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Taking a drug holiday: Benefits and risks to children with ADHD
For children with attention-deficit/hyperactivity disorder, taking a weekend or summer break from methylphenidate may have some benefits. A drug “holiday” can help assess whether a drug is still useful and possibly help with drug tolerance, weight gain, and growth suppression. But drug holidays are not without their problems, Lily Hechtman, MD, FRCP, professor at the department of psychiatry, McGill University, Montreal, said during a session at the World Congress on ADHD – Virtual Event.
Ceasing a medication can have repercussions from a health and social standpoint, cautioned Dr. Hechtman, a presenter and moderator of the session, “Unsolved mysteries in the treatment of ADHD with psychostimulants.”
The rate of drug holidays is somewhere between 30% and 40% in ADHD patients. Patients have multiple reasons for taking them, said Dr. Hechtman. The American Academy of Child & Adolescent Psychology as well as the National Institute for Health and Clinical Excellence recommend this method to assess whether a medication is still necessary. Parents may opt for a drug holiday because most would prefer their children to take less medication.
A drug holiday can counteract some of the key side effects of stimulant medication such as decreased appetite and weight loss, and the moodiness and irritability that accompanies the medication, as well as sleep problems.
It may also be used to avoid drug tolerance, the need to increase dosage as medication continues. A 2002 study of 166 children and adolescents treated with methylphenidate revealed that 60% had developed drug tolerance. Drug tolerance increases with duration. “So, the longer the child is on medication, the more likely he or she will develop some drug tolerance,” said Dr. Hechtman.
It is hypothesized that a drug holiday results in the resensitization of the neurons in the brain because they aren’t exposed to the stimulation of dopamine release and dopamine exposure.
The minimum time a patient needs a drug holiday to deal with some drug tolerance is about a month. “Even if you have a drug holiday and your drug tolerance has been decreased, it can reoccur with increasing dosages, once medication resumes” after the holiday, said Dr. Hechtman.
The growth factor
A drug holiday can also address concerns about growth suppression. “Some studies show that drug holidays help with growth suppression and others do not,” said Dr. Hechtman.
The Multimodal Treatment of ADHD (MTA) study, which followed children with ADHD from childhood to adolescence into adulthood, offers some key insights on the effects of treatment on growth.
Over a 10-year period, “you could see that the rate of medication use decreased significantly with time” among participants, said Dr. Hechtman, a coauthor of the MTA research. Only 10% who began the study aged 7-9 years were still using stimulants 10 years later. Looking at short-term effects on growth among these children, those who never went on stimulants to begin with had no growth suppression at all, whereas those who underwent early and consistent treatment experienced the greatest growth suppression.
Comparatively, inconsistently medicated participants had less growth suppression than those who remained on medication. “They were pretty close to the controls,” said Dr. Hechtman.
These patterns continued in a 16-year follow-up, as these patients became adults. Based on the results in the inconsistently treated group, this suggests that drug holidays can limit the effects of growth suppression, at least to a certain extent, said Dr. Hechtman.
Other studies have yielded varying results on the impact of drug holidays on height and weight. “The evidence for the utility of drug holidays for medication side effects is there for decreased appetite and weight, but not so much for decreased height,” summarized Dr. Hechtman.
One recent study of 230 children by James Waxmonsky and colleagues that examined drug holidays on weekends and summers showed that drug holidays did increase weight but interestingly, not height. Older studies Dr. Hechtman cited had inconsistent results on height and weight gain and loss. A 2012 study suggested that drug holidays resulted in a slight improvement in appetite for both weekend and school holidays. But only 9% of the children in the sample (n = 51) saw their appetite return to normal levels.
‘Negative things can happen’
The downside of drug holidays is parents may rationalize that their child is doing fine without the medication, and discontinue it. The process of stopping and starting medication can lead to other problems. “Negative things can happen during drug holidays,” said Dr. Hechtman.
The large variability of doses over the weekend can result in rebound and side effects.
A child may go from a full dose, which could be 50-60 mg of stimulant to zero from Friday to Saturday. As a result they have a lot of rebound on that Saturday. Similarly, they go from zero on Sunday to full dose on the Monday, causing lots of side effects. “Also, they will never have a stable effective dose because of the roller-coaster effect of being on and off the drugs,” she noted.
The lack of consistency and accommodation to the side effects can lead to discontinuation of the medication.
Off medication, the child may be more accident prone or have more injuries. “Their behavior off the medication may be such that it leads to social problems,” Dr. Hechtman continued. Weekend activities that require medication such as homework or school projects, family or religious gatherings, or sports and social activities with family and peers may be affected. If the child is behaving poorly off the medication, they may be expelled from such activities. If it’s a summer drug holiday, they may get kicked out of camp or the swimming pool.
If the child’s condition is already worsening, and a drug holiday takes place on top of this, the child may experience a rebound or relapse, in which the condition looks a lot worse than it did with the drugs.
Do drug holidays matter?
Another session speaker, James Swanson, PhD, who noted that the “emergence of tolerance may limit and eventually undermine initial relative benefit” of stimulants, said there may be instances in which drug holidays may be impractical.
Given the poor adherence to ADHD medication, “most treated ADHD cases stop medication anyway and these patients do not have an opportunity for drug holidays,” he said in an interview.
“If tolerance does emerge, then for long-term treatment the concept of drug holiday seems difficult to evaluate to me,” said Dr. Swanson, director of the Child Development Center at the University of California, Irvine.
Planned medication breaks may not be a good way to evaluate efficacy unless it is performed under “double-blind” conditions, he offered. The MTA used an approach of switching between short periods of time, with and without medication. “We did this to compare medication to placebo and to compare doses of medication to optimize the short-term benefit,” said Dr. Swanson, a coauthor of the MTA study.
Dr. Hechtman receives funding from The Canadian Institutes of Health Research. Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth on infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA).
For children with attention-deficit/hyperactivity disorder, taking a weekend or summer break from methylphenidate may have some benefits. A drug “holiday” can help assess whether a drug is still useful and possibly help with drug tolerance, weight gain, and growth suppression. But drug holidays are not without their problems, Lily Hechtman, MD, FRCP, professor at the department of psychiatry, McGill University, Montreal, said during a session at the World Congress on ADHD – Virtual Event.
Ceasing a medication can have repercussions from a health and social standpoint, cautioned Dr. Hechtman, a presenter and moderator of the session, “Unsolved mysteries in the treatment of ADHD with psychostimulants.”
The rate of drug holidays is somewhere between 30% and 40% in ADHD patients. Patients have multiple reasons for taking them, said Dr. Hechtman. The American Academy of Child & Adolescent Psychology as well as the National Institute for Health and Clinical Excellence recommend this method to assess whether a medication is still necessary. Parents may opt for a drug holiday because most would prefer their children to take less medication.
A drug holiday can counteract some of the key side effects of stimulant medication such as decreased appetite and weight loss, and the moodiness and irritability that accompanies the medication, as well as sleep problems.
It may also be used to avoid drug tolerance, the need to increase dosage as medication continues. A 2002 study of 166 children and adolescents treated with methylphenidate revealed that 60% had developed drug tolerance. Drug tolerance increases with duration. “So, the longer the child is on medication, the more likely he or she will develop some drug tolerance,” said Dr. Hechtman.
It is hypothesized that a drug holiday results in the resensitization of the neurons in the brain because they aren’t exposed to the stimulation of dopamine release and dopamine exposure.
The minimum time a patient needs a drug holiday to deal with some drug tolerance is about a month. “Even if you have a drug holiday and your drug tolerance has been decreased, it can reoccur with increasing dosages, once medication resumes” after the holiday, said Dr. Hechtman.
The growth factor
A drug holiday can also address concerns about growth suppression. “Some studies show that drug holidays help with growth suppression and others do not,” said Dr. Hechtman.
The Multimodal Treatment of ADHD (MTA) study, which followed children with ADHD from childhood to adolescence into adulthood, offers some key insights on the effects of treatment on growth.
Over a 10-year period, “you could see that the rate of medication use decreased significantly with time” among participants, said Dr. Hechtman, a coauthor of the MTA research. Only 10% who began the study aged 7-9 years were still using stimulants 10 years later. Looking at short-term effects on growth among these children, those who never went on stimulants to begin with had no growth suppression at all, whereas those who underwent early and consistent treatment experienced the greatest growth suppression.
Comparatively, inconsistently medicated participants had less growth suppression than those who remained on medication. “They were pretty close to the controls,” said Dr. Hechtman.
These patterns continued in a 16-year follow-up, as these patients became adults. Based on the results in the inconsistently treated group, this suggests that drug holidays can limit the effects of growth suppression, at least to a certain extent, said Dr. Hechtman.
Other studies have yielded varying results on the impact of drug holidays on height and weight. “The evidence for the utility of drug holidays for medication side effects is there for decreased appetite and weight, but not so much for decreased height,” summarized Dr. Hechtman.
One recent study of 230 children by James Waxmonsky and colleagues that examined drug holidays on weekends and summers showed that drug holidays did increase weight but interestingly, not height. Older studies Dr. Hechtman cited had inconsistent results on height and weight gain and loss. A 2012 study suggested that drug holidays resulted in a slight improvement in appetite for both weekend and school holidays. But only 9% of the children in the sample (n = 51) saw their appetite return to normal levels.
‘Negative things can happen’
The downside of drug holidays is parents may rationalize that their child is doing fine without the medication, and discontinue it. The process of stopping and starting medication can lead to other problems. “Negative things can happen during drug holidays,” said Dr. Hechtman.
The large variability of doses over the weekend can result in rebound and side effects.
A child may go from a full dose, which could be 50-60 mg of stimulant to zero from Friday to Saturday. As a result they have a lot of rebound on that Saturday. Similarly, they go from zero on Sunday to full dose on the Monday, causing lots of side effects. “Also, they will never have a stable effective dose because of the roller-coaster effect of being on and off the drugs,” she noted.
The lack of consistency and accommodation to the side effects can lead to discontinuation of the medication.
Off medication, the child may be more accident prone or have more injuries. “Their behavior off the medication may be such that it leads to social problems,” Dr. Hechtman continued. Weekend activities that require medication such as homework or school projects, family or religious gatherings, or sports and social activities with family and peers may be affected. If the child is behaving poorly off the medication, they may be expelled from such activities. If it’s a summer drug holiday, they may get kicked out of camp or the swimming pool.
If the child’s condition is already worsening, and a drug holiday takes place on top of this, the child may experience a rebound or relapse, in which the condition looks a lot worse than it did with the drugs.
Do drug holidays matter?
Another session speaker, James Swanson, PhD, who noted that the “emergence of tolerance may limit and eventually undermine initial relative benefit” of stimulants, said there may be instances in which drug holidays may be impractical.
Given the poor adherence to ADHD medication, “most treated ADHD cases stop medication anyway and these patients do not have an opportunity for drug holidays,” he said in an interview.
“If tolerance does emerge, then for long-term treatment the concept of drug holiday seems difficult to evaluate to me,” said Dr. Swanson, director of the Child Development Center at the University of California, Irvine.
Planned medication breaks may not be a good way to evaluate efficacy unless it is performed under “double-blind” conditions, he offered. The MTA used an approach of switching between short periods of time, with and without medication. “We did this to compare medication to placebo and to compare doses of medication to optimize the short-term benefit,” said Dr. Swanson, a coauthor of the MTA study.
Dr. Hechtman receives funding from The Canadian Institutes of Health Research. Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth on infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA).
For children with attention-deficit/hyperactivity disorder, taking a weekend or summer break from methylphenidate may have some benefits. A drug “holiday” can help assess whether a drug is still useful and possibly help with drug tolerance, weight gain, and growth suppression. But drug holidays are not without their problems, Lily Hechtman, MD, FRCP, professor at the department of psychiatry, McGill University, Montreal, said during a session at the World Congress on ADHD – Virtual Event.
Ceasing a medication can have repercussions from a health and social standpoint, cautioned Dr. Hechtman, a presenter and moderator of the session, “Unsolved mysteries in the treatment of ADHD with psychostimulants.”
The rate of drug holidays is somewhere between 30% and 40% in ADHD patients. Patients have multiple reasons for taking them, said Dr. Hechtman. The American Academy of Child & Adolescent Psychology as well as the National Institute for Health and Clinical Excellence recommend this method to assess whether a medication is still necessary. Parents may opt for a drug holiday because most would prefer their children to take less medication.
A drug holiday can counteract some of the key side effects of stimulant medication such as decreased appetite and weight loss, and the moodiness and irritability that accompanies the medication, as well as sleep problems.
It may also be used to avoid drug tolerance, the need to increase dosage as medication continues. A 2002 study of 166 children and adolescents treated with methylphenidate revealed that 60% had developed drug tolerance. Drug tolerance increases with duration. “So, the longer the child is on medication, the more likely he or she will develop some drug tolerance,” said Dr. Hechtman.
It is hypothesized that a drug holiday results in the resensitization of the neurons in the brain because they aren’t exposed to the stimulation of dopamine release and dopamine exposure.
The minimum time a patient needs a drug holiday to deal with some drug tolerance is about a month. “Even if you have a drug holiday and your drug tolerance has been decreased, it can reoccur with increasing dosages, once medication resumes” after the holiday, said Dr. Hechtman.
The growth factor
A drug holiday can also address concerns about growth suppression. “Some studies show that drug holidays help with growth suppression and others do not,” said Dr. Hechtman.
The Multimodal Treatment of ADHD (MTA) study, which followed children with ADHD from childhood to adolescence into adulthood, offers some key insights on the effects of treatment on growth.
Over a 10-year period, “you could see that the rate of medication use decreased significantly with time” among participants, said Dr. Hechtman, a coauthor of the MTA research. Only 10% who began the study aged 7-9 years were still using stimulants 10 years later. Looking at short-term effects on growth among these children, those who never went on stimulants to begin with had no growth suppression at all, whereas those who underwent early and consistent treatment experienced the greatest growth suppression.
Comparatively, inconsistently medicated participants had less growth suppression than those who remained on medication. “They were pretty close to the controls,” said Dr. Hechtman.
These patterns continued in a 16-year follow-up, as these patients became adults. Based on the results in the inconsistently treated group, this suggests that drug holidays can limit the effects of growth suppression, at least to a certain extent, said Dr. Hechtman.
Other studies have yielded varying results on the impact of drug holidays on height and weight. “The evidence for the utility of drug holidays for medication side effects is there for decreased appetite and weight, but not so much for decreased height,” summarized Dr. Hechtman.
One recent study of 230 children by James Waxmonsky and colleagues that examined drug holidays on weekends and summers showed that drug holidays did increase weight but interestingly, not height. Older studies Dr. Hechtman cited had inconsistent results on height and weight gain and loss. A 2012 study suggested that drug holidays resulted in a slight improvement in appetite for both weekend and school holidays. But only 9% of the children in the sample (n = 51) saw their appetite return to normal levels.
‘Negative things can happen’
The downside of drug holidays is parents may rationalize that their child is doing fine without the medication, and discontinue it. The process of stopping and starting medication can lead to other problems. “Negative things can happen during drug holidays,” said Dr. Hechtman.
The large variability of doses over the weekend can result in rebound and side effects.
A child may go from a full dose, which could be 50-60 mg of stimulant to zero from Friday to Saturday. As a result they have a lot of rebound on that Saturday. Similarly, they go from zero on Sunday to full dose on the Monday, causing lots of side effects. “Also, they will never have a stable effective dose because of the roller-coaster effect of being on and off the drugs,” she noted.
The lack of consistency and accommodation to the side effects can lead to discontinuation of the medication.
Off medication, the child may be more accident prone or have more injuries. “Their behavior off the medication may be such that it leads to social problems,” Dr. Hechtman continued. Weekend activities that require medication such as homework or school projects, family or religious gatherings, or sports and social activities with family and peers may be affected. If the child is behaving poorly off the medication, they may be expelled from such activities. If it’s a summer drug holiday, they may get kicked out of camp or the swimming pool.
If the child’s condition is already worsening, and a drug holiday takes place on top of this, the child may experience a rebound or relapse, in which the condition looks a lot worse than it did with the drugs.
Do drug holidays matter?
Another session speaker, James Swanson, PhD, who noted that the “emergence of tolerance may limit and eventually undermine initial relative benefit” of stimulants, said there may be instances in which drug holidays may be impractical.
Given the poor adherence to ADHD medication, “most treated ADHD cases stop medication anyway and these patients do not have an opportunity for drug holidays,” he said in an interview.
“If tolerance does emerge, then for long-term treatment the concept of drug holiday seems difficult to evaluate to me,” said Dr. Swanson, director of the Child Development Center at the University of California, Irvine.
Planned medication breaks may not be a good way to evaluate efficacy unless it is performed under “double-blind” conditions, he offered. The MTA used an approach of switching between short periods of time, with and without medication. “We did this to compare medication to placebo and to compare doses of medication to optimize the short-term benefit,” said Dr. Swanson, a coauthor of the MTA study.
Dr. Hechtman receives funding from The Canadian Institutes of Health Research. Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth on infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA).
FROM ADHD 2021
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
Study calls for sex-specific concussion management in adolescent soccer players
A large study of adolescent soccer players in Michigan revealed key differences in concussion injury metrics among males and females, underscoring a need to develop sex-specific approaches to managing injury in the sport.
Sport-related concussion (SRC) is a specific concern in young female athletes, study authors Abigail C. Bretzin, PhD, and colleagues noted in their paper, which appears in JAMA Network Open. Previous surveillance studies on SRC at the high school and college level have reported higher rates of injury risk and longer recovery outcomes in female soccer athletes. Taking a deeper dive into these trends, the investigators explored whether sex-associated differences existed in SRC, addressing the mechanics, management, and recovery from SRC.
“This is an area that is remarkably underresearched,” William Stewart, MBChB, PhD, the study’s corresponding author, said in an interview. Prior studies of males and females have shown that female axons are thinner, with fewer microtubules or internal scaffolding than male axons. This potentially increases risk of shear injury in females. Limited research has also cited differences in concussion risk across the menstrual cycle in female athletes.
Reporting system targets four injury areas
The investigators conducted a high school injury surveillance project in 43,741 male and 39,637 female soccer athletes participating in the Michigan High School Athletic Association (MHSAA) Head Injury Reporting System. The study included students from 9th to 12th grade, spanning from the beginning of academic year 2016-2017 to the end of academic year 2018-2019. Since 2015, the state has mandated high schools to submit data to MHSAA.
MHSAA captures data on four categories: person-to-person contact, person-to-object contact, person-to-playing surface contact, or uncertain about cause of the event. Study outcomes included details regarding injury mechanism, immediate management, and return-to-play time for each documented SRC.
Investigators reported notable differences among male and female players. Documented SRC risk was 1.88 times higher among adolescent girls than boys across all academic years (RR, 1.88; 95% CI, 1.69-2.09; P < .001). They also cited inconsistencies in distribution of injury mechanisms among the sexes. Females were most likely to suffer injury from equipment contact such as heading a ball (41.9%), whereas male players commonly sustained SRC from contact with another player (48.4%). The authors suggested that “female soccer athletes have lower neck strength and girth, compared with male athletes, with these variables inversely associated with linear and rotational head acceleration after soccer ball heading.”
Boys had greater odds of immediate removal from play and but also returned to the sport 2 days sooner than girls. “The possibility exists, therefore, that this longer recovery time might, in part, be reflective of our observed differences in immediate care, in particular removal from play,” the authors wrote. Immediate removal from play was also more common in cases where an athletic trainer played a part in evaluating players for SRC.
Eliminating the one-size-fits-all approach
Current concussion management is based on a “one-size-fits-all” model, said Dr. Stewart. Male and female athletes are treated following a common concussion management protocol, covering concussion detection through to rehabilitation. “This model of management is based on research that is almost exclusively in male athletes.”
What the study showed is this one-size-fits-all approach may be flawed, letting down female athletes. “We should be pursuing more research in sex differences in concussion and, importantly, putting these into practice in sex-specific concussion management protocols,” he suggested.
Future studies should also look at the effects of athletic trainer employment on SRC metrics. “Although this was a large, statewide epidemiological study of reported SRC in adolescent soccer athletes, inclusive of high schools with and without access to athletic trainers, the Head Injury Reporting System did not include information on the whether there were athletic trainer services available at each school, including specific athletic training services for soccer,” wrote the investigators, in citing the study’s limitations.
Girls report symptoms more often
“The researchers are to be commended for taking a prospective approach to address this common observation in high school sports,” said Keith J. Loud, MD, MSc, FAAP, a sports pediatrician at Children’s Hospital at Dartmouth-Hitchcock in Manchester, N.H. The results are “entirely believable,” said Dr. Loud, who was not affiliated with the study. “We have long postulated differences in neurophysiology, neck strength, style of play, and tendency to report as explanations for the observation that girls in high school soccer are diagnosed with more concussions than boys.”
The findings suggest that boys play more aggressively, but sustain fewer concussions, he added. Girls in the meantime, are more likely to speak up about their injury.
“Concussion diagnosis still relies to a large degree on the athlete to report symptoms, which is one of our hypotheses as to why girls seem to sustain more concussions – they report symptoms more often. That could also be why they have a prolonged recovery,” offered Dr. Loud. A main limitation of this study is it can’t overcome this reporting bias.
Dr. Loud was also concerned that girls were less likely to be removed from game play, even though they apparently sustained more concussions. “Perhaps that is because their injuries are less obvious on the field, and they are diagnosed when reported after the games.”
Dr. Stewart reported receiving grants from The Football Association and National Health Service Research Scotland during the study. He also served as a nonremunerated member of the Fédération Internationale de Football Association Independent Football Concussion Advisory Group and the Football Association Expert Panel on Concussion and Head Injury in Football. None of the other authors had disclosures.
A large study of adolescent soccer players in Michigan revealed key differences in concussion injury metrics among males and females, underscoring a need to develop sex-specific approaches to managing injury in the sport.
Sport-related concussion (SRC) is a specific concern in young female athletes, study authors Abigail C. Bretzin, PhD, and colleagues noted in their paper, which appears in JAMA Network Open. Previous surveillance studies on SRC at the high school and college level have reported higher rates of injury risk and longer recovery outcomes in female soccer athletes. Taking a deeper dive into these trends, the investigators explored whether sex-associated differences existed in SRC, addressing the mechanics, management, and recovery from SRC.
“This is an area that is remarkably underresearched,” William Stewart, MBChB, PhD, the study’s corresponding author, said in an interview. Prior studies of males and females have shown that female axons are thinner, with fewer microtubules or internal scaffolding than male axons. This potentially increases risk of shear injury in females. Limited research has also cited differences in concussion risk across the menstrual cycle in female athletes.
Reporting system targets four injury areas
The investigators conducted a high school injury surveillance project in 43,741 male and 39,637 female soccer athletes participating in the Michigan High School Athletic Association (MHSAA) Head Injury Reporting System. The study included students from 9th to 12th grade, spanning from the beginning of academic year 2016-2017 to the end of academic year 2018-2019. Since 2015, the state has mandated high schools to submit data to MHSAA.
MHSAA captures data on four categories: person-to-person contact, person-to-object contact, person-to-playing surface contact, or uncertain about cause of the event. Study outcomes included details regarding injury mechanism, immediate management, and return-to-play time for each documented SRC.
Investigators reported notable differences among male and female players. Documented SRC risk was 1.88 times higher among adolescent girls than boys across all academic years (RR, 1.88; 95% CI, 1.69-2.09; P < .001). They also cited inconsistencies in distribution of injury mechanisms among the sexes. Females were most likely to suffer injury from equipment contact such as heading a ball (41.9%), whereas male players commonly sustained SRC from contact with another player (48.4%). The authors suggested that “female soccer athletes have lower neck strength and girth, compared with male athletes, with these variables inversely associated with linear and rotational head acceleration after soccer ball heading.”
Boys had greater odds of immediate removal from play and but also returned to the sport 2 days sooner than girls. “The possibility exists, therefore, that this longer recovery time might, in part, be reflective of our observed differences in immediate care, in particular removal from play,” the authors wrote. Immediate removal from play was also more common in cases where an athletic trainer played a part in evaluating players for SRC.
Eliminating the one-size-fits-all approach
Current concussion management is based on a “one-size-fits-all” model, said Dr. Stewart. Male and female athletes are treated following a common concussion management protocol, covering concussion detection through to rehabilitation. “This model of management is based on research that is almost exclusively in male athletes.”
What the study showed is this one-size-fits-all approach may be flawed, letting down female athletes. “We should be pursuing more research in sex differences in concussion and, importantly, putting these into practice in sex-specific concussion management protocols,” he suggested.
Future studies should also look at the effects of athletic trainer employment on SRC metrics. “Although this was a large, statewide epidemiological study of reported SRC in adolescent soccer athletes, inclusive of high schools with and without access to athletic trainers, the Head Injury Reporting System did not include information on the whether there were athletic trainer services available at each school, including specific athletic training services for soccer,” wrote the investigators, in citing the study’s limitations.
Girls report symptoms more often
“The researchers are to be commended for taking a prospective approach to address this common observation in high school sports,” said Keith J. Loud, MD, MSc, FAAP, a sports pediatrician at Children’s Hospital at Dartmouth-Hitchcock in Manchester, N.H. The results are “entirely believable,” said Dr. Loud, who was not affiliated with the study. “We have long postulated differences in neurophysiology, neck strength, style of play, and tendency to report as explanations for the observation that girls in high school soccer are diagnosed with more concussions than boys.”
The findings suggest that boys play more aggressively, but sustain fewer concussions, he added. Girls in the meantime, are more likely to speak up about their injury.
“Concussion diagnosis still relies to a large degree on the athlete to report symptoms, which is one of our hypotheses as to why girls seem to sustain more concussions – they report symptoms more often. That could also be why they have a prolonged recovery,” offered Dr. Loud. A main limitation of this study is it can’t overcome this reporting bias.
Dr. Loud was also concerned that girls were less likely to be removed from game play, even though they apparently sustained more concussions. “Perhaps that is because their injuries are less obvious on the field, and they are diagnosed when reported after the games.”
Dr. Stewart reported receiving grants from The Football Association and National Health Service Research Scotland during the study. He also served as a nonremunerated member of the Fédération Internationale de Football Association Independent Football Concussion Advisory Group and the Football Association Expert Panel on Concussion and Head Injury in Football. None of the other authors had disclosures.
A large study of adolescent soccer players in Michigan revealed key differences in concussion injury metrics among males and females, underscoring a need to develop sex-specific approaches to managing injury in the sport.
Sport-related concussion (SRC) is a specific concern in young female athletes, study authors Abigail C. Bretzin, PhD, and colleagues noted in their paper, which appears in JAMA Network Open. Previous surveillance studies on SRC at the high school and college level have reported higher rates of injury risk and longer recovery outcomes in female soccer athletes. Taking a deeper dive into these trends, the investigators explored whether sex-associated differences existed in SRC, addressing the mechanics, management, and recovery from SRC.
“This is an area that is remarkably underresearched,” William Stewart, MBChB, PhD, the study’s corresponding author, said in an interview. Prior studies of males and females have shown that female axons are thinner, with fewer microtubules or internal scaffolding than male axons. This potentially increases risk of shear injury in females. Limited research has also cited differences in concussion risk across the menstrual cycle in female athletes.
Reporting system targets four injury areas
The investigators conducted a high school injury surveillance project in 43,741 male and 39,637 female soccer athletes participating in the Michigan High School Athletic Association (MHSAA) Head Injury Reporting System. The study included students from 9th to 12th grade, spanning from the beginning of academic year 2016-2017 to the end of academic year 2018-2019. Since 2015, the state has mandated high schools to submit data to MHSAA.
MHSAA captures data on four categories: person-to-person contact, person-to-object contact, person-to-playing surface contact, or uncertain about cause of the event. Study outcomes included details regarding injury mechanism, immediate management, and return-to-play time for each documented SRC.
Investigators reported notable differences among male and female players. Documented SRC risk was 1.88 times higher among adolescent girls than boys across all academic years (RR, 1.88; 95% CI, 1.69-2.09; P < .001). They also cited inconsistencies in distribution of injury mechanisms among the sexes. Females were most likely to suffer injury from equipment contact such as heading a ball (41.9%), whereas male players commonly sustained SRC from contact with another player (48.4%). The authors suggested that “female soccer athletes have lower neck strength and girth, compared with male athletes, with these variables inversely associated with linear and rotational head acceleration after soccer ball heading.”
Boys had greater odds of immediate removal from play and but also returned to the sport 2 days sooner than girls. “The possibility exists, therefore, that this longer recovery time might, in part, be reflective of our observed differences in immediate care, in particular removal from play,” the authors wrote. Immediate removal from play was also more common in cases where an athletic trainer played a part in evaluating players for SRC.
Eliminating the one-size-fits-all approach
Current concussion management is based on a “one-size-fits-all” model, said Dr. Stewart. Male and female athletes are treated following a common concussion management protocol, covering concussion detection through to rehabilitation. “This model of management is based on research that is almost exclusively in male athletes.”
What the study showed is this one-size-fits-all approach may be flawed, letting down female athletes. “We should be pursuing more research in sex differences in concussion and, importantly, putting these into practice in sex-specific concussion management protocols,” he suggested.
Future studies should also look at the effects of athletic trainer employment on SRC metrics. “Although this was a large, statewide epidemiological study of reported SRC in adolescent soccer athletes, inclusive of high schools with and without access to athletic trainers, the Head Injury Reporting System did not include information on the whether there were athletic trainer services available at each school, including specific athletic training services for soccer,” wrote the investigators, in citing the study’s limitations.
Girls report symptoms more often
“The researchers are to be commended for taking a prospective approach to address this common observation in high school sports,” said Keith J. Loud, MD, MSc, FAAP, a sports pediatrician at Children’s Hospital at Dartmouth-Hitchcock in Manchester, N.H. The results are “entirely believable,” said Dr. Loud, who was not affiliated with the study. “We have long postulated differences in neurophysiology, neck strength, style of play, and tendency to report as explanations for the observation that girls in high school soccer are diagnosed with more concussions than boys.”
The findings suggest that boys play more aggressively, but sustain fewer concussions, he added. Girls in the meantime, are more likely to speak up about their injury.
“Concussion diagnosis still relies to a large degree on the athlete to report symptoms, which is one of our hypotheses as to why girls seem to sustain more concussions – they report symptoms more often. That could also be why they have a prolonged recovery,” offered Dr. Loud. A main limitation of this study is it can’t overcome this reporting bias.
Dr. Loud was also concerned that girls were less likely to be removed from game play, even though they apparently sustained more concussions. “Perhaps that is because their injuries are less obvious on the field, and they are diagnosed when reported after the games.”
Dr. Stewart reported receiving grants from The Football Association and National Health Service Research Scotland during the study. He also served as a nonremunerated member of the Fédération Internationale de Football Association Independent Football Concussion Advisory Group and the Football Association Expert Panel on Concussion and Head Injury in Football. None of the other authors had disclosures.
FROM JAMA NETWORK OPEN
Asian children less likely to receive ADHD treatment
A study of U.S. children across ethnic and racial groups found that Asians were least likely to receive therapy for ADHD, compared with White children – who had the highest odds of getting some kind of treatment over other groups.
Other studies have identified disparity problems in ADHD diagnosis, although results have varied on inequality metrics. Few studies have looked at Asians separately, according to the study’s lead author, Yu Shi, MD, MPH. “They were usually just classified as ‘other’ or as non-White,” Dr. Shi, a consultant with the Mayo Clinic’s division of pediatric anesthesia in Rochester, Minn., said in an interview.
, and the way in which clinicians interpret behavior and apply diagnostic criteria.
“Further understanding of how treatment patterns for ADHD may differ based on race, at the time of initial diagnosis and in the early stages of treatment, may help all children receive appropriate evidence-based care,” Dr. Shi and colleagues reported in JAMA Network Open.
Researchers develop large birth cohort
Dr. Shi and colleagues hypothesized that non-Hispanic White children had a greater chance of getting diagnosed and treated within the first year of diagnosis than that of other ethnic and racial cohorts. Using administrative claims data with socioeconomic status information from a national commercial insurance warehouse, they constructed a retrospective birth cohort of children born between Jan. 1, 2006, and Dec. 31, 2012. The children had continuous insurance coverage for at least 4 years, and represented non-Hispanic Whites, Blacks, Hispanics, and Asians. Self-reporting identified the race/ethnicity groups.
Investigators analyzed ADHD diagnosis and treatment data on 238,011 children between October 2019 and December 2020, using a multivariate Cox regression model to adjust for sex, region, and household income. Primary and secondary outcomes included ADHD diagnosis as defined by recent ICD codes, ADHD behavior, and medication therapies in the clinical setting after initial diagnosis, respectively.
Whites made up most of the cohort (72.7%), followed by Hispanics (9.8%), Asians (6.7%), and Blacks (6.2%). Nearly half the population was female (48.8%). During the follow-up period with these children, 11,401, or 4.8%, had received an ADHD diagnosis. Mean age of diagnosis was 6.5 years, and overall incidence of ADHD was 69 per 10,000 person years (95% confidence interval, 68-70).
Pediatricians were most likely to make an ADHD diagnosis, although the study cited other clinicians, such as psychiatrists, neurologists, psychologists, and family practice clinicians, as responsible for these decisions.
Children diagnosed with ADHD had more years of coverage in the data set, and were more likely to be White and male. The Southern census region had a higher representation of diagnoses (50.6%) than did the Northeast region (11.8%).
Asians at highest odds for no treatment
Taking a closer look at race and ethnicity, Whites had the highest cumulative incidence of ADHD (14.19%), versus Asian children, who had lowest incidence (6.08%). “The curves for Black and Hispanic children were similar in shape and slightly lower than that for White children,” reported the investigators.
White children had higher odds of receiving some kind of treatment, compared with the other groups.
Incidence of medication treatment was lower among Asians and Hispanics. In a striking finding, Asians were most likely to receive no treatment at all (odds ratio compared with White children, 0.54; 95% confidence interval, 0.42-0.70). “However, the percentage of Asian children receiving psychotherapy was not significantly lower than other groups, which is different than a 2013 study finding that Asian children with ADHD were less likely to use mental health services,” they noted.
Most of the patients received medication (32.4%) in the first year after diagnosis, whereas (19.4%) received behavioral therapy only. Nineteen percent had both. More than 29% of these cases had no claims associated with either treatment. Among school-aged children, 65.5% were prescribed medications, compared with just 14.4% who received therapy. Twenty percent had no treatment.
Diagnosis with another disorder often preceded ADHD diagnosis. Results varied among racial groups. White children were more likely than were Black children to be diagnosed with an anxiety or adjustment disorder. Relative to White children, Asians were more likely to be diagnosed with autism spectrum disorder, speech sound disorders, or unspecified neurodevelopmental disorders. Even after an ADHD diagnosis, clinicians were more likely to diagnose Asian children with autism.
Parents may influence treatment decisions
Parental views and preferences may explain some of the variations in diagnosis and treatment among the racial/ethnic groups.
“In order for a diagnosis of ADHD to happen, a parent has first to recognize a problem and bring a child for clinical evaluation,” said Dr. Shi. “A certain behavior could be viewed as normal or a problem depending on a person’s cultural or racial background.” It’s unclear whether clinicians played any role in diagnosis disparities, he added. Patients’ concerns about racism might also influence the desire to get treated in health care systems.
Overall, the findings underscore the presence of racial and ethnic disparities in ADHD diagnosis and treatment. Future research should explore the underlying mechanisms, Dr. Shi suggested. While he and his colleagues have no immediate plans to do another ADHD study, “we’re planning on research to understand disparities in surgery in children,” he said.
The authors cited numerous limitations with their study. Use of ICD codes to identify cases might not have represented true clinical diagnosis, since the data were collected for billing, not research purposes. Investigators drew participants from a commercial insurance database, which did not necessarily reflect all U.S. children. The results might not represent a large number of children covered by Medicaid, for example, noted Dr. Shi. “It is more difficult to work with Medicaid data because there’s no national-level Medicaid data for research. Only state-level data is available.”
Because of other data gaps, Dr. Shi and colleagues might have underestimated the number of children in therapy.
A need for ‘culturally sensitive care’
The findings “ultimately demonstrate the need for culturally sensitive care in the diagnosis and treatment of children and adolescents,” said Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., who was not involved with the study. She specializes in child and adolescent psychiatry.
The exact cause for racial disparity in diagnosis and treatment of ADHD is unknown and likely multifaceted, she continued. “It may be due to differences in the way that disruptive behaviors are interrupted based on factors such as race. This study found that Asian parents often brought their children in for evaluation for reasons other than ADHD. Concerns surrounding the stigma of mental health treatment and racism also could contribute to the disparity in diagnosis and treatment,” she said.
Dr. Bell said she hopes to see future studies that address the impact of social determinants of health on mental illness and investigate underlying causes that contribute to disparities in treatment and diagnosis.
The Mayo Clinic supported the study but had no role in its design or research methods. The authors reported no conflicts of interest.
A study of U.S. children across ethnic and racial groups found that Asians were least likely to receive therapy for ADHD, compared with White children – who had the highest odds of getting some kind of treatment over other groups.
Other studies have identified disparity problems in ADHD diagnosis, although results have varied on inequality metrics. Few studies have looked at Asians separately, according to the study’s lead author, Yu Shi, MD, MPH. “They were usually just classified as ‘other’ or as non-White,” Dr. Shi, a consultant with the Mayo Clinic’s division of pediatric anesthesia in Rochester, Minn., said in an interview.
, and the way in which clinicians interpret behavior and apply diagnostic criteria.
“Further understanding of how treatment patterns for ADHD may differ based on race, at the time of initial diagnosis and in the early stages of treatment, may help all children receive appropriate evidence-based care,” Dr. Shi and colleagues reported in JAMA Network Open.
Researchers develop large birth cohort
Dr. Shi and colleagues hypothesized that non-Hispanic White children had a greater chance of getting diagnosed and treated within the first year of diagnosis than that of other ethnic and racial cohorts. Using administrative claims data with socioeconomic status information from a national commercial insurance warehouse, they constructed a retrospective birth cohort of children born between Jan. 1, 2006, and Dec. 31, 2012. The children had continuous insurance coverage for at least 4 years, and represented non-Hispanic Whites, Blacks, Hispanics, and Asians. Self-reporting identified the race/ethnicity groups.
Investigators analyzed ADHD diagnosis and treatment data on 238,011 children between October 2019 and December 2020, using a multivariate Cox regression model to adjust for sex, region, and household income. Primary and secondary outcomes included ADHD diagnosis as defined by recent ICD codes, ADHD behavior, and medication therapies in the clinical setting after initial diagnosis, respectively.
Whites made up most of the cohort (72.7%), followed by Hispanics (9.8%), Asians (6.7%), and Blacks (6.2%). Nearly half the population was female (48.8%). During the follow-up period with these children, 11,401, or 4.8%, had received an ADHD diagnosis. Mean age of diagnosis was 6.5 years, and overall incidence of ADHD was 69 per 10,000 person years (95% confidence interval, 68-70).
Pediatricians were most likely to make an ADHD diagnosis, although the study cited other clinicians, such as psychiatrists, neurologists, psychologists, and family practice clinicians, as responsible for these decisions.
Children diagnosed with ADHD had more years of coverage in the data set, and were more likely to be White and male. The Southern census region had a higher representation of diagnoses (50.6%) than did the Northeast region (11.8%).
Asians at highest odds for no treatment
Taking a closer look at race and ethnicity, Whites had the highest cumulative incidence of ADHD (14.19%), versus Asian children, who had lowest incidence (6.08%). “The curves for Black and Hispanic children were similar in shape and slightly lower than that for White children,” reported the investigators.
White children had higher odds of receiving some kind of treatment, compared with the other groups.
Incidence of medication treatment was lower among Asians and Hispanics. In a striking finding, Asians were most likely to receive no treatment at all (odds ratio compared with White children, 0.54; 95% confidence interval, 0.42-0.70). “However, the percentage of Asian children receiving psychotherapy was not significantly lower than other groups, which is different than a 2013 study finding that Asian children with ADHD were less likely to use mental health services,” they noted.
Most of the patients received medication (32.4%) in the first year after diagnosis, whereas (19.4%) received behavioral therapy only. Nineteen percent had both. More than 29% of these cases had no claims associated with either treatment. Among school-aged children, 65.5% were prescribed medications, compared with just 14.4% who received therapy. Twenty percent had no treatment.
Diagnosis with another disorder often preceded ADHD diagnosis. Results varied among racial groups. White children were more likely than were Black children to be diagnosed with an anxiety or adjustment disorder. Relative to White children, Asians were more likely to be diagnosed with autism spectrum disorder, speech sound disorders, or unspecified neurodevelopmental disorders. Even after an ADHD diagnosis, clinicians were more likely to diagnose Asian children with autism.
Parents may influence treatment decisions
Parental views and preferences may explain some of the variations in diagnosis and treatment among the racial/ethnic groups.
“In order for a diagnosis of ADHD to happen, a parent has first to recognize a problem and bring a child for clinical evaluation,” said Dr. Shi. “A certain behavior could be viewed as normal or a problem depending on a person’s cultural or racial background.” It’s unclear whether clinicians played any role in diagnosis disparities, he added. Patients’ concerns about racism might also influence the desire to get treated in health care systems.
Overall, the findings underscore the presence of racial and ethnic disparities in ADHD diagnosis and treatment. Future research should explore the underlying mechanisms, Dr. Shi suggested. While he and his colleagues have no immediate plans to do another ADHD study, “we’re planning on research to understand disparities in surgery in children,” he said.
The authors cited numerous limitations with their study. Use of ICD codes to identify cases might not have represented true clinical diagnosis, since the data were collected for billing, not research purposes. Investigators drew participants from a commercial insurance database, which did not necessarily reflect all U.S. children. The results might not represent a large number of children covered by Medicaid, for example, noted Dr. Shi. “It is more difficult to work with Medicaid data because there’s no national-level Medicaid data for research. Only state-level data is available.”
Because of other data gaps, Dr. Shi and colleagues might have underestimated the number of children in therapy.
A need for ‘culturally sensitive care’
The findings “ultimately demonstrate the need for culturally sensitive care in the diagnosis and treatment of children and adolescents,” said Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., who was not involved with the study. She specializes in child and adolescent psychiatry.
The exact cause for racial disparity in diagnosis and treatment of ADHD is unknown and likely multifaceted, she continued. “It may be due to differences in the way that disruptive behaviors are interrupted based on factors such as race. This study found that Asian parents often brought their children in for evaluation for reasons other than ADHD. Concerns surrounding the stigma of mental health treatment and racism also could contribute to the disparity in diagnosis and treatment,” she said.
Dr. Bell said she hopes to see future studies that address the impact of social determinants of health on mental illness and investigate underlying causes that contribute to disparities in treatment and diagnosis.
The Mayo Clinic supported the study but had no role in its design or research methods. The authors reported no conflicts of interest.
A study of U.S. children across ethnic and racial groups found that Asians were least likely to receive therapy for ADHD, compared with White children – who had the highest odds of getting some kind of treatment over other groups.
Other studies have identified disparity problems in ADHD diagnosis, although results have varied on inequality metrics. Few studies have looked at Asians separately, according to the study’s lead author, Yu Shi, MD, MPH. “They were usually just classified as ‘other’ or as non-White,” Dr. Shi, a consultant with the Mayo Clinic’s division of pediatric anesthesia in Rochester, Minn., said in an interview.
, and the way in which clinicians interpret behavior and apply diagnostic criteria.
“Further understanding of how treatment patterns for ADHD may differ based on race, at the time of initial diagnosis and in the early stages of treatment, may help all children receive appropriate evidence-based care,” Dr. Shi and colleagues reported in JAMA Network Open.
Researchers develop large birth cohort
Dr. Shi and colleagues hypothesized that non-Hispanic White children had a greater chance of getting diagnosed and treated within the first year of diagnosis than that of other ethnic and racial cohorts. Using administrative claims data with socioeconomic status information from a national commercial insurance warehouse, they constructed a retrospective birth cohort of children born between Jan. 1, 2006, and Dec. 31, 2012. The children had continuous insurance coverage for at least 4 years, and represented non-Hispanic Whites, Blacks, Hispanics, and Asians. Self-reporting identified the race/ethnicity groups.
Investigators analyzed ADHD diagnosis and treatment data on 238,011 children between October 2019 and December 2020, using a multivariate Cox regression model to adjust for sex, region, and household income. Primary and secondary outcomes included ADHD diagnosis as defined by recent ICD codes, ADHD behavior, and medication therapies in the clinical setting after initial diagnosis, respectively.
Whites made up most of the cohort (72.7%), followed by Hispanics (9.8%), Asians (6.7%), and Blacks (6.2%). Nearly half the population was female (48.8%). During the follow-up period with these children, 11,401, or 4.8%, had received an ADHD diagnosis. Mean age of diagnosis was 6.5 years, and overall incidence of ADHD was 69 per 10,000 person years (95% confidence interval, 68-70).
Pediatricians were most likely to make an ADHD diagnosis, although the study cited other clinicians, such as psychiatrists, neurologists, psychologists, and family practice clinicians, as responsible for these decisions.
Children diagnosed with ADHD had more years of coverage in the data set, and were more likely to be White and male. The Southern census region had a higher representation of diagnoses (50.6%) than did the Northeast region (11.8%).
Asians at highest odds for no treatment
Taking a closer look at race and ethnicity, Whites had the highest cumulative incidence of ADHD (14.19%), versus Asian children, who had lowest incidence (6.08%). “The curves for Black and Hispanic children were similar in shape and slightly lower than that for White children,” reported the investigators.
White children had higher odds of receiving some kind of treatment, compared with the other groups.
Incidence of medication treatment was lower among Asians and Hispanics. In a striking finding, Asians were most likely to receive no treatment at all (odds ratio compared with White children, 0.54; 95% confidence interval, 0.42-0.70). “However, the percentage of Asian children receiving psychotherapy was not significantly lower than other groups, which is different than a 2013 study finding that Asian children with ADHD were less likely to use mental health services,” they noted.
Most of the patients received medication (32.4%) in the first year after diagnosis, whereas (19.4%) received behavioral therapy only. Nineteen percent had both. More than 29% of these cases had no claims associated with either treatment. Among school-aged children, 65.5% were prescribed medications, compared with just 14.4% who received therapy. Twenty percent had no treatment.
Diagnosis with another disorder often preceded ADHD diagnosis. Results varied among racial groups. White children were more likely than were Black children to be diagnosed with an anxiety or adjustment disorder. Relative to White children, Asians were more likely to be diagnosed with autism spectrum disorder, speech sound disorders, or unspecified neurodevelopmental disorders. Even after an ADHD diagnosis, clinicians were more likely to diagnose Asian children with autism.
Parents may influence treatment decisions
Parental views and preferences may explain some of the variations in diagnosis and treatment among the racial/ethnic groups.
“In order for a diagnosis of ADHD to happen, a parent has first to recognize a problem and bring a child for clinical evaluation,” said Dr. Shi. “A certain behavior could be viewed as normal or a problem depending on a person’s cultural or racial background.” It’s unclear whether clinicians played any role in diagnosis disparities, he added. Patients’ concerns about racism might also influence the desire to get treated in health care systems.
Overall, the findings underscore the presence of racial and ethnic disparities in ADHD diagnosis and treatment. Future research should explore the underlying mechanisms, Dr. Shi suggested. While he and his colleagues have no immediate plans to do another ADHD study, “we’re planning on research to understand disparities in surgery in children,” he said.
The authors cited numerous limitations with their study. Use of ICD codes to identify cases might not have represented true clinical diagnosis, since the data were collected for billing, not research purposes. Investigators drew participants from a commercial insurance database, which did not necessarily reflect all U.S. children. The results might not represent a large number of children covered by Medicaid, for example, noted Dr. Shi. “It is more difficult to work with Medicaid data because there’s no national-level Medicaid data for research. Only state-level data is available.”
Because of other data gaps, Dr. Shi and colleagues might have underestimated the number of children in therapy.
A need for ‘culturally sensitive care’
The findings “ultimately demonstrate the need for culturally sensitive care in the diagnosis and treatment of children and adolescents,” said Tiffani L. Bell, MD, a psychiatrist in Winston-Salem, N.C., who was not involved with the study. She specializes in child and adolescent psychiatry.
The exact cause for racial disparity in diagnosis and treatment of ADHD is unknown and likely multifaceted, she continued. “It may be due to differences in the way that disruptive behaviors are interrupted based on factors such as race. This study found that Asian parents often brought their children in for evaluation for reasons other than ADHD. Concerns surrounding the stigma of mental health treatment and racism also could contribute to the disparity in diagnosis and treatment,” she said.
Dr. Bell said she hopes to see future studies that address the impact of social determinants of health on mental illness and investigate underlying causes that contribute to disparities in treatment and diagnosis.
The Mayo Clinic supported the study but had no role in its design or research methods. The authors reported no conflicts of interest.
FROM JAMA NETWORK OPEN
Boosting the presence of darker skin in rheumatology education
Studies are flagging racial and ethnic disparities in rheumatology training materials, pointing to a need to boost representation of darker skin tones and better educate physicians in evaluating this cohort.
Not enough is known about these disparities in rheumatology education, despite the fact that minorities make up 40% of the population in the United States.
The problem starts with books and references used in medical schools, Lynn McKinley-Grant, MD, immediate past president of the Skin of Color Society and associate professor of dermatology at Howard University, Washington, said in an interview. “In the medical literature there has been a dearth of images in skin of color in all specialties,” she said. With an increased diversity in the U.S. population, there is a need for health care providers to be able to recognize disease patterns in all skin types.” If a physician is training at an institution where there are not many patients of color in the community, the rheumatologists are even more limited in terms of their clinical experience.
This lack of training in diagnosis of disease has serious clinical repercussions, as seen in COVID cases, Dr. McKinley-Grant noted. “You end up not being able to recognize early erythema, jaundice, anemia, or hypoxemia because those conditions are a different color or pattern in the darker skin types. This can lead to errors in treatment, diagnosis, and medical care, resulting in increased morbidity and mortality.”
Studies point to education gaps
A team of researchers from Washington University in St. Louis called attention to this issue at the American College of Rhematology’s Convergence 2020 conference.
“Patients of color with lupus are especially vulnerable as they often carry a greater disease burden, yet studies show that individuals with darker skin tones are underrepresented in medical educational materials,” Vijay Kannuthurai, MD, and colleagues wrote in their study abstract. The team surveyed 132 providers in St. Louis, Mo., on their confidence in evaluating any rash, and rashes in patients with lupus and varied skin tones.
Participating clinicians, mostly rheumatologists, dermatologists, or internists, had a higher confidence level in diagnosing any rash versus lupus rashes, but were considerably less confident in diagnosing lupus rash on darker skin, compared with those on fair skin. This represents “a disparity between provider confidence and the patient population lupus traditionally affects,” the investigators concluded.
Another recent study found evidence of disparities in clinical education resources. “The lack of dark skin representation among rheumatology educational materials contributes to the implicit bias and structural racism present in medical education by promoting White-only models of disease,” lead author Adrienne Strait, a medical student at the University of California, San Francisco, said in an interview. “Given that rheumatic diseases disproportionately impact racial and ethnic minorities, we felt it was important to examine the representation of these groups within rheumatology training resources.”
She and her colleagues gathered images of rheumatic diseases from four major databases: the American College of Rheumatology’s Image Library, UpToDate, the New England Journal of Medicine Images in Clinical Medicine and Clinical Cases filtered by “Rheumatology,” and the 9th edition of Kelley’s Textbook of Rheumatology. They used Fitzpatrick’s skin phototypes to independently code images depicting skin as “light” (skin types I-IV), “dark” (skin types V-VI), or “indeterminate,” focusing on systemic lupus erythematosus (SLE) and rheumatoid arthritis, two conditions with a known connection to racial and ethnic health disparities.
Taking into account the high incidence of sarcoidosis and SLE in Black patients when compared with White patients, the investigators did a secondary analysis that excluded these cases.
Among 1,043 patient images studied, just 13.4% represented dark skin, compared with 84% that represented light skin. More than 2% represented an indeterminate skin color. Comparing dark-skin representation in the clinical images and SLE images with the representation of Asian, Native American, and Black individuals in the United States and within lupus cases nationally, the investigators found significant underrepresentation of dark skin.
Only 4.2% of RA images had dark-skin representation, making RA one of the diseases with the lowest representation in the study, along with juvenile idiopathic arthritis, the spondyloarthropathies, and Kawasaki disease. “Representation of dark skin in SLE was also lower than the proportion of Black individuals in SLE studies,” the investigators noted. Overall, representation of dark skin in SLE images was just 22.6%. Sarcoidosis comparatively had the largest representation of dark-skin images (69.6%, n = 32).
“Excluding sarcoidosis and SLE images, the overall representation of dark skin was 9.4% (n = 84), which was significantly lower than the proportion of Asian, Native American, and Black individuals within the U.S. Census population,” according to Ms. Strait and her associates. UpToDate contained the largest proportion of images of dark skin respective to other databases, whereas Kelley’s Textbook had the smallest.
Actionable steps
Many physicians are willing to improve upon their skills in identifying conditions on darker skin, as the study by Dr. Kannuthurai and associates suggests. Overall, 93% of the survey’s participants wanted to learn more about rashes in patients of color. “Future educational interventions may help practitioners improve their confidence when diagnosing rashes in lupus patients” with darker skin, they suggested.
Ms. Strait and her colleagues recommended a series of actionable steps to improve diversity and equity of dark skin tone representation in rheumatology curricula.
Editors of educational resources, for example, should make image diversity a priority for those diseases that are most commonly associated with cutaneous manifestations, such as SLE, vasculitis, inflammatory myopathies, systemic sclerosis, sarcoidosis, and psoriasis. They also called for educators in academic rheumatology programs to collaborate to improve diversity in resources used at the undergraduate and graduate medical education level.
Efforts should take place at the local, regional, and national level to publicly discuss and educate clinicians about rheumatic diseases in individuals of color. Speakers at rheumatology conferences should strive to educate learners about presentations of rheumatic diseases in individuals of color. The ACR in the meantime could establish a task force to enhance racial and ethnic diversity in their image library and other published resources.
“These steps may improve provider recognition and diagnosis of rheumatic disease manifestations in skin of color, which may in turn reduce health disparities among racial and ethnic minority groups,” Ms. Strait said.
Beth L. Jonas, MD, chair of the ACR’s Committee on Rheumatology Training and Workforce Issues, called the findings of this study “timely and important.” The researchers highlighted a deficiency in rheumatology training materials that needs addressing, she said in an interview. “I definitely agree that ACR needs to be mindful of this. There’s no doubt that we need to take these recommendations and move along these lines.”
The ACR took a first step in 2020 with the creation of a diversity, equity, and inclusion committee. “We are undergoing a college-wide look at what we do, with an eye toward inclusion. There is a strong interest in addressing health disparities and being an equitable and inclusive community of rheumatology health care professionals,” said Dr. Jonas, chief of the University of North Carolina at Chapel Hill’s division of rheumatology, allergy, and immunology.
The American Academy of Dermatology is also working to improve the image library with images of disease in skin of color. “Everyone’s jumping on this now,” Dr. McKinley-Grant observed. The medical profession can’t afford not to. It’s a life-threatening issue when rheumatoid arthritis and other diseases in people of color aren’t diagnosed early and correctly, she added.
Technologies seek to reduce bias
While many organizations are taking steps to improve representation of darker skin images, VisualDx has taken the lead on this, she said. “They’ve been doing this for years now. There are over 14,000 images of disease in skin of color, including all the rheumatologic diseases. There’s a mobile app and desktop decision support system, and it is very popular. A majority of medical schools have this as a library resource, and hospital systems license it for EHR integration.” Doctors can also get it individually. This enables them to share images and handouts of a diagnosis and select images of patients of color, said Dr. McKinley-Grant, who uses the VisualDx smartphone app DermExpert, which is an app for nondermatologists that features an image library of skin lesions, including darker-skin images.
ProjectIMPACT, powered by VisualDx, is another effort to support reducing health care bias in darker skin. The project is a collaboration between the New England Journal of Medicine Group and the Skin Of Color Society. According to Dr. McKinley-Grant, the organizers are building awareness of the importance of reducing the educational and clinical gaps in diagnosing patients of color and trying to get students and educators to pledge to take meaningful steps and to have real-world impact.
This isn’t just exclusive to dermatology and rheumatology – it involves all medical specialties, she stressed.
ProjectIMPACT isn’t just a resource for physicians, she continued. Librarians can also use it to develop more resources on skin of color.
The Skin Of Color Society and VisualDx have also partnered with the NEJM Group to develop a comprehensive virtual series on the impact of skin color and ethnicity on clinical research. The four-part series addresses structural racism and racial bias in medicine, hair disorders in people of color, pigmentary disorders, keloids, COVID-19 comorbidities, and cutaneous manifestations of systemic diseases in children and adults.
Nuances of recognizing disease
As a medical student, Dr. McKinley-Grant said she was fortunate to attend the Albert Schweitzer Hospital in Lambarene, Gabon, on a fellowship. For 3 months, she gained a wealth of experience examining only African patients with brown skin.
In her other training in medicine, “I’ve been at institutions with diverse populations, in Boston, New York, and Washington,” learning more about all different skin pigments.
This type of training should be more widely available, especially now, with COVID-19 producing new manifestations of skin lesions, she emphasized. Such efforts involve a diversification of images physicians are being trained on so that they can recognize the same disease in a person of color.
“Doctors have to be able to recognize different colors, different shades of brown and shades of white. Not all white skin is the same color,” she noted. In looking at a rash or lesion, “you have to learn how to discern differences in the background color of the skin, which is determined by melanin in the skin (Fitzpatrick skin types I-VI) and by what’s going on in the blood, such as how much oxygen and hemoglobin the patient has in their blood.” Inflammation and infection (erythema) will appear more violaceous in IV-VI skin types, for example.
At the University of North Carolina at Chapel Hill, a group of students and faculty have created a dermatology image library to address the deficiency in the availability of images for teaching purposes. “Our medical students recognized the gap and started this,” Dr. Jonas said. Julie Mervak, MD, assistant professor of dermatology, is spearheading this effort, with students Linnea Westerkam and Anuj Pranav Sanghvi.
“I understand that others around the country are working on similar initiatives,” Dr. Jonas said.
None of the sources for this story had any relevant disclosures.
Studies are flagging racial and ethnic disparities in rheumatology training materials, pointing to a need to boost representation of darker skin tones and better educate physicians in evaluating this cohort.
Not enough is known about these disparities in rheumatology education, despite the fact that minorities make up 40% of the population in the United States.
The problem starts with books and references used in medical schools, Lynn McKinley-Grant, MD, immediate past president of the Skin of Color Society and associate professor of dermatology at Howard University, Washington, said in an interview. “In the medical literature there has been a dearth of images in skin of color in all specialties,” she said. With an increased diversity in the U.S. population, there is a need for health care providers to be able to recognize disease patterns in all skin types.” If a physician is training at an institution where there are not many patients of color in the community, the rheumatologists are even more limited in terms of their clinical experience.
This lack of training in diagnosis of disease has serious clinical repercussions, as seen in COVID cases, Dr. McKinley-Grant noted. “You end up not being able to recognize early erythema, jaundice, anemia, or hypoxemia because those conditions are a different color or pattern in the darker skin types. This can lead to errors in treatment, diagnosis, and medical care, resulting in increased morbidity and mortality.”
Studies point to education gaps
A team of researchers from Washington University in St. Louis called attention to this issue at the American College of Rhematology’s Convergence 2020 conference.
“Patients of color with lupus are especially vulnerable as they often carry a greater disease burden, yet studies show that individuals with darker skin tones are underrepresented in medical educational materials,” Vijay Kannuthurai, MD, and colleagues wrote in their study abstract. The team surveyed 132 providers in St. Louis, Mo., on their confidence in evaluating any rash, and rashes in patients with lupus and varied skin tones.
Participating clinicians, mostly rheumatologists, dermatologists, or internists, had a higher confidence level in diagnosing any rash versus lupus rashes, but were considerably less confident in diagnosing lupus rash on darker skin, compared with those on fair skin. This represents “a disparity between provider confidence and the patient population lupus traditionally affects,” the investigators concluded.
Another recent study found evidence of disparities in clinical education resources. “The lack of dark skin representation among rheumatology educational materials contributes to the implicit bias and structural racism present in medical education by promoting White-only models of disease,” lead author Adrienne Strait, a medical student at the University of California, San Francisco, said in an interview. “Given that rheumatic diseases disproportionately impact racial and ethnic minorities, we felt it was important to examine the representation of these groups within rheumatology training resources.”
She and her colleagues gathered images of rheumatic diseases from four major databases: the American College of Rheumatology’s Image Library, UpToDate, the New England Journal of Medicine Images in Clinical Medicine and Clinical Cases filtered by “Rheumatology,” and the 9th edition of Kelley’s Textbook of Rheumatology. They used Fitzpatrick’s skin phototypes to independently code images depicting skin as “light” (skin types I-IV), “dark” (skin types V-VI), or “indeterminate,” focusing on systemic lupus erythematosus (SLE) and rheumatoid arthritis, two conditions with a known connection to racial and ethnic health disparities.
Taking into account the high incidence of sarcoidosis and SLE in Black patients when compared with White patients, the investigators did a secondary analysis that excluded these cases.
Among 1,043 patient images studied, just 13.4% represented dark skin, compared with 84% that represented light skin. More than 2% represented an indeterminate skin color. Comparing dark-skin representation in the clinical images and SLE images with the representation of Asian, Native American, and Black individuals in the United States and within lupus cases nationally, the investigators found significant underrepresentation of dark skin.
Only 4.2% of RA images had dark-skin representation, making RA one of the diseases with the lowest representation in the study, along with juvenile idiopathic arthritis, the spondyloarthropathies, and Kawasaki disease. “Representation of dark skin in SLE was also lower than the proportion of Black individuals in SLE studies,” the investigators noted. Overall, representation of dark skin in SLE images was just 22.6%. Sarcoidosis comparatively had the largest representation of dark-skin images (69.6%, n = 32).
“Excluding sarcoidosis and SLE images, the overall representation of dark skin was 9.4% (n = 84), which was significantly lower than the proportion of Asian, Native American, and Black individuals within the U.S. Census population,” according to Ms. Strait and her associates. UpToDate contained the largest proportion of images of dark skin respective to other databases, whereas Kelley’s Textbook had the smallest.
Actionable steps
Many physicians are willing to improve upon their skills in identifying conditions on darker skin, as the study by Dr. Kannuthurai and associates suggests. Overall, 93% of the survey’s participants wanted to learn more about rashes in patients of color. “Future educational interventions may help practitioners improve their confidence when diagnosing rashes in lupus patients” with darker skin, they suggested.
Ms. Strait and her colleagues recommended a series of actionable steps to improve diversity and equity of dark skin tone representation in rheumatology curricula.
Editors of educational resources, for example, should make image diversity a priority for those diseases that are most commonly associated with cutaneous manifestations, such as SLE, vasculitis, inflammatory myopathies, systemic sclerosis, sarcoidosis, and psoriasis. They also called for educators in academic rheumatology programs to collaborate to improve diversity in resources used at the undergraduate and graduate medical education level.
Efforts should take place at the local, regional, and national level to publicly discuss and educate clinicians about rheumatic diseases in individuals of color. Speakers at rheumatology conferences should strive to educate learners about presentations of rheumatic diseases in individuals of color. The ACR in the meantime could establish a task force to enhance racial and ethnic diversity in their image library and other published resources.
“These steps may improve provider recognition and diagnosis of rheumatic disease manifestations in skin of color, which may in turn reduce health disparities among racial and ethnic minority groups,” Ms. Strait said.
Beth L. Jonas, MD, chair of the ACR’s Committee on Rheumatology Training and Workforce Issues, called the findings of this study “timely and important.” The researchers highlighted a deficiency in rheumatology training materials that needs addressing, she said in an interview. “I definitely agree that ACR needs to be mindful of this. There’s no doubt that we need to take these recommendations and move along these lines.”
The ACR took a first step in 2020 with the creation of a diversity, equity, and inclusion committee. “We are undergoing a college-wide look at what we do, with an eye toward inclusion. There is a strong interest in addressing health disparities and being an equitable and inclusive community of rheumatology health care professionals,” said Dr. Jonas, chief of the University of North Carolina at Chapel Hill’s division of rheumatology, allergy, and immunology.
The American Academy of Dermatology is also working to improve the image library with images of disease in skin of color. “Everyone’s jumping on this now,” Dr. McKinley-Grant observed. The medical profession can’t afford not to. It’s a life-threatening issue when rheumatoid arthritis and other diseases in people of color aren’t diagnosed early and correctly, she added.
Technologies seek to reduce bias
While many organizations are taking steps to improve representation of darker skin images, VisualDx has taken the lead on this, she said. “They’ve been doing this for years now. There are over 14,000 images of disease in skin of color, including all the rheumatologic diseases. There’s a mobile app and desktop decision support system, and it is very popular. A majority of medical schools have this as a library resource, and hospital systems license it for EHR integration.” Doctors can also get it individually. This enables them to share images and handouts of a diagnosis and select images of patients of color, said Dr. McKinley-Grant, who uses the VisualDx smartphone app DermExpert, which is an app for nondermatologists that features an image library of skin lesions, including darker-skin images.
ProjectIMPACT, powered by VisualDx, is another effort to support reducing health care bias in darker skin. The project is a collaboration between the New England Journal of Medicine Group and the Skin Of Color Society. According to Dr. McKinley-Grant, the organizers are building awareness of the importance of reducing the educational and clinical gaps in diagnosing patients of color and trying to get students and educators to pledge to take meaningful steps and to have real-world impact.
This isn’t just exclusive to dermatology and rheumatology – it involves all medical specialties, she stressed.
ProjectIMPACT isn’t just a resource for physicians, she continued. Librarians can also use it to develop more resources on skin of color.
The Skin Of Color Society and VisualDx have also partnered with the NEJM Group to develop a comprehensive virtual series on the impact of skin color and ethnicity on clinical research. The four-part series addresses structural racism and racial bias in medicine, hair disorders in people of color, pigmentary disorders, keloids, COVID-19 comorbidities, and cutaneous manifestations of systemic diseases in children and adults.
Nuances of recognizing disease
As a medical student, Dr. McKinley-Grant said she was fortunate to attend the Albert Schweitzer Hospital in Lambarene, Gabon, on a fellowship. For 3 months, she gained a wealth of experience examining only African patients with brown skin.
In her other training in medicine, “I’ve been at institutions with diverse populations, in Boston, New York, and Washington,” learning more about all different skin pigments.
This type of training should be more widely available, especially now, with COVID-19 producing new manifestations of skin lesions, she emphasized. Such efforts involve a diversification of images physicians are being trained on so that they can recognize the same disease in a person of color.
“Doctors have to be able to recognize different colors, different shades of brown and shades of white. Not all white skin is the same color,” she noted. In looking at a rash or lesion, “you have to learn how to discern differences in the background color of the skin, which is determined by melanin in the skin (Fitzpatrick skin types I-VI) and by what’s going on in the blood, such as how much oxygen and hemoglobin the patient has in their blood.” Inflammation and infection (erythema) will appear more violaceous in IV-VI skin types, for example.
At the University of North Carolina at Chapel Hill, a group of students and faculty have created a dermatology image library to address the deficiency in the availability of images for teaching purposes. “Our medical students recognized the gap and started this,” Dr. Jonas said. Julie Mervak, MD, assistant professor of dermatology, is spearheading this effort, with students Linnea Westerkam and Anuj Pranav Sanghvi.
“I understand that others around the country are working on similar initiatives,” Dr. Jonas said.
None of the sources for this story had any relevant disclosures.
Studies are flagging racial and ethnic disparities in rheumatology training materials, pointing to a need to boost representation of darker skin tones and better educate physicians in evaluating this cohort.
Not enough is known about these disparities in rheumatology education, despite the fact that minorities make up 40% of the population in the United States.
The problem starts with books and references used in medical schools, Lynn McKinley-Grant, MD, immediate past president of the Skin of Color Society and associate professor of dermatology at Howard University, Washington, said in an interview. “In the medical literature there has been a dearth of images in skin of color in all specialties,” she said. With an increased diversity in the U.S. population, there is a need for health care providers to be able to recognize disease patterns in all skin types.” If a physician is training at an institution where there are not many patients of color in the community, the rheumatologists are even more limited in terms of their clinical experience.
This lack of training in diagnosis of disease has serious clinical repercussions, as seen in COVID cases, Dr. McKinley-Grant noted. “You end up not being able to recognize early erythema, jaundice, anemia, or hypoxemia because those conditions are a different color or pattern in the darker skin types. This can lead to errors in treatment, diagnosis, and medical care, resulting in increased morbidity and mortality.”
Studies point to education gaps
A team of researchers from Washington University in St. Louis called attention to this issue at the American College of Rhematology’s Convergence 2020 conference.
“Patients of color with lupus are especially vulnerable as they often carry a greater disease burden, yet studies show that individuals with darker skin tones are underrepresented in medical educational materials,” Vijay Kannuthurai, MD, and colleagues wrote in their study abstract. The team surveyed 132 providers in St. Louis, Mo., on their confidence in evaluating any rash, and rashes in patients with lupus and varied skin tones.
Participating clinicians, mostly rheumatologists, dermatologists, or internists, had a higher confidence level in diagnosing any rash versus lupus rashes, but were considerably less confident in diagnosing lupus rash on darker skin, compared with those on fair skin. This represents “a disparity between provider confidence and the patient population lupus traditionally affects,” the investigators concluded.
Another recent study found evidence of disparities in clinical education resources. “The lack of dark skin representation among rheumatology educational materials contributes to the implicit bias and structural racism present in medical education by promoting White-only models of disease,” lead author Adrienne Strait, a medical student at the University of California, San Francisco, said in an interview. “Given that rheumatic diseases disproportionately impact racial and ethnic minorities, we felt it was important to examine the representation of these groups within rheumatology training resources.”
She and her colleagues gathered images of rheumatic diseases from four major databases: the American College of Rheumatology’s Image Library, UpToDate, the New England Journal of Medicine Images in Clinical Medicine and Clinical Cases filtered by “Rheumatology,” and the 9th edition of Kelley’s Textbook of Rheumatology. They used Fitzpatrick’s skin phototypes to independently code images depicting skin as “light” (skin types I-IV), “dark” (skin types V-VI), or “indeterminate,” focusing on systemic lupus erythematosus (SLE) and rheumatoid arthritis, two conditions with a known connection to racial and ethnic health disparities.
Taking into account the high incidence of sarcoidosis and SLE in Black patients when compared with White patients, the investigators did a secondary analysis that excluded these cases.
Among 1,043 patient images studied, just 13.4% represented dark skin, compared with 84% that represented light skin. More than 2% represented an indeterminate skin color. Comparing dark-skin representation in the clinical images and SLE images with the representation of Asian, Native American, and Black individuals in the United States and within lupus cases nationally, the investigators found significant underrepresentation of dark skin.
Only 4.2% of RA images had dark-skin representation, making RA one of the diseases with the lowest representation in the study, along with juvenile idiopathic arthritis, the spondyloarthropathies, and Kawasaki disease. “Representation of dark skin in SLE was also lower than the proportion of Black individuals in SLE studies,” the investigators noted. Overall, representation of dark skin in SLE images was just 22.6%. Sarcoidosis comparatively had the largest representation of dark-skin images (69.6%, n = 32).
“Excluding sarcoidosis and SLE images, the overall representation of dark skin was 9.4% (n = 84), which was significantly lower than the proportion of Asian, Native American, and Black individuals within the U.S. Census population,” according to Ms. Strait and her associates. UpToDate contained the largest proportion of images of dark skin respective to other databases, whereas Kelley’s Textbook had the smallest.
Actionable steps
Many physicians are willing to improve upon their skills in identifying conditions on darker skin, as the study by Dr. Kannuthurai and associates suggests. Overall, 93% of the survey’s participants wanted to learn more about rashes in patients of color. “Future educational interventions may help practitioners improve their confidence when diagnosing rashes in lupus patients” with darker skin, they suggested.
Ms. Strait and her colleagues recommended a series of actionable steps to improve diversity and equity of dark skin tone representation in rheumatology curricula.
Editors of educational resources, for example, should make image diversity a priority for those diseases that are most commonly associated with cutaneous manifestations, such as SLE, vasculitis, inflammatory myopathies, systemic sclerosis, sarcoidosis, and psoriasis. They also called for educators in academic rheumatology programs to collaborate to improve diversity in resources used at the undergraduate and graduate medical education level.
Efforts should take place at the local, regional, and national level to publicly discuss and educate clinicians about rheumatic diseases in individuals of color. Speakers at rheumatology conferences should strive to educate learners about presentations of rheumatic diseases in individuals of color. The ACR in the meantime could establish a task force to enhance racial and ethnic diversity in their image library and other published resources.
“These steps may improve provider recognition and diagnosis of rheumatic disease manifestations in skin of color, which may in turn reduce health disparities among racial and ethnic minority groups,” Ms. Strait said.
Beth L. Jonas, MD, chair of the ACR’s Committee on Rheumatology Training and Workforce Issues, called the findings of this study “timely and important.” The researchers highlighted a deficiency in rheumatology training materials that needs addressing, she said in an interview. “I definitely agree that ACR needs to be mindful of this. There’s no doubt that we need to take these recommendations and move along these lines.”
The ACR took a first step in 2020 with the creation of a diversity, equity, and inclusion committee. “We are undergoing a college-wide look at what we do, with an eye toward inclusion. There is a strong interest in addressing health disparities and being an equitable and inclusive community of rheumatology health care professionals,” said Dr. Jonas, chief of the University of North Carolina at Chapel Hill’s division of rheumatology, allergy, and immunology.
The American Academy of Dermatology is also working to improve the image library with images of disease in skin of color. “Everyone’s jumping on this now,” Dr. McKinley-Grant observed. The medical profession can’t afford not to. It’s a life-threatening issue when rheumatoid arthritis and other diseases in people of color aren’t diagnosed early and correctly, she added.
Technologies seek to reduce bias
While many organizations are taking steps to improve representation of darker skin images, VisualDx has taken the lead on this, she said. “They’ve been doing this for years now. There are over 14,000 images of disease in skin of color, including all the rheumatologic diseases. There’s a mobile app and desktop decision support system, and it is very popular. A majority of medical schools have this as a library resource, and hospital systems license it for EHR integration.” Doctors can also get it individually. This enables them to share images and handouts of a diagnosis and select images of patients of color, said Dr. McKinley-Grant, who uses the VisualDx smartphone app DermExpert, which is an app for nondermatologists that features an image library of skin lesions, including darker-skin images.
ProjectIMPACT, powered by VisualDx, is another effort to support reducing health care bias in darker skin. The project is a collaboration between the New England Journal of Medicine Group and the Skin Of Color Society. According to Dr. McKinley-Grant, the organizers are building awareness of the importance of reducing the educational and clinical gaps in diagnosing patients of color and trying to get students and educators to pledge to take meaningful steps and to have real-world impact.
This isn’t just exclusive to dermatology and rheumatology – it involves all medical specialties, she stressed.
ProjectIMPACT isn’t just a resource for physicians, she continued. Librarians can also use it to develop more resources on skin of color.
The Skin Of Color Society and VisualDx have also partnered with the NEJM Group to develop a comprehensive virtual series on the impact of skin color and ethnicity on clinical research. The four-part series addresses structural racism and racial bias in medicine, hair disorders in people of color, pigmentary disorders, keloids, COVID-19 comorbidities, and cutaneous manifestations of systemic diseases in children and adults.
Nuances of recognizing disease
As a medical student, Dr. McKinley-Grant said she was fortunate to attend the Albert Schweitzer Hospital in Lambarene, Gabon, on a fellowship. For 3 months, she gained a wealth of experience examining only African patients with brown skin.
In her other training in medicine, “I’ve been at institutions with diverse populations, in Boston, New York, and Washington,” learning more about all different skin pigments.
This type of training should be more widely available, especially now, with COVID-19 producing new manifestations of skin lesions, she emphasized. Such efforts involve a diversification of images physicians are being trained on so that they can recognize the same disease in a person of color.
“Doctors have to be able to recognize different colors, different shades of brown and shades of white. Not all white skin is the same color,” she noted. In looking at a rash or lesion, “you have to learn how to discern differences in the background color of the skin, which is determined by melanin in the skin (Fitzpatrick skin types I-VI) and by what’s going on in the blood, such as how much oxygen and hemoglobin the patient has in their blood.” Inflammation and infection (erythema) will appear more violaceous in IV-VI skin types, for example.
At the University of North Carolina at Chapel Hill, a group of students and faculty have created a dermatology image library to address the deficiency in the availability of images for teaching purposes. “Our medical students recognized the gap and started this,” Dr. Jonas said. Julie Mervak, MD, assistant professor of dermatology, is spearheading this effort, with students Linnea Westerkam and Anuj Pranav Sanghvi.
“I understand that others around the country are working on similar initiatives,” Dr. Jonas said.
None of the sources for this story had any relevant disclosures.
Antimicrobial, pH-modulating gel shows promise in preventing common STIs
An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.
Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.
The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.
In the AMPREVENCE study, a double-blinded, placebo-controlled, randomized, phase 2b/3 trial, Todd Chappell, MD, of Adams Patterson Gynecology & Obstetrics, Memphis, and colleagues tested the efficacy and safety of EVO100 to prevent chlamydia and gonorrhea.
Investigators randomized 1:1,860 healthy, sexually active women to receive either EVO100 (n = 426) or placebo (n = 434). Participants had either been diagnosed or treated for these STIs up to 16 weeks prior to enrollment. Among those enrolled, 335 women in the EVO100 arm and 335 women in the placebo arm completed the study.
From this cohort, 764 women (EVO100: n = 376; placebo: n = 388) reported any use of either product. These women represented the “safety analysis population,” a predefined population for statistical analysis.
Participants averaged nearly 28 years of age, had a median body mass index of 28.9 kg/m2, and represented several racial/ethnic groups: White (54.3% [467/860]), African American (41.6% [358/860]), and non-Hispanic/Latinx ethnicity (67.1% [577/860]).
The women were instructed to apply the drug within 1 hour of initiating sexual intercourse. Investigators scheduled follow-up visits every 4 weeks during the 16-week study period, to obtain repeat CT/GC assessments, review diary entries, and to collect information about adverse effects and use of concomitant medications. During enrollment, participants consented to return to the clinic at each study visit. If a woman missed a visit, the study site would follow-up by telephone after the missed assessment visit.
Participants reported a mean number of 16 coital events (EVO100, 15.7 [13.5]; placebo, 16.3 [15.8]). EVO100 significantly reduced STI incidence for both types of STIs. CT infection rates among EVO100 users was 4.8% (14/289), half of what it was in placebo users (9.7% [28/290]) (P = .0256). The investigational method was even more successful in GC-analysis–eligible women: infection rates averaged 0.7% (2/280), compared with 3.2% (9/277) in the placebo group, a relative risk reduction of 78% (P = .0316).
Examining electronic diary entries of the participants, investigators reported similar adherence rates among the two treatment arms. However, additional sensitivity analyses in CT-eligible and GC-eligible populations on adherence yielded notably different results.
EVO100 users in the CT population who used the product as directed 100% of the time were significantly less likely to become infected, compared with the placebo group (2.3% vs. 16.9%, P = .0012). However, investigators found no significant differences in infection rates among women with poorer adherence rates in the two groups. Comparatively, they found no major differences in GC infection rates between the control and EVO100 groups, regardless of adherence rates, likely because of the small number of GC infections reported. Observed adverse events correlated with the drug’s known safety profile.
Most of the participants said they would likely recommend EVO100 to other women and continue using this preventive treatment.
A small GC subgroup caused by fewer infection cases and reliance on participant self-reporting of coital incidents may have limited the study’s results. “While use of the electronic diaries is helpful for collection of study data, it may encourage compliance and efficacy that may be higher in the ‘real-world’ population outside of the setting of a clinical trial,” noted Dr. Chappell and colleagues.
According to the investigators, this is the first prospective, randomized trial to study the use of an antimicrobial bioadhesive vaginal gel for preventing CT and GC infection. “EVO100 has the potential of fulfilling an unmet need in women’s sexual health as a new on-demand, woman-controlled option that reduces the risk of urogenital CT and GC infections,” the authors concluded.
The Food and Drug Administration has already approved EVO100 as a contraceptive option (Phexxi), Dr. Chappell said in an interview. Next steps are to conduct a phase 3 trial, which is currently underway. “If the findings are positive, we will submit to the FDA for review and approval of EVO100” for preventing these STIs.
These are promising results, Catherine Cansino, MD, MPH, an associate clinical professor with the department of obstetrics and gynecology at the University of California, Davis, said in an interview. It’s always helpful to look at effective treatments, “especially those that aren’t traditional antibiotics in order to decrease the risk of antibiotic resistance,” said Dr. Cansino, who was not part of the study. This is why EVO100 is such an attractive option.
Future studies should look at a broader population, she continued. “The population this study looked at is not the general population – these women had an infection at some point, previously,” which means they are potentially at higher risk for reinfection. “Looking at what their likelihood is of getting infected again, it’s hard to know if this would be the same or different from the general population.” If the drug appears to cause a decrease in new infections, the relative risk reduction is actually greater than what’s reported. If the reinfection rate for this population is lower because people who’ve had infections are practicing safer sex, the relative risk reduction would be lower, explained Dr. Cansino.
Dr. Chappell and several coauthors received research funding from Evofem Biosciences.
An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.
Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.
The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.
In the AMPREVENCE study, a double-blinded, placebo-controlled, randomized, phase 2b/3 trial, Todd Chappell, MD, of Adams Patterson Gynecology & Obstetrics, Memphis, and colleagues tested the efficacy and safety of EVO100 to prevent chlamydia and gonorrhea.
Investigators randomized 1:1,860 healthy, sexually active women to receive either EVO100 (n = 426) or placebo (n = 434). Participants had either been diagnosed or treated for these STIs up to 16 weeks prior to enrollment. Among those enrolled, 335 women in the EVO100 arm and 335 women in the placebo arm completed the study.
From this cohort, 764 women (EVO100: n = 376; placebo: n = 388) reported any use of either product. These women represented the “safety analysis population,” a predefined population for statistical analysis.
Participants averaged nearly 28 years of age, had a median body mass index of 28.9 kg/m2, and represented several racial/ethnic groups: White (54.3% [467/860]), African American (41.6% [358/860]), and non-Hispanic/Latinx ethnicity (67.1% [577/860]).
The women were instructed to apply the drug within 1 hour of initiating sexual intercourse. Investigators scheduled follow-up visits every 4 weeks during the 16-week study period, to obtain repeat CT/GC assessments, review diary entries, and to collect information about adverse effects and use of concomitant medications. During enrollment, participants consented to return to the clinic at each study visit. If a woman missed a visit, the study site would follow-up by telephone after the missed assessment visit.
Participants reported a mean number of 16 coital events (EVO100, 15.7 [13.5]; placebo, 16.3 [15.8]). EVO100 significantly reduced STI incidence for both types of STIs. CT infection rates among EVO100 users was 4.8% (14/289), half of what it was in placebo users (9.7% [28/290]) (P = .0256). The investigational method was even more successful in GC-analysis–eligible women: infection rates averaged 0.7% (2/280), compared with 3.2% (9/277) in the placebo group, a relative risk reduction of 78% (P = .0316).
Examining electronic diary entries of the participants, investigators reported similar adherence rates among the two treatment arms. However, additional sensitivity analyses in CT-eligible and GC-eligible populations on adherence yielded notably different results.
EVO100 users in the CT population who used the product as directed 100% of the time were significantly less likely to become infected, compared with the placebo group (2.3% vs. 16.9%, P = .0012). However, investigators found no significant differences in infection rates among women with poorer adherence rates in the two groups. Comparatively, they found no major differences in GC infection rates between the control and EVO100 groups, regardless of adherence rates, likely because of the small number of GC infections reported. Observed adverse events correlated with the drug’s known safety profile.
Most of the participants said they would likely recommend EVO100 to other women and continue using this preventive treatment.
A small GC subgroup caused by fewer infection cases and reliance on participant self-reporting of coital incidents may have limited the study’s results. “While use of the electronic diaries is helpful for collection of study data, it may encourage compliance and efficacy that may be higher in the ‘real-world’ population outside of the setting of a clinical trial,” noted Dr. Chappell and colleagues.
According to the investigators, this is the first prospective, randomized trial to study the use of an antimicrobial bioadhesive vaginal gel for preventing CT and GC infection. “EVO100 has the potential of fulfilling an unmet need in women’s sexual health as a new on-demand, woman-controlled option that reduces the risk of urogenital CT and GC infections,” the authors concluded.
The Food and Drug Administration has already approved EVO100 as a contraceptive option (Phexxi), Dr. Chappell said in an interview. Next steps are to conduct a phase 3 trial, which is currently underway. “If the findings are positive, we will submit to the FDA for review and approval of EVO100” for preventing these STIs.
These are promising results, Catherine Cansino, MD, MPH, an associate clinical professor with the department of obstetrics and gynecology at the University of California, Davis, said in an interview. It’s always helpful to look at effective treatments, “especially those that aren’t traditional antibiotics in order to decrease the risk of antibiotic resistance,” said Dr. Cansino, who was not part of the study. This is why EVO100 is such an attractive option.
Future studies should look at a broader population, she continued. “The population this study looked at is not the general population – these women had an infection at some point, previously,” which means they are potentially at higher risk for reinfection. “Looking at what their likelihood is of getting infected again, it’s hard to know if this would be the same or different from the general population.” If the drug appears to cause a decrease in new infections, the relative risk reduction is actually greater than what’s reported. If the reinfection rate for this population is lower because people who’ve had infections are practicing safer sex, the relative risk reduction would be lower, explained Dr. Cansino.
Dr. Chappell and several coauthors received research funding from Evofem Biosciences.
An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.
Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.
The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.
In the AMPREVENCE study, a double-blinded, placebo-controlled, randomized, phase 2b/3 trial, Todd Chappell, MD, of Adams Patterson Gynecology & Obstetrics, Memphis, and colleagues tested the efficacy and safety of EVO100 to prevent chlamydia and gonorrhea.
Investigators randomized 1:1,860 healthy, sexually active women to receive either EVO100 (n = 426) or placebo (n = 434). Participants had either been diagnosed or treated for these STIs up to 16 weeks prior to enrollment. Among those enrolled, 335 women in the EVO100 arm and 335 women in the placebo arm completed the study.
From this cohort, 764 women (EVO100: n = 376; placebo: n = 388) reported any use of either product. These women represented the “safety analysis population,” a predefined population for statistical analysis.
Participants averaged nearly 28 years of age, had a median body mass index of 28.9 kg/m2, and represented several racial/ethnic groups: White (54.3% [467/860]), African American (41.6% [358/860]), and non-Hispanic/Latinx ethnicity (67.1% [577/860]).
The women were instructed to apply the drug within 1 hour of initiating sexual intercourse. Investigators scheduled follow-up visits every 4 weeks during the 16-week study period, to obtain repeat CT/GC assessments, review diary entries, and to collect information about adverse effects and use of concomitant medications. During enrollment, participants consented to return to the clinic at each study visit. If a woman missed a visit, the study site would follow-up by telephone after the missed assessment visit.
Participants reported a mean number of 16 coital events (EVO100, 15.7 [13.5]; placebo, 16.3 [15.8]). EVO100 significantly reduced STI incidence for both types of STIs. CT infection rates among EVO100 users was 4.8% (14/289), half of what it was in placebo users (9.7% [28/290]) (P = .0256). The investigational method was even more successful in GC-analysis–eligible women: infection rates averaged 0.7% (2/280), compared with 3.2% (9/277) in the placebo group, a relative risk reduction of 78% (P = .0316).
Examining electronic diary entries of the participants, investigators reported similar adherence rates among the two treatment arms. However, additional sensitivity analyses in CT-eligible and GC-eligible populations on adherence yielded notably different results.
EVO100 users in the CT population who used the product as directed 100% of the time were significantly less likely to become infected, compared with the placebo group (2.3% vs. 16.9%, P = .0012). However, investigators found no significant differences in infection rates among women with poorer adherence rates in the two groups. Comparatively, they found no major differences in GC infection rates between the control and EVO100 groups, regardless of adherence rates, likely because of the small number of GC infections reported. Observed adverse events correlated with the drug’s known safety profile.
Most of the participants said they would likely recommend EVO100 to other women and continue using this preventive treatment.
A small GC subgroup caused by fewer infection cases and reliance on participant self-reporting of coital incidents may have limited the study’s results. “While use of the electronic diaries is helpful for collection of study data, it may encourage compliance and efficacy that may be higher in the ‘real-world’ population outside of the setting of a clinical trial,” noted Dr. Chappell and colleagues.
According to the investigators, this is the first prospective, randomized trial to study the use of an antimicrobial bioadhesive vaginal gel for preventing CT and GC infection. “EVO100 has the potential of fulfilling an unmet need in women’s sexual health as a new on-demand, woman-controlled option that reduces the risk of urogenital CT and GC infections,” the authors concluded.
The Food and Drug Administration has already approved EVO100 as a contraceptive option (Phexxi), Dr. Chappell said in an interview. Next steps are to conduct a phase 3 trial, which is currently underway. “If the findings are positive, we will submit to the FDA for review and approval of EVO100” for preventing these STIs.
These are promising results, Catherine Cansino, MD, MPH, an associate clinical professor with the department of obstetrics and gynecology at the University of California, Davis, said in an interview. It’s always helpful to look at effective treatments, “especially those that aren’t traditional antibiotics in order to decrease the risk of antibiotic resistance,” said Dr. Cansino, who was not part of the study. This is why EVO100 is such an attractive option.
Future studies should look at a broader population, she continued. “The population this study looked at is not the general population – these women had an infection at some point, previously,” which means they are potentially at higher risk for reinfection. “Looking at what their likelihood is of getting infected again, it’s hard to know if this would be the same or different from the general population.” If the drug appears to cause a decrease in new infections, the relative risk reduction is actually greater than what’s reported. If the reinfection rate for this population is lower because people who’ve had infections are practicing safer sex, the relative risk reduction would be lower, explained Dr. Cansino.
Dr. Chappell and several coauthors received research funding from Evofem Biosciences.
FROM THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Discovery of schizophrenia gene could advance research, therapies
A new genetic mutation in schizophrenia that blocks neuron communication in the brain may lead to novel treatment strategies and improve understanding of the mechanics of this disease.
The discovery of this new gene, PCDHA3, could enhance the development of genetic-risk calculators “that may help us understand vulnerability to schizophrenia in high-risk individuals and identify individuals with schizophrenia who have a greater risk for poor outcomes,” said Todd Lencz, PhD, a professor at the Feinstein Institutes for Medical Research in New York, and lead author of this research. Dr. Lencz and associates reported on this new finding in the journal Neuron.
Schizophrenia affects 20 million people worldwide. Previous research has identified the important role genes play in the disease, but isolating individual genes to better understand schizophrenia has proven to be a challenge. This is a very heterogeneous disorder, with many hundreds if not thousands of genes involved, Dr. Lencz explained in an interview. “It is very different from single-gene disorders like Huntington disease, for example. For this reason, we need very large sample sizes to find any one gene that seems to be common to many cases in a sample.”
Study focused on homogeneous population
To enhance the power of finding rare variants in a heterogeneous disease with large numbers of genes, Dr. Lencz and colleagues chose a homogeneous “founder” population, a cohort of Ashkenazi Jews, to examine genomes from schizophrenia patients and controls. “As we have reported in prior work over the last decade, the 10 million or so Ashkenazi Jews living worldwide today all are descended from just a few hundred people who lived approximately 750 years ago, and moved into Central and Eastern Europe,” said Dr. Lencz. The study included 786 cases of schizophrenia and 463 controls from this Ashkenazi population. This is considered to be an extremely small sample for a genetic study. However, because this population evolved from a few hundred individuals to a massive explosion in a historically short period of time, it had enhanced statistical power, said Dr. Lencz.
“We showed that just a few thousand Ashkenazi Jewish cases would have the statistical power of a regular population that was 5-10 times larger, from a genetic discovery perspective,” he added.
Search for ultrarare variants
The investigators used whole-genome sequencing to conduct their analysis, using public databases to filter out any variants that had been previously observed in healthy individuals worldwide. “We were looking for ultrarare variants that might have a very powerful effect on the disease,” Dr. Lencz said. Such individual mutations are very rarely seen in the general population.
Because of the disease’s ultraheterogeneity, it’s extremely unusual to find a recurrent, ultrarare variant. “In some ways, the genetics of schizophrenia is so complex that every patient worldwide is unique in the genetics that led to his or her disorder.” The goal was to find individual mutations that might be observed multiple times across the schizophrenia group, Dr. Lencz said.
Rare gene found in five cases
Dr. Lencz and colleagues accomplished this with their unique Ashkenazi Jewish population. “We identified one particular mutation that was repeatedly observed in our cases that has not been observed in healthy individuals that we’re aware of,” he said. The PCDHA3 mutation was identified in 3 out of the 786 schizophrenia cases.
In another dataset, they examined from the Schizophrenia Exome Sequencing Meta-analysis (SCHEMA) consortium, they found it two additional times, bringing the total to five cases. SCHEMA is a large international consortium of genetics studies in schizophrenia that contains thousands of cases and controls, some of which are Ashkenazi Jewish cases.
“Importantly, the mutation was not observed in any controls, in either our Ashkenazi dataset, the SCHEMA dataset, or more than 100,000 other controls reported in several publicly available genetics databases,” Dr. Lencz said.
How the gene leads to schizophrenia
PCDHA3 derives from the protocadherin gene family, which generates a unique bar code that enables neurons to recognize and communicate with other neurons. This communication creates a scaffolding of sorts that enables normal brain function. Dr. Lencz and colleagues discovered that the PCDHA3 variant blocks this normal protocadherin function.
Among the 786 cases, the investigators found several other genes in the broad cadherin family that had implications in schizophrenia development.
Much of the genetics of schizophrenia in recent years has focused on the synapse as the point of abnormality underlying the disorder. “We think our paper demonstrates in multiple ways the synaptic scaffolding role the cadherins superfamily of genes play in schizophrenia pathophysiology. The discovery of the PCDHA3 variant adds a level of detail and resolution to this process, pointing researchers toward a specific aspect of synaptic formation that may be aberrant. “So the hope is we’re not just learning about these five individuals and their synapses. This result is perhaps telling us to look very carefully at this aspect of synaptic formation.”
Implications for clinical practice
Dr. Lencz and colleagues plan to expand upon and enhance their existing Ashkenazi sample to take advantage of the founder effect in this population. “Of course, there are many large-scale efforts to recruit ethnically diverse patients with schizophrenia to study around the world. We encourage that. Our expectation is that the biology is not in any way unique to Ashkenazi individuals. This is just the approach we took to enhance our power,” he said.
The PCDHA3 discovery won’t have an immediate impact on clinical practice. In the longer term, “we are aware of certain pharmacologic approaches that might be able to manipulate the cadherins. That would be a worthy focus for future research,” Dr. Lencz said.
Additional studies will be critical to see how current medications in schizophrenia treatment could mitigate and improve any changes caused by this genetic mutation, noted Anthony T. Ng, MD, who was not involved with the study. More specifically, studies would help assess the impact of a schizophrenia patient with this mutation in areas of functioning, “so that psychosocial and rehabilitation treatment models of schizophrenia can provide more targeted treatment,” said Dr. Ng, medical director of community services and director of neuromodulation services at Northern Light Acadia Hospital in Bangor, Maine.
The work of Dr. Lencz and associates is significant in that “it started to identify a very specific genetic change that can help focus treatment of schizophrenia,” Dr. Ng said.
Neither Dr. Lencz nor his associates had any conflicts of interest. Dr. Ng had no disclosures.
A new genetic mutation in schizophrenia that blocks neuron communication in the brain may lead to novel treatment strategies and improve understanding of the mechanics of this disease.
The discovery of this new gene, PCDHA3, could enhance the development of genetic-risk calculators “that may help us understand vulnerability to schizophrenia in high-risk individuals and identify individuals with schizophrenia who have a greater risk for poor outcomes,” said Todd Lencz, PhD, a professor at the Feinstein Institutes for Medical Research in New York, and lead author of this research. Dr. Lencz and associates reported on this new finding in the journal Neuron.
Schizophrenia affects 20 million people worldwide. Previous research has identified the important role genes play in the disease, but isolating individual genes to better understand schizophrenia has proven to be a challenge. This is a very heterogeneous disorder, with many hundreds if not thousands of genes involved, Dr. Lencz explained in an interview. “It is very different from single-gene disorders like Huntington disease, for example. For this reason, we need very large sample sizes to find any one gene that seems to be common to many cases in a sample.”
Study focused on homogeneous population
To enhance the power of finding rare variants in a heterogeneous disease with large numbers of genes, Dr. Lencz and colleagues chose a homogeneous “founder” population, a cohort of Ashkenazi Jews, to examine genomes from schizophrenia patients and controls. “As we have reported in prior work over the last decade, the 10 million or so Ashkenazi Jews living worldwide today all are descended from just a few hundred people who lived approximately 750 years ago, and moved into Central and Eastern Europe,” said Dr. Lencz. The study included 786 cases of schizophrenia and 463 controls from this Ashkenazi population. This is considered to be an extremely small sample for a genetic study. However, because this population evolved from a few hundred individuals to a massive explosion in a historically short period of time, it had enhanced statistical power, said Dr. Lencz.
“We showed that just a few thousand Ashkenazi Jewish cases would have the statistical power of a regular population that was 5-10 times larger, from a genetic discovery perspective,” he added.
Search for ultrarare variants
The investigators used whole-genome sequencing to conduct their analysis, using public databases to filter out any variants that had been previously observed in healthy individuals worldwide. “We were looking for ultrarare variants that might have a very powerful effect on the disease,” Dr. Lencz said. Such individual mutations are very rarely seen in the general population.
Because of the disease’s ultraheterogeneity, it’s extremely unusual to find a recurrent, ultrarare variant. “In some ways, the genetics of schizophrenia is so complex that every patient worldwide is unique in the genetics that led to his or her disorder.” The goal was to find individual mutations that might be observed multiple times across the schizophrenia group, Dr. Lencz said.
Rare gene found in five cases
Dr. Lencz and colleagues accomplished this with their unique Ashkenazi Jewish population. “We identified one particular mutation that was repeatedly observed in our cases that has not been observed in healthy individuals that we’re aware of,” he said. The PCDHA3 mutation was identified in 3 out of the 786 schizophrenia cases.
In another dataset, they examined from the Schizophrenia Exome Sequencing Meta-analysis (SCHEMA) consortium, they found it two additional times, bringing the total to five cases. SCHEMA is a large international consortium of genetics studies in schizophrenia that contains thousands of cases and controls, some of which are Ashkenazi Jewish cases.
“Importantly, the mutation was not observed in any controls, in either our Ashkenazi dataset, the SCHEMA dataset, or more than 100,000 other controls reported in several publicly available genetics databases,” Dr. Lencz said.
How the gene leads to schizophrenia
PCDHA3 derives from the protocadherin gene family, which generates a unique bar code that enables neurons to recognize and communicate with other neurons. This communication creates a scaffolding of sorts that enables normal brain function. Dr. Lencz and colleagues discovered that the PCDHA3 variant blocks this normal protocadherin function.
Among the 786 cases, the investigators found several other genes in the broad cadherin family that had implications in schizophrenia development.
Much of the genetics of schizophrenia in recent years has focused on the synapse as the point of abnormality underlying the disorder. “We think our paper demonstrates in multiple ways the synaptic scaffolding role the cadherins superfamily of genes play in schizophrenia pathophysiology. The discovery of the PCDHA3 variant adds a level of detail and resolution to this process, pointing researchers toward a specific aspect of synaptic formation that may be aberrant. “So the hope is we’re not just learning about these five individuals and their synapses. This result is perhaps telling us to look very carefully at this aspect of synaptic formation.”
Implications for clinical practice
Dr. Lencz and colleagues plan to expand upon and enhance their existing Ashkenazi sample to take advantage of the founder effect in this population. “Of course, there are many large-scale efforts to recruit ethnically diverse patients with schizophrenia to study around the world. We encourage that. Our expectation is that the biology is not in any way unique to Ashkenazi individuals. This is just the approach we took to enhance our power,” he said.
The PCDHA3 discovery won’t have an immediate impact on clinical practice. In the longer term, “we are aware of certain pharmacologic approaches that might be able to manipulate the cadherins. That would be a worthy focus for future research,” Dr. Lencz said.
Additional studies will be critical to see how current medications in schizophrenia treatment could mitigate and improve any changes caused by this genetic mutation, noted Anthony T. Ng, MD, who was not involved with the study. More specifically, studies would help assess the impact of a schizophrenia patient with this mutation in areas of functioning, “so that psychosocial and rehabilitation treatment models of schizophrenia can provide more targeted treatment,” said Dr. Ng, medical director of community services and director of neuromodulation services at Northern Light Acadia Hospital in Bangor, Maine.
The work of Dr. Lencz and associates is significant in that “it started to identify a very specific genetic change that can help focus treatment of schizophrenia,” Dr. Ng said.
Neither Dr. Lencz nor his associates had any conflicts of interest. Dr. Ng had no disclosures.
A new genetic mutation in schizophrenia that blocks neuron communication in the brain may lead to novel treatment strategies and improve understanding of the mechanics of this disease.
The discovery of this new gene, PCDHA3, could enhance the development of genetic-risk calculators “that may help us understand vulnerability to schizophrenia in high-risk individuals and identify individuals with schizophrenia who have a greater risk for poor outcomes,” said Todd Lencz, PhD, a professor at the Feinstein Institutes for Medical Research in New York, and lead author of this research. Dr. Lencz and associates reported on this new finding in the journal Neuron.
Schizophrenia affects 20 million people worldwide. Previous research has identified the important role genes play in the disease, but isolating individual genes to better understand schizophrenia has proven to be a challenge. This is a very heterogeneous disorder, with many hundreds if not thousands of genes involved, Dr. Lencz explained in an interview. “It is very different from single-gene disorders like Huntington disease, for example. For this reason, we need very large sample sizes to find any one gene that seems to be common to many cases in a sample.”
Study focused on homogeneous population
To enhance the power of finding rare variants in a heterogeneous disease with large numbers of genes, Dr. Lencz and colleagues chose a homogeneous “founder” population, a cohort of Ashkenazi Jews, to examine genomes from schizophrenia patients and controls. “As we have reported in prior work over the last decade, the 10 million or so Ashkenazi Jews living worldwide today all are descended from just a few hundred people who lived approximately 750 years ago, and moved into Central and Eastern Europe,” said Dr. Lencz. The study included 786 cases of schizophrenia and 463 controls from this Ashkenazi population. This is considered to be an extremely small sample for a genetic study. However, because this population evolved from a few hundred individuals to a massive explosion in a historically short period of time, it had enhanced statistical power, said Dr. Lencz.
“We showed that just a few thousand Ashkenazi Jewish cases would have the statistical power of a regular population that was 5-10 times larger, from a genetic discovery perspective,” he added.
Search for ultrarare variants
The investigators used whole-genome sequencing to conduct their analysis, using public databases to filter out any variants that had been previously observed in healthy individuals worldwide. “We were looking for ultrarare variants that might have a very powerful effect on the disease,” Dr. Lencz said. Such individual mutations are very rarely seen in the general population.
Because of the disease’s ultraheterogeneity, it’s extremely unusual to find a recurrent, ultrarare variant. “In some ways, the genetics of schizophrenia is so complex that every patient worldwide is unique in the genetics that led to his or her disorder.” The goal was to find individual mutations that might be observed multiple times across the schizophrenia group, Dr. Lencz said.
Rare gene found in five cases
Dr. Lencz and colleagues accomplished this with their unique Ashkenazi Jewish population. “We identified one particular mutation that was repeatedly observed in our cases that has not been observed in healthy individuals that we’re aware of,” he said. The PCDHA3 mutation was identified in 3 out of the 786 schizophrenia cases.
In another dataset, they examined from the Schizophrenia Exome Sequencing Meta-analysis (SCHEMA) consortium, they found it two additional times, bringing the total to five cases. SCHEMA is a large international consortium of genetics studies in schizophrenia that contains thousands of cases and controls, some of which are Ashkenazi Jewish cases.
“Importantly, the mutation was not observed in any controls, in either our Ashkenazi dataset, the SCHEMA dataset, or more than 100,000 other controls reported in several publicly available genetics databases,” Dr. Lencz said.
How the gene leads to schizophrenia
PCDHA3 derives from the protocadherin gene family, which generates a unique bar code that enables neurons to recognize and communicate with other neurons. This communication creates a scaffolding of sorts that enables normal brain function. Dr. Lencz and colleagues discovered that the PCDHA3 variant blocks this normal protocadherin function.
Among the 786 cases, the investigators found several other genes in the broad cadherin family that had implications in schizophrenia development.
Much of the genetics of schizophrenia in recent years has focused on the synapse as the point of abnormality underlying the disorder. “We think our paper demonstrates in multiple ways the synaptic scaffolding role the cadherins superfamily of genes play in schizophrenia pathophysiology. The discovery of the PCDHA3 variant adds a level of detail and resolution to this process, pointing researchers toward a specific aspect of synaptic formation that may be aberrant. “So the hope is we’re not just learning about these five individuals and their synapses. This result is perhaps telling us to look very carefully at this aspect of synaptic formation.”
Implications for clinical practice
Dr. Lencz and colleagues plan to expand upon and enhance their existing Ashkenazi sample to take advantage of the founder effect in this population. “Of course, there are many large-scale efforts to recruit ethnically diverse patients with schizophrenia to study around the world. We encourage that. Our expectation is that the biology is not in any way unique to Ashkenazi individuals. This is just the approach we took to enhance our power,” he said.
The PCDHA3 discovery won’t have an immediate impact on clinical practice. In the longer term, “we are aware of certain pharmacologic approaches that might be able to manipulate the cadherins. That would be a worthy focus for future research,” Dr. Lencz said.
Additional studies will be critical to see how current medications in schizophrenia treatment could mitigate and improve any changes caused by this genetic mutation, noted Anthony T. Ng, MD, who was not involved with the study. More specifically, studies would help assess the impact of a schizophrenia patient with this mutation in areas of functioning, “so that psychosocial and rehabilitation treatment models of schizophrenia can provide more targeted treatment,” said Dr. Ng, medical director of community services and director of neuromodulation services at Northern Light Acadia Hospital in Bangor, Maine.
The work of Dr. Lencz and associates is significant in that “it started to identify a very specific genetic change that can help focus treatment of schizophrenia,” Dr. Ng said.
Neither Dr. Lencz nor his associates had any conflicts of interest. Dr. Ng had no disclosures.
FROM NEURON
Two popular screening tests for gestational diabetes clinically equivalent
Broadening the diagnosis of gestational diabetes mellitus (GDM) with a one-step screening approach does not lead to significant differences in maternal or perinatal outcomes, compared with a two-step approach. Investigators reported these findings in the New England Journal of Medicine after testing the two screening methods in more than 23,000 pregnant women.
GDM affects 6%-25% of pregnant women, increasing the risk of neonatal death and stillborn births. It can also lead to serious complications such as fetal overgrowth. Clinical guidelines recommend GDM screening between 24 and 28 weeks’ gestation to improve outcomes in mothers and infants. However, the scientific community has struggled to reach a consensus on testing approach.
For decades, clinicians used a two-step screening approach: a nonfasting 1-hour glucose challenge test and a longer 3-hour fasting oral glucose tolerance test to diagnose GDM; roughly 20% who test positive on this glucose challenge test require the second step. Results of a large study led to new diagnostic criteria on a one-step 75-g oral glucose tolerance test. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study “found a linear relationship with hyperglycemia and outcomes – the higher the glucose, the worse the outcomes,” said Teresa Hillier, MD, MS, an endocrinologist and investigator with Kaiser Permanente Center for Health Research Northwest and CHR-Hawaii. The International Association of the Diabetes and Pregnancy Study Groups (IADPSG) made a clinical recommendation on the one-step approach, now a common screening tool in the United States.
A focus on rare GDM outcomes
The IADPSG fasting one-step criteria typically identifies women with milder symptoms as having gestational diabetes, a factor expected to increase diagnosis rates by two- or threefold, said Dr. Hillier. “The unknown question was whether diagnosing and treating more women would be associated with any differences in any of the multiple GDM-associated outcomes for mother and baby.”
She and her colleagues conducted a large-scale randomized trial at two Kaiser sites to assess multiple maternal and perinatal outcomes including rare but important GDM-associated outcomes such as stillbirth and neonatal death between the two screening methods.
They randomized 23,792 pregnant women 1:1 to the one- or two-step gestational diabetes test at their first prenatal visit. Primary outcomes included diagnosis of gestational diabetes; large-for-gestational-age infants; primary cesarean section, and gestational hypertension or preeclampsia; and a composite perinatal outcome of any stillbirth, neonatal death, shoulder dystocia, bone fracture, or arm or hand nerve palsy related to birth injury.
Most participants (94%) completed screening, although there was lower adherence to screening in the one-step approach. The reasons for this aren’t entirely clear, said Dr. Hillier. Convenience may be a factor; patients have to fast for several hours to complete the one-step test, whereas the first test of the two-step screening approach can be done at any time of day, and most patients pass this test.
Corroborating HAPO’s results, twice as many women in the one-step group (16.5%) received a GDM diagnosis, compared with 8.5% in the two-step group (unadjusted relative risk, 1.94; 97.5% confidence interval, 1.79-2.11). However, for the other primary outcomes, investigators found no significant differences in incidences or unadjusted risks. Perinatal composite outcomes for the one- and two-step groups were 3.1% and 3.0%, respectively, and primary cesarean section outcomes were 24.0% and 24.6%.
In the one-step group, 8.9% experienced large-for-gestational-age infants outcomes, compared with 9.2% in the two-step group (RR, 0.95; 97.5% CI, 0.87-1.05). Among those diagnosed with gestational diabetes, similar percentages of women in the one- and two-step groups received insulin or hypoglycemic medication (42.6% and 45.6%, respectively).
Dr. Hillier and colleagues also reported comparable results among the two groups on safety outcomes and secondary outcomes such as macrosomia incidence, small-for-gestational-age infants, and factors such as neonatal hypoglycemia and respiratory distress.
“Although we did not find increased harms associated with the diagnosis and treatment of gestational diabetes in many more women with the one-step approach, some retrospective observational cohort studies have shown higher incidences of primary cesarean delivery and neonatal hypoglycemia with one-step screening after conversion from two-step protocols, with no substantive improvement in outcomes,” Dr. Hillier and colleagues noted.
The trial had several limitations. Adjustments made to address lower adherence to the one-step approach might not have accounted for all nonadherence differences. Another issue is the two sites didn’t use identical thresholds for the glucose challenge test in the two-step cohort. Demographically, the study lacked Black and American Indian representation.
“Moreover, the potential long-term benefits of increased diagnoses of gestational diabetes – such as the identification of more women at high risk for subsequent diabetes who might benefit from risk-reduction strategies – were not addressed by the trial,” Brian Casey, MD, wrote in a related editorial. Based on the study’s findings, “the perinatal benefits of the diagnosis of gestational diabetes with the use of the IADPSG single-step approach appear to be insufficient to justify the associated patient and health care costs of broadening the diagnosis” of GDM, added Dr. Casey, a professor with the department of obstetrics and gynecology at the University of Alabama at Birmingham.
U.S. doctors unlikely to change behaviors
Most U.S. physicians favor the two-step method. This has been a huge controversy worldwide, with other countries pushing the United States to use the one-step method, Vincenzo Berghella, MD, a professor with Thomas Jefferson University, Philadelphia, said in an interview. “I expect this study will increase the divide between the U.S. and the rest of the world,” since U.S. physicians will see no benefit to the one-step method, and continue to use the two-step method.
It’s not surprising that GDM diagnosis incidence went up to 16.5% with the inclusion of the one-step test, compared with 8.5% with the two-step test, Dr. Berghella continued. What’s less clear, are the details of treatment among the 8% diagnosed to have GDM with the one-step test, but not the two-step test.
These women were likely to have milder degrees of insulin resistance or GDM. Dr. Berghella, who has advocated in the past for the one-step approach, said it would be important to find out if these women, who test positive at the one-step test but would test negative at the two-step test, were treated properly with diet, exercise, and possibly insulin or other hypoglycemic agents for their mild degree of insulin resistance. The researchers concluded that expanding the definition of GDM through the one-step test didn’t make a difference. However, “it’s not just the test that will make the difference in maternal and baby outcomes, but the aggressive management of diabetes with diet, exercise, and medications as needed once that test comes back abnormal,” he said.
The randomized trial was a massive undertaking, said Dr. Hillier.
“We are still evaluating our future plans,” she added. Forthcoming subgroup analyses from the trial could further help inform clinical practice guidelines.
Dr. Hillier received a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to support this study. The investigators reported no potential conflict of interest relevant to this article.
Broadening the diagnosis of gestational diabetes mellitus (GDM) with a one-step screening approach does not lead to significant differences in maternal or perinatal outcomes, compared with a two-step approach. Investigators reported these findings in the New England Journal of Medicine after testing the two screening methods in more than 23,000 pregnant women.
GDM affects 6%-25% of pregnant women, increasing the risk of neonatal death and stillborn births. It can also lead to serious complications such as fetal overgrowth. Clinical guidelines recommend GDM screening between 24 and 28 weeks’ gestation to improve outcomes in mothers and infants. However, the scientific community has struggled to reach a consensus on testing approach.
For decades, clinicians used a two-step screening approach: a nonfasting 1-hour glucose challenge test and a longer 3-hour fasting oral glucose tolerance test to diagnose GDM; roughly 20% who test positive on this glucose challenge test require the second step. Results of a large study led to new diagnostic criteria on a one-step 75-g oral glucose tolerance test. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study “found a linear relationship with hyperglycemia and outcomes – the higher the glucose, the worse the outcomes,” said Teresa Hillier, MD, MS, an endocrinologist and investigator with Kaiser Permanente Center for Health Research Northwest and CHR-Hawaii. The International Association of the Diabetes and Pregnancy Study Groups (IADPSG) made a clinical recommendation on the one-step approach, now a common screening tool in the United States.
A focus on rare GDM outcomes
The IADPSG fasting one-step criteria typically identifies women with milder symptoms as having gestational diabetes, a factor expected to increase diagnosis rates by two- or threefold, said Dr. Hillier. “The unknown question was whether diagnosing and treating more women would be associated with any differences in any of the multiple GDM-associated outcomes for mother and baby.”
She and her colleagues conducted a large-scale randomized trial at two Kaiser sites to assess multiple maternal and perinatal outcomes including rare but important GDM-associated outcomes such as stillbirth and neonatal death between the two screening methods.
They randomized 23,792 pregnant women 1:1 to the one- or two-step gestational diabetes test at their first prenatal visit. Primary outcomes included diagnosis of gestational diabetes; large-for-gestational-age infants; primary cesarean section, and gestational hypertension or preeclampsia; and a composite perinatal outcome of any stillbirth, neonatal death, shoulder dystocia, bone fracture, or arm or hand nerve palsy related to birth injury.
Most participants (94%) completed screening, although there was lower adherence to screening in the one-step approach. The reasons for this aren’t entirely clear, said Dr. Hillier. Convenience may be a factor; patients have to fast for several hours to complete the one-step test, whereas the first test of the two-step screening approach can be done at any time of day, and most patients pass this test.
Corroborating HAPO’s results, twice as many women in the one-step group (16.5%) received a GDM diagnosis, compared with 8.5% in the two-step group (unadjusted relative risk, 1.94; 97.5% confidence interval, 1.79-2.11). However, for the other primary outcomes, investigators found no significant differences in incidences or unadjusted risks. Perinatal composite outcomes for the one- and two-step groups were 3.1% and 3.0%, respectively, and primary cesarean section outcomes were 24.0% and 24.6%.
In the one-step group, 8.9% experienced large-for-gestational-age infants outcomes, compared with 9.2% in the two-step group (RR, 0.95; 97.5% CI, 0.87-1.05). Among those diagnosed with gestational diabetes, similar percentages of women in the one- and two-step groups received insulin or hypoglycemic medication (42.6% and 45.6%, respectively).
Dr. Hillier and colleagues also reported comparable results among the two groups on safety outcomes and secondary outcomes such as macrosomia incidence, small-for-gestational-age infants, and factors such as neonatal hypoglycemia and respiratory distress.
“Although we did not find increased harms associated with the diagnosis and treatment of gestational diabetes in many more women with the one-step approach, some retrospective observational cohort studies have shown higher incidences of primary cesarean delivery and neonatal hypoglycemia with one-step screening after conversion from two-step protocols, with no substantive improvement in outcomes,” Dr. Hillier and colleagues noted.
The trial had several limitations. Adjustments made to address lower adherence to the one-step approach might not have accounted for all nonadherence differences. Another issue is the two sites didn’t use identical thresholds for the glucose challenge test in the two-step cohort. Demographically, the study lacked Black and American Indian representation.
“Moreover, the potential long-term benefits of increased diagnoses of gestational diabetes – such as the identification of more women at high risk for subsequent diabetes who might benefit from risk-reduction strategies – were not addressed by the trial,” Brian Casey, MD, wrote in a related editorial. Based on the study’s findings, “the perinatal benefits of the diagnosis of gestational diabetes with the use of the IADPSG single-step approach appear to be insufficient to justify the associated patient and health care costs of broadening the diagnosis” of GDM, added Dr. Casey, a professor with the department of obstetrics and gynecology at the University of Alabama at Birmingham.
U.S. doctors unlikely to change behaviors
Most U.S. physicians favor the two-step method. This has been a huge controversy worldwide, with other countries pushing the United States to use the one-step method, Vincenzo Berghella, MD, a professor with Thomas Jefferson University, Philadelphia, said in an interview. “I expect this study will increase the divide between the U.S. and the rest of the world,” since U.S. physicians will see no benefit to the one-step method, and continue to use the two-step method.
It’s not surprising that GDM diagnosis incidence went up to 16.5% with the inclusion of the one-step test, compared with 8.5% with the two-step test, Dr. Berghella continued. What’s less clear, are the details of treatment among the 8% diagnosed to have GDM with the one-step test, but not the two-step test.
These women were likely to have milder degrees of insulin resistance or GDM. Dr. Berghella, who has advocated in the past for the one-step approach, said it would be important to find out if these women, who test positive at the one-step test but would test negative at the two-step test, were treated properly with diet, exercise, and possibly insulin or other hypoglycemic agents for their mild degree of insulin resistance. The researchers concluded that expanding the definition of GDM through the one-step test didn’t make a difference. However, “it’s not just the test that will make the difference in maternal and baby outcomes, but the aggressive management of diabetes with diet, exercise, and medications as needed once that test comes back abnormal,” he said.
The randomized trial was a massive undertaking, said Dr. Hillier.
“We are still evaluating our future plans,” she added. Forthcoming subgroup analyses from the trial could further help inform clinical practice guidelines.
Dr. Hillier received a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to support this study. The investigators reported no potential conflict of interest relevant to this article.
Broadening the diagnosis of gestational diabetes mellitus (GDM) with a one-step screening approach does not lead to significant differences in maternal or perinatal outcomes, compared with a two-step approach. Investigators reported these findings in the New England Journal of Medicine after testing the two screening methods in more than 23,000 pregnant women.
GDM affects 6%-25% of pregnant women, increasing the risk of neonatal death and stillborn births. It can also lead to serious complications such as fetal overgrowth. Clinical guidelines recommend GDM screening between 24 and 28 weeks’ gestation to improve outcomes in mothers and infants. However, the scientific community has struggled to reach a consensus on testing approach.
For decades, clinicians used a two-step screening approach: a nonfasting 1-hour glucose challenge test and a longer 3-hour fasting oral glucose tolerance test to diagnose GDM; roughly 20% who test positive on this glucose challenge test require the second step. Results of a large study led to new diagnostic criteria on a one-step 75-g oral glucose tolerance test. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study “found a linear relationship with hyperglycemia and outcomes – the higher the glucose, the worse the outcomes,” said Teresa Hillier, MD, MS, an endocrinologist and investigator with Kaiser Permanente Center for Health Research Northwest and CHR-Hawaii. The International Association of the Diabetes and Pregnancy Study Groups (IADPSG) made a clinical recommendation on the one-step approach, now a common screening tool in the United States.
A focus on rare GDM outcomes
The IADPSG fasting one-step criteria typically identifies women with milder symptoms as having gestational diabetes, a factor expected to increase diagnosis rates by two- or threefold, said Dr. Hillier. “The unknown question was whether diagnosing and treating more women would be associated with any differences in any of the multiple GDM-associated outcomes for mother and baby.”
She and her colleagues conducted a large-scale randomized trial at two Kaiser sites to assess multiple maternal and perinatal outcomes including rare but important GDM-associated outcomes such as stillbirth and neonatal death between the two screening methods.
They randomized 23,792 pregnant women 1:1 to the one- or two-step gestational diabetes test at their first prenatal visit. Primary outcomes included diagnosis of gestational diabetes; large-for-gestational-age infants; primary cesarean section, and gestational hypertension or preeclampsia; and a composite perinatal outcome of any stillbirth, neonatal death, shoulder dystocia, bone fracture, or arm or hand nerve palsy related to birth injury.
Most participants (94%) completed screening, although there was lower adherence to screening in the one-step approach. The reasons for this aren’t entirely clear, said Dr. Hillier. Convenience may be a factor; patients have to fast for several hours to complete the one-step test, whereas the first test of the two-step screening approach can be done at any time of day, and most patients pass this test.
Corroborating HAPO’s results, twice as many women in the one-step group (16.5%) received a GDM diagnosis, compared with 8.5% in the two-step group (unadjusted relative risk, 1.94; 97.5% confidence interval, 1.79-2.11). However, for the other primary outcomes, investigators found no significant differences in incidences or unadjusted risks. Perinatal composite outcomes for the one- and two-step groups were 3.1% and 3.0%, respectively, and primary cesarean section outcomes were 24.0% and 24.6%.
In the one-step group, 8.9% experienced large-for-gestational-age infants outcomes, compared with 9.2% in the two-step group (RR, 0.95; 97.5% CI, 0.87-1.05). Among those diagnosed with gestational diabetes, similar percentages of women in the one- and two-step groups received insulin or hypoglycemic medication (42.6% and 45.6%, respectively).
Dr. Hillier and colleagues also reported comparable results among the two groups on safety outcomes and secondary outcomes such as macrosomia incidence, small-for-gestational-age infants, and factors such as neonatal hypoglycemia and respiratory distress.
“Although we did not find increased harms associated with the diagnosis and treatment of gestational diabetes in many more women with the one-step approach, some retrospective observational cohort studies have shown higher incidences of primary cesarean delivery and neonatal hypoglycemia with one-step screening after conversion from two-step protocols, with no substantive improvement in outcomes,” Dr. Hillier and colleagues noted.
The trial had several limitations. Adjustments made to address lower adherence to the one-step approach might not have accounted for all nonadherence differences. Another issue is the two sites didn’t use identical thresholds for the glucose challenge test in the two-step cohort. Demographically, the study lacked Black and American Indian representation.
“Moreover, the potential long-term benefits of increased diagnoses of gestational diabetes – such as the identification of more women at high risk for subsequent diabetes who might benefit from risk-reduction strategies – were not addressed by the trial,” Brian Casey, MD, wrote in a related editorial. Based on the study’s findings, “the perinatal benefits of the diagnosis of gestational diabetes with the use of the IADPSG single-step approach appear to be insufficient to justify the associated patient and health care costs of broadening the diagnosis” of GDM, added Dr. Casey, a professor with the department of obstetrics and gynecology at the University of Alabama at Birmingham.
U.S. doctors unlikely to change behaviors
Most U.S. physicians favor the two-step method. This has been a huge controversy worldwide, with other countries pushing the United States to use the one-step method, Vincenzo Berghella, MD, a professor with Thomas Jefferson University, Philadelphia, said in an interview. “I expect this study will increase the divide between the U.S. and the rest of the world,” since U.S. physicians will see no benefit to the one-step method, and continue to use the two-step method.
It’s not surprising that GDM diagnosis incidence went up to 16.5% with the inclusion of the one-step test, compared with 8.5% with the two-step test, Dr. Berghella continued. What’s less clear, are the details of treatment among the 8% diagnosed to have GDM with the one-step test, but not the two-step test.
These women were likely to have milder degrees of insulin resistance or GDM. Dr. Berghella, who has advocated in the past for the one-step approach, said it would be important to find out if these women, who test positive at the one-step test but would test negative at the two-step test, were treated properly with diet, exercise, and possibly insulin or other hypoglycemic agents for their mild degree of insulin resistance. The researchers concluded that expanding the definition of GDM through the one-step test didn’t make a difference. However, “it’s not just the test that will make the difference in maternal and baby outcomes, but the aggressive management of diabetes with diet, exercise, and medications as needed once that test comes back abnormal,” he said.
The randomized trial was a massive undertaking, said Dr. Hillier.
“We are still evaluating our future plans,” she added. Forthcoming subgroup analyses from the trial could further help inform clinical practice guidelines.
Dr. Hillier received a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to support this study. The investigators reported no potential conflict of interest relevant to this article.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Consensus statement issued on retinoids for ichthyosis, disorders of cornification
Clinicians using advised the authors of a new consensus statement.
In the statement, published in Pediatric Dermatology, they also addressed the effects of topical and systemic retinoid use on bone, eye, cardiovascular, and mental health, and the risks some retinoids pose to reproductive health.
Many patients with these chronic conditions, driven by multiple genetic mutations, respond to topical and/or systemic retinoids. However, to date, no specific guidance has addressed the safety, efficacy, or overall precautions for their use in the pediatric population, one of the statement authors, Moise L. Levy, MD, professor of pediatrics and medicine at the University of Texas at Austin, said in an interview.
Dr. Levy was one of the physicians on the multidisciplinary panel, The Pediatric Dermatology Research Alliance Use of Retinoids in Ichthyosis Work Group, formed to devise best practice recommendations on the use of retinoids in the management of ichthyoses and other cornification disorders in children and adolescents. The panel conducted an extensive evidence-based literature review and met in person to arrive at their conclusions. Representation from the Foundation for Ichthyosis and Related Skin Types (FIRST) was also key to this work. “Additionally, the teratogenic effects of retinoids prompted examination of gynecologic considerations and the role of the iPLEDGE program in the United States on patient access to isotretinoin,” the authors wrote.
Retinoid effects, dosing
“Both topical and systemic retinoids can improve scaling in patients with select forms of ichthyosis,” and some subtypes of disease respond better to treatment than others, they noted. Oral or topical retinoids are known to improve cases of congenital ichthyosiform erythroderma (select genotypes), Sjögren-Larsson syndrome, ichthyosis follicularis–alopecia-photophobia syndromes and keratitis-ichthyosis-deafness syndrome, erythrokeratodermia variabilis, harlequin ichthyosis, ichthyosis with confetti, and other subtypes.
Comparatively, they added, there are no data on the use of retinoids, or data showing no improvement with retinoids for several ichthyosis subtypes, including congenital hemidysplasia with ichthyosiform erythroderma and limb defects, CHIME syndrome, Conradi-Hünermann-Happle syndrome, ichthyosis-hypotrichosis syndrome, ichthyosis-hypotrichosis-sclerosing cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome, peeling skin disease, Refsum syndrome, and trichothiodystrophy though the response to such cases may vary.
Retinoids may worsen conditions that lead to peeling or skin fragility, atopic diathesis, or excessive desquamation, “and should be used with caution,” the authors advised.
Pediatric and adult patients with moderate to severe disease and significant functional or psychological impairment “should be offered the opportunity to make a benefit/risk assessment of treatment” with a systemic retinoid, they added, noting that topical retinoids have a lower risk profile and may be a better choice for milder disease.
Clinicians should aim for the lowest dose possible “that will achieve and maintain the desired therapeutic effect with acceptable mucocutaneous and systemic toxicities,” the panel recommended. Lower doses work especially well in patients with epidermolytic ichthyoses and erythrokeratodermia variabilis.
“Given the cutaneous and extracutaneous toxicities of oral retinoids, lower doses were found to achieve the most acceptable risk-benefit result. Few individuals now receive more than 1 mg/kg per day of isotretinoin or 0.5 mg/kg per day of acitretin,” according to the panel.
Dosing decisions call for a group conversation between physicians, patients and caregivers, addressing skin care, comfort and appearance issues, risk of adverse effects, and tolerance of the therapy.
Retinoid effects on organs
The impact of retinoids on the body varies by organ system, type of therapy and dosage. Dose and duration of therapy, for example, help determine the toxic effects of retinoids on bone. “Long-term use of systemic retinoids in ichthyosis/DOC is associated with skeletal concerns,” noted the authors, adding that clinicians should still consider this therapeutic approach if there is a strong clinical case for using it in a patient.
Children on long-term systemic therapy should undergo a series of tests and evaluations for bone monitoring, including an annual growth assessment. The group also recommended a baseline skeletal radiographic survey when children are on long-term systemic retinoid therapy, repeated after 3-5 years or when symptoms are present. Clinicians should also inquire about diet and discuss with patients factors that impact susceptibility to retinoid bone toxicity, such as genetic risk, diet and physical activity.
They also recommended monitoring patients taking systemic retinoids for psychiatric symptoms.
Adolescents of childbearing potential using systemic retinoids, who are sexually active, should receive counseling about contraceptive options, and should use two forms of contraception, including one highly effective method, the statement advises.
In the United States, all patients and prescribers of isotretinoin must comply with iPLEDGE guidelines; the statement addresses the issue that iPLEDGE was not designed for long-term use of isotretinoin in patients with ichthyosis, and “imposes a significant burden” in this group.
Other practice gaps and unmet needs in this area of study were discussed, calling for a closer examination of optimal timing of therapy initiation, and the adverse effects of long-term retinoid treatment. “The work, as a whole, is a starting point for these important management issues,” said Dr. Levy.
Unrestricted educational grants from Sun Pharmaceuticals and FIRST funded this effort. Dr. Levy’s disclosed serving on the advisory board and as a consultant for Cassiopea, Regeneron, and UCB, and an investigator for Fibrocell, Galderma, Janssen, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or other relationships with various pharmaceutical companies.
Clinicians using advised the authors of a new consensus statement.
In the statement, published in Pediatric Dermatology, they also addressed the effects of topical and systemic retinoid use on bone, eye, cardiovascular, and mental health, and the risks some retinoids pose to reproductive health.
Many patients with these chronic conditions, driven by multiple genetic mutations, respond to topical and/or systemic retinoids. However, to date, no specific guidance has addressed the safety, efficacy, or overall precautions for their use in the pediatric population, one of the statement authors, Moise L. Levy, MD, professor of pediatrics and medicine at the University of Texas at Austin, said in an interview.
Dr. Levy was one of the physicians on the multidisciplinary panel, The Pediatric Dermatology Research Alliance Use of Retinoids in Ichthyosis Work Group, formed to devise best practice recommendations on the use of retinoids in the management of ichthyoses and other cornification disorders in children and adolescents. The panel conducted an extensive evidence-based literature review and met in person to arrive at their conclusions. Representation from the Foundation for Ichthyosis and Related Skin Types (FIRST) was also key to this work. “Additionally, the teratogenic effects of retinoids prompted examination of gynecologic considerations and the role of the iPLEDGE program in the United States on patient access to isotretinoin,” the authors wrote.
Retinoid effects, dosing
“Both topical and systemic retinoids can improve scaling in patients with select forms of ichthyosis,” and some subtypes of disease respond better to treatment than others, they noted. Oral or topical retinoids are known to improve cases of congenital ichthyosiform erythroderma (select genotypes), Sjögren-Larsson syndrome, ichthyosis follicularis–alopecia-photophobia syndromes and keratitis-ichthyosis-deafness syndrome, erythrokeratodermia variabilis, harlequin ichthyosis, ichthyosis with confetti, and other subtypes.
Comparatively, they added, there are no data on the use of retinoids, or data showing no improvement with retinoids for several ichthyosis subtypes, including congenital hemidysplasia with ichthyosiform erythroderma and limb defects, CHIME syndrome, Conradi-Hünermann-Happle syndrome, ichthyosis-hypotrichosis syndrome, ichthyosis-hypotrichosis-sclerosing cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome, peeling skin disease, Refsum syndrome, and trichothiodystrophy though the response to such cases may vary.
Retinoids may worsen conditions that lead to peeling or skin fragility, atopic diathesis, or excessive desquamation, “and should be used with caution,” the authors advised.
Pediatric and adult patients with moderate to severe disease and significant functional or psychological impairment “should be offered the opportunity to make a benefit/risk assessment of treatment” with a systemic retinoid, they added, noting that topical retinoids have a lower risk profile and may be a better choice for milder disease.
Clinicians should aim for the lowest dose possible “that will achieve and maintain the desired therapeutic effect with acceptable mucocutaneous and systemic toxicities,” the panel recommended. Lower doses work especially well in patients with epidermolytic ichthyoses and erythrokeratodermia variabilis.
“Given the cutaneous and extracutaneous toxicities of oral retinoids, lower doses were found to achieve the most acceptable risk-benefit result. Few individuals now receive more than 1 mg/kg per day of isotretinoin or 0.5 mg/kg per day of acitretin,” according to the panel.
Dosing decisions call for a group conversation between physicians, patients and caregivers, addressing skin care, comfort and appearance issues, risk of adverse effects, and tolerance of the therapy.
Retinoid effects on organs
The impact of retinoids on the body varies by organ system, type of therapy and dosage. Dose and duration of therapy, for example, help determine the toxic effects of retinoids on bone. “Long-term use of systemic retinoids in ichthyosis/DOC is associated with skeletal concerns,” noted the authors, adding that clinicians should still consider this therapeutic approach if there is a strong clinical case for using it in a patient.
Children on long-term systemic therapy should undergo a series of tests and evaluations for bone monitoring, including an annual growth assessment. The group also recommended a baseline skeletal radiographic survey when children are on long-term systemic retinoid therapy, repeated after 3-5 years or when symptoms are present. Clinicians should also inquire about diet and discuss with patients factors that impact susceptibility to retinoid bone toxicity, such as genetic risk, diet and physical activity.
They also recommended monitoring patients taking systemic retinoids for psychiatric symptoms.
Adolescents of childbearing potential using systemic retinoids, who are sexually active, should receive counseling about contraceptive options, and should use two forms of contraception, including one highly effective method, the statement advises.
In the United States, all patients and prescribers of isotretinoin must comply with iPLEDGE guidelines; the statement addresses the issue that iPLEDGE was not designed for long-term use of isotretinoin in patients with ichthyosis, and “imposes a significant burden” in this group.
Other practice gaps and unmet needs in this area of study were discussed, calling for a closer examination of optimal timing of therapy initiation, and the adverse effects of long-term retinoid treatment. “The work, as a whole, is a starting point for these important management issues,” said Dr. Levy.
Unrestricted educational grants from Sun Pharmaceuticals and FIRST funded this effort. Dr. Levy’s disclosed serving on the advisory board and as a consultant for Cassiopea, Regeneron, and UCB, and an investigator for Fibrocell, Galderma, Janssen, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or other relationships with various pharmaceutical companies.
Clinicians using advised the authors of a new consensus statement.
In the statement, published in Pediatric Dermatology, they also addressed the effects of topical and systemic retinoid use on bone, eye, cardiovascular, and mental health, and the risks some retinoids pose to reproductive health.
Many patients with these chronic conditions, driven by multiple genetic mutations, respond to topical and/or systemic retinoids. However, to date, no specific guidance has addressed the safety, efficacy, or overall precautions for their use in the pediatric population, one of the statement authors, Moise L. Levy, MD, professor of pediatrics and medicine at the University of Texas at Austin, said in an interview.
Dr. Levy was one of the physicians on the multidisciplinary panel, The Pediatric Dermatology Research Alliance Use of Retinoids in Ichthyosis Work Group, formed to devise best practice recommendations on the use of retinoids in the management of ichthyoses and other cornification disorders in children and adolescents. The panel conducted an extensive evidence-based literature review and met in person to arrive at their conclusions. Representation from the Foundation for Ichthyosis and Related Skin Types (FIRST) was also key to this work. “Additionally, the teratogenic effects of retinoids prompted examination of gynecologic considerations and the role of the iPLEDGE program in the United States on patient access to isotretinoin,” the authors wrote.
Retinoid effects, dosing
“Both topical and systemic retinoids can improve scaling in patients with select forms of ichthyosis,” and some subtypes of disease respond better to treatment than others, they noted. Oral or topical retinoids are known to improve cases of congenital ichthyosiform erythroderma (select genotypes), Sjögren-Larsson syndrome, ichthyosis follicularis–alopecia-photophobia syndromes and keratitis-ichthyosis-deafness syndrome, erythrokeratodermia variabilis, harlequin ichthyosis, ichthyosis with confetti, and other subtypes.
Comparatively, they added, there are no data on the use of retinoids, or data showing no improvement with retinoids for several ichthyosis subtypes, including congenital hemidysplasia with ichthyosiform erythroderma and limb defects, CHIME syndrome, Conradi-Hünermann-Happle syndrome, ichthyosis-hypotrichosis syndrome, ichthyosis-hypotrichosis-sclerosing cholangitis, ichthyosis prematurity syndrome, MEDNIK syndrome, peeling skin disease, Refsum syndrome, and trichothiodystrophy though the response to such cases may vary.
Retinoids may worsen conditions that lead to peeling or skin fragility, atopic diathesis, or excessive desquamation, “and should be used with caution,” the authors advised.
Pediatric and adult patients with moderate to severe disease and significant functional or psychological impairment “should be offered the opportunity to make a benefit/risk assessment of treatment” with a systemic retinoid, they added, noting that topical retinoids have a lower risk profile and may be a better choice for milder disease.
Clinicians should aim for the lowest dose possible “that will achieve and maintain the desired therapeutic effect with acceptable mucocutaneous and systemic toxicities,” the panel recommended. Lower doses work especially well in patients with epidermolytic ichthyoses and erythrokeratodermia variabilis.
“Given the cutaneous and extracutaneous toxicities of oral retinoids, lower doses were found to achieve the most acceptable risk-benefit result. Few individuals now receive more than 1 mg/kg per day of isotretinoin or 0.5 mg/kg per day of acitretin,” according to the panel.
Dosing decisions call for a group conversation between physicians, patients and caregivers, addressing skin care, comfort and appearance issues, risk of adverse effects, and tolerance of the therapy.
Retinoid effects on organs
The impact of retinoids on the body varies by organ system, type of therapy and dosage. Dose and duration of therapy, for example, help determine the toxic effects of retinoids on bone. “Long-term use of systemic retinoids in ichthyosis/DOC is associated with skeletal concerns,” noted the authors, adding that clinicians should still consider this therapeutic approach if there is a strong clinical case for using it in a patient.
Children on long-term systemic therapy should undergo a series of tests and evaluations for bone monitoring, including an annual growth assessment. The group also recommended a baseline skeletal radiographic survey when children are on long-term systemic retinoid therapy, repeated after 3-5 years or when symptoms are present. Clinicians should also inquire about diet and discuss with patients factors that impact susceptibility to retinoid bone toxicity, such as genetic risk, diet and physical activity.
They also recommended monitoring patients taking systemic retinoids for psychiatric symptoms.
Adolescents of childbearing potential using systemic retinoids, who are sexually active, should receive counseling about contraceptive options, and should use two forms of contraception, including one highly effective method, the statement advises.
In the United States, all patients and prescribers of isotretinoin must comply with iPLEDGE guidelines; the statement addresses the issue that iPLEDGE was not designed for long-term use of isotretinoin in patients with ichthyosis, and “imposes a significant burden” in this group.
Other practice gaps and unmet needs in this area of study were discussed, calling for a closer examination of optimal timing of therapy initiation, and the adverse effects of long-term retinoid treatment. “The work, as a whole, is a starting point for these important management issues,” said Dr. Levy.
Unrestricted educational grants from Sun Pharmaceuticals and FIRST funded this effort. Dr. Levy’s disclosed serving on the advisory board and as a consultant for Cassiopea, Regeneron, and UCB, and an investigator for Fibrocell, Galderma, Janssen, and Pfizer. The other authors disclosed serving as investigators, advisers, consultants, and/or other relationships with various pharmaceutical companies.
FROM PEDIATRIC DERMATOLOGY
Women physicians and the pandemic: A snapshot
“Women physicians do not have trouble balancing competing demands any more than men physicians do. It is simply a more common expectation that women physicians will adjust their professional lives,” she observed.
The daily grind of caring for patients during a global pandemic is taking an emotional and mental toll on doctors as well as a physical one. “The recently publicized suicide of emergency physician Lorna Breen, MD, following her intense work during the pandemic in New York should cause every physician to reflect on their culture in medicine,” Dr. Brubaker wrote in the article. In an interview, she expounded on the current climate for women psychiatrists and physicians in general, offering some coping techniques.
Question: The pandemic has amplified disparities among men and women physicians. What may be the repercussions from this, not just for patient care, but for work-life balance among women physicians?
Answer: Focusing on women in academic roles, both research and clinical productivity have changed in the professional arena. Many women continue to bear a disproportionate share of family responsibilities and have reduced paid work to accommodate these needs. These changes can impact academic promotion and, therefore, subsequent academic opportunities for leadership. These gaps will add to the well-recognized gender wage gap. Women physicians are more likely to experience reduced wages associated with reduced professional activities. This reduces their annual earnings, which reduces their contributions to Social Security and other retirement programs. This can adversely impact their financial security later in life, at a time when women are already disadvantaged, compared with men.
Q: Are women psychiatrists facing additional burdens, given that many patients are suffering from anxiety and depression right now, and seeking out prescriptions?
A: We know that mental health concerns are on the rise. Although I cannot point to specific evidence, as a result. Similar to those on the more well-recognized “front lines” in the ED and critical care units, I consider my psychiatric colleagues to be on the front lines as well, as they are addressing this marked increase in care needs, for patients and for other members of the health care team.
Q: You mentioned the suicide of Dr. Breen. What might women psychiatrists take away from this incident?
A: Physicians are drawn to our vocation with a commitment to be of service to others. During such demanding times as these, the “safety” rails between service to others and self-care shift – clearly this can endanger individual doctors.
Q: What advice might you have for women in this profession? Any resources that could provide support?
A: My advice is to ensure your own well-being, knowing that this differs for each woman. Be realistic with your time and commitments, allowing time for restoration and rest. Sometimes I tell my peers to meditate or do some other form of contemplative practice. Exercise (preferably outdoors) and sleep, including preparing for good sleep, such as not reading emails or patient charts right up until sleep time, are all important. Most importantly, identify your support team and check in regularly with them. Never hesitate to reach out for help. People truly do care and want to help you.
“Women physicians do not have trouble balancing competing demands any more than men physicians do. It is simply a more common expectation that women physicians will adjust their professional lives,” she observed.
The daily grind of caring for patients during a global pandemic is taking an emotional and mental toll on doctors as well as a physical one. “The recently publicized suicide of emergency physician Lorna Breen, MD, following her intense work during the pandemic in New York should cause every physician to reflect on their culture in medicine,” Dr. Brubaker wrote in the article. In an interview, she expounded on the current climate for women psychiatrists and physicians in general, offering some coping techniques.
Question: The pandemic has amplified disparities among men and women physicians. What may be the repercussions from this, not just for patient care, but for work-life balance among women physicians?
Answer: Focusing on women in academic roles, both research and clinical productivity have changed in the professional arena. Many women continue to bear a disproportionate share of family responsibilities and have reduced paid work to accommodate these needs. These changes can impact academic promotion and, therefore, subsequent academic opportunities for leadership. These gaps will add to the well-recognized gender wage gap. Women physicians are more likely to experience reduced wages associated with reduced professional activities. This reduces their annual earnings, which reduces their contributions to Social Security and other retirement programs. This can adversely impact their financial security later in life, at a time when women are already disadvantaged, compared with men.
Q: Are women psychiatrists facing additional burdens, given that many patients are suffering from anxiety and depression right now, and seeking out prescriptions?
A: We know that mental health concerns are on the rise. Although I cannot point to specific evidence, as a result. Similar to those on the more well-recognized “front lines” in the ED and critical care units, I consider my psychiatric colleagues to be on the front lines as well, as they are addressing this marked increase in care needs, for patients and for other members of the health care team.
Q: You mentioned the suicide of Dr. Breen. What might women psychiatrists take away from this incident?
A: Physicians are drawn to our vocation with a commitment to be of service to others. During such demanding times as these, the “safety” rails between service to others and self-care shift – clearly this can endanger individual doctors.
Q: What advice might you have for women in this profession? Any resources that could provide support?
A: My advice is to ensure your own well-being, knowing that this differs for each woman. Be realistic with your time and commitments, allowing time for restoration and rest. Sometimes I tell my peers to meditate or do some other form of contemplative practice. Exercise (preferably outdoors) and sleep, including preparing for good sleep, such as not reading emails or patient charts right up until sleep time, are all important. Most importantly, identify your support team and check in regularly with them. Never hesitate to reach out for help. People truly do care and want to help you.
“Women physicians do not have trouble balancing competing demands any more than men physicians do. It is simply a more common expectation that women physicians will adjust their professional lives,” she observed.
The daily grind of caring for patients during a global pandemic is taking an emotional and mental toll on doctors as well as a physical one. “The recently publicized suicide of emergency physician Lorna Breen, MD, following her intense work during the pandemic in New York should cause every physician to reflect on their culture in medicine,” Dr. Brubaker wrote in the article. In an interview, she expounded on the current climate for women psychiatrists and physicians in general, offering some coping techniques.
Question: The pandemic has amplified disparities among men and women physicians. What may be the repercussions from this, not just for patient care, but for work-life balance among women physicians?
Answer: Focusing on women in academic roles, both research and clinical productivity have changed in the professional arena. Many women continue to bear a disproportionate share of family responsibilities and have reduced paid work to accommodate these needs. These changes can impact academic promotion and, therefore, subsequent academic opportunities for leadership. These gaps will add to the well-recognized gender wage gap. Women physicians are more likely to experience reduced wages associated with reduced professional activities. This reduces their annual earnings, which reduces their contributions to Social Security and other retirement programs. This can adversely impact their financial security later in life, at a time when women are already disadvantaged, compared with men.
Q: Are women psychiatrists facing additional burdens, given that many patients are suffering from anxiety and depression right now, and seeking out prescriptions?
A: We know that mental health concerns are on the rise. Although I cannot point to specific evidence, as a result. Similar to those on the more well-recognized “front lines” in the ED and critical care units, I consider my psychiatric colleagues to be on the front lines as well, as they are addressing this marked increase in care needs, for patients and for other members of the health care team.
Q: You mentioned the suicide of Dr. Breen. What might women psychiatrists take away from this incident?
A: Physicians are drawn to our vocation with a commitment to be of service to others. During such demanding times as these, the “safety” rails between service to others and self-care shift – clearly this can endanger individual doctors.
Q: What advice might you have for women in this profession? Any resources that could provide support?
A: My advice is to ensure your own well-being, knowing that this differs for each woman. Be realistic with your time and commitments, allowing time for restoration and rest. Sometimes I tell my peers to meditate or do some other form of contemplative practice. Exercise (preferably outdoors) and sleep, including preparing for good sleep, such as not reading emails or patient charts right up until sleep time, are all important. Most importantly, identify your support team and check in regularly with them. Never hesitate to reach out for help. People truly do care and want to help you.