User login
MDedge conference coverage features onsite reporting of the latest study results and expert perspectives from leading researchers.
SGIM annual meeting focuses on inclusivity
In her welcome video on the opening day at the annual meeting of the Society of General Internal Medicine, meeting chair Rita Lee, MD, said she hoped that this year’s event, though virtual, will allow attendees an opportunity to “regroup, find inspiration, and celebrate the incredible strengths and diverse voices of our community.”
“We are living in an incredibly polarized world,” Dr. Lee said in an interview. “ as recent events, such as the death of George Floyd and many others, plus the disparities revealed by the COVID-19 pandemic, have brought issues of structural racism and oppression in the United States to the forefront,” she said in the interview.
“Given these circumstances, it is important now, more than ever, for generalists to move our values into action – to effect change at the health system, community, and policy levels – so our patients can achieve optimal health,” Dr. Lee emphasized.
She noted that SGIM’s vision: “A just system of care in which all people can achieve optimal health,” underlies the meeting’s sessions.
Some challenges related to adopting more antiracist training in medical education center on faculty development, Dr. Lee noted. “There are also students who don’t feel that this is part of the role of being a physician. One way to overcome these challenges is by directly linking structural competency to health outcomes for our patients,” she added. “We have evidence that structural racism impacts health and we should make that clear to our educational leaders and faculty to increase buy in. So many of our SGIM members are working on developing curricula for this.”
Two of the meeting’s workshops that addressed racism in medicine and medical education and strategies for change were “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” and “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today.” Below are some details about these.
Medical education evolves to include structural competency
In the workshop “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” participants used interactive exercises to build structural differentials for patient cases. The workshop was based in part on the experiences of including structural competency in medical education at Albert Einstein College of Medicine, New York, and the University of Pittsburgh.
During the session, participants practiced building a structural differential diagnosis in small groups, and also practiced using a structurally competent version of the 1-minute preceptor to promote structural competency in learners.
“Structural competency represents a shift in medical education towards attention to forces that influence health outcomes at levels above individual clinical interactions and develop a provider’s capacity to recognize and respond to health and illness as downstream effects of social, political and economic structures,” presenter Iman Hassan, MD, of Albert Einstein College of Medicine and Montefiore Health System, both in New York, said in an interview.
“At the same time, structural competency incorporates structural humility, which decentralizes the provider role in addressing structural factors and emphasizes collaboration with patients and communities,” she said in the interview. “Structural competency is a useful antiracism framework because it explicitly engages learners with the broader structural forces that result in health disparities, including structural racism and its downstream effects,” Dr. Hassan explained.
Addressing structural competency is important in medical education because structural and social determinants of health contribute more than half of overall health outcomes, said Dr. Hassan.
A structural competency framework equips learners to identify, discuss, and work with patients to navigate social needs such as lack of health insurance, food, or transportation, that are preventing them from accessing needed health care services, Dr. Hassan noted.
“Importantly, training in structural competency empowers physicians to be agents of change within their clinics, health systems, and communities and to recognize the value of community-led advocacy in promoting health equity,” she said.
Structural competency training also “will also allow them to engage more fully with the body of literature that exists surrounding social determinants of health and health disparities, and the use of approaches such as critical race theory through which to view health care,” she emphasized. “Importantly, understanding of the historical and structural context of medicine allows clinicians to more readily recognize when their own clinical practices, such as use of race-based clinical prediction tools, may perpetuate disparities, and work collectively to eliminate those practices.”
Recalibrating calculators for clinical care
Another workshop, “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today,” took on the challenge of inherent bias in clinical care caused by various factors, notably medical calculators such as those used to measure kidney function and pulmonary function.
Lamar K. Johnson, MD, of Christiana Care Hospital Partners/Christiana Care Pediatric Hospitalists in Newark, Del., and Celeste Newby, MD, of Tulane University, New Orleans, discussed the inherent biases in some calculators and how to take those biases into account. A stated goal of the workshop was to increase awareness of the origins of medical calculators in order to enhance equity and improve shared decision-making between patients and providers.
Addressing implicit bias in clinical practice is important because such bias has been shown to negatively affect physician behavior and clinical decision making, Dr. Johnson said in an interview.
“These effects can also negatively affect the doctor-patient relationship and lead to poorer health outcomes due to delays in or avoidance of care or avoidance of the health care system, and mistrust, resulting in nonadherence,” Dr. Johnson noted.
“Implicit bias training helps empower medical students and residents to recognize and address bias and advocate for patients. Such training can potentially be beneficial to faculty, too,” Dr. Johnson emphasized in the interview.
“Race is primarily a social, not a biological, construct, and we must be careful when we use it, as its use in the past has been largely inappropriate and not scientifically sound,” he said.
During the session, one of the presenters said removing specific mentions of race from clinical documentation can reduce racial bias in clinical practice.
The presenters also highlighted the estimated glomerular filtration rate (eGFR) which is used to estimate kidney function.
The eGFR “reports higher eGFR values for Blacks based on a faulty hypothesis that Black people have higher muscle mass. This higher estimated value can delay referral for specialist care or transplantation, leading to worse outcomes,” Dr. Johnson explained in the interview.
In response, “Many major institutions have eliminated the race modifier in eGFR, and a joint task force created by the National Kidney Foundation and American Society of Nephrology has recommended against using a race modifier as of March 2021,” Dr. Johnson said.
The presenters had no relevant financial conflicts to disclose.
In her welcome video on the opening day at the annual meeting of the Society of General Internal Medicine, meeting chair Rita Lee, MD, said she hoped that this year’s event, though virtual, will allow attendees an opportunity to “regroup, find inspiration, and celebrate the incredible strengths and diverse voices of our community.”
“We are living in an incredibly polarized world,” Dr. Lee said in an interview. “ as recent events, such as the death of George Floyd and many others, plus the disparities revealed by the COVID-19 pandemic, have brought issues of structural racism and oppression in the United States to the forefront,” she said in the interview.
“Given these circumstances, it is important now, more than ever, for generalists to move our values into action – to effect change at the health system, community, and policy levels – so our patients can achieve optimal health,” Dr. Lee emphasized.
She noted that SGIM’s vision: “A just system of care in which all people can achieve optimal health,” underlies the meeting’s sessions.
Some challenges related to adopting more antiracist training in medical education center on faculty development, Dr. Lee noted. “There are also students who don’t feel that this is part of the role of being a physician. One way to overcome these challenges is by directly linking structural competency to health outcomes for our patients,” she added. “We have evidence that structural racism impacts health and we should make that clear to our educational leaders and faculty to increase buy in. So many of our SGIM members are working on developing curricula for this.”
Two of the meeting’s workshops that addressed racism in medicine and medical education and strategies for change were “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” and “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today.” Below are some details about these.
Medical education evolves to include structural competency
In the workshop “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” participants used interactive exercises to build structural differentials for patient cases. The workshop was based in part on the experiences of including structural competency in medical education at Albert Einstein College of Medicine, New York, and the University of Pittsburgh.
During the session, participants practiced building a structural differential diagnosis in small groups, and also practiced using a structurally competent version of the 1-minute preceptor to promote structural competency in learners.
“Structural competency represents a shift in medical education towards attention to forces that influence health outcomes at levels above individual clinical interactions and develop a provider’s capacity to recognize and respond to health and illness as downstream effects of social, political and economic structures,” presenter Iman Hassan, MD, of Albert Einstein College of Medicine and Montefiore Health System, both in New York, said in an interview.
“At the same time, structural competency incorporates structural humility, which decentralizes the provider role in addressing structural factors and emphasizes collaboration with patients and communities,” she said in the interview. “Structural competency is a useful antiracism framework because it explicitly engages learners with the broader structural forces that result in health disparities, including structural racism and its downstream effects,” Dr. Hassan explained.
Addressing structural competency is important in medical education because structural and social determinants of health contribute more than half of overall health outcomes, said Dr. Hassan.
A structural competency framework equips learners to identify, discuss, and work with patients to navigate social needs such as lack of health insurance, food, or transportation, that are preventing them from accessing needed health care services, Dr. Hassan noted.
“Importantly, training in structural competency empowers physicians to be agents of change within their clinics, health systems, and communities and to recognize the value of community-led advocacy in promoting health equity,” she said.
Structural competency training also “will also allow them to engage more fully with the body of literature that exists surrounding social determinants of health and health disparities, and the use of approaches such as critical race theory through which to view health care,” she emphasized. “Importantly, understanding of the historical and structural context of medicine allows clinicians to more readily recognize when their own clinical practices, such as use of race-based clinical prediction tools, may perpetuate disparities, and work collectively to eliminate those practices.”
Recalibrating calculators for clinical care
Another workshop, “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today,” took on the challenge of inherent bias in clinical care caused by various factors, notably medical calculators such as those used to measure kidney function and pulmonary function.
Lamar K. Johnson, MD, of Christiana Care Hospital Partners/Christiana Care Pediatric Hospitalists in Newark, Del., and Celeste Newby, MD, of Tulane University, New Orleans, discussed the inherent biases in some calculators and how to take those biases into account. A stated goal of the workshop was to increase awareness of the origins of medical calculators in order to enhance equity and improve shared decision-making between patients and providers.
Addressing implicit bias in clinical practice is important because such bias has been shown to negatively affect physician behavior and clinical decision making, Dr. Johnson said in an interview.
“These effects can also negatively affect the doctor-patient relationship and lead to poorer health outcomes due to delays in or avoidance of care or avoidance of the health care system, and mistrust, resulting in nonadherence,” Dr. Johnson noted.
“Implicit bias training helps empower medical students and residents to recognize and address bias and advocate for patients. Such training can potentially be beneficial to faculty, too,” Dr. Johnson emphasized in the interview.
“Race is primarily a social, not a biological, construct, and we must be careful when we use it, as its use in the past has been largely inappropriate and not scientifically sound,” he said.
During the session, one of the presenters said removing specific mentions of race from clinical documentation can reduce racial bias in clinical practice.
The presenters also highlighted the estimated glomerular filtration rate (eGFR) which is used to estimate kidney function.
The eGFR “reports higher eGFR values for Blacks based on a faulty hypothesis that Black people have higher muscle mass. This higher estimated value can delay referral for specialist care or transplantation, leading to worse outcomes,” Dr. Johnson explained in the interview.
In response, “Many major institutions have eliminated the race modifier in eGFR, and a joint task force created by the National Kidney Foundation and American Society of Nephrology has recommended against using a race modifier as of March 2021,” Dr. Johnson said.
The presenters had no relevant financial conflicts to disclose.
In her welcome video on the opening day at the annual meeting of the Society of General Internal Medicine, meeting chair Rita Lee, MD, said she hoped that this year’s event, though virtual, will allow attendees an opportunity to “regroup, find inspiration, and celebrate the incredible strengths and diverse voices of our community.”
“We are living in an incredibly polarized world,” Dr. Lee said in an interview. “ as recent events, such as the death of George Floyd and many others, plus the disparities revealed by the COVID-19 pandemic, have brought issues of structural racism and oppression in the United States to the forefront,” she said in the interview.
“Given these circumstances, it is important now, more than ever, for generalists to move our values into action – to effect change at the health system, community, and policy levels – so our patients can achieve optimal health,” Dr. Lee emphasized.
She noted that SGIM’s vision: “A just system of care in which all people can achieve optimal health,” underlies the meeting’s sessions.
Some challenges related to adopting more antiracist training in medical education center on faculty development, Dr. Lee noted. “There are also students who don’t feel that this is part of the role of being a physician. One way to overcome these challenges is by directly linking structural competency to health outcomes for our patients,” she added. “We have evidence that structural racism impacts health and we should make that clear to our educational leaders and faculty to increase buy in. So many of our SGIM members are working on developing curricula for this.”
Two of the meeting’s workshops that addressed racism in medicine and medical education and strategies for change were “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” and “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today.” Below are some details about these.
Medical education evolves to include structural competency
In the workshop “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” participants used interactive exercises to build structural differentials for patient cases. The workshop was based in part on the experiences of including structural competency in medical education at Albert Einstein College of Medicine, New York, and the University of Pittsburgh.
During the session, participants practiced building a structural differential diagnosis in small groups, and also practiced using a structurally competent version of the 1-minute preceptor to promote structural competency in learners.
“Structural competency represents a shift in medical education towards attention to forces that influence health outcomes at levels above individual clinical interactions and develop a provider’s capacity to recognize and respond to health and illness as downstream effects of social, political and economic structures,” presenter Iman Hassan, MD, of Albert Einstein College of Medicine and Montefiore Health System, both in New York, said in an interview.
“At the same time, structural competency incorporates structural humility, which decentralizes the provider role in addressing structural factors and emphasizes collaboration with patients and communities,” she said in the interview. “Structural competency is a useful antiracism framework because it explicitly engages learners with the broader structural forces that result in health disparities, including structural racism and its downstream effects,” Dr. Hassan explained.
Addressing structural competency is important in medical education because structural and social determinants of health contribute more than half of overall health outcomes, said Dr. Hassan.
A structural competency framework equips learners to identify, discuss, and work with patients to navigate social needs such as lack of health insurance, food, or transportation, that are preventing them from accessing needed health care services, Dr. Hassan noted.
“Importantly, training in structural competency empowers physicians to be agents of change within their clinics, health systems, and communities and to recognize the value of community-led advocacy in promoting health equity,” she said.
Structural competency training also “will also allow them to engage more fully with the body of literature that exists surrounding social determinants of health and health disparities, and the use of approaches such as critical race theory through which to view health care,” she emphasized. “Importantly, understanding of the historical and structural context of medicine allows clinicians to more readily recognize when their own clinical practices, such as use of race-based clinical prediction tools, may perpetuate disparities, and work collectively to eliminate those practices.”
Recalibrating calculators for clinical care
Another workshop, “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today,” took on the challenge of inherent bias in clinical care caused by various factors, notably medical calculators such as those used to measure kidney function and pulmonary function.
Lamar K. Johnson, MD, of Christiana Care Hospital Partners/Christiana Care Pediatric Hospitalists in Newark, Del., and Celeste Newby, MD, of Tulane University, New Orleans, discussed the inherent biases in some calculators and how to take those biases into account. A stated goal of the workshop was to increase awareness of the origins of medical calculators in order to enhance equity and improve shared decision-making between patients and providers.
Addressing implicit bias in clinical practice is important because such bias has been shown to negatively affect physician behavior and clinical decision making, Dr. Johnson said in an interview.
“These effects can also negatively affect the doctor-patient relationship and lead to poorer health outcomes due to delays in or avoidance of care or avoidance of the health care system, and mistrust, resulting in nonadherence,” Dr. Johnson noted.
“Implicit bias training helps empower medical students and residents to recognize and address bias and advocate for patients. Such training can potentially be beneficial to faculty, too,” Dr. Johnson emphasized in the interview.
“Race is primarily a social, not a biological, construct, and we must be careful when we use it, as its use in the past has been largely inappropriate and not scientifically sound,” he said.
During the session, one of the presenters said removing specific mentions of race from clinical documentation can reduce racial bias in clinical practice.
The presenters also highlighted the estimated glomerular filtration rate (eGFR) which is used to estimate kidney function.
The eGFR “reports higher eGFR values for Blacks based on a faulty hypothesis that Black people have higher muscle mass. This higher estimated value can delay referral for specialist care or transplantation, leading to worse outcomes,” Dr. Johnson explained in the interview.
In response, “Many major institutions have eliminated the race modifier in eGFR, and a joint task force created by the National Kidney Foundation and American Society of Nephrology has recommended against using a race modifier as of March 2021,” Dr. Johnson said.
The presenters had no relevant financial conflicts to disclose.
FROM SGIM 2021
Novel hedgehog inhibitor strategies improve BCC outcomes
MD, a Mohs surgeon and chair of the department of dermatology at the Cleveland Clinic.
She and her colleagues have noticed an accelerated and durable response to hedgehog inhibitors after debulking and are studying cell signaling before and after debulking to better understand the issue.
Dr. Vidimos shared a remarkable case to illustrate the point during a clinical pearls talk at the annual meeting of the American College of Mohs Surgery.
An 82-year-old woman presented with a crusted, hemorrhagic, nodular basal cell carcinoma (BCC) that had overgrown over nearly her entire nose and left lower eyelid. A recurrence of a previous BCC, the tumor had been growing for a decade and had invaded her nasal bones but not the periorbital tissue.
An outside surgeon suggested a full rhinectomy and removal of the lower eyelid, but the woman refused.
Dr. Vidimos decided to treat her with vismodegib, but prior to doing so, she debulked the tumor to help with the pain and bleeding. She did not curette the portion of tumor extending through the ala into the nasal vestibule. “I let the vismodegib take care of that,” she said.
After 9 months, the tumor was virtually gone, with no recurrence after 3 years. Surgical debulking prior to hedgehog inhibition “reduces the tumor burden and may increase the efficacy and shorten the course of therapy,” Dr. Vidimos said.
The hedgehog inhibitors vismodegib (Erivedge) and sonidegib Odomzo are both approved for treating locally advanced BCC, with a complete response of 31% of locally advanced disease with vismodegib, according to one report.
But monotherapy is limited by intolerable side effects, most commonly muscle spasms, alopecia, and dysgeusia. To minimize the impact, Dr. Vidimos generally puts patients on treatment with Monday through Friday dosing and gives them the weekends off, a schedule she and her colleagues have reported works as well as daily dosing.
Still, many patients discontinue the drugs because of the side effects. Hedgehog inhibitors are also expensive and responses aren’t always durable. To increase efficacy and shorten the course of therapy, “we need alternative treatment strategies,” Dr. Vidimos said.
Up-front tumor debulking is one such strategy. Altered cell signaling pathways associated with tissue remodeling might improve response, and debulking may reduce the genetic heterogeneity of tumor cells, rendering remaining cells less resistant to hedgehog inhibition, she explained.
“It is exciting to see how tumor debulking may reduce tumor burden and heterogeneity, and thus lead to a durable response in extensive tumors,” said Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who heard the presentation. “More investigation is needed to reproduce these results, but this approach may lead to improved outcomes with targeted therapies,” he said in an interview.
Combination therapy with other agents is another option, and there also seems to be a synergistic effect with radiation, with hedgehog inhibitors increasing cellular response to radiation therapy, Dr. Vidimos said.
Hedgehog inhibitors can also be used to shrink tumors before surgery. One small series found a 27% decrease in the area of the tumor after 3 to 6 months of preoperative vismodegib.
Dr. Vidimos shared another case to illustrate the point.
A 64-year-old woman fainted and presented to the ED with a hemoglobin of 3.2 mg/dL because of chronic blood loss from an ulcerated BCC on her upper back. The lesion measured 25 cm by 9 cm, and was 3.5 cm deep with no bone involvement. The woman was addicted to opioids by the time she presented.
She was started on vismodegib; the ulcer shrunk considerably after 6 months, and the woman underwent a resection. Only one small focus of BCC was found across 78 specimens submitted to Dr. Vidimos for Mohs reading.
Resection was followed by a muscle flap repair and radiation. At 5 and a half years, there is no evidence of disease; the only sign that the lesion had been there was a scar running along the woman’s upper spine.
The approach “was very successful for a very aggressive and worrisome tumor,” Dr. Vidimos said.
Dr. Vidimos did not have any relevant disclosures. Dr. Patel had no relevant disclosures.
MD, a Mohs surgeon and chair of the department of dermatology at the Cleveland Clinic.
She and her colleagues have noticed an accelerated and durable response to hedgehog inhibitors after debulking and are studying cell signaling before and after debulking to better understand the issue.
Dr. Vidimos shared a remarkable case to illustrate the point during a clinical pearls talk at the annual meeting of the American College of Mohs Surgery.
An 82-year-old woman presented with a crusted, hemorrhagic, nodular basal cell carcinoma (BCC) that had overgrown over nearly her entire nose and left lower eyelid. A recurrence of a previous BCC, the tumor had been growing for a decade and had invaded her nasal bones but not the periorbital tissue.
An outside surgeon suggested a full rhinectomy and removal of the lower eyelid, but the woman refused.
Dr. Vidimos decided to treat her with vismodegib, but prior to doing so, she debulked the tumor to help with the pain and bleeding. She did not curette the portion of tumor extending through the ala into the nasal vestibule. “I let the vismodegib take care of that,” she said.
After 9 months, the tumor was virtually gone, with no recurrence after 3 years. Surgical debulking prior to hedgehog inhibition “reduces the tumor burden and may increase the efficacy and shorten the course of therapy,” Dr. Vidimos said.
The hedgehog inhibitors vismodegib (Erivedge) and sonidegib Odomzo are both approved for treating locally advanced BCC, with a complete response of 31% of locally advanced disease with vismodegib, according to one report.
But monotherapy is limited by intolerable side effects, most commonly muscle spasms, alopecia, and dysgeusia. To minimize the impact, Dr. Vidimos generally puts patients on treatment with Monday through Friday dosing and gives them the weekends off, a schedule she and her colleagues have reported works as well as daily dosing.
Still, many patients discontinue the drugs because of the side effects. Hedgehog inhibitors are also expensive and responses aren’t always durable. To increase efficacy and shorten the course of therapy, “we need alternative treatment strategies,” Dr. Vidimos said.
Up-front tumor debulking is one such strategy. Altered cell signaling pathways associated with tissue remodeling might improve response, and debulking may reduce the genetic heterogeneity of tumor cells, rendering remaining cells less resistant to hedgehog inhibition, she explained.
“It is exciting to see how tumor debulking may reduce tumor burden and heterogeneity, and thus lead to a durable response in extensive tumors,” said Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who heard the presentation. “More investigation is needed to reproduce these results, but this approach may lead to improved outcomes with targeted therapies,” he said in an interview.
Combination therapy with other agents is another option, and there also seems to be a synergistic effect with radiation, with hedgehog inhibitors increasing cellular response to radiation therapy, Dr. Vidimos said.
Hedgehog inhibitors can also be used to shrink tumors before surgery. One small series found a 27% decrease in the area of the tumor after 3 to 6 months of preoperative vismodegib.
Dr. Vidimos shared another case to illustrate the point.
A 64-year-old woman fainted and presented to the ED with a hemoglobin of 3.2 mg/dL because of chronic blood loss from an ulcerated BCC on her upper back. The lesion measured 25 cm by 9 cm, and was 3.5 cm deep with no bone involvement. The woman was addicted to opioids by the time she presented.
She was started on vismodegib; the ulcer shrunk considerably after 6 months, and the woman underwent a resection. Only one small focus of BCC was found across 78 specimens submitted to Dr. Vidimos for Mohs reading.
Resection was followed by a muscle flap repair and radiation. At 5 and a half years, there is no evidence of disease; the only sign that the lesion had been there was a scar running along the woman’s upper spine.
The approach “was very successful for a very aggressive and worrisome tumor,” Dr. Vidimos said.
Dr. Vidimos did not have any relevant disclosures. Dr. Patel had no relevant disclosures.
MD, a Mohs surgeon and chair of the department of dermatology at the Cleveland Clinic.
She and her colleagues have noticed an accelerated and durable response to hedgehog inhibitors after debulking and are studying cell signaling before and after debulking to better understand the issue.
Dr. Vidimos shared a remarkable case to illustrate the point during a clinical pearls talk at the annual meeting of the American College of Mohs Surgery.
An 82-year-old woman presented with a crusted, hemorrhagic, nodular basal cell carcinoma (BCC) that had overgrown over nearly her entire nose and left lower eyelid. A recurrence of a previous BCC, the tumor had been growing for a decade and had invaded her nasal bones but not the periorbital tissue.
An outside surgeon suggested a full rhinectomy and removal of the lower eyelid, but the woman refused.
Dr. Vidimos decided to treat her with vismodegib, but prior to doing so, she debulked the tumor to help with the pain and bleeding. She did not curette the portion of tumor extending through the ala into the nasal vestibule. “I let the vismodegib take care of that,” she said.
After 9 months, the tumor was virtually gone, with no recurrence after 3 years. Surgical debulking prior to hedgehog inhibition “reduces the tumor burden and may increase the efficacy and shorten the course of therapy,” Dr. Vidimos said.
The hedgehog inhibitors vismodegib (Erivedge) and sonidegib Odomzo are both approved for treating locally advanced BCC, with a complete response of 31% of locally advanced disease with vismodegib, according to one report.
But monotherapy is limited by intolerable side effects, most commonly muscle spasms, alopecia, and dysgeusia. To minimize the impact, Dr. Vidimos generally puts patients on treatment with Monday through Friday dosing and gives them the weekends off, a schedule she and her colleagues have reported works as well as daily dosing.
Still, many patients discontinue the drugs because of the side effects. Hedgehog inhibitors are also expensive and responses aren’t always durable. To increase efficacy and shorten the course of therapy, “we need alternative treatment strategies,” Dr. Vidimos said.
Up-front tumor debulking is one such strategy. Altered cell signaling pathways associated with tissue remodeling might improve response, and debulking may reduce the genetic heterogeneity of tumor cells, rendering remaining cells less resistant to hedgehog inhibition, she explained.
“It is exciting to see how tumor debulking may reduce tumor burden and heterogeneity, and thus lead to a durable response in extensive tumors,” said Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who heard the presentation. “More investigation is needed to reproduce these results, but this approach may lead to improved outcomes with targeted therapies,” he said in an interview.
Combination therapy with other agents is another option, and there also seems to be a synergistic effect with radiation, with hedgehog inhibitors increasing cellular response to radiation therapy, Dr. Vidimos said.
Hedgehog inhibitors can also be used to shrink tumors before surgery. One small series found a 27% decrease in the area of the tumor after 3 to 6 months of preoperative vismodegib.
Dr. Vidimos shared another case to illustrate the point.
A 64-year-old woman fainted and presented to the ED with a hemoglobin of 3.2 mg/dL because of chronic blood loss from an ulcerated BCC on her upper back. The lesion measured 25 cm by 9 cm, and was 3.5 cm deep with no bone involvement. The woman was addicted to opioids by the time she presented.
She was started on vismodegib; the ulcer shrunk considerably after 6 months, and the woman underwent a resection. Only one small focus of BCC was found across 78 specimens submitted to Dr. Vidimos for Mohs reading.
Resection was followed by a muscle flap repair and radiation. At 5 and a half years, there is no evidence of disease; the only sign that the lesion had been there was a scar running along the woman’s upper spine.
The approach “was very successful for a very aggressive and worrisome tumor,” Dr. Vidimos said.
Dr. Vidimos did not have any relevant disclosures. Dr. Patel had no relevant disclosures.
FROM THE ACMS ANNUAL MEETING
New digital ADHD intervention tools are emerging
New digital tools are on the horizon to help patients with attention-deficit/hyperactivity disorder (ADHD) manage the condition.
Speakers at the World Congress on ADHD – Virtual Event described innovations aimed at improving medication compliance or reducing symptoms through the use of smartphone technology such as apps and text messaging, and video games. Some of these technologies have shown promising results in clinical trials, but the experts called for additional studies to further vet their efficacy.
Digital technologies have limitations and should be seen as adjunctive rather than standalone tools that can aid clinicians and educators, said Hannah Kirk, PhD, a psychology research fellow at Monash University’s Turner Institute for Brain and Mental Health in Clayton, Australia. Dr. Kirk joined three other speakers for the session: “ADHD in the digital age – From pitfalls to challenges.”
An explosion in technology
ADHD, the most common neurodevelopmental disorder, has global prevalence rates ranging from 5% to 7%, said Dr. Kirk. Digital technology and digital health “have been heralded as having enormous potential to improve early access and to improve the increasing demand in child support services,” she said.
The world has seen an explosion of digital technology innovation in the last decade, spurred on most recently by the COVID-19 pandemic. New demand exists for tools in educational and health care settings to provide information and support through websites, apps, SMS, video conferencing, and wearable devices, Dr. Kirk said.
Looking at the landscape of ADHD digital therapeutics, “there are probably tens of thousands of apps and other digital products to treat and manage conditions across the spectrum,” said Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C.
In general, few developers of these products have conducted rigorous, well-controlled trials, he noted.
Video game interventions
AKL-T01, a tool that pairs continuous fine motor tasks and perceptual reaction time tasks, went through several rounds of clinical trials to achieve federal approval as a digital therapeutic.
“This not just another video game,” said Dr. Kollins, who helped developed it. The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users.
Two phase 3 trials provided the basis for the Food and Drug Administration’s approval of AKL-T01, also known as EndeavorRx, in 2020. The first trial, published in The Lancet, randomized 348 children 1:1 to receive either the AKL-T01 treatment or a controlled intervention, which was a word game. Participating children aged 8-12 with a confirmed ADHD diagnosis were asked to play the game for about 25 minutes a day, 5 days a week over 4 weeks. The study excluded children who were taking medicine.
The researchers reported statistically significant improvements in attentional functioning in the AKL-T01 group as rated by test of variables of attention. The trial reported no serious adverse events, although one child in the AKL-T01 group withdrew from the study.
“As kids go through this treatment, it’s challenging and the difficulty levels increase, so it’s not surprising that kids get frustrated with that, or have emotional outbursts,” Dr. Kollins said. Those reactions suggest that the intervention was working, he added.
A follow-up study, published in npj Digital Medicine, broadened the scope. That study included children who had taken medication and extended the study period. Overall, 206 children aged 8-14 (130 on stimulants and 76 on no medication) played the game for 28 days, taking a pause for another 28 days, then reinitiating the treatment.
As in the first trial, AKL-T01 significantly improved ADHD-related impairment, a metric that continued to improve in the second round of treatment. Looking at secondary outcomes, the proportion of children deemed as clinical responders on the Impairment Rating Scale, 68.3% of all of the participants were responders by the end of the study on the ADHD ratings scale, meaning there was a greater than 30% improvement in symptoms. Upward of 50% of participants at the end of the second round of treatment showed substantial improvement in their ADHD ratings scale scores.
“This was really a substantial move ... the first-ever app-based video game approved by the FDA,” noted Dr. Kollins, who is affiliated with the Duke Clinical Research Institute. Some skeptics have called this a marketing ploy or have questioned the integrity of the FDA approval process.
“I would submit and argue that the rigor of the trial speaks for itself,” he said. “But it’s not surprising that there’s skepticism in the clinical community about something like this – a brand new treatment modality.”
In her own research, Dr. Kirk has studied game-based interventions aimed at assessing ADHD and improving cognitive training. In 2018, her team developed a touch screen game–based intervention for early evaluation of attention skills, using six activities. In a visual search task, children were asked to locate red lobsters on a screen that showed a variety of underwater creatures. In another selection attention task, children were asked to scan the screen for a particular target, such as a yellow star, and to indicate whether that target was absent or present on the screen. Other tasks assessed for sustained attention abilities and information processing speed.
She and her colleagues recruited 340 children aged 4-7 years to evaluate whether the tool produced consistent results over time, and compared favorably to existing measures of attention. None of the participants had been diagnosed with ADHD. To assess reliability, a subset of children completed another assessment 2 weeks after the first one. The study showed varying results according to activity. The visual search task had high test-retest reliability and the strongest validity, compared with the other tasks. The sustained attention tasks exhibited the weakest validity.
The next steps are to assess whether this tool is sensitive enough to detect differences between children with or without clinical attention difficulties such as ADHD, Dr. Kirk said.
Apps improve adherence
As some technologies focus on reducing symptoms through games, others seek to improve medication compliance through SMS and smartphone apps.
Studies have shown that medication can decrease incidence of smoking, mood disorders, traumatic brain injuries, car crashes, and educational outcomes. However, risk decreases only if compliance is good, said Joseph Biederman, MD. Right now, “there’s extremely poor adherence to stimulant medications in ADHD” across the world, said Dr. Biederman, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at Massachusetts General Hospital in Boston.
“This is a problem that’s driven by ADHD itself,” he continued. Prescribers don’t always have the time to educate the patient on medications, deal with misconceptions, or provide support for management of daily activities.
Text reminders may offer a solution. Partnering with a Canadian technology company, MEMOTEXT, Dr. Biederman and colleagues at Massachusetts General Hospital developed an SMS-based disease management intervention for ADHD.
The tool aims to manage work, home life, and social relationships by supporting the timely renewal of medications. It doesn’t just remind people to take their ADHD medication, it reminds them to take any other medication they need, and provides the reasons why it’s important to take these drugs. Through interactive questions, it also assesses the progress and knowledge of patients and families about ADHD.
Testing this app in pediatric settings, Dr. Biederman and colleagues published a study in the Journal of Psychopharmacology showing a dramatic increase in compliance – from 60% to 90%.
In another study, this one published in the Journal of Clinical Psychopharmacology, Dr. Biederman and colleagues found that compliance improved, from 35% to 70% in adults. The SMS program in these settings not only improved adherence, but it also reduced costs of ADHD-associated complications while adding beneficial support and value to patients, families, and prescribers, Dr. Biederman said.
Promising findings about the power of apps to increase ADHD medication adherence led Luis Augusto Rohde, MD, PhD, and colleagues to develop the FOCUS app in 2016, for use in his home country of Brazil. The app objectively monitors symptoms of ADHD and establishes cooperative relationships between the patient, their families, and caregivers, said Dr. Rohde, professor of child and adolescent psychiatry at the Federal University of Rio Grande do Sul’s department of psychiatry, Porto Alegre, Brazil.
FOCUS works through collaboration. Anyone involved in the patient’s care: teachers, family members, and health care professionals, can download the app. Through this shared connection with the patient, they can participate in weekly assessments of symptoms and adverse events. A task manager sends medication reminders to the patient, who can select activities to help monitor daily performance and customize rewards.
All of those features “make it much easier to plan and individualize treatments and discuss compliance and issues with the patient,” Dr. Rohde said.
FOCUS traffic ranges from 1,200 to 1,500 active users each week, offering a wealth of data to mine on compliance, behavior, and adverse events. An upcoming randomized clinical trial in three groups of patients will further explore FOCUS’s ability to increase adherence to treatment, Dr. Rohde said.
Digital tech pros and cons
The accessibility of digital technology to children living in remote areas is one of its biggest assets, Dr. Kirk said.
Digital technologies capture real time data, are easy to use, are suitable for young children with developmental disorders, have few adverse effects, and can be easily updated. However, there are some limitations, she added. Attitudes toward technology, time required to supervise their use, and funding to facilitate the use of such technology can hinder implementation. Given that digital technology is increasingly being used to collect sensitive medical data and assess clinical conditions, it’s crucial for these new technologies to be compliant with HIPAA requirements, Dr. Kirk said.
Developers need to be thoughtful and deliberate in how they design clinical evidence strategies for digital therapeutics for ADHD.
“There’s much work that needs to be done from a clinical, statistical, regulatory, and policy perspective, but this journey illustrates this can be done with ADHD and other mental health conditions.”
Dr. Kirk disclosed working previously for a small technology company in Melbourne that developed medical technologies for children. Dr. Kollins’ work has been supported by numerous U.S. agencies, including the National Institute of Mental Health. He has served as a consultant to numerous pharmaceutical companies tied to ADHD clinical psychopharmacology. Dr. Biederman has provided research support to Genentech, Headspace, Pfizer, Roche Translational & Clinical Research Center, and other pharmaceutical companies. Also, Dr. Biederman has a partnership with MEMOTEXT through Partners Healthcare Innovation. Dr. Rohde has received grant or research support from, and served as a consultant to, several companies, including Bial, Novartis, Pfizer, and Shire/Takeda. He has received authorship royalties from Oxford University Press and ArtMed, and travel grants from Shire.
New digital tools are on the horizon to help patients with attention-deficit/hyperactivity disorder (ADHD) manage the condition.
Speakers at the World Congress on ADHD – Virtual Event described innovations aimed at improving medication compliance or reducing symptoms through the use of smartphone technology such as apps and text messaging, and video games. Some of these technologies have shown promising results in clinical trials, but the experts called for additional studies to further vet their efficacy.
Digital technologies have limitations and should be seen as adjunctive rather than standalone tools that can aid clinicians and educators, said Hannah Kirk, PhD, a psychology research fellow at Monash University’s Turner Institute for Brain and Mental Health in Clayton, Australia. Dr. Kirk joined three other speakers for the session: “ADHD in the digital age – From pitfalls to challenges.”
An explosion in technology
ADHD, the most common neurodevelopmental disorder, has global prevalence rates ranging from 5% to 7%, said Dr. Kirk. Digital technology and digital health “have been heralded as having enormous potential to improve early access and to improve the increasing demand in child support services,” she said.
The world has seen an explosion of digital technology innovation in the last decade, spurred on most recently by the COVID-19 pandemic. New demand exists for tools in educational and health care settings to provide information and support through websites, apps, SMS, video conferencing, and wearable devices, Dr. Kirk said.
Looking at the landscape of ADHD digital therapeutics, “there are probably tens of thousands of apps and other digital products to treat and manage conditions across the spectrum,” said Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C.
In general, few developers of these products have conducted rigorous, well-controlled trials, he noted.
Video game interventions
AKL-T01, a tool that pairs continuous fine motor tasks and perceptual reaction time tasks, went through several rounds of clinical trials to achieve federal approval as a digital therapeutic.
“This not just another video game,” said Dr. Kollins, who helped developed it. The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users.
Two phase 3 trials provided the basis for the Food and Drug Administration’s approval of AKL-T01, also known as EndeavorRx, in 2020. The first trial, published in The Lancet, randomized 348 children 1:1 to receive either the AKL-T01 treatment or a controlled intervention, which was a word game. Participating children aged 8-12 with a confirmed ADHD diagnosis were asked to play the game for about 25 minutes a day, 5 days a week over 4 weeks. The study excluded children who were taking medicine.
The researchers reported statistically significant improvements in attentional functioning in the AKL-T01 group as rated by test of variables of attention. The trial reported no serious adverse events, although one child in the AKL-T01 group withdrew from the study.
“As kids go through this treatment, it’s challenging and the difficulty levels increase, so it’s not surprising that kids get frustrated with that, or have emotional outbursts,” Dr. Kollins said. Those reactions suggest that the intervention was working, he added.
A follow-up study, published in npj Digital Medicine, broadened the scope. That study included children who had taken medication and extended the study period. Overall, 206 children aged 8-14 (130 on stimulants and 76 on no medication) played the game for 28 days, taking a pause for another 28 days, then reinitiating the treatment.
As in the first trial, AKL-T01 significantly improved ADHD-related impairment, a metric that continued to improve in the second round of treatment. Looking at secondary outcomes, the proportion of children deemed as clinical responders on the Impairment Rating Scale, 68.3% of all of the participants were responders by the end of the study on the ADHD ratings scale, meaning there was a greater than 30% improvement in symptoms. Upward of 50% of participants at the end of the second round of treatment showed substantial improvement in their ADHD ratings scale scores.
“This was really a substantial move ... the first-ever app-based video game approved by the FDA,” noted Dr. Kollins, who is affiliated with the Duke Clinical Research Institute. Some skeptics have called this a marketing ploy or have questioned the integrity of the FDA approval process.
“I would submit and argue that the rigor of the trial speaks for itself,” he said. “But it’s not surprising that there’s skepticism in the clinical community about something like this – a brand new treatment modality.”
In her own research, Dr. Kirk has studied game-based interventions aimed at assessing ADHD and improving cognitive training. In 2018, her team developed a touch screen game–based intervention for early evaluation of attention skills, using six activities. In a visual search task, children were asked to locate red lobsters on a screen that showed a variety of underwater creatures. In another selection attention task, children were asked to scan the screen for a particular target, such as a yellow star, and to indicate whether that target was absent or present on the screen. Other tasks assessed for sustained attention abilities and information processing speed.
She and her colleagues recruited 340 children aged 4-7 years to evaluate whether the tool produced consistent results over time, and compared favorably to existing measures of attention. None of the participants had been diagnosed with ADHD. To assess reliability, a subset of children completed another assessment 2 weeks after the first one. The study showed varying results according to activity. The visual search task had high test-retest reliability and the strongest validity, compared with the other tasks. The sustained attention tasks exhibited the weakest validity.
The next steps are to assess whether this tool is sensitive enough to detect differences between children with or without clinical attention difficulties such as ADHD, Dr. Kirk said.
Apps improve adherence
As some technologies focus on reducing symptoms through games, others seek to improve medication compliance through SMS and smartphone apps.
Studies have shown that medication can decrease incidence of smoking, mood disorders, traumatic brain injuries, car crashes, and educational outcomes. However, risk decreases only if compliance is good, said Joseph Biederman, MD. Right now, “there’s extremely poor adherence to stimulant medications in ADHD” across the world, said Dr. Biederman, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at Massachusetts General Hospital in Boston.
“This is a problem that’s driven by ADHD itself,” he continued. Prescribers don’t always have the time to educate the patient on medications, deal with misconceptions, or provide support for management of daily activities.
Text reminders may offer a solution. Partnering with a Canadian technology company, MEMOTEXT, Dr. Biederman and colleagues at Massachusetts General Hospital developed an SMS-based disease management intervention for ADHD.
The tool aims to manage work, home life, and social relationships by supporting the timely renewal of medications. It doesn’t just remind people to take their ADHD medication, it reminds them to take any other medication they need, and provides the reasons why it’s important to take these drugs. Through interactive questions, it also assesses the progress and knowledge of patients and families about ADHD.
Testing this app in pediatric settings, Dr. Biederman and colleagues published a study in the Journal of Psychopharmacology showing a dramatic increase in compliance – from 60% to 90%.
In another study, this one published in the Journal of Clinical Psychopharmacology, Dr. Biederman and colleagues found that compliance improved, from 35% to 70% in adults. The SMS program in these settings not only improved adherence, but it also reduced costs of ADHD-associated complications while adding beneficial support and value to patients, families, and prescribers, Dr. Biederman said.
Promising findings about the power of apps to increase ADHD medication adherence led Luis Augusto Rohde, MD, PhD, and colleagues to develop the FOCUS app in 2016, for use in his home country of Brazil. The app objectively monitors symptoms of ADHD and establishes cooperative relationships between the patient, their families, and caregivers, said Dr. Rohde, professor of child and adolescent psychiatry at the Federal University of Rio Grande do Sul’s department of psychiatry, Porto Alegre, Brazil.
FOCUS works through collaboration. Anyone involved in the patient’s care: teachers, family members, and health care professionals, can download the app. Through this shared connection with the patient, they can participate in weekly assessments of symptoms and adverse events. A task manager sends medication reminders to the patient, who can select activities to help monitor daily performance and customize rewards.
All of those features “make it much easier to plan and individualize treatments and discuss compliance and issues with the patient,” Dr. Rohde said.
FOCUS traffic ranges from 1,200 to 1,500 active users each week, offering a wealth of data to mine on compliance, behavior, and adverse events. An upcoming randomized clinical trial in three groups of patients will further explore FOCUS’s ability to increase adherence to treatment, Dr. Rohde said.
Digital tech pros and cons
The accessibility of digital technology to children living in remote areas is one of its biggest assets, Dr. Kirk said.
Digital technologies capture real time data, are easy to use, are suitable for young children with developmental disorders, have few adverse effects, and can be easily updated. However, there are some limitations, she added. Attitudes toward technology, time required to supervise their use, and funding to facilitate the use of such technology can hinder implementation. Given that digital technology is increasingly being used to collect sensitive medical data and assess clinical conditions, it’s crucial for these new technologies to be compliant with HIPAA requirements, Dr. Kirk said.
Developers need to be thoughtful and deliberate in how they design clinical evidence strategies for digital therapeutics for ADHD.
“There’s much work that needs to be done from a clinical, statistical, regulatory, and policy perspective, but this journey illustrates this can be done with ADHD and other mental health conditions.”
Dr. Kirk disclosed working previously for a small technology company in Melbourne that developed medical technologies for children. Dr. Kollins’ work has been supported by numerous U.S. agencies, including the National Institute of Mental Health. He has served as a consultant to numerous pharmaceutical companies tied to ADHD clinical psychopharmacology. Dr. Biederman has provided research support to Genentech, Headspace, Pfizer, Roche Translational & Clinical Research Center, and other pharmaceutical companies. Also, Dr. Biederman has a partnership with MEMOTEXT through Partners Healthcare Innovation. Dr. Rohde has received grant or research support from, and served as a consultant to, several companies, including Bial, Novartis, Pfizer, and Shire/Takeda. He has received authorship royalties from Oxford University Press and ArtMed, and travel grants from Shire.
New digital tools are on the horizon to help patients with attention-deficit/hyperactivity disorder (ADHD) manage the condition.
Speakers at the World Congress on ADHD – Virtual Event described innovations aimed at improving medication compliance or reducing symptoms through the use of smartphone technology such as apps and text messaging, and video games. Some of these technologies have shown promising results in clinical trials, but the experts called for additional studies to further vet their efficacy.
Digital technologies have limitations and should be seen as adjunctive rather than standalone tools that can aid clinicians and educators, said Hannah Kirk, PhD, a psychology research fellow at Monash University’s Turner Institute for Brain and Mental Health in Clayton, Australia. Dr. Kirk joined three other speakers for the session: “ADHD in the digital age – From pitfalls to challenges.”
An explosion in technology
ADHD, the most common neurodevelopmental disorder, has global prevalence rates ranging from 5% to 7%, said Dr. Kirk. Digital technology and digital health “have been heralded as having enormous potential to improve early access and to improve the increasing demand in child support services,” she said.
The world has seen an explosion of digital technology innovation in the last decade, spurred on most recently by the COVID-19 pandemic. New demand exists for tools in educational and health care settings to provide information and support through websites, apps, SMS, video conferencing, and wearable devices, Dr. Kirk said.
Looking at the landscape of ADHD digital therapeutics, “there are probably tens of thousands of apps and other digital products to treat and manage conditions across the spectrum,” said Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C.
In general, few developers of these products have conducted rigorous, well-controlled trials, he noted.
Video game interventions
AKL-T01, a tool that pairs continuous fine motor tasks and perceptual reaction time tasks, went through several rounds of clinical trials to achieve federal approval as a digital therapeutic.
“This not just another video game,” said Dr. Kollins, who helped developed it. The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users.
Two phase 3 trials provided the basis for the Food and Drug Administration’s approval of AKL-T01, also known as EndeavorRx, in 2020. The first trial, published in The Lancet, randomized 348 children 1:1 to receive either the AKL-T01 treatment or a controlled intervention, which was a word game. Participating children aged 8-12 with a confirmed ADHD diagnosis were asked to play the game for about 25 minutes a day, 5 days a week over 4 weeks. The study excluded children who were taking medicine.
The researchers reported statistically significant improvements in attentional functioning in the AKL-T01 group as rated by test of variables of attention. The trial reported no serious adverse events, although one child in the AKL-T01 group withdrew from the study.
“As kids go through this treatment, it’s challenging and the difficulty levels increase, so it’s not surprising that kids get frustrated with that, or have emotional outbursts,” Dr. Kollins said. Those reactions suggest that the intervention was working, he added.
A follow-up study, published in npj Digital Medicine, broadened the scope. That study included children who had taken medication and extended the study period. Overall, 206 children aged 8-14 (130 on stimulants and 76 on no medication) played the game for 28 days, taking a pause for another 28 days, then reinitiating the treatment.
As in the first trial, AKL-T01 significantly improved ADHD-related impairment, a metric that continued to improve in the second round of treatment. Looking at secondary outcomes, the proportion of children deemed as clinical responders on the Impairment Rating Scale, 68.3% of all of the participants were responders by the end of the study on the ADHD ratings scale, meaning there was a greater than 30% improvement in symptoms. Upward of 50% of participants at the end of the second round of treatment showed substantial improvement in their ADHD ratings scale scores.
“This was really a substantial move ... the first-ever app-based video game approved by the FDA,” noted Dr. Kollins, who is affiliated with the Duke Clinical Research Institute. Some skeptics have called this a marketing ploy or have questioned the integrity of the FDA approval process.
“I would submit and argue that the rigor of the trial speaks for itself,” he said. “But it’s not surprising that there’s skepticism in the clinical community about something like this – a brand new treatment modality.”
In her own research, Dr. Kirk has studied game-based interventions aimed at assessing ADHD and improving cognitive training. In 2018, her team developed a touch screen game–based intervention for early evaluation of attention skills, using six activities. In a visual search task, children were asked to locate red lobsters on a screen that showed a variety of underwater creatures. In another selection attention task, children were asked to scan the screen for a particular target, such as a yellow star, and to indicate whether that target was absent or present on the screen. Other tasks assessed for sustained attention abilities and information processing speed.
She and her colleagues recruited 340 children aged 4-7 years to evaluate whether the tool produced consistent results over time, and compared favorably to existing measures of attention. None of the participants had been diagnosed with ADHD. To assess reliability, a subset of children completed another assessment 2 weeks after the first one. The study showed varying results according to activity. The visual search task had high test-retest reliability and the strongest validity, compared with the other tasks. The sustained attention tasks exhibited the weakest validity.
The next steps are to assess whether this tool is sensitive enough to detect differences between children with or without clinical attention difficulties such as ADHD, Dr. Kirk said.
Apps improve adherence
As some technologies focus on reducing symptoms through games, others seek to improve medication compliance through SMS and smartphone apps.
Studies have shown that medication can decrease incidence of smoking, mood disorders, traumatic brain injuries, car crashes, and educational outcomes. However, risk decreases only if compliance is good, said Joseph Biederman, MD. Right now, “there’s extremely poor adherence to stimulant medications in ADHD” across the world, said Dr. Biederman, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at Massachusetts General Hospital in Boston.
“This is a problem that’s driven by ADHD itself,” he continued. Prescribers don’t always have the time to educate the patient on medications, deal with misconceptions, or provide support for management of daily activities.
Text reminders may offer a solution. Partnering with a Canadian technology company, MEMOTEXT, Dr. Biederman and colleagues at Massachusetts General Hospital developed an SMS-based disease management intervention for ADHD.
The tool aims to manage work, home life, and social relationships by supporting the timely renewal of medications. It doesn’t just remind people to take their ADHD medication, it reminds them to take any other medication they need, and provides the reasons why it’s important to take these drugs. Through interactive questions, it also assesses the progress and knowledge of patients and families about ADHD.
Testing this app in pediatric settings, Dr. Biederman and colleagues published a study in the Journal of Psychopharmacology showing a dramatic increase in compliance – from 60% to 90%.
In another study, this one published in the Journal of Clinical Psychopharmacology, Dr. Biederman and colleagues found that compliance improved, from 35% to 70% in adults. The SMS program in these settings not only improved adherence, but it also reduced costs of ADHD-associated complications while adding beneficial support and value to patients, families, and prescribers, Dr. Biederman said.
Promising findings about the power of apps to increase ADHD medication adherence led Luis Augusto Rohde, MD, PhD, and colleagues to develop the FOCUS app in 2016, for use in his home country of Brazil. The app objectively monitors symptoms of ADHD and establishes cooperative relationships between the patient, their families, and caregivers, said Dr. Rohde, professor of child and adolescent psychiatry at the Federal University of Rio Grande do Sul’s department of psychiatry, Porto Alegre, Brazil.
FOCUS works through collaboration. Anyone involved in the patient’s care: teachers, family members, and health care professionals, can download the app. Through this shared connection with the patient, they can participate in weekly assessments of symptoms and adverse events. A task manager sends medication reminders to the patient, who can select activities to help monitor daily performance and customize rewards.
All of those features “make it much easier to plan and individualize treatments and discuss compliance and issues with the patient,” Dr. Rohde said.
FOCUS traffic ranges from 1,200 to 1,500 active users each week, offering a wealth of data to mine on compliance, behavior, and adverse events. An upcoming randomized clinical trial in three groups of patients will further explore FOCUS’s ability to increase adherence to treatment, Dr. Rohde said.
Digital tech pros and cons
The accessibility of digital technology to children living in remote areas is one of its biggest assets, Dr. Kirk said.
Digital technologies capture real time data, are easy to use, are suitable for young children with developmental disorders, have few adverse effects, and can be easily updated. However, there are some limitations, she added. Attitudes toward technology, time required to supervise their use, and funding to facilitate the use of such technology can hinder implementation. Given that digital technology is increasingly being used to collect sensitive medical data and assess clinical conditions, it’s crucial for these new technologies to be compliant with HIPAA requirements, Dr. Kirk said.
Developers need to be thoughtful and deliberate in how they design clinical evidence strategies for digital therapeutics for ADHD.
“There’s much work that needs to be done from a clinical, statistical, regulatory, and policy perspective, but this journey illustrates this can be done with ADHD and other mental health conditions.”
Dr. Kirk disclosed working previously for a small technology company in Melbourne that developed medical technologies for children. Dr. Kollins’ work has been supported by numerous U.S. agencies, including the National Institute of Mental Health. He has served as a consultant to numerous pharmaceutical companies tied to ADHD clinical psychopharmacology. Dr. Biederman has provided research support to Genentech, Headspace, Pfizer, Roche Translational & Clinical Research Center, and other pharmaceutical companies. Also, Dr. Biederman has a partnership with MEMOTEXT through Partners Healthcare Innovation. Dr. Rohde has received grant or research support from, and served as a consultant to, several companies, including Bial, Novartis, Pfizer, and Shire/Takeda. He has received authorship royalties from Oxford University Press and ArtMed, and travel grants from Shire.
FROM ADHD 2021
Once-nightly sodium oxybate agent effective in narcolepsy
, new research suggests. Top-line results from the phase 3 REST-ON trial released earlier this year showed that the agent known as FT218 (Avadel Pharmaceuticals) met all three of its coprimary efficacy endpoints at all three doses assessed (6 g, 7.5 g, and 9 g). Patients receiving the drug showed significantly greater improvements on the Maintenance of Wakefulness Test (MWT), the Clinical Global Impression of Improvement (CGI-I), and mean weekly attacks of cataplexy, compared with those who received placebo.
The new analyses, which focused on key secondary outcomes, showed that all three doses of the novel agent were associated with significant improvements in sleep quality, refreshing nature of sleep, sleep paralysis, disturbed nocturnal sleep, and scores on the Epworth Sleepiness Scale (ESS).
Principal investigator Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, New York, said in a news release that the results represent “the promise of a potential new treatment strategy for physicians and patients.”
“I am particularly impressed by the consistency of results as early as 3 weeks with only a 6-g dose,” he added.
Dr. Thorpy, who is also a professor of neurology at the Albert Einstein College of Medicine, noted that the new formulation will be more convenient for patients. “The advantage of this medication is its once-nightly formulation, so patients don’t need to awaken during the night and can actually have a better night’s sleep,” he said.
Dr. Thorpy presented the study findings at the 2021 annual meeting of the American Academy of Neurology.
FT218 is currently under review by the U.S. Food and Drug Administration, which has set Oct. 15 as the Prescription Drug User Fee Act target date.
Forced awakening
Sodium oxybate was first approved by the FDA in 2002 to treat cataplexy in adults with narcolepsy and was expanded in 2005 to also treat excessive daytime sleepiness (EDS). That formulation is indicated for twice-nightly administration, with the second dose taken 2.5-4 hours after the first.
“The need for forced awakening to take the second dose ... may result in noncompliance, which may lead to reduced efficacy and/or mistimed doses,” the investigators noted.
FT218 is a modified-release version of sodium oxybate. A single 6-g dose of the investigational agent “has shown bioequivalent exposure to twice-nightly immediate-release [sodium oxybate] given as two 3-g doses,” wrote the researchers.
It also currently has Orphan Drug Designation from the FDA for the treatment of narcolepsy.
The randomized, double-blind, placebo-controlled, multicenter REST-ON study was conducted from November 2016 to March 2020 and included patients 16 years or older who had narcolepsy type 1 or type 2.
Patients received the active treatment (n = 107; mean age, 30.9 years; 64.5% women) or placebo (n = 105; mean age, 31.6 years; 71.4% women) according to a four-period forced uptitration dosing schedule of 4.5 g for 1 week, 6 g for 2 weeks, 7.5 g for 5 weeks, and 9 g for 5 weeks.
Secondary outcome measures included the ESS, sleep quality/refreshing nature of sleep on a visual analog scale, sleep paralysis and hypnagogic hallucinations on a sleep symptoms diary, disturbed nocturnal sleep on polysomnographic measures, and number of arousals as defined per the American Academy of Sleep Medicine Score Manual.
Reports of adverse events (AEs) were collected from time of informed consent until 7 days after the last dose received.
Improvement across doses
Results showed that, compared with placebo, improvement in disturbed nocturnal sleep from baseline was significantly greater for the active treatment at 6 g at week 3 (mean between-group difference, –11; P < .001), at 7.5 g at week 8 (mean difference, –17.7; P < .001), and at 9 g at week 13 (mean difference, –22.6; P < .001).
The mean difference between the three doses and placebo for reduction in number of arousals was –11.3 (P < .05), –19.4 (P < .001), and –23.7 (P < .001), respectively. And the 6 g at week 3, 7.5 g at week 8, and 9 g at week 13 doses showed significant (P < .001) improvements versus placebo on the ESS (mean difference, –2.1, –3.2, and –3.9, respectively).
All three doses also showed significant improvement in sleep quality and refreshing nature of sleep (P < .001 for all comparisons), as well as improvement of sleep paralysis (P = .04, P = .02, and P = .04, respectively).
There were no significant differences between FT218 and placebo for improvement in hypnagogic hallucinations. Dr. Thorpy noted that the number of patients with baseline hallucinations “was relatively small,” which may have led to this finding. “Had there been a much larger population with hallucinations, I suspect that we would have seen a statistically significant improvement there as well,” he said.
Generally well tolerated
The investigators noted that FT218 was “generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions.”
Treatment-related AEs that occurred in more than 2% of the patients receiving FT218 included nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.
Seven serious AEs were reported, including five in those assigned to the active treatment. This included one case each of diabetes inadequate control, paresthesia, perirectal abscess, hypertension, and suicidal ideation. Only the case of suicidal ideation was considered to be a treatment-related AE.
The investigators noted that, although they have not yet delved into subgroup analysis to look for differences among sex, age, or race, they plan to do so in the future.
Overall, the results indicate that “FT218 is an effective agent not only for the major symptoms of sleepiness and cataplexy, but also the quality of sleep at night,” said Dr. Thorpy.
Asked whether he thinks the FDA will approve the drug, he said that it should be “straightforward” because it’s just a different formulation of an already-approved agent. “I very much expect there will not be any problems in this medication being approved,” Dr. Thorpy said.
Benefits ‘sleep architecture’
Commenting on the findings, Logan Schneider, MD, codirector of the Stanford/VA Alzheimer’s Center and clinical assistant professor at the Stanford Sleep Center, Redwood City, Calif., said that the investigators’ focus on these secondary outcomes “was really worthwhile.”
Dr. Schneider, who was not involved in the research, noted that, because the study only included patients with narcolepsy, the results can’t be extrapolated to groups who have other sleep disorders.
Still, “it is worthwhile now to expand beyond the two primary symptoms that are, in my consideration, life threatening: daytime sleepiness and cataplexy. We should also address more of the quality of life and other aspects of narcolepsy, including disturbed nocturnal sleep and sleep quality issues related to that,” he said.
“Being able to address those aspects and say, ‘I have a therapy that clearly helps the multidimensionality of our patients’ is very vindicating,” Dr. Schneider noted.
He was also impressed with the various measures the researchers used, rather than relying just on patient reports, “which are subject to recollection difficulties. This was a nice way to quantify possibly as a diagnostic marker the underlying disruption of sleep, as well as a possible treatment marker to show how well a therapy works.”
“It actually shows a beneficial effect on sleep architecture,” Dr. Schneider said.
The study was funded by Avadel Pharmaceuticals. Dr. Thorpy is a consultant/advisory board member for Avadel, Axsome, Balance Therapeutics, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences, and Takeda Pharmaceutical. Dr. Schneider reports being an adviser and/or on the speakers’ bureau for similar drugs by Jazz Pharmaceuticals and Harmony Biosciences.
A version of this article first appeared on Medscape.com.
, new research suggests. Top-line results from the phase 3 REST-ON trial released earlier this year showed that the agent known as FT218 (Avadel Pharmaceuticals) met all three of its coprimary efficacy endpoints at all three doses assessed (6 g, 7.5 g, and 9 g). Patients receiving the drug showed significantly greater improvements on the Maintenance of Wakefulness Test (MWT), the Clinical Global Impression of Improvement (CGI-I), and mean weekly attacks of cataplexy, compared with those who received placebo.
The new analyses, which focused on key secondary outcomes, showed that all three doses of the novel agent were associated with significant improvements in sleep quality, refreshing nature of sleep, sleep paralysis, disturbed nocturnal sleep, and scores on the Epworth Sleepiness Scale (ESS).
Principal investigator Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, New York, said in a news release that the results represent “the promise of a potential new treatment strategy for physicians and patients.”
“I am particularly impressed by the consistency of results as early as 3 weeks with only a 6-g dose,” he added.
Dr. Thorpy, who is also a professor of neurology at the Albert Einstein College of Medicine, noted that the new formulation will be more convenient for patients. “The advantage of this medication is its once-nightly formulation, so patients don’t need to awaken during the night and can actually have a better night’s sleep,” he said.
Dr. Thorpy presented the study findings at the 2021 annual meeting of the American Academy of Neurology.
FT218 is currently under review by the U.S. Food and Drug Administration, which has set Oct. 15 as the Prescription Drug User Fee Act target date.
Forced awakening
Sodium oxybate was first approved by the FDA in 2002 to treat cataplexy in adults with narcolepsy and was expanded in 2005 to also treat excessive daytime sleepiness (EDS). That formulation is indicated for twice-nightly administration, with the second dose taken 2.5-4 hours after the first.
“The need for forced awakening to take the second dose ... may result in noncompliance, which may lead to reduced efficacy and/or mistimed doses,” the investigators noted.
FT218 is a modified-release version of sodium oxybate. A single 6-g dose of the investigational agent “has shown bioequivalent exposure to twice-nightly immediate-release [sodium oxybate] given as two 3-g doses,” wrote the researchers.
It also currently has Orphan Drug Designation from the FDA for the treatment of narcolepsy.
The randomized, double-blind, placebo-controlled, multicenter REST-ON study was conducted from November 2016 to March 2020 and included patients 16 years or older who had narcolepsy type 1 or type 2.
Patients received the active treatment (n = 107; mean age, 30.9 years; 64.5% women) or placebo (n = 105; mean age, 31.6 years; 71.4% women) according to a four-period forced uptitration dosing schedule of 4.5 g for 1 week, 6 g for 2 weeks, 7.5 g for 5 weeks, and 9 g for 5 weeks.
Secondary outcome measures included the ESS, sleep quality/refreshing nature of sleep on a visual analog scale, sleep paralysis and hypnagogic hallucinations on a sleep symptoms diary, disturbed nocturnal sleep on polysomnographic measures, and number of arousals as defined per the American Academy of Sleep Medicine Score Manual.
Reports of adverse events (AEs) were collected from time of informed consent until 7 days after the last dose received.
Improvement across doses
Results showed that, compared with placebo, improvement in disturbed nocturnal sleep from baseline was significantly greater for the active treatment at 6 g at week 3 (mean between-group difference, –11; P < .001), at 7.5 g at week 8 (mean difference, –17.7; P < .001), and at 9 g at week 13 (mean difference, –22.6; P < .001).
The mean difference between the three doses and placebo for reduction in number of arousals was –11.3 (P < .05), –19.4 (P < .001), and –23.7 (P < .001), respectively. And the 6 g at week 3, 7.5 g at week 8, and 9 g at week 13 doses showed significant (P < .001) improvements versus placebo on the ESS (mean difference, –2.1, –3.2, and –3.9, respectively).
All three doses also showed significant improvement in sleep quality and refreshing nature of sleep (P < .001 for all comparisons), as well as improvement of sleep paralysis (P = .04, P = .02, and P = .04, respectively).
There were no significant differences between FT218 and placebo for improvement in hypnagogic hallucinations. Dr. Thorpy noted that the number of patients with baseline hallucinations “was relatively small,” which may have led to this finding. “Had there been a much larger population with hallucinations, I suspect that we would have seen a statistically significant improvement there as well,” he said.
Generally well tolerated
The investigators noted that FT218 was “generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions.”
Treatment-related AEs that occurred in more than 2% of the patients receiving FT218 included nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.
Seven serious AEs were reported, including five in those assigned to the active treatment. This included one case each of diabetes inadequate control, paresthesia, perirectal abscess, hypertension, and suicidal ideation. Only the case of suicidal ideation was considered to be a treatment-related AE.
The investigators noted that, although they have not yet delved into subgroup analysis to look for differences among sex, age, or race, they plan to do so in the future.
Overall, the results indicate that “FT218 is an effective agent not only for the major symptoms of sleepiness and cataplexy, but also the quality of sleep at night,” said Dr. Thorpy.
Asked whether he thinks the FDA will approve the drug, he said that it should be “straightforward” because it’s just a different formulation of an already-approved agent. “I very much expect there will not be any problems in this medication being approved,” Dr. Thorpy said.
Benefits ‘sleep architecture’
Commenting on the findings, Logan Schneider, MD, codirector of the Stanford/VA Alzheimer’s Center and clinical assistant professor at the Stanford Sleep Center, Redwood City, Calif., said that the investigators’ focus on these secondary outcomes “was really worthwhile.”
Dr. Schneider, who was not involved in the research, noted that, because the study only included patients with narcolepsy, the results can’t be extrapolated to groups who have other sleep disorders.
Still, “it is worthwhile now to expand beyond the two primary symptoms that are, in my consideration, life threatening: daytime sleepiness and cataplexy. We should also address more of the quality of life and other aspects of narcolepsy, including disturbed nocturnal sleep and sleep quality issues related to that,” he said.
“Being able to address those aspects and say, ‘I have a therapy that clearly helps the multidimensionality of our patients’ is very vindicating,” Dr. Schneider noted.
He was also impressed with the various measures the researchers used, rather than relying just on patient reports, “which are subject to recollection difficulties. This was a nice way to quantify possibly as a diagnostic marker the underlying disruption of sleep, as well as a possible treatment marker to show how well a therapy works.”
“It actually shows a beneficial effect on sleep architecture,” Dr. Schneider said.
The study was funded by Avadel Pharmaceuticals. Dr. Thorpy is a consultant/advisory board member for Avadel, Axsome, Balance Therapeutics, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences, and Takeda Pharmaceutical. Dr. Schneider reports being an adviser and/or on the speakers’ bureau for similar drugs by Jazz Pharmaceuticals and Harmony Biosciences.
A version of this article first appeared on Medscape.com.
, new research suggests. Top-line results from the phase 3 REST-ON trial released earlier this year showed that the agent known as FT218 (Avadel Pharmaceuticals) met all three of its coprimary efficacy endpoints at all three doses assessed (6 g, 7.5 g, and 9 g). Patients receiving the drug showed significantly greater improvements on the Maintenance of Wakefulness Test (MWT), the Clinical Global Impression of Improvement (CGI-I), and mean weekly attacks of cataplexy, compared with those who received placebo.
The new analyses, which focused on key secondary outcomes, showed that all three doses of the novel agent were associated with significant improvements in sleep quality, refreshing nature of sleep, sleep paralysis, disturbed nocturnal sleep, and scores on the Epworth Sleepiness Scale (ESS).
Principal investigator Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, New York, said in a news release that the results represent “the promise of a potential new treatment strategy for physicians and patients.”
“I am particularly impressed by the consistency of results as early as 3 weeks with only a 6-g dose,” he added.
Dr. Thorpy, who is also a professor of neurology at the Albert Einstein College of Medicine, noted that the new formulation will be more convenient for patients. “The advantage of this medication is its once-nightly formulation, so patients don’t need to awaken during the night and can actually have a better night’s sleep,” he said.
Dr. Thorpy presented the study findings at the 2021 annual meeting of the American Academy of Neurology.
FT218 is currently under review by the U.S. Food and Drug Administration, which has set Oct. 15 as the Prescription Drug User Fee Act target date.
Forced awakening
Sodium oxybate was first approved by the FDA in 2002 to treat cataplexy in adults with narcolepsy and was expanded in 2005 to also treat excessive daytime sleepiness (EDS). That formulation is indicated for twice-nightly administration, with the second dose taken 2.5-4 hours after the first.
“The need for forced awakening to take the second dose ... may result in noncompliance, which may lead to reduced efficacy and/or mistimed doses,” the investigators noted.
FT218 is a modified-release version of sodium oxybate. A single 6-g dose of the investigational agent “has shown bioequivalent exposure to twice-nightly immediate-release [sodium oxybate] given as two 3-g doses,” wrote the researchers.
It also currently has Orphan Drug Designation from the FDA for the treatment of narcolepsy.
The randomized, double-blind, placebo-controlled, multicenter REST-ON study was conducted from November 2016 to March 2020 and included patients 16 years or older who had narcolepsy type 1 or type 2.
Patients received the active treatment (n = 107; mean age, 30.9 years; 64.5% women) or placebo (n = 105; mean age, 31.6 years; 71.4% women) according to a four-period forced uptitration dosing schedule of 4.5 g for 1 week, 6 g for 2 weeks, 7.5 g for 5 weeks, and 9 g for 5 weeks.
Secondary outcome measures included the ESS, sleep quality/refreshing nature of sleep on a visual analog scale, sleep paralysis and hypnagogic hallucinations on a sleep symptoms diary, disturbed nocturnal sleep on polysomnographic measures, and number of arousals as defined per the American Academy of Sleep Medicine Score Manual.
Reports of adverse events (AEs) were collected from time of informed consent until 7 days after the last dose received.
Improvement across doses
Results showed that, compared with placebo, improvement in disturbed nocturnal sleep from baseline was significantly greater for the active treatment at 6 g at week 3 (mean between-group difference, –11; P < .001), at 7.5 g at week 8 (mean difference, –17.7; P < .001), and at 9 g at week 13 (mean difference, –22.6; P < .001).
The mean difference between the three doses and placebo for reduction in number of arousals was –11.3 (P < .05), –19.4 (P < .001), and –23.7 (P < .001), respectively. And the 6 g at week 3, 7.5 g at week 8, and 9 g at week 13 doses showed significant (P < .001) improvements versus placebo on the ESS (mean difference, –2.1, –3.2, and –3.9, respectively).
All three doses also showed significant improvement in sleep quality and refreshing nature of sleep (P < .001 for all comparisons), as well as improvement of sleep paralysis (P = .04, P = .02, and P = .04, respectively).
There were no significant differences between FT218 and placebo for improvement in hypnagogic hallucinations. Dr. Thorpy noted that the number of patients with baseline hallucinations “was relatively small,” which may have led to this finding. “Had there been a much larger population with hallucinations, I suspect that we would have seen a statistically significant improvement there as well,” he said.
Generally well tolerated
The investigators noted that FT218 was “generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions.”
Treatment-related AEs that occurred in more than 2% of the patients receiving FT218 included nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.
Seven serious AEs were reported, including five in those assigned to the active treatment. This included one case each of diabetes inadequate control, paresthesia, perirectal abscess, hypertension, and suicidal ideation. Only the case of suicidal ideation was considered to be a treatment-related AE.
The investigators noted that, although they have not yet delved into subgroup analysis to look for differences among sex, age, or race, they plan to do so in the future.
Overall, the results indicate that “FT218 is an effective agent not only for the major symptoms of sleepiness and cataplexy, but also the quality of sleep at night,” said Dr. Thorpy.
Asked whether he thinks the FDA will approve the drug, he said that it should be “straightforward” because it’s just a different formulation of an already-approved agent. “I very much expect there will not be any problems in this medication being approved,” Dr. Thorpy said.
Benefits ‘sleep architecture’
Commenting on the findings, Logan Schneider, MD, codirector of the Stanford/VA Alzheimer’s Center and clinical assistant professor at the Stanford Sleep Center, Redwood City, Calif., said that the investigators’ focus on these secondary outcomes “was really worthwhile.”
Dr. Schneider, who was not involved in the research, noted that, because the study only included patients with narcolepsy, the results can’t be extrapolated to groups who have other sleep disorders.
Still, “it is worthwhile now to expand beyond the two primary symptoms that are, in my consideration, life threatening: daytime sleepiness and cataplexy. We should also address more of the quality of life and other aspects of narcolepsy, including disturbed nocturnal sleep and sleep quality issues related to that,” he said.
“Being able to address those aspects and say, ‘I have a therapy that clearly helps the multidimensionality of our patients’ is very vindicating,” Dr. Schneider noted.
He was also impressed with the various measures the researchers used, rather than relying just on patient reports, “which are subject to recollection difficulties. This was a nice way to quantify possibly as a diagnostic marker the underlying disruption of sleep, as well as a possible treatment marker to show how well a therapy works.”
“It actually shows a beneficial effect on sleep architecture,” Dr. Schneider said.
The study was funded by Avadel Pharmaceuticals. Dr. Thorpy is a consultant/advisory board member for Avadel, Axsome, Balance Therapeutics, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences, and Takeda Pharmaceutical. Dr. Schneider reports being an adviser and/or on the speakers’ bureau for similar drugs by Jazz Pharmaceuticals and Harmony Biosciences.
A version of this article first appeared on Medscape.com.
FROM AAN 2021
Structural racism tied to psychosis risk in Black people
Social and economic disparities are linked to an increased risk for psychosis in Black and Latino communities, new research shows.
Results of a literature review of social and economic disparities in mental illness suggest that “structural racism” contributes to social and environmental conditions that affect psychosis risk.
“Black and Latino people suffer disproportionately from psychosis risk factors, at the neighborhood level and at the individual level, in large part as a result of structural racism,” study investigator Deidre M. Anglin, PhD, associate professor, department of psychology, City College of New York (N.Y.), told reporters attending a press briefing.
The social environment, which, for minorities, involves disadvantage and discrimination, may account for this increased psychosis risk, perhaps even more so than genetics, she said. Structural racism “is a critical public health threat,” Dr. Anglin added.
The findings were presented at the virtual American Psychiatric Association annual meeting and were simultaneously published online May 3 in The American Journal of Psychiatry.
Perpetual disadvantage
Dr. Anglin and colleagues examined U.S.-based evidence connecting characteristics of social environments with outcomes across the psychosis continuum – from psychotic experiences to schizophrenia.
Citing numerous studies, the researchers highlighted three key areas that reflect social and environmental conditions that may affect psychosis risk, and that disproportionately affect minorities. These were neighborhood factors, trauma in a U.S. context, and racial disparities during the prenatal and perinatal periods.
The data that were related to neighborhoods revealed “just how much racism has historically structured U.S. neighborhoods in ways that generationally perpetuate disadvantage for racially minoritized communities,” said Dr. Anglin.
“This happens through inequitable access to resources, such as health care, clean air, education, [and] employment, but also in terms of disproportionate exposure to environmental toxins and stressors,” she said.
These neighborhood factors are associated with cumulative stress that may be linked to heightened risk for psychosis, the investigators noted.
U.S. studies show that rates of adverse childhood experiences, such as abuse and emotional and physical neglect, are higher among racial and ethnic minorities.
Police victimization and gun violence disproportionately affect racial minorities and create what the investigators call “a unique type of collective trauma” in the United States. They note that Black men have a 1 in 1,000 chance of being victims of lethal force by police over their lifetimes. By comparison, White men have a 39 in 100,000 chance.
One study of a diverse sample from four large U.S. urban centers showed that those who self-reported different types of police victimization were more likely to report psychotic experiences. Another study showed that greater exposure to gun violence fatalities, regardless of police involvement, was positively associated with psychotic experiences.
Obstetric complications
A variety of obstetric complications, including infection, maternal inflammation, and stress, have been associated with increased risk for psychotic disorders in U.S. samples.
“What we saw emerge from the literature is that Black women in the U.S. are at substantially increased risk for many of these obstetrical complications compared to White women, and this is not necessarily explained by socioeconomic status,” said Dr. Anglin.
Neighborhood- and individual-level factors appear to affect the disparity in these outcomes. A recent study revealed that exposure to environmental contaminants such as air pollution is associated with higher rates of preterm birth and low birth weight differentially in Black mothers compared with other mothers, “possibly as a result of an interaction between prenatal stress and contaminants,” the investigators noted.
Research also indicates that Black women are more likely to have lower levels of cortisol during the second trimester of pregnancy compared with women of other racial and ethnic groups. Cortisol is essential for fetal growth. Evidence links lower cortisol levels in later stages of pregnancy with decreased fetal growth in individuals who develop schizophrenia.
, compared with White women of the same socioeconomic status.
Such findings “highlight a complex picture” involving maternal cortisol levels and other stress biomarkers, “potentially leading to poor birth outcomes and subsequent risk for psychotic disorders in adulthood,” the investigators noted.
The researchers call for the dismantling of structural racism and the social policies and norms it shapes. They also recommend changes in health care policy and in the approach to early intervention for psychosis among Black and other racially-minoritized groups.
“Altogether, the current evidence suggests the need to identify, address, and tackle the social determinants deeply ingrained in U.S. society, in tandem with empowering the most marginalized communities,” the researchers wrote.
“We recommend that the field of psychiatry devote considerably more effort to addressing structural racism and social determinants of psychosis in funding priorities, training, and intervention development,” they added.
Dr. Anglin suggests that mental health providers use what she called a “cultural formulation interview” that takes a person’s environmental and social context into consideration. Studies show that incorporating this into clinical practice helps reduce misdiagnosis of mental illness in Black populations, she said.
Call to action
Commenting on the findings in an interview, Ned H. Kalin, MD, editor of The American Journal of Psychiatry and professor and chair of the department of psychiatry, University of Wisconsin, Madison, said the study was well done and serves as a “call to action” to address the impact of structural racism on mental health issues and psychiatric diseases.
The article highlights the need for “collecting better data” on structural racism, said Dr. Kalin. “We know it’s a big issue, but we can’t even quantitate it, so we need some fundamental measures to use as a benchmark as we move forward, as we try to make change.”
He noted that racism “is so embedded in one’s experience and in our society that we sort of don’t even think about it as a trauma.”
In psychiatry, for example, trauma is often thought of as a loss or a traumatic event. “We don’t typically think of trauma as an experience that pervades one’s entire life,” but that needs to change, he said. “At the individual level and in the doctor’s office, being sensitive to and aware of these issues is absolutely critical.”
Dr. Anglin and Dr. Kalin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Social and economic disparities are linked to an increased risk for psychosis in Black and Latino communities, new research shows.
Results of a literature review of social and economic disparities in mental illness suggest that “structural racism” contributes to social and environmental conditions that affect psychosis risk.
“Black and Latino people suffer disproportionately from psychosis risk factors, at the neighborhood level and at the individual level, in large part as a result of structural racism,” study investigator Deidre M. Anglin, PhD, associate professor, department of psychology, City College of New York (N.Y.), told reporters attending a press briefing.
The social environment, which, for minorities, involves disadvantage and discrimination, may account for this increased psychosis risk, perhaps even more so than genetics, she said. Structural racism “is a critical public health threat,” Dr. Anglin added.
The findings were presented at the virtual American Psychiatric Association annual meeting and were simultaneously published online May 3 in The American Journal of Psychiatry.
Perpetual disadvantage
Dr. Anglin and colleagues examined U.S.-based evidence connecting characteristics of social environments with outcomes across the psychosis continuum – from psychotic experiences to schizophrenia.
Citing numerous studies, the researchers highlighted three key areas that reflect social and environmental conditions that may affect psychosis risk, and that disproportionately affect minorities. These were neighborhood factors, trauma in a U.S. context, and racial disparities during the prenatal and perinatal periods.
The data that were related to neighborhoods revealed “just how much racism has historically structured U.S. neighborhoods in ways that generationally perpetuate disadvantage for racially minoritized communities,” said Dr. Anglin.
“This happens through inequitable access to resources, such as health care, clean air, education, [and] employment, but also in terms of disproportionate exposure to environmental toxins and stressors,” she said.
These neighborhood factors are associated with cumulative stress that may be linked to heightened risk for psychosis, the investigators noted.
U.S. studies show that rates of adverse childhood experiences, such as abuse and emotional and physical neglect, are higher among racial and ethnic minorities.
Police victimization and gun violence disproportionately affect racial minorities and create what the investigators call “a unique type of collective trauma” in the United States. They note that Black men have a 1 in 1,000 chance of being victims of lethal force by police over their lifetimes. By comparison, White men have a 39 in 100,000 chance.
One study of a diverse sample from four large U.S. urban centers showed that those who self-reported different types of police victimization were more likely to report psychotic experiences. Another study showed that greater exposure to gun violence fatalities, regardless of police involvement, was positively associated with psychotic experiences.
Obstetric complications
A variety of obstetric complications, including infection, maternal inflammation, and stress, have been associated with increased risk for psychotic disorders in U.S. samples.
“What we saw emerge from the literature is that Black women in the U.S. are at substantially increased risk for many of these obstetrical complications compared to White women, and this is not necessarily explained by socioeconomic status,” said Dr. Anglin.
Neighborhood- and individual-level factors appear to affect the disparity in these outcomes. A recent study revealed that exposure to environmental contaminants such as air pollution is associated with higher rates of preterm birth and low birth weight differentially in Black mothers compared with other mothers, “possibly as a result of an interaction between prenatal stress and contaminants,” the investigators noted.
Research also indicates that Black women are more likely to have lower levels of cortisol during the second trimester of pregnancy compared with women of other racial and ethnic groups. Cortisol is essential for fetal growth. Evidence links lower cortisol levels in later stages of pregnancy with decreased fetal growth in individuals who develop schizophrenia.
, compared with White women of the same socioeconomic status.
Such findings “highlight a complex picture” involving maternal cortisol levels and other stress biomarkers, “potentially leading to poor birth outcomes and subsequent risk for psychotic disorders in adulthood,” the investigators noted.
The researchers call for the dismantling of structural racism and the social policies and norms it shapes. They also recommend changes in health care policy and in the approach to early intervention for psychosis among Black and other racially-minoritized groups.
“Altogether, the current evidence suggests the need to identify, address, and tackle the social determinants deeply ingrained in U.S. society, in tandem with empowering the most marginalized communities,” the researchers wrote.
“We recommend that the field of psychiatry devote considerably more effort to addressing structural racism and social determinants of psychosis in funding priorities, training, and intervention development,” they added.
Dr. Anglin suggests that mental health providers use what she called a “cultural formulation interview” that takes a person’s environmental and social context into consideration. Studies show that incorporating this into clinical practice helps reduce misdiagnosis of mental illness in Black populations, she said.
Call to action
Commenting on the findings in an interview, Ned H. Kalin, MD, editor of The American Journal of Psychiatry and professor and chair of the department of psychiatry, University of Wisconsin, Madison, said the study was well done and serves as a “call to action” to address the impact of structural racism on mental health issues and psychiatric diseases.
The article highlights the need for “collecting better data” on structural racism, said Dr. Kalin. “We know it’s a big issue, but we can’t even quantitate it, so we need some fundamental measures to use as a benchmark as we move forward, as we try to make change.”
He noted that racism “is so embedded in one’s experience and in our society that we sort of don’t even think about it as a trauma.”
In psychiatry, for example, trauma is often thought of as a loss or a traumatic event. “We don’t typically think of trauma as an experience that pervades one’s entire life,” but that needs to change, he said. “At the individual level and in the doctor’s office, being sensitive to and aware of these issues is absolutely critical.”
Dr. Anglin and Dr. Kalin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Social and economic disparities are linked to an increased risk for psychosis in Black and Latino communities, new research shows.
Results of a literature review of social and economic disparities in mental illness suggest that “structural racism” contributes to social and environmental conditions that affect psychosis risk.
“Black and Latino people suffer disproportionately from psychosis risk factors, at the neighborhood level and at the individual level, in large part as a result of structural racism,” study investigator Deidre M. Anglin, PhD, associate professor, department of psychology, City College of New York (N.Y.), told reporters attending a press briefing.
The social environment, which, for minorities, involves disadvantage and discrimination, may account for this increased psychosis risk, perhaps even more so than genetics, she said. Structural racism “is a critical public health threat,” Dr. Anglin added.
The findings were presented at the virtual American Psychiatric Association annual meeting and were simultaneously published online May 3 in The American Journal of Psychiatry.
Perpetual disadvantage
Dr. Anglin and colleagues examined U.S.-based evidence connecting characteristics of social environments with outcomes across the psychosis continuum – from psychotic experiences to schizophrenia.
Citing numerous studies, the researchers highlighted three key areas that reflect social and environmental conditions that may affect psychosis risk, and that disproportionately affect minorities. These were neighborhood factors, trauma in a U.S. context, and racial disparities during the prenatal and perinatal periods.
The data that were related to neighborhoods revealed “just how much racism has historically structured U.S. neighborhoods in ways that generationally perpetuate disadvantage for racially minoritized communities,” said Dr. Anglin.
“This happens through inequitable access to resources, such as health care, clean air, education, [and] employment, but also in terms of disproportionate exposure to environmental toxins and stressors,” she said.
These neighborhood factors are associated with cumulative stress that may be linked to heightened risk for psychosis, the investigators noted.
U.S. studies show that rates of adverse childhood experiences, such as abuse and emotional and physical neglect, are higher among racial and ethnic minorities.
Police victimization and gun violence disproportionately affect racial minorities and create what the investigators call “a unique type of collective trauma” in the United States. They note that Black men have a 1 in 1,000 chance of being victims of lethal force by police over their lifetimes. By comparison, White men have a 39 in 100,000 chance.
One study of a diverse sample from four large U.S. urban centers showed that those who self-reported different types of police victimization were more likely to report psychotic experiences. Another study showed that greater exposure to gun violence fatalities, regardless of police involvement, was positively associated with psychotic experiences.
Obstetric complications
A variety of obstetric complications, including infection, maternal inflammation, and stress, have been associated with increased risk for psychotic disorders in U.S. samples.
“What we saw emerge from the literature is that Black women in the U.S. are at substantially increased risk for many of these obstetrical complications compared to White women, and this is not necessarily explained by socioeconomic status,” said Dr. Anglin.
Neighborhood- and individual-level factors appear to affect the disparity in these outcomes. A recent study revealed that exposure to environmental contaminants such as air pollution is associated with higher rates of preterm birth and low birth weight differentially in Black mothers compared with other mothers, “possibly as a result of an interaction between prenatal stress and contaminants,” the investigators noted.
Research also indicates that Black women are more likely to have lower levels of cortisol during the second trimester of pregnancy compared with women of other racial and ethnic groups. Cortisol is essential for fetal growth. Evidence links lower cortisol levels in later stages of pregnancy with decreased fetal growth in individuals who develop schizophrenia.
, compared with White women of the same socioeconomic status.
Such findings “highlight a complex picture” involving maternal cortisol levels and other stress biomarkers, “potentially leading to poor birth outcomes and subsequent risk for psychotic disorders in adulthood,” the investigators noted.
The researchers call for the dismantling of structural racism and the social policies and norms it shapes. They also recommend changes in health care policy and in the approach to early intervention for psychosis among Black and other racially-minoritized groups.
“Altogether, the current evidence suggests the need to identify, address, and tackle the social determinants deeply ingrained in U.S. society, in tandem with empowering the most marginalized communities,” the researchers wrote.
“We recommend that the field of psychiatry devote considerably more effort to addressing structural racism and social determinants of psychosis in funding priorities, training, and intervention development,” they added.
Dr. Anglin suggests that mental health providers use what she called a “cultural formulation interview” that takes a person’s environmental and social context into consideration. Studies show that incorporating this into clinical practice helps reduce misdiagnosis of mental illness in Black populations, she said.
Call to action
Commenting on the findings in an interview, Ned H. Kalin, MD, editor of The American Journal of Psychiatry and professor and chair of the department of psychiatry, University of Wisconsin, Madison, said the study was well done and serves as a “call to action” to address the impact of structural racism on mental health issues and psychiatric diseases.
The article highlights the need for “collecting better data” on structural racism, said Dr. Kalin. “We know it’s a big issue, but we can’t even quantitate it, so we need some fundamental measures to use as a benchmark as we move forward, as we try to make change.”
He noted that racism “is so embedded in one’s experience and in our society that we sort of don’t even think about it as a trauma.”
In psychiatry, for example, trauma is often thought of as a loss or a traumatic event. “We don’t typically think of trauma as an experience that pervades one’s entire life,” but that needs to change, he said. “At the individual level and in the doctor’s office, being sensitive to and aware of these issues is absolutely critical.”
Dr. Anglin and Dr. Kalin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Genital skin exams in girls: Conduct with care, look for signs of abuse
at the American Academy of Dermatology Virtual Meeting Experience.
“One in four adult women report being childhood victims of sexual abuse, which is just a staggering number. This is an opportunity for us to identify these patients early and give them the terminology to be able to report what is happening to them,” said pediatric dermatologist Kalyani Marathe, MD, MPH, director of the division of dermatology at Cincinnati Children’s Hospital. “We also have the chance to give them a sense of agency over their bodies.”
Dr. Marathe offered the following recommendations when performing a genital skin exam:
- Make sure a “chaperone” is present. “Chaperones are a must when you’re examining children and teens,” she said. “Ask whom they prefer. For prepubertal children, you’re going to usually use the parent who’s there with them. If the parent is their father, they might ask him to step behind the curtain, in which case you can bring over your nurse or medical assistant.” Teens may ask either parent to step out of the room, she said. In that case, a nurse, medical assistant, resident, or trainee can fill in. “If you have male residents or trainees with you and the patient really does not want to be examined by a male, honor their request. Do not force them.”
- Explain why the exam is being performed. Make sure the patient understands why she is being seen, Dr. Marathe advised. For example, say something like “your pediatrician told us that you have an itchy area” or “your mom told us that there’s some loss of color in that area, that you’re having a problem there.” She added that it’s helpful to explain the type of doctor you are, with a comment such as the following: “We’re examining you because we’re doctors who specialize in skin. ... We want to help you feel better and make sure that your skin heals and is healthy.”
- Ask both the child and the parent for permission to perform the exam. While this may seem trivial, “it’s very, very important in setting the right tone for the encounter,” she said. “If the child says yes, we turn to the mom and say: ‘Mom, is it okay for us to do this exam today?’ You can see visible relief on the part of the parent, and as the parent relaxes, the child relaxes. Just saying those few things really makes the encounter so much smoother.” However, “if they say no, you have to honor the response. ... You say: ‘Okay, we’re not going to do the exam today,” and see the patient in a few weeks. If it’s urgent, an exam under anesthesia may be an option, she added.
- Talk to the child about the terms they use for private parts. It can be helpful to ask: “Do you have any terms for your private area?” According to Dr. Marathe, “this is a good chance to educate them on the terms vulva and vagina since they may be using other terminology. Making sure that they have the correct terms will actually help patients identify and report abuse earlier.” Dr. Marathe recalled that a colleague had a patient who’d been calling her private area “pound cake” and had been “reporting to her teacher that someone had been touching her ‘pound cake.’ Her teacher did not know what she meant by that, and this led to a great delay in her childhood abuse being reported.”
- Talk about what will happen during the exam. “I like to show them any instruments that we’re going to be using,” Dr. Marathe said. “If we’re using a flashlight, for example, I like to show them a picture [of a flashlight] or show them that flashlight. If we’re using a camera to do digital photography, show them that. If we’re going to be using a Q-tip or a swab to demonstrate anything or to take a culture, I like to show them that beforehand to make sure that they know what we’re doing.” In regard to photography, “make sure the parent and child know where the photos are going to go, who’s going to see them, what are they going to be used for. If they’re going to be used for educational purposes, make sure they have given explicit permission for that and they know they’ll be deidentified.”
- Make it clear that the exam won’t be painful. It’s important to put both the patient and the parent at ease on this front, Dr. Marathe said. “A lot of parents are concerned that we’re going to do a speculum exam in their prepubertal child. So make sure that it’s clarified ahead of time that we’re not going to be doing a speculum exam.”
Commenting on this topic, Tor Shwayder, MD, a pediatric dermatologist at Henry Ford Health System, Detroit, urged colleagues to take action if they feel suspicious about a possible sign of child abuse, even if they’re far from certain that anything is wrong. “Don’t ignore those feelings in the back of the brain,” he said in an interview.
Most states have child-abuse hotlines for medical professionals, and major hospitals will have child-abuse teams, Dr. Shwayder said. He urged dermatologists to take advantage of these resources when appropriate. “The professionals on the other side of the 800 number or at the hospital will help you. You don’t have to decide immediately whether this is child abuse. You just need to have a suspicion.”
Dr. Marathe and Dr. Shwayder report no disclosures.
at the American Academy of Dermatology Virtual Meeting Experience.
“One in four adult women report being childhood victims of sexual abuse, which is just a staggering number. This is an opportunity for us to identify these patients early and give them the terminology to be able to report what is happening to them,” said pediatric dermatologist Kalyani Marathe, MD, MPH, director of the division of dermatology at Cincinnati Children’s Hospital. “We also have the chance to give them a sense of agency over their bodies.”
Dr. Marathe offered the following recommendations when performing a genital skin exam:
- Make sure a “chaperone” is present. “Chaperones are a must when you’re examining children and teens,” she said. “Ask whom they prefer. For prepubertal children, you’re going to usually use the parent who’s there with them. If the parent is their father, they might ask him to step behind the curtain, in which case you can bring over your nurse or medical assistant.” Teens may ask either parent to step out of the room, she said. In that case, a nurse, medical assistant, resident, or trainee can fill in. “If you have male residents or trainees with you and the patient really does not want to be examined by a male, honor their request. Do not force them.”
- Explain why the exam is being performed. Make sure the patient understands why she is being seen, Dr. Marathe advised. For example, say something like “your pediatrician told us that you have an itchy area” or “your mom told us that there’s some loss of color in that area, that you’re having a problem there.” She added that it’s helpful to explain the type of doctor you are, with a comment such as the following: “We’re examining you because we’re doctors who specialize in skin. ... We want to help you feel better and make sure that your skin heals and is healthy.”
- Ask both the child and the parent for permission to perform the exam. While this may seem trivial, “it’s very, very important in setting the right tone for the encounter,” she said. “If the child says yes, we turn to the mom and say: ‘Mom, is it okay for us to do this exam today?’ You can see visible relief on the part of the parent, and as the parent relaxes, the child relaxes. Just saying those few things really makes the encounter so much smoother.” However, “if they say no, you have to honor the response. ... You say: ‘Okay, we’re not going to do the exam today,” and see the patient in a few weeks. If it’s urgent, an exam under anesthesia may be an option, she added.
- Talk to the child about the terms they use for private parts. It can be helpful to ask: “Do you have any terms for your private area?” According to Dr. Marathe, “this is a good chance to educate them on the terms vulva and vagina since they may be using other terminology. Making sure that they have the correct terms will actually help patients identify and report abuse earlier.” Dr. Marathe recalled that a colleague had a patient who’d been calling her private area “pound cake” and had been “reporting to her teacher that someone had been touching her ‘pound cake.’ Her teacher did not know what she meant by that, and this led to a great delay in her childhood abuse being reported.”
- Talk about what will happen during the exam. “I like to show them any instruments that we’re going to be using,” Dr. Marathe said. “If we’re using a flashlight, for example, I like to show them a picture [of a flashlight] or show them that flashlight. If we’re using a camera to do digital photography, show them that. If we’re going to be using a Q-tip or a swab to demonstrate anything or to take a culture, I like to show them that beforehand to make sure that they know what we’re doing.” In regard to photography, “make sure the parent and child know where the photos are going to go, who’s going to see them, what are they going to be used for. If they’re going to be used for educational purposes, make sure they have given explicit permission for that and they know they’ll be deidentified.”
- Make it clear that the exam won’t be painful. It’s important to put both the patient and the parent at ease on this front, Dr. Marathe said. “A lot of parents are concerned that we’re going to do a speculum exam in their prepubertal child. So make sure that it’s clarified ahead of time that we’re not going to be doing a speculum exam.”
Commenting on this topic, Tor Shwayder, MD, a pediatric dermatologist at Henry Ford Health System, Detroit, urged colleagues to take action if they feel suspicious about a possible sign of child abuse, even if they’re far from certain that anything is wrong. “Don’t ignore those feelings in the back of the brain,” he said in an interview.
Most states have child-abuse hotlines for medical professionals, and major hospitals will have child-abuse teams, Dr. Shwayder said. He urged dermatologists to take advantage of these resources when appropriate. “The professionals on the other side of the 800 number or at the hospital will help you. You don’t have to decide immediately whether this is child abuse. You just need to have a suspicion.”
Dr. Marathe and Dr. Shwayder report no disclosures.
at the American Academy of Dermatology Virtual Meeting Experience.
“One in four adult women report being childhood victims of sexual abuse, which is just a staggering number. This is an opportunity for us to identify these patients early and give them the terminology to be able to report what is happening to them,” said pediatric dermatologist Kalyani Marathe, MD, MPH, director of the division of dermatology at Cincinnati Children’s Hospital. “We also have the chance to give them a sense of agency over their bodies.”
Dr. Marathe offered the following recommendations when performing a genital skin exam:
- Make sure a “chaperone” is present. “Chaperones are a must when you’re examining children and teens,” she said. “Ask whom they prefer. For prepubertal children, you’re going to usually use the parent who’s there with them. If the parent is their father, they might ask him to step behind the curtain, in which case you can bring over your nurse or medical assistant.” Teens may ask either parent to step out of the room, she said. In that case, a nurse, medical assistant, resident, or trainee can fill in. “If you have male residents or trainees with you and the patient really does not want to be examined by a male, honor their request. Do not force them.”
- Explain why the exam is being performed. Make sure the patient understands why she is being seen, Dr. Marathe advised. For example, say something like “your pediatrician told us that you have an itchy area” or “your mom told us that there’s some loss of color in that area, that you’re having a problem there.” She added that it’s helpful to explain the type of doctor you are, with a comment such as the following: “We’re examining you because we’re doctors who specialize in skin. ... We want to help you feel better and make sure that your skin heals and is healthy.”
- Ask both the child and the parent for permission to perform the exam. While this may seem trivial, “it’s very, very important in setting the right tone for the encounter,” she said. “If the child says yes, we turn to the mom and say: ‘Mom, is it okay for us to do this exam today?’ You can see visible relief on the part of the parent, and as the parent relaxes, the child relaxes. Just saying those few things really makes the encounter so much smoother.” However, “if they say no, you have to honor the response. ... You say: ‘Okay, we’re not going to do the exam today,” and see the patient in a few weeks. If it’s urgent, an exam under anesthesia may be an option, she added.
- Talk to the child about the terms they use for private parts. It can be helpful to ask: “Do you have any terms for your private area?” According to Dr. Marathe, “this is a good chance to educate them on the terms vulva and vagina since they may be using other terminology. Making sure that they have the correct terms will actually help patients identify and report abuse earlier.” Dr. Marathe recalled that a colleague had a patient who’d been calling her private area “pound cake” and had been “reporting to her teacher that someone had been touching her ‘pound cake.’ Her teacher did not know what she meant by that, and this led to a great delay in her childhood abuse being reported.”
- Talk about what will happen during the exam. “I like to show them any instruments that we’re going to be using,” Dr. Marathe said. “If we’re using a flashlight, for example, I like to show them a picture [of a flashlight] or show them that flashlight. If we’re using a camera to do digital photography, show them that. If we’re going to be using a Q-tip or a swab to demonstrate anything or to take a culture, I like to show them that beforehand to make sure that they know what we’re doing.” In regard to photography, “make sure the parent and child know where the photos are going to go, who’s going to see them, what are they going to be used for. If they’re going to be used for educational purposes, make sure they have given explicit permission for that and they know they’ll be deidentified.”
- Make it clear that the exam won’t be painful. It’s important to put both the patient and the parent at ease on this front, Dr. Marathe said. “A lot of parents are concerned that we’re going to do a speculum exam in their prepubertal child. So make sure that it’s clarified ahead of time that we’re not going to be doing a speculum exam.”
Commenting on this topic, Tor Shwayder, MD, a pediatric dermatologist at Henry Ford Health System, Detroit, urged colleagues to take action if they feel suspicious about a possible sign of child abuse, even if they’re far from certain that anything is wrong. “Don’t ignore those feelings in the back of the brain,” he said in an interview.
Most states have child-abuse hotlines for medical professionals, and major hospitals will have child-abuse teams, Dr. Shwayder said. He urged dermatologists to take advantage of these resources when appropriate. “The professionals on the other side of the 800 number or at the hospital will help you. You don’t have to decide immediately whether this is child abuse. You just need to have a suspicion.”
Dr. Marathe and Dr. Shwayder report no disclosures.
FROM AAD VMX 2021
Novel drug offers rapid relief from agitation in serious mental illness
An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.
The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Noninvasive option
Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.
“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.
The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).
Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.
Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).
PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).
Compared with placebo, and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.
The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.
All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
Nipping it in the bud
SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.
Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).
Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.
BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.
“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.
“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.
Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
Negotiation first, medication second
Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.
“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.
“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.
He also noted that patients in the SERENITY trials had moderate to severe acute agitation.
“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.
“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.
He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.
A version of this article first appeared on Medscape.com.
An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.
The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Noninvasive option
Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.
“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.
The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).
Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.
Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).
PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).
Compared with placebo, and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.
The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.
All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
Nipping it in the bud
SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.
Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).
Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.
BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.
“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.
“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.
Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
Negotiation first, medication second
Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.
“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.
“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.
He also noted that patients in the SERENITY trials had moderate to severe acute agitation.
“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.
“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.
He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.
A version of this article first appeared on Medscape.com.
An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.
The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Noninvasive option
Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.
“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.
The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).
Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.
Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).
PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).
Compared with placebo, and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.
The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.
All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
Nipping it in the bud
SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.
Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).
Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.
BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.
“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.
“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.
Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
Negotiation first, medication second
Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.
“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.
“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.
He also noted that patients in the SERENITY trials had moderate to severe acute agitation.
“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.
“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.
He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.
A version of this article first appeared on Medscape.com.
Rituximab’s serious infection risk in ANCA-vasculitis allayed by antibiotic use
The serious infection risk associated with rituximab treatment for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is high but can be offset by co-prescribing co-trimoxazole, data from a single-center, retrospective study reaffirm.
Over the course of a 3-year study period, 14 (28%) of 50 patients with AAV treated with rituximab experienced at latest one severe infection defined as a grade 3 or higher event. The incidence of severe infections was 15.4 per 100 person-years.
However, a lower rate of infections was seen in patients who had been co-prescribed co-trimoxazole (trimethoprim and sulfamethoxazole), Francesco Dernie, a fifth-year medical student at the University of Oxford (England), reported at the British Society for Rheumatology annual conference.
“In the case of rituximab, the depletion of B cells and associated immune suppression is a double-edged sword, allowing effective disease control, but also leaving the body vulnerable to opportunistic and severe infections,” Mr. Dernie said at the meeting.
Of the patients who developed a severe infection on rituximab, just 7% had been treated with co-trimoxazole. In comparison, 44% of those who did not get a severe infection had received co-trimoxazole. Multivariate analysis confirmed that co-trimoxazole use was an influencing factor, with an odds ratio (OR) of 0.096 (95% confidence interval, 0.009–0.996; P = .05).
Another finding was that patients with low immunoglobulin G levels (less than 6 g/L) were more likely to develop a severe infection than were those with higher IgG levels. Indeed, the OR for hypogammaglobulinemia and the risk for infection was 8.782 (95% CI, 1.19–64.6; P = .033).
“Our results support the monitoring of IgG levels to identify patients who may be more susceptible to infection, as well as the prescription of prophylactic co-trimoxazole to reduce overall severe infection risk,” Mr. Dernie and associates concluded in their abstract.
It’s a “really important message around co-trimoxazole,” observed Neil Basu, MBChB, a clinical senior lecturer and honorary consultant at the Institute of Infection, Immunity & Inflammation, University of Glasgow (Scotland).
“It still frustrates me when I see that patients haven’t received that while receiving rituximab. Of course, co-trimoxazole can have its problems,” said Dr. Basu, who was not involved in the study. “It’s not uncommon for patients to develop reactions or be intolerant to the drug.”
Raashid Luqmani, DM, a senior coauthor of the work and professor of rheumatology at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, said: “The tolerance of co-trimoxazole has been remarkably good in this cohort.” If there was a problem with using co-trimoxazole, then “our standard would be to go with trimethoprim alone as the next in line and follow that with inhaled pentamidine. So, it’s kind of following what we would all generally do,” Dr. Luqmani said.
These data add further support for coprescribing antibiotic treatment with rituximab, he suggested.
“Worry about infection, worry about it a lot; not just worry about it, do something about it,” Dr. Luqmani said, and co-trimoxazole “is probably an effective means to do something about it.”
Study details
To look at the characteristics of and risk factors for serious infections associated with rituximab use in AAV, Mr. Dernie and associates retrospectively examined the electronic records of patients who had been treated between August 2016 and August 2019. Follow-up was until August 2020.
Of the 50 patients identified, nearly half (48%) were men. The average age was 60 years, ranging from 25 to 90 years. Most (n = 36; 72%) patients had a diagnosis of granulomatosis with polyangiitis, while another 2 (4%) had microscopic polyangiitis, 1 (2%) had eosinophilic granulomatosis with polyangiitis, and 11 (22%) had an overlapping type of vasculitis or undefined AAV.
Of the 18 severe infection events recorded, most (56%) involved the respiratory tract. Less than one-third (28%) were sepsis or neutropenic sepsis events, and there was one case each (6%) of cellulitis, complicated urinary tract infection, and recurrent wound infection.
There were “small numbers of individual comorbidities that were not sufficient to enter into our regression analysis,” Mr. Dernie noted. “It’s likely that comorbid conditions such as COPD [chronic obstructive pulmonary disease] also contribute to an individual’s risk of developing severe infections, and thus should factor into their individualized management.”
Mr. Dernie acknowledged in discussion: “One of the limitations of the study was we just looked at patients in a time when they were receiving rituximab, so they may have historically been exposed to other treatment options.” However, he added, “they weren’t having any other major DMARDs or immunosuppressive treatments at the time.”
Dr. Luqmani observed: “If you look at Francesco’s data on the hypogammaglobulinemia at the start of rituximab, that probably gives you a good idea of just how immunosuppressed these patients were already before we got to this point.”
Dr. Luqmani added: “I suspect that’s in keeping with a lot of other centers that have started using rituximab an awful lot for patients who previously had episodes of vasculitis treated with other disease-modifying therapies, particularly cyclophosphamide.”
But for how long should co-trimoxazole be given after the last rituximab dose? asked the chair of the session, Richard Watts, DM, of Norwich (England) Medical School. These data are purely observational, so it’s not possible to say, Mr. Dernie noted: “The patients that we included as having co-trimoxazole seem to be on it more or less consistently, permanently,” he said.
What about the best dose? “It’s a tricky one,” Dr. Luqmani said, as “we not only use co-trimoxazole for prophylaxis, but we often also want to use it for treatment of the vasculitis itself.”
It’s very likely that there was a mix of patients in the analysis that had received co-trimoxazole as either a treatment or prophylaxis, which means different doses, he said.
“It might be interesting to know whether there was a difference” between doses used and the prevention of infection, added Dr. Luqmani, “but I suspect the numbers are too small to tell.”
Mr. Dernie, Dr. Luqmani, and the other coauthors had no disclosures.
The serious infection risk associated with rituximab treatment for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is high but can be offset by co-prescribing co-trimoxazole, data from a single-center, retrospective study reaffirm.
Over the course of a 3-year study period, 14 (28%) of 50 patients with AAV treated with rituximab experienced at latest one severe infection defined as a grade 3 or higher event. The incidence of severe infections was 15.4 per 100 person-years.
However, a lower rate of infections was seen in patients who had been co-prescribed co-trimoxazole (trimethoprim and sulfamethoxazole), Francesco Dernie, a fifth-year medical student at the University of Oxford (England), reported at the British Society for Rheumatology annual conference.
“In the case of rituximab, the depletion of B cells and associated immune suppression is a double-edged sword, allowing effective disease control, but also leaving the body vulnerable to opportunistic and severe infections,” Mr. Dernie said at the meeting.
Of the patients who developed a severe infection on rituximab, just 7% had been treated with co-trimoxazole. In comparison, 44% of those who did not get a severe infection had received co-trimoxazole. Multivariate analysis confirmed that co-trimoxazole use was an influencing factor, with an odds ratio (OR) of 0.096 (95% confidence interval, 0.009–0.996; P = .05).
Another finding was that patients with low immunoglobulin G levels (less than 6 g/L) were more likely to develop a severe infection than were those with higher IgG levels. Indeed, the OR for hypogammaglobulinemia and the risk for infection was 8.782 (95% CI, 1.19–64.6; P = .033).
“Our results support the monitoring of IgG levels to identify patients who may be more susceptible to infection, as well as the prescription of prophylactic co-trimoxazole to reduce overall severe infection risk,” Mr. Dernie and associates concluded in their abstract.
It’s a “really important message around co-trimoxazole,” observed Neil Basu, MBChB, a clinical senior lecturer and honorary consultant at the Institute of Infection, Immunity & Inflammation, University of Glasgow (Scotland).
“It still frustrates me when I see that patients haven’t received that while receiving rituximab. Of course, co-trimoxazole can have its problems,” said Dr. Basu, who was not involved in the study. “It’s not uncommon for patients to develop reactions or be intolerant to the drug.”
Raashid Luqmani, DM, a senior coauthor of the work and professor of rheumatology at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, said: “The tolerance of co-trimoxazole has been remarkably good in this cohort.” If there was a problem with using co-trimoxazole, then “our standard would be to go with trimethoprim alone as the next in line and follow that with inhaled pentamidine. So, it’s kind of following what we would all generally do,” Dr. Luqmani said.
These data add further support for coprescribing antibiotic treatment with rituximab, he suggested.
“Worry about infection, worry about it a lot; not just worry about it, do something about it,” Dr. Luqmani said, and co-trimoxazole “is probably an effective means to do something about it.”
Study details
To look at the characteristics of and risk factors for serious infections associated with rituximab use in AAV, Mr. Dernie and associates retrospectively examined the electronic records of patients who had been treated between August 2016 and August 2019. Follow-up was until August 2020.
Of the 50 patients identified, nearly half (48%) were men. The average age was 60 years, ranging from 25 to 90 years. Most (n = 36; 72%) patients had a diagnosis of granulomatosis with polyangiitis, while another 2 (4%) had microscopic polyangiitis, 1 (2%) had eosinophilic granulomatosis with polyangiitis, and 11 (22%) had an overlapping type of vasculitis or undefined AAV.
Of the 18 severe infection events recorded, most (56%) involved the respiratory tract. Less than one-third (28%) were sepsis or neutropenic sepsis events, and there was one case each (6%) of cellulitis, complicated urinary tract infection, and recurrent wound infection.
There were “small numbers of individual comorbidities that were not sufficient to enter into our regression analysis,” Mr. Dernie noted. “It’s likely that comorbid conditions such as COPD [chronic obstructive pulmonary disease] also contribute to an individual’s risk of developing severe infections, and thus should factor into their individualized management.”
Mr. Dernie acknowledged in discussion: “One of the limitations of the study was we just looked at patients in a time when they were receiving rituximab, so they may have historically been exposed to other treatment options.” However, he added, “they weren’t having any other major DMARDs or immunosuppressive treatments at the time.”
Dr. Luqmani observed: “If you look at Francesco’s data on the hypogammaglobulinemia at the start of rituximab, that probably gives you a good idea of just how immunosuppressed these patients were already before we got to this point.”
Dr. Luqmani added: “I suspect that’s in keeping with a lot of other centers that have started using rituximab an awful lot for patients who previously had episodes of vasculitis treated with other disease-modifying therapies, particularly cyclophosphamide.”
But for how long should co-trimoxazole be given after the last rituximab dose? asked the chair of the session, Richard Watts, DM, of Norwich (England) Medical School. These data are purely observational, so it’s not possible to say, Mr. Dernie noted: “The patients that we included as having co-trimoxazole seem to be on it more or less consistently, permanently,” he said.
What about the best dose? “It’s a tricky one,” Dr. Luqmani said, as “we not only use co-trimoxazole for prophylaxis, but we often also want to use it for treatment of the vasculitis itself.”
It’s very likely that there was a mix of patients in the analysis that had received co-trimoxazole as either a treatment or prophylaxis, which means different doses, he said.
“It might be interesting to know whether there was a difference” between doses used and the prevention of infection, added Dr. Luqmani, “but I suspect the numbers are too small to tell.”
Mr. Dernie, Dr. Luqmani, and the other coauthors had no disclosures.
The serious infection risk associated with rituximab treatment for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is high but can be offset by co-prescribing co-trimoxazole, data from a single-center, retrospective study reaffirm.
Over the course of a 3-year study period, 14 (28%) of 50 patients with AAV treated with rituximab experienced at latest one severe infection defined as a grade 3 or higher event. The incidence of severe infections was 15.4 per 100 person-years.
However, a lower rate of infections was seen in patients who had been co-prescribed co-trimoxazole (trimethoprim and sulfamethoxazole), Francesco Dernie, a fifth-year medical student at the University of Oxford (England), reported at the British Society for Rheumatology annual conference.
“In the case of rituximab, the depletion of B cells and associated immune suppression is a double-edged sword, allowing effective disease control, but also leaving the body vulnerable to opportunistic and severe infections,” Mr. Dernie said at the meeting.
Of the patients who developed a severe infection on rituximab, just 7% had been treated with co-trimoxazole. In comparison, 44% of those who did not get a severe infection had received co-trimoxazole. Multivariate analysis confirmed that co-trimoxazole use was an influencing factor, with an odds ratio (OR) of 0.096 (95% confidence interval, 0.009–0.996; P = .05).
Another finding was that patients with low immunoglobulin G levels (less than 6 g/L) were more likely to develop a severe infection than were those with higher IgG levels. Indeed, the OR for hypogammaglobulinemia and the risk for infection was 8.782 (95% CI, 1.19–64.6; P = .033).
“Our results support the monitoring of IgG levels to identify patients who may be more susceptible to infection, as well as the prescription of prophylactic co-trimoxazole to reduce overall severe infection risk,” Mr. Dernie and associates concluded in their abstract.
It’s a “really important message around co-trimoxazole,” observed Neil Basu, MBChB, a clinical senior lecturer and honorary consultant at the Institute of Infection, Immunity & Inflammation, University of Glasgow (Scotland).
“It still frustrates me when I see that patients haven’t received that while receiving rituximab. Of course, co-trimoxazole can have its problems,” said Dr. Basu, who was not involved in the study. “It’s not uncommon for patients to develop reactions or be intolerant to the drug.”
Raashid Luqmani, DM, a senior coauthor of the work and professor of rheumatology at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, said: “The tolerance of co-trimoxazole has been remarkably good in this cohort.” If there was a problem with using co-trimoxazole, then “our standard would be to go with trimethoprim alone as the next in line and follow that with inhaled pentamidine. So, it’s kind of following what we would all generally do,” Dr. Luqmani said.
These data add further support for coprescribing antibiotic treatment with rituximab, he suggested.
“Worry about infection, worry about it a lot; not just worry about it, do something about it,” Dr. Luqmani said, and co-trimoxazole “is probably an effective means to do something about it.”
Study details
To look at the characteristics of and risk factors for serious infections associated with rituximab use in AAV, Mr. Dernie and associates retrospectively examined the electronic records of patients who had been treated between August 2016 and August 2019. Follow-up was until August 2020.
Of the 50 patients identified, nearly half (48%) were men. The average age was 60 years, ranging from 25 to 90 years. Most (n = 36; 72%) patients had a diagnosis of granulomatosis with polyangiitis, while another 2 (4%) had microscopic polyangiitis, 1 (2%) had eosinophilic granulomatosis with polyangiitis, and 11 (22%) had an overlapping type of vasculitis or undefined AAV.
Of the 18 severe infection events recorded, most (56%) involved the respiratory tract. Less than one-third (28%) were sepsis or neutropenic sepsis events, and there was one case each (6%) of cellulitis, complicated urinary tract infection, and recurrent wound infection.
There were “small numbers of individual comorbidities that were not sufficient to enter into our regression analysis,” Mr. Dernie noted. “It’s likely that comorbid conditions such as COPD [chronic obstructive pulmonary disease] also contribute to an individual’s risk of developing severe infections, and thus should factor into their individualized management.”
Mr. Dernie acknowledged in discussion: “One of the limitations of the study was we just looked at patients in a time when they were receiving rituximab, so they may have historically been exposed to other treatment options.” However, he added, “they weren’t having any other major DMARDs or immunosuppressive treatments at the time.”
Dr. Luqmani observed: “If you look at Francesco’s data on the hypogammaglobulinemia at the start of rituximab, that probably gives you a good idea of just how immunosuppressed these patients were already before we got to this point.”
Dr. Luqmani added: “I suspect that’s in keeping with a lot of other centers that have started using rituximab an awful lot for patients who previously had episodes of vasculitis treated with other disease-modifying therapies, particularly cyclophosphamide.”
But for how long should co-trimoxazole be given after the last rituximab dose? asked the chair of the session, Richard Watts, DM, of Norwich (England) Medical School. These data are purely observational, so it’s not possible to say, Mr. Dernie noted: “The patients that we included as having co-trimoxazole seem to be on it more or less consistently, permanently,” he said.
What about the best dose? “It’s a tricky one,” Dr. Luqmani said, as “we not only use co-trimoxazole for prophylaxis, but we often also want to use it for treatment of the vasculitis itself.”
It’s very likely that there was a mix of patients in the analysis that had received co-trimoxazole as either a treatment or prophylaxis, which means different doses, he said.
“It might be interesting to know whether there was a difference” between doses used and the prevention of infection, added Dr. Luqmani, “but I suspect the numbers are too small to tell.”
Mr. Dernie, Dr. Luqmani, and the other coauthors had no disclosures.
FROM BSR 2021
Insomnia? Referral, drugs not usually needed
Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.
However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.
“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.
He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.
Restricted sleep is a good place to start for chronic insomnia, he continued.
Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.
Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.
“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
Sleep specialists in short supply
Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.
He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.
CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.
However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.
Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.
“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
Insomnia among older patients
Interest in helping older patients with insomnia dominated the chat session associated with the talk.
Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.
Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.
If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.
“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.
Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.
Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.
He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.
He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.
Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.
“It has no measurable effect in a third of patients and at least unacceptable side effects in another third. Right off the bat, it’s not efficacious in two thirds of patients.”
Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”
Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.
Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.
However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.
“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.
He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.
Restricted sleep is a good place to start for chronic insomnia, he continued.
Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.
Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.
“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
Sleep specialists in short supply
Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.
He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.
CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.
However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.
Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.
“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
Insomnia among older patients
Interest in helping older patients with insomnia dominated the chat session associated with the talk.
Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.
Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.
If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.
“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.
Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.
Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.
He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.
He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.
Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.
“It has no measurable effect in a third of patients and at least unacceptable side effects in another third. Right off the bat, it’s not efficacious in two thirds of patients.”
Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”
Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.
Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Dr. Lettieri, professor in pulmonary, critical care, and sleep medicine at Johns Hopkins University, Baltimore.
However, medications alone won’t work without other behavior modifications and they come with potential side effects, he said in his talk. Prescription medications typically don’t treat the cause of the insomnia, just the symptoms.
“In the 15 years I’ve been practicing sleep medicine, I can honestly say I only have a handful of patients that I treat with long-term pharmacotherapy,” Dr. Lettieri said.
He said he typically uses pharmacotherapy only when conservative measures have failed or to help jump-start patients to behavior modifications.
Restricted sleep is a good place to start for chronic insomnia, he continued.
Physicians should ask patients the latest time they can wake up to make it to school, work, etc. If that time is 6 a.m., the goal is to move bedtime back to 10 p.m.–11 p.m. If the patient, however, is unable to sleep until 12:30 a.m., move bedtime there, he said.
Though the 5.5-hour window is not ideal, it’s better to get into bed when ready for sleep. From there, try to get the patient to move bedtime back 15 minutes each week as they train themselves to fall asleep earlier, he said.
“I promise you this works in the majority of patients and doesn’t require any medication. You can also accomplish this with one or two office visits, so it is not a huge drain on resources,” he said.
Sleep specialists in short supply
Cognitive-behavioral therapy (CBT) is “without question the best way to treat chronic insomnia and it’s recommended as first-line therapy by all published guidelines,” Dr. Lettieri said.
He defined chronic insomnia as happening most nights over at least 3 months. It affects twice as many women as men.
CBT offers a formalized way of changing sleep patterns with the help of an expert in sleep behavior disorders. It combines cognitive therapies with education about sleep and stimulus control and uses techniques such as mindfulness and relaxation.
However, most programs take 4-8 sessions with a sleep medicine provider and are usually not covered by insurance. In addition, the number of insomnia specialists is not nearly adequate to meet demand, he added.
Online and mobile-platform CBT programs are widely effective, Dr. Lettieri said. Many are free and all are convenient for patients to use. He said many of his patients use Sleepio, but many other online programs are effective.
“You can provide sufficient therapy for many of your patients and reserve CBT for patients who can’t be fixed with more conservative measures,” he said.
Insomnia among older patients
Interest in helping older patients with insomnia dominated the chat session associated with the talk.
Insomnia increases with age and older patients have often been using prescription or over-the-counter sleep aids for decades.
Additionally, “insomnia is the second-most common reason why people get admitted to long-term care facilities, second only to urinary incontinence,” Dr. Lettieri said.
If physicians use medications with older patients, he said, extra caution is needed. Older people have more neurocognitive impairments than younger adults and may already be taking several other medications. Sleep medications may come with longer elimination half-lives. Polypharmacy may increase risk for falls and have other consequences.
“If you have to go to a medication, try something simple like melatonin,” he said, adding that it should be pharmaceutical grade and extended release.
Also, bright lights during the day, movement throughout the day, and dim lights closer to bedtime are especially important for the elderly, Dr. Lettieri said.
Andrew Corr, MD, a geriatric specialist in primary care with the Riverside (Calif.) Medical Clinic, said in an interview the main message he will take back to his physician group is more CBT and less medication.
He said that, although he has long known CBT is the top first-line treatment, it is difficult to find experts in his area who are trained to do CBT for insomnia, so he was glad to hear online programs and self-directed reading are typically effective.
He also said there’s a common misperception that there’s no harm in prescribing medications such as trazodone (Desyrel), an antidepressant commonly used off label as a sleep aid.
Dr. Lettieri’s talk highlighted his recommendation against using trazodone for sleep. “Despite several recommendations against its use for insomnia, it is still commonly prescribed. You just shouldn’t use it for insomnia,” Dr. Lettieri said.
“It has no measurable effect in a third of patients and at least unacceptable side effects in another third. Right off the bat, it’s not efficacious in two thirds of patients.”
Additionally, priapism, a prolonged erection, has been associated with trazodone, Dr. Lettieri said, “and I have literally never met a patient on trazodone who was counseled about this.”
Trazodone also has a black box warning from the Food and Drug Administration warning about increased risk for suicidal thoughts.
Dr. Lettieri and Dr. Corr disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM INTERNAL MEDICINE 2021
Virtual APA vs. the real thing: Which is better?
Every spring, I look forward to attending the American Psychiatric Association’s annual meeting. It has become a ritual that starts many months before the actual conference.
Submissions for presentations are due in September, so the planning often starts in the late summer. Hotel and plane reservations are made in January, and the meeting itself begins in May.
The city that hosts the event changes each year but, for me, many things do not. The Clinical Psychiatry News editorial board meeting takes place on Monday morning at 7 a.m., and I scour the program for what sessions to attend. In recent years, I have made a point of writing an article for about one of the sessions while still at the meeting – in 2019 I wrote about the improv-acting workshops I attended – something that just doesn’t translate to a Zoom experience.
I go with the same friend every year, I always attend the Hopkins alumni reception, and I organize dinner at a nice restaurant for friends. I have collected so many funny stories and memories over the years that it would be hard to catalog them all. There was the time in Toronto that I set up a meal at a restaurant named Susur – a meal like no other I’ve ever had – and the check arrived with a jaw-dropping sum that I had not anticipated. In San Diego, we watched a gorgeous sunset over the Pacific Ocean from the veranda of the Hotel Coronado. There was the time I sunbathed on the beach in Waikiki with my book editor, and the notable distress when my colleague’s husband called from the airport to say he was not permitted to board his plane in Baltimore to join us in California! There are funny stories, but there is the sadness that one friend who joined us for so many of these events has died.
I always find the program options to be overwhelming: There is so much going on at once that it can be hard to decide what to go to. I try to attend a mix of sessions, some that are inspiring or entertaining, and others that will be informative for clinical issues.
The speakers have been incredible and over the years I’ve heard then-Vice President Joseph Biden, retired quarterback Terry Bradshaw, Oliver Sacks, Alan Alda, Archbishop Desmond Tutu, and perhaps my favorite – Lorraine Bracco, the actress who played Dr. Melfi on “The Sopranos” – to name just a few. And, of course, the opportunity to get the continuing medical education credits I need for licensing is just one more reason to attend.
Last year in May I was still adjusting to my “new” career from home with a computer screen. I had been scheduled to participate in several panels for the meeting in Philadelphia, but extra computer hours had no appeal. And while the fatigue of doing telemental health has eased, I still avoid extra hours interacting with my computer screen and I did not attend this year’s meeting. Without the lure of friends, fun, and the novelty of being somewhere new, my APA experience would have to wait for real life.
Virtual APA has had a drop in participation. In 2019, the last real-life convention in San Francisco, there were 700 scientific sessions and 11,000 professionals in attendance. This year’s virtual conference hosted 135 sessions with more than 7,000 attendees. Attendance was down, but so were costs associated with live conventions and
Tom Abdallah is a medical student at Weill Cornell Medicine–Qatar in Education City. He has never attended an in-person APA annual meeting, but he joined for this year’s virtual sessions. “The scientific sessions were fantastic and diverse. Networking was limited in comparison to in-person conferences. The meeting was very well organized, and it gave me the opportunity to attend without worrying about travel.”
Steven Daviss, MD, a psychiatrist in Maryland, also commented on the ease and financial benefit of attending the meeting from his home office. He calculated that the cost was much less: $350 for virtual APA, compared with approximately $3,500 for the real thing, allowing for transportation, hotels, meals out, and lost income. “But,” said Dr. Daviss, “engagement with colleagues was minimal.”
APA Assembly member Annette Hanson, MD, has continued to go into work throughout the pandemic. Still, she noted that meetings and committee work have made sure she does not miss out on the “Zoom fatigue” that everyone else is feeling. The virtual APA was tiring for her.
“It was brutal. There was the APA Assembly 1 weekend, right after evening Zoom reference committee meetings the week before. Then virtual APA the next weekend. By the end of the week, I had worked every day for 3 weeks straight, including my more-than-full-time job!”
It has been a challenging time, to say the least, and it has certainly helped that videoconferencing has allowed us to be there for our patients and for each other in so many different circumstances. Former APA President Paul Summergrad, MD, talked about how virtual meetings can be very good as educational tools, but he conveyed what I have been feeling in a sentence: “I miss the social aspect of meetings.”
Please get your vaccine, and I hope to see you in New Orleans next May!
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Every spring, I look forward to attending the American Psychiatric Association’s annual meeting. It has become a ritual that starts many months before the actual conference.
Submissions for presentations are due in September, so the planning often starts in the late summer. Hotel and plane reservations are made in January, and the meeting itself begins in May.
The city that hosts the event changes each year but, for me, many things do not. The Clinical Psychiatry News editorial board meeting takes place on Monday morning at 7 a.m., and I scour the program for what sessions to attend. In recent years, I have made a point of writing an article for about one of the sessions while still at the meeting – in 2019 I wrote about the improv-acting workshops I attended – something that just doesn’t translate to a Zoom experience.
I go with the same friend every year, I always attend the Hopkins alumni reception, and I organize dinner at a nice restaurant for friends. I have collected so many funny stories and memories over the years that it would be hard to catalog them all. There was the time in Toronto that I set up a meal at a restaurant named Susur – a meal like no other I’ve ever had – and the check arrived with a jaw-dropping sum that I had not anticipated. In San Diego, we watched a gorgeous sunset over the Pacific Ocean from the veranda of the Hotel Coronado. There was the time I sunbathed on the beach in Waikiki with my book editor, and the notable distress when my colleague’s husband called from the airport to say he was not permitted to board his plane in Baltimore to join us in California! There are funny stories, but there is the sadness that one friend who joined us for so many of these events has died.
I always find the program options to be overwhelming: There is so much going on at once that it can be hard to decide what to go to. I try to attend a mix of sessions, some that are inspiring or entertaining, and others that will be informative for clinical issues.
The speakers have been incredible and over the years I’ve heard then-Vice President Joseph Biden, retired quarterback Terry Bradshaw, Oliver Sacks, Alan Alda, Archbishop Desmond Tutu, and perhaps my favorite – Lorraine Bracco, the actress who played Dr. Melfi on “The Sopranos” – to name just a few. And, of course, the opportunity to get the continuing medical education credits I need for licensing is just one more reason to attend.
Last year in May I was still adjusting to my “new” career from home with a computer screen. I had been scheduled to participate in several panels for the meeting in Philadelphia, but extra computer hours had no appeal. And while the fatigue of doing telemental health has eased, I still avoid extra hours interacting with my computer screen and I did not attend this year’s meeting. Without the lure of friends, fun, and the novelty of being somewhere new, my APA experience would have to wait for real life.
Virtual APA has had a drop in participation. In 2019, the last real-life convention in San Francisco, there were 700 scientific sessions and 11,000 professionals in attendance. This year’s virtual conference hosted 135 sessions with more than 7,000 attendees. Attendance was down, but so were costs associated with live conventions and
Tom Abdallah is a medical student at Weill Cornell Medicine–Qatar in Education City. He has never attended an in-person APA annual meeting, but he joined for this year’s virtual sessions. “The scientific sessions were fantastic and diverse. Networking was limited in comparison to in-person conferences. The meeting was very well organized, and it gave me the opportunity to attend without worrying about travel.”
Steven Daviss, MD, a psychiatrist in Maryland, also commented on the ease and financial benefit of attending the meeting from his home office. He calculated that the cost was much less: $350 for virtual APA, compared with approximately $3,500 for the real thing, allowing for transportation, hotels, meals out, and lost income. “But,” said Dr. Daviss, “engagement with colleagues was minimal.”
APA Assembly member Annette Hanson, MD, has continued to go into work throughout the pandemic. Still, she noted that meetings and committee work have made sure she does not miss out on the “Zoom fatigue” that everyone else is feeling. The virtual APA was tiring for her.
“It was brutal. There was the APA Assembly 1 weekend, right after evening Zoom reference committee meetings the week before. Then virtual APA the next weekend. By the end of the week, I had worked every day for 3 weeks straight, including my more-than-full-time job!”
It has been a challenging time, to say the least, and it has certainly helped that videoconferencing has allowed us to be there for our patients and for each other in so many different circumstances. Former APA President Paul Summergrad, MD, talked about how virtual meetings can be very good as educational tools, but he conveyed what I have been feeling in a sentence: “I miss the social aspect of meetings.”
Please get your vaccine, and I hope to see you in New Orleans next May!
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Every spring, I look forward to attending the American Psychiatric Association’s annual meeting. It has become a ritual that starts many months before the actual conference.
Submissions for presentations are due in September, so the planning often starts in the late summer. Hotel and plane reservations are made in January, and the meeting itself begins in May.
The city that hosts the event changes each year but, for me, many things do not. The Clinical Psychiatry News editorial board meeting takes place on Monday morning at 7 a.m., and I scour the program for what sessions to attend. In recent years, I have made a point of writing an article for about one of the sessions while still at the meeting – in 2019 I wrote about the improv-acting workshops I attended – something that just doesn’t translate to a Zoom experience.
I go with the same friend every year, I always attend the Hopkins alumni reception, and I organize dinner at a nice restaurant for friends. I have collected so many funny stories and memories over the years that it would be hard to catalog them all. There was the time in Toronto that I set up a meal at a restaurant named Susur – a meal like no other I’ve ever had – and the check arrived with a jaw-dropping sum that I had not anticipated. In San Diego, we watched a gorgeous sunset over the Pacific Ocean from the veranda of the Hotel Coronado. There was the time I sunbathed on the beach in Waikiki with my book editor, and the notable distress when my colleague’s husband called from the airport to say he was not permitted to board his plane in Baltimore to join us in California! There are funny stories, but there is the sadness that one friend who joined us for so many of these events has died.
I always find the program options to be overwhelming: There is so much going on at once that it can be hard to decide what to go to. I try to attend a mix of sessions, some that are inspiring or entertaining, and others that will be informative for clinical issues.
The speakers have been incredible and over the years I’ve heard then-Vice President Joseph Biden, retired quarterback Terry Bradshaw, Oliver Sacks, Alan Alda, Archbishop Desmond Tutu, and perhaps my favorite – Lorraine Bracco, the actress who played Dr. Melfi on “The Sopranos” – to name just a few. And, of course, the opportunity to get the continuing medical education credits I need for licensing is just one more reason to attend.
Last year in May I was still adjusting to my “new” career from home with a computer screen. I had been scheduled to participate in several panels for the meeting in Philadelphia, but extra computer hours had no appeal. And while the fatigue of doing telemental health has eased, I still avoid extra hours interacting with my computer screen and I did not attend this year’s meeting. Without the lure of friends, fun, and the novelty of being somewhere new, my APA experience would have to wait for real life.
Virtual APA has had a drop in participation. In 2019, the last real-life convention in San Francisco, there were 700 scientific sessions and 11,000 professionals in attendance. This year’s virtual conference hosted 135 sessions with more than 7,000 attendees. Attendance was down, but so were costs associated with live conventions and
Tom Abdallah is a medical student at Weill Cornell Medicine–Qatar in Education City. He has never attended an in-person APA annual meeting, but he joined for this year’s virtual sessions. “The scientific sessions were fantastic and diverse. Networking was limited in comparison to in-person conferences. The meeting was very well organized, and it gave me the opportunity to attend without worrying about travel.”
Steven Daviss, MD, a psychiatrist in Maryland, also commented on the ease and financial benefit of attending the meeting from his home office. He calculated that the cost was much less: $350 for virtual APA, compared with approximately $3,500 for the real thing, allowing for transportation, hotels, meals out, and lost income. “But,” said Dr. Daviss, “engagement with colleagues was minimal.”
APA Assembly member Annette Hanson, MD, has continued to go into work throughout the pandemic. Still, she noted that meetings and committee work have made sure she does not miss out on the “Zoom fatigue” that everyone else is feeling. The virtual APA was tiring for her.
“It was brutal. There was the APA Assembly 1 weekend, right after evening Zoom reference committee meetings the week before. Then virtual APA the next weekend. By the end of the week, I had worked every day for 3 weeks straight, including my more-than-full-time job!”
It has been a challenging time, to say the least, and it has certainly helped that videoconferencing has allowed us to be there for our patients and for each other in so many different circumstances. Former APA President Paul Summergrad, MD, talked about how virtual meetings can be very good as educational tools, but he conveyed what I have been feeling in a sentence: “I miss the social aspect of meetings.”
Please get your vaccine, and I hope to see you in New Orleans next May!
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.