October 12, 2020

Fact-checking some KOLs…

The buzzword at the moment is fact-check.  So I thought that I would do this for two recent Key Opinion Leaders lectures from the Henry Schein webinars site.  It was interesting!

One of the consequences of the pandemic is the availability of online lectures.  I came across the HSO webinar website and watched two classes by their most prominent KOLs.  As a result, I decided to be as objective as possible, and fact check their presentations against recently published research (or lack of research).

Fact-checking

These are the recently published papers on the subject of the lectures.  I have reviewed these on my blog and I have added my comments on the papers.

Kim-Berman

This paper was significantly flawed because they excluded cases whose treatment lasted too long, and they included a historical control group.

Daniel Areeponga

The flaws in this paper were that there was no control, and the study was confined to successfully treated patients.

Yin et al

This study was retrospective, and the patients were treated by three different operators with no data on the distribution of patients between the operators.

To be honest, if I had refereed these papers, I would have strongly recommended that they should be rejected.  However, when we look at them, we must assume that they are the best that we have got. Furthermore, any biases may be towards the positive.  Importantly, all the papers were published before these presentations. As a result, there should be no reason why the KOLs did not refer to them.

The Lectures and claims

I got the lectures from the HSO webinar website.

Dr Paquette

First up was Dr Dave Paquette.  His presentation was:

fact check orthodontic

Sagittal First: The Ultimate Formula for Efficiency and Practice Success

A member of the HSO staff introduced the lecture. She told us that Dave was passionate about the education and science of orthodontics.  Dave is the major KOL for HSO. Details of his yearly payments are on Open Payments.

This is the lecture preamble;

“Dr Dave Paquette is charting new territory with the ground-breaking SAGITTAL FIRST ™ Philosophy of correcting the Class II or Class III malocclusion at the beginning of treatment when patients are most compliant. It provides greater efficiencies, shorter treatment times, and long-term aesthetics results with minimal extractions.

“Dr Paquette will show you how to integrate the Carriere® MOTION 3D™ Appliance to correct the AP, reposition the mandible, and expand the airway while achieving average treatment times of 12 months or less. His clinical results will challenge your views on the traditional practice workflow”.

Anyway, what was the lecture about?

This lecture and questions were just under two hours long. He started with a lengthy discussion about the way that the “philosophy” enables same-day starts.  I think that this is because it is easy and quick to bond a Carriere Motion appliance. I do not really understand this concept, but it may explain something that I am missing?

These were the claims he made;

Claim 1

Sagittal First corrects the A-P relationship early. This enables most treatment to start from a dental Class I relationship.  The usual correction is done in 2-4 months.

Fact check: The mean times for A-P correction reported in the papers were:

Kim (5.2 months, 95% CI=4.2-6.1), Areeponga (4.9 months) and Yin (6.3 months, 95% CI= 5.2-7.3). None of these papers included 2-4 months in the 95% Confidence Intervals.

Claim 2

The use of this technique resulted in a 50% reduction in treatment time and a 75% reduction in chair time.

Fact check: Treatment time from Kim was 18.2 months (95% CI=16.5-19.8) and Yin reported 32 months (28.4-36.8).  There is no published research on chair time.

Claim 3

He then showed some case reports. He stated that he informs patients that their treatment will be completed in a year. The intervals between treatment visits are shorter.

Fact check: I could not find any published research on intervals between treatment visits.

He also mentioned that the Motion re-positions the mandible. I am not sure what this means. Unless he means posture the mandible forwards?  There is no proof that the Motion appliance produces more or less skeletal change than any other flexible Class II corrector.

He then moved onto Carriere self-ligating brackets.

Claim 4

They are better engineered than other brackets. This leads to better force distribution, leading to better predictability and reduced treatment times.

Fact check:

He mentioned two papers, one in the EJO and the other in the Angle. I think that I found these papers. They were both in vitro studies, and they generally showed that the Carriere bracket was nothing special. Specifically, it is just a passive self-ligating bracket. There is no clinical evidence suggesting benefit in terms of treatment duration or outcome over those achieved with conventional brackets.

Luis Carriere

He is the inventor of the Carriere Motion and the new self-ligating bracket.  As he is based in the EU, there are no details of any funds he may receive as a KOL.

fact check orthodontics

 

The New Orthodontic Standard in Efficiency and Clinical Excellence

The aims of the webinar were:

  • The benefits of correcting the AP at the beginning of treatment, before placing the brackets or aligners
  • The benefits of the SAGITTAL FIRST Philosophy and SLX 3D passive self-ligation brackets and the new M-Series wires
  • How to achieve average treatment times of 12 months or less progressive technologies and a minimal-touch, high-efficiency workflow.

This was a lengthy presentation based around a few case reports. The main aim of his treatment philosophy was to simplify treatment.

Claim 1

We can reduce treatment time by increasing the intervals between appointments.  This is opposite to Dr Paquette’s suggestion?

Fact check:

See above on treatment time.

Claim 2

The Carriere Motion repositions the mandible forwards. Again, this concept of “re-positioning the mandible”.

Fact check: No evidence

Claim 3

It improves the airway.

Fact check: No evidence

Claim 4

It moves the condyle forwards and corrects TMD.

Fact check: No evidence

What did I think?

To be honest, I was surprised at the information that they presented, as nearly all their claims were not supported by research evidence.  I also found this more concerning when we consider that they were aware of recent research publications.

This was also very similar to the self-ligating presentations that I saw many years ago. We know what happened there!

Finally, while it may currently be acceptable for politicians to be “economical with the truth”.  Fortunately, this is not the case for clinicians, as we are bound by a code of ethics.  As a result, I am genuinely concerned with the claims being made by these two KOLs. Perhaps, I have missed something here and misinterpreted their presentations.  I am happy to let them have a blog post to state their case in the spirit of transparency and debate.   Let’s have a good discussion about their approach in the comments section of this post?

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Have your say!

  1. Avatar

    This is all so déjà vu. It’s another class II corrector that rotates the occlusal plane, no true distalization to be found. Plus, it’s not even compliance free. It never ceases to amaze how appliances can become all the rage if they only have a large enough marketing budget behind them. Don’t misunderstand me, there’s nothing wrong with using the Carrier appliance, as long as doctors really understand the treatment effects as use it for the right reasons. For my money, there are more effective, less expensive ways to correct a class II.

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      I agree with Sebastian. Why would one spend hundreds (USD’s) on a compliance driven anything to move teeth!? There are so many better options available (compliance-free) that create dento-alveolar changes such as Herbst and XBow that correct AP changes with simultaneous compensatory expansion (which almost always is required)!

  2. Avatar

    Dear Kevin,
    Thank you for yet another enjoyable read. In the age of “fake news” and KOLs the word evidence has clearly assumed a different meaning. Many of us that are concerned about the future of our profession, and about the training of our residents being taken away from University programs and into the hands of commercial companies are being called “fossils”. You are the voice of reason and conscience in a social-media-infected world gone mad!

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    Thank you for what you do for the profession. Orthodontics is facing some significant challenges today and getting away from fundamental scientific technique only serves to hasten our path in the wrong direction as a profession.

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    Dear Kevin,
    Dental Industry and KOLs are doing their job looking for more sales and profits. The question to be asked is how intelligent orthodontists, with their scientific background and common sense, accept unquestioningly these statements and claims? Why they do not ask “Which clinical studies? Where have they been published? Are their results identical to the corresponding interpretations and claims of the industry? Have the conflicts of interest or the commercial interests of the speakers and authors been clearly identified? Does evidence-based mean randomized prospective clinical trial, systematic review, and/or meta-analysis of the evidence?”
    One big problem is that colleagues are easily shifting intellectually from the complex, sophisticate and often unpredictable clinical reality of orthodontic practice to the simplified cookbook approach? Maybe this is an attempt to “compete” with other colleagues and clinics in the neighborhood, which utilize the same “exclusive, modern and special technique”. What happens to the critical thinking and the evidence based scientific background acquired or developed during postgraduate education? Or their specialty training was inadequate?
    Thank you for the great contribution through the blog.
    Regards,
    Athanasios E. Athanasiou

    • Avatar

      Athanasios you are correct in what you say above in terms of what should be happening. My perspective from what I have seen over time is that the answer is actually simple and indeed rather sad.
      The answer is that they want to believe this garbage they are being fed because it suits them to believe it and is convenient to believe. It justifies their approach which involves amongst other things the “cookbook approach” you mentioned as well as being easily delegable.

  5. Avatar

    Thanks Kevin for this post and for bringing the perspective of scientific evidence versus a clinical claim. This again highlights the point that clinical claims will be made by those with links to the orthodontic industry and that the onus is on the clinician to verify the facts and not to take the benefits at face-value. This is especially vital for orthodontic students in a university setting. Being in a formative stage in their profession, to not let any market-driven bias to strongly influence them unless the claim is evidence-based.

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    Dear Kevin, Thank you for highlighting an important area of Orthodontic practice. Most of these techniques are created to benefit practice management with disregard to the actual clinic effects since the “one size fits all” approach is applied. In an era where practitioners look at the debate of studying cases using Cephs similar to the debate on using masks, science is ignored.
    Best,
    Pramod Sinha

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    Kevin:
    I agree with you. These studies should not have gotten past the Reviewers; however, this issue is not confined to orthodontists. I attended two ENT conferences and was disappointed by the level of data interpretation and the claims they made based on those false findings.

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    Thanks again Kevin and a reply beautifully articulated by Prof. Athanasiou.

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    As you mentioned Kevin, the articles on the topic are not ideal but what we currently have. I totally agree that the paper by Kim-Berman should not have been accepted for publication as it was very biased in case selection. The cases came from Dr Carriere’s office and any cases that took longer than 12 months for the Class II correction were excluded; basically they selected cases that worked in the time frame they wanted! The paper by Yin is more interesting in that it compared it with elastics and the Forsus and both were significantly more efficient in overall treatment time than the Motion. It is an option that some may choose for appropriate cases but the unfounded claims are purely marketing and most of us see that. Perhaps some supporters hold desperately on to their beliefs as they feel cornered and a loss of face to say ‘Me erravisse’?

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    The only trouble I see with this blog is that it is preaching convert.

    By definition, if you attend that symposium you do not believe in evidence-based medicine. If you believe in evidence-based you will not really be interested in the Carrier motion in the first place.

    Carrier fan believes in magic and in being exceptional. I am so exceptional that I can only have extraordinary results and be disruptive. I had this discussion with the several US and French ortho already. If they believe in Carrier, they believe also in vibration and SLB. Of course, their results are exceptional, and just wait we are going to publish them and creat a new wave in orthodontics.

  11. Avatar

    The point I want to highlight (not novel as it has been noted above) is that there is a need to improve clinicians’ critical skills. Companies claim what they think is appropriate as part of their marketing. It is their business model across industries. Asking them not to do it is naive. It is about clinicians listening to and then rationalizing to decide if something is worth for their patients. It can be argued that any orthodontic device can be used under the correct set of occlusal traits. Life is not black or white but a scale of gray. Orthodontic management is not different. One approach can not solve all the problems. A skillful clinician knows when to use what is based on their individual patient’s needs. Our learning journey will hopefully get us closer to this hypothetical masterful clinician.

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    https://www.youtube.com/watch?v=HJwudJ3Re4Q

    I just watched the HS video to see how the Carriere works. Seems that it grows the mandible and/or corrects a full unit Class II in a patient with erupted wisdom teeth. Truth? Research? Bollocks! Where can I get one! 😉
    Keep fighting the good fight everyone. I have to believe the good guys win in the end…

  13. Avatar

    As ever, a well-written pieced which looks at the evidence behind claims with no emotion or vested interest.

    Unfortunately, I have found that when clinicians are emotionally invested in a particular appliance, they happily overlook the available evidence and select only the evidence which backs up their viewpoint.

    Cognitive bias. We are all guilty of it to a certain degree. It is human nature. However, some are more guilty than others!

  14. Avatar

    It strikes me that there is a bit of a “one size fits all” approach as stated above. The concept of the “problem list” seems to have taken a back seat. Every patient is simply upper and lower braces irrespective of the problem. Possibly this is due to the tyranny of Andrews class 1 where every slight deviation from the utopian ideal is seen as a problem to be corrected. I can’t help but feel that this gives patients unrealistic expectations and also leads to over-treatment. Simply because you have a hammer not everything is a nail.
    Not everything has to be “corrected”, there needs to be clinical judgement and appropriate advice. Not every patient wants every tooth straight and those that do cannot always have it. I think we need a bit more realism, pragmatism and less trying to force everyone into the same cookie-cutter shape. Obviously telling patients to leave things alone could be seen as bad for business.

  15. Avatar

    There is a difference between “treatment” and “outcome”. Our patients/ parents assume that these concepts are convergent and perhaps a linear progression. They are not.
    Treatment with a compliance-dependent appliance “when the patient is most compliant” might mean that this eponymous Class II treatment occurs well before the pubertal growth spurt. Just a thought.

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