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Re: Re: Lab information

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hi dan this is great...joyous's excellent points got me thinking about another risk factor...oriental race(less effective ADH,inc default EtG like femine gender)...just one more random thought...it is really joy's fault for making me think...regards,r joyous1_1210 <joyous1_1210@...> wrote: Dan: this is excellent! Will you be including other factors such asimpact of medical history and those with hx of hepatitis? Thank you.> > >> > > duh what is the difference between a screening

test and adiagnostic> > test???> > >> >>

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In all

likelihood, that’s a study further down the road. To establish

baseline, it’s important to initially select almost clean medical

historys. I did not provide the exclusion criteria in my first

draft, but that would be one of them. Please recognize this does not

relegate the role other medical problems such as hepatitis have on EtG

testing. Rather, the format for an initial study must define the set to

which future studies can be compared; ie, “a benchmark”. What

one does in this situation is to take all applicants information. Then,

the initial study group is populated. If during the application phase a

sufficient number of a subpopulation of subjects is acquired serendipitously, then

most protocols would allow them to be included; albeit as a separate question

that can illustrate the role a population benchmark plays when examining

subgroups.

Hope that helps.

Dan

Re:

Lab information

Dan: this is excellent!

Will you be including other factors such as

impact of medical history and those with hx of hepatitis? Thank you.

> > >

> > > duh what is the difference between a screening test and a

diagnostic

> > test???

> > >

> >

>

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I

believe you are correct. The initial population group should be age, sex,

weight and race matched, not batched.

Re:

Re: Lab information

hi dan this is great...joyous's excellent points

got me thinking about another risk

factor...oriental race(less effective ADH,inc default

EtG like femine gender)...just one more random thought...it is really joy's

fault for making me think...regards,r

joyous1_1210

<joyous1_1210 > wrote:

Dan:

this is excellent! Will you be including other factors such as

impact of medical history and those with hx of hepatitis? Thank you.

> > >

> > > duh what is the difference between a screening test and a

diagnostic

> > test???

> > >

> >

>

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Understood. Thank you. DiBona <danieldibona@...> wrote: In all likelihood, that’s a study further down the road. To establish baseline, it’s important to initially select almost clean medical historys. I did not provide the exclusion criteria in my first draft, but that would be one of them. Please recognize this

does not relegate the role other medical problems such as hepatitis have on EtG testing. Rather, the format for an initial study must define the set to which future studies can be compared; ie, “a benchmark”. What one does in this situation is to take all applicants information. Then, the initial study group is populated. If during the application phase a sufficient number of a subpopulation of subjects is acquired serendipitously, then most protocols would allow them to be included; albeit as a separate question that can illustrate the role a population benchmark plays when examining subgroups. Hope that helps. Dan Re: Lab information Dan: this is excellent! Will you be including other factors such as impact of medical history and those with hx of hepatitis? Thank you. > > > > > > duh what is the difference between a screening test

and a diagnostic > > test??? > > > > > >

Stay in the know. Pulse on the new .com. Check it out.

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I

agree. But that’s a half million dollar study.

Re:

Lab information

It seems that the

" nature " of this kind study will call on the

credibility of the study participants. Almost seems like a closed

setting would be the only way to solidify any conclusions. You know

sort of like what happened to the Nuns! lol Otherwise, it sounds

like a well though out study!

> > > >

> > > > duh what is the difference between a screening test and a

> diagnostic

> > > test???

> > > >

> > >

> >

>

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So how can we accomplish this to be as credible as we can be..recruit people not involved with boards..strict diary entries..large population..what else????

Re: Lab information

It seems that the "nature " of this kind study will call on the

credibility of the study participants. Almost seems like a closed

setting would be the only way to solidify any conclusions. You know

sort of like what happened to the Nuns! lol Otherwise, it sounds

like a well though out study!

> > > >

> > > > duh what is the difference between a screening test and a

> diagnostic

> > > test???

> > > >

> > >

> >

>

Check out the new AOL. Most comprehensive set of free safety and security tools, free access to millions of high-quality videos from across the web, free AOL Mail and more.

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yes start with a phase one study healthy but diverse subjects.

Re: Re: Lab information

hi dan this is great...joyous's excellent points got me thinking about another risk

factor...oriental race(less effective ADH,inc default EtG like femine gender)...just one more random thought...it is really joy's fault for making me think...regards,r

joyous1_1210 <joyous1_1210 > wrote:

Dan: this is excellent! Will you be including other factors such as

impact of medical history and those with hx of hepatitis? Thank you.

> > >

> > > duh what is the difference between a screening test and a

diagnostic

> > test???

> > >

> >

>

Check out the new AOL. Most comprehensive set of free safety and security tools, free access to millions of high-quality videos from across the web, free AOL Mail and more.

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I’m

putting together a Phase I NIH grant proposal to be submitted under the

auspices of UT Southwestern Medical Center in Dallas. This is a slow

process, but I honestly believe a good chance at funding exists. I’m

coordinating it through our Office of Grants and Contracts

administration. I”ll keep everyone up to date. As I examined

the design, it’s actually never been proven that effort at reducing

exposure to environmental ethanol reduces the chances of EtG positive

tests. That has to be done first. The next step is to assess the

real life sensitivity, specificity and predictive values EtG values indicating

correctly alcohol consumption. For this part of the study I randomized

occult consumption to subject chosen and protocol dictated random times of

use. The final part examines the background prevalence of positive EtG in

urine with users of alcohol foam in the clinical setting, then compares it to

scheduled exposure of fixed amounts of alcohol foam. The design is prospective,

internally controlled and blinded to the investigator. The results are then

submitted randomized and pooled, then sequentially by subject to a set of

reviewers. Inter reveiewer agreement is measured assessing the sensitivity,

specificity and predictive valuses by time interval. From that I will

find out if there is any level that confidently predicts occult alcohol

consumption or not.

Re:

Lab information

It seems that the " nature " of this kind

study will call on the

credibility of the study participants. Almost seems like a closed

setting would be the only way to solidify any conclusions. You know

sort of like what happened to the Nuns! lol Otherwise, it sounds

like a well though out study!

> > > >

> > > > duh what is the difference between a screening test and a

> diagnostic

> > > test???

> > > >

> > >

> >

>

Check out the new AOL.

Most comprehensive set of free safety and security tools, free access to

millions of high-quality videos from across the web, free AOL Mail and more.

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Share on other sites

Excellent; Dr. Dan's an amzing man. DiBona <danieldibona@...> wrote: I’m putting together a Phase I NIH grant proposal to be submitted under the auspices of UT Southwestern Medical Center in Dallas. This is a slow process, but I honestly believe a good chance at funding exists. I’m coordinating it through our Office of Grants and Contracts administration. I”ll keep everyone up to date. As I examined the design, it’s actually never been proven that effort at reducing exposure to environmental ethanol reduces the chances of EtG positive tests. That has to be done first. The next step is to assess the real life sensitivity, specificity and predictive values EtG values indicating correctly alcohol consumption. For this part of the study I randomized occult consumption to subject chosen and protocol dictated random times of use. The final part examines the background prevalence of positive EtG in urine with users of alcohol foam in the clinical setting, then compares it to scheduled exposure of fixed amounts of alcohol foam. The design is

prospective, internally controlled and blinded to the investigator. The results are then submitted randomized and pooled, then sequentially by subject to a set of reviewers. Inter reveiewer agreement is measured assessing the sensitivity, specificity and predictive valuses by time interval. From that I will find out if there is any level that confidently predicts occult alcohol consumption or not. RE: Re: Lab information I agree. But that’s a half million dollar study. -----Original Message-----From: Ethylglucuronide

[mailto:Ethylglucuronide ] On Behalf Of isanahleiSent: Monday, September 18, 2006 2:59 PMEthylglucuronide Subject: Re: Lab information It seems that the "nature " of this kind study will call on the credibility of the study participants. Almost seems like a closed setting would be the only way to solidify any conclusions. You know sort of like what happened to the Nuns! lol Otherwise, it sounds

like a well though out study! > > > >> > > > duh what is the difference between a screening test and a> diagnostic> > > test???> > > >> > >> >> Check out the new AOL. Most comprehensive set of free safety and security tools, free access to millions of high-quality videos from across the web, free AOL Mail and more.

All-new - Fire up a more powerful email and get things done faster.

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agree with m super job ,dan, pace yourself...regards,rMarsha Dienelt <marshadienelt@...> wrote: Excellent; Dr. Dan's an amzing man. DiBona <danieldibonamac> wrote: I’m putting together a Phase I NIH

grant proposal to be submitted under the auspices of UT Southwestern Medical Center in Dallas. This is a slow process, but I honestly believe a good chance at funding exists. I’m coordinating it through our Office of Grants and Contracts administration. I”ll keep everyone up to date. As I examined the design, it’s actually never been proven that effort at reducing exposure to environmental ethanol reduces the chances of EtG positive tests. That has to be done first. The next step is to assess the real life sensitivity, specificity and predictive values EtG values indicating correctly alcohol consumption. For this part of the study I randomized occult consumption to subject chosen and protocol dictated random

times of use. The final part examines the background prevalence of positive EtG in urine with users of alcohol foam in the clinical setting, then compares it to scheduled exposure of fixed amounts of alcohol foam. The design is prospective, internally controlled and blinded to the investigator. The results are then submitted randomized and pooled, then sequentially by subject to a set of reviewers. Inter reveiewer agreement is measured assessing the sensitivity, specificity and predictive valuses by time interval. From that I will find out if there is any level that confidently predicts occult alcohol consumption or not. RE: Re: Lab information I agree. But that’s a half million dollar study. -----Original Message-----From: Ethylglucuronide [mailto:Ethylglucuronide ] On Behalf Of isanahleiSent: Monday, September 18, 2006 2:59 PMEthylglucuronide Subject: Re: Lab information It seems that the "nature " of this kind study will call on the credibility of the

study participants. Almost seems like a closed setting would be the only way to solidify any conclusions. You know sort of like what happened to the Nuns! lol Otherwise, it sounds like a well though out study! > > > >> > > > duh what is the difference between a screening test and a> diagnostic> > > test???> > > >> > >> >> Check out the new AOL. Most comprehensive set of free safety and security tools, free access to millions of high-quality videos from across the web, free AOL Mail and more. All-new - Fire up a more powerful email and get things done faster.

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Good

advice. Rhythm is coming back down to a sustainable level not diverting time

and attention from other parts of life. I’ll get there. You catch a

lot, Robin.

Dan

Re:

Lab information

It seems that the " nature " of this kind

study will call on the

credibility of the study participants. Almost seems like a closed

setting would be the only way to solidify any conclusions. You know

sort of like what happened to the Nuns! lol Otherwise, it sounds

like a well though out study!

> > > >

> > > > duh what is the difference between a screening test and a

> diagnostic

> > > test???

> > > >

> > >

> >

>

Check out the new AOL.

Most comprehensive set of free safety and security tools, free access to

millions of high-quality videos from across the web, free AOL Mail and more.

All-new

- Fire up a more powerful email and get things done faster.

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Share on other sites

I think the best thing right now to do is let me see if I can massage this into

a " foundation " kind of study. For instance; since EtG appears so sensitive as

to detect environmental ehtanol exposure there are other implications from this

beyond screening recovering people. The presence, much less the effect, of

environmental alcohol exposure is unstudied. From an evolutionary standpoint,

it must be significant or we would not have developed a specific enzyme system

to eliminate it from our bodies-alcohol dehydrogenase. I mean, there isn't any

opiate glucuronidase specific to opiates. I think it would be interesting (way

down the line) to see if background etg levels could be measured against other

parameters over time, say academic performance. Certain industries may need to

screen their workers for exposure, as we do with radon and other defined risks.

So, for now, let me massage this project and make it not only fundable, but

doable with the prospect for sustained fundability over time. Let me continue

to explore other areas of relevance beyond alcohol recovery. It's a slow

process, and for me, right now, the time spent on it is whenI sacrifice other

time-like sleep.

I'll keep you up to date. Keep the questions coming. They are all good ones.

Most of the people here obviously have a triple digit IQ. If you have a

thought, just get it out there; it may not be as nuts as you feel. :)

Dan

On Tuesday, September 19, 2006, at 09:15PM, <crssemc@...> wrote:

>

><<Original Attached>>

So how can we accomplish this to be as credible as we can be..recruit people not involved with boards..strict diary entries..large population..what else????

Re: Lab information

It seems that the "nature " of this kind study will call on the

credibility of the study participants. Almost seems like a closed

setting would be the only way to solidify any conclusions. You know

sort of like what happened to the Nuns! lol Otherwise, it sounds

like a well though out study!

> > > >

> > > > duh what is the difference between a screening test and a

> diagnostic

> > > test???

> > > >

> > >

> >

>

Check out the new AOL. Most comprehensive set of free safety and security tools, free access to millions of high-quality videos from across the web, free AOL Mail and more.

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Share on other sites

You can demonstrate the credibility of the participants in the first part of the

study. No data exists that avoiding alcohol containing substances reduces EtG

results. So, first don't change a thing, then educate them (the intervention),

and remeasure. I would expect to see some drop in the incidence of EtG results.

If not, then us abvoiding everything is for naught! Once the new baseline is

established, their credibility is internally measurable in each subsequent part

of the study.

On Monday, September 18, 2006, at 04:15PM, isanahlei <ddm2903@...> wrote:

>

><<Original Attached>>

It seems that the " nature " of this kind study will call on the

credibility of the study participants. Almost seems like a closed

setting would be the only way to solidify any conclusions. You know

sort of like what happened to the Nuns! lol Otherwise, it sounds

like a well though out study!

> > > >

> > > > duh what is the difference between a screening test and a

> diagnostic

> > > test???

> > > >

> > >

> >

>

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