User login
Pediatricians called to action in addressing children’s trauma from police brutality
Pediatricians and other health care professionals who care for children are uniquely situated and qualified to educate the rest of the nation on how police brutality and overpolicing traumatizes children and teens and why those issues must be addressed, said Cornell William Brooks, JD, MDiv, a professor of public leadership and social justice at the Harvard Kennedy School of Government in Cambridge, Mass.
Mr. Brooks, also former president and CEO of the National Association for the Advancement of Colored People (NAACP), delivered an impassioned call to action during a plenary session at the annual meeting of the American Academy of Pediatrics, held virtually this year.
“In this moment, you enjoy an extraordinary measure of trust,” Mr. Brooks said. “As a consequence, I would argue that history and circumstance call upon to you to speak to this moment with a voice that is distinctive as a measure of expertise and unique as a measure of trust and credibility.”
The flood of comments throughout his live talk testified to how inspirational the AAP attendees found his words.
“We, as pediatricians, have a very powerful voice together,” wrote AAP President-elect Lee Savio Beers, MD.
“As pediatric staff we need to have our voices heard beyond the walls of our clinics, in our schools, in our legislative bodies and communities as a whole!” wrote Michelle Bucknor, MD, MBA, chief medical officer of United Healthcare of North Carolina.
Mr. Brooks opened his talk with images of Tamir Rice, Emmett Till, and George Floyd, explaining how images of Emmett Till’s dead body galvanized a movement in the same way that Rice, Floyd, Breonna Taylor, and other victims of police brutality are doing today.
“Emmett Till was killed by white racists in 1955 in Mississippi on the eve of the Montgomery boycott, and his death and his tragic image in death animated and inspired the Civil Rights movement,” Mr. Brooks said. Now “the country is divided along the fissures of class and the fault lines of race in a moment of generationally unprecedented policing. These images, tragic as they are, represent the countenance, the face of police brutality in this moment. “
How police brutality affects children
Since the death of George Floyd, at least 27 million Americans have participated in protests and demonstrations throughout at least 550 jurisdictions in the United States and throughout the world, Mr. Brooks said. But the harm of police brutality extends beyond police homicide victims.
“The harm is a matter of overpoliced patients and untreated children,” he said. Children are watching and listening as the nation grapples with police brutality and overpolicing, and the experience is traumatizing them in ways that shows up in school performance and health.
He shared findings from multiple different studies showing that exposure to police violence in the community is associated with declines in grade point averages, lower test scores, and poorer attendance. Risk of emotional disturbance is 15% greater in children exposed to police violence, and youth who have had contact with the police have reported worse health than those who hadn’t. Some of these effects increased with age, and they disproportionately fell almost entirely on Black and Hispanic students.
“Because of this trauma, school attendance and college enrollment declines,” Mr. Brooks said. “Police brutality has an impact on your patients, and beyond the patients who are right in front of you, there is a sea of millions of untreated, unattended children, and this trauma is reflected in the tremor of their voices, the trepidation, the apprehension, the fear that can be discerned in their spirits.”
Mr. Brooks shared several quotes from two qualitative studies that attempted to capture the experience of youths living in overpoliced communities and whose daily routines are criminalized. One respondent in this research said, “Sometimes I think to myself that I probably look suspicious, but I, like, shouldn’t think like that ‘cause I’m a human being.” Another said when he sees the police come around when there are groups of boys out, “I have my phone ready to record. I’m just waiting for something to happen.”
The voice of pediatricians
The voices of pediatric providers have a key role in the national discussion about this issue, Mr. Brooks said, because medical professionals have so much of America’s truth. One Pew Research Center survey found that 74% of Americans had a mostly positive view of medical doctors, compared with only 35% with a positive view of elected officials and 47% of the news media.
“As health care professionals dedicated to pediatrics, you are uniquely qualified, circumstantially and historically called in this moment to respond to this tragedy and trauma of police brutality as visited upon our children because you have been entrusted with America’s trust and credibility,” Mr. Brooks said.
He described several ways pediatricians can use storytelling to shift how the country perceives the issue of police brutality and the impact on children.
“Some children we deem to be sufficiently perfect that we can have sympathy and empathy for them,” Mr. Brooks said. “Other children are deemed to be so imperfect that we cannot have sympathy and empathy for them.” Within days of Michael Brown’s death by police in Ferguson, Mo., for example, a “post mortem character assassination” deemed Mr. Brown “too imperfect for empathy,” Mr. Brooks said.
“Dr. Brooks hit the nail on the head,” attendee Jeanette Callahan, MD, a pediatrician with Cambridge Health Alliance in Massachusetts, wrote during the session. “We must tell the stories that we hear every day from our patients.”
Pediatricians also can bring science and research into the public conversation to help people better understand children, just as the amicus briefs of pediatricians and neuroscientists in U.S. Supreme Court cases led the court to declare the death penalty and life sentences without parole as unconstitutional for minors.
“You as pediatricians, as physicians, as nurses, as health care professionals have the ability to cast doubt on things that people believe to be true and give them conviction with respect to things we know to be true as a consequence of data and our moral understanding,” Mr. Brooks said. He encouraged pediatricians to “engage in storytelling and justice-seeking by expanding and diversifying the resources we bring to public policy,” including science, data, and expertise.
Two recent examples of this professional activism include Massachusetts pediatrician Fiona Danaher’s testimony to the U.S. House of Representatives regarding current immigration policies’ impact on children and the work of Michigan pediatrician Mona Hanna-Attisha’s in exposing the Flint water crisis. Mr. Brooks shared a quote from Dr. Danaher: “For me, treating children humanely is a question of basic morality. I knew I couldn’t sit on the sidelines.”
Neither can pediatricians sit on the sidelines now with the issue of police brutality, Mr. Brooks said.
“You as pediatricians can call on America to engage in a Hippocratic approach to policing, that is to say, do no harm,” he said. “It’s not enough for us to content ourselves with children not becoming hashtags, not becoming police homicides. We have to also consider the trauma of overpolicing and oversurveilling our communities of color.”
He also recommended pediatricians remind the country that addressing social determinants of health also addresses social determinants of crime, providing an opportunity to disrupt the school-to-prison pipeline.
In the comments, attendees shared other ways pediatricians can influence policy in favor of children.
“Pediatricians can reach out to police departments, prosecutors, and public defender offices, the local judiciary, and local attorney associations, etc., to describe and explain the effects of policing on children and adolescents,” wrote Trina Anglin, MD, PhD, who retired in August 2019 as chief of the Adolescent Health Branch in the Health Resources and Services Administration’s Maternal and Child Health Bureau. “We can bring the voices of young people to others. At the community level, each professional group meets on a regular basis; each group also talks to the other groups.”
Others echoed these suggestions. “Expand your voice outside your office,” wrote Jimmell Felder, MD, of Pediatric Associates Greenwood in South Carolina. “Attend city council meetings and discuss the stories of our patients with the people who make the policies. It is part of our job to advocate for our patients.”
Joanna Betancourt, MD, a pediatrician with Salud Pediatrics in Algonquin, Ill., encouraged fellow attendees to “vote locally and nationally for people that are open to change legislation that supports the well-being of all children.”
Given all the trauma of 2020, Patricia Deffer-Valley, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, said pediatricians cannot have “moral paralysis.”
Mr. Brooks had no relevant financial disclosures. Disclosure information was unavailable for others quoted in this article
Pediatricians and other health care professionals who care for children are uniquely situated and qualified to educate the rest of the nation on how police brutality and overpolicing traumatizes children and teens and why those issues must be addressed, said Cornell William Brooks, JD, MDiv, a professor of public leadership and social justice at the Harvard Kennedy School of Government in Cambridge, Mass.
Mr. Brooks, also former president and CEO of the National Association for the Advancement of Colored People (NAACP), delivered an impassioned call to action during a plenary session at the annual meeting of the American Academy of Pediatrics, held virtually this year.
“In this moment, you enjoy an extraordinary measure of trust,” Mr. Brooks said. “As a consequence, I would argue that history and circumstance call upon to you to speak to this moment with a voice that is distinctive as a measure of expertise and unique as a measure of trust and credibility.”
The flood of comments throughout his live talk testified to how inspirational the AAP attendees found his words.
“We, as pediatricians, have a very powerful voice together,” wrote AAP President-elect Lee Savio Beers, MD.
“As pediatric staff we need to have our voices heard beyond the walls of our clinics, in our schools, in our legislative bodies and communities as a whole!” wrote Michelle Bucknor, MD, MBA, chief medical officer of United Healthcare of North Carolina.
Mr. Brooks opened his talk with images of Tamir Rice, Emmett Till, and George Floyd, explaining how images of Emmett Till’s dead body galvanized a movement in the same way that Rice, Floyd, Breonna Taylor, and other victims of police brutality are doing today.
“Emmett Till was killed by white racists in 1955 in Mississippi on the eve of the Montgomery boycott, and his death and his tragic image in death animated and inspired the Civil Rights movement,” Mr. Brooks said. Now “the country is divided along the fissures of class and the fault lines of race in a moment of generationally unprecedented policing. These images, tragic as they are, represent the countenance, the face of police brutality in this moment. “
How police brutality affects children
Since the death of George Floyd, at least 27 million Americans have participated in protests and demonstrations throughout at least 550 jurisdictions in the United States and throughout the world, Mr. Brooks said. But the harm of police brutality extends beyond police homicide victims.
“The harm is a matter of overpoliced patients and untreated children,” he said. Children are watching and listening as the nation grapples with police brutality and overpolicing, and the experience is traumatizing them in ways that shows up in school performance and health.
He shared findings from multiple different studies showing that exposure to police violence in the community is associated with declines in grade point averages, lower test scores, and poorer attendance. Risk of emotional disturbance is 15% greater in children exposed to police violence, and youth who have had contact with the police have reported worse health than those who hadn’t. Some of these effects increased with age, and they disproportionately fell almost entirely on Black and Hispanic students.
“Because of this trauma, school attendance and college enrollment declines,” Mr. Brooks said. “Police brutality has an impact on your patients, and beyond the patients who are right in front of you, there is a sea of millions of untreated, unattended children, and this trauma is reflected in the tremor of their voices, the trepidation, the apprehension, the fear that can be discerned in their spirits.”
Mr. Brooks shared several quotes from two qualitative studies that attempted to capture the experience of youths living in overpoliced communities and whose daily routines are criminalized. One respondent in this research said, “Sometimes I think to myself that I probably look suspicious, but I, like, shouldn’t think like that ‘cause I’m a human being.” Another said when he sees the police come around when there are groups of boys out, “I have my phone ready to record. I’m just waiting for something to happen.”
The voice of pediatricians
The voices of pediatric providers have a key role in the national discussion about this issue, Mr. Brooks said, because medical professionals have so much of America’s truth. One Pew Research Center survey found that 74% of Americans had a mostly positive view of medical doctors, compared with only 35% with a positive view of elected officials and 47% of the news media.
“As health care professionals dedicated to pediatrics, you are uniquely qualified, circumstantially and historically called in this moment to respond to this tragedy and trauma of police brutality as visited upon our children because you have been entrusted with America’s trust and credibility,” Mr. Brooks said.
He described several ways pediatricians can use storytelling to shift how the country perceives the issue of police brutality and the impact on children.
“Some children we deem to be sufficiently perfect that we can have sympathy and empathy for them,” Mr. Brooks said. “Other children are deemed to be so imperfect that we cannot have sympathy and empathy for them.” Within days of Michael Brown’s death by police in Ferguson, Mo., for example, a “post mortem character assassination” deemed Mr. Brown “too imperfect for empathy,” Mr. Brooks said.
“Dr. Brooks hit the nail on the head,” attendee Jeanette Callahan, MD, a pediatrician with Cambridge Health Alliance in Massachusetts, wrote during the session. “We must tell the stories that we hear every day from our patients.”
Pediatricians also can bring science and research into the public conversation to help people better understand children, just as the amicus briefs of pediatricians and neuroscientists in U.S. Supreme Court cases led the court to declare the death penalty and life sentences without parole as unconstitutional for minors.
“You as pediatricians, as physicians, as nurses, as health care professionals have the ability to cast doubt on things that people believe to be true and give them conviction with respect to things we know to be true as a consequence of data and our moral understanding,” Mr. Brooks said. He encouraged pediatricians to “engage in storytelling and justice-seeking by expanding and diversifying the resources we bring to public policy,” including science, data, and expertise.
Two recent examples of this professional activism include Massachusetts pediatrician Fiona Danaher’s testimony to the U.S. House of Representatives regarding current immigration policies’ impact on children and the work of Michigan pediatrician Mona Hanna-Attisha’s in exposing the Flint water crisis. Mr. Brooks shared a quote from Dr. Danaher: “For me, treating children humanely is a question of basic morality. I knew I couldn’t sit on the sidelines.”
Neither can pediatricians sit on the sidelines now with the issue of police brutality, Mr. Brooks said.
“You as pediatricians can call on America to engage in a Hippocratic approach to policing, that is to say, do no harm,” he said. “It’s not enough for us to content ourselves with children not becoming hashtags, not becoming police homicides. We have to also consider the trauma of overpolicing and oversurveilling our communities of color.”
He also recommended pediatricians remind the country that addressing social determinants of health also addresses social determinants of crime, providing an opportunity to disrupt the school-to-prison pipeline.
In the comments, attendees shared other ways pediatricians can influence policy in favor of children.
“Pediatricians can reach out to police departments, prosecutors, and public defender offices, the local judiciary, and local attorney associations, etc., to describe and explain the effects of policing on children and adolescents,” wrote Trina Anglin, MD, PhD, who retired in August 2019 as chief of the Adolescent Health Branch in the Health Resources and Services Administration’s Maternal and Child Health Bureau. “We can bring the voices of young people to others. At the community level, each professional group meets on a regular basis; each group also talks to the other groups.”
Others echoed these suggestions. “Expand your voice outside your office,” wrote Jimmell Felder, MD, of Pediatric Associates Greenwood in South Carolina. “Attend city council meetings and discuss the stories of our patients with the people who make the policies. It is part of our job to advocate for our patients.”
Joanna Betancourt, MD, a pediatrician with Salud Pediatrics in Algonquin, Ill., encouraged fellow attendees to “vote locally and nationally for people that are open to change legislation that supports the well-being of all children.”
Given all the trauma of 2020, Patricia Deffer-Valley, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, said pediatricians cannot have “moral paralysis.”
Mr. Brooks had no relevant financial disclosures. Disclosure information was unavailable for others quoted in this article
Pediatricians and other health care professionals who care for children are uniquely situated and qualified to educate the rest of the nation on how police brutality and overpolicing traumatizes children and teens and why those issues must be addressed, said Cornell William Brooks, JD, MDiv, a professor of public leadership and social justice at the Harvard Kennedy School of Government in Cambridge, Mass.
Mr. Brooks, also former president and CEO of the National Association for the Advancement of Colored People (NAACP), delivered an impassioned call to action during a plenary session at the annual meeting of the American Academy of Pediatrics, held virtually this year.
“In this moment, you enjoy an extraordinary measure of trust,” Mr. Brooks said. “As a consequence, I would argue that history and circumstance call upon to you to speak to this moment with a voice that is distinctive as a measure of expertise and unique as a measure of trust and credibility.”
The flood of comments throughout his live talk testified to how inspirational the AAP attendees found his words.
“We, as pediatricians, have a very powerful voice together,” wrote AAP President-elect Lee Savio Beers, MD.
“As pediatric staff we need to have our voices heard beyond the walls of our clinics, in our schools, in our legislative bodies and communities as a whole!” wrote Michelle Bucknor, MD, MBA, chief medical officer of United Healthcare of North Carolina.
Mr. Brooks opened his talk with images of Tamir Rice, Emmett Till, and George Floyd, explaining how images of Emmett Till’s dead body galvanized a movement in the same way that Rice, Floyd, Breonna Taylor, and other victims of police brutality are doing today.
“Emmett Till was killed by white racists in 1955 in Mississippi on the eve of the Montgomery boycott, and his death and his tragic image in death animated and inspired the Civil Rights movement,” Mr. Brooks said. Now “the country is divided along the fissures of class and the fault lines of race in a moment of generationally unprecedented policing. These images, tragic as they are, represent the countenance, the face of police brutality in this moment. “
How police brutality affects children
Since the death of George Floyd, at least 27 million Americans have participated in protests and demonstrations throughout at least 550 jurisdictions in the United States and throughout the world, Mr. Brooks said. But the harm of police brutality extends beyond police homicide victims.
“The harm is a matter of overpoliced patients and untreated children,” he said. Children are watching and listening as the nation grapples with police brutality and overpolicing, and the experience is traumatizing them in ways that shows up in school performance and health.
He shared findings from multiple different studies showing that exposure to police violence in the community is associated with declines in grade point averages, lower test scores, and poorer attendance. Risk of emotional disturbance is 15% greater in children exposed to police violence, and youth who have had contact with the police have reported worse health than those who hadn’t. Some of these effects increased with age, and they disproportionately fell almost entirely on Black and Hispanic students.
“Because of this trauma, school attendance and college enrollment declines,” Mr. Brooks said. “Police brutality has an impact on your patients, and beyond the patients who are right in front of you, there is a sea of millions of untreated, unattended children, and this trauma is reflected in the tremor of their voices, the trepidation, the apprehension, the fear that can be discerned in their spirits.”
Mr. Brooks shared several quotes from two qualitative studies that attempted to capture the experience of youths living in overpoliced communities and whose daily routines are criminalized. One respondent in this research said, “Sometimes I think to myself that I probably look suspicious, but I, like, shouldn’t think like that ‘cause I’m a human being.” Another said when he sees the police come around when there are groups of boys out, “I have my phone ready to record. I’m just waiting for something to happen.”
The voice of pediatricians
The voices of pediatric providers have a key role in the national discussion about this issue, Mr. Brooks said, because medical professionals have so much of America’s truth. One Pew Research Center survey found that 74% of Americans had a mostly positive view of medical doctors, compared with only 35% with a positive view of elected officials and 47% of the news media.
“As health care professionals dedicated to pediatrics, you are uniquely qualified, circumstantially and historically called in this moment to respond to this tragedy and trauma of police brutality as visited upon our children because you have been entrusted with America’s trust and credibility,” Mr. Brooks said.
He described several ways pediatricians can use storytelling to shift how the country perceives the issue of police brutality and the impact on children.
“Some children we deem to be sufficiently perfect that we can have sympathy and empathy for them,” Mr. Brooks said. “Other children are deemed to be so imperfect that we cannot have sympathy and empathy for them.” Within days of Michael Brown’s death by police in Ferguson, Mo., for example, a “post mortem character assassination” deemed Mr. Brown “too imperfect for empathy,” Mr. Brooks said.
“Dr. Brooks hit the nail on the head,” attendee Jeanette Callahan, MD, a pediatrician with Cambridge Health Alliance in Massachusetts, wrote during the session. “We must tell the stories that we hear every day from our patients.”
Pediatricians also can bring science and research into the public conversation to help people better understand children, just as the amicus briefs of pediatricians and neuroscientists in U.S. Supreme Court cases led the court to declare the death penalty and life sentences without parole as unconstitutional for minors.
“You as pediatricians, as physicians, as nurses, as health care professionals have the ability to cast doubt on things that people believe to be true and give them conviction with respect to things we know to be true as a consequence of data and our moral understanding,” Mr. Brooks said. He encouraged pediatricians to “engage in storytelling and justice-seeking by expanding and diversifying the resources we bring to public policy,” including science, data, and expertise.
Two recent examples of this professional activism include Massachusetts pediatrician Fiona Danaher’s testimony to the U.S. House of Representatives regarding current immigration policies’ impact on children and the work of Michigan pediatrician Mona Hanna-Attisha’s in exposing the Flint water crisis. Mr. Brooks shared a quote from Dr. Danaher: “For me, treating children humanely is a question of basic morality. I knew I couldn’t sit on the sidelines.”
Neither can pediatricians sit on the sidelines now with the issue of police brutality, Mr. Brooks said.
“You as pediatricians can call on America to engage in a Hippocratic approach to policing, that is to say, do no harm,” he said. “It’s not enough for us to content ourselves with children not becoming hashtags, not becoming police homicides. We have to also consider the trauma of overpolicing and oversurveilling our communities of color.”
He also recommended pediatricians remind the country that addressing social determinants of health also addresses social determinants of crime, providing an opportunity to disrupt the school-to-prison pipeline.
In the comments, attendees shared other ways pediatricians can influence policy in favor of children.
“Pediatricians can reach out to police departments, prosecutors, and public defender offices, the local judiciary, and local attorney associations, etc., to describe and explain the effects of policing on children and adolescents,” wrote Trina Anglin, MD, PhD, who retired in August 2019 as chief of the Adolescent Health Branch in the Health Resources and Services Administration’s Maternal and Child Health Bureau. “We can bring the voices of young people to others. At the community level, each professional group meets on a regular basis; each group also talks to the other groups.”
Others echoed these suggestions. “Expand your voice outside your office,” wrote Jimmell Felder, MD, of Pediatric Associates Greenwood in South Carolina. “Attend city council meetings and discuss the stories of our patients with the people who make the policies. It is part of our job to advocate for our patients.”
Joanna Betancourt, MD, a pediatrician with Salud Pediatrics in Algonquin, Ill., encouraged fellow attendees to “vote locally and nationally for people that are open to change legislation that supports the well-being of all children.”
Given all the trauma of 2020, Patricia Deffer-Valley, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, said pediatricians cannot have “moral paralysis.”
Mr. Brooks had no relevant financial disclosures. Disclosure information was unavailable for others quoted in this article
FROM AAP 2020
Fetal estrogens show promise for safer therapy for menopause
Hormone therapy for menopausal symptoms has come a long way in the past decade, but some low risks remain, particularly for certain groups of women. But new naturally occurring estrogens are on the horizon and may provide safer options with similar efficacy for treating hot flashes and other symptoms, researchers report.
“Unfortunately, there is no such thing as the perfect estrogen that has all the things that makes it favorable and none of the negative,” Hugh S. Taylor, MD, told attendees at the virtual annual meeting of the North American Menopause Society. “It probably doesn’t exist. But there’s an opportunity for us to design better estrogens or take advantage of other naturally occurring estrogens that come closer to that goal of the ideal estrogen,” said Dr. Taylor, professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn.
Those naturally occurring estrogens are the fetal estrogens, estetrol and estriol, which are produced almost exclusively during pregnancy. Only estetrol has been investigated in clinical trials, and it does show some promise, Dr. Taylor said.
“If there’s a better cardiovascular effect without the breast cancer risk, this could be something everyone would want to take,” Dr. Taylor said in an interview. We’ve never really been able to get a synthetic estrogen [that works].”
Hormone therapy still most effective for vasomotor symptoms
The primary benefits of hormone therapy for postmenopausal women are decreased hot flashes and night sweats and the prevention of bone loss, vaginal dryness, and vaginal atrophy. But as women age, particularly past age 70 years, the risks for stroke, heart disease, and breast cancer associated with hormone therapy begin to outweigh the benefits.
That leaves women who are still experiencing those symptoms in a quandary.
“Some people will take on substantial risks because they want to continue taking hormones,” Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, said in an interview. “If they understand what they’re doing and they tell me that they are that miserable, then I will continue their hormones.”
Dr. Santoro, who was not involved in Taylor’s work, said some patients have seen her because their primary care providers refused to continue prescribing them hormones at their age, despite serious vasomotor symptoms that interfered with their daily life.
“Women are sometimes not taken seriously, and I think that’s a problem,” Dr. Santoro said. “Women need to be able to make an informed choice about what kinds of risk they’re taking on. Many physicians’ rationales are that hot flashes never killed anybody. Well, they can sure make you miserable.”
Dr. Taylor echoed the importance of taking women’s symptoms seriously and helping them choose the most effective treatments to manage their symptoms.
“The rush of adrenaline, the anxiety, the palpitations, the heart racing, the sweating, all the night sweats [that mean] you can’t sleep at night, and the lack of adequate REM sleep – all these things add up and can really be disruptive to someone’s life,” Dr. Taylor said in an interview. “I think it’s important that we raise awareness of how severe it can be, about just how low the risks [of hormone therapy] are, and get people more comfortable using hormone therapy, but also continue to search for safer, better products that will eliminate even those low risks.”
A major development toward that goal in the past decade has been therapies that combine an estrogen with a selective estrogen receptor modulator (SERM), which have antiestrogen effects in the endometrium and breast without blocking estrogen in the bones and brain.
One such tissue-selective estrogen complex (TSEC) is the combination of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg). Clinical trials showed that this TSEC reduced the frequency of hot flashes by 74%, compared with 47% with placebo. In addition, TSEC reduced the severity of hot flashes by 39%, compared with 13% with placebo. The combination also improved bone density at the spine and hip without promoting endometrial hyperplasia.
“It looks like it does exactly what we want,” Dr. Taylor told NAMS attendees. “The SERM is antagonizing the effects of the estrogens in the endometrium but not in the bone or brain.” It also led to a decrease in total cholesterol, and there was no increase in breast stimulation or density.
Another advance in recent years has been more choices and more precision with dosing, Dr. Santoro said.
“Where inroads have been made is in having women be aware of all the options they have and in getting the most convenient compounds to people,” she said, despite the confusion and misinformation that have arisen from the proliferation of bioidenticals. “You can dial in a dose for just about anybody.”
New estrogens in the pipeline
Neither of these developments, however, have eliminated the risks associated with hormone therapy for women of older age or for women at high risk for breast cancer. Although total elimination of risk may not be possible, recent research suggests that the naturally occurring fetal estrogens estriol and estetrol appear to have SERM-like properties, Dr. Taylor said. These estrogens are made only in pregnancy and appear to have evolved for a purpose different from that of estrone and estradiol.
“While both are weak estrogens by traditional standards, both have unique properties that make them very interesting for therapeutic use,” Dr. Taylor said. In particular, estetrol has a much longer half-life than estriol, making it more appropriate for therapeutic investigation.
A study of estetrol that was published in Menopause in August 2020 showed encouraging results. Despite a fairly sizable placebo effect, there was also a dose-response effect from estetrol on vasomotor symptoms. Low doses did not have much effect, but with higher doses (15 mg), there was a robust, significant improvement in the frequency and severity of hot flashes. So far, Dr. Taylor said, it looks like estetrol can be a highly effective treatment for vasomotor symptoms.
In addition, preclinical research suggests that estetrol may have a better safety profile than currently available therapies, though much more work is needed to know for sure. For example, a 2015 study found that it requires extremely high doses – well above therapeutic levels – for tumor growth to occur. Similarly, a 2019 study found that very high doses of estetrol or estriol were needed before it would stimulate breast cancer cell growth, likely because these are such weak estrogens, compared with estradiol, Dr. Taylor said.
There is currently less information on estetrol’s potential cardiovascular effects, but an animal model suggests positive effects, he said. Giving a mouse estetrol led to an increase in blood vessel dilation with increased blood flow.
The reason these estrogens appear to pose less risk yet still show therapeutic effects appears related to how they bind to the estrogen receptor and what their purpose is, Dr. Taylor told attendees.
“These fetal estrogens are really there probably for developmental programming,” he said. “It’s no wonder they may have some unique and favorable properties for therapeutic use. I’m really enthusiastic to see this explored further as a potential new hormonal therapy.”
Dr. Taylor disclosed no relevant financial relationships. Dr. Santoro reported stock ownership in Menogenix and consulting or advising for Ansh Labs, Menogenix, and Ogeda/Astellas.
A version of this article originally appeared on Medscape.com.
Hormone therapy for menopausal symptoms has come a long way in the past decade, but some low risks remain, particularly for certain groups of women. But new naturally occurring estrogens are on the horizon and may provide safer options with similar efficacy for treating hot flashes and other symptoms, researchers report.
“Unfortunately, there is no such thing as the perfect estrogen that has all the things that makes it favorable and none of the negative,” Hugh S. Taylor, MD, told attendees at the virtual annual meeting of the North American Menopause Society. “It probably doesn’t exist. But there’s an opportunity for us to design better estrogens or take advantage of other naturally occurring estrogens that come closer to that goal of the ideal estrogen,” said Dr. Taylor, professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn.
Those naturally occurring estrogens are the fetal estrogens, estetrol and estriol, which are produced almost exclusively during pregnancy. Only estetrol has been investigated in clinical trials, and it does show some promise, Dr. Taylor said.
“If there’s a better cardiovascular effect without the breast cancer risk, this could be something everyone would want to take,” Dr. Taylor said in an interview. We’ve never really been able to get a synthetic estrogen [that works].”
Hormone therapy still most effective for vasomotor symptoms
The primary benefits of hormone therapy for postmenopausal women are decreased hot flashes and night sweats and the prevention of bone loss, vaginal dryness, and vaginal atrophy. But as women age, particularly past age 70 years, the risks for stroke, heart disease, and breast cancer associated with hormone therapy begin to outweigh the benefits.
That leaves women who are still experiencing those symptoms in a quandary.
“Some people will take on substantial risks because they want to continue taking hormones,” Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, said in an interview. “If they understand what they’re doing and they tell me that they are that miserable, then I will continue their hormones.”
Dr. Santoro, who was not involved in Taylor’s work, said some patients have seen her because their primary care providers refused to continue prescribing them hormones at their age, despite serious vasomotor symptoms that interfered with their daily life.
“Women are sometimes not taken seriously, and I think that’s a problem,” Dr. Santoro said. “Women need to be able to make an informed choice about what kinds of risk they’re taking on. Many physicians’ rationales are that hot flashes never killed anybody. Well, they can sure make you miserable.”
Dr. Taylor echoed the importance of taking women’s symptoms seriously and helping them choose the most effective treatments to manage their symptoms.
“The rush of adrenaline, the anxiety, the palpitations, the heart racing, the sweating, all the night sweats [that mean] you can’t sleep at night, and the lack of adequate REM sleep – all these things add up and can really be disruptive to someone’s life,” Dr. Taylor said in an interview. “I think it’s important that we raise awareness of how severe it can be, about just how low the risks [of hormone therapy] are, and get people more comfortable using hormone therapy, but also continue to search for safer, better products that will eliminate even those low risks.”
A major development toward that goal in the past decade has been therapies that combine an estrogen with a selective estrogen receptor modulator (SERM), which have antiestrogen effects in the endometrium and breast without blocking estrogen in the bones and brain.
One such tissue-selective estrogen complex (TSEC) is the combination of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg). Clinical trials showed that this TSEC reduced the frequency of hot flashes by 74%, compared with 47% with placebo. In addition, TSEC reduced the severity of hot flashes by 39%, compared with 13% with placebo. The combination also improved bone density at the spine and hip without promoting endometrial hyperplasia.
“It looks like it does exactly what we want,” Dr. Taylor told NAMS attendees. “The SERM is antagonizing the effects of the estrogens in the endometrium but not in the bone or brain.” It also led to a decrease in total cholesterol, and there was no increase in breast stimulation or density.
Another advance in recent years has been more choices and more precision with dosing, Dr. Santoro said.
“Where inroads have been made is in having women be aware of all the options they have and in getting the most convenient compounds to people,” she said, despite the confusion and misinformation that have arisen from the proliferation of bioidenticals. “You can dial in a dose for just about anybody.”
New estrogens in the pipeline
Neither of these developments, however, have eliminated the risks associated with hormone therapy for women of older age or for women at high risk for breast cancer. Although total elimination of risk may not be possible, recent research suggests that the naturally occurring fetal estrogens estriol and estetrol appear to have SERM-like properties, Dr. Taylor said. These estrogens are made only in pregnancy and appear to have evolved for a purpose different from that of estrone and estradiol.
“While both are weak estrogens by traditional standards, both have unique properties that make them very interesting for therapeutic use,” Dr. Taylor said. In particular, estetrol has a much longer half-life than estriol, making it more appropriate for therapeutic investigation.
A study of estetrol that was published in Menopause in August 2020 showed encouraging results. Despite a fairly sizable placebo effect, there was also a dose-response effect from estetrol on vasomotor symptoms. Low doses did not have much effect, but with higher doses (15 mg), there was a robust, significant improvement in the frequency and severity of hot flashes. So far, Dr. Taylor said, it looks like estetrol can be a highly effective treatment for vasomotor symptoms.
In addition, preclinical research suggests that estetrol may have a better safety profile than currently available therapies, though much more work is needed to know for sure. For example, a 2015 study found that it requires extremely high doses – well above therapeutic levels – for tumor growth to occur. Similarly, a 2019 study found that very high doses of estetrol or estriol were needed before it would stimulate breast cancer cell growth, likely because these are such weak estrogens, compared with estradiol, Dr. Taylor said.
There is currently less information on estetrol’s potential cardiovascular effects, but an animal model suggests positive effects, he said. Giving a mouse estetrol led to an increase in blood vessel dilation with increased blood flow.
The reason these estrogens appear to pose less risk yet still show therapeutic effects appears related to how they bind to the estrogen receptor and what their purpose is, Dr. Taylor told attendees.
“These fetal estrogens are really there probably for developmental programming,” he said. “It’s no wonder they may have some unique and favorable properties for therapeutic use. I’m really enthusiastic to see this explored further as a potential new hormonal therapy.”
Dr. Taylor disclosed no relevant financial relationships. Dr. Santoro reported stock ownership in Menogenix and consulting or advising for Ansh Labs, Menogenix, and Ogeda/Astellas.
A version of this article originally appeared on Medscape.com.
Hormone therapy for menopausal symptoms has come a long way in the past decade, but some low risks remain, particularly for certain groups of women. But new naturally occurring estrogens are on the horizon and may provide safer options with similar efficacy for treating hot flashes and other symptoms, researchers report.
“Unfortunately, there is no such thing as the perfect estrogen that has all the things that makes it favorable and none of the negative,” Hugh S. Taylor, MD, told attendees at the virtual annual meeting of the North American Menopause Society. “It probably doesn’t exist. But there’s an opportunity for us to design better estrogens or take advantage of other naturally occurring estrogens that come closer to that goal of the ideal estrogen,” said Dr. Taylor, professor and chair of ob.gyn. and reproductive sciences at Yale University, New Haven, Conn.
Those naturally occurring estrogens are the fetal estrogens, estetrol and estriol, which are produced almost exclusively during pregnancy. Only estetrol has been investigated in clinical trials, and it does show some promise, Dr. Taylor said.
“If there’s a better cardiovascular effect without the breast cancer risk, this could be something everyone would want to take,” Dr. Taylor said in an interview. We’ve never really been able to get a synthetic estrogen [that works].”
Hormone therapy still most effective for vasomotor symptoms
The primary benefits of hormone therapy for postmenopausal women are decreased hot flashes and night sweats and the prevention of bone loss, vaginal dryness, and vaginal atrophy. But as women age, particularly past age 70 years, the risks for stroke, heart disease, and breast cancer associated with hormone therapy begin to outweigh the benefits.
That leaves women who are still experiencing those symptoms in a quandary.
“Some people will take on substantial risks because they want to continue taking hormones,” Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, said in an interview. “If they understand what they’re doing and they tell me that they are that miserable, then I will continue their hormones.”
Dr. Santoro, who was not involved in Taylor’s work, said some patients have seen her because their primary care providers refused to continue prescribing them hormones at their age, despite serious vasomotor symptoms that interfered with their daily life.
“Women are sometimes not taken seriously, and I think that’s a problem,” Dr. Santoro said. “Women need to be able to make an informed choice about what kinds of risk they’re taking on. Many physicians’ rationales are that hot flashes never killed anybody. Well, they can sure make you miserable.”
Dr. Taylor echoed the importance of taking women’s symptoms seriously and helping them choose the most effective treatments to manage their symptoms.
“The rush of adrenaline, the anxiety, the palpitations, the heart racing, the sweating, all the night sweats [that mean] you can’t sleep at night, and the lack of adequate REM sleep – all these things add up and can really be disruptive to someone’s life,” Dr. Taylor said in an interview. “I think it’s important that we raise awareness of how severe it can be, about just how low the risks [of hormone therapy] are, and get people more comfortable using hormone therapy, but also continue to search for safer, better products that will eliminate even those low risks.”
A major development toward that goal in the past decade has been therapies that combine an estrogen with a selective estrogen receptor modulator (SERM), which have antiestrogen effects in the endometrium and breast without blocking estrogen in the bones and brain.
One such tissue-selective estrogen complex (TSEC) is the combination of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg). Clinical trials showed that this TSEC reduced the frequency of hot flashes by 74%, compared with 47% with placebo. In addition, TSEC reduced the severity of hot flashes by 39%, compared with 13% with placebo. The combination also improved bone density at the spine and hip without promoting endometrial hyperplasia.
“It looks like it does exactly what we want,” Dr. Taylor told NAMS attendees. “The SERM is antagonizing the effects of the estrogens in the endometrium but not in the bone or brain.” It also led to a decrease in total cholesterol, and there was no increase in breast stimulation or density.
Another advance in recent years has been more choices and more precision with dosing, Dr. Santoro said.
“Where inroads have been made is in having women be aware of all the options they have and in getting the most convenient compounds to people,” she said, despite the confusion and misinformation that have arisen from the proliferation of bioidenticals. “You can dial in a dose for just about anybody.”
New estrogens in the pipeline
Neither of these developments, however, have eliminated the risks associated with hormone therapy for women of older age or for women at high risk for breast cancer. Although total elimination of risk may not be possible, recent research suggests that the naturally occurring fetal estrogens estriol and estetrol appear to have SERM-like properties, Dr. Taylor said. These estrogens are made only in pregnancy and appear to have evolved for a purpose different from that of estrone and estradiol.
“While both are weak estrogens by traditional standards, both have unique properties that make them very interesting for therapeutic use,” Dr. Taylor said. In particular, estetrol has a much longer half-life than estriol, making it more appropriate for therapeutic investigation.
A study of estetrol that was published in Menopause in August 2020 showed encouraging results. Despite a fairly sizable placebo effect, there was also a dose-response effect from estetrol on vasomotor symptoms. Low doses did not have much effect, but with higher doses (15 mg), there was a robust, significant improvement in the frequency and severity of hot flashes. So far, Dr. Taylor said, it looks like estetrol can be a highly effective treatment for vasomotor symptoms.
In addition, preclinical research suggests that estetrol may have a better safety profile than currently available therapies, though much more work is needed to know for sure. For example, a 2015 study found that it requires extremely high doses – well above therapeutic levels – for tumor growth to occur. Similarly, a 2019 study found that very high doses of estetrol or estriol were needed before it would stimulate breast cancer cell growth, likely because these are such weak estrogens, compared with estradiol, Dr. Taylor said.
There is currently less information on estetrol’s potential cardiovascular effects, but an animal model suggests positive effects, he said. Giving a mouse estetrol led to an increase in blood vessel dilation with increased blood flow.
The reason these estrogens appear to pose less risk yet still show therapeutic effects appears related to how they bind to the estrogen receptor and what their purpose is, Dr. Taylor told attendees.
“These fetal estrogens are really there probably for developmental programming,” he said. “It’s no wonder they may have some unique and favorable properties for therapeutic use. I’m really enthusiastic to see this explored further as a potential new hormonal therapy.”
Dr. Taylor disclosed no relevant financial relationships. Dr. Santoro reported stock ownership in Menogenix and consulting or advising for Ansh Labs, Menogenix, and Ogeda/Astellas.
A version of this article originally appeared on Medscape.com.
Integrating ADHD care into pediatric practice is doable and essential
Integrating ADHD care into practice work flows is vitally important for all practitioners who care for children, said Herschel Lessin, MD, a senior partner of the Children’s Medical Group in Poughkeepsie, N.Y.
Although not necessarily “easy” to do, it’s far less overwhelming than it seems when doctors take the time to thoughtfully set up protocols, train others in the office, and use the ADHD Toolkit sold by the American Academy of Pediatrics, Dr. Lessin told attendees at the annual meeting of the AAP, held virtually this year. Dr. Lessin is a coeditor of the AAP’s ADHD Toolkit 3rd Ed., although he does not receive royalties from it. The toolkit includes patient handouts, clinicians tools, and rating scales that help practices incorporate ADHD care into their practices.
“The biggest complaint is: ‘But I don’t have enough time to do all of this stuff,’ ” Dr. Lessin said. “The reality is, once you’re comfortable with the visits and you know how they progress and flow, they can be done much more quickly.” He emphasized that
Dr. Lessin gave multiple reasons it’s important to integrate ADHD care into practices, starting with the condition’s prevalence and the importance of building a medical home for patients.
“ADHD affects 8%-10% of your patient population, a truly enormous number, yet many pediatricians do not treat ADHD in their practices, depriving their patients of needed care and depriving themselves from economic benefits of the visits and the revenue,” he said. The pediatrician added that more than 80% of ADHD care takes place in pediatric offices, but much of it is “badly diagnosed and poorly treated” in both primary care and specialty offices.
Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and agreed with Dr. Lessin that pediatricians are best suited to manage ADHD over other practitioners.
“One of the things he pointed out is that it’s a pediatric issue,” Dr. Hackell said. “We’re better at this than psychiatrists, than neurologists, than psychologists because we’re really focused on the whole lifestyle of the child, how it impacts them at home, how it impacts them at school, and how it impacts them in the social sphere.”
There’s also been a substantial increase in mental health issues as a proportion of visits, particularly recently with the pandemic and accompanying lockdowns. Youth already have limited access to mental health resources, making general pediatricians’ roles even more important. “Who else is going to provide this much needed service if not pediatricians?” Dr. Lessin asked.
Again, Dr. Hackell agreed, noting that the AAP’s toolkit is especially helpful in providing this care.
“It’s something that pediatricians have often been afraid to deal with and who farm them out to these other specialties, and I don’t think the children are served as well,” Dr. Hackell said. “If you do the right forms and questionnaires, you can actually make it work for the kids and work it for your office, which generates a lot of visits and generates revenue.”
Where to start
Dr. Lessin began by recommending that all pediatricians read the AAP’s clinical practice guidelines for ADHD along with its supplemental material (Process of Care Algorithm, and Systemic Barriers to Care of Children and Adolescents with ADHD).
“The first thing is you must educate yourself,” he said. “You have to learn the medicine and what are you able and comfortable doing because few of us were ever trained in our residency programs about ADHD care.”
Providers also need to learn to manage barriers to care, including referral sources and insurance company and medication hassles. Then you need to figure out how to structure the visits, determine the most appropriate visit settings, and learn to document and code appropriately. These are not quick 10-minute visits, Dr. Lessin said. Doctors must schedule enough time for them, although they may be able to do them faster with practice.
Dr. Lessin offered encouraging words for those feeling overwhelmed: “Overcome your anxiety. This is not as hard as it seems. It’s a little bit harder with comorbidities, but many chronic diseases we manage are far worse.”
In addition to reading the guidelines and review articles, seeking out mental health training programs, and learning the medications available, Dr. Lessin told attendees to get comfortable with the fact that a lot of treatment comes down to trial and error.
Again, he emphasized the value of the toolkit, which Dr. Hackell echoed.
“It’s a really nice roadmap to be able to follow and to explain how it requires two or three or four visits to treat these children well and get them started on treatment,” Dr. Hackell said. “It’s something that I recommend people use if they have not already done so to integrate ADHD care into their practices.”
Beginning the process
In figuring out how to structure visits, avoid addressing ADHD as a “by-the-way” issue, such as when a parent mentions it at the end of an appointment, Dr. Lessin said. Instead, start with an intake visit to determine whether you’re the right person to evaluate the child and hand out Parent and Teacher Evaluation scales to begin the process. Next, do the evaluation, discuss the process with the family, determine how treatment will work, and then look at comorbidities.
Visit settings can be traditional face-to-face visits, which are particularly helpful for intake visits, Dr. Lessin said, or telehealth, especially during the pandemic. In-person visits allow you more easily to make eye contact with the child and observe the parent and child behaviors and interactions, but telehealth often is adequate for titrating medication, discussing side effects, monitoring, and similar follow-up.
“Coding practices are absolutely necessary to make your practice viable, much less make money,” Dr. Lessin said. “Doing good for people and doing well for yourself are not mutually exclusive. You have to figure out a way to make it work economically for the practice or else you’re just not going to do it.”
He reminded pediatricians to code for evaluation, monitoring scales, and care coordination, and to be prepared for the big change of new coding rules coming in 2021.
“For better or worse, documentation is the key to survival in medical practice these days,” Dr. Lessin said. “This is true for all medical care these days, but it’s particularly true for ADHD because visits are all high intensity codes and should be coded as such.”
Templates are fine, he said, but box-checking isn’t enough; leave space for a narrative that explains the case complexity and decision-making.
Training staff is essential
It’s utterly essential to train all office staff, Dr. Lessin said. “I can’t tell you how important this step is because no matter how much you know or how well you understand what you want to do, you’re going to be frustrated at every turn if your staff and colleagues don’t get this stuff.”
That includes training those who make appointments, front desk staff, clinical staff, and practice colleagues regarding coding, scheduling, visit protocols, and similar procedures. Cheat sheets can be helpful here.
“They must understand the structure of the visits, what happens at each visit, the time requirements for each visit, and the standard follow-up,” including, for clinical staff, what handouts and rating scales to use, he said. “And if they aren’t sure what the parents needs or what you want, make sure they know to contact you.”
Colleagues also need to learn to properly document visits to justify coding and complexity, and not dump all patients on you.
One challenge that Dr. Lessin acknowledged as a common problem is that many pediatricians don’t have subspecialists they can refer patients to.
“Sadly, this is true almost everywhere, in rural and in big cities, near big medical centers and only local hospitals,” Dr. Lessin said. “This another reason why I think you need to learn and treat this illness to the extent you can. Your families need you.”
Dr. Hackell particularly appreciated this point, emphasizing again how important it is that pediatricians manage ADHD care of their patients.
“We see their day-to-day life, and that’s where this impacts these kids and families,” he said. “It’s really rewarding to do from my personal experience because you can really make a really big difference in these kids’ lives when they’re younger and even as they get older. When you get the rewards, it makes the work all worthwhile.”
Dr. Lessin and Dr. Hackell said they have no relevant financial disclosures.
Integrating ADHD care into practice work flows is vitally important for all practitioners who care for children, said Herschel Lessin, MD, a senior partner of the Children’s Medical Group in Poughkeepsie, N.Y.
Although not necessarily “easy” to do, it’s far less overwhelming than it seems when doctors take the time to thoughtfully set up protocols, train others in the office, and use the ADHD Toolkit sold by the American Academy of Pediatrics, Dr. Lessin told attendees at the annual meeting of the AAP, held virtually this year. Dr. Lessin is a coeditor of the AAP’s ADHD Toolkit 3rd Ed., although he does not receive royalties from it. The toolkit includes patient handouts, clinicians tools, and rating scales that help practices incorporate ADHD care into their practices.
“The biggest complaint is: ‘But I don’t have enough time to do all of this stuff,’ ” Dr. Lessin said. “The reality is, once you’re comfortable with the visits and you know how they progress and flow, they can be done much more quickly.” He emphasized that
Dr. Lessin gave multiple reasons it’s important to integrate ADHD care into practices, starting with the condition’s prevalence and the importance of building a medical home for patients.
“ADHD affects 8%-10% of your patient population, a truly enormous number, yet many pediatricians do not treat ADHD in their practices, depriving their patients of needed care and depriving themselves from economic benefits of the visits and the revenue,” he said. The pediatrician added that more than 80% of ADHD care takes place in pediatric offices, but much of it is “badly diagnosed and poorly treated” in both primary care and specialty offices.
Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and agreed with Dr. Lessin that pediatricians are best suited to manage ADHD over other practitioners.
“One of the things he pointed out is that it’s a pediatric issue,” Dr. Hackell said. “We’re better at this than psychiatrists, than neurologists, than psychologists because we’re really focused on the whole lifestyle of the child, how it impacts them at home, how it impacts them at school, and how it impacts them in the social sphere.”
There’s also been a substantial increase in mental health issues as a proportion of visits, particularly recently with the pandemic and accompanying lockdowns. Youth already have limited access to mental health resources, making general pediatricians’ roles even more important. “Who else is going to provide this much needed service if not pediatricians?” Dr. Lessin asked.
Again, Dr. Hackell agreed, noting that the AAP’s toolkit is especially helpful in providing this care.
“It’s something that pediatricians have often been afraid to deal with and who farm them out to these other specialties, and I don’t think the children are served as well,” Dr. Hackell said. “If you do the right forms and questionnaires, you can actually make it work for the kids and work it for your office, which generates a lot of visits and generates revenue.”
Where to start
Dr. Lessin began by recommending that all pediatricians read the AAP’s clinical practice guidelines for ADHD along with its supplemental material (Process of Care Algorithm, and Systemic Barriers to Care of Children and Adolescents with ADHD).
“The first thing is you must educate yourself,” he said. “You have to learn the medicine and what are you able and comfortable doing because few of us were ever trained in our residency programs about ADHD care.”
Providers also need to learn to manage barriers to care, including referral sources and insurance company and medication hassles. Then you need to figure out how to structure the visits, determine the most appropriate visit settings, and learn to document and code appropriately. These are not quick 10-minute visits, Dr. Lessin said. Doctors must schedule enough time for them, although they may be able to do them faster with practice.
Dr. Lessin offered encouraging words for those feeling overwhelmed: “Overcome your anxiety. This is not as hard as it seems. It’s a little bit harder with comorbidities, but many chronic diseases we manage are far worse.”
In addition to reading the guidelines and review articles, seeking out mental health training programs, and learning the medications available, Dr. Lessin told attendees to get comfortable with the fact that a lot of treatment comes down to trial and error.
Again, he emphasized the value of the toolkit, which Dr. Hackell echoed.
“It’s a really nice roadmap to be able to follow and to explain how it requires two or three or four visits to treat these children well and get them started on treatment,” Dr. Hackell said. “It’s something that I recommend people use if they have not already done so to integrate ADHD care into their practices.”
Beginning the process
In figuring out how to structure visits, avoid addressing ADHD as a “by-the-way” issue, such as when a parent mentions it at the end of an appointment, Dr. Lessin said. Instead, start with an intake visit to determine whether you’re the right person to evaluate the child and hand out Parent and Teacher Evaluation scales to begin the process. Next, do the evaluation, discuss the process with the family, determine how treatment will work, and then look at comorbidities.
Visit settings can be traditional face-to-face visits, which are particularly helpful for intake visits, Dr. Lessin said, or telehealth, especially during the pandemic. In-person visits allow you more easily to make eye contact with the child and observe the parent and child behaviors and interactions, but telehealth often is adequate for titrating medication, discussing side effects, monitoring, and similar follow-up.
“Coding practices are absolutely necessary to make your practice viable, much less make money,” Dr. Lessin said. “Doing good for people and doing well for yourself are not mutually exclusive. You have to figure out a way to make it work economically for the practice or else you’re just not going to do it.”
He reminded pediatricians to code for evaluation, monitoring scales, and care coordination, and to be prepared for the big change of new coding rules coming in 2021.
“For better or worse, documentation is the key to survival in medical practice these days,” Dr. Lessin said. “This is true for all medical care these days, but it’s particularly true for ADHD because visits are all high intensity codes and should be coded as such.”
Templates are fine, he said, but box-checking isn’t enough; leave space for a narrative that explains the case complexity and decision-making.
Training staff is essential
It’s utterly essential to train all office staff, Dr. Lessin said. “I can’t tell you how important this step is because no matter how much you know or how well you understand what you want to do, you’re going to be frustrated at every turn if your staff and colleagues don’t get this stuff.”
That includes training those who make appointments, front desk staff, clinical staff, and practice colleagues regarding coding, scheduling, visit protocols, and similar procedures. Cheat sheets can be helpful here.
“They must understand the structure of the visits, what happens at each visit, the time requirements for each visit, and the standard follow-up,” including, for clinical staff, what handouts and rating scales to use, he said. “And if they aren’t sure what the parents needs or what you want, make sure they know to contact you.”
Colleagues also need to learn to properly document visits to justify coding and complexity, and not dump all patients on you.
One challenge that Dr. Lessin acknowledged as a common problem is that many pediatricians don’t have subspecialists they can refer patients to.
“Sadly, this is true almost everywhere, in rural and in big cities, near big medical centers and only local hospitals,” Dr. Lessin said. “This another reason why I think you need to learn and treat this illness to the extent you can. Your families need you.”
Dr. Hackell particularly appreciated this point, emphasizing again how important it is that pediatricians manage ADHD care of their patients.
“We see their day-to-day life, and that’s where this impacts these kids and families,” he said. “It’s really rewarding to do from my personal experience because you can really make a really big difference in these kids’ lives when they’re younger and even as they get older. When you get the rewards, it makes the work all worthwhile.”
Dr. Lessin and Dr. Hackell said they have no relevant financial disclosures.
Integrating ADHD care into practice work flows is vitally important for all practitioners who care for children, said Herschel Lessin, MD, a senior partner of the Children’s Medical Group in Poughkeepsie, N.Y.
Although not necessarily “easy” to do, it’s far less overwhelming than it seems when doctors take the time to thoughtfully set up protocols, train others in the office, and use the ADHD Toolkit sold by the American Academy of Pediatrics, Dr. Lessin told attendees at the annual meeting of the AAP, held virtually this year. Dr. Lessin is a coeditor of the AAP’s ADHD Toolkit 3rd Ed., although he does not receive royalties from it. The toolkit includes patient handouts, clinicians tools, and rating scales that help practices incorporate ADHD care into their practices.
“The biggest complaint is: ‘But I don’t have enough time to do all of this stuff,’ ” Dr. Lessin said. “The reality is, once you’re comfortable with the visits and you know how they progress and flow, they can be done much more quickly.” He emphasized that
Dr. Lessin gave multiple reasons it’s important to integrate ADHD care into practices, starting with the condition’s prevalence and the importance of building a medical home for patients.
“ADHD affects 8%-10% of your patient population, a truly enormous number, yet many pediatricians do not treat ADHD in their practices, depriving their patients of needed care and depriving themselves from economic benefits of the visits and the revenue,” he said. The pediatrician added that more than 80% of ADHD care takes place in pediatric offices, but much of it is “badly diagnosed and poorly treated” in both primary care and specialty offices.
Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and agreed with Dr. Lessin that pediatricians are best suited to manage ADHD over other practitioners.
“One of the things he pointed out is that it’s a pediatric issue,” Dr. Hackell said. “We’re better at this than psychiatrists, than neurologists, than psychologists because we’re really focused on the whole lifestyle of the child, how it impacts them at home, how it impacts them at school, and how it impacts them in the social sphere.”
There’s also been a substantial increase in mental health issues as a proportion of visits, particularly recently with the pandemic and accompanying lockdowns. Youth already have limited access to mental health resources, making general pediatricians’ roles even more important. “Who else is going to provide this much needed service if not pediatricians?” Dr. Lessin asked.
Again, Dr. Hackell agreed, noting that the AAP’s toolkit is especially helpful in providing this care.
“It’s something that pediatricians have often been afraid to deal with and who farm them out to these other specialties, and I don’t think the children are served as well,” Dr. Hackell said. “If you do the right forms and questionnaires, you can actually make it work for the kids and work it for your office, which generates a lot of visits and generates revenue.”
Where to start
Dr. Lessin began by recommending that all pediatricians read the AAP’s clinical practice guidelines for ADHD along with its supplemental material (Process of Care Algorithm, and Systemic Barriers to Care of Children and Adolescents with ADHD).
“The first thing is you must educate yourself,” he said. “You have to learn the medicine and what are you able and comfortable doing because few of us were ever trained in our residency programs about ADHD care.”
Providers also need to learn to manage barriers to care, including referral sources and insurance company and medication hassles. Then you need to figure out how to structure the visits, determine the most appropriate visit settings, and learn to document and code appropriately. These are not quick 10-minute visits, Dr. Lessin said. Doctors must schedule enough time for them, although they may be able to do them faster with practice.
Dr. Lessin offered encouraging words for those feeling overwhelmed: “Overcome your anxiety. This is not as hard as it seems. It’s a little bit harder with comorbidities, but many chronic diseases we manage are far worse.”
In addition to reading the guidelines and review articles, seeking out mental health training programs, and learning the medications available, Dr. Lessin told attendees to get comfortable with the fact that a lot of treatment comes down to trial and error.
Again, he emphasized the value of the toolkit, which Dr. Hackell echoed.
“It’s a really nice roadmap to be able to follow and to explain how it requires two or three or four visits to treat these children well and get them started on treatment,” Dr. Hackell said. “It’s something that I recommend people use if they have not already done so to integrate ADHD care into their practices.”
Beginning the process
In figuring out how to structure visits, avoid addressing ADHD as a “by-the-way” issue, such as when a parent mentions it at the end of an appointment, Dr. Lessin said. Instead, start with an intake visit to determine whether you’re the right person to evaluate the child and hand out Parent and Teacher Evaluation scales to begin the process. Next, do the evaluation, discuss the process with the family, determine how treatment will work, and then look at comorbidities.
Visit settings can be traditional face-to-face visits, which are particularly helpful for intake visits, Dr. Lessin said, or telehealth, especially during the pandemic. In-person visits allow you more easily to make eye contact with the child and observe the parent and child behaviors and interactions, but telehealth often is adequate for titrating medication, discussing side effects, monitoring, and similar follow-up.
“Coding practices are absolutely necessary to make your practice viable, much less make money,” Dr. Lessin said. “Doing good for people and doing well for yourself are not mutually exclusive. You have to figure out a way to make it work economically for the practice or else you’re just not going to do it.”
He reminded pediatricians to code for evaluation, monitoring scales, and care coordination, and to be prepared for the big change of new coding rules coming in 2021.
“For better or worse, documentation is the key to survival in medical practice these days,” Dr. Lessin said. “This is true for all medical care these days, but it’s particularly true for ADHD because visits are all high intensity codes and should be coded as such.”
Templates are fine, he said, but box-checking isn’t enough; leave space for a narrative that explains the case complexity and decision-making.
Training staff is essential
It’s utterly essential to train all office staff, Dr. Lessin said. “I can’t tell you how important this step is because no matter how much you know or how well you understand what you want to do, you’re going to be frustrated at every turn if your staff and colleagues don’t get this stuff.”
That includes training those who make appointments, front desk staff, clinical staff, and practice colleagues regarding coding, scheduling, visit protocols, and similar procedures. Cheat sheets can be helpful here.
“They must understand the structure of the visits, what happens at each visit, the time requirements for each visit, and the standard follow-up,” including, for clinical staff, what handouts and rating scales to use, he said. “And if they aren’t sure what the parents needs or what you want, make sure they know to contact you.”
Colleagues also need to learn to properly document visits to justify coding and complexity, and not dump all patients on you.
One challenge that Dr. Lessin acknowledged as a common problem is that many pediatricians don’t have subspecialists they can refer patients to.
“Sadly, this is true almost everywhere, in rural and in big cities, near big medical centers and only local hospitals,” Dr. Lessin said. “This another reason why I think you need to learn and treat this illness to the extent you can. Your families need you.”
Dr. Hackell particularly appreciated this point, emphasizing again how important it is that pediatricians manage ADHD care of their patients.
“We see their day-to-day life, and that’s where this impacts these kids and families,” he said. “It’s really rewarding to do from my personal experience because you can really make a really big difference in these kids’ lives when they’re younger and even as they get older. When you get the rewards, it makes the work all worthwhile.”
Dr. Lessin and Dr. Hackell said they have no relevant financial disclosures.
FROM AAP 2020
Four-week, 8-week CAB/RPV injections safe, effective in women
according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.
Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.
Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.
Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.
At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.
Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.
There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.
Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.
Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
This article first appeared on Medscape.com.
according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.
Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.
Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.
Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.
At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.
Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.
There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.
Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.
Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
This article first appeared on Medscape.com.
according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.
Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.
Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.
Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.
At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.
Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.
There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.
Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.
Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
This article first appeared on Medscape.com.
Heterosexual men likely to have unmet HIV treatment needs
according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.
Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.
In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.
Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).
A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).
Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.
By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.
The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.
MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).
The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
A version of this article originally appeared on Medscape.com.
according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.
Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.
In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.
Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).
A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).
Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.
By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.
The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.
MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).
The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
A version of this article originally appeared on Medscape.com.
according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.
Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.
In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.
Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).
A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).
Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.
By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.
The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.
MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).
The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
A version of this article originally appeared on Medscape.com.
Flexibility, innovation key to practice management during pandemic
Practice management is the responsibility of every pediatrician, and leadership is more important than ever in a crisis like the COVID-19 pandemic.
“Ultimately you have a critical role in ensuring that your practice remains sustainable so that you can continue to deliver great care,” Sue Kressly, MD, a retired pediatrician from Warrington, Pa., said at the virtual annual meeting of the American Academy of Pediatrics. “None of us escaped some impact of the COVID crisis, and many of us are going to experience lasting change.”
Dr. Kressly and Suzanne Berman, MD, a pediatrician in central Tennessee, presented a live online session on how the pandemic is affecting practices and how pediatricians can effectively address those challenges.
Three ways a crisis impacts practices
“When a practice experiences a crisis, it really exposes what your practice is made of, for better or for worse,” Dr. Berman said. “The COVID crisis has been profound and broad and long enough to really stress the core tensile strength of practices along at least three axes.” Those are staffing, financial health, and partnerships.
It’s a normal human response to enter survival mode during a crisis, so staff management becomes more important than ever. Some things to consider are whether you have a truly collaborative team culture in your practice and whether you’re really listening to the staff’s struggles and suggestions.
“Staffing challenges can be very difficult,” Dr. Berman said. “Permitting staff to work from home is the single biggest thing you can do when staff needs to self-isolate.”
Financially, most medical practices have adequate cash on hand not to have to pay close attention to the numbers, Dr. Kressly said, but if physicians are looking at their books for the first time during a crisis, they have no way of knowing what their baseline expectations should be or how much to worry about their finances. It’s important to understand your practice’s or department’s budget.
Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and appreciated this point on finances.
“In order to provide good quality care to kids, you need to be financially successful because otherwise you’ll close your doors,” Dr. Hackell said in an interview. “It’s making yourself available to be able to provide care.”
Stressors among partners during a crisis arise from responding to the challenges of the crisis, such as who should be impacted by pay cuts or furloughs, how to account for overhead, how to distribute revenue and how to divide the work equitably. Other issues include how to protect higher risk providers fairly and how to shift schedules or case load based on unforeseen events, including quarantining.
“There is no ‘fair’ in a crisis,” Dr. Berman said. “We must use the equity paradigm to be sure everyone has what they need to survive and have the best outcome possible.”
The speakers also discussed the importance of a practice’s situation before the pandemic began, a point that resonated with attendee Jason Terk, MD, a pediatrician who practices in a large pediatric health care system near Fort Worth, Texas.
“Just like the pandemic impacts the health of people in different ways based upon their baseline health, the pandemic impacts practices in different ways based on the practice’s baseline health,” he said in an interview. “If you had good operations, a good culture, good communication and all those other good indicators of practice health before, then you stood a much better chance of surviving the pandemic as a practice than practices that had weaknesses before.”
The size of a practice did not necessarily predict the impact of the crisis, Dr. Berman said. Rather, practices with good patient engagement, active recall programs, and good fiscal planning did better.
Dr. Hackell said. “We had never seen anything like this before,” he said in an interview. “From the start we had no idea what was going to work. Try something and see if it works. If it fails, try something else. We were all operating blind here.”
The focus of most practices in the spring was on well visits, chronic care follow-up, and telehealth. Going into fall and winter, innovation will be necessary to provide appropriate care for all children while keeping in mind that the choices pediatricians make will have long-lasting implications for their staff and patients. The speakers stressed the importance of communication and transparency within the office team and to patients and the community.
Dr. Hackell appreciated the speakers’ point that kids need care, and pediatricians need to meet that need.
“Kids need well care and immunizations, and kids get sick and need sick care,” he said. “Parents need a lot more reassurance during times like this. We need to be able to provide that care and be sure that we do it safely. To give the right care at the right time in the right location is key.”
Making practice adaptations
In balancing risk and access to care, Dr. Kressly described the importance of multiple interventions, including managing some patients out of the office and making physical changes, such as putting in physical barriers and eliminating waiting rooms.
“Many practices are highly focused on PPE [personal protective equipment],” Dr. Kressly said, but even Centers for Disease Control and Prevention guidance emphasizes that PPE is the last line of defense. “There are many things we can do to protect our teams and our patients, and we know that not one single adaption is going to be 100% effective. But like the Swiss cheese model indicates, when you layer all of these efforts on top of one another, many defenses allow for the protection of the majority of people.”
Other changes include restricting office visitors to one per patient, implementing social distancing, requiring visitors to wear masks, and considering alternate locations for visits, including car and parking lot visits.
“No idea is too crazy, and some of the best ideas come from your staff,” Dr. Kressly said. She also recommended asking families where they feel most comfortable meeting.
“Don’t make any assumptions about where they want to be seen, but ask and together decide where the patient can most safely and effectively be given appropriate care,” she said.
Dr. Kressly also noted the new CPT code, 99072, that can be used to bill for “additional supplies, materials, and clinical staff time over and above those usually included in an office visit or other nonfacility service(s), when performed during a public health emergency as defined by law, due to respiratory-transmitted infectious disease.”
Pediatricians should think of ways they can remove barriers to access, such as adjusting no-show cancellation penalties and adjusting practice policies as needed when things change. “Avoid creating a culture where families do not disclose all information for fear of not being seen,” Dr. Kressly said.
A slower pace because of delays and hiccups is also normal at this time, Dr. Berman said. “If you feel like you’re just not as efficient as you were prior to COVID, it’s not just you,” she said. “It’s true. Everyone has to grapple with new things now. It takes longer.”
Things that add time include remote check-in and paperwork, more time to don and doff PPE and disinfect, dealing with technology failures, adjusting to new procedures or policies, and the general mental fatigue of adhering to PPE best practices. Patience is vital during this time, Dr. Berman said.
Several ways to improve efficiency include cutting out unnecessary steps, using standing orders and Advance Beneficiary Notice of Noncoverage (ABNs) for flu vaccinations, keeping credit card numbers on file for contactless payment, and considering the clinical and financial value of lab testing before ordering it.
“Effective triage helps patient satisfaction, access to care, and efficiency of your office workload,” Dr. Kressly said. “Use technology where it’s appropriate, but then add people where it’s needed. Connections to caring people matter even more in a time of crisis.”
The speakers also highlighted the importance of early flu vaccinations.
“One of the single biggest things you can do for value in COVID is to get your flu vaccine numbers up,” Dr. Berman said. “Severely reducing the burden of influenza will help flatten the curve, it will reduce febrile respiratory illness, and it will protect your most fragile patients.”
Two ways to do that include flu clinics and making a strong push for immunizations during the first 8 weeks after getting the vaccines. Dr Berman shared numbers from two practices showing how many more total immunizations were done in the practice that began vaccinating in early August versus early September.
A crisis is an opportunity
The speakers closed on an optimistic note that emphasized the opportunities that can grow out of the challenges presented by the pandemic, a point Dr Terk elaborated on.
“One of the most important things is realizing how we can potentially use a crisis to transform our practices,” Dr. Terk said in the interview. “As had been said before, a crisis is a terrible thing to waste. Those practices that have the gumption to innovate and find different ways to improve the way they provide care are probably going to be in better shape as we go forward.”
Critical to that success is taking risks, he added.
“When you’re innovating, failure has to be something you are permissive of because if you’re risk-averse and failure-averse, you’re not going to have the opportunity to grow and innovate, and this is another opportunity to innovate,” Dr. Terk said.
He also stressed the value of learning from one another. “We need to help each other by sharing our good practices, and on the flip side, be open to learning from each other,” he said. “Those pediatricians who are struggling need to be open-minded and open-hearted to understanding how we can operate our practices better and know that the things we think are barriers we can’t change are probably things we probably haven’t allowed ourselves to think about changing.”
Dr. Kressly and Dr. Berman recommended several specific actions for pediatricians to take:
- Creating a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis regarding your practice management response to the pandemic.
- Articulating three goals for improving your understanding or the implementation of management in your practice.
- Creating a working group to identify and implement ways to improve clinical work flow and communication strategies.
“Now is the time to meaningfully address disparities of access to appropriate health care and the impact of social determinants of health,” Dr. Kressly said. It’s also an opportunity to build meaningful relationships with patient families based on trust, science, and “true shared decision-making with health literacy in mind.”
Dr Kressly is the medical director of and owns shares in Office Practicum. Dr. Berman is the assistant medical director of and owns shares in Office Practicum, and is the owner of Script Doctor LLC. Dr. Terk and Dr. Hackell had no relevant financial disclosures.
Practice management is the responsibility of every pediatrician, and leadership is more important than ever in a crisis like the COVID-19 pandemic.
“Ultimately you have a critical role in ensuring that your practice remains sustainable so that you can continue to deliver great care,” Sue Kressly, MD, a retired pediatrician from Warrington, Pa., said at the virtual annual meeting of the American Academy of Pediatrics. “None of us escaped some impact of the COVID crisis, and many of us are going to experience lasting change.”
Dr. Kressly and Suzanne Berman, MD, a pediatrician in central Tennessee, presented a live online session on how the pandemic is affecting practices and how pediatricians can effectively address those challenges.
Three ways a crisis impacts practices
“When a practice experiences a crisis, it really exposes what your practice is made of, for better or for worse,” Dr. Berman said. “The COVID crisis has been profound and broad and long enough to really stress the core tensile strength of practices along at least three axes.” Those are staffing, financial health, and partnerships.
It’s a normal human response to enter survival mode during a crisis, so staff management becomes more important than ever. Some things to consider are whether you have a truly collaborative team culture in your practice and whether you’re really listening to the staff’s struggles and suggestions.
“Staffing challenges can be very difficult,” Dr. Berman said. “Permitting staff to work from home is the single biggest thing you can do when staff needs to self-isolate.”
Financially, most medical practices have adequate cash on hand not to have to pay close attention to the numbers, Dr. Kressly said, but if physicians are looking at their books for the first time during a crisis, they have no way of knowing what their baseline expectations should be or how much to worry about their finances. It’s important to understand your practice’s or department’s budget.
Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and appreciated this point on finances.
“In order to provide good quality care to kids, you need to be financially successful because otherwise you’ll close your doors,” Dr. Hackell said in an interview. “It’s making yourself available to be able to provide care.”
Stressors among partners during a crisis arise from responding to the challenges of the crisis, such as who should be impacted by pay cuts or furloughs, how to account for overhead, how to distribute revenue and how to divide the work equitably. Other issues include how to protect higher risk providers fairly and how to shift schedules or case load based on unforeseen events, including quarantining.
“There is no ‘fair’ in a crisis,” Dr. Berman said. “We must use the equity paradigm to be sure everyone has what they need to survive and have the best outcome possible.”
The speakers also discussed the importance of a practice’s situation before the pandemic began, a point that resonated with attendee Jason Terk, MD, a pediatrician who practices in a large pediatric health care system near Fort Worth, Texas.
“Just like the pandemic impacts the health of people in different ways based upon their baseline health, the pandemic impacts practices in different ways based on the practice’s baseline health,” he said in an interview. “If you had good operations, a good culture, good communication and all those other good indicators of practice health before, then you stood a much better chance of surviving the pandemic as a practice than practices that had weaknesses before.”
The size of a practice did not necessarily predict the impact of the crisis, Dr. Berman said. Rather, practices with good patient engagement, active recall programs, and good fiscal planning did better.
Dr. Hackell said. “We had never seen anything like this before,” he said in an interview. “From the start we had no idea what was going to work. Try something and see if it works. If it fails, try something else. We were all operating blind here.”
The focus of most practices in the spring was on well visits, chronic care follow-up, and telehealth. Going into fall and winter, innovation will be necessary to provide appropriate care for all children while keeping in mind that the choices pediatricians make will have long-lasting implications for their staff and patients. The speakers stressed the importance of communication and transparency within the office team and to patients and the community.
Dr. Hackell appreciated the speakers’ point that kids need care, and pediatricians need to meet that need.
“Kids need well care and immunizations, and kids get sick and need sick care,” he said. “Parents need a lot more reassurance during times like this. We need to be able to provide that care and be sure that we do it safely. To give the right care at the right time in the right location is key.”
Making practice adaptations
In balancing risk and access to care, Dr. Kressly described the importance of multiple interventions, including managing some patients out of the office and making physical changes, such as putting in physical barriers and eliminating waiting rooms.
“Many practices are highly focused on PPE [personal protective equipment],” Dr. Kressly said, but even Centers for Disease Control and Prevention guidance emphasizes that PPE is the last line of defense. “There are many things we can do to protect our teams and our patients, and we know that not one single adaption is going to be 100% effective. But like the Swiss cheese model indicates, when you layer all of these efforts on top of one another, many defenses allow for the protection of the majority of people.”
Other changes include restricting office visitors to one per patient, implementing social distancing, requiring visitors to wear masks, and considering alternate locations for visits, including car and parking lot visits.
“No idea is too crazy, and some of the best ideas come from your staff,” Dr. Kressly said. She also recommended asking families where they feel most comfortable meeting.
“Don’t make any assumptions about where they want to be seen, but ask and together decide where the patient can most safely and effectively be given appropriate care,” she said.
Dr. Kressly also noted the new CPT code, 99072, that can be used to bill for “additional supplies, materials, and clinical staff time over and above those usually included in an office visit or other nonfacility service(s), when performed during a public health emergency as defined by law, due to respiratory-transmitted infectious disease.”
Pediatricians should think of ways they can remove barriers to access, such as adjusting no-show cancellation penalties and adjusting practice policies as needed when things change. “Avoid creating a culture where families do not disclose all information for fear of not being seen,” Dr. Kressly said.
A slower pace because of delays and hiccups is also normal at this time, Dr. Berman said. “If you feel like you’re just not as efficient as you were prior to COVID, it’s not just you,” she said. “It’s true. Everyone has to grapple with new things now. It takes longer.”
Things that add time include remote check-in and paperwork, more time to don and doff PPE and disinfect, dealing with technology failures, adjusting to new procedures or policies, and the general mental fatigue of adhering to PPE best practices. Patience is vital during this time, Dr. Berman said.
Several ways to improve efficiency include cutting out unnecessary steps, using standing orders and Advance Beneficiary Notice of Noncoverage (ABNs) for flu vaccinations, keeping credit card numbers on file for contactless payment, and considering the clinical and financial value of lab testing before ordering it.
“Effective triage helps patient satisfaction, access to care, and efficiency of your office workload,” Dr. Kressly said. “Use technology where it’s appropriate, but then add people where it’s needed. Connections to caring people matter even more in a time of crisis.”
The speakers also highlighted the importance of early flu vaccinations.
“One of the single biggest things you can do for value in COVID is to get your flu vaccine numbers up,” Dr. Berman said. “Severely reducing the burden of influenza will help flatten the curve, it will reduce febrile respiratory illness, and it will protect your most fragile patients.”
Two ways to do that include flu clinics and making a strong push for immunizations during the first 8 weeks after getting the vaccines. Dr Berman shared numbers from two practices showing how many more total immunizations were done in the practice that began vaccinating in early August versus early September.
A crisis is an opportunity
The speakers closed on an optimistic note that emphasized the opportunities that can grow out of the challenges presented by the pandemic, a point Dr Terk elaborated on.
“One of the most important things is realizing how we can potentially use a crisis to transform our practices,” Dr. Terk said in the interview. “As had been said before, a crisis is a terrible thing to waste. Those practices that have the gumption to innovate and find different ways to improve the way they provide care are probably going to be in better shape as we go forward.”
Critical to that success is taking risks, he added.
“When you’re innovating, failure has to be something you are permissive of because if you’re risk-averse and failure-averse, you’re not going to have the opportunity to grow and innovate, and this is another opportunity to innovate,” Dr. Terk said.
He also stressed the value of learning from one another. “We need to help each other by sharing our good practices, and on the flip side, be open to learning from each other,” he said. “Those pediatricians who are struggling need to be open-minded and open-hearted to understanding how we can operate our practices better and know that the things we think are barriers we can’t change are probably things we probably haven’t allowed ourselves to think about changing.”
Dr. Kressly and Dr. Berman recommended several specific actions for pediatricians to take:
- Creating a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis regarding your practice management response to the pandemic.
- Articulating three goals for improving your understanding or the implementation of management in your practice.
- Creating a working group to identify and implement ways to improve clinical work flow and communication strategies.
“Now is the time to meaningfully address disparities of access to appropriate health care and the impact of social determinants of health,” Dr. Kressly said. It’s also an opportunity to build meaningful relationships with patient families based on trust, science, and “true shared decision-making with health literacy in mind.”
Dr Kressly is the medical director of and owns shares in Office Practicum. Dr. Berman is the assistant medical director of and owns shares in Office Practicum, and is the owner of Script Doctor LLC. Dr. Terk and Dr. Hackell had no relevant financial disclosures.
Practice management is the responsibility of every pediatrician, and leadership is more important than ever in a crisis like the COVID-19 pandemic.
“Ultimately you have a critical role in ensuring that your practice remains sustainable so that you can continue to deliver great care,” Sue Kressly, MD, a retired pediatrician from Warrington, Pa., said at the virtual annual meeting of the American Academy of Pediatrics. “None of us escaped some impact of the COVID crisis, and many of us are going to experience lasting change.”
Dr. Kressly and Suzanne Berman, MD, a pediatrician in central Tennessee, presented a live online session on how the pandemic is affecting practices and how pediatricians can effectively address those challenges.
Three ways a crisis impacts practices
“When a practice experiences a crisis, it really exposes what your practice is made of, for better or for worse,” Dr. Berman said. “The COVID crisis has been profound and broad and long enough to really stress the core tensile strength of practices along at least three axes.” Those are staffing, financial health, and partnerships.
It’s a normal human response to enter survival mode during a crisis, so staff management becomes more important than ever. Some things to consider are whether you have a truly collaborative team culture in your practice and whether you’re really listening to the staff’s struggles and suggestions.
“Staffing challenges can be very difficult,” Dr. Berman said. “Permitting staff to work from home is the single biggest thing you can do when staff needs to self-isolate.”
Financially, most medical practices have adequate cash on hand not to have to pay close attention to the numbers, Dr. Kressly said, but if physicians are looking at their books for the first time during a crisis, they have no way of knowing what their baseline expectations should be or how much to worry about their finances. It’s important to understand your practice’s or department’s budget.
Jesse Hackell, MD, a private practice pediatrician in a suburb of New York City and vice president of the New York AAP Chapter 3, attended the session and appreciated this point on finances.
“In order to provide good quality care to kids, you need to be financially successful because otherwise you’ll close your doors,” Dr. Hackell said in an interview. “It’s making yourself available to be able to provide care.”
Stressors among partners during a crisis arise from responding to the challenges of the crisis, such as who should be impacted by pay cuts or furloughs, how to account for overhead, how to distribute revenue and how to divide the work equitably. Other issues include how to protect higher risk providers fairly and how to shift schedules or case load based on unforeseen events, including quarantining.
“There is no ‘fair’ in a crisis,” Dr. Berman said. “We must use the equity paradigm to be sure everyone has what they need to survive and have the best outcome possible.”
The speakers also discussed the importance of a practice’s situation before the pandemic began, a point that resonated with attendee Jason Terk, MD, a pediatrician who practices in a large pediatric health care system near Fort Worth, Texas.
“Just like the pandemic impacts the health of people in different ways based upon their baseline health, the pandemic impacts practices in different ways based on the practice’s baseline health,” he said in an interview. “If you had good operations, a good culture, good communication and all those other good indicators of practice health before, then you stood a much better chance of surviving the pandemic as a practice than practices that had weaknesses before.”
The size of a practice did not necessarily predict the impact of the crisis, Dr. Berman said. Rather, practices with good patient engagement, active recall programs, and good fiscal planning did better.
Dr. Hackell said. “We had never seen anything like this before,” he said in an interview. “From the start we had no idea what was going to work. Try something and see if it works. If it fails, try something else. We were all operating blind here.”
The focus of most practices in the spring was on well visits, chronic care follow-up, and telehealth. Going into fall and winter, innovation will be necessary to provide appropriate care for all children while keeping in mind that the choices pediatricians make will have long-lasting implications for their staff and patients. The speakers stressed the importance of communication and transparency within the office team and to patients and the community.
Dr. Hackell appreciated the speakers’ point that kids need care, and pediatricians need to meet that need.
“Kids need well care and immunizations, and kids get sick and need sick care,” he said. “Parents need a lot more reassurance during times like this. We need to be able to provide that care and be sure that we do it safely. To give the right care at the right time in the right location is key.”
Making practice adaptations
In balancing risk and access to care, Dr. Kressly described the importance of multiple interventions, including managing some patients out of the office and making physical changes, such as putting in physical barriers and eliminating waiting rooms.
“Many practices are highly focused on PPE [personal protective equipment],” Dr. Kressly said, but even Centers for Disease Control and Prevention guidance emphasizes that PPE is the last line of defense. “There are many things we can do to protect our teams and our patients, and we know that not one single adaption is going to be 100% effective. But like the Swiss cheese model indicates, when you layer all of these efforts on top of one another, many defenses allow for the protection of the majority of people.”
Other changes include restricting office visitors to one per patient, implementing social distancing, requiring visitors to wear masks, and considering alternate locations for visits, including car and parking lot visits.
“No idea is too crazy, and some of the best ideas come from your staff,” Dr. Kressly said. She also recommended asking families where they feel most comfortable meeting.
“Don’t make any assumptions about where they want to be seen, but ask and together decide where the patient can most safely and effectively be given appropriate care,” she said.
Dr. Kressly also noted the new CPT code, 99072, that can be used to bill for “additional supplies, materials, and clinical staff time over and above those usually included in an office visit or other nonfacility service(s), when performed during a public health emergency as defined by law, due to respiratory-transmitted infectious disease.”
Pediatricians should think of ways they can remove barriers to access, such as adjusting no-show cancellation penalties and adjusting practice policies as needed when things change. “Avoid creating a culture where families do not disclose all information for fear of not being seen,” Dr. Kressly said.
A slower pace because of delays and hiccups is also normal at this time, Dr. Berman said. “If you feel like you’re just not as efficient as you were prior to COVID, it’s not just you,” she said. “It’s true. Everyone has to grapple with new things now. It takes longer.”
Things that add time include remote check-in and paperwork, more time to don and doff PPE and disinfect, dealing with technology failures, adjusting to new procedures or policies, and the general mental fatigue of adhering to PPE best practices. Patience is vital during this time, Dr. Berman said.
Several ways to improve efficiency include cutting out unnecessary steps, using standing orders and Advance Beneficiary Notice of Noncoverage (ABNs) for flu vaccinations, keeping credit card numbers on file for contactless payment, and considering the clinical and financial value of lab testing before ordering it.
“Effective triage helps patient satisfaction, access to care, and efficiency of your office workload,” Dr. Kressly said. “Use technology where it’s appropriate, but then add people where it’s needed. Connections to caring people matter even more in a time of crisis.”
The speakers also highlighted the importance of early flu vaccinations.
“One of the single biggest things you can do for value in COVID is to get your flu vaccine numbers up,” Dr. Berman said. “Severely reducing the burden of influenza will help flatten the curve, it will reduce febrile respiratory illness, and it will protect your most fragile patients.”
Two ways to do that include flu clinics and making a strong push for immunizations during the first 8 weeks after getting the vaccines. Dr Berman shared numbers from two practices showing how many more total immunizations were done in the practice that began vaccinating in early August versus early September.
A crisis is an opportunity
The speakers closed on an optimistic note that emphasized the opportunities that can grow out of the challenges presented by the pandemic, a point Dr Terk elaborated on.
“One of the most important things is realizing how we can potentially use a crisis to transform our practices,” Dr. Terk said in the interview. “As had been said before, a crisis is a terrible thing to waste. Those practices that have the gumption to innovate and find different ways to improve the way they provide care are probably going to be in better shape as we go forward.”
Critical to that success is taking risks, he added.
“When you’re innovating, failure has to be something you are permissive of because if you’re risk-averse and failure-averse, you’re not going to have the opportunity to grow and innovate, and this is another opportunity to innovate,” Dr. Terk said.
He also stressed the value of learning from one another. “We need to help each other by sharing our good practices, and on the flip side, be open to learning from each other,” he said. “Those pediatricians who are struggling need to be open-minded and open-hearted to understanding how we can operate our practices better and know that the things we think are barriers we can’t change are probably things we probably haven’t allowed ourselves to think about changing.”
Dr. Kressly and Dr. Berman recommended several specific actions for pediatricians to take:
- Creating a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis regarding your practice management response to the pandemic.
- Articulating three goals for improving your understanding or the implementation of management in your practice.
- Creating a working group to identify and implement ways to improve clinical work flow and communication strategies.
“Now is the time to meaningfully address disparities of access to appropriate health care and the impact of social determinants of health,” Dr. Kressly said. It’s also an opportunity to build meaningful relationships with patient families based on trust, science, and “true shared decision-making with health literacy in mind.”
Dr Kressly is the medical director of and owns shares in Office Practicum. Dr. Berman is the assistant medical director of and owns shares in Office Practicum, and is the owner of Script Doctor LLC. Dr. Terk and Dr. Hackell had no relevant financial disclosures.
FROM AAP 2020
New nonhormonal hot flash treatments on the way
researchers told attendees at the virtual North American Menopause Society 2020 Annual Meeting.
“The KNDy [kisspeptin/neurokinin B/dynorphin] neuron manipulation is really exciting and holds great promise for rapid and highly effective amelioration of hot flashes, up to 80%, and improvement in other menopausal symptoms, though we’re still looking at the safety in phase 3 trials,” reported Susan D. Reed, MD, MPH, director of the Women’s Reproductive Health Research Program at the University of Washington, Seattle.
“If we continue to see good safety data, these are going to be the greatest things since sliced bread,” Dr. Reed said in an interview. “I don’t think we’ve seen anything like this in menopause therapeutics in a long time.”
While several nonhormonal drugs are already used to treat vasomotor symptoms in menopausal women with and without breast cancer, none are as effective as hormone treatments.
“For now, the SSRIs, SNRIs [serotonin norepinephrine reuptake inhibitors], and GABAergics are the best frontline nonhormonal options with a moderate effect, and clonidine and oxybutynin are effective, but we see more side effects with these,” Dr. Reed said. She noted the importance of considering patients’ mood, sleep, pain, sexual function, weight gain, overactive bladder, blood pressure, and individual quality of life (QOL) goals in tailoring those therapies.
But women still need more nonhormonal options that are at least as effective as hormonal options, Dr. Reed said. Some women are unable to take hormonal options because they are at risk for blood clots or breast cancer.
“Then there’s preference,” she said. “Sometimes people don’t like the way they feel when they take hormones, or they just don’t want hormones in their body. It’s absolutely critical to have these options available for women.”
Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, who was not involved in the presentation, said in an interview that physicians may not always realize the extent to which vasomotor symptoms interfere with women’s daily lives.
“They have an eroding effect on QOL that is not appreciated sometimes,” she said. Though hot flashes eventually subside in most women, others may continue to experience them into their 70s, when hormonal therapies can begin causing more harm than benefit.
“It goes underappreciated that, for a proportion of women, hot flashes will never go away, and they’re just as bad [as] when they were in their 50s,” Dr. Santoro said. “They need to be treated, and the nonhormonal treatments do not work for everybody.”
Promising KNDy therapeutics
Autopsy studies of postmenopausal women revealed that a complex of neurons in the hypothalamus was “massively hypertrophied” and sits right next to the thermoregulatory center of the brain, Dr. Reed explained.
The complex produces three types of molecules: kisspeptin (a neuropeptide), neurokinin B (a neuropeptide), and dynorphin (a kappa opioid), collectively referred to as the KNDy. The KNDy neural complex is located in the same place as the majority of hormone receptors in the arcuate nucleus, a collection of nerve cells in the hypothalamus.
The current hypothesis is that the KNDy neurons, which communicate with each other, become hyperactivated and cause hot flashes by spilling over to and triggering the thermoregulatory center next door. NKB (kisspeptin and neurokinin B) agonists activate KNDy neurons and dynorphin agonists inactivate KNDy, so the expectation is that NKB antagonists or dynorphin agonists would stop hot flashes.
Indeed, research published in 2015 showed that women taking kappa agonists experienced fewer hot flashes than women in the placebo group. However, no peripherally restricted kappa agonists are currently in clinical trials, so their future as therapeutics is unclear.
Right now, three different NK antagonists are in the pipeline for reducing vasomotor symptoms: MLE 4901 (pavinetant) and ESN364 (fezolinetant) are both NK3R antagonists, and NT-814 is a dual NK1R/NK3R antagonist. All three of these drugs were originally developed to treat schizophrenia.
Phase 2 clinical trials of pavinetant were discontinued in November 2017 by Millendo Therapeutics because 3 of 28 women experienced abnormal liver function, which normalized within 90 days. However, the study had shown an 80% decrease in hot flashes in women taking pavinetant, compared with a 30% decrease in the placebo group.
Fezolinetant, currently in phase 3 trials with Astellas, showed a dose response effect on reproductive hormones in phase 1 studies and a short half-life (4-6 hours) in women. It also showed no concerning side effects.
“There was, in fact, a decrease in the endometrial thickness, a delayed or impeded ovulation and a prolonged cycle duration,” Reed said.
The subsequent phase 2a study showed a reduction of five hot flashes a day (93% decrease), compared with placebo (54% decrease, P <.001) “with an abrupt return to baseline hot flash frequency after cessation,” she said. Improvements also occurred in sleep quality, quality of life, disability, and interference of hot flashes in daily life.
The phase 2b study found no difference in effects between once-daily versus twice-daily doses. However, two severe adverse events occurred: a drug-induced liver injury in one woman and cholelithiasis in another, both on the 60-mg, once-daily dose. Additionally, five women on varying doses had transient increases (above 1000 U/L) in creatinine kinase, though apparently without dose response.
A 52-week, three-arm, phase 3 trial of fezolinetant is currently under way with a goal of enrolling 1,740 participants, and plans to be completed by December 2021. Participants will undergo regular adverse event screening first biweekly, then monthly, with vital signs, blood, and urine monitoring.
Meanwhile, NT-814 from KaNDy Therapeutics, has completed phase 2a and phase 2b trials with phase 3 slated to begin in 2021. Adverse events in phase 1 included sleepiness and headache, and it had a long half-life (about 26 hours) and rapid absorption (an hour).
The phase 2a trial found a reduction of five hot flashes a day, compared with placebo, with main side effects again being sleepiness and headache. No events of abnormal liver function occurred. Phase 2b results have not been published.
So far, existing research suggests that KNDy interventions will involve a single daily oral dose that begins taking effect within 3 days and is fully in effect within 1-2 weeks. The reduction in hot flashes, about five fewer a day, is more effective than any other currently used nonhormonal medications for vasomotor symptoms. SSRIs and SNRIs tend to result in 1.5-2 fewer hot flashes a day, and gabapentin results in about 3 fewer per day. It will take longer-term studies, however, and paying attention to liver concerns for the NK3R antagonists to move into clinic.
“We want to keep our eye on the [luteinizing hormone] because if it decreases too much, it could adversely affect sexual function, and this does appear to be a dose-response finding,” Dr. Reed said. It would also be ideal, she said, to target only the KNDy neurons with NK3 antagonists without effects on the NK3 receptors in the liver.
Other nonhormonal options
Oxybutynin is another a nonhormonal agent under investigation for vasomotor symptoms. It’s an anticholinergic that resulted in 80% fewer hot flashes, compared with 30% with placebo in a 2016 trial, but 52% of women complained of dry mouth. A more recent study similarly found high efficacy – a 60%-80% drop in hot flashes, compared with 30% with placebo – but also side effects of dry mouth, difficulty urinating, and abdominal pain.
Finally, Dr. Reed mentioned three other agents under investigation as possible nonhormonal therapeutics, though she has little information about them. They include MT-8554 by Mitsubishi Tanabe; FP-101 by Fervent Pharmaceuticals; and Q-122 by QUE Oncology with Emory University, Atlanta, and the University of Queensland, Brisbane, Australia.
None of the currently available nonhormonal options provide as high efficacy as hormones, but they do reduce symptoms:
Clonidine is an off-label option some physicians already use as a nonhormonal treatment for vasomotor symptoms, but again, the side effects are problematic: dry mouth, constipation, drowsiness, postural hypotension, and poor sleep.
Paroxetine, at 7.5-10 mg, is the only FDA-approved nonhormonal treatment for vasomotor symptoms, but she listed other off-label options found effective in evidence reviews: gabapentin (100-2,400 mg), venlafaxine (37.5-75 mg), citalopram (10 mg), desvenlafaxine (150 mg), and escitalopram (10 mg).
“I want you to take note of the lower doses in all of these products that are efficacious above those doses that might be used for mood,” Dr. Reed added.
Dr. Reed receives royalties from UpToDate and research funding from Bayer. Dr. Santoro owns stock in MenoGeniX and serves as a consultant or advisor to Ansh Labs, MenoGeniX, and Ogeda/Astellas.
A version of this article originally appeared on Medscape.com.
researchers told attendees at the virtual North American Menopause Society 2020 Annual Meeting.
“The KNDy [kisspeptin/neurokinin B/dynorphin] neuron manipulation is really exciting and holds great promise for rapid and highly effective amelioration of hot flashes, up to 80%, and improvement in other menopausal symptoms, though we’re still looking at the safety in phase 3 trials,” reported Susan D. Reed, MD, MPH, director of the Women’s Reproductive Health Research Program at the University of Washington, Seattle.
“If we continue to see good safety data, these are going to be the greatest things since sliced bread,” Dr. Reed said in an interview. “I don’t think we’ve seen anything like this in menopause therapeutics in a long time.”
While several nonhormonal drugs are already used to treat vasomotor symptoms in menopausal women with and without breast cancer, none are as effective as hormone treatments.
“For now, the SSRIs, SNRIs [serotonin norepinephrine reuptake inhibitors], and GABAergics are the best frontline nonhormonal options with a moderate effect, and clonidine and oxybutynin are effective, but we see more side effects with these,” Dr. Reed said. She noted the importance of considering patients’ mood, sleep, pain, sexual function, weight gain, overactive bladder, blood pressure, and individual quality of life (QOL) goals in tailoring those therapies.
But women still need more nonhormonal options that are at least as effective as hormonal options, Dr. Reed said. Some women are unable to take hormonal options because they are at risk for blood clots or breast cancer.
“Then there’s preference,” she said. “Sometimes people don’t like the way they feel when they take hormones, or they just don’t want hormones in their body. It’s absolutely critical to have these options available for women.”
Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, who was not involved in the presentation, said in an interview that physicians may not always realize the extent to which vasomotor symptoms interfere with women’s daily lives.
“They have an eroding effect on QOL that is not appreciated sometimes,” she said. Though hot flashes eventually subside in most women, others may continue to experience them into their 70s, when hormonal therapies can begin causing more harm than benefit.
“It goes underappreciated that, for a proportion of women, hot flashes will never go away, and they’re just as bad [as] when they were in their 50s,” Dr. Santoro said. “They need to be treated, and the nonhormonal treatments do not work for everybody.”
Promising KNDy therapeutics
Autopsy studies of postmenopausal women revealed that a complex of neurons in the hypothalamus was “massively hypertrophied” and sits right next to the thermoregulatory center of the brain, Dr. Reed explained.
The complex produces three types of molecules: kisspeptin (a neuropeptide), neurokinin B (a neuropeptide), and dynorphin (a kappa opioid), collectively referred to as the KNDy. The KNDy neural complex is located in the same place as the majority of hormone receptors in the arcuate nucleus, a collection of nerve cells in the hypothalamus.
The current hypothesis is that the KNDy neurons, which communicate with each other, become hyperactivated and cause hot flashes by spilling over to and triggering the thermoregulatory center next door. NKB (kisspeptin and neurokinin B) agonists activate KNDy neurons and dynorphin agonists inactivate KNDy, so the expectation is that NKB antagonists or dynorphin agonists would stop hot flashes.
Indeed, research published in 2015 showed that women taking kappa agonists experienced fewer hot flashes than women in the placebo group. However, no peripherally restricted kappa agonists are currently in clinical trials, so their future as therapeutics is unclear.
Right now, three different NK antagonists are in the pipeline for reducing vasomotor symptoms: MLE 4901 (pavinetant) and ESN364 (fezolinetant) are both NK3R antagonists, and NT-814 is a dual NK1R/NK3R antagonist. All three of these drugs were originally developed to treat schizophrenia.
Phase 2 clinical trials of pavinetant were discontinued in November 2017 by Millendo Therapeutics because 3 of 28 women experienced abnormal liver function, which normalized within 90 days. However, the study had shown an 80% decrease in hot flashes in women taking pavinetant, compared with a 30% decrease in the placebo group.
Fezolinetant, currently in phase 3 trials with Astellas, showed a dose response effect on reproductive hormones in phase 1 studies and a short half-life (4-6 hours) in women. It also showed no concerning side effects.
“There was, in fact, a decrease in the endometrial thickness, a delayed or impeded ovulation and a prolonged cycle duration,” Reed said.
The subsequent phase 2a study showed a reduction of five hot flashes a day (93% decrease), compared with placebo (54% decrease, P <.001) “with an abrupt return to baseline hot flash frequency after cessation,” she said. Improvements also occurred in sleep quality, quality of life, disability, and interference of hot flashes in daily life.
The phase 2b study found no difference in effects between once-daily versus twice-daily doses. However, two severe adverse events occurred: a drug-induced liver injury in one woman and cholelithiasis in another, both on the 60-mg, once-daily dose. Additionally, five women on varying doses had transient increases (above 1000 U/L) in creatinine kinase, though apparently without dose response.
A 52-week, three-arm, phase 3 trial of fezolinetant is currently under way with a goal of enrolling 1,740 participants, and plans to be completed by December 2021. Participants will undergo regular adverse event screening first biweekly, then monthly, with vital signs, blood, and urine monitoring.
Meanwhile, NT-814 from KaNDy Therapeutics, has completed phase 2a and phase 2b trials with phase 3 slated to begin in 2021. Adverse events in phase 1 included sleepiness and headache, and it had a long half-life (about 26 hours) and rapid absorption (an hour).
The phase 2a trial found a reduction of five hot flashes a day, compared with placebo, with main side effects again being sleepiness and headache. No events of abnormal liver function occurred. Phase 2b results have not been published.
So far, existing research suggests that KNDy interventions will involve a single daily oral dose that begins taking effect within 3 days and is fully in effect within 1-2 weeks. The reduction in hot flashes, about five fewer a day, is more effective than any other currently used nonhormonal medications for vasomotor symptoms. SSRIs and SNRIs tend to result in 1.5-2 fewer hot flashes a day, and gabapentin results in about 3 fewer per day. It will take longer-term studies, however, and paying attention to liver concerns for the NK3R antagonists to move into clinic.
“We want to keep our eye on the [luteinizing hormone] because if it decreases too much, it could adversely affect sexual function, and this does appear to be a dose-response finding,” Dr. Reed said. It would also be ideal, she said, to target only the KNDy neurons with NK3 antagonists without effects on the NK3 receptors in the liver.
Other nonhormonal options
Oxybutynin is another a nonhormonal agent under investigation for vasomotor symptoms. It’s an anticholinergic that resulted in 80% fewer hot flashes, compared with 30% with placebo in a 2016 trial, but 52% of women complained of dry mouth. A more recent study similarly found high efficacy – a 60%-80% drop in hot flashes, compared with 30% with placebo – but also side effects of dry mouth, difficulty urinating, and abdominal pain.
Finally, Dr. Reed mentioned three other agents under investigation as possible nonhormonal therapeutics, though she has little information about them. They include MT-8554 by Mitsubishi Tanabe; FP-101 by Fervent Pharmaceuticals; and Q-122 by QUE Oncology with Emory University, Atlanta, and the University of Queensland, Brisbane, Australia.
None of the currently available nonhormonal options provide as high efficacy as hormones, but they do reduce symptoms:
Clonidine is an off-label option some physicians already use as a nonhormonal treatment for vasomotor symptoms, but again, the side effects are problematic: dry mouth, constipation, drowsiness, postural hypotension, and poor sleep.
Paroxetine, at 7.5-10 mg, is the only FDA-approved nonhormonal treatment for vasomotor symptoms, but she listed other off-label options found effective in evidence reviews: gabapentin (100-2,400 mg), venlafaxine (37.5-75 mg), citalopram (10 mg), desvenlafaxine (150 mg), and escitalopram (10 mg).
“I want you to take note of the lower doses in all of these products that are efficacious above those doses that might be used for mood,” Dr. Reed added.
Dr. Reed receives royalties from UpToDate and research funding from Bayer. Dr. Santoro owns stock in MenoGeniX and serves as a consultant or advisor to Ansh Labs, MenoGeniX, and Ogeda/Astellas.
A version of this article originally appeared on Medscape.com.
researchers told attendees at the virtual North American Menopause Society 2020 Annual Meeting.
“The KNDy [kisspeptin/neurokinin B/dynorphin] neuron manipulation is really exciting and holds great promise for rapid and highly effective amelioration of hot flashes, up to 80%, and improvement in other menopausal symptoms, though we’re still looking at the safety in phase 3 trials,” reported Susan D. Reed, MD, MPH, director of the Women’s Reproductive Health Research Program at the University of Washington, Seattle.
“If we continue to see good safety data, these are going to be the greatest things since sliced bread,” Dr. Reed said in an interview. “I don’t think we’ve seen anything like this in menopause therapeutics in a long time.”
While several nonhormonal drugs are already used to treat vasomotor symptoms in menopausal women with and without breast cancer, none are as effective as hormone treatments.
“For now, the SSRIs, SNRIs [serotonin norepinephrine reuptake inhibitors], and GABAergics are the best frontline nonhormonal options with a moderate effect, and clonidine and oxybutynin are effective, but we see more side effects with these,” Dr. Reed said. She noted the importance of considering patients’ mood, sleep, pain, sexual function, weight gain, overactive bladder, blood pressure, and individual quality of life (QOL) goals in tailoring those therapies.
But women still need more nonhormonal options that are at least as effective as hormonal options, Dr. Reed said. Some women are unable to take hormonal options because they are at risk for blood clots or breast cancer.
“Then there’s preference,” she said. “Sometimes people don’t like the way they feel when they take hormones, or they just don’t want hormones in their body. It’s absolutely critical to have these options available for women.”
Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, who was not involved in the presentation, said in an interview that physicians may not always realize the extent to which vasomotor symptoms interfere with women’s daily lives.
“They have an eroding effect on QOL that is not appreciated sometimes,” she said. Though hot flashes eventually subside in most women, others may continue to experience them into their 70s, when hormonal therapies can begin causing more harm than benefit.
“It goes underappreciated that, for a proportion of women, hot flashes will never go away, and they’re just as bad [as] when they were in their 50s,” Dr. Santoro said. “They need to be treated, and the nonhormonal treatments do not work for everybody.”
Promising KNDy therapeutics
Autopsy studies of postmenopausal women revealed that a complex of neurons in the hypothalamus was “massively hypertrophied” and sits right next to the thermoregulatory center of the brain, Dr. Reed explained.
The complex produces three types of molecules: kisspeptin (a neuropeptide), neurokinin B (a neuropeptide), and dynorphin (a kappa opioid), collectively referred to as the KNDy. The KNDy neural complex is located in the same place as the majority of hormone receptors in the arcuate nucleus, a collection of nerve cells in the hypothalamus.
The current hypothesis is that the KNDy neurons, which communicate with each other, become hyperactivated and cause hot flashes by spilling over to and triggering the thermoregulatory center next door. NKB (kisspeptin and neurokinin B) agonists activate KNDy neurons and dynorphin agonists inactivate KNDy, so the expectation is that NKB antagonists or dynorphin agonists would stop hot flashes.
Indeed, research published in 2015 showed that women taking kappa agonists experienced fewer hot flashes than women in the placebo group. However, no peripherally restricted kappa agonists are currently in clinical trials, so their future as therapeutics is unclear.
Right now, three different NK antagonists are in the pipeline for reducing vasomotor symptoms: MLE 4901 (pavinetant) and ESN364 (fezolinetant) are both NK3R antagonists, and NT-814 is a dual NK1R/NK3R antagonist. All three of these drugs were originally developed to treat schizophrenia.
Phase 2 clinical trials of pavinetant were discontinued in November 2017 by Millendo Therapeutics because 3 of 28 women experienced abnormal liver function, which normalized within 90 days. However, the study had shown an 80% decrease in hot flashes in women taking pavinetant, compared with a 30% decrease in the placebo group.
Fezolinetant, currently in phase 3 trials with Astellas, showed a dose response effect on reproductive hormones in phase 1 studies and a short half-life (4-6 hours) in women. It also showed no concerning side effects.
“There was, in fact, a decrease in the endometrial thickness, a delayed or impeded ovulation and a prolonged cycle duration,” Reed said.
The subsequent phase 2a study showed a reduction of five hot flashes a day (93% decrease), compared with placebo (54% decrease, P <.001) “with an abrupt return to baseline hot flash frequency after cessation,” she said. Improvements also occurred in sleep quality, quality of life, disability, and interference of hot flashes in daily life.
The phase 2b study found no difference in effects between once-daily versus twice-daily doses. However, two severe adverse events occurred: a drug-induced liver injury in one woman and cholelithiasis in another, both on the 60-mg, once-daily dose. Additionally, five women on varying doses had transient increases (above 1000 U/L) in creatinine kinase, though apparently without dose response.
A 52-week, three-arm, phase 3 trial of fezolinetant is currently under way with a goal of enrolling 1,740 participants, and plans to be completed by December 2021. Participants will undergo regular adverse event screening first biweekly, then monthly, with vital signs, blood, and urine monitoring.
Meanwhile, NT-814 from KaNDy Therapeutics, has completed phase 2a and phase 2b trials with phase 3 slated to begin in 2021. Adverse events in phase 1 included sleepiness and headache, and it had a long half-life (about 26 hours) and rapid absorption (an hour).
The phase 2a trial found a reduction of five hot flashes a day, compared with placebo, with main side effects again being sleepiness and headache. No events of abnormal liver function occurred. Phase 2b results have not been published.
So far, existing research suggests that KNDy interventions will involve a single daily oral dose that begins taking effect within 3 days and is fully in effect within 1-2 weeks. The reduction in hot flashes, about five fewer a day, is more effective than any other currently used nonhormonal medications for vasomotor symptoms. SSRIs and SNRIs tend to result in 1.5-2 fewer hot flashes a day, and gabapentin results in about 3 fewer per day. It will take longer-term studies, however, and paying attention to liver concerns for the NK3R antagonists to move into clinic.
“We want to keep our eye on the [luteinizing hormone] because if it decreases too much, it could adversely affect sexual function, and this does appear to be a dose-response finding,” Dr. Reed said. It would also be ideal, she said, to target only the KNDy neurons with NK3 antagonists without effects on the NK3 receptors in the liver.
Other nonhormonal options
Oxybutynin is another a nonhormonal agent under investigation for vasomotor symptoms. It’s an anticholinergic that resulted in 80% fewer hot flashes, compared with 30% with placebo in a 2016 trial, but 52% of women complained of dry mouth. A more recent study similarly found high efficacy – a 60%-80% drop in hot flashes, compared with 30% with placebo – but also side effects of dry mouth, difficulty urinating, and abdominal pain.
Finally, Dr. Reed mentioned three other agents under investigation as possible nonhormonal therapeutics, though she has little information about them. They include MT-8554 by Mitsubishi Tanabe; FP-101 by Fervent Pharmaceuticals; and Q-122 by QUE Oncology with Emory University, Atlanta, and the University of Queensland, Brisbane, Australia.
None of the currently available nonhormonal options provide as high efficacy as hormones, but they do reduce symptoms:
Clonidine is an off-label option some physicians already use as a nonhormonal treatment for vasomotor symptoms, but again, the side effects are problematic: dry mouth, constipation, drowsiness, postural hypotension, and poor sleep.
Paroxetine, at 7.5-10 mg, is the only FDA-approved nonhormonal treatment for vasomotor symptoms, but she listed other off-label options found effective in evidence reviews: gabapentin (100-2,400 mg), venlafaxine (37.5-75 mg), citalopram (10 mg), desvenlafaxine (150 mg), and escitalopram (10 mg).
“I want you to take note of the lower doses in all of these products that are efficacious above those doses that might be used for mood,” Dr. Reed added.
Dr. Reed receives royalties from UpToDate and research funding from Bayer. Dr. Santoro owns stock in MenoGeniX and serves as a consultant or advisor to Ansh Labs, MenoGeniX, and Ogeda/Astellas.
A version of this article originally appeared on Medscape.com.
Beyond microcephaly: Zika-affected children near school age
In 2020, “the virus” has come to mean one thing: SARS-CoV-2. But just a few years ago, Zika had the world's attention, as one news report after another described children with microcephaly born to women who'd been infected while pregnant.
It can be difficult for physicians to determine whether a birth defect is the result of Zika. Most infections have few or no symptoms, and mothers may not know if they’ve been exposed. Karin Nielsen, MD, remembers one child in particular, a 9-month-old boy born with microcephaly whose parents brought the infant to her in 2018 because he had started having seizures.
The child was born in Mexico in 2017, when the Zika virus was still known to be circulating in the Americas, said Dr. Nielsen, a pediatric infectious disease specialist at the University of California, Los Angeles. Brain imaging revealed calcifications and other signs in the boy’s brain that were consistent with exposure. But his mother said she was never sick during pregnancy.
Because Zika is transmitted not just via mosquito and from mother to fetus but also sexually, Dr. Nielsen thinks the mother probably contracted an asymptomatic infection from her husband, who recalled having a rash when she was 4 months pregnant. When they participated in a research study, both parents tested positive for Zika antibodies.
“The child had the classic symptoms of congenital Zika syndrome,” Dr. Nielsen said. “He was 9 months old, he had microcephaly, and he was having mal seizures.”
Researchers have since learned that children with such classic symptoms represent only a small proportion of those affected by prenatal Zika exposure – about 3%-5%. The virus was at its height during the 2016-2016 epidemic and is not currently causing outbreaks. But as researchers have followed cohorts of children exposed to Zika in utero, they have found many subtler effects physicians will need to monitor as the children grow up.
“When we’re seeing hundreds of kids with microcephaly, we had a lot of people infected,” Dr. Nielsen said. “Microcephaly is only the tip of the iceberg.”
Early evidence
Microcephaly may be the most identifiable symptom of fetal Zika infection, but researchers tracking cohorts of exposed children have begun to build a more complete picture of what long-term effects might look like. But hundreds, if not thousands, of children have been exposed to Zika in the womb – it’s not clear how many, Dr. Nielsen said – and many show a range of effects that don’t officially qualify as congenital Zika syndrome.
Current estimates suggest about one third of exposed children have some type of neurologic or neurodevelopmental problem, even though prevalence of visible effects is much lower. Over time, the incidence of these effects has fluctuated; some developmental delays and sensory deficits began manifesting later in childhood whereas others, at least in a few children, have resolved.
“We’re just beginning to have some of the data that we need to think about the full spectrum of outcomes,” said Cindy Moore, MD, chief medical officer in the Division of Congenital and Developmental Disorders in the Centers for Disease Control and Prevention’s National Center on Birth Defects and Developmental Disabilities.
“As we’re learning more and more, we’re learning the spectrum is expanding to less severe forms,” Dr. Moore said. “We do know that with some infections, there are later onset of problems.”
Studies published in 2018 described cohorts of children whose mothers had confirmed or suspected Zika infections during pregnancy in the French Territories of America (Guadalupe, Martinique, and French Guiana) and in Salvador, Brazil. The research provided valuable early data on the incidence of microcephaly and other severe effects in newborns, but noted the need for long-term follow up.
The U.S. Zika Pregnancy and Infant Registry is one of the largest such cohorts. In August 2018, researchers made their first report on data from the registry They looked at 1450 children age 1 or older who had undergone neuroimaging or screenings (developmental, vision, hearing) or both. In 6%, at least one birth defect was linked to Zika, and 9% had at least one neurodevelopmental abnormality.
As these children age past developmental milestones, more effects will likely manifest – even in those children whose appearance and imaging presented as healthy at birth.
Longer-term follow up
Nielsen at UCLA and M. Elisabeth Lopes Moreira, MD, of the Oswaldo Cruz Foundation in Rio de Janeiro, are following a cohort of more than 100 children born in Rio de Janeiro during Brazil’s 2015-2016 epidemic to mothers with symptomatic, PCR-confirmed Zika infections during pregnancy. In December 2018, their team reported that rates of severe neurodevelopmental delay and sensory dysfunction – 14% of 131 children aged 12-18 months – were higher than those found in earlier studies.
In August 2019, the team described neurodevelopmental, vision, and hearing outcomes in 216 Zika-exposed children 2 years after birth. They used the Bayley-III Scales of Infant and Toddler Development to assess cognitive, language and motor skills in 146 of the children. Forty percent of them were below or very below average in development, more than one third (35%) had language delays, 12% percent had hearing loss, and 7% had abnormal eye anatomy, such as underdeveloped retinas.
In two of the eight children in the cohort with microcephaly, the abnormality unexpectedly resolved. Although that finding received a lot of press, Dr. Nielsen pointed out that “not all microcephalies are created equal.”
In one case, a child born small for gestational age had proportional microcephaly: the baby›s head circumference met the criteria for microcephaly, but the infant›s head was proportional to the body so, as the child grew, the apparent microcephaly disappeared.
In the other case, the child was born with craniosynostosis, in which the skull sutures fuse too early – another effect seen with prenatal Zika exposure, Dr. Nielsen said. After corrective surgery, the child’s head circumference no longer met the definition of microcephaly, but the child still had symptoms related to congenital Zika: a developmental delay and calcifications in the brain. Meanwhile, two other children in the Rio cohort developed secondary microcephaly.
In another follow-up study of children up to age 4, Dr. Nielsen and colleagues found that both clinicians and family may think that Zika-exposed infants without microcephaly are developing normally, but that may not be true. Nearly 70% of children without microcephaly had neurologic abnormalities on physical examination, and more than half had failure to thrive because of poor feeding related to neurologic abnormalities.
Initially, some children may be able to mask subtle problems. A study published in January from Sarah B. Mulkey, MD, PhD, of Children’s National Hospital in Washington, DC, and colleagues described neurodevelopmental outcomes in 70 Colombian children up to 18 months old who had been exposed to Zika in utero. The children had a normal head circumference at birth and a normal fetal MRI, but – compared with typically developing peers – their communication, social cognition, and mobility scores on standardized assessments tended to decline as they got older.
“Especially in a very young child, there’s always going to be a possibility that you can compensate for a deficit, and it appears that at least some of these children are doing so,” said William J. Muller, MD, PhD, associate professor of pediatrics at Northwestern University, Chicago. When the children are older, certain behavioral effects will become easier to assess.
“With these children now approaching school age, understanding the full spectrum of neurodevelopmental abnormalities has important public health and educational system implications,” Dr. Muller and Dr. Mulkey wrote in a commentary about one of Dr. Nielsen’s studies.
Researchers face multiple barriers to understanding the long-term effects of fetal Zika infection. Many infants known to have been exposed in utero never received the recommended early assessments and haven’t been followed long-term. Particularly in Brazil, poverty, poor access to healthcare, and overcrowding all complicate surveillance efforts, Dr. Muller said. Stigma related to children’s neurodevelopmental problems also can potentially reduce a mother’s willingness to attend all follow-ups and assessments.
Some children may have been exposed but were never recognized as such, making it difficult for researchers to track their development and assemble a complete picture of prenatal Zika infection outcomes. Asymptomatic infection occurs in about 80% of Zika infections, though it’s not clear if that number holds for infections during pregnancy as well, according to Dr. Muller and Dr. Mulkey. Because nearly all the current research involves children whose mothers had symptomatic infections, the studies’ generalizability may be limited.
Those likely asymptomatic infections are also a major reason none of the cohorts have comparison groups.
“There are literally hundreds of things that can contribute to or cause developmental problems,” said Dr. Moore of the CDC, who noted that it would be nice to have a comparison group so as to know what Zika may not be responsible for. That said, it would be difficult-to-impossible to create a control group with similar geographic and demographic characteristics as the exposed children, a group who researchers can be certain weren’t exposed.
Neurodevelopmental disabilities occur in about 15% of the general population, making it difficult to determine whether Zika causes any or all long-term, less severe developmental findings in exposed children. The difficulty only compounds with time: the older a child is when a developmental problem is recognized, the harder it is to go back and say the problem is a result of something that occurred before birth, Dr. Moore said. “It’s a challenging field to say, this is what caused that outcome.”
Exposed children need continued evaluation
Interpreting the clinical implications of available studies is also challenging. It can be difficult to distinguish between central nervous system damage and peripheral damage, leaving the true etiology of poor vision or hearing elusive. The Zika virus can attack both the optic nerve and the part of the brain that interprets what a person sees: “Are you not seeing well because that part of your brain is not developed, or is it just a problem with the eye?” Dr. Nielsen said.
When problems can’t be precisely identified, successful interventions are harder. If the cochlea is normal, for instance, but the part of the brain that interprets sound or language has deficits, a hearing aid won’t help.
The services and interventions that children need depend on their specific developmental or cognitive deficits, regardless of the cause. But if clinicians know the cause is likely Zika exposure, they also know to look for other deficits.
Children showing likely effects of congenital Zika infection should be further evaluated for other possible birth defects and referred to a developmental specialist, early intervention services, and family support services. Depending on the child, primary care providers might consider referrals to an infectious disease specialist, clinical geneticist, neurologist, or other specialists.
Even with no confirmed infection or visible signs at birth, clinicians should remain vigilant with children who had possible exposure. A recently published study of 120 children conceived during the Zika outbreak in Paraíba, Brazil, assessed as infants and then again at 2 years old, exemplifies why. Researchers identified adverse neurologic outcomes and developmental delays in several children who had no physical evidence of birth defects as newborns, but whose antibody tests showed possible infection.
“In this post-epidemic period, with decreased Zika transmission and less public awareness,” wrote Dr. Mulkey and a colleague, “follow-up of these children is now more important than ever”.
A version of this article originally appeared on Medscape.com.
In 2020, “the virus” has come to mean one thing: SARS-CoV-2. But just a few years ago, Zika had the world's attention, as one news report after another described children with microcephaly born to women who'd been infected while pregnant.
It can be difficult for physicians to determine whether a birth defect is the result of Zika. Most infections have few or no symptoms, and mothers may not know if they’ve been exposed. Karin Nielsen, MD, remembers one child in particular, a 9-month-old boy born with microcephaly whose parents brought the infant to her in 2018 because he had started having seizures.
The child was born in Mexico in 2017, when the Zika virus was still known to be circulating in the Americas, said Dr. Nielsen, a pediatric infectious disease specialist at the University of California, Los Angeles. Brain imaging revealed calcifications and other signs in the boy’s brain that were consistent with exposure. But his mother said she was never sick during pregnancy.
Because Zika is transmitted not just via mosquito and from mother to fetus but also sexually, Dr. Nielsen thinks the mother probably contracted an asymptomatic infection from her husband, who recalled having a rash when she was 4 months pregnant. When they participated in a research study, both parents tested positive for Zika antibodies.
“The child had the classic symptoms of congenital Zika syndrome,” Dr. Nielsen said. “He was 9 months old, he had microcephaly, and he was having mal seizures.”
Researchers have since learned that children with such classic symptoms represent only a small proportion of those affected by prenatal Zika exposure – about 3%-5%. The virus was at its height during the 2016-2016 epidemic and is not currently causing outbreaks. But as researchers have followed cohorts of children exposed to Zika in utero, they have found many subtler effects physicians will need to monitor as the children grow up.
“When we’re seeing hundreds of kids with microcephaly, we had a lot of people infected,” Dr. Nielsen said. “Microcephaly is only the tip of the iceberg.”
Early evidence
Microcephaly may be the most identifiable symptom of fetal Zika infection, but researchers tracking cohorts of exposed children have begun to build a more complete picture of what long-term effects might look like. But hundreds, if not thousands, of children have been exposed to Zika in the womb – it’s not clear how many, Dr. Nielsen said – and many show a range of effects that don’t officially qualify as congenital Zika syndrome.
Current estimates suggest about one third of exposed children have some type of neurologic or neurodevelopmental problem, even though prevalence of visible effects is much lower. Over time, the incidence of these effects has fluctuated; some developmental delays and sensory deficits began manifesting later in childhood whereas others, at least in a few children, have resolved.
“We’re just beginning to have some of the data that we need to think about the full spectrum of outcomes,” said Cindy Moore, MD, chief medical officer in the Division of Congenital and Developmental Disorders in the Centers for Disease Control and Prevention’s National Center on Birth Defects and Developmental Disabilities.
“As we’re learning more and more, we’re learning the spectrum is expanding to less severe forms,” Dr. Moore said. “We do know that with some infections, there are later onset of problems.”
Studies published in 2018 described cohorts of children whose mothers had confirmed or suspected Zika infections during pregnancy in the French Territories of America (Guadalupe, Martinique, and French Guiana) and in Salvador, Brazil. The research provided valuable early data on the incidence of microcephaly and other severe effects in newborns, but noted the need for long-term follow up.
The U.S. Zika Pregnancy and Infant Registry is one of the largest such cohorts. In August 2018, researchers made their first report on data from the registry They looked at 1450 children age 1 or older who had undergone neuroimaging or screenings (developmental, vision, hearing) or both. In 6%, at least one birth defect was linked to Zika, and 9% had at least one neurodevelopmental abnormality.
As these children age past developmental milestones, more effects will likely manifest – even in those children whose appearance and imaging presented as healthy at birth.
Longer-term follow up
Nielsen at UCLA and M. Elisabeth Lopes Moreira, MD, of the Oswaldo Cruz Foundation in Rio de Janeiro, are following a cohort of more than 100 children born in Rio de Janeiro during Brazil’s 2015-2016 epidemic to mothers with symptomatic, PCR-confirmed Zika infections during pregnancy. In December 2018, their team reported that rates of severe neurodevelopmental delay and sensory dysfunction – 14% of 131 children aged 12-18 months – were higher than those found in earlier studies.
In August 2019, the team described neurodevelopmental, vision, and hearing outcomes in 216 Zika-exposed children 2 years after birth. They used the Bayley-III Scales of Infant and Toddler Development to assess cognitive, language and motor skills in 146 of the children. Forty percent of them were below or very below average in development, more than one third (35%) had language delays, 12% percent had hearing loss, and 7% had abnormal eye anatomy, such as underdeveloped retinas.
In two of the eight children in the cohort with microcephaly, the abnormality unexpectedly resolved. Although that finding received a lot of press, Dr. Nielsen pointed out that “not all microcephalies are created equal.”
In one case, a child born small for gestational age had proportional microcephaly: the baby›s head circumference met the criteria for microcephaly, but the infant›s head was proportional to the body so, as the child grew, the apparent microcephaly disappeared.
In the other case, the child was born with craniosynostosis, in which the skull sutures fuse too early – another effect seen with prenatal Zika exposure, Dr. Nielsen said. After corrective surgery, the child’s head circumference no longer met the definition of microcephaly, but the child still had symptoms related to congenital Zika: a developmental delay and calcifications in the brain. Meanwhile, two other children in the Rio cohort developed secondary microcephaly.
In another follow-up study of children up to age 4, Dr. Nielsen and colleagues found that both clinicians and family may think that Zika-exposed infants without microcephaly are developing normally, but that may not be true. Nearly 70% of children without microcephaly had neurologic abnormalities on physical examination, and more than half had failure to thrive because of poor feeding related to neurologic abnormalities.
Initially, some children may be able to mask subtle problems. A study published in January from Sarah B. Mulkey, MD, PhD, of Children’s National Hospital in Washington, DC, and colleagues described neurodevelopmental outcomes in 70 Colombian children up to 18 months old who had been exposed to Zika in utero. The children had a normal head circumference at birth and a normal fetal MRI, but – compared with typically developing peers – their communication, social cognition, and mobility scores on standardized assessments tended to decline as they got older.
“Especially in a very young child, there’s always going to be a possibility that you can compensate for a deficit, and it appears that at least some of these children are doing so,” said William J. Muller, MD, PhD, associate professor of pediatrics at Northwestern University, Chicago. When the children are older, certain behavioral effects will become easier to assess.
“With these children now approaching school age, understanding the full spectrum of neurodevelopmental abnormalities has important public health and educational system implications,” Dr. Muller and Dr. Mulkey wrote in a commentary about one of Dr. Nielsen’s studies.
Researchers face multiple barriers to understanding the long-term effects of fetal Zika infection. Many infants known to have been exposed in utero never received the recommended early assessments and haven’t been followed long-term. Particularly in Brazil, poverty, poor access to healthcare, and overcrowding all complicate surveillance efforts, Dr. Muller said. Stigma related to children’s neurodevelopmental problems also can potentially reduce a mother’s willingness to attend all follow-ups and assessments.
Some children may have been exposed but were never recognized as such, making it difficult for researchers to track their development and assemble a complete picture of prenatal Zika infection outcomes. Asymptomatic infection occurs in about 80% of Zika infections, though it’s not clear if that number holds for infections during pregnancy as well, according to Dr. Muller and Dr. Mulkey. Because nearly all the current research involves children whose mothers had symptomatic infections, the studies’ generalizability may be limited.
Those likely asymptomatic infections are also a major reason none of the cohorts have comparison groups.
“There are literally hundreds of things that can contribute to or cause developmental problems,” said Dr. Moore of the CDC, who noted that it would be nice to have a comparison group so as to know what Zika may not be responsible for. That said, it would be difficult-to-impossible to create a control group with similar geographic and demographic characteristics as the exposed children, a group who researchers can be certain weren’t exposed.
Neurodevelopmental disabilities occur in about 15% of the general population, making it difficult to determine whether Zika causes any or all long-term, less severe developmental findings in exposed children. The difficulty only compounds with time: the older a child is when a developmental problem is recognized, the harder it is to go back and say the problem is a result of something that occurred before birth, Dr. Moore said. “It’s a challenging field to say, this is what caused that outcome.”
Exposed children need continued evaluation
Interpreting the clinical implications of available studies is also challenging. It can be difficult to distinguish between central nervous system damage and peripheral damage, leaving the true etiology of poor vision or hearing elusive. The Zika virus can attack both the optic nerve and the part of the brain that interprets what a person sees: “Are you not seeing well because that part of your brain is not developed, or is it just a problem with the eye?” Dr. Nielsen said.
When problems can’t be precisely identified, successful interventions are harder. If the cochlea is normal, for instance, but the part of the brain that interprets sound or language has deficits, a hearing aid won’t help.
The services and interventions that children need depend on their specific developmental or cognitive deficits, regardless of the cause. But if clinicians know the cause is likely Zika exposure, they also know to look for other deficits.
Children showing likely effects of congenital Zika infection should be further evaluated for other possible birth defects and referred to a developmental specialist, early intervention services, and family support services. Depending on the child, primary care providers might consider referrals to an infectious disease specialist, clinical geneticist, neurologist, or other specialists.
Even with no confirmed infection or visible signs at birth, clinicians should remain vigilant with children who had possible exposure. A recently published study of 120 children conceived during the Zika outbreak in Paraíba, Brazil, assessed as infants and then again at 2 years old, exemplifies why. Researchers identified adverse neurologic outcomes and developmental delays in several children who had no physical evidence of birth defects as newborns, but whose antibody tests showed possible infection.
“In this post-epidemic period, with decreased Zika transmission and less public awareness,” wrote Dr. Mulkey and a colleague, “follow-up of these children is now more important than ever”.
A version of this article originally appeared on Medscape.com.
In 2020, “the virus” has come to mean one thing: SARS-CoV-2. But just a few years ago, Zika had the world's attention, as one news report after another described children with microcephaly born to women who'd been infected while pregnant.
It can be difficult for physicians to determine whether a birth defect is the result of Zika. Most infections have few or no symptoms, and mothers may not know if they’ve been exposed. Karin Nielsen, MD, remembers one child in particular, a 9-month-old boy born with microcephaly whose parents brought the infant to her in 2018 because he had started having seizures.
The child was born in Mexico in 2017, when the Zika virus was still known to be circulating in the Americas, said Dr. Nielsen, a pediatric infectious disease specialist at the University of California, Los Angeles. Brain imaging revealed calcifications and other signs in the boy’s brain that were consistent with exposure. But his mother said she was never sick during pregnancy.
Because Zika is transmitted not just via mosquito and from mother to fetus but also sexually, Dr. Nielsen thinks the mother probably contracted an asymptomatic infection from her husband, who recalled having a rash when she was 4 months pregnant. When they participated in a research study, both parents tested positive for Zika antibodies.
“The child had the classic symptoms of congenital Zika syndrome,” Dr. Nielsen said. “He was 9 months old, he had microcephaly, and he was having mal seizures.”
Researchers have since learned that children with such classic symptoms represent only a small proportion of those affected by prenatal Zika exposure – about 3%-5%. The virus was at its height during the 2016-2016 epidemic and is not currently causing outbreaks. But as researchers have followed cohorts of children exposed to Zika in utero, they have found many subtler effects physicians will need to monitor as the children grow up.
“When we’re seeing hundreds of kids with microcephaly, we had a lot of people infected,” Dr. Nielsen said. “Microcephaly is only the tip of the iceberg.”
Early evidence
Microcephaly may be the most identifiable symptom of fetal Zika infection, but researchers tracking cohorts of exposed children have begun to build a more complete picture of what long-term effects might look like. But hundreds, if not thousands, of children have been exposed to Zika in the womb – it’s not clear how many, Dr. Nielsen said – and many show a range of effects that don’t officially qualify as congenital Zika syndrome.
Current estimates suggest about one third of exposed children have some type of neurologic or neurodevelopmental problem, even though prevalence of visible effects is much lower. Over time, the incidence of these effects has fluctuated; some developmental delays and sensory deficits began manifesting later in childhood whereas others, at least in a few children, have resolved.
“We’re just beginning to have some of the data that we need to think about the full spectrum of outcomes,” said Cindy Moore, MD, chief medical officer in the Division of Congenital and Developmental Disorders in the Centers for Disease Control and Prevention’s National Center on Birth Defects and Developmental Disabilities.
“As we’re learning more and more, we’re learning the spectrum is expanding to less severe forms,” Dr. Moore said. “We do know that with some infections, there are later onset of problems.”
Studies published in 2018 described cohorts of children whose mothers had confirmed or suspected Zika infections during pregnancy in the French Territories of America (Guadalupe, Martinique, and French Guiana) and in Salvador, Brazil. The research provided valuable early data on the incidence of microcephaly and other severe effects in newborns, but noted the need for long-term follow up.
The U.S. Zika Pregnancy and Infant Registry is one of the largest such cohorts. In August 2018, researchers made their first report on data from the registry They looked at 1450 children age 1 or older who had undergone neuroimaging or screenings (developmental, vision, hearing) or both. In 6%, at least one birth defect was linked to Zika, and 9% had at least one neurodevelopmental abnormality.
As these children age past developmental milestones, more effects will likely manifest – even in those children whose appearance and imaging presented as healthy at birth.
Longer-term follow up
Nielsen at UCLA and M. Elisabeth Lopes Moreira, MD, of the Oswaldo Cruz Foundation in Rio de Janeiro, are following a cohort of more than 100 children born in Rio de Janeiro during Brazil’s 2015-2016 epidemic to mothers with symptomatic, PCR-confirmed Zika infections during pregnancy. In December 2018, their team reported that rates of severe neurodevelopmental delay and sensory dysfunction – 14% of 131 children aged 12-18 months – were higher than those found in earlier studies.
In August 2019, the team described neurodevelopmental, vision, and hearing outcomes in 216 Zika-exposed children 2 years after birth. They used the Bayley-III Scales of Infant and Toddler Development to assess cognitive, language and motor skills in 146 of the children. Forty percent of them were below or very below average in development, more than one third (35%) had language delays, 12% percent had hearing loss, and 7% had abnormal eye anatomy, such as underdeveloped retinas.
In two of the eight children in the cohort with microcephaly, the abnormality unexpectedly resolved. Although that finding received a lot of press, Dr. Nielsen pointed out that “not all microcephalies are created equal.”
In one case, a child born small for gestational age had proportional microcephaly: the baby›s head circumference met the criteria for microcephaly, but the infant›s head was proportional to the body so, as the child grew, the apparent microcephaly disappeared.
In the other case, the child was born with craniosynostosis, in which the skull sutures fuse too early – another effect seen with prenatal Zika exposure, Dr. Nielsen said. After corrective surgery, the child’s head circumference no longer met the definition of microcephaly, but the child still had symptoms related to congenital Zika: a developmental delay and calcifications in the brain. Meanwhile, two other children in the Rio cohort developed secondary microcephaly.
In another follow-up study of children up to age 4, Dr. Nielsen and colleagues found that both clinicians and family may think that Zika-exposed infants without microcephaly are developing normally, but that may not be true. Nearly 70% of children without microcephaly had neurologic abnormalities on physical examination, and more than half had failure to thrive because of poor feeding related to neurologic abnormalities.
Initially, some children may be able to mask subtle problems. A study published in January from Sarah B. Mulkey, MD, PhD, of Children’s National Hospital in Washington, DC, and colleagues described neurodevelopmental outcomes in 70 Colombian children up to 18 months old who had been exposed to Zika in utero. The children had a normal head circumference at birth and a normal fetal MRI, but – compared with typically developing peers – their communication, social cognition, and mobility scores on standardized assessments tended to decline as they got older.
“Especially in a very young child, there’s always going to be a possibility that you can compensate for a deficit, and it appears that at least some of these children are doing so,” said William J. Muller, MD, PhD, associate professor of pediatrics at Northwestern University, Chicago. When the children are older, certain behavioral effects will become easier to assess.
“With these children now approaching school age, understanding the full spectrum of neurodevelopmental abnormalities has important public health and educational system implications,” Dr. Muller and Dr. Mulkey wrote in a commentary about one of Dr. Nielsen’s studies.
Researchers face multiple barriers to understanding the long-term effects of fetal Zika infection. Many infants known to have been exposed in utero never received the recommended early assessments and haven’t been followed long-term. Particularly in Brazil, poverty, poor access to healthcare, and overcrowding all complicate surveillance efforts, Dr. Muller said. Stigma related to children’s neurodevelopmental problems also can potentially reduce a mother’s willingness to attend all follow-ups and assessments.
Some children may have been exposed but were never recognized as such, making it difficult for researchers to track their development and assemble a complete picture of prenatal Zika infection outcomes. Asymptomatic infection occurs in about 80% of Zika infections, though it’s not clear if that number holds for infections during pregnancy as well, according to Dr. Muller and Dr. Mulkey. Because nearly all the current research involves children whose mothers had symptomatic infections, the studies’ generalizability may be limited.
Those likely asymptomatic infections are also a major reason none of the cohorts have comparison groups.
“There are literally hundreds of things that can contribute to or cause developmental problems,” said Dr. Moore of the CDC, who noted that it would be nice to have a comparison group so as to know what Zika may not be responsible for. That said, it would be difficult-to-impossible to create a control group with similar geographic and demographic characteristics as the exposed children, a group who researchers can be certain weren’t exposed.
Neurodevelopmental disabilities occur in about 15% of the general population, making it difficult to determine whether Zika causes any or all long-term, less severe developmental findings in exposed children. The difficulty only compounds with time: the older a child is when a developmental problem is recognized, the harder it is to go back and say the problem is a result of something that occurred before birth, Dr. Moore said. “It’s a challenging field to say, this is what caused that outcome.”
Exposed children need continued evaluation
Interpreting the clinical implications of available studies is also challenging. It can be difficult to distinguish between central nervous system damage and peripheral damage, leaving the true etiology of poor vision or hearing elusive. The Zika virus can attack both the optic nerve and the part of the brain that interprets what a person sees: “Are you not seeing well because that part of your brain is not developed, or is it just a problem with the eye?” Dr. Nielsen said.
When problems can’t be precisely identified, successful interventions are harder. If the cochlea is normal, for instance, but the part of the brain that interprets sound or language has deficits, a hearing aid won’t help.
The services and interventions that children need depend on their specific developmental or cognitive deficits, regardless of the cause. But if clinicians know the cause is likely Zika exposure, they also know to look for other deficits.
Children showing likely effects of congenital Zika infection should be further evaluated for other possible birth defects and referred to a developmental specialist, early intervention services, and family support services. Depending on the child, primary care providers might consider referrals to an infectious disease specialist, clinical geneticist, neurologist, or other specialists.
Even with no confirmed infection or visible signs at birth, clinicians should remain vigilant with children who had possible exposure. A recently published study of 120 children conceived during the Zika outbreak in Paraíba, Brazil, assessed as infants and then again at 2 years old, exemplifies why. Researchers identified adverse neurologic outcomes and developmental delays in several children who had no physical evidence of birth defects as newborns, but whose antibody tests showed possible infection.
“In this post-epidemic period, with decreased Zika transmission and less public awareness,” wrote Dr. Mulkey and a colleague, “follow-up of these children is now more important than ever”.
A version of this article originally appeared on Medscape.com.
ACS disagrees with CDC on HPV vaccination in adults
The ACS has endorsed two recommendations made by the CDC’s Advisory Committee on Immunization Practices, but the ACS does not agree with a third recommendation for older adults.
The ACIP recommends shared clinical decision-making regarding human papillomavirus (HPV) vaccination in some adults aged 27-45 years who are not adequately vaccinated. The ACS does not endorse this recommendation “because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision-making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit,” wrote Debbie Saslow, PhD, of the ACS’s section on human papillomavirus and gynecologic cancers, and colleagues.
Dr. Saslow and colleagues detailed the ACS recommendations in CA: A Cancer Journal for Clinicians.
The HPV vaccine protects against the virus that can cause cervical, oropharyngeal, anal, vaginal, vulvar, and penile cancers. For younger people, the ACIP recommends routine HPV vaccination of boys and girls aged 9-12 years and catch-up vaccination in everyone up to age 26 who has not been fully immunized against HPV.
The ACS endorses both of these recommendations. It also advises clinicians to tell patients aged 22-26 years who haven’t received the HPV vaccine or completed the series that the vaccine is less effective at reducing the risk of cancer at older ages.
After the Food and Drug Administration approved the HPV vaccine for adults aged 27-45 years, the ACIP updated its recommendations to state that routine catch-up vaccination is not recommended for anyone aged over 26 years. However, the ACIP recommended that these older adults talk with their providers about the risks and benefits of the vaccine to determine whether to get it.
The ACS subsequently conducted a methodological review of the ACIP’s recommendations and published its own adapted guidance, stating that the ACS does not endorse the shared decision-making. Administering the HPV vaccine to adults aged over 26 years would only prevent an estimated 0.5% of additional cancer cases, 0.4% additional cases of cervical precancer, and 0.3% additional cases of genital warts over the next 100 years, compared with vaccination under age 26.
“In addition to the low effectiveness and low cancer prevention potential of vaccination in this age group, other considerations included the burden of decision-making on patients and clinicians and the lack of sufficient guidance on the selection of individuals who might benefit,” according to the guidance. The ACS also expressed concern that these provider-patient discussions could interfere with the public health goal of increasing HPV vaccination in younger people.
HPV vaccination rates have lagged substantially behind other routinely recommended childhood vaccinations. Just over half (51%) of U.S. teens aged 13-17 years were up to date with HPV vaccination, and 68% had received one dose of the vaccine in 2018, according to the National Immunization Survey.
It’s very uncommon for a professional medical organization to not endorse recommendations from the CDC, particularly with vaccines, according to Robert A. Bednarczyk, PhD, an assistant professor of public health at Emory University, Atlanta, who specializes in HPV vaccination research but was not involved with the ACS statement or the ACIP recommendations.
“Often, for vaccination recommendations, there is a harmonization between health care provider organizations, such as the American Academy of Pediatrics, American Academy of Family Physicians, etc., when new vaccination schedules are released,” Dr. Bednarczyk said.
He acknowledged the ACS’s reasons for not endorsing the ACIP’s HPV recommendations in older adults: the burden of shared decision-making given the communication issues, the vaccine’s lower effectiveness in this population, and the ongoing HPV vaccine shortage.
But Dr. Bednarczyk also pointed out that the ACIP’s recommendation opens the door to these discussions when they may actually be needed, such as in adults at greater risk for HPV. He cited data suggesting that, in 2015, divorces occurred in 24 out of 1,000 married people aged 25-39 years and 21 out of 1,000 people aged 40-49.
“When you consider these marriages that end, in addition to marriages that end when one spouse dies, there is a potential for individuals who previously had a low risk of HPV acquisition now entering into new potential sexual relationships,” Dr. Bednarczyk said. “Additionally, it has been estimated that approximately 4% of the U.S. population are in open or consensually nonmonogamous relationships, where exposure to more sexual partners may increase their risk for HPV. These are just some examples of where conversations with health care providers, and shared clinical decision-making, can help with a targeted reduction of HPV risk.”
The ACIP recommendation regarding adults aged 27-45 years also provides people in this age group with insurance coverage for the HPV vaccine if they choose to get it, Dr. Bednarczyk pointed out. Insurance companies may not be required to cover HPV vaccination in people aged over 26 years without the CDC’s recommendation, even if it’s not for routine immunization.
Dr. Bednarczyk agreed, however, with how the ACS adapted the CDC’s recommendation for routine vaccination in youth. The CDC’s routine recommendation is at ages 11-12 but can begin at 9 years, according to the ACIP. The ACS guidance qualifies this statement to place more emphasis on encouraging the vaccine earlier.
“Routine HPV vaccination between ages 9-12 is expected to achieve higher on-time vaccination rates, resulting in increased numbers of cancers prevented,” according to the ACS. “Health care providers are encouraged to start offering the HPV vaccine at age 9 or 10.”
Dr. Bednarczyk pointed to some of his past research finding low proportions of teens fully vaccinated against HPV by age 13 years (J Infect Dis. 2019 Jul 31;220[5]:730-4). Therefore, “any efforts to encourage vaccination, including starting the series at ages 9-10 years may help,” he said.
He also agreed that there may be diminished effectiveness with vaccinating adults aged 22-26, “but this should also be considered relative to an individual’s risk of acquiring HPV.”
While an HPV vaccine shortage is a major concern and HPV vaccination efforts should remain most focused on young teens, adults should not necessarily be neglected, Dr. Bednarczyk noted.
“Given how common HPV infection is in the population, open discussion between patients and health care providers can help identify those adults for whom HPV vaccination can be effective,” he said.
The development of the ACS guideline was supported by ACS operational funds. The ACS has received an independent educational grant from Merck Sharp & Dohme for a project intended to increase HPV vaccination rates. Dr. Saslow is the principal investigator for a cooperative agreement between the ACS and the CDC to support the National HPV Vaccination Roundtable and is coprincipal investigator of a cooperative agreement between the ACS and CDC to support initiatives to increase HPV vaccination. The remaining authors and Dr. Bednarczyk reported no relevant disclosures.
SOURCE: Saslow D et al. CA Cancer J Clin. 2020 Jul 8. doi: 10.3322/caac.21616.
The ACS has endorsed two recommendations made by the CDC’s Advisory Committee on Immunization Practices, but the ACS does not agree with a third recommendation for older adults.
The ACIP recommends shared clinical decision-making regarding human papillomavirus (HPV) vaccination in some adults aged 27-45 years who are not adequately vaccinated. The ACS does not endorse this recommendation “because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision-making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit,” wrote Debbie Saslow, PhD, of the ACS’s section on human papillomavirus and gynecologic cancers, and colleagues.
Dr. Saslow and colleagues detailed the ACS recommendations in CA: A Cancer Journal for Clinicians.
The HPV vaccine protects against the virus that can cause cervical, oropharyngeal, anal, vaginal, vulvar, and penile cancers. For younger people, the ACIP recommends routine HPV vaccination of boys and girls aged 9-12 years and catch-up vaccination in everyone up to age 26 who has not been fully immunized against HPV.
The ACS endorses both of these recommendations. It also advises clinicians to tell patients aged 22-26 years who haven’t received the HPV vaccine or completed the series that the vaccine is less effective at reducing the risk of cancer at older ages.
After the Food and Drug Administration approved the HPV vaccine for adults aged 27-45 years, the ACIP updated its recommendations to state that routine catch-up vaccination is not recommended for anyone aged over 26 years. However, the ACIP recommended that these older adults talk with their providers about the risks and benefits of the vaccine to determine whether to get it.
The ACS subsequently conducted a methodological review of the ACIP’s recommendations and published its own adapted guidance, stating that the ACS does not endorse the shared decision-making. Administering the HPV vaccine to adults aged over 26 years would only prevent an estimated 0.5% of additional cancer cases, 0.4% additional cases of cervical precancer, and 0.3% additional cases of genital warts over the next 100 years, compared with vaccination under age 26.
“In addition to the low effectiveness and low cancer prevention potential of vaccination in this age group, other considerations included the burden of decision-making on patients and clinicians and the lack of sufficient guidance on the selection of individuals who might benefit,” according to the guidance. The ACS also expressed concern that these provider-patient discussions could interfere with the public health goal of increasing HPV vaccination in younger people.
HPV vaccination rates have lagged substantially behind other routinely recommended childhood vaccinations. Just over half (51%) of U.S. teens aged 13-17 years were up to date with HPV vaccination, and 68% had received one dose of the vaccine in 2018, according to the National Immunization Survey.
It’s very uncommon for a professional medical organization to not endorse recommendations from the CDC, particularly with vaccines, according to Robert A. Bednarczyk, PhD, an assistant professor of public health at Emory University, Atlanta, who specializes in HPV vaccination research but was not involved with the ACS statement or the ACIP recommendations.
“Often, for vaccination recommendations, there is a harmonization between health care provider organizations, such as the American Academy of Pediatrics, American Academy of Family Physicians, etc., when new vaccination schedules are released,” Dr. Bednarczyk said.
He acknowledged the ACS’s reasons for not endorsing the ACIP’s HPV recommendations in older adults: the burden of shared decision-making given the communication issues, the vaccine’s lower effectiveness in this population, and the ongoing HPV vaccine shortage.
But Dr. Bednarczyk also pointed out that the ACIP’s recommendation opens the door to these discussions when they may actually be needed, such as in adults at greater risk for HPV. He cited data suggesting that, in 2015, divorces occurred in 24 out of 1,000 married people aged 25-39 years and 21 out of 1,000 people aged 40-49.
“When you consider these marriages that end, in addition to marriages that end when one spouse dies, there is a potential for individuals who previously had a low risk of HPV acquisition now entering into new potential sexual relationships,” Dr. Bednarczyk said. “Additionally, it has been estimated that approximately 4% of the U.S. population are in open or consensually nonmonogamous relationships, where exposure to more sexual partners may increase their risk for HPV. These are just some examples of where conversations with health care providers, and shared clinical decision-making, can help with a targeted reduction of HPV risk.”
The ACIP recommendation regarding adults aged 27-45 years also provides people in this age group with insurance coverage for the HPV vaccine if they choose to get it, Dr. Bednarczyk pointed out. Insurance companies may not be required to cover HPV vaccination in people aged over 26 years without the CDC’s recommendation, even if it’s not for routine immunization.
Dr. Bednarczyk agreed, however, with how the ACS adapted the CDC’s recommendation for routine vaccination in youth. The CDC’s routine recommendation is at ages 11-12 but can begin at 9 years, according to the ACIP. The ACS guidance qualifies this statement to place more emphasis on encouraging the vaccine earlier.
“Routine HPV vaccination between ages 9-12 is expected to achieve higher on-time vaccination rates, resulting in increased numbers of cancers prevented,” according to the ACS. “Health care providers are encouraged to start offering the HPV vaccine at age 9 or 10.”
Dr. Bednarczyk pointed to some of his past research finding low proportions of teens fully vaccinated against HPV by age 13 years (J Infect Dis. 2019 Jul 31;220[5]:730-4). Therefore, “any efforts to encourage vaccination, including starting the series at ages 9-10 years may help,” he said.
He also agreed that there may be diminished effectiveness with vaccinating adults aged 22-26, “but this should also be considered relative to an individual’s risk of acquiring HPV.”
While an HPV vaccine shortage is a major concern and HPV vaccination efforts should remain most focused on young teens, adults should not necessarily be neglected, Dr. Bednarczyk noted.
“Given how common HPV infection is in the population, open discussion between patients and health care providers can help identify those adults for whom HPV vaccination can be effective,” he said.
The development of the ACS guideline was supported by ACS operational funds. The ACS has received an independent educational grant from Merck Sharp & Dohme for a project intended to increase HPV vaccination rates. Dr. Saslow is the principal investigator for a cooperative agreement between the ACS and the CDC to support the National HPV Vaccination Roundtable and is coprincipal investigator of a cooperative agreement between the ACS and CDC to support initiatives to increase HPV vaccination. The remaining authors and Dr. Bednarczyk reported no relevant disclosures.
SOURCE: Saslow D et al. CA Cancer J Clin. 2020 Jul 8. doi: 10.3322/caac.21616.
The ACS has endorsed two recommendations made by the CDC’s Advisory Committee on Immunization Practices, but the ACS does not agree with a third recommendation for older adults.
The ACIP recommends shared clinical decision-making regarding human papillomavirus (HPV) vaccination in some adults aged 27-45 years who are not adequately vaccinated. The ACS does not endorse this recommendation “because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision-making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit,” wrote Debbie Saslow, PhD, of the ACS’s section on human papillomavirus and gynecologic cancers, and colleagues.
Dr. Saslow and colleagues detailed the ACS recommendations in CA: A Cancer Journal for Clinicians.
The HPV vaccine protects against the virus that can cause cervical, oropharyngeal, anal, vaginal, vulvar, and penile cancers. For younger people, the ACIP recommends routine HPV vaccination of boys and girls aged 9-12 years and catch-up vaccination in everyone up to age 26 who has not been fully immunized against HPV.
The ACS endorses both of these recommendations. It also advises clinicians to tell patients aged 22-26 years who haven’t received the HPV vaccine or completed the series that the vaccine is less effective at reducing the risk of cancer at older ages.
After the Food and Drug Administration approved the HPV vaccine for adults aged 27-45 years, the ACIP updated its recommendations to state that routine catch-up vaccination is not recommended for anyone aged over 26 years. However, the ACIP recommended that these older adults talk with their providers about the risks and benefits of the vaccine to determine whether to get it.
The ACS subsequently conducted a methodological review of the ACIP’s recommendations and published its own adapted guidance, stating that the ACS does not endorse the shared decision-making. Administering the HPV vaccine to adults aged over 26 years would only prevent an estimated 0.5% of additional cancer cases, 0.4% additional cases of cervical precancer, and 0.3% additional cases of genital warts over the next 100 years, compared with vaccination under age 26.
“In addition to the low effectiveness and low cancer prevention potential of vaccination in this age group, other considerations included the burden of decision-making on patients and clinicians and the lack of sufficient guidance on the selection of individuals who might benefit,” according to the guidance. The ACS also expressed concern that these provider-patient discussions could interfere with the public health goal of increasing HPV vaccination in younger people.
HPV vaccination rates have lagged substantially behind other routinely recommended childhood vaccinations. Just over half (51%) of U.S. teens aged 13-17 years were up to date with HPV vaccination, and 68% had received one dose of the vaccine in 2018, according to the National Immunization Survey.
It’s very uncommon for a professional medical organization to not endorse recommendations from the CDC, particularly with vaccines, according to Robert A. Bednarczyk, PhD, an assistant professor of public health at Emory University, Atlanta, who specializes in HPV vaccination research but was not involved with the ACS statement or the ACIP recommendations.
“Often, for vaccination recommendations, there is a harmonization between health care provider organizations, such as the American Academy of Pediatrics, American Academy of Family Physicians, etc., when new vaccination schedules are released,” Dr. Bednarczyk said.
He acknowledged the ACS’s reasons for not endorsing the ACIP’s HPV recommendations in older adults: the burden of shared decision-making given the communication issues, the vaccine’s lower effectiveness in this population, and the ongoing HPV vaccine shortage.
But Dr. Bednarczyk also pointed out that the ACIP’s recommendation opens the door to these discussions when they may actually be needed, such as in adults at greater risk for HPV. He cited data suggesting that, in 2015, divorces occurred in 24 out of 1,000 married people aged 25-39 years and 21 out of 1,000 people aged 40-49.
“When you consider these marriages that end, in addition to marriages that end when one spouse dies, there is a potential for individuals who previously had a low risk of HPV acquisition now entering into new potential sexual relationships,” Dr. Bednarczyk said. “Additionally, it has been estimated that approximately 4% of the U.S. population are in open or consensually nonmonogamous relationships, where exposure to more sexual partners may increase their risk for HPV. These are just some examples of where conversations with health care providers, and shared clinical decision-making, can help with a targeted reduction of HPV risk.”
The ACIP recommendation regarding adults aged 27-45 years also provides people in this age group with insurance coverage for the HPV vaccine if they choose to get it, Dr. Bednarczyk pointed out. Insurance companies may not be required to cover HPV vaccination in people aged over 26 years without the CDC’s recommendation, even if it’s not for routine immunization.
Dr. Bednarczyk agreed, however, with how the ACS adapted the CDC’s recommendation for routine vaccination in youth. The CDC’s routine recommendation is at ages 11-12 but can begin at 9 years, according to the ACIP. The ACS guidance qualifies this statement to place more emphasis on encouraging the vaccine earlier.
“Routine HPV vaccination between ages 9-12 is expected to achieve higher on-time vaccination rates, resulting in increased numbers of cancers prevented,” according to the ACS. “Health care providers are encouraged to start offering the HPV vaccine at age 9 or 10.”
Dr. Bednarczyk pointed to some of his past research finding low proportions of teens fully vaccinated against HPV by age 13 years (J Infect Dis. 2019 Jul 31;220[5]:730-4). Therefore, “any efforts to encourage vaccination, including starting the series at ages 9-10 years may help,” he said.
He also agreed that there may be diminished effectiveness with vaccinating adults aged 22-26, “but this should also be considered relative to an individual’s risk of acquiring HPV.”
While an HPV vaccine shortage is a major concern and HPV vaccination efforts should remain most focused on young teens, adults should not necessarily be neglected, Dr. Bednarczyk noted.
“Given how common HPV infection is in the population, open discussion between patients and health care providers can help identify those adults for whom HPV vaccination can be effective,” he said.
The development of the ACS guideline was supported by ACS operational funds. The ACS has received an independent educational grant from Merck Sharp & Dohme for a project intended to increase HPV vaccination rates. Dr. Saslow is the principal investigator for a cooperative agreement between the ACS and the CDC to support the National HPV Vaccination Roundtable and is coprincipal investigator of a cooperative agreement between the ACS and CDC to support initiatives to increase HPV vaccination. The remaining authors and Dr. Bednarczyk reported no relevant disclosures.
SOURCE: Saslow D et al. CA Cancer J Clin. 2020 Jul 8. doi: 10.3322/caac.21616.
FROM CA: A CANCER JOURNAL FOR CLINICIANS
One-week postsurgical interval for voiding trial increases pass rate
Women who underwent vaginal prolapse surgery and did not immediately have a successful voiding trial were seven times more likely to pass their second voiding trial if their follow-up was 7 days after surgery instead of 4 days, according to a study in the American Journal of Obstetrics and Gynecology.
“This information is useful for setting expectations and for counseling patients on when it might be best to repeat a voiding trial in those with transient incomplete bladder emptying on the day of surgery, especially for those who may not live close to their surgeon, or for those who have difficulty traveling to the office,” said Jeffrey S. Schachar, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., and colleagues. “Despite a higher rate of initial unsuccessful office voiding trials, however, the early group did have significantly fewer days with an indwelling transurethral catheter, as well as total catheterization days,” including self-catheterization.
The researchers note that rates of temporary use of catheters after surgery vary widely, from 12% to 83%, likely because no consensus exists on how long to wait for voiding trials and what constitutes a successful trial.
“It is critical to identify patients with incomplete bladder emptying in order to prevent pain, myogenic and neurogenic damage, ureteral reflux and bladder overdistension that may further impair voiding function,” the authors wrote. “However, extending bladder drainage beyond the necessary recovery period may be associated with higher rates of urinary tract infection (UTI) and patient bother.”
To learn more about the best duration for postoperative catheter use, the researchers enrolled 102 patients before they underwent vaginal prolapse surgery at Wake Forest Baptist Health and Cleveland Clinic Florida from February 2017 to November 2019. The 29 patients with a successful voiding trial within 6 hours after surgery left the study, and 5 others were excluded for needing longer vaginal packing.
The voiding trial involved helping the patient stand to drain the bladder via the catheter, backfilling the bladder with 300 mL of saline solution through the catheter, removing the catheter to give women 1 hour to urinate, and then measuring the postvoid residual with a catheter or ultrasound. At least 100 mL postvoid residual was considered persistent incomplete bladder emptying.
The 60 remaining patients who did not pass the initial voiding trial and opted to remain in the study received a transurethral indwelling catheter and were randomly assigned to return for a second voiding trial either 2-4 days after surgery (depending on day of the week) or 7 days after surgery. The groups were demographically and clinically similar, with predominantly white postmenopausal, non-smoking women with stage II or III multicompartment pelvic organ prolapse.
Women without successful trials could continue with the transurethral catheter or give themselves intermittent catheterizations with a follow-up schedule determined by their surgeon. The researchers then tracked the women for 6 weeks to determine the rate of unsuccessful repeat voiding trials.
Among the women who returned 2-4 days post surgery, 23% had unsuccessful follow-up voiding trials, compared with 3% in the group returning 7 days after surgery (relative risk = 7; P = .02). The researchers calculated that one case of persistent postoperative incomplete bladder emptying was prevented for every five patients who used a catheter for 7 days after surgery.
Kevin A. Ault, MD, professor of obstetrics and gynecology at the University of Kansas Medical Center in Kansas City, said the study was well done, although the findings were unsurprising. He said the clinical implication is straightforward – to wait a week before doing a second voiding trial.
“I suspect these findings match the clinical experience of many surgeons. It is always good to see a well-done clinical trial on a topic,” Dr Ault said in an interview. “The most notable finding is how this impacts patient counseling. Gynecologists should tell their patients that it will take a week with a catheter when this problem arises.”
“The main limitation is whether this finding can be extrapolated to other gynecological surgeries, such as hysterectomy,” said Dr. Ault, who was not involved in the study. “Urinary retention is likely less common after that surgery, but it is still bothersome to patients.”
Dr. Schachar and associates also reported that patients in the earlier group “used significantly more morphine dose equivalents within 24 hours of the office voiding trial than the late-voiding trial group, which was expected given the proximity to surgery” (3 vs. 0.38; P = .005). However, new postoperative pain medication prescriptions and refills were similar in both groups.
Secondary endpoints included UTI rates, total days with a catheter, and patient experience of discomfort with the catheter. The two groups of women reported similar levels of catheter bother, but there was a nonsignificant difference in UTI rates: 23% in the earlier group, compared with 7% in the later group (P = .07).
The early-voiding trial group had an average 5 days with an indwelling transurethral catheter, compared with a significantly different 7 days in the later group (P = .0007). The early group also had fewer total days with an indwelling transurethral catheter and self-catheterization (6 days), compared with the late group (7 days; P = .0013). No patients had persistent incomplete bladder emptying after 17 days post surgery.
“Being able to adequately predict which patients are more likely to have unsuccessful postoperative voiding trials allows surgeons to better counsel their patients and may guide clinical decisions,” Dr. Schachar and associates said. They acknowledged, however, that their study’s biggest weakness is the small enrollment, which led to larger confidence intervals related to relative risk differences between the groups.
The study did not use external funding. Four of the investigators received grant, research funding, or honoraria from one or many medical device or pharmaceutical companies. The remaining researchers had no disclosures. Dr. Ault said he had no relevant financial disclosures.
SOURCE: Schachar JS et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.001.
Women who underwent vaginal prolapse surgery and did not immediately have a successful voiding trial were seven times more likely to pass their second voiding trial if their follow-up was 7 days after surgery instead of 4 days, according to a study in the American Journal of Obstetrics and Gynecology.
“This information is useful for setting expectations and for counseling patients on when it might be best to repeat a voiding trial in those with transient incomplete bladder emptying on the day of surgery, especially for those who may not live close to their surgeon, or for those who have difficulty traveling to the office,” said Jeffrey S. Schachar, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., and colleagues. “Despite a higher rate of initial unsuccessful office voiding trials, however, the early group did have significantly fewer days with an indwelling transurethral catheter, as well as total catheterization days,” including self-catheterization.
The researchers note that rates of temporary use of catheters after surgery vary widely, from 12% to 83%, likely because no consensus exists on how long to wait for voiding trials and what constitutes a successful trial.
“It is critical to identify patients with incomplete bladder emptying in order to prevent pain, myogenic and neurogenic damage, ureteral reflux and bladder overdistension that may further impair voiding function,” the authors wrote. “However, extending bladder drainage beyond the necessary recovery period may be associated with higher rates of urinary tract infection (UTI) and patient bother.”
To learn more about the best duration for postoperative catheter use, the researchers enrolled 102 patients before they underwent vaginal prolapse surgery at Wake Forest Baptist Health and Cleveland Clinic Florida from February 2017 to November 2019. The 29 patients with a successful voiding trial within 6 hours after surgery left the study, and 5 others were excluded for needing longer vaginal packing.
The voiding trial involved helping the patient stand to drain the bladder via the catheter, backfilling the bladder with 300 mL of saline solution through the catheter, removing the catheter to give women 1 hour to urinate, and then measuring the postvoid residual with a catheter or ultrasound. At least 100 mL postvoid residual was considered persistent incomplete bladder emptying.
The 60 remaining patients who did not pass the initial voiding trial and opted to remain in the study received a transurethral indwelling catheter and were randomly assigned to return for a second voiding trial either 2-4 days after surgery (depending on day of the week) or 7 days after surgery. The groups were demographically and clinically similar, with predominantly white postmenopausal, non-smoking women with stage II or III multicompartment pelvic organ prolapse.
Women without successful trials could continue with the transurethral catheter or give themselves intermittent catheterizations with a follow-up schedule determined by their surgeon. The researchers then tracked the women for 6 weeks to determine the rate of unsuccessful repeat voiding trials.
Among the women who returned 2-4 days post surgery, 23% had unsuccessful follow-up voiding trials, compared with 3% in the group returning 7 days after surgery (relative risk = 7; P = .02). The researchers calculated that one case of persistent postoperative incomplete bladder emptying was prevented for every five patients who used a catheter for 7 days after surgery.
Kevin A. Ault, MD, professor of obstetrics and gynecology at the University of Kansas Medical Center in Kansas City, said the study was well done, although the findings were unsurprising. He said the clinical implication is straightforward – to wait a week before doing a second voiding trial.
“I suspect these findings match the clinical experience of many surgeons. It is always good to see a well-done clinical trial on a topic,” Dr Ault said in an interview. “The most notable finding is how this impacts patient counseling. Gynecologists should tell their patients that it will take a week with a catheter when this problem arises.”
“The main limitation is whether this finding can be extrapolated to other gynecological surgeries, such as hysterectomy,” said Dr. Ault, who was not involved in the study. “Urinary retention is likely less common after that surgery, but it is still bothersome to patients.”
Dr. Schachar and associates also reported that patients in the earlier group “used significantly more morphine dose equivalents within 24 hours of the office voiding trial than the late-voiding trial group, which was expected given the proximity to surgery” (3 vs. 0.38; P = .005). However, new postoperative pain medication prescriptions and refills were similar in both groups.
Secondary endpoints included UTI rates, total days with a catheter, and patient experience of discomfort with the catheter. The two groups of women reported similar levels of catheter bother, but there was a nonsignificant difference in UTI rates: 23% in the earlier group, compared with 7% in the later group (P = .07).
The early-voiding trial group had an average 5 days with an indwelling transurethral catheter, compared with a significantly different 7 days in the later group (P = .0007). The early group also had fewer total days with an indwelling transurethral catheter and self-catheterization (6 days), compared with the late group (7 days; P = .0013). No patients had persistent incomplete bladder emptying after 17 days post surgery.
“Being able to adequately predict which patients are more likely to have unsuccessful postoperative voiding trials allows surgeons to better counsel their patients and may guide clinical decisions,” Dr. Schachar and associates said. They acknowledged, however, that their study’s biggest weakness is the small enrollment, which led to larger confidence intervals related to relative risk differences between the groups.
The study did not use external funding. Four of the investigators received grant, research funding, or honoraria from one or many medical device or pharmaceutical companies. The remaining researchers had no disclosures. Dr. Ault said he had no relevant financial disclosures.
SOURCE: Schachar JS et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.001.
Women who underwent vaginal prolapse surgery and did not immediately have a successful voiding trial were seven times more likely to pass their second voiding trial if their follow-up was 7 days after surgery instead of 4 days, according to a study in the American Journal of Obstetrics and Gynecology.
“This information is useful for setting expectations and for counseling patients on when it might be best to repeat a voiding trial in those with transient incomplete bladder emptying on the day of surgery, especially for those who may not live close to their surgeon, or for those who have difficulty traveling to the office,” said Jeffrey S. Schachar, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., and colleagues. “Despite a higher rate of initial unsuccessful office voiding trials, however, the early group did have significantly fewer days with an indwelling transurethral catheter, as well as total catheterization days,” including self-catheterization.
The researchers note that rates of temporary use of catheters after surgery vary widely, from 12% to 83%, likely because no consensus exists on how long to wait for voiding trials and what constitutes a successful trial.
“It is critical to identify patients with incomplete bladder emptying in order to prevent pain, myogenic and neurogenic damage, ureteral reflux and bladder overdistension that may further impair voiding function,” the authors wrote. “However, extending bladder drainage beyond the necessary recovery period may be associated with higher rates of urinary tract infection (UTI) and patient bother.”
To learn more about the best duration for postoperative catheter use, the researchers enrolled 102 patients before they underwent vaginal prolapse surgery at Wake Forest Baptist Health and Cleveland Clinic Florida from February 2017 to November 2019. The 29 patients with a successful voiding trial within 6 hours after surgery left the study, and 5 others were excluded for needing longer vaginal packing.
The voiding trial involved helping the patient stand to drain the bladder via the catheter, backfilling the bladder with 300 mL of saline solution through the catheter, removing the catheter to give women 1 hour to urinate, and then measuring the postvoid residual with a catheter or ultrasound. At least 100 mL postvoid residual was considered persistent incomplete bladder emptying.
The 60 remaining patients who did not pass the initial voiding trial and opted to remain in the study received a transurethral indwelling catheter and were randomly assigned to return for a second voiding trial either 2-4 days after surgery (depending on day of the week) or 7 days after surgery. The groups were demographically and clinically similar, with predominantly white postmenopausal, non-smoking women with stage II or III multicompartment pelvic organ prolapse.
Women without successful trials could continue with the transurethral catheter or give themselves intermittent catheterizations with a follow-up schedule determined by their surgeon. The researchers then tracked the women for 6 weeks to determine the rate of unsuccessful repeat voiding trials.
Among the women who returned 2-4 days post surgery, 23% had unsuccessful follow-up voiding trials, compared with 3% in the group returning 7 days after surgery (relative risk = 7; P = .02). The researchers calculated that one case of persistent postoperative incomplete bladder emptying was prevented for every five patients who used a catheter for 7 days after surgery.
Kevin A. Ault, MD, professor of obstetrics and gynecology at the University of Kansas Medical Center in Kansas City, said the study was well done, although the findings were unsurprising. He said the clinical implication is straightforward – to wait a week before doing a second voiding trial.
“I suspect these findings match the clinical experience of many surgeons. It is always good to see a well-done clinical trial on a topic,” Dr Ault said in an interview. “The most notable finding is how this impacts patient counseling. Gynecologists should tell their patients that it will take a week with a catheter when this problem arises.”
“The main limitation is whether this finding can be extrapolated to other gynecological surgeries, such as hysterectomy,” said Dr. Ault, who was not involved in the study. “Urinary retention is likely less common after that surgery, but it is still bothersome to patients.”
Dr. Schachar and associates also reported that patients in the earlier group “used significantly more morphine dose equivalents within 24 hours of the office voiding trial than the late-voiding trial group, which was expected given the proximity to surgery” (3 vs. 0.38; P = .005). However, new postoperative pain medication prescriptions and refills were similar in both groups.
Secondary endpoints included UTI rates, total days with a catheter, and patient experience of discomfort with the catheter. The two groups of women reported similar levels of catheter bother, but there was a nonsignificant difference in UTI rates: 23% in the earlier group, compared with 7% in the later group (P = .07).
The early-voiding trial group had an average 5 days with an indwelling transurethral catheter, compared with a significantly different 7 days in the later group (P = .0007). The early group also had fewer total days with an indwelling transurethral catheter and self-catheterization (6 days), compared with the late group (7 days; P = .0013). No patients had persistent incomplete bladder emptying after 17 days post surgery.
“Being able to adequately predict which patients are more likely to have unsuccessful postoperative voiding trials allows surgeons to better counsel their patients and may guide clinical decisions,” Dr. Schachar and associates said. They acknowledged, however, that their study’s biggest weakness is the small enrollment, which led to larger confidence intervals related to relative risk differences between the groups.
The study did not use external funding. Four of the investigators received grant, research funding, or honoraria from one or many medical device or pharmaceutical companies. The remaining researchers had no disclosures. Dr. Ault said he had no relevant financial disclosures.
SOURCE: Schachar JS et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.001.
FROM AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY