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Re: Look at this validation study guys, worth reading!

 
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Re: Look at this validation study guys, worth reading! - January 14, 2005 7:07:00 AM   
Jon Newman

 

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Thanks for the reply,

Your concern about stand alone evidence is well taken, which is why I emphasized the intersection of those things. Patient values, I think, strongly influence outcomes. I have had great success colluding with patients who value ultrasound and I was once reprimanded for telling a patient that I didn't think it would be helpful based on the evidence. They complained to my bosses, stating that ultrasound had helped them in the past. Like clinical experience and values, "evidence" cannot stand alone.

And I agree, I hate those unreliable measurements that can be felt one way by one practioner but differently by another.

jon

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Re: Look at this validation study guys, worth reading! - January 14, 2005 7:18:00 AM   
Bournephysio

 

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First, I would like to make it clear that no matter where a study is published or who publishes it, it needs to be read critically. Some things make it through the review process that shouldn’t. Some of the bigger non-physio journals don’t really understand physiotherapy. There was one journal that published a physio vs chiro paper which was really a mckenzie vs chiro paper. Most of the medical doctors reading the journal would not recognize the difference.

Second, I take exception to the claim that the evidence against ultrasound conclusive. There are now two studies showing the effectiveness of ultrasound, one on calcific “tendonitis” of the shoulder and the other on carpal tunnel syndrome. I think that the key difference between these studies and others that have failed to show effectiveness has been the dosages. Not only was the frequency of treatment higher but (I suspect more importantly) the intensity was higher (2.5W/cm2). I think that more work needs to be done to determine what an effective dose is. I think that this highlights another difficulty with research, not only do you need to determine what subgroups would benefit from a treatment you also need to determine the correct dosage.

Doug

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Re: Look at this validation study guys, worth reading! - January 14, 2005 8:01:00 AM   
childsjd

 

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Doug:

Your point about the need to critically examine all published studies, regardless of the source, is well taken, for the reasons you outlined. I certainly did not mean to give the impression that published papers are beyond receiving further scrutiny and interpretation.

I think I referred to bicipital tendinitis but was referring to the calcific tendinitis study you mentioned in your post. My point about ultrasound is that there is far less evidence to support many of the modalities we use, yet the utilization rates for these types of procedures far exceed utilization of more evidence-based strategies such as manipulation for patients with back pain. There is a huge disconnect between what the evidence suggests we should be doing, and what we actually do in practice, which should compel all of us to consider why this is, then set out to fix it.

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Post #: 123
Re: Look at this validation study guys, worth reading! - January 14, 2005 4:04:00 PM   
Jon Newman

 

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I've got a few questions on the use of EBM, some of which have floated about before but I can't remember which thread.

1.) If you deviate from the published study in population selection or parameters of how the studied variable was performed, is this still evidenced based?

2.) Can you realistically combine the results of two or more studies and expect better results (see polymeal link eariler in this thread). What if the constructs of the variables in the two studies were in opposition to each other?

3.) If a good study with one variable shows good short term gains and a second good study with a different variable shows good long term gains, which should I use?

jon

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Post #: 124
Re: Look at this validation study guys, worth reading! - January 15, 2005 1:48:00 AM   
childsjd

 

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Jon:

You ask several good questions, the answers to which ultimately depend on the context of the individual situation. I am not going to weigh in on your questions in detail (perhaps someone would like to), but I want to make sure that everyone reading these posts understands that the issues we have been discussing over the last few days related to "fringe" continuing education (just my description) cannot be simply chalked up to a a subtle over-generalization about existing evidence. Simply, there is no evidence upon which to even confront the questions you raise in your post. I think I have asked at least 4-5 times for someone to show us the evidence. The persistent lack of response to this simple question communicates volumes about the lack of credibility among some in our profession who proliferate misinformation (however well-intended) weekend after weekend out on the continuing education circuit. I know this may seem harsh to some reading this, but the consequences of this propaganda are not benign. We must look inward as we continue our profession's transition to a doctoring profession because we routinely sacrifice our credibility at the expense of moving our profession forward. We are our own worst enemies.

John

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Post #: 125
Re: Look at this validation study guys, worth reading! - January 15, 2005 5:01:00 AM   
Jon Newman

 

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Hi John,

I posted a question earlier about the Hides reference. In that article, they demonstrated good long term effects of specific stabilizing exercises for first episode low back pain. They performed a 1 and 3 year follow up demonstrating enduring relief in a large majority of the patients. Can we create a "polymeal" of one study of short term gain with one of long term gains? If I make the "polymeal" presumption, is that evidence based medicine?

jon

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Post #: 126
Re: Look at this validation study guys, worth reading! - January 15, 2005 5:45:00 AM   
Barrett

 

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Well, John, you’re nothing if not focused. It’s unfortunate that this focus seems only to include a single issue within the realm of evidence and studiously avoids all others. When your question regarding an outcome study is answered in the negative you are quick to label an entire approach to care as “fringe” and full of “misinformation.” But if the credibility of our profession was entirely dependent upon outcome studies and not at all upon the complexities of human interaction, individual motivation, therapeutic environment and the often unpredictable nature of nervous physiology then I would imagine that your study would impress me more, but it doesn’t. Your contempt for those of us who offer explanations of clinical phenomena based upon a deep model that is rational and fully supported by the research literature continues to confound me. Wouldn’t a craftsman determine what kind of wood he was working with before he started to carve? Do you understand that tissues have qualities that preclude their changing in certain ways and that your patient might have something to say about that?

I’m going to stand before a hundred or so of our colleagues next week and talk about clinical life and painful problems. That movement can alter the mechanical deformation responsible for the pain doesn’t need proof; this is something inherent to life. Are you seriously suggesting that we don’t know this without an outcome study? I’m going to refer to the latest research in neurobiology indicating how it is we can come to understand why our patients feel the things they do and how movement of various sorts might change that. This is not “misinformation” in any sense; it is part of the dialogue that has formed the core of our profession’s progression from technician to thoughtful clinician, from robotic performance of protocols to individual application of therapeutic care.

I will make no apology for what I teach, and if you think the people who attend these courses are fools maybe you ought to just say so.

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Post #: 127
Re: Look at this validation study guys, worth reading! - January 15, 2005 6:21:00 AM   
SJBird55

 

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Barrett, an engaging discussion on movement and how movement patterns can change pain and the neurobiology of pain isn't proof of anything. A good discussion, sure... one that propels one to think about matters from a different view, sure.... but it isn't proof that your techniques/philosophy is the optimal approach without the statistics to support your belief. To say that your approach gets results is the "misinformation" because you really don't know to what degree you get results, how quickly you get results and in what defined patient population you get those results. Actually, I appreciate hearing your views and they do lead me to read different topics. But... I've never appreciated how you insinuate that your noncoersion is optimal care or that you insinuate that it is the best choice for clinicians - and the only reason is because you haven't taken the time, energy or effort to actually prove that what you say is true.

No one has said anything about protocols. I would hate to see our profession go in that direction in regard to treating patients. I fully agree with you that patients are individuals. The clinical prediction rule is different than a protocol... the prediction rule inherently provides us with a defined population that should have a particular response which means it helps with prognosing and knowing the expected results from the clinical choice of following the rule.

This is different than you think also because I recall in the past that you don't predict how patients will respond and you don't have any preset expectations in your mind on how a patient should respond. I don't choose to practice that way... I do have a prognosis and a prediction in my mind in how I expect patients to respond and in what time frame. If my prediction is wrong or different than I expected, sometimes and most of the time, that leads me to change my approach. That's just how I practice though and there isn't any evidence-based anything out there on how or when clinicians make their decisions or change their original decisions.

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Post #: 128
Re: Look at this validation study guys, worth reading! - January 15, 2005 7:23:00 AM   
Barrett

 

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My approach is just my approach. I have never, never said that it was optimal, and, considering the number of times I have indicated it was not successful for reasons invisible to me, I don't think you could say I thought it was better than anyone else's.

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Post #: 129
Re: Look at this validation study guys, worth reading! - January 15, 2005 8:00:00 AM   
PTupdate.com


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Well, I finally got to read (and re-read) the article, and have considered some points:

I have seen the manipulation used in this study practiced in the region for my entire 13 years of clinical practice....under the names "Reverse Erhard Maneuver" and "Chicago Thrust". Perhaps the terminology has been bastardized over the years, or the exact technique, or both. I once had a patient show me how a friend performed the technique on him...basically the same thing without the sidebending. Neither person was a medical professional, so the "technique" may have actually fallen into that generic class of manipulations that college frat guys practice on each other when bored.

When working at a large teaching hosptial my first year out of school, a student used this technique during his inservice. He was taught to perform it as described in the article, and if no "pop" occurs, switch to the other side and try. My director at the time was floored, and asked the intern "what pops"...he did not know. It did not seem real scientific to me...."do this way, and if no luck, try the other side"

Either way, I have performed this on people and have had success, and even put a movie of it on my website a couple of years ago. It does and can work for patients, but I have found other methods to achieve my desired goals.

Someone earlier in the thread mentions low risk for lumbar manipulation. What defines risk? Death? Is this safe to perform on someone with a grade II spondylolisthesis?

When I herniated L4-5 and fragmented L5-S1 with a sneeze 5 years ago, I fell into the inclusion group for this study for over 10 days. I did not have a positive SLR, and the myotomal deficits did not come on until later..perhaps the steroids helped control the inflammation, or a multitude of other factors. I did have some neural tension issues that most PT's would not have found. I think this manipulation would have landed me in the doghouse.

And what exactly is "popping" during this manipulation? I have had it done on me, and really cannot isolate. SI joint? With such a long lever arm, I suspect it is the most hypermobile segment that is popping. It would have been nice to have seen a re-assessment of mobility after the manipulation, to determine what segment may have cavitated.

I think it is possible this article scares some of us. Basically, a generic manipulation MAY improve many LBP patients, and makes treatment easier for those clinicians not skilled enough to dig deeper. I suspect that most of those posting on this thread could achieve similar results without the back-crackin.

Go Steelers

John Duffy, PT OCS
[URL=http://www.PTupdate.com]www.PTupdate.com[/URL]

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Post #: 130
Re: Look at this validation study guys, worth reading! - January 15, 2005 8:26:00 AM   
nari

 

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John D, Barrett,

Well said. I have also been manipulated, and have felt quite OK afterwards, but I have also felt less pain and more movement during episodes of quite disabling LBP just practising Trans Ab contractions, neural mobs and nothing else.

I think the fact that we have no idea what the 'crack/pop' indicates (it has been suggested on NOI in the past that it is placebo, but I can't really buy that one) means we are just as much in the dark about manips as we are about a lot of techniques. They work anecdotally, we do not know why.
They have been shown to be effective - we do not know why.

Again, it comes back to personal knowledge and experience; and provided we work within the general parameters of clinical practice (the main tenet of which is do no harm), we have the choice of lots of different ways to treat the patient before us. Many patients will improve and lead a very acceptable lifestyle, but how much we have to do with that outcome is also a moot point...but that is another complex thread on its own.


Nari

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Post #: 131
Re: Look at this validation study guys, worth reading! - January 15, 2005 11:55:00 AM   
childsjd

 

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Barrett:

SJBird55 makes excellent points above, stating correctly that "an engaging discussion on movement and how movement patterns can change pain and the neurobiology of pain isn't proof of anything." Barrett, you should be careful in your comments lest you make the case yourself for why outcome studies are so important. You actually make the case quite nicely -- here is why. Our interventions do not operate in a vacuum, but must overcome, interact with, co-exist with, etc. the "complexities of human interaction, individual motivation, therapeutic environment, and the often unpredictable nature of nervous physiology" (you said it, not me). Because of these complexities, we frequently find (negative trial results are far more common than positive trial results) that what we think to be effective, based on what may be a very otherwise logical hypothesis based on sound theory, actually turns out to be ineffective, no better than some other compelling intervention with existing evidence for its use, or even harmful! THUS CLINICAL RESEARCH IN PATIENTS IS SO IMPORTANT BECAUSE WHAT WE THINK SHOULD HAPPEN OFTEN DOES NOT HAPPEN IN THE CONTEXT OF MANY COMPLEXITIES THAT WE CANNOT YET CAPTURE OR MEASURE! The only way we can account for these complexities is to perform clinical trials and compare treatments in substantively large groups of patients where these complexities become evenly distributed between the groups, allowing us to really understand what works and what does not. The reason that outcome studies are so essential does not get any more clear than this, again a case you made yourself in quite a convincing way.

John

John

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Post #: 132
Re: Look at this validation study guys, worth reading! - January 15, 2005 12:47:00 PM   
Andrew M. Ball PT PhD

 

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John,

Before I run out an order your new article from Ann of IM, I'm having a hard time seeing from the abstract how this article is all that different from your previous JOSPT article. Is it a different patient population? Was the JOSPT article just a pilot? Or was the data simply presented in two forums, one with PT's as the audience and the other with medical professionals as the audience?

Also, many states (North Carolina being one of them) strictly forbid manipulation by PT's without physician authorization. Asking for such authorization outside of the POPTS envirnoment can sometimes be detrimental to referral relationships. Just curious. How do you think that your research will be used in such an environment?

Dr. Andrew M. Ball
Physical Therapist

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Re: Look at this validation study guys, worth reading! - January 15, 2005 3:25:00 PM   
Jon Newman

 

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Hi John,

I was wondering if you've considered performing a trial that takes into account patient beliefs? Patient/provider congruence does seem to be an important factor, especially in resolving non-pathologic painful conditions (or at least lack of ability to detect pathology). In order to find out if something "really works" (versus what we think is really working) I would think this is would be an important variable to control for. Although, I think it would be difficult to come up with an N size of people who didn't find the construct of manipulation plausible and appealing.

I'm still curious what the process is that a participant went through in this study. Was all patient education standardized between the two groups? What did the informed consent state? None of these question would, nor are they intended to, invalidate your validation study. It stands that those predictive factors work.

jon

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Post #: 134
Re: Look at this validation study guys, worth reading! - January 15, 2005 3:35:00 PM   
childsjd

 

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Andrew:

I'm not sure what you're asking. The only paper I have published in JOSPT related to the prediction rule was a case report. The paper in Annals is a RCT with 131 patients.

John

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Post #: 135
Re: Look at this validation study guys, worth reading! - January 15, 2005 3:46:00 PM   
childsjd

 

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Jon:

The education component was identical between the groups. Patients in both groups recieved positive information and advice about their back pain and to maintain usual levels of physical activity.

Assessing patient expectations is an important component of any clinical trial, and we assessed expectations in our study. Before randomization, patients rated to what extent they believed a particular treatment (including manipulation, modalites, stretching, etc. -- it was a long list) would be helpful for their back pain. The patient expectations data is part of a secondary analysis we are writing, but here is the gist. The literature clearly indicates that meeting a patient’s expectation results in improved patient satisfaction. However, only limited evidence exists regarding the influence of patient expectations about specific treatments on clinical outcomes in patients with back pain. Among 78 patients in our study indicating an expectation that manipulation would be at least somewhat likely to benefit them, patients who received manipulation did experience a significantly greater reduction in disability after 1 week. However, the magnitude of this effect was clinically trivial and no longer significant after 4 weeks or 6 months. Among this same subgroup, patients who were positive on the rule and received manipulation still experienced significantly greater and clinically important reductions in disability and pain compared to patients negative on the rule receiving manipulation. In other words, consideration of the patient’s status on the rule outweighed the influence of patient expectations.

John

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Post #: 136
Re: Look at this validation study guys, worth reading! - January 15, 2005 4:01:00 PM   
childsjd

 

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Andrew:

I forgot to address your question about the practice act in North Carolina. The answer is simple. We must be politically active as a profession and demand that regressive practice acts such as these be changed. Period. Although research can be helpful for making this case, the single most helpful thing that any professional can do is join the APTA. If you are reading this post and not a member of the APTA, you have no right to complain about anything. It's like folks who don't vote. By the way, I am not paid by the APTA to say this, nor do I always agree with the APTA's stance on every issue. But being a professional means at a minimum, being a part of your professional association, regardless of any petty excuse about some disagreement you have with how the APTA runs their affairs or that it's too expensive. We are not all at stages in our lives where we can be integrally involved in professional service, but everyone can be a member. The reason the chiros are so productive in the ledislature is because they are committed to their profession. I am less certain about many in our own. That's a "soap box" answer to your question, but if a substantial majority of PTs were members of the APTA, we would begin to see the practice acts of the few regressive states remaining changed almost overnight (at least in political time).

John

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Post #: 137
Re: Look at this validation study guys, worth reading! - January 15, 2005 4:10:00 PM   
Jon Newman

 

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Thanks for the reply. Pardon me for getting a little lost in what you wrote. I'd like to make sure I've got things straight.

78 people indicated that they would be at least "somewhat likely to benefit". As a group, compared to those rating lower, they experienced good relief during the interim the manipulation was being performed.

Of those 78, there were a certain amount who fell either into positive on prediction or negative on prediction. Of those positive on prediction, they fared better than those negative on prediction.

Do I have that correct?

Of those negative on prediction but positive on beliefs, did they fare better than those negative on prediction and negative on beliefs?

What type of reasoning was given by the PT for performing the manipulation or the stabilization or was the PT instructed to refrain from that kind of talk?

As per the informed consent, what did the patients understand they were signing up for? Did they know they would be assigned to an experiment or a "control" group?

jon

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Post #: 138
Re: Look at this validation study guys, worth reading! - January 15, 2005 4:24:00 PM   
childsjd

 

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Nari:

I would take exception to this statement:

"we have the choice of lots of different ways to treat the patient before us."

You are correct that we have a choice, but we should let the evidence guide us as to which option is most compelling based on the evidence. I can assure you that is the choice that most patients would want us to select. Someone mentioned earlier about not wanting protocols to treat patients. Although we can certainly appreciate that our patients are not all the same, there is not an infinite number of choices that can be made, with all of them offering an equal prognosis for a successful outcome. The key to advancing our profession is standardizing our practice patterns based on evidence, whenever it is available. Otherwise, we are merely technicians randomly picking whatever feels good or seems convenient. The fact that there is so much variability in our profession about how a particular patient gets managed with a given condition can mean only two things: 1) There is not sufficient evidence to guide decision-making, suggesting the need for outcomes research to answer the question, or 2) Therapists are simply not practicing in a manner consisent with the evidence. With evidence now being published at ever growing rate over the last 5-10 years, I am convinced that more of our problem now rests with #2 than #1.

John

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Post #: 139
Re: Look at this validation study guys, worth reading! - January 15, 2005 5:43:00 PM   
nari

 

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John

All I can really say is that a technician can only follow orders, and is restricted to protocols. That is the physiotherapy of a long time ago.

A professional chooses, from a number of options available, what best fits the complete assessment. A professional does not rely on referrals with orders to treat in a certain way.
In this country, doctors' referrals are simply a courteous note asking for assessment and opinion.

I agree up that PTs should be reasonably consistent in their approaches to clinical reasoning and decision-making. I agree that research is important in reaching this goal.

But I never said there is 'an infinite number of choices' concerning Rx planning - you did.
But for most patients there are 3 or 4, depending on, as I said before, the clinician's experience.


Nari

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Post #: 140
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