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‘No one’s talking about it’: Infertility and one specialty’s onerous board exams
It would be impossible for her to fly the 2,500 miles from New York to the test site in Tucson, Ariz., when she could go into labor at any moment. She asked the American Board of Radiology – which oversees the process – if she could take the oral exam on Zoom or shift the timing a few weeks earlier or later.
The response: If she decided not to sit for the exam in person on the date specified, she would have to wait an entire year for the next test.
“I felt: Angry. Sad. Helpless. Inconsequential,” Dr. Dover tweeted. “But I will not be silent.”
The experience motivated Dr. Dover and six colleagues to conduct a study about how radiation oncology’s onerous four-exam board certification process has disproportionately burdened women.
The study, published online in Practical Radiation Oncology on Nov. 3, 2021, revealed that almost 60% of the early-career female radiation oncologists surveyed had delayed or were timing their pregnancies to accommodate their board exams. Women who chose to delay pregnancy were 2.5 times more likely to experience infertility.
“When we started doing the study, we didn’t realize just how common it was for people to wrap so much of their [family planning decisions] around taking these board exams,” said study coauthor Adrianna Henson Masters, MD, a radiation oncologist at Springfield (Ill.) Clinic. “How crazy is that? And no one’s talking about it.”
However, once the study appeared online, physicians took to Twitter to comment on the challenges of the board certification process, while others demanded change. One radiation oncologist even shared her decision not to have a child until she passed her board exams.
The study also got the attention of the American Board of Radiology, which governs certification for the specialty. In a response, leaders of the organization agreed that “the issues raised are significant and worthy of thoughtful consideration” and highlighted how, in light of the COVID-19 pandemic, the board has provided greater flexibility to the exam process – transitioning to remote testing and offering two dates for each exam in 2021.
But will the changes last? And will they help reduce the burden these exams place on families and family planning?
Inside board certification before the pandemic
While other specialties require one or two exams for board certification, radiation oncology is the only medical field that requires candidates pass four exams – three qualifying written tests, followed by a certifying oral exam. Since 2004, these exams, which cover physics, radiation biology, and clinical radiation oncology, have taken place over 3 years at specific locations across the country.
Radiation oncology residents have reported spending hundreds of hours preparing for each of these high-stakes evaluations. Fail or miss one and an already time-consuming process draws out, with major repercussions for career advancement and earnings.
“Passing and achieving board certification is the capstone of medical specialty training and, for many, is a prerequisite for attaining partnership or a promotion,” said study coauthor Chelain Goodman, MD, PhD, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.
To top it off, this process may be contributing to the gender disparity in radiation oncology, the study suggests. Only 25%-30% of practicing radiation oncologists are women, making it one of the lowest-ranking specialties when it comes to female representation.
“I think [this exam process] creates some disincentive when female medical students see that these are issues that early-career radiation oncologists are facing,” said Dr. Dover, who practices at Memorial Sloan Kettering Cancer Center, New York. “[Students may instead] choose a specialty that they believe will be more supportive of them and their family planning goals. That’s definitely a big concern for a field that wants to attract the top candidates.”
For those who do pick radiation oncology, the system of board exams often requires prospective parents to choose among three options: Try to time delivery before or between exams, put off pregnancy or adoption until exams are done, or delay board certification.
A balancing act: Board exams and family planning
Like Dr. Dover, Dr. Masters opted for door No. 1. She tried to time the birth of her daughter to fall several months before her first board exam.
She hoped her careful planning would reduce the stress of both major life events. But that was not the case. At 35 weeks, Dr. Masters found herself in the hospital with preeclampsia and symptomatic hypertension.
While receiving a magnesium sulfate drip to prevent a seizure, she frantically typed her patient list before her vision got too blurry to see the screen.
“That is ridiculous,” Dr. Masters said. “But so is a system that makes this the expectation [for pregnant physicians].”
During her hospital stay, Dr. Masters was induced. She suspects the stress of prepping for the board exam coupled with being pregnant and continuing to work long hours as a resident contributed to her pregnancy complications.
This juggling act can bleed into exam day as well. When interviewing women for their study, Dr. Masters and colleagues uncovered personal accounts of the challenges pregnant women and new mothers faced during their exams.
One woman described being granted lactation accommodation ahead of time, but when she arrived for her first two written exams, the testing center had no record of her request. She ended up breast-pumping in a coat closet next to the cleaning supplies while her male coresidents ate lunch and reviewed their notes.
“I started my physics exam in tears, completely anxious,” she reported. “I didn’t get to eat lunch. I was physically uncomfortable and emotionally wiped during both exams.”
Another woman had contractions during her written clinical boards, but “thankfully” passed her exam and gave birth 2 days later.
“It might sound crazy that we would put ourselves through things like that just to take an exam,” Dr. Dover said. “But because it does have the potential to sharply shape our early professional trajectory, we push through it. Otherwise, we’re going to be left behind by our male peers.”
This pressure to push through can be intense.
Still recovering from a difficult pregnancy, Dr. Masters returned to work when her daughter was just 5 weeks old. Although not ready to return to work, she felt too scared to ask for more time off after seeing other new mothers receive negative comments about not working hard enough.
Enter door No. 2: The pregnancy and postpregnancy experiences were so traumatizing that she decided to put off trying for a second child until after her exams.
Now board certified and 38 years old, Dr. Masters is worried she won’t be able to conceive as easily as before.
“So, we’re stuck in limbo, starting the process again and being nervous about it because what if it’s not so easy at this age?” she said. “And what if it could have been easy, in different circumstances, with a different specialty?”
Dr. Masters’ concerns are justified. Of the 126 women interviewed for the study, those who delayed pregnancy because of the board exams were significantly more likely to have fertility problems (46% vs. 18%), and 20% reported experiencing infertility.
This finding dovetails with previous research showing that almost 25% of female physicians who attempt to become pregnant are diagnosed with infertility – nearly twice the rate of the general population. This high rate of infertility has been attributed to professional pressures and stress, long hours on the job, and delaying pregnancy during medical training.
But choosing door No. 3 – focusing on family over exams – has downsides as well. Board certification is a prerequisite for almost every partnership position or promotion track within academic medicine and delaying certification can significantly hinder a physician’s career and finances.
Radiation oncologists who aren’t certified often remain in salaried positions until they can make partnership and earn a portion of the practice’s profits, “which could easily change your annual compensation by six digits,” Dr. Dover said.
According to the team’s study, annual compensation typically increases by $30,000-$50,000 after board certification, with some reporting an increase of over $100,000. That salary hike also impacts physicians’ ability to pay off medical school loans, make financial investments, and afford the cost of childcare.
In other words, when it comes to family planning, there’s often no good option.
Change on the horizon
When the pandemic struck, the American Board of Radiology quickly went into triage mode, postponing in-person board certification exams scheduled in 2020 and brainstorming solutions.
By June, the organization announced that the exams would switch to a virtual format in 2021. Each test would be offered twice – once early in the year for candidates like Dover whose postponed 2020 exams had ultimately been canceled, and then again for those already planning to take their tests in 2021.
The shift to remote testing was a boon. Taking the tests from home not only allowed candidates to forgo the cost, stress, and time of travel, it also mitigated the burden of juggling pregnancy and parenting needs.
For example, Courtney Hentz, MD, a pediatric radiation oncologist at Loyola University Chicago, Maywood, Ill., and a study coauthor, was given the choice to take a virtual exam in one day with two breastfeeding breaks or to spread the exam over 2 days with one breastfeeding break each day.
“Transitioning exams to a virtual format has been a really big achievement that the American Board of Radiology should be applauded for,” Dr. Dover said.
Not only that, offering the exams multiple times a year has “significantly increased flexibility for candidates as they juggle completing residency, starting at their first practice, and balancing time with their family,” Dr. Goodman added.
Brent Wagner, MD, MBA, executive director of the American Board of Radiology, Tucson, Ariz., said in an interviewthat remote exams are here to stay. “I don’t foresee us ever going back to in-person board exams,” said Dr. Wagner, a diagnostic radiologist. “Administering exams remotely last year worked better than I could have expected.”
Dr. Wagner said the American Board of Radiology also plans to keep two dates for the oral certifying exam for the foreseeable future, though will revert to one date for the written qualifying exams.
“In a perfect world, we’d offer an exam every quarter,” he said. However, providing multiple dates for the written exams “is not practical with a cohort of a few hundred people,” given the staff resources needed to create and score twice the number of items each year. The board did not rule out reassessing this decision in the future, “as examination development software improves and more resources become available.”
Another big change, proposed by Dr. Dover, Dr. Goodman, and others, would be to combine the four exams into fewer tests, such as consolidating the three written exams into one. Such a shift would allow physicians to launch their careers sooner and begin focusing on other career-advancing endeavors such as research and publishing. It would also significantly improve radiation oncologists’ quality of life.
“The amount of time that you spend studying for these very high-level, high-stakes exams really puts a toll on your mental health,” Dr. Dover said. “The longer it’s dragged out, the longer you’re dealing with that, and it contributes tremendously to poor job satisfaction and work-life balance.”
The American Board of Radiology said it is discussing options for consolidating the exams, but the challenge with combining the three written exams into one comes down to scoring. “We need to get a statistically valid result in all three categories,” Dr. Wagner said.
Another recent change: The American Board of Radiology is now allowing residents flexibility on the sequence of the written exams.
“In the past, we said you had to pass the physics exam before moving on to clinical radiology, but now we’re letting residents decide the order for themselves,” Dr. Wagner said. “This change may introduce more flexibility for someone who missed their first opportunity to take the physics exam but is ready to take the clinical exam.”
Dr. Wagner added: “We’re learning as we go, and I tell our staff that there’s no reason we should think we’re done making improvements. It’s going to keep getting better.”
The recent changes have already made a difference to radiation oncologists. And many hope to build on this new foundation to move the specialty toward a more family-friendly, equitable culture.
“I think as people in a caregiver profession, it’s hard to prioritize doing things for yourself or your own family sometimes; it’s hard to speak up and say: ‘We need something different,’ ” Dr. Masters said. “I think we have [an opportunity] to capitalize on the momentum we have now.”
A version of this article first appeared on Medscape.com.
It would be impossible for her to fly the 2,500 miles from New York to the test site in Tucson, Ariz., when she could go into labor at any moment. She asked the American Board of Radiology – which oversees the process – if she could take the oral exam on Zoom or shift the timing a few weeks earlier or later.
The response: If she decided not to sit for the exam in person on the date specified, she would have to wait an entire year for the next test.
“I felt: Angry. Sad. Helpless. Inconsequential,” Dr. Dover tweeted. “But I will not be silent.”
The experience motivated Dr. Dover and six colleagues to conduct a study about how radiation oncology’s onerous four-exam board certification process has disproportionately burdened women.
The study, published online in Practical Radiation Oncology on Nov. 3, 2021, revealed that almost 60% of the early-career female radiation oncologists surveyed had delayed or were timing their pregnancies to accommodate their board exams. Women who chose to delay pregnancy were 2.5 times more likely to experience infertility.
“When we started doing the study, we didn’t realize just how common it was for people to wrap so much of their [family planning decisions] around taking these board exams,” said study coauthor Adrianna Henson Masters, MD, a radiation oncologist at Springfield (Ill.) Clinic. “How crazy is that? And no one’s talking about it.”
However, once the study appeared online, physicians took to Twitter to comment on the challenges of the board certification process, while others demanded change. One radiation oncologist even shared her decision not to have a child until she passed her board exams.
The study also got the attention of the American Board of Radiology, which governs certification for the specialty. In a response, leaders of the organization agreed that “the issues raised are significant and worthy of thoughtful consideration” and highlighted how, in light of the COVID-19 pandemic, the board has provided greater flexibility to the exam process – transitioning to remote testing and offering two dates for each exam in 2021.
But will the changes last? And will they help reduce the burden these exams place on families and family planning?
Inside board certification before the pandemic
While other specialties require one or two exams for board certification, radiation oncology is the only medical field that requires candidates pass four exams – three qualifying written tests, followed by a certifying oral exam. Since 2004, these exams, which cover physics, radiation biology, and clinical radiation oncology, have taken place over 3 years at specific locations across the country.
Radiation oncology residents have reported spending hundreds of hours preparing for each of these high-stakes evaluations. Fail or miss one and an already time-consuming process draws out, with major repercussions for career advancement and earnings.
“Passing and achieving board certification is the capstone of medical specialty training and, for many, is a prerequisite for attaining partnership or a promotion,” said study coauthor Chelain Goodman, MD, PhD, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.
To top it off, this process may be contributing to the gender disparity in radiation oncology, the study suggests. Only 25%-30% of practicing radiation oncologists are women, making it one of the lowest-ranking specialties when it comes to female representation.
“I think [this exam process] creates some disincentive when female medical students see that these are issues that early-career radiation oncologists are facing,” said Dr. Dover, who practices at Memorial Sloan Kettering Cancer Center, New York. “[Students may instead] choose a specialty that they believe will be more supportive of them and their family planning goals. That’s definitely a big concern for a field that wants to attract the top candidates.”
For those who do pick radiation oncology, the system of board exams often requires prospective parents to choose among three options: Try to time delivery before or between exams, put off pregnancy or adoption until exams are done, or delay board certification.
A balancing act: Board exams and family planning
Like Dr. Dover, Dr. Masters opted for door No. 1. She tried to time the birth of her daughter to fall several months before her first board exam.
She hoped her careful planning would reduce the stress of both major life events. But that was not the case. At 35 weeks, Dr. Masters found herself in the hospital with preeclampsia and symptomatic hypertension.
While receiving a magnesium sulfate drip to prevent a seizure, she frantically typed her patient list before her vision got too blurry to see the screen.
“That is ridiculous,” Dr. Masters said. “But so is a system that makes this the expectation [for pregnant physicians].”
During her hospital stay, Dr. Masters was induced. She suspects the stress of prepping for the board exam coupled with being pregnant and continuing to work long hours as a resident contributed to her pregnancy complications.
This juggling act can bleed into exam day as well. When interviewing women for their study, Dr. Masters and colleagues uncovered personal accounts of the challenges pregnant women and new mothers faced during their exams.
One woman described being granted lactation accommodation ahead of time, but when she arrived for her first two written exams, the testing center had no record of her request. She ended up breast-pumping in a coat closet next to the cleaning supplies while her male coresidents ate lunch and reviewed their notes.
“I started my physics exam in tears, completely anxious,” she reported. “I didn’t get to eat lunch. I was physically uncomfortable and emotionally wiped during both exams.”
Another woman had contractions during her written clinical boards, but “thankfully” passed her exam and gave birth 2 days later.
“It might sound crazy that we would put ourselves through things like that just to take an exam,” Dr. Dover said. “But because it does have the potential to sharply shape our early professional trajectory, we push through it. Otherwise, we’re going to be left behind by our male peers.”
This pressure to push through can be intense.
Still recovering from a difficult pregnancy, Dr. Masters returned to work when her daughter was just 5 weeks old. Although not ready to return to work, she felt too scared to ask for more time off after seeing other new mothers receive negative comments about not working hard enough.
Enter door No. 2: The pregnancy and postpregnancy experiences were so traumatizing that she decided to put off trying for a second child until after her exams.
Now board certified and 38 years old, Dr. Masters is worried she won’t be able to conceive as easily as before.
“So, we’re stuck in limbo, starting the process again and being nervous about it because what if it’s not so easy at this age?” she said. “And what if it could have been easy, in different circumstances, with a different specialty?”
Dr. Masters’ concerns are justified. Of the 126 women interviewed for the study, those who delayed pregnancy because of the board exams were significantly more likely to have fertility problems (46% vs. 18%), and 20% reported experiencing infertility.
This finding dovetails with previous research showing that almost 25% of female physicians who attempt to become pregnant are diagnosed with infertility – nearly twice the rate of the general population. This high rate of infertility has been attributed to professional pressures and stress, long hours on the job, and delaying pregnancy during medical training.
But choosing door No. 3 – focusing on family over exams – has downsides as well. Board certification is a prerequisite for almost every partnership position or promotion track within academic medicine and delaying certification can significantly hinder a physician’s career and finances.
Radiation oncologists who aren’t certified often remain in salaried positions until they can make partnership and earn a portion of the practice’s profits, “which could easily change your annual compensation by six digits,” Dr. Dover said.
According to the team’s study, annual compensation typically increases by $30,000-$50,000 after board certification, with some reporting an increase of over $100,000. That salary hike also impacts physicians’ ability to pay off medical school loans, make financial investments, and afford the cost of childcare.
In other words, when it comes to family planning, there’s often no good option.
Change on the horizon
When the pandemic struck, the American Board of Radiology quickly went into triage mode, postponing in-person board certification exams scheduled in 2020 and brainstorming solutions.
By June, the organization announced that the exams would switch to a virtual format in 2021. Each test would be offered twice – once early in the year for candidates like Dover whose postponed 2020 exams had ultimately been canceled, and then again for those already planning to take their tests in 2021.
The shift to remote testing was a boon. Taking the tests from home not only allowed candidates to forgo the cost, stress, and time of travel, it also mitigated the burden of juggling pregnancy and parenting needs.
For example, Courtney Hentz, MD, a pediatric radiation oncologist at Loyola University Chicago, Maywood, Ill., and a study coauthor, was given the choice to take a virtual exam in one day with two breastfeeding breaks or to spread the exam over 2 days with one breastfeeding break each day.
“Transitioning exams to a virtual format has been a really big achievement that the American Board of Radiology should be applauded for,” Dr. Dover said.
Not only that, offering the exams multiple times a year has “significantly increased flexibility for candidates as they juggle completing residency, starting at their first practice, and balancing time with their family,” Dr. Goodman added.
Brent Wagner, MD, MBA, executive director of the American Board of Radiology, Tucson, Ariz., said in an interviewthat remote exams are here to stay. “I don’t foresee us ever going back to in-person board exams,” said Dr. Wagner, a diagnostic radiologist. “Administering exams remotely last year worked better than I could have expected.”
Dr. Wagner said the American Board of Radiology also plans to keep two dates for the oral certifying exam for the foreseeable future, though will revert to one date for the written qualifying exams.
“In a perfect world, we’d offer an exam every quarter,” he said. However, providing multiple dates for the written exams “is not practical with a cohort of a few hundred people,” given the staff resources needed to create and score twice the number of items each year. The board did not rule out reassessing this decision in the future, “as examination development software improves and more resources become available.”
Another big change, proposed by Dr. Dover, Dr. Goodman, and others, would be to combine the four exams into fewer tests, such as consolidating the three written exams into one. Such a shift would allow physicians to launch their careers sooner and begin focusing on other career-advancing endeavors such as research and publishing. It would also significantly improve radiation oncologists’ quality of life.
“The amount of time that you spend studying for these very high-level, high-stakes exams really puts a toll on your mental health,” Dr. Dover said. “The longer it’s dragged out, the longer you’re dealing with that, and it contributes tremendously to poor job satisfaction and work-life balance.”
The American Board of Radiology said it is discussing options for consolidating the exams, but the challenge with combining the three written exams into one comes down to scoring. “We need to get a statistically valid result in all three categories,” Dr. Wagner said.
Another recent change: The American Board of Radiology is now allowing residents flexibility on the sequence of the written exams.
“In the past, we said you had to pass the physics exam before moving on to clinical radiology, but now we’re letting residents decide the order for themselves,” Dr. Wagner said. “This change may introduce more flexibility for someone who missed their first opportunity to take the physics exam but is ready to take the clinical exam.”
Dr. Wagner added: “We’re learning as we go, and I tell our staff that there’s no reason we should think we’re done making improvements. It’s going to keep getting better.”
The recent changes have already made a difference to radiation oncologists. And many hope to build on this new foundation to move the specialty toward a more family-friendly, equitable culture.
“I think as people in a caregiver profession, it’s hard to prioritize doing things for yourself or your own family sometimes; it’s hard to speak up and say: ‘We need something different,’ ” Dr. Masters said. “I think we have [an opportunity] to capitalize on the momentum we have now.”
A version of this article first appeared on Medscape.com.
It would be impossible for her to fly the 2,500 miles from New York to the test site in Tucson, Ariz., when she could go into labor at any moment. She asked the American Board of Radiology – which oversees the process – if she could take the oral exam on Zoom or shift the timing a few weeks earlier or later.
The response: If she decided not to sit for the exam in person on the date specified, she would have to wait an entire year for the next test.
“I felt: Angry. Sad. Helpless. Inconsequential,” Dr. Dover tweeted. “But I will not be silent.”
The experience motivated Dr. Dover and six colleagues to conduct a study about how radiation oncology’s onerous four-exam board certification process has disproportionately burdened women.
The study, published online in Practical Radiation Oncology on Nov. 3, 2021, revealed that almost 60% of the early-career female radiation oncologists surveyed had delayed or were timing their pregnancies to accommodate their board exams. Women who chose to delay pregnancy were 2.5 times more likely to experience infertility.
“When we started doing the study, we didn’t realize just how common it was for people to wrap so much of their [family planning decisions] around taking these board exams,” said study coauthor Adrianna Henson Masters, MD, a radiation oncologist at Springfield (Ill.) Clinic. “How crazy is that? And no one’s talking about it.”
However, once the study appeared online, physicians took to Twitter to comment on the challenges of the board certification process, while others demanded change. One radiation oncologist even shared her decision not to have a child until she passed her board exams.
The study also got the attention of the American Board of Radiology, which governs certification for the specialty. In a response, leaders of the organization agreed that “the issues raised are significant and worthy of thoughtful consideration” and highlighted how, in light of the COVID-19 pandemic, the board has provided greater flexibility to the exam process – transitioning to remote testing and offering two dates for each exam in 2021.
But will the changes last? And will they help reduce the burden these exams place on families and family planning?
Inside board certification before the pandemic
While other specialties require one or two exams for board certification, radiation oncology is the only medical field that requires candidates pass four exams – three qualifying written tests, followed by a certifying oral exam. Since 2004, these exams, which cover physics, radiation biology, and clinical radiation oncology, have taken place over 3 years at specific locations across the country.
Radiation oncology residents have reported spending hundreds of hours preparing for each of these high-stakes evaluations. Fail or miss one and an already time-consuming process draws out, with major repercussions for career advancement and earnings.
“Passing and achieving board certification is the capstone of medical specialty training and, for many, is a prerequisite for attaining partnership or a promotion,” said study coauthor Chelain Goodman, MD, PhD, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.
To top it off, this process may be contributing to the gender disparity in radiation oncology, the study suggests. Only 25%-30% of practicing radiation oncologists are women, making it one of the lowest-ranking specialties when it comes to female representation.
“I think [this exam process] creates some disincentive when female medical students see that these are issues that early-career radiation oncologists are facing,” said Dr. Dover, who practices at Memorial Sloan Kettering Cancer Center, New York. “[Students may instead] choose a specialty that they believe will be more supportive of them and their family planning goals. That’s definitely a big concern for a field that wants to attract the top candidates.”
For those who do pick radiation oncology, the system of board exams often requires prospective parents to choose among three options: Try to time delivery before or between exams, put off pregnancy or adoption until exams are done, or delay board certification.
A balancing act: Board exams and family planning
Like Dr. Dover, Dr. Masters opted for door No. 1. She tried to time the birth of her daughter to fall several months before her first board exam.
She hoped her careful planning would reduce the stress of both major life events. But that was not the case. At 35 weeks, Dr. Masters found herself in the hospital with preeclampsia and symptomatic hypertension.
While receiving a magnesium sulfate drip to prevent a seizure, she frantically typed her patient list before her vision got too blurry to see the screen.
“That is ridiculous,” Dr. Masters said. “But so is a system that makes this the expectation [for pregnant physicians].”
During her hospital stay, Dr. Masters was induced. She suspects the stress of prepping for the board exam coupled with being pregnant and continuing to work long hours as a resident contributed to her pregnancy complications.
This juggling act can bleed into exam day as well. When interviewing women for their study, Dr. Masters and colleagues uncovered personal accounts of the challenges pregnant women and new mothers faced during their exams.
One woman described being granted lactation accommodation ahead of time, but when she arrived for her first two written exams, the testing center had no record of her request. She ended up breast-pumping in a coat closet next to the cleaning supplies while her male coresidents ate lunch and reviewed their notes.
“I started my physics exam in tears, completely anxious,” she reported. “I didn’t get to eat lunch. I was physically uncomfortable and emotionally wiped during both exams.”
Another woman had contractions during her written clinical boards, but “thankfully” passed her exam and gave birth 2 days later.
“It might sound crazy that we would put ourselves through things like that just to take an exam,” Dr. Dover said. “But because it does have the potential to sharply shape our early professional trajectory, we push through it. Otherwise, we’re going to be left behind by our male peers.”
This pressure to push through can be intense.
Still recovering from a difficult pregnancy, Dr. Masters returned to work when her daughter was just 5 weeks old. Although not ready to return to work, she felt too scared to ask for more time off after seeing other new mothers receive negative comments about not working hard enough.
Enter door No. 2: The pregnancy and postpregnancy experiences were so traumatizing that she decided to put off trying for a second child until after her exams.
Now board certified and 38 years old, Dr. Masters is worried she won’t be able to conceive as easily as before.
“So, we’re stuck in limbo, starting the process again and being nervous about it because what if it’s not so easy at this age?” she said. “And what if it could have been easy, in different circumstances, with a different specialty?”
Dr. Masters’ concerns are justified. Of the 126 women interviewed for the study, those who delayed pregnancy because of the board exams were significantly more likely to have fertility problems (46% vs. 18%), and 20% reported experiencing infertility.
This finding dovetails with previous research showing that almost 25% of female physicians who attempt to become pregnant are diagnosed with infertility – nearly twice the rate of the general population. This high rate of infertility has been attributed to professional pressures and stress, long hours on the job, and delaying pregnancy during medical training.
But choosing door No. 3 – focusing on family over exams – has downsides as well. Board certification is a prerequisite for almost every partnership position or promotion track within academic medicine and delaying certification can significantly hinder a physician’s career and finances.
Radiation oncologists who aren’t certified often remain in salaried positions until they can make partnership and earn a portion of the practice’s profits, “which could easily change your annual compensation by six digits,” Dr. Dover said.
According to the team’s study, annual compensation typically increases by $30,000-$50,000 after board certification, with some reporting an increase of over $100,000. That salary hike also impacts physicians’ ability to pay off medical school loans, make financial investments, and afford the cost of childcare.
In other words, when it comes to family planning, there’s often no good option.
Change on the horizon
When the pandemic struck, the American Board of Radiology quickly went into triage mode, postponing in-person board certification exams scheduled in 2020 and brainstorming solutions.
By June, the organization announced that the exams would switch to a virtual format in 2021. Each test would be offered twice – once early in the year for candidates like Dover whose postponed 2020 exams had ultimately been canceled, and then again for those already planning to take their tests in 2021.
The shift to remote testing was a boon. Taking the tests from home not only allowed candidates to forgo the cost, stress, and time of travel, it also mitigated the burden of juggling pregnancy and parenting needs.
For example, Courtney Hentz, MD, a pediatric radiation oncologist at Loyola University Chicago, Maywood, Ill., and a study coauthor, was given the choice to take a virtual exam in one day with two breastfeeding breaks or to spread the exam over 2 days with one breastfeeding break each day.
“Transitioning exams to a virtual format has been a really big achievement that the American Board of Radiology should be applauded for,” Dr. Dover said.
Not only that, offering the exams multiple times a year has “significantly increased flexibility for candidates as they juggle completing residency, starting at their first practice, and balancing time with their family,” Dr. Goodman added.
Brent Wagner, MD, MBA, executive director of the American Board of Radiology, Tucson, Ariz., said in an interviewthat remote exams are here to stay. “I don’t foresee us ever going back to in-person board exams,” said Dr. Wagner, a diagnostic radiologist. “Administering exams remotely last year worked better than I could have expected.”
Dr. Wagner said the American Board of Radiology also plans to keep two dates for the oral certifying exam for the foreseeable future, though will revert to one date for the written qualifying exams.
“In a perfect world, we’d offer an exam every quarter,” he said. However, providing multiple dates for the written exams “is not practical with a cohort of a few hundred people,” given the staff resources needed to create and score twice the number of items each year. The board did not rule out reassessing this decision in the future, “as examination development software improves and more resources become available.”
Another big change, proposed by Dr. Dover, Dr. Goodman, and others, would be to combine the four exams into fewer tests, such as consolidating the three written exams into one. Such a shift would allow physicians to launch their careers sooner and begin focusing on other career-advancing endeavors such as research and publishing. It would also significantly improve radiation oncologists’ quality of life.
“The amount of time that you spend studying for these very high-level, high-stakes exams really puts a toll on your mental health,” Dr. Dover said. “The longer it’s dragged out, the longer you’re dealing with that, and it contributes tremendously to poor job satisfaction and work-life balance.”
The American Board of Radiology said it is discussing options for consolidating the exams, but the challenge with combining the three written exams into one comes down to scoring. “We need to get a statistically valid result in all three categories,” Dr. Wagner said.
Another recent change: The American Board of Radiology is now allowing residents flexibility on the sequence of the written exams.
“In the past, we said you had to pass the physics exam before moving on to clinical radiology, but now we’re letting residents decide the order for themselves,” Dr. Wagner said. “This change may introduce more flexibility for someone who missed their first opportunity to take the physics exam but is ready to take the clinical exam.”
Dr. Wagner added: “We’re learning as we go, and I tell our staff that there’s no reason we should think we’re done making improvements. It’s going to keep getting better.”
The recent changes have already made a difference to radiation oncologists. And many hope to build on this new foundation to move the specialty toward a more family-friendly, equitable culture.
“I think as people in a caregiver profession, it’s hard to prioritize doing things for yourself or your own family sometimes; it’s hard to speak up and say: ‘We need something different,’ ” Dr. Masters said. “I think we have [an opportunity] to capitalize on the momentum we have now.”
A version of this article first appeared on Medscape.com.
Study finds sharp drop in opioid scripts among most specialties
The volume of prescription opioids dispensed at retail pharmacies in the United States dropped by 21% in recent years amid efforts to reduce unnecessary use of the painkillers, but the rate of decline varied greatly among types of patients and by type of clinician, a study found.
In a brief report published by Annals of Internal Medicine, researchers from the nonprofit RAND Corp reported an analysis of opioid prescriptions from two periods, 2008-2009 and 2017-2018.
The researchers sought to assess total opioid use rather than simply track the number of pills dispensed. So they used days’ supply and total daily dose to calculate per capita morphine milligram equivalents (MME) for opioid prescriptions, write Bradley D. Stein, MD, PhD, MPH, the study’s lead author and a senior physician researcher at RAND Corp, and his coauthors in their paper.
For the study, the researchers used data from the consulting firm IQVIA, which they say covers about 90% of U.S. prescriptions. Total opioid volume per capita by prescriptions filled in retail pharmacies decreased from 951.4 MME in 2008-2009 to 749.3 MME in 2017-2018, Dr. Stein’s group found.
(In 2020, IQVIA separately said that prescription opioid use per adult in this country rose from an average of 16 pills, or 134 MMEs, in 1992 to a peak of about 55 pills a person, or 790 MMEs, in 2011. By 2019, opioid use per adult had declined to 29 pills and 366 MMEs per capita.)
The RAND report found substantial variation in opioid volume by type of insurance, including a 41.5% decline (636.5 MME to 372.6 MME) among people covered by commercial health plans. That exceeded the 27.7% drop seen for people enrolled in Medicaid (646.8 MME to 467.7 MME). The decline was smaller (17.5%; 2,780.2 MME to 2,294.2 MME) for those on Medicare, who as a group used the most opioids.
‘Almost functions as a Rorschach test’
The causes of the decline are easy to guess, although definitive conclusions are impossible, Dr. Stein told this news organization.
Significant work has been done in recent years to change attitudes about opioid prescriptions by physicians, researchers, and lawmakers. Aggressive promotion of prescription painkillers, particularly Purdue Pharma’s OxyContin, in the 1990s, is widely cited as the triggering event for the national opioid crisis.
In response, states created databases known as prescription drug monitoring programs. The Centers for Disease Control and Prevention in 2016 issued guidelines intended to curb unnecessary use of opioids. The guidelines noted that other medicines could treat chronic pain without raising the risk of addiction. The Choosing Wisely campaign, run by a foundation of the American Board of Internal Medicine, also offered recommendations about limiting use of opioids. And insurers have restricted access to opioids through the prior authorization process. As a result, researchers will make their own guesses at the causes of the decline in opioid prescriptions, based on their own experiences and research interests, Dr. Stein said.
“It almost functions as a Rorschach test,” he said.
Dr. Stein’s group also looked at trends among medical specialties. They found the largest reduction between 2008-2009 and 2017-2018 among emergency physicians (70.5% drop from 99,254.5 MME to 29,234.3 MME), psychiatrists (67.2% drop from 50,464.3 MME to 16,533.0 MME) and oncologists (59.5% drop from 51,731.2 MME to 20,941.4).
Among surgeons, the RAND researchers found a drop of 49.3% from 220,764.6 to 111,904.4. Among dentists, they found a drop of 41.3% from 22,345.3 to 13,126.1.
Among pain specialists, they found a drop of 15.4% from 1,020,808.4 MME to 863,140.7 MME.
Among adult primary care clinicians, Dr. Stein and his colleagues found a drop of 40% from 651,489.4 MME in 2008-2009 to 390,841.0 MME in 2017-2018.
However, one of the groups tracked in the study increased the volume of opioid prescriptions written: advanced practice providers, among whom scripts for the drugs rose 22.7%, from 112,873.9 MME to 138,459.3 MME.
Dr. Stein said he suspects that this gain reflects a change in the nature of the practice of primary care, with nurse practitioners and physician assistants taking more active roles in treatment of patients. Some of the reduction seen among primary care clinicians who treat adults may reflect a shift in which medical personnel in a practice write the opioid prescriptions.
Still, the trends in general seen by Dr. Stein and coauthors are encouraging, even if further study of these patterns is needed, he said.
“This is one of those papers that I think potentially raises as many questions as it provides answers for,” he said.
What’s missing
Maya Hambright, MD, a family medicine physician in New York’s Hudson Valley, who has been working mainly in addiction in response to the opioid overdose crisis, observed that the drop in total prescribed volume of prescription painkillers does not necessarily translate into a reduction in use of opioids
“No one is taking fewer opioids,” Dr. Hambright told this news organization. “I can say that comfortably. They are just getting them from other sources.”
CDC data support Dr. Hambright’s view.
An estimated 100,306 people in the United States died of a drug overdose in the 12 months that ended in April 2021, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the CDC.
Dr. Hambright said more physicians need to be involved in prescribing medication-assisted treatment (MAT).
The federal government has in the past year loosened restrictions on a requirement, known as an X waiver. Certain clinicians have been exempted from training requirements, as explained in the frequently asked questions page on the Substance Abuse and Mental Health Services Administration website.
SAMHSA says legislation is required to eliminate the waiver. As of Dec. 30, 2021, more than half of the members of the U.S. House of Representatives were listed as sponsors of the Mainstreaming Addiction Treatment (MAT) Act (HR 1384), which would end the need for X waivers. The bill has the backing of 187 Democrats and 43 Republicans.
At this time, too many physicians shy away from offering MAT, Dr. Hambright said.
“People are still scared of it,” she said. “People don’t want to deal with addicts.”
But Dr. Hambright said it’s well worth the initial time invested in having the needed conversations with patients about MAT.
“Afterwards, it’s so straightforward. People feel better. They’re healthier. It’s amazing,” she said. “You’re changing lives.”
The research was supported by grants from the National Institutes of Health. Dr. Stein and coauthors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The volume of prescription opioids dispensed at retail pharmacies in the United States dropped by 21% in recent years amid efforts to reduce unnecessary use of the painkillers, but the rate of decline varied greatly among types of patients and by type of clinician, a study found.
In a brief report published by Annals of Internal Medicine, researchers from the nonprofit RAND Corp reported an analysis of opioid prescriptions from two periods, 2008-2009 and 2017-2018.
The researchers sought to assess total opioid use rather than simply track the number of pills dispensed. So they used days’ supply and total daily dose to calculate per capita morphine milligram equivalents (MME) for opioid prescriptions, write Bradley D. Stein, MD, PhD, MPH, the study’s lead author and a senior physician researcher at RAND Corp, and his coauthors in their paper.
For the study, the researchers used data from the consulting firm IQVIA, which they say covers about 90% of U.S. prescriptions. Total opioid volume per capita by prescriptions filled in retail pharmacies decreased from 951.4 MME in 2008-2009 to 749.3 MME in 2017-2018, Dr. Stein’s group found.
(In 2020, IQVIA separately said that prescription opioid use per adult in this country rose from an average of 16 pills, or 134 MMEs, in 1992 to a peak of about 55 pills a person, or 790 MMEs, in 2011. By 2019, opioid use per adult had declined to 29 pills and 366 MMEs per capita.)
The RAND report found substantial variation in opioid volume by type of insurance, including a 41.5% decline (636.5 MME to 372.6 MME) among people covered by commercial health plans. That exceeded the 27.7% drop seen for people enrolled in Medicaid (646.8 MME to 467.7 MME). The decline was smaller (17.5%; 2,780.2 MME to 2,294.2 MME) for those on Medicare, who as a group used the most opioids.
‘Almost functions as a Rorschach test’
The causes of the decline are easy to guess, although definitive conclusions are impossible, Dr. Stein told this news organization.
Significant work has been done in recent years to change attitudes about opioid prescriptions by physicians, researchers, and lawmakers. Aggressive promotion of prescription painkillers, particularly Purdue Pharma’s OxyContin, in the 1990s, is widely cited as the triggering event for the national opioid crisis.
In response, states created databases known as prescription drug monitoring programs. The Centers for Disease Control and Prevention in 2016 issued guidelines intended to curb unnecessary use of opioids. The guidelines noted that other medicines could treat chronic pain without raising the risk of addiction. The Choosing Wisely campaign, run by a foundation of the American Board of Internal Medicine, also offered recommendations about limiting use of opioids. And insurers have restricted access to opioids through the prior authorization process. As a result, researchers will make their own guesses at the causes of the decline in opioid prescriptions, based on their own experiences and research interests, Dr. Stein said.
“It almost functions as a Rorschach test,” he said.
Dr. Stein’s group also looked at trends among medical specialties. They found the largest reduction between 2008-2009 and 2017-2018 among emergency physicians (70.5% drop from 99,254.5 MME to 29,234.3 MME), psychiatrists (67.2% drop from 50,464.3 MME to 16,533.0 MME) and oncologists (59.5% drop from 51,731.2 MME to 20,941.4).
Among surgeons, the RAND researchers found a drop of 49.3% from 220,764.6 to 111,904.4. Among dentists, they found a drop of 41.3% from 22,345.3 to 13,126.1.
Among pain specialists, they found a drop of 15.4% from 1,020,808.4 MME to 863,140.7 MME.
Among adult primary care clinicians, Dr. Stein and his colleagues found a drop of 40% from 651,489.4 MME in 2008-2009 to 390,841.0 MME in 2017-2018.
However, one of the groups tracked in the study increased the volume of opioid prescriptions written: advanced practice providers, among whom scripts for the drugs rose 22.7%, from 112,873.9 MME to 138,459.3 MME.
Dr. Stein said he suspects that this gain reflects a change in the nature of the practice of primary care, with nurse practitioners and physician assistants taking more active roles in treatment of patients. Some of the reduction seen among primary care clinicians who treat adults may reflect a shift in which medical personnel in a practice write the opioid prescriptions.
Still, the trends in general seen by Dr. Stein and coauthors are encouraging, even if further study of these patterns is needed, he said.
“This is one of those papers that I think potentially raises as many questions as it provides answers for,” he said.
What’s missing
Maya Hambright, MD, a family medicine physician in New York’s Hudson Valley, who has been working mainly in addiction in response to the opioid overdose crisis, observed that the drop in total prescribed volume of prescription painkillers does not necessarily translate into a reduction in use of opioids
“No one is taking fewer opioids,” Dr. Hambright told this news organization. “I can say that comfortably. They are just getting them from other sources.”
CDC data support Dr. Hambright’s view.
An estimated 100,306 people in the United States died of a drug overdose in the 12 months that ended in April 2021, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the CDC.
Dr. Hambright said more physicians need to be involved in prescribing medication-assisted treatment (MAT).
The federal government has in the past year loosened restrictions on a requirement, known as an X waiver. Certain clinicians have been exempted from training requirements, as explained in the frequently asked questions page on the Substance Abuse and Mental Health Services Administration website.
SAMHSA says legislation is required to eliminate the waiver. As of Dec. 30, 2021, more than half of the members of the U.S. House of Representatives were listed as sponsors of the Mainstreaming Addiction Treatment (MAT) Act (HR 1384), which would end the need for X waivers. The bill has the backing of 187 Democrats and 43 Republicans.
At this time, too many physicians shy away from offering MAT, Dr. Hambright said.
“People are still scared of it,” she said. “People don’t want to deal with addicts.”
But Dr. Hambright said it’s well worth the initial time invested in having the needed conversations with patients about MAT.
“Afterwards, it’s so straightforward. People feel better. They’re healthier. It’s amazing,” she said. “You’re changing lives.”
The research was supported by grants from the National Institutes of Health. Dr. Stein and coauthors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The volume of prescription opioids dispensed at retail pharmacies in the United States dropped by 21% in recent years amid efforts to reduce unnecessary use of the painkillers, but the rate of decline varied greatly among types of patients and by type of clinician, a study found.
In a brief report published by Annals of Internal Medicine, researchers from the nonprofit RAND Corp reported an analysis of opioid prescriptions from two periods, 2008-2009 and 2017-2018.
The researchers sought to assess total opioid use rather than simply track the number of pills dispensed. So they used days’ supply and total daily dose to calculate per capita morphine milligram equivalents (MME) for opioid prescriptions, write Bradley D. Stein, MD, PhD, MPH, the study’s lead author and a senior physician researcher at RAND Corp, and his coauthors in their paper.
For the study, the researchers used data from the consulting firm IQVIA, which they say covers about 90% of U.S. prescriptions. Total opioid volume per capita by prescriptions filled in retail pharmacies decreased from 951.4 MME in 2008-2009 to 749.3 MME in 2017-2018, Dr. Stein’s group found.
(In 2020, IQVIA separately said that prescription opioid use per adult in this country rose from an average of 16 pills, or 134 MMEs, in 1992 to a peak of about 55 pills a person, or 790 MMEs, in 2011. By 2019, opioid use per adult had declined to 29 pills and 366 MMEs per capita.)
The RAND report found substantial variation in opioid volume by type of insurance, including a 41.5% decline (636.5 MME to 372.6 MME) among people covered by commercial health plans. That exceeded the 27.7% drop seen for people enrolled in Medicaid (646.8 MME to 467.7 MME). The decline was smaller (17.5%; 2,780.2 MME to 2,294.2 MME) for those on Medicare, who as a group used the most opioids.
‘Almost functions as a Rorschach test’
The causes of the decline are easy to guess, although definitive conclusions are impossible, Dr. Stein told this news organization.
Significant work has been done in recent years to change attitudes about opioid prescriptions by physicians, researchers, and lawmakers. Aggressive promotion of prescription painkillers, particularly Purdue Pharma’s OxyContin, in the 1990s, is widely cited as the triggering event for the national opioid crisis.
In response, states created databases known as prescription drug monitoring programs. The Centers for Disease Control and Prevention in 2016 issued guidelines intended to curb unnecessary use of opioids. The guidelines noted that other medicines could treat chronic pain without raising the risk of addiction. The Choosing Wisely campaign, run by a foundation of the American Board of Internal Medicine, also offered recommendations about limiting use of opioids. And insurers have restricted access to opioids through the prior authorization process. As a result, researchers will make their own guesses at the causes of the decline in opioid prescriptions, based on their own experiences and research interests, Dr. Stein said.
“It almost functions as a Rorschach test,” he said.
Dr. Stein’s group also looked at trends among medical specialties. They found the largest reduction between 2008-2009 and 2017-2018 among emergency physicians (70.5% drop from 99,254.5 MME to 29,234.3 MME), psychiatrists (67.2% drop from 50,464.3 MME to 16,533.0 MME) and oncologists (59.5% drop from 51,731.2 MME to 20,941.4).
Among surgeons, the RAND researchers found a drop of 49.3% from 220,764.6 to 111,904.4. Among dentists, they found a drop of 41.3% from 22,345.3 to 13,126.1.
Among pain specialists, they found a drop of 15.4% from 1,020,808.4 MME to 863,140.7 MME.
Among adult primary care clinicians, Dr. Stein and his colleagues found a drop of 40% from 651,489.4 MME in 2008-2009 to 390,841.0 MME in 2017-2018.
However, one of the groups tracked in the study increased the volume of opioid prescriptions written: advanced practice providers, among whom scripts for the drugs rose 22.7%, from 112,873.9 MME to 138,459.3 MME.
Dr. Stein said he suspects that this gain reflects a change in the nature of the practice of primary care, with nurse practitioners and physician assistants taking more active roles in treatment of patients. Some of the reduction seen among primary care clinicians who treat adults may reflect a shift in which medical personnel in a practice write the opioid prescriptions.
Still, the trends in general seen by Dr. Stein and coauthors are encouraging, even if further study of these patterns is needed, he said.
“This is one of those papers that I think potentially raises as many questions as it provides answers for,” he said.
What’s missing
Maya Hambright, MD, a family medicine physician in New York’s Hudson Valley, who has been working mainly in addiction in response to the opioid overdose crisis, observed that the drop in total prescribed volume of prescription painkillers does not necessarily translate into a reduction in use of opioids
“No one is taking fewer opioids,” Dr. Hambright told this news organization. “I can say that comfortably. They are just getting them from other sources.”
CDC data support Dr. Hambright’s view.
An estimated 100,306 people in the United States died of a drug overdose in the 12 months that ended in April 2021, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the CDC.
Dr. Hambright said more physicians need to be involved in prescribing medication-assisted treatment (MAT).
The federal government has in the past year loosened restrictions on a requirement, known as an X waiver. Certain clinicians have been exempted from training requirements, as explained in the frequently asked questions page on the Substance Abuse and Mental Health Services Administration website.
SAMHSA says legislation is required to eliminate the waiver. As of Dec. 30, 2021, more than half of the members of the U.S. House of Representatives were listed as sponsors of the Mainstreaming Addiction Treatment (MAT) Act (HR 1384), which would end the need for X waivers. The bill has the backing of 187 Democrats and 43 Republicans.
At this time, too many physicians shy away from offering MAT, Dr. Hambright said.
“People are still scared of it,” she said. “People don’t want to deal with addicts.”
But Dr. Hambright said it’s well worth the initial time invested in having the needed conversations with patients about MAT.
“Afterwards, it’s so straightforward. People feel better. They’re healthier. It’s amazing,” she said. “You’re changing lives.”
The research was supported by grants from the National Institutes of Health. Dr. Stein and coauthors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CDC defends new COVID guidance as doctors raise concerns
, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.
Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.
Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.
“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”
“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.
But for many, the CDC guidelines are murky and seem to always change.
“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”
About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.
“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”
Instead, Dr. Harmon said a negative test should be required for ending isolation.
“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.
Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.
“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.
He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”
Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.
Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.
“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”
A version of this article first appeared on WebMD.com.
, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.
Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.
Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.
“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”
“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.
But for many, the CDC guidelines are murky and seem to always change.
“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”
About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.
“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”
Instead, Dr. Harmon said a negative test should be required for ending isolation.
“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.
Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.
“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.
He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”
Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.
Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.
“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”
A version of this article first appeared on WebMD.com.
, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.
Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.
Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.
“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”
“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.
But for many, the CDC guidelines are murky and seem to always change.
“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”
About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.
“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”
Instead, Dr. Harmon said a negative test should be required for ending isolation.
“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.
Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.
“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.
He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”
Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.
Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.
“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”
A version of this article first appeared on WebMD.com.
Freshwater aquarium provides source for melioidosis infection
A Maryland woman came down with a severe tropical infection called melioidosis from her freshwater home aquarium, says a report in Emerging Infectious Diseases describing a new route of transmission. Melioidosis is caused by the bacteria Burkholderia pseudomallei in soil or water.
Until last year, almost all U.S. cases of melioidosis were from people who lived or traveled to disease-endemic areas. It has been a rare infection in the United States.
But this is not the first case of melioidosis from an unusual source. Earlier in 2021, CDC and state epidemiologists traced an outbreak of melioidosis in Georgia, Kansas, Minnesota, and Texas to B pseudomallei in a bottle of “Better Homes & Gardens Lavender & Chamomile Essential Oil Infused Aromatherapy Room Spray with Gemstones.”
In the aquarium case, the patient was a 56-year-old woman with diabetes and rheumatologic disease. She had been on immunosuppressives (methotrexate, azathioprine, and prednisone) until 1 month before she became symptomatic. She was hospitalized for fever and pneumonia.
Multiple blood cultures obtained on days 1-4 grew B. pseudomallei, but she had no evidence of endocarditis or intravascular seeding. Despite weeks of meropenem (Merrem), she developed evidence of a lung abscess, and trimethoprim/sulfamethoxazole (Bactrim) was added. Ultimately, the patient required a 12-week course of antibiotics.
CDC epidemiologist Patrick Dawson, PhD, first author of the report, told this news organization that although outbreak investigators always ask about pet ownership, they have not explicitly asked about fish. In this case, the patient did not volunteer exposure to the fish.
When state epidemiologists visited the patient’s home, “one of the first things they saw was a few aquariums,” Dr. Dawson said. Seeing the water and knowing “that most freshwater tropical fish in the U.S. are imported from Southeast Asia” led them to culture specifically for B. pseudomallei, which can be difficult for the microbiology lab to identify.
From there, Dr. Dawson explained, “The Maryland Department of Health sent a team to the local pet store” but did not find any of the bacteria there. (The patient had bought her fish 6 months earlier.) The investigators then worked with the national brand “to identify where they had actually sourced the fish from.”
Two retailers supply almost all of U.S. guppies and plants. While investigators could not find an exact matching isolate after so many months had elapsed, they found a positive PCR for B. pseudomallei in a water sample from imported fish in Los Angeles.
Dr. Dawson said tropical fish are imported from southeast Asia and typically come from small family fish farms. The fish import industry has “certain products that they add to the water to hopefully kill any bacteria.” He was unaware whether this included antibiotics but suggested, “we would have seen many more cases [of antibiotic resistance] by now” if it did.
In general advice for the public, Dr. Dawson said, “I would recommend washing hands before and after contact with the aquarium. If you have cuts or wounds on your hands, it’s really important to wear gloves if you have to go clean or maintain the aquarium and you’re putting your hands in the water, just for that extra layer of protection. It’s probably a strong idea to just avoid that altogether if someone’s immunocompromised. And not letting young children under 5 years old clean aquariums.” These are the “simplest things to do to protect yourself.”
Stephen A. Smith, DVM, PhD, a professor in the Aquatic Medicine Program at Virginia-Maryland College of Veterinary Medicine, Blacksburg, also stressed the importance of careful hand hygiene when caring for aquariums. He said that the filter, filter floss, biofilm, charcoal, and gravel might have exceptionally high concentrations of bacteria. Dr. Smith also recommended gloves when cleaning aquariums and not doing this task if immunocompromised.
Dr. Smith, who was not involved in the CDC study, shared a broader perspective, noting that “the reason why it’s important to federal regulators is that [B. pseudomallei] is a tier 1 select agent. And so, when that was isolated, it sent up all the red flags.” The far more common Mycobacterium marinum, or fish handler’s disease, is not reportable.
Mycobacterium marinum is another pathogen of concern that can be acquired from aquariums. These infections typically occur as nodular lesions on the arms and require months of therapy.
Dr. Smith stressed the importance of physicians eliciting a careful exposure history as the key to diagnosing zoonoses. For most exotic aquarium animals, he noted, “They’re caught in the wild wherever they are. They’re transported to a major hub to transport to the U.S., and a lot of times, we don’t have quarantine for those animals.”
Dr. Smith said.
Many infections also occur in the course of water sports – or even hiking and getting a cut or abrasion wet from a stream or lake. Aeromonas hydrophila can cause life-threatening infections. Vibrio vulnificus infections from salt-water injuries can cause sepsis and characteristic hemorrhagic bullae – large, discolored blisters filled with body fluid – during the summer. And eating contaminated shellfish has a 50%-60% death rate.
Other exposures to water-loving bacteria happen during fishing or cleaning/preparing fish. For example, Streptococcus iniae has caused cellulitis, arthritis, endocarditis, and meningitis following superficial or puncture injuries, notably from cleaning tilapia.
Other infections from contact with fish include Erysipelothrix rhusiopathiae (primarily skin infections) and gastroenteritis from Plesiomonas shigelloides, Campylobacter spp, and Salmonella spp.
Each of these zoonoses illustrates the importance of a careful exposure history when there’s an atypical presentation or an infection that is not responding promptly to empiric treatment. The aquarium case broadens the differential to include melioidosis, a serious disease from southeast Asia.
Dr. Dawson and Dr. Smith have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A Maryland woman came down with a severe tropical infection called melioidosis from her freshwater home aquarium, says a report in Emerging Infectious Diseases describing a new route of transmission. Melioidosis is caused by the bacteria Burkholderia pseudomallei in soil or water.
Until last year, almost all U.S. cases of melioidosis were from people who lived or traveled to disease-endemic areas. It has been a rare infection in the United States.
But this is not the first case of melioidosis from an unusual source. Earlier in 2021, CDC and state epidemiologists traced an outbreak of melioidosis in Georgia, Kansas, Minnesota, and Texas to B pseudomallei in a bottle of “Better Homes & Gardens Lavender & Chamomile Essential Oil Infused Aromatherapy Room Spray with Gemstones.”
In the aquarium case, the patient was a 56-year-old woman with diabetes and rheumatologic disease. She had been on immunosuppressives (methotrexate, azathioprine, and prednisone) until 1 month before she became symptomatic. She was hospitalized for fever and pneumonia.
Multiple blood cultures obtained on days 1-4 grew B. pseudomallei, but she had no evidence of endocarditis or intravascular seeding. Despite weeks of meropenem (Merrem), she developed evidence of a lung abscess, and trimethoprim/sulfamethoxazole (Bactrim) was added. Ultimately, the patient required a 12-week course of antibiotics.
CDC epidemiologist Patrick Dawson, PhD, first author of the report, told this news organization that although outbreak investigators always ask about pet ownership, they have not explicitly asked about fish. In this case, the patient did not volunteer exposure to the fish.
When state epidemiologists visited the patient’s home, “one of the first things they saw was a few aquariums,” Dr. Dawson said. Seeing the water and knowing “that most freshwater tropical fish in the U.S. are imported from Southeast Asia” led them to culture specifically for B. pseudomallei, which can be difficult for the microbiology lab to identify.
From there, Dr. Dawson explained, “The Maryland Department of Health sent a team to the local pet store” but did not find any of the bacteria there. (The patient had bought her fish 6 months earlier.) The investigators then worked with the national brand “to identify where they had actually sourced the fish from.”
Two retailers supply almost all of U.S. guppies and plants. While investigators could not find an exact matching isolate after so many months had elapsed, they found a positive PCR for B. pseudomallei in a water sample from imported fish in Los Angeles.
Dr. Dawson said tropical fish are imported from southeast Asia and typically come from small family fish farms. The fish import industry has “certain products that they add to the water to hopefully kill any bacteria.” He was unaware whether this included antibiotics but suggested, “we would have seen many more cases [of antibiotic resistance] by now” if it did.
In general advice for the public, Dr. Dawson said, “I would recommend washing hands before and after contact with the aquarium. If you have cuts or wounds on your hands, it’s really important to wear gloves if you have to go clean or maintain the aquarium and you’re putting your hands in the water, just for that extra layer of protection. It’s probably a strong idea to just avoid that altogether if someone’s immunocompromised. And not letting young children under 5 years old clean aquariums.” These are the “simplest things to do to protect yourself.”
Stephen A. Smith, DVM, PhD, a professor in the Aquatic Medicine Program at Virginia-Maryland College of Veterinary Medicine, Blacksburg, also stressed the importance of careful hand hygiene when caring for aquariums. He said that the filter, filter floss, biofilm, charcoal, and gravel might have exceptionally high concentrations of bacteria. Dr. Smith also recommended gloves when cleaning aquariums and not doing this task if immunocompromised.
Dr. Smith, who was not involved in the CDC study, shared a broader perspective, noting that “the reason why it’s important to federal regulators is that [B. pseudomallei] is a tier 1 select agent. And so, when that was isolated, it sent up all the red flags.” The far more common Mycobacterium marinum, or fish handler’s disease, is not reportable.
Mycobacterium marinum is another pathogen of concern that can be acquired from aquariums. These infections typically occur as nodular lesions on the arms and require months of therapy.
Dr. Smith stressed the importance of physicians eliciting a careful exposure history as the key to diagnosing zoonoses. For most exotic aquarium animals, he noted, “They’re caught in the wild wherever they are. They’re transported to a major hub to transport to the U.S., and a lot of times, we don’t have quarantine for those animals.”
Dr. Smith said.
Many infections also occur in the course of water sports – or even hiking and getting a cut or abrasion wet from a stream or lake. Aeromonas hydrophila can cause life-threatening infections. Vibrio vulnificus infections from salt-water injuries can cause sepsis and characteristic hemorrhagic bullae – large, discolored blisters filled with body fluid – during the summer. And eating contaminated shellfish has a 50%-60% death rate.
Other exposures to water-loving bacteria happen during fishing or cleaning/preparing fish. For example, Streptococcus iniae has caused cellulitis, arthritis, endocarditis, and meningitis following superficial or puncture injuries, notably from cleaning tilapia.
Other infections from contact with fish include Erysipelothrix rhusiopathiae (primarily skin infections) and gastroenteritis from Plesiomonas shigelloides, Campylobacter spp, and Salmonella spp.
Each of these zoonoses illustrates the importance of a careful exposure history when there’s an atypical presentation or an infection that is not responding promptly to empiric treatment. The aquarium case broadens the differential to include melioidosis, a serious disease from southeast Asia.
Dr. Dawson and Dr. Smith have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A Maryland woman came down with a severe tropical infection called melioidosis from her freshwater home aquarium, says a report in Emerging Infectious Diseases describing a new route of transmission. Melioidosis is caused by the bacteria Burkholderia pseudomallei in soil or water.
Until last year, almost all U.S. cases of melioidosis were from people who lived or traveled to disease-endemic areas. It has been a rare infection in the United States.
But this is not the first case of melioidosis from an unusual source. Earlier in 2021, CDC and state epidemiologists traced an outbreak of melioidosis in Georgia, Kansas, Minnesota, and Texas to B pseudomallei in a bottle of “Better Homes & Gardens Lavender & Chamomile Essential Oil Infused Aromatherapy Room Spray with Gemstones.”
In the aquarium case, the patient was a 56-year-old woman with diabetes and rheumatologic disease. She had been on immunosuppressives (methotrexate, azathioprine, and prednisone) until 1 month before she became symptomatic. She was hospitalized for fever and pneumonia.
Multiple blood cultures obtained on days 1-4 grew B. pseudomallei, but she had no evidence of endocarditis or intravascular seeding. Despite weeks of meropenem (Merrem), she developed evidence of a lung abscess, and trimethoprim/sulfamethoxazole (Bactrim) was added. Ultimately, the patient required a 12-week course of antibiotics.
CDC epidemiologist Patrick Dawson, PhD, first author of the report, told this news organization that although outbreak investigators always ask about pet ownership, they have not explicitly asked about fish. In this case, the patient did not volunteer exposure to the fish.
When state epidemiologists visited the patient’s home, “one of the first things they saw was a few aquariums,” Dr. Dawson said. Seeing the water and knowing “that most freshwater tropical fish in the U.S. are imported from Southeast Asia” led them to culture specifically for B. pseudomallei, which can be difficult for the microbiology lab to identify.
From there, Dr. Dawson explained, “The Maryland Department of Health sent a team to the local pet store” but did not find any of the bacteria there. (The patient had bought her fish 6 months earlier.) The investigators then worked with the national brand “to identify where they had actually sourced the fish from.”
Two retailers supply almost all of U.S. guppies and plants. While investigators could not find an exact matching isolate after so many months had elapsed, they found a positive PCR for B. pseudomallei in a water sample from imported fish in Los Angeles.
Dr. Dawson said tropical fish are imported from southeast Asia and typically come from small family fish farms. The fish import industry has “certain products that they add to the water to hopefully kill any bacteria.” He was unaware whether this included antibiotics but suggested, “we would have seen many more cases [of antibiotic resistance] by now” if it did.
In general advice for the public, Dr. Dawson said, “I would recommend washing hands before and after contact with the aquarium. If you have cuts or wounds on your hands, it’s really important to wear gloves if you have to go clean or maintain the aquarium and you’re putting your hands in the water, just for that extra layer of protection. It’s probably a strong idea to just avoid that altogether if someone’s immunocompromised. And not letting young children under 5 years old clean aquariums.” These are the “simplest things to do to protect yourself.”
Stephen A. Smith, DVM, PhD, a professor in the Aquatic Medicine Program at Virginia-Maryland College of Veterinary Medicine, Blacksburg, also stressed the importance of careful hand hygiene when caring for aquariums. He said that the filter, filter floss, biofilm, charcoal, and gravel might have exceptionally high concentrations of bacteria. Dr. Smith also recommended gloves when cleaning aquariums and not doing this task if immunocompromised.
Dr. Smith, who was not involved in the CDC study, shared a broader perspective, noting that “the reason why it’s important to federal regulators is that [B. pseudomallei] is a tier 1 select agent. And so, when that was isolated, it sent up all the red flags.” The far more common Mycobacterium marinum, or fish handler’s disease, is not reportable.
Mycobacterium marinum is another pathogen of concern that can be acquired from aquariums. These infections typically occur as nodular lesions on the arms and require months of therapy.
Dr. Smith stressed the importance of physicians eliciting a careful exposure history as the key to diagnosing zoonoses. For most exotic aquarium animals, he noted, “They’re caught in the wild wherever they are. They’re transported to a major hub to transport to the U.S., and a lot of times, we don’t have quarantine for those animals.”
Dr. Smith said.
Many infections also occur in the course of water sports – or even hiking and getting a cut or abrasion wet from a stream or lake. Aeromonas hydrophila can cause life-threatening infections. Vibrio vulnificus infections from salt-water injuries can cause sepsis and characteristic hemorrhagic bullae – large, discolored blisters filled with body fluid – during the summer. And eating contaminated shellfish has a 50%-60% death rate.
Other exposures to water-loving bacteria happen during fishing or cleaning/preparing fish. For example, Streptococcus iniae has caused cellulitis, arthritis, endocarditis, and meningitis following superficial or puncture injuries, notably from cleaning tilapia.
Other infections from contact with fish include Erysipelothrix rhusiopathiae (primarily skin infections) and gastroenteritis from Plesiomonas shigelloides, Campylobacter spp, and Salmonella spp.
Each of these zoonoses illustrates the importance of a careful exposure history when there’s an atypical presentation or an infection that is not responding promptly to empiric treatment. The aquarium case broadens the differential to include melioidosis, a serious disease from southeast Asia.
Dr. Dawson and Dr. Smith have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Real-world practice informs tofacitinib use in UC
A real-world analysis of tofacitinib, presented at the annual Advances in Inflammatory Bowel Disease conference, confirms that long-term use of the selective immunosuppressant agent tofacitinib is associated with high rates of steroid-free remission in patients with ulcerative colitis (UC). These findings, along with clinical practice observations made during another session at the conference, further validate the efficacy of tofacitinib beyond that currently reported in specific clinical trial populations.
Tofacitinib is a small-molecule Janus kinase inhibitor that interferes with the intracellular JAK/signal transducer and activators of transcription pathway. Compared with other biologic agents, tofacitinib simultaneously acts on several cytokines and exerts broader effects on gastrointestinal inflammation.
Tofacitinib’s approval for moderate to severe UC was based on data from the OCTAVE clinical trial program. Although the phase 3 OCTAVE trial showed the JAK inhibitor features dose-dependent efficacy in inducing and maintaining remission in UC, stringent inclusion and exclusion criteria limit the generalizability of the trial’s findings across the broader, real-world UC population.
Findings from the recent analysis on tofacitinib were presented at AIBD 2021 by Knyazev Oleg, MD, who is the head of department of inflammatory bowel diseases at A.S. Loginov Moscow Clinical Scientific and Practical Center.
Dr. Oleg and colleagues reported on real-world treatment observations of 58 tofacitinib-treated patients with UC. Treatment efficacy was evaluated using the Mayo index (score <2), erythrocyte sedimentation rate, C-reactive protein, hemoglobin, fecal calprotectin, and the need for glucocorticoids (GCS).
At the time of tofacitinib initiation, all patients received GCS, with a mean therapeutic dose of 40 mg. In all 49 patients who responded to therapy, corticosteroids were discontinued after induction.
Only 15.5% (n = 9) of the study cohort did not respond to the JAK inhibitor during the follow-up period. A total of 14 patients (24.1%) who previously received anti-TNF therapies required a prolonged induction course of 20 mg tofacitinib. More than one out of five patients (22.4%) required repeated corticosteroids to manage exacerbations or dwindled tofacitinib response.
During another session, which discussed prescription treatment for moderate to severe UC, Bincy Abraham, MD, a professor of clinical medicine at Houston Methodist Academic Institute, summarized currently available clinical trial data on tofacitinib and discussed her own observations in her practice regarding the efficacy of the JAK inhibitor in the UC population.
The current data show the oral JAK inhibitor allows patients to reach remission as early as 8 weeks, with corresponding reductions observed in rectal bleeding and stool frequency as early as 2 weeks after therapy initiation. While the efficacy findings are corroborated by her own clinical practice, Dr. Abraham largely discussed the safety implications of the treatment.
Dr. Abraham emphasized the need for risk-mitigation strategies before initiating tofacitinib in appropriately selected patients with UC. In particular, Dr. Abraham explained that clinicians should be alerted to the possibility of tuberculosis as an opportunistic infection in tofacitinib-treated patients. “Before starting, I always liked to make sure that patients are getting checked for tuberculosis,” she said, adding that she performs annual monitoring for patients treated with the agent.
When considering tofacitinib, Dr. Abraham added that clinicians should ultimately consider discussing the risks of therapy versus the benefits in eligible patients.
During the question-and-answer portion of her session, Dr. Abraham noted that she has observed mixed findings in regard to tofacitinib’s effects on lipid levels. Specifically, only a small number of patients with UC in her practice have had to initiate cholesterol therapy while taking tofacitinib, but these patients typically have high-risk factors for hyperlipidemia, including family history and elevated body mass index.
On a question regarding the risk of shingles, Dr. Abraham noted that, if a patient does indeed develop the condition while taking tofacitinib, the therapy should be halted until shingles is resolved. In her practice, Dr. Abraham explained shingles vaccination is a priority before starting tofacitinib, suggesting this strategy has thus far prevented her tofacitinib-treated patients from developing the condition.
In patients with flares, Dr. Abraham noted that “we don’t have any specific clinical trial data specifically looking at” how to manage tofacitinib doses to further manage difficult-to-treat disease. She stated that, in her practice, she increases the dose of tofacitinib in patients who experience flares, as this often improves response. Subsequent dose reductions should be based on an individualized basis, with many patients requiring higher doses at varying periods.
Dr. Oleg has no relevant financial disclosures. Dr. Abraham reported conflicts of interest with Pfizer, which sponsored her discussion.
A real-world analysis of tofacitinib, presented at the annual Advances in Inflammatory Bowel Disease conference, confirms that long-term use of the selective immunosuppressant agent tofacitinib is associated with high rates of steroid-free remission in patients with ulcerative colitis (UC). These findings, along with clinical practice observations made during another session at the conference, further validate the efficacy of tofacitinib beyond that currently reported in specific clinical trial populations.
Tofacitinib is a small-molecule Janus kinase inhibitor that interferes with the intracellular JAK/signal transducer and activators of transcription pathway. Compared with other biologic agents, tofacitinib simultaneously acts on several cytokines and exerts broader effects on gastrointestinal inflammation.
Tofacitinib’s approval for moderate to severe UC was based on data from the OCTAVE clinical trial program. Although the phase 3 OCTAVE trial showed the JAK inhibitor features dose-dependent efficacy in inducing and maintaining remission in UC, stringent inclusion and exclusion criteria limit the generalizability of the trial’s findings across the broader, real-world UC population.
Findings from the recent analysis on tofacitinib were presented at AIBD 2021 by Knyazev Oleg, MD, who is the head of department of inflammatory bowel diseases at A.S. Loginov Moscow Clinical Scientific and Practical Center.
Dr. Oleg and colleagues reported on real-world treatment observations of 58 tofacitinib-treated patients with UC. Treatment efficacy was evaluated using the Mayo index (score <2), erythrocyte sedimentation rate, C-reactive protein, hemoglobin, fecal calprotectin, and the need for glucocorticoids (GCS).
At the time of tofacitinib initiation, all patients received GCS, with a mean therapeutic dose of 40 mg. In all 49 patients who responded to therapy, corticosteroids were discontinued after induction.
Only 15.5% (n = 9) of the study cohort did not respond to the JAK inhibitor during the follow-up period. A total of 14 patients (24.1%) who previously received anti-TNF therapies required a prolonged induction course of 20 mg tofacitinib. More than one out of five patients (22.4%) required repeated corticosteroids to manage exacerbations or dwindled tofacitinib response.
During another session, which discussed prescription treatment for moderate to severe UC, Bincy Abraham, MD, a professor of clinical medicine at Houston Methodist Academic Institute, summarized currently available clinical trial data on tofacitinib and discussed her own observations in her practice regarding the efficacy of the JAK inhibitor in the UC population.
The current data show the oral JAK inhibitor allows patients to reach remission as early as 8 weeks, with corresponding reductions observed in rectal bleeding and stool frequency as early as 2 weeks after therapy initiation. While the efficacy findings are corroborated by her own clinical practice, Dr. Abraham largely discussed the safety implications of the treatment.
Dr. Abraham emphasized the need for risk-mitigation strategies before initiating tofacitinib in appropriately selected patients with UC. In particular, Dr. Abraham explained that clinicians should be alerted to the possibility of tuberculosis as an opportunistic infection in tofacitinib-treated patients. “Before starting, I always liked to make sure that patients are getting checked for tuberculosis,” she said, adding that she performs annual monitoring for patients treated with the agent.
When considering tofacitinib, Dr. Abraham added that clinicians should ultimately consider discussing the risks of therapy versus the benefits in eligible patients.
During the question-and-answer portion of her session, Dr. Abraham noted that she has observed mixed findings in regard to tofacitinib’s effects on lipid levels. Specifically, only a small number of patients with UC in her practice have had to initiate cholesterol therapy while taking tofacitinib, but these patients typically have high-risk factors for hyperlipidemia, including family history and elevated body mass index.
On a question regarding the risk of shingles, Dr. Abraham noted that, if a patient does indeed develop the condition while taking tofacitinib, the therapy should be halted until shingles is resolved. In her practice, Dr. Abraham explained shingles vaccination is a priority before starting tofacitinib, suggesting this strategy has thus far prevented her tofacitinib-treated patients from developing the condition.
In patients with flares, Dr. Abraham noted that “we don’t have any specific clinical trial data specifically looking at” how to manage tofacitinib doses to further manage difficult-to-treat disease. She stated that, in her practice, she increases the dose of tofacitinib in patients who experience flares, as this often improves response. Subsequent dose reductions should be based on an individualized basis, with many patients requiring higher doses at varying periods.
Dr. Oleg has no relevant financial disclosures. Dr. Abraham reported conflicts of interest with Pfizer, which sponsored her discussion.
A real-world analysis of tofacitinib, presented at the annual Advances in Inflammatory Bowel Disease conference, confirms that long-term use of the selective immunosuppressant agent tofacitinib is associated with high rates of steroid-free remission in patients with ulcerative colitis (UC). These findings, along with clinical practice observations made during another session at the conference, further validate the efficacy of tofacitinib beyond that currently reported in specific clinical trial populations.
Tofacitinib is a small-molecule Janus kinase inhibitor that interferes with the intracellular JAK/signal transducer and activators of transcription pathway. Compared with other biologic agents, tofacitinib simultaneously acts on several cytokines and exerts broader effects on gastrointestinal inflammation.
Tofacitinib’s approval for moderate to severe UC was based on data from the OCTAVE clinical trial program. Although the phase 3 OCTAVE trial showed the JAK inhibitor features dose-dependent efficacy in inducing and maintaining remission in UC, stringent inclusion and exclusion criteria limit the generalizability of the trial’s findings across the broader, real-world UC population.
Findings from the recent analysis on tofacitinib were presented at AIBD 2021 by Knyazev Oleg, MD, who is the head of department of inflammatory bowel diseases at A.S. Loginov Moscow Clinical Scientific and Practical Center.
Dr. Oleg and colleagues reported on real-world treatment observations of 58 tofacitinib-treated patients with UC. Treatment efficacy was evaluated using the Mayo index (score <2), erythrocyte sedimentation rate, C-reactive protein, hemoglobin, fecal calprotectin, and the need for glucocorticoids (GCS).
At the time of tofacitinib initiation, all patients received GCS, with a mean therapeutic dose of 40 mg. In all 49 patients who responded to therapy, corticosteroids were discontinued after induction.
Only 15.5% (n = 9) of the study cohort did not respond to the JAK inhibitor during the follow-up period. A total of 14 patients (24.1%) who previously received anti-TNF therapies required a prolonged induction course of 20 mg tofacitinib. More than one out of five patients (22.4%) required repeated corticosteroids to manage exacerbations or dwindled tofacitinib response.
During another session, which discussed prescription treatment for moderate to severe UC, Bincy Abraham, MD, a professor of clinical medicine at Houston Methodist Academic Institute, summarized currently available clinical trial data on tofacitinib and discussed her own observations in her practice regarding the efficacy of the JAK inhibitor in the UC population.
The current data show the oral JAK inhibitor allows patients to reach remission as early as 8 weeks, with corresponding reductions observed in rectal bleeding and stool frequency as early as 2 weeks after therapy initiation. While the efficacy findings are corroborated by her own clinical practice, Dr. Abraham largely discussed the safety implications of the treatment.
Dr. Abraham emphasized the need for risk-mitigation strategies before initiating tofacitinib in appropriately selected patients with UC. In particular, Dr. Abraham explained that clinicians should be alerted to the possibility of tuberculosis as an opportunistic infection in tofacitinib-treated patients. “Before starting, I always liked to make sure that patients are getting checked for tuberculosis,” she said, adding that she performs annual monitoring for patients treated with the agent.
When considering tofacitinib, Dr. Abraham added that clinicians should ultimately consider discussing the risks of therapy versus the benefits in eligible patients.
During the question-and-answer portion of her session, Dr. Abraham noted that she has observed mixed findings in regard to tofacitinib’s effects on lipid levels. Specifically, only a small number of patients with UC in her practice have had to initiate cholesterol therapy while taking tofacitinib, but these patients typically have high-risk factors for hyperlipidemia, including family history and elevated body mass index.
On a question regarding the risk of shingles, Dr. Abraham noted that, if a patient does indeed develop the condition while taking tofacitinib, the therapy should be halted until shingles is resolved. In her practice, Dr. Abraham explained shingles vaccination is a priority before starting tofacitinib, suggesting this strategy has thus far prevented her tofacitinib-treated patients from developing the condition.
In patients with flares, Dr. Abraham noted that “we don’t have any specific clinical trial data specifically looking at” how to manage tofacitinib doses to further manage difficult-to-treat disease. She stated that, in her practice, she increases the dose of tofacitinib in patients who experience flares, as this often improves response. Subsequent dose reductions should be based on an individualized basis, with many patients requiring higher doses at varying periods.
Dr. Oleg has no relevant financial disclosures. Dr. Abraham reported conflicts of interest with Pfizer, which sponsored her discussion.
FROM AIBD 2021
FDA approves levoketoconazole for Cushing syndrome
The Food and Drug Administration has approved levoketoconazole (Recorlev, Xeris Biopharma) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not possible or was not curative.
Endogenous Cushing syndrome is a relatively rare condition characterized by chronically elevated cortisol levels, typically arising from a benign pituitary tumor. Left untreated, it can lead to reproductive problems and hirsutism in women, as well as serious complications, including diabetes, hypertension, tissue fragility, and mood disorders. Half of patients will die within 5 years if left untreated.
Levoketoconazole inhibits cortisol synthesis. The FDA approval was based on efficacy and safety data from two phase 3 studies involving a total of 166 patients with endogenous Cushing syndrome. In both the open-label, single-arm SONICS study and the randomized, placebo-controlled LOGICS trial, the drug significantly reduced and normalized mean urinary free cortisol levels and improved several secondary endpoints. The ongoing open-label OPTICS study will gather long-term data.
The Recorlev label includes boxed warnings about the potential for life-threatening hepatotoxicity and QT prolongation. Prior to and during treatment, patients should undergo liver enzyme testing, ECG, and correction of hypokalemia and hypomagnesemia.
The most common adverse reactions (occurring in less than 20%) include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
“Cushing syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options ... We are excited to see that the long and complicated path of rare drug development has reached FDA approval on a new therapeutic option for our underserved Cushing’s community,” Leslie Edwin, president of the Cushing’s Support & Research Foundation, said in a Xeris statement.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved levoketoconazole (Recorlev, Xeris Biopharma) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not possible or was not curative.
Endogenous Cushing syndrome is a relatively rare condition characterized by chronically elevated cortisol levels, typically arising from a benign pituitary tumor. Left untreated, it can lead to reproductive problems and hirsutism in women, as well as serious complications, including diabetes, hypertension, tissue fragility, and mood disorders. Half of patients will die within 5 years if left untreated.
Levoketoconazole inhibits cortisol synthesis. The FDA approval was based on efficacy and safety data from two phase 3 studies involving a total of 166 patients with endogenous Cushing syndrome. In both the open-label, single-arm SONICS study and the randomized, placebo-controlled LOGICS trial, the drug significantly reduced and normalized mean urinary free cortisol levels and improved several secondary endpoints. The ongoing open-label OPTICS study will gather long-term data.
The Recorlev label includes boxed warnings about the potential for life-threatening hepatotoxicity and QT prolongation. Prior to and during treatment, patients should undergo liver enzyme testing, ECG, and correction of hypokalemia and hypomagnesemia.
The most common adverse reactions (occurring in less than 20%) include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
“Cushing syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options ... We are excited to see that the long and complicated path of rare drug development has reached FDA approval on a new therapeutic option for our underserved Cushing’s community,” Leslie Edwin, president of the Cushing’s Support & Research Foundation, said in a Xeris statement.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved levoketoconazole (Recorlev, Xeris Biopharma) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not possible or was not curative.
Endogenous Cushing syndrome is a relatively rare condition characterized by chronically elevated cortisol levels, typically arising from a benign pituitary tumor. Left untreated, it can lead to reproductive problems and hirsutism in women, as well as serious complications, including diabetes, hypertension, tissue fragility, and mood disorders. Half of patients will die within 5 years if left untreated.
Levoketoconazole inhibits cortisol synthesis. The FDA approval was based on efficacy and safety data from two phase 3 studies involving a total of 166 patients with endogenous Cushing syndrome. In both the open-label, single-arm SONICS study and the randomized, placebo-controlled LOGICS trial, the drug significantly reduced and normalized mean urinary free cortisol levels and improved several secondary endpoints. The ongoing open-label OPTICS study will gather long-term data.
The Recorlev label includes boxed warnings about the potential for life-threatening hepatotoxicity and QT prolongation. Prior to and during treatment, patients should undergo liver enzyme testing, ECG, and correction of hypokalemia and hypomagnesemia.
The most common adverse reactions (occurring in less than 20%) include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.
“Cushing syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options ... We are excited to see that the long and complicated path of rare drug development has reached FDA approval on a new therapeutic option for our underserved Cushing’s community,” Leslie Edwin, president of the Cushing’s Support & Research Foundation, said in a Xeris statement.
A version of this article first appeared on Medscape.com.
Infectious disease pop quiz: Clinical challenge #9 for the ObGyn
For uncomplicated chlamydia infection in a pregnant woman, what is the most appropriate treatment?
Continue to the answer...
Uncomplicated chlamydia infection in a pregnant woman should be treated with a single 1,000-mg oral dose of azithromycin. An acceptable alternative is amoxicillin 500 mg orally 3 times daily for 7 days.
In a nonpregnant patient, doxycycline 100 mg orally twice daily for 7 days is also an appropriate alternative. However, doxycycline is relatively expensive and may not be well tolerated because of gastrointestinal adverse effects. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)
- Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
- Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
For uncomplicated chlamydia infection in a pregnant woman, what is the most appropriate treatment?
Continue to the answer...
Uncomplicated chlamydia infection in a pregnant woman should be treated with a single 1,000-mg oral dose of azithromycin. An acceptable alternative is amoxicillin 500 mg orally 3 times daily for 7 days.
In a nonpregnant patient, doxycycline 100 mg orally twice daily for 7 days is also an appropriate alternative. However, doxycycline is relatively expensive and may not be well tolerated because of gastrointestinal adverse effects. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)
For uncomplicated chlamydia infection in a pregnant woman, what is the most appropriate treatment?
Continue to the answer...
Uncomplicated chlamydia infection in a pregnant woman should be treated with a single 1,000-mg oral dose of azithromycin. An acceptable alternative is amoxicillin 500 mg orally 3 times daily for 7 days.
In a nonpregnant patient, doxycycline 100 mg orally twice daily for 7 days is also an appropriate alternative. However, doxycycline is relatively expensive and may not be well tolerated because of gastrointestinal adverse effects. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)
- Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
- Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
- Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
- Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
AAN updates treatment guidance on painful diabetic neuropathy
Painful diabetic neuropathy is very common and can greatly affect an individual’s quality of life, guideline author Brian Callaghan, MD, University of Michigan, Ann Arbor, noted in a news release.
“This guideline aims to help neurologists and other doctors provide the highest quality patient care based on the latest evidence,” Dr. Callaghan said.
The recommendations update the 2011 AAN guideline on the treatment of painful diabetic neuropathy. The new guidance was published online Dec. 27, 2021, in Neurology and has been endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine.
Multiple options
To update the guideline, an expert panel reviewed data from more than 100 randomized controlled trials published from January 2008 to April 2020.
The panel noted that more than 16% of individuals with diabetes experience painful diabetic neuropathy, but it often goes unrecognized and untreated. The guideline recommends clinicians assess patients with diabetes for peripheral neuropathic pain and its effect on their function and quality of life.
Before prescribing treatment, health providers should determine if the patient also has mood or sleep problems as both can influence pain perception.
The guideline recommends offering one of four classes of oral medications found to be effective for neuropathic pain: tricyclic antidepressants such as amitriptyline, nortriptyline, or imipramine; serotonin norepinephrine reuptake inhibitors such as duloxetine, venlafaxine, or desvenlafaxine; gabapentinoids such as gabapentin or pregabalin; and/or sodium channel blockers such as carbamazepine, oxcarbazepine, lamotrigine, or lacosamide.
All four classes of medications have “comparable effect sizes just above or just below our cutoff for a medium effect size” (standardized median difference, 0.5), the panel noted.
In addition, “new studies on sodium channel blockers published since the last guideline have resulted in these drugs now being recommended and considered as effective at providing pain relief as the other drug classes recommended in this guideline,” said Dr. Callaghan.
When an initial medication fails to provide meaningful improvement in pain, or produces significant side effects, a trial of another medication from a different class is recommended.
Pain reduction, not elimination
Opioids are not recommended for painful diabetic neuropathy. Not only do they come with risks, there is also no strong evidence they are effective for painful diabetic neuropathy in the long term, the panel wrote. Tramadol and tapentadol are also not recommended for the treatment of painful diabetic neuropathy.
“Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed,” Dr. Callaghan said.
For patients interested in trying topical, nontraditional, or nondrug interventions to reduce pain, the guideline recommends a number of options including capsaicin, glyceryl trinitrate spray, and Citrullus colocynthis. Ginkgo biloba, exercise, mindfulness, cognitive-behavioral therapy, and tai chi are also suggested.
“It is important to note that the recommended drugs and topical treatments in this guideline may not eliminate pain, but they have been shown to reduce pain,” Dr. Callaghan said. “The good news is there are many treatment options for painful diabetic neuropathy, so a treatment plan can be tailored specifically to each person living with this condition.”
Along with the updated guideline, the AAN has also published a new Polyneuropathy Quality Measurement Set to assist neurologists and other health care providers in treating patients with painful diabetic neuropathy.
The updated guideline was developed with financial support from the AAN.
A version of this article first appeared on Medscape.com.
Painful diabetic neuropathy is very common and can greatly affect an individual’s quality of life, guideline author Brian Callaghan, MD, University of Michigan, Ann Arbor, noted in a news release.
“This guideline aims to help neurologists and other doctors provide the highest quality patient care based on the latest evidence,” Dr. Callaghan said.
The recommendations update the 2011 AAN guideline on the treatment of painful diabetic neuropathy. The new guidance was published online Dec. 27, 2021, in Neurology and has been endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine.
Multiple options
To update the guideline, an expert panel reviewed data from more than 100 randomized controlled trials published from January 2008 to April 2020.
The panel noted that more than 16% of individuals with diabetes experience painful diabetic neuropathy, but it often goes unrecognized and untreated. The guideline recommends clinicians assess patients with diabetes for peripheral neuropathic pain and its effect on their function and quality of life.
Before prescribing treatment, health providers should determine if the patient also has mood or sleep problems as both can influence pain perception.
The guideline recommends offering one of four classes of oral medications found to be effective for neuropathic pain: tricyclic antidepressants such as amitriptyline, nortriptyline, or imipramine; serotonin norepinephrine reuptake inhibitors such as duloxetine, venlafaxine, or desvenlafaxine; gabapentinoids such as gabapentin or pregabalin; and/or sodium channel blockers such as carbamazepine, oxcarbazepine, lamotrigine, or lacosamide.
All four classes of medications have “comparable effect sizes just above or just below our cutoff for a medium effect size” (standardized median difference, 0.5), the panel noted.
In addition, “new studies on sodium channel blockers published since the last guideline have resulted in these drugs now being recommended and considered as effective at providing pain relief as the other drug classes recommended in this guideline,” said Dr. Callaghan.
When an initial medication fails to provide meaningful improvement in pain, or produces significant side effects, a trial of another medication from a different class is recommended.
Pain reduction, not elimination
Opioids are not recommended for painful diabetic neuropathy. Not only do they come with risks, there is also no strong evidence they are effective for painful diabetic neuropathy in the long term, the panel wrote. Tramadol and tapentadol are also not recommended for the treatment of painful diabetic neuropathy.
“Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed,” Dr. Callaghan said.
For patients interested in trying topical, nontraditional, or nondrug interventions to reduce pain, the guideline recommends a number of options including capsaicin, glyceryl trinitrate spray, and Citrullus colocynthis. Ginkgo biloba, exercise, mindfulness, cognitive-behavioral therapy, and tai chi are also suggested.
“It is important to note that the recommended drugs and topical treatments in this guideline may not eliminate pain, but they have been shown to reduce pain,” Dr. Callaghan said. “The good news is there are many treatment options for painful diabetic neuropathy, so a treatment plan can be tailored specifically to each person living with this condition.”
Along with the updated guideline, the AAN has also published a new Polyneuropathy Quality Measurement Set to assist neurologists and other health care providers in treating patients with painful diabetic neuropathy.
The updated guideline was developed with financial support from the AAN.
A version of this article first appeared on Medscape.com.
Painful diabetic neuropathy is very common and can greatly affect an individual’s quality of life, guideline author Brian Callaghan, MD, University of Michigan, Ann Arbor, noted in a news release.
“This guideline aims to help neurologists and other doctors provide the highest quality patient care based on the latest evidence,” Dr. Callaghan said.
The recommendations update the 2011 AAN guideline on the treatment of painful diabetic neuropathy. The new guidance was published online Dec. 27, 2021, in Neurology and has been endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine.
Multiple options
To update the guideline, an expert panel reviewed data from more than 100 randomized controlled trials published from January 2008 to April 2020.
The panel noted that more than 16% of individuals with diabetes experience painful diabetic neuropathy, but it often goes unrecognized and untreated. The guideline recommends clinicians assess patients with diabetes for peripheral neuropathic pain and its effect on their function and quality of life.
Before prescribing treatment, health providers should determine if the patient also has mood or sleep problems as both can influence pain perception.
The guideline recommends offering one of four classes of oral medications found to be effective for neuropathic pain: tricyclic antidepressants such as amitriptyline, nortriptyline, or imipramine; serotonin norepinephrine reuptake inhibitors such as duloxetine, venlafaxine, or desvenlafaxine; gabapentinoids such as gabapentin or pregabalin; and/or sodium channel blockers such as carbamazepine, oxcarbazepine, lamotrigine, or lacosamide.
All four classes of medications have “comparable effect sizes just above or just below our cutoff for a medium effect size” (standardized median difference, 0.5), the panel noted.
In addition, “new studies on sodium channel blockers published since the last guideline have resulted in these drugs now being recommended and considered as effective at providing pain relief as the other drug classes recommended in this guideline,” said Dr. Callaghan.
When an initial medication fails to provide meaningful improvement in pain, or produces significant side effects, a trial of another medication from a different class is recommended.
Pain reduction, not elimination
Opioids are not recommended for painful diabetic neuropathy. Not only do they come with risks, there is also no strong evidence they are effective for painful diabetic neuropathy in the long term, the panel wrote. Tramadol and tapentadol are also not recommended for the treatment of painful diabetic neuropathy.
“Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed,” Dr. Callaghan said.
For patients interested in trying topical, nontraditional, or nondrug interventions to reduce pain, the guideline recommends a number of options including capsaicin, glyceryl trinitrate spray, and Citrullus colocynthis. Ginkgo biloba, exercise, mindfulness, cognitive-behavioral therapy, and tai chi are also suggested.
“It is important to note that the recommended drugs and topical treatments in this guideline may not eliminate pain, but they have been shown to reduce pain,” Dr. Callaghan said. “The good news is there are many treatment options for painful diabetic neuropathy, so a treatment plan can be tailored specifically to each person living with this condition.”
Along with the updated guideline, the AAN has also published a new Polyneuropathy Quality Measurement Set to assist neurologists and other health care providers in treating patients with painful diabetic neuropathy.
The updated guideline was developed with financial support from the AAN.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
Posttraumatic epilepsy is common, even after ‘mild’ TBI
, new research suggests.
Results from a multicenter, prospective cohort study showed 2.7% of nearly 1,500 participants with TBI reported also having posttraumatic epilepsy, and these patients had significantly worse outcomes than those without posttraumatic epilepsy.
“Posttraumatic epilepsy is common even in so-called mild TBI, and we should be on the lookout for patients reporting these kinds of spells,” said coinvestigator Ramon Diaz-Arrastia, MD, PhD, professor of neurology and director of the TBI Clinical Research Center, University of Pennsylvania, Philadelphia.
Dr. Diaz-Arrastia said he dislikes the term “mild TBI” because many of these injuries have “pretty substantial consequences.”
The findings were published online Dec. 29 in JAMA Network Open.
Novel study
Seizures can occur after TBI, most commonly after a severe brain injury, such as those leading to coma or bleeding in the brain or requiring surgical intervention. However, there have been “hints” that some patients with milder brain injuries are also at increased risk for epilepsy, said Dr. Diaz-Arrastia.
To investigate, the researchers assessed data from the large, multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) database. Participants with TBI, defined as a Glasgow Coma Scale (GCS) score of 3-15, had presented to a level I trauma center within 24 hours of a head trauma needing evaluation with a CT scan.
The study included patients with relatively mild TBI (GCS score, 13-15), which is a “novel feature” of the study, the authors noted. Most prior studies of posttraumatic epilepsy focused on moderate to severe TBI.
The researchers included two sex- and age-matched control groups. The orthopedic trauma control (OTC) group consisted of patients with isolated trauma to the limbs, pelvis, and/or ribs. The “friend” or peer control group had backgrounds and lifestyles similar to those with TBI but had no history of TBI, concussion, or traumatic injury in the previous year.
The analysis included 1,885 participants (mean age, 41.3 years; 65.8% men). Of these, 1,493 had TBI, 182 were in the OTC group, and 210 were in the friends group. At 6- and 12-month follow-ups, investigators administered the Epilepsy Screening Questionnaire (ESQ), developed by the National Institute of Neurological Disorders and Stroke (NINDS).
Confirmatory data
Participants were asked about experiencing uncontrolled movements, unexplained changes in mental state, and repeated unusual attacks or convulsions, and whether they had been told they had epilepsy or seizures. If they answered yes to any of these questions, they received second-level screening, which asked about seizures.
Patients were deemed to have posttraumatic epilepsy if they answered affirmatively to any first-level screening item, experienced seizures 7 days after injury, and were diagnosed with epilepsy.
The primary outcome was rate of positive posttraumatic epilepsy diagnoses. At 12 months, 2.7% of those with TBI reported a posttraumatic epilepsy diagnosis compared with none of either of the control groups (P < .001).
This rate is consistent with prior literature and is “pretty close to what we expected,” said Dr. Diaz-Arrastia.
Among those with TBI and posttraumatic epilepsy, 12.2% had GCS scores of 3-8 (severe), 5.3% had scores of 9-12 (moderate), and 0.9% had scores of 13-15 (mild). That figure for mild TBI is not insignificant, said Dr. Diaz-Arrastia.
“Probably 90% of all those coming to the emergency room with a brain injury are diagnosed with mild TBI not requiring admission,” he noted.
The risk for posttraumatic epilepsy was higher the more severe the head injury, and among those with hemorrhage on head CT imaging. In patients with mild TBI, hemorrhage was associated with a two- to threefold risk of developing posttraumatic epilepsy.
“This prospective observational study confirms the epidemiologic data that even after mild brain injury, there is an increased risk for epilepsy,” said Dr. Diaz-Arrastia.
Universal screening?
The researchers also looked at whether seizures worsen other outcomes. Compared with those who had TBI but not posttraumatic epilepsy, those with posttraumatic epilepsy had significantly lower Glasgow Outcome Scale Extended (GOSE) scores (mean, 4.7 vs. 6.1; P < .001), higher Brief Symptom Inventory (BSI) scores (58.6 vs. 50.2; P = .02), and higher Rivermead Cognitive Metric (RCM) scores (5.3 vs. 3.1; P = .002) at 12 months after adjustment for age, initial GCS score, and imaging findings.
Higher GOSE and RCM scores reflect better outcomes, but a higher score on the BSI, which assesses overall mood, reflects a worse outcome, the investigators noted.
Previous evidence suggests prophylactic use of antiepileptic drugs in patients with TBI does not reduce risks. These drugs “are neither 100% safe nor 100% effective,” said Dr. Diaz-Arrastia. Some studies showed that certain agents actually worsen outcomes, he added.
What the field needs instead are antiepileptogenic drugs – those that interfere with the maladaptive synaptic plasticity that ends up in an epileptic circuit, he noted.
The new results suggest screening for posttraumatic epilepsy using the NINDS-ESQ “should be done pretty much routinely as a follow-up for all brain injuries,” Dr. Diaz-Arrastia said.
The investigators plan to have study participants assessed by an epileptologist later. A significant number of people with TBI, he noted, won’t develop posttraumatic epilepsy until 1-5 years after their injury – and even later in some cases.
A limitation of the study was that some patients reporting posttraumatic epilepsy may have had psychogenic nonepileptiform seizures, which are common in TBI patients, the investigators noted.
The study was supported by grants from One Mind, National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS, and Department of Defence. Dr. Diaz-Arrastia reported receiving grants from the NIH, NINDS, and DOD during the conduct of the study.
A version of this article first appeared on Medscape.com.
, new research suggests.
Results from a multicenter, prospective cohort study showed 2.7% of nearly 1,500 participants with TBI reported also having posttraumatic epilepsy, and these patients had significantly worse outcomes than those without posttraumatic epilepsy.
“Posttraumatic epilepsy is common even in so-called mild TBI, and we should be on the lookout for patients reporting these kinds of spells,” said coinvestigator Ramon Diaz-Arrastia, MD, PhD, professor of neurology and director of the TBI Clinical Research Center, University of Pennsylvania, Philadelphia.
Dr. Diaz-Arrastia said he dislikes the term “mild TBI” because many of these injuries have “pretty substantial consequences.”
The findings were published online Dec. 29 in JAMA Network Open.
Novel study
Seizures can occur after TBI, most commonly after a severe brain injury, such as those leading to coma or bleeding in the brain or requiring surgical intervention. However, there have been “hints” that some patients with milder brain injuries are also at increased risk for epilepsy, said Dr. Diaz-Arrastia.
To investigate, the researchers assessed data from the large, multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) database. Participants with TBI, defined as a Glasgow Coma Scale (GCS) score of 3-15, had presented to a level I trauma center within 24 hours of a head trauma needing evaluation with a CT scan.
The study included patients with relatively mild TBI (GCS score, 13-15), which is a “novel feature” of the study, the authors noted. Most prior studies of posttraumatic epilepsy focused on moderate to severe TBI.
The researchers included two sex- and age-matched control groups. The orthopedic trauma control (OTC) group consisted of patients with isolated trauma to the limbs, pelvis, and/or ribs. The “friend” or peer control group had backgrounds and lifestyles similar to those with TBI but had no history of TBI, concussion, or traumatic injury in the previous year.
The analysis included 1,885 participants (mean age, 41.3 years; 65.8% men). Of these, 1,493 had TBI, 182 were in the OTC group, and 210 were in the friends group. At 6- and 12-month follow-ups, investigators administered the Epilepsy Screening Questionnaire (ESQ), developed by the National Institute of Neurological Disorders and Stroke (NINDS).
Confirmatory data
Participants were asked about experiencing uncontrolled movements, unexplained changes in mental state, and repeated unusual attacks or convulsions, and whether they had been told they had epilepsy or seizures. If they answered yes to any of these questions, they received second-level screening, which asked about seizures.
Patients were deemed to have posttraumatic epilepsy if they answered affirmatively to any first-level screening item, experienced seizures 7 days after injury, and were diagnosed with epilepsy.
The primary outcome was rate of positive posttraumatic epilepsy diagnoses. At 12 months, 2.7% of those with TBI reported a posttraumatic epilepsy diagnosis compared with none of either of the control groups (P < .001).
This rate is consistent with prior literature and is “pretty close to what we expected,” said Dr. Diaz-Arrastia.
Among those with TBI and posttraumatic epilepsy, 12.2% had GCS scores of 3-8 (severe), 5.3% had scores of 9-12 (moderate), and 0.9% had scores of 13-15 (mild). That figure for mild TBI is not insignificant, said Dr. Diaz-Arrastia.
“Probably 90% of all those coming to the emergency room with a brain injury are diagnosed with mild TBI not requiring admission,” he noted.
The risk for posttraumatic epilepsy was higher the more severe the head injury, and among those with hemorrhage on head CT imaging. In patients with mild TBI, hemorrhage was associated with a two- to threefold risk of developing posttraumatic epilepsy.
“This prospective observational study confirms the epidemiologic data that even after mild brain injury, there is an increased risk for epilepsy,” said Dr. Diaz-Arrastia.
Universal screening?
The researchers also looked at whether seizures worsen other outcomes. Compared with those who had TBI but not posttraumatic epilepsy, those with posttraumatic epilepsy had significantly lower Glasgow Outcome Scale Extended (GOSE) scores (mean, 4.7 vs. 6.1; P < .001), higher Brief Symptom Inventory (BSI) scores (58.6 vs. 50.2; P = .02), and higher Rivermead Cognitive Metric (RCM) scores (5.3 vs. 3.1; P = .002) at 12 months after adjustment for age, initial GCS score, and imaging findings.
Higher GOSE and RCM scores reflect better outcomes, but a higher score on the BSI, which assesses overall mood, reflects a worse outcome, the investigators noted.
Previous evidence suggests prophylactic use of antiepileptic drugs in patients with TBI does not reduce risks. These drugs “are neither 100% safe nor 100% effective,” said Dr. Diaz-Arrastia. Some studies showed that certain agents actually worsen outcomes, he added.
What the field needs instead are antiepileptogenic drugs – those that interfere with the maladaptive synaptic plasticity that ends up in an epileptic circuit, he noted.
The new results suggest screening for posttraumatic epilepsy using the NINDS-ESQ “should be done pretty much routinely as a follow-up for all brain injuries,” Dr. Diaz-Arrastia said.
The investigators plan to have study participants assessed by an epileptologist later. A significant number of people with TBI, he noted, won’t develop posttraumatic epilepsy until 1-5 years after their injury – and even later in some cases.
A limitation of the study was that some patients reporting posttraumatic epilepsy may have had psychogenic nonepileptiform seizures, which are common in TBI patients, the investigators noted.
The study was supported by grants from One Mind, National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS, and Department of Defence. Dr. Diaz-Arrastia reported receiving grants from the NIH, NINDS, and DOD during the conduct of the study.
A version of this article first appeared on Medscape.com.
, new research suggests.
Results from a multicenter, prospective cohort study showed 2.7% of nearly 1,500 participants with TBI reported also having posttraumatic epilepsy, and these patients had significantly worse outcomes than those without posttraumatic epilepsy.
“Posttraumatic epilepsy is common even in so-called mild TBI, and we should be on the lookout for patients reporting these kinds of spells,” said coinvestigator Ramon Diaz-Arrastia, MD, PhD, professor of neurology and director of the TBI Clinical Research Center, University of Pennsylvania, Philadelphia.
Dr. Diaz-Arrastia said he dislikes the term “mild TBI” because many of these injuries have “pretty substantial consequences.”
The findings were published online Dec. 29 in JAMA Network Open.
Novel study
Seizures can occur after TBI, most commonly after a severe brain injury, such as those leading to coma or bleeding in the brain or requiring surgical intervention. However, there have been “hints” that some patients with milder brain injuries are also at increased risk for epilepsy, said Dr. Diaz-Arrastia.
To investigate, the researchers assessed data from the large, multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) database. Participants with TBI, defined as a Glasgow Coma Scale (GCS) score of 3-15, had presented to a level I trauma center within 24 hours of a head trauma needing evaluation with a CT scan.
The study included patients with relatively mild TBI (GCS score, 13-15), which is a “novel feature” of the study, the authors noted. Most prior studies of posttraumatic epilepsy focused on moderate to severe TBI.
The researchers included two sex- and age-matched control groups. The orthopedic trauma control (OTC) group consisted of patients with isolated trauma to the limbs, pelvis, and/or ribs. The “friend” or peer control group had backgrounds and lifestyles similar to those with TBI but had no history of TBI, concussion, or traumatic injury in the previous year.
The analysis included 1,885 participants (mean age, 41.3 years; 65.8% men). Of these, 1,493 had TBI, 182 were in the OTC group, and 210 were in the friends group. At 6- and 12-month follow-ups, investigators administered the Epilepsy Screening Questionnaire (ESQ), developed by the National Institute of Neurological Disorders and Stroke (NINDS).
Confirmatory data
Participants were asked about experiencing uncontrolled movements, unexplained changes in mental state, and repeated unusual attacks or convulsions, and whether they had been told they had epilepsy or seizures. If they answered yes to any of these questions, they received second-level screening, which asked about seizures.
Patients were deemed to have posttraumatic epilepsy if they answered affirmatively to any first-level screening item, experienced seizures 7 days after injury, and were diagnosed with epilepsy.
The primary outcome was rate of positive posttraumatic epilepsy diagnoses. At 12 months, 2.7% of those with TBI reported a posttraumatic epilepsy diagnosis compared with none of either of the control groups (P < .001).
This rate is consistent with prior literature and is “pretty close to what we expected,” said Dr. Diaz-Arrastia.
Among those with TBI and posttraumatic epilepsy, 12.2% had GCS scores of 3-8 (severe), 5.3% had scores of 9-12 (moderate), and 0.9% had scores of 13-15 (mild). That figure for mild TBI is not insignificant, said Dr. Diaz-Arrastia.
“Probably 90% of all those coming to the emergency room with a brain injury are diagnosed with mild TBI not requiring admission,” he noted.
The risk for posttraumatic epilepsy was higher the more severe the head injury, and among those with hemorrhage on head CT imaging. In patients with mild TBI, hemorrhage was associated with a two- to threefold risk of developing posttraumatic epilepsy.
“This prospective observational study confirms the epidemiologic data that even after mild brain injury, there is an increased risk for epilepsy,” said Dr. Diaz-Arrastia.
Universal screening?
The researchers also looked at whether seizures worsen other outcomes. Compared with those who had TBI but not posttraumatic epilepsy, those with posttraumatic epilepsy had significantly lower Glasgow Outcome Scale Extended (GOSE) scores (mean, 4.7 vs. 6.1; P < .001), higher Brief Symptom Inventory (BSI) scores (58.6 vs. 50.2; P = .02), and higher Rivermead Cognitive Metric (RCM) scores (5.3 vs. 3.1; P = .002) at 12 months after adjustment for age, initial GCS score, and imaging findings.
Higher GOSE and RCM scores reflect better outcomes, but a higher score on the BSI, which assesses overall mood, reflects a worse outcome, the investigators noted.
Previous evidence suggests prophylactic use of antiepileptic drugs in patients with TBI does not reduce risks. These drugs “are neither 100% safe nor 100% effective,” said Dr. Diaz-Arrastia. Some studies showed that certain agents actually worsen outcomes, he added.
What the field needs instead are antiepileptogenic drugs – those that interfere with the maladaptive synaptic plasticity that ends up in an epileptic circuit, he noted.
The new results suggest screening for posttraumatic epilepsy using the NINDS-ESQ “should be done pretty much routinely as a follow-up for all brain injuries,” Dr. Diaz-Arrastia said.
The investigators plan to have study participants assessed by an epileptologist later. A significant number of people with TBI, he noted, won’t develop posttraumatic epilepsy until 1-5 years after their injury – and even later in some cases.
A limitation of the study was that some patients reporting posttraumatic epilepsy may have had psychogenic nonepileptiform seizures, which are common in TBI patients, the investigators noted.
The study was supported by grants from One Mind, National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS, and Department of Defence. Dr. Diaz-Arrastia reported receiving grants from the NIH, NINDS, and DOD during the conduct of the study.
A version of this article first appeared on Medscape.com.
Obesity prevention in infants benefits second-born too
According to a statement from the National Institutes of Health, who funded the study, it is the first such infant obesity intervention to show the spillover effect. Findings were published online Dec. 21, 2021, in Obesity.
The program is called Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, and it included guidance on feeding, sleep, interactive play, and regulating emotion.
Parents were given guidance by nurses who came to their homes on how to respond when their child is drowsy, sleeping, fussy, and alert. They also learned how to put infants to bed drowsy, but awake, and avoid feeding infants to get them to sleep; how to respond to infants waking up at night; when to start solid foods; how to limit inactive time; and how to use growth charts.
The control group program focused on safety and matched the guidance categories. For example, early visits included information on prevention of sudden infant death syndrome for sleep, breast milk storage and formula for feeding, and safe bathing.
Jennifer S. Savage, Center for Childhood Obesity Research, Penn State University, University Park, led the study that enrolled 117 infants in a randomized controlled trial. Mother and firstborn children were randomized to the RP or home safety intervention (control) group 10-14 days after delivery. Their second-born siblings were enrolled in an observation-only ancillary study.
Second-born children were delivered 2.5 (standard deviation, 0.9) years after firstborns. Anthropometrics were measured in both siblings at ages 3, 16, 28, and 52 weeks.
Firstborn children at 1 year had a body mass index (BMI) that was 0.44 kg/m2 lower than the control group (95% confidence interval, −0.82 to −0.06), and second-born children whose parents received the RP intervention with their first child had BMI that was 0.36 kg/m2 lower.
“What we saw here is that it worked again,” coauthor Ian Paul, MD, MSc, professor of pediatrics and public health sciences at Penn State University, Hershey, said in an interview.
“Once we imprint them with a certain approach to parenting with the first child, they’re doing the same thing with the second child, which is wonderful to see,” he said.
He noted that this happened with second children without any reinforcements or booster information.
Dr. Paul said it’s still not clear which of the interventions – whether related to feeding techniques or sleeping or activity – helps most. And for each family the problematic behaviors may be different.
Responsive parenting programs have shown success previously among firstborns, the authors wrote, but 80% of those children grow up with younger siblings, so an intervention that also benefits them is important.
Weighing the costs of the intervention
The intervention was extensive. It involved four hour-plus nurse visits a year, often by the same nurse who built a relationship with the family.
But Ms. Savage said that it is possible to replicate INSIGHT on a larger scale in the United States with the dozens of home visitation models.
“Currently, 21 home visitation models meet the U.S. Department of Health & Human Services criteria for evidence of effectiveness, such as Nurse Family Partnership, Family Check-up, and Early Head Start Home Based Option. There is an opportunity to use home visitation models at the national scale to potentially interrupt the cycle of poor multigenerational outcomes such as obesity,” she said.
Dr. Paul said the initial investment “can save money in the long term,” given what’s at stake. “We know that 20%-25% of 2- to 5-year-olds are already overweight or obese and if they are already overweight or obese at that age, that;’s likely to persist.”
However, he acknowledged that staff shortages and costs are a challenge.
“Other countries have made that investment in their health care system,” he said. “In the U.S. only a fraction of new mothers and babies get home visitation. The kind of work that we did for obesity prevention has not yet been incorporated into evidence-based models of home visitation, though it certainly could be.”
Dr. Paul said his team is hoping to collaborate with others in the near future on expanding this program to such models of home visitation.
Telehealth, though a less desirable option, compared with in-home visits, could also be utilized, he said.
Short of the comprehensive intervention, he said, many of the concepts can be put into practice by pediatricians and parents.
Dr. Paul noted that the Robert Wood Johnson Foundation has endorsed “responsive feeding” as the preferred approach to feeding infants and toddlers. Responsive feeding – helping parents recognize hunger and satiety cues as opposed to other distress cues – is a big part of the intervention.
“Feeding to soothe is not the preferred approach,” he said. “Food and milk and formula should be used for hunger.” That’s something pediatricians may not be stressing to parents, he said.
Pediatricians can also counsel parents on not using food as a reward. “We shouldn’t be giving kids M&Ms to teach them how to potty train,” he said.
‘Promising’ findings
Charles Wood, MD, a childhood obesity specialist at Duke University, Durham, N.C., who was not part of the study, called the findings “very promising.”
It also makes sense that the “aha moments” of first-time parents learning from the INSIGHT intervention would carry over to the second sibling, he said.
Dr. Wood agreed costs are a big factor. However, he said, the potential downstream costs of not preventing obesity are worse. And this study indicates the benefits may keep spreading with future siblings.
Dr. Wood said accessing obesity interventions outside the pediatrician visit can also help. Connecting patients with support groups or dietitians or with a counselor from Women, Infants, and Children can help. However, consistent messaging among the providers is key, he noted.
Dr. Wood’s research group is investigating text messaging platforms so parents can get answer to real-time questions, such as those about feeding behaviors.
He pointed to a limitation the authors mention, which is that the study was done in mostly White, highly educated, higher-income families.
“There’s a big problem with racial disparities and obesity,” Dr. Wood noted. “We definitely need solutions that address disparities as well.”
Mothers included in the study had given birth for the first time and their infants were enrolled after birth from a single maternity ward between January 2012 and March 2014. Major eligibility criteria were that the babies were full term (at least 37 weeks’ gestation), single births, and delivered to English-speaking mothers at least 20 years of age. Infants who weighed less than 2,500 g at birth were excluded.
The paper’s authors and Dr. Wood declared no relevant financial relationships.
This research was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases; and the Department of Agriculture.
According to a statement from the National Institutes of Health, who funded the study, it is the first such infant obesity intervention to show the spillover effect. Findings were published online Dec. 21, 2021, in Obesity.
The program is called Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, and it included guidance on feeding, sleep, interactive play, and regulating emotion.
Parents were given guidance by nurses who came to their homes on how to respond when their child is drowsy, sleeping, fussy, and alert. They also learned how to put infants to bed drowsy, but awake, and avoid feeding infants to get them to sleep; how to respond to infants waking up at night; when to start solid foods; how to limit inactive time; and how to use growth charts.
The control group program focused on safety and matched the guidance categories. For example, early visits included information on prevention of sudden infant death syndrome for sleep, breast milk storage and formula for feeding, and safe bathing.
Jennifer S. Savage, Center for Childhood Obesity Research, Penn State University, University Park, led the study that enrolled 117 infants in a randomized controlled trial. Mother and firstborn children were randomized to the RP or home safety intervention (control) group 10-14 days after delivery. Their second-born siblings were enrolled in an observation-only ancillary study.
Second-born children were delivered 2.5 (standard deviation, 0.9) years after firstborns. Anthropometrics were measured in both siblings at ages 3, 16, 28, and 52 weeks.
Firstborn children at 1 year had a body mass index (BMI) that was 0.44 kg/m2 lower than the control group (95% confidence interval, −0.82 to −0.06), and second-born children whose parents received the RP intervention with their first child had BMI that was 0.36 kg/m2 lower.
“What we saw here is that it worked again,” coauthor Ian Paul, MD, MSc, professor of pediatrics and public health sciences at Penn State University, Hershey, said in an interview.
“Once we imprint them with a certain approach to parenting with the first child, they’re doing the same thing with the second child, which is wonderful to see,” he said.
He noted that this happened with second children without any reinforcements or booster information.
Dr. Paul said it’s still not clear which of the interventions – whether related to feeding techniques or sleeping or activity – helps most. And for each family the problematic behaviors may be different.
Responsive parenting programs have shown success previously among firstborns, the authors wrote, but 80% of those children grow up with younger siblings, so an intervention that also benefits them is important.
Weighing the costs of the intervention
The intervention was extensive. It involved four hour-plus nurse visits a year, often by the same nurse who built a relationship with the family.
But Ms. Savage said that it is possible to replicate INSIGHT on a larger scale in the United States with the dozens of home visitation models.
“Currently, 21 home visitation models meet the U.S. Department of Health & Human Services criteria for evidence of effectiveness, such as Nurse Family Partnership, Family Check-up, and Early Head Start Home Based Option. There is an opportunity to use home visitation models at the national scale to potentially interrupt the cycle of poor multigenerational outcomes such as obesity,” she said.
Dr. Paul said the initial investment “can save money in the long term,” given what’s at stake. “We know that 20%-25% of 2- to 5-year-olds are already overweight or obese and if they are already overweight or obese at that age, that;’s likely to persist.”
However, he acknowledged that staff shortages and costs are a challenge.
“Other countries have made that investment in their health care system,” he said. “In the U.S. only a fraction of new mothers and babies get home visitation. The kind of work that we did for obesity prevention has not yet been incorporated into evidence-based models of home visitation, though it certainly could be.”
Dr. Paul said his team is hoping to collaborate with others in the near future on expanding this program to such models of home visitation.
Telehealth, though a less desirable option, compared with in-home visits, could also be utilized, he said.
Short of the comprehensive intervention, he said, many of the concepts can be put into practice by pediatricians and parents.
Dr. Paul noted that the Robert Wood Johnson Foundation has endorsed “responsive feeding” as the preferred approach to feeding infants and toddlers. Responsive feeding – helping parents recognize hunger and satiety cues as opposed to other distress cues – is a big part of the intervention.
“Feeding to soothe is not the preferred approach,” he said. “Food and milk and formula should be used for hunger.” That’s something pediatricians may not be stressing to parents, he said.
Pediatricians can also counsel parents on not using food as a reward. “We shouldn’t be giving kids M&Ms to teach them how to potty train,” he said.
‘Promising’ findings
Charles Wood, MD, a childhood obesity specialist at Duke University, Durham, N.C., who was not part of the study, called the findings “very promising.”
It also makes sense that the “aha moments” of first-time parents learning from the INSIGHT intervention would carry over to the second sibling, he said.
Dr. Wood agreed costs are a big factor. However, he said, the potential downstream costs of not preventing obesity are worse. And this study indicates the benefits may keep spreading with future siblings.
Dr. Wood said accessing obesity interventions outside the pediatrician visit can also help. Connecting patients with support groups or dietitians or with a counselor from Women, Infants, and Children can help. However, consistent messaging among the providers is key, he noted.
Dr. Wood’s research group is investigating text messaging platforms so parents can get answer to real-time questions, such as those about feeding behaviors.
He pointed to a limitation the authors mention, which is that the study was done in mostly White, highly educated, higher-income families.
“There’s a big problem with racial disparities and obesity,” Dr. Wood noted. “We definitely need solutions that address disparities as well.”
Mothers included in the study had given birth for the first time and their infants were enrolled after birth from a single maternity ward between January 2012 and March 2014. Major eligibility criteria were that the babies were full term (at least 37 weeks’ gestation), single births, and delivered to English-speaking mothers at least 20 years of age. Infants who weighed less than 2,500 g at birth were excluded.
The paper’s authors and Dr. Wood declared no relevant financial relationships.
This research was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases; and the Department of Agriculture.
According to a statement from the National Institutes of Health, who funded the study, it is the first such infant obesity intervention to show the spillover effect. Findings were published online Dec. 21, 2021, in Obesity.
The program is called Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, and it included guidance on feeding, sleep, interactive play, and regulating emotion.
Parents were given guidance by nurses who came to their homes on how to respond when their child is drowsy, sleeping, fussy, and alert. They also learned how to put infants to bed drowsy, but awake, and avoid feeding infants to get them to sleep; how to respond to infants waking up at night; when to start solid foods; how to limit inactive time; and how to use growth charts.
The control group program focused on safety and matched the guidance categories. For example, early visits included information on prevention of sudden infant death syndrome for sleep, breast milk storage and formula for feeding, and safe bathing.
Jennifer S. Savage, Center for Childhood Obesity Research, Penn State University, University Park, led the study that enrolled 117 infants in a randomized controlled trial. Mother and firstborn children were randomized to the RP or home safety intervention (control) group 10-14 days after delivery. Their second-born siblings were enrolled in an observation-only ancillary study.
Second-born children were delivered 2.5 (standard deviation, 0.9) years after firstborns. Anthropometrics were measured in both siblings at ages 3, 16, 28, and 52 weeks.
Firstborn children at 1 year had a body mass index (BMI) that was 0.44 kg/m2 lower than the control group (95% confidence interval, −0.82 to −0.06), and second-born children whose parents received the RP intervention with their first child had BMI that was 0.36 kg/m2 lower.
“What we saw here is that it worked again,” coauthor Ian Paul, MD, MSc, professor of pediatrics and public health sciences at Penn State University, Hershey, said in an interview.
“Once we imprint them with a certain approach to parenting with the first child, they’re doing the same thing with the second child, which is wonderful to see,” he said.
He noted that this happened with second children without any reinforcements or booster information.
Dr. Paul said it’s still not clear which of the interventions – whether related to feeding techniques or sleeping or activity – helps most. And for each family the problematic behaviors may be different.
Responsive parenting programs have shown success previously among firstborns, the authors wrote, but 80% of those children grow up with younger siblings, so an intervention that also benefits them is important.
Weighing the costs of the intervention
The intervention was extensive. It involved four hour-plus nurse visits a year, often by the same nurse who built a relationship with the family.
But Ms. Savage said that it is possible to replicate INSIGHT on a larger scale in the United States with the dozens of home visitation models.
“Currently, 21 home visitation models meet the U.S. Department of Health & Human Services criteria for evidence of effectiveness, such as Nurse Family Partnership, Family Check-up, and Early Head Start Home Based Option. There is an opportunity to use home visitation models at the national scale to potentially interrupt the cycle of poor multigenerational outcomes such as obesity,” she said.
Dr. Paul said the initial investment “can save money in the long term,” given what’s at stake. “We know that 20%-25% of 2- to 5-year-olds are already overweight or obese and if they are already overweight or obese at that age, that;’s likely to persist.”
However, he acknowledged that staff shortages and costs are a challenge.
“Other countries have made that investment in their health care system,” he said. “In the U.S. only a fraction of new mothers and babies get home visitation. The kind of work that we did for obesity prevention has not yet been incorporated into evidence-based models of home visitation, though it certainly could be.”
Dr. Paul said his team is hoping to collaborate with others in the near future on expanding this program to such models of home visitation.
Telehealth, though a less desirable option, compared with in-home visits, could also be utilized, he said.
Short of the comprehensive intervention, he said, many of the concepts can be put into practice by pediatricians and parents.
Dr. Paul noted that the Robert Wood Johnson Foundation has endorsed “responsive feeding” as the preferred approach to feeding infants and toddlers. Responsive feeding – helping parents recognize hunger and satiety cues as opposed to other distress cues – is a big part of the intervention.
“Feeding to soothe is not the preferred approach,” he said. “Food and milk and formula should be used for hunger.” That’s something pediatricians may not be stressing to parents, he said.
Pediatricians can also counsel parents on not using food as a reward. “We shouldn’t be giving kids M&Ms to teach them how to potty train,” he said.
‘Promising’ findings
Charles Wood, MD, a childhood obesity specialist at Duke University, Durham, N.C., who was not part of the study, called the findings “very promising.”
It also makes sense that the “aha moments” of first-time parents learning from the INSIGHT intervention would carry over to the second sibling, he said.
Dr. Wood agreed costs are a big factor. However, he said, the potential downstream costs of not preventing obesity are worse. And this study indicates the benefits may keep spreading with future siblings.
Dr. Wood said accessing obesity interventions outside the pediatrician visit can also help. Connecting patients with support groups or dietitians or with a counselor from Women, Infants, and Children can help. However, consistent messaging among the providers is key, he noted.
Dr. Wood’s research group is investigating text messaging platforms so parents can get answer to real-time questions, such as those about feeding behaviors.
He pointed to a limitation the authors mention, which is that the study was done in mostly White, highly educated, higher-income families.
“There’s a big problem with racial disparities and obesity,” Dr. Wood noted. “We definitely need solutions that address disparities as well.”
Mothers included in the study had given birth for the first time and their infants were enrolled after birth from a single maternity ward between January 2012 and March 2014. Major eligibility criteria were that the babies were full term (at least 37 weeks’ gestation), single births, and delivered to English-speaking mothers at least 20 years of age. Infants who weighed less than 2,500 g at birth were excluded.
The paper’s authors and Dr. Wood declared no relevant financial relationships.
This research was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases; and the Department of Agriculture.
FROM OBESITY