RSI and Intubation (answering Don)

[Guest guest]

Kenny,

Thank you for this summary of the study. It points up what I wrote

earlier about the deficiencies in the education and training we give medics in

airway care.

I firmly believe that medics, given the right education and training, with

the right devices and equipment, and with sufficient numbers of patients to

intubate, can achieve comparable success rates to physicians. Notice that

I put in three qualifiers. The problem is that most medics have none of

the qualifiers. The fact is that most systems are, by design, failing to

provide adequate intubation opportunities for medics because they have way more

medics than available intubations.

Now, before you scream that I'm against paramedics, just stop! I am not.

But we're talking about one skill that needs to be performed regularly in

order to maintain proficiency. And many of our systems are structured in

such a way as to work against that.

Do RSI procedures done in the ER by physicians have any different outcomes?

IS THE PROBLEM WITH THE PROCEDURE OR THE OPERATOR? If it's the

operator, then that's fixable. If it's the procedure, then why are people doing

it

in the hospital? Are there any studies that have looked at the effects of

RSI on outcomes when done in the hospital? I do not know.

Most physicians that I know were just folks like us before they went to

medical school. Matter of fact, all of them were. The difference between

them and us is the amount of training and experience they have had. Actually,

many of them are not trained well in airway care during their schooling,

but they learn it the hard way (and sometimes at their patients' expense.

Read Atul Gawande's book, Complications, and you'll see what I mean.) Give

us the same training and I suspect that we'll do about as well. Note: the

study that looked at the ventilation rates after intubation showed that

doctors were just as bad at overventilating as the rest of us.

I would like to see a study done in a system that has all the qualifiers,

that has available both wave-form capnography and pulse oxymetry, knows how

to use each of them and what they do and don't do, and has an intelligently

put-together intubation kit with bougies and several alternative airways,

CPAP, BIPAP, and all the necessary bells and whistles and devices, with

protocols and drugs to go with it. AND a program of continuing education that

gives the medics the information base to make critical decisions and the

practice to do it over and over. Since few obtain the necessary education in

their initial courses, CE is the only rational way to fix the problem, I think.

Keep in mind that my qualifiers suppose that people fully understand the

anatomy and physiology of airway care, the changes that occur with this

condition and that, and how to make rational decisions about what to do and when

to do it. It also presupposes that alternative devices are available and

people are fully trained in their use.

I believe that this takes greatly more than the few hours usually spent on

this subject. I would be interested in anybody's comments about how much

time is spent in Basic EMT class on airway management, how much in EMT-I, and

how much in Paramedic. One hour? Four hours? Eight hours? More?

How many intubations are required? My anesthesiologist friends usually say

100 intubations are necessary before one achieves a high level of

proficiency. Is this a completely unrealistic goal for paramedics? Is there

any

place where paramedic students are getting that number of intubations? How

much time do YOU think is necessary to get somebody to the point where s/he

is turned loose with the tools of intubation and airway care and allowed to

use them in the field?

I ask this question: Is there ANY service in the USA where all these

items are present? Is it possible to do a study where all the dynamics are

taken into consideration? It would be quite difficult, I expect.

The arguments for EMS to revert to basic airway care are loud and growing.

The trend is toward eliminating ETI in EMS. If we do that, will our

patients be better off? Some think they will. But do we know? What is the

EMS community doing to measure our impact on patient care?

Well, nothing. None of us, including me, have tried to run research

programs designed to show that what we do works. Surely there are SOME among

us

who have the education and understanding to construct research projects and

carry them out. Why is all the research being done at the physician

level? Is there nobody in EMS who can put together a research project, secure

a

grant, and do it?

If we do not step up and correct the deficiencies in our education and

training in airway care, I have no doubt that in a few years ETI will be

prohibited in the field. I'll say this again. If we do not step up and

correct

the deficiencies in our education and training in airway care, ETI will go

away.

Are we up to the challenge? Right now we CANNOT PROVE that our airway

care benefits patients. And even if we're great at ETI, the studies that find

terrible success rates in individual service areas are automatically and

rapidly applied to all of us.

Let's see. The studies we have show that medics in San Diego, LA,

Pittsburgh, and one area in Florida have a dismal success rate. So, therefore,

all medics everywhere have the same deficiencies. See how that works?

And one last thing. Let's not attack the folks who have done studies,

regardless of how flawed we think they have been. I once was a basher of

Henry Wang, but after I learned that he started out to prove that paramedics

could intubate efficiently and correctly, and his study showed the opposite, he

was distraught, I changed my tune. If we truly believe that paramedics

can intubate and that ETI benefits patients, then it's up to us to do the

research and prove it. Otherwise, we're going to lose it.

E. Gandy, JD, LP, NREMT-P

EMS Education

Tucson, AZ

GG

In a message dated 8/1/09 10:59:28 PM, kenneth.navarro@...

writes:

>  

> Don Elbert wrote: >>> Has RSI changed survival rates measurably (by

> formal study & not personal opinion)? <<<

>

> Don,

>

> Without reviewing every published article on rapid sequence induction

> (RSI) in the prehospital arena, I think it is safe to say that the single most

> studied condition associated with the procedure is traumatic brain injury.

> In 2007, a panel of airway experts published a review of the literature and

> attempted to answer five important questions. I will summarize the article

> here but NO ONE should classify anything I write as truthful or

> definitive. The citation will follow and everyone should look at the article

for

> himself or herself.

>

> Question 1. What are the results of outcomes studies of out-of-hospital

> RSI in severe TBI, and what do they mean?

>

> The panel noted that most of the prehospital airway studies addressing

> efficacy found an association between prehospital endotracheal intubation

> (ETI) and increased mortality (Note: an association does NOT equal cause and

> effect). The only study that demonstrated an improvement did not adjust for

> important confounders and subsequent evaluations (in the same system)

> produced dissimilar results.

>

> To be fair, all the evaluated studies had limitations including

> retrospective design, heterogeneous exposure groups, varied statistical

analysis, and

> inability to adjust for confounders. However, if 13 out of 14 studies were

> not favorable, the theory that we are harming TBI patients with RSI and

> ETI in the field seems plausible.

>

> The panel concluded that, " There are no prospective, controlled trials

> available to provide definitive conclusions regarding the efficacy of

> paramedic RSI in severe TBI. Therefore, no definitive recommendation can be

made at

> this time. "

>

> Question 2. Which patients, if any, benefit from prehospital RSI?

>

> The panel noted that no scientific study exists that has definitively

> identified the subgroup of patients who benefit from prehospital ETI. Glasgow

> coma scores are not an accurate marker of head injury severity. Harm from

> aspiration or hypoxic insult that occurs prior to EMS arrival may not be

> reversible.

>

> The decision to initiate RSI and ETI is complex and cannot be reduced to

> bumper sticker slogans such as " GSC of 8 = intubate " . The panel notes that

> medics must use multiple assessment findings, such as pulse oximetry and

> capnography values, GCS scores, the presence of hypotension and airway

> reflexes, and emerging technologies to identify those patients in need of

> aggressive airway maneuvers. The decision tree and risk/benefit analysis takes

time

> to teach and cannot be accomplished with a two-hour class on RSI drugs and

> a single intubation simulation scenario.

>

> Question 3. Are the adverse outcomes with prehospital RSI related to

> suboptimal performance of the procedure?

>

> The panel noted that systems that saw improvements in intubation success

> rates (for example from 39% to 86%) realized no mortality benefit suggesting

> that placement success might not be sufficient to improve outcomes.

> Unrecognized oxygen desaturation during the intubation attempt may contribute

to

> mortality (How many of us closely monitor heart rate and oxygen saturation

> levels during the procedure? I am not talking about putting the patient on

> an oximeter and recording the reading before and after the procedure.)

>

> The panel also noted that hyperventilation following intubation is common,

> thus reducing carbon dioxide levels and blood flow to the brain.

> Increasing intrathoracic pressure (from aggressive ventilation strategies

through

> the endotracheal tube) may increase intracranial pressure.

>

> Even systems that used the advanced monitoring technologies during and

> after the intubation attempt found the medics focused on the ETI skill and not

> the ventilation readings.

>

> The panel concluded that being competent involves considerably more than

> correctly placing a tube in the trachea.

>

> Question 4. What role does training, experience, and skills maintenance

> have in RSI-related outcomes?

>

> The panel noted that systems with intensive training and continuing

> education can achieve respectable RSI success rates, but there is no evidence

of

> resulting improvements in outcome. Skill dilution plagues many systems as

> too many intubators compete for limited intubation attempts.

>

> Question 5. What system-level factors are required to support paramedic

> RSI?

>

> Before implementing RSI, the panel recommends that careful assessment of

> the system should quantify the actual and perceived need for the procedure.

> This involves an extensive review of all personnel and intubations in the

> system including chart audits, outcome assessments, educational

> infrastructure, logistical capabilities, and available hospital resources.

>

> In my summary, I tried to be as accurate as I could. However, DO NOT hold

> my words as sacrosanct. Give a hoot and read a book . . . or something like

> that.

>

> Kenny Navarro

> Dallas

>

> Citation: , D. P., Fakhry, S. M., Wang, H. E., Bulger, E. M.,

> Domeier, R. M., Trask, A. L., Bochicchio, G. V., Hauda, W. E., & , L.

> (2007). Paramedic rapid sequence intubation for severe traumatic brain injury:

> perspectives from an expert panel. Prehospital Emergency Care, 11, 1–8.

>

>

>

>

**************

A Good Credit Score is 700 or Above. See yours in just 2 easy

steps!

(http://pr.atwola.com/promoclk/100126575x1222846709x1201493018/aol?redir=http://\

www.freecreditreport.com/pm/default.aspx?sc=668072 & hmpgID=115 &

bcd=JulystepsfooterNO115)

[Guest guest]

Don Elbert wrote: >>> Has RSI changed survival rates measurably (by formal

study & not personal opinion)? <<<

Don,

Without reviewing every published article on rapid sequence induction (RSI) in

the prehospital arena, I think it is safe to say that the single most studied

condition associated with the procedure is traumatic brain injury. In 2007, a

panel of airway experts published a review of the literature and attempted to

answer five important questions. I will summarize the article here but NO ONE

should classify anything I write as truthful or definitive. The citation will

follow and everyone should look at the article for himself or herself.

Question 1. What are the results of outcomes studies of out-of-hospital RSI in

severe TBI, and what do they mean?

The panel noted that most of the prehospital airway studies addressing efficacy

found an association between prehospital endotracheal intubation (ETI) and

increased mortality (Note: an association does NOT equal cause and effect). The

only study that demonstrated an improvement did not adjust for important

confounders and subsequent evaluations (in the same system) produced dissimilar

results.

To be fair, all the evaluated studies had limitations including retrospective

design, heterogeneous exposure groups, varied statistical analysis, and

inability to adjust for confounders. However, if 13 out of 14 studies were not

favorable, the theory that we are harming TBI patients with RSI and ETI in the

field seems plausible.

The panel concluded that, " There are no prospective, controlled trials available

to provide definitive conclusions regarding the efficacy of paramedic RSI in

severe TBI. Therefore, no definitive recommendation can be made at this time. "

Question 2. Which patients, if any, benefit from prehospital RSI?

The panel noted that no scientific study exists that has definitively identified

the subgroup of patients who benefit from prehospital ETI. Glasgow coma scores

are not an accurate marker of head injury severity. Harm from aspiration or

hypoxic insult that occurs prior to EMS arrival may not be reversible.

The decision to initiate RSI and ETI is complex and cannot be reduced to bumper

sticker slogans such as " GSC of 8 = intubate " . The panel notes that medics must

use multiple assessment findings, such as pulse oximetry and capnography values,

GCS scores, the presence of hypotension and airway reflexes, and emerging

technologies to identify those patients in need of aggressive airway maneuvers.

The decision tree and risk/benefit analysis takes time to teach and cannot be

accomplished with a two-hour class on RSI drugs and a single intubation

simulation scenario.

Question 3. Are the adverse outcomes with prehospital RSI related to suboptimal

performance of the procedure?

The panel noted that systems that saw improvements in intubation success rates

(for example from 39% to 86%) realized no mortality benefit suggesting that

placement success might not be sufficient to improve outcomes. Unrecognized

oxygen desaturation during the intubation attempt may contribute to mortality

(How many of us closely monitor heart rate and oxygen saturation levels during

the procedure? I am not talking about putting the patient on an oximeter and

recording the reading before and after the procedure.)

The panel also noted that hyperventilation following intubation is common, thus

reducing carbon dioxide levels and blood flow to the brain. Increasing

intrathoracic pressure (from aggressive ventilation strategies through the

endotracheal tube) may increase intracranial pressure.

Even systems that used the advanced monitoring technologies during and after the

intubation attempt found the medics focused on the ETI skill and not the

ventilation readings.

The panel concluded that being competent involves considerably more than

correctly placing a tube in the trachea.

Question 4. What role does training, experience, and skills maintenance have in

RSI-related outcomes?

The panel noted that systems with intensive training and continuing education

can achieve respectable RSI success rates, but there is no evidence of resulting

improvements in outcome. Skill dilution plagues many systems as too many

intubators compete for limited intubation attempts.

Question 5. What system-level factors are required to support paramedic RSI?

Before implementing RSI, the panel recommends that careful assessment of the

system should quantify the actual and perceived need for the procedure. This

involves an extensive review of all personnel and intubations in the system

including chart audits, outcome assessments, educational infrastructure,

logistical capabilities, and available hospital resources.

In my summary, I tried to be as accurate as I could. However, DO NOT hold my

words as sacrosanct. Give a hoot and read a book . . . or something like that.

Kenny Navarro

Dallas

Citation: , D. P., Fakhry, S. M., Wang, H. E., Bulger, E. M., Domeier, R.

M., Trask, A. L., Bochicchio, G. V., Hauda, W. E., & , L. (2007).

Paramedic rapid sequence intubation for severe traumatic brain injury:

perspectives from an expert panel. Prehospital Emergency Care, 11, 1–8.

[Guest guest]

If you want to talk about pre-hospital research projects, how they are put

together and how successful they are I would tell you to look at the IMMEDIATE

TRIAL and the ROC study, specifically in the BioTel system. Both were failures

and for many different reasons but one of the main issues with both were that

the education/buy-in at the physician level was not adequate thus when EMS was

told that the ER/Cardiology or Neuro docs were not going to play then EMS

quietly stopped playing too and eventually the study appears to have

disappeared. These studies included things like ACI-TIPI software for the

monitors, ICD devices and Hypertonic Saline. There were many people hired as

researchers and/or assistants and were all paid with federal funds. When one

hospital’s doc’s (cardiologists) decided not to participate then the

research people began trying to manipulate the system to force EMS to either

participate or divert to a facility that would participate, well since this is

a totally fire based system you can probably figure out how that worked out for

them.

I think, just like injury prevention is, research in EMS is everyone’s job.

We don’t even have to talk about stuff like ETI or RSI, we can’t

prove/disprove that even stuff like nebulized meds or IV fluids make a

difference in the outcome of patients. And, like Gene and several others have

said many times, just because a study seems to prove a point doesn’t mean that

it is applicable across the board. There is an old saying in city government

that also applies in this situation, “there are lies, damn lies and

statistics†you can prove or disprove anything you want by manipulating

numbers. This is exactly why NAEMT put an entire chapter in the 6th edition

PHTLS text about reading and applying research in EMS.

Let the stones fly!!!!!!

Lee

From: texasems-l [mailto:texasems-l ] On Behalf

Of wegandy1938@...

Sent: Sunday, August 02, 2009 3:08 AM

To: texasems-l

Subject: Re: RSI and Intubation (answering Don)

Kenny,

Thank you for this summary of the study. It points up what I wrote

earlier about the deficiencies in the education and training we give medics in

airway care.

I firmly believe that medics, given the right education and training, with

the right devices and equipment, and with sufficient numbers of patients to

intubate, can achieve comparable success rates to physicians. Notice that

I put in three qualifiers. The problem is that most medics have none of

the qualifiers. The fact is that most systems are, by design, failing to

provide adequate intubation opportunities for medics because they have way more

medics than available intubations.

Now, before you scream that I'm against paramedics, just stop! I am not.

But we're talking about one skill that needs to be performed regularly in

order to maintain proficiency. And many of our systems are structured in

such a way as to work against that.

Do RSI procedures done in the ER by physicians have any different outcomes?

IS THE PROBLEM WITH THE PROCEDURE OR THE OPERATOR? If it's the

operator, then that's fixable. If it's the procedure, then why are people doing

it

in the hospital? Are there any studies that have looked at the effects of

RSI on outcomes when done in the hospital? I do not know.

Most physicians that I know were just folks like us before they went to

medical school. Matter of fact, all of them were. The difference between

them and us is the amount of training and experience they have had. Actually,

many of them are not trained well in airway care during their schooling,

but they learn it the hard way (and sometimes at their patients' expense.

Read Atul Gawande's book, Complications, and you'll see what I mean.) Give

us the same training and I suspect that we'll do about as well. Note: the

study that looked at the ventilation rates after intubation showed that

doctors were just as bad at overventilating as the rest of us.

I would like to see a study done in a system that has all the qualifiers,

that has available both wave-form capnography and pulse oxymetry, knows how

to use each of them and what they do and don't do, and has an intelligently

put-together intubation kit with bougies and several alternative airways,

CPAP, BIPAP, and all the necessary bells and whistles and devices, with

protocols and drugs to go with it. AND a program of continuing education that

gives the medics the information base to make critical decisions and the

practice to do it over and over. Since few obtain the necessary education in

their initial courses, CE is the only rational way to fix the problem, I think.

Keep in mind that my qualifiers suppose that people fully understand the

anatomy and physiology of airway care, the changes that occur with this

condition and that, and how to make rational decisions about what to do and when

to do it. It also presupposes that alternative devices are available and

people are fully trained in their use.

I believe that this takes greatly more than the few hours usually spent on

this subject. I would be interested in anybody's comments about how much

time is spent in Basic EMT class on airway management, how much in EMT-I, and

how much in Paramedic. One hour? Four hours? Eight hours? More?

How many intubations are required? My anesthesiologist friends usually say

100 intubations are necessary before one achieves a high level of

proficiency. Is this a completely unrealistic goal for paramedics? Is there any

place where paramedic students are getting that number of intubations? How

much time do YOU think is necessary to get somebody to the point where s/he

is turned loose with the tools of intubation and airway care and allowed to

use them in the field?

I ask this question: Is there ANY service in the USA where all these

items are present? Is it possible to do a study where all the dynamics are

taken into consideration? It would be quite difficult, I expect.

The arguments for EMS to revert to basic airway care are loud and growing.

The trend is toward eliminating ETI in EMS. If we do that, will our

patients be better off? Some think they will. But do we know? What is the

EMS community doing to measure our impact on patient care?

Well, nothing. None of us, including me, have tried to run research

programs designed to show that what we do works. Surely there are SOME among us

who have the education and understanding to construct research projects and

carry them out. Why is all the research being done at the physician

level? Is there nobody in EMS who can put together a research project, secure a

grant, and do it?

If we do not step up and correct the deficiencies in our education and

training in airway care, I have no doubt that in a few years ETI will be

prohibited in the field. I'll say this again. If we do not step up and correct

the deficiencies in our education and training in airway care, ETI will go

away.

Are we up to the challenge? Right now we CANNOT PROVE that our airway

care benefits patients. And even if we're great at ETI, the studies that find

terrible success rates in individual service areas are automatically and

rapidly applied to all of us.

Let's see. The studies we have show that medics in San Diego, LA,

Pittsburgh, and one area in Florida have a dismal success rate. So, therefore,

all medics everywhere have the same deficiencies. See how that works?

And one last thing. Let's not attack the folks who have done studies,

regardless of how flawed we think they have been. I once was a basher of

Henry Wang, but after I learned that he started out to prove that paramedics

could intubate efficiently and correctly, and his study showed the opposite, he

was distraught, I changed my tune. If we truly believe that paramedics

can intubate and that ETI benefits patients, then it's up to us to do the

research and prove it. Otherwise, we're going to lose it.

E. Gandy, JD, LP, NREMT-P

EMS Education

Tucson, AZ

GG

In a message dated 8/1/09 10:59:28 PM, kenneth.navarro@...

writes:

>

> Don Elbert wrote: >>> Has RSI changed survival rates measurably (by

> formal study & not personal opinion)? <<<

>

> Don,

>

> Without reviewing every published article on rapid sequence induction

> (RSI) in the prehospital arena, I think it is safe to say that the single most

> studied condition associated with the procedure is traumatic brain injury.

> In 2007, a panel of airway experts published a review of the literature and

> attempted to answer five important questions. I will summarize the article

> here but NO ONE should classify anything I write as truthful or

> definitive. The citation will follow and everyone should look at the article

for

> himself or herself.

>

> Question 1. What are the results of outcomes studies of out-of-hospital

> RSI in severe TBI, and what do they mean?

>

> The panel noted that most of the prehospital airway studies addressing

> efficacy found an association between prehospital endotracheal intubation

> (ETI) and increased mortality (Note: an association does NOT equal cause and

> effect). The only study that demonstrated an improvement did not adjust for

> important confounders and subsequent evaluations (in the same system)

> produced dissimilar results.

>

> To be fair, all the evaluated studies had limitations including

> retrospective design, heterogeneous exposure groups, varied statistical

analysis, and

> inability to adjust for confounders. However, if 13 out of 14 studies were

> not favorable, the theory that we are harming TBI patients with RSI and

> ETI in the field seems plausible.

>

> The panel concluded that, " There are no prospective, controlled trials

> available to provide definitive conclusions regarding the efficacy of

> paramedic RSI in severe TBI. Therefore, no definitive recommendation can be

made at

> this time. "

>

> Question 2. Which patients, if any, benefit from prehospital RSI?

>

> The panel noted that no scientific study exists that has definitively

> identified the subgroup of patients who benefit from prehospital ETI. Glasgow

> coma scores are not an accurate marker of head injury severity. Harm from

> aspiration or hypoxic insult that occurs prior to EMS arrival may not be

> reversible.

>

> The decision to initiate RSI and ETI is complex and cannot be reduced to

> bumper sticker slogans such as " GSC of 8 = intubate " . The panel notes that

> medics must use multiple assessment findings, such as pulse oximetry and

> capnography values, GCS scores, the presence of hypotension and airway

> reflexes, and emerging technologies to identify those patients in need of

> aggressive airway maneuvers. The decision tree and risk/benefit analysis takes

time

> to teach and cannot be accomplished with a two-hour class on RSI drugs and

> a single intubation simulation scenario.

>

> Question 3. Are the adverse outcomes with prehospital RSI related to

> suboptimal performance of the procedure?

>

> The panel noted that systems that saw improvements in intubation success

> rates (for example from 39% to 86%) realized no mortality benefit suggesting

> that placement success might not be sufficient to improve outcomes.

> Unrecognized oxygen desaturation during the intubation attempt may contribute

to

> mortality (How many of us closely monitor heart rate and oxygen saturation

> levels during the procedure? I am not talking about putting the patient on

> an oximeter and recording the reading before and after the procedure.)

>

> The panel also noted that hyperventilation following intubation is common,

> thus reducing carbon dioxide levels and blood flow to the brain.

> Increasing intrathoracic pressure (from aggressive ventilation strategies

through

> the endotracheal tube) may increase intracranial pressure.

>

> Even systems that used the advanced monitoring technologies during and

> after the intubation attempt found the medics focused on the ETI skill and not

> the ventilation readings.

>

> The panel concluded that being competent involves considerably more than

> correctly placing a tube in the trachea.

>

> Question 4. What role does training, experience, and skills maintenance

> have in RSI-related outcomes?

>

> The panel noted that systems with intensive training and continuing

> education can achieve respectable RSI success rates, but there is no evidence

of

> resulting improvements in outcome. Skill dilution plagues many systems as

> too many intubators compete for limited intubation attempts.

>

> Question 5. What system-level factors are required to support paramedic

> RSI?

>

> Before implementing RSI, the panel recommends that careful assessment of

> the system should quantify the actual and perceived need for the procedure.

> This involves an extensive review of all personnel and intubations in the

> system including chart audits, outcome assessments, educational

> infrastructure, logistical capabilities, and available hospital resources.

>

> In my summary, I tried to be as accurate as I could. However, DO NOT hold

> my words as sacrosanct. Give a hoot and read a book . . . or something like

> that.

>

> Kenny Navarro

> Dallas

>

> Citation: , D. P., Fakhry, S. M., Wang, H. E., Bulger, E. M.,

> Domeier, R. M., Trask, A. L., Bochicchio, G. V., Hauda, W. E., & , L.

> (2007). Paramedic rapid sequence intubation for severe traumatic brain injury:

> perspectives from an expert panel. Prehospital Emergency Care, 11, 1–8.

>

>

>

>

**************

A Good Credit Score is 700 or Above. See yours in just 2 easy

steps!

(http://pr.atwola.com/promoclk/100126575x1222846709x1201493018/aol?redir=http://\

www.freecreditreport.com/pm/default.aspx?sc=668072

http://pr.atwola.com/promoclk/100126575x1222846709x1201493018/aol?redir=http://\

www.freecreditreport.com/pm/default.aspx?sc=668072 & hmpgID=115 & >

& hmpgID=115 &

bcd=JulystepsfooterNO115)

[Guest guest]

If you want to talk about pre-hospital research projects, how they are put

together and how successful they are I would tell you to look at the IMMEDIATE

TRIAL and the ROC study, specifically in the BioTel system. Both were failures

and for many different reasons but one of the main issues with both were that

the education/buy-in at the physician level was not adequate thus when EMS was

told that the ER/Cardiology or Neuro docs were not going to play then EMS

quietly stopped playing too and eventually the study appears to have

disappeared. These studies included things like ACI-TIPI software for the

monitors, ICD devices and Hypertonic Saline. There were many people hired as

researchers and/or assistants and were all paid with federal funds. When one

hospital’s doc’s (cardiologists) decided not to participate then the

research people began trying to manipulate the system to force EMS to either

participate or divert to a facility that would participate, well since this is

a totally fire based system you can probably figure out how that worked out for

them.

I think, just like injury prevention is, research in EMS is everyone’s job.

We don’t even have to talk about stuff like ETI or RSI, we can’t

prove/disprove that even stuff like nebulized meds or IV fluids make a

difference in the outcome of patients. And, like Gene and several others have

said many times, just because a study seems to prove a point doesn’t mean that

it is applicable across the board. There is an old saying in city government

that also applies in this situation, “there are lies, damn lies and

statistics†you can prove or disprove anything you want by manipulating

numbers. This is exactly why NAEMT put an entire chapter in the 6th edition

PHTLS text about reading and applying research in EMS.

Let the stones fly!!!!!!

Lee

From: texasems-l [mailto:texasems-l ] On Behalf

Of wegandy1938@...

Sent: Sunday, August 02, 2009 3:08 AM

To: texasems-l

Subject: Re: RSI and Intubation (answering Don)

Kenny,

Thank you for this summary of the study. It points up what I wrote

earlier about the deficiencies in the education and training we give medics in

airway care.

I firmly believe that medics, given the right education and training, with

the right devices and equipment, and with sufficient numbers of patients to

intubate, can achieve comparable success rates to physicians. Notice that

I put in three qualifiers. The problem is that most medics have none of

the qualifiers. The fact is that most systems are, by design, failing to

provide adequate intubation opportunities for medics because they have way more

medics than available intubations.

Now, before you scream that I'm against paramedics, just stop! I am not.

But we're talking about one skill that needs to be performed regularly in

order to maintain proficiency. And many of our systems are structured in

such a way as to work against that.

Do RSI procedures done in the ER by physicians have any different outcomes?

IS THE PROBLEM WITH THE PROCEDURE OR THE OPERATOR? If it's the

operator, then that's fixable. If it's the procedure, then why are people doing

it

in the hospital? Are there any studies that have looked at the effects of

RSI on outcomes when done in the hospital? I do not know.

Most physicians that I know were just folks like us before they went to

medical school. Matter of fact, all of them were. The difference between

them and us is the amount of training and experience they have had. Actually,

many of them are not trained well in airway care during their schooling,

but they learn it the hard way (and sometimes at their patients' expense.

Read Atul Gawande's book, Complications, and you'll see what I mean.) Give

us the same training and I suspect that we'll do about as well. Note: the

study that looked at the ventilation rates after intubation showed that

doctors were just as bad at overventilating as the rest of us.

I would like to see a study done in a system that has all the qualifiers,

that has available both wave-form capnography and pulse oxymetry, knows how

to use each of them and what they do and don't do, and has an intelligently

put-together intubation kit with bougies and several alternative airways,

CPAP, BIPAP, and all the necessary bells and whistles and devices, with

protocols and drugs to go with it. AND a program of continuing education that

gives the medics the information base to make critical decisions and the

practice to do it over and over. Since few obtain the necessary education in

their initial courses, CE is the only rational way to fix the problem, I think.

Keep in mind that my qualifiers suppose that people fully understand the

anatomy and physiology of airway care, the changes that occur with this

condition and that, and how to make rational decisions about what to do and when

to do it. It also presupposes that alternative devices are available and

people are fully trained in their use.

I believe that this takes greatly more than the few hours usually spent on

this subject. I would be interested in anybody's comments about how much

time is spent in Basic EMT class on airway management, how much in EMT-I, and

how much in Paramedic. One hour? Four hours? Eight hours? More?

How many intubations are required? My anesthesiologist friends usually say

100 intubations are necessary before one achieves a high level of

proficiency. Is this a completely unrealistic goal for paramedics? Is there any

place where paramedic students are getting that number of intubations? How

much time do YOU think is necessary to get somebody to the point where s/he

is turned loose with the tools of intubation and airway care and allowed to

use them in the field?

I ask this question: Is there ANY service in the USA where all these

items are present? Is it possible to do a study where all the dynamics are

taken into consideration? It would be quite difficult, I expect.

The arguments for EMS to revert to basic airway care are loud and growing.

The trend is toward eliminating ETI in EMS. If we do that, will our

patients be better off? Some think they will. But do we know? What is the

EMS community doing to measure our impact on patient care?

Well, nothing. None of us, including me, have tried to run research

programs designed to show that what we do works. Surely there are SOME among us

who have the education and understanding to construct research projects and

carry them out. Why is all the research being done at the physician

level? Is there nobody in EMS who can put together a research project, secure a

grant, and do it?

If we do not step up and correct the deficiencies in our education and

training in airway care, I have no doubt that in a few years ETI will be

prohibited in the field. I'll say this again. If we do not step up and correct

the deficiencies in our education and training in airway care, ETI will go

away.

Are we up to the challenge? Right now we CANNOT PROVE that our airway

care benefits patients. And even if we're great at ETI, the studies that find

terrible success rates in individual service areas are automatically and

rapidly applied to all of us.

Let's see. The studies we have show that medics in San Diego, LA,

Pittsburgh, and one area in Florida have a dismal success rate. So, therefore,

all medics everywhere have the same deficiencies. See how that works?

And one last thing. Let's not attack the folks who have done studies,

regardless of how flawed we think they have been. I once was a basher of

Henry Wang, but after I learned that he started out to prove that paramedics

could intubate efficiently and correctly, and his study showed the opposite, he

was distraught, I changed my tune. If we truly believe that paramedics

can intubate and that ETI benefits patients, then it's up to us to do the

research and prove it. Otherwise, we're going to lose it.

E. Gandy, JD, LP, NREMT-P

EMS Education

Tucson, AZ

GG

In a message dated 8/1/09 10:59:28 PM, kenneth.navarro@...

writes:

>

> Don Elbert wrote: >>> Has RSI changed survival rates measurably (by

> formal study & not personal opinion)? <<<

>

> Don,

>

> Without reviewing every published article on rapid sequence induction

> (RSI) in the prehospital arena, I think it is safe to say that the single most

> studied condition associated with the procedure is traumatic brain injury.

> In 2007, a panel of airway experts published a review of the literature and

> attempted to answer five important questions. I will summarize the article

> here but NO ONE should classify anything I write as truthful or

> definitive. The citation will follow and everyone should look at the article

for

> himself or herself.

>

> Question 1. What are the results of outcomes studies of out-of-hospital

> RSI in severe TBI, and what do they mean?

>

> The panel noted that most of the prehospital airway studies addressing

> efficacy found an association between prehospital endotracheal intubation

> (ETI) and increased mortality (Note: an association does NOT equal cause and

> effect). The only study that demonstrated an improvement did not adjust for

> important confounders and subsequent evaluations (in the same system)

> produced dissimilar results.

>

> To be fair, all the evaluated studies had limitations including

> retrospective design, heterogeneous exposure groups, varied statistical

analysis, and

> inability to adjust for confounders. However, if 13 out of 14 studies were

> not favorable, the theory that we are harming TBI patients with RSI and

> ETI in the field seems plausible.

>

> The panel concluded that, " There are no prospective, controlled trials

> available to provide definitive conclusions regarding the efficacy of

> paramedic RSI in severe TBI. Therefore, no definitive recommendation can be

made at

> this time. "

>

> Question 2. Which patients, if any, benefit from prehospital RSI?

>

> The panel noted that no scientific study exists that has definitively

> identified the subgroup of patients who benefit from prehospital ETI. Glasgow

> coma scores are not an accurate marker of head injury severity. Harm from

> aspiration or hypoxic insult that occurs prior to EMS arrival may not be

> reversible.

>

> The decision to initiate RSI and ETI is complex and cannot be reduced to

> bumper sticker slogans such as " GSC of 8 = intubate " . The panel notes that

> medics must use multiple assessment findings, such as pulse oximetry and

> capnography values, GCS scores, the presence of hypotension and airway

> reflexes, and emerging technologies to identify those patients in need of

> aggressive airway maneuvers. The decision tree and risk/benefit analysis takes

time

> to teach and cannot be accomplished with a two-hour class on RSI drugs and

> a single intubation simulation scenario.

>

> Question 3. Are the adverse outcomes with prehospital RSI related to

> suboptimal performance of the procedure?

>

> The panel noted that systems that saw improvements in intubation success

> rates (for example from 39% to 86%) realized no mortality benefit suggesting

> that placement success might not be sufficient to improve outcomes.

> Unrecognized oxygen desaturation during the intubation attempt may contribute

to

> mortality (How many of us closely monitor heart rate and oxygen saturation

> levels during the procedure? I am not talking about putting the patient on

> an oximeter and recording the reading before and after the procedure.)

>

> The panel also noted that hyperventilation following intubation is common,

> thus reducing carbon dioxide levels and blood flow to the brain.

> Increasing intrathoracic pressure (from aggressive ventilation strategies

through

> the endotracheal tube) may increase intracranial pressure.

>

> Even systems that used the advanced monitoring technologies during and

> after the intubation attempt found the medics focused on the ETI skill and not

> the ventilation readings.

>

> The panel concluded that being competent involves considerably more than

> correctly placing a tube in the trachea.

>

> Question 4. What role does training, experience, and skills maintenance

> have in RSI-related outcomes?

>

> The panel noted that systems with intensive training and continuing

> education can achieve respectable RSI success rates, but there is no evidence

of

> resulting improvements in outcome. Skill dilution plagues many systems as

> too many intubators compete for limited intubation attempts.

>

> Question 5. What system-level factors are required to support paramedic

> RSI?

>

> Before implementing RSI, the panel recommends that careful assessment of

> the system should quantify the actual and perceived need for the procedure.

> This involves an extensive review of all personnel and intubations in the

> system including chart audits, outcome assessments, educational

> infrastructure, logistical capabilities, and available hospital resources.

>

> In my summary, I tried to be as accurate as I could. However, DO NOT hold

> my words as sacrosanct. Give a hoot and read a book . . . or something like

> that.

>

> Kenny Navarro

> Dallas

>

> Citation: , D. P., Fakhry, S. M., Wang, H. E., Bulger, E. M.,

> Domeier, R. M., Trask, A. L., Bochicchio, G. V., Hauda, W. E., & , L.

> (2007). Paramedic rapid sequence intubation for severe traumatic brain injury:

> perspectives from an expert panel. Prehospital Emergency Care, 11, 1–8.

>

>

>

>

**************

A Good Credit Score is 700 or Above. See yours in just 2 easy

steps!

(http://pr.atwola.com/promoclk/100126575x1222846709x1201493018/aol?redir=http://\

www.freecreditreport.com/pm/default.aspx?sc=668072

http://pr.atwola.com/promoclk/100126575x1222846709x1201493018/aol?redir=http://\

www.freecreditreport.com/pm/default.aspx?sc=668072 & hmpgID=115 & >

& hmpgID=115 &

bcd=JulystepsfooterNO115)

[Guest guest]

If you want to talk about pre-hospital research projects, how they are put

together and how successful they are I would tell you to look at the IMMEDIATE

TRIAL and the ROC study, specifically in the BioTel system. Both were failures

and for many different reasons but one of the main issues with both were that

the education/buy-in at the physician level was not adequate thus when EMS was

told that the ER/Cardiology or Neuro docs were not going to play then EMS

quietly stopped playing too and eventually the study appears to have

disappeared. These studies included things like ACI-TIPI software for the

monitors, ICD devices and Hypertonic Saline. There were many people hired as

researchers and/or assistants and were all paid with federal funds. When one

hospital’s doc’s (cardiologists) decided not to participate then the

research people began trying to manipulate the system to force EMS to either

participate or divert to a facility that would participate, well since this is

a totally fire based system you can probably figure out how that worked out for

them.

I think, just like injury prevention is, research in EMS is everyone’s job.

We don’t even have to talk about stuff like ETI or RSI, we can’t

prove/disprove that even stuff like nebulized meds or IV fluids make a

difference in the outcome of patients. And, like Gene and several others have

said many times, just because a study seems to prove a point doesn’t mean that

it is applicable across the board. There is an old saying in city government

that also applies in this situation, “there are lies, damn lies and

statistics†you can prove or disprove anything you want by manipulating

numbers. This is exactly why NAEMT put an entire chapter in the 6th edition

PHTLS text about reading and applying research in EMS.

Let the stones fly!!!!!!

Lee

From: texasems-l [mailto:texasems-l ] On Behalf

Of wegandy1938@...

Sent: Sunday, August 02, 2009 3:08 AM

To: texasems-l

Subject: Re: RSI and Intubation (answering Don)

Kenny,

Thank you for this summary of the study. It points up what I wrote

earlier about the deficiencies in the education and training we give medics in

airway care.

I firmly believe that medics, given the right education and training, with

the right devices and equipment, and with sufficient numbers of patients to

intubate, can achieve comparable success rates to physicians. Notice that

I put in three qualifiers. The problem is that most medics have none of

the qualifiers. The fact is that most systems are, by design, failing to

provide adequate intubation opportunities for medics because they have way more

medics than available intubations.

Now, before you scream that I'm against paramedics, just stop! I am not.

But we're talking about one skill that needs to be performed regularly in

order to maintain proficiency. And many of our systems are structured in

such a way as to work against that.

Do RSI procedures done in the ER by physicians have any different outcomes?

IS THE PROBLEM WITH THE PROCEDURE OR THE OPERATOR? If it's the

operator, then that's fixable. If it's the procedure, then why are people doing

it

in the hospital? Are there any studies that have looked at the effects of

RSI on outcomes when done in the hospital? I do not know.

Most physicians that I know were just folks like us before they went to

medical school. Matter of fact, all of them were. The difference between

them and us is the amount of training and experience they have had. Actually,

many of them are not trained well in airway care during their schooling,

but they learn it the hard way (and sometimes at their patients' expense.

Read Atul Gawande's book, Complications, and you'll see what I mean.) Give

us the same training and I suspect that we'll do about as well. Note: the

study that looked at the ventilation rates after intubation showed that

doctors were just as bad at overventilating as the rest of us.

I would like to see a study done in a system that has all the qualifiers,

that has available both wave-form capnography and pulse oxymetry, knows how

to use each of them and what they do and don't do, and has an intelligently

put-together intubation kit with bougies and several alternative airways,

CPAP, BIPAP, and all the necessary bells and whistles and devices, with

protocols and drugs to go with it. AND a program of continuing education that

gives the medics the information base to make critical decisions and the

practice to do it over and over. Since few obtain the necessary education in

their initial courses, CE is the only rational way to fix the problem, I think.

Keep in mind that my qualifiers suppose that people fully understand the

anatomy and physiology of airway care, the changes that occur with this

condition and that, and how to make rational decisions about what to do and when

to do it. It also presupposes that alternative devices are available and

people are fully trained in their use.

I believe that this takes greatly more than the few hours usually spent on

this subject. I would be interested in anybody's comments about how much

time is spent in Basic EMT class on airway management, how much in EMT-I, and

how much in Paramedic. One hour? Four hours? Eight hours? More?

How many intubations are required? My anesthesiologist friends usually say

100 intubations are necessary before one achieves a high level of

proficiency. Is this a completely unrealistic goal for paramedics? Is there any

place where paramedic students are getting that number of intubations? How

much time do YOU think is necessary to get somebody to the point where s/he

is turned loose with the tools of intubation and airway care and allowed to

use them in the field?

I ask this question: Is there ANY service in the USA where all these

items are present? Is it possible to do a study where all the dynamics are

taken into consideration? It would be quite difficult, I expect.

The arguments for EMS to revert to basic airway care are loud and growing.

The trend is toward eliminating ETI in EMS. If we do that, will our

patients be better off? Some think they will. But do we know? What is the

EMS community doing to measure our impact on patient care?

Well, nothing. None of us, including me, have tried to run research

programs designed to show that what we do works. Surely there are SOME among us

who have the education and understanding to construct research projects and

carry them out. Why is all the research being done at the physician

level? Is there nobody in EMS who can put together a research project, secure a

grant, and do it?

If we do not step up and correct the deficiencies in our education and

training in airway care, I have no doubt that in a few years ETI will be

prohibited in the field. I'll say this again. If we do not step up and correct

the deficiencies in our education and training in airway care, ETI will go

away.

Are we up to the challenge? Right now we CANNOT PROVE that our airway

care benefits patients. And even if we're great at ETI, the studies that find

terrible success rates in individual service areas are automatically and

rapidly applied to all of us.

Let's see. The studies we have show that medics in San Diego, LA,

Pittsburgh, and one area in Florida have a dismal success rate. So, therefore,

all medics everywhere have the same deficiencies. See how that works?

And one last thing. Let's not attack the folks who have done studies,

regardless of how flawed we think they have been. I once was a basher of

Henry Wang, but after I learned that he started out to prove that paramedics

could intubate efficiently and correctly, and his study showed the opposite, he

was distraught, I changed my tune. If we truly believe that paramedics

can intubate and that ETI benefits patients, then it's up to us to do the

research and prove it. Otherwise, we're going to lose it.

E. Gandy, JD, LP, NREMT-P

EMS Education

Tucson, AZ

GG

In a message dated 8/1/09 10:59:28 PM, kenneth.navarro@...

writes:

>

> Don Elbert wrote: >>> Has RSI changed survival rates measurably (by

> formal study & not personal opinion)? <<<

>

> Don,

>

> Without reviewing every published article on rapid sequence induction

> (RSI) in the prehospital arena, I think it is safe to say that the single most

> studied condition associated with the procedure is traumatic brain injury.

> In 2007, a panel of airway experts published a review of the literature and

> attempted to answer five important questions. I will summarize the article

> here but NO ONE should classify anything I write as truthful or

> definitive. The citation will follow and everyone should look at the article

for

> himself or herself.

>

> Question 1. What are the results of outcomes studies of out-of-hospital

> RSI in severe TBI, and what do they mean?

>

> The panel noted that most of the prehospital airway studies addressing

> efficacy found an association between prehospital endotracheal intubation

> (ETI) and increased mortality (Note: an association does NOT equal cause and

> effect). The only study that demonstrated an improvement did not adjust for

> important confounders and subsequent evaluations (in the same system)

> produced dissimilar results.

>

> To be fair, all the evaluated studies had limitations including

> retrospective design, heterogeneous exposure groups, varied statistical

analysis, and

> inability to adjust for confounders. However, if 13 out of 14 studies were

> not favorable, the theory that we are harming TBI patients with RSI and

> ETI in the field seems plausible.

>

> The panel concluded that, " There are no prospective, controlled trials

> available to provide definitive conclusions regarding the efficacy of

> paramedic RSI in severe TBI. Therefore, no definitive recommendation can be

made at

> this time. "

>

> Question 2. Which patients, if any, benefit from prehospital RSI?

>

> The panel noted that no scientific study exists that has definitively

> identified the subgroup of patients who benefit from prehospital ETI. Glasgow

> coma scores are not an accurate marker of head injury severity. Harm from

> aspiration or hypoxic insult that occurs prior to EMS arrival may not be

> reversible.

>

> The decision to initiate RSI and ETI is complex and cannot be reduced to

> bumper sticker slogans such as " GSC of 8 = intubate " . The panel notes that

> medics must use multiple assessment findings, such as pulse oximetry and

> capnography values, GCS scores, the presence of hypotension and airway

> reflexes, and emerging technologies to identify those patients in need of

> aggressive airway maneuvers. The decision tree and risk/benefit analysis takes

time

> to teach and cannot be accomplished with a two-hour class on RSI drugs and

> a single intubation simulation scenario.

>

> Question 3. Are the adverse outcomes with prehospital RSI related to

> suboptimal performance of the procedure?

>

> The panel noted that systems that saw improvements in intubation success

> rates (for example from 39% to 86%) realized no mortality benefit suggesting

> that placement success might not be sufficient to improve outcomes.

> Unrecognized oxygen desaturation during the intubation attempt may contribute

to

> mortality (How many of us closely monitor heart rate and oxygen saturation

> levels during the procedure? I am not talking about putting the patient on

> an oximeter and recording the reading before and after the procedure.)

>

> The panel also noted that hyperventilation following intubation is common,

> thus reducing carbon dioxide levels and blood flow to the brain.

> Increasing intrathoracic pressure (from aggressive ventilation strategies

through

> the endotracheal tube) may increase intracranial pressure.

>

> Even systems that used the advanced monitoring technologies during and

> after the intubation attempt found the medics focused on the ETI skill and not

> the ventilation readings.

>

> The panel concluded that being competent involves considerably more than

> correctly placing a tube in the trachea.

>

> Question 4. What role does training, experience, and skills maintenance

> have in RSI-related outcomes?

>

> The panel noted that systems with intensive training and continuing

> education can achieve respectable RSI success rates, but there is no evidence

of

> resulting improvements in outcome. Skill dilution plagues many systems as

> too many intubators compete for limited intubation attempts.

>

> Question 5. What system-level factors are required to support paramedic

> RSI?

>

> Before implementing RSI, the panel recommends that careful assessment of

> the system should quantify the actual and perceived need for the procedure.

> This involves an extensive review of all personnel and intubations in the

> system including chart audits, outcome assessments, educational

> infrastructure, logistical capabilities, and available hospital resources.

>

> In my summary, I tried to be as accurate as I could. However, DO NOT hold

> my words as sacrosanct. Give a hoot and read a book . . . or something like

> that.

>

> Kenny Navarro

> Dallas

>

> Citation: , D. P., Fakhry, S. M., Wang, H. E., Bulger, E. M.,

> Domeier, R. M., Trask, A. L., Bochicchio, G. V., Hauda, W. E., & , L.

> (2007). Paramedic rapid sequence intubation for severe traumatic brain injury:

> perspectives from an expert panel. Prehospital Emergency Care, 11, 1–8.

>

>

>

>

**************

A Good Credit Score is 700 or Above. See yours in just 2 easy

steps!

(http://pr.atwola.com/promoclk/100126575x1222846709x1201493018/aol?redir=http://\

www.freecreditreport.com/pm/default.aspx?sc=668072

http://pr.atwola.com/promoclk/100126575x1222846709x1201493018/aol?redir=http://\

www.freecreditreport.com/pm/default.aspx?sc=668072 & hmpgID=115 & >

& hmpgID=115 &

bcd=JulystepsfooterNO115)

[Guest guest]

Lee wrote: >>> If you want to talk about pre-hospital research

projects, how they are put together and how successful they are I would tell you

to look at the IMMEDIATE TRIAL and the ROC study, specifically in the BioTel

system. Both were failures and for many different reasons . . . . . .

<<<

Your characterization of the prehospital research projects in the BioTel system

is not accurate. It is true that the IMMEDIATE trial is no longer ongoing

within our system, but it is still active at other sites across the country. It

is also true that the trial was plagued with problems; however, I likely do not

have all the details to speak intelligently about the reasons.

The Hypertonic Saline Trial was a two-armed trial. The system stopped enrolling

shock patients because that part of the trial was complete. The steering

committee prospectively calculated the necessary population size and after

meeting that goal, there was no need to continue to enroll patients. The BioTel

system performed very well and was responsible for enrolling a significant

number of patients into the trial. For the results, we must now wait for

analysis of the data and publication of the papers, which usually takes a couple

of years.

The system continued to enroll traumatic brain injury patients for the second

arm of the trial. That has recently stopped following a scheduled independent

review of the early data. That usually means one of two things. Either the

data suggests that the intervention is superior to conventional therapy, in

which case, it would be unethical to withhold it from the control group.

Alternatively, the conventional therapy could be superior to the investigational

therapy, in which case it would be unethical to continue to place the

interventional group at risk. We are going to have to wait for the publication

in order to find out which.

The Analyze Early – Analyze Late Trial is ongoing and doing very well.

>>> There is an old saying in city government that also applies in this

situation, there are lies, damn lies and statistics <<<

Moreover, the only time we invoke that phase is when the statistics are contrary

to our preconceived reality. I think the phrase is akin to the Jedi Mind Trick

.. . . it only convinces the weak.

>>> . . . . . . you can prove or disprove anything you want by

manipulating numbers. <<<

Suddenly, I feel like these are not the droids we have been looking for.

Actually, you do not manipulate the numbers to gain the answer you want.

Manipulation occurs in the trial design; well-designed studies give results with

greater generalizability; poorly designed trials offer less generalizability.

Reputation (some might say ego) plays a major role in the academic research

world. The peer review team in most reputable journals can easily spot a

researcher " manipulating numbers " and the price to pay for the manipulator is

tremendous. Outright falsification of data requires a conspiracy when the

project involves more than one researcher, is more difficult to spot, and often

results in a permanent ban from federal funds, loss of credibility, and

expulsion from academia. Editorial and peer review teams shred researchers who

attempt to publish papers with a nefarious agenda (in fact, these papers may

never reach the print journal). Researchers are suspicious of authors with

irreproducible results.

Lee, thanks for the banter. You and I are closer than it may appear. I

remember when you were a boy scout!

Kenny Navarro

Dallas

[Guest guest]

Lee wrote: >>> If you want to talk about pre-hospital research

projects, how they are put together and how successful they are I would tell you

to look at the IMMEDIATE TRIAL and the ROC study, specifically in the BioTel

system. Both were failures and for many different reasons . . . . . .

<<<

Your characterization of the prehospital research projects in the BioTel system

is not accurate. It is true that the IMMEDIATE trial is no longer ongoing

within our system, but it is still active at other sites across the country. It

is also true that the trial was plagued with problems; however, I likely do not

have all the details to speak intelligently about the reasons.

The Hypertonic Saline Trial was a two-armed trial. The system stopped enrolling

shock patients because that part of the trial was complete. The steering

committee prospectively calculated the necessary population size and after

meeting that goal, there was no need to continue to enroll patients. The BioTel

system performed very well and was responsible for enrolling a significant

number of patients into the trial. For the results, we must now wait for

analysis of the data and publication of the papers, which usually takes a couple

of years.

The system continued to enroll traumatic brain injury patients for the second

arm of the trial. That has recently stopped following a scheduled independent

review of the early data. That usually means one of two things. Either the

data suggests that the intervention is superior to conventional therapy, in

which case, it would be unethical to withhold it from the control group.

Alternatively, the conventional therapy could be superior to the investigational

therapy, in which case it would be unethical to continue to place the

interventional group at risk. We are going to have to wait for the publication

in order to find out which.

The Analyze Early – Analyze Late Trial is ongoing and doing very well.

>>> There is an old saying in city government that also applies in this

situation, there are lies, damn lies and statistics <<<

Moreover, the only time we invoke that phase is when the statistics are contrary

to our preconceived reality. I think the phrase is akin to the Jedi Mind Trick

.. . . it only convinces the weak.

>>> . . . . . . you can prove or disprove anything you want by

manipulating numbers. <<<

Suddenly, I feel like these are not the droids we have been looking for.

Actually, you do not manipulate the numbers to gain the answer you want.

Manipulation occurs in the trial design; well-designed studies give results with

greater generalizability; poorly designed trials offer less generalizability.

Reputation (some might say ego) plays a major role in the academic research

world. The peer review team in most reputable journals can easily spot a

researcher " manipulating numbers " and the price to pay for the manipulator is

tremendous. Outright falsification of data requires a conspiracy when the

project involves more than one researcher, is more difficult to spot, and often

results in a permanent ban from federal funds, loss of credibility, and

expulsion from academia. Editorial and peer review teams shred researchers who

attempt to publish papers with a nefarious agenda (in fact, these papers may

never reach the print journal). Researchers are suspicious of authors with

irreproducible results.

Lee, thanks for the banter. You and I are closer than it may appear. I

remember when you were a boy scout!

Kenny Navarro

Dallas

[Guest guest]

Lee wrote: >>> If you want to talk about pre-hospital research

projects, how they are put together and how successful they are I would tell you

to look at the IMMEDIATE TRIAL and the ROC study, specifically in the BioTel

system. Both were failures and for many different reasons . . . . . .

<<<

Your characterization of the prehospital research projects in the BioTel system

is not accurate. It is true that the IMMEDIATE trial is no longer ongoing

within our system, but it is still active at other sites across the country. It

is also true that the trial was plagued with problems; however, I likely do not

have all the details to speak intelligently about the reasons.

The Hypertonic Saline Trial was a two-armed trial. The system stopped enrolling

shock patients because that part of the trial was complete. The steering

committee prospectively calculated the necessary population size and after

meeting that goal, there was no need to continue to enroll patients. The BioTel

system performed very well and was responsible for enrolling a significant

number of patients into the trial. For the results, we must now wait for

analysis of the data and publication of the papers, which usually takes a couple

of years.

The system continued to enroll traumatic brain injury patients for the second

arm of the trial. That has recently stopped following a scheduled independent

review of the early data. That usually means one of two things. Either the

data suggests that the intervention is superior to conventional therapy, in

which case, it would be unethical to withhold it from the control group.

Alternatively, the conventional therapy could be superior to the investigational

therapy, in which case it would be unethical to continue to place the

interventional group at risk. We are going to have to wait for the publication

in order to find out which.

The Analyze Early – Analyze Late Trial is ongoing and doing very well.

>>> There is an old saying in city government that also applies in this

situation, there are lies, damn lies and statistics <<<

Moreover, the only time we invoke that phase is when the statistics are contrary

to our preconceived reality. I think the phrase is akin to the Jedi Mind Trick

.. . . it only convinces the weak.

>>> . . . . . . you can prove or disprove anything you want by

manipulating numbers. <<<

Suddenly, I feel like these are not the droids we have been looking for.

Actually, you do not manipulate the numbers to gain the answer you want.

Manipulation occurs in the trial design; well-designed studies give results with

greater generalizability; poorly designed trials offer less generalizability.

Reputation (some might say ego) plays a major role in the academic research

world. The peer review team in most reputable journals can easily spot a

researcher " manipulating numbers " and the price to pay for the manipulator is

tremendous. Outright falsification of data requires a conspiracy when the

project involves more than one researcher, is more difficult to spot, and often

results in a permanent ban from federal funds, loss of credibility, and

expulsion from academia. Editorial and peer review teams shred researchers who

attempt to publish papers with a nefarious agenda (in fact, these papers may

never reach the print journal). Researchers are suspicious of authors with

irreproducible results.

Lee, thanks for the banter. You and I are closer than it may appear. I

remember when you were a boy scout!

Kenny Navarro

Dallas