Re: Reasearch Shut Down

[Guest guest]

Normal documentation would be on the order of: " Pt meets criteria

established for inclusion in Trauma Study Protocol. IV established (size, site,

attempts), and fluid (bag #) started as per protocol. " Neither the patient, nor

the

care givers are aware of what's in the fluid. (double blind study)

cross documentation is turned in to the study center, giving a patient

reference number and the bag number. Periodically, there is a correlation of pt

outcomes with fluid given, and then a decision is made to continue or

discontinue the study is made. In this case, hypertonic saline did NOT improve

the

trauma outcome, and the study was terminated early. In other cases, the new

agent was such an improvement over the previous 'standard care,' that the study

was also terminated early...I believe that the original ExoSurf study in the

late 1980s was such a study.

ck

S. Krin, DO

In a message dated 4/3/2009 11:23:41 Central Standard Time,

rob.davis@... writes:

On Friday, April 3, 2009 11:03, " Hopkins " _rhopkins@..._

(mailto:rhopkins@...) > said:

>

> Paramedics don't know which fluid they are giving patients.

I'm curious exactly how one documents administering an IV, the content of

which is unknown. Sounds a little tricky.

Rob

**************Feeling the pinch at the grocery store? Make dinner for $10 or

less. (http://food.aol.com/frugal-feasts?ncid=emlcntusfood00000001)

[Guest guest]

Normal documentation would be on the order of: " Pt meets criteria

established for inclusion in Trauma Study Protocol. IV established (size, site,

attempts), and fluid (bag #) started as per protocol. " Neither the patient, nor

the

care givers are aware of what's in the fluid. (double blind study)

cross documentation is turned in to the study center, giving a patient

reference number and the bag number. Periodically, there is a correlation of pt

outcomes with fluid given, and then a decision is made to continue or

discontinue the study is made. In this case, hypertonic saline did NOT improve

the

trauma outcome, and the study was terminated early. In other cases, the new

agent was such an improvement over the previous 'standard care,' that the study

was also terminated early...I believe that the original ExoSurf study in the

late 1980s was such a study.

ck

S. Krin, DO

In a message dated 4/3/2009 11:23:41 Central Standard Time,

rob.davis@... writes:

On Friday, April 3, 2009 11:03, " Hopkins " _rhopkins@..._

(mailto:rhopkins@...) > said:

>

> Paramedics don't know which fluid they are giving patients.

I'm curious exactly how one documents administering an IV, the content of

which is unknown. Sounds a little tricky.

Rob

**************Feeling the pinch at the grocery store? Make dinner for $10 or

less. (http://food.aol.com/frugal-feasts?ncid=emlcntusfood00000001)

[Guest guest]

On Friday, April 3, 2009 11:03, " Hopkins " rhopkins@...> said:

>

> Paramedics don't know which fluid they are giving patients.

I'm curious exactly how one documents administering an IV, the content of which

is unknown. Sounds a little tricky.

Rob

[Guest guest]

On Friday, April 3, 2009 11:03, " Hopkins " rhopkins@...> said:

>

> Paramedics don't know which fluid they are giving patients.

I'm curious exactly how one documents administering an IV, the content of which

is unknown. Sounds a little tricky.

Rob

[Guest guest]

Chuck,

Correct me if I'm wrong, but my impression of the trouble with these studies

is that there is no way to categorize the patient's injuries and conditions

and correlate them to outcomes.

What I mean is that in many studies where this or that population did better

or worse with a specific intervention, they were more seriously injured and

had less chance of survival to begin with.

So, when patients are to the point that fluid resuscitation would make a

difference, they're way down the slippery slope toward The Heavenly Kingdom to

begin with, verdad?

So given the variables among patients in injury severity it's almost

impossible to draw conclusions based upon administration of one fluid vs.

another.

Were the patient's ages, general level of health prior to injury, details of

organ insult, and so forth taken into consideration? I don't think so.

I know trauma surgeons who really believe that hypertonic saline has a place,

but if we can't do studies because there's a difference in outcomes, and we

can't identify the reasons for those differences other than one got NS and the

other got 8%, then we'll never know, will we?

GG

>

> Normal documentation would be on the order of: " Pt meets criteria

> established for inclusion in Trauma Study Protocol. IV established (size,

> site,

> attempts), and fluid (bag #) started as per protocol. " Neither the patient,

> nor the

> care givers are aware of what's in the fluid. (double blind study)

>

> cross documentation is turned in to the study center, giving a patient

> reference number and the bag number. Periodically, there is a correlation of

> pt

> outcomes with fluid given, and then a decision is made to continue or

> discontinue the study is made. In this case, hypertonic saline did NOT

> improve the

> trauma outcome, and the study was terminated early. In other cases, the new

> agent was such an improvement over the previous 'standard care,' that the

> study

> was also terminated early...I believe that the original ExoSurf study in the

> late 1980s was such a study.

>

> ck

> S. Krin, DO

>

>

> In a message dated 4/3/2009 11:23:41 Central Standard Time,

> rob.davis@... writes:

>

> On Friday, April 3, 2009 11:03, " Hopkins " <_rhopkins (AT) talho (DOT) _rh_

> (mailto:rhopkins@...) > said:

>

> >

> > Paramedics don't know which fluid they are giving patients.

>

> I'm curious exactly how one documents administering an IV, the content of

> which is unknown. Sounds a little tricky.

>

> Rob

>

> ************ ************ **Feeling the pinch at the grocery store? Make

> less. (http://food.http://food.wbhttp://food.http://food.

>

[Guest guest]

Gene:

I agree, and suspect that was part of the reason that the study was

terminated early...

I was simply pointing out how the report would be written up to both satisfy

the acute needs of the handoff to the ED, and provide the needed information

for the study.

ck

S. Krin, DO

In a message dated 4/3/2009 19:59:29 Central Standard Time, wegandy1938 (AT) aol (DOT)

com writes:

So given the variables among patients in injury severity it's almost

impossible to draw conclusions based upon administration of one fluid vs.

another.

Were the patient's ages, general level of health prior to injury, details of

organ insult, and so forth taken into consideration? I don't think so.

**************Feeling the pinch at the grocery store? Make dinner for $10 or

less. (http://food.aol.com/frugal-feasts?ncid=emlcntusfood00000001)

[Guest guest]

Chuck,

How can we structure studies to get around this? It seems to me that we

desperately need studies about stuff like this, but we can't do them because of

(1) the IRB constraints and (2) inability to structure the studies in the right

way.

Any thoughts?

GG

>

> Gene:

>

> I agree, and suspect that was part of the reason that the study was

> terminated early...

>

> I was simply pointing out how the report would be written up to both satisfy

> the acute needs of the handoff to the ED, and provide the needed information

> for the study.

>

> ck

> S. Krin, DO

>

>

> In a message dated 4/3/2009 19:59:29 Central Standard Time, wegandy1938@ In

> com writes:

>

> So given the variables among patients in injury severity it's almost

> impossible to draw conclusions based upon administration of one fluid vs.

> another.

> Were the patient's ages, general level of health prior to injury, details of

> organ insult, and so forth taken into consideration? I don't think so.

>

> ************ ************ **Feeling the pinch at the grocery store? Make

> less. (http://food.http://food.wbhttp://food.http://food.

>

[Guest guest]

I honestly don't know. Let's look at some of the limitations of science in

medicine, especially in trauma.

The first part of the problem with such studies involves both the limited

number of bodies available to be IN the study, and the multiple ways those

bodies interact in the study, as you previously noted. Remember that in 'hard

sciences' (chemistry, physics, and to a certain extent microbiology),

researchers can depend on Avagadro's number...a far larger selection than even

the

broadest based sociological or anthropological study can boast...and in

general,

population based studies in medicine are much closer to the numbers available

to the soft sciences than the hard ones.

As you noted, another limitation is the IRB (Institutional Review Board), a

system set up to prevent the abuses most notorious in the 1920-1950 time

frame (ranging from untreated syphilis as the 'control arm' of a study, to

forced

sterilization of 'mental defectives', to prefrontal lobotomies of

'uncontrollable subjects'). The system does work at reining in the worst

excesses, but

does add another layer of complexity in subject selection including how to

get 'informed consent' in acute situations. Some of the trauma studies have

used 'opt out' programs (publicity in an area, notifying the public of the on

going program, and presuming consent if not refused), others have tried to

obtain consent in an acute setting. Many programs have utilized 'non

consenting'

cases as part of the control arm of the study, as they are 'only' provided

'standard care.'

The third limitation is the need for 'blinding' in the studies, to reduce

the placebo effect. Considering the variations of human physiology, the 'best'

study is a 'double blinded cross over study,' where neither the primary

investigator nor the patient knows what particular drug or procedure is being

used

until the codes are 'broken' and the results are in, and the patient ends up

in both arms of the study over time, allowing each patient to be their own

control. Perhaps the most famous recent study of this nature is ALLHAT, where

thousands of patients were enrolled and followed for up to 10 years in an

effort to better understand hypertension. One of the most important findings of

this study was that the cheap generics really do work as well as the newer,

more expensive medications to control high blood pressure when given in

adequate doses and adequate compliance. Obviously, operative procedures are much

more difficult to double blind, and very, very tough to cross over...which

introduces a fair amount of observer effect.

The last limitation I will discuss involves the various methods of

quantifying seriously ill patients which have been developed over the years.

These

include ASA scores _http://en.wikipedia.org/wiki/ASA_score_

(http://en.wikipedia.org/wiki/ASA_score) , APACHE II

_http://en.wikipedia.org/wiki/APACHE_II_

(http://en.wikipedia.org/wiki/APACHE_II) , TRISS

_http://www.traumacare.no/Resources/Trauma/SeverityTriss.aspx_

(http://www.traumacare.no/Resources/Trauma/SeverityTriss.aspx) and others. All

of them suffer from various limitations,

ranging from inter-rater variability to the cussedness of human survivability.

Until we get a *repeatable* standard for measuring the damage to human beings,

we will be limited in our ability to match cases across multiple centers ,

and figure out what works and what doesn't (or even worse, what causes more

damage). This is one place where the hypertonic saline study fell down.

On the positive side, folks with far more statistical training than I have

indicated that some studies (one being discussed on another list that may

start this year involves the operative repair of multiple contiguous fractured

ribs, aka flail segments) can be done with less than 200 patients over all,

with more of a limitation on the minimum number needed in each study center (to

make sure each involved surgeon has an adequate number of cases to develop

his technique). The start point of this study, (trauma patients on the vent due

solely to a flail segment), and end point of this study, (how much faster do

the operated patients come off the vent due to improved pain control from

the operation) have *much* clearer boundaries than most studies on trauma. With

enough patients with bilateral fractured ribs, (and possibly the willingness

to do 'sham' operations on one side,) there could be immense power to this

study with even a limited number of patients.

I hope that this clarifies some of the current limitations of scientific

medicine, especially involving emergency medicine and trauma.

ck

S. Krin, DO

In a message dated 4/3/2009 21:51:19 Central Standard Time,

wegandy1938@... writes:

Chuck,

How can we structure studies to get around this? It seems to me that we

desperately need studies about stuff like this, but we can't do them because

of

(1) the IRB constraints and (2) inability to structure the studies in the

right

way.

Any thoughts?

GG

**************Feeling the pinch at the grocery store? Make dinner for $10 or

less. (http://food.aol.com/frugal-feasts?ncid=emlcntusfood00000001)

[Guest guest]

It's really not tricky at all. The study drug would still maintain a name from

the drug manufacturer. So when you document study medication there are specifics

in the way the?documentation is complete, each case is different dependent on

what they drug sponsor is looking for and what?data they need to collect.?So

to?documented successful completion of an IV and?that study?fluid

administration, a paramedic would document the placement of the IV, then they

study name of the drug and then document the?amount of infusion. This?would also

be closely?monitored for effects and adverse effects. It's a detailed oriented

process, but a simple one to follow. It's as simple as the process as we have

now with Saline, or Ringers. If you think about it all those medication started

in case studies just like this medication.