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Poison centers fielding more calls about teen cannabis use
Poison control centers in the United States now receive more calls about adolescents abusing cannabis than alcohol or any other substance, according to a new study.
Many helpline calls about cannabis involve edible products, the researchers noted.
Over-the-counter medications – especially dextromethorphan-containing cough and cold medications and oral antihistamines, such as Benadryl – are other commonly abused substances.
But cannabis recently started topping the list.
“Since 2018, the most reported misused/abused substance involved exposure to marijuana,” according to the study, which was published online in Clinical Toxicology.
Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health & Science University, Portland, and colleagues analyzed calls to United States poison control centers between 2000 and 2020. They focused on 338,000 calls about intentional substance abuse or misuse, including for the purpose of getting high, in individuals aged 6-18 years.
The calls were made to 55 certified helplines for health professionals, public health agencies, and members of the public seeking guidance about exposures to various substances.
Cannabis vs. alcohol
In 2000, alcohol was the substance involved in the largest number of cases (1,318, or 9.8% of all calls). Between 2000 and 2013, cases of alcohol abuse exceeded the number of cannabis cases each year.
But that changed in 2014, when cannabis overtook alcohol.
Over the 20-year study period, calls about exposure to cannabis increased 245%, from 510 in 2000 to 1,761 in 2020.
Edibles played a key role.
“Edible marijuana preparations accounted for the highest increase in call rates, compared with all other forms of marijuana,” the researchers reported.
Edible products are “often marketed in ways that are attractive to young people, and they are considered more discrete and convenient,” Dr. Hughes said. But they can have “unpredictable” effects.
“Compared to smoking cannabis, which typically results in an immediate high, intoxication from edible forms usually takes several hours, which may lead some individuals to consume greater amounts and experience unexpected and unpredictable highs,” she said.
For example, prior research has shown that edible cannabis consumption may lead to more acute psychiatric symptoms and cardiovascular events than does inhaled cannabis.
Trends in alcohol use may have held relatively steady, despite some minor declines in the poison center data, Dr. Hughes said.
“Anecdotally, there hasn’t been an obvious notable reduction in alcohol cases in the emergency department,” she said. “However, I wouldn’t expect a huge change given our data only found a slow mild decline in alcohol cases over the study period.”
The increase in cannabis-related calls coincides with more states legalizing or decriminalizing the drug for medical or recreational purposes. Currently, 21 states have approved recreational cannabis for adults who are at least 21 years old.
What are the risks?
Parents typically call a poison center about cannabis exposure after they see or suspect that their child has ingested loose cannabis leaves or edibles containing the substance, Dr. Hughes said.
“The poison center provides guidance to parents about whether or not their child can be watched at home or requires referral to a health care facility,” she said. “While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products.”
Intentional misuse or abuse tends to occur in older children and teens.
Nonprescription drugs have a high potential for abuse because they are legal and may be perceived as safe, Dr. Hughes said.
If a child has a history of misusing or abusing substances or if a parent is worried that their child is at high risk for this behavior, they should consider securing medicines in a lock box, she advised.
That applies to cannabis too.
“I would recommend that parents also consider locking up their cannabis products,” she said.
The National Poison Data System relies on voluntary reporting, and the data are not expected to represent the actual number of intentional misuse and abuse exposures, the researchers noted.
Poison control centers in the United States are available for consultation about patients with known or suspected cannabis ingestion or other suspected poisonings (1-800-222-1222).
The researchers had no disclosures.
A version of this article first appeared on Medscape.com.
Poison control centers in the United States now receive more calls about adolescents abusing cannabis than alcohol or any other substance, according to a new study.
Many helpline calls about cannabis involve edible products, the researchers noted.
Over-the-counter medications – especially dextromethorphan-containing cough and cold medications and oral antihistamines, such as Benadryl – are other commonly abused substances.
But cannabis recently started topping the list.
“Since 2018, the most reported misused/abused substance involved exposure to marijuana,” according to the study, which was published online in Clinical Toxicology.
Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health & Science University, Portland, and colleagues analyzed calls to United States poison control centers between 2000 and 2020. They focused on 338,000 calls about intentional substance abuse or misuse, including for the purpose of getting high, in individuals aged 6-18 years.
The calls were made to 55 certified helplines for health professionals, public health agencies, and members of the public seeking guidance about exposures to various substances.
Cannabis vs. alcohol
In 2000, alcohol was the substance involved in the largest number of cases (1,318, or 9.8% of all calls). Between 2000 and 2013, cases of alcohol abuse exceeded the number of cannabis cases each year.
But that changed in 2014, when cannabis overtook alcohol.
Over the 20-year study period, calls about exposure to cannabis increased 245%, from 510 in 2000 to 1,761 in 2020.
Edibles played a key role.
“Edible marijuana preparations accounted for the highest increase in call rates, compared with all other forms of marijuana,” the researchers reported.
Edible products are “often marketed in ways that are attractive to young people, and they are considered more discrete and convenient,” Dr. Hughes said. But they can have “unpredictable” effects.
“Compared to smoking cannabis, which typically results in an immediate high, intoxication from edible forms usually takes several hours, which may lead some individuals to consume greater amounts and experience unexpected and unpredictable highs,” she said.
For example, prior research has shown that edible cannabis consumption may lead to more acute psychiatric symptoms and cardiovascular events than does inhaled cannabis.
Trends in alcohol use may have held relatively steady, despite some minor declines in the poison center data, Dr. Hughes said.
“Anecdotally, there hasn’t been an obvious notable reduction in alcohol cases in the emergency department,” she said. “However, I wouldn’t expect a huge change given our data only found a slow mild decline in alcohol cases over the study period.”
The increase in cannabis-related calls coincides with more states legalizing or decriminalizing the drug for medical or recreational purposes. Currently, 21 states have approved recreational cannabis for adults who are at least 21 years old.
What are the risks?
Parents typically call a poison center about cannabis exposure after they see or suspect that their child has ingested loose cannabis leaves or edibles containing the substance, Dr. Hughes said.
“The poison center provides guidance to parents about whether or not their child can be watched at home or requires referral to a health care facility,” she said. “While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products.”
Intentional misuse or abuse tends to occur in older children and teens.
Nonprescription drugs have a high potential for abuse because they are legal and may be perceived as safe, Dr. Hughes said.
If a child has a history of misusing or abusing substances or if a parent is worried that their child is at high risk for this behavior, they should consider securing medicines in a lock box, she advised.
That applies to cannabis too.
“I would recommend that parents also consider locking up their cannabis products,” she said.
The National Poison Data System relies on voluntary reporting, and the data are not expected to represent the actual number of intentional misuse and abuse exposures, the researchers noted.
Poison control centers in the United States are available for consultation about patients with known or suspected cannabis ingestion or other suspected poisonings (1-800-222-1222).
The researchers had no disclosures.
A version of this article first appeared on Medscape.com.
Poison control centers in the United States now receive more calls about adolescents abusing cannabis than alcohol or any other substance, according to a new study.
Many helpline calls about cannabis involve edible products, the researchers noted.
Over-the-counter medications – especially dextromethorphan-containing cough and cold medications and oral antihistamines, such as Benadryl – are other commonly abused substances.
But cannabis recently started topping the list.
“Since 2018, the most reported misused/abused substance involved exposure to marijuana,” according to the study, which was published online in Clinical Toxicology.
Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health & Science University, Portland, and colleagues analyzed calls to United States poison control centers between 2000 and 2020. They focused on 338,000 calls about intentional substance abuse or misuse, including for the purpose of getting high, in individuals aged 6-18 years.
The calls were made to 55 certified helplines for health professionals, public health agencies, and members of the public seeking guidance about exposures to various substances.
Cannabis vs. alcohol
In 2000, alcohol was the substance involved in the largest number of cases (1,318, or 9.8% of all calls). Between 2000 and 2013, cases of alcohol abuse exceeded the number of cannabis cases each year.
But that changed in 2014, when cannabis overtook alcohol.
Over the 20-year study period, calls about exposure to cannabis increased 245%, from 510 in 2000 to 1,761 in 2020.
Edibles played a key role.
“Edible marijuana preparations accounted for the highest increase in call rates, compared with all other forms of marijuana,” the researchers reported.
Edible products are “often marketed in ways that are attractive to young people, and they are considered more discrete and convenient,” Dr. Hughes said. But they can have “unpredictable” effects.
“Compared to smoking cannabis, which typically results in an immediate high, intoxication from edible forms usually takes several hours, which may lead some individuals to consume greater amounts and experience unexpected and unpredictable highs,” she said.
For example, prior research has shown that edible cannabis consumption may lead to more acute psychiatric symptoms and cardiovascular events than does inhaled cannabis.
Trends in alcohol use may have held relatively steady, despite some minor declines in the poison center data, Dr. Hughes said.
“Anecdotally, there hasn’t been an obvious notable reduction in alcohol cases in the emergency department,” she said. “However, I wouldn’t expect a huge change given our data only found a slow mild decline in alcohol cases over the study period.”
The increase in cannabis-related calls coincides with more states legalizing or decriminalizing the drug for medical or recreational purposes. Currently, 21 states have approved recreational cannabis for adults who are at least 21 years old.
What are the risks?
Parents typically call a poison center about cannabis exposure after they see or suspect that their child has ingested loose cannabis leaves or edibles containing the substance, Dr. Hughes said.
“The poison center provides guidance to parents about whether or not their child can be watched at home or requires referral to a health care facility,” she said. “While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products.”
Intentional misuse or abuse tends to occur in older children and teens.
Nonprescription drugs have a high potential for abuse because they are legal and may be perceived as safe, Dr. Hughes said.
If a child has a history of misusing or abusing substances or if a parent is worried that their child is at high risk for this behavior, they should consider securing medicines in a lock box, she advised.
That applies to cannabis too.
“I would recommend that parents also consider locking up their cannabis products,” she said.
The National Poison Data System relies on voluntary reporting, and the data are not expected to represent the actual number of intentional misuse and abuse exposures, the researchers noted.
Poison control centers in the United States are available for consultation about patients with known or suspected cannabis ingestion or other suspected poisonings (1-800-222-1222).
The researchers had no disclosures.
A version of this article first appeared on Medscape.com.
Teens’ undisclosed dieting may precede anorexia nervosa diagnosis
Adolescents later diagnosed with anorexia nervosa (AN) likely embark on the trajectory to AN with undisclosed dieting for weight loss at about age 14, a study of teens and parents found.
In the interview-based study, both adolescents and their parents described a similar prediagnosis sequence of behavioral changes occurring over roughly 1 year to 18 months, but parents lagged some 6 months behind in noticing their children’s disordered eating.
The findings suggest that even teens of normal weight should be asked about their eating habits and monitored more closely for contact with those who endorse these potentially harmful eating behaviors, according to Lisa M. Ranzenhofer, PhD, assistant professor of clinical psychology in psychiatry at Columbia University Medical Center in New York, and colleagues. Their report is in the Journal of Adolescent Health.
“We know that adolescents often have eating disorder behaviors long before they’re diagnosed, so we developed this interview as a tool to figure out how long a maladaptive behavior has been present,” Dr. Ranzenhofer said in an interview. “Most studies that report illness duration do so based on diagnosis, so this interview provides a more fine-grained assessment of the duration of problematic behavior, which may help improve understanding of the impact of duration on outcome, and hopefully facilitate better methods for early detection.” Since healthy adolescents are often seen once per year at an annual pediatrician visit, she added, teens engaging in significant dieting might benefit from more frequent monitoring since this behavior can evolve into an eating disorder over a relatively short time frame.
AN is associated with significant medical and psychiatric comorbidity and has a mortality rate among the highest of any psychiatric illness, the authors noted.
The study
The study cohort consisted of 71 girls ages 12-18 years participating in research from 2017 to 2021 at the Eating Disorders Research Unit of New York (N.Y.) State Psychiatric Institute. Patients had either the restricting or binge-eating/purging subtype of AN as diagnosed by the Eating Disorder Assessment–5 questionnaire. A semistructured 15-minute interview with the girls and their parents explored food restriction, dieting, loss of control/binge eating, purging, excessive/compulsive exercise, weight history, and amenorrhea.
Both parents and children were asked whether and when the children had been underweight or overweight, and whether and when primary amenorrhea (no menarche) or secondary amenorrhea (periods missed for 3 months) became evident. Dieting was defined as “deliberately changing eating patterns in any way to influence your shape or weight,” and restriction as “deliberately cutting down on the amount of food that you are eating, in order to change your shape or weight.” Loss-of-control eating was defined as “feeling unable to stop eating or control what or how much you are eating.”
In other characterizations, purging was defined as making yourself vomit on purpose, taking diuretics, or feeling driven to engage in these behaviors. Questions on exercise explored whether children might feel anxious when they do not exercise or inclined to exercise even if sick or injured, with excessive exercise defined as “Feeling like you must exercise, might continue exercising, sometimes in secret, if parents or doctors have told you to stop.”
Other questions focused on use of diuretics or laxatives and other strategies to compensate for calories consumed.
Responses revealed that restriction, underweight, dieting, and excessive exercise were present in most of the sample, while purging, loss-of-control eating, and overweight were reported by fewer than a third. With dieting typically emerging first around age 14, the other behaviors tended to manifest from age 14 to 14 and a half. The average age of formal diagnosis was just over 15 years. Parent-child dyads showed good agreement on the presence and timing of all behaviors except for dieting, for which children reported onset about 6 months earlier or longer duration compared with parents.
Although older age at the time of interview was associated with a lower body mass index percentile and higher eating disorder score, neither age of onset nor duration of disordered eating was associated with severity when researchers controlled for current age.
Telltale signs for parents
“For teens starting at a healthy weight, significant and intentional weight loss of more than 5-10 pounds can be a cause for concern,” Dr. Ranzenhofer said. Missed periods, refusing meals, skipping meals, fighting or arguing about eating, and withdrawal from normal activities and relationships are other signs of disordered eating. For overweight or obese teens, rapid weight loss and weight loss above and beyond that recommended are also concerning.
As for compulsive exercise, she said, “Altered exercise behavior might look like exercise that interferes with other activities, for example, being late to school or not doing homework in order to exercise.” Other red flags would be physical activity that varies considerably from that of peers, for instance, going running after a 2-hour sports practice and an inflexible routine that precludes being able to skip a day.
“All adolescents, male and female, should be screened regardless of weight trends – underweight, overweight, obese, or normal weight – regarding their body image and thoughts of dieting,” said Margaret E. Thew, DNP, FNP-BC, of the Medical College of Wisconsin, and medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, commenting on the study but not involved in it. “Most adolescents make decisions to lose weight after trying to ‘eat healthy’ but may take an aggressive approach when they don’t see the weight loss they hope to see.”
According to Ms. Thew, the study findings support the benefit of giving medical caregivers and parents training on the red flags regarding eating disorders to foster early detection. “These include starting a new fad diet, eliminating foods, ‘healthy eating,’ over-exercising, skipping meals, or no longer eating foods they previously loved.”
She added that times of transition are key junctures to watch: The transition from grade school to middle school, middle to high school, and high school to college. “These tend to provoke eating disorder onset or relapse of eating disorder thoughts and behaviors after diagnosis,” Ms. Thew said. “It would benefit the patient to screen for concerns about disordered eating and provide resources, including consultation with a dietitian, as appropriate.”
This study was supported by grants from the National Institute of Mental Health and the Hilda and Preston Davis Foundation. Coauthor Joanna E. Steinglass, MD, disclosed receiving royalties from UpToDate. Ms. Thew disclosed no competing interests with regard to her comments.
Adolescents later diagnosed with anorexia nervosa (AN) likely embark on the trajectory to AN with undisclosed dieting for weight loss at about age 14, a study of teens and parents found.
In the interview-based study, both adolescents and their parents described a similar prediagnosis sequence of behavioral changes occurring over roughly 1 year to 18 months, but parents lagged some 6 months behind in noticing their children’s disordered eating.
The findings suggest that even teens of normal weight should be asked about their eating habits and monitored more closely for contact with those who endorse these potentially harmful eating behaviors, according to Lisa M. Ranzenhofer, PhD, assistant professor of clinical psychology in psychiatry at Columbia University Medical Center in New York, and colleagues. Their report is in the Journal of Adolescent Health.
“We know that adolescents often have eating disorder behaviors long before they’re diagnosed, so we developed this interview as a tool to figure out how long a maladaptive behavior has been present,” Dr. Ranzenhofer said in an interview. “Most studies that report illness duration do so based on diagnosis, so this interview provides a more fine-grained assessment of the duration of problematic behavior, which may help improve understanding of the impact of duration on outcome, and hopefully facilitate better methods for early detection.” Since healthy adolescents are often seen once per year at an annual pediatrician visit, she added, teens engaging in significant dieting might benefit from more frequent monitoring since this behavior can evolve into an eating disorder over a relatively short time frame.
AN is associated with significant medical and psychiatric comorbidity and has a mortality rate among the highest of any psychiatric illness, the authors noted.
The study
The study cohort consisted of 71 girls ages 12-18 years participating in research from 2017 to 2021 at the Eating Disorders Research Unit of New York (N.Y.) State Psychiatric Institute. Patients had either the restricting or binge-eating/purging subtype of AN as diagnosed by the Eating Disorder Assessment–5 questionnaire. A semistructured 15-minute interview with the girls and their parents explored food restriction, dieting, loss of control/binge eating, purging, excessive/compulsive exercise, weight history, and amenorrhea.
Both parents and children were asked whether and when the children had been underweight or overweight, and whether and when primary amenorrhea (no menarche) or secondary amenorrhea (periods missed for 3 months) became evident. Dieting was defined as “deliberately changing eating patterns in any way to influence your shape or weight,” and restriction as “deliberately cutting down on the amount of food that you are eating, in order to change your shape or weight.” Loss-of-control eating was defined as “feeling unable to stop eating or control what or how much you are eating.”
In other characterizations, purging was defined as making yourself vomit on purpose, taking diuretics, or feeling driven to engage in these behaviors. Questions on exercise explored whether children might feel anxious when they do not exercise or inclined to exercise even if sick or injured, with excessive exercise defined as “Feeling like you must exercise, might continue exercising, sometimes in secret, if parents or doctors have told you to stop.”
Other questions focused on use of diuretics or laxatives and other strategies to compensate for calories consumed.
Responses revealed that restriction, underweight, dieting, and excessive exercise were present in most of the sample, while purging, loss-of-control eating, and overweight were reported by fewer than a third. With dieting typically emerging first around age 14, the other behaviors tended to manifest from age 14 to 14 and a half. The average age of formal diagnosis was just over 15 years. Parent-child dyads showed good agreement on the presence and timing of all behaviors except for dieting, for which children reported onset about 6 months earlier or longer duration compared with parents.
Although older age at the time of interview was associated with a lower body mass index percentile and higher eating disorder score, neither age of onset nor duration of disordered eating was associated with severity when researchers controlled for current age.
Telltale signs for parents
“For teens starting at a healthy weight, significant and intentional weight loss of more than 5-10 pounds can be a cause for concern,” Dr. Ranzenhofer said. Missed periods, refusing meals, skipping meals, fighting or arguing about eating, and withdrawal from normal activities and relationships are other signs of disordered eating. For overweight or obese teens, rapid weight loss and weight loss above and beyond that recommended are also concerning.
As for compulsive exercise, she said, “Altered exercise behavior might look like exercise that interferes with other activities, for example, being late to school or not doing homework in order to exercise.” Other red flags would be physical activity that varies considerably from that of peers, for instance, going running after a 2-hour sports practice and an inflexible routine that precludes being able to skip a day.
“All adolescents, male and female, should be screened regardless of weight trends – underweight, overweight, obese, or normal weight – regarding their body image and thoughts of dieting,” said Margaret E. Thew, DNP, FNP-BC, of the Medical College of Wisconsin, and medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, commenting on the study but not involved in it. “Most adolescents make decisions to lose weight after trying to ‘eat healthy’ but may take an aggressive approach when they don’t see the weight loss they hope to see.”
According to Ms. Thew, the study findings support the benefit of giving medical caregivers and parents training on the red flags regarding eating disorders to foster early detection. “These include starting a new fad diet, eliminating foods, ‘healthy eating,’ over-exercising, skipping meals, or no longer eating foods they previously loved.”
She added that times of transition are key junctures to watch: The transition from grade school to middle school, middle to high school, and high school to college. “These tend to provoke eating disorder onset or relapse of eating disorder thoughts and behaviors after diagnosis,” Ms. Thew said. “It would benefit the patient to screen for concerns about disordered eating and provide resources, including consultation with a dietitian, as appropriate.”
This study was supported by grants from the National Institute of Mental Health and the Hilda and Preston Davis Foundation. Coauthor Joanna E. Steinglass, MD, disclosed receiving royalties from UpToDate. Ms. Thew disclosed no competing interests with regard to her comments.
Adolescents later diagnosed with anorexia nervosa (AN) likely embark on the trajectory to AN with undisclosed dieting for weight loss at about age 14, a study of teens and parents found.
In the interview-based study, both adolescents and their parents described a similar prediagnosis sequence of behavioral changes occurring over roughly 1 year to 18 months, but parents lagged some 6 months behind in noticing their children’s disordered eating.
The findings suggest that even teens of normal weight should be asked about their eating habits and monitored more closely for contact with those who endorse these potentially harmful eating behaviors, according to Lisa M. Ranzenhofer, PhD, assistant professor of clinical psychology in psychiatry at Columbia University Medical Center in New York, and colleagues. Their report is in the Journal of Adolescent Health.
“We know that adolescents often have eating disorder behaviors long before they’re diagnosed, so we developed this interview as a tool to figure out how long a maladaptive behavior has been present,” Dr. Ranzenhofer said in an interview. “Most studies that report illness duration do so based on diagnosis, so this interview provides a more fine-grained assessment of the duration of problematic behavior, which may help improve understanding of the impact of duration on outcome, and hopefully facilitate better methods for early detection.” Since healthy adolescents are often seen once per year at an annual pediatrician visit, she added, teens engaging in significant dieting might benefit from more frequent monitoring since this behavior can evolve into an eating disorder over a relatively short time frame.
AN is associated with significant medical and psychiatric comorbidity and has a mortality rate among the highest of any psychiatric illness, the authors noted.
The study
The study cohort consisted of 71 girls ages 12-18 years participating in research from 2017 to 2021 at the Eating Disorders Research Unit of New York (N.Y.) State Psychiatric Institute. Patients had either the restricting or binge-eating/purging subtype of AN as diagnosed by the Eating Disorder Assessment–5 questionnaire. A semistructured 15-minute interview with the girls and their parents explored food restriction, dieting, loss of control/binge eating, purging, excessive/compulsive exercise, weight history, and amenorrhea.
Both parents and children were asked whether and when the children had been underweight or overweight, and whether and when primary amenorrhea (no menarche) or secondary amenorrhea (periods missed for 3 months) became evident. Dieting was defined as “deliberately changing eating patterns in any way to influence your shape or weight,” and restriction as “deliberately cutting down on the amount of food that you are eating, in order to change your shape or weight.” Loss-of-control eating was defined as “feeling unable to stop eating or control what or how much you are eating.”
In other characterizations, purging was defined as making yourself vomit on purpose, taking diuretics, or feeling driven to engage in these behaviors. Questions on exercise explored whether children might feel anxious when they do not exercise or inclined to exercise even if sick or injured, with excessive exercise defined as “Feeling like you must exercise, might continue exercising, sometimes in secret, if parents or doctors have told you to stop.”
Other questions focused on use of diuretics or laxatives and other strategies to compensate for calories consumed.
Responses revealed that restriction, underweight, dieting, and excessive exercise were present in most of the sample, while purging, loss-of-control eating, and overweight were reported by fewer than a third. With dieting typically emerging first around age 14, the other behaviors tended to manifest from age 14 to 14 and a half. The average age of formal diagnosis was just over 15 years. Parent-child dyads showed good agreement on the presence and timing of all behaviors except for dieting, for which children reported onset about 6 months earlier or longer duration compared with parents.
Although older age at the time of interview was associated with a lower body mass index percentile and higher eating disorder score, neither age of onset nor duration of disordered eating was associated with severity when researchers controlled for current age.
Telltale signs for parents
“For teens starting at a healthy weight, significant and intentional weight loss of more than 5-10 pounds can be a cause for concern,” Dr. Ranzenhofer said. Missed periods, refusing meals, skipping meals, fighting or arguing about eating, and withdrawal from normal activities and relationships are other signs of disordered eating. For overweight or obese teens, rapid weight loss and weight loss above and beyond that recommended are also concerning.
As for compulsive exercise, she said, “Altered exercise behavior might look like exercise that interferes with other activities, for example, being late to school or not doing homework in order to exercise.” Other red flags would be physical activity that varies considerably from that of peers, for instance, going running after a 2-hour sports practice and an inflexible routine that precludes being able to skip a day.
“All adolescents, male and female, should be screened regardless of weight trends – underweight, overweight, obese, or normal weight – regarding their body image and thoughts of dieting,” said Margaret E. Thew, DNP, FNP-BC, of the Medical College of Wisconsin, and medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, commenting on the study but not involved in it. “Most adolescents make decisions to lose weight after trying to ‘eat healthy’ but may take an aggressive approach when they don’t see the weight loss they hope to see.”
According to Ms. Thew, the study findings support the benefit of giving medical caregivers and parents training on the red flags regarding eating disorders to foster early detection. “These include starting a new fad diet, eliminating foods, ‘healthy eating,’ over-exercising, skipping meals, or no longer eating foods they previously loved.”
She added that times of transition are key junctures to watch: The transition from grade school to middle school, middle to high school, and high school to college. “These tend to provoke eating disorder onset or relapse of eating disorder thoughts and behaviors after diagnosis,” Ms. Thew said. “It would benefit the patient to screen for concerns about disordered eating and provide resources, including consultation with a dietitian, as appropriate.”
This study was supported by grants from the National Institute of Mental Health and the Hilda and Preston Davis Foundation. Coauthor Joanna E. Steinglass, MD, disclosed receiving royalties from UpToDate. Ms. Thew disclosed no competing interests with regard to her comments.
FROM JOURNAL OF ADOLESCENT HEALTH
Youths have strong opinions on language about body weight
With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.
Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel.
“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.”
A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.
Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27 terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.
Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
Words matter
In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.
But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.
“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.
“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.
“In essence, this is a low-hanging fruit intervention,” she said.
Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
One piece of the puzzle
Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.
For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.
Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”
The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.
“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.
A version of this article first appeared on Medscape.com.
With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.
Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel.
“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.”
A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.
Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27 terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.
Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
Words matter
In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.
But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.
“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.
“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.
“In essence, this is a low-hanging fruit intervention,” she said.
Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
One piece of the puzzle
Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.
For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.
Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”
The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.
“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.
A version of this article first appeared on Medscape.com.
With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.
Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel.
“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.”
A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.
Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27 terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.
Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
Words matter
In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.
But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.
“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.
“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.
“In essence, this is a low-hanging fruit intervention,” she said.
Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
One piece of the puzzle
Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.
For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.
Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”
The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.
“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.
A version of this article first appeared on Medscape.com.
FROM PEDIATRICS
With type 1 diabetes delay possible, focus now on screening
The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.
The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.
It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.
The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.
Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.
But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.
During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.”
Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”
During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.
Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
How would screening happen?
While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.
Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.
Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.
However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.
The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.
“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.
He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.
And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.
“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”
A two-pronged approach to screening could work best
Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.
“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”
Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.
“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”
He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”
While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”
But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”
During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.
Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.
A version of this article first appeared on Medscape.com.
The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.
The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.
It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.
The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.
Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.
But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.
During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.”
Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”
During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.
Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
How would screening happen?
While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.
Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.
Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.
However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.
The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.
“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.
He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.
And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.
“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”
A two-pronged approach to screening could work best
Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.
“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”
Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.
“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”
He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”
While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”
But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”
During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.
Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.
A version of this article first appeared on Medscape.com.
The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.
The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.
It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.
The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.
Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.
But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.
During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.”
Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”
During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.
Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
How would screening happen?
While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.
Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.
Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.
However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.
The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.
“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.
He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.
And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.
“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”
A two-pronged approach to screening could work best
Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.
“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”
Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.
“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”
He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”
While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”
But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”
During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.
Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.
A version of this article first appeared on Medscape.com.
Your patients are rotting their teeth with vaping
Primary care physicians, and especially pediatricians, should consider telling their patients about the long-term oral health problems associated with vaping.
A new study found that patients who use vapes were at a higher risk of developing tooth decay and periodontal disease.
Vapes were introduced to the U.S. market in 2006 as an alternative to conventional cigarettes and have become widely popular among youth. According to a 2022 survey from the U.S. Centers for Disease Control and Prevention, 2.55 million middle and high school students in this country reported using the devices in the previous 30 days.
The new study, published in the Journal of the American Dental Association, expands on an initial case series published in 2020 of patients who reported use of vapes and who had severe dental decay. Karina Irusa, BDS, assistant professor of comprehensive care at Tufts University, Boston, and lead author of the case series, wanted to investigate whether her initial findings would apply to a large population of vape users.
For the new study, Dr. Irusa and colleagues collected data on 13,216 patients aged 16-40 who attended Tufts dental clinics between 2019 and 2021. All patients had received a diagnosis of tooth decay, had a tooth decay risk assessment on record, and had answered “yes” or “no” to use of vapes in a health history questionnaire.
Patients had records on file of varying types of dental lesions, cavities filled within the previous 3 years, heavy plaque on teeth, inadequate brushing and flushing, and a self-report of recreational drug use and frequent snacking. If patients had these factors on their file, they were at high risk of developing decay that leads to cavities.
The study found that 79% of patients who responded “yes” to being a current user of vapes were at high risk for dental decay, compared with 60% of those who did not report using the devices.
Materials in the vaping liquids further cause an inflammatory response that disrupts an individual’s internal microbiome, according to numerous studies.
“All the ingredients of vaping are surely a recipe for overgrowth of cavities causing bacteria,” said Jennifer Genuardi, MD, an internist and pediatrician at federally qualified community health center Urban Health Plan, in New York, who was not involved in the study.
Dr. Irusa said information on patient’s vaping habits should be included in routine dental and medical history questionnaires as part of their overall electronic health record.
“Decay in its severe form not only affects one’s ability to eat but affects facial aesthetics and self-esteem as well,” Dr. Irusa said.
Dr. Genuardi called the findings unsurprising.
“We are learning daily more and more about the dangers of vaping,” Dr. Genuardi said. “There’s a focus of today’s research on the effect of actions on our microbiome and the subsequent effects on our health.”
Dr. Genuardi also said many of her teenage patients do not enjoy dental visits or having cavities filled, which could serve as a useful deterrent to vaping for a demographic that has been targeted with marketing from vape manufacturers.
“Cavity formation and the experience of having cavities filled is an experience teens can identify with, so this to me seems like perhaps an even more effective angle to try to curb this unhealthy behavior of vaping,” Dr. Genuardi said.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Primary care physicians, and especially pediatricians, should consider telling their patients about the long-term oral health problems associated with vaping.
A new study found that patients who use vapes were at a higher risk of developing tooth decay and periodontal disease.
Vapes were introduced to the U.S. market in 2006 as an alternative to conventional cigarettes and have become widely popular among youth. According to a 2022 survey from the U.S. Centers for Disease Control and Prevention, 2.55 million middle and high school students in this country reported using the devices in the previous 30 days.
The new study, published in the Journal of the American Dental Association, expands on an initial case series published in 2020 of patients who reported use of vapes and who had severe dental decay. Karina Irusa, BDS, assistant professor of comprehensive care at Tufts University, Boston, and lead author of the case series, wanted to investigate whether her initial findings would apply to a large population of vape users.
For the new study, Dr. Irusa and colleagues collected data on 13,216 patients aged 16-40 who attended Tufts dental clinics between 2019 and 2021. All patients had received a diagnosis of tooth decay, had a tooth decay risk assessment on record, and had answered “yes” or “no” to use of vapes in a health history questionnaire.
Patients had records on file of varying types of dental lesions, cavities filled within the previous 3 years, heavy plaque on teeth, inadequate brushing and flushing, and a self-report of recreational drug use and frequent snacking. If patients had these factors on their file, they were at high risk of developing decay that leads to cavities.
The study found that 79% of patients who responded “yes” to being a current user of vapes were at high risk for dental decay, compared with 60% of those who did not report using the devices.
Materials in the vaping liquids further cause an inflammatory response that disrupts an individual’s internal microbiome, according to numerous studies.
“All the ingredients of vaping are surely a recipe for overgrowth of cavities causing bacteria,” said Jennifer Genuardi, MD, an internist and pediatrician at federally qualified community health center Urban Health Plan, in New York, who was not involved in the study.
Dr. Irusa said information on patient’s vaping habits should be included in routine dental and medical history questionnaires as part of their overall electronic health record.
“Decay in its severe form not only affects one’s ability to eat but affects facial aesthetics and self-esteem as well,” Dr. Irusa said.
Dr. Genuardi called the findings unsurprising.
“We are learning daily more and more about the dangers of vaping,” Dr. Genuardi said. “There’s a focus of today’s research on the effect of actions on our microbiome and the subsequent effects on our health.”
Dr. Genuardi also said many of her teenage patients do not enjoy dental visits or having cavities filled, which could serve as a useful deterrent to vaping for a demographic that has been targeted with marketing from vape manufacturers.
“Cavity formation and the experience of having cavities filled is an experience teens can identify with, so this to me seems like perhaps an even more effective angle to try to curb this unhealthy behavior of vaping,” Dr. Genuardi said.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Primary care physicians, and especially pediatricians, should consider telling their patients about the long-term oral health problems associated with vaping.
A new study found that patients who use vapes were at a higher risk of developing tooth decay and periodontal disease.
Vapes were introduced to the U.S. market in 2006 as an alternative to conventional cigarettes and have become widely popular among youth. According to a 2022 survey from the U.S. Centers for Disease Control and Prevention, 2.55 million middle and high school students in this country reported using the devices in the previous 30 days.
The new study, published in the Journal of the American Dental Association, expands on an initial case series published in 2020 of patients who reported use of vapes and who had severe dental decay. Karina Irusa, BDS, assistant professor of comprehensive care at Tufts University, Boston, and lead author of the case series, wanted to investigate whether her initial findings would apply to a large population of vape users.
For the new study, Dr. Irusa and colleagues collected data on 13,216 patients aged 16-40 who attended Tufts dental clinics between 2019 and 2021. All patients had received a diagnosis of tooth decay, had a tooth decay risk assessment on record, and had answered “yes” or “no” to use of vapes in a health history questionnaire.
Patients had records on file of varying types of dental lesions, cavities filled within the previous 3 years, heavy plaque on teeth, inadequate brushing and flushing, and a self-report of recreational drug use and frequent snacking. If patients had these factors on their file, they were at high risk of developing decay that leads to cavities.
The study found that 79% of patients who responded “yes” to being a current user of vapes were at high risk for dental decay, compared with 60% of those who did not report using the devices.
Materials in the vaping liquids further cause an inflammatory response that disrupts an individual’s internal microbiome, according to numerous studies.
“All the ingredients of vaping are surely a recipe for overgrowth of cavities causing bacteria,” said Jennifer Genuardi, MD, an internist and pediatrician at federally qualified community health center Urban Health Plan, in New York, who was not involved in the study.
Dr. Irusa said information on patient’s vaping habits should be included in routine dental and medical history questionnaires as part of their overall electronic health record.
“Decay in its severe form not only affects one’s ability to eat but affects facial aesthetics and self-esteem as well,” Dr. Irusa said.
Dr. Genuardi called the findings unsurprising.
“We are learning daily more and more about the dangers of vaping,” Dr. Genuardi said. “There’s a focus of today’s research on the effect of actions on our microbiome and the subsequent effects on our health.”
Dr. Genuardi also said many of her teenage patients do not enjoy dental visits or having cavities filled, which could serve as a useful deterrent to vaping for a demographic that has been targeted with marketing from vape manufacturers.
“Cavity formation and the experience of having cavities filled is an experience teens can identify with, so this to me seems like perhaps an even more effective angle to try to curb this unhealthy behavior of vaping,” Dr. Genuardi said.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN DENTAL ASSOCIATION
Rates of health care use after bariatric surgery in teens
Researchers found significantly lower rates of both emergency department (ED) use and hospitalization 5 years after sleeve gastrectomy compared with gastric bypass, and similarly low rates of adverse events.
The study, by researchers with the department of surgery and Center for Health Outcomes and Policy, University of Michigan, Ann Arbor, was published in JAMA.
Studies have shown that sleeve gastrectomy and gastric bypass both lead to significant weight loss and are associated with low complication rates among adolescents with severe obesity.
Until now, however, comparative outcomes for these two weight-loss procedures have not been described for adolescents insured by Medicaid, the largest insurer of adolescents in the United States.
Using Medicaid claims data, Ryan Howard, MD, and colleagues identified 855 adolescents who underwent sleeve gastrectomy and 277 who underwent Roux-en-Y gastric bypass between 2012 and 2018.
Adolescents in both groups were about 18 years old on average at the time of surgery, and about three-quarters were female.
Sleeve gastrectomy became more common over the study period. The annual percentage of sleeve gastrectomy relative to gastric bypass increased from 48.8% in 2012 to 82.6% in 2018.
There was no significant difference in rates of complications (P = .31) or reoperation (P = .78), defined as abdominal operation potentially related to the index procedure, including biliary procedures and abdominal wall, internal, and paraesophageal hernia repair.
Researchers also found no difference between sleeve gastrectomy and gastric bypass in rates of death (P = .42) or revision (P = .63), which included any operation that directly modified the index procedure.
The results “may help inform the treatment of severe obesity in adolescents insured by Medicaid, although future studies should also evaluate long-term weight loss and comorbidity resolution in this population,” Dr. Howard and colleagues write.
They caution that their analysis is subject to selection bias because patient characteristics may influence the choice of procedure, although appropriate statistical adjustment was used.
Other limitations include the small sample size, which increases the possibility of type II error; the relatively short follow-up period; and the inability to directly attribute outcomes to the index procedure.
Funding for the study was provided by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers found significantly lower rates of both emergency department (ED) use and hospitalization 5 years after sleeve gastrectomy compared with gastric bypass, and similarly low rates of adverse events.
The study, by researchers with the department of surgery and Center for Health Outcomes and Policy, University of Michigan, Ann Arbor, was published in JAMA.
Studies have shown that sleeve gastrectomy and gastric bypass both lead to significant weight loss and are associated with low complication rates among adolescents with severe obesity.
Until now, however, comparative outcomes for these two weight-loss procedures have not been described for adolescents insured by Medicaid, the largest insurer of adolescents in the United States.
Using Medicaid claims data, Ryan Howard, MD, and colleagues identified 855 adolescents who underwent sleeve gastrectomy and 277 who underwent Roux-en-Y gastric bypass between 2012 and 2018.
Adolescents in both groups were about 18 years old on average at the time of surgery, and about three-quarters were female.
Sleeve gastrectomy became more common over the study period. The annual percentage of sleeve gastrectomy relative to gastric bypass increased from 48.8% in 2012 to 82.6% in 2018.
There was no significant difference in rates of complications (P = .31) or reoperation (P = .78), defined as abdominal operation potentially related to the index procedure, including biliary procedures and abdominal wall, internal, and paraesophageal hernia repair.
Researchers also found no difference between sleeve gastrectomy and gastric bypass in rates of death (P = .42) or revision (P = .63), which included any operation that directly modified the index procedure.
The results “may help inform the treatment of severe obesity in adolescents insured by Medicaid, although future studies should also evaluate long-term weight loss and comorbidity resolution in this population,” Dr. Howard and colleagues write.
They caution that their analysis is subject to selection bias because patient characteristics may influence the choice of procedure, although appropriate statistical adjustment was used.
Other limitations include the small sample size, which increases the possibility of type II error; the relatively short follow-up period; and the inability to directly attribute outcomes to the index procedure.
Funding for the study was provided by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers found significantly lower rates of both emergency department (ED) use and hospitalization 5 years after sleeve gastrectomy compared with gastric bypass, and similarly low rates of adverse events.
The study, by researchers with the department of surgery and Center for Health Outcomes and Policy, University of Michigan, Ann Arbor, was published in JAMA.
Studies have shown that sleeve gastrectomy and gastric bypass both lead to significant weight loss and are associated with low complication rates among adolescents with severe obesity.
Until now, however, comparative outcomes for these two weight-loss procedures have not been described for adolescents insured by Medicaid, the largest insurer of adolescents in the United States.
Using Medicaid claims data, Ryan Howard, MD, and colleagues identified 855 adolescents who underwent sleeve gastrectomy and 277 who underwent Roux-en-Y gastric bypass between 2012 and 2018.
Adolescents in both groups were about 18 years old on average at the time of surgery, and about three-quarters were female.
Sleeve gastrectomy became more common over the study period. The annual percentage of sleeve gastrectomy relative to gastric bypass increased from 48.8% in 2012 to 82.6% in 2018.
There was no significant difference in rates of complications (P = .31) or reoperation (P = .78), defined as abdominal operation potentially related to the index procedure, including biliary procedures and abdominal wall, internal, and paraesophageal hernia repair.
Researchers also found no difference between sleeve gastrectomy and gastric bypass in rates of death (P = .42) or revision (P = .63), which included any operation that directly modified the index procedure.
The results “may help inform the treatment of severe obesity in adolescents insured by Medicaid, although future studies should also evaluate long-term weight loss and comorbidity resolution in this population,” Dr. Howard and colleagues write.
They caution that their analysis is subject to selection bias because patient characteristics may influence the choice of procedure, although appropriate statistical adjustment was used.
Other limitations include the small sample size, which increases the possibility of type II error; the relatively short follow-up period; and the inability to directly attribute outcomes to the index procedure.
Funding for the study was provided by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA
More work needed to optimize STI screening in primary care settings
TAMPA – Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.
Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.
However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.
In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”
Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.
If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.
“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”
Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.
He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.
Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
Compliance was a challenge
Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.
Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.
The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.
The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”
An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”
The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TAMPA – Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.
Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.
However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.
In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”
Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.
If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.
“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”
Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.
He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.
Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
Compliance was a challenge
Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.
Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.
The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.
The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”
An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”
The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TAMPA – Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.
Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.
However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.
In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”
Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.
If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.
“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”
Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.
He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.
Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
Compliance was a challenge
Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.
Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.
The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.
The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”
An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”
The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
More vaccinated people dying of COVID as fewer get booster shots
“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.
People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.
Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.
- A large majority of people in the United States have been vaccinated (267 million people, the said).
- People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
- Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.
The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.
“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.
The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.
A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.
“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.
They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”
A version of this article first appeared on WebMD.com.
“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.
People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.
Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.
- A large majority of people in the United States have been vaccinated (267 million people, the said).
- People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
- Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.
The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.
“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.
The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.
A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.
“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.
They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”
A version of this article first appeared on WebMD.com.
“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.
People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.
Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.
- A large majority of people in the United States have been vaccinated (267 million people, the said).
- People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
- Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.
The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.
“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.
The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.
A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.
“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.
They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”
A version of this article first appeared on WebMD.com.
Laser and light devices for acne treatment continue to advance
The calendar year
This was preceded by the FDA clearance of AviClear, marketed by Cutera, in March, and the commercial launch of TheraClearX, marketed by StrataSkin, in July.
“It’s an exciting time to be working with acne,” Fernanda H. Sakamoto, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “We’ll see a lot of people using new devices. I’m looking forward to seeing results in the long term.”
AviClear and the Accure Laser System, marketed by Accure, are both powered by a 1,726-nm laser, but they work differently. AviClear, which was cleared for the treatment of mild, moderate, and severe acne, has a maximum fluence of 30 J/cm2 in single-pulse mode and a maximum fluence of 20 J/cm2 in double-pulse mode. The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern. “It’s a little bit lower powered than the Accure and has a maximum pulse energy of 5 joules and a pulse duration of up to 50 milliseconds,” Dr. Sakamoto said. In the treatment of acne, laser and light treatments target the sebaceous gland.
In pivotal data submitted to the FDA, 104 patients with acne who were enrolled at 7 U.S. sites received 304 treatments with AviClear spaced 2-5 weeks apart. Each treatment took about 30 minutes. Treatment success was defined as having at least 50% fewer inflammatory acne lesions 12 weeks after the final treatment visit, compared with baseline. At the week 4 follow-up visit, there were median and mean reductions of 42% and 37%, respectively, in the inflammatory lesion counts from baseline (P < .001). The researchers found that, at the week 4 follow-up visit, 36% of patients had achieved treatment success, which increased to 78% at the 12-week follow-up visit. Treatment was considered safe and tolerable, according to the manufacturer.
The other newcomer device with a 1,726-nm wavelength is the Accure Laser System, which features a smart laser handpiece for real-time thermal monitoring and precise delivery of laser emissions. The device received CE Mark approval in 2020 for the treatment of moderate acne, and on Nov. 22, 2022, the manufacturer announced that it had been cleared by the FDA for the treatment of mild to severe inflammatory acne vulgaris.
Dr. Sakamoto and her Wellman colleagues have been working with five dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, and Mitchel Goldman, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2022, more than 50 patients with mild to severe acne were enrolled in four studies and an additional 30 were enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.
Among patients enrolled in the facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment after four monthly treatment sessions. The average lesion reduction at week 12 was 82% and the mean visual analog scale score immediately after treatment was 2.09 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device overall with no adverse events reported. At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histologic studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other skin structures.
Dr. Sakamoto emphasized that to date no direct clinical comparisons have been made between the AviClear and Accure devices. “Are all 1,726-nm lasers made equal? That is a question that we have to keep in our mind,” she said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “They are using the same wavelength, but they are different types of lasers.”
For example, the Accure Laser treats to temperature, relies on air cooling, and is targeted to dermatologists and plastic surgeons, while the AviClear treats to fluence, relies on contact cooling, and includes med spas and other nonphysician providers as the target users. “Mathematically, the difference between the two devices is that the Accure can achieve deeper penetration in a single pulse, while the AviClear is a little more superficial,” she said. “Whether that is translated clinically is unknown at this point.”
Dr. Sakamoto also discussed the TheraClearX, which is FDA cleared for the treatment of mild, moderate, and severe acne, including comedonal, pustular, and inflammatory acne vulgaris. The device, which is a new version of the Palomar Acleara, uses a vacuum technique with up to 3 psi pressure in conjunction with broadband light with a wavelength spectrum of 500 nm–1,200 nm delivered through a liquid-cooled, handheld delivery system. The predicate device was the Aesthera Isolaz System. The vacuum extracts buildup of sebaceous material. “At the same time, it takes the blood out of the competing chromophore,” she said. “By doing so, it potentially damages the sebaceous glands and reduces the inflammatory lesions.”
Dr. Sakamoto disclosed that she is the founder of and science advisor for Lightwater Bioscience. She is also a science advisor for Accure Acne and has received portions of patent royalties from Massachusetts General Hospital.
The calendar year
This was preceded by the FDA clearance of AviClear, marketed by Cutera, in March, and the commercial launch of TheraClearX, marketed by StrataSkin, in July.
“It’s an exciting time to be working with acne,” Fernanda H. Sakamoto, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “We’ll see a lot of people using new devices. I’m looking forward to seeing results in the long term.”
AviClear and the Accure Laser System, marketed by Accure, are both powered by a 1,726-nm laser, but they work differently. AviClear, which was cleared for the treatment of mild, moderate, and severe acne, has a maximum fluence of 30 J/cm2 in single-pulse mode and a maximum fluence of 20 J/cm2 in double-pulse mode. The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern. “It’s a little bit lower powered than the Accure and has a maximum pulse energy of 5 joules and a pulse duration of up to 50 milliseconds,” Dr. Sakamoto said. In the treatment of acne, laser and light treatments target the sebaceous gland.
In pivotal data submitted to the FDA, 104 patients with acne who were enrolled at 7 U.S. sites received 304 treatments with AviClear spaced 2-5 weeks apart. Each treatment took about 30 minutes. Treatment success was defined as having at least 50% fewer inflammatory acne lesions 12 weeks after the final treatment visit, compared with baseline. At the week 4 follow-up visit, there were median and mean reductions of 42% and 37%, respectively, in the inflammatory lesion counts from baseline (P < .001). The researchers found that, at the week 4 follow-up visit, 36% of patients had achieved treatment success, which increased to 78% at the 12-week follow-up visit. Treatment was considered safe and tolerable, according to the manufacturer.
The other newcomer device with a 1,726-nm wavelength is the Accure Laser System, which features a smart laser handpiece for real-time thermal monitoring and precise delivery of laser emissions. The device received CE Mark approval in 2020 for the treatment of moderate acne, and on Nov. 22, 2022, the manufacturer announced that it had been cleared by the FDA for the treatment of mild to severe inflammatory acne vulgaris.
Dr. Sakamoto and her Wellman colleagues have been working with five dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, and Mitchel Goldman, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2022, more than 50 patients with mild to severe acne were enrolled in four studies and an additional 30 were enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.
Among patients enrolled in the facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment after four monthly treatment sessions. The average lesion reduction at week 12 was 82% and the mean visual analog scale score immediately after treatment was 2.09 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device overall with no adverse events reported. At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histologic studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other skin structures.
Dr. Sakamoto emphasized that to date no direct clinical comparisons have been made between the AviClear and Accure devices. “Are all 1,726-nm lasers made equal? That is a question that we have to keep in our mind,” she said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “They are using the same wavelength, but they are different types of lasers.”
For example, the Accure Laser treats to temperature, relies on air cooling, and is targeted to dermatologists and plastic surgeons, while the AviClear treats to fluence, relies on contact cooling, and includes med spas and other nonphysician providers as the target users. “Mathematically, the difference between the two devices is that the Accure can achieve deeper penetration in a single pulse, while the AviClear is a little more superficial,” she said. “Whether that is translated clinically is unknown at this point.”
Dr. Sakamoto also discussed the TheraClearX, which is FDA cleared for the treatment of mild, moderate, and severe acne, including comedonal, pustular, and inflammatory acne vulgaris. The device, which is a new version of the Palomar Acleara, uses a vacuum technique with up to 3 psi pressure in conjunction with broadband light with a wavelength spectrum of 500 nm–1,200 nm delivered through a liquid-cooled, handheld delivery system. The predicate device was the Aesthera Isolaz System. The vacuum extracts buildup of sebaceous material. “At the same time, it takes the blood out of the competing chromophore,” she said. “By doing so, it potentially damages the sebaceous glands and reduces the inflammatory lesions.”
Dr. Sakamoto disclosed that she is the founder of and science advisor for Lightwater Bioscience. She is also a science advisor for Accure Acne and has received portions of patent royalties from Massachusetts General Hospital.
The calendar year
This was preceded by the FDA clearance of AviClear, marketed by Cutera, in March, and the commercial launch of TheraClearX, marketed by StrataSkin, in July.
“It’s an exciting time to be working with acne,” Fernanda H. Sakamoto, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “We’ll see a lot of people using new devices. I’m looking forward to seeing results in the long term.”
AviClear and the Accure Laser System, marketed by Accure, are both powered by a 1,726-nm laser, but they work differently. AviClear, which was cleared for the treatment of mild, moderate, and severe acne, has a maximum fluence of 30 J/cm2 in single-pulse mode and a maximum fluence of 20 J/cm2 in double-pulse mode. The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern. “It’s a little bit lower powered than the Accure and has a maximum pulse energy of 5 joules and a pulse duration of up to 50 milliseconds,” Dr. Sakamoto said. In the treatment of acne, laser and light treatments target the sebaceous gland.
In pivotal data submitted to the FDA, 104 patients with acne who were enrolled at 7 U.S. sites received 304 treatments with AviClear spaced 2-5 weeks apart. Each treatment took about 30 minutes. Treatment success was defined as having at least 50% fewer inflammatory acne lesions 12 weeks after the final treatment visit, compared with baseline. At the week 4 follow-up visit, there were median and mean reductions of 42% and 37%, respectively, in the inflammatory lesion counts from baseline (P < .001). The researchers found that, at the week 4 follow-up visit, 36% of patients had achieved treatment success, which increased to 78% at the 12-week follow-up visit. Treatment was considered safe and tolerable, according to the manufacturer.
The other newcomer device with a 1,726-nm wavelength is the Accure Laser System, which features a smart laser handpiece for real-time thermal monitoring and precise delivery of laser emissions. The device received CE Mark approval in 2020 for the treatment of moderate acne, and on Nov. 22, 2022, the manufacturer announced that it had been cleared by the FDA for the treatment of mild to severe inflammatory acne vulgaris.
Dr. Sakamoto and her Wellman colleagues have been working with five dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, and Mitchel Goldman, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2022, more than 50 patients with mild to severe acne were enrolled in four studies and an additional 30 were enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.
Among patients enrolled in the facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment after four monthly treatment sessions. The average lesion reduction at week 12 was 82% and the mean visual analog scale score immediately after treatment was 2.09 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device overall with no adverse events reported. At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histologic studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other skin structures.
Dr. Sakamoto emphasized that to date no direct clinical comparisons have been made between the AviClear and Accure devices. “Are all 1,726-nm lasers made equal? That is a question that we have to keep in our mind,” she said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “They are using the same wavelength, but they are different types of lasers.”
For example, the Accure Laser treats to temperature, relies on air cooling, and is targeted to dermatologists and plastic surgeons, while the AviClear treats to fluence, relies on contact cooling, and includes med spas and other nonphysician providers as the target users. “Mathematically, the difference between the two devices is that the Accure can achieve deeper penetration in a single pulse, while the AviClear is a little more superficial,” she said. “Whether that is translated clinically is unknown at this point.”
Dr. Sakamoto also discussed the TheraClearX, which is FDA cleared for the treatment of mild, moderate, and severe acne, including comedonal, pustular, and inflammatory acne vulgaris. The device, which is a new version of the Palomar Acleara, uses a vacuum technique with up to 3 psi pressure in conjunction with broadband light with a wavelength spectrum of 500 nm–1,200 nm delivered through a liquid-cooled, handheld delivery system. The predicate device was the Aesthera Isolaz System. The vacuum extracts buildup of sebaceous material. “At the same time, it takes the blood out of the competing chromophore,” she said. “By doing so, it potentially damages the sebaceous glands and reduces the inflammatory lesions.”
Dr. Sakamoto disclosed that she is the founder of and science advisor for Lightwater Bioscience. She is also a science advisor for Accure Acne and has received portions of patent royalties from Massachusetts General Hospital.
FROM A LASER & AESTHETIC SKIN THERAPY COURSE
AAP issues clinical update to cerebral palsy guidelines
Updated clinical guidelines for the early diagnosis and management of cerebral palsy have been issued by the American Academy of Pediatrics.
Coauthored with the American Academy for Cerebral Palsy and Developmental Medicine, the report builds on new evidence for improved care and outcomes since the 2006 consensus guidelines.
Cerebral palsy, the most common neuromotor disorder of childhood, is often accompanied by cognitive impairments, epilepsy, sensory impairments, behavioral problems, communication difficulties, breathing and sleep problems, gastrointestinal and nutritional problems, and bone and orthopedic problems.
In the United States, the estimated prevalence of cerebral palsy ranges from 1.5 to 4 per 1,000 live births.
“Early identification and initiation of evidence-based motor therapies can improve outcomes by taking advantage of the neuroplasticity in the infant brain,” said the guideline authors in an executive summary.
The guideline, published in Pediatrics, is directed to primary care physicians with pediatrics, family practice, or internal medicine training. “It’s a much more comprehensive overview of the important role that primary care providers play in the lifetime care of people with cerebral palsy,” explained Garey Noritz, MD, chair of the 2021-2022 Executive Committee of the Council on Children with Disabilities. Dr. Noritz, a professor of pediatrics at Ohio State University and division chief of the complex health care program at Nationwide Children’s Hospital, both in Columbus, said: “The combined efforts of the primary care physician and specialty providers are needed to achieve the best outcomes.”
The AAP recommends that primary care pediatricians, neonatologists, and other specialists caring for hospitalized newborns recognize those at high risk of cerebral palsy, diagnose them as early as possible, and promptly refer them for therapy. Primary care physicians are advised to identify motor delays early by formalizing standardized developmental surveillance and screening at 9, 18, and 30 months, and to implement family-centered care across multiple specialists.
“If a motor disorder is suspected, primary care physicians should simultaneously begin a medical evaluation, refer to a specialist for definitive diagnosis, and to therapists for treatment,” Dr. Noritz emphasized.
“The earlier any possible movement disorder is recognized and intervention begins, the better a child can develop a gait pattern and work toward living an independent life, said Manish N. Shah, MD, associate professor of pediatric neurosurgery at the University of Texas, Houston, who was not involved in developing the guidelines.
For children in whom physical therapy and medication have not reduced leg spasticity, a minimally invasive spinal procedure can help release contracted tendons and encourage independent walking. The optimal age for selective dorsal rhizotomy is about 4 years, said Dr. Shah, who is director of the Texas Comprehensive Spasticity Center at Children’s Memorial Hermann Hospital in Houston. “You can turn these children into walkers. As adults, they can get jobs, have their own families. It’s life-changing.”
Importantly, the guidelines address the health care disparities leading to a higher prevalence of cerebral palsy in Black children and in those from families with lower socioeconomic status. “Efforts to combat racism and eliminate barriers to culturally sensitive prenatal, perinatal, and later pediatric care may help to improve outcomes for all children with cerebral palsy,” the authors said.
“Every child with cerebral palsy needs an individual plan, but only 30% or 40% are getting interventions,” said Dr. Shah. The updated guidelines could help payers rethink the 15-20 visits a year that are often approved, compared with the 2-3 visits per week that are needed for speech, physical, and occupational therapy, he pointed out.
“Financial issues often compromise the interdisciplinary and coordinated care associated with favorable outcomes in children with cerebral palsy,” said Heidi Feldman, MD, PhD, a developmental and behavioral pediatric specialist at Stanford (Calif.) Medicine Children’s Health’s Johnson Center for Pregnancy and Newborn Services. “With a new guideline, there may be greater willingness to fund these essential services.”
In the meantime, the AAP recommends that pediatricians advise families about available medical, social, and educational services, such as early intervention services, the Title V Maternal and Child Health block grant program, and special education services through the public school system.
Children with cerebral palsy need the same standardized primary care as any child, including the full schedule of recommended vaccinations and vision and hearing testing. They also need to be monitored and treated for the many problems that commonly co-occur, including chronic pain.
When secondary complications arise, the frequency of visits should increase.
Pneumonia, the leading cause of death in children and adolescents with cerebral palsy, can be prevented or minimized through immunization against respiratory diseases and screening for signs and symptoms of aspiration and sleep-disordered breathing.
The AAP also recommends that symptoms or functional declines undergo full investigation into other potential causes.
Since the sedentary lifestyle associated with cerebral palsy is now known to be related to the higher rates of cardiovascular complications in this patient population, the AAP recommends more attention be paid to physical activity and a healthy diet early in life. Pediatricians are advised to help families locate suitable opportunities for adaptive sports and recreation.
Almost 50% of children and adolescents with cerebral palsy have intellectual disability, 60%-80% have difficulty speaking, and about 25% are nonverbal. To address this, pediatricians should maximize the use of augmentative and alternative communication devices and involve experts in speech and language pathology, according to the guidelines.
“Many individuals with cerebral palsy and severe motor limitations have active, creative minds, and may need assistive technology, such as electronic talking devices, to demonstrate that mental life,” said Dr. Feldman. “Primary care clinicians should advocate for assistive technology.”
For challenging behavior, especially in the patient with limited verbal skills, potential nonbehavioral culprits such as constipation, esophageal reflux disease, and musculoskeletal or dental pain must be ruled out.
In the lead-up to adolescence, youth with cerebral palsy must be prepared for puberty, menstruation, and healthy, safe sexual relationships, much like their nonaffected peers. Since a disproportionate number of children with cerebral palsy experience neglect and physical, sexual, and emotional abuse, however, family stressors should be identified and caregivers referred for support services.
For the transition from pediatric to adult health care, the AAP recommends that structured planning begin between 12 and 14 years of age. Before transfer, the pediatrician should prepare a comprehensive medical summary with the input of the patient, parent/guardian, and pediatric subspecialists.
Without a proper handoff, “there is an increased risk of morbidity, medical complications, unnecessary emergency department visits, hospitalizations, and procedures,” the authors warned.
Transitions are likely to run more smoothly when youth are given the opportunity to understand their medical condition and be involved in decisions about their health. With this in mind, the AAP recommends that pediatricians actively discourage overprotective parents from getting in the way of their child developing “maximal independence.”
No potential conflicts of interest were disclosed by the authors, Dr. Shah, or Dr. Feldman.
*This story was updated on Nov. 28, 2022.
Updated clinical guidelines for the early diagnosis and management of cerebral palsy have been issued by the American Academy of Pediatrics.
Coauthored with the American Academy for Cerebral Palsy and Developmental Medicine, the report builds on new evidence for improved care and outcomes since the 2006 consensus guidelines.
Cerebral palsy, the most common neuromotor disorder of childhood, is often accompanied by cognitive impairments, epilepsy, sensory impairments, behavioral problems, communication difficulties, breathing and sleep problems, gastrointestinal and nutritional problems, and bone and orthopedic problems.
In the United States, the estimated prevalence of cerebral palsy ranges from 1.5 to 4 per 1,000 live births.
“Early identification and initiation of evidence-based motor therapies can improve outcomes by taking advantage of the neuroplasticity in the infant brain,” said the guideline authors in an executive summary.
The guideline, published in Pediatrics, is directed to primary care physicians with pediatrics, family practice, or internal medicine training. “It’s a much more comprehensive overview of the important role that primary care providers play in the lifetime care of people with cerebral palsy,” explained Garey Noritz, MD, chair of the 2021-2022 Executive Committee of the Council on Children with Disabilities. Dr. Noritz, a professor of pediatrics at Ohio State University and division chief of the complex health care program at Nationwide Children’s Hospital, both in Columbus, said: “The combined efforts of the primary care physician and specialty providers are needed to achieve the best outcomes.”
The AAP recommends that primary care pediatricians, neonatologists, and other specialists caring for hospitalized newborns recognize those at high risk of cerebral palsy, diagnose them as early as possible, and promptly refer them for therapy. Primary care physicians are advised to identify motor delays early by formalizing standardized developmental surveillance and screening at 9, 18, and 30 months, and to implement family-centered care across multiple specialists.
“If a motor disorder is suspected, primary care physicians should simultaneously begin a medical evaluation, refer to a specialist for definitive diagnosis, and to therapists for treatment,” Dr. Noritz emphasized.
“The earlier any possible movement disorder is recognized and intervention begins, the better a child can develop a gait pattern and work toward living an independent life, said Manish N. Shah, MD, associate professor of pediatric neurosurgery at the University of Texas, Houston, who was not involved in developing the guidelines.
For children in whom physical therapy and medication have not reduced leg spasticity, a minimally invasive spinal procedure can help release contracted tendons and encourage independent walking. The optimal age for selective dorsal rhizotomy is about 4 years, said Dr. Shah, who is director of the Texas Comprehensive Spasticity Center at Children’s Memorial Hermann Hospital in Houston. “You can turn these children into walkers. As adults, they can get jobs, have their own families. It’s life-changing.”
Importantly, the guidelines address the health care disparities leading to a higher prevalence of cerebral palsy in Black children and in those from families with lower socioeconomic status. “Efforts to combat racism and eliminate barriers to culturally sensitive prenatal, perinatal, and later pediatric care may help to improve outcomes for all children with cerebral palsy,” the authors said.
“Every child with cerebral palsy needs an individual plan, but only 30% or 40% are getting interventions,” said Dr. Shah. The updated guidelines could help payers rethink the 15-20 visits a year that are often approved, compared with the 2-3 visits per week that are needed for speech, physical, and occupational therapy, he pointed out.
“Financial issues often compromise the interdisciplinary and coordinated care associated with favorable outcomes in children with cerebral palsy,” said Heidi Feldman, MD, PhD, a developmental and behavioral pediatric specialist at Stanford (Calif.) Medicine Children’s Health’s Johnson Center for Pregnancy and Newborn Services. “With a new guideline, there may be greater willingness to fund these essential services.”
In the meantime, the AAP recommends that pediatricians advise families about available medical, social, and educational services, such as early intervention services, the Title V Maternal and Child Health block grant program, and special education services through the public school system.
Children with cerebral palsy need the same standardized primary care as any child, including the full schedule of recommended vaccinations and vision and hearing testing. They also need to be monitored and treated for the many problems that commonly co-occur, including chronic pain.
When secondary complications arise, the frequency of visits should increase.
Pneumonia, the leading cause of death in children and adolescents with cerebral palsy, can be prevented or minimized through immunization against respiratory diseases and screening for signs and symptoms of aspiration and sleep-disordered breathing.
The AAP also recommends that symptoms or functional declines undergo full investigation into other potential causes.
Since the sedentary lifestyle associated with cerebral palsy is now known to be related to the higher rates of cardiovascular complications in this patient population, the AAP recommends more attention be paid to physical activity and a healthy diet early in life. Pediatricians are advised to help families locate suitable opportunities for adaptive sports and recreation.
Almost 50% of children and adolescents with cerebral palsy have intellectual disability, 60%-80% have difficulty speaking, and about 25% are nonverbal. To address this, pediatricians should maximize the use of augmentative and alternative communication devices and involve experts in speech and language pathology, according to the guidelines.
“Many individuals with cerebral palsy and severe motor limitations have active, creative minds, and may need assistive technology, such as electronic talking devices, to demonstrate that mental life,” said Dr. Feldman. “Primary care clinicians should advocate for assistive technology.”
For challenging behavior, especially in the patient with limited verbal skills, potential nonbehavioral culprits such as constipation, esophageal reflux disease, and musculoskeletal or dental pain must be ruled out.
In the lead-up to adolescence, youth with cerebral palsy must be prepared for puberty, menstruation, and healthy, safe sexual relationships, much like their nonaffected peers. Since a disproportionate number of children with cerebral palsy experience neglect and physical, sexual, and emotional abuse, however, family stressors should be identified and caregivers referred for support services.
For the transition from pediatric to adult health care, the AAP recommends that structured planning begin between 12 and 14 years of age. Before transfer, the pediatrician should prepare a comprehensive medical summary with the input of the patient, parent/guardian, and pediatric subspecialists.
Without a proper handoff, “there is an increased risk of morbidity, medical complications, unnecessary emergency department visits, hospitalizations, and procedures,” the authors warned.
Transitions are likely to run more smoothly when youth are given the opportunity to understand their medical condition and be involved in decisions about their health. With this in mind, the AAP recommends that pediatricians actively discourage overprotective parents from getting in the way of their child developing “maximal independence.”
No potential conflicts of interest were disclosed by the authors, Dr. Shah, or Dr. Feldman.
*This story was updated on Nov. 28, 2022.
Updated clinical guidelines for the early diagnosis and management of cerebral palsy have been issued by the American Academy of Pediatrics.
Coauthored with the American Academy for Cerebral Palsy and Developmental Medicine, the report builds on new evidence for improved care and outcomes since the 2006 consensus guidelines.
Cerebral palsy, the most common neuromotor disorder of childhood, is often accompanied by cognitive impairments, epilepsy, sensory impairments, behavioral problems, communication difficulties, breathing and sleep problems, gastrointestinal and nutritional problems, and bone and orthopedic problems.
In the United States, the estimated prevalence of cerebral palsy ranges from 1.5 to 4 per 1,000 live births.
“Early identification and initiation of evidence-based motor therapies can improve outcomes by taking advantage of the neuroplasticity in the infant brain,” said the guideline authors in an executive summary.
The guideline, published in Pediatrics, is directed to primary care physicians with pediatrics, family practice, or internal medicine training. “It’s a much more comprehensive overview of the important role that primary care providers play in the lifetime care of people with cerebral palsy,” explained Garey Noritz, MD, chair of the 2021-2022 Executive Committee of the Council on Children with Disabilities. Dr. Noritz, a professor of pediatrics at Ohio State University and division chief of the complex health care program at Nationwide Children’s Hospital, both in Columbus, said: “The combined efforts of the primary care physician and specialty providers are needed to achieve the best outcomes.”
The AAP recommends that primary care pediatricians, neonatologists, and other specialists caring for hospitalized newborns recognize those at high risk of cerebral palsy, diagnose them as early as possible, and promptly refer them for therapy. Primary care physicians are advised to identify motor delays early by formalizing standardized developmental surveillance and screening at 9, 18, and 30 months, and to implement family-centered care across multiple specialists.
“If a motor disorder is suspected, primary care physicians should simultaneously begin a medical evaluation, refer to a specialist for definitive diagnosis, and to therapists for treatment,” Dr. Noritz emphasized.
“The earlier any possible movement disorder is recognized and intervention begins, the better a child can develop a gait pattern and work toward living an independent life, said Manish N. Shah, MD, associate professor of pediatric neurosurgery at the University of Texas, Houston, who was not involved in developing the guidelines.
For children in whom physical therapy and medication have not reduced leg spasticity, a minimally invasive spinal procedure can help release contracted tendons and encourage independent walking. The optimal age for selective dorsal rhizotomy is about 4 years, said Dr. Shah, who is director of the Texas Comprehensive Spasticity Center at Children’s Memorial Hermann Hospital in Houston. “You can turn these children into walkers. As adults, they can get jobs, have their own families. It’s life-changing.”
Importantly, the guidelines address the health care disparities leading to a higher prevalence of cerebral palsy in Black children and in those from families with lower socioeconomic status. “Efforts to combat racism and eliminate barriers to culturally sensitive prenatal, perinatal, and later pediatric care may help to improve outcomes for all children with cerebral palsy,” the authors said.
“Every child with cerebral palsy needs an individual plan, but only 30% or 40% are getting interventions,” said Dr. Shah. The updated guidelines could help payers rethink the 15-20 visits a year that are often approved, compared with the 2-3 visits per week that are needed for speech, physical, and occupational therapy, he pointed out.
“Financial issues often compromise the interdisciplinary and coordinated care associated with favorable outcomes in children with cerebral palsy,” said Heidi Feldman, MD, PhD, a developmental and behavioral pediatric specialist at Stanford (Calif.) Medicine Children’s Health’s Johnson Center for Pregnancy and Newborn Services. “With a new guideline, there may be greater willingness to fund these essential services.”
In the meantime, the AAP recommends that pediatricians advise families about available medical, social, and educational services, such as early intervention services, the Title V Maternal and Child Health block grant program, and special education services through the public school system.
Children with cerebral palsy need the same standardized primary care as any child, including the full schedule of recommended vaccinations and vision and hearing testing. They also need to be monitored and treated for the many problems that commonly co-occur, including chronic pain.
When secondary complications arise, the frequency of visits should increase.
Pneumonia, the leading cause of death in children and adolescents with cerebral palsy, can be prevented or minimized through immunization against respiratory diseases and screening for signs and symptoms of aspiration and sleep-disordered breathing.
The AAP also recommends that symptoms or functional declines undergo full investigation into other potential causes.
Since the sedentary lifestyle associated with cerebral palsy is now known to be related to the higher rates of cardiovascular complications in this patient population, the AAP recommends more attention be paid to physical activity and a healthy diet early in life. Pediatricians are advised to help families locate suitable opportunities for adaptive sports and recreation.
Almost 50% of children and adolescents with cerebral palsy have intellectual disability, 60%-80% have difficulty speaking, and about 25% are nonverbal. To address this, pediatricians should maximize the use of augmentative and alternative communication devices and involve experts in speech and language pathology, according to the guidelines.
“Many individuals with cerebral palsy and severe motor limitations have active, creative minds, and may need assistive technology, such as electronic talking devices, to demonstrate that mental life,” said Dr. Feldman. “Primary care clinicians should advocate for assistive technology.”
For challenging behavior, especially in the patient with limited verbal skills, potential nonbehavioral culprits such as constipation, esophageal reflux disease, and musculoskeletal or dental pain must be ruled out.
In the lead-up to adolescence, youth with cerebral palsy must be prepared for puberty, menstruation, and healthy, safe sexual relationships, much like their nonaffected peers. Since a disproportionate number of children with cerebral palsy experience neglect and physical, sexual, and emotional abuse, however, family stressors should be identified and caregivers referred for support services.
For the transition from pediatric to adult health care, the AAP recommends that structured planning begin between 12 and 14 years of age. Before transfer, the pediatrician should prepare a comprehensive medical summary with the input of the patient, parent/guardian, and pediatric subspecialists.
Without a proper handoff, “there is an increased risk of morbidity, medical complications, unnecessary emergency department visits, hospitalizations, and procedures,” the authors warned.
Transitions are likely to run more smoothly when youth are given the opportunity to understand their medical condition and be involved in decisions about their health. With this in mind, the AAP recommends that pediatricians actively discourage overprotective parents from getting in the way of their child developing “maximal independence.”
No potential conflicts of interest were disclosed by the authors, Dr. Shah, or Dr. Feldman.
*This story was updated on Nov. 28, 2022.
FROM PEDIATRICS