Pediatric News

New guidelines from the American Association of Clinical Chemistry (AACC) and American Diabetes Association (ADA) address laboratory measures in the diagnosis and management of diabetes.

The document, titled, “Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus,” is primarily aimed at both laboratory professionals and clinicians involved in diabetes care.

The guidance is focused “on the practical aspects of care in order to assist with decisions regarding the use or interpretation of laboratory tests while screening, diagnosing, or monitoring patients with diabetes,” wrote David B. Sacks, MBChB, chief of the clinical chemistry service at the National Institutes of Health (NIH), Bethesda, Md., and coauthors. It was published online in both Clinical Chemistry and Diabetes Care, including the guidelines and executive summary.  

Coauthor M. Sue Kirkman, MD, of the University of North Carolina, Chapel Hill, said in an interview: “One objective of the guidelines is to increase clinicians’ understanding of the strengths and limitations of tests done in a laboratory and also at the point of care, or in daily life, by people with diabetes.”

The evidence-based recommendations, an update of prior versions published in 2011 and 2002, are meant as a supplement to the ADA Standards of Care in Diabetes and do not address aspects of clinical management, she stressed.
 

Addition of advice on CGM

A significant addition since 2011 is detailed information regarding the use of real-time continuous glucose monitoring (CGM), with a “strong” recommendation based on a “high” level of evidence for use in teens and adults with type 1 diabetes who meet certain criteria, and lower-grade advice to use real-time or intermittently scanned CGM in other populations, including children with diabetes, pregnant women with type 1 diabetes, and adults with type 2 diabetes taking insulin.

The document also reminds clinicians to consider test limitations, Dr. Kirkman pointed out.

“We do a lot of testing in screening, diagnosis, and monitoring of diabetes and its complications, yet for many clinicians we think that any result we get – or that a patient gets from home testing – is perfect. We often don’t think about the accuracy or precision of some tests, things that might interfere with the result, intra-individual variation of the test, or how one test may compare to a test of higher accuracy,” she said.

One example is a recommendation to collect blood samples for glucose analysis in tubes containing a rapidly effective inhibitor of glycolysis such as a granulated citrate buffer. If unavailable, the sample tube should be placed immediately into an ice water slurry and centrifuged within 15-30 minutes to remove the cells.

Without those measures, “red cells in blood sitting in the test tube continue to break down glucose, so the concentration of glucose will start to fall very soon. ... How the specimen is handled makes a huge difference in the result,” Dr. Kirkman emphasized.

Another is the recommendation of a confirmatory test when diagnosing diabetes, regardless of the initial test used (A1c, fasting glucose, or oral glucose tolerance test). “There is large intra-individual variation of fasting glucose and even larger for 2-hour glucose on the oral glucose tolerance test. ... This means if you do the test one week and then repeat it the next day or a week later, the results will be quite different. This is a reason why confirmation of an abnormal test is important. Yet many times this isn’t done,” she noted.

Other “strong” recommendations based on “high” evidence levels include:

• Fasting glucose should be measured in venous plasma when used to establish the diagnosis of diabetes, with a diagnostic cutoff of > 7.0 mmol/L (> 126 mg/dL) for diabetes.
• Frequent blood glucose monitoring is recommended for all people with diabetes treated with intensive insulin regimens (with multiple daily injections or insulin pump therapy) and who are not using CGM.
• Routine use of blood glucose monitoring is not recommended for people with type 2 diabetes who are treated with diet and/or oral agents alone.
• Treatment goals should be based on ADA recommendations, i.e., A1c < 7% (< 53 mmol/mol) if it can be achieved without significant hypoglycemia or other adverse treatment effects, with higher targets for special populations.
• Annual testing for albuminuria should begin in pubertal or postpubertal individuals 5 years after diagnosis of type 1 diabetes and at time of diagnosis of type 2 diabetes, regardless of treatment.
• Urine albumin should be measured annually in adults with diabetes using morning spot urine albumin-to-creatinine ratio.

Other guidance in the document pertains to use of ketone testing, genetic markers, autoimmune markers, and C-peptide.

According to Dr. Sacks, “It’s important to measure accurately, but it’s also very important to communicate the relevance to clinicians and to listen to them and share information. ... Patient care is a team effort.”

Dr. Sachs has reported receiving funding from the NIH. Dr. Kirkman has reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

New guidelines from the American Association of Clinical Chemistry (AACC) and American Diabetes Association (ADA) address laboratory measures in the diagnosis and management of diabetes.

The document, titled, “Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus,” is primarily aimed at both laboratory professionals and clinicians involved in diabetes care.

The guidance is focused “on the practical aspects of care in order to assist with decisions regarding the use or interpretation of laboratory tests while screening, diagnosing, or monitoring patients with diabetes,” wrote David B. Sacks, MBChB, chief of the clinical chemistry service at the National Institutes of Health (NIH), Bethesda, Md., and coauthors. It was published online in both Clinical Chemistry and Diabetes Care, including the guidelines and executive summary.  

Coauthor M. Sue Kirkman, MD, of the University of North Carolina, Chapel Hill, said in an interview: “One objective of the guidelines is to increase clinicians’ understanding of the strengths and limitations of tests done in a laboratory and also at the point of care, or in daily life, by people with diabetes.”

The evidence-based recommendations, an update of prior versions published in 2011 and 2002, are meant as a supplement to the ADA Standards of Care in Diabetes and do not address aspects of clinical management, she stressed.
 

Addition of advice on CGM

A significant addition since 2011 is detailed information regarding the use of real-time continuous glucose monitoring (CGM), with a “strong” recommendation based on a “high” level of evidence for use in teens and adults with type 1 diabetes who meet certain criteria, and lower-grade advice to use real-time or intermittently scanned CGM in other populations, including children with diabetes, pregnant women with type 1 diabetes, and adults with type 2 diabetes taking insulin.

The document also reminds clinicians to consider test limitations, Dr. Kirkman pointed out.

“We do a lot of testing in screening, diagnosis, and monitoring of diabetes and its complications, yet for many clinicians we think that any result we get – or that a patient gets from home testing – is perfect. We often don’t think about the accuracy or precision of some tests, things that might interfere with the result, intra-individual variation of the test, or how one test may compare to a test of higher accuracy,” she said.

One example is a recommendation to collect blood samples for glucose analysis in tubes containing a rapidly effective inhibitor of glycolysis such as a granulated citrate buffer. If unavailable, the sample tube should be placed immediately into an ice water slurry and centrifuged within 15-30 minutes to remove the cells.

Without those measures, “red cells in blood sitting in the test tube continue to break down glucose, so the concentration of glucose will start to fall very soon. ... How the specimen is handled makes a huge difference in the result,” Dr. Kirkman emphasized.

Another is the recommendation of a confirmatory test when diagnosing diabetes, regardless of the initial test used (A1c, fasting glucose, or oral glucose tolerance test). “There is large intra-individual variation of fasting glucose and even larger for 2-hour glucose on the oral glucose tolerance test. ... This means if you do the test one week and then repeat it the next day or a week later, the results will be quite different. This is a reason why confirmation of an abnormal test is important. Yet many times this isn’t done,” she noted.

Other “strong” recommendations based on “high” evidence levels include:

• Fasting glucose should be measured in venous plasma when used to establish the diagnosis of diabetes, with a diagnostic cutoff of > 7.0 mmol/L (> 126 mg/dL) for diabetes.
• Frequent blood glucose monitoring is recommended for all people with diabetes treated with intensive insulin regimens (with multiple daily injections or insulin pump therapy) and who are not using CGM.
• Routine use of blood glucose monitoring is not recommended for people with type 2 diabetes who are treated with diet and/or oral agents alone.
• Treatment goals should be based on ADA recommendations, i.e., A1c < 7% (< 53 mmol/mol) if it can be achieved without significant hypoglycemia or other adverse treatment effects, with higher targets for special populations.
• Annual testing for albuminuria should begin in pubertal or postpubertal individuals 5 years after diagnosis of type 1 diabetes and at time of diagnosis of type 2 diabetes, regardless of treatment.
• Urine albumin should be measured annually in adults with diabetes using morning spot urine albumin-to-creatinine ratio.

Other guidance in the document pertains to use of ketone testing, genetic markers, autoimmune markers, and C-peptide.

According to Dr. Sacks, “It’s important to measure accurately, but it’s also very important to communicate the relevance to clinicians and to listen to them and share information. ... Patient care is a team effort.”

Dr. Sachs has reported receiving funding from the NIH. Dr. Kirkman has reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

New guidelines from the American Association of Clinical Chemistry (AACC) and American Diabetes Association (ADA) address laboratory measures in the diagnosis and management of diabetes.

The document, titled, “Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus,” is primarily aimed at both laboratory professionals and clinicians involved in diabetes care.

The guidance is focused “on the practical aspects of care in order to assist with decisions regarding the use or interpretation of laboratory tests while screening, diagnosing, or monitoring patients with diabetes,” wrote David B. Sacks, MBChB, chief of the clinical chemistry service at the National Institutes of Health (NIH), Bethesda, Md., and coauthors. It was published online in both Clinical Chemistry and Diabetes Care, including the guidelines and executive summary.  

Coauthor M. Sue Kirkman, MD, of the University of North Carolina, Chapel Hill, said in an interview: “One objective of the guidelines is to increase clinicians’ understanding of the strengths and limitations of tests done in a laboratory and also at the point of care, or in daily life, by people with diabetes.”

The evidence-based recommendations, an update of prior versions published in 2011 and 2002, are meant as a supplement to the ADA Standards of Care in Diabetes and do not address aspects of clinical management, she stressed.
 

Addition of advice on CGM

A significant addition since 2011 is detailed information regarding the use of real-time continuous glucose monitoring (CGM), with a “strong” recommendation based on a “high” level of evidence for use in teens and adults with type 1 diabetes who meet certain criteria, and lower-grade advice to use real-time or intermittently scanned CGM in other populations, including children with diabetes, pregnant women with type 1 diabetes, and adults with type 2 diabetes taking insulin.

The document also reminds clinicians to consider test limitations, Dr. Kirkman pointed out.

“We do a lot of testing in screening, diagnosis, and monitoring of diabetes and its complications, yet for many clinicians we think that any result we get – or that a patient gets from home testing – is perfect. We often don’t think about the accuracy or precision of some tests, things that might interfere with the result, intra-individual variation of the test, or how one test may compare to a test of higher accuracy,” she said.

One example is a recommendation to collect blood samples for glucose analysis in tubes containing a rapidly effective inhibitor of glycolysis such as a granulated citrate buffer. If unavailable, the sample tube should be placed immediately into an ice water slurry and centrifuged within 15-30 minutes to remove the cells.

Without those measures, “red cells in blood sitting in the test tube continue to break down glucose, so the concentration of glucose will start to fall very soon. ... How the specimen is handled makes a huge difference in the result,” Dr. Kirkman emphasized.

Another is the recommendation of a confirmatory test when diagnosing diabetes, regardless of the initial test used (A1c, fasting glucose, or oral glucose tolerance test). “There is large intra-individual variation of fasting glucose and even larger for 2-hour glucose on the oral glucose tolerance test. ... This means if you do the test one week and then repeat it the next day or a week later, the results will be quite different. This is a reason why confirmation of an abnormal test is important. Yet many times this isn’t done,” she noted.

Other “strong” recommendations based on “high” evidence levels include:

• Fasting glucose should be measured in venous plasma when used to establish the diagnosis of diabetes, with a diagnostic cutoff of > 7.0 mmol/L (> 126 mg/dL) for diabetes.
• Frequent blood glucose monitoring is recommended for all people with diabetes treated with intensive insulin regimens (with multiple daily injections or insulin pump therapy) and who are not using CGM.
• Routine use of blood glucose monitoring is not recommended for people with type 2 diabetes who are treated with diet and/or oral agents alone.
• Treatment goals should be based on ADA recommendations, i.e., A1c < 7% (< 53 mmol/mol) if it can be achieved without significant hypoglycemia or other adverse treatment effects, with higher targets for special populations.
• Annual testing for albuminuria should begin in pubertal or postpubertal individuals 5 years after diagnosis of type 1 diabetes and at time of diagnosis of type 2 diabetes, regardless of treatment.
• Urine albumin should be measured annually in adults with diabetes using morning spot urine albumin-to-creatinine ratio.

Other guidance in the document pertains to use of ketone testing, genetic markers, autoimmune markers, and C-peptide.

According to Dr. Sacks, “It’s important to measure accurately, but it’s also very important to communicate the relevance to clinicians and to listen to them and share information. ... Patient care is a team effort.”

Dr. Sachs has reported receiving funding from the NIH. Dr. Kirkman has reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Testing children with acute sinusitis symptoms for specific bacteria may dramatically decrease unnecessary antibiotic use, new research suggests.

The study, published in JAMA, found that children with positive nasopharyngeal tests for one or more of Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis had better resolution of symptoms with antibiotics than those without these bacteria.

If antibiotic use was limited to children with H. influenzae or S. pneumoniae in their nasopharynx at the time of diagnosis, antibiotic use would decrease by 53%, according to the study authors.

Sinusitis is common in children, and symptoms are similar with uncomplicated viral upper respiratory infections.

“We have not had a good way to predict which children will benefit from antibiotics,” said Nader Shaikh, MD, MPH, professor of pediatrics and clinical and translational science at the University of Pittsburgh, and the lead study author. “When a child comes in with a sore throat, we test for strep. If the test is positive, we prescribe antibiotics.”

Dr. Shaikh and his colleagues found that the same approach – swabbing the nose and testing for various bacteria – worked for children with sinusitis.

“Children who tested negative for bacteria did not benefit from antibiotics,” Dr. Shaikh said.

In the double-blind clinical trial, Dr. Shaikh and his colleagues randomized 510 children between ages 2 and 11 with acute sinusitis at six academic primary care offices over a 6-year period. Almost two-thirds of participants were between ages 2 and 5, around half were male, and around half were White. All participants had an initial score of nine or higher on the validated Pediatric Rhinosinusitis Symptom Scale (PRSS).

For 10 days, 254 children received oral amoxicillin (90 mg/kg/day) and clavulanate (6.4mg/kg/day) and 256 received placebo.

In children receiving antibiotics, symptoms resolved over a median of 7 days, compared with 9 days for those given placebo (P = .003).

Children without detected nasopharyngeal pathogens did not benefit from antibiotics as much as those with the pathogens, the researchers found. Among those with pathogens, the mean symptom burden score was 1.95 points lower in the group that received antibiotics, compared with the group that received placebo. For those without pathogens, there was a 0.88-point difference between the antibiotic and placebo groups (P = .02).

The researchers also took nasal swabs at the first and final study visits and tested for S. pneumoniae, H. influenzae, and M. catarrhalis. During that time, parents or caregivers used the PRSS to assess their child’s symptoms, and they recorded the nasal discharge color. Nasal discharge color, Dr. Shaikh and colleagues found, was not linked with antibiotic effect.
 

Welcome findings

Pediatricians and primary care providers face a significant clinical dilemma when they consider using antibiotics with upper respiratory tract infections (URTIs), according to John H. Greinwald Jr., MD, professor in the department of pediatrics at Cincinnati Children’s Hospital Medical Center.

“These findings certainly make sense because most respiratory infections in children are viral,” Dr. Greinwald said. “The investigators follow the appropriate clinical guidelines for considering antibiotic use in patients with URTIs, which include URTI symptoms lasting longer than 10 days or symptoms initially getting better, then worsening again day 6 through 10.”

Not only is antibiotic resistance a major public health concern, but the drugs can have side effects such as diarrhea, and their long-term effects on the microbiome are unknown.

“Differentiating who has acute sinusitis from who has a viral infection is difficult for primary care providers,” said Eelam A. Adil, MD, MBA, assistant professor of otolaryngology at Harvard Medical School in Boston.

The findings may help clinicians be more selective with antibiotic prescriptions, according to Jacob G. Eide, MD, a head and neck surgeon at Henry Ford Health in Detroit.

“However, we do not want to deny antibiotics when they are beneficial,” Dr. Eide said. “And the difficulty and costs involved in developing the tests need to be considered.”

Dr. Shaikh and his team are studying ways to bring nasal testing into clinical practice, potentially utilizing commercially available molecular testing and rapid antigen tests that work like COVID-19 at-home tests. They are also exploring if other biomarkers in nasal discharge may indicate the presence of bacteria.

All study authors as well as outside experts reported no relevant financial relationships. The study was supported by the National Institute of Allergy and Infectious Diseases.

A version of this article first appeared on Medscape.com.

Testing children with acute sinusitis symptoms for specific bacteria may dramatically decrease unnecessary antibiotic use, new research suggests.

The study, published in JAMA, found that children with positive nasopharyngeal tests for one or more of Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis had better resolution of symptoms with antibiotics than those without these bacteria.

If antibiotic use was limited to children with H. influenzae or S. pneumoniae in their nasopharynx at the time of diagnosis, antibiotic use would decrease by 53%, according to the study authors.

Sinusitis is common in children, and symptoms are similar with uncomplicated viral upper respiratory infections.

“We have not had a good way to predict which children will benefit from antibiotics,” said Nader Shaikh, MD, MPH, professor of pediatrics and clinical and translational science at the University of Pittsburgh, and the lead study author. “When a child comes in with a sore throat, we test for strep. If the test is positive, we prescribe antibiotics.”

Dr. Shaikh and his colleagues found that the same approach – swabbing the nose and testing for various bacteria – worked for children with sinusitis.

“Children who tested negative for bacteria did not benefit from antibiotics,” Dr. Shaikh said.

In the double-blind clinical trial, Dr. Shaikh and his colleagues randomized 510 children between ages 2 and 11 with acute sinusitis at six academic primary care offices over a 6-year period. Almost two-thirds of participants were between ages 2 and 5, around half were male, and around half were White. All participants had an initial score of nine or higher on the validated Pediatric Rhinosinusitis Symptom Scale (PRSS).

For 10 days, 254 children received oral amoxicillin (90 mg/kg/day) and clavulanate (6.4mg/kg/day) and 256 received placebo.

In children receiving antibiotics, symptoms resolved over a median of 7 days, compared with 9 days for those given placebo (P = .003).

Children without detected nasopharyngeal pathogens did not benefit from antibiotics as much as those with the pathogens, the researchers found. Among those with pathogens, the mean symptom burden score was 1.95 points lower in the group that received antibiotics, compared with the group that received placebo. For those without pathogens, there was a 0.88-point difference between the antibiotic and placebo groups (P = .02).

The researchers also took nasal swabs at the first and final study visits and tested for S. pneumoniae, H. influenzae, and M. catarrhalis. During that time, parents or caregivers used the PRSS to assess their child’s symptoms, and they recorded the nasal discharge color. Nasal discharge color, Dr. Shaikh and colleagues found, was not linked with antibiotic effect.
 

Welcome findings

Pediatricians and primary care providers face a significant clinical dilemma when they consider using antibiotics with upper respiratory tract infections (URTIs), according to John H. Greinwald Jr., MD, professor in the department of pediatrics at Cincinnati Children’s Hospital Medical Center.

“These findings certainly make sense because most respiratory infections in children are viral,” Dr. Greinwald said. “The investigators follow the appropriate clinical guidelines for considering antibiotic use in patients with URTIs, which include URTI symptoms lasting longer than 10 days or symptoms initially getting better, then worsening again day 6 through 10.”

Not only is antibiotic resistance a major public health concern, but the drugs can have side effects such as diarrhea, and their long-term effects on the microbiome are unknown.

“Differentiating who has acute sinusitis from who has a viral infection is difficult for primary care providers,” said Eelam A. Adil, MD, MBA, assistant professor of otolaryngology at Harvard Medical School in Boston.

The findings may help clinicians be more selective with antibiotic prescriptions, according to Jacob G. Eide, MD, a head and neck surgeon at Henry Ford Health in Detroit.

“However, we do not want to deny antibiotics when they are beneficial,” Dr. Eide said. “And the difficulty and costs involved in developing the tests need to be considered.”

Dr. Shaikh and his team are studying ways to bring nasal testing into clinical practice, potentially utilizing commercially available molecular testing and rapid antigen tests that work like COVID-19 at-home tests. They are also exploring if other biomarkers in nasal discharge may indicate the presence of bacteria.

All study authors as well as outside experts reported no relevant financial relationships. The study was supported by the National Institute of Allergy and Infectious Diseases.

A version of this article first appeared on Medscape.com.

Testing children with acute sinusitis symptoms for specific bacteria may dramatically decrease unnecessary antibiotic use, new research suggests.

The study, published in JAMA, found that children with positive nasopharyngeal tests for one or more of Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis had better resolution of symptoms with antibiotics than those without these bacteria.

If antibiotic use was limited to children with H. influenzae or S. pneumoniae in their nasopharynx at the time of diagnosis, antibiotic use would decrease by 53%, according to the study authors.

Sinusitis is common in children, and symptoms are similar with uncomplicated viral upper respiratory infections.

“We have not had a good way to predict which children will benefit from antibiotics,” said Nader Shaikh, MD, MPH, professor of pediatrics and clinical and translational science at the University of Pittsburgh, and the lead study author. “When a child comes in with a sore throat, we test for strep. If the test is positive, we prescribe antibiotics.”

Dr. Shaikh and his colleagues found that the same approach – swabbing the nose and testing for various bacteria – worked for children with sinusitis.

“Children who tested negative for bacteria did not benefit from antibiotics,” Dr. Shaikh said.

In the double-blind clinical trial, Dr. Shaikh and his colleagues randomized 510 children between ages 2 and 11 with acute sinusitis at six academic primary care offices over a 6-year period. Almost two-thirds of participants were between ages 2 and 5, around half were male, and around half were White. All participants had an initial score of nine or higher on the validated Pediatric Rhinosinusitis Symptom Scale (PRSS).

For 10 days, 254 children received oral amoxicillin (90 mg/kg/day) and clavulanate (6.4mg/kg/day) and 256 received placebo.

In children receiving antibiotics, symptoms resolved over a median of 7 days, compared with 9 days for those given placebo (P = .003).

Children without detected nasopharyngeal pathogens did not benefit from antibiotics as much as those with the pathogens, the researchers found. Among those with pathogens, the mean symptom burden score was 1.95 points lower in the group that received antibiotics, compared with the group that received placebo. For those without pathogens, there was a 0.88-point difference between the antibiotic and placebo groups (P = .02).

The researchers also took nasal swabs at the first and final study visits and tested for S. pneumoniae, H. influenzae, and M. catarrhalis. During that time, parents or caregivers used the PRSS to assess their child’s symptoms, and they recorded the nasal discharge color. Nasal discharge color, Dr. Shaikh and colleagues found, was not linked with antibiotic effect.
 

Welcome findings

Pediatricians and primary care providers face a significant clinical dilemma when they consider using antibiotics with upper respiratory tract infections (URTIs), according to John H. Greinwald Jr., MD, professor in the department of pediatrics at Cincinnati Children’s Hospital Medical Center.

“These findings certainly make sense because most respiratory infections in children are viral,” Dr. Greinwald said. “The investigators follow the appropriate clinical guidelines for considering antibiotic use in patients with URTIs, which include URTI symptoms lasting longer than 10 days or symptoms initially getting better, then worsening again day 6 through 10.”

Not only is antibiotic resistance a major public health concern, but the drugs can have side effects such as diarrhea, and their long-term effects on the microbiome are unknown.

“Differentiating who has acute sinusitis from who has a viral infection is difficult for primary care providers,” said Eelam A. Adil, MD, MBA, assistant professor of otolaryngology at Harvard Medical School in Boston.

The findings may help clinicians be more selective with antibiotic prescriptions, according to Jacob G. Eide, MD, a head and neck surgeon at Henry Ford Health in Detroit.

“However, we do not want to deny antibiotics when they are beneficial,” Dr. Eide said. “And the difficulty and costs involved in developing the tests need to be considered.”

Dr. Shaikh and his team are studying ways to bring nasal testing into clinical practice, potentially utilizing commercially available molecular testing and rapid antigen tests that work like COVID-19 at-home tests. They are also exploring if other biomarkers in nasal discharge may indicate the presence of bacteria.

All study authors as well as outside experts reported no relevant financial relationships. The study was supported by the National Institute of Allergy and Infectious Diseases.

A version of this article first appeared on Medscape.com.

A Georgia doctor was cleared in June of having failed to diagnose and treat a child whose acute pancreatitis developed life-threatening complications, according to a report posted on the website of Courtroom View Network.

In 2018, the parents of the then 9-year-old child brought him to Wellstar Paulding Hospital in Hiram, Ga., because of his severe abdominal pain and distention, among other symptoms. Following their examination, medical personnel at the hospital suspected the child’s symptoms were the result of severe constipation.

That evening, he was transferred to Children’s Healthcare of Atlanta, where a pediatric gastroenterologist oversaw his care. (Neither the Atlanta hospital nor Wellstar Paulding were defendants in the subsequent lawsuit.)

Late the following day, the child went into hypovolemic shock, a condition that interrupted the blood supply to his body. Admitted to the pediatric ICU, he was diagnosed with a dangerous complication of acute pancreatitis, necrotizing pancreatitis.

Further complications of his original disease led to a 4-month hospital stay, multiple surgeries, and other interventions. To this point, his medical expenses totaled more than $2.5 million.

His parents then sued the pediatric gastroenterologist who had overseen their child’s care. At issue during the 4-day trial was whether the doctor had properly monitored and treated his patient before his hypovolemic shock set in.

Their attorney sketched the “timeline” of the child’s decline, including his rapid heart rate and repeated vomiting. Given these symptoms, he argued, the standard of care required that steps be taken – including the proper tests and other interventions – to prevent the child’s acute pancreatitis from progressing even further.

“We are not asking you to say, ‘Should [the doctor] have immediately diagnosed pancreatitis,’ “ the attorney told the jury. “But the totality here requires you to think, ‘This might be more than just a backed-up kid.’ ”

The defense pushed back strenuously, however. It argued that the pediatric gastroenterologist had acted appropriately given the prevailing consensus, namely that the child was suffering from extreme constipation. Doctors at Wellstar Paulding, the first hospital where he was seen, suspected this diagnosis – and so, based on his exam and the child’s “non-specific” symptoms, did their client, the pediatric gastroenterologist, who saw him subsequently. “The only clinicians who actually laid hands on [the child] all thought constipation,” the attorney said during his closing argument.

The jury agreed, finding that the pediatric gastroenterologist had acted appropriately, based on the available evidence. Following the jury verdict, the defense attorney noted: Absent the “classic” symptoms of pancreatitis, the jury saw that his client “was working with a reasonable diagnosis until [the child’s] clinical picture deteriorated.”
 

ED doctors can reduce system errors, study says

Emergency physicians are often blamed for system errors beyond their control, asserts a study in the June issue of Emergency Medicine News.

The study – conducted by Tom Belanger, MD, an emergency physician in Texas and chair-elect of the American College of Emergency Physicians Workforce Section – sought to understand to what extent doctors themselves were aware of systemic problems affecting their job. Dr. Belanger surveyed 99 doctors who were asked to comment on a series of ED–related adverse outcomes.

To mitigate response bias, he randomly manipulated the degree to which system error was a perceived factor in each of the adverse cases. In other words, in some cases, the system was represented as a major factor leading to error, while, in other cases, its role was diminished.

Dr. Belanger also divided his doctor/respondents into two groups: The first was asked about his or her personal experience with systemic issues before being presented with the adverse cases; the second group was queried about this experience after being presented with the cases.

The result confirmed Dr. Belanger’s suspicions: Physicians in the first group – that is, those asked about “system factors” before reading about the cases – “were 1.7 times more likely ... to attribute the adverse outcomes in the cases to system factors. (Other significant variables – including whether their shift was busy – also contributed to doctors’ perceptions of adverse outcomes.)

Concluded Dr. Belanger: Since doctors “can identify factors that increase their chances of making mistakes,” system designers should take heed and make efforts to reduce “the probability of error.” If they drag their heels or continue to point to individual doctor error, “they should be held medically and legally liable.”
 

A version of this article first appeared on Medscape.com.

A Georgia doctor was cleared in June of having failed to diagnose and treat a child whose acute pancreatitis developed life-threatening complications, according to a report posted on the website of Courtroom View Network.

In 2018, the parents of the then 9-year-old child brought him to Wellstar Paulding Hospital in Hiram, Ga., because of his severe abdominal pain and distention, among other symptoms. Following their examination, medical personnel at the hospital suspected the child’s symptoms were the result of severe constipation.

That evening, he was transferred to Children’s Healthcare of Atlanta, where a pediatric gastroenterologist oversaw his care. (Neither the Atlanta hospital nor Wellstar Paulding were defendants in the subsequent lawsuit.)

Late the following day, the child went into hypovolemic shock, a condition that interrupted the blood supply to his body. Admitted to the pediatric ICU, he was diagnosed with a dangerous complication of acute pancreatitis, necrotizing pancreatitis.

Further complications of his original disease led to a 4-month hospital stay, multiple surgeries, and other interventions. To this point, his medical expenses totaled more than $2.5 million.

His parents then sued the pediatric gastroenterologist who had overseen their child’s care. At issue during the 4-day trial was whether the doctor had properly monitored and treated his patient before his hypovolemic shock set in.

Their attorney sketched the “timeline” of the child’s decline, including his rapid heart rate and repeated vomiting. Given these symptoms, he argued, the standard of care required that steps be taken – including the proper tests and other interventions – to prevent the child’s acute pancreatitis from progressing even further.

“We are not asking you to say, ‘Should [the doctor] have immediately diagnosed pancreatitis,’ “ the attorney told the jury. “But the totality here requires you to think, ‘This might be more than just a backed-up kid.’ ”

The defense pushed back strenuously, however. It argued that the pediatric gastroenterologist had acted appropriately given the prevailing consensus, namely that the child was suffering from extreme constipation. Doctors at Wellstar Paulding, the first hospital where he was seen, suspected this diagnosis – and so, based on his exam and the child’s “non-specific” symptoms, did their client, the pediatric gastroenterologist, who saw him subsequently. “The only clinicians who actually laid hands on [the child] all thought constipation,” the attorney said during his closing argument.

The jury agreed, finding that the pediatric gastroenterologist had acted appropriately, based on the available evidence. Following the jury verdict, the defense attorney noted: Absent the “classic” symptoms of pancreatitis, the jury saw that his client “was working with a reasonable diagnosis until [the child’s] clinical picture deteriorated.”
 

ED doctors can reduce system errors, study says

Emergency physicians are often blamed for system errors beyond their control, asserts a study in the June issue of Emergency Medicine News.

The study – conducted by Tom Belanger, MD, an emergency physician in Texas and chair-elect of the American College of Emergency Physicians Workforce Section – sought to understand to what extent doctors themselves were aware of systemic problems affecting their job. Dr. Belanger surveyed 99 doctors who were asked to comment on a series of ED–related adverse outcomes.

To mitigate response bias, he randomly manipulated the degree to which system error was a perceived factor in each of the adverse cases. In other words, in some cases, the system was represented as a major factor leading to error, while, in other cases, its role was diminished.

Dr. Belanger also divided his doctor/respondents into two groups: The first was asked about his or her personal experience with systemic issues before being presented with the adverse cases; the second group was queried about this experience after being presented with the cases.

The result confirmed Dr. Belanger’s suspicions: Physicians in the first group – that is, those asked about “system factors” before reading about the cases – “were 1.7 times more likely ... to attribute the adverse outcomes in the cases to system factors. (Other significant variables – including whether their shift was busy – also contributed to doctors’ perceptions of adverse outcomes.)

Concluded Dr. Belanger: Since doctors “can identify factors that increase their chances of making mistakes,” system designers should take heed and make efforts to reduce “the probability of error.” If they drag their heels or continue to point to individual doctor error, “they should be held medically and legally liable.”
 

A version of this article first appeared on Medscape.com.

A Georgia doctor was cleared in June of having failed to diagnose and treat a child whose acute pancreatitis developed life-threatening complications, according to a report posted on the website of Courtroom View Network.

In 2018, the parents of the then 9-year-old child brought him to Wellstar Paulding Hospital in Hiram, Ga., because of his severe abdominal pain and distention, among other symptoms. Following their examination, medical personnel at the hospital suspected the child’s symptoms were the result of severe constipation.

That evening, he was transferred to Children’s Healthcare of Atlanta, where a pediatric gastroenterologist oversaw his care. (Neither the Atlanta hospital nor Wellstar Paulding were defendants in the subsequent lawsuit.)

Late the following day, the child went into hypovolemic shock, a condition that interrupted the blood supply to his body. Admitted to the pediatric ICU, he was diagnosed with a dangerous complication of acute pancreatitis, necrotizing pancreatitis.

Further complications of his original disease led to a 4-month hospital stay, multiple surgeries, and other interventions. To this point, his medical expenses totaled more than $2.5 million.

His parents then sued the pediatric gastroenterologist who had overseen their child’s care. At issue during the 4-day trial was whether the doctor had properly monitored and treated his patient before his hypovolemic shock set in.

Their attorney sketched the “timeline” of the child’s decline, including his rapid heart rate and repeated vomiting. Given these symptoms, he argued, the standard of care required that steps be taken – including the proper tests and other interventions – to prevent the child’s acute pancreatitis from progressing even further.

“We are not asking you to say, ‘Should [the doctor] have immediately diagnosed pancreatitis,’ “ the attorney told the jury. “But the totality here requires you to think, ‘This might be more than just a backed-up kid.’ ”

The defense pushed back strenuously, however. It argued that the pediatric gastroenterologist had acted appropriately given the prevailing consensus, namely that the child was suffering from extreme constipation. Doctors at Wellstar Paulding, the first hospital where he was seen, suspected this diagnosis – and so, based on his exam and the child’s “non-specific” symptoms, did their client, the pediatric gastroenterologist, who saw him subsequently. “The only clinicians who actually laid hands on [the child] all thought constipation,” the attorney said during his closing argument.

The jury agreed, finding that the pediatric gastroenterologist had acted appropriately, based on the available evidence. Following the jury verdict, the defense attorney noted: Absent the “classic” symptoms of pancreatitis, the jury saw that his client “was working with a reasonable diagnosis until [the child’s] clinical picture deteriorated.”
 

ED doctors can reduce system errors, study says

Emergency physicians are often blamed for system errors beyond their control, asserts a study in the June issue of Emergency Medicine News.

The study – conducted by Tom Belanger, MD, an emergency physician in Texas and chair-elect of the American College of Emergency Physicians Workforce Section – sought to understand to what extent doctors themselves were aware of systemic problems affecting their job. Dr. Belanger surveyed 99 doctors who were asked to comment on a series of ED–related adverse outcomes.

To mitigate response bias, he randomly manipulated the degree to which system error was a perceived factor in each of the adverse cases. In other words, in some cases, the system was represented as a major factor leading to error, while, in other cases, its role was diminished.

Dr. Belanger also divided his doctor/respondents into two groups: The first was asked about his or her personal experience with systemic issues before being presented with the adverse cases; the second group was queried about this experience after being presented with the cases.

The result confirmed Dr. Belanger’s suspicions: Physicians in the first group – that is, those asked about “system factors” before reading about the cases – “were 1.7 times more likely ... to attribute the adverse outcomes in the cases to system factors. (Other significant variables – including whether their shift was busy – also contributed to doctors’ perceptions of adverse outcomes.)

Concluded Dr. Belanger: Since doctors “can identify factors that increase their chances of making mistakes,” system designers should take heed and make efforts to reduce “the probability of error.” If they drag their heels or continue to point to individual doctor error, “they should be held medically and legally liable.”
 

A version of this article first appeared on Medscape.com.

ASHEVILLE, N.C. – TikTok, typical of several forms of social media, has been intentionally repositioned to rival Google as a primary source of information, meaning that health care professionals, including those who provide dermatologic care to children, should be thinking about how to get on board to counter myths, erroneous facts, and fake news, warned an expert at the annual meeting of the Society for Pediatric Dermatology.

“If we don’t get involved, we are basically letting misinformation win. We need to be there,” said Angelo Landriscina, MD, director of dermatology at a Mount Sinai Doctors Clinic in New York.

Most of the content currently available on medical topics, including dermatology and pediatric dermatology, is not created by health care professionals, Dr. Landriscina noted. Not surprisingly, given that much of the content is based on personal opinion from individuals who have no expertise in medical care, he described the information as being of “low quality” when not fully erroneous.

Dr. Landriscina has been active on social media, including TikTok, for several years. Most of his posts involve responses to misinformation. When he sets the record straight on the basis of existing evidence, he often supports his counterargument with references.

He acknowledged that when he became involved in social media he faced criticism from colleagues about participating on an entertainment platform that many considered unworthy of providing objective information. If that was ever true, he argued, it is no longer the case.

“TikTok has adopted a new strategy. The goal is to unseat Google as a search tool, and it’s working,” he said. He explained that many people now use TikTok and other social media sites as their primary source of information on essentially every topic, from where to eat to whether to be screened for cancer.

The particular problem with TikTok – one of the most popular social media outlets – is that there is no mechanism for vetting the source of information. YouTube, by contrast, now requires some sort of validation for anyone who claims to have a medical degree or any other verifiable qualification, according to Dr. Landriscina. TikTok, like many other platforms, has no such requirement.

“Anyone can buy a pair of scrubs [implying expertise] and then post a video,” Dr. Landriscina said.

Even if information from one content provider is more valid than information from others, the TikTok algorithm is specifically designed to emphasize content that has the potential for going viral, which means it favors videos that are provocative over those that are not.

“The algorithm favors any content that is more controversial, more surprising, and keeps viewers engaged,” Dr. Landriscina pointed out.

This does not mean that objective and factual information is ignored, but the algorithm is indifferent to the validity of information, meaning that it allows videos to be posted without regard to whether the content is true, untrue, purposefully misleading, or utter nonsense. For that reason, it is often easier to attract attention by responding to a post that has already gone viral. Information that is clear and digestible can attract viewers and therefore is distributed more widely with the TikTok algorithm.
 

Parents are on Tiktok too

There is a misperception that the TikTok audience is younger, according to Dr. Landriscina. While peak use in the United States fell among people between the ages of 25 and 34 years in 2022, he said the number of users falls off relatively slowly with subsequent 10-year increments in age. In 2022, there were nearly 20 million users in the peak 10-year age range, but 7.5 million users were 55 years of age or older.

“Pediatric dermatologists should recognize that it is not just kids who are looking for information about their skin diseases, but also their parents,” Dr. Landriscina said.

The top three dermatology topics searched on TikTok in a recent period were acne, alopecia, and cysts. But top searches are very fluid and are extremely hard to quantify, because the basis of the algorithm, which is a proprietary secret, is not only unknown but produces different results for every user.

“The second you touch the app, it changes,” Dr. Landriscina said. He explained that an inquiry about any subject, including those that are medically related, yields content that is different, or at least ordered differently, “depending on how you behaved on the app in the past.”

The phenomenon that drives social media predates this technology. Dr. Landriscina cited a study in 1956 that described the “parasocial interaction theory.” The theory was based on the observation that those who consume media, such as television, which was relatively new in 1956, believed that they had a personal relationship with media figures.

“The users begin to trust influencers as a source, like a friend providing them advice,” Dr. Landriscina said. As an example, he suggested that a fan of the television show Friends who follows actor Jennifer Aniston on social media platforms may begin to think of her as a trusted source of information on any topic, including those for which she may not have expertise.

The reason that he urges medical professionals to become active on TikTok and other social media platforms is that they have a potentially critical role in responding to information that is not just wrong but harmful.

On TikTok and other social media platforms, “there is a lot of interest in content about dermatologic conditions in children. There is a real need for accurate information,” he said,

In the question-and-answer session following his presentation, Dr. Landriscina’s message was not uniformly embraced. One risk, according to an audience member, is that medical professionals will begin to express their own personal opinions rather than rely on evidence, with the result that they will “just add to the sea of misinformation.”

However, this opinion appeared to be the minority view. Most of those who commented took a “that-ship-has-sailed” stance, recognizing the irreversible ascendancy of social media.

“Whether you like it or not, social media is here to stay. We cannot fight it. Rather, we need to embrace it in a responsible way,” said Dakara R. Wright, MD, a dermatologist at the Mid-Atlantic Kaiser Permanente Group, Halethorpe, Md. She, like others, reported that she has come to recognize that social media is a major source of medical information for her patients.

“We need to be a presence on these platforms for the benefit of our patients and their parents,” she said. She acknowledged that she has not been active in posting on social media in the past but said that she has been speaking with administrators in her organization about how to become involved in a responsible way that can be useful to patients.

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, has been active on social media for several years, posting content on her own account, which is not related to her academic affiliation. She posts for many reasons, not least of which is drawing attention to her expertise.

Like Dr. Landriscina, she recognizes that users of these platforms are guided by the content to make decisions about health care. She also agreed that physicians should not ignore this phenomenon.

Tips on providing content

Given the fact that the algorithm is intended to produce posts that go viral, Dr. Landriscina urged clinicians to make their content easy to watch. He said it is not necessary to overthink content beyond providing accurate information, but he advised that videos be made with attention to adequate lighting and other simple factors to promote visual quality. He said that accurate information is not necessarily dull.

“Some facts can actually be surprising to patients,” he said. He noted that a calm, coherent video can be particularly effective in attracting an audience when it is in reaction to information that has gone viral but is misleading or patently incorrect.

Dr. Landriscina has been an influencer associated with multiple social media platforms, including TikTok. He has in the past been paid for consulting work for TikTok. Dr. Wright and Dr. Heath reported no potential conflicts of interest.

A version of this article first appeared on Medscape.com.

ASHEVILLE, N.C. – TikTok, typical of several forms of social media, has been intentionally repositioned to rival Google as a primary source of information, meaning that health care professionals, including those who provide dermatologic care to children, should be thinking about how to get on board to counter myths, erroneous facts, and fake news, warned an expert at the annual meeting of the Society for Pediatric Dermatology.

“If we don’t get involved, we are basically letting misinformation win. We need to be there,” said Angelo Landriscina, MD, director of dermatology at a Mount Sinai Doctors Clinic in New York.

Most of the content currently available on medical topics, including dermatology and pediatric dermatology, is not created by health care professionals, Dr. Landriscina noted. Not surprisingly, given that much of the content is based on personal opinion from individuals who have no expertise in medical care, he described the information as being of “low quality” when not fully erroneous.

Dr. Landriscina has been active on social media, including TikTok, for several years. Most of his posts involve responses to misinformation. When he sets the record straight on the basis of existing evidence, he often supports his counterargument with references.

He acknowledged that when he became involved in social media he faced criticism from colleagues about participating on an entertainment platform that many considered unworthy of providing objective information. If that was ever true, he argued, it is no longer the case.

“TikTok has adopted a new strategy. The goal is to unseat Google as a search tool, and it’s working,” he said. He explained that many people now use TikTok and other social media sites as their primary source of information on essentially every topic, from where to eat to whether to be screened for cancer.

The particular problem with TikTok – one of the most popular social media outlets – is that there is no mechanism for vetting the source of information. YouTube, by contrast, now requires some sort of validation for anyone who claims to have a medical degree or any other verifiable qualification, according to Dr. Landriscina. TikTok, like many other platforms, has no such requirement.

“Anyone can buy a pair of scrubs [implying expertise] and then post a video,” Dr. Landriscina said.

Even if information from one content provider is more valid than information from others, the TikTok algorithm is specifically designed to emphasize content that has the potential for going viral, which means it favors videos that are provocative over those that are not.

“The algorithm favors any content that is more controversial, more surprising, and keeps viewers engaged,” Dr. Landriscina pointed out.

This does not mean that objective and factual information is ignored, but the algorithm is indifferent to the validity of information, meaning that it allows videos to be posted without regard to whether the content is true, untrue, purposefully misleading, or utter nonsense. For that reason, it is often easier to attract attention by responding to a post that has already gone viral. Information that is clear and digestible can attract viewers and therefore is distributed more widely with the TikTok algorithm.
 

Parents are on Tiktok too

There is a misperception that the TikTok audience is younger, according to Dr. Landriscina. While peak use in the United States fell among people between the ages of 25 and 34 years in 2022, he said the number of users falls off relatively slowly with subsequent 10-year increments in age. In 2022, there were nearly 20 million users in the peak 10-year age range, but 7.5 million users were 55 years of age or older.

“Pediatric dermatologists should recognize that it is not just kids who are looking for information about their skin diseases, but also their parents,” Dr. Landriscina said.

The top three dermatology topics searched on TikTok in a recent period were acne, alopecia, and cysts. But top searches are very fluid and are extremely hard to quantify, because the basis of the algorithm, which is a proprietary secret, is not only unknown but produces different results for every user.

“The second you touch the app, it changes,” Dr. Landriscina said. He explained that an inquiry about any subject, including those that are medically related, yields content that is different, or at least ordered differently, “depending on how you behaved on the app in the past.”

The phenomenon that drives social media predates this technology. Dr. Landriscina cited a study in 1956 that described the “parasocial interaction theory.” The theory was based on the observation that those who consume media, such as television, which was relatively new in 1956, believed that they had a personal relationship with media figures.

“The users begin to trust influencers as a source, like a friend providing them advice,” Dr. Landriscina said. As an example, he suggested that a fan of the television show Friends who follows actor Jennifer Aniston on social media platforms may begin to think of her as a trusted source of information on any topic, including those for which she may not have expertise.

The reason that he urges medical professionals to become active on TikTok and other social media platforms is that they have a potentially critical role in responding to information that is not just wrong but harmful.

On TikTok and other social media platforms, “there is a lot of interest in content about dermatologic conditions in children. There is a real need for accurate information,” he said,

In the question-and-answer session following his presentation, Dr. Landriscina’s message was not uniformly embraced. One risk, according to an audience member, is that medical professionals will begin to express their own personal opinions rather than rely on evidence, with the result that they will “just add to the sea of misinformation.”

However, this opinion appeared to be the minority view. Most of those who commented took a “that-ship-has-sailed” stance, recognizing the irreversible ascendancy of social media.

“Whether you like it or not, social media is here to stay. We cannot fight it. Rather, we need to embrace it in a responsible way,” said Dakara R. Wright, MD, a dermatologist at the Mid-Atlantic Kaiser Permanente Group, Halethorpe, Md. She, like others, reported that she has come to recognize that social media is a major source of medical information for her patients.

“We need to be a presence on these platforms for the benefit of our patients and their parents,” she said. She acknowledged that she has not been active in posting on social media in the past but said that she has been speaking with administrators in her organization about how to become involved in a responsible way that can be useful to patients.

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, has been active on social media for several years, posting content on her own account, which is not related to her academic affiliation. She posts for many reasons, not least of which is drawing attention to her expertise.

Like Dr. Landriscina, she recognizes that users of these platforms are guided by the content to make decisions about health care. She also agreed that physicians should not ignore this phenomenon.

Tips on providing content

Given the fact that the algorithm is intended to produce posts that go viral, Dr. Landriscina urged clinicians to make their content easy to watch. He said it is not necessary to overthink content beyond providing accurate information, but he advised that videos be made with attention to adequate lighting and other simple factors to promote visual quality. He said that accurate information is not necessarily dull.

“Some facts can actually be surprising to patients,” he said. He noted that a calm, coherent video can be particularly effective in attracting an audience when it is in reaction to information that has gone viral but is misleading or patently incorrect.

Dr. Landriscina has been an influencer associated with multiple social media platforms, including TikTok. He has in the past been paid for consulting work for TikTok. Dr. Wright and Dr. Heath reported no potential conflicts of interest.

A version of this article first appeared on Medscape.com.

ASHEVILLE, N.C. – TikTok, typical of several forms of social media, has been intentionally repositioned to rival Google as a primary source of information, meaning that health care professionals, including those who provide dermatologic care to children, should be thinking about how to get on board to counter myths, erroneous facts, and fake news, warned an expert at the annual meeting of the Society for Pediatric Dermatology.

“If we don’t get involved, we are basically letting misinformation win. We need to be there,” said Angelo Landriscina, MD, director of dermatology at a Mount Sinai Doctors Clinic in New York.

Most of the content currently available on medical topics, including dermatology and pediatric dermatology, is not created by health care professionals, Dr. Landriscina noted. Not surprisingly, given that much of the content is based on personal opinion from individuals who have no expertise in medical care, he described the information as being of “low quality” when not fully erroneous.

Dr. Landriscina has been active on social media, including TikTok, for several years. Most of his posts involve responses to misinformation. When he sets the record straight on the basis of existing evidence, he often supports his counterargument with references.

He acknowledged that when he became involved in social media he faced criticism from colleagues about participating on an entertainment platform that many considered unworthy of providing objective information. If that was ever true, he argued, it is no longer the case.

“TikTok has adopted a new strategy. The goal is to unseat Google as a search tool, and it’s working,” he said. He explained that many people now use TikTok and other social media sites as their primary source of information on essentially every topic, from where to eat to whether to be screened for cancer.

The particular problem with TikTok – one of the most popular social media outlets – is that there is no mechanism for vetting the source of information. YouTube, by contrast, now requires some sort of validation for anyone who claims to have a medical degree or any other verifiable qualification, according to Dr. Landriscina. TikTok, like many other platforms, has no such requirement.

“Anyone can buy a pair of scrubs [implying expertise] and then post a video,” Dr. Landriscina said.

Even if information from one content provider is more valid than information from others, the TikTok algorithm is specifically designed to emphasize content that has the potential for going viral, which means it favors videos that are provocative over those that are not.

“The algorithm favors any content that is more controversial, more surprising, and keeps viewers engaged,” Dr. Landriscina pointed out.

This does not mean that objective and factual information is ignored, but the algorithm is indifferent to the validity of information, meaning that it allows videos to be posted without regard to whether the content is true, untrue, purposefully misleading, or utter nonsense. For that reason, it is often easier to attract attention by responding to a post that has already gone viral. Information that is clear and digestible can attract viewers and therefore is distributed more widely with the TikTok algorithm.
 

Parents are on Tiktok too

There is a misperception that the TikTok audience is younger, according to Dr. Landriscina. While peak use in the United States fell among people between the ages of 25 and 34 years in 2022, he said the number of users falls off relatively slowly with subsequent 10-year increments in age. In 2022, there were nearly 20 million users in the peak 10-year age range, but 7.5 million users were 55 years of age or older.

“Pediatric dermatologists should recognize that it is not just kids who are looking for information about their skin diseases, but also their parents,” Dr. Landriscina said.

The top three dermatology topics searched on TikTok in a recent period were acne, alopecia, and cysts. But top searches are very fluid and are extremely hard to quantify, because the basis of the algorithm, which is a proprietary secret, is not only unknown but produces different results for every user.

“The second you touch the app, it changes,” Dr. Landriscina said. He explained that an inquiry about any subject, including those that are medically related, yields content that is different, or at least ordered differently, “depending on how you behaved on the app in the past.”

The phenomenon that drives social media predates this technology. Dr. Landriscina cited a study in 1956 that described the “parasocial interaction theory.” The theory was based on the observation that those who consume media, such as television, which was relatively new in 1956, believed that they had a personal relationship with media figures.

“The users begin to trust influencers as a source, like a friend providing them advice,” Dr. Landriscina said. As an example, he suggested that a fan of the television show Friends who follows actor Jennifer Aniston on social media platforms may begin to think of her as a trusted source of information on any topic, including those for which she may not have expertise.

The reason that he urges medical professionals to become active on TikTok and other social media platforms is that they have a potentially critical role in responding to information that is not just wrong but harmful.

On TikTok and other social media platforms, “there is a lot of interest in content about dermatologic conditions in children. There is a real need for accurate information,” he said,

In the question-and-answer session following his presentation, Dr. Landriscina’s message was not uniformly embraced. One risk, according to an audience member, is that medical professionals will begin to express their own personal opinions rather than rely on evidence, with the result that they will “just add to the sea of misinformation.”

However, this opinion appeared to be the minority view. Most of those who commented took a “that-ship-has-sailed” stance, recognizing the irreversible ascendancy of social media.

“Whether you like it or not, social media is here to stay. We cannot fight it. Rather, we need to embrace it in a responsible way,” said Dakara R. Wright, MD, a dermatologist at the Mid-Atlantic Kaiser Permanente Group, Halethorpe, Md. She, like others, reported that she has come to recognize that social media is a major source of medical information for her patients.

“We need to be a presence on these platforms for the benefit of our patients and their parents,” she said. She acknowledged that she has not been active in posting on social media in the past but said that she has been speaking with administrators in her organization about how to become involved in a responsible way that can be useful to patients.

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, has been active on social media for several years, posting content on her own account, which is not related to her academic affiliation. She posts for many reasons, not least of which is drawing attention to her expertise.

Like Dr. Landriscina, she recognizes that users of these platforms are guided by the content to make decisions about health care. She also agreed that physicians should not ignore this phenomenon.

Tips on providing content

Given the fact that the algorithm is intended to produce posts that go viral, Dr. Landriscina urged clinicians to make their content easy to watch. He said it is not necessary to overthink content beyond providing accurate information, but he advised that videos be made with attention to adequate lighting and other simple factors to promote visual quality. He said that accurate information is not necessarily dull.

“Some facts can actually be surprising to patients,” he said. He noted that a calm, coherent video can be particularly effective in attracting an audience when it is in reaction to information that has gone viral but is misleading or patently incorrect.

Dr. Landriscina has been an influencer associated with multiple social media platforms, including TikTok. He has in the past been paid for consulting work for TikTok. Dr. Wright and Dr. Heath reported no potential conflicts of interest.

A version of this article first appeared on Medscape.com.

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

A version of this article first appeared on Medscape.com .

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

A version of this article first appeared on Medscape.com .

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

A version of this article first appeared on Medscape.com .

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

• Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
• Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
• The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
• Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
• Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

A version of this article first appeared on Medscape.com.

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

• Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
• Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
• The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
• Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
• Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

A version of this article first appeared on Medscape.com.

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

• Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
• Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
• The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
• Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
• Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

A version of this article first appeared on Medscape.com.

Children and adults with attention-deficit/hyperactivity disorder (ADHD) show greater improvement in symptoms with viloxazine extended release (ER) compared with treatment with atomoxetine, new research suggests.

Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.

Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.

In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.

“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
 

Nonstimulant treatment options

Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”

Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.

Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.

Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.

However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.

There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.

“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.

The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.

The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.

Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.

At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
 

‘Paradigm shift’

At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).

Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).

By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.

Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.

Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.

“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”

The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
 

Real-world study

Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”

This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.

“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.

“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.

A version of this article first appeared on Medscape.com.

Children and adults with attention-deficit/hyperactivity disorder (ADHD) show greater improvement in symptoms with viloxazine extended release (ER) compared with treatment with atomoxetine, new research suggests.

Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.

Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.

In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.

“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
 

Nonstimulant treatment options

Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”

Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.

Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.

Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.

However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.

There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.

“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.

The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.

The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.

Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.

At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
 

‘Paradigm shift’

At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).

Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).

By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.

Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.

Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.

“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”

The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
 

Real-world study

Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”

This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.

“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.

“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.

A version of this article first appeared on Medscape.com.

Children and adults with attention-deficit/hyperactivity disorder (ADHD) show greater improvement in symptoms with viloxazine extended release (ER) compared with treatment with atomoxetine, new research suggests.

Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.

Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.

In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.

“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
 

Nonstimulant treatment options

Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”

Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.

Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.

Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.

However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.

There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.

“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.

The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.

The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.

Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.

At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
 

‘Paradigm shift’

At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).

Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).

By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.

Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.

Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.

“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”

The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
 

Real-world study

Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”

This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.

“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.

“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.

A version of this article first appeared on Medscape.com.

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.

These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.

“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.

“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.

For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.

The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).

The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).

There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).

“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.

In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context. 

“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”

Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”

Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic. 

UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.

These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.

“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.

“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.

For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.

The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).

The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).

There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).

“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.

In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context. 

“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”

Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”

Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic. 

UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.

These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.

“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.

“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.

For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.

The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).

The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).

There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).

“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.

In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context. 

“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”

Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”

Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic. 

UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.

The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.

The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.






 

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.

The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.

The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.






 

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.

The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.

The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.