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“NONINVASIVE PRENATAL DNA TESTING: WHO IS USING IT, AND HOW?”
JANELLE YATES (AUDIO, JUNE 2013)
Noninvasive prenatal DNA tests are unproven and costly
The sudden upsurge of this testing is somewhat troubling. The available tests are in-house, self-evaluated products that have not been approved by the US Food and Drug Administration (FDA). The tests have yet to be verified by extensive independent evaluation, and there are concerns that the data could be skewed by the omission of women whose fetal DNA fragments are too few to be measured accurately. Yet, there is a lemming-like rush to adopt them.
Complicating the issue is the fact that many large insurance carriers refuse to cover these tests—along with a plethora of other prenatal and early neonatal genetic tests proffered to avoid, at any cost, the delivery of a “defective” baby. This lack of coverage often leaves the patient with thousands of dollars of unexpected expense.
Although they are more invasive, the quad screen, chorionic villus sampling, and amniocentesis remain the gold standard of aneuploidy detection.
Obstetricians need to ask themselves questions such as “Why am I ordering this test—to avoid a ‘wrongful birth’ suit?” “Do I really believe the testing is necessary, given the infrequency of cystic fibrosis among low-risk women?” “Should I inform the patient that the testing probably won’t be covered by insurance?”
I doubt that this expensive array of testing survives the coming national health scheme. To perform the entire panoply of prenatal and early neonatal screening tests now costs upwards of $3,000—and that figure does not include the more esoteric tests that some providers are ordering. Add this amount to the cost of covering an additional 50 million people under health-care reform, and it is obvious that the tests lack sufficient benefit to justify their costs. It would be better to adopt some sanity now instead of rushing to adopt every new test that maternal-fetal medicine specialists and industrial geneticists create.
David A. Carpenter, MD
Paris, Texas
It shouldn’t take a hospital to end elective early term delivery
I’ve been in private practice since 1988. Until the past decade or so, the timing of “elective induction” was never debated. Although I usually do not appreciate hospital intrusion into my practice of medicine, I welcome the policy of requiring a gestational age of at least 39 weeks for elective induction. Too bad it requires hospital regulation for us to schedule elective induction properly. If only we could go back to the days when a physician just did what was right for the patient.
Steve Godfrey, MD
Wichita Falls, Texas
Hysteroscopy is under-used for AUB
I agree with Dr. Amy Garcia that hysteroscopy is under-utilized for evaluation of abnormal uterine bleeding (AUB).
When evaluating patients with AUB, I divide them into three age groups: 1) the adolescent (ages 13–18 years); 2) the reproductive woman (19–39 years); and 3) the peri-, meno-, and postmenopausal woman (40 years and above).1 In the third group, AUB is more often attributed to intracavitary pathology. Therefore, women with AUB in this age group should be evaluated using transvaginal ultrasonography (TVUS), sonohysteroscopy, magnetic resonance imaging (MRI), endometrial sampling, and hysteroscopy.1
TVUS should be the first imaging used to assess pelvic pathology. Both sonohysteroscopy and MRI can provide detailed diagnostic information; however, they are not therapeutic or cost-effective. If lesions such as myomas, polyps, thickened endometrium, or a malignancy are diagnosed, then further procedures with hysteroscopy are warranted to remove or to sample.2
As the incidence of endometrial malignancy increases in women above age 45, the American College of Obstetricians and Gynecologists (ACOG) recommends endometrial sampling to rule out malignancy.1 However, Dr. Garcia’s article clearly points out that blinded biopsy has low sensitivity for diagnosing polyps (11%), myomas (13%), and hyperplasia (25%), and that sensitivity with hysteroscopy increased to 89% for polyps, 100% for myomas, and 74% for hyperplasia.
Hysteroscopic procedures can be both diagnostic and therapeutic. In the presence of intracavitary pathology, hysteroscopy can offer therapeutic interventions as part of a “see and treat” venue. Despite the potential risks of infection, hemorrhage, perforation, cervical laceration, fluid overload, electrolyte imbalance, and embolization, complications are relatively rare.2 I agree that this minimally invasive procedure should be offered to appropriately selected patients with AUB.
Takeko Takeshige, DO
Bronx, New York
Tell us what you think, at [email protected]. Please include your name and city and state.
References
1. ACOG Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 128: Diagnosis of abnormal uterine bleeding in reproductive-aged women. Obstet Gynecol. 2012;120(1):197–206.
2. American College of Obstetricians and Gynecologists. Technology Assessment No. 7: Hysteroscopy. Obstet Gynecol. 2011;117(6):1486–1491.
“NONINVASIVE PRENATAL DNA TESTING: WHO IS USING IT, AND HOW?”
JANELLE YATES (AUDIO, JUNE 2013)
Noninvasive prenatal DNA tests are unproven and costly
The sudden upsurge of this testing is somewhat troubling. The available tests are in-house, self-evaluated products that have not been approved by the US Food and Drug Administration (FDA). The tests have yet to be verified by extensive independent evaluation, and there are concerns that the data could be skewed by the omission of women whose fetal DNA fragments are too few to be measured accurately. Yet, there is a lemming-like rush to adopt them.
Complicating the issue is the fact that many large insurance carriers refuse to cover these tests—along with a plethora of other prenatal and early neonatal genetic tests proffered to avoid, at any cost, the delivery of a “defective” baby. This lack of coverage often leaves the patient with thousands of dollars of unexpected expense.
Although they are more invasive, the quad screen, chorionic villus sampling, and amniocentesis remain the gold standard of aneuploidy detection.
Obstetricians need to ask themselves questions such as “Why am I ordering this test—to avoid a ‘wrongful birth’ suit?” “Do I really believe the testing is necessary, given the infrequency of cystic fibrosis among low-risk women?” “Should I inform the patient that the testing probably won’t be covered by insurance?”
I doubt that this expensive array of testing survives the coming national health scheme. To perform the entire panoply of prenatal and early neonatal screening tests now costs upwards of $3,000—and that figure does not include the more esoteric tests that some providers are ordering. Add this amount to the cost of covering an additional 50 million people under health-care reform, and it is obvious that the tests lack sufficient benefit to justify their costs. It would be better to adopt some sanity now instead of rushing to adopt every new test that maternal-fetal medicine specialists and industrial geneticists create.
David A. Carpenter, MD
Paris, Texas
It shouldn’t take a hospital to end elective early term delivery
I’ve been in private practice since 1988. Until the past decade or so, the timing of “elective induction” was never debated. Although I usually do not appreciate hospital intrusion into my practice of medicine, I welcome the policy of requiring a gestational age of at least 39 weeks for elective induction. Too bad it requires hospital regulation for us to schedule elective induction properly. If only we could go back to the days when a physician just did what was right for the patient.
Steve Godfrey, MD
Wichita Falls, Texas
Hysteroscopy is under-used for AUB
I agree with Dr. Amy Garcia that hysteroscopy is under-utilized for evaluation of abnormal uterine bleeding (AUB).
When evaluating patients with AUB, I divide them into three age groups: 1) the adolescent (ages 13–18 years); 2) the reproductive woman (19–39 years); and 3) the peri-, meno-, and postmenopausal woman (40 years and above).1 In the third group, AUB is more often attributed to intracavitary pathology. Therefore, women with AUB in this age group should be evaluated using transvaginal ultrasonography (TVUS), sonohysteroscopy, magnetic resonance imaging (MRI), endometrial sampling, and hysteroscopy.1
TVUS should be the first imaging used to assess pelvic pathology. Both sonohysteroscopy and MRI can provide detailed diagnostic information; however, they are not therapeutic or cost-effective. If lesions such as myomas, polyps, thickened endometrium, or a malignancy are diagnosed, then further procedures with hysteroscopy are warranted to remove or to sample.2
As the incidence of endometrial malignancy increases in women above age 45, the American College of Obstetricians and Gynecologists (ACOG) recommends endometrial sampling to rule out malignancy.1 However, Dr. Garcia’s article clearly points out that blinded biopsy has low sensitivity for diagnosing polyps (11%), myomas (13%), and hyperplasia (25%), and that sensitivity with hysteroscopy increased to 89% for polyps, 100% for myomas, and 74% for hyperplasia.
Hysteroscopic procedures can be both diagnostic and therapeutic. In the presence of intracavitary pathology, hysteroscopy can offer therapeutic interventions as part of a “see and treat” venue. Despite the potential risks of infection, hemorrhage, perforation, cervical laceration, fluid overload, electrolyte imbalance, and embolization, complications are relatively rare.2 I agree that this minimally invasive procedure should be offered to appropriately selected patients with AUB.
Takeko Takeshige, DO
Bronx, New York
Tell us what you think, at [email protected]. Please include your name and city and state.
References
1. ACOG Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 128: Diagnosis of abnormal uterine bleeding in reproductive-aged women. Obstet Gynecol. 2012;120(1):197–206.
2. American College of Obstetricians and Gynecologists. Technology Assessment No. 7: Hysteroscopy. Obstet Gynecol. 2011;117(6):1486–1491.
“NONINVASIVE PRENATAL DNA TESTING: WHO IS USING IT, AND HOW?”
JANELLE YATES (AUDIO, JUNE 2013)
Noninvasive prenatal DNA tests are unproven and costly
The sudden upsurge of this testing is somewhat troubling. The available tests are in-house, self-evaluated products that have not been approved by the US Food and Drug Administration (FDA). The tests have yet to be verified by extensive independent evaluation, and there are concerns that the data could be skewed by the omission of women whose fetal DNA fragments are too few to be measured accurately. Yet, there is a lemming-like rush to adopt them.
Complicating the issue is the fact that many large insurance carriers refuse to cover these tests—along with a plethora of other prenatal and early neonatal genetic tests proffered to avoid, at any cost, the delivery of a “defective” baby. This lack of coverage often leaves the patient with thousands of dollars of unexpected expense.
Although they are more invasive, the quad screen, chorionic villus sampling, and amniocentesis remain the gold standard of aneuploidy detection.
Obstetricians need to ask themselves questions such as “Why am I ordering this test—to avoid a ‘wrongful birth’ suit?” “Do I really believe the testing is necessary, given the infrequency of cystic fibrosis among low-risk women?” “Should I inform the patient that the testing probably won’t be covered by insurance?”
I doubt that this expensive array of testing survives the coming national health scheme. To perform the entire panoply of prenatal and early neonatal screening tests now costs upwards of $3,000—and that figure does not include the more esoteric tests that some providers are ordering. Add this amount to the cost of covering an additional 50 million people under health-care reform, and it is obvious that the tests lack sufficient benefit to justify their costs. It would be better to adopt some sanity now instead of rushing to adopt every new test that maternal-fetal medicine specialists and industrial geneticists create.
David A. Carpenter, MD
Paris, Texas
It shouldn’t take a hospital to end elective early term delivery
I’ve been in private practice since 1988. Until the past decade or so, the timing of “elective induction” was never debated. Although I usually do not appreciate hospital intrusion into my practice of medicine, I welcome the policy of requiring a gestational age of at least 39 weeks for elective induction. Too bad it requires hospital regulation for us to schedule elective induction properly. If only we could go back to the days when a physician just did what was right for the patient.
Steve Godfrey, MD
Wichita Falls, Texas
Hysteroscopy is under-used for AUB
I agree with Dr. Amy Garcia that hysteroscopy is under-utilized for evaluation of abnormal uterine bleeding (AUB).
When evaluating patients with AUB, I divide them into three age groups: 1) the adolescent (ages 13–18 years); 2) the reproductive woman (19–39 years); and 3) the peri-, meno-, and postmenopausal woman (40 years and above).1 In the third group, AUB is more often attributed to intracavitary pathology. Therefore, women with AUB in this age group should be evaluated using transvaginal ultrasonography (TVUS), sonohysteroscopy, magnetic resonance imaging (MRI), endometrial sampling, and hysteroscopy.1
TVUS should be the first imaging used to assess pelvic pathology. Both sonohysteroscopy and MRI can provide detailed diagnostic information; however, they are not therapeutic or cost-effective. If lesions such as myomas, polyps, thickened endometrium, or a malignancy are diagnosed, then further procedures with hysteroscopy are warranted to remove or to sample.2
As the incidence of endometrial malignancy increases in women above age 45, the American College of Obstetricians and Gynecologists (ACOG) recommends endometrial sampling to rule out malignancy.1 However, Dr. Garcia’s article clearly points out that blinded biopsy has low sensitivity for diagnosing polyps (11%), myomas (13%), and hyperplasia (25%), and that sensitivity with hysteroscopy increased to 89% for polyps, 100% for myomas, and 74% for hyperplasia.
Hysteroscopic procedures can be both diagnostic and therapeutic. In the presence of intracavitary pathology, hysteroscopy can offer therapeutic interventions as part of a “see and treat” venue. Despite the potential risks of infection, hemorrhage, perforation, cervical laceration, fluid overload, electrolyte imbalance, and embolization, complications are relatively rare.2 I agree that this minimally invasive procedure should be offered to appropriately selected patients with AUB.
Takeko Takeshige, DO
Bronx, New York
Tell us what you think, at [email protected]. Please include your name and city and state.
References
1. ACOG Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 128: Diagnosis of abnormal uterine bleeding in reproductive-aged women. Obstet Gynecol. 2012;120(1):197–206.
2. American College of Obstetricians and Gynecologists. Technology Assessment No. 7: Hysteroscopy. Obstet Gynecol. 2011;117(6):1486–1491.