The "Panel"

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On Sun, 12 Oct 2008 01:09:39 -0400, "Stephen Richey"
<stephen.richey at gmail.com> said:
> 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.

Isn't one of the roles of the IRB to evaluate whether the study is
ethical to perform?

Doesn't human experimentation, purely for the purpose of publication,
raise some ethical dilemma that should be addressed by the IRB?

If the research is unlikely to contribute anything to our understanding
of a subject, if it is the equivalent of a me-too drug, but only
imitating previous uninformative research, doesn't the IRB have a
responsibility to say - "This is experimenting with patients with
nothing to be gained, except prestige of publication."

There are many small studies that are for the purpose of evaluating
hypotheses on a small scale. An entirely different situation. This is an
area where we should conversely be seeking counterintuitive approaches.
So much of science is advanced by the accidental discovery. 

But the studies looking at the same old questions, in ways that will
answer questions only if we have already made up our minds about those
questions - these need to be questioned by the IRB. 

I agree that others bear responsibility in the experimental process, but
that does not mean that the IRB should be blinded to poor study design,
or extravagant claims of insight to be obtained from small numbers of
subjects.

The drunk looking under the light, not because that was where he thinks
he dropped the keys, but because the light is better under the light,
should not be receiving the go ahead to experiment on humans with that
kind of rationale. The IRB should have some sane approach to an ethical
treatment of humans.


> > 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.

Yes, but creative minds debating something may lead to some insights.
These shouldn't be tested by a minor variation on a previously
unproductive experiment.


> > 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 have a medical director with that kind of approach. I have had several
others with this approach. 

I do have the ability to have input on the protocols. I do not have the
authority to change the protocols, but I have persuaded physicians that
things were in need of change. They changed the protocol. I had
suggested it. I could not, and did not, change the protocol
independently.


> > 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.

I agree that protocols should be open to responsible deviation. It seems
that statewide protocols skip the medical director, the county/regional
medical director, and go straight to the state medical director for any
and all protocol deviations. Even those suggested by the medical command
physician. Does the state medical director have the familiarity with the
medic to evaluate the approach to care in one individual instance? This
is glorified chart review, which is not much more than interpretive
fiction.


> 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?

There needs to be an evaluation of what a well run EMS system, with
aggressive medical oversight, does with these patients. Part of the
problem with the studies is that they are looking at EMS agencies with
diverse approaches, more diverse assessment abilities, yet they want to
claim that this is providing THE answer. 

Part of the problem is the lack of demand for competence among EMS
providers. One of the excuses given for flying patients is the lack of
competence among ground providers. To accept this argument is wrong, but
it does affect the value of some studies. The medical director, who puts
incompetent medics on the street, with the expectation that HEMS will
bail them out of their incompetence, is a fool. 

The medical director is using horrible logic. It should not be
tolerated. Nobody should make excuses for putting incompetent EMS
providers on the street. The medical director, who does this, deserves
no quarter.


> > 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.

I agree.


> 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.

Yes. Finding out what works and what doesn't is much easier when the
agenda is the truth.

 
> 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.

Yes.

 
> 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.

That is how we really learn.


> 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).

It is appreciated. Thank you.

Tim Noonan.
 
 
> -- 
> 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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