After a patient’s face was burned in the outline of a mask worn during a 3-Tesla MRI neck scan, the US Food and Drug Administration (FDA) cautioned that face masks containing metal can heat to unsafe temperatures during scanning.

Clinicians have known for years to ask patients to remove all metal jewelry and other objects prior to an MRI. The widespread wearing of face masks during the COVID-19 pandemic, however, adds one more consideration to the list.

The FDA’s December 7 safety communication applies to surgical and nonsurgical face masks and respirators.

The injury risk relates to rapid heating of metal components. Many face masks contain a nose wire or metal clip that helps the product conform to the face. Some masks contain metal nanoparticles, while others feature antimicrobial coatings with silver or copper. Each of these products should be avoided during MRI scanning. Also watch out for staples on headbands, the FDA warned.

If the metal content of a face mask is unknown, the FDA suggests providing the patient with a facial covering that is known not to contain any metal.

Robert E. Watson Jr, MD, PhD, chair of the American College of Radiology (ACR) Committee on MR Safety, agreed. He recommended that facilities “provide patients with masks known to be MRI-safe and not permit patient-owned masks in the MRI.”

Watson suggested this strategy at a time when face masks are required.

“COVID-19 safety protocols require that patients wear masks when being scanned, to decrease infection risk to MRI staff, decrease risk of contaminating the MRI scanner, and to protect themselves from infection,” he told Medscape Medical News. “Any conducting metal that enters the MRI machine is at risk of heating due to the radiofrequency fields inherent to image generation.”

Adverse events related to the metal components of a face mask should be reported to the FDA using the MedWatch voluntary reporting form. In addition, healthcare providers subject to the FDA user facility reporting requirements should follow procedures at their facilities to report such events.

This article first appeared on Medscape.com.

After a patient’s face was burned in the outline of a mask worn during a 3-Tesla MRI neck scan, the US Food and Drug Administration (FDA) cautioned that face masks containing metal can heat to unsafe temperatures during scanning.

Clinicians have known for years to ask patients to remove all metal jewelry and other objects prior to an MRI. The widespread wearing of face masks during the COVID-19 pandemic, however, adds one more consideration to the list.

The FDA’s December 7 safety communication applies to surgical and nonsurgical face masks and respirators.

The injury risk relates to rapid heating of metal components. Many face masks contain a nose wire or metal clip that helps the product conform to the face. Some masks contain metal nanoparticles, while others feature antimicrobial coatings with silver or copper. Each of these products should be avoided during MRI scanning. Also watch out for staples on headbands, the FDA warned.

If the metal content of a face mask is unknown, the FDA suggests providing the patient with a facial covering that is known not to contain any metal.

Robert E. Watson Jr, MD, PhD, chair of the American College of Radiology (ACR) Committee on MR Safety, agreed. He recommended that facilities “provide patients with masks known to be MRI-safe and not permit patient-owned masks in the MRI.”

Watson suggested this strategy at a time when face masks are required.

“COVID-19 safety protocols require that patients wear masks when being scanned, to decrease infection risk to MRI staff, decrease risk of contaminating the MRI scanner, and to protect themselves from infection,” he told Medscape Medical News. “Any conducting metal that enters the MRI machine is at risk of heating due to the radiofrequency fields inherent to image generation.”

Adverse events related to the metal components of a face mask should be reported to the FDA using the MedWatch voluntary reporting form. In addition, healthcare providers subject to the FDA user facility reporting requirements should follow procedures at their facilities to report such events.

This article first appeared on Medscape.com.

After a patient’s face was burned in the outline of a mask worn during a 3-Tesla MRI neck scan, the US Food and Drug Administration (FDA) cautioned that face masks containing metal can heat to unsafe temperatures during scanning.

Clinicians have known for years to ask patients to remove all metal jewelry and other objects prior to an MRI. The widespread wearing of face masks during the COVID-19 pandemic, however, adds one more consideration to the list.

The FDA’s December 7 safety communication applies to surgical and nonsurgical face masks and respirators.

The injury risk relates to rapid heating of metal components. Many face masks contain a nose wire or metal clip that helps the product conform to the face. Some masks contain metal nanoparticles, while others feature antimicrobial coatings with silver or copper. Each of these products should be avoided during MRI scanning. Also watch out for staples on headbands, the FDA warned.

If the metal content of a face mask is unknown, the FDA suggests providing the patient with a facial covering that is known not to contain any metal.

Robert E. Watson Jr, MD, PhD, chair of the American College of Radiology (ACR) Committee on MR Safety, agreed. He recommended that facilities “provide patients with masks known to be MRI-safe and not permit patient-owned masks in the MRI.”

Watson suggested this strategy at a time when face masks are required.

“COVID-19 safety protocols require that patients wear masks when being scanned, to decrease infection risk to MRI staff, decrease risk of contaminating the MRI scanner, and to protect themselves from infection,” he told Medscape Medical News. “Any conducting metal that enters the MRI machine is at risk of heating due to the radiofrequency fields inherent to image generation.”

Adverse events related to the metal components of a face mask should be reported to the FDA using the MedWatch voluntary reporting form. In addition, healthcare providers subject to the FDA user facility reporting requirements should follow procedures at their facilities to report such events.

This article first appeared on Medscape.com.

The widespread use of biologics extended life expectancy but also increased medical costs for adults with RA, based on insurance claims data from nearly 30,000 cases.

“With the advancement of treatment in recent decades, the mortality seems to decrease, while medical expenditures increase,” but previous studies estimating the life-years lost because of RA have shown large variations in results, wrote Ying-Ming Chiu, MD, PhD, of China Medical University, Taichung, Taiwan, and colleagues.

“Estimating long-term or lifetime costs could provide an overall figure of the future impact on the health care system after disease occurrence, and would be useful for cost-effectiveness analysis,” they added.

In a study published in Arthritis & Rheumatology, the researchers identified 29,352 new cases of RA in Taiwan between 2003 and 2016, after the introduction of biologics in Taiwan in 2003. They estimate survival using an algorithm with matched controls and used the survival rates to calculate monthly and lifetime health care expenses.

Overall, the average estimated life expectancy after a diagnosis of RA was 26.3 years, and the average lifetime cost was $72,953 (USD). The average life expectancy was 23.4 years for women and 21.6 years for men. The average lifetime cost was higher for women than for men ($73,112 vs. $63,557), but the annual costs were similar for women and men ($3,123 vs. $2,942). However, “the older the age of diagnosis of RA, the higher the average annual cost for treating RA,” regardless of gender, the researchers noted.

Despite the reduced mortality during the study period, the researchers also identified some loss of life expectancy among RA patients, compared with the general population. The average loss of life expectancy was nearly 5 years during the 14-year study period. The loss of life expectancy ranged from 2 to 13 years (average 9.7 years) for women with RA and from 2 to 8 years (average 4.1 years) for men with RA, compared with those without RA after controlling for age, gender, and year of diagnosis.

The study findings were limited by several factors including the lack of data on quality of life and functional disability, possible underestimation of life expectancy because of delayed RA diagnosis, and limited accuracy on follow-up of younger patients, the researchers noted.

However, the results support evidence from previous studies of an overall increase in life expectancy after the introduction of biologics, with increased expenses that should be monitored for cost-effectiveness, they concluded. More research is needed to determine the effect of biologics on functional disability, quality of life, and cost-effectiveness in a way that also incorporates productivity loss and the need for social services such as long-term care in order to inform decision-making for RA treatment.

The study was supported by the Ministry of Science and Technology, Taiwan, and China Medical University Hospital. The researchers had no financial conflicts to disclose.

SOURCE: Chiu Y-M et al. Arthritis Rheumatol. 2020 Dec 8. doi: 10.1002/ART.41597.

The widespread use of biologics extended life expectancy but also increased medical costs for adults with RA, based on insurance claims data from nearly 30,000 cases.

“With the advancement of treatment in recent decades, the mortality seems to decrease, while medical expenditures increase,” but previous studies estimating the life-years lost because of RA have shown large variations in results, wrote Ying-Ming Chiu, MD, PhD, of China Medical University, Taichung, Taiwan, and colleagues.

“Estimating long-term or lifetime costs could provide an overall figure of the future impact on the health care system after disease occurrence, and would be useful for cost-effectiveness analysis,” they added.

In a study published in Arthritis & Rheumatology, the researchers identified 29,352 new cases of RA in Taiwan between 2003 and 2016, after the introduction of biologics in Taiwan in 2003. They estimate survival using an algorithm with matched controls and used the survival rates to calculate monthly and lifetime health care expenses.

Overall, the average estimated life expectancy after a diagnosis of RA was 26.3 years, and the average lifetime cost was $72,953 (USD). The average life expectancy was 23.4 years for women and 21.6 years for men. The average lifetime cost was higher for women than for men ($73,112 vs. $63,557), but the annual costs were similar for women and men ($3,123 vs. $2,942). However, “the older the age of diagnosis of RA, the higher the average annual cost for treating RA,” regardless of gender, the researchers noted.

Despite the reduced mortality during the study period, the researchers also identified some loss of life expectancy among RA patients, compared with the general population. The average loss of life expectancy was nearly 5 years during the 14-year study period. The loss of life expectancy ranged from 2 to 13 years (average 9.7 years) for women with RA and from 2 to 8 years (average 4.1 years) for men with RA, compared with those without RA after controlling for age, gender, and year of diagnosis.

The study findings were limited by several factors including the lack of data on quality of life and functional disability, possible underestimation of life expectancy because of delayed RA diagnosis, and limited accuracy on follow-up of younger patients, the researchers noted.

However, the results support evidence from previous studies of an overall increase in life expectancy after the introduction of biologics, with increased expenses that should be monitored for cost-effectiveness, they concluded. More research is needed to determine the effect of biologics on functional disability, quality of life, and cost-effectiveness in a way that also incorporates productivity loss and the need for social services such as long-term care in order to inform decision-making for RA treatment.

The study was supported by the Ministry of Science and Technology, Taiwan, and China Medical University Hospital. The researchers had no financial conflicts to disclose.

SOURCE: Chiu Y-M et al. Arthritis Rheumatol. 2020 Dec 8. doi: 10.1002/ART.41597.

The widespread use of biologics extended life expectancy but also increased medical costs for adults with RA, based on insurance claims data from nearly 30,000 cases.

“With the advancement of treatment in recent decades, the mortality seems to decrease, while medical expenditures increase,” but previous studies estimating the life-years lost because of RA have shown large variations in results, wrote Ying-Ming Chiu, MD, PhD, of China Medical University, Taichung, Taiwan, and colleagues.

“Estimating long-term or lifetime costs could provide an overall figure of the future impact on the health care system after disease occurrence, and would be useful for cost-effectiveness analysis,” they added.

In a study published in Arthritis & Rheumatology, the researchers identified 29,352 new cases of RA in Taiwan between 2003 and 2016, after the introduction of biologics in Taiwan in 2003. They estimate survival using an algorithm with matched controls and used the survival rates to calculate monthly and lifetime health care expenses.

Overall, the average estimated life expectancy after a diagnosis of RA was 26.3 years, and the average lifetime cost was $72,953 (USD). The average life expectancy was 23.4 years for women and 21.6 years for men. The average lifetime cost was higher for women than for men ($73,112 vs. $63,557), but the annual costs were similar for women and men ($3,123 vs. $2,942). However, “the older the age of diagnosis of RA, the higher the average annual cost for treating RA,” regardless of gender, the researchers noted.

Despite the reduced mortality during the study period, the researchers also identified some loss of life expectancy among RA patients, compared with the general population. The average loss of life expectancy was nearly 5 years during the 14-year study period. The loss of life expectancy ranged from 2 to 13 years (average 9.7 years) for women with RA and from 2 to 8 years (average 4.1 years) for men with RA, compared with those without RA after controlling for age, gender, and year of diagnosis.

The study findings were limited by several factors including the lack of data on quality of life and functional disability, possible underestimation of life expectancy because of delayed RA diagnosis, and limited accuracy on follow-up of younger patients, the researchers noted.

However, the results support evidence from previous studies of an overall increase in life expectancy after the introduction of biologics, with increased expenses that should be monitored for cost-effectiveness, they concluded. More research is needed to determine the effect of biologics on functional disability, quality of life, and cost-effectiveness in a way that also incorporates productivity loss and the need for social services such as long-term care in order to inform decision-making for RA treatment.

The study was supported by the Ministry of Science and Technology, Taiwan, and China Medical University Hospital. The researchers had no financial conflicts to disclose.

SOURCE: Chiu Y-M et al. Arthritis Rheumatol. 2020 Dec 8. doi: 10.1002/ART.41597.

New technologies being developed at the Wellman Center for Photomedicine, Boston, that dermatologists will likely be using in the next 5 years include injection of ice slurry to remove fat, a cooling device for benign pigmented lesions, and a focused laser beam that delivers energy without injuring the skin’s surface.

During a virtual course on laser and aesthetic skin therapy, Lilit Garibyan, MD, PhD, discussed findings from a swine study published online in January 2020 that used an injectable physiologic ice slurry for the nonsurgical removal of fat, a technology that could give CoolSculpting a run for its money. “It does lead to more efficient and effective cryolipolysis,” said Dr. Garibyan, the lead study author who is an assistant professor of dermatology at Harvard University, and director of The Magic Wand Initiative at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “The treatment of fat tissue with ice slurry injection can be done in less than 1 minute, as opposed to an hour of cooling with CoolSculpting. In addition, because cooling is delivered directly into target tissue, it is more effective.”

For the study, she and her colleagues at the Wellman Center injected the slurry – a mix of ice, saline, and glycol – into the flanks of swine and followed them for up to 8 weeks. They used ultrasound imaging to show the location of the fat loss and to quantify it. The researchers observed about 40%-50% loss of fat in the treated area, compared with a 60% fat gain in swine who served as controls. “This is because the pig is growing and gaining weight, so the fat is increasing,” she explained.

Gross histologic images also showed fat loss in the subcutaneous fat tissue of treated swine, but not in controls. “When we quantified this loss, there was about a 60% loss of fat after a single injection of ice slurry in the subcutaneous fat,” Dr. Garibyan said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “On histology there was loss of fat in the subcutaneous area and it was replaced by new collagen. No damage to surrounding skin or muscle tissue was seen.”

She characterized the approach as “a minimally invasive and novel method of adipose tissue removal. It’s very simple, because it’s just a simple injection, and it’s very efficient and effective in fat removal. Most importantly, it can target any anatomic site accessible with a needle.”

Human studies are currently underway.

Another emerging technology Dr. Garibyan discussed is a novel controlled skin cooling device for the treatment of benign pigmented lesions. The approach, known as Cryomodulation, was invented by R. Rox Anderson, MD, Dieter Manstein, MD, PhD, and Henry HL Chan, MD, at Massachusetts General Hospital, Boston, and is being commercialized by R2 Technologies. It delivers precise controlled and titratable freezing of benign pigmented lesions without damage to the epidermal barrier. It has been cleared by the Food and Drug Administration, and R2 Technologies plans to launch its first commercial product in the United States in December 2020.

The handpiece of the device, which is placed on top of the skin, provides localized and controlled freezing to targeted benign pigmented lesions. “The cold, or the freeze, is delivered to where the melanocytes reside,” Dr. Garibyan said. “The ice nucleation essentially pauses melanin production. As cell turnover occurs, cells that are melanin-free migrate upward and renew freshly healthy skin. So, melanocyte function is still preserved but there is no destruction to the epidermal barrier. This technology is totally color blind, and there is no persistent inflammatory response.”

After this treatment, histology reveals a reduction of epidermal melanin without destruction of melanocytes. The treatment impairs melanocyte transfer, but not the melanocytes. “Clinically, that is seen as lightening of the skin,” she said. More than 550 patients have been treated with Cryomodulation to demonstrate its safety and effectiveness, described in a study published in 2019, and an ASLMS e-poster.

The final technology Dr. Garibyan discussed is a novel device for removing dermal pigment with a highly focused laser beam. “The problem with current lasers is that the maximum absorption of energy happens at the dermal/epidermal junction,” she said. “This not only increases the risk of epidermal injury, especially in skin of color, but it also leaves very little energy to reach the pigmented target tissue or cells. In addition, there is scattering in the skin, which also reduces the amount of fluence or energy that can reach the target depth, therefore reducing the efficacy of treatment with currently available laser.”

The investigative focused laser beam with high-speed scanning creates a large differential between the fluence at the surface and the fluence at the target, which improves safety. “It’s able to deliver enhanced energy to the target,” she said. “Therefore it’s more effective than destroying the target pigmented cells. There is no injury outside of the focal point, so it offers improved safety, efficacy, and spatial selectivity. The end result on histology is a selective destruction of the pigmented cells, which are typically melanophages.”

Dr. Garibyan predicted that this device will be an ideal therapy for postinflammatory hyperpigmentation and for melasma, “as no effective therapies are available for those conditions.”

She disclosed that she has received royalties/inventorship assigned to MGH. She holds equity in, is a consultant to, and is a member of the scientific advisory board of Brixton Biosciences. She is a consultant to Vyome Therapeutics, Blossom Innovations, Aegle Therapeutics, and ClearifiRx.

[email protected]

New technologies being developed at the Wellman Center for Photomedicine, Boston, that dermatologists will likely be using in the next 5 years include injection of ice slurry to remove fat, a cooling device for benign pigmented lesions, and a focused laser beam that delivers energy without injuring the skin’s surface.

During a virtual course on laser and aesthetic skin therapy, Lilit Garibyan, MD, PhD, discussed findings from a swine study published online in January 2020 that used an injectable physiologic ice slurry for the nonsurgical removal of fat, a technology that could give CoolSculpting a run for its money. “It does lead to more efficient and effective cryolipolysis,” said Dr. Garibyan, the lead study author who is an assistant professor of dermatology at Harvard University, and director of The Magic Wand Initiative at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “The treatment of fat tissue with ice slurry injection can be done in less than 1 minute, as opposed to an hour of cooling with CoolSculpting. In addition, because cooling is delivered directly into target tissue, it is more effective.”

For the study, she and her colleagues at the Wellman Center injected the slurry – a mix of ice, saline, and glycol – into the flanks of swine and followed them for up to 8 weeks. They used ultrasound imaging to show the location of the fat loss and to quantify it. The researchers observed about 40%-50% loss of fat in the treated area, compared with a 60% fat gain in swine who served as controls. “This is because the pig is growing and gaining weight, so the fat is increasing,” she explained.

Gross histologic images also showed fat loss in the subcutaneous fat tissue of treated swine, but not in controls. “When we quantified this loss, there was about a 60% loss of fat after a single injection of ice slurry in the subcutaneous fat,” Dr. Garibyan said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “On histology there was loss of fat in the subcutaneous area and it was replaced by new collagen. No damage to surrounding skin or muscle tissue was seen.”

She characterized the approach as “a minimally invasive and novel method of adipose tissue removal. It’s very simple, because it’s just a simple injection, and it’s very efficient and effective in fat removal. Most importantly, it can target any anatomic site accessible with a needle.”

Human studies are currently underway.

Another emerging technology Dr. Garibyan discussed is a novel controlled skin cooling device for the treatment of benign pigmented lesions. The approach, known as Cryomodulation, was invented by R. Rox Anderson, MD, Dieter Manstein, MD, PhD, and Henry HL Chan, MD, at Massachusetts General Hospital, Boston, and is being commercialized by R2 Technologies. It delivers precise controlled and titratable freezing of benign pigmented lesions without damage to the epidermal barrier. It has been cleared by the Food and Drug Administration, and R2 Technologies plans to launch its first commercial product in the United States in December 2020.

The handpiece of the device, which is placed on top of the skin, provides localized and controlled freezing to targeted benign pigmented lesions. “The cold, or the freeze, is delivered to where the melanocytes reside,” Dr. Garibyan said. “The ice nucleation essentially pauses melanin production. As cell turnover occurs, cells that are melanin-free migrate upward and renew freshly healthy skin. So, melanocyte function is still preserved but there is no destruction to the epidermal barrier. This technology is totally color blind, and there is no persistent inflammatory response.”

After this treatment, histology reveals a reduction of epidermal melanin without destruction of melanocytes. The treatment impairs melanocyte transfer, but not the melanocytes. “Clinically, that is seen as lightening of the skin,” she said. More than 550 patients have been treated with Cryomodulation to demonstrate its safety and effectiveness, described in a study published in 2019, and an ASLMS e-poster.

The final technology Dr. Garibyan discussed is a novel device for removing dermal pigment with a highly focused laser beam. “The problem with current lasers is that the maximum absorption of energy happens at the dermal/epidermal junction,” she said. “This not only increases the risk of epidermal injury, especially in skin of color, but it also leaves very little energy to reach the pigmented target tissue or cells. In addition, there is scattering in the skin, which also reduces the amount of fluence or energy that can reach the target depth, therefore reducing the efficacy of treatment with currently available laser.”

The investigative focused laser beam with high-speed scanning creates a large differential between the fluence at the surface and the fluence at the target, which improves safety. “It’s able to deliver enhanced energy to the target,” she said. “Therefore it’s more effective than destroying the target pigmented cells. There is no injury outside of the focal point, so it offers improved safety, efficacy, and spatial selectivity. The end result on histology is a selective destruction of the pigmented cells, which are typically melanophages.”

Dr. Garibyan predicted that this device will be an ideal therapy for postinflammatory hyperpigmentation and for melasma, “as no effective therapies are available for those conditions.”

She disclosed that she has received royalties/inventorship assigned to MGH. She holds equity in, is a consultant to, and is a member of the scientific advisory board of Brixton Biosciences. She is a consultant to Vyome Therapeutics, Blossom Innovations, Aegle Therapeutics, and ClearifiRx.

[email protected]

New technologies being developed at the Wellman Center for Photomedicine, Boston, that dermatologists will likely be using in the next 5 years include injection of ice slurry to remove fat, a cooling device for benign pigmented lesions, and a focused laser beam that delivers energy without injuring the skin’s surface.

During a virtual course on laser and aesthetic skin therapy, Lilit Garibyan, MD, PhD, discussed findings from a swine study published online in January 2020 that used an injectable physiologic ice slurry for the nonsurgical removal of fat, a technology that could give CoolSculpting a run for its money. “It does lead to more efficient and effective cryolipolysis,” said Dr. Garibyan, the lead study author who is an assistant professor of dermatology at Harvard University, and director of The Magic Wand Initiative at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “The treatment of fat tissue with ice slurry injection can be done in less than 1 minute, as opposed to an hour of cooling with CoolSculpting. In addition, because cooling is delivered directly into target tissue, it is more effective.”

For the study, she and her colleagues at the Wellman Center injected the slurry – a mix of ice, saline, and glycol – into the flanks of swine and followed them for up to 8 weeks. They used ultrasound imaging to show the location of the fat loss and to quantify it. The researchers observed about 40%-50% loss of fat in the treated area, compared with a 60% fat gain in swine who served as controls. “This is because the pig is growing and gaining weight, so the fat is increasing,” she explained.

Gross histologic images also showed fat loss in the subcutaneous fat tissue of treated swine, but not in controls. “When we quantified this loss, there was about a 60% loss of fat after a single injection of ice slurry in the subcutaneous fat,” Dr. Garibyan said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “On histology there was loss of fat in the subcutaneous area and it was replaced by new collagen. No damage to surrounding skin or muscle tissue was seen.”

She characterized the approach as “a minimally invasive and novel method of adipose tissue removal. It’s very simple, because it’s just a simple injection, and it’s very efficient and effective in fat removal. Most importantly, it can target any anatomic site accessible with a needle.”

Human studies are currently underway.

Another emerging technology Dr. Garibyan discussed is a novel controlled skin cooling device for the treatment of benign pigmented lesions. The approach, known as Cryomodulation, was invented by R. Rox Anderson, MD, Dieter Manstein, MD, PhD, and Henry HL Chan, MD, at Massachusetts General Hospital, Boston, and is being commercialized by R2 Technologies. It delivers precise controlled and titratable freezing of benign pigmented lesions without damage to the epidermal barrier. It has been cleared by the Food and Drug Administration, and R2 Technologies plans to launch its first commercial product in the United States in December 2020.

The handpiece of the device, which is placed on top of the skin, provides localized and controlled freezing to targeted benign pigmented lesions. “The cold, or the freeze, is delivered to where the melanocytes reside,” Dr. Garibyan said. “The ice nucleation essentially pauses melanin production. As cell turnover occurs, cells that are melanin-free migrate upward and renew freshly healthy skin. So, melanocyte function is still preserved but there is no destruction to the epidermal barrier. This technology is totally color blind, and there is no persistent inflammatory response.”

After this treatment, histology reveals a reduction of epidermal melanin without destruction of melanocytes. The treatment impairs melanocyte transfer, but not the melanocytes. “Clinically, that is seen as lightening of the skin,” she said. More than 550 patients have been treated with Cryomodulation to demonstrate its safety and effectiveness, described in a study published in 2019, and an ASLMS e-poster.

The final technology Dr. Garibyan discussed is a novel device for removing dermal pigment with a highly focused laser beam. “The problem with current lasers is that the maximum absorption of energy happens at the dermal/epidermal junction,” she said. “This not only increases the risk of epidermal injury, especially in skin of color, but it also leaves very little energy to reach the pigmented target tissue or cells. In addition, there is scattering in the skin, which also reduces the amount of fluence or energy that can reach the target depth, therefore reducing the efficacy of treatment with currently available laser.”

The investigative focused laser beam with high-speed scanning creates a large differential between the fluence at the surface and the fluence at the target, which improves safety. “It’s able to deliver enhanced energy to the target,” she said. “Therefore it’s more effective than destroying the target pigmented cells. There is no injury outside of the focal point, so it offers improved safety, efficacy, and spatial selectivity. The end result on histology is a selective destruction of the pigmented cells, which are typically melanophages.”

Dr. Garibyan predicted that this device will be an ideal therapy for postinflammatory hyperpigmentation and for melasma, “as no effective therapies are available for those conditions.”

She disclosed that she has received royalties/inventorship assigned to MGH. She holds equity in, is a consultant to, and is a member of the scientific advisory board of Brixton Biosciences. She is a consultant to Vyome Therapeutics, Blossom Innovations, Aegle Therapeutics, and ClearifiRx.

[email protected]

The cognitive and emotional status of children with sickle cell disease (SCD) appears to have a significant effect on how they cope with pain and use health care resources, investigators have found.

Results of a retrospective study of 112 children and adolescents with SCD, the majority of whom had sickle cell anemia, showed that ED visits and hospitalizations were significantly lower among children with SCD who performed better on an attention task, as well as those who were better able to cope emotionally with having SCD and pain, reported Zaria Williams, a second-year medical student at Howard University, Washington, and colleagues.

“Since I started learning more about sickle cell disease, I’ve been very concerned about the great disease burden that this condition can place on pediatric patients, particularly those who suffer from pain,” Ms. Williams said in an oral abstract presented at the annual meeting of the American Society of Hematology.

Although many children and adolescents with SCD can have their pain effectively managed at home with opioids and other medications, some require ED visits and potentially hospitalizations for pain management.

“There is great variability in health care utilization among patients with sickle cell disease, with some having to come to the ED and be admit to the hospital more than others. In searching for reasons why this might be the case, we thought about cognitive function and emotional differences between children with sickle cell disease as potentially affecting disease management,” she said.
 

Anxiety and catastrophizing

Children with SCD are known to be susceptible to affective comorbidities such as anxiety and catastrophizing, and to conditions that have the potential for deleterious effects on executive function, attention, and working memory. To determine whether cognitive and emotional factors affect the disease self-management in children and adolescents with SCD, Ms. Williams and coinvestigators looked at a cohort of 112 SCD patients aged 7-16 years treated at Children’s National Hospital in Washington, D.C.

The patients had participated in a previous pilot study of computerized working memory training. The authors reviewed charts for data on health care utilization, focusing on ED visits and hospitalization for pain 1 and 3 years after enrollment in the study.

They collected data on SCD genotype, disease-related variables, psychosocial information, and measures of cognition and emotion from the dataset. The information included socioeconomic status, parent education level, household income, and number of adults in the household.

Cognitive measures included the Weschler Intelligence Scale for Children full scale IQ, and the Cogstate computerized cognitive assessment system, which measures attention, executive function, and working memory.

Emotional measures were captured from the Pediatric Quality of Life Inventory Sickle Cell Disease module, including questions about worrying and emotions such as anger regarding SCD and pain.

The mean age of participants was 10.61 years. Of the 112 children/adolescents in the study, 65 (58%) were female, and 83 (74%) had sickle cell anemia (either HbSS or HbSβ0 thalassemia).

The participants had a median number of ED visits for pain of one within a year of enrollment, and a median of three within 3 years of enrollment,

The median number of hospital admissions for pain was zero and one, respectively.
 

Attention, emotions linked to higher use

Factors significantly associated with ED visits for pain within the first year were higher (worse) scores for attention (P = .001) and self-reported emotion (P = .049). ED visits within 3 years of enrollment were associated with attention (P = .003) and working memory (P = .039).

Similarly, hospitalizations for pain within the first year were significantly associated with worse attention scores (P = .009) and child-reported emotion (P = .013). Hospitalizations for pain within 3 years of enrollment were also significantly associated with attention deficits (P = .006) and with worse emotional function as reported by a parent (P = .020).

There was no significant effect of SCD genotype or socioeconomic status on either pain-related ED visits or hospitalizations, however.

The investigators theorized that poor attention may make it difficult to distract children from focusing on their pain, and could also hamper disease self-management strategies such as medication adherence and avoiding pain triggers.
 

Age-related differences?

In the question-and-answer session following her presentation, comoderator Susanna A Curtis, MD, from Yale New Haven (Conn.) Hospital, commented that “some previous work has shown that adolescents and young adults with sickle cell disease have higher utilization as compared to their younger counterparts,” and asked whether the investigators found differences between cognition and utilization among different age groups within the cohort.

“We didn’t find a significant association with age, but I’m also very interested in that as well, especially considering that maybe there is more or less parent involvement, considering how old the child is,” Ms. Williams said.

Dr. Curtis noted that many of the comorbidities of sickle cell disease such as stroke or degree of anemia can affect cognitive function, but can also have an effect on health care utilization as well, asked whether the investigators were able to look at the potential confounding effects of comorbidities.

Ms. Williams said that, although they have not looked at potential confounders as yet, they hope to do so in future research.

Asked by another audience member whether the authors had considered using the Pain Catastrophizing Scale for children and/or their parents, in addition to other markers, Ms. Williams replied that “I definitely have considered it. Under recommendations from my mentors, we just focused on the quality-of-life scale first, but catastrophizing is something I’m very interested in. Especially, I would love to have the parent factors as well, so along the journey I hope to include that.”

The study was sponsored in part by a grant from the Doris Duke Charitable Foundation. Ms Williams is the recipient of an ASH Minority Medical Student Award. Dr. Curtis and Ms. Williams both reported no relevant conflicts of interest to disclose.

SOURCE: Williams Z et al. ASH 2020, Abstract 366

The cognitive and emotional status of children with sickle cell disease (SCD) appears to have a significant effect on how they cope with pain and use health care resources, investigators have found.

Results of a retrospective study of 112 children and adolescents with SCD, the majority of whom had sickle cell anemia, showed that ED visits and hospitalizations were significantly lower among children with SCD who performed better on an attention task, as well as those who were better able to cope emotionally with having SCD and pain, reported Zaria Williams, a second-year medical student at Howard University, Washington, and colleagues.

“Since I started learning more about sickle cell disease, I’ve been very concerned about the great disease burden that this condition can place on pediatric patients, particularly those who suffer from pain,” Ms. Williams said in an oral abstract presented at the annual meeting of the American Society of Hematology.

Although many children and adolescents with SCD can have their pain effectively managed at home with opioids and other medications, some require ED visits and potentially hospitalizations for pain management.

“There is great variability in health care utilization among patients with sickle cell disease, with some having to come to the ED and be admit to the hospital more than others. In searching for reasons why this might be the case, we thought about cognitive function and emotional differences between children with sickle cell disease as potentially affecting disease management,” she said.
 

Anxiety and catastrophizing

Children with SCD are known to be susceptible to affective comorbidities such as anxiety and catastrophizing, and to conditions that have the potential for deleterious effects on executive function, attention, and working memory. To determine whether cognitive and emotional factors affect the disease self-management in children and adolescents with SCD, Ms. Williams and coinvestigators looked at a cohort of 112 SCD patients aged 7-16 years treated at Children’s National Hospital in Washington, D.C.

The patients had participated in a previous pilot study of computerized working memory training. The authors reviewed charts for data on health care utilization, focusing on ED visits and hospitalization for pain 1 and 3 years after enrollment in the study.

They collected data on SCD genotype, disease-related variables, psychosocial information, and measures of cognition and emotion from the dataset. The information included socioeconomic status, parent education level, household income, and number of adults in the household.

Cognitive measures included the Weschler Intelligence Scale for Children full scale IQ, and the Cogstate computerized cognitive assessment system, which measures attention, executive function, and working memory.

Emotional measures were captured from the Pediatric Quality of Life Inventory Sickle Cell Disease module, including questions about worrying and emotions such as anger regarding SCD and pain.

The mean age of participants was 10.61 years. Of the 112 children/adolescents in the study, 65 (58%) were female, and 83 (74%) had sickle cell anemia (either HbSS or HbSβ0 thalassemia).

The participants had a median number of ED visits for pain of one within a year of enrollment, and a median of three within 3 years of enrollment,

The median number of hospital admissions for pain was zero and one, respectively.
 

Attention, emotions linked to higher use

Factors significantly associated with ED visits for pain within the first year were higher (worse) scores for attention (P = .001) and self-reported emotion (P = .049). ED visits within 3 years of enrollment were associated with attention (P = .003) and working memory (P = .039).

Similarly, hospitalizations for pain within the first year were significantly associated with worse attention scores (P = .009) and child-reported emotion (P = .013). Hospitalizations for pain within 3 years of enrollment were also significantly associated with attention deficits (P = .006) and with worse emotional function as reported by a parent (P = .020).

There was no significant effect of SCD genotype or socioeconomic status on either pain-related ED visits or hospitalizations, however.

The investigators theorized that poor attention may make it difficult to distract children from focusing on their pain, and could also hamper disease self-management strategies such as medication adherence and avoiding pain triggers.
 

Age-related differences?

In the question-and-answer session following her presentation, comoderator Susanna A Curtis, MD, from Yale New Haven (Conn.) Hospital, commented that “some previous work has shown that adolescents and young adults with sickle cell disease have higher utilization as compared to their younger counterparts,” and asked whether the investigators found differences between cognition and utilization among different age groups within the cohort.

“We didn’t find a significant association with age, but I’m also very interested in that as well, especially considering that maybe there is more or less parent involvement, considering how old the child is,” Ms. Williams said.

Dr. Curtis noted that many of the comorbidities of sickle cell disease such as stroke or degree of anemia can affect cognitive function, but can also have an effect on health care utilization as well, asked whether the investigators were able to look at the potential confounding effects of comorbidities.

Ms. Williams said that, although they have not looked at potential confounders as yet, they hope to do so in future research.

Asked by another audience member whether the authors had considered using the Pain Catastrophizing Scale for children and/or their parents, in addition to other markers, Ms. Williams replied that “I definitely have considered it. Under recommendations from my mentors, we just focused on the quality-of-life scale first, but catastrophizing is something I’m very interested in. Especially, I would love to have the parent factors as well, so along the journey I hope to include that.”

The study was sponsored in part by a grant from the Doris Duke Charitable Foundation. Ms Williams is the recipient of an ASH Minority Medical Student Award. Dr. Curtis and Ms. Williams both reported no relevant conflicts of interest to disclose.

SOURCE: Williams Z et al. ASH 2020, Abstract 366

The cognitive and emotional status of children with sickle cell disease (SCD) appears to have a significant effect on how they cope with pain and use health care resources, investigators have found.

Results of a retrospective study of 112 children and adolescents with SCD, the majority of whom had sickle cell anemia, showed that ED visits and hospitalizations were significantly lower among children with SCD who performed better on an attention task, as well as those who were better able to cope emotionally with having SCD and pain, reported Zaria Williams, a second-year medical student at Howard University, Washington, and colleagues.

“Since I started learning more about sickle cell disease, I’ve been very concerned about the great disease burden that this condition can place on pediatric patients, particularly those who suffer from pain,” Ms. Williams said in an oral abstract presented at the annual meeting of the American Society of Hematology.

Although many children and adolescents with SCD can have their pain effectively managed at home with opioids and other medications, some require ED visits and potentially hospitalizations for pain management.

“There is great variability in health care utilization among patients with sickle cell disease, with some having to come to the ED and be admit to the hospital more than others. In searching for reasons why this might be the case, we thought about cognitive function and emotional differences between children with sickle cell disease as potentially affecting disease management,” she said.
 

Anxiety and catastrophizing

Children with SCD are known to be susceptible to affective comorbidities such as anxiety and catastrophizing, and to conditions that have the potential for deleterious effects on executive function, attention, and working memory. To determine whether cognitive and emotional factors affect the disease self-management in children and adolescents with SCD, Ms. Williams and coinvestigators looked at a cohort of 112 SCD patients aged 7-16 years treated at Children’s National Hospital in Washington, D.C.

The patients had participated in a previous pilot study of computerized working memory training. The authors reviewed charts for data on health care utilization, focusing on ED visits and hospitalization for pain 1 and 3 years after enrollment in the study.

They collected data on SCD genotype, disease-related variables, psychosocial information, and measures of cognition and emotion from the dataset. The information included socioeconomic status, parent education level, household income, and number of adults in the household.

Cognitive measures included the Weschler Intelligence Scale for Children full scale IQ, and the Cogstate computerized cognitive assessment system, which measures attention, executive function, and working memory.

Emotional measures were captured from the Pediatric Quality of Life Inventory Sickle Cell Disease module, including questions about worrying and emotions such as anger regarding SCD and pain.

The mean age of participants was 10.61 years. Of the 112 children/adolescents in the study, 65 (58%) were female, and 83 (74%) had sickle cell anemia (either HbSS or HbSβ0 thalassemia).

The participants had a median number of ED visits for pain of one within a year of enrollment, and a median of three within 3 years of enrollment,

The median number of hospital admissions for pain was zero and one, respectively.
 

Attention, emotions linked to higher use

Factors significantly associated with ED visits for pain within the first year were higher (worse) scores for attention (P = .001) and self-reported emotion (P = .049). ED visits within 3 years of enrollment were associated with attention (P = .003) and working memory (P = .039).

Similarly, hospitalizations for pain within the first year were significantly associated with worse attention scores (P = .009) and child-reported emotion (P = .013). Hospitalizations for pain within 3 years of enrollment were also significantly associated with attention deficits (P = .006) and with worse emotional function as reported by a parent (P = .020).

There was no significant effect of SCD genotype or socioeconomic status on either pain-related ED visits or hospitalizations, however.

The investigators theorized that poor attention may make it difficult to distract children from focusing on their pain, and could also hamper disease self-management strategies such as medication adherence and avoiding pain triggers.
 

Age-related differences?

In the question-and-answer session following her presentation, comoderator Susanna A Curtis, MD, from Yale New Haven (Conn.) Hospital, commented that “some previous work has shown that adolescents and young adults with sickle cell disease have higher utilization as compared to their younger counterparts,” and asked whether the investigators found differences between cognition and utilization among different age groups within the cohort.

“We didn’t find a significant association with age, but I’m also very interested in that as well, especially considering that maybe there is more or less parent involvement, considering how old the child is,” Ms. Williams said.

Dr. Curtis noted that many of the comorbidities of sickle cell disease such as stroke or degree of anemia can affect cognitive function, but can also have an effect on health care utilization as well, asked whether the investigators were able to look at the potential confounding effects of comorbidities.

Ms. Williams said that, although they have not looked at potential confounders as yet, they hope to do so in future research.

Asked by another audience member whether the authors had considered using the Pain Catastrophizing Scale for children and/or their parents, in addition to other markers, Ms. Williams replied that “I definitely have considered it. Under recommendations from my mentors, we just focused on the quality-of-life scale first, but catastrophizing is something I’m very interested in. Especially, I would love to have the parent factors as well, so along the journey I hope to include that.”

The study was sponsored in part by a grant from the Doris Duke Charitable Foundation. Ms Williams is the recipient of an ASH Minority Medical Student Award. Dr. Curtis and Ms. Williams both reported no relevant conflicts of interest to disclose.

SOURCE: Williams Z et al. ASH 2020, Abstract 366

A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.

Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.

Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.

In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.

All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).

Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.

SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.

A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.

Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.

Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.

In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.

All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).

Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.

SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.

A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.

Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.

Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.

In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.

All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).

Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.

SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.

When a new phenotype approach to the diagnosis of rosacea was proposed 2 years ago, this simpler and more accurate method was accompanied by several corollary advantages, including a more rational approach to treatment and better methods of measuring treatment efficacy, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.

“By looking at rosacea in a more simple way – but a more accurate way – we are able to track what happens [to key features] over time,” explained Jerry Tan, MD, of the University of Western Ontario, London.

The newer method of diagnosing rosacea, which relies on phenotyping rather than subtyping, focuses on symptoms and their clinical impact. With the previous method of subtyping, many rosacea patients failed to fit neatly into any of the four categories, producing confusion and diverting attention from troublesome symptoms.

“Rosacea patients often present with a range of features that span multiple subtypes or progress between them,” Dr. Tan explained. The risk is not just a delay in diagnosis but a failure to focus on symptoms patients find most bothersome.

The previous diagnostic criteria for rosacea, published in 2002, identified primary and secondary symptoms within its four subtypes. The new diagnostic criteria, endorsed by the National Rosacea Society and published in 2018, rely on phenotypes defined by diagnostic, major, and minor symptoms. Rather than the four previous subtypes, which were erythematotelangiectatic, papulopustular, phymatous, and ocular, the phenotypes facilitate diagnosis in patients with mixed features.

By replacing “the old thought process of subtyping” with a newer focus on phenotypes, the updated criteria were “aimed toward accuracy, simplicity and practicality,” Dr. Tan said.

Moreover, without squeezing patients into subgroups where they do not neatly fit, the new criteria draw attention to the specific symptoms that bring patients to the clinician.

The phenotype approach to treatment strategies was reflected in a systematic review of treatments based on phenotypes that was published in 2019, not long after the new classification system became available. In this review, coauthored by Dr. Tan, the GRADE certainty-of-evidence approach was employed to identify effective therapies, matching specific symptoms with specific therapies such as low-dose isotretinoin for papules or omega-3 fatty acids for dry eyes.

Based on a patient-centric approach that emphasizes control of key symptoms, Dr. Tan also described a method of documenting the severity of major and minor symptoms at each visit. With this method, called a rosacea patient tracker, patients and physicians can determine whether therapies are effective against the signs and symptoms of disease that they find most burdensome, according to Dr. Tan, who was the first author of an article he cited as a reference to this phenotype-based methodology.

Overall, the phenotype approach to rosacea “rationalizes treatment,” he said.

Specifically, the heterogeneity of symptoms in rosacea is mirrored in the heterogeneity of underlying pathophysiology. According to Dr. Tan, the upregulation of cytokines for inflammation, of angiogenic pathways for vascular symptoms, and of matrix metalloproteinases for tissue remodeling are all implicated in rosacea but drive different types of symptoms. While appropriate skin care and efforts to identify and minimize symptom triggers is appropriate for all patients, phenotypes provide a guide to the most appropriate therapies.

He said he hopes that the focus on phenotypes will draw attention to differences in these pathophysiological mechanisms. According to Dr. Tan, evaluating rosacea from the perspective of phenotypes has represented an important paradigm shift that extends beyond diagnosis.

“The move to the phenotype approach is hopefully simpler, more accurate, and more relevant,” Dr. Tan said.

This same approach has been advocated by others, including Esther J. van Zurren, MD, professor of dermatology at Leiden University Medical Centre in the Netherlands, the lead author of the 2018 systematic review article discussed by Dr. Tan. In this review article on the phenotype approach, specific strategies were recommended for specific symptoms on the basis of grading by an international group of experts that included Dr. Tan, a coauthor.

“These strategies should be directed toward achieving improvements in general well-being by targeting those aspects most bothersome to the patient,” the article advises. Like Dr. Tan, she considers this phenotype-based approach to diagnosis and treatment to be a meaningful clinical advance over the guidelines published in 2002.

“Management strategies for people with rosacea should include phenotype-based treatments,” she agreed, adding that specific choices should be made on the basis of these phenotypes “instead of the previous subtype classification.”

The meeting was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
 

When a new phenotype approach to the diagnosis of rosacea was proposed 2 years ago, this simpler and more accurate method was accompanied by several corollary advantages, including a more rational approach to treatment and better methods of measuring treatment efficacy, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.

“By looking at rosacea in a more simple way – but a more accurate way – we are able to track what happens [to key features] over time,” explained Jerry Tan, MD, of the University of Western Ontario, London.

The newer method of diagnosing rosacea, which relies on phenotyping rather than subtyping, focuses on symptoms and their clinical impact. With the previous method of subtyping, many rosacea patients failed to fit neatly into any of the four categories, producing confusion and diverting attention from troublesome symptoms.

“Rosacea patients often present with a range of features that span multiple subtypes or progress between them,” Dr. Tan explained. The risk is not just a delay in diagnosis but a failure to focus on symptoms patients find most bothersome.

The previous diagnostic criteria for rosacea, published in 2002, identified primary and secondary symptoms within its four subtypes. The new diagnostic criteria, endorsed by the National Rosacea Society and published in 2018, rely on phenotypes defined by diagnostic, major, and minor symptoms. Rather than the four previous subtypes, which were erythematotelangiectatic, papulopustular, phymatous, and ocular, the phenotypes facilitate diagnosis in patients with mixed features.

By replacing “the old thought process of subtyping” with a newer focus on phenotypes, the updated criteria were “aimed toward accuracy, simplicity and practicality,” Dr. Tan said.

Moreover, without squeezing patients into subgroups where they do not neatly fit, the new criteria draw attention to the specific symptoms that bring patients to the clinician.

The phenotype approach to treatment strategies was reflected in a systematic review of treatments based on phenotypes that was published in 2019, not long after the new classification system became available. In this review, coauthored by Dr. Tan, the GRADE certainty-of-evidence approach was employed to identify effective therapies, matching specific symptoms with specific therapies such as low-dose isotretinoin for papules or omega-3 fatty acids for dry eyes.

Based on a patient-centric approach that emphasizes control of key symptoms, Dr. Tan also described a method of documenting the severity of major and minor symptoms at each visit. With this method, called a rosacea patient tracker, patients and physicians can determine whether therapies are effective against the signs and symptoms of disease that they find most burdensome, according to Dr. Tan, who was the first author of an article he cited as a reference to this phenotype-based methodology.

Overall, the phenotype approach to rosacea “rationalizes treatment,” he said.

Specifically, the heterogeneity of symptoms in rosacea is mirrored in the heterogeneity of underlying pathophysiology. According to Dr. Tan, the upregulation of cytokines for inflammation, of angiogenic pathways for vascular symptoms, and of matrix metalloproteinases for tissue remodeling are all implicated in rosacea but drive different types of symptoms. While appropriate skin care and efforts to identify and minimize symptom triggers is appropriate for all patients, phenotypes provide a guide to the most appropriate therapies.

He said he hopes that the focus on phenotypes will draw attention to differences in these pathophysiological mechanisms. According to Dr. Tan, evaluating rosacea from the perspective of phenotypes has represented an important paradigm shift that extends beyond diagnosis.

“The move to the phenotype approach is hopefully simpler, more accurate, and more relevant,” Dr. Tan said.

This same approach has been advocated by others, including Esther J. van Zurren, MD, professor of dermatology at Leiden University Medical Centre in the Netherlands, the lead author of the 2018 systematic review article discussed by Dr. Tan. In this review article on the phenotype approach, specific strategies were recommended for specific symptoms on the basis of grading by an international group of experts that included Dr. Tan, a coauthor.

“These strategies should be directed toward achieving improvements in general well-being by targeting those aspects most bothersome to the patient,” the article advises. Like Dr. Tan, she considers this phenotype-based approach to diagnosis and treatment to be a meaningful clinical advance over the guidelines published in 2002.

“Management strategies for people with rosacea should include phenotype-based treatments,” she agreed, adding that specific choices should be made on the basis of these phenotypes “instead of the previous subtype classification.”

The meeting was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
 

When a new phenotype approach to the diagnosis of rosacea was proposed 2 years ago, this simpler and more accurate method was accompanied by several corollary advantages, including a more rational approach to treatment and better methods of measuring treatment efficacy, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.

“By looking at rosacea in a more simple way – but a more accurate way – we are able to track what happens [to key features] over time,” explained Jerry Tan, MD, of the University of Western Ontario, London.

The newer method of diagnosing rosacea, which relies on phenotyping rather than subtyping, focuses on symptoms and their clinical impact. With the previous method of subtyping, many rosacea patients failed to fit neatly into any of the four categories, producing confusion and diverting attention from troublesome symptoms.

“Rosacea patients often present with a range of features that span multiple subtypes or progress between them,” Dr. Tan explained. The risk is not just a delay in diagnosis but a failure to focus on symptoms patients find most bothersome.

The previous diagnostic criteria for rosacea, published in 2002, identified primary and secondary symptoms within its four subtypes. The new diagnostic criteria, endorsed by the National Rosacea Society and published in 2018, rely on phenotypes defined by diagnostic, major, and minor symptoms. Rather than the four previous subtypes, which were erythematotelangiectatic, papulopustular, phymatous, and ocular, the phenotypes facilitate diagnosis in patients with mixed features.

By replacing “the old thought process of subtyping” with a newer focus on phenotypes, the updated criteria were “aimed toward accuracy, simplicity and practicality,” Dr. Tan said.

Moreover, without squeezing patients into subgroups where they do not neatly fit, the new criteria draw attention to the specific symptoms that bring patients to the clinician.

The phenotype approach to treatment strategies was reflected in a systematic review of treatments based on phenotypes that was published in 2019, not long after the new classification system became available. In this review, coauthored by Dr. Tan, the GRADE certainty-of-evidence approach was employed to identify effective therapies, matching specific symptoms with specific therapies such as low-dose isotretinoin for papules or omega-3 fatty acids for dry eyes.

Based on a patient-centric approach that emphasizes control of key symptoms, Dr. Tan also described a method of documenting the severity of major and minor symptoms at each visit. With this method, called a rosacea patient tracker, patients and physicians can determine whether therapies are effective against the signs and symptoms of disease that they find most burdensome, according to Dr. Tan, who was the first author of an article he cited as a reference to this phenotype-based methodology.

Overall, the phenotype approach to rosacea “rationalizes treatment,” he said.

Specifically, the heterogeneity of symptoms in rosacea is mirrored in the heterogeneity of underlying pathophysiology. According to Dr. Tan, the upregulation of cytokines for inflammation, of angiogenic pathways for vascular symptoms, and of matrix metalloproteinases for tissue remodeling are all implicated in rosacea but drive different types of symptoms. While appropriate skin care and efforts to identify and minimize symptom triggers is appropriate for all patients, phenotypes provide a guide to the most appropriate therapies.

He said he hopes that the focus on phenotypes will draw attention to differences in these pathophysiological mechanisms. According to Dr. Tan, evaluating rosacea from the perspective of phenotypes has represented an important paradigm shift that extends beyond diagnosis.

“The move to the phenotype approach is hopefully simpler, more accurate, and more relevant,” Dr. Tan said.

This same approach has been advocated by others, including Esther J. van Zurren, MD, professor of dermatology at Leiden University Medical Centre in the Netherlands, the lead author of the 2018 systematic review article discussed by Dr. Tan. In this review article on the phenotype approach, specific strategies were recommended for specific symptoms on the basis of grading by an international group of experts that included Dr. Tan, a coauthor.

“These strategies should be directed toward achieving improvements in general well-being by targeting those aspects most bothersome to the patient,” the article advises. Like Dr. Tan, she considers this phenotype-based approach to diagnosis and treatment to be a meaningful clinical advance over the guidelines published in 2002.

“Management strategies for people with rosacea should include phenotype-based treatments,” she agreed, adding that specific choices should be made on the basis of these phenotypes “instead of the previous subtype classification.”

The meeting was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
 

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

References to mental health issues in popular rap music more than doubled in the period from 1998 to 2018, based on data from a review of 125 songs.

portishead1/Getty Images

Mental health distress is rising but often is undertreated among children and young adults in the United States, wrote Alex Kresovich, MA, of the University of North Carolina, Chapel Hill, and colleagues.

“Mental health risk especially is increasing among young Black/ African American male individuals (YBAAM), who are often disproportionately exposed to environmental, economic, and family stressors linked with depression and anxiety,” they said. Adolescents and young adults, especially YBAAM, make up a large part of the audience for rap music.

In recent years, more rap artists have disclosed mental health issues, and they have included mental health topics such as depression and suicidal thoughts into their music, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 125 songs from the period between 1998 and 2018, then assessed them for references to mental health. The song selections included the top 25 rap songs in 1998, 2003, 2008, 2013, and 2018, based on the Billboard music charts.

The majority of the songs (123) featured lead artists from North America, and 97 of them were Black/African American males. The average age of the artists was 28 years. “Prominent artists captured in the sample included 50 Cent, Drake, Eminem, Kanye West, Jay-Z, and Lil’Wayne, among others,” they said. The researchers divided mental health issues into four categories: anxiety or anxious thinking; depression or depressive thinking; metaphors (such as struggling with mental stability); and suicide or suicidal ideation.
 

Mental health references rise

Across the study period, 35 songs (28%) mentioned anxiety, 28 (22%) mentioned depression, 8 (6%) mentioned suicide, and 26 (21%) mentioned a mental health metaphor. The proportion of songs with a mental health reference increased in a significant linear trend across the study period for suicide (0%-12%), depression (16%-32%), and mental health metaphors (8%-44%).

All references to suicide or suicidal ideation were found in songs that were popular between 2013 and 2018, the researchers noted.

“This increase is important, given that rap artists serve as role models to their audience, which extends beyond YBAAM to include U.S. young people across strata, constituting a large group with increased risk of mental health issues and underuse of mental health services,” Mr. Kresovich and associates said.

In addition, the researchers found that stressors related to environmental conditions and love were significantly more likely to co-occur with mental health references (adjusted odds ratios 8.1 and 4.8, respectively).

The study findings were limited by several factors including the selection of songs only from the Billboard hot rap songs year-end charts, which “does not fully represent the population of rap music between 1998 and 2018,” the researchers said. In addition, they could not address causation or motivations for the increased mental health references over the study period. “We are also unable to ascertain how U.S. youth interact with this music or are positively or negatively affected by its messages.”

“For example, positively framed references to mental health awareness, treatment, or support may lead to reduced stigma and increased willingness to seek treatment,” Mr. Kresovich and associates wrote. “However, negatively framed references to mental health struggles might lead to negative outcomes, including copycat behavior in which listeners model harmful behavior, such as suicide attempts, if those behaviors are described in lyrics (i.e., the Werther effect),” they added.

Despite these limitations, the results support the need for more research on the impact of rap music as a way to reduce stigma and potentially reduce mental health risk in adolescents and young adults, Mr. Kresovich and associates concluded.
 

Music may help raise tough topics

The study is important because children and adolescents have more control than ever over the media they consume, Sarah Vinson, MD, founder of the Lorio Psych Group in Atlanta, said in an interview.

“With more and more children with access to their own devices, they spend a great amount of time consuming content, including music,” Dr. Vinson said. “The norms reflected in the lyrics they hear have an impact on their emerging view of themselves, others, and the world.”  

The increased recognition of mental health issues by rap musicians as a topic “certainly has the potential to have a positive impact; however, the way that it is discussed can influence [the] nature of that impact,” she explained.

“It is important for people who are dealing with the normal range of human emotions to know that they are not alone. It is even more important for people dealing with suicidality or mental illness to know that,” Dr. Vinson said.

“Validation and sense of connection are human needs, and stigma related to mental illness can be isolating,” she emphasized. “Rappers have a platform and are often people that children and adolescents look up to, for better or for worse.” Through their music, “the rappers are signaling that these topics are worthy of our attention and okay to talk about.”

Unfortunately, many barriers persist for adolescents in need of mental health treatment, said Dr. Vinson. “The children’s mental health workforce, quantitatively, is not enough to meet the current needs,” she said. “Mental health is not reimbursed at the same rate as other kinds of health care, which contributes to healthy systems not prioritizing these services. Additionally, the racial, ethnic, and socioeconomic background of those who are mental health providers is not reflective of the larger population, and mental health training insufficiently incorporates the cultural and structural humility needed to help professionals navigate those differences,” she explained.

“Children at increased risk are those who face many of those environmental barriers that the rappers reference in those lyrics. They are likely to have even poorer access because they are disproportionately impacted by residential segregation, transportation challenges, financial barriers, and structural racism in mental health care,” Dr. Vinson added. A take-home message for clinicians is to find out what their patients are listening to. “One way to understand what is on the hearts and minds of children is to ask them what’s in their playlist,” she said. 

Additional research is needed to examine “moderating factors for the impact, good or bad, of increased mental health content in hip hop for young listeners’ mental health awareness, symptoms and/or interest in seeking treatment,” Dr. Vinson concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Dr. Vinson served as chair for a workshop on mental health and hip-hop at the American Psychiatric Association annual meeting. She had no financial conflicts to disclose.

SOURCE: Kresovich A et al. JAMA Pediatr. 2020 Dec 7. doi: 10.1001/jamapediatrics.2020.5155.

This article was updated on December 21, 2020.

References to mental health issues in popular rap music more than doubled in the period from 1998 to 2018, based on data from a review of 125 songs.

portishead1/Getty Images

Mental health distress is rising but often is undertreated among children and young adults in the United States, wrote Alex Kresovich, MA, of the University of North Carolina, Chapel Hill, and colleagues.

“Mental health risk especially is increasing among young Black/ African American male individuals (YBAAM), who are often disproportionately exposed to environmental, economic, and family stressors linked with depression and anxiety,” they said. Adolescents and young adults, especially YBAAM, make up a large part of the audience for rap music.

In recent years, more rap artists have disclosed mental health issues, and they have included mental health topics such as depression and suicidal thoughts into their music, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 125 songs from the period between 1998 and 2018, then assessed them for references to mental health. The song selections included the top 25 rap songs in 1998, 2003, 2008, 2013, and 2018, based on the Billboard music charts.

The majority of the songs (123) featured lead artists from North America, and 97 of them were Black/African American males. The average age of the artists was 28 years. “Prominent artists captured in the sample included 50 Cent, Drake, Eminem, Kanye West, Jay-Z, and Lil’Wayne, among others,” they said. The researchers divided mental health issues into four categories: anxiety or anxious thinking; depression or depressive thinking; metaphors (such as struggling with mental stability); and suicide or suicidal ideation.
 

Mental health references rise

Across the study period, 35 songs (28%) mentioned anxiety, 28 (22%) mentioned depression, 8 (6%) mentioned suicide, and 26 (21%) mentioned a mental health metaphor. The proportion of songs with a mental health reference increased in a significant linear trend across the study period for suicide (0%-12%), depression (16%-32%), and mental health metaphors (8%-44%).

All references to suicide or suicidal ideation were found in songs that were popular between 2013 and 2018, the researchers noted.

“This increase is important, given that rap artists serve as role models to their audience, which extends beyond YBAAM to include U.S. young people across strata, constituting a large group with increased risk of mental health issues and underuse of mental health services,” Mr. Kresovich and associates said.

In addition, the researchers found that stressors related to environmental conditions and love were significantly more likely to co-occur with mental health references (adjusted odds ratios 8.1 and 4.8, respectively).

The study findings were limited by several factors including the selection of songs only from the Billboard hot rap songs year-end charts, which “does not fully represent the population of rap music between 1998 and 2018,” the researchers said. In addition, they could not address causation or motivations for the increased mental health references over the study period. “We are also unable to ascertain how U.S. youth interact with this music or are positively or negatively affected by its messages.”

“For example, positively framed references to mental health awareness, treatment, or support may lead to reduced stigma and increased willingness to seek treatment,” Mr. Kresovich and associates wrote. “However, negatively framed references to mental health struggles might lead to negative outcomes, including copycat behavior in which listeners model harmful behavior, such as suicide attempts, if those behaviors are described in lyrics (i.e., the Werther effect),” they added.

Despite these limitations, the results support the need for more research on the impact of rap music as a way to reduce stigma and potentially reduce mental health risk in adolescents and young adults, Mr. Kresovich and associates concluded.
 

Music may help raise tough topics

The study is important because children and adolescents have more control than ever over the media they consume, Sarah Vinson, MD, founder of the Lorio Psych Group in Atlanta, said in an interview.

“With more and more children with access to their own devices, they spend a great amount of time consuming content, including music,” Dr. Vinson said. “The norms reflected in the lyrics they hear have an impact on their emerging view of themselves, others, and the world.”  

The increased recognition of mental health issues by rap musicians as a topic “certainly has the potential to have a positive impact; however, the way that it is discussed can influence [the] nature of that impact,” she explained.

“It is important for people who are dealing with the normal range of human emotions to know that they are not alone. It is even more important for people dealing with suicidality or mental illness to know that,” Dr. Vinson said.

“Validation and sense of connection are human needs, and stigma related to mental illness can be isolating,” she emphasized. “Rappers have a platform and are often people that children and adolescents look up to, for better or for worse.” Through their music, “the rappers are signaling that these topics are worthy of our attention and okay to talk about.”

Unfortunately, many barriers persist for adolescents in need of mental health treatment, said Dr. Vinson. “The children’s mental health workforce, quantitatively, is not enough to meet the current needs,” she said. “Mental health is not reimbursed at the same rate as other kinds of health care, which contributes to healthy systems not prioritizing these services. Additionally, the racial, ethnic, and socioeconomic background of those who are mental health providers is not reflective of the larger population, and mental health training insufficiently incorporates the cultural and structural humility needed to help professionals navigate those differences,” she explained.

“Children at increased risk are those who face many of those environmental barriers that the rappers reference in those lyrics. They are likely to have even poorer access because they are disproportionately impacted by residential segregation, transportation challenges, financial barriers, and structural racism in mental health care,” Dr. Vinson added. A take-home message for clinicians is to find out what their patients are listening to. “One way to understand what is on the hearts and minds of children is to ask them what’s in their playlist,” she said. 

Additional research is needed to examine “moderating factors for the impact, good or bad, of increased mental health content in hip hop for young listeners’ mental health awareness, symptoms and/or interest in seeking treatment,” Dr. Vinson concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Dr. Vinson served as chair for a workshop on mental health and hip-hop at the American Psychiatric Association annual meeting. She had no financial conflicts to disclose.

SOURCE: Kresovich A et al. JAMA Pediatr. 2020 Dec 7. doi: 10.1001/jamapediatrics.2020.5155.

This article was updated on December 21, 2020.

References to mental health issues in popular rap music more than doubled in the period from 1998 to 2018, based on data from a review of 125 songs.

portishead1/Getty Images

Mental health distress is rising but often is undertreated among children and young adults in the United States, wrote Alex Kresovich, MA, of the University of North Carolina, Chapel Hill, and colleagues.

“Mental health risk especially is increasing among young Black/ African American male individuals (YBAAM), who are often disproportionately exposed to environmental, economic, and family stressors linked with depression and anxiety,” they said. Adolescents and young adults, especially YBAAM, make up a large part of the audience for rap music.

In recent years, more rap artists have disclosed mental health issues, and they have included mental health topics such as depression and suicidal thoughts into their music, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 125 songs from the period between 1998 and 2018, then assessed them for references to mental health. The song selections included the top 25 rap songs in 1998, 2003, 2008, 2013, and 2018, based on the Billboard music charts.

The majority of the songs (123) featured lead artists from North America, and 97 of them were Black/African American males. The average age of the artists was 28 years. “Prominent artists captured in the sample included 50 Cent, Drake, Eminem, Kanye West, Jay-Z, and Lil’Wayne, among others,” they said. The researchers divided mental health issues into four categories: anxiety or anxious thinking; depression or depressive thinking; metaphors (such as struggling with mental stability); and suicide or suicidal ideation.
 

Mental health references rise

Across the study period, 35 songs (28%) mentioned anxiety, 28 (22%) mentioned depression, 8 (6%) mentioned suicide, and 26 (21%) mentioned a mental health metaphor. The proportion of songs with a mental health reference increased in a significant linear trend across the study period for suicide (0%-12%), depression (16%-32%), and mental health metaphors (8%-44%).

All references to suicide or suicidal ideation were found in songs that were popular between 2013 and 2018, the researchers noted.

“This increase is important, given that rap artists serve as role models to their audience, which extends beyond YBAAM to include U.S. young people across strata, constituting a large group with increased risk of mental health issues and underuse of mental health services,” Mr. Kresovich and associates said.

In addition, the researchers found that stressors related to environmental conditions and love were significantly more likely to co-occur with mental health references (adjusted odds ratios 8.1 and 4.8, respectively).

The study findings were limited by several factors including the selection of songs only from the Billboard hot rap songs year-end charts, which “does not fully represent the population of rap music between 1998 and 2018,” the researchers said. In addition, they could not address causation or motivations for the increased mental health references over the study period. “We are also unable to ascertain how U.S. youth interact with this music or are positively or negatively affected by its messages.”

“For example, positively framed references to mental health awareness, treatment, or support may lead to reduced stigma and increased willingness to seek treatment,” Mr. Kresovich and associates wrote. “However, negatively framed references to mental health struggles might lead to negative outcomes, including copycat behavior in which listeners model harmful behavior, such as suicide attempts, if those behaviors are described in lyrics (i.e., the Werther effect),” they added.

Despite these limitations, the results support the need for more research on the impact of rap music as a way to reduce stigma and potentially reduce mental health risk in adolescents and young adults, Mr. Kresovich and associates concluded.
 

Music may help raise tough topics

The study is important because children and adolescents have more control than ever over the media they consume, Sarah Vinson, MD, founder of the Lorio Psych Group in Atlanta, said in an interview.

“With more and more children with access to their own devices, they spend a great amount of time consuming content, including music,” Dr. Vinson said. “The norms reflected in the lyrics they hear have an impact on their emerging view of themselves, others, and the world.”  

The increased recognition of mental health issues by rap musicians as a topic “certainly has the potential to have a positive impact; however, the way that it is discussed can influence [the] nature of that impact,” she explained.

“It is important for people who are dealing with the normal range of human emotions to know that they are not alone. It is even more important for people dealing with suicidality or mental illness to know that,” Dr. Vinson said.

“Validation and sense of connection are human needs, and stigma related to mental illness can be isolating,” she emphasized. “Rappers have a platform and are often people that children and adolescents look up to, for better or for worse.” Through their music, “the rappers are signaling that these topics are worthy of our attention and okay to talk about.”

Unfortunately, many barriers persist for adolescents in need of mental health treatment, said Dr. Vinson. “The children’s mental health workforce, quantitatively, is not enough to meet the current needs,” she said. “Mental health is not reimbursed at the same rate as other kinds of health care, which contributes to healthy systems not prioritizing these services. Additionally, the racial, ethnic, and socioeconomic background of those who are mental health providers is not reflective of the larger population, and mental health training insufficiently incorporates the cultural and structural humility needed to help professionals navigate those differences,” she explained.

“Children at increased risk are those who face many of those environmental barriers that the rappers reference in those lyrics. They are likely to have even poorer access because they are disproportionately impacted by residential segregation, transportation challenges, financial barriers, and structural racism in mental health care,” Dr. Vinson added. A take-home message for clinicians is to find out what their patients are listening to. “One way to understand what is on the hearts and minds of children is to ask them what’s in their playlist,” she said. 

Additional research is needed to examine “moderating factors for the impact, good or bad, of increased mental health content in hip hop for young listeners’ mental health awareness, symptoms and/or interest in seeking treatment,” Dr. Vinson concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Dr. Vinson served as chair for a workshop on mental health and hip-hop at the American Psychiatric Association annual meeting. She had no financial conflicts to disclose.

SOURCE: Kresovich A et al. JAMA Pediatr. 2020 Dec 7. doi: 10.1001/jamapediatrics.2020.5155.

This article was updated on December 21, 2020.

Cryoballoon and cryospray ablation were equivalent for eradicating dysplastic Barrett’s esophagus, according to the findings of a single-center retrospective study of 71 ablation-naive patients.

At 18 months, rates of complete eradication of dysplasia were 95.6% in patients who received cryoballoon therapy and 96% in recipients of cryospray, reported Mohammed Alshelleh, MD, of Northwell Health System, a tertiary care system in New Hyde Park, N.Y. Rates of complete eradication of intestinal metaplasia were 84.75% and 80%, respectively. However, selection bias was likely, and a post hoc power calculation suggested that the cryospray group was underpowered by four patients. “Prospective studies are needed to confirm [these] data,” Dr. Alshelleh and associates wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Cryotherapy is common for treating dysplastic Barrett’s esophagus when patients do not achieve remission with radiofrequency ablation. For treatment-naive individuals, prospective studies suggest that cryotherapy may be less painful and as effective as radiofrequency ablation, but no studies have directly compared the two commercially available systems: a cryogenic balloon catheter (C2 Cryoballoon, Pentax Medical, Montvale, N.J.) that delivers cryogenic nitrous oxide (–85° C) into an inflated balloon in direct contact with the esophageal mucosa, and a spray cryotherapy system (truFreeze, Steris Endoscopy, Mentor, Ohio), which flash-freezes the mucosa to –196° C by delivering liquid nitrogen through a low-pressure catheter that is not directly in contact with the esophagus.

For the study, the investigators retrospectively compared rates of complete eradication of dysplasia, and complete eradication of intestinal metaplasia, among ablation-naive patients at their institution who had received one of these two cryogenic modalities between 2015 and 2019. All patients were treated at least twice, at 3-month intervals, and were followed for least 12 months, or until complete eradication of intestinal metaplasia was confirmed by at least one endoscopic biopsy. In all, 46 patients received cryoballoon therapy and 25 received cryospray. Outcomes between the two modalities showed no significant differences in subgroups stratified by baseline histology, nor were there significant differences in rates of postprocedural stricture (8.7% in the cryoballoon group vs. 12% in the cryospray group). However, the investigators acknowledged that the study was underpowered. Overall, clinicians tended to prefer cryoballoon because it uses prefilled nitrous oxide cartridges, making it unnecessary to fill up a large nitrogen tank or use a “cumbersome decompression tube,” the investigators wrote. “However, in patients with a very large hiatal hernia or if there was a need to treat in a retroflexed position, spray cryotherapy was used given its ease of use over cryoballoon in these scenarios. Finally, cryospray is more amenable to treat larger surface areas of Barrett’s versus the focal cryoballoon that treats focal areas, and thus was the cryotherapy choice for a long segment of Barrett’s.”

The investigators reported receiving no grant support. One investigator disclosed ties to Olympus America, Pentax Medical Research, and Ninepoint Medical.

SOURCE: Alshelleh M et al. Tech Innov Gastrointest Endosc. 2020 Jul 26. doi: 10.1016/j.tige.2020.07.004.

Cryoballoon and cryospray ablation were equivalent for eradicating dysplastic Barrett’s esophagus, according to the findings of a single-center retrospective study of 71 ablation-naive patients.

At 18 months, rates of complete eradication of dysplasia were 95.6% in patients who received cryoballoon therapy and 96% in recipients of cryospray, reported Mohammed Alshelleh, MD, of Northwell Health System, a tertiary care system in New Hyde Park, N.Y. Rates of complete eradication of intestinal metaplasia were 84.75% and 80%, respectively. However, selection bias was likely, and a post hoc power calculation suggested that the cryospray group was underpowered by four patients. “Prospective studies are needed to confirm [these] data,” Dr. Alshelleh and associates wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Cryotherapy is common for treating dysplastic Barrett’s esophagus when patients do not achieve remission with radiofrequency ablation. For treatment-naive individuals, prospective studies suggest that cryotherapy may be less painful and as effective as radiofrequency ablation, but no studies have directly compared the two commercially available systems: a cryogenic balloon catheter (C2 Cryoballoon, Pentax Medical, Montvale, N.J.) that delivers cryogenic nitrous oxide (–85° C) into an inflated balloon in direct contact with the esophageal mucosa, and a spray cryotherapy system (truFreeze, Steris Endoscopy, Mentor, Ohio), which flash-freezes the mucosa to –196° C by delivering liquid nitrogen through a low-pressure catheter that is not directly in contact with the esophagus.

For the study, the investigators retrospectively compared rates of complete eradication of dysplasia, and complete eradication of intestinal metaplasia, among ablation-naive patients at their institution who had received one of these two cryogenic modalities between 2015 and 2019. All patients were treated at least twice, at 3-month intervals, and were followed for least 12 months, or until complete eradication of intestinal metaplasia was confirmed by at least one endoscopic biopsy. In all, 46 patients received cryoballoon therapy and 25 received cryospray. Outcomes between the two modalities showed no significant differences in subgroups stratified by baseline histology, nor were there significant differences in rates of postprocedural stricture (8.7% in the cryoballoon group vs. 12% in the cryospray group). However, the investigators acknowledged that the study was underpowered. Overall, clinicians tended to prefer cryoballoon because it uses prefilled nitrous oxide cartridges, making it unnecessary to fill up a large nitrogen tank or use a “cumbersome decompression tube,” the investigators wrote. “However, in patients with a very large hiatal hernia or if there was a need to treat in a retroflexed position, spray cryotherapy was used given its ease of use over cryoballoon in these scenarios. Finally, cryospray is more amenable to treat larger surface areas of Barrett’s versus the focal cryoballoon that treats focal areas, and thus was the cryotherapy choice for a long segment of Barrett’s.”

The investigators reported receiving no grant support. One investigator disclosed ties to Olympus America, Pentax Medical Research, and Ninepoint Medical.

SOURCE: Alshelleh M et al. Tech Innov Gastrointest Endosc. 2020 Jul 26. doi: 10.1016/j.tige.2020.07.004.

Cryoballoon and cryospray ablation were equivalent for eradicating dysplastic Barrett’s esophagus, according to the findings of a single-center retrospective study of 71 ablation-naive patients.

At 18 months, rates of complete eradication of dysplasia were 95.6% in patients who received cryoballoon therapy and 96% in recipients of cryospray, reported Mohammed Alshelleh, MD, of Northwell Health System, a tertiary care system in New Hyde Park, N.Y. Rates of complete eradication of intestinal metaplasia were 84.75% and 80%, respectively. However, selection bias was likely, and a post hoc power calculation suggested that the cryospray group was underpowered by four patients. “Prospective studies are needed to confirm [these] data,” Dr. Alshelleh and associates wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

Cryotherapy is common for treating dysplastic Barrett’s esophagus when patients do not achieve remission with radiofrequency ablation. For treatment-naive individuals, prospective studies suggest that cryotherapy may be less painful and as effective as radiofrequency ablation, but no studies have directly compared the two commercially available systems: a cryogenic balloon catheter (C2 Cryoballoon, Pentax Medical, Montvale, N.J.) that delivers cryogenic nitrous oxide (–85° C) into an inflated balloon in direct contact with the esophageal mucosa, and a spray cryotherapy system (truFreeze, Steris Endoscopy, Mentor, Ohio), which flash-freezes the mucosa to –196° C by delivering liquid nitrogen through a low-pressure catheter that is not directly in contact with the esophagus.

For the study, the investigators retrospectively compared rates of complete eradication of dysplasia, and complete eradication of intestinal metaplasia, among ablation-naive patients at their institution who had received one of these two cryogenic modalities between 2015 and 2019. All patients were treated at least twice, at 3-month intervals, and were followed for least 12 months, or until complete eradication of intestinal metaplasia was confirmed by at least one endoscopic biopsy. In all, 46 patients received cryoballoon therapy and 25 received cryospray. Outcomes between the two modalities showed no significant differences in subgroups stratified by baseline histology, nor were there significant differences in rates of postprocedural stricture (8.7% in the cryoballoon group vs. 12% in the cryospray group). However, the investigators acknowledged that the study was underpowered. Overall, clinicians tended to prefer cryoballoon because it uses prefilled nitrous oxide cartridges, making it unnecessary to fill up a large nitrogen tank or use a “cumbersome decompression tube,” the investigators wrote. “However, in patients with a very large hiatal hernia or if there was a need to treat in a retroflexed position, spray cryotherapy was used given its ease of use over cryoballoon in these scenarios. Finally, cryospray is more amenable to treat larger surface areas of Barrett’s versus the focal cryoballoon that treats focal areas, and thus was the cryotherapy choice for a long segment of Barrett’s.”

The investigators reported receiving no grant support. One investigator disclosed ties to Olympus America, Pentax Medical Research, and Ninepoint Medical.

SOURCE: Alshelleh M et al. Tech Innov Gastrointest Endosc. 2020 Jul 26. doi: 10.1016/j.tige.2020.07.004.

Response rates were high without dose-limiting toxicities in a small phase 1 study that evaluated the addition of propranolol to pembrolizumab in treatment-naive patients with metastatic melanoma.

“To our knowledge, this effort is the first prospective clinical trial to show that the combination of propranolol with pembrolizumab is safe, and additionally suggests preliminary synergistic antitumor activity in treatment-naive metastatic melanoma,” wrote the two co-first authors, Shipra Gandhi, MD, and Manu Pandey, MBBS, from the Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and coauthors.

The need for combinations built on anti-PD1 checkpoint inhibitor therapy strategies in metastatic melanoma that safely improve outcomes is underscored by the high (59%) grade 3 or 4 treatment-related adverse event (TRAE) rates when an anti-CTLA4 agent (ipilimumab) was added to an anti-PD-1 agent (nivolumab), they noted. In contrast, a TRAE rate of only 17% has been reported with pembrolizumab monotherapy.

The phase 1b study was stimulated by preclinical, retrospective observations of improved overall survival (OS) in cancer patients treated with beta-blockers. These were preceded by murine melanoma studies showing decreased tumor growth and metastasis with the nonselective beta-blocker propranolol. “Propranolol exerts an antitumor effect,” the authors stated, “by favorably modulating the tumor microenvironment (TME) by decreasing myeloid-derived suppressor cells and increasing CD8+ T-cell and natural killer cells in the TME.” Other research in a melanoma model in chronically-stressed mice has demonstrated synergy between an anti-PD1 antibody and propranolol.

“We know that stress can have a significant negative effect on health, but the extent to which stress may impact the outcome of cancer therapy is not well understood at all,” Dr. Ghandi said in a statement provided by Roswell Park. “We set out to better understand this relationship and to explore its implications for cancer treatment.”

The investigators recruited nine White adults (median age 65 years) with treatment-naive, histologically confirmed unresectable stage III or IV melanoma and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 to the open-label, single arm, nonrandomized, single-center, dose-finding study. Patients received standard of care intravenous pembrolizumab 200 mg every 3 weeks and, in three groups, propranolol doses of 10 mg, 20 mg, or 30 mg twice a day until 2 years on study or disease progression or the development of dose-limiting toxicities (DLTs). Assessing the safety and efficacy (overall response rate [ORR] within 6 months of starting therapy) of pembrolizumab with the increasing doses of propranolol and selecting the recommended phase 2 dose were the study’s primary objectives.

Objective responses (complete or partial responses) were reported in seven of the nine patients, with partial tumor responses in two patients in the propranolol 10-mg group, two partial responses in the 20-mg group, and three partial responses in the 30-mg group.

While all patients experienced TRAEs, only one was above grade 2. The most commonly reported TRAEs were fatigue, rash and vitiligo, reported in four of the nine patients. Two patients in the 20-mg twice-a-day group discontinued therapy because of TRAEs (hemophagocytic lymphohistiocytosis and labyrinthitis). No DLTs were observed at any of the three dose levels, and no deaths occurred on study treatment.

The authors said that propranolol 30 mg twice a day was chosen as the recommended phase 2 dose, because in combination with pembrolizumab, there were no DLTs, and preliminary antitumor efficacy was observed in all three patients. Also, in all three patients, the investigators observed a trend toward higher CD8+T-cell percentage, higher ratios of CD8+T-cell/ Treg and CD8+T-cell/ polymorphonuclear myeloid-derived suppressor cells. They underscored, however, that the small size and significant heterogeneity in biomarkers made a statistically sound and meaningful interpretation of biomarkers for deciding the phase 2 dose difficult.

“In repurposing propranolol,” Dr. Pandey said in the Roswell statement, “we’ve gained important insights on how to manage stress in people with cancer – who can face dangerously elevated levels of mental and physical stress related to their diagnosis and treatment.”

In an interview, one of the two senior authors, Elizabeth Repasky, PhD, professor of oncology and immunology at Roswell Park, said, “it’s exciting that an extremely inexpensive drug like propranolol that could be used in every country around the world could have an impact on cancer by blocking stress, especially chronic stress.” Her murine research showing that adding propranolol to immunotherapy or radiotherapy or chemotherapy improved tumor growth control provided rationale for the current study.

“The breakthrough in this study is that it reveals the immune system as the best target to look at, and shows that what stress reduction is doing is improving a patient’s immune response to his or her own tumor,” Dr. Repasky said. “The mind/body connection is so important, but we have not had a handle on how to study it,” she added.

Further research funded by Herd of Hope grants at Roswell will look at tumor effects of propranolol and nonpharmacological reducers of chronic stress such as exercise, meditation, yoga, and Tai Chi, with first studies in breast cancer.

The study was funded by Roswell Park, private, and NIH grants. The authors had no disclosures.
 

SOURCE: Gandhi S et al. Clin Cancer Res. 2020 Oct 30. doi: 10.1158/1078-0432.CCR-20-2381

Response rates were high without dose-limiting toxicities in a small phase 1 study that evaluated the addition of propranolol to pembrolizumab in treatment-naive patients with metastatic melanoma.

“To our knowledge, this effort is the first prospective clinical trial to show that the combination of propranolol with pembrolizumab is safe, and additionally suggests preliminary synergistic antitumor activity in treatment-naive metastatic melanoma,” wrote the two co-first authors, Shipra Gandhi, MD, and Manu Pandey, MBBS, from the Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and coauthors.

The need for combinations built on anti-PD1 checkpoint inhibitor therapy strategies in metastatic melanoma that safely improve outcomes is underscored by the high (59%) grade 3 or 4 treatment-related adverse event (TRAE) rates when an anti-CTLA4 agent (ipilimumab) was added to an anti-PD-1 agent (nivolumab), they noted. In contrast, a TRAE rate of only 17% has been reported with pembrolizumab monotherapy.

The phase 1b study was stimulated by preclinical, retrospective observations of improved overall survival (OS) in cancer patients treated with beta-blockers. These were preceded by murine melanoma studies showing decreased tumor growth and metastasis with the nonselective beta-blocker propranolol. “Propranolol exerts an antitumor effect,” the authors stated, “by favorably modulating the tumor microenvironment (TME) by decreasing myeloid-derived suppressor cells and increasing CD8+ T-cell and natural killer cells in the TME.” Other research in a melanoma model in chronically-stressed mice has demonstrated synergy between an anti-PD1 antibody and propranolol.

“We know that stress can have a significant negative effect on health, but the extent to which stress may impact the outcome of cancer therapy is not well understood at all,” Dr. Ghandi said in a statement provided by Roswell Park. “We set out to better understand this relationship and to explore its implications for cancer treatment.”

The investigators recruited nine White adults (median age 65 years) with treatment-naive, histologically confirmed unresectable stage III or IV melanoma and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 to the open-label, single arm, nonrandomized, single-center, dose-finding study. Patients received standard of care intravenous pembrolizumab 200 mg every 3 weeks and, in three groups, propranolol doses of 10 mg, 20 mg, or 30 mg twice a day until 2 years on study or disease progression or the development of dose-limiting toxicities (DLTs). Assessing the safety and efficacy (overall response rate [ORR] within 6 months of starting therapy) of pembrolizumab with the increasing doses of propranolol and selecting the recommended phase 2 dose were the study’s primary objectives.

Objective responses (complete or partial responses) were reported in seven of the nine patients, with partial tumor responses in two patients in the propranolol 10-mg group, two partial responses in the 20-mg group, and three partial responses in the 30-mg group.

While all patients experienced TRAEs, only one was above grade 2. The most commonly reported TRAEs were fatigue, rash and vitiligo, reported in four of the nine patients. Two patients in the 20-mg twice-a-day group discontinued therapy because of TRAEs (hemophagocytic lymphohistiocytosis and labyrinthitis). No DLTs were observed at any of the three dose levels, and no deaths occurred on study treatment.

The authors said that propranolol 30 mg twice a day was chosen as the recommended phase 2 dose, because in combination with pembrolizumab, there were no DLTs, and preliminary antitumor efficacy was observed in all three patients. Also, in all three patients, the investigators observed a trend toward higher CD8+T-cell percentage, higher ratios of CD8+T-cell/ Treg and CD8+T-cell/ polymorphonuclear myeloid-derived suppressor cells. They underscored, however, that the small size and significant heterogeneity in biomarkers made a statistically sound and meaningful interpretation of biomarkers for deciding the phase 2 dose difficult.

“In repurposing propranolol,” Dr. Pandey said in the Roswell statement, “we’ve gained important insights on how to manage stress in people with cancer – who can face dangerously elevated levels of mental and physical stress related to their diagnosis and treatment.”

In an interview, one of the two senior authors, Elizabeth Repasky, PhD, professor of oncology and immunology at Roswell Park, said, “it’s exciting that an extremely inexpensive drug like propranolol that could be used in every country around the world could have an impact on cancer by blocking stress, especially chronic stress.” Her murine research showing that adding propranolol to immunotherapy or radiotherapy or chemotherapy improved tumor growth control provided rationale for the current study.

“The breakthrough in this study is that it reveals the immune system as the best target to look at, and shows that what stress reduction is doing is improving a patient’s immune response to his or her own tumor,” Dr. Repasky said. “The mind/body connection is so important, but we have not had a handle on how to study it,” she added.

Further research funded by Herd of Hope grants at Roswell will look at tumor effects of propranolol and nonpharmacological reducers of chronic stress such as exercise, meditation, yoga, and Tai Chi, with first studies in breast cancer.

The study was funded by Roswell Park, private, and NIH grants. The authors had no disclosures.
 

SOURCE: Gandhi S et al. Clin Cancer Res. 2020 Oct 30. doi: 10.1158/1078-0432.CCR-20-2381

Response rates were high without dose-limiting toxicities in a small phase 1 study that evaluated the addition of propranolol to pembrolizumab in treatment-naive patients with metastatic melanoma.

“To our knowledge, this effort is the first prospective clinical trial to show that the combination of propranolol with pembrolizumab is safe, and additionally suggests preliminary synergistic antitumor activity in treatment-naive metastatic melanoma,” wrote the two co-first authors, Shipra Gandhi, MD, and Manu Pandey, MBBS, from the Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and coauthors.

The need for combinations built on anti-PD1 checkpoint inhibitor therapy strategies in metastatic melanoma that safely improve outcomes is underscored by the high (59%) grade 3 or 4 treatment-related adverse event (TRAE) rates when an anti-CTLA4 agent (ipilimumab) was added to an anti-PD-1 agent (nivolumab), they noted. In contrast, a TRAE rate of only 17% has been reported with pembrolizumab monotherapy.

The phase 1b study was stimulated by preclinical, retrospective observations of improved overall survival (OS) in cancer patients treated with beta-blockers. These were preceded by murine melanoma studies showing decreased tumor growth and metastasis with the nonselective beta-blocker propranolol. “Propranolol exerts an antitumor effect,” the authors stated, “by favorably modulating the tumor microenvironment (TME) by decreasing myeloid-derived suppressor cells and increasing CD8+ T-cell and natural killer cells in the TME.” Other research in a melanoma model in chronically-stressed mice has demonstrated synergy between an anti-PD1 antibody and propranolol.

“We know that stress can have a significant negative effect on health, but the extent to which stress may impact the outcome of cancer therapy is not well understood at all,” Dr. Ghandi said in a statement provided by Roswell Park. “We set out to better understand this relationship and to explore its implications for cancer treatment.”

The investigators recruited nine White adults (median age 65 years) with treatment-naive, histologically confirmed unresectable stage III or IV melanoma and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 to the open-label, single arm, nonrandomized, single-center, dose-finding study. Patients received standard of care intravenous pembrolizumab 200 mg every 3 weeks and, in three groups, propranolol doses of 10 mg, 20 mg, or 30 mg twice a day until 2 years on study or disease progression or the development of dose-limiting toxicities (DLTs). Assessing the safety and efficacy (overall response rate [ORR] within 6 months of starting therapy) of pembrolizumab with the increasing doses of propranolol and selecting the recommended phase 2 dose were the study’s primary objectives.

Objective responses (complete or partial responses) were reported in seven of the nine patients, with partial tumor responses in two patients in the propranolol 10-mg group, two partial responses in the 20-mg group, and three partial responses in the 30-mg group.

While all patients experienced TRAEs, only one was above grade 2. The most commonly reported TRAEs were fatigue, rash and vitiligo, reported in four of the nine patients. Two patients in the 20-mg twice-a-day group discontinued therapy because of TRAEs (hemophagocytic lymphohistiocytosis and labyrinthitis). No DLTs were observed at any of the three dose levels, and no deaths occurred on study treatment.

The authors said that propranolol 30 mg twice a day was chosen as the recommended phase 2 dose, because in combination with pembrolizumab, there were no DLTs, and preliminary antitumor efficacy was observed in all three patients. Also, in all three patients, the investigators observed a trend toward higher CD8+T-cell percentage, higher ratios of CD8+T-cell/ Treg and CD8+T-cell/ polymorphonuclear myeloid-derived suppressor cells. They underscored, however, that the small size and significant heterogeneity in biomarkers made a statistically sound and meaningful interpretation of biomarkers for deciding the phase 2 dose difficult.

“In repurposing propranolol,” Dr. Pandey said in the Roswell statement, “we’ve gained important insights on how to manage stress in people with cancer – who can face dangerously elevated levels of mental and physical stress related to their diagnosis and treatment.”

In an interview, one of the two senior authors, Elizabeth Repasky, PhD, professor of oncology and immunology at Roswell Park, said, “it’s exciting that an extremely inexpensive drug like propranolol that could be used in every country around the world could have an impact on cancer by blocking stress, especially chronic stress.” Her murine research showing that adding propranolol to immunotherapy or radiotherapy or chemotherapy improved tumor growth control provided rationale for the current study.

“The breakthrough in this study is that it reveals the immune system as the best target to look at, and shows that what stress reduction is doing is improving a patient’s immune response to his or her own tumor,” Dr. Repasky said. “The mind/body connection is so important, but we have not had a handle on how to study it,” she added.

Further research funded by Herd of Hope grants at Roswell will look at tumor effects of propranolol and nonpharmacological reducers of chronic stress such as exercise, meditation, yoga, and Tai Chi, with first studies in breast cancer.

The study was funded by Roswell Park, private, and NIH grants. The authors had no disclosures.
 

SOURCE: Gandhi S et al. Clin Cancer Res. 2020 Oct 30. doi: 10.1158/1078-0432.CCR-20-2381