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Social Determinants of Health: The Impact on Pediatric Health and Well-Being
Case vignette: A 16-year-old Nepali-born English-speaking adolescent presents for a well-child visit and notes concerns for anxiety, depression, and a history of trauma. She resides with her parents who work in hospitality with limited time off, and thus she presented for the initial office visit with a neighbor. Parents were not readily available to discuss treatment recommendations, including medication options. The teen shares a number of challenges that makes coming to appointments difficult. You also notice that the patient currently is not enrolled in insurance, though she appears eligible.
The above vignette highlights various social issues and concerns that impact access to healthcare and overall health/well-being. Social determinants of health (SDOH) and factors centered on mental health are now widely known to impact pediatric health and wellbeing. The Office of Disease Prevention and Health Promotion defines SDOH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” SDOH can be grouped into five domains: Economic Stability, Education Access and Quality, Health Care Access and Quality, Neighborhood and Built Environment, and Social and Community Context.1
Additionally, when considering determinants that impact the mental health of children, it is prudent to consider parental psychosocial factors and adverse childhood experiences (ACEs), such as witnessing interpersonal violence, child abuse, parental substance use, and parental depression.2 All these factors have been shown to impact an individual’s mental and physical health not only contemporaneously but also later in life.3
Screening Tool for Pediatric Social Histories
developed by Kenyon et al,4 with further derivations from Colvin et al.5 Utilizing this tool can assist providers with identifying social needs.
The tool begins with a framing statement — “Let me ask you some questions I ask every family” — then proceeds to discuss relevant topics as shared below:
I: Income; Insurance
- Do you have any concerns about making ends meet?
- Do you have any concerns about your child’s health insurance?
H: Hunger, Housing Conditions; Homeless
- Do you have any concerns about having enough food?
- Have you ever been worried whether your food would run out before you got money to buy more?
- Within the past year has the food you bought ever not lasted, and you didn’t have money to get more?
- Do you have any concerns about poor housing conditions like mice, mold, or cockroaches?
- Do you have any concerns about being evicted or not being able to pay the rent?
- Do you have any concerns about not being able to pay your mortgage?
E: Education; Ensuring Safety (Violence)
- Do you have any concerns about your child’s educational needs?
- [DO NOT ASK IN FRONT OF CHILD 3 OR OLDER OR IN FRONT OF OTHER PARTNER] “From speaking to families, I have learned that violence in the home is common and now I ask all families about violence in the home. Do you have any concerns about violence in your home?”
L: Legal status (Immigration)
- What hospital was your child born in?
- If not in the United States: “Are you aware that your child may be eligible for benefits even though they were not born in the US? If you would like, I can have a social worker come talk to you about some possible benefits your child may be eligible for. Would you like me to do that?”
P: Power of Attorney; Guardianship
- Are you the biological mother or father of this child?
- [If not] “Can you show me the power of attorney or guardianship document you have?”
- **PATIENTS >17+ with Mental Incapacity: Ask for Guardianship.
This tool can help with identifying families with significant social needs so that one can attain further historical information and subsequently share resources to assist with any challenges.
Consider the Role of Adverse Childhood Experiences
Additionally, as noted, ACEs often play an important role in overall health and well-being; they include experiencing childhood abuse, neglect, and/or household dysfunction. The impact of these early exposures can lead to toxic stress that can negatively alter the brain and the body’s response to stress over time.3 There are various tools readily available online that can assist with identifying ACEs and interpreting their prevalence. The American Academy of Pediatrics has an updated page of commonly used screening tools. Early identification and intervention can help mitigate the impact of these experiences on long-term outcomes.
Important Considerations Regarding Screening for SDOH and/or ACEs:
- Please consider if screening is helpful in your space, recognizing that there are benefits and potential ethical considerations to screen or not. Ensure an interdisciplinary approach if screening is implemented to ensure that the patient’s experience and well-being is prioritized.
- Try to be intentional in your communication with parents. The patient and family are our teachers and know best what they need.
- Consider what is available in your community and what can be offered to ensure that parents and families are appropriate and eligible for a particular resource.
- Encourage continuous collaboration and partnership with community providers who offer resources that a family may benefit from to ensure that the resource continues to be available.
Returning to the Vignette
Administering the IHELP tool has led to identifying that the adolescent’s insurance has lapsed, but she remains eligible, and the family seeks support to re-enroll. The family shares concerns regarding educational needs, as the child has not attended school for the past year and is not on track to graduate. The IHELP tool also helps you identify inconsistent transportation availability. Ultimately, a social work consultation is placed which assists with re-enrolling in insurance for the child and obtaining a bus pass for in-person visits. The patient is also supported in enrolling in the use of a videoconferencing platform for virtual visits. You and your team reach out to the school, which provides valuable information regarding the child’s status and how best to support re-engagement. On follow-up, she is now readily engaged in appointments and shares she is no longer worrying about transportation, which has been helpful. She has started initial conversations with the school and has a condensed schedule for reintegration.
Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
References
1. Office of Disease Prevention and Health Promotion, US Department of Health & Human Services. Social Determinants of Health. https://odphp.health.gov/healthypeople/priority-areas/social-determinants-health
2. Cotton N and Shim R. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1385-1389. doi: 10.1016/j.jaac.2022.04.020.
3. US Centers for Disease Control and Prevention. Adverse Childhood Experiences (ACEs): Preventing Early Trauma to Improve Adult Health. https://www.cdc.gov/vitalsigns/aces/index.html.
4. Kenyon C et al. Pediatrics. 2007 Sep;120(3):e734-e738. doi: 10.1542/peds.2006-2495.
5. Colvin JD et al. Acad Pediatr. 2016 Mar;16(2):168-174. doi: 10.1016/j.acap.2015.06.001.
Case vignette: A 16-year-old Nepali-born English-speaking adolescent presents for a well-child visit and notes concerns for anxiety, depression, and a history of trauma. She resides with her parents who work in hospitality with limited time off, and thus she presented for the initial office visit with a neighbor. Parents were not readily available to discuss treatment recommendations, including medication options. The teen shares a number of challenges that makes coming to appointments difficult. You also notice that the patient currently is not enrolled in insurance, though she appears eligible.
The above vignette highlights various social issues and concerns that impact access to healthcare and overall health/well-being. Social determinants of health (SDOH) and factors centered on mental health are now widely known to impact pediatric health and wellbeing. The Office of Disease Prevention and Health Promotion defines SDOH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” SDOH can be grouped into five domains: Economic Stability, Education Access and Quality, Health Care Access and Quality, Neighborhood and Built Environment, and Social and Community Context.1
Additionally, when considering determinants that impact the mental health of children, it is prudent to consider parental psychosocial factors and adverse childhood experiences (ACEs), such as witnessing interpersonal violence, child abuse, parental substance use, and parental depression.2 All these factors have been shown to impact an individual’s mental and physical health not only contemporaneously but also later in life.3
Screening Tool for Pediatric Social Histories
developed by Kenyon et al,4 with further derivations from Colvin et al.5 Utilizing this tool can assist providers with identifying social needs.
The tool begins with a framing statement — “Let me ask you some questions I ask every family” — then proceeds to discuss relevant topics as shared below:
I: Income; Insurance
- Do you have any concerns about making ends meet?
- Do you have any concerns about your child’s health insurance?
H: Hunger, Housing Conditions; Homeless
- Do you have any concerns about having enough food?
- Have you ever been worried whether your food would run out before you got money to buy more?
- Within the past year has the food you bought ever not lasted, and you didn’t have money to get more?
- Do you have any concerns about poor housing conditions like mice, mold, or cockroaches?
- Do you have any concerns about being evicted or not being able to pay the rent?
- Do you have any concerns about not being able to pay your mortgage?
E: Education; Ensuring Safety (Violence)
- Do you have any concerns about your child’s educational needs?
- [DO NOT ASK IN FRONT OF CHILD 3 OR OLDER OR IN FRONT OF OTHER PARTNER] “From speaking to families, I have learned that violence in the home is common and now I ask all families about violence in the home. Do you have any concerns about violence in your home?”
L: Legal status (Immigration)
- What hospital was your child born in?
- If not in the United States: “Are you aware that your child may be eligible for benefits even though they were not born in the US? If you would like, I can have a social worker come talk to you about some possible benefits your child may be eligible for. Would you like me to do that?”
P: Power of Attorney; Guardianship
- Are you the biological mother or father of this child?
- [If not] “Can you show me the power of attorney or guardianship document you have?”
- **PATIENTS >17+ with Mental Incapacity: Ask for Guardianship.
This tool can help with identifying families with significant social needs so that one can attain further historical information and subsequently share resources to assist with any challenges.
Consider the Role of Adverse Childhood Experiences
Additionally, as noted, ACEs often play an important role in overall health and well-being; they include experiencing childhood abuse, neglect, and/or household dysfunction. The impact of these early exposures can lead to toxic stress that can negatively alter the brain and the body’s response to stress over time.3 There are various tools readily available online that can assist with identifying ACEs and interpreting their prevalence. The American Academy of Pediatrics has an updated page of commonly used screening tools. Early identification and intervention can help mitigate the impact of these experiences on long-term outcomes.
Important Considerations Regarding Screening for SDOH and/or ACEs:
- Please consider if screening is helpful in your space, recognizing that there are benefits and potential ethical considerations to screen or not. Ensure an interdisciplinary approach if screening is implemented to ensure that the patient’s experience and well-being is prioritized.
- Try to be intentional in your communication with parents. The patient and family are our teachers and know best what they need.
- Consider what is available in your community and what can be offered to ensure that parents and families are appropriate and eligible for a particular resource.
- Encourage continuous collaboration and partnership with community providers who offer resources that a family may benefit from to ensure that the resource continues to be available.
Returning to the Vignette
Administering the IHELP tool has led to identifying that the adolescent’s insurance has lapsed, but she remains eligible, and the family seeks support to re-enroll. The family shares concerns regarding educational needs, as the child has not attended school for the past year and is not on track to graduate. The IHELP tool also helps you identify inconsistent transportation availability. Ultimately, a social work consultation is placed which assists with re-enrolling in insurance for the child and obtaining a bus pass for in-person visits. The patient is also supported in enrolling in the use of a videoconferencing platform for virtual visits. You and your team reach out to the school, which provides valuable information regarding the child’s status and how best to support re-engagement. On follow-up, she is now readily engaged in appointments and shares she is no longer worrying about transportation, which has been helpful. She has started initial conversations with the school and has a condensed schedule for reintegration.
Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
References
1. Office of Disease Prevention and Health Promotion, US Department of Health & Human Services. Social Determinants of Health. https://odphp.health.gov/healthypeople/priority-areas/social-determinants-health
2. Cotton N and Shim R. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1385-1389. doi: 10.1016/j.jaac.2022.04.020.
3. US Centers for Disease Control and Prevention. Adverse Childhood Experiences (ACEs): Preventing Early Trauma to Improve Adult Health. https://www.cdc.gov/vitalsigns/aces/index.html.
4. Kenyon C et al. Pediatrics. 2007 Sep;120(3):e734-e738. doi: 10.1542/peds.2006-2495.
5. Colvin JD et al. Acad Pediatr. 2016 Mar;16(2):168-174. doi: 10.1016/j.acap.2015.06.001.
Case vignette: A 16-year-old Nepali-born English-speaking adolescent presents for a well-child visit and notes concerns for anxiety, depression, and a history of trauma. She resides with her parents who work in hospitality with limited time off, and thus she presented for the initial office visit with a neighbor. Parents were not readily available to discuss treatment recommendations, including medication options. The teen shares a number of challenges that makes coming to appointments difficult. You also notice that the patient currently is not enrolled in insurance, though she appears eligible.
The above vignette highlights various social issues and concerns that impact access to healthcare and overall health/well-being. Social determinants of health (SDOH) and factors centered on mental health are now widely known to impact pediatric health and wellbeing. The Office of Disease Prevention and Health Promotion defines SDOH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” SDOH can be grouped into five domains: Economic Stability, Education Access and Quality, Health Care Access and Quality, Neighborhood and Built Environment, and Social and Community Context.1
Additionally, when considering determinants that impact the mental health of children, it is prudent to consider parental psychosocial factors and adverse childhood experiences (ACEs), such as witnessing interpersonal violence, child abuse, parental substance use, and parental depression.2 All these factors have been shown to impact an individual’s mental and physical health not only contemporaneously but also later in life.3
Screening Tool for Pediatric Social Histories
developed by Kenyon et al,4 with further derivations from Colvin et al.5 Utilizing this tool can assist providers with identifying social needs.
The tool begins with a framing statement — “Let me ask you some questions I ask every family” — then proceeds to discuss relevant topics as shared below:
I: Income; Insurance
- Do you have any concerns about making ends meet?
- Do you have any concerns about your child’s health insurance?
H: Hunger, Housing Conditions; Homeless
- Do you have any concerns about having enough food?
- Have you ever been worried whether your food would run out before you got money to buy more?
- Within the past year has the food you bought ever not lasted, and you didn’t have money to get more?
- Do you have any concerns about poor housing conditions like mice, mold, or cockroaches?
- Do you have any concerns about being evicted or not being able to pay the rent?
- Do you have any concerns about not being able to pay your mortgage?
E: Education; Ensuring Safety (Violence)
- Do you have any concerns about your child’s educational needs?
- [DO NOT ASK IN FRONT OF CHILD 3 OR OLDER OR IN FRONT OF OTHER PARTNER] “From speaking to families, I have learned that violence in the home is common and now I ask all families about violence in the home. Do you have any concerns about violence in your home?”
L: Legal status (Immigration)
- What hospital was your child born in?
- If not in the United States: “Are you aware that your child may be eligible for benefits even though they were not born in the US? If you would like, I can have a social worker come talk to you about some possible benefits your child may be eligible for. Would you like me to do that?”
P: Power of Attorney; Guardianship
- Are you the biological mother or father of this child?
- [If not] “Can you show me the power of attorney or guardianship document you have?”
- **PATIENTS >17+ with Mental Incapacity: Ask for Guardianship.
This tool can help with identifying families with significant social needs so that one can attain further historical information and subsequently share resources to assist with any challenges.
Consider the Role of Adverse Childhood Experiences
Additionally, as noted, ACEs often play an important role in overall health and well-being; they include experiencing childhood abuse, neglect, and/or household dysfunction. The impact of these early exposures can lead to toxic stress that can negatively alter the brain and the body’s response to stress over time.3 There are various tools readily available online that can assist with identifying ACEs and interpreting their prevalence. The American Academy of Pediatrics has an updated page of commonly used screening tools. Early identification and intervention can help mitigate the impact of these experiences on long-term outcomes.
Important Considerations Regarding Screening for SDOH and/or ACEs:
- Please consider if screening is helpful in your space, recognizing that there are benefits and potential ethical considerations to screen or not. Ensure an interdisciplinary approach if screening is implemented to ensure that the patient’s experience and well-being is prioritized.
- Try to be intentional in your communication with parents. The patient and family are our teachers and know best what they need.
- Consider what is available in your community and what can be offered to ensure that parents and families are appropriate and eligible for a particular resource.
- Encourage continuous collaboration and partnership with community providers who offer resources that a family may benefit from to ensure that the resource continues to be available.
Returning to the Vignette
Administering the IHELP tool has led to identifying that the adolescent’s insurance has lapsed, but she remains eligible, and the family seeks support to re-enroll. The family shares concerns regarding educational needs, as the child has not attended school for the past year and is not on track to graduate. The IHELP tool also helps you identify inconsistent transportation availability. Ultimately, a social work consultation is placed which assists with re-enrolling in insurance for the child and obtaining a bus pass for in-person visits. The patient is also supported in enrolling in the use of a videoconferencing platform for virtual visits. You and your team reach out to the school, which provides valuable information regarding the child’s status and how best to support re-engagement. On follow-up, she is now readily engaged in appointments and shares she is no longer worrying about transportation, which has been helpful. She has started initial conversations with the school and has a condensed schedule for reintegration.
Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
References
1. Office of Disease Prevention and Health Promotion, US Department of Health & Human Services. Social Determinants of Health. https://odphp.health.gov/healthypeople/priority-areas/social-determinants-health
2. Cotton N and Shim R. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1385-1389. doi: 10.1016/j.jaac.2022.04.020.
3. US Centers for Disease Control and Prevention. Adverse Childhood Experiences (ACEs): Preventing Early Trauma to Improve Adult Health. https://www.cdc.gov/vitalsigns/aces/index.html.
4. Kenyon C et al. Pediatrics. 2007 Sep;120(3):e734-e738. doi: 10.1542/peds.2006-2495.
5. Colvin JD et al. Acad Pediatr. 2016 Mar;16(2):168-174. doi: 10.1016/j.acap.2015.06.001.
Children With Severe Atopic Dermatitis Catch Up on Growth With Dupilumab
AMSTERDAM — , revealed a post hoc trial analysis.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The trial included a “rigorously selected … well-characterized, well-studied” population of children aged 6-11 years, said presenter Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland.
It showed that “severe atopic dermatitis does cause restriction of growth, as well as a higher weight, and therefore obviously a higher BMI [body mass index].”
He continued, however, that children at the lower percentiles of height receiving prompt treatment with dupilumab (Dupixent) “were able to rapidly move through the centiles over the 16 weeks of the study, and that may be the window for catch-up growth … when children are growing rapidly.”
Anna Yasmine Kirkorian, MD, chief of dermatology, Children’s National Hospital, Washington, DC, who was not involved in the study, said that she was “surprised” at the degree of growth achieved over the study period, as height is not something that jumps up “overnight.”
“On the other hand, it fits with my experience with children who’ve had the brakes on all of their life due to inflammation, whether it be height, going to school, sleeping — everything is sort of put on pause by this terrible inflammatory process,” she said.
“When you take the brakes off, they get to be who they are going to be,” Kirkorian added. “So I was surprised by the speed of it, but not by the fact that height was acquired.”
Her belief is that in the pre-dupilumab era, severe atopic dermatitis was often insufficiently controlled, so children were “smaller than you would predict from parental height,” and the treatment is “allowing them to reach their genetic potential.”
Post Hoc Analysis
In his presentation, Irvine emphasized that it has been clearly demonstrated that adolescents with moderate and severe atopic dermatitis have a significantly higher likelihood of being below the 25th percentile of height on growth reference charts.
Such children are also at a higher risk of having low bone mineral density and low serum alkaline phosphatase (ALP) levels . While data presented at the EADV 2023 Congress showed that dupilumab significantly increased serum levels of bone ALP compared with placebo, the underlying mechanism remains unclear.
For the current analysis, Irvine and colleagues determined that the proportion of children aged 6-11 years with severe atopic dermatitis and lower stature reach a ≥ 5 centile improvement in height following 16 weeks of dupilumab treatment.
They examined data from the LIBERTY AD PEDS trial, in which patients aged 6-11 years with severe atopic dermatitis were randomized to 300 mg dupilumab every 4 weeks or placebo along with a mild or moderately potent topical corticosteroid. The study found that, overall, dupilumab was associated with significant improvements in signs, symptoms, and quality of life compared with placebo.
Height measures at baseline revealed that “more boys and more girls were below the 50th centile than you would predict for a healthy, normal control population,” Irvine said. “If we look at weight, we see the opposite,” he continued, “with a disproportionate number of boys and girls who are above the 50th centile for weight at baseline.”
Consequently, “we’re seeing these children who are shorter and heavier than the predicted healthy weight range and, as a result, obviously have higher BMI,” Irvine noted, with 67% girls and 62% boys found to have a higher BMI than normal for their age.
After 16 weeks of treatment with dupilumab, there was a much greater gain in height than that seen among those on placebo, with the most pronounced effect seen in children who had the lowest height at baseline. Indeed, among children in the lowest 25% height percentile at baseline, 30.6% on dupilumab vs 11.9% on placebo experienced an increase in height of 5 centiles or more(P < .05).
“This reflects what we see in clinical practice,” Irvine said. “Children often grow dramatically on treatment for atopic dermatitis.”
Among patients with a baseline height below the 30th percentile, 31.9% treated with dupilumab vs 11.1% treated with placebo gained at least 5 centiles in height. The figures for children below the 40th height percentile at baseline were 31.3% vs 15.5% (P < .05 for both).
Although there remained a marked difference in the proportion of children below the 50th height percentile at baseline gaining 5 centiles or more in height, at 29.0% with dupilumab versus 15.7% with placebo, it was no longer significant.
“So the effect of catch-up growth, or growth through the centiles, is most marked in those who are in the 40th centile or below,” Irvine said, indicating that the “more growth restricted kids have much more potential to catch up.”
‘Convincing’ Data
Overall, Kirkorian said in the interview, the data are “convincing” and support her view that severe atopic dermatitis is a “terrible chronic disease that we really underappreciate.” Atopic dermatitis, she added, “should get the respect that any severe chronic illness would have, whether that be arthritis, diabetes, or cardiac disease, because it is a systemic disorder that … profoundly affects quality of life, every minute of every day.”
However, “we don’t get all the referrals we should, until the child has suffered for years and years, and the family has suffered,” as there is a bias that it can be outgrown — although not everybody does — and it “doesn’t look as conspicuous as other chronic skin disorders,” such as psoriasis.
“Now with this study,” Kirkorian said, “it gives us a really compelling point to make to parents, to the community, and to insurers that not only are we affecting the quality of life from the itch standpoint [with dupilumab] but we may have long profound effects on growth and bone health.”
The research was sponsored by Sanofi and Regeneron Pharmaceuticals. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAI, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome. Kirkorian declared relationships with Dermavant, Verrica Pharmaceuticals, Pfizer, and Incyte.
A version of this article first appeared on Medscape.com.
AMSTERDAM — , revealed a post hoc trial analysis.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The trial included a “rigorously selected … well-characterized, well-studied” population of children aged 6-11 years, said presenter Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland.
It showed that “severe atopic dermatitis does cause restriction of growth, as well as a higher weight, and therefore obviously a higher BMI [body mass index].”
He continued, however, that children at the lower percentiles of height receiving prompt treatment with dupilumab (Dupixent) “were able to rapidly move through the centiles over the 16 weeks of the study, and that may be the window for catch-up growth … when children are growing rapidly.”
Anna Yasmine Kirkorian, MD, chief of dermatology, Children’s National Hospital, Washington, DC, who was not involved in the study, said that she was “surprised” at the degree of growth achieved over the study period, as height is not something that jumps up “overnight.”
“On the other hand, it fits with my experience with children who’ve had the brakes on all of their life due to inflammation, whether it be height, going to school, sleeping — everything is sort of put on pause by this terrible inflammatory process,” she said.
“When you take the brakes off, they get to be who they are going to be,” Kirkorian added. “So I was surprised by the speed of it, but not by the fact that height was acquired.”
Her belief is that in the pre-dupilumab era, severe atopic dermatitis was often insufficiently controlled, so children were “smaller than you would predict from parental height,” and the treatment is “allowing them to reach their genetic potential.”
Post Hoc Analysis
In his presentation, Irvine emphasized that it has been clearly demonstrated that adolescents with moderate and severe atopic dermatitis have a significantly higher likelihood of being below the 25th percentile of height on growth reference charts.
Such children are also at a higher risk of having low bone mineral density and low serum alkaline phosphatase (ALP) levels . While data presented at the EADV 2023 Congress showed that dupilumab significantly increased serum levels of bone ALP compared with placebo, the underlying mechanism remains unclear.
For the current analysis, Irvine and colleagues determined that the proportion of children aged 6-11 years with severe atopic dermatitis and lower stature reach a ≥ 5 centile improvement in height following 16 weeks of dupilumab treatment.
They examined data from the LIBERTY AD PEDS trial, in which patients aged 6-11 years with severe atopic dermatitis were randomized to 300 mg dupilumab every 4 weeks or placebo along with a mild or moderately potent topical corticosteroid. The study found that, overall, dupilumab was associated with significant improvements in signs, symptoms, and quality of life compared with placebo.
Height measures at baseline revealed that “more boys and more girls were below the 50th centile than you would predict for a healthy, normal control population,” Irvine said. “If we look at weight, we see the opposite,” he continued, “with a disproportionate number of boys and girls who are above the 50th centile for weight at baseline.”
Consequently, “we’re seeing these children who are shorter and heavier than the predicted healthy weight range and, as a result, obviously have higher BMI,” Irvine noted, with 67% girls and 62% boys found to have a higher BMI than normal for their age.
After 16 weeks of treatment with dupilumab, there was a much greater gain in height than that seen among those on placebo, with the most pronounced effect seen in children who had the lowest height at baseline. Indeed, among children in the lowest 25% height percentile at baseline, 30.6% on dupilumab vs 11.9% on placebo experienced an increase in height of 5 centiles or more(P < .05).
“This reflects what we see in clinical practice,” Irvine said. “Children often grow dramatically on treatment for atopic dermatitis.”
Among patients with a baseline height below the 30th percentile, 31.9% treated with dupilumab vs 11.1% treated with placebo gained at least 5 centiles in height. The figures for children below the 40th height percentile at baseline were 31.3% vs 15.5% (P < .05 for both).
Although there remained a marked difference in the proportion of children below the 50th height percentile at baseline gaining 5 centiles or more in height, at 29.0% with dupilumab versus 15.7% with placebo, it was no longer significant.
“So the effect of catch-up growth, or growth through the centiles, is most marked in those who are in the 40th centile or below,” Irvine said, indicating that the “more growth restricted kids have much more potential to catch up.”
‘Convincing’ Data
Overall, Kirkorian said in the interview, the data are “convincing” and support her view that severe atopic dermatitis is a “terrible chronic disease that we really underappreciate.” Atopic dermatitis, she added, “should get the respect that any severe chronic illness would have, whether that be arthritis, diabetes, or cardiac disease, because it is a systemic disorder that … profoundly affects quality of life, every minute of every day.”
However, “we don’t get all the referrals we should, until the child has suffered for years and years, and the family has suffered,” as there is a bias that it can be outgrown — although not everybody does — and it “doesn’t look as conspicuous as other chronic skin disorders,” such as psoriasis.
“Now with this study,” Kirkorian said, “it gives us a really compelling point to make to parents, to the community, and to insurers that not only are we affecting the quality of life from the itch standpoint [with dupilumab] but we may have long profound effects on growth and bone health.”
The research was sponsored by Sanofi and Regeneron Pharmaceuticals. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAI, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome. Kirkorian declared relationships with Dermavant, Verrica Pharmaceuticals, Pfizer, and Incyte.
A version of this article first appeared on Medscape.com.
AMSTERDAM — , revealed a post hoc trial analysis.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The trial included a “rigorously selected … well-characterized, well-studied” population of children aged 6-11 years, said presenter Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland.
It showed that “severe atopic dermatitis does cause restriction of growth, as well as a higher weight, and therefore obviously a higher BMI [body mass index].”
He continued, however, that children at the lower percentiles of height receiving prompt treatment with dupilumab (Dupixent) “were able to rapidly move through the centiles over the 16 weeks of the study, and that may be the window for catch-up growth … when children are growing rapidly.”
Anna Yasmine Kirkorian, MD, chief of dermatology, Children’s National Hospital, Washington, DC, who was not involved in the study, said that she was “surprised” at the degree of growth achieved over the study period, as height is not something that jumps up “overnight.”
“On the other hand, it fits with my experience with children who’ve had the brakes on all of their life due to inflammation, whether it be height, going to school, sleeping — everything is sort of put on pause by this terrible inflammatory process,” she said.
“When you take the brakes off, they get to be who they are going to be,” Kirkorian added. “So I was surprised by the speed of it, but not by the fact that height was acquired.”
Her belief is that in the pre-dupilumab era, severe atopic dermatitis was often insufficiently controlled, so children were “smaller than you would predict from parental height,” and the treatment is “allowing them to reach their genetic potential.”
Post Hoc Analysis
In his presentation, Irvine emphasized that it has been clearly demonstrated that adolescents with moderate and severe atopic dermatitis have a significantly higher likelihood of being below the 25th percentile of height on growth reference charts.
Such children are also at a higher risk of having low bone mineral density and low serum alkaline phosphatase (ALP) levels . While data presented at the EADV 2023 Congress showed that dupilumab significantly increased serum levels of bone ALP compared with placebo, the underlying mechanism remains unclear.
For the current analysis, Irvine and colleagues determined that the proportion of children aged 6-11 years with severe atopic dermatitis and lower stature reach a ≥ 5 centile improvement in height following 16 weeks of dupilumab treatment.
They examined data from the LIBERTY AD PEDS trial, in which patients aged 6-11 years with severe atopic dermatitis were randomized to 300 mg dupilumab every 4 weeks or placebo along with a mild or moderately potent topical corticosteroid. The study found that, overall, dupilumab was associated with significant improvements in signs, symptoms, and quality of life compared with placebo.
Height measures at baseline revealed that “more boys and more girls were below the 50th centile than you would predict for a healthy, normal control population,” Irvine said. “If we look at weight, we see the opposite,” he continued, “with a disproportionate number of boys and girls who are above the 50th centile for weight at baseline.”
Consequently, “we’re seeing these children who are shorter and heavier than the predicted healthy weight range and, as a result, obviously have higher BMI,” Irvine noted, with 67% girls and 62% boys found to have a higher BMI than normal for their age.
After 16 weeks of treatment with dupilumab, there was a much greater gain in height than that seen among those on placebo, with the most pronounced effect seen in children who had the lowest height at baseline. Indeed, among children in the lowest 25% height percentile at baseline, 30.6% on dupilumab vs 11.9% on placebo experienced an increase in height of 5 centiles or more(P < .05).
“This reflects what we see in clinical practice,” Irvine said. “Children often grow dramatically on treatment for atopic dermatitis.”
Among patients with a baseline height below the 30th percentile, 31.9% treated with dupilumab vs 11.1% treated with placebo gained at least 5 centiles in height. The figures for children below the 40th height percentile at baseline were 31.3% vs 15.5% (P < .05 for both).
Although there remained a marked difference in the proportion of children below the 50th height percentile at baseline gaining 5 centiles or more in height, at 29.0% with dupilumab versus 15.7% with placebo, it was no longer significant.
“So the effect of catch-up growth, or growth through the centiles, is most marked in those who are in the 40th centile or below,” Irvine said, indicating that the “more growth restricted kids have much more potential to catch up.”
‘Convincing’ Data
Overall, Kirkorian said in the interview, the data are “convincing” and support her view that severe atopic dermatitis is a “terrible chronic disease that we really underappreciate.” Atopic dermatitis, she added, “should get the respect that any severe chronic illness would have, whether that be arthritis, diabetes, or cardiac disease, because it is a systemic disorder that … profoundly affects quality of life, every minute of every day.”
However, “we don’t get all the referrals we should, until the child has suffered for years and years, and the family has suffered,” as there is a bias that it can be outgrown — although not everybody does — and it “doesn’t look as conspicuous as other chronic skin disorders,” such as psoriasis.
“Now with this study,” Kirkorian said, “it gives us a really compelling point to make to parents, to the community, and to insurers that not only are we affecting the quality of life from the itch standpoint [with dupilumab] but we may have long profound effects on growth and bone health.”
The research was sponsored by Sanofi and Regeneron Pharmaceuticals. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAI, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome. Kirkorian declared relationships with Dermavant, Verrica Pharmaceuticals, Pfizer, and Incyte.
A version of this article first appeared on Medscape.com.
FROM EADV 2024
Nemolizumab Benefits for Atopic Dermatitis Maintained in Long-Term Follow-Up Study
(AD), revealed an interim analysis of the ARCADIA open-label extension study.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The results showed nemolizumab was associated with “ongoing clinically meaningful improvements in itch, skin lesions, and sleep disturbance,” said study presenter Diamant Thaçi, MD, PhD, of the Comprehensive Center for Inflammation Medicine, University of Lü̈beck in Germany.
Moreover, “patient-reported outcomes, including quality of life ... continued to improve over 56 weeks of treatment.” In addition, Thaçi added, the “safety data support the long-term use of nemolizumab for the treatment of adolescent and adult patients with moderate to severe atopic dermatitis.”
He explained that interleukin (IL) 31 is a key neuroimmune cytokine in AD, triggering itch, skin barrier disruption, and exacerbation of inflammation via its receptor. Nemolizumab inhibits IL-31 receptor binding and was shown in the ARCADIA 1 and ARCADIA 2 trials to provide, along with background topical corticosteroids, clinically meaningful improvements in itch, skin lesions, and sleep for up to weeks 48 of follow-up in adolescents and adults with moderate to severe AD.
The current open-label long-term extension study involved patients who were enrolled in both ARCADIA 1 and 2 trials, as well as those from four phase 2 and 2b studies, a phase 3b study, and adolescents who had not been included in a trial but who met the criteria for the extension study. All patients, whether they started on placebo plus background topical corticosteroids in a prior study, were treated with nemolizumab 30 mg subcutaneously every 4 weeks along with topical corticosteroids.
The interim analysis included all efficacy and safety data up to the cutoff of September 30, 2022, on 723 patients who had completed 56 weeks of treatment among the 1751 patients initially enrolled in the extension study.
The results showed that, regardless of whether patients were nemolizumab naive at enrollment or had previously taken the drug, there were increases in the proportion of patients with an Investigator Global Assessment (IGA) score of 0/1 and an Eczema Area and Severity Index (EASI) score of at least 75 (EASI-75) over the 56 weeks of the study.
In those naive to nemolizumab, the increase in the proportion with an IGA score of 0/1 increased from 17.7% at baseline to 49.0% at 56 weeks, while the proportion with an EASI-75 increased from 24.0% to 78.7%.
The increase in the proportion of patients with an IGA score 0/1 among those who had previously received nemolizumab increased from 28.5% at baseline to 47.1% at 56 weeks. The proportion with an EASI-75 was 38.1% at baseline, rising to 73.0% at 56 weeks.
Increases in the proportion of patients with an EASI score of at least 50 and at least 90 were also seen with nemolizumab, as were increases in the proportion of patients with an improvement of at least four points on the SCORing Atopic Dermatitis Pruritus visual analogue scale and Sleep loss scores.
Similarly, the proportion of patients with a reduction in Dermatology Life Quality Index of at least four points increased over the study period.
Regarding safety, Thaçi said, there appeared to be fewer adverse events than had been previously reported with nemolizumab. “We don’t see any signs of conjunctivitis,” he continued, or significant risk of infection apart from for COVID-19, but he pointed out that the study was conducted during the pandemic, which was “a very difficult time.”
The most common treatment-related adverse events were, aside from COVID-19, nasopharyngitis in about 10%-11% of patients, upper respiratory tract infection in about 6% to almost 7%, and headache in about 5%.
Among the adverse events of special interest, newly diagnosed asthma or worsening of asthma occurred in 4.7%-4.8% of patients, while peripheral edema was seen in 0.8%-1.7%.
“Besides this, the study results are really looking very good,” he said, adding: “It means, in a long-term study, we can say today that nemolizumab has revealed the [same] safety profile that was shown in the ARCADIA 1 and 2 trials.”
Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin in Ireland, who was not involved in the study, underlined that the current interim assessment does not represent the complete dataset and is based on observed cases rather than a more rigorous methodology, such as net reclassification improvement analysis.
“So it makes it a little harder to interpret when you don’t know how many people are dropping out and why they’re dropping out,” he told this news organization. “That said, those who remain on drug out to 56 weeks do experience ongoing improvement in disease control.”
Consequently, “the most reliable message you can take from this interim analysis of long-term data is that there were no new safety signals,” and nemolizumab looks “safe and well-tolerated.”
Where nemolizumab would fit into the treatment pathway for moderate to severe AD remains an open question, Irvine said, although he believes that IL-13 pathway inhibitors such as dupilumab, tralokinumab, and lebrikizumab “will remain the treatment of choice for the immediate future due to prescriber familiarity and good efficacy data.”
However, for patients who are unsuitable for IL-13 inhibitors and/or Janus kinase inhibitors such as abrocitinib and upadacitinib, nemolizumab “could be an interesting alternative.”
“That’s probably where it is going to start,” Irvine said, “and then obviously that will change over time and as the data mature and prescribers become more familiar with the drug in the real world.”
Nemolizumab (Nemluvio) is approved for treating prurigo nodularis (PN) in the United States and in Japan and is under Food and Drug Administration review for treating AD. It is also under review for PN and AD in Europe, Canada, the United Kingdom, and several other countries, according to Galderma. It is also approved for treating pruritus associated with AD in pediatric, adolescent, and adult patients in Japan.
The study was funded by Galderma. Thaçi declared relationships with AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, Target RWE, and UCB. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAl, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome.
A version of this article first appeared on Medscape.com.
(AD), revealed an interim analysis of the ARCADIA open-label extension study.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The results showed nemolizumab was associated with “ongoing clinically meaningful improvements in itch, skin lesions, and sleep disturbance,” said study presenter Diamant Thaçi, MD, PhD, of the Comprehensive Center for Inflammation Medicine, University of Lü̈beck in Germany.
Moreover, “patient-reported outcomes, including quality of life ... continued to improve over 56 weeks of treatment.” In addition, Thaçi added, the “safety data support the long-term use of nemolizumab for the treatment of adolescent and adult patients with moderate to severe atopic dermatitis.”
He explained that interleukin (IL) 31 is a key neuroimmune cytokine in AD, triggering itch, skin barrier disruption, and exacerbation of inflammation via its receptor. Nemolizumab inhibits IL-31 receptor binding and was shown in the ARCADIA 1 and ARCADIA 2 trials to provide, along with background topical corticosteroids, clinically meaningful improvements in itch, skin lesions, and sleep for up to weeks 48 of follow-up in adolescents and adults with moderate to severe AD.
The current open-label long-term extension study involved patients who were enrolled in both ARCADIA 1 and 2 trials, as well as those from four phase 2 and 2b studies, a phase 3b study, and adolescents who had not been included in a trial but who met the criteria for the extension study. All patients, whether they started on placebo plus background topical corticosteroids in a prior study, were treated with nemolizumab 30 mg subcutaneously every 4 weeks along with topical corticosteroids.
The interim analysis included all efficacy and safety data up to the cutoff of September 30, 2022, on 723 patients who had completed 56 weeks of treatment among the 1751 patients initially enrolled in the extension study.
The results showed that, regardless of whether patients were nemolizumab naive at enrollment or had previously taken the drug, there were increases in the proportion of patients with an Investigator Global Assessment (IGA) score of 0/1 and an Eczema Area and Severity Index (EASI) score of at least 75 (EASI-75) over the 56 weeks of the study.
In those naive to nemolizumab, the increase in the proportion with an IGA score of 0/1 increased from 17.7% at baseline to 49.0% at 56 weeks, while the proportion with an EASI-75 increased from 24.0% to 78.7%.
The increase in the proportion of patients with an IGA score 0/1 among those who had previously received nemolizumab increased from 28.5% at baseline to 47.1% at 56 weeks. The proportion with an EASI-75 was 38.1% at baseline, rising to 73.0% at 56 weeks.
Increases in the proportion of patients with an EASI score of at least 50 and at least 90 were also seen with nemolizumab, as were increases in the proportion of patients with an improvement of at least four points on the SCORing Atopic Dermatitis Pruritus visual analogue scale and Sleep loss scores.
Similarly, the proportion of patients with a reduction in Dermatology Life Quality Index of at least four points increased over the study period.
Regarding safety, Thaçi said, there appeared to be fewer adverse events than had been previously reported with nemolizumab. “We don’t see any signs of conjunctivitis,” he continued, or significant risk of infection apart from for COVID-19, but he pointed out that the study was conducted during the pandemic, which was “a very difficult time.”
The most common treatment-related adverse events were, aside from COVID-19, nasopharyngitis in about 10%-11% of patients, upper respiratory tract infection in about 6% to almost 7%, and headache in about 5%.
Among the adverse events of special interest, newly diagnosed asthma or worsening of asthma occurred in 4.7%-4.8% of patients, while peripheral edema was seen in 0.8%-1.7%.
“Besides this, the study results are really looking very good,” he said, adding: “It means, in a long-term study, we can say today that nemolizumab has revealed the [same] safety profile that was shown in the ARCADIA 1 and 2 trials.”
Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin in Ireland, who was not involved in the study, underlined that the current interim assessment does not represent the complete dataset and is based on observed cases rather than a more rigorous methodology, such as net reclassification improvement analysis.
“So it makes it a little harder to interpret when you don’t know how many people are dropping out and why they’re dropping out,” he told this news organization. “That said, those who remain on drug out to 56 weeks do experience ongoing improvement in disease control.”
Consequently, “the most reliable message you can take from this interim analysis of long-term data is that there were no new safety signals,” and nemolizumab looks “safe and well-tolerated.”
Where nemolizumab would fit into the treatment pathway for moderate to severe AD remains an open question, Irvine said, although he believes that IL-13 pathway inhibitors such as dupilumab, tralokinumab, and lebrikizumab “will remain the treatment of choice for the immediate future due to prescriber familiarity and good efficacy data.”
However, for patients who are unsuitable for IL-13 inhibitors and/or Janus kinase inhibitors such as abrocitinib and upadacitinib, nemolizumab “could be an interesting alternative.”
“That’s probably where it is going to start,” Irvine said, “and then obviously that will change over time and as the data mature and prescribers become more familiar with the drug in the real world.”
Nemolizumab (Nemluvio) is approved for treating prurigo nodularis (PN) in the United States and in Japan and is under Food and Drug Administration review for treating AD. It is also under review for PN and AD in Europe, Canada, the United Kingdom, and several other countries, according to Galderma. It is also approved for treating pruritus associated with AD in pediatric, adolescent, and adult patients in Japan.
The study was funded by Galderma. Thaçi declared relationships with AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, Target RWE, and UCB. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAl, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome.
A version of this article first appeared on Medscape.com.
(AD), revealed an interim analysis of the ARCADIA open-label extension study.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The results showed nemolizumab was associated with “ongoing clinically meaningful improvements in itch, skin lesions, and sleep disturbance,” said study presenter Diamant Thaçi, MD, PhD, of the Comprehensive Center for Inflammation Medicine, University of Lü̈beck in Germany.
Moreover, “patient-reported outcomes, including quality of life ... continued to improve over 56 weeks of treatment.” In addition, Thaçi added, the “safety data support the long-term use of nemolizumab for the treatment of adolescent and adult patients with moderate to severe atopic dermatitis.”
He explained that interleukin (IL) 31 is a key neuroimmune cytokine in AD, triggering itch, skin barrier disruption, and exacerbation of inflammation via its receptor. Nemolizumab inhibits IL-31 receptor binding and was shown in the ARCADIA 1 and ARCADIA 2 trials to provide, along with background topical corticosteroids, clinically meaningful improvements in itch, skin lesions, and sleep for up to weeks 48 of follow-up in adolescents and adults with moderate to severe AD.
The current open-label long-term extension study involved patients who were enrolled in both ARCADIA 1 and 2 trials, as well as those from four phase 2 and 2b studies, a phase 3b study, and adolescents who had not been included in a trial but who met the criteria for the extension study. All patients, whether they started on placebo plus background topical corticosteroids in a prior study, were treated with nemolizumab 30 mg subcutaneously every 4 weeks along with topical corticosteroids.
The interim analysis included all efficacy and safety data up to the cutoff of September 30, 2022, on 723 patients who had completed 56 weeks of treatment among the 1751 patients initially enrolled in the extension study.
The results showed that, regardless of whether patients were nemolizumab naive at enrollment or had previously taken the drug, there were increases in the proportion of patients with an Investigator Global Assessment (IGA) score of 0/1 and an Eczema Area and Severity Index (EASI) score of at least 75 (EASI-75) over the 56 weeks of the study.
In those naive to nemolizumab, the increase in the proportion with an IGA score of 0/1 increased from 17.7% at baseline to 49.0% at 56 weeks, while the proportion with an EASI-75 increased from 24.0% to 78.7%.
The increase in the proportion of patients with an IGA score 0/1 among those who had previously received nemolizumab increased from 28.5% at baseline to 47.1% at 56 weeks. The proportion with an EASI-75 was 38.1% at baseline, rising to 73.0% at 56 weeks.
Increases in the proportion of patients with an EASI score of at least 50 and at least 90 were also seen with nemolizumab, as were increases in the proportion of patients with an improvement of at least four points on the SCORing Atopic Dermatitis Pruritus visual analogue scale and Sleep loss scores.
Similarly, the proportion of patients with a reduction in Dermatology Life Quality Index of at least four points increased over the study period.
Regarding safety, Thaçi said, there appeared to be fewer adverse events than had been previously reported with nemolizumab. “We don’t see any signs of conjunctivitis,” he continued, or significant risk of infection apart from for COVID-19, but he pointed out that the study was conducted during the pandemic, which was “a very difficult time.”
The most common treatment-related adverse events were, aside from COVID-19, nasopharyngitis in about 10%-11% of patients, upper respiratory tract infection in about 6% to almost 7%, and headache in about 5%.
Among the adverse events of special interest, newly diagnosed asthma or worsening of asthma occurred in 4.7%-4.8% of patients, while peripheral edema was seen in 0.8%-1.7%.
“Besides this, the study results are really looking very good,” he said, adding: “It means, in a long-term study, we can say today that nemolizumab has revealed the [same] safety profile that was shown in the ARCADIA 1 and 2 trials.”
Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin in Ireland, who was not involved in the study, underlined that the current interim assessment does not represent the complete dataset and is based on observed cases rather than a more rigorous methodology, such as net reclassification improvement analysis.
“So it makes it a little harder to interpret when you don’t know how many people are dropping out and why they’re dropping out,” he told this news organization. “That said, those who remain on drug out to 56 weeks do experience ongoing improvement in disease control.”
Consequently, “the most reliable message you can take from this interim analysis of long-term data is that there were no new safety signals,” and nemolizumab looks “safe and well-tolerated.”
Where nemolizumab would fit into the treatment pathway for moderate to severe AD remains an open question, Irvine said, although he believes that IL-13 pathway inhibitors such as dupilumab, tralokinumab, and lebrikizumab “will remain the treatment of choice for the immediate future due to prescriber familiarity and good efficacy data.”
However, for patients who are unsuitable for IL-13 inhibitors and/or Janus kinase inhibitors such as abrocitinib and upadacitinib, nemolizumab “could be an interesting alternative.”
“That’s probably where it is going to start,” Irvine said, “and then obviously that will change over time and as the data mature and prescribers become more familiar with the drug in the real world.”
Nemolizumab (Nemluvio) is approved for treating prurigo nodularis (PN) in the United States and in Japan and is under Food and Drug Administration review for treating AD. It is also under review for PN and AD in Europe, Canada, the United Kingdom, and several other countries, according to Galderma. It is also approved for treating pruritus associated with AD in pediatric, adolescent, and adult patients in Japan.
The study was funded by Galderma. Thaçi declared relationships with AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, Target RWE, and UCB. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAl, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome.
A version of this article first appeared on Medscape.com.
FROM EADV 2024
Triple P
Podcasts, websites, and large “Parenting” sections in bookstores testify to the large demand for parent guidance and support, but also to the fact that there is no one universally accepted guidebook, such as Benjamin Spock provided for parents almost 80 years ago with Baby and Child Care.
We will describe the basic components of this curriculum so that you may determine whether it might be useful to the families in your practice. Then we will expand upon the domains that have proven essential for parents to nurture healthy development in their children. Even if you do not have the time or resources to provide the full Triple P curriculum, you can offer these principles directly to parents and decide when to refer them to access more formal parent training and coaching.
Triple P was developed by psychologist Matthew Sanders, to “promote positive, caring relationships between parents and their children and to help parents develop effective management strategies for dealing with a variety of childhood behavior problems and common developmental issues” as his doctoral project in Australia in the 1980s. Research in the 1990s suggested substantial efficacy, and it was packaged for broader adoption in the early 2000s. It is a tiered approach, meaning there is content for universal education (level 1), up through more intensive, specialized, and individualized content to be delivered in group or individual settings focused on building specific skills or addressing select problems. It was originally developed for the parents of 0- to 11-year-old children, with additional curricula for parents of teenagers created later. It always is delivered to parents only, through a mix of video and reading, or in-person groups or individual coaching. While the universal education resources are available for free to families of children under 12 in Australia, resources and training are available for a fee in the United states (triplep.net). Research has demonstrated considerable efficacy at reducing some of the common behavioral problems of childhood, improving parental confidence and family harmony, and decreasing rates of parental depression. It has even demonstrated efficacy in reducing the incidence of child maltreatment.
Triple P focuses on what Sanders calls the five key principles of positive parenting:
- 1. Creating a safe and engaging environment for children
- 2. Providing a positive learning environment for children
- 3. Assertive discipline
- 4. Having realistic expectations
- 5. Parental self-care.
The educational materials and more intensive parent trainings are all focused on developing knowledge and skills in the parents that will promote a positive relationship with their children, teach the children new skills while encouraging desirable behaviors, and managing problematic behaviors. The training happens with written or video scenarios, up through individualized skill coaching with homework and direct feedback from trained clinicians. While information about the universally helpful knowledge and skills can be found online or accessed through some local programs in the United States, the higher levels of intervention are less consistently available. You should explore what is available in your community, but even if you don’t have the resources for your own training, you are already offering parent guidance at every visit.
Practical Strategies
Below are practical strategies to offer parents the knowledge and support that are essential to “positive parenting,” so they may nurture their children’s healthiest development.
Attunement: Attunement is simply a parent’s ability to know who their child is and where their child is at any given time. This covers an appreciation of the child’s temperament, style, interests, strengths, and vulnerabilities. Where their child is at includes being able to read that particular child’s cues: Are they hungry? Sleepy? Sick? Frustrated? Parents are the experts on their children, but their children are also always changing. You can help the parents in your practice be intentional about being attuned to their children, so they can always be deepening their understanding of who their children are (becoming) and where they are at in any given moment. This requires protecting regular, unstructured time when they can give their children their full attention: reading, doing an art project, practicing music, or basketball. Schedules are often packed with work and school, driving between many structured activities. Reassure the parents in your practice that time spent in play is just as important. When a parent is present, attentive, and curious, asking questions, learning about the child’s thoughts, feelings and ideas, they are doing some of the most essential (and delightful) work of raising children.
Positive Environment: A “positive environment” is child-centered, with access to age-appropriate activities of a wide range. Offering first-time parents written resources about child development and age-appropriate games, books, and activities is an easy way to support positive parenting. A positive environment also has structure and routines, so children can play and explore with the comfort of knowing what to expect and what is expected of them. Do they have a regular bedtime and bedtime routines? Do they consistently eat dinner together and clean up as a family? Do they have reliable unstructured time together, maybe playing board games or kickball after dinner? These varying but predictable routines provide opportunities for children to practice helping, following through, sharing, and tolerating frustration or failure, and they give parents low-stakes opportunities to offer praise for their effort, compassion when they struggle, and affection for no reason at all. They lower the chances of parent-child interactions being predominantly reactive, demanding, pleading, or angry.
Effective Discipline: A positive environment includes reasonable and consistent consequences for rule breaking and poor behavior, and an essential part of predictability includes clear ground rules for what is expected of children at home, around chores, getting ready for school and bedtime, and their behavior. Parents need to agree on and children should understand what the consequences will be for breaking rules. Parents should also have a clear strategy for consistently and calmly enforcing rules. This is not easy, but is just as important as affection and play. If parents are struggling with discipline, it is worth asking for a specific example to learn about where the trouble lies. Are parents not on the same page? Are they worried about their children’s distress? Do they lose their temper and the matter escalates? Clear ground rules and a game plan can help them to stay calm instead of resorting to pleading and yelling. Speaking with them about the value of planning and communicating about these expectations and rules during a quiet time, not in the midst of conflict, might be enough to help them with effective discipline. Others may need more support. Books like 123 Magic with more detail on how to manage time outs can be helpful. For those parents who are managing greater difficulty, a referral to parent coaching (with a modality such as Triple P, Parent-Child Interaction Training or Collaborative Problem Solving) may be needed.
Parental Well-Being: Being aligned with one’s spouse (or other caregiver) in how to manage challenging child behaviors is essential to a healthy relationship, and overall well-being is an essential ingredient in creating a nurturing, positive environment at home. How is the parents’ communication with each other overall? Do they have time together that is not focused on the children? Does each parent have time for outside interests or hobbies? How about other important relationships? Do they prioritize their own sleep, regular exercise, and good nutrition? It can be powerful if they plan family activities that are centered on their own passions and interests as well as their children’s. It is powerful for parents to hear from you that when they protect some of their time and energy to simply care for their own health and well-being, they are building a positive environment for their children, both in how they will show up for their family and in what they model.
Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
Suggested Reading
Sanders MR et al. The Development and Dissemination of the Triple P – Positive Parenting Program: A Multilevel Evidence-Based System of Parenting and Family Support. Prev Sci. 2002 Sep;3(3):173-89. doi: 10.1023/a:1019942516231.
Sanders MR. The Triple P System of Evidence-Based Parenting Support: Past, Present, and Future Directions. Clin Child Fam Psychol Rev. 2023 Dec;26(4):880-903. doi: 10.1007/s10567-023-00441-8.
Podcasts, websites, and large “Parenting” sections in bookstores testify to the large demand for parent guidance and support, but also to the fact that there is no one universally accepted guidebook, such as Benjamin Spock provided for parents almost 80 years ago with Baby and Child Care.
We will describe the basic components of this curriculum so that you may determine whether it might be useful to the families in your practice. Then we will expand upon the domains that have proven essential for parents to nurture healthy development in their children. Even if you do not have the time or resources to provide the full Triple P curriculum, you can offer these principles directly to parents and decide when to refer them to access more formal parent training and coaching.
Triple P was developed by psychologist Matthew Sanders, to “promote positive, caring relationships between parents and their children and to help parents develop effective management strategies for dealing with a variety of childhood behavior problems and common developmental issues” as his doctoral project in Australia in the 1980s. Research in the 1990s suggested substantial efficacy, and it was packaged for broader adoption in the early 2000s. It is a tiered approach, meaning there is content for universal education (level 1), up through more intensive, specialized, and individualized content to be delivered in group or individual settings focused on building specific skills or addressing select problems. It was originally developed for the parents of 0- to 11-year-old children, with additional curricula for parents of teenagers created later. It always is delivered to parents only, through a mix of video and reading, or in-person groups or individual coaching. While the universal education resources are available for free to families of children under 12 in Australia, resources and training are available for a fee in the United states (triplep.net). Research has demonstrated considerable efficacy at reducing some of the common behavioral problems of childhood, improving parental confidence and family harmony, and decreasing rates of parental depression. It has even demonstrated efficacy in reducing the incidence of child maltreatment.
Triple P focuses on what Sanders calls the five key principles of positive parenting:
- 1. Creating a safe and engaging environment for children
- 2. Providing a positive learning environment for children
- 3. Assertive discipline
- 4. Having realistic expectations
- 5. Parental self-care.
The educational materials and more intensive parent trainings are all focused on developing knowledge and skills in the parents that will promote a positive relationship with their children, teach the children new skills while encouraging desirable behaviors, and managing problematic behaviors. The training happens with written or video scenarios, up through individualized skill coaching with homework and direct feedback from trained clinicians. While information about the universally helpful knowledge and skills can be found online or accessed through some local programs in the United States, the higher levels of intervention are less consistently available. You should explore what is available in your community, but even if you don’t have the resources for your own training, you are already offering parent guidance at every visit.
Practical Strategies
Below are practical strategies to offer parents the knowledge and support that are essential to “positive parenting,” so they may nurture their children’s healthiest development.
Attunement: Attunement is simply a parent’s ability to know who their child is and where their child is at any given time. This covers an appreciation of the child’s temperament, style, interests, strengths, and vulnerabilities. Where their child is at includes being able to read that particular child’s cues: Are they hungry? Sleepy? Sick? Frustrated? Parents are the experts on their children, but their children are also always changing. You can help the parents in your practice be intentional about being attuned to their children, so they can always be deepening their understanding of who their children are (becoming) and where they are at in any given moment. This requires protecting regular, unstructured time when they can give their children their full attention: reading, doing an art project, practicing music, or basketball. Schedules are often packed with work and school, driving between many structured activities. Reassure the parents in your practice that time spent in play is just as important. When a parent is present, attentive, and curious, asking questions, learning about the child’s thoughts, feelings and ideas, they are doing some of the most essential (and delightful) work of raising children.
Positive Environment: A “positive environment” is child-centered, with access to age-appropriate activities of a wide range. Offering first-time parents written resources about child development and age-appropriate games, books, and activities is an easy way to support positive parenting. A positive environment also has structure and routines, so children can play and explore with the comfort of knowing what to expect and what is expected of them. Do they have a regular bedtime and bedtime routines? Do they consistently eat dinner together and clean up as a family? Do they have reliable unstructured time together, maybe playing board games or kickball after dinner? These varying but predictable routines provide opportunities for children to practice helping, following through, sharing, and tolerating frustration or failure, and they give parents low-stakes opportunities to offer praise for their effort, compassion when they struggle, and affection for no reason at all. They lower the chances of parent-child interactions being predominantly reactive, demanding, pleading, or angry.
Effective Discipline: A positive environment includes reasonable and consistent consequences for rule breaking and poor behavior, and an essential part of predictability includes clear ground rules for what is expected of children at home, around chores, getting ready for school and bedtime, and their behavior. Parents need to agree on and children should understand what the consequences will be for breaking rules. Parents should also have a clear strategy for consistently and calmly enforcing rules. This is not easy, but is just as important as affection and play. If parents are struggling with discipline, it is worth asking for a specific example to learn about where the trouble lies. Are parents not on the same page? Are they worried about their children’s distress? Do they lose their temper and the matter escalates? Clear ground rules and a game plan can help them to stay calm instead of resorting to pleading and yelling. Speaking with them about the value of planning and communicating about these expectations and rules during a quiet time, not in the midst of conflict, might be enough to help them with effective discipline. Others may need more support. Books like 123 Magic with more detail on how to manage time outs can be helpful. For those parents who are managing greater difficulty, a referral to parent coaching (with a modality such as Triple P, Parent-Child Interaction Training or Collaborative Problem Solving) may be needed.
Parental Well-Being: Being aligned with one’s spouse (or other caregiver) in how to manage challenging child behaviors is essential to a healthy relationship, and overall well-being is an essential ingredient in creating a nurturing, positive environment at home. How is the parents’ communication with each other overall? Do they have time together that is not focused on the children? Does each parent have time for outside interests or hobbies? How about other important relationships? Do they prioritize their own sleep, regular exercise, and good nutrition? It can be powerful if they plan family activities that are centered on their own passions and interests as well as their children’s. It is powerful for parents to hear from you that when they protect some of their time and energy to simply care for their own health and well-being, they are building a positive environment for their children, both in how they will show up for their family and in what they model.
Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
Suggested Reading
Sanders MR et al. The Development and Dissemination of the Triple P – Positive Parenting Program: A Multilevel Evidence-Based System of Parenting and Family Support. Prev Sci. 2002 Sep;3(3):173-89. doi: 10.1023/a:1019942516231.
Sanders MR. The Triple P System of Evidence-Based Parenting Support: Past, Present, and Future Directions. Clin Child Fam Psychol Rev. 2023 Dec;26(4):880-903. doi: 10.1007/s10567-023-00441-8.
Podcasts, websites, and large “Parenting” sections in bookstores testify to the large demand for parent guidance and support, but also to the fact that there is no one universally accepted guidebook, such as Benjamin Spock provided for parents almost 80 years ago with Baby and Child Care.
We will describe the basic components of this curriculum so that you may determine whether it might be useful to the families in your practice. Then we will expand upon the domains that have proven essential for parents to nurture healthy development in their children. Even if you do not have the time or resources to provide the full Triple P curriculum, you can offer these principles directly to parents and decide when to refer them to access more formal parent training and coaching.
Triple P was developed by psychologist Matthew Sanders, to “promote positive, caring relationships between parents and their children and to help parents develop effective management strategies for dealing with a variety of childhood behavior problems and common developmental issues” as his doctoral project in Australia in the 1980s. Research in the 1990s suggested substantial efficacy, and it was packaged for broader adoption in the early 2000s. It is a tiered approach, meaning there is content for universal education (level 1), up through more intensive, specialized, and individualized content to be delivered in group or individual settings focused on building specific skills or addressing select problems. It was originally developed for the parents of 0- to 11-year-old children, with additional curricula for parents of teenagers created later. It always is delivered to parents only, through a mix of video and reading, or in-person groups or individual coaching. While the universal education resources are available for free to families of children under 12 in Australia, resources and training are available for a fee in the United states (triplep.net). Research has demonstrated considerable efficacy at reducing some of the common behavioral problems of childhood, improving parental confidence and family harmony, and decreasing rates of parental depression. It has even demonstrated efficacy in reducing the incidence of child maltreatment.
Triple P focuses on what Sanders calls the five key principles of positive parenting:
- 1. Creating a safe and engaging environment for children
- 2. Providing a positive learning environment for children
- 3. Assertive discipline
- 4. Having realistic expectations
- 5. Parental self-care.
The educational materials and more intensive parent trainings are all focused on developing knowledge and skills in the parents that will promote a positive relationship with their children, teach the children new skills while encouraging desirable behaviors, and managing problematic behaviors. The training happens with written or video scenarios, up through individualized skill coaching with homework and direct feedback from trained clinicians. While information about the universally helpful knowledge and skills can be found online or accessed through some local programs in the United States, the higher levels of intervention are less consistently available. You should explore what is available in your community, but even if you don’t have the resources for your own training, you are already offering parent guidance at every visit.
Practical Strategies
Below are practical strategies to offer parents the knowledge and support that are essential to “positive parenting,” so they may nurture their children’s healthiest development.
Attunement: Attunement is simply a parent’s ability to know who their child is and where their child is at any given time. This covers an appreciation of the child’s temperament, style, interests, strengths, and vulnerabilities. Where their child is at includes being able to read that particular child’s cues: Are they hungry? Sleepy? Sick? Frustrated? Parents are the experts on their children, but their children are also always changing. You can help the parents in your practice be intentional about being attuned to their children, so they can always be deepening their understanding of who their children are (becoming) and where they are at in any given moment. This requires protecting regular, unstructured time when they can give their children their full attention: reading, doing an art project, practicing music, or basketball. Schedules are often packed with work and school, driving between many structured activities. Reassure the parents in your practice that time spent in play is just as important. When a parent is present, attentive, and curious, asking questions, learning about the child’s thoughts, feelings and ideas, they are doing some of the most essential (and delightful) work of raising children.
Positive Environment: A “positive environment” is child-centered, with access to age-appropriate activities of a wide range. Offering first-time parents written resources about child development and age-appropriate games, books, and activities is an easy way to support positive parenting. A positive environment also has structure and routines, so children can play and explore with the comfort of knowing what to expect and what is expected of them. Do they have a regular bedtime and bedtime routines? Do they consistently eat dinner together and clean up as a family? Do they have reliable unstructured time together, maybe playing board games or kickball after dinner? These varying but predictable routines provide opportunities for children to practice helping, following through, sharing, and tolerating frustration or failure, and they give parents low-stakes opportunities to offer praise for their effort, compassion when they struggle, and affection for no reason at all. They lower the chances of parent-child interactions being predominantly reactive, demanding, pleading, or angry.
Effective Discipline: A positive environment includes reasonable and consistent consequences for rule breaking and poor behavior, and an essential part of predictability includes clear ground rules for what is expected of children at home, around chores, getting ready for school and bedtime, and their behavior. Parents need to agree on and children should understand what the consequences will be for breaking rules. Parents should also have a clear strategy for consistently and calmly enforcing rules. This is not easy, but is just as important as affection and play. If parents are struggling with discipline, it is worth asking for a specific example to learn about where the trouble lies. Are parents not on the same page? Are they worried about their children’s distress? Do they lose their temper and the matter escalates? Clear ground rules and a game plan can help them to stay calm instead of resorting to pleading and yelling. Speaking with them about the value of planning and communicating about these expectations and rules during a quiet time, not in the midst of conflict, might be enough to help them with effective discipline. Others may need more support. Books like 123 Magic with more detail on how to manage time outs can be helpful. For those parents who are managing greater difficulty, a referral to parent coaching (with a modality such as Triple P, Parent-Child Interaction Training or Collaborative Problem Solving) may be needed.
Parental Well-Being: Being aligned with one’s spouse (or other caregiver) in how to manage challenging child behaviors is essential to a healthy relationship, and overall well-being is an essential ingredient in creating a nurturing, positive environment at home. How is the parents’ communication with each other overall? Do they have time together that is not focused on the children? Does each parent have time for outside interests or hobbies? How about other important relationships? Do they prioritize their own sleep, regular exercise, and good nutrition? It can be powerful if they plan family activities that are centered on their own passions and interests as well as their children’s. It is powerful for parents to hear from you that when they protect some of their time and energy to simply care for their own health and well-being, they are building a positive environment for their children, both in how they will show up for their family and in what they model.
Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
Suggested Reading
Sanders MR et al. The Development and Dissemination of the Triple P – Positive Parenting Program: A Multilevel Evidence-Based System of Parenting and Family Support. Prev Sci. 2002 Sep;3(3):173-89. doi: 10.1023/a:1019942516231.
Sanders MR. The Triple P System of Evidence-Based Parenting Support: Past, Present, and Future Directions. Clin Child Fam Psychol Rev. 2023 Dec;26(4):880-903. doi: 10.1007/s10567-023-00441-8.
Rosacea: Ivermectin’s Benefits May Include Impact on Skin Microbiome
TOPLINE:
in a small study.
METHODOLOGY:
- In this single-center, open label study, 10 adults (mean age, 66.4 years) with papulopustular rosacea were treated with 1% ivermectin cream daily for 12 weeks.
- Skin swabs from lesional and nonlesional sites were collected at baseline and after 3 months of treatment to assess changes in the bacterial microbiome and the density of Demodex mites.
- The average baseline total papule count was 26.9, and the Clinician’s Erythema Assessment (CEA) score was 2 (average value on a scale of 0-4 from five locations on the face).
- For comparison, baseline swabs were taken from 10 healthy age-matched individuals.
TAKEAWAY:
- The density of Demodex mites was significantly reduced on lesional skin (P = .002) with topical ivermectin, which has anthelmintic effects against Demodex and is an effective treatment for rosacea.
- The absolute abundance of S epidermidis increased after ivermectin treatment on lesional skin (P = .039), while no changes were seen in Cutibacterium acnes.
- No changes were noted on nonlesional skin in the patients with rosacea.
- Topical ivermectin also reduced the number of papules and CEA scores (both P = .002) in individuals with rosacea.
IN PRACTICE:
“Treatment with topical ivermectin may improve the symptoms of rosacea through modulation of the skin microbiome beyond decreasing Demodex,” the authors concluded. “The results of this study,” they added, “provide valuable insights into the intricacies of the cutaneous microbiome in the pathophysiology of rosacea and highlight the potential therapeutic interventions targeting the skin microbiome.”
SOURCE:
The study was led by Teruaki Nakatsuji, PhD, of the department of dermatology, University of California, San Diego. It was published online on October 29 in the Journal of Investigative Dermatology.
LIMITATIONS:
The small sample size of 10 patients with rosacea limits the generalizability of the findings, and the study’s open-label design may introduce bias in the clinical assessments. Further research with larger sample sizes and randomized controlled trials is needed to confirm these findings.
DISCLOSURES:
This work was funded by a grant from the National Rosacea Society. One author disclosed being the cofounder and consultant, with equity interest in MatriSys Bioscience. The other authors reported no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
in a small study.
METHODOLOGY:
- In this single-center, open label study, 10 adults (mean age, 66.4 years) with papulopustular rosacea were treated with 1% ivermectin cream daily for 12 weeks.
- Skin swabs from lesional and nonlesional sites were collected at baseline and after 3 months of treatment to assess changes in the bacterial microbiome and the density of Demodex mites.
- The average baseline total papule count was 26.9, and the Clinician’s Erythema Assessment (CEA) score was 2 (average value on a scale of 0-4 from five locations on the face).
- For comparison, baseline swabs were taken from 10 healthy age-matched individuals.
TAKEAWAY:
- The density of Demodex mites was significantly reduced on lesional skin (P = .002) with topical ivermectin, which has anthelmintic effects against Demodex and is an effective treatment for rosacea.
- The absolute abundance of S epidermidis increased after ivermectin treatment on lesional skin (P = .039), while no changes were seen in Cutibacterium acnes.
- No changes were noted on nonlesional skin in the patients with rosacea.
- Topical ivermectin also reduced the number of papules and CEA scores (both P = .002) in individuals with rosacea.
IN PRACTICE:
“Treatment with topical ivermectin may improve the symptoms of rosacea through modulation of the skin microbiome beyond decreasing Demodex,” the authors concluded. “The results of this study,” they added, “provide valuable insights into the intricacies of the cutaneous microbiome in the pathophysiology of rosacea and highlight the potential therapeutic interventions targeting the skin microbiome.”
SOURCE:
The study was led by Teruaki Nakatsuji, PhD, of the department of dermatology, University of California, San Diego. It was published online on October 29 in the Journal of Investigative Dermatology.
LIMITATIONS:
The small sample size of 10 patients with rosacea limits the generalizability of the findings, and the study’s open-label design may introduce bias in the clinical assessments. Further research with larger sample sizes and randomized controlled trials is needed to confirm these findings.
DISCLOSURES:
This work was funded by a grant from the National Rosacea Society. One author disclosed being the cofounder and consultant, with equity interest in MatriSys Bioscience. The other authors reported no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
in a small study.
METHODOLOGY:
- In this single-center, open label study, 10 adults (mean age, 66.4 years) with papulopustular rosacea were treated with 1% ivermectin cream daily for 12 weeks.
- Skin swabs from lesional and nonlesional sites were collected at baseline and after 3 months of treatment to assess changes in the bacterial microbiome and the density of Demodex mites.
- The average baseline total papule count was 26.9, and the Clinician’s Erythema Assessment (CEA) score was 2 (average value on a scale of 0-4 from five locations on the face).
- For comparison, baseline swabs were taken from 10 healthy age-matched individuals.
TAKEAWAY:
- The density of Demodex mites was significantly reduced on lesional skin (P = .002) with topical ivermectin, which has anthelmintic effects against Demodex and is an effective treatment for rosacea.
- The absolute abundance of S epidermidis increased after ivermectin treatment on lesional skin (P = .039), while no changes were seen in Cutibacterium acnes.
- No changes were noted on nonlesional skin in the patients with rosacea.
- Topical ivermectin also reduced the number of papules and CEA scores (both P = .002) in individuals with rosacea.
IN PRACTICE:
“Treatment with topical ivermectin may improve the symptoms of rosacea through modulation of the skin microbiome beyond decreasing Demodex,” the authors concluded. “The results of this study,” they added, “provide valuable insights into the intricacies of the cutaneous microbiome in the pathophysiology of rosacea and highlight the potential therapeutic interventions targeting the skin microbiome.”
SOURCE:
The study was led by Teruaki Nakatsuji, PhD, of the department of dermatology, University of California, San Diego. It was published online on October 29 in the Journal of Investigative Dermatology.
LIMITATIONS:
The small sample size of 10 patients with rosacea limits the generalizability of the findings, and the study’s open-label design may introduce bias in the clinical assessments. Further research with larger sample sizes and randomized controlled trials is needed to confirm these findings.
DISCLOSURES:
This work was funded by a grant from the National Rosacea Society. One author disclosed being the cofounder and consultant, with equity interest in MatriSys Bioscience. The other authors reported no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Rituximab Not Inferior to Cyclophosphamide in Pediatric Vasculitis
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Fall Vaccine Updates From the Advisory Committee on Immunization Practices: New Recommendations
This transcript has been edited for clarity.
This episode of Medicine Matters reviews highlights from the Advisory Committee on Immunization Practices’ (ACIP’s) October 2024 meeting, with new recommendations for pneumococcal, COVID, and meningococcal B (Men B) vaccines, as well as a safety update for maternal RSV vaccination.
Pneumococcal Vaccination and New Lower Age-Based Recommendations
New age-based recommendation. ACIP has lowered the age for routine vaccination with the pneumococcal conjugate vaccine (PCV) from age 65 down to age 50, but only with PCV. Review of data revealed that more than half of those in the 50- to 64-year-old age group already had a risk indication to receive a PCV dose. In addition, rates of invasive pneumococcal disease peak at younger ages in Black patients compared with White patients. The rate of invasive pneumococcal disease (IPD) among Black adults aged 50 or older exceeds the average rate of IPD for all adults aged 65 or older. The goal of this age-based change is to reduce disease in demographic groups with the highest burden of disease.
The new expanded age-based recommendation applies only to vaccination with PCV. Conjugate vaccines trigger memory B-cell production and therefore induce greater long-term immunity. New research is now focusing on higher-valent PCV vaccines. Two 24-valent pneumococcal conjugate vaccines and one 31-valent pneumococcal conjugate vaccine are now in advanced stages of development.
Risk-based recommendation. A risk-based recommendation for ages 19 through 49 years still applies to those with certain medical conditions, including diabetes; chronic heart, lung, liver, or kidney disease; and also for those with immunocompromising conditions. Risk-based recommendations are harder to implement particularly because many vaccines are now administered in pharmacies and pharmacists don’t know the patients as well as their physicians do, so it’s harder for them to know who should get the vaccine if the recommendation is based on risk.
COVID-19 Vaccines With Additional Dose Recommendations
Everyone 6 months or older is recommended to receive a dose of the updated 2024-2025 COVID vaccine. An additional updated COVID vaccine dose is now recommended for everyone aged 65 or older, and for those aged 6 months or older with immunocompromising (moderate or severe) conditions. Review of data revealed that 1 in 6 patients hospitalized with COVID have an immunocompromising condition, and 70% of COVID hospitalizations are in those aged 65 or older. This older age group also has the highest death rates due to COVID-19. We know that vaccination protection wanes with time. Data from previous studies show that additional vaccine doses provide additional protection. Additional doses are now being recommended for those at highest risk.
Timing of additional doses. This second dose is recommended at 6 months after the last updated COVID-19 vaccine dose. However, the additional dose can be given as early as 2 months after the last dose. Those who recently had COVID-19 can wait 3 months before getting an additional vaccine dose. This flexibility allows patients to maximize additional protection by timing additional doses around travel and life events, such as weddings, family get-togethers, or chemotherapy.
Those with immunocompromising conditions may receive more doses. Patients with immunocompromising conditions can receive even more additional doses, if recommended by their physician, under shared clinical decision-making.
Meningococcal Vaccines
Meningococcal disease is rare but deadly. The disease can progress rapidly. As many as 10%-15% of people with meningococcal infection die, even with appropriate antibiotic therapy. And for those who survive, about 20% suffer long-term sequalae (cognitive deficits, hearing loss, limb amputations).
Aligning Men B vaccine dosing intervals. The new ACIP vote applies only to Men B vaccines, of which there are two: one by GSK (brand name Bexsero), and the other by Wyeth, a Pfizer subsidiary (brand name Trumenba). The two MenB vaccine products are not interchangeable. The same type of MenB vaccine has to be used to complete the series.
The MenB vaccines initially had different dosing schedules and now they don’t. ACIP voted to harmonize and align the dosing schedule for the two different MenB products to mirror recent FDA (Food and Drug Administration) labeling updates. So now the dosing recommendations for both MenB vaccines are the same: either two doses given 6 months apart to healthy adolescents and young adults, or a three-dose series given at zero, 1-2 months, and 6 months for those at high risk or for those who want to optimize rapid protection (for example, if they are starting the series within 6 months of going off to college). But understand that the current recommendation for MenB vaccination for healthy adolescents and young adults is based on shared clinical decision-making, preferably for those aged 16-18.
MenACWY. Two doses of MenACWY are routinely recommended, with the first dose at age 11-12 and a second dose at age 16. The MenACWY vaccines are interchangeable.
Implementation challenges and new pentavalent vaccines. Having to use the same MenB vaccine product for all doses in a patient’s series is difficult. It’s even more difficult when the patient needs both MenACWY and MenB vaccinations.
Adding to the complexity is a new pentavalent vaccine from Pfizer (brand name Penbraya) that combines MenACWY with the MenB vaccine. And another pentavalent vaccine version by GSK is up for regulatory decision in February 2025.
The work group did say that they plan to take a fresh look at the meningococcal vaccination schedule. Let’s hope it gets simpler, so more to come on that.
Respiratory Syncytial Virus (RSV) Vaccines
Current RSV vaccine recommendations for older adults. RSV vaccine has both age- and risk-based recommendations. Now, everyone aged 75 or older needs a dose of RSV vaccine. Adults aged 60-75 with risk factors for severe RSV are also recommended to receive a dose of RSV vaccine, but not adults without these risk factors. The conditions associated with increased risk for severe RSV disease include lung disease, heart disease, immune compromise, diabetes, obesity with BMI (body mass index) of 40 or higher, neurologic or neuromuscular conditions, chronic kidney disease, liver disorders, and hematologic disorders. Frailty, as well as living in a nursing home or other long-term care facility, are other risk factors for severe RSV disease. Those aged 60-75 without these risk factors are no longer recommended to receive it.
Three RSV vaccines. We now have three RSV vaccine to choose from. Two are protein subunit vaccines. One is by Pfizer (brand name Abrysvo) that does not contain an adjuvant. The other protein-based RSV vaccine by GSK (brand name Arexvy) does contain an adjuvant. The third RSV vaccine by Moderna (brand name mRESVIA) uses an mRNA platform, and durability of protection is still unclear. However, recent studies now suggest that the RSV protein subunit vaccines confer 36 months of protection rather than only 24 months.
All three RSV vaccines are licensed for those aged 60 or older. The age indication for GSK’s RSV vaccine, Arexvy, has already been lowered by the FDA to age 50. FDA recently lowered the age approval for Abrysvo to age 18 for those at high risk. However, ACIP has not yet expanded its age recommendations for getting these vaccines. One of the main hesitations is vaccine safety concerns. FDA›s safety update presented to ACIP still suggests an increased risk for Guillain-Barré syndrome with both protein-based RSV vaccines among those aged 65 or older. Fortunately, the risk is rare: less than 10 cases per million vaccinations.
RSV immunization for infant protection. RSV season starts in October and goes through March. We now have two new ways to protect babies. One is a maternal RSV vaccine, given at 32-36 weeks of pregnancy to moms who will deliver their babies during RSV season. But only Pfizer’s RSV vaccine (brand name Abrysvo, without an adjuvant) can be given during pregnancy.
A maternal RSV vaccine safety update, presented at ACIP, was reassuring. Abrysvo was not associated with increased risk for preterm birth or small gestational age at birth.
Nirsevimab, a long-acting monoclonal antibody, can be given to infants. Nirsevimab is indicated for all babies under 8 months of age entering their first RSV season.
People who received a maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during subsequent pregnancies. However, infants born to women who were vaccinated during a prior pregnancy should receive nirsevimab.
Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed conflicts of interest with the American Medical Association, the Medical Association of Atlanta, ACIP, and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
This episode of Medicine Matters reviews highlights from the Advisory Committee on Immunization Practices’ (ACIP’s) October 2024 meeting, with new recommendations for pneumococcal, COVID, and meningococcal B (Men B) vaccines, as well as a safety update for maternal RSV vaccination.
Pneumococcal Vaccination and New Lower Age-Based Recommendations
New age-based recommendation. ACIP has lowered the age for routine vaccination with the pneumococcal conjugate vaccine (PCV) from age 65 down to age 50, but only with PCV. Review of data revealed that more than half of those in the 50- to 64-year-old age group already had a risk indication to receive a PCV dose. In addition, rates of invasive pneumococcal disease peak at younger ages in Black patients compared with White patients. The rate of invasive pneumococcal disease (IPD) among Black adults aged 50 or older exceeds the average rate of IPD for all adults aged 65 or older. The goal of this age-based change is to reduce disease in demographic groups with the highest burden of disease.
The new expanded age-based recommendation applies only to vaccination with PCV. Conjugate vaccines trigger memory B-cell production and therefore induce greater long-term immunity. New research is now focusing on higher-valent PCV vaccines. Two 24-valent pneumococcal conjugate vaccines and one 31-valent pneumococcal conjugate vaccine are now in advanced stages of development.
Risk-based recommendation. A risk-based recommendation for ages 19 through 49 years still applies to those with certain medical conditions, including diabetes; chronic heart, lung, liver, or kidney disease; and also for those with immunocompromising conditions. Risk-based recommendations are harder to implement particularly because many vaccines are now administered in pharmacies and pharmacists don’t know the patients as well as their physicians do, so it’s harder for them to know who should get the vaccine if the recommendation is based on risk.
COVID-19 Vaccines With Additional Dose Recommendations
Everyone 6 months or older is recommended to receive a dose of the updated 2024-2025 COVID vaccine. An additional updated COVID vaccine dose is now recommended for everyone aged 65 or older, and for those aged 6 months or older with immunocompromising (moderate or severe) conditions. Review of data revealed that 1 in 6 patients hospitalized with COVID have an immunocompromising condition, and 70% of COVID hospitalizations are in those aged 65 or older. This older age group also has the highest death rates due to COVID-19. We know that vaccination protection wanes with time. Data from previous studies show that additional vaccine doses provide additional protection. Additional doses are now being recommended for those at highest risk.
Timing of additional doses. This second dose is recommended at 6 months after the last updated COVID-19 vaccine dose. However, the additional dose can be given as early as 2 months after the last dose. Those who recently had COVID-19 can wait 3 months before getting an additional vaccine dose. This flexibility allows patients to maximize additional protection by timing additional doses around travel and life events, such as weddings, family get-togethers, or chemotherapy.
Those with immunocompromising conditions may receive more doses. Patients with immunocompromising conditions can receive even more additional doses, if recommended by their physician, under shared clinical decision-making.
Meningococcal Vaccines
Meningococcal disease is rare but deadly. The disease can progress rapidly. As many as 10%-15% of people with meningococcal infection die, even with appropriate antibiotic therapy. And for those who survive, about 20% suffer long-term sequalae (cognitive deficits, hearing loss, limb amputations).
Aligning Men B vaccine dosing intervals. The new ACIP vote applies only to Men B vaccines, of which there are two: one by GSK (brand name Bexsero), and the other by Wyeth, a Pfizer subsidiary (brand name Trumenba). The two MenB vaccine products are not interchangeable. The same type of MenB vaccine has to be used to complete the series.
The MenB vaccines initially had different dosing schedules and now they don’t. ACIP voted to harmonize and align the dosing schedule for the two different MenB products to mirror recent FDA (Food and Drug Administration) labeling updates. So now the dosing recommendations for both MenB vaccines are the same: either two doses given 6 months apart to healthy adolescents and young adults, or a three-dose series given at zero, 1-2 months, and 6 months for those at high risk or for those who want to optimize rapid protection (for example, if they are starting the series within 6 months of going off to college). But understand that the current recommendation for MenB vaccination for healthy adolescents and young adults is based on shared clinical decision-making, preferably for those aged 16-18.
MenACWY. Two doses of MenACWY are routinely recommended, with the first dose at age 11-12 and a second dose at age 16. The MenACWY vaccines are interchangeable.
Implementation challenges and new pentavalent vaccines. Having to use the same MenB vaccine product for all doses in a patient’s series is difficult. It’s even more difficult when the patient needs both MenACWY and MenB vaccinations.
Adding to the complexity is a new pentavalent vaccine from Pfizer (brand name Penbraya) that combines MenACWY with the MenB vaccine. And another pentavalent vaccine version by GSK is up for regulatory decision in February 2025.
The work group did say that they plan to take a fresh look at the meningococcal vaccination schedule. Let’s hope it gets simpler, so more to come on that.
Respiratory Syncytial Virus (RSV) Vaccines
Current RSV vaccine recommendations for older adults. RSV vaccine has both age- and risk-based recommendations. Now, everyone aged 75 or older needs a dose of RSV vaccine. Adults aged 60-75 with risk factors for severe RSV are also recommended to receive a dose of RSV vaccine, but not adults without these risk factors. The conditions associated with increased risk for severe RSV disease include lung disease, heart disease, immune compromise, diabetes, obesity with BMI (body mass index) of 40 or higher, neurologic or neuromuscular conditions, chronic kidney disease, liver disorders, and hematologic disorders. Frailty, as well as living in a nursing home or other long-term care facility, are other risk factors for severe RSV disease. Those aged 60-75 without these risk factors are no longer recommended to receive it.
Three RSV vaccines. We now have three RSV vaccine to choose from. Two are protein subunit vaccines. One is by Pfizer (brand name Abrysvo) that does not contain an adjuvant. The other protein-based RSV vaccine by GSK (brand name Arexvy) does contain an adjuvant. The third RSV vaccine by Moderna (brand name mRESVIA) uses an mRNA platform, and durability of protection is still unclear. However, recent studies now suggest that the RSV protein subunit vaccines confer 36 months of protection rather than only 24 months.
All three RSV vaccines are licensed for those aged 60 or older. The age indication for GSK’s RSV vaccine, Arexvy, has already been lowered by the FDA to age 50. FDA recently lowered the age approval for Abrysvo to age 18 for those at high risk. However, ACIP has not yet expanded its age recommendations for getting these vaccines. One of the main hesitations is vaccine safety concerns. FDA›s safety update presented to ACIP still suggests an increased risk for Guillain-Barré syndrome with both protein-based RSV vaccines among those aged 65 or older. Fortunately, the risk is rare: less than 10 cases per million vaccinations.
RSV immunization for infant protection. RSV season starts in October and goes through March. We now have two new ways to protect babies. One is a maternal RSV vaccine, given at 32-36 weeks of pregnancy to moms who will deliver their babies during RSV season. But only Pfizer’s RSV vaccine (brand name Abrysvo, without an adjuvant) can be given during pregnancy.
A maternal RSV vaccine safety update, presented at ACIP, was reassuring. Abrysvo was not associated with increased risk for preterm birth or small gestational age at birth.
Nirsevimab, a long-acting monoclonal antibody, can be given to infants. Nirsevimab is indicated for all babies under 8 months of age entering their first RSV season.
People who received a maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during subsequent pregnancies. However, infants born to women who were vaccinated during a prior pregnancy should receive nirsevimab.
Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed conflicts of interest with the American Medical Association, the Medical Association of Atlanta, ACIP, and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
This episode of Medicine Matters reviews highlights from the Advisory Committee on Immunization Practices’ (ACIP’s) October 2024 meeting, with new recommendations for pneumococcal, COVID, and meningococcal B (Men B) vaccines, as well as a safety update for maternal RSV vaccination.
Pneumococcal Vaccination and New Lower Age-Based Recommendations
New age-based recommendation. ACIP has lowered the age for routine vaccination with the pneumococcal conjugate vaccine (PCV) from age 65 down to age 50, but only with PCV. Review of data revealed that more than half of those in the 50- to 64-year-old age group already had a risk indication to receive a PCV dose. In addition, rates of invasive pneumococcal disease peak at younger ages in Black patients compared with White patients. The rate of invasive pneumococcal disease (IPD) among Black adults aged 50 or older exceeds the average rate of IPD for all adults aged 65 or older. The goal of this age-based change is to reduce disease in demographic groups with the highest burden of disease.
The new expanded age-based recommendation applies only to vaccination with PCV. Conjugate vaccines trigger memory B-cell production and therefore induce greater long-term immunity. New research is now focusing on higher-valent PCV vaccines. Two 24-valent pneumococcal conjugate vaccines and one 31-valent pneumococcal conjugate vaccine are now in advanced stages of development.
Risk-based recommendation. A risk-based recommendation for ages 19 through 49 years still applies to those with certain medical conditions, including diabetes; chronic heart, lung, liver, or kidney disease; and also for those with immunocompromising conditions. Risk-based recommendations are harder to implement particularly because many vaccines are now administered in pharmacies and pharmacists don’t know the patients as well as their physicians do, so it’s harder for them to know who should get the vaccine if the recommendation is based on risk.
COVID-19 Vaccines With Additional Dose Recommendations
Everyone 6 months or older is recommended to receive a dose of the updated 2024-2025 COVID vaccine. An additional updated COVID vaccine dose is now recommended for everyone aged 65 or older, and for those aged 6 months or older with immunocompromising (moderate or severe) conditions. Review of data revealed that 1 in 6 patients hospitalized with COVID have an immunocompromising condition, and 70% of COVID hospitalizations are in those aged 65 or older. This older age group also has the highest death rates due to COVID-19. We know that vaccination protection wanes with time. Data from previous studies show that additional vaccine doses provide additional protection. Additional doses are now being recommended for those at highest risk.
Timing of additional doses. This second dose is recommended at 6 months after the last updated COVID-19 vaccine dose. However, the additional dose can be given as early as 2 months after the last dose. Those who recently had COVID-19 can wait 3 months before getting an additional vaccine dose. This flexibility allows patients to maximize additional protection by timing additional doses around travel and life events, such as weddings, family get-togethers, or chemotherapy.
Those with immunocompromising conditions may receive more doses. Patients with immunocompromising conditions can receive even more additional doses, if recommended by their physician, under shared clinical decision-making.
Meningococcal Vaccines
Meningococcal disease is rare but deadly. The disease can progress rapidly. As many as 10%-15% of people with meningococcal infection die, even with appropriate antibiotic therapy. And for those who survive, about 20% suffer long-term sequalae (cognitive deficits, hearing loss, limb amputations).
Aligning Men B vaccine dosing intervals. The new ACIP vote applies only to Men B vaccines, of which there are two: one by GSK (brand name Bexsero), and the other by Wyeth, a Pfizer subsidiary (brand name Trumenba). The two MenB vaccine products are not interchangeable. The same type of MenB vaccine has to be used to complete the series.
The MenB vaccines initially had different dosing schedules and now they don’t. ACIP voted to harmonize and align the dosing schedule for the two different MenB products to mirror recent FDA (Food and Drug Administration) labeling updates. So now the dosing recommendations for both MenB vaccines are the same: either two doses given 6 months apart to healthy adolescents and young adults, or a three-dose series given at zero, 1-2 months, and 6 months for those at high risk or for those who want to optimize rapid protection (for example, if they are starting the series within 6 months of going off to college). But understand that the current recommendation for MenB vaccination for healthy adolescents and young adults is based on shared clinical decision-making, preferably for those aged 16-18.
MenACWY. Two doses of MenACWY are routinely recommended, with the first dose at age 11-12 and a second dose at age 16. The MenACWY vaccines are interchangeable.
Implementation challenges and new pentavalent vaccines. Having to use the same MenB vaccine product for all doses in a patient’s series is difficult. It’s even more difficult when the patient needs both MenACWY and MenB vaccinations.
Adding to the complexity is a new pentavalent vaccine from Pfizer (brand name Penbraya) that combines MenACWY with the MenB vaccine. And another pentavalent vaccine version by GSK is up for regulatory decision in February 2025.
The work group did say that they plan to take a fresh look at the meningococcal vaccination schedule. Let’s hope it gets simpler, so more to come on that.
Respiratory Syncytial Virus (RSV) Vaccines
Current RSV vaccine recommendations for older adults. RSV vaccine has both age- and risk-based recommendations. Now, everyone aged 75 or older needs a dose of RSV vaccine. Adults aged 60-75 with risk factors for severe RSV are also recommended to receive a dose of RSV vaccine, but not adults without these risk factors. The conditions associated with increased risk for severe RSV disease include lung disease, heart disease, immune compromise, diabetes, obesity with BMI (body mass index) of 40 or higher, neurologic or neuromuscular conditions, chronic kidney disease, liver disorders, and hematologic disorders. Frailty, as well as living in a nursing home or other long-term care facility, are other risk factors for severe RSV disease. Those aged 60-75 without these risk factors are no longer recommended to receive it.
Three RSV vaccines. We now have three RSV vaccine to choose from. Two are protein subunit vaccines. One is by Pfizer (brand name Abrysvo) that does not contain an adjuvant. The other protein-based RSV vaccine by GSK (brand name Arexvy) does contain an adjuvant. The third RSV vaccine by Moderna (brand name mRESVIA) uses an mRNA platform, and durability of protection is still unclear. However, recent studies now suggest that the RSV protein subunit vaccines confer 36 months of protection rather than only 24 months.
All three RSV vaccines are licensed for those aged 60 or older. The age indication for GSK’s RSV vaccine, Arexvy, has already been lowered by the FDA to age 50. FDA recently lowered the age approval for Abrysvo to age 18 for those at high risk. However, ACIP has not yet expanded its age recommendations for getting these vaccines. One of the main hesitations is vaccine safety concerns. FDA›s safety update presented to ACIP still suggests an increased risk for Guillain-Barré syndrome with both protein-based RSV vaccines among those aged 65 or older. Fortunately, the risk is rare: less than 10 cases per million vaccinations.
RSV immunization for infant protection. RSV season starts in October and goes through March. We now have two new ways to protect babies. One is a maternal RSV vaccine, given at 32-36 weeks of pregnancy to moms who will deliver their babies during RSV season. But only Pfizer’s RSV vaccine (brand name Abrysvo, without an adjuvant) can be given during pregnancy.
A maternal RSV vaccine safety update, presented at ACIP, was reassuring. Abrysvo was not associated with increased risk for preterm birth or small gestational age at birth.
Nirsevimab, a long-acting monoclonal antibody, can be given to infants. Nirsevimab is indicated for all babies under 8 months of age entering their first RSV season.
People who received a maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during subsequent pregnancies. However, infants born to women who were vaccinated during a prior pregnancy should receive nirsevimab.
Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed conflicts of interest with the American Medical Association, the Medical Association of Atlanta, ACIP, and Medscape.
A version of this article first appeared on Medscape.com.
Digital Danger: How Cyberattacks Put Patients at Risk
On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.
In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.
In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
Healthcare Systems = ‘Soft Targets’
Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”
Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”
Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.
The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
Vulnerable Users
Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.
“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”
Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.
High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
The Impact of Cyberattacks on Patients
Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.
According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:
- 56% of respondents saw a delay in patient tests/procedures
- 53% experienced increased patient complications from medical procedures
- 52% noted a longer patient length of stay
- 44% saw an increase in patient transfers to other facilities
- 28% had an increase in mortality rate
What Hospitals and Physicians Can Do
Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.
Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”
Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
A Continuing Threat
Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”
That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.
A version of this article first appeared on Medscape.com.
On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.
In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.
In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
Healthcare Systems = ‘Soft Targets’
Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”
Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”
Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.
The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
Vulnerable Users
Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.
“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”
Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.
High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
The Impact of Cyberattacks on Patients
Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.
According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:
- 56% of respondents saw a delay in patient tests/procedures
- 53% experienced increased patient complications from medical procedures
- 52% noted a longer patient length of stay
- 44% saw an increase in patient transfers to other facilities
- 28% had an increase in mortality rate
What Hospitals and Physicians Can Do
Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.
Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”
Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
A Continuing Threat
Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”
That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.
A version of this article first appeared on Medscape.com.
On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.
In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.
In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
Healthcare Systems = ‘Soft Targets’
Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”
Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”
Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.
The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
Vulnerable Users
Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.
“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”
Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.
High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
The Impact of Cyberattacks on Patients
Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.
According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:
- 56% of respondents saw a delay in patient tests/procedures
- 53% experienced increased patient complications from medical procedures
- 52% noted a longer patient length of stay
- 44% saw an increase in patient transfers to other facilities
- 28% had an increase in mortality rate
What Hospitals and Physicians Can Do
Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.
Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”
Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
A Continuing Threat
Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”
That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.
A version of this article first appeared on Medscape.com.
When Your Malpractice Insurer Investigates You: What to Know
When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.
“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.
The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.
“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
How Medical Board and Malpractice Insurer Investigations Differ
Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.
When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.
Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.
When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.
The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.
Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.
Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.
“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.
If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.
Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.
If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
Who Is Your Attorney Really Working for?
The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.
Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”
If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.
“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”
Physicians who find any conflict of interest with their insurer should seek counsel.
Such conflicts could include:
- Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
- The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.
In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.
Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.
A version of this article first appeared on Medscape.com.
When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.
“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.
The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.
“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
How Medical Board and Malpractice Insurer Investigations Differ
Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.
When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.
Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.
When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.
The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.
Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.
Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.
“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.
If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.
Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.
If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
Who Is Your Attorney Really Working for?
The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.
Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”
If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.
“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”
Physicians who find any conflict of interest with their insurer should seek counsel.
Such conflicts could include:
- Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
- The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.
In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.
Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.
A version of this article first appeared on Medscape.com.
When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.
“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.
The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.
“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
How Medical Board and Malpractice Insurer Investigations Differ
Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.
When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.
Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.
When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.
The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.
Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.
Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.
“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.
If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.
Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.
If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
Who Is Your Attorney Really Working for?
The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.
Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”
If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.
“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”
Physicians who find any conflict of interest with their insurer should seek counsel.
Such conflicts could include:
- Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
- The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.
In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.
Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.
A version of this article first appeared on Medscape.com.
The Rise of Sham Peer Reviews
While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.
They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.
Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.
This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.
“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”
“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.
Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.
The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.
“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”
Complaints are generally filed via incident reporting software.
“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.
After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.
The entire experience can take a physician by surprise.
“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.
York added that there may also be a misperception of what is actually happening.
“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
If You’re a Victim of a Sham Peer Review
Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”
Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”
Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”
Given the seriousness of a sham peer review, following these guidelines can help.
Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.
“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”
Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.
“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”
A version of this article first appeared on Medscape.com.
While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.
They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.
Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.
This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.
“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”
“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.
Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.
The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.
“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”
Complaints are generally filed via incident reporting software.
“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.
After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.
The entire experience can take a physician by surprise.
“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.
York added that there may also be a misperception of what is actually happening.
“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
If You’re a Victim of a Sham Peer Review
Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”
Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”
Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”
Given the seriousness of a sham peer review, following these guidelines can help.
Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.
“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”
Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.
“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”
A version of this article first appeared on Medscape.com.
While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.
They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.
Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.
This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.
“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”
“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.
Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.
The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.
“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”
Complaints are generally filed via incident reporting software.
“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.
After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.
The entire experience can take a physician by surprise.
“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.
York added that there may also be a misperception of what is actually happening.
“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
If You’re a Victim of a Sham Peer Review
Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”
Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”
Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”
Given the seriousness of a sham peer review, following these guidelines can help.
Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.
“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”
Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.
“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”
A version of this article first appeared on Medscape.com.