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Sun Oct 12 06:09:39 BST 2008

On Sat, Oct 11, 2008 at 11:43 PM, <htaed_rd at 123mail.org> wrote:

> 2. IRBs continue to approve studies that are too small to show any
> statistically significant result.
>

There job is not to assure the validity of the study, just to protect the
rights of study subjects and to keep the university/hospital/etc from
getting sued into oblivion.   The issues of assuring statistical
significance and controlling for variables is the responsibility of the
researchers and, to a lesser degree, the peer reviewers of the journal(s)
the research is submitted to.  If there is a problem with significance or
confounding variables, then the paper should be sent back to have the issues
addressed.

> 3. IRBs continue to approve studies that do a poor job of controlling for
> variables that are controllable.
>

See above.

> 4. Few seem to have a problem with the absence of good research in areas
> that are very controversial.
>

Personally, I think some of the people who ignore the evidence on subjects
such as this do it, at least in part, simply because they enjoy heated
debates.

The controversy is due to the lack of good research.
>

Well, not entirely, but the research could certainly be more extensive.

>  Granted, the overall quality of HEMS is literature is fairly low. But,
> like many things in EMS, there has been a reversal of the burden of proof.
> That is, the HEMS  system  has become widespread and entrenched and instead
> of proponents publishing  literature supporting their point, they say "prove
> it doesn't work."   Where
> else in health care does that occur?
>

I don't know of any in health care, but it reminds me sadly of the responses
of people who believe in aliens when asked to provide evidence of their
stance.

> As a paramedic, I do not have the authority to change protocols. I can push
> the edges of the protocol. I can even violate the protocol. I can also be
> censured/decertified for either action, if any of those with authority to
> oversee EMS wish to exercise that authority.
>

I miss my old service- the medical director allowed us to have input on the
protocols.  If we could provide a legitimate reason why our option was more
viable or beneficial, he was all for it.  This is one of the best arguments
for requiring EMS medical directors to have actually worked as EMTs or
paramedics.  It helps counter the "edict from the ivory tower" feeling that
one often encounters in protocol development.

>
> I agree with the second statement with some reservations. I should have to
> demonstrate a good reason for my violation of protocol. There should not be
> carte blanche for a medic to violate protocols just because the medic does
> not like them.
>

The service I worked for the longest actually had a *protocol for violating
protocols*.  The stance was basically that if you had a valid reason for not
doing something that was implicitly required in the protocols or skipping
steps in the protocol (for example: airway management and not even trying to
intubate before going to a surgical airway in a patient with their face
taken most of the way off by a shotgun, etc) or frankly doing something that
was not in our skill set (example: sticking my fingers into a trauma
patient's thigh to get control of a femoral bleed that we could not control
otherwise), you could do so.  The one stipulation was that it had to be
defensible and it had to be done in the best interest of the patient and not
for the convenience or ego of the medic.

Still, where are the good studies that show clearly the effects of HEMS?

What about the studies that show most patients are discharged soon after
arrival?  What about the studies that show minimal survival benefit in most
settings?  What about that study from the NTSB about the hazards of the
current manner in which aeromedical operations are conducted?

> The studies that demonstrate clearly which patients are most likely to
> benefit?

The answer to this boils down more to the distance (or more accurately, the
trasnport time) to definitive care than the care delivered because of the
few differences in care delivered and the increased difficulty in delivering
care in a helicopter.   Therefore, the benefit is going to occur in remote
or rugged areas where evacuation by other means is going to result in a
dramatic delay.   Most of the time, the patient is going to benefit most by
being taken to the closest hospital and then be referred up the echelon of
care (to use the military medical vernacular) as the treating physician
dictates.

The studies that show which are most likely put patients at excessive risk?
>

The NTSB has a searchable database of these. ;)

> There is resistance to even studying this, because the "experts" are so
> convinced that they are right, that there is opposition to subjecting
> "their" patients to randomization to a treatment arm they do not approve of.
> In other words, these experts are guaranteeing that there will NOT be
> convincing research until someone with a decoder ring comes along.
>

 That is the problem.  I wish more people were just interested in doing what
is correct based on evidence than trying to advance their own agenda.  The
truth is likely in the middle somewhere between the two camps and we really
need to find a middle ground on who gets flown, but we can not compromise on
the "when" of flying people because of the safety ramifications.

We can believe anything we want, but until we can point to large, well
> designed studies, all we are doing is worshiping in different temples of
> ignorance.
>

Well said.  I am happy to work with anyone (regardless of which side of the
issue they are on, so long as the study gets published not matter which side
of the argument it supports) who is willing to open their records to settle
this.   One of you all out there has to have the data and if you can get the
funding for a study, let's run with it.

We need for the proponents of the various treatments to get together to set
> up a study in a way that they all agree on one thing. This study is large
> enough, well controlled enough, . . . , that if the results are negative for
> what I believe - I will change my mind. Otherwise those who believe
> differently will always be able to come up with some excuse for why the
> study is being misinterpreted.

See my above comment.

Or we continue to hide behind the claim of the FDA that a standard of care
> based on expert opinion is not experimental treatment. That not studying
> these untested or poorly tested opinions is somehow ethical.
>

One more reason to dislike the FDA.

> Now, I apologize for using Dr. Bledsoe's post as an excuse for a rant, but
> there is a decoder ring. It appears to be a secret to a lot of supposed
> scientists. It does not say, "Be sure to drink your Ovaltine." It says,
> science means trying to disprove what you believe.

I've disproven more of my previous beliefs about aircraft crashes in the
course of my research than I have reinforced.

I do not think it is disrespectful to offer constructive criticism. This
> is meant as constructive criticism.
>

It is some of the best worded criticism I have seen in a long time.   You
have my respect (whatever that is worth to you).

-- 
Stephen L. Richey, CRT
Aviation Injury Research Project Leader
Saginaw Valley State University
Work E-mail: slrichey at svsu.edu
Home Office Phone: 248-366-4452

"It is the characteristic excellence of the strong man that he can bring
momentous issues to the fore and make a decision about them. The weak are
always forced to decide between alternatives they have not chosen
themselves."- Dietrich Bonhoeffer

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