Guest guest Posted September 17, 2006 Report Share Posted September 17, 2006 Dig through all of your old things like this and keep posting for people like me new to this group. This is outrageous. I’m currently working up a double blinded prospective reasearch proposal. I’ll go ahead and post it for open criticism. Please understand this is a first draft of thoughts only. Rationale Urine EtG testing is being marketed and used by regulatory agencies to determine whether or not a person followed by them is abstaining from alcohol use. At this time, individuals testing positive for extremely low levels of urine EtG are experiencing harsh consequences based on this test alone. No prospective controlled studies exist validating the use of urine EtG as a marker for occult alcohol consumption. Type of project: Blinded, prospective Costs involved: • Very rough estimate = I don’t have a clue. ? Thirty grand? • Investigator and administrative time. • Supplies (urine collection kits, alcohol foam hand wash, paper, printer, computer) • Payment to study participants • Payment to lab performing analysis for urine EtG • Payment to urine collection and processing site? • Postage • Consultation for clinical statistics and project design Funding Source: At the time of this writing, I don’t have a clue. Investigators: • Collaboration with Greg Skipper, M.D.? (He pioneered urine EtG testing in the U.S.) • Interested faculty in the Section of Hospital Medicine • Interested faculty or staff in the department of statistics Questions to answer: • How predictive is urine EtG of occult ethanol ingestion in men and woman working in a hospital environment? • What is the inter-reviewer agreement when identifying alcohol consumption and non-consumption? • Does the use of alcohol foam hand cleanser influence the predictive value of urine EtG results by level reported? • Are there identifiable male-female differences? GROUPS Needs to be run by the statisticians to determine the NNT. Population One: Groups of ten male and female physicians, nurses, pharmacists, residents and medical students by sex. Group 1: No intervention, except asked to not drink alcohol. Group 2: Assigned to consume evening alcohol, 0.2g/kg on two randomly selected nights BY THE PARTICIPANT. Group 3: Assigned to consume evening alcohol, 0.2g/kg on two randomly selected nights BY PROTOCOL ASSIGNMENT. Group 4: Same as Group 1, with further instructions to avoid known exposure to alcohol containing substances, except alcohol foam. The participants in this group are to use alcohol foam no less than twenty times per day during the study period. They record use in excess as well. Group 5: Same as Group 1, with further instructions to avoid known exposure to alcohol containing substances, except alcohol foam. This group simply records their routine use of alcohol foam. Group 6: Same as Groups 5, but with instructions to avoid all use of alcohol foam and all known alcohol containing substances. Possible Population: Age and sex matched people who are non-hospital, non-medical people working at least forty hours a week. Population Two: A group of individuals called “Results Reviewers” Reviewer 1: The investigator Reviewer 2: ? Greg Skipper or another well informed urine EtG expert. Reviewers 3, 4: General MRO officers. Reviewers 5, 6: Medical or nursing board physician members Reviewers 7, 8: Judges Reviewers 9, 10: Non medical, non legal individuals, one woman, one man age matched. Requirements: • Blinded to the investigator and reviewers, subjects randomly assigned to groups, not to disclose consumption of alcohol except by study protocol. • No less than forty hours over the seven day period inside the hospital performing clinical duties. • Daily morning and afternoon samples for urine EtOH, urine EtG and urine creatinine. • Study period: Ten days Day 1, no interventions, Days 2-8 interventions performed, Days 9, 10 no interventions. • As subjects become available, they can be started on the protocol • At the completion of the study, reviewers receive subject data pooled and presented randomly. Afterwards, the results are presented serially per subject. • Each reviewer answers a question in a yes or no format. • The only information provided to the reviewer is “Urine EtG is a chemical specific to the breakdown of ethanol. Knowing this fact, please indicate yes or no whether the subject drank alcohol.” : Outcome questions: When and how often did the reviewers correctly identify alcohol consumption? When and how often did the reviewers correctly identify no alcohol consumption? When and how often did alcohol foam score as alcohol and no alcohol consumption? Is there a difference in the results for men and women? Is there a difference in the results scored versus actual by reviewer presented randomly? Is there a difference in the results scored versus actual by reviewer presented serially? Data collected: Age, Sex, Weight, medications, medical history of each subject Dates of alcohol consumption. Dates of no alcohol consumption. Dates and amounts of alcohol foam use. Dates and amounts of no alcohol foam use. Dates and times of both alcohol use and foam use. Dates and times of no alcohol use and no foam use. Daily morning and noon urine EtOH, EtG and creatinine levels. Lab information Dan, In terms of what information the labs are disseminating, we focus on the websites, because that is the information to which we have access. There's a little history here. Dr. Feldman was Sr. VP and GM of NWTox until Quest took them over in Nov 05. He's a toxicologist and was a frequent contributor to Dr. Skipper's old discussion group. In Aug 05, there was an interesting thread in which we were very interested in what information the labs were giving our boards with regards to EtG. We really badgered Feldman to give us that information. Here was part of that exchange: Lorie: You work for NWTox, don't you? Any chance you could post the information that is provided to the Boards to educate them on making the decision which cutoff to use? Feldman: To all clients of our any of our alcohol testing services, we provide an overview of the appropriate applications and limitations of each of our alcohol tests (blood, oral fluid, urine, breath and urine EtG), and require that they sign an acknowledgement of understanding with their request for services. This documents that they have read the overview prior to ordering any alcohol test. Lorie: Can you please post this overview for us to review? Feldman: We can share this information with customers. It presents the EtG issues we have discussed, regarding incidental exposure and cutoffs. We are restricted on what we can release to the general public, since we do not sell our services “over the counter”. Lorie: Who are your " customers " , Dr. Feldman? I have paid for at least 34 tests performed by NW Toxicology. Doesn't that make me a customer? I cannot believe that someone (other than NWT's legal dept.) would restrict you from releasing that information. Since your services aren't " over the counter " , that would make them " prescription only " . As a pharmacist, I can tell you that it is both unethical and illegal to withhold information about a " prescription only " product from the general public. This WREAKS of a scandal! Feldman: We do not sell our laboratory services directly to the public. We take orders form physicians and other healthcare business clients (TPAs, licensing agencies, rehab centers, etc). All of our donor specimens come to us through these clients. I have been forthcoming with information, on this website, and resent the assertion that we are hiding anything. I have to abide by certain guidelines, as you are probably very well aware. Re: Screening vs, Diagnostic Testing What strikes me here is that in all of these examples, we are dealing with laboratory tests used to diagnose or screen for a medical condition. This is medicine and requires a skilled clinician. Doctors carry malpractice insurance so if, God forbid, they are too aggressive in making a diagnosis, they can be held responsible. So how did lab tests wind up in the hands of social workers and probation officers? Could this be categorized as " practicing medicine without a license " ? > > > > duh what is the difference between a screening test and a diagnostic > test??? > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 17, 2006 Report Share Posted September 17, 2006 I LOVE THIS, ! The results of this study would be so rich with information. I think it would certainly have the potential to blow this whole thing out of the water. I wish I knew more about applying for research grants. I know it's preliminary, but have you considered running it past Dr. Skipper? Brilliant! RE: Re: Screening vs, Diagnostic Testing The labs operate in the grey zone. The are in the business of providing the numbers, and depending on their level of certification, responsible for providing interpretive guidelines. Where the labs stepped over the line is marketing urine EtG as proof positive of occult EtOH ingestion. They always put this little disclaimer at the bottom of their results. Where the liability data is going to come from is freeze framing their websites. Another project, which I am too busy to do is the following: All licensing boards must record public minutes. A lot of the time you have to find the site map to locate the minutes and agendas. Once found, Google offers a nice site search engine. Typing in EtG, ethyl glucuronide, or even just alcohol should find any record. As contracts with testing companies is public information and in most cases does not qualify for executive sessions, there should be a record. It would also identify individuals who had action taken against them solely because of a positive urine EtG. It’s my guess that buried in those minutes are presentations by lab companies marketing urine EtG to the boards. As the transcript is a legal document, it is not alterable, unlike a website. So…if anyone has the hours on hand to puruse all fifty states board of medicine, nursing, pharmacy, veternarians, pilots, etc. minutes my prediction is that some very useful and condeming information will be found. -----Original Message-----From: Ethylglucuronide [mailto:Ethylglucuronide ] On Behalf Of LorieSent: Sunday, September 17, 2006 12:25 PMEthylglucuronide Subject: Re: Screening vs, Diagnostic Testing What strikes me here is that in all of these examples, we are dealing with laboratory tests used to diagnose or screen for a medical condition. This is medicine and requires a skilled clinician. Doctors carry malpractice insurance so if, God forbid, they are too aggressive in making a diagnosis, they can be held responsible. So how did lab tests wind up in the hands of social workers and probation officers? Could this be categorized as "practicing medicine without a license"? > >> > duh what is the difference between a screening test and a diagnostic> test???> >> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 17, 2006 Report Share Posted September 17, 2006 Skipper and I are in communication. It’s way too early to say anything. Thank you, for all of your support, Lorie. This has been an increbily stressful week for me to have everything most dear threatened. It’s not like I’m sloppy or have anything to “clean up” Also, it’s not like getting an “all’s clear” signal fixes anything for me. I mean, crap…everything I consider as contrbuting interference was settled long ago… I remember when a urine screen was a nice way to summarize the quality of my recovery win a nice and tidy clean void. Now I feel like I’m playing some sort of death lottery with everything important to me contingent upon some random roll of the cosmic death dice. Thank you so very much, Lorie. I’m exhausted, and I have to round with an exhausting Resident at six. Dan Re: Lab information I LOVE THIS, ! The results of this study would be so rich with information. I think it would certainly have the potential to blow this whole thing out of the water. I wish I knew more about applying for research grants. I know it's preliminary, but have you considered running it past Dr. Skipper? Brilliant! Re: Screening vs, Diagnostic Testing What strikes me here is that in all of these examples, we are dealing with laboratory tests used to diagnose or screen for a medical condition. This is medicine and requires a skilled clinician. Doctors carry malpractice insurance so if, God forbid, they are too aggressive in making a diagnosis, they can be held responsible. So how did lab tests wind up in the hands of social workers and probation officers? Could this be categorized as " practicing medicine without a license " ? > > > > duh what is the difference between a screening test and a diagnostic > test??? > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 18, 2006 Report Share Posted September 18, 2006 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??? > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 18, 2006 Report Share Posted September 18, 2006 I will happily take the blame, we like it when you think! > > > > > > > > duh what is the difference between a screening test and a > diagnostic > > > test??? > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 18, 2006 Report Share Posted September 18, 2006 Understood, thank you, joy > > > > > > > > duh what is the difference between a screening test and a > diagnostic > > > test??? > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 18, 2006 Report Share Posted September 18, 2006 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??? > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 I know, I didn't say it was possible.........smile > > > > > > > > > > duh what is the difference between a screening test and a > > diagnostic > > > > test??? > > > > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 Do you really want to specify "foam" hand wash, or just alcohol based hand wash? Lab information Dan, In terms of what information the labs are disseminating, we focus on the websites, because that is the information to which we have access. There's a little history here. Dr. Feldman was Sr. VP and GM of NWTox until Quest took them over in Nov 05. He's a toxicologist and was a frequent contributor to Dr. Skipper's old discussion group. In Aug 05, there was an interesting thread in which we were very interested in what information the labs were giving our boards with regards to EtG. We really badgered Feldman to give us that information. Here was part of that exchange: Lorie: You work for NWTox, don't you? Any chance you could post the information that is provided to the Boards to educate them on making the decision which cutoff to use? Feldman: To all clients of our any of our alcohol testing services, we provide an overview of the appropriate applications and limitations of each of our alcohol tests (blood, oral fluid, urine, breath and urine EtG), and require that they sign an acknowledgement of understanding with their request for services. This documents that they have read the overview prior to ordering any alcohol test. Lorie: Can you please post this overview for us to review? Feldman: We can share this information with customers. It presents the EtG issues we have discussed, regarding incidental exposure and cutoffs. We are restricted on what we can release to the general public, since we do not sell our services “over the counterâ€. Lorie: Who are your "customers", Dr. Feldman? I have paid for at least 34 tests performed by NW Toxicology. Doesn't that make me a customer? I cannot believe that someone (other than NWT's legal dept.) would restrict you from releasing that information. Since your services aren't "over the counter", that would make them "prescription only". As a pharmacist, I can tell you that it is both unethical and illegal to withhold information about a "prescription only" product from the general public. This WREAKS of a scandal! Feldman: We do not sell our laboratory services directly to the public. We take orders form physicians and other healthcare business clients (TPAs, licensing agencies, rehab centers, etc). All of our donor specimens come to us through these clients. I have been forthcoming with information, on this website, and resent the assertion that we are hiding anything. I have to abide by certain guidelines, as you are probably very well aware. Re: Screening vs, Diagnostic Testing What strikes me here is that in all of these examples, we are dealing with laboratory tests used to diagnose or screen for a medical condition. This is medicine and requires a skilled clinician. Doctors carry malpractice insurance so if, God forbid, they are too aggressive in making a diagnosis, they can be held responsible. So how did lab tests wind up in the hands of social workers and probation officers? Could this be categorized as "practicing medicine without a license"? > > > > 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. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 Do you really want to specify "foam" hand wash, or just alcohol based hand wash? Lab information Dan, In terms of what information the labs are disseminating, we focus on the websites, because that is the information to which we have access. There's a little history here. Dr. Feldman was Sr. VP and GM of NWTox until Quest took them over in Nov 05. He's a toxicologist and was a frequent contributor to Dr. Skipper's old discussion group. In Aug 05, there was an interesting thread in which we were very interested in what information the labs were giving our boards with regards to EtG. We really badgered Feldman to give us that information. Here was part of that exchange: Lorie: You work for NWTox, don't you? Any chance you could post the information that is provided to the Boards to educate them on making the decision which cutoff to use? Feldman: To all clients of our any of our alcohol testing services, we provide an overview of the appropriate applications and limitations of each of our alcohol tests (blood, oral fluid, urine, breath and urine EtG), and require that they sign an acknowledgement of understanding with their request for services. This documents that they have read the overview prior to ordering any alcohol test. Lorie: Can you please post this overview for us to review? Feldman: We can share this information with customers. It presents the EtG issues we have discussed, regarding incidental exposure and cutoffs. We are restricted on what we can release to the general public, since we do not sell our services “over the counterâ€. Lorie: Who are your "customers", Dr. Feldman? I have paid for at least 34 tests performed by NW Toxicology. Doesn't that make me a customer? I cannot believe that someone (other than NWT's legal dept.) would restrict you from releasing that information. Since your services aren't "over the counter", that would make them "prescription only". As a pharmacist, I can tell you that it is both unethical and illegal to withhold information about a "prescription only" product from the general public. This WREAKS of a scandal! Feldman: We do not sell our laboratory services directly to the public. We take orders form physicians and other healthcare business clients (TPAs, licensing agencies, rehab centers, etc). All of our donor specimens come to us through these clients. I have been forthcoming with information, on this website, and resent the assertion that we are hiding anything. I have to abide by certain guidelines, as you are probably very well aware. Re: Screening vs, Diagnostic Testing What strikes me here is that in all of these examples, we are dealing with laboratory tests used to diagnose or screen for a medical condition. This is medicine and requires a skilled clinician. Doctors carry malpractice insurance so if, God forbid, they are too aggressive in making a diagnosis, they can be held responsible. So how did lab tests wind up in the hands of social workers and probation officers? Could this be categorized as "practicing medicine without a license"? > > > > 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. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 yes, it's a bit like russian roulette isn't it??? Re: Lab information I LOVE THIS, ! The results of this study would be so rich with information. I think it would certainly have the potential to blow this whole thing out of the water. I wish I knew more about applying for research grants. I know it's preliminary, but have you considered running it past Dr. Skipper? Brilliant! Re: Screening vs, Diagnostic Testing What strikes me here is that in all of these examples, we are dealing with laboratory tests used to diagnose or screen for a medical condition. This is medicine and requires a skilled clinician. Doctors carry malpractice insurance so if, God forbid, they are too aggressive in making a diagnosis, they can be held responsible. So how did lab tests wind up in the hands of social workers and probation officers? Could this be categorized as "practicing medicine without a license"? > > > > 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. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 20, 2006 Report Share Posted September 20, 2006 I believe that exposure to alcohol gel through inhalation will provide positive EtG VS. foam. > > > > > > > > > > duh what is the difference between a screening test and a > > diagnostic > > > > test??? > > > > > > > > > > > > > > > > _____ > > > <http://pr.atwola.com/promoclk/1615326657x4311227241x4298082137/aol? redir=ht > tp%3A%2F%2Fwww%2Eaol%2Ecom%2Fnewaol> 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. > Quote Link to comment Share on other sites More sharing options...
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