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Photobiomodulation: Evaluation in a wide range of medical specialties underway

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Changed
Thu, 06/17/2021 - 14:27

 

Advances in photobiomodulation have propelled the use of therapeutic applications in a variety of medical specialties, according to Juanita J. Anders, PhD.

Dr. Juanita Anders

During the annual conference of the American Society for Laser Medicine and Surgery, Dr. Anders, professor of anatomy, physiology, and genetics at the Uniformed Services University of the Health Sciences, Bethesda, Md., defined photobiomodulation (PBM) as the mechanism by which nonionizing optical radiation in the visible and near-infrared spectral range is absorbed by endogenous chromophores to elicit photophysical and photochemical events at various biological scales. Photobiomodulation therapy (PBMT) involves the use of light sources including lasers, LEDs, and broadband light, that emit visible and/or near-infrared light to cause physiological changes in cells and tissues and result in therapeutic benefits.

In dermatology, LED light therapy devices are commonly used for PBMT in wavelengths that range from blue (415 nm) and red (633 nm) to near infrared (830 nm). “Often, when PBMT is referred to by dermatologists it’s called LED therapy or LED light therapy,” Dr. Anders noted. “Some people are under the impression that this is different from PBMT. But remember: It’s not the device that’s producing the photons that is clinically relevant, but it’s the photons themselves. In both cases, the same radiances and fluence ranges are being used and the mechanisms are the same, so it’s all PBMT.”

The therapy is used to treat a wide variety of medical and aesthetic disorders including acne vulgaris, psoriasis, burns, and wound healing. It has also been used in conjunction with surgical aesthetic and resurfacing procedures and has been reported to reduce erythema, edema, bruising, and days to healing. It’s been shown that PBMT stimulates fibroblast proliferation, collagen synthesis, and extracellular matrix resulting in lifting and tightening lax skin.

According to Dr. Anders, French dermatologists Linda Fouque, MD, and Michele Pelletier, MD, performed a series of in vivo and in vitro studies in which they tested the effects of yellow and red light for skin rejuvenation when used individually or in combination. “They found that fibroblasts and keratinocytes in vitro had great improvement in their morphology both with the yellow and red light, but the best improvement was seen with combination therapy,” Dr. Anders said. “This held true in their work looking at epidermal and dermal markers in the skin, where they found the best up-regulation in protein synthesis of such markers as collagens and fibronectin were produced when a combination wavelength light was used.”

Oral mucositis and pain

PBMT is also being used to treat oral mucositis (OM), a common adverse response to chemotherapy and/or radiation therapy, which causes pain, difficulty in swallowing and eating, and oral ulceration, and often interrupts the course of treatments. Authors of a recently published review on the risks and benefits of PBMT concluded that there is consistent evidence from a small number of high-quality studies that PBMT can help prevent the development of cancer therapy–induced OM, reduce pain intensity, as well as promote healing, and enhance patient quality of life.

“They also cautioned that, due to the limited long-term follow-up of patients, there is still concern for the potential long-term risks of PBMT in cancer cell mutation and amplification,” Dr. Anders said. “They advised that PBMT should be used carefully when the irradiation beam is in the direction of the tumor zone.”

Using PBMT for modulation of pain is another area of active research. Based on work from the laboratory of Dr. Anders and others, there are two methods to modulate pain. The first is to target tissue at irradiances below 100 mW/cm2.

“In my laboratory, based on in vivo preclinical animal models of neuropathic pain, we used a 980-nm wavelength laser at 43.25 mW/cm2 transcutaneously delivered to the level of the nerve for 20 seconds,” said Dr. Anders, who is a past president of the ASLMS. “Essentially, we found that the pain was modulated by reducing sensitivity to mechanical stimulation and also by causing an anti-inflammatory shift in microglial and macrophage phenotype in the dorsal root ganglion and spinal cord of affected segments.”

The second way to modulate pain, she continued, is to target tissue at irradiances above 250 mW/cm2. She and her colleagues have conducted in vitro and in vivo studies, which indicate that treatment with an irradiance/fluence rate at 270 mW/cm2 or higher at the nerve can rapidly block pain transmission.

“In vitro, we found that if we used an 810-nm wavelength light at 300 mW/cm2, we got a disruption of microtubules in the DRG neurons in culture, specifically the small neurons, the nociceptive fibers, but we did not affect the proprioceptive fibers unless we increased the length of the treatment,” she said. “We essentially found the same thing in vivo in a rodent model of neuropathic pain.”

In a pilot study, Dr. Anders and coauthors examined the efficacy of laser irradiation of the dorsal root ganglion of the second lumbar spinal nerve for patients with chronic back pain.

They found that PBMT effectively reduced back pain equal to the effects of lidocaine.

Based on these two irradiation approaches of targeting tissue, Dr. Anders recommends that a combination therapy be used to modulate neuropathic pain going forward. “This approach would involve the initial use of a high-irradiance treatment [at least 250 mW/cm2] at the nerve to block the pain transmission,” she said. “That treatment would be followed by a series of low-irradiance treatments [10-100 mW/cm2] along the course of the involved nerve to alter chronic pathology and inflammation.”
 

Potential applications in neurology

Dr. Anders also discussed research efforts under way involving transcranial PBMT: the delivery of near-infrared light through the tissues of the scalp and skull to targeted brain regions to treat neurologic injuries and disorders. “There have been some exciting results in preclinical animal work and in small clinical pilot work that show that there could be possible beneficial effects in Parkinson’s disease, Alzheimer’s disease, depression, and improvement in cognition and memory after a brain injury, such as a TBI,” she said.

“Initially, though, there were a lot of questions about whether you could really deliver light to the brain through the scalp. In my laboratory, we used slices of nonfixed brain and found that the sulci within the human brain act as light-wave guides. We used an 808-nm near-infrared wavelength of light, so that the light could penetrate more deeply.” Using nonfixed cadaver heads, where the light was applied at the scalp surface, Dr. Anders and colleagues were able to measure photons down to the depth of 4 cm. “It’s generally agreed now, though, that it’s to a maximum depth of 2.5-3 cm that enough photons are delivered that would cause a beneficial therapeutic effect,” she said.

Dr. Anders disclosed that she has received equipment from LiteCure, grant funding from the Department of Defense, and that she holds advisory board roles with LiteCure and Neurothera. She has also served in leadership roles for the Optical Society and holds intellectual property rights for the Henry M. Jackson Foundation for the Advancement of Military Medicine.

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Advances in photobiomodulation have propelled the use of therapeutic applications in a variety of medical specialties, according to Juanita J. Anders, PhD.

Dr. Juanita Anders

During the annual conference of the American Society for Laser Medicine and Surgery, Dr. Anders, professor of anatomy, physiology, and genetics at the Uniformed Services University of the Health Sciences, Bethesda, Md., defined photobiomodulation (PBM) as the mechanism by which nonionizing optical radiation in the visible and near-infrared spectral range is absorbed by endogenous chromophores to elicit photophysical and photochemical events at various biological scales. Photobiomodulation therapy (PBMT) involves the use of light sources including lasers, LEDs, and broadband light, that emit visible and/or near-infrared light to cause physiological changes in cells and tissues and result in therapeutic benefits.

In dermatology, LED light therapy devices are commonly used for PBMT in wavelengths that range from blue (415 nm) and red (633 nm) to near infrared (830 nm). “Often, when PBMT is referred to by dermatologists it’s called LED therapy or LED light therapy,” Dr. Anders noted. “Some people are under the impression that this is different from PBMT. But remember: It’s not the device that’s producing the photons that is clinically relevant, but it’s the photons themselves. In both cases, the same radiances and fluence ranges are being used and the mechanisms are the same, so it’s all PBMT.”

The therapy is used to treat a wide variety of medical and aesthetic disorders including acne vulgaris, psoriasis, burns, and wound healing. It has also been used in conjunction with surgical aesthetic and resurfacing procedures and has been reported to reduce erythema, edema, bruising, and days to healing. It’s been shown that PBMT stimulates fibroblast proliferation, collagen synthesis, and extracellular matrix resulting in lifting and tightening lax skin.

According to Dr. Anders, French dermatologists Linda Fouque, MD, and Michele Pelletier, MD, performed a series of in vivo and in vitro studies in which they tested the effects of yellow and red light for skin rejuvenation when used individually or in combination. “They found that fibroblasts and keratinocytes in vitro had great improvement in their morphology both with the yellow and red light, but the best improvement was seen with combination therapy,” Dr. Anders said. “This held true in their work looking at epidermal and dermal markers in the skin, where they found the best up-regulation in protein synthesis of such markers as collagens and fibronectin were produced when a combination wavelength light was used.”

Oral mucositis and pain

PBMT is also being used to treat oral mucositis (OM), a common adverse response to chemotherapy and/or radiation therapy, which causes pain, difficulty in swallowing and eating, and oral ulceration, and often interrupts the course of treatments. Authors of a recently published review on the risks and benefits of PBMT concluded that there is consistent evidence from a small number of high-quality studies that PBMT can help prevent the development of cancer therapy–induced OM, reduce pain intensity, as well as promote healing, and enhance patient quality of life.

“They also cautioned that, due to the limited long-term follow-up of patients, there is still concern for the potential long-term risks of PBMT in cancer cell mutation and amplification,” Dr. Anders said. “They advised that PBMT should be used carefully when the irradiation beam is in the direction of the tumor zone.”

Using PBMT for modulation of pain is another area of active research. Based on work from the laboratory of Dr. Anders and others, there are two methods to modulate pain. The first is to target tissue at irradiances below 100 mW/cm2.

“In my laboratory, based on in vivo preclinical animal models of neuropathic pain, we used a 980-nm wavelength laser at 43.25 mW/cm2 transcutaneously delivered to the level of the nerve for 20 seconds,” said Dr. Anders, who is a past president of the ASLMS. “Essentially, we found that the pain was modulated by reducing sensitivity to mechanical stimulation and also by causing an anti-inflammatory shift in microglial and macrophage phenotype in the dorsal root ganglion and spinal cord of affected segments.”

The second way to modulate pain, she continued, is to target tissue at irradiances above 250 mW/cm2. She and her colleagues have conducted in vitro and in vivo studies, which indicate that treatment with an irradiance/fluence rate at 270 mW/cm2 or higher at the nerve can rapidly block pain transmission.

“In vitro, we found that if we used an 810-nm wavelength light at 300 mW/cm2, we got a disruption of microtubules in the DRG neurons in culture, specifically the small neurons, the nociceptive fibers, but we did not affect the proprioceptive fibers unless we increased the length of the treatment,” she said. “We essentially found the same thing in vivo in a rodent model of neuropathic pain.”

In a pilot study, Dr. Anders and coauthors examined the efficacy of laser irradiation of the dorsal root ganglion of the second lumbar spinal nerve for patients with chronic back pain.

They found that PBMT effectively reduced back pain equal to the effects of lidocaine.

Based on these two irradiation approaches of targeting tissue, Dr. Anders recommends that a combination therapy be used to modulate neuropathic pain going forward. “This approach would involve the initial use of a high-irradiance treatment [at least 250 mW/cm2] at the nerve to block the pain transmission,” she said. “That treatment would be followed by a series of low-irradiance treatments [10-100 mW/cm2] along the course of the involved nerve to alter chronic pathology and inflammation.”
 

Potential applications in neurology

Dr. Anders also discussed research efforts under way involving transcranial PBMT: the delivery of near-infrared light through the tissues of the scalp and skull to targeted brain regions to treat neurologic injuries and disorders. “There have been some exciting results in preclinical animal work and in small clinical pilot work that show that there could be possible beneficial effects in Parkinson’s disease, Alzheimer’s disease, depression, and improvement in cognition and memory after a brain injury, such as a TBI,” she said.

“Initially, though, there were a lot of questions about whether you could really deliver light to the brain through the scalp. In my laboratory, we used slices of nonfixed brain and found that the sulci within the human brain act as light-wave guides. We used an 808-nm near-infrared wavelength of light, so that the light could penetrate more deeply.” Using nonfixed cadaver heads, where the light was applied at the scalp surface, Dr. Anders and colleagues were able to measure photons down to the depth of 4 cm. “It’s generally agreed now, though, that it’s to a maximum depth of 2.5-3 cm that enough photons are delivered that would cause a beneficial therapeutic effect,” she said.

Dr. Anders disclosed that she has received equipment from LiteCure, grant funding from the Department of Defense, and that she holds advisory board roles with LiteCure and Neurothera. She has also served in leadership roles for the Optical Society and holds intellectual property rights for the Henry M. Jackson Foundation for the Advancement of Military Medicine.

 

Advances in photobiomodulation have propelled the use of therapeutic applications in a variety of medical specialties, according to Juanita J. Anders, PhD.

Dr. Juanita Anders

During the annual conference of the American Society for Laser Medicine and Surgery, Dr. Anders, professor of anatomy, physiology, and genetics at the Uniformed Services University of the Health Sciences, Bethesda, Md., defined photobiomodulation (PBM) as the mechanism by which nonionizing optical radiation in the visible and near-infrared spectral range is absorbed by endogenous chromophores to elicit photophysical and photochemical events at various biological scales. Photobiomodulation therapy (PBMT) involves the use of light sources including lasers, LEDs, and broadband light, that emit visible and/or near-infrared light to cause physiological changes in cells and tissues and result in therapeutic benefits.

In dermatology, LED light therapy devices are commonly used for PBMT in wavelengths that range from blue (415 nm) and red (633 nm) to near infrared (830 nm). “Often, when PBMT is referred to by dermatologists it’s called LED therapy or LED light therapy,” Dr. Anders noted. “Some people are under the impression that this is different from PBMT. But remember: It’s not the device that’s producing the photons that is clinically relevant, but it’s the photons themselves. In both cases, the same radiances and fluence ranges are being used and the mechanisms are the same, so it’s all PBMT.”

The therapy is used to treat a wide variety of medical and aesthetic disorders including acne vulgaris, psoriasis, burns, and wound healing. It has also been used in conjunction with surgical aesthetic and resurfacing procedures and has been reported to reduce erythema, edema, bruising, and days to healing. It’s been shown that PBMT stimulates fibroblast proliferation, collagen synthesis, and extracellular matrix resulting in lifting and tightening lax skin.

According to Dr. Anders, French dermatologists Linda Fouque, MD, and Michele Pelletier, MD, performed a series of in vivo and in vitro studies in which they tested the effects of yellow and red light for skin rejuvenation when used individually or in combination. “They found that fibroblasts and keratinocytes in vitro had great improvement in their morphology both with the yellow and red light, but the best improvement was seen with combination therapy,” Dr. Anders said. “This held true in their work looking at epidermal and dermal markers in the skin, where they found the best up-regulation in protein synthesis of such markers as collagens and fibronectin were produced when a combination wavelength light was used.”

Oral mucositis and pain

PBMT is also being used to treat oral mucositis (OM), a common adverse response to chemotherapy and/or radiation therapy, which causes pain, difficulty in swallowing and eating, and oral ulceration, and often interrupts the course of treatments. Authors of a recently published review on the risks and benefits of PBMT concluded that there is consistent evidence from a small number of high-quality studies that PBMT can help prevent the development of cancer therapy–induced OM, reduce pain intensity, as well as promote healing, and enhance patient quality of life.

“They also cautioned that, due to the limited long-term follow-up of patients, there is still concern for the potential long-term risks of PBMT in cancer cell mutation and amplification,” Dr. Anders said. “They advised that PBMT should be used carefully when the irradiation beam is in the direction of the tumor zone.”

Using PBMT for modulation of pain is another area of active research. Based on work from the laboratory of Dr. Anders and others, there are two methods to modulate pain. The first is to target tissue at irradiances below 100 mW/cm2.

“In my laboratory, based on in vivo preclinical animal models of neuropathic pain, we used a 980-nm wavelength laser at 43.25 mW/cm2 transcutaneously delivered to the level of the nerve for 20 seconds,” said Dr. Anders, who is a past president of the ASLMS. “Essentially, we found that the pain was modulated by reducing sensitivity to mechanical stimulation and also by causing an anti-inflammatory shift in microglial and macrophage phenotype in the dorsal root ganglion and spinal cord of affected segments.”

The second way to modulate pain, she continued, is to target tissue at irradiances above 250 mW/cm2. She and her colleagues have conducted in vitro and in vivo studies, which indicate that treatment with an irradiance/fluence rate at 270 mW/cm2 or higher at the nerve can rapidly block pain transmission.

“In vitro, we found that if we used an 810-nm wavelength light at 300 mW/cm2, we got a disruption of microtubules in the DRG neurons in culture, specifically the small neurons, the nociceptive fibers, but we did not affect the proprioceptive fibers unless we increased the length of the treatment,” she said. “We essentially found the same thing in vivo in a rodent model of neuropathic pain.”

In a pilot study, Dr. Anders and coauthors examined the efficacy of laser irradiation of the dorsal root ganglion of the second lumbar spinal nerve for patients with chronic back pain.

They found that PBMT effectively reduced back pain equal to the effects of lidocaine.

Based on these two irradiation approaches of targeting tissue, Dr. Anders recommends that a combination therapy be used to modulate neuropathic pain going forward. “This approach would involve the initial use of a high-irradiance treatment [at least 250 mW/cm2] at the nerve to block the pain transmission,” she said. “That treatment would be followed by a series of low-irradiance treatments [10-100 mW/cm2] along the course of the involved nerve to alter chronic pathology and inflammation.”
 

Potential applications in neurology

Dr. Anders also discussed research efforts under way involving transcranial PBMT: the delivery of near-infrared light through the tissues of the scalp and skull to targeted brain regions to treat neurologic injuries and disorders. “There have been some exciting results in preclinical animal work and in small clinical pilot work that show that there could be possible beneficial effects in Parkinson’s disease, Alzheimer’s disease, depression, and improvement in cognition and memory after a brain injury, such as a TBI,” she said.

“Initially, though, there were a lot of questions about whether you could really deliver light to the brain through the scalp. In my laboratory, we used slices of nonfixed brain and found that the sulci within the human brain act as light-wave guides. We used an 808-nm near-infrared wavelength of light, so that the light could penetrate more deeply.” Using nonfixed cadaver heads, where the light was applied at the scalp surface, Dr. Anders and colleagues were able to measure photons down to the depth of 4 cm. “It’s generally agreed now, though, that it’s to a maximum depth of 2.5-3 cm that enough photons are delivered that would cause a beneficial therapeutic effect,” she said.

Dr. Anders disclosed that she has received equipment from LiteCure, grant funding from the Department of Defense, and that she holds advisory board roles with LiteCure and Neurothera. She has also served in leadership roles for the Optical Society and holds intellectual property rights for the Henry M. Jackson Foundation for the Advancement of Military Medicine.

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‘COVID toes’ chilblain-like lesions not related to COVID-19

Article Type
Changed
Thu, 08/26/2021 - 15:45

 

Chilblain-like lesions seen in adolescents during the COVID-19 pandemic are nonischemic and not related to systemic or localized SARS-CoV-2 infection, suggests a case series from Italy.

These lesions are “most likely are benign” and resolve on their own after 2-6 weeks, Valentina Discepolo, MD, PhD, University of Naples Federico II, told this news organization.

“They do not seem to be the manifestation of systemic inflammatory or autoimmune phenomena. According to our experience, they should not require a SARS-CoV-2–specific molecular or serological test since in all cases in our series they were negative,” said Dr. Discepolo.

The study was published online June 10, 2021, in JAMA Network Open.
 

‘COVID toes’ a fallacy?

The temporal association between the COVID-19 pandemic and the increasing number of chilblain-like lesions has led some in the media to call it “COVID toes,” the investigators wrote. However, data on the association with SARS-CoV-2 are controversial.

For this report, Dr. Discepolo and colleagues evaluated 17 adolescents who presented with chilblain-like lesions of the toes during the first wave of the pandemic in southern Italy.

None had evidence of current, past, or local SARS-CoV-2 infection.

“In our experience, chilblain-like lesions are not a manifestation of COVID-19, as shown by negative serological and molecular specific for SARS-CoV2,” Dr. Discepolo said in an interview.

The lesions were bilaterally distributed in 16 adolescents (94.1%) and heel skin was involved in 7 (41.2%). Ulceration complicated one patient during the active phase of the disease, and desquamation developed over time in three patients (17.6%). Only two patients (11.8%) had concurrent involvement of the fingers.



Self-administered therapies included topical antibiotics and/or corticosteroids, disinfectants, and antifungal agents; systemic antibiotics or corticosteroids were used rarely.

None of the therapies substantially changed the course of the lesions. Duration was “extremely variable,” ranging from 49 to 145 days; however, at follow-up, all patients had full resolution.

Almost invariably, the lesions were characterized by a triad of red dots, white rosettes, and white streaks on an erythematous background, the investigators reported.

In more than half the patients (56%), red dots often appeared as dotted and comma-shaped congested vessels that surrounded the rosettes in the early stage of the lesions. In later stages, red dots were still present, but the rosettes had disappeared.

Although found inconsistently in inflammatory cutaneous conditions, these three signs do not characterize the dermoscopic picture of perniosis, suggesting a distinct disease process, the investigators said.

 

Don’t blame it on ischemia, clots

Histologic analysis revealed “remodeling of the dermal blood vessels with a lobular arrangement, wall thickening, and a mild perivascular lymphocytic infiltrate,” they noted.

Punch biopsy of the involved skin mostly showed endothelial hyperplasia, mild lymphocytic infiltrate, and vessels’ architecture disruption with no papillary dermal edema or eosinophilic or neutrophilic infiltrate.

Pathology did not reveal any ischemic changes, which argues against systemic vasculopathy, Farzam Gorouhi, MD, from Kaiser Permanente, South Sacramento Medical Center, noted in a linked editorial. “Thus, this study provides further evidence against the thromboembolic nature of the presented pattern in adolescents during the COVID-19 pandemic.”

Results of capillaroscopy, used to investigate structural changes in peripheral microcirculation, were either completely normal or showed rare ectasias, supporting a lack of systemic inflammatory process.

“The lack of capillaroscopic features of a major vasculopathic event in the study by Discepolo et al. argues against the ischemic nature of this disease and, thus, indicates that this presentation is not associated with systemic ischemia or an embolic event,” Dr. Gorouhi noted.

Chilblain-like lesions have been one of the most commonly described cutaneous manifestations during the COVID-19 pandemic, but their etiopathogenesis, including the role of SARS-CoV-2, has remained elusive, the investigators wrote.

The findings in this case series do not support the association of the lesions with SARS-CoV-2 infection, they concluded.

The fact that only three new cases of chilblain-like lesions were reported during the highest peaks of the pandemic further supports a lack of association with SARS-CoV-2 infection, they noted.

In addition, none of these patients tested positive for SARS-CoV-2 and all three cases during the second wave occurred in the winter months, suggesting that exposure to the cold might, at least in some cases, trigger the skin lesions, the investigators said.

In line with this hypothesis, seven of the adolescents in this case series (41.2%) relapsed during the winter months while again testing negative for SARS-CoV-2.

“We believe that lifestyle modifications [reduced physical activity, microtraumatisms caused by walking barefoot at home] during the first strict lockdown played a role, likely promoting a local inflammatory process promoted by vascular stasis that led in genetically susceptible individuals to the onset of these lesions,” Dr. Discepolo said in an interview.

This research had no specific funding. The investigators and Dr. Gorouhi declared no relevant conflicts of interest.
 

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

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Chilblain-like lesions seen in adolescents during the COVID-19 pandemic are nonischemic and not related to systemic or localized SARS-CoV-2 infection, suggests a case series from Italy.

These lesions are “most likely are benign” and resolve on their own after 2-6 weeks, Valentina Discepolo, MD, PhD, University of Naples Federico II, told this news organization.

“They do not seem to be the manifestation of systemic inflammatory or autoimmune phenomena. According to our experience, they should not require a SARS-CoV-2–specific molecular or serological test since in all cases in our series they were negative,” said Dr. Discepolo.

The study was published online June 10, 2021, in JAMA Network Open.
 

‘COVID toes’ a fallacy?

The temporal association between the COVID-19 pandemic and the increasing number of chilblain-like lesions has led some in the media to call it “COVID toes,” the investigators wrote. However, data on the association with SARS-CoV-2 are controversial.

For this report, Dr. Discepolo and colleagues evaluated 17 adolescents who presented with chilblain-like lesions of the toes during the first wave of the pandemic in southern Italy.

None had evidence of current, past, or local SARS-CoV-2 infection.

“In our experience, chilblain-like lesions are not a manifestation of COVID-19, as shown by negative serological and molecular specific for SARS-CoV2,” Dr. Discepolo said in an interview.

The lesions were bilaterally distributed in 16 adolescents (94.1%) and heel skin was involved in 7 (41.2%). Ulceration complicated one patient during the active phase of the disease, and desquamation developed over time in three patients (17.6%). Only two patients (11.8%) had concurrent involvement of the fingers.



Self-administered therapies included topical antibiotics and/or corticosteroids, disinfectants, and antifungal agents; systemic antibiotics or corticosteroids were used rarely.

None of the therapies substantially changed the course of the lesions. Duration was “extremely variable,” ranging from 49 to 145 days; however, at follow-up, all patients had full resolution.

Almost invariably, the lesions were characterized by a triad of red dots, white rosettes, and white streaks on an erythematous background, the investigators reported.

In more than half the patients (56%), red dots often appeared as dotted and comma-shaped congested vessels that surrounded the rosettes in the early stage of the lesions. In later stages, red dots were still present, but the rosettes had disappeared.

Although found inconsistently in inflammatory cutaneous conditions, these three signs do not characterize the dermoscopic picture of perniosis, suggesting a distinct disease process, the investigators said.

 

Don’t blame it on ischemia, clots

Histologic analysis revealed “remodeling of the dermal blood vessels with a lobular arrangement, wall thickening, and a mild perivascular lymphocytic infiltrate,” they noted.

Punch biopsy of the involved skin mostly showed endothelial hyperplasia, mild lymphocytic infiltrate, and vessels’ architecture disruption with no papillary dermal edema or eosinophilic or neutrophilic infiltrate.

Pathology did not reveal any ischemic changes, which argues against systemic vasculopathy, Farzam Gorouhi, MD, from Kaiser Permanente, South Sacramento Medical Center, noted in a linked editorial. “Thus, this study provides further evidence against the thromboembolic nature of the presented pattern in adolescents during the COVID-19 pandemic.”

Results of capillaroscopy, used to investigate structural changes in peripheral microcirculation, were either completely normal or showed rare ectasias, supporting a lack of systemic inflammatory process.

“The lack of capillaroscopic features of a major vasculopathic event in the study by Discepolo et al. argues against the ischemic nature of this disease and, thus, indicates that this presentation is not associated with systemic ischemia or an embolic event,” Dr. Gorouhi noted.

Chilblain-like lesions have been one of the most commonly described cutaneous manifestations during the COVID-19 pandemic, but their etiopathogenesis, including the role of SARS-CoV-2, has remained elusive, the investigators wrote.

The findings in this case series do not support the association of the lesions with SARS-CoV-2 infection, they concluded.

The fact that only three new cases of chilblain-like lesions were reported during the highest peaks of the pandemic further supports a lack of association with SARS-CoV-2 infection, they noted.

In addition, none of these patients tested positive for SARS-CoV-2 and all three cases during the second wave occurred in the winter months, suggesting that exposure to the cold might, at least in some cases, trigger the skin lesions, the investigators said.

In line with this hypothesis, seven of the adolescents in this case series (41.2%) relapsed during the winter months while again testing negative for SARS-CoV-2.

“We believe that lifestyle modifications [reduced physical activity, microtraumatisms caused by walking barefoot at home] during the first strict lockdown played a role, likely promoting a local inflammatory process promoted by vascular stasis that led in genetically susceptible individuals to the onset of these lesions,” Dr. Discepolo said in an interview.

This research had no specific funding. The investigators and Dr. Gorouhi declared no relevant conflicts of interest.
 

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

 

Chilblain-like lesions seen in adolescents during the COVID-19 pandemic are nonischemic and not related to systemic or localized SARS-CoV-2 infection, suggests a case series from Italy.

These lesions are “most likely are benign” and resolve on their own after 2-6 weeks, Valentina Discepolo, MD, PhD, University of Naples Federico II, told this news organization.

“They do not seem to be the manifestation of systemic inflammatory or autoimmune phenomena. According to our experience, they should not require a SARS-CoV-2–specific molecular or serological test since in all cases in our series they were negative,” said Dr. Discepolo.

The study was published online June 10, 2021, in JAMA Network Open.
 

‘COVID toes’ a fallacy?

The temporal association between the COVID-19 pandemic and the increasing number of chilblain-like lesions has led some in the media to call it “COVID toes,” the investigators wrote. However, data on the association with SARS-CoV-2 are controversial.

For this report, Dr. Discepolo and colleagues evaluated 17 adolescents who presented with chilblain-like lesions of the toes during the first wave of the pandemic in southern Italy.

None had evidence of current, past, or local SARS-CoV-2 infection.

“In our experience, chilblain-like lesions are not a manifestation of COVID-19, as shown by negative serological and molecular specific for SARS-CoV2,” Dr. Discepolo said in an interview.

The lesions were bilaterally distributed in 16 adolescents (94.1%) and heel skin was involved in 7 (41.2%). Ulceration complicated one patient during the active phase of the disease, and desquamation developed over time in three patients (17.6%). Only two patients (11.8%) had concurrent involvement of the fingers.



Self-administered therapies included topical antibiotics and/or corticosteroids, disinfectants, and antifungal agents; systemic antibiotics or corticosteroids were used rarely.

None of the therapies substantially changed the course of the lesions. Duration was “extremely variable,” ranging from 49 to 145 days; however, at follow-up, all patients had full resolution.

Almost invariably, the lesions were characterized by a triad of red dots, white rosettes, and white streaks on an erythematous background, the investigators reported.

In more than half the patients (56%), red dots often appeared as dotted and comma-shaped congested vessels that surrounded the rosettes in the early stage of the lesions. In later stages, red dots were still present, but the rosettes had disappeared.

Although found inconsistently in inflammatory cutaneous conditions, these three signs do not characterize the dermoscopic picture of perniosis, suggesting a distinct disease process, the investigators said.

 

Don’t blame it on ischemia, clots

Histologic analysis revealed “remodeling of the dermal blood vessels with a lobular arrangement, wall thickening, and a mild perivascular lymphocytic infiltrate,” they noted.

Punch biopsy of the involved skin mostly showed endothelial hyperplasia, mild lymphocytic infiltrate, and vessels’ architecture disruption with no papillary dermal edema or eosinophilic or neutrophilic infiltrate.

Pathology did not reveal any ischemic changes, which argues against systemic vasculopathy, Farzam Gorouhi, MD, from Kaiser Permanente, South Sacramento Medical Center, noted in a linked editorial. “Thus, this study provides further evidence against the thromboembolic nature of the presented pattern in adolescents during the COVID-19 pandemic.”

Results of capillaroscopy, used to investigate structural changes in peripheral microcirculation, were either completely normal or showed rare ectasias, supporting a lack of systemic inflammatory process.

“The lack of capillaroscopic features of a major vasculopathic event in the study by Discepolo et al. argues against the ischemic nature of this disease and, thus, indicates that this presentation is not associated with systemic ischemia or an embolic event,” Dr. Gorouhi noted.

Chilblain-like lesions have been one of the most commonly described cutaneous manifestations during the COVID-19 pandemic, but their etiopathogenesis, including the role of SARS-CoV-2, has remained elusive, the investigators wrote.

The findings in this case series do not support the association of the lesions with SARS-CoV-2 infection, they concluded.

The fact that only three new cases of chilblain-like lesions were reported during the highest peaks of the pandemic further supports a lack of association with SARS-CoV-2 infection, they noted.

In addition, none of these patients tested positive for SARS-CoV-2 and all three cases during the second wave occurred in the winter months, suggesting that exposure to the cold might, at least in some cases, trigger the skin lesions, the investigators said.

In line with this hypothesis, seven of the adolescents in this case series (41.2%) relapsed during the winter months while again testing negative for SARS-CoV-2.

“We believe that lifestyle modifications [reduced physical activity, microtraumatisms caused by walking barefoot at home] during the first strict lockdown played a role, likely promoting a local inflammatory process promoted by vascular stasis that led in genetically susceptible individuals to the onset of these lesions,” Dr. Discepolo said in an interview.

This research had no specific funding. The investigators and Dr. Gorouhi declared no relevant conflicts of interest.
 

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

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New biomarkers may predict interstitial lung disease progression in patients with systemic sclerosis

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Wed, 06/16/2021 - 14:17

Quantitative assessment of the extent of interstitial lung disease in patients with systemic sclerosis and levels of certain proteins in bronchoalveolar lavage samples have potential for predicting mortality and disease progression, according to two analyses of data from the Scleroderma Lung Study I and II.

Dr. Elizabeth Volkmann

The analyses, presented at the annual European Congress of Rheumatology, aim to improve current prognostic abilities in patients with systemic sclerosis–interstitial lung disease (SSc-ILD). Although forced vital capacity is commonly used as a biomarker for survival in many SSc-ILD trials, other factors can affect FVC, such as respiratory muscle weakness and skin fibrosis. Further, FVC correlates poorly with patient-reported outcomes, explained first author Elizabeth Volkmann, MD, director of the scleroderma program at the University of California, Los Angeles, and the founder and codirector of the UCLA connective tissue disease–related interstitial lung disease program.

Dr. Volkmann presented two studies that investigated the potential of radiographic and protein biomarkers for predicting mortality and identifying patients at risk for ILD progression. The biomarkers may also help to identify patients who would benefit most from immunosuppressive therapy.

The first study found that tracking the quantitative extent of ILD (QILD) over time with high-resolution CT (HRCT) predicted poorer outcomes and could therefore act as a surrogate endpoint for mortality among patients with SSc-ILD. The other study identified associations between specific proteins from bronchoalveolar lavage (BAL) and the likelihood of ILD progression, although some associations were treatment dependent.

Dr. Jacob M. van Laar

Jacob M. van Laar, MD, PhD, professor of rheumatology at the University Medical Center Utrecht (the Netherlands), who was not involved in the study, found the results intriguing and noted the importance of further validation in research before these biomarkers are considered for clinical use.

“It would be wonderful if we can tailor therapy based on BAL biomarkers in the future, as clinicians often struggle to decide on selection, timing, and duration of immunosuppressive treatment,” Dr. van Laar told this news organization. “This has become even more relevant with the introduction of new drugs such as nintedanib.”
 

Extent of ILD progression as a surrogate for mortality

Scleroderma Lung Study I involved 158 patients with SSc-ILD who were randomly assigned to receive either cyclophosphamide or placebo for 12 months. Scleroderma Lung Study II included 142 patients with SSc-ILD who were randomly assigned to receive either mycophenolate for 24 months or cyclophosphamide for 12 months followed by placebo for 12 months.

The researchers calculated QILD in the whole lung at baseline, at 12 months in the first trial, and at 24 months in the second trial. However, only 82 participants from the first trial and 90 participants from the second trial underwent HRCT. Demographic and disease characteristics were similar between the two groups on follow-up scans.

Follow-up continued for 12 years for patients in the first trial and 8 years in the second. The researchers compared survival rates between the 41% of participants from the first study and 31% of participants from the second study who had poorer QILD scores (at least a 2% increase) with the participants who had stable or improved scores (less than 2% increase).

Participants from both trials had significantly poorer long-term survival if their QILD scores had increased by at least 2% at follow-up (P = .01 for I; P = .019 for II). The association was no longer significant after adjustment for baseline FVC, age, and modified Rodnan skin score in the first trial (hazard ratio, 1.98; P = .089), but it remained significant for participants of the second trial (HR, 3.86; P = .014).

“Data from two independent trial cohorts demonstrated that radiographic progression of SSc-ILD at 1 and 2 years is associated with worse long-term survival,” Dr. Volkmann told attendees.

However, FVC did not significantly predict risk of mortality in either trial.

“To me, the most striking finding from the first study was that change in QILD performed better as a predictor of survival than change in FVC,” Dr. van Laar said in an interview. “This indicates QILD is fit for purpose and worth including in future clinical trials.”

Limitations of the study included lack of HRCT for all participants in the trials and the difference in timing (1 year and 2 years) of HRCT assessment between the two trials. The greater hazard ratio for worsened QILD in the second trial may suggest that assessment at 2 years provides more reliable data as a biomarker, Dr. Volkmann said.

“QILD may represent a better proxy for how a patient feels, functions, and survives than FVC,” she said.
 

 

 

Treatment-dependent biomarkers for worsening lung fibrosis

In the second study, the researchers looked for any associations between changes in the radiographic extent of SSc-ILD and 68 proteins from BAL.

“Being able to risk-stratify patients with interstitial lung disease at the time of diagnosis and predict which patients are likely to have a stable versus progressive disease course is critical for making important treatment decisions for these patients,” Dr. Volkmann told attendees.

The second study she presented involved Scleroderma Lung Study I. Of the 158 participants, 144 underwent a bronchoscopy, yielding BAL protein samples from 103 participants. The researchers determined the extent of radiographic fibrosis in the whole lung with quantitative imaging analysis of HRCT of the chest at baseline and 12 months.

Although the researchers identified several statistically significant associations between certain proteins and changes in radiographic fibrosis, “baseline protein levels were differentially associated with the course of ILD based on treatment status,” she told attendees.

For example, increased levels of the following proteins were linked to poor radiographic fibrosis scores for patients who received placebo:

  • Granulocyte-macrophage colony-stimulating factor
  • Interleukin-1
  • Monocyte chemoattractant protein–3
  • Chemokine ligand–5
  • Transforming growth factor–beta
  • Hepatocyte growth factor
  • Stem cell factor
  • IL-4
  • TGF-alpha

Yet increases in these proteins predicted improvement in radiographic fibrosis in patients who had taken cyclophosphamide.

Independently of treatment, the researchers also identified an association between higher levels of fractalkine and poorer radiographic fibrosis scores and between higher IL-7 levels and improved radiographic fibrosis scores.

After adjusting for treatment arm and baseline severity of ILD, significant associations remained between change in radiographic fibrosis score and IL-1, MCP-3, surfactant protein C, IL-7 and CCL-5 levels.

“Biomarker discovery is really central to our ability to risk stratify patients with SSc-ILD,” Dr. Volkmann told attendees. “Understanding how biomarkers predict outcomes in treated and untreated patients may improve personalized medicine to patients with SSc-ILD and could also reveal novel treatment targets.”

Dr. van Laar said in an interview that this study’s biggest strength lay in its large sample size and in the comprehensiveness of the biomarkers studied.

“The findings are interesting from a research perspective and potentially relevant for clinical practice, but the utility of measuring biomarkers in BAL should be further studied for predictive value on clinical endpoints,” Dr. van Laar said. “BAL is an invasive procedure [that] is not routinely done.”

The research was funded by the National Institutes of Health. Dr. Volkmann has consulted for Boehringer Ingelheim and received grant funding from Corbus, Forbius, and Kadmon. Dr. van Laar has received grant funding or personal fees from Arthrogen, Arxx Therapeutics, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Gesynta, Leadiant, Merck Sharp & Dohme, Roche, Sanofi, and Thermofisher.

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

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Quantitative assessment of the extent of interstitial lung disease in patients with systemic sclerosis and levels of certain proteins in bronchoalveolar lavage samples have potential for predicting mortality and disease progression, according to two analyses of data from the Scleroderma Lung Study I and II.

Dr. Elizabeth Volkmann

The analyses, presented at the annual European Congress of Rheumatology, aim to improve current prognostic abilities in patients with systemic sclerosis–interstitial lung disease (SSc-ILD). Although forced vital capacity is commonly used as a biomarker for survival in many SSc-ILD trials, other factors can affect FVC, such as respiratory muscle weakness and skin fibrosis. Further, FVC correlates poorly with patient-reported outcomes, explained first author Elizabeth Volkmann, MD, director of the scleroderma program at the University of California, Los Angeles, and the founder and codirector of the UCLA connective tissue disease–related interstitial lung disease program.

Dr. Volkmann presented two studies that investigated the potential of radiographic and protein biomarkers for predicting mortality and identifying patients at risk for ILD progression. The biomarkers may also help to identify patients who would benefit most from immunosuppressive therapy.

The first study found that tracking the quantitative extent of ILD (QILD) over time with high-resolution CT (HRCT) predicted poorer outcomes and could therefore act as a surrogate endpoint for mortality among patients with SSc-ILD. The other study identified associations between specific proteins from bronchoalveolar lavage (BAL) and the likelihood of ILD progression, although some associations were treatment dependent.

Dr. Jacob M. van Laar

Jacob M. van Laar, MD, PhD, professor of rheumatology at the University Medical Center Utrecht (the Netherlands), who was not involved in the study, found the results intriguing and noted the importance of further validation in research before these biomarkers are considered for clinical use.

“It would be wonderful if we can tailor therapy based on BAL biomarkers in the future, as clinicians often struggle to decide on selection, timing, and duration of immunosuppressive treatment,” Dr. van Laar told this news organization. “This has become even more relevant with the introduction of new drugs such as nintedanib.”
 

Extent of ILD progression as a surrogate for mortality

Scleroderma Lung Study I involved 158 patients with SSc-ILD who were randomly assigned to receive either cyclophosphamide or placebo for 12 months. Scleroderma Lung Study II included 142 patients with SSc-ILD who were randomly assigned to receive either mycophenolate for 24 months or cyclophosphamide for 12 months followed by placebo for 12 months.

The researchers calculated QILD in the whole lung at baseline, at 12 months in the first trial, and at 24 months in the second trial. However, only 82 participants from the first trial and 90 participants from the second trial underwent HRCT. Demographic and disease characteristics were similar between the two groups on follow-up scans.

Follow-up continued for 12 years for patients in the first trial and 8 years in the second. The researchers compared survival rates between the 41% of participants from the first study and 31% of participants from the second study who had poorer QILD scores (at least a 2% increase) with the participants who had stable or improved scores (less than 2% increase).

Participants from both trials had significantly poorer long-term survival if their QILD scores had increased by at least 2% at follow-up (P = .01 for I; P = .019 for II). The association was no longer significant after adjustment for baseline FVC, age, and modified Rodnan skin score in the first trial (hazard ratio, 1.98; P = .089), but it remained significant for participants of the second trial (HR, 3.86; P = .014).

“Data from two independent trial cohorts demonstrated that radiographic progression of SSc-ILD at 1 and 2 years is associated with worse long-term survival,” Dr. Volkmann told attendees.

However, FVC did not significantly predict risk of mortality in either trial.

“To me, the most striking finding from the first study was that change in QILD performed better as a predictor of survival than change in FVC,” Dr. van Laar said in an interview. “This indicates QILD is fit for purpose and worth including in future clinical trials.”

Limitations of the study included lack of HRCT for all participants in the trials and the difference in timing (1 year and 2 years) of HRCT assessment between the two trials. The greater hazard ratio for worsened QILD in the second trial may suggest that assessment at 2 years provides more reliable data as a biomarker, Dr. Volkmann said.

“QILD may represent a better proxy for how a patient feels, functions, and survives than FVC,” she said.
 

 

 

Treatment-dependent biomarkers for worsening lung fibrosis

In the second study, the researchers looked for any associations between changes in the radiographic extent of SSc-ILD and 68 proteins from BAL.

“Being able to risk-stratify patients with interstitial lung disease at the time of diagnosis and predict which patients are likely to have a stable versus progressive disease course is critical for making important treatment decisions for these patients,” Dr. Volkmann told attendees.

The second study she presented involved Scleroderma Lung Study I. Of the 158 participants, 144 underwent a bronchoscopy, yielding BAL protein samples from 103 participants. The researchers determined the extent of radiographic fibrosis in the whole lung with quantitative imaging analysis of HRCT of the chest at baseline and 12 months.

Although the researchers identified several statistically significant associations between certain proteins and changes in radiographic fibrosis, “baseline protein levels were differentially associated with the course of ILD based on treatment status,” she told attendees.

For example, increased levels of the following proteins were linked to poor radiographic fibrosis scores for patients who received placebo:

  • Granulocyte-macrophage colony-stimulating factor
  • Interleukin-1
  • Monocyte chemoattractant protein–3
  • Chemokine ligand–5
  • Transforming growth factor–beta
  • Hepatocyte growth factor
  • Stem cell factor
  • IL-4
  • TGF-alpha

Yet increases in these proteins predicted improvement in radiographic fibrosis in patients who had taken cyclophosphamide.

Independently of treatment, the researchers also identified an association between higher levels of fractalkine and poorer radiographic fibrosis scores and between higher IL-7 levels and improved radiographic fibrosis scores.

After adjusting for treatment arm and baseline severity of ILD, significant associations remained between change in radiographic fibrosis score and IL-1, MCP-3, surfactant protein C, IL-7 and CCL-5 levels.

“Biomarker discovery is really central to our ability to risk stratify patients with SSc-ILD,” Dr. Volkmann told attendees. “Understanding how biomarkers predict outcomes in treated and untreated patients may improve personalized medicine to patients with SSc-ILD and could also reveal novel treatment targets.”

Dr. van Laar said in an interview that this study’s biggest strength lay in its large sample size and in the comprehensiveness of the biomarkers studied.

“The findings are interesting from a research perspective and potentially relevant for clinical practice, but the utility of measuring biomarkers in BAL should be further studied for predictive value on clinical endpoints,” Dr. van Laar said. “BAL is an invasive procedure [that] is not routinely done.”

The research was funded by the National Institutes of Health. Dr. Volkmann has consulted for Boehringer Ingelheim and received grant funding from Corbus, Forbius, and Kadmon. Dr. van Laar has received grant funding or personal fees from Arthrogen, Arxx Therapeutics, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Gesynta, Leadiant, Merck Sharp & Dohme, Roche, Sanofi, and Thermofisher.

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

Quantitative assessment of the extent of interstitial lung disease in patients with systemic sclerosis and levels of certain proteins in bronchoalveolar lavage samples have potential for predicting mortality and disease progression, according to two analyses of data from the Scleroderma Lung Study I and II.

Dr. Elizabeth Volkmann

The analyses, presented at the annual European Congress of Rheumatology, aim to improve current prognostic abilities in patients with systemic sclerosis–interstitial lung disease (SSc-ILD). Although forced vital capacity is commonly used as a biomarker for survival in many SSc-ILD trials, other factors can affect FVC, such as respiratory muscle weakness and skin fibrosis. Further, FVC correlates poorly with patient-reported outcomes, explained first author Elizabeth Volkmann, MD, director of the scleroderma program at the University of California, Los Angeles, and the founder and codirector of the UCLA connective tissue disease–related interstitial lung disease program.

Dr. Volkmann presented two studies that investigated the potential of radiographic and protein biomarkers for predicting mortality and identifying patients at risk for ILD progression. The biomarkers may also help to identify patients who would benefit most from immunosuppressive therapy.

The first study found that tracking the quantitative extent of ILD (QILD) over time with high-resolution CT (HRCT) predicted poorer outcomes and could therefore act as a surrogate endpoint for mortality among patients with SSc-ILD. The other study identified associations between specific proteins from bronchoalveolar lavage (BAL) and the likelihood of ILD progression, although some associations were treatment dependent.

Dr. Jacob M. van Laar

Jacob M. van Laar, MD, PhD, professor of rheumatology at the University Medical Center Utrecht (the Netherlands), who was not involved in the study, found the results intriguing and noted the importance of further validation in research before these biomarkers are considered for clinical use.

“It would be wonderful if we can tailor therapy based on BAL biomarkers in the future, as clinicians often struggle to decide on selection, timing, and duration of immunosuppressive treatment,” Dr. van Laar told this news organization. “This has become even more relevant with the introduction of new drugs such as nintedanib.”
 

Extent of ILD progression as a surrogate for mortality

Scleroderma Lung Study I involved 158 patients with SSc-ILD who were randomly assigned to receive either cyclophosphamide or placebo for 12 months. Scleroderma Lung Study II included 142 patients with SSc-ILD who were randomly assigned to receive either mycophenolate for 24 months or cyclophosphamide for 12 months followed by placebo for 12 months.

The researchers calculated QILD in the whole lung at baseline, at 12 months in the first trial, and at 24 months in the second trial. However, only 82 participants from the first trial and 90 participants from the second trial underwent HRCT. Demographic and disease characteristics were similar between the two groups on follow-up scans.

Follow-up continued for 12 years for patients in the first trial and 8 years in the second. The researchers compared survival rates between the 41% of participants from the first study and 31% of participants from the second study who had poorer QILD scores (at least a 2% increase) with the participants who had stable or improved scores (less than 2% increase).

Participants from both trials had significantly poorer long-term survival if their QILD scores had increased by at least 2% at follow-up (P = .01 for I; P = .019 for II). The association was no longer significant after adjustment for baseline FVC, age, and modified Rodnan skin score in the first trial (hazard ratio, 1.98; P = .089), but it remained significant for participants of the second trial (HR, 3.86; P = .014).

“Data from two independent trial cohorts demonstrated that radiographic progression of SSc-ILD at 1 and 2 years is associated with worse long-term survival,” Dr. Volkmann told attendees.

However, FVC did not significantly predict risk of mortality in either trial.

“To me, the most striking finding from the first study was that change in QILD performed better as a predictor of survival than change in FVC,” Dr. van Laar said in an interview. “This indicates QILD is fit for purpose and worth including in future clinical trials.”

Limitations of the study included lack of HRCT for all participants in the trials and the difference in timing (1 year and 2 years) of HRCT assessment between the two trials. The greater hazard ratio for worsened QILD in the second trial may suggest that assessment at 2 years provides more reliable data as a biomarker, Dr. Volkmann said.

“QILD may represent a better proxy for how a patient feels, functions, and survives than FVC,” she said.
 

 

 

Treatment-dependent biomarkers for worsening lung fibrosis

In the second study, the researchers looked for any associations between changes in the radiographic extent of SSc-ILD and 68 proteins from BAL.

“Being able to risk-stratify patients with interstitial lung disease at the time of diagnosis and predict which patients are likely to have a stable versus progressive disease course is critical for making important treatment decisions for these patients,” Dr. Volkmann told attendees.

The second study she presented involved Scleroderma Lung Study I. Of the 158 participants, 144 underwent a bronchoscopy, yielding BAL protein samples from 103 participants. The researchers determined the extent of radiographic fibrosis in the whole lung with quantitative imaging analysis of HRCT of the chest at baseline and 12 months.

Although the researchers identified several statistically significant associations between certain proteins and changes in radiographic fibrosis, “baseline protein levels were differentially associated with the course of ILD based on treatment status,” she told attendees.

For example, increased levels of the following proteins were linked to poor radiographic fibrosis scores for patients who received placebo:

  • Granulocyte-macrophage colony-stimulating factor
  • Interleukin-1
  • Monocyte chemoattractant protein–3
  • Chemokine ligand–5
  • Transforming growth factor–beta
  • Hepatocyte growth factor
  • Stem cell factor
  • IL-4
  • TGF-alpha

Yet increases in these proteins predicted improvement in radiographic fibrosis in patients who had taken cyclophosphamide.

Independently of treatment, the researchers also identified an association between higher levels of fractalkine and poorer radiographic fibrosis scores and between higher IL-7 levels and improved radiographic fibrosis scores.

After adjusting for treatment arm and baseline severity of ILD, significant associations remained between change in radiographic fibrosis score and IL-1, MCP-3, surfactant protein C, IL-7 and CCL-5 levels.

“Biomarker discovery is really central to our ability to risk stratify patients with SSc-ILD,” Dr. Volkmann told attendees. “Understanding how biomarkers predict outcomes in treated and untreated patients may improve personalized medicine to patients with SSc-ILD and could also reveal novel treatment targets.”

Dr. van Laar said in an interview that this study’s biggest strength lay in its large sample size and in the comprehensiveness of the biomarkers studied.

“The findings are interesting from a research perspective and potentially relevant for clinical practice, but the utility of measuring biomarkers in BAL should be further studied for predictive value on clinical endpoints,” Dr. van Laar said. “BAL is an invasive procedure [that] is not routinely done.”

The research was funded by the National Institutes of Health. Dr. Volkmann has consulted for Boehringer Ingelheim and received grant funding from Corbus, Forbius, and Kadmon. Dr. van Laar has received grant funding or personal fees from Arthrogen, Arxx Therapeutics, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Gesynta, Leadiant, Merck Sharp & Dohme, Roche, Sanofi, and Thermofisher.

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

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Inpatient care for HS higher for Black and Hispanic patients

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Mon, 10/11/2021 - 10:16

 

Inpatient care utilization for hidradenitis suppurativa (HS) was higher for Black and Hispanic patients, compared with White patients, in an analysis of the 2012-2017 National Inpatient Sample.

The differences occurred despite Black and Hispanic patients being younger at the time of admission than White patients, and may reflect increased disease severity and management challenges in these patients with skin of color, Nishadh Sutaria, BS, a medical student at Tufts University, Boston, said at the annual Skin of Color Society symposium. “They may also reflect social inequities in access to dermatologists, with racial and ethnic minorities using inpatient services in lieu of outpatient care.”

Mr. Sutaria and coinvestigators, led by Shawn Kwatra, MD, of Johns Hopkins University, Baltimore, identified 8,040 HS admissions for White patients, 16,490 Black patients, and 2,405 for Hispanic patients during the 5-year period.

Black and Hispanic patients were significantly younger than White patients, with a mean age of 38.1 years and 35 years, respectively, compared with 42 years for White patients (P < .001 in each case). Compared with White patients, Black patients had more procedures (2.03 vs. 1.84, P = .006), a longer length of stay (5.82 days vs. 4.97 days, P = .001), and higher cost of care ($46,119 vs. $39,862, P = .010). Compared with White patients, Hispanic patients had higher cost of care ($52,334 vs. $39,862, P = .004).

“In these models, Black patients stayed almost a full day longer and accrued a charge of $8,000 more than White patients, and Hispanic patients stayed about a half-day longer and accrued a charge of almost $15,000 more than White patients,” Mr. Sutaria said.



In a multilinear regression analysis adjusting for age, sex, and insurance type, Black race correlated with more procedures, higher length of stay, and higher cost of care, and Hispanic ethnicity with more procedures and higher cost of care.

Prior research has shown that Black patients may be disproportionately affected by HS. A 2017 analysis of electronic health record data for tens of millions of patients nationally, for instance, showed an incidence of HS that was over 2.5 times greater in Blacks than Whites. And a recent analysis of electronic data in Wisconsin for patients with an HS diagnosis and 3 or more encounters for the disease showed that Blacks are more likely to have HS that is Hurley Stage 3, the most severe type.

Increased severity “has not been explicitly shown in Hispanic patients,” Dr. Kwatra said in an interview, “[but] there is a strong relationship between obesity/metabolic syndrome with HS. Because Hispanic patients have higher rates of obesity and metabolic syndrome, it’s [thought] that they may have more severe HS.”

HS patients with skin of color are underrepresented in clinical trials, he said. “Severe HS can be difficult to treat because there are few effective treatments,” he said, noting that adalimumab is the only Food and Drug Administration–approved therapy.

The National Inpatient Sample is a publicly available, all-payer inpatient care database developed for the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

Mr. Sutaria is a dermatology research fellow working under the guidance of Dr. Kwatra.

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Inpatient care utilization for hidradenitis suppurativa (HS) was higher for Black and Hispanic patients, compared with White patients, in an analysis of the 2012-2017 National Inpatient Sample.

The differences occurred despite Black and Hispanic patients being younger at the time of admission than White patients, and may reflect increased disease severity and management challenges in these patients with skin of color, Nishadh Sutaria, BS, a medical student at Tufts University, Boston, said at the annual Skin of Color Society symposium. “They may also reflect social inequities in access to dermatologists, with racial and ethnic minorities using inpatient services in lieu of outpatient care.”

Mr. Sutaria and coinvestigators, led by Shawn Kwatra, MD, of Johns Hopkins University, Baltimore, identified 8,040 HS admissions for White patients, 16,490 Black patients, and 2,405 for Hispanic patients during the 5-year period.

Black and Hispanic patients were significantly younger than White patients, with a mean age of 38.1 years and 35 years, respectively, compared with 42 years for White patients (P < .001 in each case). Compared with White patients, Black patients had more procedures (2.03 vs. 1.84, P = .006), a longer length of stay (5.82 days vs. 4.97 days, P = .001), and higher cost of care ($46,119 vs. $39,862, P = .010). Compared with White patients, Hispanic patients had higher cost of care ($52,334 vs. $39,862, P = .004).

“In these models, Black patients stayed almost a full day longer and accrued a charge of $8,000 more than White patients, and Hispanic patients stayed about a half-day longer and accrued a charge of almost $15,000 more than White patients,” Mr. Sutaria said.



In a multilinear regression analysis adjusting for age, sex, and insurance type, Black race correlated with more procedures, higher length of stay, and higher cost of care, and Hispanic ethnicity with more procedures and higher cost of care.

Prior research has shown that Black patients may be disproportionately affected by HS. A 2017 analysis of electronic health record data for tens of millions of patients nationally, for instance, showed an incidence of HS that was over 2.5 times greater in Blacks than Whites. And a recent analysis of electronic data in Wisconsin for patients with an HS diagnosis and 3 or more encounters for the disease showed that Blacks are more likely to have HS that is Hurley Stage 3, the most severe type.

Increased severity “has not been explicitly shown in Hispanic patients,” Dr. Kwatra said in an interview, “[but] there is a strong relationship between obesity/metabolic syndrome with HS. Because Hispanic patients have higher rates of obesity and metabolic syndrome, it’s [thought] that they may have more severe HS.”

HS patients with skin of color are underrepresented in clinical trials, he said. “Severe HS can be difficult to treat because there are few effective treatments,” he said, noting that adalimumab is the only Food and Drug Administration–approved therapy.

The National Inpatient Sample is a publicly available, all-payer inpatient care database developed for the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

Mr. Sutaria is a dermatology research fellow working under the guidance of Dr. Kwatra.

 

Inpatient care utilization for hidradenitis suppurativa (HS) was higher for Black and Hispanic patients, compared with White patients, in an analysis of the 2012-2017 National Inpatient Sample.

The differences occurred despite Black and Hispanic patients being younger at the time of admission than White patients, and may reflect increased disease severity and management challenges in these patients with skin of color, Nishadh Sutaria, BS, a medical student at Tufts University, Boston, said at the annual Skin of Color Society symposium. “They may also reflect social inequities in access to dermatologists, with racial and ethnic minorities using inpatient services in lieu of outpatient care.”

Mr. Sutaria and coinvestigators, led by Shawn Kwatra, MD, of Johns Hopkins University, Baltimore, identified 8,040 HS admissions for White patients, 16,490 Black patients, and 2,405 for Hispanic patients during the 5-year period.

Black and Hispanic patients were significantly younger than White patients, with a mean age of 38.1 years and 35 years, respectively, compared with 42 years for White patients (P < .001 in each case). Compared with White patients, Black patients had more procedures (2.03 vs. 1.84, P = .006), a longer length of stay (5.82 days vs. 4.97 days, P = .001), and higher cost of care ($46,119 vs. $39,862, P = .010). Compared with White patients, Hispanic patients had higher cost of care ($52,334 vs. $39,862, P = .004).

“In these models, Black patients stayed almost a full day longer and accrued a charge of $8,000 more than White patients, and Hispanic patients stayed about a half-day longer and accrued a charge of almost $15,000 more than White patients,” Mr. Sutaria said.



In a multilinear regression analysis adjusting for age, sex, and insurance type, Black race correlated with more procedures, higher length of stay, and higher cost of care, and Hispanic ethnicity with more procedures and higher cost of care.

Prior research has shown that Black patients may be disproportionately affected by HS. A 2017 analysis of electronic health record data for tens of millions of patients nationally, for instance, showed an incidence of HS that was over 2.5 times greater in Blacks than Whites. And a recent analysis of electronic data in Wisconsin for patients with an HS diagnosis and 3 or more encounters for the disease showed that Blacks are more likely to have HS that is Hurley Stage 3, the most severe type.

Increased severity “has not been explicitly shown in Hispanic patients,” Dr. Kwatra said in an interview, “[but] there is a strong relationship between obesity/metabolic syndrome with HS. Because Hispanic patients have higher rates of obesity and metabolic syndrome, it’s [thought] that they may have more severe HS.”

HS patients with skin of color are underrepresented in clinical trials, he said. “Severe HS can be difficult to treat because there are few effective treatments,” he said, noting that adalimumab is the only Food and Drug Administration–approved therapy.

The National Inpatient Sample is a publicly available, all-payer inpatient care database developed for the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

Mr. Sutaria is a dermatology research fellow working under the guidance of Dr. Kwatra.

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AMA selects dermatologist as incoming president for 2022

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Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Dr. Jack Resneck Jr.

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

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Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Dr. Jack Resneck Jr.

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

 

Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Dr. Jack Resneck Jr.

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

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Minnesota named best place to practice in 2021

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Wed, 06/16/2021 - 11:08

 

For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

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For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

 

For physicians who are just starting out or thinking about moving, the “Land of 10,000 Lakes” could be the land of opportunity, according to a recent Medscape analysis.

In a ranking of the 50 states, Minnesota “claimed top marks for livability, low incidence of adverse actions against doctors, and the performance of its health system,” Shelly Reese wrote in Medscape’s “Best & Worst Places to Practice 2021.”

Minnesota is below average where it’s good to be below average – share of physicians reporting burnout and/or depression – but above average in the share of physicians who say they’re “very happy” outside of work, Medscape said in the annual report.

Second on this year’s list is Wisconsin, which benefits from low levels of malpractice payouts and adverse actions and a high level of livability. Third place went to Washington (called the most livable state in the country by U.S. News and World Report), fourth to Colorado (physicians happy at and outside of work, high retention rate for residents), and fifth to Utah (low crime rate, high quality of life), Medscape said.

At the bottom of the list for 2021 is West Virginia, where physicians “may confront a bevy of challenges” in the form of low livability, a high rate of adverse actions, and relatively high malpractice payouts, Ms. Reese noted in the report.

State number 49 is Louisiana, where livability is low, malpractice payouts are high, and more than half of physicians say that they’re burned out and/or depressed. New Mexico is 48th (very high rate of adverse actions, poor resident retention), Nevada is 47th (low marks for avoidable hospital use and disparity in care), and Rhode Island is 46th (high malpractice payouts, low physician compensation), Medscape said.

Continuing with the group-of-five theme, America’s three most populous states finished in the top half of the ranking – California 16th, Texas 11th, and Florida 21st – but New York and Pennsylvania, numbers four and five by population size, did not.

The rankings are based on states’ performance in 10 different measures, three of which were sourced from Medscape surveys – happiness at work, happiness outside of work, and burnout/depression – and seven from other organizations: adverse actions against physicians, malpractice payouts, compensation (adjusted for cost of living), overall health, health system performance, overall livability, resident retention.
 

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Risankizumab shows efficacy, tolerability in patients with PsA

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Tue, 02/07/2023 - 16:45

 

Risankizumab (Skyrizi) was effective for treating psoriatic arthritis (PsA) in patients who did not respond to or who could not tolerate other biologics or standard disease-modifying antirheumatic drugs (DMARDs), according to a study presented at the annual European Congress of Rheumatology. It was also well tolerated.

“Treatment with risankizumab resulted in significantly greater improvements in signs and symptoms of psoriatic arthritis, including assessments of disease activity in joints and skin and patient-reported outcomes, compared with placebo, in patients who did not respond to or were intolerant to biologics or DMARDs,” reported Andrew Ostor, MD, of Monash University and Cabrini Hospital, both in Melbourne,. The safety profile was “consistent with that established for risankizumab in the treatment moderate to severe psoriasis,” he told attendees.

Risankizumab is approved in the United States for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits cytokine interleukin-23 by binding to its p19 subunit. IL-23 has been implicated in the development of PsA.

This was a phase 3 trial with “promising results in line with the ACR 20 response [at least 20% improvement in American College of Rheumatology response criteria] of other biologics in psoriatic arthritis,” according to Gaëlle Varkas, MD, PhD, of the Ghent (the Netherlands) University VIB Center for Inflammation Research and the department of rheumatology, Ghent University Hospital. “Especially in patients with severe and/or refractory skin disease or inadequate response at the level of the joint to other DMARDs or biologics, risankizumab is filling a void,” Dr. Varkas, who was not involved in the research, said in an interview.

There were no major safety problems, although long-term data, especially in regard to cancer and cardiovascular effects, “are always of interest, as they can be missed in randomized, controlled trials,” she said. In addition, “efficacy in concomitant axial disease, uveitis, and inflammatory bowel disease might favor one treatment over the other.” Another clinically significant takeaway was risankizumab’s “better effect on skin psoriasis while maintaining the effect on joint manifestations.”
 

Details of 24-week trial results

The phase 3, randomized, placebo-controlled, double-blind KEEPSAKE 2 trial involved 444 patients who had active PsA, defined as at least five swollen joints and at least five tender joints. All the patients either had an inadequate response to or were intolerant of one or two biologics or at least one conventional synthetic DMARD.

A total of 224 patients were randomly assigned to receive 150 mg of subcutaneous risankizumab at baseline and at 4 and 16 weeks after baseline; 220 participants received placebo injections. The primary endpoint was the proportion of patients who had at least 20% improvement in American College of Rheumatology response criteria at week 24.

Demographic and clinical characteristics were similar in both groups at baseline. Among the participants, the total mean number of swollen joints was 13.3, and the total mean number of tender joints was 22.6. The participants had PsA for an average of 8.2 years. The proportions of patients previously treated with biologics and DMARDs were similar in both groups, as were the proportions of patients currently taking glucocorticoids, NSAIDs, or methotrexate or another DMARD. At week 24, there remained 199 patients in the placebo group and 215 in the risankizumab group.

Just over half (51.3%) of patients who took risankizumab achieved at least 20% improvement in their ACR 20 score, compared with just over a quarter (26.5%) of those who received placebo (P < .001). All secondary endpoints also showed statistically significant improvements (P < .001 for all except P < .009 for the Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] secondary endpoint).

Scores on the Health Assessment Questionnaire–Disability Index were –0.22 in the risankizumab group and –0.05 in the placebo group (P < .001). In the risankizumab group, 55% of patients achieved at least a 90% reduction in scores on the Psoriasis Area Severity Index, compared with 10.2% of patients who received placebo. Similarly, 25.6% of patients who took risankizumab and 11.4% of patients who received placebo had minimal disease activity 24 weeks after baseline.



In the 36-item Short Form Health Survey Physical Component Summary, the score change among risankizumab patients was 5.9, compared with 2 among the patients who received placebo. The change in FACIT-Fatigue score was 4.9 for patients who took risankizumab and 2.6 for patients who received placebo.

The researchers also assessed how many patients achieved higher levels of response to treatment. At least a 50% improvement in ACR response criteria occurred among 26.3% of patients taking risankizumab and 9.3% of patients taking placebo (P < .001). ACR 70 responses were seen in 12% of patients receiving risankizumab, compared with 5.9% of patients receiving placebo (P < .02). In the risankizumab group, 72.5% of patients had resolution of dactylitis and 42.9% had resolution of enthesitis, compared with 42.1% and 30.4%, respectively, in the placebo group.

Serious adverse events occurred in 4% of patients who received risankizumab and 5.5% of patients who received placebo. Serious infections occurred in 0.9% of those receiving risankizumab and 2.3% of those receiving placebo. Rates of treatment-emergent adverse events were also similar in the risankizumab (55.4%) and placebo (54.8%) groups.

In response to a question about whether it was possible to identify patients who might respond better to IL-23 inhibitors, compared with IL-17 inhibitors, Dr. Ostor acknowledged that rheumatologic practice is not yet proficient at using biomarkers to direct therapy, so the benefit from these drugs lay elsewhere.

“What I think is great is the luxury of choice these days,” Dr. Ostor told attendees. “We have these agents now, including risankizumab, that do work very effectively across the spectrum of the clinical features. It’s just lovely to have these agents available that can truly make a difference to the clinical picture of the individual.”

The trial was sponsored by AbbVie. Dr. Ostor has received research grants or speaking or consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB. Dr. Varkas has received research grants or speaker fees from AbbVie and Pfizer.

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

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Risankizumab (Skyrizi) was effective for treating psoriatic arthritis (PsA) in patients who did not respond to or who could not tolerate other biologics or standard disease-modifying antirheumatic drugs (DMARDs), according to a study presented at the annual European Congress of Rheumatology. It was also well tolerated.

“Treatment with risankizumab resulted in significantly greater improvements in signs and symptoms of psoriatic arthritis, including assessments of disease activity in joints and skin and patient-reported outcomes, compared with placebo, in patients who did not respond to or were intolerant to biologics or DMARDs,” reported Andrew Ostor, MD, of Monash University and Cabrini Hospital, both in Melbourne,. The safety profile was “consistent with that established for risankizumab in the treatment moderate to severe psoriasis,” he told attendees.

Risankizumab is approved in the United States for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits cytokine interleukin-23 by binding to its p19 subunit. IL-23 has been implicated in the development of PsA.

This was a phase 3 trial with “promising results in line with the ACR 20 response [at least 20% improvement in American College of Rheumatology response criteria] of other biologics in psoriatic arthritis,” according to Gaëlle Varkas, MD, PhD, of the Ghent (the Netherlands) University VIB Center for Inflammation Research and the department of rheumatology, Ghent University Hospital. “Especially in patients with severe and/or refractory skin disease or inadequate response at the level of the joint to other DMARDs or biologics, risankizumab is filling a void,” Dr. Varkas, who was not involved in the research, said in an interview.

There were no major safety problems, although long-term data, especially in regard to cancer and cardiovascular effects, “are always of interest, as they can be missed in randomized, controlled trials,” she said. In addition, “efficacy in concomitant axial disease, uveitis, and inflammatory bowel disease might favor one treatment over the other.” Another clinically significant takeaway was risankizumab’s “better effect on skin psoriasis while maintaining the effect on joint manifestations.”
 

Details of 24-week trial results

The phase 3, randomized, placebo-controlled, double-blind KEEPSAKE 2 trial involved 444 patients who had active PsA, defined as at least five swollen joints and at least five tender joints. All the patients either had an inadequate response to or were intolerant of one or two biologics or at least one conventional synthetic DMARD.

A total of 224 patients were randomly assigned to receive 150 mg of subcutaneous risankizumab at baseline and at 4 and 16 weeks after baseline; 220 participants received placebo injections. The primary endpoint was the proportion of patients who had at least 20% improvement in American College of Rheumatology response criteria at week 24.

Demographic and clinical characteristics were similar in both groups at baseline. Among the participants, the total mean number of swollen joints was 13.3, and the total mean number of tender joints was 22.6. The participants had PsA for an average of 8.2 years. The proportions of patients previously treated with biologics and DMARDs were similar in both groups, as were the proportions of patients currently taking glucocorticoids, NSAIDs, or methotrexate or another DMARD. At week 24, there remained 199 patients in the placebo group and 215 in the risankizumab group.

Just over half (51.3%) of patients who took risankizumab achieved at least 20% improvement in their ACR 20 score, compared with just over a quarter (26.5%) of those who received placebo (P < .001). All secondary endpoints also showed statistically significant improvements (P < .001 for all except P < .009 for the Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] secondary endpoint).

Scores on the Health Assessment Questionnaire–Disability Index were –0.22 in the risankizumab group and –0.05 in the placebo group (P < .001). In the risankizumab group, 55% of patients achieved at least a 90% reduction in scores on the Psoriasis Area Severity Index, compared with 10.2% of patients who received placebo. Similarly, 25.6% of patients who took risankizumab and 11.4% of patients who received placebo had minimal disease activity 24 weeks after baseline.



In the 36-item Short Form Health Survey Physical Component Summary, the score change among risankizumab patients was 5.9, compared with 2 among the patients who received placebo. The change in FACIT-Fatigue score was 4.9 for patients who took risankizumab and 2.6 for patients who received placebo.

The researchers also assessed how many patients achieved higher levels of response to treatment. At least a 50% improvement in ACR response criteria occurred among 26.3% of patients taking risankizumab and 9.3% of patients taking placebo (P < .001). ACR 70 responses were seen in 12% of patients receiving risankizumab, compared with 5.9% of patients receiving placebo (P < .02). In the risankizumab group, 72.5% of patients had resolution of dactylitis and 42.9% had resolution of enthesitis, compared with 42.1% and 30.4%, respectively, in the placebo group.

Serious adverse events occurred in 4% of patients who received risankizumab and 5.5% of patients who received placebo. Serious infections occurred in 0.9% of those receiving risankizumab and 2.3% of those receiving placebo. Rates of treatment-emergent adverse events were also similar in the risankizumab (55.4%) and placebo (54.8%) groups.

In response to a question about whether it was possible to identify patients who might respond better to IL-23 inhibitors, compared with IL-17 inhibitors, Dr. Ostor acknowledged that rheumatologic practice is not yet proficient at using biomarkers to direct therapy, so the benefit from these drugs lay elsewhere.

“What I think is great is the luxury of choice these days,” Dr. Ostor told attendees. “We have these agents now, including risankizumab, that do work very effectively across the spectrum of the clinical features. It’s just lovely to have these agents available that can truly make a difference to the clinical picture of the individual.”

The trial was sponsored by AbbVie. Dr. Ostor has received research grants or speaking or consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB. Dr. Varkas has received research grants or speaker fees from AbbVie and Pfizer.

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

 

Risankizumab (Skyrizi) was effective for treating psoriatic arthritis (PsA) in patients who did not respond to or who could not tolerate other biologics or standard disease-modifying antirheumatic drugs (DMARDs), according to a study presented at the annual European Congress of Rheumatology. It was also well tolerated.

“Treatment with risankizumab resulted in significantly greater improvements in signs and symptoms of psoriatic arthritis, including assessments of disease activity in joints and skin and patient-reported outcomes, compared with placebo, in patients who did not respond to or were intolerant to biologics or DMARDs,” reported Andrew Ostor, MD, of Monash University and Cabrini Hospital, both in Melbourne,. The safety profile was “consistent with that established for risankizumab in the treatment moderate to severe psoriasis,” he told attendees.

Risankizumab is approved in the United States for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits cytokine interleukin-23 by binding to its p19 subunit. IL-23 has been implicated in the development of PsA.

This was a phase 3 trial with “promising results in line with the ACR 20 response [at least 20% improvement in American College of Rheumatology response criteria] of other biologics in psoriatic arthritis,” according to Gaëlle Varkas, MD, PhD, of the Ghent (the Netherlands) University VIB Center for Inflammation Research and the department of rheumatology, Ghent University Hospital. “Especially in patients with severe and/or refractory skin disease or inadequate response at the level of the joint to other DMARDs or biologics, risankizumab is filling a void,” Dr. Varkas, who was not involved in the research, said in an interview.

There were no major safety problems, although long-term data, especially in regard to cancer and cardiovascular effects, “are always of interest, as they can be missed in randomized, controlled trials,” she said. In addition, “efficacy in concomitant axial disease, uveitis, and inflammatory bowel disease might favor one treatment over the other.” Another clinically significant takeaway was risankizumab’s “better effect on skin psoriasis while maintaining the effect on joint manifestations.”
 

Details of 24-week trial results

The phase 3, randomized, placebo-controlled, double-blind KEEPSAKE 2 trial involved 444 patients who had active PsA, defined as at least five swollen joints and at least five tender joints. All the patients either had an inadequate response to or were intolerant of one or two biologics or at least one conventional synthetic DMARD.

A total of 224 patients were randomly assigned to receive 150 mg of subcutaneous risankizumab at baseline and at 4 and 16 weeks after baseline; 220 participants received placebo injections. The primary endpoint was the proportion of patients who had at least 20% improvement in American College of Rheumatology response criteria at week 24.

Demographic and clinical characteristics were similar in both groups at baseline. Among the participants, the total mean number of swollen joints was 13.3, and the total mean number of tender joints was 22.6. The participants had PsA for an average of 8.2 years. The proportions of patients previously treated with biologics and DMARDs were similar in both groups, as were the proportions of patients currently taking glucocorticoids, NSAIDs, or methotrexate or another DMARD. At week 24, there remained 199 patients in the placebo group and 215 in the risankizumab group.

Just over half (51.3%) of patients who took risankizumab achieved at least 20% improvement in their ACR 20 score, compared with just over a quarter (26.5%) of those who received placebo (P < .001). All secondary endpoints also showed statistically significant improvements (P < .001 for all except P < .009 for the Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] secondary endpoint).

Scores on the Health Assessment Questionnaire–Disability Index were –0.22 in the risankizumab group and –0.05 in the placebo group (P < .001). In the risankizumab group, 55% of patients achieved at least a 90% reduction in scores on the Psoriasis Area Severity Index, compared with 10.2% of patients who received placebo. Similarly, 25.6% of patients who took risankizumab and 11.4% of patients who received placebo had minimal disease activity 24 weeks after baseline.



In the 36-item Short Form Health Survey Physical Component Summary, the score change among risankizumab patients was 5.9, compared with 2 among the patients who received placebo. The change in FACIT-Fatigue score was 4.9 for patients who took risankizumab and 2.6 for patients who received placebo.

The researchers also assessed how many patients achieved higher levels of response to treatment. At least a 50% improvement in ACR response criteria occurred among 26.3% of patients taking risankizumab and 9.3% of patients taking placebo (P < .001). ACR 70 responses were seen in 12% of patients receiving risankizumab, compared with 5.9% of patients receiving placebo (P < .02). In the risankizumab group, 72.5% of patients had resolution of dactylitis and 42.9% had resolution of enthesitis, compared with 42.1% and 30.4%, respectively, in the placebo group.

Serious adverse events occurred in 4% of patients who received risankizumab and 5.5% of patients who received placebo. Serious infections occurred in 0.9% of those receiving risankizumab and 2.3% of those receiving placebo. Rates of treatment-emergent adverse events were also similar in the risankizumab (55.4%) and placebo (54.8%) groups.

In response to a question about whether it was possible to identify patients who might respond better to IL-23 inhibitors, compared with IL-17 inhibitors, Dr. Ostor acknowledged that rheumatologic practice is not yet proficient at using biomarkers to direct therapy, so the benefit from these drugs lay elsewhere.

“What I think is great is the luxury of choice these days,” Dr. Ostor told attendees. “We have these agents now, including risankizumab, that do work very effectively across the spectrum of the clinical features. It’s just lovely to have these agents available that can truly make a difference to the clinical picture of the individual.”

The trial was sponsored by AbbVie. Dr. Ostor has received research grants or speaking or consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB. Dr. Varkas has received research grants or speaker fees from AbbVie and Pfizer.

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

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The Cures Act: Is the “cure” worse than the disease?

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Thu, 06/17/2021 - 11:03

 

Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

PxHere

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

 

 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at fpnews@mdedge.com.

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Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

PxHere

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

 

 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at fpnews@mdedge.com.

 

Imagine this scenario: You are seated at the dinner table with your family when your smartphone buzzes; you look over, and the push notification reads “new biopsy results!”

PxHere

There is a sudden spill of icy anxiety down your spine as you pick up your phone in your shaking hands. It’s 6 p.m.; your doctor’s office is closed. You open the message, and your worst fears are confirmed ... the cancer is back.

Or is it? You’re not sure. The biopsy sure sounds bad. But you’re an English teacher, not a doctor, and you spend the rest of the night Googling words like “tubulovillous” and “high-grade dysplasia.” You sit awake, terrified in front of the computer screen desperately trying to make sense of the possibly life-changing results. You wish you knew someone who could help you understand; you consider calling your doctor’s emergency line, or your cousin who is an ophthalmologist – anybody who can help you make sense of the results.

Or imagine another scenario: you’re a trans teen who has asked your doctor to refer to you by your preferred pronouns. You’re still presenting as your birth sex, in part because your family would disown you if they knew, and you’re not financially or emotionally ready for that step. You feel proud of yourself for advocating for your needs to your long-time physician, and excited about the resources they’ve included in your after visit summary and the referrals they’d made to gender-confirming specialists.

When you get home, you are confronted with a terrible reality that your doctor’s notes, orders, and recommendations are immediately viewable to anybody with your MyChart login – your parents knew the second your doctor signed the note. They received the notification, logged on as your guardians, and you have effectively been “outed” by the physician who took and oath to care for you and who you trusted implicitly.
 

How the Cures Act is affecting patients

While these examples may sound extreme, they are becoming more and more commonplace thanks to a recently enacted 21st Century Cures Act. The act was originally written to improve communication between physicians and patients. Part of the act stipulates that nearly all medical information – from notes to biopsies to lab results – must be available within 24 hours, published to a patient portal and a notification be sent to the patient by phone.

Oftentimes, this occurs before the ordering physician has even seen the results, much less interpreted them and made a plan for the patient. What happens now, not long after its enactment date, when it has become clear that the Cures Act is causing extreme harm to our patients?

Take, for example, the real example of a physician whose patient found out about her own intrauterine fetal demise by way of an EMR text message alert of “new imaging results!” sent directly to her phone. Or a physician colleague who witnessed firsthand the intrusive unhelpfulness of the Cures Act when she was informed via patient portal releasing her imaging information that she had a large, possibly malignant breast mass. “No phone call,” she said. “No human being for questions or comfort. Just a notification on my phone.”

The stories about the impact of the Cures Act across the medical community are an endless stream of anxiety, hurt, and broken trust. The relationship between a physician and a patient should be sacred, bolstered by communication and mutual respect.

In many ways, the new act feels like a third party to the patient-physician relationship – a digital imposter, oftentimes blurting out personal and life-altering medical information without any of the finesse, context, and perspective of an experienced physician.
 

 

 

Breaking ‘bad news’ to a patient

In training, some residents are taught how to “break bad news” to a patient. Some good practices for doing this are to have information available for the patient, provide emotional support, have a plan for their next steps already formulated, and call the appropriate specialist ahead of time if you can.

Above all, it’s most important to let the patient be the one to direct their own care. Give them time to ask questions and answer them honestly and clearly. Ask them how much they want to know and help them to understand the complex change in their usual state of health.

Now, unless physicians are keeping a very close eye on their inbox, results are slipping out to patients in a void. The bad news conversations aren’t happening at all, or if they are, they’re happening at 8 p.m. on a phone call after an exhausted physician ends their shift but has to slog through their results bin, calling all the patients who shouldn’t have to find out their results in solitude.

Reaching out to these patients immediately is an honorable, kind thing to, but for a physician, knowing they need to beat the patient to opening an email creates anxiety. Plus, making these calls at whatever hour the results are released to a patient is another burden added to doctors’ already-full plates.
 

Interpreting results

None of us want to harm our patients. All of us want to be there for them. But this act stands in the way of delivering quality, humanizing medical care.

It is true that patients have a right to access their own medical information. It is also true that waiting anxiously on results can cause undue harm to a patient. But the across-the-board, breakneck speed of information release mandated in this act causes irreparable harm not only to patients, but to the patient-physician relationship.

No patient should find out their cancer recurred while checking their emails at their desk. No patient should first learn of a life-altering diagnosis by way of scrolling through their smartphone in bed. The role of a physician is more than just a healer – we should also be educators, interpreters, partners and, first and foremost, advocates for our patients’ needs.

Our patients are depending on us to stand up and speak out about necessary changes to this act. Result releases should be delayed until they are viewed by a physician. Our patients deserve the dignity and opportunity of a conversation with their medical provider about their test results, and physicians deserve the chance to interpret results and frame the conversation in a way which is conducive to patient understanding and healing.

Dr. Persampiere is a first-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece. You can contact them at fpnews@mdedge.com.

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Pyoderma gangrenosum: Understanding the difficult diagnosis

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Tue, 06/15/2021 - 10:01

Pyoderma gangrenosum (PG), a rare and painful ulcerative skin disorder, requires special care because “it’s a challenging diagnosis to make” and is frequently linked to serious comorbid conditions, a dermatologist told colleagues.

PG is also challenging to manage, said Jeffrey Callen, MD, professor and chief of the division of dermatology at the University of Louisville (Ky.), who spoke at the Inaugural Symposium for Inflammatory Skin Disease. “There are multiple treatments, but few have a high level of evidence to document their efficacy.”

PG is a neutrophilic dermatosis that usually occurs with a small lesion, often pustular, that spreads, and is a diagnosis of exclusion. “There’s no way you can possibly exclude everything, but the major things that have to be excluded are infection and malignancies,” he said. “Doing a good history and physical examination is critical, and a biopsy should be done in the vast majority of patients.”

Cultures and routine labs should be obtained, said Dr. Callen, highlighting tests that measure immunofixation (IFE), antineutrophil cytoplasmic antibodies (ANCE), anticardiolipin antibody (aCL), and lupus anticoagulant (LA).

Bowel and bone marrow tests may be appropriate in some patients, he said, noting that about half of PG cases are linked to comorbid conditions such as inflammatory bowel disease (IBD), arthritis, and hematologic diseases.



Dr. Callen also made the following points about making the diagnosis:

  • Several clinical variants exist: classic, peristomal, and atypical.
  • Pathergy – hyperreactivity of skin to injury – occurs in about a third of patients.
  • Neutrophilic infiltrates may occur in other organs.
  • Numerous drugs, including isotretinoin, can cause PG.
  • PG may be misdiagnosed as necrotizing fasciitis.
  • Several diagnostic frameworks exist: the Su Criteria, the PARACELCUS Score, and the Delphi Consensus Criteria. The Delphi criteria identified the highest percentage of cases (89%) in a study comparing the three, published in 2020. The frameworks “are helpful in the clinic, but they are not to be used as criteria for diagnosis. They’re really for classification,” Dr. Callen said.

Once the diagnosis has been made, he said, focus on healing the wound, which he said “can be done as any other wound would be healed,” and calming the inflammation.

“Patients who have mild disease might be treated with lower doses of prednisone, topical medications, or intralesional injections,” he said. “Corticosteroids are never wrong in the beginning.” Some patients may have genetic abnormalities related to PG, he added, and medications that target them may be appropriate.

Antibiotics and biologic agents, particularly TNF-alpha inhibitors, are possible treatments, Dr. Callen said. He highlighted a 2018 systematic review that evaluated treatments and found the most evidence supported systemic corticosteroids, cyclosporine, and TNF-alpha inhibitors. However, the quality of studies was limited, and the authors noted that the lesions frequently failed to respond or recurred.

When appropriate, surgery can be performed, he said.

Dr. Callen reported no relevant disclosures.

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Pyoderma gangrenosum (PG), a rare and painful ulcerative skin disorder, requires special care because “it’s a challenging diagnosis to make” and is frequently linked to serious comorbid conditions, a dermatologist told colleagues.

PG is also challenging to manage, said Jeffrey Callen, MD, professor and chief of the division of dermatology at the University of Louisville (Ky.), who spoke at the Inaugural Symposium for Inflammatory Skin Disease. “There are multiple treatments, but few have a high level of evidence to document their efficacy.”

PG is a neutrophilic dermatosis that usually occurs with a small lesion, often pustular, that spreads, and is a diagnosis of exclusion. “There’s no way you can possibly exclude everything, but the major things that have to be excluded are infection and malignancies,” he said. “Doing a good history and physical examination is critical, and a biopsy should be done in the vast majority of patients.”

Cultures and routine labs should be obtained, said Dr. Callen, highlighting tests that measure immunofixation (IFE), antineutrophil cytoplasmic antibodies (ANCE), anticardiolipin antibody (aCL), and lupus anticoagulant (LA).

Bowel and bone marrow tests may be appropriate in some patients, he said, noting that about half of PG cases are linked to comorbid conditions such as inflammatory bowel disease (IBD), arthritis, and hematologic diseases.



Dr. Callen also made the following points about making the diagnosis:

  • Several clinical variants exist: classic, peristomal, and atypical.
  • Pathergy – hyperreactivity of skin to injury – occurs in about a third of patients.
  • Neutrophilic infiltrates may occur in other organs.
  • Numerous drugs, including isotretinoin, can cause PG.
  • PG may be misdiagnosed as necrotizing fasciitis.
  • Several diagnostic frameworks exist: the Su Criteria, the PARACELCUS Score, and the Delphi Consensus Criteria. The Delphi criteria identified the highest percentage of cases (89%) in a study comparing the three, published in 2020. The frameworks “are helpful in the clinic, but they are not to be used as criteria for diagnosis. They’re really for classification,” Dr. Callen said.

Once the diagnosis has been made, he said, focus on healing the wound, which he said “can be done as any other wound would be healed,” and calming the inflammation.

“Patients who have mild disease might be treated with lower doses of prednisone, topical medications, or intralesional injections,” he said. “Corticosteroids are never wrong in the beginning.” Some patients may have genetic abnormalities related to PG, he added, and medications that target them may be appropriate.

Antibiotics and biologic agents, particularly TNF-alpha inhibitors, are possible treatments, Dr. Callen said. He highlighted a 2018 systematic review that evaluated treatments and found the most evidence supported systemic corticosteroids, cyclosporine, and TNF-alpha inhibitors. However, the quality of studies was limited, and the authors noted that the lesions frequently failed to respond or recurred.

When appropriate, surgery can be performed, he said.

Dr. Callen reported no relevant disclosures.

Pyoderma gangrenosum (PG), a rare and painful ulcerative skin disorder, requires special care because “it’s a challenging diagnosis to make” and is frequently linked to serious comorbid conditions, a dermatologist told colleagues.

PG is also challenging to manage, said Jeffrey Callen, MD, professor and chief of the division of dermatology at the University of Louisville (Ky.), who spoke at the Inaugural Symposium for Inflammatory Skin Disease. “There are multiple treatments, but few have a high level of evidence to document their efficacy.”

PG is a neutrophilic dermatosis that usually occurs with a small lesion, often pustular, that spreads, and is a diagnosis of exclusion. “There’s no way you can possibly exclude everything, but the major things that have to be excluded are infection and malignancies,” he said. “Doing a good history and physical examination is critical, and a biopsy should be done in the vast majority of patients.”

Cultures and routine labs should be obtained, said Dr. Callen, highlighting tests that measure immunofixation (IFE), antineutrophil cytoplasmic antibodies (ANCE), anticardiolipin antibody (aCL), and lupus anticoagulant (LA).

Bowel and bone marrow tests may be appropriate in some patients, he said, noting that about half of PG cases are linked to comorbid conditions such as inflammatory bowel disease (IBD), arthritis, and hematologic diseases.



Dr. Callen also made the following points about making the diagnosis:

  • Several clinical variants exist: classic, peristomal, and atypical.
  • Pathergy – hyperreactivity of skin to injury – occurs in about a third of patients.
  • Neutrophilic infiltrates may occur in other organs.
  • Numerous drugs, including isotretinoin, can cause PG.
  • PG may be misdiagnosed as necrotizing fasciitis.
  • Several diagnostic frameworks exist: the Su Criteria, the PARACELCUS Score, and the Delphi Consensus Criteria. The Delphi criteria identified the highest percentage of cases (89%) in a study comparing the three, published in 2020. The frameworks “are helpful in the clinic, but they are not to be used as criteria for diagnosis. They’re really for classification,” Dr. Callen said.

Once the diagnosis has been made, he said, focus on healing the wound, which he said “can be done as any other wound would be healed,” and calming the inflammation.

“Patients who have mild disease might be treated with lower doses of prednisone, topical medications, or intralesional injections,” he said. “Corticosteroids are never wrong in the beginning.” Some patients may have genetic abnormalities related to PG, he added, and medications that target them may be appropriate.

Antibiotics and biologic agents, particularly TNF-alpha inhibitors, are possible treatments, Dr. Callen said. He highlighted a 2018 systematic review that evaluated treatments and found the most evidence supported systemic corticosteroids, cyclosporine, and TNF-alpha inhibitors. However, the quality of studies was limited, and the authors noted that the lesions frequently failed to respond or recurred.

When appropriate, surgery can be performed, he said.

Dr. Callen reported no relevant disclosures.

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Expert offers 10 ‘tips and tricks’ for everyday cosmetic practice

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During the annual conference of the American Society for Laser Medicine and Surgery, H. Ray Jalian, MD, shared his “top 10” tips and tricks for everyday cosmetic practice, based on nearly 10 years of experience treating patients on both coasts of the United States.

Dr. H. Ray Jalian

They are as follows:

1. Know your clinical endpoints. “One of the things that was drilled into me during my fellowship in lasers and cosmetics at Mass General was to know your clinical endpoints and to avoid a cookbook approach,” said Dr. Jalian, who practices dermatology in Los Angeles. “You should treat based on the pathology that you’re seeing on the skin and let the endpoints be your guide. The skin will tell you what you’re doing right, and the skin will tell you what you’re doing wrong. Picking up on these cues will allow you to deliver a safe and effective treatment to your patients.”

The selection of proper treatment parameters is driven by selective photothermolysis, a microsurgery technique that uses customized wavelengths, pulse durations, and fluences to target a chromophore. “Knowing the size and shape of your target allows you to pick the right pulse duration,” he said. “This is dictated by thermal relaxation time, which is proportional to the size and shape of the target. Smaller targets require a shorter pulse width, while larger targets require a longer pulse width.”

2. Do not perform a procedure for which you cannot recognize and treat the side effects. “I can’t tell you how many times I’ve gotten referrals from outside providers with a side effect that, if it had been recognized and treated, would have been inconsequential long-term for the patient,” Dr. Jalian said. “You can only avoid complications by not firing the laser. The more you practice, the more complications you’re going to have. This is inevitable, but good practice and common sense can reduce complications significantly.”



Even the most skilled clinicians encounter side effects from time to time. “The most important thing is to form a network of physicians you trust that you can call or text when you need help in managing a particular complication,” he continued. “This happens to all of us,” he said. Don’t be afraid to phone a colleague, he advised, “and get a fresh set of eyes because oftentimes they can provide insights, especially when you’re having tunnel vision during a complication, that can ultimately result in better patient care.”

3. Don’t forget your clinical training. “Trust your clinical judgment,” Dr. Jalian said. “If something doesn’t seem right, even if it was a case referred to you by experienced practitioners, you are a clinician first and foremost, and you are allowed to make a clinical judgment on lesions.” He referred to a 2011 report in which the authors described a series of four cases where patients presented for cosmetic evaluation of vascular lesions that turned out to be more significant pathologic disease. “Trust your clinical insight because this will serve you in the long term,” he said.

4. Set realistic expectations. Patients with unrealistically high expectations are likely to express dissatisfaction with their treatment results, “no matter how good of a job you do,” Dr. Jalian said. “In addition to safely treating the patient, we strive for patient satisfaction, because with these elective procedures we’re trying to give a patient a result they’re looking for. But our No. 1 job is also to be realistic about the results we can obtain. If someone comes in wanting treatment with a skin-tightening device but clearly needs a face-lift because they have too much laxity, your job is to tell them that this is not the appropriate device for them. Learn the art of saying no. If handled correctly, the patient will often thank you before she heads out the door. Ultimately, honesty is the best policy. I may say something like, ‘I’m not telling you the answer you want to hear, I’m telling you the truth.’ That often goes over well.”

5. Use proper anesthesia. Patients come to you for results, but they’re also likely to remember how well you controlled their pain during procedures. Strategies favored by Dr. Jalian include applying extra topical anesthetic to “hot spots” and splitting up treatment sessions when tackling a large area. “Consider using adjunctive analgesics such as oral medications and nitrous oxide,” he added. Other options, he said, are cooling techniques and distraction techniques, such as the use of a stress ball, consideration of the gate control theory of pain, and “talkesthesia”(using conversation to distract the patient).

6. Obtain proper informed consent. A lack of informed consent ranks as a common reason why doctors get sued. “This happens when a physician fails to inform the patient of all medically reasonable alternatives and their risks, even for noninvasive procedures prior to administering treatment,” Dr. Jalian said. “All patients have the right to an informed consent prior to any treatment. It doesn’t necessarily have to be in a written form, but it’s important to at least have a discussion and document it for all procedures, including medical and cosmetic procedures and oral and topical treatments. Keep it simple. A written consent is ineffective if the patient does not understand material about the procedure.” Avoid the use of excessive medical terms. For example, use bruising instead of purpura, redness instead of erythema, and drooping instead of ptosis.

7. Lower the laser treatment density for darker skin types. According to Dr. Jalian, several clinical studies have demonstrated that lower densities are associated with less postinflammatory hyperpigmentation in Asian and Black patients, without sacrificing clinical outcomes. “Density determines how ‘aggressive’ a treatment is,” he said. “The greater the density, the more downtime is required.”

8. Have a vascular occlusion emergency kit on hand. At a minimum, the kit should contain at least 1,500 units of hyaluronidase, aspirin, timolol/acetazolamide, a Snellen chart, steroids, and an EpiPen.

9. Use standardized photography. Even the slightest change in lighting can manipulate your results. According to Dr. Jalian, standardized photos enable you to monitor patient progress, minimize liability, and can serve as a marketing tool “so that you can capitalize on your talent.”

10. Consider combination treatments. He combines lasers based on target and depth. For example, prior to resurfacing he often performs a pass or two with a color laser such as intense pulsed light. “Depending on what’s being done, we’ll do soft-tissue augmentation before or after treatment with certain lasers,” Dr. Jalian added. “If you’re performing a toxin treatment on the same day as a laser procedure, do not treat the lower face or neck. Do the laser procedure first and limit that to the upper third of the face.”

He reported having no relevant financial disclosures.

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During the annual conference of the American Society for Laser Medicine and Surgery, H. Ray Jalian, MD, shared his “top 10” tips and tricks for everyday cosmetic practice, based on nearly 10 years of experience treating patients on both coasts of the United States.

Dr. H. Ray Jalian

They are as follows:

1. Know your clinical endpoints. “One of the things that was drilled into me during my fellowship in lasers and cosmetics at Mass General was to know your clinical endpoints and to avoid a cookbook approach,” said Dr. Jalian, who practices dermatology in Los Angeles. “You should treat based on the pathology that you’re seeing on the skin and let the endpoints be your guide. The skin will tell you what you’re doing right, and the skin will tell you what you’re doing wrong. Picking up on these cues will allow you to deliver a safe and effective treatment to your patients.”

The selection of proper treatment parameters is driven by selective photothermolysis, a microsurgery technique that uses customized wavelengths, pulse durations, and fluences to target a chromophore. “Knowing the size and shape of your target allows you to pick the right pulse duration,” he said. “This is dictated by thermal relaxation time, which is proportional to the size and shape of the target. Smaller targets require a shorter pulse width, while larger targets require a longer pulse width.”

2. Do not perform a procedure for which you cannot recognize and treat the side effects. “I can’t tell you how many times I’ve gotten referrals from outside providers with a side effect that, if it had been recognized and treated, would have been inconsequential long-term for the patient,” Dr. Jalian said. “You can only avoid complications by not firing the laser. The more you practice, the more complications you’re going to have. This is inevitable, but good practice and common sense can reduce complications significantly.”



Even the most skilled clinicians encounter side effects from time to time. “The most important thing is to form a network of physicians you trust that you can call or text when you need help in managing a particular complication,” he continued. “This happens to all of us,” he said. Don’t be afraid to phone a colleague, he advised, “and get a fresh set of eyes because oftentimes they can provide insights, especially when you’re having tunnel vision during a complication, that can ultimately result in better patient care.”

3. Don’t forget your clinical training. “Trust your clinical judgment,” Dr. Jalian said. “If something doesn’t seem right, even if it was a case referred to you by experienced practitioners, you are a clinician first and foremost, and you are allowed to make a clinical judgment on lesions.” He referred to a 2011 report in which the authors described a series of four cases where patients presented for cosmetic evaluation of vascular lesions that turned out to be more significant pathologic disease. “Trust your clinical insight because this will serve you in the long term,” he said.

4. Set realistic expectations. Patients with unrealistically high expectations are likely to express dissatisfaction with their treatment results, “no matter how good of a job you do,” Dr. Jalian said. “In addition to safely treating the patient, we strive for patient satisfaction, because with these elective procedures we’re trying to give a patient a result they’re looking for. But our No. 1 job is also to be realistic about the results we can obtain. If someone comes in wanting treatment with a skin-tightening device but clearly needs a face-lift because they have too much laxity, your job is to tell them that this is not the appropriate device for them. Learn the art of saying no. If handled correctly, the patient will often thank you before she heads out the door. Ultimately, honesty is the best policy. I may say something like, ‘I’m not telling you the answer you want to hear, I’m telling you the truth.’ That often goes over well.”

5. Use proper anesthesia. Patients come to you for results, but they’re also likely to remember how well you controlled their pain during procedures. Strategies favored by Dr. Jalian include applying extra topical anesthetic to “hot spots” and splitting up treatment sessions when tackling a large area. “Consider using adjunctive analgesics such as oral medications and nitrous oxide,” he added. Other options, he said, are cooling techniques and distraction techniques, such as the use of a stress ball, consideration of the gate control theory of pain, and “talkesthesia”(using conversation to distract the patient).

6. Obtain proper informed consent. A lack of informed consent ranks as a common reason why doctors get sued. “This happens when a physician fails to inform the patient of all medically reasonable alternatives and their risks, even for noninvasive procedures prior to administering treatment,” Dr. Jalian said. “All patients have the right to an informed consent prior to any treatment. It doesn’t necessarily have to be in a written form, but it’s important to at least have a discussion and document it for all procedures, including medical and cosmetic procedures and oral and topical treatments. Keep it simple. A written consent is ineffective if the patient does not understand material about the procedure.” Avoid the use of excessive medical terms. For example, use bruising instead of purpura, redness instead of erythema, and drooping instead of ptosis.

7. Lower the laser treatment density for darker skin types. According to Dr. Jalian, several clinical studies have demonstrated that lower densities are associated with less postinflammatory hyperpigmentation in Asian and Black patients, without sacrificing clinical outcomes. “Density determines how ‘aggressive’ a treatment is,” he said. “The greater the density, the more downtime is required.”

8. Have a vascular occlusion emergency kit on hand. At a minimum, the kit should contain at least 1,500 units of hyaluronidase, aspirin, timolol/acetazolamide, a Snellen chart, steroids, and an EpiPen.

9. Use standardized photography. Even the slightest change in lighting can manipulate your results. According to Dr. Jalian, standardized photos enable you to monitor patient progress, minimize liability, and can serve as a marketing tool “so that you can capitalize on your talent.”

10. Consider combination treatments. He combines lasers based on target and depth. For example, prior to resurfacing he often performs a pass or two with a color laser such as intense pulsed light. “Depending on what’s being done, we’ll do soft-tissue augmentation before or after treatment with certain lasers,” Dr. Jalian added. “If you’re performing a toxin treatment on the same day as a laser procedure, do not treat the lower face or neck. Do the laser procedure first and limit that to the upper third of the face.”

He reported having no relevant financial disclosures.

During the annual conference of the American Society for Laser Medicine and Surgery, H. Ray Jalian, MD, shared his “top 10” tips and tricks for everyday cosmetic practice, based on nearly 10 years of experience treating patients on both coasts of the United States.

Dr. H. Ray Jalian

They are as follows:

1. Know your clinical endpoints. “One of the things that was drilled into me during my fellowship in lasers and cosmetics at Mass General was to know your clinical endpoints and to avoid a cookbook approach,” said Dr. Jalian, who practices dermatology in Los Angeles. “You should treat based on the pathology that you’re seeing on the skin and let the endpoints be your guide. The skin will tell you what you’re doing right, and the skin will tell you what you’re doing wrong. Picking up on these cues will allow you to deliver a safe and effective treatment to your patients.”

The selection of proper treatment parameters is driven by selective photothermolysis, a microsurgery technique that uses customized wavelengths, pulse durations, and fluences to target a chromophore. “Knowing the size and shape of your target allows you to pick the right pulse duration,” he said. “This is dictated by thermal relaxation time, which is proportional to the size and shape of the target. Smaller targets require a shorter pulse width, while larger targets require a longer pulse width.”

2. Do not perform a procedure for which you cannot recognize and treat the side effects. “I can’t tell you how many times I’ve gotten referrals from outside providers with a side effect that, if it had been recognized and treated, would have been inconsequential long-term for the patient,” Dr. Jalian said. “You can only avoid complications by not firing the laser. The more you practice, the more complications you’re going to have. This is inevitable, but good practice and common sense can reduce complications significantly.”



Even the most skilled clinicians encounter side effects from time to time. “The most important thing is to form a network of physicians you trust that you can call or text when you need help in managing a particular complication,” he continued. “This happens to all of us,” he said. Don’t be afraid to phone a colleague, he advised, “and get a fresh set of eyes because oftentimes they can provide insights, especially when you’re having tunnel vision during a complication, that can ultimately result in better patient care.”

3. Don’t forget your clinical training. “Trust your clinical judgment,” Dr. Jalian said. “If something doesn’t seem right, even if it was a case referred to you by experienced practitioners, you are a clinician first and foremost, and you are allowed to make a clinical judgment on lesions.” He referred to a 2011 report in which the authors described a series of four cases where patients presented for cosmetic evaluation of vascular lesions that turned out to be more significant pathologic disease. “Trust your clinical insight because this will serve you in the long term,” he said.

4. Set realistic expectations. Patients with unrealistically high expectations are likely to express dissatisfaction with their treatment results, “no matter how good of a job you do,” Dr. Jalian said. “In addition to safely treating the patient, we strive for patient satisfaction, because with these elective procedures we’re trying to give a patient a result they’re looking for. But our No. 1 job is also to be realistic about the results we can obtain. If someone comes in wanting treatment with a skin-tightening device but clearly needs a face-lift because they have too much laxity, your job is to tell them that this is not the appropriate device for them. Learn the art of saying no. If handled correctly, the patient will often thank you before she heads out the door. Ultimately, honesty is the best policy. I may say something like, ‘I’m not telling you the answer you want to hear, I’m telling you the truth.’ That often goes over well.”

5. Use proper anesthesia. Patients come to you for results, but they’re also likely to remember how well you controlled their pain during procedures. Strategies favored by Dr. Jalian include applying extra topical anesthetic to “hot spots” and splitting up treatment sessions when tackling a large area. “Consider using adjunctive analgesics such as oral medications and nitrous oxide,” he added. Other options, he said, are cooling techniques and distraction techniques, such as the use of a stress ball, consideration of the gate control theory of pain, and “talkesthesia”(using conversation to distract the patient).

6. Obtain proper informed consent. A lack of informed consent ranks as a common reason why doctors get sued. “This happens when a physician fails to inform the patient of all medically reasonable alternatives and their risks, even for noninvasive procedures prior to administering treatment,” Dr. Jalian said. “All patients have the right to an informed consent prior to any treatment. It doesn’t necessarily have to be in a written form, but it’s important to at least have a discussion and document it for all procedures, including medical and cosmetic procedures and oral and topical treatments. Keep it simple. A written consent is ineffective if the patient does not understand material about the procedure.” Avoid the use of excessive medical terms. For example, use bruising instead of purpura, redness instead of erythema, and drooping instead of ptosis.

7. Lower the laser treatment density for darker skin types. According to Dr. Jalian, several clinical studies have demonstrated that lower densities are associated with less postinflammatory hyperpigmentation in Asian and Black patients, without sacrificing clinical outcomes. “Density determines how ‘aggressive’ a treatment is,” he said. “The greater the density, the more downtime is required.”

8. Have a vascular occlusion emergency kit on hand. At a minimum, the kit should contain at least 1,500 units of hyaluronidase, aspirin, timolol/acetazolamide, a Snellen chart, steroids, and an EpiPen.

9. Use standardized photography. Even the slightest change in lighting can manipulate your results. According to Dr. Jalian, standardized photos enable you to monitor patient progress, minimize liability, and can serve as a marketing tool “so that you can capitalize on your talent.”

10. Consider combination treatments. He combines lasers based on target and depth. For example, prior to resurfacing he often performs a pass or two with a color laser such as intense pulsed light. “Depending on what’s being done, we’ll do soft-tissue augmentation before or after treatment with certain lasers,” Dr. Jalian added. “If you’re performing a toxin treatment on the same day as a laser procedure, do not treat the lower face or neck. Do the laser procedure first and limit that to the upper third of the face.”

He reported having no relevant financial disclosures.

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