the orthosis makes a succesful outcome out of an unsuccesful outcome. Modifications should be included in the grading of a protocol.
cheers,
Eric Fuller -
The problem with audit type research is that it does not isolate the effects of foot orthoses from other concurrent treatments. Personally, I rarely use foot orthoses in isolation in my management of patient's complaints.
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Guest
Re: The researcher vs the clinician
I didn't say anything about it being equivalent; these are your words not mine. None of us is free from bias nor vested interest. Are you suggesting that a researcher has no vested interest in the paper that they have put forward for publication?
Yeh, just like this chap:
http://news.bbc.co.uk/1/hi/health/6289166.stm
& all the others who carry out research on a product for which (coincidentally) they have financial or other forms of backing from the company that manufactures it and/ or have vested interest in that company.
Think about it, which studies are memorable and have created the greatest number of letters to the Editor and discussion from peers? When was the last time you wrote to a Journal to praise the author? Controversy gives coverage; favourable results rarely make the news nor stir the responders.
I'm not saying it's right, but I don't think it should be swept under the carpet either.
Re: The researcher vs the clinician
I think that it is essential that researchers don't draw sweeping conclusions which extrapolate beyond the data such as:
"This study found no evidence to justify the use of in-shoe orthoses in the management of flexible excess foot pronation in children"
I also think it is essential that researchers don't become segregated from clinicians by becoming overly defensive when their work is critiqued as occurred here:
http://www.podiatry-arena.com/podiatry-forum/showthread.php?t=2527
Last edited: Jul 16, 2007
Hi all,
This discussion has been prompted by Craig after seeing a recent thread about an unfavourable research paper going down a familiar path.
I'm only a minnow in the research arena with moderate appreciation of some aspects and close to zero retained skills in understanding the statistical testing.
Nevertheless, I took exception in that previous thread to the researchers stating a conclusion that to me had no VALIDITY whatsoever. They absolutely, cannot conclude that from their study 'customised orthoses are ineffective in treating flexible pes planus ' in children. They can say that the methodology they used was ineffective and no one could argue with that.
I do appreciate that researches need to minimise the number of variables to reduce confounding elements in their projects but then they cannot then use a broad brush to describe what they did. As Hylton saidAnd so they need to be very specific about saying that the results apply to the 'cut' they took and not to everything.
I also appreciate that clinicians are seriously hampered by holding on to belief systems that are not prooven in any way. This then limits options in the resolution of clinical problems. In all probability the stronger the belief system the more limited is the approach.
A couple of other topics for another paragraph could be on "intention to treat" being a requisite of such research projects and being honoured.
"Peer review" also relates to experts in that exact field and also needs to be honoured.
Cheers
Shane
Re: The researcher vs the clinician
Perhaps they should have stated
"This study using the outcome measures we used found no evidence to justify the use of in-shoe orthoses of the type we used in the management of flexible excess foot pronation in children"
Guest
Re: The researcher vs the clinician
Simon:
"Vested interest on all sides" sounds a lot like equivalence to me, but you're splitting hairs here.
Conflict of interest in relation to industry-funded trials is a different issue worthy of a separate discussion. You were suggesting (I think) that some researchers have a vested interest in that they benefit from publishing controversial studies. I agreed, but argued that this sort of activity is not common. Your highly atypical example of Dr Wakefield illustrates this point. Also, I would probably argue that in the longer term, there would be a greater vested interest in producing studies with favourable outcomes. After all, who would pay money to attend a seminar in which a researcher tells the audience that what they do doesn't work?
Re: The researcher vs the clinician
Hylton and Colleagues:
For the patient, clinical experience is not only very valuable, it is sometimes life-changing.
For myself, being primarily a clinician that has done some research (but has read very much research), my concern with foot orthosis research is that there seems to be very little attempt to make a true patient-specific custom foot orthosis for a patient in these research projects other than the researchers take a negative cast of the foot, choosing a plate type (with or without a rearfoot post), use a shallow heel cup, put on a generic topcover without any forefoot extensions and then balance all the subjects' orthoses vertically. If I made all my foot orthoses like that for my patients, I would probably be out of business by now due to their low success rate.
As an example, at least a few times a week in my practice, a take a pair of foot orthoses made by another practitioner, I adjust it in the office in a few minutes, make the orthosis go from being uncomfortable to comfortable and the patient then goes from being skeptical of orthoses to being happy that they found a clinician that "knows orthotics". These sort of experiences, repeated time and again, for the past 20+ years tells me that one custom foot orthosis is not the same as another custom foot orthosis and that there are nearly limitless design permutations of foot orthoses that can be used to achieve optimum therapeutic results. This also leads me to suspect that the generic, non-specific casted orthoses used by so many researchers in their studies are not truly patient-specific custom foot orthoses, but rather are non-specific casted orthosis designs that have allowed the reseachers to simplify their research sufficiently to attain statistical significance one way or another. Is this the best researchers can do? I know it isn't.
Ethical clinicians base their practice on getting patients better, resolving their pain, and improving their lives, hoping that there is "any evidence" and sometimes regardless of what the "best available evidence" says. Even though I understand the concept of "evidence based medicine", the evidence for effective treatment of many podiatric pathologies is simply not there for many patients who suffer daily with foot and lower extremity pain and disability. Because of this fact, I am happy to join the ranks of the alternative/complementary therapy professions if this means that my patients are getting better, are happier and are leading fuller lives than those clinicians who handcuff themselves in practice by solely by using the "best availalble evidence".
For example, where is the evidence for the therapeutic efficacy for the medial heel skive technique? There is none. I have been using the medial heel skive on orthoses for over 17 years (and many other podiatrists around the world have also used the technique) to treat literally thousands of patients with symptoms related to abnormal magnitudes of subtalar pronation moments. In the world of evidence based medicine, the medial heel skive technique is certainly one of the lowest forms of evidence to the worshipers of evidence-based practice. Funny, but my patients who have gotten better from the judicious use of the medial heel skive technique along with other specific orthosis techniques certainly don't seem to mind one bit that their pain went away and/or didn't need surgery and/or can still walk with their spouses in the evenings without pain. But, hey, what do these people know, they are only human beings with feelings and lives......they don't even have a research degree!!
Certainly clinicians are as much at fault in this discussion as are researchers since many clinicians make orthoses that are worthless for their patients. I could go on and on about poor orthosis design from clinicians much longer than I could go on about poor orthosis design by researchers. However, if researchers want to see what custom foot orthoses can really do for patients, then they need to treat their research subjects with truly patient-specific custom foot orthoses, not non-specific generic casted orthoses.
Good discussion, Craig. Keep 'em coming......
Re: The researcher vs the clinician
Good one, Simon. I still very well remember that episode where I was trying to be funny about plantar fasciitis research and then had my comments deleted by one of the moderators. Guess, he didn't like my sense of humor in regard to one of his departmental colleagues. However, JISCmail did seem to become quite active for a full month or two after that incident on Podiatry Arena. :rolleyes: :eek:
Guest
I understand and you make a good point, Hylton. However I do get tired of researchers and other evidence-based advocates implying that clinicians that use treatment methods that have not yet had randomized clinical trials performed on that treatment method are not practicing the best medicine available for the patient.
Here's a question for you, Hylton. Which of the many foot and lower extremity pathologies that podiatrists commonly treat successfully in their practices have had, what you would determine to be, high level evidence to support the continued use of that treatment for that pathology?
You don't already know my answer to that one?? :rolleyes:
I think it would be like trying to get a bunch of biomechanics researchers to develop a consensus document on the best method to research foot orthosis therapy. :cool:
Possibly because terbinafine treats only onychomycosis, when, in the hands of a skilled clinician, foot orthoses can successfully treat the following:
Plantar fasciitis
Peroneal tendinitis
Intermetatarsal neuroma
Sesamoiditis
Hallux limitus/rigidus
Joplin’s neuroma
2nd metatarsophalangeal joint capsulitis
Abductor hallucis muscle strain
Plantar ligament stress syndrome
Plantar intrinsic stress syndrome
Posterior tibial tendinitis/dysfunction
Dorsal midfoot interosseous compression syndrome
Sinus tarsi syndrome
Anterior tibial tendinitis
Achilles tendinitis
Iliotibial band syndrome
Medial tibial stress syndrome
Patello-femoral syndrome
Pes anserinus bursitis
Postural fatigue of lower extremities
Low back pain
Medial compartment osteoarthritis of knee
Lateral compartment osteoarthritis of knee
Greater trochanteric bursitis/tendinitis
Lateral plantar compression neuropathy
Tarsal tunnel syndrome
Metatarsalgia
Plantar neuropathic ulcers
Osteoarthritis of subtalar joint
Talo-navicular joint osteoarthritis
When you have a treatment method that can effectively treat all these pathologies, and the more skilled you get at it the better results you attain for your patients, you tend to get a little more excited about the treatment and the biomechanics behind the treatment than by simply handing someone a prescription for an antifungal medicine.
netizens
In the world of biomagic all things are possible and development in biotechnology should easily see an antimicrobial impregnated orthotic shell, anytime now. :)
toeslayer
Guest
Re: The researcher vs the clinician
Kevin asked:
The best place to find this info is in the list of Cochrane reviews collated here:
http://www.podiatry-arena.com/podiatry-forum/showthread.php?t=2573
I wonder if there is a very practical element to this.
In a previous working life it was common to find that it took approximately 20 years for a new idea to filter from inception through to grudging acceptance and then practical application. All the usual reasons applied including vested interest.
Like it or not, given the best EBM there is still the actual aspect of practical application of that EBM to the patient by a possibly bewildered practioner. Given that the said practitioner may have graduated 10 years ago (and done their CPD to an extent) some of what has been discussed relies upon practitioners being able to access adequate practical tution on some of these things.
Accessing this is not always straight forward and must go beyond attending courses where possibly 50 to 100 attendees are present and practical instruction is almost impossible.
So in Kevins example, If the EBM says that reconstructing an orthosis in a certain way in office is the best then many Pods may find this practically difficult to do as many may need to see it done and be led by the hand for the first time.
Given using a tried and trusted and successful method or having to adapt to using a method based upon EBM, that may be outside of a persons experience, then many will naturally and reasonably default to the former.
This is not so much a clinician versus researcher issue but one of practical nuturing of application in a practioner. This of course is referring to Orthosis adaptation and does not take into account the many variables already mentioned. Hopefully it illustrates the point.
Ian
Re: The researcher vs the clinician
This list covers about 5-10% of what I treat in my practice and none of the Cochrane reviews are specific enough to give a detailed approach of how to accomplish the techniques. So, for the remaining 90-95% of the pathologies I treat in my practice (and to get good clinical results from what the Cochrane reviews do cover), I guess the "best evidence" is my clinical experience, common sense, prior education and the experiences of other talented clinicians. Therefore, this "evidence based medicine" approach that we are all supposed to get excited about hasn't really changed much for me or my patients over my past 22 years of clinical practice other than I now better understand the concepts of "evidence based medicine".
Simon
I know this is a little slow of me but I get your previous analogy of statistics used to measure outcomes of orthotic intervention (I think). You wouldn't use a different drug for each patient to test the effectiveness of drugs on cancer but this is effectively what we are doing with bespoke orthoses since each person requires a unique prescription.
BTW I was also Danny KaySmitt, I used another computer and couldn’t remember my password so I registered with a different name. (did you guess?)
Isn’t there always this problem with statistically evaluating clinical or medical interventions even if the intervention is the same inter subject.?
Statistics are different methods of finding means and medians and comparing them.
But it is convenient to ignore outliers. This is fine if we are grading beans or engineering tolerances but those outliers in medicine are real people and the problem is we don’t know who they are pre intervention. Therefore it may be necessary to tailor each persons treatment rather than use standardised interventions that EBM show statistically to be superior over large groups of people. Unfortunately or fortunately we treat individuals and so perhaps for the best outcome we require individual bespoke interventions that cannot be reliably statistically assessed.
Is this what you are saying?
Cheers Dave
http://www.algeos.com/cgi-bin/sh000..._PORON__4400__Green__100.html#aOB2173#aOB2173
:D
Keep up! ;)
On the subject of EBM i think much of the dissonance stems from the application of double standards. Nobody expects to need a double blind study to prove that enucleating a HD makes it hurt less so we claim it to be common knowledge, common sense, based on a good rational or based on expert opinion. If however somebody comes along with a product we suspect to be bogus, (mentioning no names
BRIAN
)
We say "aha, you have no evidence, we sneer at you with scorn" and similar.
Robert
Pretty much. At best the large trials are testing the prescription protocol. This, as we know, is subject to measurement reliability issues and the ability for the prescription to be accurately produced within the finished devices. If we take a paper recently discussed on this list in which "experts in the field" (note the plural) produced the prescriptions and said devices I would expect inter-tester reliability to be disclosed within the paper.
One of the main problems with orthosis research is that these research papers rarely outline what exact orthosis prescription parameters were used in producing these orthoses. Even something as simple as saying that 4 mm polypropylene plate was used doesn't mean a lot since polypropylene will vary in stiffness with different shapes, foot sizes, orthosis modifications used and with different heating times and temperatures. With Simon's upcoming orthosis FEA lecture at PFOLA in San Diego, I think it is about time we standardized orthosis stiffness/performance issues with material testing machines so that apples can be compared to apples from one research project to another instead of apples always being compared to oranges.
How about it Simon? Any ideas on the best physical parameters to measure with a material testing machine for mechanical characteristics of orthoses??
Here are some starters:
1. Orthosis medial longitudinal arch load vs. deformation curve.
2. Orthosis lateral longitudinal arch load vs. deformation curve.
3. Force required to achieve 5 mm deformation of medial longitudinal arch.
4. Force required to achieve 5 mm deformation of lateral longitudinal arch.
5. Distance from medial edge of orthosis longitudinal arch to corresponding area on foot in non-weightbearing STJ neutral position of foot.
6. Inversion-eversion moment required to produce lifting of orthosis medial-lateral anterior edges.
Last edited: Jul 18, 2007
Kevin,
Let me first put on my researcher head...:p
Surface stiffness is basically = force/ deformation
Which is what you are suggesting measuring above Kevin.
Physical testing in a material testing machine has to overcome the physical limitations of the loading apparatus i.e. the jig set-up, I think greater potential lies in the application of FEA since we can link with in-shoe pressure plate data and simulate what is really occurring in 4D with "real" loading patterns (You never did send me that data Craig :( ) and create many virtual orthoses without the need to ever actually manufacture them. Indeed, in the FEA world we are not limited to looking at deformation at discreet areas of the orthoses such as the medial or lateral longitudinal arch, but can look at this in 3D across the whole of the orthoses. Although, for some aspects of the research it may be useful to validate the models through physical testing.
Surface stiffness has been successfully manipulated to decrease injury rates by 50% and improve efficiency in runners (McMahon TA and Greene PR. The influence of track compliance on running. J Biomech 12: 893–904, 1979). It is also a key aspect of Nigg's paradigm (Nigg BM. The role of impact forces and foot pronation: A new paradigm. Clin J Sport Med 2001;11:2-9). So there appears great potential here. Early days though and worth remembering that both the foot and the shoe deform under loading too. Making this much more complicated- :cool:
N.B. I have vested interest in this research since I am the one funding it, carrying it out, writing it up and presenting it. And would I prefer it to result in provocative findings? Yes, because provoking a reaction is the aim. That's why we do it ;)
Actually, a couple of studies show that debriding hyperkeratotic lesions has the potential to make them worse- so perhaps we do need the research.
Yet another perfectly good presumption goes spiraling down in flames. You love doing that to me don't you! :mad: ;)