Re: !st Trimester Screening For Downs

From: Gary (jafar6@optonline.net)
Sun Feb 8 21:19:08 2004


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I applaud Dan for obtaining AIUM, I mean Fetal Medicine Foundation certification in nuchal translucency screening. It is demanding, requires significant effort and shows a commitment to quality.

My thoughts are as follows:

1. I am certified to obtain nuchal translucencies for prenatal screening by an organization based in the United States and not by the FMF. I have a pretty certificate to verify this and would be glad to tell anyone privately (by e-mail) how they can get one too. One may ask who allows this American group to certify. I believe God, Who has who has not spoken out against this, some very qualified experts, and the marketplace. I believe the Fetal Medicine Foundation has a similar allowance to certify from those sources. I guess that's all you need, as long as you don't try to be exclusive and imply greater legitimacy than that. D'Alton and Malone's ** article quoted below does not mention FMF certification as necessary or even mention it.

2. I am pleased with my current certifying organization and have several concerns about the Fetal Medicine Foundation.

A. The FMF has promoted statistics that have not been confirmed in large controlled studies. In the Article by Dalton and Malone, mentioned below. The FMF quotes a sensitivity of 77% for trisomy 21 detection with a standard FP rate of 5%. This is based on modeling, and not on clinical tests. The SURUSS study (mentioned in Malone's article), the FASTER trial (just presented at the Society for Maternal-Fetal Medicine meeting) and the EATABUN **(love that name), study show a lower sensitivity and do not show significantly better detection and false positive rates than the quad screen.

B. The FASTER and SURUSS trials showed that integrated first and second trimester screening have better sensitivities and lower false positive rates than first trimester screens alone. The genetics labs working with the FMF do not (as of last week) provide integrated risk assessment based on first and second trimester screening. With close to a 90% detection rate, at about 2% false positive rate, this test results in less invasive procedures, less fetal losses and better detection. My "required" FMF course didn't mention it. It was run by a genetics lab who didn't offer it, or believe in it.

When I tell patients that integrated screening is more accurate and safer for the baby, although the results come back 2-3 weeks later, many jump at it. Patients who have non-invasive screening are usually looking to avoid invasive procedures, and these integrated screens give them the best detection rate, and the best chance of avoiding an invasive test.

C. The FMF has found nasal bone screening to be about as effective as nuchal translucency screening. The FASTER trial could not confirm it.

D. I feel that the Genetics labs participating in the FMF education process in the USA steer physicians to use their labs. They make it seem that they are are the official arm of the official certifying organization. Most don't offer integrated 1st and 2nd trimester screening and they quote stats from the FMF models that have not been confirmed.

3. I think Drs, Malone, Dr. Wapner**, Dr. D'Alton, Dr. Wald and all the others who did such beautiful work in the large US and UK studies should make recommendations for training and quality control. I am guessing and hoping that they wont put all of us through the FMF process.

4. It only gets better. The day is nearing when invasive studies for Down syndrome will be a rarity. Several promising screens within our reach include, iliac wing angle by 3-D ultrasound, and free fetal DNA in the maternal circulation (which is increased in fetuses with trisomy 21). Maybe 3-D ultrasound will save nasal bone screening and make nuchal translucencies easier to obtain. Meanwhile, our nuchal certification diplomas and $2.00 still get us on the NYC Subways.

Btw, all my info about the FASTER trial comes from the abstract. I couldn't attend the meeting. Could someone fill me in on what I missed regarding this topic? I bet the same flame war was fought there.

Thank you in advance for that info.

--
Gary Kleinman, M.D.
Maternal-Fetal Medicine/Genetics
Bridgeport Hospital
Bridgeport, CT

*Malone, F, D'Alton, M and the Society for Maternal Fetal Medicine. First-Trimester Sonographic Screening for Down Syndrome Obstetrics & Gynecology 2003;102:1066-1079. For those certified by the FMF. Look carefully at the box on page 1068. You will see that #'s 3 and 10 are a bit different than the FMF's recommendations. Is July 4 closer than I think?

**I believe it was Dr. Wapner who coined the acronym for the EATABUN Study, for "Early Amniocentesis, Transabdominal, with Biochemical Ultrasound Nuchal translucency. The study showed that first trimester screening outperfromed second trimester screens, but did not mention what proportion of the screens were quad screens. From my initial Evelyn Wood type skimming of the methods section, it seems they compared first trimester combined screening to a triple screen.

On Sunday, February 8, 2004, at 09:09 PM, Charlie Chambers wrote: > ........If you know about this process, the Fetal Med Foundation, is > trying to make sure that there is uniformity and quality assurance > associated with this screening method. They also give continued > feedback to already certified individuals in order to maintain > quality. I've seen too many physicians who are using nuchal > translucency without a basic understanding of the correct method. The > criteria were nicely laid out in the Green journal about 2-3 months > ago by Mary D'Alton et al, and echoed by F.M.F. ......

> Charlie Chambers > Hood River, OR USA > cchamber@alumni.rice.edu

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I applaud Dan for obtaining AIUM, I mean Fetal Medicine Foundation certification in nuchal translucency screening. It is demanding, requires significant effort and shows a commitment to quality.

My thoughts are as follows:

1. I am certified to obtain nuchal translucencies for prenatal screening by an organization based in the United States and not by the FMF. I have a pretty certificate to verify this and would be glad to tell anyone privately (by e-mail) how they can get one too. One may ask who allows this American group to certify. I believe God, Who has who has not spoken out against this, some very qualified experts, and the marketplace. I believe the Fetal Medicine Foundation has a similar allowance to certify from those sources. I guess that's all you need, as long as you don't try to be exclusive and imply greater legitimacy than that. D'Alton and Malone's ** article quoted below does not mention FMF certification as necessary or even mention it.

2. I am pleased with my current certifying organization and have several concerns about the Fetal Medicine Foundation.

A. The FMF has promoted statistics that have not been confirmed in large controlled studies. In the Article by Dalton and Malone, mentioned below. The FMF quotes a sensitivity of 77% for trisomy 21 detection with a standard FP rate of 5%. This is based on modeling, and not on clinical tests. The SURUSS study (mentioned in Malone's article), the FASTER trial (just presented at the Society for Maternal-Fetal Medicine meeting) and the EATABUN **(love that name), study show a lower sensitivity and do not show significantly better detection and false positive rates than the quad screen.

B. The FASTER and SURUSS trials showed that integrated first and second trimester screening have better sensitivities and lower false positive rates than first trimester screens alone. The genetics labs working with the FMF do not (as of last week) provide integrated risk assessment based on first and second trimester screening. With close to a 90% detection rate, at about 2% false positive rate, this test results in less invasive procedures, less fetal losses and better detection. My "required" FMF course didn't mention it. It was run by a genetics lab who didn't offer it, or believe in it.

When I tell patients that integrated screening is more accurate and safer for the baby, although the results come back 2-3 weeks later, many jump at it. Patients who have non-invasive screening are usually looking to avoid invasive procedures, and these integrated screens give them the best detection rate, and the best chance of avoiding an invasive test.

C. The FMF has found nasal bone screening to be about as effective as nuchal translucency screening. The FASTER trial could not confirm it.

D. I feel that the Genetics labs participating in the FMF education process in the USA steer physicians to use their labs. They make it seem that they are are the official arm of the official certifying organization. Most don't offer integrated 1st and 2nd trimester screening and they quote stats from the FMF models that have not been confirmed.

3. I think Drs, Malone, Dr. Wapner**, Dr. D'Alton, Dr. Wald and all the others who did such beautiful work in the large US and UK studies should make recommendations for training and quality control. I am guessing and hoping that they wont put all of us through the FMF process.

4. It only gets better. The day is nearing when invasive studies for Down syndrome will be a rarity. Several promising screens within our reach include, iliac wing angle by 3-D ultrasound, and free fetal DNA in the maternal circulation (which is increased in fetuses with trisomy 21). Maybe 3-D ultrasound will save nasal bone screening and make nuchal translucencies easier to obtain. Meanwhile, our nuchal certification diplomas and $2.00 still get us on the NYC Subways.

Btw, all my info about the FASTER trial comes from the abstract. I couldn't attend the meeting. Could someone fill me in on what I missed regarding this topic? I bet the same flame war was fought there.

Thank you in advance for that info.

Gary Kleinman, M.D.

Maternal-Fetal Medicine/Genetics

Bridgeport Hospital

Bridgeport, CT

<bold><color><param>0000,5656,3F3F</param>*Malone, F, D'Alton, M and the Society for Maternal Fetal Medicine. </color><fontfamily><param>Lucida Grande</param>First-Trimester Sonographic Screening for <color><param>CCCC,0000,0000</param>Down </color>Syndrome </fontfamily><italic><color><param>0000,5656,3F3F</param>Obstetrics & Gynecology </color></italic><fontfamily><param>Lucida Grande</param><color><param>0000,5656,3F3F</param>2003;102:1066-1079. For those certified by the FMF. Look carefully at the box on page 1068. You will see that #'s 3 and 10 are a bit different than the FMF's recommendations. Is July 4 closer than I think?

**I believe it was Dr. Wapner who coined the acronym for the EATABUN Study, for "Early Amniocentesis, Transabdominal, with Biochemical Ultrasound Nuchal translucency. The study showed that first trimester screening outperfromed second trimester screens, but did not mention what proportion of the screens were quad screens. From my initial Evelyn Wood type skimming of the methods section, it seems they compared first trimester combined screening to a triple screen. </color><bigger>

</bigger></fontfamily></bold>

On Sunday, February 8, 2004, at 09:09 PM, Charlie Chambers wrote:

<excerpt>........If you know about this process, the Fetal Med Foundation, is trying to make sure that there is uniformity and quality assurance associated with this screening method. They also give continued feedback to already certified individuals in order to maintain quality. I've seen too many physicians who are using nuchal translucency without a basic understanding of the correct method. The criteria were nicely laid out in the Green journal about 2-3 months ago by Mary D'Alton et al, and echoed by F.M.F. ......<bigger>

</bigger></excerpt>

<excerpt><bigger>Charlie Chambers

Hood River, OR USA

cchamber@alumni.rice.edu

</bigger></excerpt>

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