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Manners matter
Have you been surprised and impressed by a child who says after a visit, “Thank you, Doctor [Howard]”? While it may seem antiquated to teach such manners to children these days, there are several important benefits to this education.
Manners serve important functions in benefiting a person’s group with cohesiveness and the individuals themselves with acceptance in the group. Use of manners instantly suggests a more trustworthy person.
There are three main categories of manners: hygiene, courtesy, and cultural norm manners.
Hygiene manners, from using the toilet to refraining from picking one’s nose, have obvious health benefits of not spreading disease. Hygiene manners take time to teach, but parents are motivated and helped by natural reactions of disgust that even infants recognize.
Courtesy manners, on the other hand, are habits of self-control and good-faith behaviors that signal that one is putting the interests of others ahead of one’s own for the moment. Taking another’s comfort into account, basic to kindness and respect, does not require agreeing with or submitting to the other. Courtesy manners require a developing self-awareness (I can choose to act this way) and awareness of social status (I am not more important than everyone else) that begins in toddlerhood. Modeling manners around the child is the most important way to teach courtesy. Parents usually start actively teaching the child to say “please” and “thank you,” and show pride in this apparent “demonstration of appreciation” even when it is simply reinforced behavior at first. The delight of grandparents reinforces both the parents and children, and reflects manners as building tribe cohesiveness.
Good manners become a habit
Manners such as warm greetings, a firm handshake (before COVID-19), and prompt thanks are most believable when occurring promptly when appropriate – when they come from habit. This immediate reaction, a result of so-called “fast thinking,” develops when behaviors learned from “slow thinking” are instilled early and often until they are automatic. The other benefit of this overlearning is that the behavior then looks unambivalent; a lag of too many milliseconds makes the recipient doubt genuineness.
Parents often ask us how to handle their child‘s rude or disrespectful behavior. Praise for manners is a simple start. Toddlers and preschoolers are taught manners best by adult modeling, but also by reinforcement and praise for the basics: to say “Hello,” ask “Please,” and say “Thank you,” “Excuse me,” “You’re welcome,” or “Would you help me, please?” The behaviors also include avoiding raising one’s voice, suppressing interrupting, and apologizing when appropriate. Even shy children can learn eye contact by making a game of figuring out the other’s eye color. Shaming, yelling, and punishing for poor manners usually backfires because it shows disrespect of the child who will likely give this back.
Older children can be taught to offer other people the opportunity to go through a door first, to be first to select a seat, speak first and without interruption, or order first. There are daily opportunities for these manners of showing respect. Opening doors for others, or standing when a guest enters the room are more formal but still appreciated. Parents who use and expect courtesy manners with everyone – irrespective of gender, race, ethnicity, or role as a server versus professional – show that they value others and build antiracism.
School age is a time to learn to wait before speaking to consider whether what they say could be experienced as hurtful to the other person. This requires taking someone else’s point of view, an ability that emerges around age 6 years and can be promoted when parents review with their child “How would you feel if it were you?” Role playing common scenarios of how to behave and speak when seeing a person who looks or acts different is also effective. Avoiding interrupting may be more difficult for very talkative or impulsive children, especially those with ADHD. Practicing waiting for permission to speak by being handed a “talking stick” at the dinner table can be good practice for everyone.
Manners are a group asset
Beyond personal benefits, manners are the basis of a civil society. Cultural norm manners are particular to groups, helping members feel affiliated, as well as identifying those with different manners as “other.”
Teens are particularly likely to use a different code of behavior to fit in with a subgroup. This may be acceptable if restricted to within their group (such as swear words) or within certain agreed-upon limits with family members. But teens need to understand the value of learning, practicing, and using manners for their own, as well as their group’s and nation’s, well-being.
As a developmental-behavioral pediatrician, I have cared for many children with intellectual disabilities and autism spectrum disorder (ASD). Deficits in social interaction skills are a basic criterion for the diagnosis of ASD. Overtraining is especially needed for children with ASD whose mirror movements, social attention, and imitation are weak. For children with these conditions, making manners a strong habit takes more effort but is even more vital than for neurotypical children. Temple Grandin, a famous adult with ASD, has described how her mother taught her manners as a survival skill. She reports incorporating manners very consciously and methodically because they did not come naturally. Children with even rote social skills are liked better by peers and teachers, their atypical behaviors is better tolerated, and they get more positive feedback that encourages integration inside and outside the classroom. Manners may make the difference between being allowed in or expelled from classrooms, libraries, clubs, teams, or religious institutions. When it is time to get a job, social skills are the key factor for employment for these individuals and a significant help for neurotypical individuals as well. Failure to signal socially appropriate behavior can make a person appear threatening and has had the rare but tragic result of rough or fatal handling by police.
Has the teaching of manners waned? Perhaps, because, for some families, the child is being socialized mostly by nonfamily caregivers who have low use of manners. Some parents have made teaching manners a low priority or even resisted using manners themselves as inauthentic. This may reflect prioritizing a “laid-back” lifestyle and speaking crudely as a sign of independence, perhaps in reaction to lack of autonomy at work. Mastering the careful interactions developed over time to avoid invoking an aggressive response depend on direct feedback from reactions of the recipient. With so much of our communication done electronically, asynchronously, even anonymously, the usual feedback has been reduced. Practicing curses, insults, and put-downs online easily extends to in-person interactions without the perpetrator even noticing and are generally reinforced and repeated without parental supervision. Disrespectful behavior from community leaders also reduces the threshold for society.
When people are ignorant of or choose not to use manners they may be perceived as “other” and hostile. This may lead to distrust, dislike, and lowered ability to find the common ground needed for making decisions that benefit the greater society. Oliver Wendell Holmes said “Under bad manners ... lies very commonly an overestimate of our special individuality, as distinguished from our generic humanity (“The Professor at the Breakfast Table,” 1858). Working for major goals that benefit all of humanity is essential to survival in our highly interconnected world. Considering all of humanity is a difficult concept for children, and even for many adults, but it starts with using civil behavior at home, in school, and in one’s community.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Have you been surprised and impressed by a child who says after a visit, “Thank you, Doctor [Howard]”? While it may seem antiquated to teach such manners to children these days, there are several important benefits to this education.
Manners serve important functions in benefiting a person’s group with cohesiveness and the individuals themselves with acceptance in the group. Use of manners instantly suggests a more trustworthy person.
There are three main categories of manners: hygiene, courtesy, and cultural norm manners.
Hygiene manners, from using the toilet to refraining from picking one’s nose, have obvious health benefits of not spreading disease. Hygiene manners take time to teach, but parents are motivated and helped by natural reactions of disgust that even infants recognize.
Courtesy manners, on the other hand, are habits of self-control and good-faith behaviors that signal that one is putting the interests of others ahead of one’s own for the moment. Taking another’s comfort into account, basic to kindness and respect, does not require agreeing with or submitting to the other. Courtesy manners require a developing self-awareness (I can choose to act this way) and awareness of social status (I am not more important than everyone else) that begins in toddlerhood. Modeling manners around the child is the most important way to teach courtesy. Parents usually start actively teaching the child to say “please” and “thank you,” and show pride in this apparent “demonstration of appreciation” even when it is simply reinforced behavior at first. The delight of grandparents reinforces both the parents and children, and reflects manners as building tribe cohesiveness.
Good manners become a habit
Manners such as warm greetings, a firm handshake (before COVID-19), and prompt thanks are most believable when occurring promptly when appropriate – when they come from habit. This immediate reaction, a result of so-called “fast thinking,” develops when behaviors learned from “slow thinking” are instilled early and often until they are automatic. The other benefit of this overlearning is that the behavior then looks unambivalent; a lag of too many milliseconds makes the recipient doubt genuineness.
Parents often ask us how to handle their child‘s rude or disrespectful behavior. Praise for manners is a simple start. Toddlers and preschoolers are taught manners best by adult modeling, but also by reinforcement and praise for the basics: to say “Hello,” ask “Please,” and say “Thank you,” “Excuse me,” “You’re welcome,” or “Would you help me, please?” The behaviors also include avoiding raising one’s voice, suppressing interrupting, and apologizing when appropriate. Even shy children can learn eye contact by making a game of figuring out the other’s eye color. Shaming, yelling, and punishing for poor manners usually backfires because it shows disrespect of the child who will likely give this back.
Older children can be taught to offer other people the opportunity to go through a door first, to be first to select a seat, speak first and without interruption, or order first. There are daily opportunities for these manners of showing respect. Opening doors for others, or standing when a guest enters the room are more formal but still appreciated. Parents who use and expect courtesy manners with everyone – irrespective of gender, race, ethnicity, or role as a server versus professional – show that they value others and build antiracism.
School age is a time to learn to wait before speaking to consider whether what they say could be experienced as hurtful to the other person. This requires taking someone else’s point of view, an ability that emerges around age 6 years and can be promoted when parents review with their child “How would you feel if it were you?” Role playing common scenarios of how to behave and speak when seeing a person who looks or acts different is also effective. Avoiding interrupting may be more difficult for very talkative or impulsive children, especially those with ADHD. Practicing waiting for permission to speak by being handed a “talking stick” at the dinner table can be good practice for everyone.
Manners are a group asset
Beyond personal benefits, manners are the basis of a civil society. Cultural norm manners are particular to groups, helping members feel affiliated, as well as identifying those with different manners as “other.”
Teens are particularly likely to use a different code of behavior to fit in with a subgroup. This may be acceptable if restricted to within their group (such as swear words) or within certain agreed-upon limits with family members. But teens need to understand the value of learning, practicing, and using manners for their own, as well as their group’s and nation’s, well-being.
As a developmental-behavioral pediatrician, I have cared for many children with intellectual disabilities and autism spectrum disorder (ASD). Deficits in social interaction skills are a basic criterion for the diagnosis of ASD. Overtraining is especially needed for children with ASD whose mirror movements, social attention, and imitation are weak. For children with these conditions, making manners a strong habit takes more effort but is even more vital than for neurotypical children. Temple Grandin, a famous adult with ASD, has described how her mother taught her manners as a survival skill. She reports incorporating manners very consciously and methodically because they did not come naturally. Children with even rote social skills are liked better by peers and teachers, their atypical behaviors is better tolerated, and they get more positive feedback that encourages integration inside and outside the classroom. Manners may make the difference between being allowed in or expelled from classrooms, libraries, clubs, teams, or religious institutions. When it is time to get a job, social skills are the key factor for employment for these individuals and a significant help for neurotypical individuals as well. Failure to signal socially appropriate behavior can make a person appear threatening and has had the rare but tragic result of rough or fatal handling by police.
Has the teaching of manners waned? Perhaps, because, for some families, the child is being socialized mostly by nonfamily caregivers who have low use of manners. Some parents have made teaching manners a low priority or even resisted using manners themselves as inauthentic. This may reflect prioritizing a “laid-back” lifestyle and speaking crudely as a sign of independence, perhaps in reaction to lack of autonomy at work. Mastering the careful interactions developed over time to avoid invoking an aggressive response depend on direct feedback from reactions of the recipient. With so much of our communication done electronically, asynchronously, even anonymously, the usual feedback has been reduced. Practicing curses, insults, and put-downs online easily extends to in-person interactions without the perpetrator even noticing and are generally reinforced and repeated without parental supervision. Disrespectful behavior from community leaders also reduces the threshold for society.
When people are ignorant of or choose not to use manners they may be perceived as “other” and hostile. This may lead to distrust, dislike, and lowered ability to find the common ground needed for making decisions that benefit the greater society. Oliver Wendell Holmes said “Under bad manners ... lies very commonly an overestimate of our special individuality, as distinguished from our generic humanity (“The Professor at the Breakfast Table,” 1858). Working for major goals that benefit all of humanity is essential to survival in our highly interconnected world. Considering all of humanity is a difficult concept for children, and even for many adults, but it starts with using civil behavior at home, in school, and in one’s community.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Have you been surprised and impressed by a child who says after a visit, “Thank you, Doctor [Howard]”? While it may seem antiquated to teach such manners to children these days, there are several important benefits to this education.
Manners serve important functions in benefiting a person’s group with cohesiveness and the individuals themselves with acceptance in the group. Use of manners instantly suggests a more trustworthy person.
There are three main categories of manners: hygiene, courtesy, and cultural norm manners.
Hygiene manners, from using the toilet to refraining from picking one’s nose, have obvious health benefits of not spreading disease. Hygiene manners take time to teach, but parents are motivated and helped by natural reactions of disgust that even infants recognize.
Courtesy manners, on the other hand, are habits of self-control and good-faith behaviors that signal that one is putting the interests of others ahead of one’s own for the moment. Taking another’s comfort into account, basic to kindness and respect, does not require agreeing with or submitting to the other. Courtesy manners require a developing self-awareness (I can choose to act this way) and awareness of social status (I am not more important than everyone else) that begins in toddlerhood. Modeling manners around the child is the most important way to teach courtesy. Parents usually start actively teaching the child to say “please” and “thank you,” and show pride in this apparent “demonstration of appreciation” even when it is simply reinforced behavior at first. The delight of grandparents reinforces both the parents and children, and reflects manners as building tribe cohesiveness.
Good manners become a habit
Manners such as warm greetings, a firm handshake (before COVID-19), and prompt thanks are most believable when occurring promptly when appropriate – when they come from habit. This immediate reaction, a result of so-called “fast thinking,” develops when behaviors learned from “slow thinking” are instilled early and often until they are automatic. The other benefit of this overlearning is that the behavior then looks unambivalent; a lag of too many milliseconds makes the recipient doubt genuineness.
Parents often ask us how to handle their child‘s rude or disrespectful behavior. Praise for manners is a simple start. Toddlers and preschoolers are taught manners best by adult modeling, but also by reinforcement and praise for the basics: to say “Hello,” ask “Please,” and say “Thank you,” “Excuse me,” “You’re welcome,” or “Would you help me, please?” The behaviors also include avoiding raising one’s voice, suppressing interrupting, and apologizing when appropriate. Even shy children can learn eye contact by making a game of figuring out the other’s eye color. Shaming, yelling, and punishing for poor manners usually backfires because it shows disrespect of the child who will likely give this back.
Older children can be taught to offer other people the opportunity to go through a door first, to be first to select a seat, speak first and without interruption, or order first. There are daily opportunities for these manners of showing respect. Opening doors for others, or standing when a guest enters the room are more formal but still appreciated. Parents who use and expect courtesy manners with everyone – irrespective of gender, race, ethnicity, or role as a server versus professional – show that they value others and build antiracism.
School age is a time to learn to wait before speaking to consider whether what they say could be experienced as hurtful to the other person. This requires taking someone else’s point of view, an ability that emerges around age 6 years and can be promoted when parents review with their child “How would you feel if it were you?” Role playing common scenarios of how to behave and speak when seeing a person who looks or acts different is also effective. Avoiding interrupting may be more difficult for very talkative or impulsive children, especially those with ADHD. Practicing waiting for permission to speak by being handed a “talking stick” at the dinner table can be good practice for everyone.
Manners are a group asset
Beyond personal benefits, manners are the basis of a civil society. Cultural norm manners are particular to groups, helping members feel affiliated, as well as identifying those with different manners as “other.”
Teens are particularly likely to use a different code of behavior to fit in with a subgroup. This may be acceptable if restricted to within their group (such as swear words) or within certain agreed-upon limits with family members. But teens need to understand the value of learning, practicing, and using manners for their own, as well as their group’s and nation’s, well-being.
As a developmental-behavioral pediatrician, I have cared for many children with intellectual disabilities and autism spectrum disorder (ASD). Deficits in social interaction skills are a basic criterion for the diagnosis of ASD. Overtraining is especially needed for children with ASD whose mirror movements, social attention, and imitation are weak. For children with these conditions, making manners a strong habit takes more effort but is even more vital than for neurotypical children. Temple Grandin, a famous adult with ASD, has described how her mother taught her manners as a survival skill. She reports incorporating manners very consciously and methodically because they did not come naturally. Children with even rote social skills are liked better by peers and teachers, their atypical behaviors is better tolerated, and they get more positive feedback that encourages integration inside and outside the classroom. Manners may make the difference between being allowed in or expelled from classrooms, libraries, clubs, teams, or religious institutions. When it is time to get a job, social skills are the key factor for employment for these individuals and a significant help for neurotypical individuals as well. Failure to signal socially appropriate behavior can make a person appear threatening and has had the rare but tragic result of rough or fatal handling by police.
Has the teaching of manners waned? Perhaps, because, for some families, the child is being socialized mostly by nonfamily caregivers who have low use of manners. Some parents have made teaching manners a low priority or even resisted using manners themselves as inauthentic. This may reflect prioritizing a “laid-back” lifestyle and speaking crudely as a sign of independence, perhaps in reaction to lack of autonomy at work. Mastering the careful interactions developed over time to avoid invoking an aggressive response depend on direct feedback from reactions of the recipient. With so much of our communication done electronically, asynchronously, even anonymously, the usual feedback has been reduced. Practicing curses, insults, and put-downs online easily extends to in-person interactions without the perpetrator even noticing and are generally reinforced and repeated without parental supervision. Disrespectful behavior from community leaders also reduces the threshold for society.
When people are ignorant of or choose not to use manners they may be perceived as “other” and hostile. This may lead to distrust, dislike, and lowered ability to find the common ground needed for making decisions that benefit the greater society. Oliver Wendell Holmes said “Under bad manners ... lies very commonly an overestimate of our special individuality, as distinguished from our generic humanity (“The Professor at the Breakfast Table,” 1858). Working for major goals that benefit all of humanity is essential to survival in our highly interconnected world. Considering all of humanity is a difficult concept for children, and even for many adults, but it starts with using civil behavior at home, in school, and in one’s community.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Gene signature found similarly prognostic in ILC and IDC
ILC is enriched with features indicating low proliferative activity, noted investigator Otto Metzger, MD, of the Dana Farber Cancer Institute in Boston.
“Data from retrospective series have indicated no benefit with adjuvant chemotherapy for patients diagnosed with early-stage ILC,” he said. “It’s fair to say that chemotherapy decisions for patients with ILC remain controversial.”
With this in mind, Dr. Metzger and colleagues analyzed data for 5,313 women who underwent surgery for early-stage breast cancer (node-negative or up to three positive lymph nodes) and were risk-stratified to receive or skip adjuvant chemotherapy based on both clinical risk and the MammaPrint score for genomic risk. Fully 44% of women with ILC had discordant clinical and genomic risks.
With a median follow-up of 8.7 years, the 5-year rate of distant metastasis–free survival among all patients classified as genomic high risk was 92.1% in women with IDC and 88.1% in women with ILC, with overlapping 95% confidence intervals. Rates of distant metastasis–free survival for patients with genomic low risk were 96.4% in women with IDC and 96.6% in women with ILC, again with confidence intervals that overlapped.
The pattern was essentially the same for overall survival, and results carried over into 8-year outcomes as well.
“We believe that MammaPrint is a clinically useful test for patients diagnosed with ILC,” Dr. Metzger said. “There are similar survival outcomes for ILC and IDC when matched by genomic risk. This is an important message.”
It should be standard to omit chemotherapy for patients who have ILC classified as high clinical risk but low genomic risk by MammaPrint, Dr. Metzger recommended. “By contrast, MammaPrint should facilitate chemotherapy treatment decisions for patients diagnosed with ILC and high-risk MammaPrint,” he said.
Prognostic, but predictive?
“This is a well-designed prospective multicenter trial and provides the best evidence to date that MammaPrint is an important prognostic tool for ILC,” Todd Tuttle, MD, of University of Minnesota in Minneapolis, said in an interview.
Dr. Tuttle said he mainly uses the MammaPrint test and the OncoType 21-gene recurrence score to estimate prognosis for his patients with ILC.
These new data establish that MammaPrint is prognostic in ILC, but the value of MammaPrint’s genomic high risk result for making the decision about chemotherapy is still unclear, according to Dr. Tuttle.
“I don’t think we know whether MammaPrint can predict the benefit of chemotherapy for patients with stage I or II ILC,” he elaborated. “We need further high-quality studies such as this one to determine the best treatment strategies for ILC, which is a difficult breast cancer.”
Study details
Of the 5,313 patients studied, 487 had ILC (255 classic and 232 variant) and 4,826 had IDC according to central pathology assessment, Dr. Metzger reported.
MammaPrint classified 39% of the IDC group and 16% of the ILC group (10% of those with classic disease and 23% of those with variant disease) as genomically high risk for recurrence. The Adjuvant! Online tool classified 48.3% of ILC and 51.5% of IDC patients as clinically high risk.
Among the 44% of women with ILC having discordant genomic and clinical risk, discordance was usually due to the combination of low genomic risk and high clinical risk, seen in 38%.
The curves for 5-year distant metastasis–free survival stratified by genomic risk essentially overlapped for the IDC and ILC groups. Furthermore, there was no significant interaction of histologic type and genomic risk on this outcome (P = .547).
The 5-year rate of overall survival among women with genomic high risk was 95.6% in the IDC group and 93.5% in the ILC group. Among women with genomic low risk, 5-year overall survival was 98.1% in the IDC group and 97.7% in the ILC group, again with overlapping confidence intervals within each risk category.
The study was funded with support from the Breast Cancer Research Foundation. Dr. Metzger disclosed consulting fees from AbbVie, Genentech, Roche, and Pfizer. Dr. Tuttle disclosed no conflicts of interest.
SOURCE: Metzger O et al. EBCC-12 Virtual Conference. Abstract 6.
ILC is enriched with features indicating low proliferative activity, noted investigator Otto Metzger, MD, of the Dana Farber Cancer Institute in Boston.
“Data from retrospective series have indicated no benefit with adjuvant chemotherapy for patients diagnosed with early-stage ILC,” he said. “It’s fair to say that chemotherapy decisions for patients with ILC remain controversial.”
With this in mind, Dr. Metzger and colleagues analyzed data for 5,313 women who underwent surgery for early-stage breast cancer (node-negative or up to three positive lymph nodes) and were risk-stratified to receive or skip adjuvant chemotherapy based on both clinical risk and the MammaPrint score for genomic risk. Fully 44% of women with ILC had discordant clinical and genomic risks.
With a median follow-up of 8.7 years, the 5-year rate of distant metastasis–free survival among all patients classified as genomic high risk was 92.1% in women with IDC and 88.1% in women with ILC, with overlapping 95% confidence intervals. Rates of distant metastasis–free survival for patients with genomic low risk were 96.4% in women with IDC and 96.6% in women with ILC, again with confidence intervals that overlapped.
The pattern was essentially the same for overall survival, and results carried over into 8-year outcomes as well.
“We believe that MammaPrint is a clinically useful test for patients diagnosed with ILC,” Dr. Metzger said. “There are similar survival outcomes for ILC and IDC when matched by genomic risk. This is an important message.”
It should be standard to omit chemotherapy for patients who have ILC classified as high clinical risk but low genomic risk by MammaPrint, Dr. Metzger recommended. “By contrast, MammaPrint should facilitate chemotherapy treatment decisions for patients diagnosed with ILC and high-risk MammaPrint,” he said.
Prognostic, but predictive?
“This is a well-designed prospective multicenter trial and provides the best evidence to date that MammaPrint is an important prognostic tool for ILC,” Todd Tuttle, MD, of University of Minnesota in Minneapolis, said in an interview.
Dr. Tuttle said he mainly uses the MammaPrint test and the OncoType 21-gene recurrence score to estimate prognosis for his patients with ILC.
These new data establish that MammaPrint is prognostic in ILC, but the value of MammaPrint’s genomic high risk result for making the decision about chemotherapy is still unclear, according to Dr. Tuttle.
“I don’t think we know whether MammaPrint can predict the benefit of chemotherapy for patients with stage I or II ILC,” he elaborated. “We need further high-quality studies such as this one to determine the best treatment strategies for ILC, which is a difficult breast cancer.”
Study details
Of the 5,313 patients studied, 487 had ILC (255 classic and 232 variant) and 4,826 had IDC according to central pathology assessment, Dr. Metzger reported.
MammaPrint classified 39% of the IDC group and 16% of the ILC group (10% of those with classic disease and 23% of those with variant disease) as genomically high risk for recurrence. The Adjuvant! Online tool classified 48.3% of ILC and 51.5% of IDC patients as clinically high risk.
Among the 44% of women with ILC having discordant genomic and clinical risk, discordance was usually due to the combination of low genomic risk and high clinical risk, seen in 38%.
The curves for 5-year distant metastasis–free survival stratified by genomic risk essentially overlapped for the IDC and ILC groups. Furthermore, there was no significant interaction of histologic type and genomic risk on this outcome (P = .547).
The 5-year rate of overall survival among women with genomic high risk was 95.6% in the IDC group and 93.5% in the ILC group. Among women with genomic low risk, 5-year overall survival was 98.1% in the IDC group and 97.7% in the ILC group, again with overlapping confidence intervals within each risk category.
The study was funded with support from the Breast Cancer Research Foundation. Dr. Metzger disclosed consulting fees from AbbVie, Genentech, Roche, and Pfizer. Dr. Tuttle disclosed no conflicts of interest.
SOURCE: Metzger O et al. EBCC-12 Virtual Conference. Abstract 6.
ILC is enriched with features indicating low proliferative activity, noted investigator Otto Metzger, MD, of the Dana Farber Cancer Institute in Boston.
“Data from retrospective series have indicated no benefit with adjuvant chemotherapy for patients diagnosed with early-stage ILC,” he said. “It’s fair to say that chemotherapy decisions for patients with ILC remain controversial.”
With this in mind, Dr. Metzger and colleagues analyzed data for 5,313 women who underwent surgery for early-stage breast cancer (node-negative or up to three positive lymph nodes) and were risk-stratified to receive or skip adjuvant chemotherapy based on both clinical risk and the MammaPrint score for genomic risk. Fully 44% of women with ILC had discordant clinical and genomic risks.
With a median follow-up of 8.7 years, the 5-year rate of distant metastasis–free survival among all patients classified as genomic high risk was 92.1% in women with IDC and 88.1% in women with ILC, with overlapping 95% confidence intervals. Rates of distant metastasis–free survival for patients with genomic low risk were 96.4% in women with IDC and 96.6% in women with ILC, again with confidence intervals that overlapped.
The pattern was essentially the same for overall survival, and results carried over into 8-year outcomes as well.
“We believe that MammaPrint is a clinically useful test for patients diagnosed with ILC,” Dr. Metzger said. “There are similar survival outcomes for ILC and IDC when matched by genomic risk. This is an important message.”
It should be standard to omit chemotherapy for patients who have ILC classified as high clinical risk but low genomic risk by MammaPrint, Dr. Metzger recommended. “By contrast, MammaPrint should facilitate chemotherapy treatment decisions for patients diagnosed with ILC and high-risk MammaPrint,” he said.
Prognostic, but predictive?
“This is a well-designed prospective multicenter trial and provides the best evidence to date that MammaPrint is an important prognostic tool for ILC,” Todd Tuttle, MD, of University of Minnesota in Minneapolis, said in an interview.
Dr. Tuttle said he mainly uses the MammaPrint test and the OncoType 21-gene recurrence score to estimate prognosis for his patients with ILC.
These new data establish that MammaPrint is prognostic in ILC, but the value of MammaPrint’s genomic high risk result for making the decision about chemotherapy is still unclear, according to Dr. Tuttle.
“I don’t think we know whether MammaPrint can predict the benefit of chemotherapy for patients with stage I or II ILC,” he elaborated. “We need further high-quality studies such as this one to determine the best treatment strategies for ILC, which is a difficult breast cancer.”
Study details
Of the 5,313 patients studied, 487 had ILC (255 classic and 232 variant) and 4,826 had IDC according to central pathology assessment, Dr. Metzger reported.
MammaPrint classified 39% of the IDC group and 16% of the ILC group (10% of those with classic disease and 23% of those with variant disease) as genomically high risk for recurrence. The Adjuvant! Online tool classified 48.3% of ILC and 51.5% of IDC patients as clinically high risk.
Among the 44% of women with ILC having discordant genomic and clinical risk, discordance was usually due to the combination of low genomic risk and high clinical risk, seen in 38%.
The curves for 5-year distant metastasis–free survival stratified by genomic risk essentially overlapped for the IDC and ILC groups. Furthermore, there was no significant interaction of histologic type and genomic risk on this outcome (P = .547).
The 5-year rate of overall survival among women with genomic high risk was 95.6% in the IDC group and 93.5% in the ILC group. Among women with genomic low risk, 5-year overall survival was 98.1% in the IDC group and 97.7% in the ILC group, again with overlapping confidence intervals within each risk category.
The study was funded with support from the Breast Cancer Research Foundation. Dr. Metzger disclosed consulting fees from AbbVie, Genentech, Roche, and Pfizer. Dr. Tuttle disclosed no conflicts of interest.
SOURCE: Metzger O et al. EBCC-12 Virtual Conference. Abstract 6.
FROM EBCC-12 VIRTUAL CONFERENCE
Guselkumab improvements for psoriatic arthritis persist through 1 year
Adults with active psoriatic arthritis (PsA) treated with guselkumab (Tremfya) showed significant improvement in American College of Rheumatology response criteria and disease activity after 1 year, based on data from the phase 3 DISCOVER-2 trial.
The findings, published in Arthritis & Rheumatology, extend the previously published 24-week, primary endpoint results of the trial, which tested guselkumab for adults with PsA who had not previously taken a biologic drug. Guselkumab was approved in July 2020 in the United States.
Iain B. McInnes, MD, PhD, of the University of Glasgow and his colleagues described guselkumab as “a fully-human monoclonal antibody specific to interleukin (IL)-23’s p19-subunit” that offers a potential alternative for PsA patients who discontinue their index tumor necrosis factor inhibitor because of insufficient efficacy.
The study enrolled 739 PsA patients at 118 sites worldwide. Participants were randomized to receive subcutaneous injections of 100 mg guselkumab every 4 weeks; 100 mg guselkumab at week 0 and 4, then every 8 weeks; or a placebo; 238 placebo-treated patients crossed over at 24 weeks to receive 100 mg guselkumab every 4 weeks. Patients on nonbiologic disease-modifying antirheumatic drugs at baseline were allowed to continue stable doses. Overall, about 93% of patients originally randomized to the three groups remained on guselkumab at 52 weeks.
Overall, 71% and 75% of 4-week and 8-week guselkumab patients, respectively, showed an improvement of at least 20% from baseline in ACR response criteria components at 52 weeks, which was up from 64% of patients seen at 24 weeks in both groups.
The study participants had an average disease duration of more than 5 years with no biologic treatment, and an average of 12-13 swollen joints and 20-22 tender joints at baseline. Approximately half were male, half had psoriasis or dactylitis, and two-thirds had enthesitis. Skin disease severity was assessed using the Investigator’s Global Assessment and Psoriasis Area Severity Index (PASI).
At 52 weeks, 75% and 58% of patients in the guselkumab groups had resolution of dactylitis and enthesitis, respectively. In addition, 86% of patients in both guselkumab groups achieved PASI 75 at 52 weeks, and 58% and 53% of the 4-week and 8-week groups, respectively, achieved PASI 100.
In addition, patients treated with guselkumab showed low levels of radiographic progression and significant improvements from baseline in measures of physical function and quality of life.
The most frequently reported adverse events in guselkumab patients were upper respiratory tract infections, nasopharyngitis, bronchitis, and investigator-reported laboratory values of increased alanine aminotransferase and aspartate aminotransferase; these rates were similar to those seen in the previously published 24-week data. Approximately 2% of guselkumab and placebo patients discontinued their treatments because of adverse events.
No patient developed an opportunistic infection or died during the study period.
The study findings were limited by several factors including the relatively short 1-year duration, the shorter duration of placebo, compared with guselkumab, and by potential confounding from missing data on patients who discontinued, the researchers noted. However, the results support the effectiveness of guselkumab for improving a range of manifestations of active PsA, and the overall treatment and safety profiles seen at 24 weeks were maintained, they said.
“Data obtained during the second year of DISCOVER-2 will augment current knowledge of the guselkumab benefit-risk profile and further our understanding of longer-term radiographic outcomes with both guselkumab dosing regimens,” they concluded.
The study was supported by Janssen. Many authors reported financial relationships with Janssen and other pharmaceutical companies. Nine of the 15 authors are employees of Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock or stock options.
SOURCE: McInnes IB et al. Arthritis Rheumatol. 2020 Oct 11. doi: 10.1002/art.41553.
Adults with active psoriatic arthritis (PsA) treated with guselkumab (Tremfya) showed significant improvement in American College of Rheumatology response criteria and disease activity after 1 year, based on data from the phase 3 DISCOVER-2 trial.
The findings, published in Arthritis & Rheumatology, extend the previously published 24-week, primary endpoint results of the trial, which tested guselkumab for adults with PsA who had not previously taken a biologic drug. Guselkumab was approved in July 2020 in the United States.
Iain B. McInnes, MD, PhD, of the University of Glasgow and his colleagues described guselkumab as “a fully-human monoclonal antibody specific to interleukin (IL)-23’s p19-subunit” that offers a potential alternative for PsA patients who discontinue their index tumor necrosis factor inhibitor because of insufficient efficacy.
The study enrolled 739 PsA patients at 118 sites worldwide. Participants were randomized to receive subcutaneous injections of 100 mg guselkumab every 4 weeks; 100 mg guselkumab at week 0 and 4, then every 8 weeks; or a placebo; 238 placebo-treated patients crossed over at 24 weeks to receive 100 mg guselkumab every 4 weeks. Patients on nonbiologic disease-modifying antirheumatic drugs at baseline were allowed to continue stable doses. Overall, about 93% of patients originally randomized to the three groups remained on guselkumab at 52 weeks.
Overall, 71% and 75% of 4-week and 8-week guselkumab patients, respectively, showed an improvement of at least 20% from baseline in ACR response criteria components at 52 weeks, which was up from 64% of patients seen at 24 weeks in both groups.
The study participants had an average disease duration of more than 5 years with no biologic treatment, and an average of 12-13 swollen joints and 20-22 tender joints at baseline. Approximately half were male, half had psoriasis or dactylitis, and two-thirds had enthesitis. Skin disease severity was assessed using the Investigator’s Global Assessment and Psoriasis Area Severity Index (PASI).
At 52 weeks, 75% and 58% of patients in the guselkumab groups had resolution of dactylitis and enthesitis, respectively. In addition, 86% of patients in both guselkumab groups achieved PASI 75 at 52 weeks, and 58% and 53% of the 4-week and 8-week groups, respectively, achieved PASI 100.
In addition, patients treated with guselkumab showed low levels of radiographic progression and significant improvements from baseline in measures of physical function and quality of life.
The most frequently reported adverse events in guselkumab patients were upper respiratory tract infections, nasopharyngitis, bronchitis, and investigator-reported laboratory values of increased alanine aminotransferase and aspartate aminotransferase; these rates were similar to those seen in the previously published 24-week data. Approximately 2% of guselkumab and placebo patients discontinued their treatments because of adverse events.
No patient developed an opportunistic infection or died during the study period.
The study findings were limited by several factors including the relatively short 1-year duration, the shorter duration of placebo, compared with guselkumab, and by potential confounding from missing data on patients who discontinued, the researchers noted. However, the results support the effectiveness of guselkumab for improving a range of manifestations of active PsA, and the overall treatment and safety profiles seen at 24 weeks were maintained, they said.
“Data obtained during the second year of DISCOVER-2 will augment current knowledge of the guselkumab benefit-risk profile and further our understanding of longer-term radiographic outcomes with both guselkumab dosing regimens,” they concluded.
The study was supported by Janssen. Many authors reported financial relationships with Janssen and other pharmaceutical companies. Nine of the 15 authors are employees of Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock or stock options.
SOURCE: McInnes IB et al. Arthritis Rheumatol. 2020 Oct 11. doi: 10.1002/art.41553.
Adults with active psoriatic arthritis (PsA) treated with guselkumab (Tremfya) showed significant improvement in American College of Rheumatology response criteria and disease activity after 1 year, based on data from the phase 3 DISCOVER-2 trial.
The findings, published in Arthritis & Rheumatology, extend the previously published 24-week, primary endpoint results of the trial, which tested guselkumab for adults with PsA who had not previously taken a biologic drug. Guselkumab was approved in July 2020 in the United States.
Iain B. McInnes, MD, PhD, of the University of Glasgow and his colleagues described guselkumab as “a fully-human monoclonal antibody specific to interleukin (IL)-23’s p19-subunit” that offers a potential alternative for PsA patients who discontinue their index tumor necrosis factor inhibitor because of insufficient efficacy.
The study enrolled 739 PsA patients at 118 sites worldwide. Participants were randomized to receive subcutaneous injections of 100 mg guselkumab every 4 weeks; 100 mg guselkumab at week 0 and 4, then every 8 weeks; or a placebo; 238 placebo-treated patients crossed over at 24 weeks to receive 100 mg guselkumab every 4 weeks. Patients on nonbiologic disease-modifying antirheumatic drugs at baseline were allowed to continue stable doses. Overall, about 93% of patients originally randomized to the three groups remained on guselkumab at 52 weeks.
Overall, 71% and 75% of 4-week and 8-week guselkumab patients, respectively, showed an improvement of at least 20% from baseline in ACR response criteria components at 52 weeks, which was up from 64% of patients seen at 24 weeks in both groups.
The study participants had an average disease duration of more than 5 years with no biologic treatment, and an average of 12-13 swollen joints and 20-22 tender joints at baseline. Approximately half were male, half had psoriasis or dactylitis, and two-thirds had enthesitis. Skin disease severity was assessed using the Investigator’s Global Assessment and Psoriasis Area Severity Index (PASI).
At 52 weeks, 75% and 58% of patients in the guselkumab groups had resolution of dactylitis and enthesitis, respectively. In addition, 86% of patients in both guselkumab groups achieved PASI 75 at 52 weeks, and 58% and 53% of the 4-week and 8-week groups, respectively, achieved PASI 100.
In addition, patients treated with guselkumab showed low levels of radiographic progression and significant improvements from baseline in measures of physical function and quality of life.
The most frequently reported adverse events in guselkumab patients were upper respiratory tract infections, nasopharyngitis, bronchitis, and investigator-reported laboratory values of increased alanine aminotransferase and aspartate aminotransferase; these rates were similar to those seen in the previously published 24-week data. Approximately 2% of guselkumab and placebo patients discontinued their treatments because of adverse events.
No patient developed an opportunistic infection or died during the study period.
The study findings were limited by several factors including the relatively short 1-year duration, the shorter duration of placebo, compared with guselkumab, and by potential confounding from missing data on patients who discontinued, the researchers noted. However, the results support the effectiveness of guselkumab for improving a range of manifestations of active PsA, and the overall treatment and safety profiles seen at 24 weeks were maintained, they said.
“Data obtained during the second year of DISCOVER-2 will augment current knowledge of the guselkumab benefit-risk profile and further our understanding of longer-term radiographic outcomes with both guselkumab dosing regimens,” they concluded.
The study was supported by Janssen. Many authors reported financial relationships with Janssen and other pharmaceutical companies. Nine of the 15 authors are employees of Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock or stock options.
SOURCE: McInnes IB et al. Arthritis Rheumatol. 2020 Oct 11. doi: 10.1002/art.41553.
FROM ARTHRITIS & RHEUMATOLOGY
Decline in febuxostat use trends with cardiovascular concerns
Use of febuxostat (Uloric) decreased among patients with gout in the United States following a Food and Drug Administration–mandated black-box warning that cited cardiovascular concerns, but overall use of urate-lowering therapy remained stable, according to data from a study of commercial insurance enrollees in the United States between 2009 and 2019.
Initiation of urate-lowering therapy (ULT) is recommended for gout patients, and allopurinol remains the first-line treatment, but it is not effective in all patients, and febuxostat was developed as an alternative, wrote Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
However, based on data from a postmarketing safety trial (the CARES trial) mandated by the FDA, the agency first issued a safety announcement about an increased risk of cardiovascular mortality with febuxostat in November 2017, followed in February 2019 with a black-box warning after full CARES trial results were published in March 2018 showing a greater risk of cardiovascular and all-cause mortality in febuxostat versus allopurinol.
In a study published in Arthritis & Rheumatology, the researchers examined trends in the use of ULT before and after the FDA warning. They analyzed claims data from a national commercial health database that included 838,432 adult ULT users and 633,229 gout patients.
Overall, allopurinol accounted for the majority of ULT use between 2009 (95% in the first quarter) and 2019 (92% in the fourth quarter).
Febuxostat use peaked at 10% of all ULT use in 2013 and 2014, after a gradual increase following its introduction into the market in 2009, the researchers noted, but decreased to 6% of all ULT use in the fourth quarter of 2019. Other medications, including probenecid, lesinurad (Zurampic), and pegloticase (Krystexxa), accounted for no more than 5% of ULT use.
When the researchers examined gout patients in particular, they found a slight increase in any ULT use from 567 per 1,000 patients in the first quarter of 2009 to 656 per 1,000 patients in the fourth quarter of 2019.
The study findings were limited by several factors, including potential lack of generalizability to other health plans and lack of adjustment for comorbid conditions, the researchers noted.
However, the results highlight the suboptimal use of ULT as a class and the need to address the treatment gap in gout patients “with appropriate ULT prescribing and monitoring,” they said. “While the decrease in febuxostat use was accompanied by a compensatory increase in allopurinol use, the proportion of patients with gout without any ULT remained high throughout the study period,” they concluded.
The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Dr. Kim disclosed receiving research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for research unrelated to the current study.
SOURCE: Kim SC et al. Arthritis Rheumatol. 2020 Oct 7. doi: 10.1002/art.41550.
Use of febuxostat (Uloric) decreased among patients with gout in the United States following a Food and Drug Administration–mandated black-box warning that cited cardiovascular concerns, but overall use of urate-lowering therapy remained stable, according to data from a study of commercial insurance enrollees in the United States between 2009 and 2019.
Initiation of urate-lowering therapy (ULT) is recommended for gout patients, and allopurinol remains the first-line treatment, but it is not effective in all patients, and febuxostat was developed as an alternative, wrote Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
However, based on data from a postmarketing safety trial (the CARES trial) mandated by the FDA, the agency first issued a safety announcement about an increased risk of cardiovascular mortality with febuxostat in November 2017, followed in February 2019 with a black-box warning after full CARES trial results were published in March 2018 showing a greater risk of cardiovascular and all-cause mortality in febuxostat versus allopurinol.
In a study published in Arthritis & Rheumatology, the researchers examined trends in the use of ULT before and after the FDA warning. They analyzed claims data from a national commercial health database that included 838,432 adult ULT users and 633,229 gout patients.
Overall, allopurinol accounted for the majority of ULT use between 2009 (95% in the first quarter) and 2019 (92% in the fourth quarter).
Febuxostat use peaked at 10% of all ULT use in 2013 and 2014, after a gradual increase following its introduction into the market in 2009, the researchers noted, but decreased to 6% of all ULT use in the fourth quarter of 2019. Other medications, including probenecid, lesinurad (Zurampic), and pegloticase (Krystexxa), accounted for no more than 5% of ULT use.
When the researchers examined gout patients in particular, they found a slight increase in any ULT use from 567 per 1,000 patients in the first quarter of 2009 to 656 per 1,000 patients in the fourth quarter of 2019.
The study findings were limited by several factors, including potential lack of generalizability to other health plans and lack of adjustment for comorbid conditions, the researchers noted.
However, the results highlight the suboptimal use of ULT as a class and the need to address the treatment gap in gout patients “with appropriate ULT prescribing and monitoring,” they said. “While the decrease in febuxostat use was accompanied by a compensatory increase in allopurinol use, the proportion of patients with gout without any ULT remained high throughout the study period,” they concluded.
The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Dr. Kim disclosed receiving research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for research unrelated to the current study.
SOURCE: Kim SC et al. Arthritis Rheumatol. 2020 Oct 7. doi: 10.1002/art.41550.
Use of febuxostat (Uloric) decreased among patients with gout in the United States following a Food and Drug Administration–mandated black-box warning that cited cardiovascular concerns, but overall use of urate-lowering therapy remained stable, according to data from a study of commercial insurance enrollees in the United States between 2009 and 2019.
Initiation of urate-lowering therapy (ULT) is recommended for gout patients, and allopurinol remains the first-line treatment, but it is not effective in all patients, and febuxostat was developed as an alternative, wrote Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
However, based on data from a postmarketing safety trial (the CARES trial) mandated by the FDA, the agency first issued a safety announcement about an increased risk of cardiovascular mortality with febuxostat in November 2017, followed in February 2019 with a black-box warning after full CARES trial results were published in March 2018 showing a greater risk of cardiovascular and all-cause mortality in febuxostat versus allopurinol.
In a study published in Arthritis & Rheumatology, the researchers examined trends in the use of ULT before and after the FDA warning. They analyzed claims data from a national commercial health database that included 838,432 adult ULT users and 633,229 gout patients.
Overall, allopurinol accounted for the majority of ULT use between 2009 (95% in the first quarter) and 2019 (92% in the fourth quarter).
Febuxostat use peaked at 10% of all ULT use in 2013 and 2014, after a gradual increase following its introduction into the market in 2009, the researchers noted, but decreased to 6% of all ULT use in the fourth quarter of 2019. Other medications, including probenecid, lesinurad (Zurampic), and pegloticase (Krystexxa), accounted for no more than 5% of ULT use.
When the researchers examined gout patients in particular, they found a slight increase in any ULT use from 567 per 1,000 patients in the first quarter of 2009 to 656 per 1,000 patients in the fourth quarter of 2019.
The study findings were limited by several factors, including potential lack of generalizability to other health plans and lack of adjustment for comorbid conditions, the researchers noted.
However, the results highlight the suboptimal use of ULT as a class and the need to address the treatment gap in gout patients “with appropriate ULT prescribing and monitoring,” they said. “While the decrease in febuxostat use was accompanied by a compensatory increase in allopurinol use, the proportion of patients with gout without any ULT remained high throughout the study period,” they concluded.
The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Dr. Kim disclosed receiving research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for research unrelated to the current study.
SOURCE: Kim SC et al. Arthritis Rheumatol. 2020 Oct 7. doi: 10.1002/art.41550.
FROM ARTHRITIS & RHEUMATOLOGY
Blood group O linked to decreased risk of SARS-CoV-2 infection
Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.
Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.
Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.
The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
Reduced prevalence
The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.
There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.
Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.
There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
Possible causes
The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.
“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.
One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.
SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.
Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.
Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.
Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.
The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
Reduced prevalence
The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.
There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.
Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.
There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
Possible causes
The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.
“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.
One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.
SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.
Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.
Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.
Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.
The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
Reduced prevalence
The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.
There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.
Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.
There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
Possible causes
The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.
“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.
One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.
SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.
FROM BLOOD ADVANCES
Ticagrelor monotherapy beats DAPT in STEMI
, a major randomized trial.
“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).
TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).
The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.
Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.
In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.
Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.
“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.
Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.
“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.
“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.
Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.
“From a clinical standpoint, this strategy seems particularly appealing in high bleeding risk patients,” the cardiologist concluded at the at the meeting, which was sponsored by the Cardiovascular Research Foundation.
He added, however, that the TICO-STEMI data with respect to complex PCI “are not really reassuring and are probably worth another investigation.”
Dr. Kim reported having no financial conflicts regarding the TICO-STEMI trial, funded by Biotronik.
, a major randomized trial.
“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).
TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).
The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.
Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.
In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.
Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.
“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.
Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.
“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.
“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.
Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.
“From a clinical standpoint, this strategy seems particularly appealing in high bleeding risk patients,” the cardiologist concluded at the at the meeting, which was sponsored by the Cardiovascular Research Foundation.
He added, however, that the TICO-STEMI data with respect to complex PCI “are not really reassuring and are probably worth another investigation.”
Dr. Kim reported having no financial conflicts regarding the TICO-STEMI trial, funded by Biotronik.
, a major randomized trial.
“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).
TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).
The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.
Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.
In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.
Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.
“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.
Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.
“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.
“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.
Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.
“From a clinical standpoint, this strategy seems particularly appealing in high bleeding risk patients,” the cardiologist concluded at the at the meeting, which was sponsored by the Cardiovascular Research Foundation.
He added, however, that the TICO-STEMI data with respect to complex PCI “are not really reassuring and are probably worth another investigation.”
Dr. Kim reported having no financial conflicts regarding the TICO-STEMI trial, funded by Biotronik.
AT TCT 2020
Study: Complications from childhood ALL and its treatment are common, but can be managed
Despite survival after treatment of acute lymphoblastic leukemia (ALL), a high percentage of children suffered acute complications, even without relapse, according to a report published online in Clinical Lymphoma, Myeloma & Leukemia.
In a retrospective study of 110 children with acute lymphoblastic leukemia (ALL), Ayse Pınar Öztürk, MD, and colleagues at Istanbul University, Cerrahpasa Faculty of Medicine, evaluated the acute complications that occurred during the treatment of childhood ALL and documented their survival rates. The 110 patients, comprising 65 boys and 45 girls, were all treated with the Children’s Oncology Group protocol from 1999 to 2014.
The mean age at admission was 8.3 years and 97 patients (88.2%) were diagnosed with pre–B-cell ALL, 11 (10%) with T-cell ALL, 1 (0.9%) with mixed phenotype acute leukemia, and 1 (0.9%) with mature B-cell acute leukemia. A total of 36.3% were evaluated to be in the standard-risk group and the rest were in the high-risk group. Regular follow-up and evaluation for acute complications was available for 105 of the patients.
Survival and complications
Of the 110 patients, 98 were assessed in the survival analyses. The 5- and 10-year overall survival rates were both 85.9%, while the relapse-free survival rates at 1, 3, and 5 years were 97.9%, 91.3%, and 86.3%, respectively. These results are favorable and in line with good results reported in the literature, according to the researchers.
In terms of acute complications, infection was the most common (88.5%), followed by gastrointestinal (27.6%), neurologic (26.6%), metabolic/endocrine (15.2%), drug-related hypersensitivity (15.2%), avascular necrosis (12.3%), thrombotic (10.4%), severe psychiatric (1.9%), and various other complications (11.4%).
In the present study, 13 of the 98 patients (13.3%) died. All 13 patients had been in the high-risk group and 9 had had relapsed ALL. Of the 13 deaths, 8 (8.2%) had resulted from treatment resistance and toxicity and 5 (5.1%) from severe infection (sepsis).
During ALL treatment, various complications can occur related to the disease itself or the treatment, according to the authors. However, they added that in regularly and closely monitored patients, complications can be effectively prevented, treated, and eliminated by aggressive observation and prompt intervention.
“In our study, the short hospitalization period, prompt implementation of protocol updates, rapid analysis of laboratory tests, continuous supportive care, efficient education given to the parents of children, and consistently undertaking patient care and treatment management by the same expert team increased the success of the therapy and ensured low complication rates,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Öztürk AP et al. Clin Lymphoma Myeloma Leuk. 2020 Sep 17. doi: 10.1016/j.clml.2020.08.025.
Despite survival after treatment of acute lymphoblastic leukemia (ALL), a high percentage of children suffered acute complications, even without relapse, according to a report published online in Clinical Lymphoma, Myeloma & Leukemia.
In a retrospective study of 110 children with acute lymphoblastic leukemia (ALL), Ayse Pınar Öztürk, MD, and colleagues at Istanbul University, Cerrahpasa Faculty of Medicine, evaluated the acute complications that occurred during the treatment of childhood ALL and documented their survival rates. The 110 patients, comprising 65 boys and 45 girls, were all treated with the Children’s Oncology Group protocol from 1999 to 2014.
The mean age at admission was 8.3 years and 97 patients (88.2%) were diagnosed with pre–B-cell ALL, 11 (10%) with T-cell ALL, 1 (0.9%) with mixed phenotype acute leukemia, and 1 (0.9%) with mature B-cell acute leukemia. A total of 36.3% were evaluated to be in the standard-risk group and the rest were in the high-risk group. Regular follow-up and evaluation for acute complications was available for 105 of the patients.
Survival and complications
Of the 110 patients, 98 were assessed in the survival analyses. The 5- and 10-year overall survival rates were both 85.9%, while the relapse-free survival rates at 1, 3, and 5 years were 97.9%, 91.3%, and 86.3%, respectively. These results are favorable and in line with good results reported in the literature, according to the researchers.
In terms of acute complications, infection was the most common (88.5%), followed by gastrointestinal (27.6%), neurologic (26.6%), metabolic/endocrine (15.2%), drug-related hypersensitivity (15.2%), avascular necrosis (12.3%), thrombotic (10.4%), severe psychiatric (1.9%), and various other complications (11.4%).
In the present study, 13 of the 98 patients (13.3%) died. All 13 patients had been in the high-risk group and 9 had had relapsed ALL. Of the 13 deaths, 8 (8.2%) had resulted from treatment resistance and toxicity and 5 (5.1%) from severe infection (sepsis).
During ALL treatment, various complications can occur related to the disease itself or the treatment, according to the authors. However, they added that in regularly and closely monitored patients, complications can be effectively prevented, treated, and eliminated by aggressive observation and prompt intervention.
“In our study, the short hospitalization period, prompt implementation of protocol updates, rapid analysis of laboratory tests, continuous supportive care, efficient education given to the parents of children, and consistently undertaking patient care and treatment management by the same expert team increased the success of the therapy and ensured low complication rates,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Öztürk AP et al. Clin Lymphoma Myeloma Leuk. 2020 Sep 17. doi: 10.1016/j.clml.2020.08.025.
Despite survival after treatment of acute lymphoblastic leukemia (ALL), a high percentage of children suffered acute complications, even without relapse, according to a report published online in Clinical Lymphoma, Myeloma & Leukemia.
In a retrospective study of 110 children with acute lymphoblastic leukemia (ALL), Ayse Pınar Öztürk, MD, and colleagues at Istanbul University, Cerrahpasa Faculty of Medicine, evaluated the acute complications that occurred during the treatment of childhood ALL and documented their survival rates. The 110 patients, comprising 65 boys and 45 girls, were all treated with the Children’s Oncology Group protocol from 1999 to 2014.
The mean age at admission was 8.3 years and 97 patients (88.2%) were diagnosed with pre–B-cell ALL, 11 (10%) with T-cell ALL, 1 (0.9%) with mixed phenotype acute leukemia, and 1 (0.9%) with mature B-cell acute leukemia. A total of 36.3% were evaluated to be in the standard-risk group and the rest were in the high-risk group. Regular follow-up and evaluation for acute complications was available for 105 of the patients.
Survival and complications
Of the 110 patients, 98 were assessed in the survival analyses. The 5- and 10-year overall survival rates were both 85.9%, while the relapse-free survival rates at 1, 3, and 5 years were 97.9%, 91.3%, and 86.3%, respectively. These results are favorable and in line with good results reported in the literature, according to the researchers.
In terms of acute complications, infection was the most common (88.5%), followed by gastrointestinal (27.6%), neurologic (26.6%), metabolic/endocrine (15.2%), drug-related hypersensitivity (15.2%), avascular necrosis (12.3%), thrombotic (10.4%), severe psychiatric (1.9%), and various other complications (11.4%).
In the present study, 13 of the 98 patients (13.3%) died. All 13 patients had been in the high-risk group and 9 had had relapsed ALL. Of the 13 deaths, 8 (8.2%) had resulted from treatment resistance and toxicity and 5 (5.1%) from severe infection (sepsis).
During ALL treatment, various complications can occur related to the disease itself or the treatment, according to the authors. However, they added that in regularly and closely monitored patients, complications can be effectively prevented, treated, and eliminated by aggressive observation and prompt intervention.
“In our study, the short hospitalization period, prompt implementation of protocol updates, rapid analysis of laboratory tests, continuous supportive care, efficient education given to the parents of children, and consistently undertaking patient care and treatment management by the same expert team increased the success of the therapy and ensured low complication rates,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Öztürk AP et al. Clin Lymphoma Myeloma Leuk. 2020 Sep 17. doi: 10.1016/j.clml.2020.08.025.
FROM Clinical Lymphoma, Myeloma & Leukemia
Patch Testing 101, Part 1: Performing the Test
Our apologies, dear reader. It seems we have gotten ahead of ourselves. While we were writing about the Allergen of the Year, systemic dermatitis, and patch testing in children, we forgot to start with the basics. Let us remedy that. This is the first of a 2-part series addressing the basics of patch testing. In this article, we examine patch test systems, allergens, patch test readings, testing while on medications, and patch testing pearls and pitfalls. Let us begin!
Patch Test Systems
There are 2 patch test systems in North America: the Thin-layer Rapid Use Epicutaneous (T.R.U.E.) test (SmartPractice), which is approved by the US Food and Drug Administration for those 6 years and older, and the chamber method.
The T.R.U.E. test consists of 3 panels with 35 allergens and 1 negative control. The T.R.U.E. package insert1 describes surgical tape with individual polyester patches, each coated with an allergen film. Benefits of T.R.U.E. include ease of use (ie, easy storage and preparation, quick and straightforward application) and a readily identifiable set of allergens. The main drawback of T.R.U.E. is that only a limited number of allergens are tested, and as a result, it may miss the identification of some contact allergies. In an analysis of the 2015-2016 North American Contact Dermatitis Group (NACDG) patch test screening series, 25% to 40% of positive patch tests would have been missed if patch testing was performed with T.R.U.E. alone.2
Chamber method patch testing describes the process by which allergens are loaded into either metal or plastic chambers and then applied to the patient’s skin. The major benefit of the chamber method is that patches may be truly customized for the patient. The chamber method is time and labor intensive for patch preparation and application. Most comprehensive patch test clinics in North America use the chamber method, including the NACDG.
Patch test chambers largely can be divided into 2 categories: metal (aluminum) or plastic. Aluminum chambers, also known as Finn chambers, traditionally are used in patch testing. There are rare reports of hypersensitivity to aluminum chambers with associated diffuse positive patch test reactions,3,4 which may be more common in the pediatric population and likely is due to the fact that aluminum is present as an adjuvant in many childhood vaccines. As a precaution, some patch text experts recommend using plastic chambers in children younger than 16 to 18 years (M.R. and A.R.A., personal communication). Metal chambers require the additional application of diffusion discs for liquid allergens, and plastic chambers typically already contain the necessary diffusion discs. Finn chambers traditionally are applied with hypoallergenic porous surgical tape, but a waterproof tape also is available. To keep the chambers in place for the necessary 48 hours, additional tape may be applied over the patches.
Allergens
In patch test clinics, many dermatologists use a standard or screening allergen series. An appropriate standard series encompasses allergens that are most likely to be positive and relevant in the tested population. Some patch test experts recommend that allergens with a positive patch test frequency of greater than 0.5% to 1% should be included in a standard series.5 However, geographic differences in positive reactions can influence which allergens are appropriate to include. As a result, there is no universal standard series. Examples of standard or screening series include the American Contact Dermatitis Society (ACDS) allergen series,6 North American Baseline Series or North American 80 Comprehensive Series, European Baseline Series, NACDG series,2 and the Pediatric Baseline Series,7 as well as many other country- or region-specific series. There currently are 2 major commercial allergen distribution companies—Chemotechnique Diagnostics/Dormer Laboratories (series, individual allergens) and SmartPractice/allerGEAZE (series, individual allergens, T.R.U.E.).
In addition to a properly selected standard or screening series, supplemental patch testing with additional allergens can increase the diagnostic yield. Numerous supplemental series exist, including cosmetic, dental, textile, rubber, adhesive, plastics, and glue, among many others. In the NACDG 2015-2016 patch test cycle, it was found that 23% of 5597 patients reacted to an allergen that was not present on the NACDG screening series.2
In some situations, it is appropriate to patch test patient products, or nonstandard allergens. An abundance of caution, understanding of patch testing, and experience is necessary; for example, some chemicals are not recommended for testing, such as cleaning products, certain industrial chemicals, and those that may be carcinogens. We frequently consult De Groot’s Patch Testing8 for recommended allergen test concentrations and vehicles.
Patch Test Readings
The timing of the patch test reading is an important component of the test. Most North American comprehensive patch test clinics perform both first and delayed readings. After application, patches remain in place for 48 hours and then are removed, and a first reading is completed. Results are recorded as +/− (weak/doubtful), + (mild), ++ (strong), +++ (very strong), irritant, and negative.2 Many patch test specialists use side lighting to achieve the best reading and palpate to confirm the presence of induration; panel alignment devices commonly are utilized. There are some scenarios where shorter or longer application times are indicated, but this is beyond the scope of this article. A second, or delayed, reading should be completed 72 to 144 hours after initial application. We usually complete the delayed reading at 96 to 120 hours.
Certain patch test reactions may peak at different times, with fragrances often reacting earlier, and metals, topical antibiotics, and textile dyes reacting later.9 In the scenario of delayed peak reactions, third readings may be indicated.
Neglecting to complete a delayed reading is a potential pitfall and can increase the risk for both false-positive and false-negative reactions.10,11 In 1996, Uter et al10 published a large study of 9946 patients who were patch tested over a 4-year period. The authors compared patch test reactions at 48 and 72 hours and found that 34.5% of all positive reactions occurred at 72 hours; an additional 15.1% were positive at 96 hours. Importantly, one reading at 48 hours missed approximately one-third of positive patch test reactions, emphasizing the importance of delayed patch test readings.10 Furthermore, another study of 9997 consecutively patch tested patients examined reactions that were either negative or doubtful between days 3 or 4 and followed to see which of those reactions were positive at days 6 or 7. Of the negative reactions, the authors found that 4.4% were positive on days 6 or 7, and of the doubtful reactions, 9.1% were positive on days 6 or 7, meaning that up to 13.5% of positive reactions can be missed when a later reading is not performed.11
Medications During Patch Testing
Topical Medications
Topical medications generally can be continued during patch testing; however, patients should not apply topical medications to the patch test application site. Ideally, there should be no topical medication applied to the patch test application site for 1 to 2 weeks prior to patch test placement.12 Use of topical medications such as corticosteroids, calcineurin inhibitors, and theoretically even phosphodiesterase 4 inhibitors can not only result in suppression of positive patch test reactions but also can make patch adherence difficult.
Phototherapy
Phototherapy can result in local cutaneous immune suppression; therefore, it is recommended that it not be applied to the patch test area either during the patch test process or for 1 to 2 weeks prior to patch test application. In addition, if heat or sweating are generated during phototherapy, they can affect the success of patch testing by poor patch adherence and/or disruption of allergen distribution.
Systemic Medications
Oral antihistamines do not affect patch testing and can be continued during the patch test process.
It is ideal to avoid systemic immunomodulatory agents during the patch test process, but they occasionally are unavoidable, either because they are necessary to manage other medical conditions or because they are needed to achieve clear enough skin to proceed with patch testing. If it is required, prednisone is not recommended to exceed 10 mg daily.12,13 If intramuscular triamcinolone acetonide has been administered, patch testing should occur at least 1 month after the most recent injection.12 Oral methotrexate can probably be continued during patch testing but should be kept at the lowest possible dose and should be held during the week of testing, if possible. Adalimumab, etanercept, infliximab, and ustekinumab can be continued, as they are unlikely to interfere with patch testing.12 There are reports of positive patch test reactions on dupilumab,14,15 and some authors have described the response as variable and potentially allergen dependent.16,17 We believe that it generally is acceptable to continue dupilumab during patch testing. Data on cyclosporine during patch testing are mixed, and caution is advised as higher doses may suppress a positive patch test. Azathioprine and mycophenolate should be avoided, if possible.12
Pearls and Pitfalls
A few tips along the way can help assure your success in patch testing.
- Proper patient counseling determines a successful test. Provide your patient with verbal and written instructions about the patch test process, patch care, and any other necessary information.
- A simple sponge bath is permissible during patch testing provided the back stays dry. One of the authors (A.R.A.) advises patients to sit in a small amount of water in a bathtub to bathe, wash only the front of the body in the shower, and wash hair in the sink.
- No sweating, swimming, heavy exercise, or heavy physical labor. If your patient is planning to run a marathon the week of patch testing, they will be sorely disappointed when you tell them no sweating or showering is allowed! Patients with an occupation that requires physical labor may require a work excuse.
- Tape does not adhere to areas of the skin with excess hair. A scissor trim or electric shave will help the patches stay occluded and in place. We use an electric razor with a disposable replaceable head. A traditional straight razor should not be used, as it can increase the risk for folliculitis, which can make patch readings quite difficult.
- Securing the patches in place with an extra layer of tape provides added security. Large sheets of transparent medical dressings work particularly well for children or if there is difficulty with tape adherence.
Avoid application of patches to areas of the skin with tattoos. In theory, tattooed skin may have a decreased immune response, and tattoo pigment can obscure results.18 However, this is sometimes unavoidable, and Fowler and McTigue18 described a case of successful patch testing on a diffusely tattooed back.
- Avoid skin lesions (eg, scars, seborrheic keratoses, dermatitis) that can affect tape application, patch adherence, or patch readings.
Final Interpretation
The first step to excellent patch testing is understanding the patch test process. Patch test systems include T.R.U.E. and the chamber method. There are several allergen screening series, and the best series for each patient is determined based on geographic region, exposures, and allergen prevalence. The timing and practice of the patch test reading is vital, and physicians should be cognizant of medications and phototherapy use during the patch test process. An understanding of common pearls and pitfalls makes the difference between a good and great patch tester.
Now that you are an expert in performing the test, watch out for part 2 of this series on patch test interpretation, relevance, education, and counseling. Happy testing!
- T.R.U.E TEST [package insert]. Phoenix, AZ: SmartPractice; 1994.
- DeKoven JG, Warshaw EM, Zug KA, et al. North American Contact Dermatitis Group patch test results: 2015-2016. Dermatitis. 2018;29:297-309.
- Ward JM, Walsh RK, Bellet JS, et al. Allergic contact dermatitis to aluminum-based chambers during routine patch testing. Paper presented at: American Contact Dermatitis Society Annual Meeting; March 19, 2020; Denver, CO.
- Deleuran MG, Ahlström MG, Zachariae C, et al. Patch test reactivity to aluminum chambers. Contact Dermatitis. 2019;81:318-319.
- Bruze M, Condé-Salazar L, Goossens A, et al. European Society of Contact Dermatitis. thoughts on sensitizers in a standard patch test series. Contact Dermatitis. 1999;41:241-250.
- Schalock PC, Dunnick CA, Nedorost S, et al. American Contact Dermatitis Society Core Allergen Series: 2017 update. Dermatitis. 2017;28:141-143.
- Yu J, Atwater AR, Brod B, et al. Pediatric baseline patch test series: Pediatric Contact Dermatitis Workgroup. Dermatitis. 2018;29:206-212.
- De Groot AC. Patch Testing: Test Concentrations and Vehicles for 4900 Chemicals. 4th ed. Wapserveen, The Netherlands: Acdegroot Publishing; 2018.
- Chaudhry HM, Drage LA, El-Azhary RA, et al. Delayed patch-test reading after 5 days: an update from the Mayo Clinic Contact Dermatitis Group. Dermatitis. 2017;28:253-260.
- Uter WJ, Geier J, Schnuch A. Good clinical practice in patch testing: readings beyond day 2 are necessary: a confirmatory analysis. Members of the Information Network of Departments of Dermatology. Am J Contact Dermat. 1996;7:231-237.
- Madsen JT, Andersen KE. Outcome of a second patch test reading of T.R.U.E. Tests® on D6/7. Contact Dermatitis. 2013;68:94-97.
- Lampel H, Atwater AR. Patch testing tools of the trade: use of immunosuppressants and antihistamines during patch testing. J Dermatol Nurses’ Assoc. 2016;8:209-211.
- Fowler JF, Maibach HI, Zirwas M, et al. Effects of immunomodulatory agents on patch testing: expert opinion 2012. Dermatitis. 2012;23:301-303.
- Puza CJ, Atwater AR. Positive patch test reaction in a patient taking dupilumab. Dermatitis. 2018;29:89.
- Hoot JW, Douglas JD, Falo LD. Patch testing in a patient on dupilumab. Dermatitis. 2018;29:164.
- Stout M, Silverberg JI. Variable impact of dupilumab on patch testing results and allergic contact dermatitis in adults with atopic dermatitis. J Am Acad Dermatol. 2019;81:157-162.
- Raffi J, Botto N. Patch testing and allergen-specific inhibition in a patient taking dupilumab. JAMA Dermatol. 2019;155:120-121.
- Fowler JF, McTigue MK. Patch testing over tattoos. Am J Contact Dermat. 2002;13:19-20.
Our apologies, dear reader. It seems we have gotten ahead of ourselves. While we were writing about the Allergen of the Year, systemic dermatitis, and patch testing in children, we forgot to start with the basics. Let us remedy that. This is the first of a 2-part series addressing the basics of patch testing. In this article, we examine patch test systems, allergens, patch test readings, testing while on medications, and patch testing pearls and pitfalls. Let us begin!
Patch Test Systems
There are 2 patch test systems in North America: the Thin-layer Rapid Use Epicutaneous (T.R.U.E.) test (SmartPractice), which is approved by the US Food and Drug Administration for those 6 years and older, and the chamber method.
The T.R.U.E. test consists of 3 panels with 35 allergens and 1 negative control. The T.R.U.E. package insert1 describes surgical tape with individual polyester patches, each coated with an allergen film. Benefits of T.R.U.E. include ease of use (ie, easy storage and preparation, quick and straightforward application) and a readily identifiable set of allergens. The main drawback of T.R.U.E. is that only a limited number of allergens are tested, and as a result, it may miss the identification of some contact allergies. In an analysis of the 2015-2016 North American Contact Dermatitis Group (NACDG) patch test screening series, 25% to 40% of positive patch tests would have been missed if patch testing was performed with T.R.U.E. alone.2
Chamber method patch testing describes the process by which allergens are loaded into either metal or plastic chambers and then applied to the patient’s skin. The major benefit of the chamber method is that patches may be truly customized for the patient. The chamber method is time and labor intensive for patch preparation and application. Most comprehensive patch test clinics in North America use the chamber method, including the NACDG.
Patch test chambers largely can be divided into 2 categories: metal (aluminum) or plastic. Aluminum chambers, also known as Finn chambers, traditionally are used in patch testing. There are rare reports of hypersensitivity to aluminum chambers with associated diffuse positive patch test reactions,3,4 which may be more common in the pediatric population and likely is due to the fact that aluminum is present as an adjuvant in many childhood vaccines. As a precaution, some patch text experts recommend using plastic chambers in children younger than 16 to 18 years (M.R. and A.R.A., personal communication). Metal chambers require the additional application of diffusion discs for liquid allergens, and plastic chambers typically already contain the necessary diffusion discs. Finn chambers traditionally are applied with hypoallergenic porous surgical tape, but a waterproof tape also is available. To keep the chambers in place for the necessary 48 hours, additional tape may be applied over the patches.
Allergens
In patch test clinics, many dermatologists use a standard or screening allergen series. An appropriate standard series encompasses allergens that are most likely to be positive and relevant in the tested population. Some patch test experts recommend that allergens with a positive patch test frequency of greater than 0.5% to 1% should be included in a standard series.5 However, geographic differences in positive reactions can influence which allergens are appropriate to include. As a result, there is no universal standard series. Examples of standard or screening series include the American Contact Dermatitis Society (ACDS) allergen series,6 North American Baseline Series or North American 80 Comprehensive Series, European Baseline Series, NACDG series,2 and the Pediatric Baseline Series,7 as well as many other country- or region-specific series. There currently are 2 major commercial allergen distribution companies—Chemotechnique Diagnostics/Dormer Laboratories (series, individual allergens) and SmartPractice/allerGEAZE (series, individual allergens, T.R.U.E.).
In addition to a properly selected standard or screening series, supplemental patch testing with additional allergens can increase the diagnostic yield. Numerous supplemental series exist, including cosmetic, dental, textile, rubber, adhesive, plastics, and glue, among many others. In the NACDG 2015-2016 patch test cycle, it was found that 23% of 5597 patients reacted to an allergen that was not present on the NACDG screening series.2
In some situations, it is appropriate to patch test patient products, or nonstandard allergens. An abundance of caution, understanding of patch testing, and experience is necessary; for example, some chemicals are not recommended for testing, such as cleaning products, certain industrial chemicals, and those that may be carcinogens. We frequently consult De Groot’s Patch Testing8 for recommended allergen test concentrations and vehicles.
Patch Test Readings
The timing of the patch test reading is an important component of the test. Most North American comprehensive patch test clinics perform both first and delayed readings. After application, patches remain in place for 48 hours and then are removed, and a first reading is completed. Results are recorded as +/− (weak/doubtful), + (mild), ++ (strong), +++ (very strong), irritant, and negative.2 Many patch test specialists use side lighting to achieve the best reading and palpate to confirm the presence of induration; panel alignment devices commonly are utilized. There are some scenarios where shorter or longer application times are indicated, but this is beyond the scope of this article. A second, or delayed, reading should be completed 72 to 144 hours after initial application. We usually complete the delayed reading at 96 to 120 hours.
Certain patch test reactions may peak at different times, with fragrances often reacting earlier, and metals, topical antibiotics, and textile dyes reacting later.9 In the scenario of delayed peak reactions, third readings may be indicated.
Neglecting to complete a delayed reading is a potential pitfall and can increase the risk for both false-positive and false-negative reactions.10,11 In 1996, Uter et al10 published a large study of 9946 patients who were patch tested over a 4-year period. The authors compared patch test reactions at 48 and 72 hours and found that 34.5% of all positive reactions occurred at 72 hours; an additional 15.1% were positive at 96 hours. Importantly, one reading at 48 hours missed approximately one-third of positive patch test reactions, emphasizing the importance of delayed patch test readings.10 Furthermore, another study of 9997 consecutively patch tested patients examined reactions that were either negative or doubtful between days 3 or 4 and followed to see which of those reactions were positive at days 6 or 7. Of the negative reactions, the authors found that 4.4% were positive on days 6 or 7, and of the doubtful reactions, 9.1% were positive on days 6 or 7, meaning that up to 13.5% of positive reactions can be missed when a later reading is not performed.11
Medications During Patch Testing
Topical Medications
Topical medications generally can be continued during patch testing; however, patients should not apply topical medications to the patch test application site. Ideally, there should be no topical medication applied to the patch test application site for 1 to 2 weeks prior to patch test placement.12 Use of topical medications such as corticosteroids, calcineurin inhibitors, and theoretically even phosphodiesterase 4 inhibitors can not only result in suppression of positive patch test reactions but also can make patch adherence difficult.
Phototherapy
Phototherapy can result in local cutaneous immune suppression; therefore, it is recommended that it not be applied to the patch test area either during the patch test process or for 1 to 2 weeks prior to patch test application. In addition, if heat or sweating are generated during phototherapy, they can affect the success of patch testing by poor patch adherence and/or disruption of allergen distribution.
Systemic Medications
Oral antihistamines do not affect patch testing and can be continued during the patch test process.
It is ideal to avoid systemic immunomodulatory agents during the patch test process, but they occasionally are unavoidable, either because they are necessary to manage other medical conditions or because they are needed to achieve clear enough skin to proceed with patch testing. If it is required, prednisone is not recommended to exceed 10 mg daily.12,13 If intramuscular triamcinolone acetonide has been administered, patch testing should occur at least 1 month after the most recent injection.12 Oral methotrexate can probably be continued during patch testing but should be kept at the lowest possible dose and should be held during the week of testing, if possible. Adalimumab, etanercept, infliximab, and ustekinumab can be continued, as they are unlikely to interfere with patch testing.12 There are reports of positive patch test reactions on dupilumab,14,15 and some authors have described the response as variable and potentially allergen dependent.16,17 We believe that it generally is acceptable to continue dupilumab during patch testing. Data on cyclosporine during patch testing are mixed, and caution is advised as higher doses may suppress a positive patch test. Azathioprine and mycophenolate should be avoided, if possible.12
Pearls and Pitfalls
A few tips along the way can help assure your success in patch testing.
- Proper patient counseling determines a successful test. Provide your patient with verbal and written instructions about the patch test process, patch care, and any other necessary information.
- A simple sponge bath is permissible during patch testing provided the back stays dry. One of the authors (A.R.A.) advises patients to sit in a small amount of water in a bathtub to bathe, wash only the front of the body in the shower, and wash hair in the sink.
- No sweating, swimming, heavy exercise, or heavy physical labor. If your patient is planning to run a marathon the week of patch testing, they will be sorely disappointed when you tell them no sweating or showering is allowed! Patients with an occupation that requires physical labor may require a work excuse.
- Tape does not adhere to areas of the skin with excess hair. A scissor trim or electric shave will help the patches stay occluded and in place. We use an electric razor with a disposable replaceable head. A traditional straight razor should not be used, as it can increase the risk for folliculitis, which can make patch readings quite difficult.
- Securing the patches in place with an extra layer of tape provides added security. Large sheets of transparent medical dressings work particularly well for children or if there is difficulty with tape adherence.
Avoid application of patches to areas of the skin with tattoos. In theory, tattooed skin may have a decreased immune response, and tattoo pigment can obscure results.18 However, this is sometimes unavoidable, and Fowler and McTigue18 described a case of successful patch testing on a diffusely tattooed back.
- Avoid skin lesions (eg, scars, seborrheic keratoses, dermatitis) that can affect tape application, patch adherence, or patch readings.
Final Interpretation
The first step to excellent patch testing is understanding the patch test process. Patch test systems include T.R.U.E. and the chamber method. There are several allergen screening series, and the best series for each patient is determined based on geographic region, exposures, and allergen prevalence. The timing and practice of the patch test reading is vital, and physicians should be cognizant of medications and phototherapy use during the patch test process. An understanding of common pearls and pitfalls makes the difference between a good and great patch tester.
Now that you are an expert in performing the test, watch out for part 2 of this series on patch test interpretation, relevance, education, and counseling. Happy testing!
Our apologies, dear reader. It seems we have gotten ahead of ourselves. While we were writing about the Allergen of the Year, systemic dermatitis, and patch testing in children, we forgot to start with the basics. Let us remedy that. This is the first of a 2-part series addressing the basics of patch testing. In this article, we examine patch test systems, allergens, patch test readings, testing while on medications, and patch testing pearls and pitfalls. Let us begin!
Patch Test Systems
There are 2 patch test systems in North America: the Thin-layer Rapid Use Epicutaneous (T.R.U.E.) test (SmartPractice), which is approved by the US Food and Drug Administration for those 6 years and older, and the chamber method.
The T.R.U.E. test consists of 3 panels with 35 allergens and 1 negative control. The T.R.U.E. package insert1 describes surgical tape with individual polyester patches, each coated with an allergen film. Benefits of T.R.U.E. include ease of use (ie, easy storage and preparation, quick and straightforward application) and a readily identifiable set of allergens. The main drawback of T.R.U.E. is that only a limited number of allergens are tested, and as a result, it may miss the identification of some contact allergies. In an analysis of the 2015-2016 North American Contact Dermatitis Group (NACDG) patch test screening series, 25% to 40% of positive patch tests would have been missed if patch testing was performed with T.R.U.E. alone.2
Chamber method patch testing describes the process by which allergens are loaded into either metal or plastic chambers and then applied to the patient’s skin. The major benefit of the chamber method is that patches may be truly customized for the patient. The chamber method is time and labor intensive for patch preparation and application. Most comprehensive patch test clinics in North America use the chamber method, including the NACDG.
Patch test chambers largely can be divided into 2 categories: metal (aluminum) or plastic. Aluminum chambers, also known as Finn chambers, traditionally are used in patch testing. There are rare reports of hypersensitivity to aluminum chambers with associated diffuse positive patch test reactions,3,4 which may be more common in the pediatric population and likely is due to the fact that aluminum is present as an adjuvant in many childhood vaccines. As a precaution, some patch text experts recommend using plastic chambers in children younger than 16 to 18 years (M.R. and A.R.A., personal communication). Metal chambers require the additional application of diffusion discs for liquid allergens, and plastic chambers typically already contain the necessary diffusion discs. Finn chambers traditionally are applied with hypoallergenic porous surgical tape, but a waterproof tape also is available. To keep the chambers in place for the necessary 48 hours, additional tape may be applied over the patches.
Allergens
In patch test clinics, many dermatologists use a standard or screening allergen series. An appropriate standard series encompasses allergens that are most likely to be positive and relevant in the tested population. Some patch test experts recommend that allergens with a positive patch test frequency of greater than 0.5% to 1% should be included in a standard series.5 However, geographic differences in positive reactions can influence which allergens are appropriate to include. As a result, there is no universal standard series. Examples of standard or screening series include the American Contact Dermatitis Society (ACDS) allergen series,6 North American Baseline Series or North American 80 Comprehensive Series, European Baseline Series, NACDG series,2 and the Pediatric Baseline Series,7 as well as many other country- or region-specific series. There currently are 2 major commercial allergen distribution companies—Chemotechnique Diagnostics/Dormer Laboratories (series, individual allergens) and SmartPractice/allerGEAZE (series, individual allergens, T.R.U.E.).
In addition to a properly selected standard or screening series, supplemental patch testing with additional allergens can increase the diagnostic yield. Numerous supplemental series exist, including cosmetic, dental, textile, rubber, adhesive, plastics, and glue, among many others. In the NACDG 2015-2016 patch test cycle, it was found that 23% of 5597 patients reacted to an allergen that was not present on the NACDG screening series.2
In some situations, it is appropriate to patch test patient products, or nonstandard allergens. An abundance of caution, understanding of patch testing, and experience is necessary; for example, some chemicals are not recommended for testing, such as cleaning products, certain industrial chemicals, and those that may be carcinogens. We frequently consult De Groot’s Patch Testing8 for recommended allergen test concentrations and vehicles.
Patch Test Readings
The timing of the patch test reading is an important component of the test. Most North American comprehensive patch test clinics perform both first and delayed readings. After application, patches remain in place for 48 hours and then are removed, and a first reading is completed. Results are recorded as +/− (weak/doubtful), + (mild), ++ (strong), +++ (very strong), irritant, and negative.2 Many patch test specialists use side lighting to achieve the best reading and palpate to confirm the presence of induration; panel alignment devices commonly are utilized. There are some scenarios where shorter or longer application times are indicated, but this is beyond the scope of this article. A second, or delayed, reading should be completed 72 to 144 hours after initial application. We usually complete the delayed reading at 96 to 120 hours.
Certain patch test reactions may peak at different times, with fragrances often reacting earlier, and metals, topical antibiotics, and textile dyes reacting later.9 In the scenario of delayed peak reactions, third readings may be indicated.
Neglecting to complete a delayed reading is a potential pitfall and can increase the risk for both false-positive and false-negative reactions.10,11 In 1996, Uter et al10 published a large study of 9946 patients who were patch tested over a 4-year period. The authors compared patch test reactions at 48 and 72 hours and found that 34.5% of all positive reactions occurred at 72 hours; an additional 15.1% were positive at 96 hours. Importantly, one reading at 48 hours missed approximately one-third of positive patch test reactions, emphasizing the importance of delayed patch test readings.10 Furthermore, another study of 9997 consecutively patch tested patients examined reactions that were either negative or doubtful between days 3 or 4 and followed to see which of those reactions were positive at days 6 or 7. Of the negative reactions, the authors found that 4.4% were positive on days 6 or 7, and of the doubtful reactions, 9.1% were positive on days 6 or 7, meaning that up to 13.5% of positive reactions can be missed when a later reading is not performed.11
Medications During Patch Testing
Topical Medications
Topical medications generally can be continued during patch testing; however, patients should not apply topical medications to the patch test application site. Ideally, there should be no topical medication applied to the patch test application site for 1 to 2 weeks prior to patch test placement.12 Use of topical medications such as corticosteroids, calcineurin inhibitors, and theoretically even phosphodiesterase 4 inhibitors can not only result in suppression of positive patch test reactions but also can make patch adherence difficult.
Phototherapy
Phototherapy can result in local cutaneous immune suppression; therefore, it is recommended that it not be applied to the patch test area either during the patch test process or for 1 to 2 weeks prior to patch test application. In addition, if heat or sweating are generated during phototherapy, they can affect the success of patch testing by poor patch adherence and/or disruption of allergen distribution.
Systemic Medications
Oral antihistamines do not affect patch testing and can be continued during the patch test process.
It is ideal to avoid systemic immunomodulatory agents during the patch test process, but they occasionally are unavoidable, either because they are necessary to manage other medical conditions or because they are needed to achieve clear enough skin to proceed with patch testing. If it is required, prednisone is not recommended to exceed 10 mg daily.12,13 If intramuscular triamcinolone acetonide has been administered, patch testing should occur at least 1 month after the most recent injection.12 Oral methotrexate can probably be continued during patch testing but should be kept at the lowest possible dose and should be held during the week of testing, if possible. Adalimumab, etanercept, infliximab, and ustekinumab can be continued, as they are unlikely to interfere with patch testing.12 There are reports of positive patch test reactions on dupilumab,14,15 and some authors have described the response as variable and potentially allergen dependent.16,17 We believe that it generally is acceptable to continue dupilumab during patch testing. Data on cyclosporine during patch testing are mixed, and caution is advised as higher doses may suppress a positive patch test. Azathioprine and mycophenolate should be avoided, if possible.12
Pearls and Pitfalls
A few tips along the way can help assure your success in patch testing.
- Proper patient counseling determines a successful test. Provide your patient with verbal and written instructions about the patch test process, patch care, and any other necessary information.
- A simple sponge bath is permissible during patch testing provided the back stays dry. One of the authors (A.R.A.) advises patients to sit in a small amount of water in a bathtub to bathe, wash only the front of the body in the shower, and wash hair in the sink.
- No sweating, swimming, heavy exercise, or heavy physical labor. If your patient is planning to run a marathon the week of patch testing, they will be sorely disappointed when you tell them no sweating or showering is allowed! Patients with an occupation that requires physical labor may require a work excuse.
- Tape does not adhere to areas of the skin with excess hair. A scissor trim or electric shave will help the patches stay occluded and in place. We use an electric razor with a disposable replaceable head. A traditional straight razor should not be used, as it can increase the risk for folliculitis, which can make patch readings quite difficult.
- Securing the patches in place with an extra layer of tape provides added security. Large sheets of transparent medical dressings work particularly well for children or if there is difficulty with tape adherence.
Avoid application of patches to areas of the skin with tattoos. In theory, tattooed skin may have a decreased immune response, and tattoo pigment can obscure results.18 However, this is sometimes unavoidable, and Fowler and McTigue18 described a case of successful patch testing on a diffusely tattooed back.
- Avoid skin lesions (eg, scars, seborrheic keratoses, dermatitis) that can affect tape application, patch adherence, or patch readings.
Final Interpretation
The first step to excellent patch testing is understanding the patch test process. Patch test systems include T.R.U.E. and the chamber method. There are several allergen screening series, and the best series for each patient is determined based on geographic region, exposures, and allergen prevalence. The timing and practice of the patch test reading is vital, and physicians should be cognizant of medications and phototherapy use during the patch test process. An understanding of common pearls and pitfalls makes the difference between a good and great patch tester.
Now that you are an expert in performing the test, watch out for part 2 of this series on patch test interpretation, relevance, education, and counseling. Happy testing!
- T.R.U.E TEST [package insert]. Phoenix, AZ: SmartPractice; 1994.
- DeKoven JG, Warshaw EM, Zug KA, et al. North American Contact Dermatitis Group patch test results: 2015-2016. Dermatitis. 2018;29:297-309.
- Ward JM, Walsh RK, Bellet JS, et al. Allergic contact dermatitis to aluminum-based chambers during routine patch testing. Paper presented at: American Contact Dermatitis Society Annual Meeting; March 19, 2020; Denver, CO.
- Deleuran MG, Ahlström MG, Zachariae C, et al. Patch test reactivity to aluminum chambers. Contact Dermatitis. 2019;81:318-319.
- Bruze M, Condé-Salazar L, Goossens A, et al. European Society of Contact Dermatitis. thoughts on sensitizers in a standard patch test series. Contact Dermatitis. 1999;41:241-250.
- Schalock PC, Dunnick CA, Nedorost S, et al. American Contact Dermatitis Society Core Allergen Series: 2017 update. Dermatitis. 2017;28:141-143.
- Yu J, Atwater AR, Brod B, et al. Pediatric baseline patch test series: Pediatric Contact Dermatitis Workgroup. Dermatitis. 2018;29:206-212.
- De Groot AC. Patch Testing: Test Concentrations and Vehicles for 4900 Chemicals. 4th ed. Wapserveen, The Netherlands: Acdegroot Publishing; 2018.
- Chaudhry HM, Drage LA, El-Azhary RA, et al. Delayed patch-test reading after 5 days: an update from the Mayo Clinic Contact Dermatitis Group. Dermatitis. 2017;28:253-260.
- Uter WJ, Geier J, Schnuch A. Good clinical practice in patch testing: readings beyond day 2 are necessary: a confirmatory analysis. Members of the Information Network of Departments of Dermatology. Am J Contact Dermat. 1996;7:231-237.
- Madsen JT, Andersen KE. Outcome of a second patch test reading of T.R.U.E. Tests® on D6/7. Contact Dermatitis. 2013;68:94-97.
- Lampel H, Atwater AR. Patch testing tools of the trade: use of immunosuppressants and antihistamines during patch testing. J Dermatol Nurses’ Assoc. 2016;8:209-211.
- Fowler JF, Maibach HI, Zirwas M, et al. Effects of immunomodulatory agents on patch testing: expert opinion 2012. Dermatitis. 2012;23:301-303.
- Puza CJ, Atwater AR. Positive patch test reaction in a patient taking dupilumab. Dermatitis. 2018;29:89.
- Hoot JW, Douglas JD, Falo LD. Patch testing in a patient on dupilumab. Dermatitis. 2018;29:164.
- Stout M, Silverberg JI. Variable impact of dupilumab on patch testing results and allergic contact dermatitis in adults with atopic dermatitis. J Am Acad Dermatol. 2019;81:157-162.
- Raffi J, Botto N. Patch testing and allergen-specific inhibition in a patient taking dupilumab. JAMA Dermatol. 2019;155:120-121.
- Fowler JF, McTigue MK. Patch testing over tattoos. Am J Contact Dermat. 2002;13:19-20.
- T.R.U.E TEST [package insert]. Phoenix, AZ: SmartPractice; 1994.
- DeKoven JG, Warshaw EM, Zug KA, et al. North American Contact Dermatitis Group patch test results: 2015-2016. Dermatitis. 2018;29:297-309.
- Ward JM, Walsh RK, Bellet JS, et al. Allergic contact dermatitis to aluminum-based chambers during routine patch testing. Paper presented at: American Contact Dermatitis Society Annual Meeting; March 19, 2020; Denver, CO.
- Deleuran MG, Ahlström MG, Zachariae C, et al. Patch test reactivity to aluminum chambers. Contact Dermatitis. 2019;81:318-319.
- Bruze M, Condé-Salazar L, Goossens A, et al. European Society of Contact Dermatitis. thoughts on sensitizers in a standard patch test series. Contact Dermatitis. 1999;41:241-250.
- Schalock PC, Dunnick CA, Nedorost S, et al. American Contact Dermatitis Society Core Allergen Series: 2017 update. Dermatitis. 2017;28:141-143.
- Yu J, Atwater AR, Brod B, et al. Pediatric baseline patch test series: Pediatric Contact Dermatitis Workgroup. Dermatitis. 2018;29:206-212.
- De Groot AC. Patch Testing: Test Concentrations and Vehicles for 4900 Chemicals. 4th ed. Wapserveen, The Netherlands: Acdegroot Publishing; 2018.
- Chaudhry HM, Drage LA, El-Azhary RA, et al. Delayed patch-test reading after 5 days: an update from the Mayo Clinic Contact Dermatitis Group. Dermatitis. 2017;28:253-260.
- Uter WJ, Geier J, Schnuch A. Good clinical practice in patch testing: readings beyond day 2 are necessary: a confirmatory analysis. Members of the Information Network of Departments of Dermatology. Am J Contact Dermat. 1996;7:231-237.
- Madsen JT, Andersen KE. Outcome of a second patch test reading of T.R.U.E. Tests® on D6/7. Contact Dermatitis. 2013;68:94-97.
- Lampel H, Atwater AR. Patch testing tools of the trade: use of immunosuppressants and antihistamines during patch testing. J Dermatol Nurses’ Assoc. 2016;8:209-211.
- Fowler JF, Maibach HI, Zirwas M, et al. Effects of immunomodulatory agents on patch testing: expert opinion 2012. Dermatitis. 2012;23:301-303.
- Puza CJ, Atwater AR. Positive patch test reaction in a patient taking dupilumab. Dermatitis. 2018;29:89.
- Hoot JW, Douglas JD, Falo LD. Patch testing in a patient on dupilumab. Dermatitis. 2018;29:164.
- Stout M, Silverberg JI. Variable impact of dupilumab on patch testing results and allergic contact dermatitis in adults with atopic dermatitis. J Am Acad Dermatol. 2019;81:157-162.
- Raffi J, Botto N. Patch testing and allergen-specific inhibition in a patient taking dupilumab. JAMA Dermatol. 2019;155:120-121.
- Fowler JF, McTigue MK. Patch testing over tattoos. Am J Contact Dermat. 2002;13:19-20.
Practice Points
- There are 2 basic patch testing systems: the T.R.U.E. test and the chamber method.
- Patches should be applied to the upper back and should be removed after 48 hours. A delayed reading is necessary and should be performed 72 to 144 hours after placement.
- Certain oral and topical medications and phototherapy may interfere with patch test results.
Lack of Knowledge About Surgical Smoke, Masks, and Respirators Among US Dermatology Residents and Fellows in the Era of COVID-19
During dermatologic surgery, surgical smoke created by electrocautery is known to contain not only nanoparticles and carcinogenic compounds but also infectious particles.1 Poor awareness of the risks associated with breathing surgical smoke and lack of safety practices among US dermatology residents has been documented.2 In this era of the novel coronavirus disease 2019 (COVID-19) pandemic, these issues are particularly pertinent due to the theoretical risk of viral transmission through aerosolized particles. There are few studies investigating viral transmission during surgery, but large numbers of health care workers in close contact with the upper aerodigestive tract during diagnostic and therapeutic procedures have become infected with COVID-19, leading to the recommendation of added safety measures for surgeons in other fields.3 Recommendations do not yet exist for dermatologic surgeons, and it is not yet known if this population is at higher risk for COVID-19 infection due to aerosolized viral particles in the air or in surgical smoke. Nonetheless, we feel that additional safety measures during dermatologic surgery are warranted, particularly when operating on areas of higher viral load such as the nasal or oral mucosae, and understanding of safety equipment is paramount. Thus, we aimed to assess the awareness of safety measures among training dermatologists and dermatologic surgeons during the COVID-19 pandemic.
In April 2020, one of the authors (S.I.B.J.) gave a lecture to residents and fellows of accredited dermatology residency or fellowship programs in the United States on surgical masks and surgical smoke in dermatologic surgery on an online videoconferencing platform through our institution. During the lecture, participants were polled regarding their understanding of these topics. Forty-one attendees were included in this analysis, with a 100% response rate. Results showed that 54% (22/41) of respondents indicated they had not had formal lectures on surgical smoke content and management, and 51% (21/41) responded that they do not use a smoke evacuator during surgical procedures. When asked why smoke evacuators are not used, 27% (11/41) responded that the equipment is too cumbersome, 12% (5/41) reported that smoke evacuators are not available at their practice or institution, 7% did not believe that smoke evacuators are necessary, and 5% did not know they are used in dermatology. Additionally, 66% (27/41) said they had not had formal presentations on personal protective equipment (PPE) or masks, though 93% (38/41) said they wear a surgical mask during surgery. Despite the high percentage of respondents using masks, 82% (31/38) did not know what type of mask they were wearing, and the remainder wore a variety of American Society for Testing and Materials–rated (levels 1, 2, or 3) and European Standards type II (EN14683) masks. Following the presentation, 100% of respondents said they were likely to use a smoke evacuator if made available, and 100% reported that they had a better understanding of respirators and masks.
In summary, more than 50% of dermatology trainees in our study had not been formally educated regarding PPE despite its importance during the COVID-19 pandemic. The majority of respondents were unaware of the dangers of surgical smoke, and a small number of respondents believed that smoke evacuators were not necessary or did not know that they were even used in dermatology. Based on the results of this quick survey during a lecture to dermatology trainees, we believe it is important to alert educators to this knowledge gap regarding PPE in the dermatology teaching curriculum. We have shown that even a short lecture format was an effective way of disseminating information about PPE and surgical safety. We believe that safety measures are more important now during a time when risk for infection with a potentially fatal virus is high. We encourage clinical educators to emphasize the importance of personal safety to trainees during residency, especially during the COVID-19 pandemic.
- Georgesen C, Lipner SR. Surgical smoke: risk assessment and mitigation strategies. J Am Acad Dermatol. 2018;79:746-755.
- Chapman LW, Korta DZ, Lee PK, et al. Awareness of surgical smoke risks and assessment of safety practices during electrosurgery among US dermatology residents. JAMA Dermatol. 2017;153:467.
- Givi B, Schiff BA, Chinn SB, et al. Safety recommendations for evaluation and surgery of the head and neck during the COVID-19 pandemic [published online March 31, 2020]. JAMA Otolaryngol Neck Surg. doi:10.1001/jamaoto.2020.0780.
During dermatologic surgery, surgical smoke created by electrocautery is known to contain not only nanoparticles and carcinogenic compounds but also infectious particles.1 Poor awareness of the risks associated with breathing surgical smoke and lack of safety practices among US dermatology residents has been documented.2 In this era of the novel coronavirus disease 2019 (COVID-19) pandemic, these issues are particularly pertinent due to the theoretical risk of viral transmission through aerosolized particles. There are few studies investigating viral transmission during surgery, but large numbers of health care workers in close contact with the upper aerodigestive tract during diagnostic and therapeutic procedures have become infected with COVID-19, leading to the recommendation of added safety measures for surgeons in other fields.3 Recommendations do not yet exist for dermatologic surgeons, and it is not yet known if this population is at higher risk for COVID-19 infection due to aerosolized viral particles in the air or in surgical smoke. Nonetheless, we feel that additional safety measures during dermatologic surgery are warranted, particularly when operating on areas of higher viral load such as the nasal or oral mucosae, and understanding of safety equipment is paramount. Thus, we aimed to assess the awareness of safety measures among training dermatologists and dermatologic surgeons during the COVID-19 pandemic.
In April 2020, one of the authors (S.I.B.J.) gave a lecture to residents and fellows of accredited dermatology residency or fellowship programs in the United States on surgical masks and surgical smoke in dermatologic surgery on an online videoconferencing platform through our institution. During the lecture, participants were polled regarding their understanding of these topics. Forty-one attendees were included in this analysis, with a 100% response rate. Results showed that 54% (22/41) of respondents indicated they had not had formal lectures on surgical smoke content and management, and 51% (21/41) responded that they do not use a smoke evacuator during surgical procedures. When asked why smoke evacuators are not used, 27% (11/41) responded that the equipment is too cumbersome, 12% (5/41) reported that smoke evacuators are not available at their practice or institution, 7% did not believe that smoke evacuators are necessary, and 5% did not know they are used in dermatology. Additionally, 66% (27/41) said they had not had formal presentations on personal protective equipment (PPE) or masks, though 93% (38/41) said they wear a surgical mask during surgery. Despite the high percentage of respondents using masks, 82% (31/38) did not know what type of mask they were wearing, and the remainder wore a variety of American Society for Testing and Materials–rated (levels 1, 2, or 3) and European Standards type II (EN14683) masks. Following the presentation, 100% of respondents said they were likely to use a smoke evacuator if made available, and 100% reported that they had a better understanding of respirators and masks.
In summary, more than 50% of dermatology trainees in our study had not been formally educated regarding PPE despite its importance during the COVID-19 pandemic. The majority of respondents were unaware of the dangers of surgical smoke, and a small number of respondents believed that smoke evacuators were not necessary or did not know that they were even used in dermatology. Based on the results of this quick survey during a lecture to dermatology trainees, we believe it is important to alert educators to this knowledge gap regarding PPE in the dermatology teaching curriculum. We have shown that even a short lecture format was an effective way of disseminating information about PPE and surgical safety. We believe that safety measures are more important now during a time when risk for infection with a potentially fatal virus is high. We encourage clinical educators to emphasize the importance of personal safety to trainees during residency, especially during the COVID-19 pandemic.
During dermatologic surgery, surgical smoke created by electrocautery is known to contain not only nanoparticles and carcinogenic compounds but also infectious particles.1 Poor awareness of the risks associated with breathing surgical smoke and lack of safety practices among US dermatology residents has been documented.2 In this era of the novel coronavirus disease 2019 (COVID-19) pandemic, these issues are particularly pertinent due to the theoretical risk of viral transmission through aerosolized particles. There are few studies investigating viral transmission during surgery, but large numbers of health care workers in close contact with the upper aerodigestive tract during diagnostic and therapeutic procedures have become infected with COVID-19, leading to the recommendation of added safety measures for surgeons in other fields.3 Recommendations do not yet exist for dermatologic surgeons, and it is not yet known if this population is at higher risk for COVID-19 infection due to aerosolized viral particles in the air or in surgical smoke. Nonetheless, we feel that additional safety measures during dermatologic surgery are warranted, particularly when operating on areas of higher viral load such as the nasal or oral mucosae, and understanding of safety equipment is paramount. Thus, we aimed to assess the awareness of safety measures among training dermatologists and dermatologic surgeons during the COVID-19 pandemic.
In April 2020, one of the authors (S.I.B.J.) gave a lecture to residents and fellows of accredited dermatology residency or fellowship programs in the United States on surgical masks and surgical smoke in dermatologic surgery on an online videoconferencing platform through our institution. During the lecture, participants were polled regarding their understanding of these topics. Forty-one attendees were included in this analysis, with a 100% response rate. Results showed that 54% (22/41) of respondents indicated they had not had formal lectures on surgical smoke content and management, and 51% (21/41) responded that they do not use a smoke evacuator during surgical procedures. When asked why smoke evacuators are not used, 27% (11/41) responded that the equipment is too cumbersome, 12% (5/41) reported that smoke evacuators are not available at their practice or institution, 7% did not believe that smoke evacuators are necessary, and 5% did not know they are used in dermatology. Additionally, 66% (27/41) said they had not had formal presentations on personal protective equipment (PPE) or masks, though 93% (38/41) said they wear a surgical mask during surgery. Despite the high percentage of respondents using masks, 82% (31/38) did not know what type of mask they were wearing, and the remainder wore a variety of American Society for Testing and Materials–rated (levels 1, 2, or 3) and European Standards type II (EN14683) masks. Following the presentation, 100% of respondents said they were likely to use a smoke evacuator if made available, and 100% reported that they had a better understanding of respirators and masks.
In summary, more than 50% of dermatology trainees in our study had not been formally educated regarding PPE despite its importance during the COVID-19 pandemic. The majority of respondents were unaware of the dangers of surgical smoke, and a small number of respondents believed that smoke evacuators were not necessary or did not know that they were even used in dermatology. Based on the results of this quick survey during a lecture to dermatology trainees, we believe it is important to alert educators to this knowledge gap regarding PPE in the dermatology teaching curriculum. We have shown that even a short lecture format was an effective way of disseminating information about PPE and surgical safety. We believe that safety measures are more important now during a time when risk for infection with a potentially fatal virus is high. We encourage clinical educators to emphasize the importance of personal safety to trainees during residency, especially during the COVID-19 pandemic.
- Georgesen C, Lipner SR. Surgical smoke: risk assessment and mitigation strategies. J Am Acad Dermatol. 2018;79:746-755.
- Chapman LW, Korta DZ, Lee PK, et al. Awareness of surgical smoke risks and assessment of safety practices during electrosurgery among US dermatology residents. JAMA Dermatol. 2017;153:467.
- Givi B, Schiff BA, Chinn SB, et al. Safety recommendations for evaluation and surgery of the head and neck during the COVID-19 pandemic [published online March 31, 2020]. JAMA Otolaryngol Neck Surg. doi:10.1001/jamaoto.2020.0780.
- Georgesen C, Lipner SR. Surgical smoke: risk assessment and mitigation strategies. J Am Acad Dermatol. 2018;79:746-755.
- Chapman LW, Korta DZ, Lee PK, et al. Awareness of surgical smoke risks and assessment of safety practices during electrosurgery among US dermatology residents. JAMA Dermatol. 2017;153:467.
- Givi B, Schiff BA, Chinn SB, et al. Safety recommendations for evaluation and surgery of the head and neck during the COVID-19 pandemic [published online March 31, 2020]. JAMA Otolaryngol Neck Surg. doi:10.1001/jamaoto.2020.0780.
Practice Points
- Harmful surgical smoke is created with electrocautery. Smoke evacuators and approved surgical masks can help mitigate the harmful effects of smoke on the health of dermatologic surgeons.
- Dermatology curricula for residents and medical students should include information on surgical smoke safety.
SHM Chapter innovations: A provider exchange program
The SHM Annual Conference is more than an educational event. It also provides an opportunity to collaborate, network and create innovative ideas to improve the quality of inpatient care.
During the 2019 Annual Conference (HM19) – the last “in-person” Annual Conference before the COVID pandemic – SHM chapter leaders from the New Mexico chapter (Krystle Apodaca) and the Wiregrass chapter (Amith Skandhan), which covers the counties of Southern Alabama and the Panhandle of Florida, met during a networking event.
As we talked, we realized the unique differences and similarities our practice settings shared. We debated the role of clinician wellbeing, quality of medical education, and faculty development on individual hospital medicine group (HMG) practice styles.
Clinician well-being is the prerequisite to the Triple Aim of improving the health of populations, enhancing the patient experience, and reducing the cost of care. Engagement in local SHM chapter activities promotes the efficiency of practice, a culture of wellness, and personal resilience. Each HMG faces similar challenges but approaches to solving them vary. Professional challenges can affect the well-being of individual clinicians. During our discussion we realized that an interinstitutional exchange programs could provide a platform to exchange ideas and establish mentors.
The quality of medical education is directly linked to the quality of faculty development. Improving the quality of medical education requires a multifaceted approach by highly developed faculty. The complex factors affecting medical education and faculty development are further complicated by geographic location, patient characteristics, and professional growth opportunities.
Overcoming these obstacles requires an innovative and collaborative approach. Although faculty exchanges are common in academic medicine, they are not commonly attempted with HMGs. Hospitalists are responsible for a significant part of inpatient training for residents, medical students, and nurse practitioners/physician assistants (NPs/PAs) but their faculty training can vary based on location.
As a young specialty, hospital medicine is still evolving and incorporating NPs/PAs and physician hospitalists in varied practice models. Each HMG addresses common obstacles differently based on their culture and practice styles. As chapter leaders we determined that an exchange program would afford the opportunity for visiting faculty members to experience these differences.
We shared the idea of a chapter-level exchange with SHM’s Chapter Development Committee and obtained chapter development funds to execute the event. We also requested that an SHM national board member visit during the exchange to provide insight and feedback. We researched the characteristics of individual academic HMGs and structured a faculty exchange involving physicians and NPs/PAs. During the exchange program planning, the visiting faculty itinerary was tailored to a well-planned agenda for one week, with separate tracks for physicians and NPs/PAs, giving increased access to their individual peer practice styles. Additionally, the visiting faculty had meetings and discussions with the HMG and hospital leadership, to specifically address the visiting faculty’s institutional challenges.
The overall goal of the exchange program was to promote cross-institutional collaboration, increase engagement, improve medical education through faculty development and improve the quality of care. The focus of the exchange program was to share ideas and innovation, and learn the approaches to unique challenges at each institution. Out of this also grew collaboration and mentoring opportunities.
SHM’s New Mexico chapter is based in Albuquerque, a city in the desert Southwest with an ethnically diverse population of 545,000, The chapter leadership works at the University of New Mexico (UNM), a 553-bed medical center. UNM has a well-established internal medicine residency program, an academic hospitalist program, and an NP/PA fellowship program embedded within the hospital medicine department. At the time of the exchange, the HMG at UNM has 26 physicians and 9 NP/PA’s.
The SHM Wiregrass chapter is located in Dothan, Ala., a town of 80,000 near the Gulf of Mexico. Chapter leadership works at Southeast Health, a tertiary care facility with 420 beds, an affiliated medical school, and an internal medicine residency program. At the time of the exchange, the HMG at SEH has 28 physicians and 5 NP/PA’s.
These are two similarly sized hospital medicine programs, located in different geographic regions, and serving different populations. SHM board member Howard Epstein, MD, SFHM, vice president and chief medical officer of Presbyterian Healthcare Services in Albuquerque, participated on behalf of the Society when SEH faculty visited UNM. Kris Rehm, MD, SFHM, a pediatric hospitalist and the vice chair of outreach medicine at Vanderbilt University Medical Center, Nashville, came to Dothan during the faculty visit by UNM.
Two SEH faculty members, a physician and an NP, visited the University of New Mexico Hospital for one week. They participated as observers, rounding with the teams and meeting the UNM HMG leadership. The focus of the discussions included faculty education, a curriculum for quality improvement, and ways to address practice challenges. The SEH faculty also presented a QI project from their institution, and established collaborative relationships.
During the second part of the exchange, three UNM faculty members, including one physician and two NPs, visited SEH for one week. During the visit, they observed NP/PA hospitalist team models, discussed innovations, established mentoring relationships with leadership, and discussed QI projects at SEH. Additionally, the visiting UNM faculty participated in Women In Medicine events and participated as judges for a poster competition. They also had an opportunity to explore the rural landscape and visit the beach.
The evaluation process after the exchanges involved interviews, a survey, and the establishment of shared QI projects in mutual areas of challenge. The survey provided feedback, lessons learned from the exchange, and areas to be improved. Collaborative QI projects currently underway as a result of the exchange include paging etiquette, quality of sleep for hospitalized patients, and onboarding of NPs/PAs in HMGs.
This innovation changed our thinking as medical educators by addressing faculty development and medical education via clinician well-being. The physician and NP/PA Faculty Exchange program was an essential and meaningful innovation that resulted in increased SHM member engagement, crossinstitutional collaboration, networking, and mentorship.
This event created opportunities for faculty collaboration and expanded the professional network of participating institutions. The costs of the exchange were minimal given support from SHM. We believe that once the COVID pandemic has ended, this initiative has the potential to expand facilitated exchanges nationally and internationally, enhance faculty development, and improve medical education.
Dr. Apodaca is assistant professor and nurse practitioner hospitalist at the University of New Mexico. She serves as codirector of the UNM APP Hospital Medicine Fellowship and director of the APP Hospital Medicine Team. Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization.
The SHM Annual Conference is more than an educational event. It also provides an opportunity to collaborate, network and create innovative ideas to improve the quality of inpatient care.
During the 2019 Annual Conference (HM19) – the last “in-person” Annual Conference before the COVID pandemic – SHM chapter leaders from the New Mexico chapter (Krystle Apodaca) and the Wiregrass chapter (Amith Skandhan), which covers the counties of Southern Alabama and the Panhandle of Florida, met during a networking event.
As we talked, we realized the unique differences and similarities our practice settings shared. We debated the role of clinician wellbeing, quality of medical education, and faculty development on individual hospital medicine group (HMG) practice styles.
Clinician well-being is the prerequisite to the Triple Aim of improving the health of populations, enhancing the patient experience, and reducing the cost of care. Engagement in local SHM chapter activities promotes the efficiency of practice, a culture of wellness, and personal resilience. Each HMG faces similar challenges but approaches to solving them vary. Professional challenges can affect the well-being of individual clinicians. During our discussion we realized that an interinstitutional exchange programs could provide a platform to exchange ideas and establish mentors.
The quality of medical education is directly linked to the quality of faculty development. Improving the quality of medical education requires a multifaceted approach by highly developed faculty. The complex factors affecting medical education and faculty development are further complicated by geographic location, patient characteristics, and professional growth opportunities.
Overcoming these obstacles requires an innovative and collaborative approach. Although faculty exchanges are common in academic medicine, they are not commonly attempted with HMGs. Hospitalists are responsible for a significant part of inpatient training for residents, medical students, and nurse practitioners/physician assistants (NPs/PAs) but their faculty training can vary based on location.
As a young specialty, hospital medicine is still evolving and incorporating NPs/PAs and physician hospitalists in varied practice models. Each HMG addresses common obstacles differently based on their culture and practice styles. As chapter leaders we determined that an exchange program would afford the opportunity for visiting faculty members to experience these differences.
We shared the idea of a chapter-level exchange with SHM’s Chapter Development Committee and obtained chapter development funds to execute the event. We also requested that an SHM national board member visit during the exchange to provide insight and feedback. We researched the characteristics of individual academic HMGs and structured a faculty exchange involving physicians and NPs/PAs. During the exchange program planning, the visiting faculty itinerary was tailored to a well-planned agenda for one week, with separate tracks for physicians and NPs/PAs, giving increased access to their individual peer practice styles. Additionally, the visiting faculty had meetings and discussions with the HMG and hospital leadership, to specifically address the visiting faculty’s institutional challenges.
The overall goal of the exchange program was to promote cross-institutional collaboration, increase engagement, improve medical education through faculty development and improve the quality of care. The focus of the exchange program was to share ideas and innovation, and learn the approaches to unique challenges at each institution. Out of this also grew collaboration and mentoring opportunities.
SHM’s New Mexico chapter is based in Albuquerque, a city in the desert Southwest with an ethnically diverse population of 545,000, The chapter leadership works at the University of New Mexico (UNM), a 553-bed medical center. UNM has a well-established internal medicine residency program, an academic hospitalist program, and an NP/PA fellowship program embedded within the hospital medicine department. At the time of the exchange, the HMG at UNM has 26 physicians and 9 NP/PA’s.
The SHM Wiregrass chapter is located in Dothan, Ala., a town of 80,000 near the Gulf of Mexico. Chapter leadership works at Southeast Health, a tertiary care facility with 420 beds, an affiliated medical school, and an internal medicine residency program. At the time of the exchange, the HMG at SEH has 28 physicians and 5 NP/PA’s.
These are two similarly sized hospital medicine programs, located in different geographic regions, and serving different populations. SHM board member Howard Epstein, MD, SFHM, vice president and chief medical officer of Presbyterian Healthcare Services in Albuquerque, participated on behalf of the Society when SEH faculty visited UNM. Kris Rehm, MD, SFHM, a pediatric hospitalist and the vice chair of outreach medicine at Vanderbilt University Medical Center, Nashville, came to Dothan during the faculty visit by UNM.
Two SEH faculty members, a physician and an NP, visited the University of New Mexico Hospital for one week. They participated as observers, rounding with the teams and meeting the UNM HMG leadership. The focus of the discussions included faculty education, a curriculum for quality improvement, and ways to address practice challenges. The SEH faculty also presented a QI project from their institution, and established collaborative relationships.
During the second part of the exchange, three UNM faculty members, including one physician and two NPs, visited SEH for one week. During the visit, they observed NP/PA hospitalist team models, discussed innovations, established mentoring relationships with leadership, and discussed QI projects at SEH. Additionally, the visiting UNM faculty participated in Women In Medicine events and participated as judges for a poster competition. They also had an opportunity to explore the rural landscape and visit the beach.
The evaluation process after the exchanges involved interviews, a survey, and the establishment of shared QI projects in mutual areas of challenge. The survey provided feedback, lessons learned from the exchange, and areas to be improved. Collaborative QI projects currently underway as a result of the exchange include paging etiquette, quality of sleep for hospitalized patients, and onboarding of NPs/PAs in HMGs.
This innovation changed our thinking as medical educators by addressing faculty development and medical education via clinician well-being. The physician and NP/PA Faculty Exchange program was an essential and meaningful innovation that resulted in increased SHM member engagement, crossinstitutional collaboration, networking, and mentorship.
This event created opportunities for faculty collaboration and expanded the professional network of participating institutions. The costs of the exchange were minimal given support from SHM. We believe that once the COVID pandemic has ended, this initiative has the potential to expand facilitated exchanges nationally and internationally, enhance faculty development, and improve medical education.
Dr. Apodaca is assistant professor and nurse practitioner hospitalist at the University of New Mexico. She serves as codirector of the UNM APP Hospital Medicine Fellowship and director of the APP Hospital Medicine Team. Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization.
The SHM Annual Conference is more than an educational event. It also provides an opportunity to collaborate, network and create innovative ideas to improve the quality of inpatient care.
During the 2019 Annual Conference (HM19) – the last “in-person” Annual Conference before the COVID pandemic – SHM chapter leaders from the New Mexico chapter (Krystle Apodaca) and the Wiregrass chapter (Amith Skandhan), which covers the counties of Southern Alabama and the Panhandle of Florida, met during a networking event.
As we talked, we realized the unique differences and similarities our practice settings shared. We debated the role of clinician wellbeing, quality of medical education, and faculty development on individual hospital medicine group (HMG) practice styles.
Clinician well-being is the prerequisite to the Triple Aim of improving the health of populations, enhancing the patient experience, and reducing the cost of care. Engagement in local SHM chapter activities promotes the efficiency of practice, a culture of wellness, and personal resilience. Each HMG faces similar challenges but approaches to solving them vary. Professional challenges can affect the well-being of individual clinicians. During our discussion we realized that an interinstitutional exchange programs could provide a platform to exchange ideas and establish mentors.
The quality of medical education is directly linked to the quality of faculty development. Improving the quality of medical education requires a multifaceted approach by highly developed faculty. The complex factors affecting medical education and faculty development are further complicated by geographic location, patient characteristics, and professional growth opportunities.
Overcoming these obstacles requires an innovative and collaborative approach. Although faculty exchanges are common in academic medicine, they are not commonly attempted with HMGs. Hospitalists are responsible for a significant part of inpatient training for residents, medical students, and nurse practitioners/physician assistants (NPs/PAs) but their faculty training can vary based on location.
As a young specialty, hospital medicine is still evolving and incorporating NPs/PAs and physician hospitalists in varied practice models. Each HMG addresses common obstacles differently based on their culture and practice styles. As chapter leaders we determined that an exchange program would afford the opportunity for visiting faculty members to experience these differences.
We shared the idea of a chapter-level exchange with SHM’s Chapter Development Committee and obtained chapter development funds to execute the event. We also requested that an SHM national board member visit during the exchange to provide insight and feedback. We researched the characteristics of individual academic HMGs and structured a faculty exchange involving physicians and NPs/PAs. During the exchange program planning, the visiting faculty itinerary was tailored to a well-planned agenda for one week, with separate tracks for physicians and NPs/PAs, giving increased access to their individual peer practice styles. Additionally, the visiting faculty had meetings and discussions with the HMG and hospital leadership, to specifically address the visiting faculty’s institutional challenges.
The overall goal of the exchange program was to promote cross-institutional collaboration, increase engagement, improve medical education through faculty development and improve the quality of care. The focus of the exchange program was to share ideas and innovation, and learn the approaches to unique challenges at each institution. Out of this also grew collaboration and mentoring opportunities.
SHM’s New Mexico chapter is based in Albuquerque, a city in the desert Southwest with an ethnically diverse population of 545,000, The chapter leadership works at the University of New Mexico (UNM), a 553-bed medical center. UNM has a well-established internal medicine residency program, an academic hospitalist program, and an NP/PA fellowship program embedded within the hospital medicine department. At the time of the exchange, the HMG at UNM has 26 physicians and 9 NP/PA’s.
The SHM Wiregrass chapter is located in Dothan, Ala., a town of 80,000 near the Gulf of Mexico. Chapter leadership works at Southeast Health, a tertiary care facility with 420 beds, an affiliated medical school, and an internal medicine residency program. At the time of the exchange, the HMG at SEH has 28 physicians and 5 NP/PA’s.
These are two similarly sized hospital medicine programs, located in different geographic regions, and serving different populations. SHM board member Howard Epstein, MD, SFHM, vice president and chief medical officer of Presbyterian Healthcare Services in Albuquerque, participated on behalf of the Society when SEH faculty visited UNM. Kris Rehm, MD, SFHM, a pediatric hospitalist and the vice chair of outreach medicine at Vanderbilt University Medical Center, Nashville, came to Dothan during the faculty visit by UNM.
Two SEH faculty members, a physician and an NP, visited the University of New Mexico Hospital for one week. They participated as observers, rounding with the teams and meeting the UNM HMG leadership. The focus of the discussions included faculty education, a curriculum for quality improvement, and ways to address practice challenges. The SEH faculty also presented a QI project from their institution, and established collaborative relationships.
During the second part of the exchange, three UNM faculty members, including one physician and two NPs, visited SEH for one week. During the visit, they observed NP/PA hospitalist team models, discussed innovations, established mentoring relationships with leadership, and discussed QI projects at SEH. Additionally, the visiting UNM faculty participated in Women In Medicine events and participated as judges for a poster competition. They also had an opportunity to explore the rural landscape and visit the beach.
The evaluation process after the exchanges involved interviews, a survey, and the establishment of shared QI projects in mutual areas of challenge. The survey provided feedback, lessons learned from the exchange, and areas to be improved. Collaborative QI projects currently underway as a result of the exchange include paging etiquette, quality of sleep for hospitalized patients, and onboarding of NPs/PAs in HMGs.
This innovation changed our thinking as medical educators by addressing faculty development and medical education via clinician well-being. The physician and NP/PA Faculty Exchange program was an essential and meaningful innovation that resulted in increased SHM member engagement, crossinstitutional collaboration, networking, and mentorship.
This event created opportunities for faculty collaboration and expanded the professional network of participating institutions. The costs of the exchange were minimal given support from SHM. We believe that once the COVID pandemic has ended, this initiative has the potential to expand facilitated exchanges nationally and internationally, enhance faculty development, and improve medical education.
Dr. Apodaca is assistant professor and nurse practitioner hospitalist at the University of New Mexico. She serves as codirector of the UNM APP Hospital Medicine Fellowship and director of the APP Hospital Medicine Team. Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization.