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Commentary: Reversal of Roe v. Wade affects adolescents
The Supreme Court decision to strike down the 50-year ruling on Roe v. Wade, which allowed legal abortion, will affect all patients and families seeking care in pediatric and adolescent medicine clinics. Regardless of how you view abortion, the reality is your adolescent female patients and their parents will seek your counsel.
The overturning of Roe has resulted in much confusion for both patients and providers. The overall effect of this decision in Wisconsin is yet to be known but currently we have had to create road maps to direct adolescent patients who experience an unplanned pregnancy and wish to abort. Unfortunately, these road maps include only resources out of state or online. Providing adolescents confidential care may be challenged as the teens may need to disclose the unplanned pregnancy to an adult to access resources.
Providers remain unsettled regarding their risk of assisting an adolescent who discloses an unplanned pregnancy. Recently, many questions arose regarding dispensing Plan B and the risk to prescribers. Communication was needed to assure providers that Plan B is contraception and at this time contraception remains legal in our state.
Daily I educate adolescent females on the risks of unplanned pregnancy and what the Supreme Court decision will mean to them if they become pregnant. Unfortunately, many teens do not understand the ruling and how this decision affects them personally. Education is needed today more than ever regarding pregnancy prevention.
The recent AAP policy statement reaffirms its position that the rights of adolescents to seek confidential care when considering abortion must be protected.1 It further reaffirms access to safe and legal abortion is a core tenant of sexual and reproductive health care.
A recent article published in AAP News by Elise D. Berlan, MD, “AAP’s teen reproductive health policies reaffirm right to comprehensive care,” further advises on the role of the pediatric provider.2 Pediatric providers should continue offering option counseling for pregnant adolescents, be prepared to provide accurate information regarding these options with awareness that some options such as the IUD may no longer be available, remain supportive of the decision they choose, and encourage discussion with a family member to support their decisions. It is imperative that we familiarize ourselves with the abortion policies in our states, advocate to prevent government interference with the patient-doctor relationship, and recognize the impact restrictive abortion has regarding marginalized individuals, she stated. Finally we must recognize our own bias regarding option counseling and refer appropriately to another professional if we are unable to confidently offer guidance.
Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee.
References
1. AAP Committee on Adolescence. Pediatrics. 2022. doi: 10.1542/peds.2022-058780.
2. Berlan ED. AAP’s teen reproductive health policies reaffirm right to comprehensive care. 2022. AAP News.
The Supreme Court decision to strike down the 50-year ruling on Roe v. Wade, which allowed legal abortion, will affect all patients and families seeking care in pediatric and adolescent medicine clinics. Regardless of how you view abortion, the reality is your adolescent female patients and their parents will seek your counsel.
The overturning of Roe has resulted in much confusion for both patients and providers. The overall effect of this decision in Wisconsin is yet to be known but currently we have had to create road maps to direct adolescent patients who experience an unplanned pregnancy and wish to abort. Unfortunately, these road maps include only resources out of state or online. Providing adolescents confidential care may be challenged as the teens may need to disclose the unplanned pregnancy to an adult to access resources.
Providers remain unsettled regarding their risk of assisting an adolescent who discloses an unplanned pregnancy. Recently, many questions arose regarding dispensing Plan B and the risk to prescribers. Communication was needed to assure providers that Plan B is contraception and at this time contraception remains legal in our state.
Daily I educate adolescent females on the risks of unplanned pregnancy and what the Supreme Court decision will mean to them if they become pregnant. Unfortunately, many teens do not understand the ruling and how this decision affects them personally. Education is needed today more than ever regarding pregnancy prevention.
The recent AAP policy statement reaffirms its position that the rights of adolescents to seek confidential care when considering abortion must be protected.1 It further reaffirms access to safe and legal abortion is a core tenant of sexual and reproductive health care.
A recent article published in AAP News by Elise D. Berlan, MD, “AAP’s teen reproductive health policies reaffirm right to comprehensive care,” further advises on the role of the pediatric provider.2 Pediatric providers should continue offering option counseling for pregnant adolescents, be prepared to provide accurate information regarding these options with awareness that some options such as the IUD may no longer be available, remain supportive of the decision they choose, and encourage discussion with a family member to support their decisions. It is imperative that we familiarize ourselves with the abortion policies in our states, advocate to prevent government interference with the patient-doctor relationship, and recognize the impact restrictive abortion has regarding marginalized individuals, she stated. Finally we must recognize our own bias regarding option counseling and refer appropriately to another professional if we are unable to confidently offer guidance.
Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee.
References
1. AAP Committee on Adolescence. Pediatrics. 2022. doi: 10.1542/peds.2022-058780.
2. Berlan ED. AAP’s teen reproductive health policies reaffirm right to comprehensive care. 2022. AAP News.
The Supreme Court decision to strike down the 50-year ruling on Roe v. Wade, which allowed legal abortion, will affect all patients and families seeking care in pediatric and adolescent medicine clinics. Regardless of how you view abortion, the reality is your adolescent female patients and their parents will seek your counsel.
The overturning of Roe has resulted in much confusion for both patients and providers. The overall effect of this decision in Wisconsin is yet to be known but currently we have had to create road maps to direct adolescent patients who experience an unplanned pregnancy and wish to abort. Unfortunately, these road maps include only resources out of state or online. Providing adolescents confidential care may be challenged as the teens may need to disclose the unplanned pregnancy to an adult to access resources.
Providers remain unsettled regarding their risk of assisting an adolescent who discloses an unplanned pregnancy. Recently, many questions arose regarding dispensing Plan B and the risk to prescribers. Communication was needed to assure providers that Plan B is contraception and at this time contraception remains legal in our state.
Daily I educate adolescent females on the risks of unplanned pregnancy and what the Supreme Court decision will mean to them if they become pregnant. Unfortunately, many teens do not understand the ruling and how this decision affects them personally. Education is needed today more than ever regarding pregnancy prevention.
The recent AAP policy statement reaffirms its position that the rights of adolescents to seek confidential care when considering abortion must be protected.1 It further reaffirms access to safe and legal abortion is a core tenant of sexual and reproductive health care.
A recent article published in AAP News by Elise D. Berlan, MD, “AAP’s teen reproductive health policies reaffirm right to comprehensive care,” further advises on the role of the pediatric provider.2 Pediatric providers should continue offering option counseling for pregnant adolescents, be prepared to provide accurate information regarding these options with awareness that some options such as the IUD may no longer be available, remain supportive of the decision they choose, and encourage discussion with a family member to support their decisions. It is imperative that we familiarize ourselves with the abortion policies in our states, advocate to prevent government interference with the patient-doctor relationship, and recognize the impact restrictive abortion has regarding marginalized individuals, she stated. Finally we must recognize our own bias regarding option counseling and refer appropriately to another professional if we are unable to confidently offer guidance.
Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee.
References
1. AAP Committee on Adolescence. Pediatrics. 2022. doi: 10.1542/peds.2022-058780.
2. Berlan ED. AAP’s teen reproductive health policies reaffirm right to comprehensive care. 2022. AAP News.
Think of pediatric morphea as a systemic, chronic disease, expert advises
INDIANAPOLIS – In the opinion of Elena Pope, MD, MSc,
“There is no correlation between the extent and activity of skin lesions and the presence, severity, and activity of extracutaneous manifestations,” Dr. Pope, professor of pediatrics at the University of Toronto and division head of pediatric dermatology at the Hospital for Sick Children in Toronto, said during the annual meeting of the Society for Pediatric Dermatology. “Treatment needs to be tailored to the extent of cutaneous manifestations, and I think we need to be aware of and address the impact on patients’ quality of life,” she added. There is also a need for more research “on targeted and better-tolerated therapies to put a stop to the progression of disease.”
Congenital morphea is a form of localized scleroderma that presents at birth but can be confused with port wine stain. Results from a multicenter retrospective review of 25 cases conducted by Dr. Pope and colleagues found that the median age at diagnosis was 2.9 years and 76% had linear-type lesions. In addition, 48% had extracutaneous involvement (all of these patients had linear morphea), most commonly of the central nervous system.
“It’s important to realize these lesions may become active over time,” Dr. Pope said. “In my experience, there are two different courses. Either you have innocuous lesions when the patients are born and they may become active around 3-4 years of age, or you have early intrauterine involvement, with lesions inactive at birth but with potential for significant damage in utero.”
She cautioned against treating a suspected port wine stain lesion with laser until congenital morphea is ruled out. “I’m aware of at least one lawsuit of a child where someone used a laser in a child who had progression with significant sclerosis,” she said. “The parents assumed it was the use of the laser that led to the progression, not the actual disease.”
Extracutaneous manifestations are common in morphea patients. A multicenter study of 750 patients with juvenile scleroderma found that 22% had extracutaneous manifestations. Almost half of patients (47%) had arthritis, but 17% had neurologic findings such as seizures and headaches, 9% had vascular manifestations, and 8% had uveitis. Subsequent studies found that neurological disease affects between 11% and 19% of cases, especially in those involving the head and neck.
“There is a wide range of manifestations from headache and neuropsychiatric changes to brain atrophy, seizures, and CNS cavernoma,” Dr. Pope said. “There also can be orthodental involvement such as malocclusion. It’s important to do a brain MRI, eye exam for uveitis, and don’t forget the orthodental assessment.”
She recalled a 10-year-old boy who presented to the Hospital for Sick Children with tissue loss on the forehead and eyebrow and eyelashes. He had no other congenital morphea symptoms and the MRI was normal, but the eye exam revealed uveitis. “It’s important to remember that uveitis is asymptomatic, so unless you look for it, you’re not going to find it,” she said.
According to unpublished data in 42 congenital morphea patients with lesions limited to the head and neck, who underwent MRI imaging at the Hospital for Sick Children, 57% had CNS changes that were ipsilateral in 68% of cases. “White matter changes were the most common, and to our surprise, there were patients who had progressive CNS disease, including CNS vasculitis, new lesions, and enhancement of prior stable lesions,” Dr. Pope said.
She recalled the case of an 8-year-old boy who presented to the hospital with intractable seizures. Upon completion of the MRI, one of the radiologists noted that the imaging showed subtle thinning of the forehead, and he was referred to Dr. Pope and colleagues for assessment. In the span of 4 years, despite aggressive treatment, the boy’s CNS disease progressed. “There was more enhancement, more tissue loss, his seizures are very hard to control, and he has many neurodevelopmental changes,” she recalled. “What I learned from this case is that skin activity does not correlate with imaging. Don’t assume that just because the skin is burnt out that the CNS will be the same. Also, the extent of skin disease does not predict involvement or progression of the CNS.”
Linear lesions on the lower extremities are a harbinger of orthopedic complications, which can occur in about half of patients. Joint contractures in this subset of patients are seen in about 81% of cases, while other sequelae can include arthritis, limb atrophy, leg-leg discrepancy, and angular deformity. “About 14% of patients require intervention,” Dr. Pope said. “In terms of working those patients up, you need to do an MRI and assess the extent of muscle and fascial involvement. Early physiotherapy and an orthopedic evaluation are also recommended.”
As for possible markers of morphea, antinuclear antibody is positive in 22%-68% of cases and correlates with disease severity, extracutaneous manifestations, and disease flare-up. Antihistone antibodies (AHA) are positive in about 47% of cases, “and that tends to correlate with the extent of skin and muscle involvement,” Dr. Pope said. “Anti–double-stranded DNA correlates with extent of disease, but the only known biomarker to date that correlates with disease activity is CXCL9/10. This has been documented in the skin as well as in the blood. So, this marker may help us determine if the patient needs to be treated or not.”
Treatments
For treatment of active localized disease, topical medications are helpful in some cases. Options include topical steroids, calcipotriol with or without betamethasone, imiquimod, and tacrolimus. “In my experience the combination of calcipotriol with betamethasone is best,” she said. “It really shuts down the activity fairly soon, and you can scale down to calcipotriol alone. I don’t find imiquimod very helpful for active lesions, although it has a role for inactive lesions.”
For patients with linear or generalized/mixed disease, “the combination of methotrexate and corticosteroids or methotrexate alone is probably the way to go,” Dr. Pope said. “The addition of steroids really depends on where the lesion is and how worried you are about other problems.”
According to the best available literature, 88% of patients should respond to treatment with methotrexate (MTX) and/or steroids within 3-6 months, and 74% within 3 months. “If they don’t, you have to wonder if the patient’s taking the medication, or you need to think about other alternative treatments,” she said. “Complete remission is possible in most of the patients, and the longer you treat the more you will see that. On average, most of us treat patients for about 3 years, but there are treatment failures as well. This can occur in up to 16% of patients.”
As for second-line treatment agents for congenital morphea, clinicians often turn to mycophenolate mofetil (MMF). Results from a retrospective longitudinal study of juvenile localized scleroderma patients found that after a mean of 9 years 91% of patients on MMF and 100% of patients on MTX had inactive disease. “There were no differences in relapse rates, although MMF seems to have a more sustained long-term effect and overall is better tolerated,” said Dr. Pope, who was not involved with the study. “However, it’s more immunosuppressive than MTX, which is important, especially in the era of COVID-19. You also need to think about the potential for more hematological suppression with MMF use.” If standard therapy fails, there is anecdotal data supporting the use of abatacept (which suppresses the T-cell activity in affected patients), tofacitinib (which inhibits transforming growth factor–beta), or dupilumab (which inhibits interleukin-4).
Dr. Pope emphasized the effect congenital morphea has on quality of life. Remarks from patients with facial morphea and their parents who participated in a focus group on the topic organized by the Hospital for Sick Children included, “You just want to stay inside because you are afraid of what people will say,” “They laugh at her. They make fun of her, and it’s terrible,” and “MTX makes me feel weird. I would throw up, feel dizzy.”
“You have to take that into consideration, because we cannot make the treatment worse than the disease,” Dr. Pope said. “There are many domains where patients could be affected, including skin symptoms, physical functioning, body image and social support, side effects of medication, and presence of extracutaneous manifestations. Predictors of poor quality of life include female sex and involvement of hands and feet.”
Dr. Pope disclosed that she has received grants/research support from AbbVie, Centocor, and Amgen. She has also received consulting fees from AbbVie, Sanofi, Novartis, Boehringer-Ingelheim, Phoenix, Amryt Pharma, and Timber Pharmaceuticals.
INDIANAPOLIS – In the opinion of Elena Pope, MD, MSc,
“There is no correlation between the extent and activity of skin lesions and the presence, severity, and activity of extracutaneous manifestations,” Dr. Pope, professor of pediatrics at the University of Toronto and division head of pediatric dermatology at the Hospital for Sick Children in Toronto, said during the annual meeting of the Society for Pediatric Dermatology. “Treatment needs to be tailored to the extent of cutaneous manifestations, and I think we need to be aware of and address the impact on patients’ quality of life,” she added. There is also a need for more research “on targeted and better-tolerated therapies to put a stop to the progression of disease.”
Congenital morphea is a form of localized scleroderma that presents at birth but can be confused with port wine stain. Results from a multicenter retrospective review of 25 cases conducted by Dr. Pope and colleagues found that the median age at diagnosis was 2.9 years and 76% had linear-type lesions. In addition, 48% had extracutaneous involvement (all of these patients had linear morphea), most commonly of the central nervous system.
“It’s important to realize these lesions may become active over time,” Dr. Pope said. “In my experience, there are two different courses. Either you have innocuous lesions when the patients are born and they may become active around 3-4 years of age, or you have early intrauterine involvement, with lesions inactive at birth but with potential for significant damage in utero.”
She cautioned against treating a suspected port wine stain lesion with laser until congenital morphea is ruled out. “I’m aware of at least one lawsuit of a child where someone used a laser in a child who had progression with significant sclerosis,” she said. “The parents assumed it was the use of the laser that led to the progression, not the actual disease.”
Extracutaneous manifestations are common in morphea patients. A multicenter study of 750 patients with juvenile scleroderma found that 22% had extracutaneous manifestations. Almost half of patients (47%) had arthritis, but 17% had neurologic findings such as seizures and headaches, 9% had vascular manifestations, and 8% had uveitis. Subsequent studies found that neurological disease affects between 11% and 19% of cases, especially in those involving the head and neck.
“There is a wide range of manifestations from headache and neuropsychiatric changes to brain atrophy, seizures, and CNS cavernoma,” Dr. Pope said. “There also can be orthodental involvement such as malocclusion. It’s important to do a brain MRI, eye exam for uveitis, and don’t forget the orthodental assessment.”
She recalled a 10-year-old boy who presented to the Hospital for Sick Children with tissue loss on the forehead and eyebrow and eyelashes. He had no other congenital morphea symptoms and the MRI was normal, but the eye exam revealed uveitis. “It’s important to remember that uveitis is asymptomatic, so unless you look for it, you’re not going to find it,” she said.
According to unpublished data in 42 congenital morphea patients with lesions limited to the head and neck, who underwent MRI imaging at the Hospital for Sick Children, 57% had CNS changes that were ipsilateral in 68% of cases. “White matter changes were the most common, and to our surprise, there were patients who had progressive CNS disease, including CNS vasculitis, new lesions, and enhancement of prior stable lesions,” Dr. Pope said.
She recalled the case of an 8-year-old boy who presented to the hospital with intractable seizures. Upon completion of the MRI, one of the radiologists noted that the imaging showed subtle thinning of the forehead, and he was referred to Dr. Pope and colleagues for assessment. In the span of 4 years, despite aggressive treatment, the boy’s CNS disease progressed. “There was more enhancement, more tissue loss, his seizures are very hard to control, and he has many neurodevelopmental changes,” she recalled. “What I learned from this case is that skin activity does not correlate with imaging. Don’t assume that just because the skin is burnt out that the CNS will be the same. Also, the extent of skin disease does not predict involvement or progression of the CNS.”
Linear lesions on the lower extremities are a harbinger of orthopedic complications, which can occur in about half of patients. Joint contractures in this subset of patients are seen in about 81% of cases, while other sequelae can include arthritis, limb atrophy, leg-leg discrepancy, and angular deformity. “About 14% of patients require intervention,” Dr. Pope said. “In terms of working those patients up, you need to do an MRI and assess the extent of muscle and fascial involvement. Early physiotherapy and an orthopedic evaluation are also recommended.”
As for possible markers of morphea, antinuclear antibody is positive in 22%-68% of cases and correlates with disease severity, extracutaneous manifestations, and disease flare-up. Antihistone antibodies (AHA) are positive in about 47% of cases, “and that tends to correlate with the extent of skin and muscle involvement,” Dr. Pope said. “Anti–double-stranded DNA correlates with extent of disease, but the only known biomarker to date that correlates with disease activity is CXCL9/10. This has been documented in the skin as well as in the blood. So, this marker may help us determine if the patient needs to be treated or not.”
Treatments
For treatment of active localized disease, topical medications are helpful in some cases. Options include topical steroids, calcipotriol with or without betamethasone, imiquimod, and tacrolimus. “In my experience the combination of calcipotriol with betamethasone is best,” she said. “It really shuts down the activity fairly soon, and you can scale down to calcipotriol alone. I don’t find imiquimod very helpful for active lesions, although it has a role for inactive lesions.”
For patients with linear or generalized/mixed disease, “the combination of methotrexate and corticosteroids or methotrexate alone is probably the way to go,” Dr. Pope said. “The addition of steroids really depends on where the lesion is and how worried you are about other problems.”
According to the best available literature, 88% of patients should respond to treatment with methotrexate (MTX) and/or steroids within 3-6 months, and 74% within 3 months. “If they don’t, you have to wonder if the patient’s taking the medication, or you need to think about other alternative treatments,” she said. “Complete remission is possible in most of the patients, and the longer you treat the more you will see that. On average, most of us treat patients for about 3 years, but there are treatment failures as well. This can occur in up to 16% of patients.”
As for second-line treatment agents for congenital morphea, clinicians often turn to mycophenolate mofetil (MMF). Results from a retrospective longitudinal study of juvenile localized scleroderma patients found that after a mean of 9 years 91% of patients on MMF and 100% of patients on MTX had inactive disease. “There were no differences in relapse rates, although MMF seems to have a more sustained long-term effect and overall is better tolerated,” said Dr. Pope, who was not involved with the study. “However, it’s more immunosuppressive than MTX, which is important, especially in the era of COVID-19. You also need to think about the potential for more hematological suppression with MMF use.” If standard therapy fails, there is anecdotal data supporting the use of abatacept (which suppresses the T-cell activity in affected patients), tofacitinib (which inhibits transforming growth factor–beta), or dupilumab (which inhibits interleukin-4).
Dr. Pope emphasized the effect congenital morphea has on quality of life. Remarks from patients with facial morphea and their parents who participated in a focus group on the topic organized by the Hospital for Sick Children included, “You just want to stay inside because you are afraid of what people will say,” “They laugh at her. They make fun of her, and it’s terrible,” and “MTX makes me feel weird. I would throw up, feel dizzy.”
“You have to take that into consideration, because we cannot make the treatment worse than the disease,” Dr. Pope said. “There are many domains where patients could be affected, including skin symptoms, physical functioning, body image and social support, side effects of medication, and presence of extracutaneous manifestations. Predictors of poor quality of life include female sex and involvement of hands and feet.”
Dr. Pope disclosed that she has received grants/research support from AbbVie, Centocor, and Amgen. She has also received consulting fees from AbbVie, Sanofi, Novartis, Boehringer-Ingelheim, Phoenix, Amryt Pharma, and Timber Pharmaceuticals.
INDIANAPOLIS – In the opinion of Elena Pope, MD, MSc,
“There is no correlation between the extent and activity of skin lesions and the presence, severity, and activity of extracutaneous manifestations,” Dr. Pope, professor of pediatrics at the University of Toronto and division head of pediatric dermatology at the Hospital for Sick Children in Toronto, said during the annual meeting of the Society for Pediatric Dermatology. “Treatment needs to be tailored to the extent of cutaneous manifestations, and I think we need to be aware of and address the impact on patients’ quality of life,” she added. There is also a need for more research “on targeted and better-tolerated therapies to put a stop to the progression of disease.”
Congenital morphea is a form of localized scleroderma that presents at birth but can be confused with port wine stain. Results from a multicenter retrospective review of 25 cases conducted by Dr. Pope and colleagues found that the median age at diagnosis was 2.9 years and 76% had linear-type lesions. In addition, 48% had extracutaneous involvement (all of these patients had linear morphea), most commonly of the central nervous system.
“It’s important to realize these lesions may become active over time,” Dr. Pope said. “In my experience, there are two different courses. Either you have innocuous lesions when the patients are born and they may become active around 3-4 years of age, or you have early intrauterine involvement, with lesions inactive at birth but with potential for significant damage in utero.”
She cautioned against treating a suspected port wine stain lesion with laser until congenital morphea is ruled out. “I’m aware of at least one lawsuit of a child where someone used a laser in a child who had progression with significant sclerosis,” she said. “The parents assumed it was the use of the laser that led to the progression, not the actual disease.”
Extracutaneous manifestations are common in morphea patients. A multicenter study of 750 patients with juvenile scleroderma found that 22% had extracutaneous manifestations. Almost half of patients (47%) had arthritis, but 17% had neurologic findings such as seizures and headaches, 9% had vascular manifestations, and 8% had uveitis. Subsequent studies found that neurological disease affects between 11% and 19% of cases, especially in those involving the head and neck.
“There is a wide range of manifestations from headache and neuropsychiatric changes to brain atrophy, seizures, and CNS cavernoma,” Dr. Pope said. “There also can be orthodental involvement such as malocclusion. It’s important to do a brain MRI, eye exam for uveitis, and don’t forget the orthodental assessment.”
She recalled a 10-year-old boy who presented to the Hospital for Sick Children with tissue loss on the forehead and eyebrow and eyelashes. He had no other congenital morphea symptoms and the MRI was normal, but the eye exam revealed uveitis. “It’s important to remember that uveitis is asymptomatic, so unless you look for it, you’re not going to find it,” she said.
According to unpublished data in 42 congenital morphea patients with lesions limited to the head and neck, who underwent MRI imaging at the Hospital for Sick Children, 57% had CNS changes that were ipsilateral in 68% of cases. “White matter changes were the most common, and to our surprise, there were patients who had progressive CNS disease, including CNS vasculitis, new lesions, and enhancement of prior stable lesions,” Dr. Pope said.
She recalled the case of an 8-year-old boy who presented to the hospital with intractable seizures. Upon completion of the MRI, one of the radiologists noted that the imaging showed subtle thinning of the forehead, and he was referred to Dr. Pope and colleagues for assessment. In the span of 4 years, despite aggressive treatment, the boy’s CNS disease progressed. “There was more enhancement, more tissue loss, his seizures are very hard to control, and he has many neurodevelopmental changes,” she recalled. “What I learned from this case is that skin activity does not correlate with imaging. Don’t assume that just because the skin is burnt out that the CNS will be the same. Also, the extent of skin disease does not predict involvement or progression of the CNS.”
Linear lesions on the lower extremities are a harbinger of orthopedic complications, which can occur in about half of patients. Joint contractures in this subset of patients are seen in about 81% of cases, while other sequelae can include arthritis, limb atrophy, leg-leg discrepancy, and angular deformity. “About 14% of patients require intervention,” Dr. Pope said. “In terms of working those patients up, you need to do an MRI and assess the extent of muscle and fascial involvement. Early physiotherapy and an orthopedic evaluation are also recommended.”
As for possible markers of morphea, antinuclear antibody is positive in 22%-68% of cases and correlates with disease severity, extracutaneous manifestations, and disease flare-up. Antihistone antibodies (AHA) are positive in about 47% of cases, “and that tends to correlate with the extent of skin and muscle involvement,” Dr. Pope said. “Anti–double-stranded DNA correlates with extent of disease, but the only known biomarker to date that correlates with disease activity is CXCL9/10. This has been documented in the skin as well as in the blood. So, this marker may help us determine if the patient needs to be treated or not.”
Treatments
For treatment of active localized disease, topical medications are helpful in some cases. Options include topical steroids, calcipotriol with or without betamethasone, imiquimod, and tacrolimus. “In my experience the combination of calcipotriol with betamethasone is best,” she said. “It really shuts down the activity fairly soon, and you can scale down to calcipotriol alone. I don’t find imiquimod very helpful for active lesions, although it has a role for inactive lesions.”
For patients with linear or generalized/mixed disease, “the combination of methotrexate and corticosteroids or methotrexate alone is probably the way to go,” Dr. Pope said. “The addition of steroids really depends on where the lesion is and how worried you are about other problems.”
According to the best available literature, 88% of patients should respond to treatment with methotrexate (MTX) and/or steroids within 3-6 months, and 74% within 3 months. “If they don’t, you have to wonder if the patient’s taking the medication, or you need to think about other alternative treatments,” she said. “Complete remission is possible in most of the patients, and the longer you treat the more you will see that. On average, most of us treat patients for about 3 years, but there are treatment failures as well. This can occur in up to 16% of patients.”
As for second-line treatment agents for congenital morphea, clinicians often turn to mycophenolate mofetil (MMF). Results from a retrospective longitudinal study of juvenile localized scleroderma patients found that after a mean of 9 years 91% of patients on MMF and 100% of patients on MTX had inactive disease. “There were no differences in relapse rates, although MMF seems to have a more sustained long-term effect and overall is better tolerated,” said Dr. Pope, who was not involved with the study. “However, it’s more immunosuppressive than MTX, which is important, especially in the era of COVID-19. You also need to think about the potential for more hematological suppression with MMF use.” If standard therapy fails, there is anecdotal data supporting the use of abatacept (which suppresses the T-cell activity in affected patients), tofacitinib (which inhibits transforming growth factor–beta), or dupilumab (which inhibits interleukin-4).
Dr. Pope emphasized the effect congenital morphea has on quality of life. Remarks from patients with facial morphea and their parents who participated in a focus group on the topic organized by the Hospital for Sick Children included, “You just want to stay inside because you are afraid of what people will say,” “They laugh at her. They make fun of her, and it’s terrible,” and “MTX makes me feel weird. I would throw up, feel dizzy.”
“You have to take that into consideration, because we cannot make the treatment worse than the disease,” Dr. Pope said. “There are many domains where patients could be affected, including skin symptoms, physical functioning, body image and social support, side effects of medication, and presence of extracutaneous manifestations. Predictors of poor quality of life include female sex and involvement of hands and feet.”
Dr. Pope disclosed that she has received grants/research support from AbbVie, Centocor, and Amgen. She has also received consulting fees from AbbVie, Sanofi, Novartis, Boehringer-Ingelheim, Phoenix, Amryt Pharma, and Timber Pharmaceuticals.
AT SPD 2022
Medical assistants
When I began in private practice several eons ago, I employed only registered nurses (RNs) and licensed practical nurses (LPNs) in my office – as did, I think, most other physicians.
That is still the preferred way to go from an efficiency perspective, as well as the ability to delegate such tasks as blood collection and administering intramuscular injections. Unfortunately,
Given this reality, it makes sense to understand how the use of medical assistants has changed private medical practice, and how the most effective MAs manage their roles and maximize their efficiency in the office.
A recent article by two physicians at the University of Michigan, Ann Arbor, is one of the few published papers to address this issue. It presents the results of a cross-sectional study examining the MA’s experience and key factors that enhance or reduce efficiencies.
The authors sent an email survey to 86 MAs working in six clinics within the department of family medicine at the University of Michigan Medical Center, and received responses from 75 of them, including 61 who completed the entire survey. They then singled out 18 individuals deemed “most efficient” by their peers and conducted face-to-face interviews with them.
The surveys and interviews looked at how MAs identified personal strategies for efficiency, dealt with barriers to implementing those strategies, and navigated interoffice relationships, as well as how all of this affected overall job satisfaction.
All 61 respondents who completed the full survey agreed that the MA role was “very important to keep the clinic functioning” and nearly all said that working in health care was “a calling” for them. About half agreed that their work was very stressful, and about the same percentage reported that there was inadequate MA staffing at their clinic. Others complained of limited pay and promotion opportunities.
The surveyed MAs described important work values that increased their efficiency. These included good communication, strong teamwork, and workload sharing, as well as individual strategies such as multitasking, limiting patient conversations, and completing tasks in a consistent way to improve accuracy.
Other strategies identified as contributing to an efficient operation included preclinic huddles, reviews of patient records before the patient’s arrival, and completing routine office duties before the start of office hours.
Respondents were then asked to identify barriers to clinic efficiency, and most of them involved physicians who barked orders at them, did not complete paperwork or sign orders in a timely manner, and agreed to see late-arriving patients. Some MAs suggested that physicians refrain from “talking down” to them, and teach rather than criticize. They also faulted decisions affecting patient flow made by other staffers without soliciting the MAs’ input.
Despite these barriers, the authors found that most of the surveyed MAs agreed that their work was valued by doctors. “Proper training of managers to provide ... support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial,” they said.
“Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier,” they added.
At the same time, the authors noted that most survey subjects reported that their jobs were “stressful,” and believed that their stress went underrecognized by physicians. They argued that “it’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.”
Since this study involved only MAs in a family practice setting, further studies will be needed to determine whether these results translate to specialty offices – and whether the unique issues inherent in various specialty environments elicit different efficiency contributors and barriers.
Overall, though, “staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients,” the authors wrote. “Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
When I began in private practice several eons ago, I employed only registered nurses (RNs) and licensed practical nurses (LPNs) in my office – as did, I think, most other physicians.
That is still the preferred way to go from an efficiency perspective, as well as the ability to delegate such tasks as blood collection and administering intramuscular injections. Unfortunately,
Given this reality, it makes sense to understand how the use of medical assistants has changed private medical practice, and how the most effective MAs manage their roles and maximize their efficiency in the office.
A recent article by two physicians at the University of Michigan, Ann Arbor, is one of the few published papers to address this issue. It presents the results of a cross-sectional study examining the MA’s experience and key factors that enhance or reduce efficiencies.
The authors sent an email survey to 86 MAs working in six clinics within the department of family medicine at the University of Michigan Medical Center, and received responses from 75 of them, including 61 who completed the entire survey. They then singled out 18 individuals deemed “most efficient” by their peers and conducted face-to-face interviews with them.
The surveys and interviews looked at how MAs identified personal strategies for efficiency, dealt with barriers to implementing those strategies, and navigated interoffice relationships, as well as how all of this affected overall job satisfaction.
All 61 respondents who completed the full survey agreed that the MA role was “very important to keep the clinic functioning” and nearly all said that working in health care was “a calling” for them. About half agreed that their work was very stressful, and about the same percentage reported that there was inadequate MA staffing at their clinic. Others complained of limited pay and promotion opportunities.
The surveyed MAs described important work values that increased their efficiency. These included good communication, strong teamwork, and workload sharing, as well as individual strategies such as multitasking, limiting patient conversations, and completing tasks in a consistent way to improve accuracy.
Other strategies identified as contributing to an efficient operation included preclinic huddles, reviews of patient records before the patient’s arrival, and completing routine office duties before the start of office hours.
Respondents were then asked to identify barriers to clinic efficiency, and most of them involved physicians who barked orders at them, did not complete paperwork or sign orders in a timely manner, and agreed to see late-arriving patients. Some MAs suggested that physicians refrain from “talking down” to them, and teach rather than criticize. They also faulted decisions affecting patient flow made by other staffers without soliciting the MAs’ input.
Despite these barriers, the authors found that most of the surveyed MAs agreed that their work was valued by doctors. “Proper training of managers to provide ... support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial,” they said.
“Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier,” they added.
At the same time, the authors noted that most survey subjects reported that their jobs were “stressful,” and believed that their stress went underrecognized by physicians. They argued that “it’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.”
Since this study involved only MAs in a family practice setting, further studies will be needed to determine whether these results translate to specialty offices – and whether the unique issues inherent in various specialty environments elicit different efficiency contributors and barriers.
Overall, though, “staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients,” the authors wrote. “Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
When I began in private practice several eons ago, I employed only registered nurses (RNs) and licensed practical nurses (LPNs) in my office – as did, I think, most other physicians.
That is still the preferred way to go from an efficiency perspective, as well as the ability to delegate such tasks as blood collection and administering intramuscular injections. Unfortunately,
Given this reality, it makes sense to understand how the use of medical assistants has changed private medical practice, and how the most effective MAs manage their roles and maximize their efficiency in the office.
A recent article by two physicians at the University of Michigan, Ann Arbor, is one of the few published papers to address this issue. It presents the results of a cross-sectional study examining the MA’s experience and key factors that enhance or reduce efficiencies.
The authors sent an email survey to 86 MAs working in six clinics within the department of family medicine at the University of Michigan Medical Center, and received responses from 75 of them, including 61 who completed the entire survey. They then singled out 18 individuals deemed “most efficient” by their peers and conducted face-to-face interviews with them.
The surveys and interviews looked at how MAs identified personal strategies for efficiency, dealt with barriers to implementing those strategies, and navigated interoffice relationships, as well as how all of this affected overall job satisfaction.
All 61 respondents who completed the full survey agreed that the MA role was “very important to keep the clinic functioning” and nearly all said that working in health care was “a calling” for them. About half agreed that their work was very stressful, and about the same percentage reported that there was inadequate MA staffing at their clinic. Others complained of limited pay and promotion opportunities.
The surveyed MAs described important work values that increased their efficiency. These included good communication, strong teamwork, and workload sharing, as well as individual strategies such as multitasking, limiting patient conversations, and completing tasks in a consistent way to improve accuracy.
Other strategies identified as contributing to an efficient operation included preclinic huddles, reviews of patient records before the patient’s arrival, and completing routine office duties before the start of office hours.
Respondents were then asked to identify barriers to clinic efficiency, and most of them involved physicians who barked orders at them, did not complete paperwork or sign orders in a timely manner, and agreed to see late-arriving patients. Some MAs suggested that physicians refrain from “talking down” to them, and teach rather than criticize. They also faulted decisions affecting patient flow made by other staffers without soliciting the MAs’ input.
Despite these barriers, the authors found that most of the surveyed MAs agreed that their work was valued by doctors. “Proper training of managers to provide ... support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial,” they said.
“Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier,” they added.
At the same time, the authors noted that most survey subjects reported that their jobs were “stressful,” and believed that their stress went underrecognized by physicians. They argued that “it’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.”
Since this study involved only MAs in a family practice setting, further studies will be needed to determine whether these results translate to specialty offices – and whether the unique issues inherent in various specialty environments elicit different efficiency contributors and barriers.
Overall, though, “staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients,” the authors wrote. “Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
Violent patient throws scalding oil on MD; other patient dangers
Ralph Newman, MD, got a taste of how dangerous medicine could be at age 10, when he witnessed a physician being shot by a patient.
“I was visiting a friend whose father was a psychiatrist,” Dr. Newman recalled. “We were playing in the living room when the doorbell rang. My friend went to the door and opened it. Then I heard a shot. I ran to the front hall and saw my friend’s father slumped at the bottom of the stairs. He had come down the stairs to see who was there. It was a patient armed with a shotgun.”
As a result of the shooting, a large portion of the psychiatrist’s intestines was removed. In spite of this traumatic incident, Dr. Newman went on to become a psychiatrist – who treated many violent prisoners. “I knew it was dangerous,” he said, “but I rationalized that I wouldn’t be attacked because I would be nicer.”
That attitude seemed to work until 2002, when a prisoner threw boiling oil on him. Dr. Newman was working at the Federal Medical Center Butner, a facility for prisoners in North Carolina. “A prisoner I had been treating was denied parole, based on my recommendation,” he said. “From then on, he was looking for a way to exact revenge.”
“One day I was sitting in the nursing station, typing up notes,” Dr. Newman said. “Two new nurses, who were also there, had forgotten to lock the door, and the prisoner noticed that. He heated up some baby oil in a microwave, which was available to prisoners at the time. Then he walked into the office, threw the oil on my back, and came at me with a sharp pencil.”
Dr. Newman said the nurses fled to an adjoining office, locked the door, and wouldn’t let him in. He went into another office and collapsed in exhaustion. He was saved by an inmate who came on the scene, fended off the attacker, and called for help.
“I was taken to the burn unit,” Dr. Newman recalled. “I had second- and third-degree burns on 9% of my body. It was extremely painful. It took me 45 days to recover enough to get back to work.” The two nurses were fired.
Doctors take threats by patients more seriously now
When orthopedic surgeon Preston Phillips, MD, was killed by a patient in Tulsa, Okla., on June 1, Jennifer M. Weiss, MD, recognized the potential danger to physicians.
“The news left me feeling very shaken,” said Dr. Weiss, a pediatric orthopedic surgeon at Southern California Permanente Medical Group, Los Angeles. “Every orthopedic surgeon I talked to about it felt shaken.”
Dr. Weiss said the impact of that event prompted her to take a patient’s abuse more seriously than she might have previously. “Before the killing, my colleagues and I might have swept the incident under the rug, but we reported it to the authorities,” she said.
“What happened was I told a parent of a school-aged child that the child wasn’t ready to go back to sports,” Dr. Weiss says. “This parent was incredibly triggered – screaming and making verbal threats. The parent was standing between me and the door, so I couldn’t get out.”
Coworkers down the hall heard the yelling and helped Dr. Weiss get out of the room. “The parent was escorted out of the building, and the incident was reported to our risk management team,” she said.
Shooters/killers vs. agitated patients
Patients who shoot to kill are very different from agitated patients seen by many doctors on a regular basis – particularly in emergency departments (EDs), psychiatric units, and pain clinics, said Scott Zeller, MD, a psychiatrist who is vice president of Acute Psychiatric Medicine at Vituity, a multistate physician partnership based in Emeryville, California.
“Agitated patients have trouble communicating their needs and can become physically and verbally aggressive,” Dr. Zeller said. He reports that there are 1.7 million such incidents a year in this country, but most of the incidents of verbal aggression can be kept from exploding into physical violence.
Shooters, however, are very hard to stop because they usually plan the action in advance, Dr. Zeller said. He recalled the 2017 murder of Todd Graham, MD, a friend from medical school. Dr. Graham, an orthopedic surgeon in South Bend, Ind., was gunned down by the husband of one of his patients after Dr. Graham declined to prescribe opioids for her.
Playing down the risk of violence
Doctors may play down the risk of violence, even after they have experienced it personally. “Patients can get angry and may make threatening comments,” Dr. Weiss said. “A lot of doctors just brush it off.”
Simple remarks can set off violence-prone patients, as happened to James P. Phillips, MD, director of disaster and operational medicine at George Washington University, Washington. He recalled asking a prisoner who was visiting his hospital to “lower the volume,” and the man exploded. “Even though he was handcuffed to the bed, he heaved an oxygen tank into a window,” Dr. Phillips said. “He said he would be coming back to kill me.”
Sometimes threats or other types of verbal abuse can be as destructive as physical violence. Diann Krywko, MD, an emergency physician at the Medical University of South Carolina (MUSC) Health, Charleston, has had some tough assignments. She worked in EDs in Detroit and Flint, Mich., for a decade before coming to MUSC, where she serves as director of wellness, health, and resilience. One of the incidents that has bothered her the most involved a threat.
It happened when Dr. Krywko denied a patient’s request for narcotics. “She was very angry and said she’d come to my home and cut my children’s heads off,” Dr. Krywko said. “To this day, what she said horrifies me. I still see her smile as she said that.”
Dr. Krywko considered filing for a restraining order against the patient but didn’t because the patient could have learned her address. Dr. Phillips said fear of retaliation is one reason many doctors don’t report threats from patients. “The patient you report knows where you work and may come there to take revenge,” he said. “Also, you may have to continue caring for the person who punched you.”
Online threats also may cause a great deal of angst. Dr. Phillips said he received many online threats when was a medical analyst for CNN in 2020. “Someone sent my address to his Twitter followers, and they shared it with others, so now the whole world knows where I live,” he said. “I had to upgrade security at my home.”
How to deal with volatile patients
Being nice may not always work, but in many cases, it can keep a volatile situation from exploding, according to Dr. Krywko.
“When patients begin to show signs of agitation or are already there, we always try to verbally deescalate the situation, which involves listening,” Dr. Krywko said. “They want someone to hear them out.”
Doctors speak to patients from a position of authority, but Dr. Krywko advises that they should not be too blunt. “Don’t tell patients they’re wrong,” she said. “Even if they may be incorrect, they feel their viewpoint is valid. Encourage a dialogue with words like, ‘Tell me more,’ ” Dr. Krywko said.
Defending yourself
Doctors may have little warning of an impending attack because a patient’s mood can change quickly. This happened several years ago to Jennifer Casaletto, MD, an emergency physician in Charlotte, N.C.
“A man was brought into my ED by ambulance,” she said. “He seemed very calm for a long while, but then he became completely unhinged. A male nurse placed himself between the patient and others and was attacked. He got hurt but was able to continue working.”
Dr. Zeller said health care teams sometimes overreact when patients lash out. “The old-fashioned way to deal with an agitated patient is to call in the cavalry – everyone does a group takedown,” he said. “The patient is put in restraints and heavily sedated. This is not good for anybody. Not only is it likely to injure and traumatize the patient, it can also injure the care team.”
Many hospital EDs have security guards. “I feel safer when a hospital has armed security guards, but they need to be well trained,” Dr. Casaletto said. “Many small hospitals and freestanding EDs do not have security officers at all, or the guards are undertrained or told not to touch anybody.”
In many electronic health record systems, doctors can flag violent patients so future caregivers can be forewarned. However, Dr. Zeller advises against writing about patients’ violence or rudeness in the medical record, because patients can have access to it and might take revenge.
Rising violence from patients
“It feels like it has become much more dangerous to work in the ED,” said Hasan Gokal, MD, an emergency physician working in EDs at the Texas Medical Center. “Just last week, a woman pulled out a gun and fired it in an ED near Houston.”
The statistics back up Dr. Gokal’s assessment. Injuries caused by violent attacks against medical professionals grew by 67% from 2011 to 2018, according to the U.S. Bureau of Labor Statistics. Those levels rose even more during the COVID-19 pandemic – the assault rate in hospitals rose 23% just in 2020.
Dr. Krywko said she had “a patient who said she wanted to hurt the next person who irritated her, and that happened to me. She jumped out of her bed swinging and punching, and I wasn’t ready for it. I yelled for help and the care team came.”
“The rise in violence has to do with a decline in respect for authority,” Dr. Phillips said. “Some people now believe doctors are lying to them about the need for COVID precautions because they are taking money from the vaccine companies. The pandemic has exacerbated violence in every way.”
Dr. Phillips said that a growing lack of resources had led to more anger among patients. “There are fewer nurses and reduced physician coverage,” he said. “That means longer wait times for patients, which increases patients’ frustrations.”
Dr. Weiss said patients have higher expectations. “In sports medicine, the expectations are incredible,” she said. “Parents want their kids to get back to playing as soon as possible.”
“Hospitals in particular are soft targets for violence,” Dr. Phillips said. “People know you can’t assault a flight attendant, because it’s a federal offense, but there is no such federal offense for violence against health care personnel.”
A version of this article first appeared on Medscape.com.
Ralph Newman, MD, got a taste of how dangerous medicine could be at age 10, when he witnessed a physician being shot by a patient.
“I was visiting a friend whose father was a psychiatrist,” Dr. Newman recalled. “We were playing in the living room when the doorbell rang. My friend went to the door and opened it. Then I heard a shot. I ran to the front hall and saw my friend’s father slumped at the bottom of the stairs. He had come down the stairs to see who was there. It was a patient armed with a shotgun.”
As a result of the shooting, a large portion of the psychiatrist’s intestines was removed. In spite of this traumatic incident, Dr. Newman went on to become a psychiatrist – who treated many violent prisoners. “I knew it was dangerous,” he said, “but I rationalized that I wouldn’t be attacked because I would be nicer.”
That attitude seemed to work until 2002, when a prisoner threw boiling oil on him. Dr. Newman was working at the Federal Medical Center Butner, a facility for prisoners in North Carolina. “A prisoner I had been treating was denied parole, based on my recommendation,” he said. “From then on, he was looking for a way to exact revenge.”
“One day I was sitting in the nursing station, typing up notes,” Dr. Newman said. “Two new nurses, who were also there, had forgotten to lock the door, and the prisoner noticed that. He heated up some baby oil in a microwave, which was available to prisoners at the time. Then he walked into the office, threw the oil on my back, and came at me with a sharp pencil.”
Dr. Newman said the nurses fled to an adjoining office, locked the door, and wouldn’t let him in. He went into another office and collapsed in exhaustion. He was saved by an inmate who came on the scene, fended off the attacker, and called for help.
“I was taken to the burn unit,” Dr. Newman recalled. “I had second- and third-degree burns on 9% of my body. It was extremely painful. It took me 45 days to recover enough to get back to work.” The two nurses were fired.
Doctors take threats by patients more seriously now
When orthopedic surgeon Preston Phillips, MD, was killed by a patient in Tulsa, Okla., on June 1, Jennifer M. Weiss, MD, recognized the potential danger to physicians.
“The news left me feeling very shaken,” said Dr. Weiss, a pediatric orthopedic surgeon at Southern California Permanente Medical Group, Los Angeles. “Every orthopedic surgeon I talked to about it felt shaken.”
Dr. Weiss said the impact of that event prompted her to take a patient’s abuse more seriously than she might have previously. “Before the killing, my colleagues and I might have swept the incident under the rug, but we reported it to the authorities,” she said.
“What happened was I told a parent of a school-aged child that the child wasn’t ready to go back to sports,” Dr. Weiss says. “This parent was incredibly triggered – screaming and making verbal threats. The parent was standing between me and the door, so I couldn’t get out.”
Coworkers down the hall heard the yelling and helped Dr. Weiss get out of the room. “The parent was escorted out of the building, and the incident was reported to our risk management team,” she said.
Shooters/killers vs. agitated patients
Patients who shoot to kill are very different from agitated patients seen by many doctors on a regular basis – particularly in emergency departments (EDs), psychiatric units, and pain clinics, said Scott Zeller, MD, a psychiatrist who is vice president of Acute Psychiatric Medicine at Vituity, a multistate physician partnership based in Emeryville, California.
“Agitated patients have trouble communicating their needs and can become physically and verbally aggressive,” Dr. Zeller said. He reports that there are 1.7 million such incidents a year in this country, but most of the incidents of verbal aggression can be kept from exploding into physical violence.
Shooters, however, are very hard to stop because they usually plan the action in advance, Dr. Zeller said. He recalled the 2017 murder of Todd Graham, MD, a friend from medical school. Dr. Graham, an orthopedic surgeon in South Bend, Ind., was gunned down by the husband of one of his patients after Dr. Graham declined to prescribe opioids for her.
Playing down the risk of violence
Doctors may play down the risk of violence, even after they have experienced it personally. “Patients can get angry and may make threatening comments,” Dr. Weiss said. “A lot of doctors just brush it off.”
Simple remarks can set off violence-prone patients, as happened to James P. Phillips, MD, director of disaster and operational medicine at George Washington University, Washington. He recalled asking a prisoner who was visiting his hospital to “lower the volume,” and the man exploded. “Even though he was handcuffed to the bed, he heaved an oxygen tank into a window,” Dr. Phillips said. “He said he would be coming back to kill me.”
Sometimes threats or other types of verbal abuse can be as destructive as physical violence. Diann Krywko, MD, an emergency physician at the Medical University of South Carolina (MUSC) Health, Charleston, has had some tough assignments. She worked in EDs in Detroit and Flint, Mich., for a decade before coming to MUSC, where she serves as director of wellness, health, and resilience. One of the incidents that has bothered her the most involved a threat.
It happened when Dr. Krywko denied a patient’s request for narcotics. “She was very angry and said she’d come to my home and cut my children’s heads off,” Dr. Krywko said. “To this day, what she said horrifies me. I still see her smile as she said that.”
Dr. Krywko considered filing for a restraining order against the patient but didn’t because the patient could have learned her address. Dr. Phillips said fear of retaliation is one reason many doctors don’t report threats from patients. “The patient you report knows where you work and may come there to take revenge,” he said. “Also, you may have to continue caring for the person who punched you.”
Online threats also may cause a great deal of angst. Dr. Phillips said he received many online threats when was a medical analyst for CNN in 2020. “Someone sent my address to his Twitter followers, and they shared it with others, so now the whole world knows where I live,” he said. “I had to upgrade security at my home.”
How to deal with volatile patients
Being nice may not always work, but in many cases, it can keep a volatile situation from exploding, according to Dr. Krywko.
“When patients begin to show signs of agitation or are already there, we always try to verbally deescalate the situation, which involves listening,” Dr. Krywko said. “They want someone to hear them out.”
Doctors speak to patients from a position of authority, but Dr. Krywko advises that they should not be too blunt. “Don’t tell patients they’re wrong,” she said. “Even if they may be incorrect, they feel their viewpoint is valid. Encourage a dialogue with words like, ‘Tell me more,’ ” Dr. Krywko said.
Defending yourself
Doctors may have little warning of an impending attack because a patient’s mood can change quickly. This happened several years ago to Jennifer Casaletto, MD, an emergency physician in Charlotte, N.C.
“A man was brought into my ED by ambulance,” she said. “He seemed very calm for a long while, but then he became completely unhinged. A male nurse placed himself between the patient and others and was attacked. He got hurt but was able to continue working.”
Dr. Zeller said health care teams sometimes overreact when patients lash out. “The old-fashioned way to deal with an agitated patient is to call in the cavalry – everyone does a group takedown,” he said. “The patient is put in restraints and heavily sedated. This is not good for anybody. Not only is it likely to injure and traumatize the patient, it can also injure the care team.”
Many hospital EDs have security guards. “I feel safer when a hospital has armed security guards, but they need to be well trained,” Dr. Casaletto said. “Many small hospitals and freestanding EDs do not have security officers at all, or the guards are undertrained or told not to touch anybody.”
In many electronic health record systems, doctors can flag violent patients so future caregivers can be forewarned. However, Dr. Zeller advises against writing about patients’ violence or rudeness in the medical record, because patients can have access to it and might take revenge.
Rising violence from patients
“It feels like it has become much more dangerous to work in the ED,” said Hasan Gokal, MD, an emergency physician working in EDs at the Texas Medical Center. “Just last week, a woman pulled out a gun and fired it in an ED near Houston.”
The statistics back up Dr. Gokal’s assessment. Injuries caused by violent attacks against medical professionals grew by 67% from 2011 to 2018, according to the U.S. Bureau of Labor Statistics. Those levels rose even more during the COVID-19 pandemic – the assault rate in hospitals rose 23% just in 2020.
Dr. Krywko said she had “a patient who said she wanted to hurt the next person who irritated her, and that happened to me. She jumped out of her bed swinging and punching, and I wasn’t ready for it. I yelled for help and the care team came.”
“The rise in violence has to do with a decline in respect for authority,” Dr. Phillips said. “Some people now believe doctors are lying to them about the need for COVID precautions because they are taking money from the vaccine companies. The pandemic has exacerbated violence in every way.”
Dr. Phillips said that a growing lack of resources had led to more anger among patients. “There are fewer nurses and reduced physician coverage,” he said. “That means longer wait times for patients, which increases patients’ frustrations.”
Dr. Weiss said patients have higher expectations. “In sports medicine, the expectations are incredible,” she said. “Parents want their kids to get back to playing as soon as possible.”
“Hospitals in particular are soft targets for violence,” Dr. Phillips said. “People know you can’t assault a flight attendant, because it’s a federal offense, but there is no such federal offense for violence against health care personnel.”
A version of this article first appeared on Medscape.com.
Ralph Newman, MD, got a taste of how dangerous medicine could be at age 10, when he witnessed a physician being shot by a patient.
“I was visiting a friend whose father was a psychiatrist,” Dr. Newman recalled. “We were playing in the living room when the doorbell rang. My friend went to the door and opened it. Then I heard a shot. I ran to the front hall and saw my friend’s father slumped at the bottom of the stairs. He had come down the stairs to see who was there. It was a patient armed with a shotgun.”
As a result of the shooting, a large portion of the psychiatrist’s intestines was removed. In spite of this traumatic incident, Dr. Newman went on to become a psychiatrist – who treated many violent prisoners. “I knew it was dangerous,” he said, “but I rationalized that I wouldn’t be attacked because I would be nicer.”
That attitude seemed to work until 2002, when a prisoner threw boiling oil on him. Dr. Newman was working at the Federal Medical Center Butner, a facility for prisoners in North Carolina. “A prisoner I had been treating was denied parole, based on my recommendation,” he said. “From then on, he was looking for a way to exact revenge.”
“One day I was sitting in the nursing station, typing up notes,” Dr. Newman said. “Two new nurses, who were also there, had forgotten to lock the door, and the prisoner noticed that. He heated up some baby oil in a microwave, which was available to prisoners at the time. Then he walked into the office, threw the oil on my back, and came at me with a sharp pencil.”
Dr. Newman said the nurses fled to an adjoining office, locked the door, and wouldn’t let him in. He went into another office and collapsed in exhaustion. He was saved by an inmate who came on the scene, fended off the attacker, and called for help.
“I was taken to the burn unit,” Dr. Newman recalled. “I had second- and third-degree burns on 9% of my body. It was extremely painful. It took me 45 days to recover enough to get back to work.” The two nurses were fired.
Doctors take threats by patients more seriously now
When orthopedic surgeon Preston Phillips, MD, was killed by a patient in Tulsa, Okla., on June 1, Jennifer M. Weiss, MD, recognized the potential danger to physicians.
“The news left me feeling very shaken,” said Dr. Weiss, a pediatric orthopedic surgeon at Southern California Permanente Medical Group, Los Angeles. “Every orthopedic surgeon I talked to about it felt shaken.”
Dr. Weiss said the impact of that event prompted her to take a patient’s abuse more seriously than she might have previously. “Before the killing, my colleagues and I might have swept the incident under the rug, but we reported it to the authorities,” she said.
“What happened was I told a parent of a school-aged child that the child wasn’t ready to go back to sports,” Dr. Weiss says. “This parent was incredibly triggered – screaming and making verbal threats. The parent was standing between me and the door, so I couldn’t get out.”
Coworkers down the hall heard the yelling and helped Dr. Weiss get out of the room. “The parent was escorted out of the building, and the incident was reported to our risk management team,” she said.
Shooters/killers vs. agitated patients
Patients who shoot to kill are very different from agitated patients seen by many doctors on a regular basis – particularly in emergency departments (EDs), psychiatric units, and pain clinics, said Scott Zeller, MD, a psychiatrist who is vice president of Acute Psychiatric Medicine at Vituity, a multistate physician partnership based in Emeryville, California.
“Agitated patients have trouble communicating their needs and can become physically and verbally aggressive,” Dr. Zeller said. He reports that there are 1.7 million such incidents a year in this country, but most of the incidents of verbal aggression can be kept from exploding into physical violence.
Shooters, however, are very hard to stop because they usually plan the action in advance, Dr. Zeller said. He recalled the 2017 murder of Todd Graham, MD, a friend from medical school. Dr. Graham, an orthopedic surgeon in South Bend, Ind., was gunned down by the husband of one of his patients after Dr. Graham declined to prescribe opioids for her.
Playing down the risk of violence
Doctors may play down the risk of violence, even after they have experienced it personally. “Patients can get angry and may make threatening comments,” Dr. Weiss said. “A lot of doctors just brush it off.”
Simple remarks can set off violence-prone patients, as happened to James P. Phillips, MD, director of disaster and operational medicine at George Washington University, Washington. He recalled asking a prisoner who was visiting his hospital to “lower the volume,” and the man exploded. “Even though he was handcuffed to the bed, he heaved an oxygen tank into a window,” Dr. Phillips said. “He said he would be coming back to kill me.”
Sometimes threats or other types of verbal abuse can be as destructive as physical violence. Diann Krywko, MD, an emergency physician at the Medical University of South Carolina (MUSC) Health, Charleston, has had some tough assignments. She worked in EDs in Detroit and Flint, Mich., for a decade before coming to MUSC, where she serves as director of wellness, health, and resilience. One of the incidents that has bothered her the most involved a threat.
It happened when Dr. Krywko denied a patient’s request for narcotics. “She was very angry and said she’d come to my home and cut my children’s heads off,” Dr. Krywko said. “To this day, what she said horrifies me. I still see her smile as she said that.”
Dr. Krywko considered filing for a restraining order against the patient but didn’t because the patient could have learned her address. Dr. Phillips said fear of retaliation is one reason many doctors don’t report threats from patients. “The patient you report knows where you work and may come there to take revenge,” he said. “Also, you may have to continue caring for the person who punched you.”
Online threats also may cause a great deal of angst. Dr. Phillips said he received many online threats when was a medical analyst for CNN in 2020. “Someone sent my address to his Twitter followers, and they shared it with others, so now the whole world knows where I live,” he said. “I had to upgrade security at my home.”
How to deal with volatile patients
Being nice may not always work, but in many cases, it can keep a volatile situation from exploding, according to Dr. Krywko.
“When patients begin to show signs of agitation or are already there, we always try to verbally deescalate the situation, which involves listening,” Dr. Krywko said. “They want someone to hear them out.”
Doctors speak to patients from a position of authority, but Dr. Krywko advises that they should not be too blunt. “Don’t tell patients they’re wrong,” she said. “Even if they may be incorrect, they feel their viewpoint is valid. Encourage a dialogue with words like, ‘Tell me more,’ ” Dr. Krywko said.
Defending yourself
Doctors may have little warning of an impending attack because a patient’s mood can change quickly. This happened several years ago to Jennifer Casaletto, MD, an emergency physician in Charlotte, N.C.
“A man was brought into my ED by ambulance,” she said. “He seemed very calm for a long while, but then he became completely unhinged. A male nurse placed himself between the patient and others and was attacked. He got hurt but was able to continue working.”
Dr. Zeller said health care teams sometimes overreact when patients lash out. “The old-fashioned way to deal with an agitated patient is to call in the cavalry – everyone does a group takedown,” he said. “The patient is put in restraints and heavily sedated. This is not good for anybody. Not only is it likely to injure and traumatize the patient, it can also injure the care team.”
Many hospital EDs have security guards. “I feel safer when a hospital has armed security guards, but they need to be well trained,” Dr. Casaletto said. “Many small hospitals and freestanding EDs do not have security officers at all, or the guards are undertrained or told not to touch anybody.”
In many electronic health record systems, doctors can flag violent patients so future caregivers can be forewarned. However, Dr. Zeller advises against writing about patients’ violence or rudeness in the medical record, because patients can have access to it and might take revenge.
Rising violence from patients
“It feels like it has become much more dangerous to work in the ED,” said Hasan Gokal, MD, an emergency physician working in EDs at the Texas Medical Center. “Just last week, a woman pulled out a gun and fired it in an ED near Houston.”
The statistics back up Dr. Gokal’s assessment. Injuries caused by violent attacks against medical professionals grew by 67% from 2011 to 2018, according to the U.S. Bureau of Labor Statistics. Those levels rose even more during the COVID-19 pandemic – the assault rate in hospitals rose 23% just in 2020.
Dr. Krywko said she had “a patient who said she wanted to hurt the next person who irritated her, and that happened to me. She jumped out of her bed swinging and punching, and I wasn’t ready for it. I yelled for help and the care team came.”
“The rise in violence has to do with a decline in respect for authority,” Dr. Phillips said. “Some people now believe doctors are lying to them about the need for COVID precautions because they are taking money from the vaccine companies. The pandemic has exacerbated violence in every way.”
Dr. Phillips said that a growing lack of resources had led to more anger among patients. “There are fewer nurses and reduced physician coverage,” he said. “That means longer wait times for patients, which increases patients’ frustrations.”
Dr. Weiss said patients have higher expectations. “In sports medicine, the expectations are incredible,” she said. “Parents want their kids to get back to playing as soon as possible.”
“Hospitals in particular are soft targets for violence,” Dr. Phillips said. “People know you can’t assault a flight attendant, because it’s a federal offense, but there is no such federal offense for violence against health care personnel.”
A version of this article first appeared on Medscape.com.
Ten steps for clinicians to avoid being racist: The Francis commitment
As a Black man who grew up in this country, I can tell you first-hand what it does to you. The scars never go away, and your status is always in question, no matter your title or uniforms of respect. Eventually it wears you down.
I was born into poverty and the segregation of southwest Louisiana. I experienced the dehumanization intended for me: separate drinking fountains and poor foundational education. I was lucky to attend a historically Black college or university (Southern University, Baton Rouge, La.), that gave me my bearings. I then went to some of the very best, predominantly White institutions.
When I looked for a job after training, there were few integrated medical groups, so I started my own. It included practitioners who were White, Black, Jewish, Asian, Middle Eastern, Muslim, Christian, etc. We cross covered and treated patients from every corner of the globe.
In medicine, we treat human beings with disease. The disease should be the only difference that sets us apart. There is absolutely no place for racism.
It is difficult to be called a racist, and I have met only a handful of people in health care whom I would label as such. But racism is structural and institutionalized so that it is often hidden.
One way to overcome this is to make every effort possible to get to know people as individuals. Only then can we see that there are few real differences between us. I would often seek out a colleague from a different culture or race to have lunch with so I could learn more about them.
We all strive for the same things – validation, happiness, love, family, and a future. We all grieve over the same things.
What some caregivers may not realize is that, just as clinicians have been trained to recognize subtle signs and symptoms of disease, minorities can recognize racism immediately during a medical encounter. Our past experiences make us skilled at picking up a lack of eye contact or body language and tone of voice that are dismissive and disrespectful.
A patient who has felt racism may still return for care because of insurance coverage limitations, location, or a lack of alternatives. But trust and loyalty will never develop on the part of this patient, and empathy will be absent on the part of their caregiver.
To counter this in my own practice, I developed the Francis Commitment to avoid any hint of racism or bias toward my patients.
I commit to the following:
1. I see you.
2. I hear you.
3. I accept who you are.
4. I will try to understand how you must feel (empathy).
5. Treating you is very important to me.
6. I would like to gain your trust that I will do my very best to make you better.
7. I value you as a human being and will treat you as if you are family.
8. I care about what happens to you.
9. I want us to work together to fight this disease.
10. I am grateful that you chose me as your caregiver.
The INOVA health care system where I work has undertaken an initiative called What Matters Most to better understand the needs of every patient. We are currently working on a strategy of patient personalization to not only learn about their medical needs but also to discover who they are as a person. We incorporate Social Determinants of Health in our dealings with patients. We also have participated in a program called “A Long Talk”, where we learned that those of us who remain silent when we see or hear racism are responsible for its persistence and growth.
But we must do more. Racism will propagate if we live in silos surrounded by people whose ideas reflect our own. As long as we have nondiversified board rooms, departments, and staff, the problem will persist.
A lot of the biases that we unconsciously carry in our heads and hearts have no basis in reality and were placed there without our permission by parents, society, and friends. But we can replace these divisive thoughts and impulses.
What’s in your heart can only be known and controlled by you. How tolerant we are of racism is up to us: Do you call out racism; do you challenge any inkling of racism from friends or acquaintances; do you put pressure on institutions where you work to diversify in recruiting and hiring?
Think of all the advances in medicine that were achieved by people from different cultures and races. Racism has no place in what we have all devoted our lives to do – take care of our fellow humans.
A version of this article first appeared on Medscape.com.
As a Black man who grew up in this country, I can tell you first-hand what it does to you. The scars never go away, and your status is always in question, no matter your title or uniforms of respect. Eventually it wears you down.
I was born into poverty and the segregation of southwest Louisiana. I experienced the dehumanization intended for me: separate drinking fountains and poor foundational education. I was lucky to attend a historically Black college or university (Southern University, Baton Rouge, La.), that gave me my bearings. I then went to some of the very best, predominantly White institutions.
When I looked for a job after training, there were few integrated medical groups, so I started my own. It included practitioners who were White, Black, Jewish, Asian, Middle Eastern, Muslim, Christian, etc. We cross covered and treated patients from every corner of the globe.
In medicine, we treat human beings with disease. The disease should be the only difference that sets us apart. There is absolutely no place for racism.
It is difficult to be called a racist, and I have met only a handful of people in health care whom I would label as such. But racism is structural and institutionalized so that it is often hidden.
One way to overcome this is to make every effort possible to get to know people as individuals. Only then can we see that there are few real differences between us. I would often seek out a colleague from a different culture or race to have lunch with so I could learn more about them.
We all strive for the same things – validation, happiness, love, family, and a future. We all grieve over the same things.
What some caregivers may not realize is that, just as clinicians have been trained to recognize subtle signs and symptoms of disease, minorities can recognize racism immediately during a medical encounter. Our past experiences make us skilled at picking up a lack of eye contact or body language and tone of voice that are dismissive and disrespectful.
A patient who has felt racism may still return for care because of insurance coverage limitations, location, or a lack of alternatives. But trust and loyalty will never develop on the part of this patient, and empathy will be absent on the part of their caregiver.
To counter this in my own practice, I developed the Francis Commitment to avoid any hint of racism or bias toward my patients.
I commit to the following:
1. I see you.
2. I hear you.
3. I accept who you are.
4. I will try to understand how you must feel (empathy).
5. Treating you is very important to me.
6. I would like to gain your trust that I will do my very best to make you better.
7. I value you as a human being and will treat you as if you are family.
8. I care about what happens to you.
9. I want us to work together to fight this disease.
10. I am grateful that you chose me as your caregiver.
The INOVA health care system where I work has undertaken an initiative called What Matters Most to better understand the needs of every patient. We are currently working on a strategy of patient personalization to not only learn about their medical needs but also to discover who they are as a person. We incorporate Social Determinants of Health in our dealings with patients. We also have participated in a program called “A Long Talk”, where we learned that those of us who remain silent when we see or hear racism are responsible for its persistence and growth.
But we must do more. Racism will propagate if we live in silos surrounded by people whose ideas reflect our own. As long as we have nondiversified board rooms, departments, and staff, the problem will persist.
A lot of the biases that we unconsciously carry in our heads and hearts have no basis in reality and were placed there without our permission by parents, society, and friends. But we can replace these divisive thoughts and impulses.
What’s in your heart can only be known and controlled by you. How tolerant we are of racism is up to us: Do you call out racism; do you challenge any inkling of racism from friends or acquaintances; do you put pressure on institutions where you work to diversify in recruiting and hiring?
Think of all the advances in medicine that were achieved by people from different cultures and races. Racism has no place in what we have all devoted our lives to do – take care of our fellow humans.
A version of this article first appeared on Medscape.com.
As a Black man who grew up in this country, I can tell you first-hand what it does to you. The scars never go away, and your status is always in question, no matter your title or uniforms of respect. Eventually it wears you down.
I was born into poverty and the segregation of southwest Louisiana. I experienced the dehumanization intended for me: separate drinking fountains and poor foundational education. I was lucky to attend a historically Black college or university (Southern University, Baton Rouge, La.), that gave me my bearings. I then went to some of the very best, predominantly White institutions.
When I looked for a job after training, there were few integrated medical groups, so I started my own. It included practitioners who were White, Black, Jewish, Asian, Middle Eastern, Muslim, Christian, etc. We cross covered and treated patients from every corner of the globe.
In medicine, we treat human beings with disease. The disease should be the only difference that sets us apart. There is absolutely no place for racism.
It is difficult to be called a racist, and I have met only a handful of people in health care whom I would label as such. But racism is structural and institutionalized so that it is often hidden.
One way to overcome this is to make every effort possible to get to know people as individuals. Only then can we see that there are few real differences between us. I would often seek out a colleague from a different culture or race to have lunch with so I could learn more about them.
We all strive for the same things – validation, happiness, love, family, and a future. We all grieve over the same things.
What some caregivers may not realize is that, just as clinicians have been trained to recognize subtle signs and symptoms of disease, minorities can recognize racism immediately during a medical encounter. Our past experiences make us skilled at picking up a lack of eye contact or body language and tone of voice that are dismissive and disrespectful.
A patient who has felt racism may still return for care because of insurance coverage limitations, location, or a lack of alternatives. But trust and loyalty will never develop on the part of this patient, and empathy will be absent on the part of their caregiver.
To counter this in my own practice, I developed the Francis Commitment to avoid any hint of racism or bias toward my patients.
I commit to the following:
1. I see you.
2. I hear you.
3. I accept who you are.
4. I will try to understand how you must feel (empathy).
5. Treating you is very important to me.
6. I would like to gain your trust that I will do my very best to make you better.
7. I value you as a human being and will treat you as if you are family.
8. I care about what happens to you.
9. I want us to work together to fight this disease.
10. I am grateful that you chose me as your caregiver.
The INOVA health care system where I work has undertaken an initiative called What Matters Most to better understand the needs of every patient. We are currently working on a strategy of patient personalization to not only learn about their medical needs but also to discover who they are as a person. We incorporate Social Determinants of Health in our dealings with patients. We also have participated in a program called “A Long Talk”, where we learned that those of us who remain silent when we see or hear racism are responsible for its persistence and growth.
But we must do more. Racism will propagate if we live in silos surrounded by people whose ideas reflect our own. As long as we have nondiversified board rooms, departments, and staff, the problem will persist.
A lot of the biases that we unconsciously carry in our heads and hearts have no basis in reality and were placed there without our permission by parents, society, and friends. But we can replace these divisive thoughts and impulses.
What’s in your heart can only be known and controlled by you. How tolerant we are of racism is up to us: Do you call out racism; do you challenge any inkling of racism from friends or acquaintances; do you put pressure on institutions where you work to diversify in recruiting and hiring?
Think of all the advances in medicine that were achieved by people from different cultures and races. Racism has no place in what we have all devoted our lives to do – take care of our fellow humans.
A version of this article first appeared on Medscape.com.
Berdazimer gel beats vehicle for molluscum contagiosum in phase 3 study
Treatment with .
Molluscum contagiosum (MC) remains a common infection that, despite being self-limiting, may persist for months or years, and is associated with quality of life concerns and the need for ongoing therapy, wrote John C. Browning, MD, of Texas Dermatology and Laser Specialists, San Antonio, and colleagues, who conducted the phase 3 randomized study.
The infection is most common in children aged 1-14 years, and treatment may be needed in part to avoid infecting peers and family members, they said. No treatments for molluscum are currently approved by the Food and Drug Administration.
In the study, which was published in JAMA Dermatology, the researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years (range was 0.9-49 years), and about 85% were White. Participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment. At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.
Most adverse events were mild or moderate, and rates of adverse events resulting in treatment discontinuation were low overall for both groups; the most common adverse events were application-site pain and erythema, which were mostly mild. Overall, 4.1% of berdazimer-treated patients and 0.7% of placebo patients discontinued the study because of adverse events.
The study findings were limited by several factors, including the small number of patients in subgroups for race, ethnicity, and age; and the lack of data on patients with sexually transmitted MC and on concomitant use with other topical MC therapies, the researchers noted.
However, the results represent the largest randomized clinical trial of berdazimer 10.3% to date, and support its potential as a first-line therapy for MC patients aged 6 months and older, according to the authors. “Berdazimer is under consideration as a first in-class therapeutic agent for MC and may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition,” they said.
Having a reliable, steroid-free, safe, and efficacious medication to treat molluscum in the pediatric population, as early as age 6 months, that can be used at home would “change the whole therapeutic paradigm,” one of the study authors, Adelaide Hebert, MD, said in an interview at the Society for Pediatric Dermatology annual meeting in July, where she presented phase 2 data on berdazimer gel. “This is a common problem and the rate of infections among siblings if it goes untreated is 41%. Affected kids have a sense of isolation; they don’t get invited to swimming parties.”
The lack of a safe and effective topical therapy “has been challenging,” added Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. She noted that treatments that have been used but have not been successful include imiquimod. “I’m not impressed with tretinoin,” although it is prescribed for MC, and the most common treatment prescribed by pediatricians for molluscum – mupirocin – is “usually not effective,” she said.
Another MC treatment in trials
Another investigative treatment for molluscum contagiosum, VP-102, a drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, has been evaluated in phase 3 studies of patients with MC aged 2 years and older. The results of two phase 3 studies were published in 2020.
In May 2022, Verrica Pharmaceuticals, which is developing VP-102, announced that Food and Drug Administration approval had been delayed because of deficiencies identified at a contract manufacturing organization, and that the company was working with the agency to bring VP-102 to the market as soon as possible.
A step in the right direction
Although MC is self-resolving, cases last an average of 13.5 months, and “many families look to fast-forward their child’s experience with the infection,” Vikash S. Oza, MD, a pediatric dermatologist at New York University, New York, wrote in an editorial that accompanied the berdazimer study.
“To truly create a paradigm shift in the decision to treat MC, a therapeutic treatment would need to be developed that would lead to resolution of the infection over a short time frame (ideally, weeks) with minimal discomfort,” Dr. Oza noted. “Both VP-102 and berdazimer gel, 10.3%, have the potential to be the first-ever MC therapies approved by the U.S. Food and Drug Administration,” and families seeking to reduce MC in visible areas would welcome this option for a home therapy, he said.
However, Dr. Oza emphasized that potential barriers to widespread use of these therapies include whether the efficacy can be maintained in patients who fail to comply with daily application, and the ongoing need for office-based therapy to manage sexually transmitted MC in adults and periocular and perianal MC in children. The study was funded by Novan. Lead author Dr. Browning disclosed grants from Novan during the conduct of the study; Dr. Hebert reported grants from the University of Texas Health Science Center McGovern Medical School-Houston during the conduct of the study. Disclosures of other authors included having reported equity in Novan during the conduct of the study and receiving a grant from Novan. Dr. Oza had no financial conflicts to disclose.
Treatment with .
Molluscum contagiosum (MC) remains a common infection that, despite being self-limiting, may persist for months or years, and is associated with quality of life concerns and the need for ongoing therapy, wrote John C. Browning, MD, of Texas Dermatology and Laser Specialists, San Antonio, and colleagues, who conducted the phase 3 randomized study.
The infection is most common in children aged 1-14 years, and treatment may be needed in part to avoid infecting peers and family members, they said. No treatments for molluscum are currently approved by the Food and Drug Administration.
In the study, which was published in JAMA Dermatology, the researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years (range was 0.9-49 years), and about 85% were White. Participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment. At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.
Most adverse events were mild or moderate, and rates of adverse events resulting in treatment discontinuation were low overall for both groups; the most common adverse events were application-site pain and erythema, which were mostly mild. Overall, 4.1% of berdazimer-treated patients and 0.7% of placebo patients discontinued the study because of adverse events.
The study findings were limited by several factors, including the small number of patients in subgroups for race, ethnicity, and age; and the lack of data on patients with sexually transmitted MC and on concomitant use with other topical MC therapies, the researchers noted.
However, the results represent the largest randomized clinical trial of berdazimer 10.3% to date, and support its potential as a first-line therapy for MC patients aged 6 months and older, according to the authors. “Berdazimer is under consideration as a first in-class therapeutic agent for MC and may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition,” they said.
Having a reliable, steroid-free, safe, and efficacious medication to treat molluscum in the pediatric population, as early as age 6 months, that can be used at home would “change the whole therapeutic paradigm,” one of the study authors, Adelaide Hebert, MD, said in an interview at the Society for Pediatric Dermatology annual meeting in July, where she presented phase 2 data on berdazimer gel. “This is a common problem and the rate of infections among siblings if it goes untreated is 41%. Affected kids have a sense of isolation; they don’t get invited to swimming parties.”
The lack of a safe and effective topical therapy “has been challenging,” added Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. She noted that treatments that have been used but have not been successful include imiquimod. “I’m not impressed with tretinoin,” although it is prescribed for MC, and the most common treatment prescribed by pediatricians for molluscum – mupirocin – is “usually not effective,” she said.
Another MC treatment in trials
Another investigative treatment for molluscum contagiosum, VP-102, a drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, has been evaluated in phase 3 studies of patients with MC aged 2 years and older. The results of two phase 3 studies were published in 2020.
In May 2022, Verrica Pharmaceuticals, which is developing VP-102, announced that Food and Drug Administration approval had been delayed because of deficiencies identified at a contract manufacturing organization, and that the company was working with the agency to bring VP-102 to the market as soon as possible.
A step in the right direction
Although MC is self-resolving, cases last an average of 13.5 months, and “many families look to fast-forward their child’s experience with the infection,” Vikash S. Oza, MD, a pediatric dermatologist at New York University, New York, wrote in an editorial that accompanied the berdazimer study.
“To truly create a paradigm shift in the decision to treat MC, a therapeutic treatment would need to be developed that would lead to resolution of the infection over a short time frame (ideally, weeks) with minimal discomfort,” Dr. Oza noted. “Both VP-102 and berdazimer gel, 10.3%, have the potential to be the first-ever MC therapies approved by the U.S. Food and Drug Administration,” and families seeking to reduce MC in visible areas would welcome this option for a home therapy, he said.
However, Dr. Oza emphasized that potential barriers to widespread use of these therapies include whether the efficacy can be maintained in patients who fail to comply with daily application, and the ongoing need for office-based therapy to manage sexually transmitted MC in adults and periocular and perianal MC in children. The study was funded by Novan. Lead author Dr. Browning disclosed grants from Novan during the conduct of the study; Dr. Hebert reported grants from the University of Texas Health Science Center McGovern Medical School-Houston during the conduct of the study. Disclosures of other authors included having reported equity in Novan during the conduct of the study and receiving a grant from Novan. Dr. Oza had no financial conflicts to disclose.
Treatment with .
Molluscum contagiosum (MC) remains a common infection that, despite being self-limiting, may persist for months or years, and is associated with quality of life concerns and the need for ongoing therapy, wrote John C. Browning, MD, of Texas Dermatology and Laser Specialists, San Antonio, and colleagues, who conducted the phase 3 randomized study.
The infection is most common in children aged 1-14 years, and treatment may be needed in part to avoid infecting peers and family members, they said. No treatments for molluscum are currently approved by the Food and Drug Administration.
In the study, which was published in JAMA Dermatology, the researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years (range was 0.9-49 years), and about 85% were White. Participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment. At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.
Most adverse events were mild or moderate, and rates of adverse events resulting in treatment discontinuation were low overall for both groups; the most common adverse events were application-site pain and erythema, which were mostly mild. Overall, 4.1% of berdazimer-treated patients and 0.7% of placebo patients discontinued the study because of adverse events.
The study findings were limited by several factors, including the small number of patients in subgroups for race, ethnicity, and age; and the lack of data on patients with sexually transmitted MC and on concomitant use with other topical MC therapies, the researchers noted.
However, the results represent the largest randomized clinical trial of berdazimer 10.3% to date, and support its potential as a first-line therapy for MC patients aged 6 months and older, according to the authors. “Berdazimer is under consideration as a first in-class therapeutic agent for MC and may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition,” they said.
Having a reliable, steroid-free, safe, and efficacious medication to treat molluscum in the pediatric population, as early as age 6 months, that can be used at home would “change the whole therapeutic paradigm,” one of the study authors, Adelaide Hebert, MD, said in an interview at the Society for Pediatric Dermatology annual meeting in July, where she presented phase 2 data on berdazimer gel. “This is a common problem and the rate of infections among siblings if it goes untreated is 41%. Affected kids have a sense of isolation; they don’t get invited to swimming parties.”
The lack of a safe and effective topical therapy “has been challenging,” added Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. She noted that treatments that have been used but have not been successful include imiquimod. “I’m not impressed with tretinoin,” although it is prescribed for MC, and the most common treatment prescribed by pediatricians for molluscum – mupirocin – is “usually not effective,” she said.
Another MC treatment in trials
Another investigative treatment for molluscum contagiosum, VP-102, a drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, has been evaluated in phase 3 studies of patients with MC aged 2 years and older. The results of two phase 3 studies were published in 2020.
In May 2022, Verrica Pharmaceuticals, which is developing VP-102, announced that Food and Drug Administration approval had been delayed because of deficiencies identified at a contract manufacturing organization, and that the company was working with the agency to bring VP-102 to the market as soon as possible.
A step in the right direction
Although MC is self-resolving, cases last an average of 13.5 months, and “many families look to fast-forward their child’s experience with the infection,” Vikash S. Oza, MD, a pediatric dermatologist at New York University, New York, wrote in an editorial that accompanied the berdazimer study.
“To truly create a paradigm shift in the decision to treat MC, a therapeutic treatment would need to be developed that would lead to resolution of the infection over a short time frame (ideally, weeks) with minimal discomfort,” Dr. Oza noted. “Both VP-102 and berdazimer gel, 10.3%, have the potential to be the first-ever MC therapies approved by the U.S. Food and Drug Administration,” and families seeking to reduce MC in visible areas would welcome this option for a home therapy, he said.
However, Dr. Oza emphasized that potential barriers to widespread use of these therapies include whether the efficacy can be maintained in patients who fail to comply with daily application, and the ongoing need for office-based therapy to manage sexually transmitted MC in adults and periocular and perianal MC in children. The study was funded by Novan. Lead author Dr. Browning disclosed grants from Novan during the conduct of the study; Dr. Hebert reported grants from the University of Texas Health Science Center McGovern Medical School-Houston during the conduct of the study. Disclosures of other authors included having reported equity in Novan during the conduct of the study and receiving a grant from Novan. Dr. Oza had no financial conflicts to disclose.
FROM JAMA DERMATOLOGY
Eight must-read GI studies for the primary care physician
This transcript has been edited for clarity.
Hi. I’m Dr. Vivek Kaul, and I’m professor of medicine in the division of gastroenterology and hepatology at the University of Rochester (N.Y.) Medical Center. It gives me great pleasure to do this presentation in collaboration with Medscape. I have just returned from Digestive Disease Week 2022, which is the largest international GI conference, and it was held in person for the first time in 3 years because of the pandemic.
Whereas there are a lot of “Best of DDW” presentations for gastroenterologists, there are not that many for primary care providers, so I thought it would be a good idea to do this. , talk a little about the middle-future range where things will become available in the next few months to years, and then, of course, reflect upon concepts that might become more standard paradigms of care in the distant future.
My collection of papers is divided into the esophagus and the colon, and then finishes up with the liver. [Editor’s note: Some of the abstracts that Dr Kaul refers to are available here.]
The first paper in the esophagus realm is a multicenter study called “The Association of Proton Pump Inhibitor Use and Cognitive Decline and Incident Dementia in Older Adults.” The researchers looked at about 19,000 patients, 65 years and older, who were on PPI therapy and had no significant disability or prior dementia. They followed them for about 5 years and found that a total of about 566 of them developed dementia in this time frame and 235 or so had Alzheimer’s. What they concluded based on that analysis was that PPI use was not associated with dementia or changes in the overall cognitive score.
This is important information. As the American Gastroenterological Association guidelines and others have recommended, those patients who do require a PPI on clinical grounds should definitely receive it, and the side-effect profiles are quite acceptable.
The second paper, “Double-Blind Randomized Trial of the Potassium-Competitive Acid Blocker Vonoprazan vs. the Proton Pump Inhibitor Lansoprazole in U.S. and European Patients with Erosive Esophagitis,” is also related to GERD [gastroesophageal reflux disease] therapy but introduces a new paradigm known as potassium-competitive channel blockers. This is a new drug that has now become available, called vonoprazan.
This was a double-blinded, randomized trial of the potassium-competitive acid blocker vonoprazan in comparison with lansoprazole, which is a well-established medical agent available for the treatment of esophagitis. These are patients with erosive esophagitis in a multicenter U.S. and European cohort of about 1,000 patients who were prospectively treated. The crux of this study was to say that vonoprazan is quicker to provide healing and symptom relief, and that these results are maintained in both the initial phase, which is the treatment phase, and the maintenance phase.
So, there might be some advantages in terms of how quickly we can treat these patients and get them symptom free. I thought that study was worth mentioning because it reflects, after a long period of time, a new class of acid-suppression therapy, which we should all be familiar with, and certainly at the primary care level.
The next paper relates to Barrett’s esophagus and esophageal cancer. This paper came out of the OneFlorida+ Clinical Research Network and was titled “Alarming Rise Found in Esophageal Cancer and Barrett’s Esophagus in Middle-Aged Adults: Findings From a Statewide Database of Over 5 Million Patients.” This paper talks about the increasing prevalence of esophageal cancer in Barrett’s in middle-aged patients – those in the 45- to 64-years age group; the prevalence of esophageal cancer is rising in this cohort. So, as is shown in the first graph, the orange line is depicting the 45-64 age group patients whose esophageal cancer prevalence has gone up. And in the second graph, it’s actually the gray line which looks at the Barrett’s esophagus prevalence, which is also increasing. And all the other cohorts have either plateaued or are declining.
This is important information because these patients who are at risk in these age groups with these demographic profiles should be referred on for endoscopic screening to rule out Barrett’s at least once in their lifetime. And most certainly a percentage of them will be found to have dysplasia and or early esophageal cancer that might be amenable to endoscopic therapy.
The next section that we’ll talk about is the colon section. We have a few very good, high-quality papers with some provocative information in this realm. The first paper (“Multi-modal Blood-based Colorectal Cancer Screening Is a Viable Colorectal Cancer Screening Option – a Prospective Study”) in the colonoscopy section involves the concept of colorectal cancer screening. While we have multiple modalities available for colorectal cancer screening today, a third of eligible patients are not getting screened.
This study looks at a blood test for colorectal cancer screening. We have colonoscopy, we have stool DNA and other tests, but now we have a blood test looking at circulating tumor DNA. For this prospective, multicenter study, researchers from Madrid enrolled about 550 patients between 45 and 84 years of age. The blood test was completed prior to the complete colonoscopy. The prevalence of colorectal cancer screening in this study was about 2%; the sensitivity ranged from about 90% to 95%, and the specificity ranged from about 100% to 88%, depending on what confidence levels you were looking at.
In this prospective study, a blood-based colorectal cancer screening test was able to perform very similarly to stool-based options. Therefore, it may further increase the probability that patients might come in for screening.
The message from this paper is that there’s yet another modality for colorectal cancer screening, and now we have a blood test potentially, but obviously we look forward to more data on how the test itself performs. And there probably will be other candidates in the same realm.
The second paper (“Real-World Comparative Effectiveness of Fidaxomicin vs. Vancomycin Among Medicare Beneficiaries with Clostridioides difficile Infection”) in the colon section is also about a very important topic in clinical practice for all of us, and that is C. difficile infection. As you may know, current guidelines have recommended the use of fidaxomicin over vancomycin as the initial treatment for C. diff infection. This paper looked retrospectively at a cohort of patients in the real world and compared the efficacy of fidaxomicin vs. vancomycin among Medicare beneficiaries with C. diff infection.
The initial results of this multicenter study suggest that treatment with fidaxomicin had higher sustained response compared with vancomycin at both weeks 4 and 8, as well as decreased recurrence of C. difficile.
This retrospective study further confirms that C. diff infection remains a problem and that we might have better solutions now with fidaxomicin compared with vancomycin. That’s important information and is already endorsed by the guidelines.
The next paper in the colon realm, “A Randomized Controlled Trial on the Effectiveness of Cognitive-Behavioral and Mindfulness Intervention on Pain, Fatigue and Impairments at Work and Daily Activity in Patients With Crohn’s Disease,” is also an important paradigm that has entered our medical practice. When we are treating patients with GI symptoms, the role for cognitive-behavioral therapy and mindfulness interventions has now come of age.
This paper was a randomized controlled trial on the effectiveness of cognitive-behavioral therapy and mindfulness intervention on the aspects of pain and fatigue, as well as impairments at work and daily activity in patients with Crohn’s disease.
This is a difficult population with chronic illness, and this study comes out of Israel. About 120 patients were randomized to seven 1-hour sessions of psychological training over 12 weeks. The placebo group was the control group that did not get this treatment.
These interventions reduced both fatigue as well as pain levels, and also reduced work and home impairment, and so overall led to a better quality of life.
This paper is important because it shows us in a randomized trial design fashion that a difficult clinical population with Crohn’s disease, with a multitude of systemic symptoms and psychological, psychosomatic issues as well, can be positively impacted by these newer strategies related to cognitive-behavioral therapy and mindfulness interventions. We’ll likely be seeing more of these types of papers coming out, not just for Crohn’s and inflammatory bowel disease, but also for functional disease, which is where this started.
Our final paper in the colon section relates to an interesting concept, which is the treatment of chronic idiopathic constipation – not irritable bowel syndrome with constipation, but chronic idiopathic constipation – being managed with a novel device known as the Vibrant capsule. The Vibrant capsule is exactly that: It’s a capsule that the patient ingests, and it vibrates and therefore creates a mechanical movement.
“Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (Vibrant)” was a U.S. multicenter study. The device is an orally ingestible, programmable vibrating capsule developed in Israel. It basically mimics the biological clock and increases the stool frequency by augmenting the circadian rhythm. This was a prospective trial of around 350 patients, and there was significant improvement in the complete spontaneous bowel movement pattern, both for one and two bowel movements per week. This significant improvement persisted at week 3, peaked at about week 6, and then remained sustained through 8 weeks.
The Vibrant capsule also was able to improve stool consistency and the overall quality of life. So this is a novel treatment intervention over and above all the medical therapies in the bowel regimens, which of course our patients find somewhat difficult, understandably. But this might be a complementary direction to go in, and we’ll probably hear more of these novel interventions for chronic constipation, which is a huge problem both at the primary care level as well as in subspecialty practice.
In the final section, which is the liver section, I found one paper very interesting, which refers to the concept of lean nonalcoholic fatty liver disease (NAFLD) (“Lean NAFLD in the United States is Characterized by Increased Central and Visceral Adiposity That Is Comparable to Overweight and Obese Persons”). NAFLD is an epidemic throughout the country, with obvious implications both for the metabolic syndrome as well as chronic liver disease. This paper from Wisconsin looks at lean NALFD in the United States, characterizes the central and visceral adiposity, and compares it with that of overweight and obese patients. Lean NAFLD occurs in about 10%-20% of patients with a normal body mass index; 1,800 patients were evaluated in this particular study, and they underwent cross-sectional analysis and the so-called gap score, which looks at the measurement of fat in the liver, DEXA measurements, and so forth.
What they found was that patients with lean NAFLD are more likely to have hypertension, diabetes, high triglycerides, and are more likely to smoke, compared with lean patients without NAFLD, despite having similar BMIs.
A couple of additional observations from the study were that central adiposity was similar in lean NAFLD compared with the obese non-NAFLD population, and the visceral abdominal fat in patients who have lean NAFLD was slightly higher, actually, than in the obese NAFLD patients, but the P values were not significant.
The overall summary from this paper was that NAFLD should be considered in lean patients with risk factors of the metabolic syndrome. This is an important paper because it highlights the fact that we don’t necessarily have to be externally obese or have a high BMI to be at risk for the metabolic syndrome. I think the importance of evaluating for the metabolic syndrome, even in those patients who have a relatively lower BMI, is underscored by this paper, which has significant implications given the larger denominator of this population in this country.
So, with that, we come to the conclusion of these top papers from Digestive Disease Week 2022. We covered the gamut of conditions, from the esophagus to the colon and to the liver. And these represent some of the best science that was presented at this very large international meeting. I hope you will find value in this information for the care of your patients, and I look forward to presenting again when the next opportunity arises.
Vivek Kaul, MD, is Segal-Watson Professor of Medicine in the gastroenterology & hepatology division at the University of Rochester Medical Center in Rochester, N.Y.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Dr. Vivek Kaul, and I’m professor of medicine in the division of gastroenterology and hepatology at the University of Rochester (N.Y.) Medical Center. It gives me great pleasure to do this presentation in collaboration with Medscape. I have just returned from Digestive Disease Week 2022, which is the largest international GI conference, and it was held in person for the first time in 3 years because of the pandemic.
Whereas there are a lot of “Best of DDW” presentations for gastroenterologists, there are not that many for primary care providers, so I thought it would be a good idea to do this. , talk a little about the middle-future range where things will become available in the next few months to years, and then, of course, reflect upon concepts that might become more standard paradigms of care in the distant future.
My collection of papers is divided into the esophagus and the colon, and then finishes up with the liver. [Editor’s note: Some of the abstracts that Dr Kaul refers to are available here.]
The first paper in the esophagus realm is a multicenter study called “The Association of Proton Pump Inhibitor Use and Cognitive Decline and Incident Dementia in Older Adults.” The researchers looked at about 19,000 patients, 65 years and older, who were on PPI therapy and had no significant disability or prior dementia. They followed them for about 5 years and found that a total of about 566 of them developed dementia in this time frame and 235 or so had Alzheimer’s. What they concluded based on that analysis was that PPI use was not associated with dementia or changes in the overall cognitive score.
This is important information. As the American Gastroenterological Association guidelines and others have recommended, those patients who do require a PPI on clinical grounds should definitely receive it, and the side-effect profiles are quite acceptable.
The second paper, “Double-Blind Randomized Trial of the Potassium-Competitive Acid Blocker Vonoprazan vs. the Proton Pump Inhibitor Lansoprazole in U.S. and European Patients with Erosive Esophagitis,” is also related to GERD [gastroesophageal reflux disease] therapy but introduces a new paradigm known as potassium-competitive channel blockers. This is a new drug that has now become available, called vonoprazan.
This was a double-blinded, randomized trial of the potassium-competitive acid blocker vonoprazan in comparison with lansoprazole, which is a well-established medical agent available for the treatment of esophagitis. These are patients with erosive esophagitis in a multicenter U.S. and European cohort of about 1,000 patients who were prospectively treated. The crux of this study was to say that vonoprazan is quicker to provide healing and symptom relief, and that these results are maintained in both the initial phase, which is the treatment phase, and the maintenance phase.
So, there might be some advantages in terms of how quickly we can treat these patients and get them symptom free. I thought that study was worth mentioning because it reflects, after a long period of time, a new class of acid-suppression therapy, which we should all be familiar with, and certainly at the primary care level.
The next paper relates to Barrett’s esophagus and esophageal cancer. This paper came out of the OneFlorida+ Clinical Research Network and was titled “Alarming Rise Found in Esophageal Cancer and Barrett’s Esophagus in Middle-Aged Adults: Findings From a Statewide Database of Over 5 Million Patients.” This paper talks about the increasing prevalence of esophageal cancer in Barrett’s in middle-aged patients – those in the 45- to 64-years age group; the prevalence of esophageal cancer is rising in this cohort. So, as is shown in the first graph, the orange line is depicting the 45-64 age group patients whose esophageal cancer prevalence has gone up. And in the second graph, it’s actually the gray line which looks at the Barrett’s esophagus prevalence, which is also increasing. And all the other cohorts have either plateaued or are declining.
This is important information because these patients who are at risk in these age groups with these demographic profiles should be referred on for endoscopic screening to rule out Barrett’s at least once in their lifetime. And most certainly a percentage of them will be found to have dysplasia and or early esophageal cancer that might be amenable to endoscopic therapy.
The next section that we’ll talk about is the colon section. We have a few very good, high-quality papers with some provocative information in this realm. The first paper (“Multi-modal Blood-based Colorectal Cancer Screening Is a Viable Colorectal Cancer Screening Option – a Prospective Study”) in the colonoscopy section involves the concept of colorectal cancer screening. While we have multiple modalities available for colorectal cancer screening today, a third of eligible patients are not getting screened.
This study looks at a blood test for colorectal cancer screening. We have colonoscopy, we have stool DNA and other tests, but now we have a blood test looking at circulating tumor DNA. For this prospective, multicenter study, researchers from Madrid enrolled about 550 patients between 45 and 84 years of age. The blood test was completed prior to the complete colonoscopy. The prevalence of colorectal cancer screening in this study was about 2%; the sensitivity ranged from about 90% to 95%, and the specificity ranged from about 100% to 88%, depending on what confidence levels you were looking at.
In this prospective study, a blood-based colorectal cancer screening test was able to perform very similarly to stool-based options. Therefore, it may further increase the probability that patients might come in for screening.
The message from this paper is that there’s yet another modality for colorectal cancer screening, and now we have a blood test potentially, but obviously we look forward to more data on how the test itself performs. And there probably will be other candidates in the same realm.
The second paper (“Real-World Comparative Effectiveness of Fidaxomicin vs. Vancomycin Among Medicare Beneficiaries with Clostridioides difficile Infection”) in the colon section is also about a very important topic in clinical practice for all of us, and that is C. difficile infection. As you may know, current guidelines have recommended the use of fidaxomicin over vancomycin as the initial treatment for C. diff infection. This paper looked retrospectively at a cohort of patients in the real world and compared the efficacy of fidaxomicin vs. vancomycin among Medicare beneficiaries with C. diff infection.
The initial results of this multicenter study suggest that treatment with fidaxomicin had higher sustained response compared with vancomycin at both weeks 4 and 8, as well as decreased recurrence of C. difficile.
This retrospective study further confirms that C. diff infection remains a problem and that we might have better solutions now with fidaxomicin compared with vancomycin. That’s important information and is already endorsed by the guidelines.
The next paper in the colon realm, “A Randomized Controlled Trial on the Effectiveness of Cognitive-Behavioral and Mindfulness Intervention on Pain, Fatigue and Impairments at Work and Daily Activity in Patients With Crohn’s Disease,” is also an important paradigm that has entered our medical practice. When we are treating patients with GI symptoms, the role for cognitive-behavioral therapy and mindfulness interventions has now come of age.
This paper was a randomized controlled trial on the effectiveness of cognitive-behavioral therapy and mindfulness intervention on the aspects of pain and fatigue, as well as impairments at work and daily activity in patients with Crohn’s disease.
This is a difficult population with chronic illness, and this study comes out of Israel. About 120 patients were randomized to seven 1-hour sessions of psychological training over 12 weeks. The placebo group was the control group that did not get this treatment.
These interventions reduced both fatigue as well as pain levels, and also reduced work and home impairment, and so overall led to a better quality of life.
This paper is important because it shows us in a randomized trial design fashion that a difficult clinical population with Crohn’s disease, with a multitude of systemic symptoms and psychological, psychosomatic issues as well, can be positively impacted by these newer strategies related to cognitive-behavioral therapy and mindfulness interventions. We’ll likely be seeing more of these types of papers coming out, not just for Crohn’s and inflammatory bowel disease, but also for functional disease, which is where this started.
Our final paper in the colon section relates to an interesting concept, which is the treatment of chronic idiopathic constipation – not irritable bowel syndrome with constipation, but chronic idiopathic constipation – being managed with a novel device known as the Vibrant capsule. The Vibrant capsule is exactly that: It’s a capsule that the patient ingests, and it vibrates and therefore creates a mechanical movement.
“Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (Vibrant)” was a U.S. multicenter study. The device is an orally ingestible, programmable vibrating capsule developed in Israel. It basically mimics the biological clock and increases the stool frequency by augmenting the circadian rhythm. This was a prospective trial of around 350 patients, and there was significant improvement in the complete spontaneous bowel movement pattern, both for one and two bowel movements per week. This significant improvement persisted at week 3, peaked at about week 6, and then remained sustained through 8 weeks.
The Vibrant capsule also was able to improve stool consistency and the overall quality of life. So this is a novel treatment intervention over and above all the medical therapies in the bowel regimens, which of course our patients find somewhat difficult, understandably. But this might be a complementary direction to go in, and we’ll probably hear more of these novel interventions for chronic constipation, which is a huge problem both at the primary care level as well as in subspecialty practice.
In the final section, which is the liver section, I found one paper very interesting, which refers to the concept of lean nonalcoholic fatty liver disease (NAFLD) (“Lean NAFLD in the United States is Characterized by Increased Central and Visceral Adiposity That Is Comparable to Overweight and Obese Persons”). NAFLD is an epidemic throughout the country, with obvious implications both for the metabolic syndrome as well as chronic liver disease. This paper from Wisconsin looks at lean NALFD in the United States, characterizes the central and visceral adiposity, and compares it with that of overweight and obese patients. Lean NAFLD occurs in about 10%-20% of patients with a normal body mass index; 1,800 patients were evaluated in this particular study, and they underwent cross-sectional analysis and the so-called gap score, which looks at the measurement of fat in the liver, DEXA measurements, and so forth.
What they found was that patients with lean NAFLD are more likely to have hypertension, diabetes, high triglycerides, and are more likely to smoke, compared with lean patients without NAFLD, despite having similar BMIs.
A couple of additional observations from the study were that central adiposity was similar in lean NAFLD compared with the obese non-NAFLD population, and the visceral abdominal fat in patients who have lean NAFLD was slightly higher, actually, than in the obese NAFLD patients, but the P values were not significant.
The overall summary from this paper was that NAFLD should be considered in lean patients with risk factors of the metabolic syndrome. This is an important paper because it highlights the fact that we don’t necessarily have to be externally obese or have a high BMI to be at risk for the metabolic syndrome. I think the importance of evaluating for the metabolic syndrome, even in those patients who have a relatively lower BMI, is underscored by this paper, which has significant implications given the larger denominator of this population in this country.
So, with that, we come to the conclusion of these top papers from Digestive Disease Week 2022. We covered the gamut of conditions, from the esophagus to the colon and to the liver. And these represent some of the best science that was presented at this very large international meeting. I hope you will find value in this information for the care of your patients, and I look forward to presenting again when the next opportunity arises.
Vivek Kaul, MD, is Segal-Watson Professor of Medicine in the gastroenterology & hepatology division at the University of Rochester Medical Center in Rochester, N.Y.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Dr. Vivek Kaul, and I’m professor of medicine in the division of gastroenterology and hepatology at the University of Rochester (N.Y.) Medical Center. It gives me great pleasure to do this presentation in collaboration with Medscape. I have just returned from Digestive Disease Week 2022, which is the largest international GI conference, and it was held in person for the first time in 3 years because of the pandemic.
Whereas there are a lot of “Best of DDW” presentations for gastroenterologists, there are not that many for primary care providers, so I thought it would be a good idea to do this. , talk a little about the middle-future range where things will become available in the next few months to years, and then, of course, reflect upon concepts that might become more standard paradigms of care in the distant future.
My collection of papers is divided into the esophagus and the colon, and then finishes up with the liver. [Editor’s note: Some of the abstracts that Dr Kaul refers to are available here.]
The first paper in the esophagus realm is a multicenter study called “The Association of Proton Pump Inhibitor Use and Cognitive Decline and Incident Dementia in Older Adults.” The researchers looked at about 19,000 patients, 65 years and older, who were on PPI therapy and had no significant disability or prior dementia. They followed them for about 5 years and found that a total of about 566 of them developed dementia in this time frame and 235 or so had Alzheimer’s. What they concluded based on that analysis was that PPI use was not associated with dementia or changes in the overall cognitive score.
This is important information. As the American Gastroenterological Association guidelines and others have recommended, those patients who do require a PPI on clinical grounds should definitely receive it, and the side-effect profiles are quite acceptable.
The second paper, “Double-Blind Randomized Trial of the Potassium-Competitive Acid Blocker Vonoprazan vs. the Proton Pump Inhibitor Lansoprazole in U.S. and European Patients with Erosive Esophagitis,” is also related to GERD [gastroesophageal reflux disease] therapy but introduces a new paradigm known as potassium-competitive channel blockers. This is a new drug that has now become available, called vonoprazan.
This was a double-blinded, randomized trial of the potassium-competitive acid blocker vonoprazan in comparison with lansoprazole, which is a well-established medical agent available for the treatment of esophagitis. These are patients with erosive esophagitis in a multicenter U.S. and European cohort of about 1,000 patients who were prospectively treated. The crux of this study was to say that vonoprazan is quicker to provide healing and symptom relief, and that these results are maintained in both the initial phase, which is the treatment phase, and the maintenance phase.
So, there might be some advantages in terms of how quickly we can treat these patients and get them symptom free. I thought that study was worth mentioning because it reflects, after a long period of time, a new class of acid-suppression therapy, which we should all be familiar with, and certainly at the primary care level.
The next paper relates to Barrett’s esophagus and esophageal cancer. This paper came out of the OneFlorida+ Clinical Research Network and was titled “Alarming Rise Found in Esophageal Cancer and Barrett’s Esophagus in Middle-Aged Adults: Findings From a Statewide Database of Over 5 Million Patients.” This paper talks about the increasing prevalence of esophageal cancer in Barrett’s in middle-aged patients – those in the 45- to 64-years age group; the prevalence of esophageal cancer is rising in this cohort. So, as is shown in the first graph, the orange line is depicting the 45-64 age group patients whose esophageal cancer prevalence has gone up. And in the second graph, it’s actually the gray line which looks at the Barrett’s esophagus prevalence, which is also increasing. And all the other cohorts have either plateaued or are declining.
This is important information because these patients who are at risk in these age groups with these demographic profiles should be referred on for endoscopic screening to rule out Barrett’s at least once in their lifetime. And most certainly a percentage of them will be found to have dysplasia and or early esophageal cancer that might be amenable to endoscopic therapy.
The next section that we’ll talk about is the colon section. We have a few very good, high-quality papers with some provocative information in this realm. The first paper (“Multi-modal Blood-based Colorectal Cancer Screening Is a Viable Colorectal Cancer Screening Option – a Prospective Study”) in the colonoscopy section involves the concept of colorectal cancer screening. While we have multiple modalities available for colorectal cancer screening today, a third of eligible patients are not getting screened.
This study looks at a blood test for colorectal cancer screening. We have colonoscopy, we have stool DNA and other tests, but now we have a blood test looking at circulating tumor DNA. For this prospective, multicenter study, researchers from Madrid enrolled about 550 patients between 45 and 84 years of age. The blood test was completed prior to the complete colonoscopy. The prevalence of colorectal cancer screening in this study was about 2%; the sensitivity ranged from about 90% to 95%, and the specificity ranged from about 100% to 88%, depending on what confidence levels you were looking at.
In this prospective study, a blood-based colorectal cancer screening test was able to perform very similarly to stool-based options. Therefore, it may further increase the probability that patients might come in for screening.
The message from this paper is that there’s yet another modality for colorectal cancer screening, and now we have a blood test potentially, but obviously we look forward to more data on how the test itself performs. And there probably will be other candidates in the same realm.
The second paper (“Real-World Comparative Effectiveness of Fidaxomicin vs. Vancomycin Among Medicare Beneficiaries with Clostridioides difficile Infection”) in the colon section is also about a very important topic in clinical practice for all of us, and that is C. difficile infection. As you may know, current guidelines have recommended the use of fidaxomicin over vancomycin as the initial treatment for C. diff infection. This paper looked retrospectively at a cohort of patients in the real world and compared the efficacy of fidaxomicin vs. vancomycin among Medicare beneficiaries with C. diff infection.
The initial results of this multicenter study suggest that treatment with fidaxomicin had higher sustained response compared with vancomycin at both weeks 4 and 8, as well as decreased recurrence of C. difficile.
This retrospective study further confirms that C. diff infection remains a problem and that we might have better solutions now with fidaxomicin compared with vancomycin. That’s important information and is already endorsed by the guidelines.
The next paper in the colon realm, “A Randomized Controlled Trial on the Effectiveness of Cognitive-Behavioral and Mindfulness Intervention on Pain, Fatigue and Impairments at Work and Daily Activity in Patients With Crohn’s Disease,” is also an important paradigm that has entered our medical practice. When we are treating patients with GI symptoms, the role for cognitive-behavioral therapy and mindfulness interventions has now come of age.
This paper was a randomized controlled trial on the effectiveness of cognitive-behavioral therapy and mindfulness intervention on the aspects of pain and fatigue, as well as impairments at work and daily activity in patients with Crohn’s disease.
This is a difficult population with chronic illness, and this study comes out of Israel. About 120 patients were randomized to seven 1-hour sessions of psychological training over 12 weeks. The placebo group was the control group that did not get this treatment.
These interventions reduced both fatigue as well as pain levels, and also reduced work and home impairment, and so overall led to a better quality of life.
This paper is important because it shows us in a randomized trial design fashion that a difficult clinical population with Crohn’s disease, with a multitude of systemic symptoms and psychological, psychosomatic issues as well, can be positively impacted by these newer strategies related to cognitive-behavioral therapy and mindfulness interventions. We’ll likely be seeing more of these types of papers coming out, not just for Crohn’s and inflammatory bowel disease, but also for functional disease, which is where this started.
Our final paper in the colon section relates to an interesting concept, which is the treatment of chronic idiopathic constipation – not irritable bowel syndrome with constipation, but chronic idiopathic constipation – being managed with a novel device known as the Vibrant capsule. The Vibrant capsule is exactly that: It’s a capsule that the patient ingests, and it vibrates and therefore creates a mechanical movement.
“Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (Vibrant)” was a U.S. multicenter study. The device is an orally ingestible, programmable vibrating capsule developed in Israel. It basically mimics the biological clock and increases the stool frequency by augmenting the circadian rhythm. This was a prospective trial of around 350 patients, and there was significant improvement in the complete spontaneous bowel movement pattern, both for one and two bowel movements per week. This significant improvement persisted at week 3, peaked at about week 6, and then remained sustained through 8 weeks.
The Vibrant capsule also was able to improve stool consistency and the overall quality of life. So this is a novel treatment intervention over and above all the medical therapies in the bowel regimens, which of course our patients find somewhat difficult, understandably. But this might be a complementary direction to go in, and we’ll probably hear more of these novel interventions for chronic constipation, which is a huge problem both at the primary care level as well as in subspecialty practice.
In the final section, which is the liver section, I found one paper very interesting, which refers to the concept of lean nonalcoholic fatty liver disease (NAFLD) (“Lean NAFLD in the United States is Characterized by Increased Central and Visceral Adiposity That Is Comparable to Overweight and Obese Persons”). NAFLD is an epidemic throughout the country, with obvious implications both for the metabolic syndrome as well as chronic liver disease. This paper from Wisconsin looks at lean NALFD in the United States, characterizes the central and visceral adiposity, and compares it with that of overweight and obese patients. Lean NAFLD occurs in about 10%-20% of patients with a normal body mass index; 1,800 patients were evaluated in this particular study, and they underwent cross-sectional analysis and the so-called gap score, which looks at the measurement of fat in the liver, DEXA measurements, and so forth.
What they found was that patients with lean NAFLD are more likely to have hypertension, diabetes, high triglycerides, and are more likely to smoke, compared with lean patients without NAFLD, despite having similar BMIs.
A couple of additional observations from the study were that central adiposity was similar in lean NAFLD compared with the obese non-NAFLD population, and the visceral abdominal fat in patients who have lean NAFLD was slightly higher, actually, than in the obese NAFLD patients, but the P values were not significant.
The overall summary from this paper was that NAFLD should be considered in lean patients with risk factors of the metabolic syndrome. This is an important paper because it highlights the fact that we don’t necessarily have to be externally obese or have a high BMI to be at risk for the metabolic syndrome. I think the importance of evaluating for the metabolic syndrome, even in those patients who have a relatively lower BMI, is underscored by this paper, which has significant implications given the larger denominator of this population in this country.
So, with that, we come to the conclusion of these top papers from Digestive Disease Week 2022. We covered the gamut of conditions, from the esophagus to the colon and to the liver. And these represent some of the best science that was presented at this very large international meeting. I hope you will find value in this information for the care of your patients, and I look forward to presenting again when the next opportunity arises.
Vivek Kaul, MD, is Segal-Watson Professor of Medicine in the gastroenterology & hepatology division at the University of Rochester Medical Center in Rochester, N.Y.
A version of this article first appeared on Medscape.com.
LGBTQ+ Youth Consult: Let’s talk about PrEP!
As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).1 While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.2 Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.3
Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.4 When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.5 Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.6
Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.7 Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.8 Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.
In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.6 PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.
Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.
- Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
- For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
- Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
- Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.
Resources
CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.
References
1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.
2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.
3. Mayer KH et al. Adv Ther. 2020;37:1778-811.
4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.
5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.
6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.
7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.
8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).
As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).1 While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.2 Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.3
Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.4 When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.5 Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.6
Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.7 Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.8 Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.
In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.6 PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.
Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.
- Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
- For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
- Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
- Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.
Resources
CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.
References
1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.
2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.
3. Mayer KH et al. Adv Ther. 2020;37:1778-811.
4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.
5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.
6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.
7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.
8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).
As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).1 While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.2 Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.3
Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.4 When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.5 Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.6
Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.7 Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.8 Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.
In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.6 PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.
Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.
- Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
- For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
- Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
- Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.
Resources
CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.
References
1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.
2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.
3. Mayer KH et al. Adv Ther. 2020;37:1778-811.
4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.
5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.
6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.
7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.
8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).
Two congressmen targeting ‘gender transition’ physicians
Two GOP congressmen have introduced legislation aimed at holding doctors who perform gender transition procedures on minors liable for their actions, says a story reported on KATV.com, among other news sites.
The two GOP lawmakers – Rep. Jim Banks (IN) and Sen. Tom Cotton (AR) – introduced the Protecting Minors from Medical Malpractice Act in their respective chambers.
If passed, the House and Senate bills would make doctors liable for any gender transition surgery on a minor that results in injury, whether physical, psychological, emotional, or physiological. Minors who believe they’ve been harmed would have up to 30 years from when they turn 18 to file a claim.
The House proposal would also strip federal funding from states that require health care professionals to provide gender transition procedures, including puberty blockers, cross-sex hormones, and gender reassignment surgeries.
A companion House bill, also sponsored by Banks, targets another issue related to gender transitioning for minors: parental consent.
If passed, the Empower Parents to Protect Their Kids Act of 2022 would deny federal funding to any elementary and secondary schools that initiate a minor’s gender transition without first securing parental consent. (Last October, Sen. Cotton released a similar bill in the Senate.)
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
Two GOP congressmen have introduced legislation aimed at holding doctors who perform gender transition procedures on minors liable for their actions, says a story reported on KATV.com, among other news sites.
The two GOP lawmakers – Rep. Jim Banks (IN) and Sen. Tom Cotton (AR) – introduced the Protecting Minors from Medical Malpractice Act in their respective chambers.
If passed, the House and Senate bills would make doctors liable for any gender transition surgery on a minor that results in injury, whether physical, psychological, emotional, or physiological. Minors who believe they’ve been harmed would have up to 30 years from when they turn 18 to file a claim.
The House proposal would also strip federal funding from states that require health care professionals to provide gender transition procedures, including puberty blockers, cross-sex hormones, and gender reassignment surgeries.
A companion House bill, also sponsored by Banks, targets another issue related to gender transitioning for minors: parental consent.
If passed, the Empower Parents to Protect Their Kids Act of 2022 would deny federal funding to any elementary and secondary schools that initiate a minor’s gender transition without first securing parental consent. (Last October, Sen. Cotton released a similar bill in the Senate.)
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
Two GOP congressmen have introduced legislation aimed at holding doctors who perform gender transition procedures on minors liable for their actions, says a story reported on KATV.com, among other news sites.
The two GOP lawmakers – Rep. Jim Banks (IN) and Sen. Tom Cotton (AR) – introduced the Protecting Minors from Medical Malpractice Act in their respective chambers.
If passed, the House and Senate bills would make doctors liable for any gender transition surgery on a minor that results in injury, whether physical, psychological, emotional, or physiological. Minors who believe they’ve been harmed would have up to 30 years from when they turn 18 to file a claim.
The House proposal would also strip federal funding from states that require health care professionals to provide gender transition procedures, including puberty blockers, cross-sex hormones, and gender reassignment surgeries.
A companion House bill, also sponsored by Banks, targets another issue related to gender transitioning for minors: parental consent.
If passed, the Empower Parents to Protect Their Kids Act of 2022 would deny federal funding to any elementary and secondary schools that initiate a minor’s gender transition without first securing parental consent. (Last October, Sen. Cotton released a similar bill in the Senate.)
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
Link between pediatric hepatitis and adenovirus 41 still unclear
While two new studies reiterate a possible relationship between adenovirus 41 and acute hepatitis of unknown cause in children, whether these infections are significant or merely bystanders remains unclear.
In both studies – one conducted in Alabama and the other conducted in the United Kingdom – researchers found that 90% of children with acute hepatitis of unknown cause tested positive for adenovirus 41. The virus subtype is not an uncommon infection, but it usually causes gastroenteritis in children.
“Across the world, adenovirus continues to be a common signal” in these pediatric hepatitis cases, said Helena Gutierrez, MD, the medical director of the Pediatric Liver Transplant Program at the University of Alabama at Birmingham, in an interview. She led one of the studies. More data are necessary to understand what role this virus may play in these cases, she said.
In November, the Alabama Department of Public Health and the U.S. Centers for Disease Control and Prevention began investigating a cluster of severe pediatric hepatitis cases at the Children’s of Alabama hospital in Birmingham. These children also tested positive for adenovirus. In April, the United Kingdom announced they were investigating similar cases, and the CDC expanded their search nationally. As of July 8, 1,010 cases in 35 countries have been reported to the World Health Organization. There are 263 confirmed cases in the United Kingdom and 332 cases under investigation by the CDC in the United States, according to the most recent counts.
The two studies, both published in the New England Journal of Medicine, provide additional clinical data on a number of these mysterious hepatitis cases. Dr. Gutierrez’s study looked at nine children admitted for hepatitis of unknown origin between October 1 and February 28. Patients had a median age of 2 years 11 months and two required liver transplants, and there were no deaths.
Eight out of nine patients (89%) tested positive for adenovirus, and all five of the samples that were of sufficient quality for gene sequencing tested positive for adenovirus 41. None of the six liver biopsies performed found signs of adenovirus infection, but the liver tissue samples of three patients tested positive for adenovirus via PCR.
The second study involved 44 children referred to a liver transplantation center in the United Kingdom between January 1 and April 11, 2022. The median age for patients was 4 years. Six children required liver transplants, and there were no deaths. Of the 30 patients who underwent molecular adenovirus testing, 27 (90%) were positive for adenovirus 41. Liver samples of nine children (3 from biopsies and 6 from explanted livers) all tested negative for adenovirus antibodies.
In both studies, however, the median adenovirus viral load of patients needing a transplant was much higher than the viral loads in children who did not require liver transplants.
Although most of the clinical features and test results of these cases suggest that adenovirus may be involved, the negative results in histology are “intriguing,” Chayarani Kelgeri, MD, a consultant pediatric hepatologist at the Birmingham Women’s and Children’s Hospital, U.K., said in an email. She is the lead author of the U.K. study. “Whether this is because the liver injury we see is an aftermath of the viral infection, the mechanism of injury is immune mediated, and if other cofactors are involved is being explored,” she added. “Further investigations being undertaken by UK Health Security Agency will add to our understanding of this illness.”
Although there is a high adenovirus positivity rate amongst these cases, there is not enough evidence yet to say adenovirus 41 is a new cause of pediatric hepatitis in previously healthy children, said Saul Karpen, MD, PhD, the division chief of pediatric gastroenterology, hepatology, and nutrition at Emory University School of Medicine, Atlanta. He wrote an editorial accompanying the two NEJM studies.
The CDC has not yet found an increase in pediatric hepatitis cases, according to a recent analysis, though the United Kingdom has found an uptick in cases this year, he told this news organization. Also, the cases highlighted in both articles showed no histological evidence of adenovirus in liver biopsies. “That’s completely opposite of what we generally see in adenoviral hepatitis that can be quite severe,” he said, adding that in general, there are detectable viral particles and antigens in affected livers.
“These two important reports indicate to those inside and outside the field of pediatric hepatology that registries and clinical studies of acute hepatitis in children are sorely needed,” Dr. Karpen writes in the editorial; “It is likely that with greater attention to collecting data on cases and biospecimens from children with acute hepatitis, we will be able to determine whether this one virus, human adenovirus 41, is of relevance to this important and serious condition in children.”
Dr. Gutierrez, Dr. Kelgeri, and Dr. Karpen report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
While two new studies reiterate a possible relationship between adenovirus 41 and acute hepatitis of unknown cause in children, whether these infections are significant or merely bystanders remains unclear.
In both studies – one conducted in Alabama and the other conducted in the United Kingdom – researchers found that 90% of children with acute hepatitis of unknown cause tested positive for adenovirus 41. The virus subtype is not an uncommon infection, but it usually causes gastroenteritis in children.
“Across the world, adenovirus continues to be a common signal” in these pediatric hepatitis cases, said Helena Gutierrez, MD, the medical director of the Pediatric Liver Transplant Program at the University of Alabama at Birmingham, in an interview. She led one of the studies. More data are necessary to understand what role this virus may play in these cases, she said.
In November, the Alabama Department of Public Health and the U.S. Centers for Disease Control and Prevention began investigating a cluster of severe pediatric hepatitis cases at the Children’s of Alabama hospital in Birmingham. These children also tested positive for adenovirus. In April, the United Kingdom announced they were investigating similar cases, and the CDC expanded their search nationally. As of July 8, 1,010 cases in 35 countries have been reported to the World Health Organization. There are 263 confirmed cases in the United Kingdom and 332 cases under investigation by the CDC in the United States, according to the most recent counts.
The two studies, both published in the New England Journal of Medicine, provide additional clinical data on a number of these mysterious hepatitis cases. Dr. Gutierrez’s study looked at nine children admitted for hepatitis of unknown origin between October 1 and February 28. Patients had a median age of 2 years 11 months and two required liver transplants, and there were no deaths.
Eight out of nine patients (89%) tested positive for adenovirus, and all five of the samples that were of sufficient quality for gene sequencing tested positive for adenovirus 41. None of the six liver biopsies performed found signs of adenovirus infection, but the liver tissue samples of three patients tested positive for adenovirus via PCR.
The second study involved 44 children referred to a liver transplantation center in the United Kingdom between January 1 and April 11, 2022. The median age for patients was 4 years. Six children required liver transplants, and there were no deaths. Of the 30 patients who underwent molecular adenovirus testing, 27 (90%) were positive for adenovirus 41. Liver samples of nine children (3 from biopsies and 6 from explanted livers) all tested negative for adenovirus antibodies.
In both studies, however, the median adenovirus viral load of patients needing a transplant was much higher than the viral loads in children who did not require liver transplants.
Although most of the clinical features and test results of these cases suggest that adenovirus may be involved, the negative results in histology are “intriguing,” Chayarani Kelgeri, MD, a consultant pediatric hepatologist at the Birmingham Women’s and Children’s Hospital, U.K., said in an email. She is the lead author of the U.K. study. “Whether this is because the liver injury we see is an aftermath of the viral infection, the mechanism of injury is immune mediated, and if other cofactors are involved is being explored,” she added. “Further investigations being undertaken by UK Health Security Agency will add to our understanding of this illness.”
Although there is a high adenovirus positivity rate amongst these cases, there is not enough evidence yet to say adenovirus 41 is a new cause of pediatric hepatitis in previously healthy children, said Saul Karpen, MD, PhD, the division chief of pediatric gastroenterology, hepatology, and nutrition at Emory University School of Medicine, Atlanta. He wrote an editorial accompanying the two NEJM studies.
The CDC has not yet found an increase in pediatric hepatitis cases, according to a recent analysis, though the United Kingdom has found an uptick in cases this year, he told this news organization. Also, the cases highlighted in both articles showed no histological evidence of adenovirus in liver biopsies. “That’s completely opposite of what we generally see in adenoviral hepatitis that can be quite severe,” he said, adding that in general, there are detectable viral particles and antigens in affected livers.
“These two important reports indicate to those inside and outside the field of pediatric hepatology that registries and clinical studies of acute hepatitis in children are sorely needed,” Dr. Karpen writes in the editorial; “It is likely that with greater attention to collecting data on cases and biospecimens from children with acute hepatitis, we will be able to determine whether this one virus, human adenovirus 41, is of relevance to this important and serious condition in children.”
Dr. Gutierrez, Dr. Kelgeri, and Dr. Karpen report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
While two new studies reiterate a possible relationship between adenovirus 41 and acute hepatitis of unknown cause in children, whether these infections are significant or merely bystanders remains unclear.
In both studies – one conducted in Alabama and the other conducted in the United Kingdom – researchers found that 90% of children with acute hepatitis of unknown cause tested positive for adenovirus 41. The virus subtype is not an uncommon infection, but it usually causes gastroenteritis in children.
“Across the world, adenovirus continues to be a common signal” in these pediatric hepatitis cases, said Helena Gutierrez, MD, the medical director of the Pediatric Liver Transplant Program at the University of Alabama at Birmingham, in an interview. She led one of the studies. More data are necessary to understand what role this virus may play in these cases, she said.
In November, the Alabama Department of Public Health and the U.S. Centers for Disease Control and Prevention began investigating a cluster of severe pediatric hepatitis cases at the Children’s of Alabama hospital in Birmingham. These children also tested positive for adenovirus. In April, the United Kingdom announced they were investigating similar cases, and the CDC expanded their search nationally. As of July 8, 1,010 cases in 35 countries have been reported to the World Health Organization. There are 263 confirmed cases in the United Kingdom and 332 cases under investigation by the CDC in the United States, according to the most recent counts.
The two studies, both published in the New England Journal of Medicine, provide additional clinical data on a number of these mysterious hepatitis cases. Dr. Gutierrez’s study looked at nine children admitted for hepatitis of unknown origin between October 1 and February 28. Patients had a median age of 2 years 11 months and two required liver transplants, and there were no deaths.
Eight out of nine patients (89%) tested positive for adenovirus, and all five of the samples that were of sufficient quality for gene sequencing tested positive for adenovirus 41. None of the six liver biopsies performed found signs of adenovirus infection, but the liver tissue samples of three patients tested positive for adenovirus via PCR.
The second study involved 44 children referred to a liver transplantation center in the United Kingdom between January 1 and April 11, 2022. The median age for patients was 4 years. Six children required liver transplants, and there were no deaths. Of the 30 patients who underwent molecular adenovirus testing, 27 (90%) were positive for adenovirus 41. Liver samples of nine children (3 from biopsies and 6 from explanted livers) all tested negative for adenovirus antibodies.
In both studies, however, the median adenovirus viral load of patients needing a transplant was much higher than the viral loads in children who did not require liver transplants.
Although most of the clinical features and test results of these cases suggest that adenovirus may be involved, the negative results in histology are “intriguing,” Chayarani Kelgeri, MD, a consultant pediatric hepatologist at the Birmingham Women’s and Children’s Hospital, U.K., said in an email. She is the lead author of the U.K. study. “Whether this is because the liver injury we see is an aftermath of the viral infection, the mechanism of injury is immune mediated, and if other cofactors are involved is being explored,” she added. “Further investigations being undertaken by UK Health Security Agency will add to our understanding of this illness.”
Although there is a high adenovirus positivity rate amongst these cases, there is not enough evidence yet to say adenovirus 41 is a new cause of pediatric hepatitis in previously healthy children, said Saul Karpen, MD, PhD, the division chief of pediatric gastroenterology, hepatology, and nutrition at Emory University School of Medicine, Atlanta. He wrote an editorial accompanying the two NEJM studies.
The CDC has not yet found an increase in pediatric hepatitis cases, according to a recent analysis, though the United Kingdom has found an uptick in cases this year, he told this news organization. Also, the cases highlighted in both articles showed no histological evidence of adenovirus in liver biopsies. “That’s completely opposite of what we generally see in adenoviral hepatitis that can be quite severe,” he said, adding that in general, there are detectable viral particles and antigens in affected livers.
“These two important reports indicate to those inside and outside the field of pediatric hepatology that registries and clinical studies of acute hepatitis in children are sorely needed,” Dr. Karpen writes in the editorial; “It is likely that with greater attention to collecting data on cases and biospecimens from children with acute hepatitis, we will be able to determine whether this one virus, human adenovirus 41, is of relevance to this important and serious condition in children.”
Dr. Gutierrez, Dr. Kelgeri, and Dr. Karpen report no relevant financial relationships.
A version of this article first appeared on Medscape.com.