Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.

Rapid urine test could aid in preeclampsia diagnosis

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Thu, 05/23/2019 - 12:05

 

A novel rapid urine test strongly correlates with preeclampsia, according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.

Wendy L. Davis

The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.

Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.

The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”



The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.

The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.

“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.



“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”

This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.

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A novel rapid urine test strongly correlates with preeclampsia, according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.

Wendy L. Davis

The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.

Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.

The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”



The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.

The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.

“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.



“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”

This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.

 

A novel rapid urine test strongly correlates with preeclampsia, according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.

Wendy L. Davis

The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.

Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.

The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”



The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.

The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.

“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.



“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”

This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.

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Targeted sequencing panel IDs Lynch syndrome in women with/at risk for endometrial cancer

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Wed, 05/22/2019 - 16:01

 

A targeted next-generation sequencing panel rapidly identifies both germline and somatic Lynch syndrome pathogenic mutations in women with – or at risk for – endometrial cancer, according to findings in a prospective patient cohort.

Sharon Worcester/MDedge News
Dr. Maria Mercedes M. Padron

The findings, which also suggest that the incidence of Lynch syndrome among endometrial cancer patients is higher than previously recognized, have “immediate and major implications for the individual patient with endometrial cancer ... and implications for related family members,” Maria Mercedes M. Padron, MD, reported during an e-poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Of 71 patients included in the study, 67 were undergoing endometrial cancer treatment and 7 (3 among those undergoing endometrial cancer treatment and 4 who did not have endometrial cancer) were known to have Lynch syndrome.

Of the 67 undergoing treatment, 22 (33%) were identified by the direct sequencing panel as having Lynch syndrome mutations, and of those, 7 (10%) had mutations classified as high confidence inactivating mutations in either MLH1, MSH6, PMS2, or MSH2 genes, said Dr. Padron, a research scholar at Icahn School of Medicine at Mount Sinai, New York. The remaining 15 patients had rare mutations and met previously defined phenotypic criteria for Lynch syndrome pathogenicity, she reported.

The sequencing panel–based results were compared with commercially available gene tests, including immunohistochemistry (IHC) and microsatellite instability testing (MSI); 10 patients were identified by IHC to have loss of nuclear mismatch repair (MMR) protein expression, and 8 of those were Lynch syndrome mutation positive. In addition, two patients were MSI-high, and both of those were Lynch syndrome mutation positive.

Thus, two Lynch syndrome patients were missed by direct sequencing, noted Dr. Padron.

However, an additional 10 patients who were not identified as having Lynch syndrome by IHC and MSI testing were potentially identified as such using the sequencing panel, Dr. Padron said, noting that “the pathogenicity of these additional variants needs to be defined.”



Lynch syndrome is a hereditary cancer syndrome caused by germline mutations in DNA MMR genes; it is the third most common malignancy in women and it confers an increased risk of several types of cancer, including colorectal, ovarian, gastric, and endometrial cancer, among others.

“It is estimated that 3% to 5% of endometrial cancers will arise from Lynch syndrome,” Dr. Padron explained during the poster session.

Because the presence of Lynch syndrome directly affects immediate clinical management and future risk-reducing and surveillance strategies for patients and at-risk family members, screening is recommended in all women with endometrial cancer, she added, noting, however, that “the optimum screening method has yet to be established.”

The sequencing panel evaluated in this study – Swift’s Accel-Amplicon Plus Lynch Syndrome Panel – requires only low input amounts of DNA, and in an earlier test using 10 control samples, it exhibited greater than 90% on-target and coverage uniformity. The work flow allowed for data analysis within 2 days, Dr. Padron noted.

The panel then was tested in the current cohort of patients who were referred to a gynecology oncology clinic for either treatment of endometrial cancer or for evaluation of risk for endometrial cancer.

Germline/tumor DNA was isolated and 10 ng DNA was used for targeted exon-level hotspot coverage of MLH1, MSH2, MSH6, and PMS2.

The findings suggest that the prevalence of Lynch syndrome may be six to seven times greater than previously estimated, Dr. Padron said during the poster presentation.



“If confirmed, this would have huge implications for our patients and health care system,” she said, adding that the ability to perform and analyze the sequencing within 48 hours of sample collection using a very low DNA input also was of note.

Taken together, “the findings of this study support future larger studies that can be performed concurrently with current standard of care technologies,” she and her colleagues concluded, noting that such studies would better determine more robust estimates of the prevalence of Lynch syndrome in women with endometrial cancer, help define improved standard-of-care guidelines, and provide future guidance for possible universal/targeted screening programs – all with the goal of improving the clinical care of women.

Dr. Padron reported having no relevant financial disclosures.

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A targeted next-generation sequencing panel rapidly identifies both germline and somatic Lynch syndrome pathogenic mutations in women with – or at risk for – endometrial cancer, according to findings in a prospective patient cohort.

Sharon Worcester/MDedge News
Dr. Maria Mercedes M. Padron

The findings, which also suggest that the incidence of Lynch syndrome among endometrial cancer patients is higher than previously recognized, have “immediate and major implications for the individual patient with endometrial cancer ... and implications for related family members,” Maria Mercedes M. Padron, MD, reported during an e-poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Of 71 patients included in the study, 67 were undergoing endometrial cancer treatment and 7 (3 among those undergoing endometrial cancer treatment and 4 who did not have endometrial cancer) were known to have Lynch syndrome.

Of the 67 undergoing treatment, 22 (33%) were identified by the direct sequencing panel as having Lynch syndrome mutations, and of those, 7 (10%) had mutations classified as high confidence inactivating mutations in either MLH1, MSH6, PMS2, or MSH2 genes, said Dr. Padron, a research scholar at Icahn School of Medicine at Mount Sinai, New York. The remaining 15 patients had rare mutations and met previously defined phenotypic criteria for Lynch syndrome pathogenicity, she reported.

The sequencing panel–based results were compared with commercially available gene tests, including immunohistochemistry (IHC) and microsatellite instability testing (MSI); 10 patients were identified by IHC to have loss of nuclear mismatch repair (MMR) protein expression, and 8 of those were Lynch syndrome mutation positive. In addition, two patients were MSI-high, and both of those were Lynch syndrome mutation positive.

Thus, two Lynch syndrome patients were missed by direct sequencing, noted Dr. Padron.

However, an additional 10 patients who were not identified as having Lynch syndrome by IHC and MSI testing were potentially identified as such using the sequencing panel, Dr. Padron said, noting that “the pathogenicity of these additional variants needs to be defined.”



Lynch syndrome is a hereditary cancer syndrome caused by germline mutations in DNA MMR genes; it is the third most common malignancy in women and it confers an increased risk of several types of cancer, including colorectal, ovarian, gastric, and endometrial cancer, among others.

“It is estimated that 3% to 5% of endometrial cancers will arise from Lynch syndrome,” Dr. Padron explained during the poster session.

Because the presence of Lynch syndrome directly affects immediate clinical management and future risk-reducing and surveillance strategies for patients and at-risk family members, screening is recommended in all women with endometrial cancer, she added, noting, however, that “the optimum screening method has yet to be established.”

The sequencing panel evaluated in this study – Swift’s Accel-Amplicon Plus Lynch Syndrome Panel – requires only low input amounts of DNA, and in an earlier test using 10 control samples, it exhibited greater than 90% on-target and coverage uniformity. The work flow allowed for data analysis within 2 days, Dr. Padron noted.

The panel then was tested in the current cohort of patients who were referred to a gynecology oncology clinic for either treatment of endometrial cancer or for evaluation of risk for endometrial cancer.

Germline/tumor DNA was isolated and 10 ng DNA was used for targeted exon-level hotspot coverage of MLH1, MSH2, MSH6, and PMS2.

The findings suggest that the prevalence of Lynch syndrome may be six to seven times greater than previously estimated, Dr. Padron said during the poster presentation.



“If confirmed, this would have huge implications for our patients and health care system,” she said, adding that the ability to perform and analyze the sequencing within 48 hours of sample collection using a very low DNA input also was of note.

Taken together, “the findings of this study support future larger studies that can be performed concurrently with current standard of care technologies,” she and her colleagues concluded, noting that such studies would better determine more robust estimates of the prevalence of Lynch syndrome in women with endometrial cancer, help define improved standard-of-care guidelines, and provide future guidance for possible universal/targeted screening programs – all with the goal of improving the clinical care of women.

Dr. Padron reported having no relevant financial disclosures.

 

A targeted next-generation sequencing panel rapidly identifies both germline and somatic Lynch syndrome pathogenic mutations in women with – or at risk for – endometrial cancer, according to findings in a prospective patient cohort.

Sharon Worcester/MDedge News
Dr. Maria Mercedes M. Padron

The findings, which also suggest that the incidence of Lynch syndrome among endometrial cancer patients is higher than previously recognized, have “immediate and major implications for the individual patient with endometrial cancer ... and implications for related family members,” Maria Mercedes M. Padron, MD, reported during an e-poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Of 71 patients included in the study, 67 were undergoing endometrial cancer treatment and 7 (3 among those undergoing endometrial cancer treatment and 4 who did not have endometrial cancer) were known to have Lynch syndrome.

Of the 67 undergoing treatment, 22 (33%) were identified by the direct sequencing panel as having Lynch syndrome mutations, and of those, 7 (10%) had mutations classified as high confidence inactivating mutations in either MLH1, MSH6, PMS2, or MSH2 genes, said Dr. Padron, a research scholar at Icahn School of Medicine at Mount Sinai, New York. The remaining 15 patients had rare mutations and met previously defined phenotypic criteria for Lynch syndrome pathogenicity, she reported.

The sequencing panel–based results were compared with commercially available gene tests, including immunohistochemistry (IHC) and microsatellite instability testing (MSI); 10 patients were identified by IHC to have loss of nuclear mismatch repair (MMR) protein expression, and 8 of those were Lynch syndrome mutation positive. In addition, two patients were MSI-high, and both of those were Lynch syndrome mutation positive.

Thus, two Lynch syndrome patients were missed by direct sequencing, noted Dr. Padron.

However, an additional 10 patients who were not identified as having Lynch syndrome by IHC and MSI testing were potentially identified as such using the sequencing panel, Dr. Padron said, noting that “the pathogenicity of these additional variants needs to be defined.”



Lynch syndrome is a hereditary cancer syndrome caused by germline mutations in DNA MMR genes; it is the third most common malignancy in women and it confers an increased risk of several types of cancer, including colorectal, ovarian, gastric, and endometrial cancer, among others.

“It is estimated that 3% to 5% of endometrial cancers will arise from Lynch syndrome,” Dr. Padron explained during the poster session.

Because the presence of Lynch syndrome directly affects immediate clinical management and future risk-reducing and surveillance strategies for patients and at-risk family members, screening is recommended in all women with endometrial cancer, she added, noting, however, that “the optimum screening method has yet to be established.”

The sequencing panel evaluated in this study – Swift’s Accel-Amplicon Plus Lynch Syndrome Panel – requires only low input amounts of DNA, and in an earlier test using 10 control samples, it exhibited greater than 90% on-target and coverage uniformity. The work flow allowed for data analysis within 2 days, Dr. Padron noted.

The panel then was tested in the current cohort of patients who were referred to a gynecology oncology clinic for either treatment of endometrial cancer or for evaluation of risk for endometrial cancer.

Germline/tumor DNA was isolated and 10 ng DNA was used for targeted exon-level hotspot coverage of MLH1, MSH2, MSH6, and PMS2.

The findings suggest that the prevalence of Lynch syndrome may be six to seven times greater than previously estimated, Dr. Padron said during the poster presentation.



“If confirmed, this would have huge implications for our patients and health care system,” she said, adding that the ability to perform and analyze the sequencing within 48 hours of sample collection using a very low DNA input also was of note.

Taken together, “the findings of this study support future larger studies that can be performed concurrently with current standard of care technologies,” she and her colleagues concluded, noting that such studies would better determine more robust estimates of the prevalence of Lynch syndrome in women with endometrial cancer, help define improved standard-of-care guidelines, and provide future guidance for possible universal/targeted screening programs – all with the goal of improving the clinical care of women.

Dr. Padron reported having no relevant financial disclosures.

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Ultrasound or biopsy for evaluation of endometrium? It depends

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Mon, 05/20/2019 - 07:31

 

– Biopsy isn’t usually the first step in evaluating the endometrium of a reproductive-age woman who presents with abnormal uterine bleeding, but that’s not always the case, according to James M. Shwayder, MD.

Vidyard Video

“If we have young women come in, generally speaking, we don’t think much about doing biopsies, but there are those patients who really require a biopsy very early on: If they are obese and if they have long histories of oligomenorrhea ... they are at significantly greater risk for either endometrial hyperplasia or cancer, so in those patients I recommend biopsy very early on,” Dr. Shwayder said in this video interview about his presentation entitled “Modern Evaluation of the Endometrium: When to Use Ultrasound, When to Biopsy,” as presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Conversely, in some cases when biopsy is typically considered the first-line step in evaluation, ultrasound may actually be better, he argued.

“[ACOG] recommends that women over 45 ... should have a biopsy done as their first-line evaluation. I kind of take issue with that a little bit,” said Dr. Shwayder, a professor at the University of Mississippi Medical Center, Jackson, and president and chief executive officer of Shwayder Consulting in Venice, Fla.

Data suggest that a “blind biopsy” could miss up to 18% of cases involving either a submucous myoma or a polyp and that one-third to one-fourth of patients have a structural defect such as a polyp or fibroid that can’t be diagnosed with a biopsy, he explained, noting that sonohysterography is best for preoperative evaluation in such case.

Ultrasound also has utility for evaluating other abnormalities, and it can be a very simple way to evaluate the patient and decide whether they need further evaluation or further treatment, he said.

Dr. Shwayder also discussed evidence for making a choice between biopsy and ultrasound for initial evaluation in postmenopausal women and for assessing women with asymptomatic thickened endometrium.

Dr. Shwayder is a consultant for GE Ultrasound.

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– Biopsy isn’t usually the first step in evaluating the endometrium of a reproductive-age woman who presents with abnormal uterine bleeding, but that’s not always the case, according to James M. Shwayder, MD.

Vidyard Video

“If we have young women come in, generally speaking, we don’t think much about doing biopsies, but there are those patients who really require a biopsy very early on: If they are obese and if they have long histories of oligomenorrhea ... they are at significantly greater risk for either endometrial hyperplasia or cancer, so in those patients I recommend biopsy very early on,” Dr. Shwayder said in this video interview about his presentation entitled “Modern Evaluation of the Endometrium: When to Use Ultrasound, When to Biopsy,” as presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Conversely, in some cases when biopsy is typically considered the first-line step in evaluation, ultrasound may actually be better, he argued.

“[ACOG] recommends that women over 45 ... should have a biopsy done as their first-line evaluation. I kind of take issue with that a little bit,” said Dr. Shwayder, a professor at the University of Mississippi Medical Center, Jackson, and president and chief executive officer of Shwayder Consulting in Venice, Fla.

Data suggest that a “blind biopsy” could miss up to 18% of cases involving either a submucous myoma or a polyp and that one-third to one-fourth of patients have a structural defect such as a polyp or fibroid that can’t be diagnosed with a biopsy, he explained, noting that sonohysterography is best for preoperative evaluation in such case.

Ultrasound also has utility for evaluating other abnormalities, and it can be a very simple way to evaluate the patient and decide whether they need further evaluation or further treatment, he said.

Dr. Shwayder also discussed evidence for making a choice between biopsy and ultrasound for initial evaluation in postmenopausal women and for assessing women with asymptomatic thickened endometrium.

Dr. Shwayder is a consultant for GE Ultrasound.

 

– Biopsy isn’t usually the first step in evaluating the endometrium of a reproductive-age woman who presents with abnormal uterine bleeding, but that’s not always the case, according to James M. Shwayder, MD.

Vidyard Video

“If we have young women come in, generally speaking, we don’t think much about doing biopsies, but there are those patients who really require a biopsy very early on: If they are obese and if they have long histories of oligomenorrhea ... they are at significantly greater risk for either endometrial hyperplasia or cancer, so in those patients I recommend biopsy very early on,” Dr. Shwayder said in this video interview about his presentation entitled “Modern Evaluation of the Endometrium: When to Use Ultrasound, When to Biopsy,” as presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Conversely, in some cases when biopsy is typically considered the first-line step in evaluation, ultrasound may actually be better, he argued.

“[ACOG] recommends that women over 45 ... should have a biopsy done as their first-line evaluation. I kind of take issue with that a little bit,” said Dr. Shwayder, a professor at the University of Mississippi Medical Center, Jackson, and president and chief executive officer of Shwayder Consulting in Venice, Fla.

Data suggest that a “blind biopsy” could miss up to 18% of cases involving either a submucous myoma or a polyp and that one-third to one-fourth of patients have a structural defect such as a polyp or fibroid that can’t be diagnosed with a biopsy, he explained, noting that sonohysterography is best for preoperative evaluation in such case.

Ultrasound also has utility for evaluating other abnormalities, and it can be a very simple way to evaluate the patient and decide whether they need further evaluation or further treatment, he said.

Dr. Shwayder also discussed evidence for making a choice between biopsy and ultrasound for initial evaluation in postmenopausal women and for assessing women with asymptomatic thickened endometrium.

Dr. Shwayder is a consultant for GE Ultrasound.

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Immediate postpartum LARC: ‘Agony and ecstasy’

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Wed, 06/23/2021 - 12:41

Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.



It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”



In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

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Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.



It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”



In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.



It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”



In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

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TVEC may improve response rates in nonmetastatic TNBC

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Changed
Wed, 01/04/2023 - 16:44

– Adding intratumoral talimogene laherparepvec (TVEC) to neoadjuvant chemotherapy appears to improve response rates in patients with nonmetastatic triple-negative breast cancer, according to findings from a phase 1 trial.

The pathologic complete response rate (pCR) in nine patients aged 18-70 years with stage T2-T3NO-2 disease who were enrolled in the single-center trial was 55%, whereas the expected rate with neoadjuvant chemotherapy alone was 30%, Hatem Soliman, MD, reported at the annual meeting of the American Association for Cancer Research.

“Even in the patients with residual disease, they had almost complete obliteration of their tumors, as well,” said Dr. Soliman of Moffitt Cancer Center, Tampa, Fla., adding that preliminary analyses of T cell subtypes indicated that CD45RO+ cells, which are associated with activated memory effector phenotype cells, were found in higher percentages in tumor specimens from patients who had pCR vs. those who did not.

“This could be an emerging marker that could be associated with pCR from TVEC,” he said, stressing, however, that “this is preliminary data [that] needs to be borne out in subsequent studies.”

Of the nine participants, six had stage II disease and three had stage III disease, and tumor size was greater than 5 cm in 2 patients, and 2-5 cm in 7 patients. Three received 106 plaque-forming units (PFUs) x 5 injections (dose level 1), and 6 received 106 PFUs for the first injection then 108 PFUs for 4 additional injections. Patients also received neoadjuvant paclitaxel followed by doxorubicin/cyclophosphamide chemotherapy.

They then went on to surgery and were evaluated for pCR.

No dose-limiting toxicities occurred, therefore the maximum-tolerated dose was dose level 2, Dr. Soliman noted.

The most common toxicities due to TVEC were fevers, chills, and injection site reactions, and “these are considered expected side effects of TVEC administration and were manageable,” he said.

Two serious adverse events occurred in the trial: a pulmonary embolism and a postoperative case of severe bradycardia thought to be a vasovagal episode; there were no deaths or any sequelae from these adverse events and they completely resolved.

One latent genital wild type herpes simplex 1 virus (HSV1) reactivation event occurred and was treated with a topical agent.


Early-stage triple-negative breast cancer is associated with a higher risk of early relapse, but attaining a pCR after neoadjuvant chemotherapy is associated with improved prognosis, Dr. Soliman said.

“Historically, standard regimens used for triple-negative breast cancer include an anthracycline and a taxane, and the rates of pCR in those patients hover around 30%,” he said. “Others have looked at the relationship of increased tumor infiltrating lymphocytes (TILs] in triple-negative breast cancers and other breast cancers, and found that those tumors that did have a higher de novo TIL infiltrate, either at the beginning of treatment or acquired during treatment, seemed to have a higher rate of pCR and also seemed to have improved prognosis.”

This suggested that these TIL infiltrates may be both a predictive and prognostic biologic marker for the biology of the disease, he noted.

Further, promising prior research on the role of oncolytic viruses as a potential treatment modality for cancer led to interest in their use during neoadjuvant chemotherapy “with the idea that we could potentially improve pathologic complete response rates both through direct tumor cell lysis of treated tumors, but also through recruitment of a robust antitumor immune response caused by the viruses’ mechanism of action,” he said, adding that “this could be beneficial, particularly in those immunologically ‘cold’ tumors.”

This led to the incorporation of TVEC, a genetically engineered oncolytic HSV1 currently approved for the treatment of melanoma, in this neoadjuvant trial. TVEC preferentially lyses tumor cells over normal tissue to release tumor associated antigens, produces granulocyte-macrophage colony-stimulating factor to activate dendritic cells, and stimulates T cells to provoke an adaptive immune response, he explained.

“[This] then can not only potentially attack tumor cells at the primary site, but then may potentially spread around the body to improve host surveillance and try to eradicate micrometastatic disease, as well,” he said.

The current findings show that adding TVEC to neoadjuvant chemotherapy is feasible at the full Food and Drug Administration–approved dose and has manageable toxicity, he concluded, noting that “a phase 2 single-arm trial of this regimen is ongoing, and we are actively accruing patients to further evaluate the efficacy signal and formally test the hypothesis along with immune correlates.”

Dr. Soliman reported relationships with Eli Lilly, Pfizer, Celgene, AstraZeneca, PUMA, Novartis, Eisai, and Amgen.

SOURCE: Soliman H et al. AACR 2019, Abstract CT040.

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– Adding intratumoral talimogene laherparepvec (TVEC) to neoadjuvant chemotherapy appears to improve response rates in patients with nonmetastatic triple-negative breast cancer, according to findings from a phase 1 trial.

The pathologic complete response rate (pCR) in nine patients aged 18-70 years with stage T2-T3NO-2 disease who were enrolled in the single-center trial was 55%, whereas the expected rate with neoadjuvant chemotherapy alone was 30%, Hatem Soliman, MD, reported at the annual meeting of the American Association for Cancer Research.

“Even in the patients with residual disease, they had almost complete obliteration of their tumors, as well,” said Dr. Soliman of Moffitt Cancer Center, Tampa, Fla., adding that preliminary analyses of T cell subtypes indicated that CD45RO+ cells, which are associated with activated memory effector phenotype cells, were found in higher percentages in tumor specimens from patients who had pCR vs. those who did not.

“This could be an emerging marker that could be associated with pCR from TVEC,” he said, stressing, however, that “this is preliminary data [that] needs to be borne out in subsequent studies.”

Of the nine participants, six had stage II disease and three had stage III disease, and tumor size was greater than 5 cm in 2 patients, and 2-5 cm in 7 patients. Three received 106 plaque-forming units (PFUs) x 5 injections (dose level 1), and 6 received 106 PFUs for the first injection then 108 PFUs for 4 additional injections. Patients also received neoadjuvant paclitaxel followed by doxorubicin/cyclophosphamide chemotherapy.

They then went on to surgery and were evaluated for pCR.

No dose-limiting toxicities occurred, therefore the maximum-tolerated dose was dose level 2, Dr. Soliman noted.

The most common toxicities due to TVEC were fevers, chills, and injection site reactions, and “these are considered expected side effects of TVEC administration and were manageable,” he said.

Two serious adverse events occurred in the trial: a pulmonary embolism and a postoperative case of severe bradycardia thought to be a vasovagal episode; there were no deaths or any sequelae from these adverse events and they completely resolved.

One latent genital wild type herpes simplex 1 virus (HSV1) reactivation event occurred and was treated with a topical agent.


Early-stage triple-negative breast cancer is associated with a higher risk of early relapse, but attaining a pCR after neoadjuvant chemotherapy is associated with improved prognosis, Dr. Soliman said.

“Historically, standard regimens used for triple-negative breast cancer include an anthracycline and a taxane, and the rates of pCR in those patients hover around 30%,” he said. “Others have looked at the relationship of increased tumor infiltrating lymphocytes (TILs] in triple-negative breast cancers and other breast cancers, and found that those tumors that did have a higher de novo TIL infiltrate, either at the beginning of treatment or acquired during treatment, seemed to have a higher rate of pCR and also seemed to have improved prognosis.”

This suggested that these TIL infiltrates may be both a predictive and prognostic biologic marker for the biology of the disease, he noted.

Further, promising prior research on the role of oncolytic viruses as a potential treatment modality for cancer led to interest in their use during neoadjuvant chemotherapy “with the idea that we could potentially improve pathologic complete response rates both through direct tumor cell lysis of treated tumors, but also through recruitment of a robust antitumor immune response caused by the viruses’ mechanism of action,” he said, adding that “this could be beneficial, particularly in those immunologically ‘cold’ tumors.”

This led to the incorporation of TVEC, a genetically engineered oncolytic HSV1 currently approved for the treatment of melanoma, in this neoadjuvant trial. TVEC preferentially lyses tumor cells over normal tissue to release tumor associated antigens, produces granulocyte-macrophage colony-stimulating factor to activate dendritic cells, and stimulates T cells to provoke an adaptive immune response, he explained.

“[This] then can not only potentially attack tumor cells at the primary site, but then may potentially spread around the body to improve host surveillance and try to eradicate micrometastatic disease, as well,” he said.

The current findings show that adding TVEC to neoadjuvant chemotherapy is feasible at the full Food and Drug Administration–approved dose and has manageable toxicity, he concluded, noting that “a phase 2 single-arm trial of this regimen is ongoing, and we are actively accruing patients to further evaluate the efficacy signal and formally test the hypothesis along with immune correlates.”

Dr. Soliman reported relationships with Eli Lilly, Pfizer, Celgene, AstraZeneca, PUMA, Novartis, Eisai, and Amgen.

SOURCE: Soliman H et al. AACR 2019, Abstract CT040.

– Adding intratumoral talimogene laherparepvec (TVEC) to neoadjuvant chemotherapy appears to improve response rates in patients with nonmetastatic triple-negative breast cancer, according to findings from a phase 1 trial.

The pathologic complete response rate (pCR) in nine patients aged 18-70 years with stage T2-T3NO-2 disease who were enrolled in the single-center trial was 55%, whereas the expected rate with neoadjuvant chemotherapy alone was 30%, Hatem Soliman, MD, reported at the annual meeting of the American Association for Cancer Research.

“Even in the patients with residual disease, they had almost complete obliteration of their tumors, as well,” said Dr. Soliman of Moffitt Cancer Center, Tampa, Fla., adding that preliminary analyses of T cell subtypes indicated that CD45RO+ cells, which are associated with activated memory effector phenotype cells, were found in higher percentages in tumor specimens from patients who had pCR vs. those who did not.

“This could be an emerging marker that could be associated with pCR from TVEC,” he said, stressing, however, that “this is preliminary data [that] needs to be borne out in subsequent studies.”

Of the nine participants, six had stage II disease and three had stage III disease, and tumor size was greater than 5 cm in 2 patients, and 2-5 cm in 7 patients. Three received 106 plaque-forming units (PFUs) x 5 injections (dose level 1), and 6 received 106 PFUs for the first injection then 108 PFUs for 4 additional injections. Patients also received neoadjuvant paclitaxel followed by doxorubicin/cyclophosphamide chemotherapy.

They then went on to surgery and were evaluated for pCR.

No dose-limiting toxicities occurred, therefore the maximum-tolerated dose was dose level 2, Dr. Soliman noted.

The most common toxicities due to TVEC were fevers, chills, and injection site reactions, and “these are considered expected side effects of TVEC administration and were manageable,” he said.

Two serious adverse events occurred in the trial: a pulmonary embolism and a postoperative case of severe bradycardia thought to be a vasovagal episode; there were no deaths or any sequelae from these adverse events and they completely resolved.

One latent genital wild type herpes simplex 1 virus (HSV1) reactivation event occurred and was treated with a topical agent.


Early-stage triple-negative breast cancer is associated with a higher risk of early relapse, but attaining a pCR after neoadjuvant chemotherapy is associated with improved prognosis, Dr. Soliman said.

“Historically, standard regimens used for triple-negative breast cancer include an anthracycline and a taxane, and the rates of pCR in those patients hover around 30%,” he said. “Others have looked at the relationship of increased tumor infiltrating lymphocytes (TILs] in triple-negative breast cancers and other breast cancers, and found that those tumors that did have a higher de novo TIL infiltrate, either at the beginning of treatment or acquired during treatment, seemed to have a higher rate of pCR and also seemed to have improved prognosis.”

This suggested that these TIL infiltrates may be both a predictive and prognostic biologic marker for the biology of the disease, he noted.

Further, promising prior research on the role of oncolytic viruses as a potential treatment modality for cancer led to interest in their use during neoadjuvant chemotherapy “with the idea that we could potentially improve pathologic complete response rates both through direct tumor cell lysis of treated tumors, but also through recruitment of a robust antitumor immune response caused by the viruses’ mechanism of action,” he said, adding that “this could be beneficial, particularly in those immunologically ‘cold’ tumors.”

This led to the incorporation of TVEC, a genetically engineered oncolytic HSV1 currently approved for the treatment of melanoma, in this neoadjuvant trial. TVEC preferentially lyses tumor cells over normal tissue to release tumor associated antigens, produces granulocyte-macrophage colony-stimulating factor to activate dendritic cells, and stimulates T cells to provoke an adaptive immune response, he explained.

“[This] then can not only potentially attack tumor cells at the primary site, but then may potentially spread around the body to improve host surveillance and try to eradicate micrometastatic disease, as well,” he said.

The current findings show that adding TVEC to neoadjuvant chemotherapy is feasible at the full Food and Drug Administration–approved dose and has manageable toxicity, he concluded, noting that “a phase 2 single-arm trial of this regimen is ongoing, and we are actively accruing patients to further evaluate the efficacy signal and formally test the hypothesis along with immune correlates.”

Dr. Soliman reported relationships with Eli Lilly, Pfizer, Celgene, AstraZeneca, PUMA, Novartis, Eisai, and Amgen.

SOURCE: Soliman H et al. AACR 2019, Abstract CT040.

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Key clinical point: Adding TVEC to neoadjuvant chemotherapy for nonmetastatic TNBC appears to improve pCR response rates.

Major finding: The pCR was 55% with TVEC compared with an expected rate of 30% without TVEC.

Study details: A phase 1 study of 9 patients.

Disclosures: Dr. Soliman reported relationships with Eli Lilly, Pfizer, Celgene, AstraZeneca, PUMA, Novartis, Eisai, and Amgen.

Source: Soliman H et al. AACR 2019, Abstract CT040.

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C-sections play role in 300% higher severe maternal morbidity in twin pregnancies

Twin deliveries: Better training needed
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Changed
Mon, 05/13/2019 - 15:14

 

Twin versus singleton pregnancies confer a 300% increased risk of severe acute maternal complications, and 21% of that risk is mediated by cesarean delivery, according to findings from the prospective EPIMOMS study.

micheldenijs/iStock/Getty Images Plus

The population-based incidence of severe acute maternal morbidity occurring between 22 weeks’ of gestation and 42 days post partum in the 2012-2013 French multicenter study was 6.2% among 3,202 twin pregnancies and 1.3% among 179,107 singleton pregnancies, Hugo Madar, MD, MPH, of Bordeaux University Hospital, France, and colleagues reported on behalf of the EPIMOMS (Epidémiologie de la Morbidité Maternelle Sévère) study group.

For the current analysis – a population-based, cohort-nested, case-control analysis of study data – the investigators compared 2,500 case patients (8% had twin pregnancies) and 3,650 controls (2% had twin pregnancies) who did not experience severe acute maternal morbidity during that time period (odds ratio, 4.7). After accounting for confounding factors, the increased risk among women with twin versus singleton pregnancies persisted (OR, 4.2) during both the antepartum (OR, 4.1) and intrapartum/postpartum (OR, 4.2) periods.



The majority of events (77%) occurred during the latter periods, and the two most common underlying causal conditions were severe obstetric hemorrhage (66%) and severe hypertensive complications (20%); however, the increased risk in twin pregnancies was apparent, regardless of the underlying cause.

The cesarean delivery rates for twin versus singleton pregnancies were 72% and 34%, respectively, in the case group, and 58% and 18%, respectively, in the control group. A path analysis taking potential indication bias into account showed that 21% of the total risk of intrapartum or postpartum severe acute maternal morbidity risk associated with twin pregnancy was mediated by cesarean delivery, Dr. Madar and associates noted, explaining that, “in other words, if twin pregnancies had the same probability of cesarean delivery as singleton pregnancies, the association found between twin pregnancy and intrapartum or postpartum severe acute maternal morbidity would be reduced by one-fifth.”



This provides further support for limiting the use of cesarean for twin deliveries to cases with clear medical indications, as increasing the rate of vaginal deliveries may decrease the rate of severe acute maternal morbidity, they concluded.

EPIMOMS was supported by the National Research Agency and the Ile de France Regional Health Agency. Dr. Madar received a training grant from the Aquitaine Regional Health Agency. The authors reported having no other relevant financial disclosures.

SOURCE: Madar H et al. Obstet Gynecol. 2019;133:1141-50.

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Twin pregnancies are known to be associated with increased risk of maternal morbidity, so the findings of this “very well-designed” study by Madar et al. are “not strikingly different than what we know,” according to Ozhan M. Turan, MD, PhD.

Courtesy University of Maryland School of Medicine
Dr. M. Ozhan Turan
Given the robust statistical methods used, they do, however, offer one important new detail regarding the contribution of cesarean delivery to that risk: “This study demonstrated that 20% of complications are actually directly related with cesarean delivery,” Dr. Turan said in an interview.

These data alone will do little to change practice, but paired with an increased focus on training with respect to vaginal twin delivery – including in cases of breech presentation of the second baby – they could lead to improved maternal outcomes, he explained, adding that “breech extraction can be very fast and safe in skilled hands.”

Except for the lack of information in the study about whether the twins were monozygotic or dizygotic, the study is sound, and the data may prove useful for counseling patients about the risks and benefits of vaginal versus cesarean delivery and for promoting improved training of residents, maternal-fetal medicine fellows, and junior obstetricians in vaginal twin delivery techniques, he said.

Dr. Turan is director of the division of maternal and fetal medicine and of fetal therapy & complex obstetric surgery at the University of Maryland, Baltimore County. He reported having no relevant financial disclosures.

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Twin pregnancies are known to be associated with increased risk of maternal morbidity, so the findings of this “very well-designed” study by Madar et al. are “not strikingly different than what we know,” according to Ozhan M. Turan, MD, PhD.

Courtesy University of Maryland School of Medicine
Dr. M. Ozhan Turan
Given the robust statistical methods used, they do, however, offer one important new detail regarding the contribution of cesarean delivery to that risk: “This study demonstrated that 20% of complications are actually directly related with cesarean delivery,” Dr. Turan said in an interview.

These data alone will do little to change practice, but paired with an increased focus on training with respect to vaginal twin delivery – including in cases of breech presentation of the second baby – they could lead to improved maternal outcomes, he explained, adding that “breech extraction can be very fast and safe in skilled hands.”

Except for the lack of information in the study about whether the twins were monozygotic or dizygotic, the study is sound, and the data may prove useful for counseling patients about the risks and benefits of vaginal versus cesarean delivery and for promoting improved training of residents, maternal-fetal medicine fellows, and junior obstetricians in vaginal twin delivery techniques, he said.

Dr. Turan is director of the division of maternal and fetal medicine and of fetal therapy & complex obstetric surgery at the University of Maryland, Baltimore County. He reported having no relevant financial disclosures.

Body

 

Twin pregnancies are known to be associated with increased risk of maternal morbidity, so the findings of this “very well-designed” study by Madar et al. are “not strikingly different than what we know,” according to Ozhan M. Turan, MD, PhD.

Courtesy University of Maryland School of Medicine
Dr. M. Ozhan Turan
Given the robust statistical methods used, they do, however, offer one important new detail regarding the contribution of cesarean delivery to that risk: “This study demonstrated that 20% of complications are actually directly related with cesarean delivery,” Dr. Turan said in an interview.

These data alone will do little to change practice, but paired with an increased focus on training with respect to vaginal twin delivery – including in cases of breech presentation of the second baby – they could lead to improved maternal outcomes, he explained, adding that “breech extraction can be very fast and safe in skilled hands.”

Except for the lack of information in the study about whether the twins were monozygotic or dizygotic, the study is sound, and the data may prove useful for counseling patients about the risks and benefits of vaginal versus cesarean delivery and for promoting improved training of residents, maternal-fetal medicine fellows, and junior obstetricians in vaginal twin delivery techniques, he said.

Dr. Turan is director of the division of maternal and fetal medicine and of fetal therapy & complex obstetric surgery at the University of Maryland, Baltimore County. He reported having no relevant financial disclosures.

Title
Twin deliveries: Better training needed
Twin deliveries: Better training needed

 

Twin versus singleton pregnancies confer a 300% increased risk of severe acute maternal complications, and 21% of that risk is mediated by cesarean delivery, according to findings from the prospective EPIMOMS study.

micheldenijs/iStock/Getty Images Plus

The population-based incidence of severe acute maternal morbidity occurring between 22 weeks’ of gestation and 42 days post partum in the 2012-2013 French multicenter study was 6.2% among 3,202 twin pregnancies and 1.3% among 179,107 singleton pregnancies, Hugo Madar, MD, MPH, of Bordeaux University Hospital, France, and colleagues reported on behalf of the EPIMOMS (Epidémiologie de la Morbidité Maternelle Sévère) study group.

For the current analysis – a population-based, cohort-nested, case-control analysis of study data – the investigators compared 2,500 case patients (8% had twin pregnancies) and 3,650 controls (2% had twin pregnancies) who did not experience severe acute maternal morbidity during that time period (odds ratio, 4.7). After accounting for confounding factors, the increased risk among women with twin versus singleton pregnancies persisted (OR, 4.2) during both the antepartum (OR, 4.1) and intrapartum/postpartum (OR, 4.2) periods.



The majority of events (77%) occurred during the latter periods, and the two most common underlying causal conditions were severe obstetric hemorrhage (66%) and severe hypertensive complications (20%); however, the increased risk in twin pregnancies was apparent, regardless of the underlying cause.

The cesarean delivery rates for twin versus singleton pregnancies were 72% and 34%, respectively, in the case group, and 58% and 18%, respectively, in the control group. A path analysis taking potential indication bias into account showed that 21% of the total risk of intrapartum or postpartum severe acute maternal morbidity risk associated with twin pregnancy was mediated by cesarean delivery, Dr. Madar and associates noted, explaining that, “in other words, if twin pregnancies had the same probability of cesarean delivery as singleton pregnancies, the association found between twin pregnancy and intrapartum or postpartum severe acute maternal morbidity would be reduced by one-fifth.”



This provides further support for limiting the use of cesarean for twin deliveries to cases with clear medical indications, as increasing the rate of vaginal deliveries may decrease the rate of severe acute maternal morbidity, they concluded.

EPIMOMS was supported by the National Research Agency and the Ile de France Regional Health Agency. Dr. Madar received a training grant from the Aquitaine Regional Health Agency. The authors reported having no other relevant financial disclosures.

SOURCE: Madar H et al. Obstet Gynecol. 2019;133:1141-50.

 

Twin versus singleton pregnancies confer a 300% increased risk of severe acute maternal complications, and 21% of that risk is mediated by cesarean delivery, according to findings from the prospective EPIMOMS study.

micheldenijs/iStock/Getty Images Plus

The population-based incidence of severe acute maternal morbidity occurring between 22 weeks’ of gestation and 42 days post partum in the 2012-2013 French multicenter study was 6.2% among 3,202 twin pregnancies and 1.3% among 179,107 singleton pregnancies, Hugo Madar, MD, MPH, of Bordeaux University Hospital, France, and colleagues reported on behalf of the EPIMOMS (Epidémiologie de la Morbidité Maternelle Sévère) study group.

For the current analysis – a population-based, cohort-nested, case-control analysis of study data – the investigators compared 2,500 case patients (8% had twin pregnancies) and 3,650 controls (2% had twin pregnancies) who did not experience severe acute maternal morbidity during that time period (odds ratio, 4.7). After accounting for confounding factors, the increased risk among women with twin versus singleton pregnancies persisted (OR, 4.2) during both the antepartum (OR, 4.1) and intrapartum/postpartum (OR, 4.2) periods.



The majority of events (77%) occurred during the latter periods, and the two most common underlying causal conditions were severe obstetric hemorrhage (66%) and severe hypertensive complications (20%); however, the increased risk in twin pregnancies was apparent, regardless of the underlying cause.

The cesarean delivery rates for twin versus singleton pregnancies were 72% and 34%, respectively, in the case group, and 58% and 18%, respectively, in the control group. A path analysis taking potential indication bias into account showed that 21% of the total risk of intrapartum or postpartum severe acute maternal morbidity risk associated with twin pregnancy was mediated by cesarean delivery, Dr. Madar and associates noted, explaining that, “in other words, if twin pregnancies had the same probability of cesarean delivery as singleton pregnancies, the association found between twin pregnancy and intrapartum or postpartum severe acute maternal morbidity would be reduced by one-fifth.”



This provides further support for limiting the use of cesarean for twin deliveries to cases with clear medical indications, as increasing the rate of vaginal deliveries may decrease the rate of severe acute maternal morbidity, they concluded.

EPIMOMS was supported by the National Research Agency and the Ile de France Regional Health Agency. Dr. Madar received a training grant from the Aquitaine Regional Health Agency. The authors reported having no other relevant financial disclosures.

SOURCE: Madar H et al. Obstet Gynecol. 2019;133:1141-50.

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2019 Update: Contraceptives and unintended pregnancy rates

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Thu, 06/29/2023 - 16:45

– The unintended pregnancy rate is declining after years of hovering at close to 50%.

While the rates among women of color remain high – currently at 58 and 79 per 1,000 women aged 15-44 years for Hispanic and black women, respectively – they have declined from 79 and 92 per 1,000 Hispanic and black women in that age group in 2008, and the overall rate is now at about 45%, Eve Espey, MD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Considering the scope and number of women affected by unplanned pregnancy, this is actually a huge public health achievement,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology at the University of New Mexico, Albuquerque.



The declines in unintended pregnancies are largely attributable to “better and more consistent use of contraceptives, and, interestingly, increased abstinence,” she noted, adding that “another enormous determinant of this decrease in unintended pregnancy is the use of long-acting reversible contraception [LARC].” About 2% of women used contraceptives in 2002, and now, based on the latest cycle of data from 2015-2017, 16% of women use contraceptives.

In this video interview, Dr. Espey discusses the main points of her talk entitled “Contraceptives: What you need to know in 2019,” including:

  • The importance of “following reproductive justice–based principles and counseling” when it comes to prescribing contraceptives.
  • The latest data showing that certain LARC methods remain safe and effective beyond their approved duration of use.
  • Trends with respect to tubal ligation and salpingectomy.
  • The value of the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (MEC) for evidence-based guidance on selecting contraceptives based on patients’ individual needs.

“[MEC] is something every ob.gyn. should consider using,” she said, noting that access is available through a free app. “As our patients are more complex and have more comorbidities, it’s particularly helpful for matching up patients and their conditions with recommendations for specific contraceptive methods.”

Dr. Espey reported having no financial disclosures.

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– The unintended pregnancy rate is declining after years of hovering at close to 50%.

While the rates among women of color remain high – currently at 58 and 79 per 1,000 women aged 15-44 years for Hispanic and black women, respectively – they have declined from 79 and 92 per 1,000 Hispanic and black women in that age group in 2008, and the overall rate is now at about 45%, Eve Espey, MD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Considering the scope and number of women affected by unplanned pregnancy, this is actually a huge public health achievement,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology at the University of New Mexico, Albuquerque.



The declines in unintended pregnancies are largely attributable to “better and more consistent use of contraceptives, and, interestingly, increased abstinence,” she noted, adding that “another enormous determinant of this decrease in unintended pregnancy is the use of long-acting reversible contraception [LARC].” About 2% of women used contraceptives in 2002, and now, based on the latest cycle of data from 2015-2017, 16% of women use contraceptives.

In this video interview, Dr. Espey discusses the main points of her talk entitled “Contraceptives: What you need to know in 2019,” including:

  • The importance of “following reproductive justice–based principles and counseling” when it comes to prescribing contraceptives.
  • The latest data showing that certain LARC methods remain safe and effective beyond their approved duration of use.
  • Trends with respect to tubal ligation and salpingectomy.
  • The value of the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (MEC) for evidence-based guidance on selecting contraceptives based on patients’ individual needs.

“[MEC] is something every ob.gyn. should consider using,” she said, noting that access is available through a free app. “As our patients are more complex and have more comorbidities, it’s particularly helpful for matching up patients and their conditions with recommendations for specific contraceptive methods.”

Dr. Espey reported having no financial disclosures.

– The unintended pregnancy rate is declining after years of hovering at close to 50%.

While the rates among women of color remain high – currently at 58 and 79 per 1,000 women aged 15-44 years for Hispanic and black women, respectively – they have declined from 79 and 92 per 1,000 Hispanic and black women in that age group in 2008, and the overall rate is now at about 45%, Eve Espey, MD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Considering the scope and number of women affected by unplanned pregnancy, this is actually a huge public health achievement,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology at the University of New Mexico, Albuquerque.



The declines in unintended pregnancies are largely attributable to “better and more consistent use of contraceptives, and, interestingly, increased abstinence,” she noted, adding that “another enormous determinant of this decrease in unintended pregnancy is the use of long-acting reversible contraception [LARC].” About 2% of women used contraceptives in 2002, and now, based on the latest cycle of data from 2015-2017, 16% of women use contraceptives.

In this video interview, Dr. Espey discusses the main points of her talk entitled “Contraceptives: What you need to know in 2019,” including:

  • The importance of “following reproductive justice–based principles and counseling” when it comes to prescribing contraceptives.
  • The latest data showing that certain LARC methods remain safe and effective beyond their approved duration of use.
  • Trends with respect to tubal ligation and salpingectomy.
  • The value of the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (MEC) for evidence-based guidance on selecting contraceptives based on patients’ individual needs.

“[MEC] is something every ob.gyn. should consider using,” she said, noting that access is available through a free app. “As our patients are more complex and have more comorbidities, it’s particularly helpful for matching up patients and their conditions with recommendations for specific contraceptive methods.”

Dr. Espey reported having no financial disclosures.

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Consider varying generational needs, preferences in the workplace and with patients

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Wed, 06/23/2021 - 12:45

– By 2020, millennials will comprise more than a third of individuals in the workplace, and that has important implications for employment, communication, and education, according to Patrice M. Weiss, MD.

Each generation brings a unique set of experiences and expectations. Millennials – or members of “Generation Y,” who comprised 18% of the workforce in 2018 and 0% in 2008 – tend to prefer flexible work hours and communication via technology, she said during a session on navigating generational differences in the workplace during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

They, along with members of “Generation X” (generally those born between 1962 and 1981) and “Generation Z” (generally those born from 1987 on), tend to be technology savvy, whereas the “Silent Generation” (generally those born between 1925 and 1942) and older members of the “Baby Boomer Generation” (generally those born between 1943 and 1961), may prefer printed communication and phone calls, said Dr. Weiss, chief medical officer at the Carilion Clinic in Roanoke, Va.

“It’s not good, it’s not bad – it’s just the way things are changing,” she said, adding that it’s important to look at the strengths that each generation brings to the workplace.

Importantly, the generational differences also affect patient expectations and therefore should guide physician-patient interactions, she said.

In this video interview, she further discusses how generational differences should be considered in medical practice, and how clinicians can adapt to the changing expectations and different needs of patients from different generations.



“Gen Ys want to communicate with us through technology. They don’t want to pick up the phone and schedule an appointment, they want to be able to go online ... through an app and self-schedule an appointment,” she said. “And they want health care when they want it.

“We as health care providers and health care organizations, we need to meet the needs of each generation ... so what we need to do is really identify what are the needs of all the generations as patients.”

During her presentation, Dr. Weiss further noted that these generational differences present a major challenge with respect to teaching, learning, and communicating.

“Rather than becoming frustrated ... let’s hope that we can ... reach across generations, identify what their strengths are, capitalize on those, and then, as health care providers, be more user and consumer friendly to the generations, particularly the millennials [so] that they have access to us and to information.”

Dr. Weiss said she had no relevant financial disclosures.

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– By 2020, millennials will comprise more than a third of individuals in the workplace, and that has important implications for employment, communication, and education, according to Patrice M. Weiss, MD.

Each generation brings a unique set of experiences and expectations. Millennials – or members of “Generation Y,” who comprised 18% of the workforce in 2018 and 0% in 2008 – tend to prefer flexible work hours and communication via technology, she said during a session on navigating generational differences in the workplace during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

They, along with members of “Generation X” (generally those born between 1962 and 1981) and “Generation Z” (generally those born from 1987 on), tend to be technology savvy, whereas the “Silent Generation” (generally those born between 1925 and 1942) and older members of the “Baby Boomer Generation” (generally those born between 1943 and 1961), may prefer printed communication and phone calls, said Dr. Weiss, chief medical officer at the Carilion Clinic in Roanoke, Va.

“It’s not good, it’s not bad – it’s just the way things are changing,” she said, adding that it’s important to look at the strengths that each generation brings to the workplace.

Importantly, the generational differences also affect patient expectations and therefore should guide physician-patient interactions, she said.

In this video interview, she further discusses how generational differences should be considered in medical practice, and how clinicians can adapt to the changing expectations and different needs of patients from different generations.



“Gen Ys want to communicate with us through technology. They don’t want to pick up the phone and schedule an appointment, they want to be able to go online ... through an app and self-schedule an appointment,” she said. “And they want health care when they want it.

“We as health care providers and health care organizations, we need to meet the needs of each generation ... so what we need to do is really identify what are the needs of all the generations as patients.”

During her presentation, Dr. Weiss further noted that these generational differences present a major challenge with respect to teaching, learning, and communicating.

“Rather than becoming frustrated ... let’s hope that we can ... reach across generations, identify what their strengths are, capitalize on those, and then, as health care providers, be more user and consumer friendly to the generations, particularly the millennials [so] that they have access to us and to information.”

Dr. Weiss said she had no relevant financial disclosures.

– By 2020, millennials will comprise more than a third of individuals in the workplace, and that has important implications for employment, communication, and education, according to Patrice M. Weiss, MD.

Each generation brings a unique set of experiences and expectations. Millennials – or members of “Generation Y,” who comprised 18% of the workforce in 2018 and 0% in 2008 – tend to prefer flexible work hours and communication via technology, she said during a session on navigating generational differences in the workplace during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

They, along with members of “Generation X” (generally those born between 1962 and 1981) and “Generation Z” (generally those born from 1987 on), tend to be technology savvy, whereas the “Silent Generation” (generally those born between 1925 and 1942) and older members of the “Baby Boomer Generation” (generally those born between 1943 and 1961), may prefer printed communication and phone calls, said Dr. Weiss, chief medical officer at the Carilion Clinic in Roanoke, Va.

“It’s not good, it’s not bad – it’s just the way things are changing,” she said, adding that it’s important to look at the strengths that each generation brings to the workplace.

Importantly, the generational differences also affect patient expectations and therefore should guide physician-patient interactions, she said.

In this video interview, she further discusses how generational differences should be considered in medical practice, and how clinicians can adapt to the changing expectations and different needs of patients from different generations.



“Gen Ys want to communicate with us through technology. They don’t want to pick up the phone and schedule an appointment, they want to be able to go online ... through an app and self-schedule an appointment,” she said. “And they want health care when they want it.

“We as health care providers and health care organizations, we need to meet the needs of each generation ... so what we need to do is really identify what are the needs of all the generations as patients.”

During her presentation, Dr. Weiss further noted that these generational differences present a major challenge with respect to teaching, learning, and communicating.

“Rather than becoming frustrated ... let’s hope that we can ... reach across generations, identify what their strengths are, capitalize on those, and then, as health care providers, be more user and consumer friendly to the generations, particularly the millennials [so] that they have access to us and to information.”

Dr. Weiss said she had no relevant financial disclosures.

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Managing 2nd trimester loss: Shared decision making, honor patient preference

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Wed, 06/23/2021 - 12:43

The decision regarding medical versus surgical management of second trimester fetal demise is one that should be shared between the physician and patient, according to Sara W. Prager, MD.

Information transfer between the physician and patient, as opposed to a provider-driven or patient-driven decision-making process, better ensures that “the best possible decision” will be reached, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington in Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Engaging the patient in the process – actively involving and supporting her in health care and treatment decision-making activities – is critically important, especially when dealing with pregnancy loss, which involves an acute sense of powerlessness, she said. Patient engagement is essential for respecting her autonomy, enhancing her agency, improving health status, reducing decisional conflict, and improving overall satisfaction.

Shared decision making requires a discussion about how the two approaches compare, particularly with respect to specific complications associated with each, Dr. Prager said, noting that discussion of values also should be encouraged.

Although surgical management is used more often, both approaches are safe and effective, and in the absence of clear contraindications in settings where both medication and a practitioner skilled in dilatation and evacuation are available, patient preference should honored, she said.

In this video interview, Dr. Prager further explains her position. “Using evidence-based medicine to have a shared decision-making process ... is extremely helpful for patients to feel like they have some control in this out-of-control situation where they’re experiencing a pregnancy loss.”



She also discussed how the use of mifepristone plus misoprostol for medical management of second-trimester loss has the potential to improve access.

“This is medication that, because of stigma surrounding abortion, is not always available ... so actually using it for non–abortion-related activities can be a way to help reduce that stigma around the medication itself, and get it into clinical sites, because it really does meaningfully improve management in the second trimester, as well as in the first trimester.”

In fact, the combination can cut nearly in half the amount of time it takes from the start of an induction until the end of the induction process, she said.

Dr. Prager also discussed surgical training resources and how to advocate for patient access to family planning experts who have the appropriate training.

Dr. Prager said she had no relevant financial disclosures.

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The decision regarding medical versus surgical management of second trimester fetal demise is one that should be shared between the physician and patient, according to Sara W. Prager, MD.

Information transfer between the physician and patient, as opposed to a provider-driven or patient-driven decision-making process, better ensures that “the best possible decision” will be reached, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington in Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Engaging the patient in the process – actively involving and supporting her in health care and treatment decision-making activities – is critically important, especially when dealing with pregnancy loss, which involves an acute sense of powerlessness, she said. Patient engagement is essential for respecting her autonomy, enhancing her agency, improving health status, reducing decisional conflict, and improving overall satisfaction.

Shared decision making requires a discussion about how the two approaches compare, particularly with respect to specific complications associated with each, Dr. Prager said, noting that discussion of values also should be encouraged.

Although surgical management is used more often, both approaches are safe and effective, and in the absence of clear contraindications in settings where both medication and a practitioner skilled in dilatation and evacuation are available, patient preference should honored, she said.

In this video interview, Dr. Prager further explains her position. “Using evidence-based medicine to have a shared decision-making process ... is extremely helpful for patients to feel like they have some control in this out-of-control situation where they’re experiencing a pregnancy loss.”



She also discussed how the use of mifepristone plus misoprostol for medical management of second-trimester loss has the potential to improve access.

“This is medication that, because of stigma surrounding abortion, is not always available ... so actually using it for non–abortion-related activities can be a way to help reduce that stigma around the medication itself, and get it into clinical sites, because it really does meaningfully improve management in the second trimester, as well as in the first trimester.”

In fact, the combination can cut nearly in half the amount of time it takes from the start of an induction until the end of the induction process, she said.

Dr. Prager also discussed surgical training resources and how to advocate for patient access to family planning experts who have the appropriate training.

Dr. Prager said she had no relevant financial disclosures.

The decision regarding medical versus surgical management of second trimester fetal demise is one that should be shared between the physician and patient, according to Sara W. Prager, MD.

Information transfer between the physician and patient, as opposed to a provider-driven or patient-driven decision-making process, better ensures that “the best possible decision” will be reached, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington in Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Engaging the patient in the process – actively involving and supporting her in health care and treatment decision-making activities – is critically important, especially when dealing with pregnancy loss, which involves an acute sense of powerlessness, she said. Patient engagement is essential for respecting her autonomy, enhancing her agency, improving health status, reducing decisional conflict, and improving overall satisfaction.

Shared decision making requires a discussion about how the two approaches compare, particularly with respect to specific complications associated with each, Dr. Prager said, noting that discussion of values also should be encouraged.

Although surgical management is used more often, both approaches are safe and effective, and in the absence of clear contraindications in settings where both medication and a practitioner skilled in dilatation and evacuation are available, patient preference should honored, she said.

In this video interview, Dr. Prager further explains her position. “Using evidence-based medicine to have a shared decision-making process ... is extremely helpful for patients to feel like they have some control in this out-of-control situation where they’re experiencing a pregnancy loss.”



She also discussed how the use of mifepristone plus misoprostol for medical management of second-trimester loss has the potential to improve access.

“This is medication that, because of stigma surrounding abortion, is not always available ... so actually using it for non–abortion-related activities can be a way to help reduce that stigma around the medication itself, and get it into clinical sites, because it really does meaningfully improve management in the second trimester, as well as in the first trimester.”

In fact, the combination can cut nearly in half the amount of time it takes from the start of an induction until the end of the induction process, she said.

Dr. Prager also discussed surgical training resources and how to advocate for patient access to family planning experts who have the appropriate training.

Dr. Prager said she had no relevant financial disclosures.

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Online counseling clarifies treatment options for menopausal women

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Mon, 05/06/2019 - 14:40

The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News
Dr. Sandra Dayaratna

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

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The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News
Dr. Sandra Dayaratna

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

The vast majority of women with menopausal symptoms who completed an online shared decision-making counseling session felt better prepared to discuss treatment options with their provider, a post-intervention survey showed.

Sharon Worcester/MDedge News
Dr. Sandra Dayaratna

Of 36 women who completed the counseling, 72% were able to express a clear preference for a particular treatment. Additionally, 90% to 100% of those who completed the final survey said the various components of the counseling–such as an educational brochure or a telephone call from a research nurse–made them feel more prepared to speak with their provider about treatment options, Sandra Dayaratna, MD, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Among 18 women with vasomotor symptoms, 6 (33%) preferred non-hormone treatment, 7 (39%) preferred hormone treatment, and 5 (28%) were unsure; among 18 with genitourinary symptoms of menopause, 6 (33%) preferred non-prescription treatment, 7 (39%) preferred topical hormone therapy, and 5 (28%) were unsure, Dr. Dayaratna, division director and clinical associate professor at Thomas Jefferson University Hospital and Sidney Kimmel Medical College, Philadelphia, found.

Of women who were not being treated for vasomotor symptoms, 5 (56%) expressed a clear treatment preference after counseling, whereas 8 (80%) of those not receiving treatment for genitourinary symptoms expressed a clear preference. Among 7 women receiving systemic hormone therapy for vasomotor symptoms, 86% preferred this treatment after counseling, and 3 women (50%) receiving topical hormone therapy preferred topical treatment after counseling.

The study included women aged 36-50 years from diverse educational and racial backgrounds who were referred to the counseling program after reporting menopausal symptoms, completing a baseline survey, and providing consent. The counseling, which was adapted from a tool developed at Thomas Jefferson University Hospital for the assessment of patients with colon and cancer or lung cancer, involved an educational brochure that was mailed to participants. It also offered access to an online tool that provided information about systemic hormone therapy, non-hormone prescription therapy, topical hormone treatment, and non-prescription treatment for vasomotor and genitourinary symptoms of menopause.

A research nurse contacted participants by phone and used the online program to review the brochure, clarify treatment preference, and produce a summary of the results.

In an interview, Dr. Dayaratna noted that the concept of “shared decision making” is often misunderstood to mean that patients are provided with information about options and then they make a choice.

Actually, this study demonstrates that shared decision making really involves a “values clarification” component, she explained. In this study, counseling that incorporates this type of shared decision making helped women feel more prepared to speak with their providers about treatment and thus may add value to care of menopausal women, she concluded.

“This is relevant because we know that over 50% of patients within 90 minutes of leaving their doctor’s office have forgotten what they were told, and over 50% do not comply with their treatment prescriptions,” she said. “So if patients can do this process ahead of time, when they come to speak to their physician about their symptoms and selection of medication, it’s a more effective and efficient conversation.”

Further research should evaluate impact on the subsequent office visit, she added.

This study was funded by an educational grant from Pfizer, Inc. and by the National Cancer Institute. Dr. Dayaratna reported having no disclosures.

SOURCE: Dayaratna S et al., ACOG 2019: Abstract 21M.

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