Tardive dyskinesia: Screening and management

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Dr. Gupta is Clinical Professor, SUNY Upstate Medical University, Syracuse, New York, and Clinical Professor, University at Buffalo, Buffalo, New York. He is a member of the Current Psychiatry Editorial Board.

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Dr. Gupta is Clinical Professor, SUNY Upstate Medical University, Syracuse, New York, and Clinical Professor, University at Buffalo, Buffalo, New York. He is a member of the Current Psychiatry Editorial Board.

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VIDEO: Postpartum care gets a new look

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– While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.

Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.

To address preferred changes to this system of care, the American College of Obstetricians and Gynecologists recently released a revised committee opinion, which Dr. Stuebe helped create, to provide better care for mothers right after giving birth..

“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.

Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.

One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.

According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.

As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.

 

 

“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”

The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”

Dr. Stuebe receives support from Janssen.

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– While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.

Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.

To address preferred changes to this system of care, the American College of Obstetricians and Gynecologists recently released a revised committee opinion, which Dr. Stuebe helped create, to provide better care for mothers right after giving birth..

“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.

Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.

One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.

According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.

As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.

 

 

“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”

The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”

Dr. Stuebe receives support from Janssen.

– While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.

Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.

To address preferred changes to this system of care, the American College of Obstetricians and Gynecologists recently released a revised committee opinion, which Dr. Stuebe helped create, to provide better care for mothers right after giving birth..

“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.

Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.

One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.

According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.

As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.

 

 

“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”

The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”

Dr. Stuebe receives support from Janssen.

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VIDEO: To boost newborn breastfeeding rates, hide the EHR formula order

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– When the check box for ordering formula for newborns was removed as a standard newborn order option in the electronic health record (EHR), rates of exclusive breastfeeding climbed significantly in Los Angeles County hospitals, according to a recent study.

“The saying, ‘out of sight, out of mind’ cannot be overstated when it comes to physician order entry,” wrote Ramy Eskander, MD, and his colleagues in the poster accompanying the presentation at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.

In a video interview, Dr. Eskander said that he and his colleagues at the University of California, Los Angeles, were looking for an intervention that would use the EHR as a quality improvement tool.

What they decided to do was to see “how could we possibly ‘get in the way’ and have an intervention between the provider and the patient that didn’t necessarily involve much work on the provider’s end, that had a significant impact on the back end,” he said. What they ended up doing was remove the order to request formula for mothers from the physician order set in the EHR.

Study data were collected in three stages for the academic tertiary care hospital within the Los Angeles County Department of Health Services system.

First, Dr. Eskander and his colleagues collected baseline data from January to July of 2016. Then, data were collected from July to the end of 2016, while a campaign was underway to bring staff and patients up to speed on the benefits of exclusive breastfeeding. There were no statistically significant differences in the rates of exclusive breastfeeding on discharge between these two time periods, when rates hovered between 30% and 40%.

The final data collection period began in January 2017. At that time, the option to order formula for a newborn was removed as an option for the EHR newborn order set.

 

 

“When we did that, providers weren’t looking at the possibility of having that easy check box right there to fill in … and we know that when people have to go through more steps, they invariably don’t do it,” Dr. Eskander said.

He and his colleagues saw an almost immediate leap in rates of exclusive breastfeeding once clinicians had to click through an additional set of screens to reach the formula order. Once the formula order was removed, breastfeeding rates rose from 40.57% to 53.90% (P less than .001). Rates have been sustained since the removal of the EHR option for formula.

There was no difference in how infants fared after the intervention, said Dr. Eskander. “The outcomes for those infants was identical. There were no increased NICU admissions, there were no increased poor outcomes.”

Length of stay remained the same as well. “The babies were being discharged in the same state of health, just more of them were getting breast milk only, and we know the benefits that tends to portend,” he added.

There was some initial grumbling when the formula order was pulled from the newborn order set, he conceded. “The providers were not very happy about having to look for the newborn order for formula.” However, it took just about a month for the new workflow to seem normal, he said.

Dr. Eskander envisions a future where the EHR is “smart” enough to prompt appropriate orders and interventions for serious conditions such as preeclampsia. The electronic record, he said, could recognize the maternal diagnosis “and immediately create a system and structure around that mother to be able to help protect her and her baby. ... then having those diagnoses be able to drive outcomes can be very significant.”

koakes@mdedge.com

SOURCE: Eskander, R et al. ACOG 2018, Abstract 31I.

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– When the check box for ordering formula for newborns was removed as a standard newborn order option in the electronic health record (EHR), rates of exclusive breastfeeding climbed significantly in Los Angeles County hospitals, according to a recent study.

“The saying, ‘out of sight, out of mind’ cannot be overstated when it comes to physician order entry,” wrote Ramy Eskander, MD, and his colleagues in the poster accompanying the presentation at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.

In a video interview, Dr. Eskander said that he and his colleagues at the University of California, Los Angeles, were looking for an intervention that would use the EHR as a quality improvement tool.

What they decided to do was to see “how could we possibly ‘get in the way’ and have an intervention between the provider and the patient that didn’t necessarily involve much work on the provider’s end, that had a significant impact on the back end,” he said. What they ended up doing was remove the order to request formula for mothers from the physician order set in the EHR.

Study data were collected in three stages for the academic tertiary care hospital within the Los Angeles County Department of Health Services system.

First, Dr. Eskander and his colleagues collected baseline data from January to July of 2016. Then, data were collected from July to the end of 2016, while a campaign was underway to bring staff and patients up to speed on the benefits of exclusive breastfeeding. There were no statistically significant differences in the rates of exclusive breastfeeding on discharge between these two time periods, when rates hovered between 30% and 40%.

The final data collection period began in January 2017. At that time, the option to order formula for a newborn was removed as an option for the EHR newborn order set.

 

 

“When we did that, providers weren’t looking at the possibility of having that easy check box right there to fill in … and we know that when people have to go through more steps, they invariably don’t do it,” Dr. Eskander said.

He and his colleagues saw an almost immediate leap in rates of exclusive breastfeeding once clinicians had to click through an additional set of screens to reach the formula order. Once the formula order was removed, breastfeeding rates rose from 40.57% to 53.90% (P less than .001). Rates have been sustained since the removal of the EHR option for formula.

There was no difference in how infants fared after the intervention, said Dr. Eskander. “The outcomes for those infants was identical. There were no increased NICU admissions, there were no increased poor outcomes.”

Length of stay remained the same as well. “The babies were being discharged in the same state of health, just more of them were getting breast milk only, and we know the benefits that tends to portend,” he added.

There was some initial grumbling when the formula order was pulled from the newborn order set, he conceded. “The providers were not very happy about having to look for the newborn order for formula.” However, it took just about a month for the new workflow to seem normal, he said.

Dr. Eskander envisions a future where the EHR is “smart” enough to prompt appropriate orders and interventions for serious conditions such as preeclampsia. The electronic record, he said, could recognize the maternal diagnosis “and immediately create a system and structure around that mother to be able to help protect her and her baby. ... then having those diagnoses be able to drive outcomes can be very significant.”

koakes@mdedge.com

SOURCE: Eskander, R et al. ACOG 2018, Abstract 31I.

– When the check box for ordering formula for newborns was removed as a standard newborn order option in the electronic health record (EHR), rates of exclusive breastfeeding climbed significantly in Los Angeles County hospitals, according to a recent study.

“The saying, ‘out of sight, out of mind’ cannot be overstated when it comes to physician order entry,” wrote Ramy Eskander, MD, and his colleagues in the poster accompanying the presentation at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.

In a video interview, Dr. Eskander said that he and his colleagues at the University of California, Los Angeles, were looking for an intervention that would use the EHR as a quality improvement tool.

What they decided to do was to see “how could we possibly ‘get in the way’ and have an intervention between the provider and the patient that didn’t necessarily involve much work on the provider’s end, that had a significant impact on the back end,” he said. What they ended up doing was remove the order to request formula for mothers from the physician order set in the EHR.

Study data were collected in three stages for the academic tertiary care hospital within the Los Angeles County Department of Health Services system.

First, Dr. Eskander and his colleagues collected baseline data from January to July of 2016. Then, data were collected from July to the end of 2016, while a campaign was underway to bring staff and patients up to speed on the benefits of exclusive breastfeeding. There were no statistically significant differences in the rates of exclusive breastfeeding on discharge between these two time periods, when rates hovered between 30% and 40%.

The final data collection period began in January 2017. At that time, the option to order formula for a newborn was removed as an option for the EHR newborn order set.

 

 

“When we did that, providers weren’t looking at the possibility of having that easy check box right there to fill in … and we know that when people have to go through more steps, they invariably don’t do it,” Dr. Eskander said.

He and his colleagues saw an almost immediate leap in rates of exclusive breastfeeding once clinicians had to click through an additional set of screens to reach the formula order. Once the formula order was removed, breastfeeding rates rose from 40.57% to 53.90% (P less than .001). Rates have been sustained since the removal of the EHR option for formula.

There was no difference in how infants fared after the intervention, said Dr. Eskander. “The outcomes for those infants was identical. There were no increased NICU admissions, there were no increased poor outcomes.”

Length of stay remained the same as well. “The babies were being discharged in the same state of health, just more of them were getting breast milk only, and we know the benefits that tends to portend,” he added.

There was some initial grumbling when the formula order was pulled from the newborn order set, he conceded. “The providers were not very happy about having to look for the newborn order for formula.” However, it took just about a month for the new workflow to seem normal, he said.

Dr. Eskander envisions a future where the EHR is “smart” enough to prompt appropriate orders and interventions for serious conditions such as preeclampsia. The electronic record, he said, could recognize the maternal diagnosis “and immediately create a system and structure around that mother to be able to help protect her and her baby. ... then having those diagnoses be able to drive outcomes can be very significant.”

koakes@mdedge.com

SOURCE: Eskander, R et al. ACOG 2018, Abstract 31I.

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VIDEO: Novel postpartum depression drug effective in phase 3 trial

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– A novel therapeutic agent shows promise for postpartum depression in a phase 3 trial presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Brexanolone, administered intravenously, differs from other antidepressants currently used to treat postpartum depression. It targets GABAA receptors, according to presenter Christine Clemson, PhD, senior medical director at Sage Therapeutics, the company developing brexanolone.

The randomized, placebo-controlled, double-blind study enrolled 138 women who were 6 months postpartum or less, and had been diagnosed with a major depressive episode during the third trimester or at 4 or fewer weeks postpartum, and had a 17-item Hamilton Rating Scale for Depression (HAM-D) score of 26 or greater.

They were randomized to either brexanolone 60 mcg/kg/hour or 90 mcg/kg/hour administered intravenously over 60 hours as inpatients, or placebo. All three groups were an average aged 27 years old, the majority were white, and they had a HAM-D score between 28.4 and 29.1 at baseline.

After the first 60 hours of treatment, patients in the brexanolone group had mean reductions in the HAM-D score of about 20 in the 60 mcg group (P less than .01) and 18 in the 90 mcg group (P less than .05), compared with almost 14 in the placebo group. This was the primary endpoint,

Patients retained improvement through day 30, while those in the placebo group experienced a slight swing in the opposite direction.

Adverse effects in the brexanolone-treated groups were minimal; the majority of events reported were headaches or dizziness. However, Dr. Clemson said that some patients had to stop breastfeeding for a week.

 

 


An application for brexanolone for treating postpartum depression was submitted to the Food and Drug Administration on April 23; if approved, it would be the first drug of its kind to become available to treat postpartum depression.

The study was funded by Sage Therapeutics; two of the six authors are company employees. Two authors, including the lead author, are from the department of psychiatry, at the University of North Carolina, Chapel Hill.

SOURCE: S. Meltzer-Brody S et al. ACOG 2018, Poster 29B.

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– A novel therapeutic agent shows promise for postpartum depression in a phase 3 trial presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Brexanolone, administered intravenously, differs from other antidepressants currently used to treat postpartum depression. It targets GABAA receptors, according to presenter Christine Clemson, PhD, senior medical director at Sage Therapeutics, the company developing brexanolone.

The randomized, placebo-controlled, double-blind study enrolled 138 women who were 6 months postpartum or less, and had been diagnosed with a major depressive episode during the third trimester or at 4 or fewer weeks postpartum, and had a 17-item Hamilton Rating Scale for Depression (HAM-D) score of 26 or greater.

They were randomized to either brexanolone 60 mcg/kg/hour or 90 mcg/kg/hour administered intravenously over 60 hours as inpatients, or placebo. All three groups were an average aged 27 years old, the majority were white, and they had a HAM-D score between 28.4 and 29.1 at baseline.

After the first 60 hours of treatment, patients in the brexanolone group had mean reductions in the HAM-D score of about 20 in the 60 mcg group (P less than .01) and 18 in the 90 mcg group (P less than .05), compared with almost 14 in the placebo group. This was the primary endpoint,

Patients retained improvement through day 30, while those in the placebo group experienced a slight swing in the opposite direction.

Adverse effects in the brexanolone-treated groups were minimal; the majority of events reported were headaches or dizziness. However, Dr. Clemson said that some patients had to stop breastfeeding for a week.

 

 


An application for brexanolone for treating postpartum depression was submitted to the Food and Drug Administration on April 23; if approved, it would be the first drug of its kind to become available to treat postpartum depression.

The study was funded by Sage Therapeutics; two of the six authors are company employees. Two authors, including the lead author, are from the department of psychiatry, at the University of North Carolina, Chapel Hill.

SOURCE: S. Meltzer-Brody S et al. ACOG 2018, Poster 29B.

– A novel therapeutic agent shows promise for postpartum depression in a phase 3 trial presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Brexanolone, administered intravenously, differs from other antidepressants currently used to treat postpartum depression. It targets GABAA receptors, according to presenter Christine Clemson, PhD, senior medical director at Sage Therapeutics, the company developing brexanolone.

The randomized, placebo-controlled, double-blind study enrolled 138 women who were 6 months postpartum or less, and had been diagnosed with a major depressive episode during the third trimester or at 4 or fewer weeks postpartum, and had a 17-item Hamilton Rating Scale for Depression (HAM-D) score of 26 or greater.

They were randomized to either brexanolone 60 mcg/kg/hour or 90 mcg/kg/hour administered intravenously over 60 hours as inpatients, or placebo. All three groups were an average aged 27 years old, the majority were white, and they had a HAM-D score between 28.4 and 29.1 at baseline.

After the first 60 hours of treatment, patients in the brexanolone group had mean reductions in the HAM-D score of about 20 in the 60 mcg group (P less than .01) and 18 in the 90 mcg group (P less than .05), compared with almost 14 in the placebo group. This was the primary endpoint,

Patients retained improvement through day 30, while those in the placebo group experienced a slight swing in the opposite direction.

Adverse effects in the brexanolone-treated groups were minimal; the majority of events reported were headaches or dizziness. However, Dr. Clemson said that some patients had to stop breastfeeding for a week.

 

 


An application for brexanolone for treating postpartum depression was submitted to the Food and Drug Administration on April 23; if approved, it would be the first drug of its kind to become available to treat postpartum depression.

The study was funded by Sage Therapeutics; two of the six authors are company employees. Two authors, including the lead author, are from the department of psychiatry, at the University of North Carolina, Chapel Hill.

SOURCE: S. Meltzer-Brody S et al. ACOG 2018, Poster 29B.

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VIDEO: Office-based hereditary cancer risk testing is doable

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A simple process change helped increase the number of genetic screenings for hereditary cancer risk performed in community ob.gyn. practices, according to Mark S. DeFrancesco, MD, and his associates.

Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.

A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.

Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.

The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.

Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.

A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.

 

 


Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).

“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.

Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.

SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.

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A simple process change helped increase the number of genetic screenings for hereditary cancer risk performed in community ob.gyn. practices, according to Mark S. DeFrancesco, MD, and his associates.

Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.

A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.

Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.

The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.

Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.

A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.

 

 


Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).

“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.

Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.

SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.

A simple process change helped increase the number of genetic screenings for hereditary cancer risk performed in community ob.gyn. practices, according to Mark S. DeFrancesco, MD, and his associates.

Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.

A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.

Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.

The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.

Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.

A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.

 

 


Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).

“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.

Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.

SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.

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Key clinical point: Ob.gyns. can successfully integrate hereditary cancer risk testing into their practices.

Major finding: Office-based genetic testing increased from 1% to 4% of patients seen.

Study details: Prospective, single-arm process intervention study screening more than 4,000 women at 5 ob.gyn. practice sites.

Disclosures: Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors included employees of Myriad Genetics, some with ownership interests.

Source: DeFrancesco, MS et al. ACOG 2018 poster 3K.

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VIDEO: Prepaid prenatal care bundle delivers quality care to uninsured

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Fri, 01/18/2019 - 17:36

 

– The experiences of one safety net hospital showed the feasibility of delivering prenatal care to low-risk, uninsured women in a prepaid, bundled package.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Women with low-risk pregnancies saw quality of care better than that provided with Medicaid coverage when receiving bundled care. The adjusted odds ratio for predefined adequacy of care was 3.75 for the low-risk bundled care recipients compared with those on Medicaid (P = .015), according to the experience at Grady Memorial Hospital, Atlanta, presented at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.

For hospitals with large numbers of undocumented patients and others who are uninsured but ineligible for Medicaid, considerable cost savings could be realized, said Erin Duncan, MD, who completed the work while in training at Emory University.

“Using data from previous studies, Grady Memorial Hospital could see a savings of over $1 million per year by providing care to its undocumented population,” she and her collaborators wrote in the poster accompanying the presentation.

Dr. Duncan said that since implementation in 2010, about 40% of deliveries at the facility have occurred under the “Grady Healthy Baby” (GHB) bundle.

The one-payment package of bundled prenatal care was developed assuming that most participants would have low-risk pregnancies, said Dr. Duncan, who is currently an ob.gyn. in private practice in the Atlanta area.

To look further into maternal and pregnancy characteristics of GHB participants and compare them with those on Medicaid, Dr. Duncan and her collaborators performed a retrospective cohort study. Examining viable singleton pregnancies delivered at Grady between 2011 and 2014, the investigators compared 100 randomly selected GHB participants with 100 randomly selected Medicaid participants.

 

 


Comparing patients receiving care under GHB and Medicaid, Dr. Duncan and her colleagues found that “GHB participants were older, more likely to be Hispanic, and less likely to be black compared to Medicaid recipients (P less than .001 for all,)” they wrote in the poster accompanying the presentation.

Hispanic patients made up 59% of the GHB group, compared with 8% of the Medicaid group, said Dr. Duncan, adding in an interview that over half of Hispanics in the state of Georgia during the study period were undocumented.

Parity was similar between the two groups, as were gestational age at delivery and mode of delivery.

In their analysis, Dr. Duncan and her collaborators looked at both complexity and adequacy of care for the 200 patients studied. They found that there was no significant difference in the number of patients in each care group who remained low risk throughout their pregnancies, transitioned from low risk to high risk, or entered prenatal care with a high risk pregnancy, a circumstance that occurred in about 1 in 10 pregnancies.

 

 


For the approximately 50% of patients who remained low risk through their pregnancies, care under the GHB model was significantly more likely to be assessed as adequate throughout pregnancy than for those patients on Medicaid (61.7% vs 35.5%, P = .001).

Patients who became high risk during prenatal care were no more likely to receive adequate care under one model than the other.

For high risk patients, delivery of adequate care happened only under the Medicaid care model. Numbers in this group were small; 7 of 100 GHB and 15 of 100 Medicaid patients entered prenatal care with high risk pregnancies. However, no high risk GHB patients received adequate care, while that standard was met for 80% of the Medicaid patients (P less than .001).

Adequacy of care was assessed using the Kotelchuck index for low-risk pregnancies; this model assumes care is “adequate” when 80% of the number of expected visits were attended by the woman receiving prenatal care. Additionally, care was deemed adequate for high-risk pregnancies if at least 80% of the number of expected ultrasound appointments were attended.

 

 


“In the current political climate, this study has implications for all pregnancies that begin as uninsured, regardless of maternal documentation status,” wrote Dr. Duncan and her colleagues.

Dr. Duncan reported no conflicts of interest.

SOURCE: Duncan, E et al. ACOG 2018, Abstract 28C.

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– The experiences of one safety net hospital showed the feasibility of delivering prenatal care to low-risk, uninsured women in a prepaid, bundled package.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Women with low-risk pregnancies saw quality of care better than that provided with Medicaid coverage when receiving bundled care. The adjusted odds ratio for predefined adequacy of care was 3.75 for the low-risk bundled care recipients compared with those on Medicaid (P = .015), according to the experience at Grady Memorial Hospital, Atlanta, presented at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.

For hospitals with large numbers of undocumented patients and others who are uninsured but ineligible for Medicaid, considerable cost savings could be realized, said Erin Duncan, MD, who completed the work while in training at Emory University.

“Using data from previous studies, Grady Memorial Hospital could see a savings of over $1 million per year by providing care to its undocumented population,” she and her collaborators wrote in the poster accompanying the presentation.

Dr. Duncan said that since implementation in 2010, about 40% of deliveries at the facility have occurred under the “Grady Healthy Baby” (GHB) bundle.

The one-payment package of bundled prenatal care was developed assuming that most participants would have low-risk pregnancies, said Dr. Duncan, who is currently an ob.gyn. in private practice in the Atlanta area.

To look further into maternal and pregnancy characteristics of GHB participants and compare them with those on Medicaid, Dr. Duncan and her collaborators performed a retrospective cohort study. Examining viable singleton pregnancies delivered at Grady between 2011 and 2014, the investigators compared 100 randomly selected GHB participants with 100 randomly selected Medicaid participants.

 

 


Comparing patients receiving care under GHB and Medicaid, Dr. Duncan and her colleagues found that “GHB participants were older, more likely to be Hispanic, and less likely to be black compared to Medicaid recipients (P less than .001 for all,)” they wrote in the poster accompanying the presentation.

Hispanic patients made up 59% of the GHB group, compared with 8% of the Medicaid group, said Dr. Duncan, adding in an interview that over half of Hispanics in the state of Georgia during the study period were undocumented.

Parity was similar between the two groups, as were gestational age at delivery and mode of delivery.

In their analysis, Dr. Duncan and her collaborators looked at both complexity and adequacy of care for the 200 patients studied. They found that there was no significant difference in the number of patients in each care group who remained low risk throughout their pregnancies, transitioned from low risk to high risk, or entered prenatal care with a high risk pregnancy, a circumstance that occurred in about 1 in 10 pregnancies.

 

 


For the approximately 50% of patients who remained low risk through their pregnancies, care under the GHB model was significantly more likely to be assessed as adequate throughout pregnancy than for those patients on Medicaid (61.7% vs 35.5%, P = .001).

Patients who became high risk during prenatal care were no more likely to receive adequate care under one model than the other.

For high risk patients, delivery of adequate care happened only under the Medicaid care model. Numbers in this group were small; 7 of 100 GHB and 15 of 100 Medicaid patients entered prenatal care with high risk pregnancies. However, no high risk GHB patients received adequate care, while that standard was met for 80% of the Medicaid patients (P less than .001).

Adequacy of care was assessed using the Kotelchuck index for low-risk pregnancies; this model assumes care is “adequate” when 80% of the number of expected visits were attended by the woman receiving prenatal care. Additionally, care was deemed adequate for high-risk pregnancies if at least 80% of the number of expected ultrasound appointments were attended.

 

 


“In the current political climate, this study has implications for all pregnancies that begin as uninsured, regardless of maternal documentation status,” wrote Dr. Duncan and her colleagues.

Dr. Duncan reported no conflicts of interest.

SOURCE: Duncan, E et al. ACOG 2018, Abstract 28C.

 

– The experiences of one safety net hospital showed the feasibility of delivering prenatal care to low-risk, uninsured women in a prepaid, bundled package.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Women with low-risk pregnancies saw quality of care better than that provided with Medicaid coverage when receiving bundled care. The adjusted odds ratio for predefined adequacy of care was 3.75 for the low-risk bundled care recipients compared with those on Medicaid (P = .015), according to the experience at Grady Memorial Hospital, Atlanta, presented at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.

For hospitals with large numbers of undocumented patients and others who are uninsured but ineligible for Medicaid, considerable cost savings could be realized, said Erin Duncan, MD, who completed the work while in training at Emory University.

“Using data from previous studies, Grady Memorial Hospital could see a savings of over $1 million per year by providing care to its undocumented population,” she and her collaborators wrote in the poster accompanying the presentation.

Dr. Duncan said that since implementation in 2010, about 40% of deliveries at the facility have occurred under the “Grady Healthy Baby” (GHB) bundle.

The one-payment package of bundled prenatal care was developed assuming that most participants would have low-risk pregnancies, said Dr. Duncan, who is currently an ob.gyn. in private practice in the Atlanta area.

To look further into maternal and pregnancy characteristics of GHB participants and compare them with those on Medicaid, Dr. Duncan and her collaborators performed a retrospective cohort study. Examining viable singleton pregnancies delivered at Grady between 2011 and 2014, the investigators compared 100 randomly selected GHB participants with 100 randomly selected Medicaid participants.

 

 


Comparing patients receiving care under GHB and Medicaid, Dr. Duncan and her colleagues found that “GHB participants were older, more likely to be Hispanic, and less likely to be black compared to Medicaid recipients (P less than .001 for all,)” they wrote in the poster accompanying the presentation.

Hispanic patients made up 59% of the GHB group, compared with 8% of the Medicaid group, said Dr. Duncan, adding in an interview that over half of Hispanics in the state of Georgia during the study period were undocumented.

Parity was similar between the two groups, as were gestational age at delivery and mode of delivery.

In their analysis, Dr. Duncan and her collaborators looked at both complexity and adequacy of care for the 200 patients studied. They found that there was no significant difference in the number of patients in each care group who remained low risk throughout their pregnancies, transitioned from low risk to high risk, or entered prenatal care with a high risk pregnancy, a circumstance that occurred in about 1 in 10 pregnancies.

 

 


For the approximately 50% of patients who remained low risk through their pregnancies, care under the GHB model was significantly more likely to be assessed as adequate throughout pregnancy than for those patients on Medicaid (61.7% vs 35.5%, P = .001).

Patients who became high risk during prenatal care were no more likely to receive adequate care under one model than the other.

For high risk patients, delivery of adequate care happened only under the Medicaid care model. Numbers in this group were small; 7 of 100 GHB and 15 of 100 Medicaid patients entered prenatal care with high risk pregnancies. However, no high risk GHB patients received adequate care, while that standard was met for 80% of the Medicaid patients (P less than .001).

Adequacy of care was assessed using the Kotelchuck index for low-risk pregnancies; this model assumes care is “adequate” when 80% of the number of expected visits were attended by the woman receiving prenatal care. Additionally, care was deemed adequate for high-risk pregnancies if at least 80% of the number of expected ultrasound appointments were attended.

 

 


“In the current political climate, this study has implications for all pregnancies that begin as uninsured, regardless of maternal documentation status,” wrote Dr. Duncan and her colleagues.

Dr. Duncan reported no conflicts of interest.

SOURCE: Duncan, E et al. ACOG 2018, Abstract 28C.

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VIDEO: National suicide hotline could result from pending U.S. law

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Thu, 01/21/2021 - 11:44

– A bill working its way through the U.S. Congress that would mandate study of the feasibility of a three-digit phone number for suicide prevention and mental health crisis has the potential to establish not only a much-needed national hotline, but more broadly “reboot U.S. crisis care,” Michael F. Hogan, PhD, said at the annual conference of the American Association of Suicidology.

“If we get this legislation passed and some funding, it is a remarkable opportunity to get it right,” said Dr. Hogan, a mental health policy consultant based in Delmar, N.Y., and former commissioner of the New York State Office of Mental Health. A single, “N11,” three-digit phone number for suicide prevention, substance abuse, and mental health crises would “provide a skeleton for a whole new system of crisis centers.”

The pending legislation, the National Suicide Hotline Improvement Act of 2017, “would create parity between brain health and heart health,” Dr. Hogan noted in a video interview. The bill passed the Senate in November 2017, and in late March 2018 had a positive hearing before the Energy and Commerce Committee of the House of Representatives. “The prospects are pretty good,” he said.

Currently, U.S. services are “a mess,” bemoaned Dr. Hogan, who attributed the problem to abandonment of a national program starting in 1981 because of funding changes introduced by the Reagan administration. The centerpiece of the current U.S. system, the National Suicide Prevention Lifeline, receives limited and indirect federal support and relies on coordination among more than 160 local crisis line operations across the country that get no federal funding. Many calls into the Lifeline are, by necessity, answered outside of the locality or even the state from where the call was placed. Inadequacies in the resources available to help people who are suicidal or having other mental health crises have placed the response burden on police departments and emergency departments, “the worst place to go” for mental health care, Dr. Hogan said.

“The primary way around the country to address the problem is cops and EDs; that’s expensive and bad. When you don’t have good crisis services, people go to emergency departments where it’s ‘go upstairs or go home,’ ” he lamented. “We need EMS for the brain; we need one number to call.”

Establishment of a centralized and funded U.S. crisis call system would tie into other measures aimed at transforming national crisis services called for by the Crisis Now program of the National Association of State Mental Health Program Directors, Dr. Hogan said.

Dr. Hogan had no disclosures.

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– A bill working its way through the U.S. Congress that would mandate study of the feasibility of a three-digit phone number for suicide prevention and mental health crisis has the potential to establish not only a much-needed national hotline, but more broadly “reboot U.S. crisis care,” Michael F. Hogan, PhD, said at the annual conference of the American Association of Suicidology.

“If we get this legislation passed and some funding, it is a remarkable opportunity to get it right,” said Dr. Hogan, a mental health policy consultant based in Delmar, N.Y., and former commissioner of the New York State Office of Mental Health. A single, “N11,” three-digit phone number for suicide prevention, substance abuse, and mental health crises would “provide a skeleton for a whole new system of crisis centers.”

The pending legislation, the National Suicide Hotline Improvement Act of 2017, “would create parity between brain health and heart health,” Dr. Hogan noted in a video interview. The bill passed the Senate in November 2017, and in late March 2018 had a positive hearing before the Energy and Commerce Committee of the House of Representatives. “The prospects are pretty good,” he said.

Currently, U.S. services are “a mess,” bemoaned Dr. Hogan, who attributed the problem to abandonment of a national program starting in 1981 because of funding changes introduced by the Reagan administration. The centerpiece of the current U.S. system, the National Suicide Prevention Lifeline, receives limited and indirect federal support and relies on coordination among more than 160 local crisis line operations across the country that get no federal funding. Many calls into the Lifeline are, by necessity, answered outside of the locality or even the state from where the call was placed. Inadequacies in the resources available to help people who are suicidal or having other mental health crises have placed the response burden on police departments and emergency departments, “the worst place to go” for mental health care, Dr. Hogan said.

“The primary way around the country to address the problem is cops and EDs; that’s expensive and bad. When you don’t have good crisis services, people go to emergency departments where it’s ‘go upstairs or go home,’ ” he lamented. “We need EMS for the brain; we need one number to call.”

Establishment of a centralized and funded U.S. crisis call system would tie into other measures aimed at transforming national crisis services called for by the Crisis Now program of the National Association of State Mental Health Program Directors, Dr. Hogan said.

Dr. Hogan had no disclosures.

– A bill working its way through the U.S. Congress that would mandate study of the feasibility of a three-digit phone number for suicide prevention and mental health crisis has the potential to establish not only a much-needed national hotline, but more broadly “reboot U.S. crisis care,” Michael F. Hogan, PhD, said at the annual conference of the American Association of Suicidology.

“If we get this legislation passed and some funding, it is a remarkable opportunity to get it right,” said Dr. Hogan, a mental health policy consultant based in Delmar, N.Y., and former commissioner of the New York State Office of Mental Health. A single, “N11,” three-digit phone number for suicide prevention, substance abuse, and mental health crises would “provide a skeleton for a whole new system of crisis centers.”

The pending legislation, the National Suicide Hotline Improvement Act of 2017, “would create parity between brain health and heart health,” Dr. Hogan noted in a video interview. The bill passed the Senate in November 2017, and in late March 2018 had a positive hearing before the Energy and Commerce Committee of the House of Representatives. “The prospects are pretty good,” he said.

Currently, U.S. services are “a mess,” bemoaned Dr. Hogan, who attributed the problem to abandonment of a national program starting in 1981 because of funding changes introduced by the Reagan administration. The centerpiece of the current U.S. system, the National Suicide Prevention Lifeline, receives limited and indirect federal support and relies on coordination among more than 160 local crisis line operations across the country that get no federal funding. Many calls into the Lifeline are, by necessity, answered outside of the locality or even the state from where the call was placed. Inadequacies in the resources available to help people who are suicidal or having other mental health crises have placed the response burden on police departments and emergency departments, “the worst place to go” for mental health care, Dr. Hogan said.

“The primary way around the country to address the problem is cops and EDs; that’s expensive and bad. When you don’t have good crisis services, people go to emergency departments where it’s ‘go upstairs or go home,’ ” he lamented. “We need EMS for the brain; we need one number to call.”

Establishment of a centralized and funded U.S. crisis call system would tie into other measures aimed at transforming national crisis services called for by the Crisis Now program of the National Association of State Mental Health Program Directors, Dr. Hogan said.

Dr. Hogan had no disclosures.

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VIDEO: Assessing consumer knowledge about cosmetic procedures

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Mon, 01/14/2019 - 10:22

 

– Most people rely on physicians, family, and friends to obtain relevant information about cosmetic procedures, but a knowledge gap exists regarding which cosmetic providers are medical doctors.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Those are two key findings from a national survey that set out to assess how consumers research, educate themselves, and choose cosmetic procedures and providers. At the annual conference of the American Society for Laser Medicine and Surgery, study author Adam J. Wulkan, MD, discussed results from the 20-item survey, which was based on responses from 323 people who have obtained or have considered obtaining a cosmetic procedure such as laser hair removal.

Dr. Wulkan is a dermatologist at Massachusetts General Hospital, Boston. He reported having no financial disclosures. Study coauthor Mathew Avram, MD, serves on the medical advisory board of Sciton and on the scientific advisory boards of Sienna Biopharmaceuticals, Cytrellis, and Allergan. He also is consultant for Merz Aesthetics, Allergan, Soliton, Invasix, and Revance, and has intellectual property with Cytrellis. He also holds stock options with Cytrellis, Invasix, and Zalea.

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– Most people rely on physicians, family, and friends to obtain relevant information about cosmetic procedures, but a knowledge gap exists regarding which cosmetic providers are medical doctors.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Those are two key findings from a national survey that set out to assess how consumers research, educate themselves, and choose cosmetic procedures and providers. At the annual conference of the American Society for Laser Medicine and Surgery, study author Adam J. Wulkan, MD, discussed results from the 20-item survey, which was based on responses from 323 people who have obtained or have considered obtaining a cosmetic procedure such as laser hair removal.

Dr. Wulkan is a dermatologist at Massachusetts General Hospital, Boston. He reported having no financial disclosures. Study coauthor Mathew Avram, MD, serves on the medical advisory board of Sciton and on the scientific advisory boards of Sienna Biopharmaceuticals, Cytrellis, and Allergan. He also is consultant for Merz Aesthetics, Allergan, Soliton, Invasix, and Revance, and has intellectual property with Cytrellis. He also holds stock options with Cytrellis, Invasix, and Zalea.

 

– Most people rely on physicians, family, and friends to obtain relevant information about cosmetic procedures, but a knowledge gap exists regarding which cosmetic providers are medical doctors.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Those are two key findings from a national survey that set out to assess how consumers research, educate themselves, and choose cosmetic procedures and providers. At the annual conference of the American Society for Laser Medicine and Surgery, study author Adam J. Wulkan, MD, discussed results from the 20-item survey, which was based on responses from 323 people who have obtained or have considered obtaining a cosmetic procedure such as laser hair removal.

Dr. Wulkan is a dermatologist at Massachusetts General Hospital, Boston. He reported having no financial disclosures. Study coauthor Mathew Avram, MD, serves on the medical advisory board of Sciton and on the scientific advisory boards of Sienna Biopharmaceuticals, Cytrellis, and Allergan. He also is consultant for Merz Aesthetics, Allergan, Soliton, Invasix, and Revance, and has intellectual property with Cytrellis. He also holds stock options with Cytrellis, Invasix, and Zalea.

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VIDEO: Meeting stroke screening demand will require systems’ reorganization

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Tue, 01/05/2021 - 14:11

– A reorganization of stroke systems of care is needed to meet the rising demand for screening, triaging, and treating acute ischemic stroke patients who may benefit from mechanical thrombectomy, according to Lawrence Wechsler, MD.

In a video interview at the annual meeting of the American Academy of Neurology, Dr. Wechsler described steps being taken at the University of Pittsburgh Medical Center’s comprehensive stroke center to handle the additional workload.

UPMC conducts telemedicine acute stroke evaluations of patients at community hospitals’ primary stroke centers in the greater Pittsburgh area to make sure that only the cases that require mechanical thrombectomy are transferred to them for specialized care, while also continuing to see nontransferred patients via telemedicine for follow-up, said Dr. Wechsler, chair of the department of neurology at UPMC and founder of its Stroke Institute and telestroke network.

This sort of solution may be more feasible and practical for comprehensive stroke centers to implement in order to manage the number of cases, instead of expanding neurology residencies, capping stroke services, adding a nonteaching service, adding advanced practice providers, or increasing the case loads of vascular neurology fellows and attending neurologists, he said.

 

 


In just the short time since the DAWN trial results were released in November 2017 and set the new standard for treating eligible patients with large-vessel occlusions with mechanical thrombectomy within 6-24 hours, stroke admissions and transfers to the comprehensive stroke center at UPMC from November 2017 to February 2018 rose 18% from the same time period a year before, including a 5% rise in telemedicine transfers, Dr. Wechsler said in a presentation at the meeting. These additional cases led to a 35% increase in thrombectomy cases.

Putting the matter into additional perspective, in the time period from November 2014 to February 2017, 30% of all 2,667 acute ischemic stroke patients seen at UPMC would have met DAWN trial inclusion criteria with a 6- to 24-hour window, but less than 3% of all the strokes seen at UPMC would have qualified for thrombectomy under criteria from the DAWN and DEFUSE-3 trials. That makes it imperative for comprehensive stroke centers to triage cases and receive only those that require endovascular treatment, he said.

Meeting the already-rising needs for triaging acute ischemic stroke patients arriving in the window of 6-24 hours will be difficult, considering that there are about 800,000 new strokes per year in the United States but only 1,100 vascular neurologists, nearly 1,100 primary stroke centers, and only 110 comprehensive stroke centers at which endovascular thrombectomy treatment may be offered. As of 2016, he noted that there also were only 74 U.S. stroke fellowship programs with 123 positions offered, of which 34% went unfilled.
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– A reorganization of stroke systems of care is needed to meet the rising demand for screening, triaging, and treating acute ischemic stroke patients who may benefit from mechanical thrombectomy, according to Lawrence Wechsler, MD.

In a video interview at the annual meeting of the American Academy of Neurology, Dr. Wechsler described steps being taken at the University of Pittsburgh Medical Center’s comprehensive stroke center to handle the additional workload.

UPMC conducts telemedicine acute stroke evaluations of patients at community hospitals’ primary stroke centers in the greater Pittsburgh area to make sure that only the cases that require mechanical thrombectomy are transferred to them for specialized care, while also continuing to see nontransferred patients via telemedicine for follow-up, said Dr. Wechsler, chair of the department of neurology at UPMC and founder of its Stroke Institute and telestroke network.

This sort of solution may be more feasible and practical for comprehensive stroke centers to implement in order to manage the number of cases, instead of expanding neurology residencies, capping stroke services, adding a nonteaching service, adding advanced practice providers, or increasing the case loads of vascular neurology fellows and attending neurologists, he said.

 

 


In just the short time since the DAWN trial results were released in November 2017 and set the new standard for treating eligible patients with large-vessel occlusions with mechanical thrombectomy within 6-24 hours, stroke admissions and transfers to the comprehensive stroke center at UPMC from November 2017 to February 2018 rose 18% from the same time period a year before, including a 5% rise in telemedicine transfers, Dr. Wechsler said in a presentation at the meeting. These additional cases led to a 35% increase in thrombectomy cases.

Putting the matter into additional perspective, in the time period from November 2014 to February 2017, 30% of all 2,667 acute ischemic stroke patients seen at UPMC would have met DAWN trial inclusion criteria with a 6- to 24-hour window, but less than 3% of all the strokes seen at UPMC would have qualified for thrombectomy under criteria from the DAWN and DEFUSE-3 trials. That makes it imperative for comprehensive stroke centers to triage cases and receive only those that require endovascular treatment, he said.

Meeting the already-rising needs for triaging acute ischemic stroke patients arriving in the window of 6-24 hours will be difficult, considering that there are about 800,000 new strokes per year in the United States but only 1,100 vascular neurologists, nearly 1,100 primary stroke centers, and only 110 comprehensive stroke centers at which endovascular thrombectomy treatment may be offered. As of 2016, he noted that there also were only 74 U.S. stroke fellowship programs with 123 positions offered, of which 34% went unfilled.

– A reorganization of stroke systems of care is needed to meet the rising demand for screening, triaging, and treating acute ischemic stroke patients who may benefit from mechanical thrombectomy, according to Lawrence Wechsler, MD.

In a video interview at the annual meeting of the American Academy of Neurology, Dr. Wechsler described steps being taken at the University of Pittsburgh Medical Center’s comprehensive stroke center to handle the additional workload.

UPMC conducts telemedicine acute stroke evaluations of patients at community hospitals’ primary stroke centers in the greater Pittsburgh area to make sure that only the cases that require mechanical thrombectomy are transferred to them for specialized care, while also continuing to see nontransferred patients via telemedicine for follow-up, said Dr. Wechsler, chair of the department of neurology at UPMC and founder of its Stroke Institute and telestroke network.

This sort of solution may be more feasible and practical for comprehensive stroke centers to implement in order to manage the number of cases, instead of expanding neurology residencies, capping stroke services, adding a nonteaching service, adding advanced practice providers, or increasing the case loads of vascular neurology fellows and attending neurologists, he said.

 

 


In just the short time since the DAWN trial results were released in November 2017 and set the new standard for treating eligible patients with large-vessel occlusions with mechanical thrombectomy within 6-24 hours, stroke admissions and transfers to the comprehensive stroke center at UPMC from November 2017 to February 2018 rose 18% from the same time period a year before, including a 5% rise in telemedicine transfers, Dr. Wechsler said in a presentation at the meeting. These additional cases led to a 35% increase in thrombectomy cases.

Putting the matter into additional perspective, in the time period from November 2014 to February 2017, 30% of all 2,667 acute ischemic stroke patients seen at UPMC would have met DAWN trial inclusion criteria with a 6- to 24-hour window, but less than 3% of all the strokes seen at UPMC would have qualified for thrombectomy under criteria from the DAWN and DEFUSE-3 trials. That makes it imperative for comprehensive stroke centers to triage cases and receive only those that require endovascular treatment, he said.

Meeting the already-rising needs for triaging acute ischemic stroke patients arriving in the window of 6-24 hours will be difficult, considering that there are about 800,000 new strokes per year in the United States but only 1,100 vascular neurologists, nearly 1,100 primary stroke centers, and only 110 comprehensive stroke centers at which endovascular thrombectomy treatment may be offered. As of 2016, he noted that there also were only 74 U.S. stroke fellowship programs with 123 positions offered, of which 34% went unfilled.
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VIDEO: Eptinezumab shows efficacy in episodic and chronic migraine trials

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– New results from phase 3 randomized trials of the prophylactic migraine treatment eptinezumab show significant reductions in the number of monthly migraine headache days experienced by patients with chronic or frequent episodic migraines.

Eptinezumab, an experimental monoclonal antibody delivered by intravenous infusion, is one of several antimigraine agents in development that targets calcitonin gene-related peptide (CGRP), a key mediator of migraine.

At the annual meeting of the American Academy of Neurology, Richard Lipton, MD, of Albert Einstein College of Medicine in New York, presented results from PROMISE 2, a phase 3 randomized, placebo-controlled trial of eptinezumab in patients with chronic migraine, or 15 or more days with migraine per month.

The investigators randomized 1,072 patients to quarterly IV infusions of eptinezumab 100 or 300 mg or placebo.

The vast majority of patients in the study were women, (86%-90% across groups) with a mean age of about 40 years. Patients reported 11-12 years of chronic migraine and about 16 migraine days per month at baseline, Dr. Lipton told the conference, reflecting a high level of disability in the cohort.

The primary endpoint of the study was mean change in monthly migraine days from baseline through week 12. Dr. Lipton reported that the placebo group saw a 5.6-day reduction in migraine, while the 100-mg group saw a 7.7-day reduction, and patients receiving the 300-mg dose saw an 8.2-day reduction during the first 12 weeks after injection (P less than .0001 for both).

One-third of patients receiving the highest dose saw a 75% or greater reduction in monthly migraine days by week 12, “a relatively high bar” to meet, Dr. Lipton said. Some 61% of patients on the high dose saw a reduction of 50% or more in the same time period.

 

 


A unique secondary endpoint of the study was the proportion of patients who experienced migraine on day 1 after the initial dose. The treatment groups saw a 52% reduction 1 day after receiving the study drug, while the placebo group saw a 27% reduction in the expected prevalence of migraine in the cohort for any single day, and the decrease was sustained through day 28. The results suggest a rapid onset of action for eptinezumab, followed by a sustained benefit, Dr. Lipton said.

Also at AAN, Stephen D. Silberstein, MD, of Thomas Jefferson University in Philadelphia, presented new 12-month results from the PROMISE 1 trial, a randomized clinical trial to evaluate quarterly IV infusions of eptinezumab 30 mg, 100 mg, 300 mg, or placebo, in 888 patients with episodic migraines, defined as 14 or fewer days per month with migraine.

The researchers, who last year published 6-month results showing significant reductions in monthly migraine days associated with eptinezumab treatment over placebo, described further reductions from patients’ baseline frequency of migraines with longer duration of treatment.

After their third and fourth quarterly injections, 70.7% of eptinezumab-treated patients achieved a 50% reduction of monthly migraine days from baseline, compared with 58.7% for placebo, the investigators reported. These findings represent an 8.9% improvement over the reductions experienced during the first two quarterly doses of eptinezumab in this cohort.

More than half of patients in the treatment arms achieved on average a 75% reduction or greater of monthly migraine days from baseline, compared with 38.7% for placebo, a 12.8% improvement from the reductions experienced with the first two doses of eptinezumab.

Adverse effects seen in the trials were upper respiratory infection, nasopharyngitis, sinusitis, and nausea.

Both trials were sponsored by eptinezumab’s manufacturer, Alder. Dr. Lipton, Dr. Silberstein, and several of their coauthors disclosed support from Alder and other manufacturers, while some coauthors on the studies are employees of Alder.

SOURCE: Saper J et al. AAN 2018, Abstract S20.001 and Lipton R et al. AAN 2018, Clinical Trials Plenary Session Abstract.

 

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– New results from phase 3 randomized trials of the prophylactic migraine treatment eptinezumab show significant reductions in the number of monthly migraine headache days experienced by patients with chronic or frequent episodic migraines.

Eptinezumab, an experimental monoclonal antibody delivered by intravenous infusion, is one of several antimigraine agents in development that targets calcitonin gene-related peptide (CGRP), a key mediator of migraine.

At the annual meeting of the American Academy of Neurology, Richard Lipton, MD, of Albert Einstein College of Medicine in New York, presented results from PROMISE 2, a phase 3 randomized, placebo-controlled trial of eptinezumab in patients with chronic migraine, or 15 or more days with migraine per month.

The investigators randomized 1,072 patients to quarterly IV infusions of eptinezumab 100 or 300 mg or placebo.

The vast majority of patients in the study were women, (86%-90% across groups) with a mean age of about 40 years. Patients reported 11-12 years of chronic migraine and about 16 migraine days per month at baseline, Dr. Lipton told the conference, reflecting a high level of disability in the cohort.

The primary endpoint of the study was mean change in monthly migraine days from baseline through week 12. Dr. Lipton reported that the placebo group saw a 5.6-day reduction in migraine, while the 100-mg group saw a 7.7-day reduction, and patients receiving the 300-mg dose saw an 8.2-day reduction during the first 12 weeks after injection (P less than .0001 for both).

One-third of patients receiving the highest dose saw a 75% or greater reduction in monthly migraine days by week 12, “a relatively high bar” to meet, Dr. Lipton said. Some 61% of patients on the high dose saw a reduction of 50% or more in the same time period.

 

 


A unique secondary endpoint of the study was the proportion of patients who experienced migraine on day 1 after the initial dose. The treatment groups saw a 52% reduction 1 day after receiving the study drug, while the placebo group saw a 27% reduction in the expected prevalence of migraine in the cohort for any single day, and the decrease was sustained through day 28. The results suggest a rapid onset of action for eptinezumab, followed by a sustained benefit, Dr. Lipton said.

Also at AAN, Stephen D. Silberstein, MD, of Thomas Jefferson University in Philadelphia, presented new 12-month results from the PROMISE 1 trial, a randomized clinical trial to evaluate quarterly IV infusions of eptinezumab 30 mg, 100 mg, 300 mg, or placebo, in 888 patients with episodic migraines, defined as 14 or fewer days per month with migraine.

The researchers, who last year published 6-month results showing significant reductions in monthly migraine days associated with eptinezumab treatment over placebo, described further reductions from patients’ baseline frequency of migraines with longer duration of treatment.

After their third and fourth quarterly injections, 70.7% of eptinezumab-treated patients achieved a 50% reduction of monthly migraine days from baseline, compared with 58.7% for placebo, the investigators reported. These findings represent an 8.9% improvement over the reductions experienced during the first two quarterly doses of eptinezumab in this cohort.

More than half of patients in the treatment arms achieved on average a 75% reduction or greater of monthly migraine days from baseline, compared with 38.7% for placebo, a 12.8% improvement from the reductions experienced with the first two doses of eptinezumab.

Adverse effects seen in the trials were upper respiratory infection, nasopharyngitis, sinusitis, and nausea.

Both trials were sponsored by eptinezumab’s manufacturer, Alder. Dr. Lipton, Dr. Silberstein, and several of their coauthors disclosed support from Alder and other manufacturers, while some coauthors on the studies are employees of Alder.

SOURCE: Saper J et al. AAN 2018, Abstract S20.001 and Lipton R et al. AAN 2018, Clinical Trials Plenary Session Abstract.

 

– New results from phase 3 randomized trials of the prophylactic migraine treatment eptinezumab show significant reductions in the number of monthly migraine headache days experienced by patients with chronic or frequent episodic migraines.

Eptinezumab, an experimental monoclonal antibody delivered by intravenous infusion, is one of several antimigraine agents in development that targets calcitonin gene-related peptide (CGRP), a key mediator of migraine.

At the annual meeting of the American Academy of Neurology, Richard Lipton, MD, of Albert Einstein College of Medicine in New York, presented results from PROMISE 2, a phase 3 randomized, placebo-controlled trial of eptinezumab in patients with chronic migraine, or 15 or more days with migraine per month.

The investigators randomized 1,072 patients to quarterly IV infusions of eptinezumab 100 or 300 mg or placebo.

The vast majority of patients in the study were women, (86%-90% across groups) with a mean age of about 40 years. Patients reported 11-12 years of chronic migraine and about 16 migraine days per month at baseline, Dr. Lipton told the conference, reflecting a high level of disability in the cohort.

The primary endpoint of the study was mean change in monthly migraine days from baseline through week 12. Dr. Lipton reported that the placebo group saw a 5.6-day reduction in migraine, while the 100-mg group saw a 7.7-day reduction, and patients receiving the 300-mg dose saw an 8.2-day reduction during the first 12 weeks after injection (P less than .0001 for both).

One-third of patients receiving the highest dose saw a 75% or greater reduction in monthly migraine days by week 12, “a relatively high bar” to meet, Dr. Lipton said. Some 61% of patients on the high dose saw a reduction of 50% or more in the same time period.

 

 


A unique secondary endpoint of the study was the proportion of patients who experienced migraine on day 1 after the initial dose. The treatment groups saw a 52% reduction 1 day after receiving the study drug, while the placebo group saw a 27% reduction in the expected prevalence of migraine in the cohort for any single day, and the decrease was sustained through day 28. The results suggest a rapid onset of action for eptinezumab, followed by a sustained benefit, Dr. Lipton said.

Also at AAN, Stephen D. Silberstein, MD, of Thomas Jefferson University in Philadelphia, presented new 12-month results from the PROMISE 1 trial, a randomized clinical trial to evaluate quarterly IV infusions of eptinezumab 30 mg, 100 mg, 300 mg, or placebo, in 888 patients with episodic migraines, defined as 14 or fewer days per month with migraine.

The researchers, who last year published 6-month results showing significant reductions in monthly migraine days associated with eptinezumab treatment over placebo, described further reductions from patients’ baseline frequency of migraines with longer duration of treatment.

After their third and fourth quarterly injections, 70.7% of eptinezumab-treated patients achieved a 50% reduction of monthly migraine days from baseline, compared with 58.7% for placebo, the investigators reported. These findings represent an 8.9% improvement over the reductions experienced during the first two quarterly doses of eptinezumab in this cohort.

More than half of patients in the treatment arms achieved on average a 75% reduction or greater of monthly migraine days from baseline, compared with 38.7% for placebo, a 12.8% improvement from the reductions experienced with the first two doses of eptinezumab.

Adverse effects seen in the trials were upper respiratory infection, nasopharyngitis, sinusitis, and nausea.

Both trials were sponsored by eptinezumab’s manufacturer, Alder. Dr. Lipton, Dr. Silberstein, and several of their coauthors disclosed support from Alder and other manufacturers, while some coauthors on the studies are employees of Alder.

SOURCE: Saper J et al. AAN 2018, Abstract S20.001 and Lipton R et al. AAN 2018, Clinical Trials Plenary Session Abstract.

 

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