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‘Loss-frame’ approach makes psoriasis patients more agreeable to treatment
, held virtually.
“We typically explain to patients the benefits of treatment,” Ari A. Kassardjian, BS, of the University of Southern California, Los Angeles, said in his presentation. “However, explaining to them the harmful effects on their skin and joint diseases, such as exacerbation of psoriasis and/or psoriatic arthritis, could offer some patients a new perspective that may influence their treatment preferences; and ultimately, better communication may lead to better medication adherence in patients.”
In the study he presented, explaining to patients possible outcomes without treatment was more effective in getting them to agree to treatment than was messaging that focused on the positive effects of a therapy (reducing disease severity and pain, and improved health).
He noted that the impact of framing choices in terms of gain or loss on decision-making has been measured in other areas of medicine, including in patients with multiple sclerosis where medication adherence is an issue (J Health Commun. 2017 Jun;22[6]:523-31). “Gain-framed” messages focus on the benefits of taking a medication, while “loss-framed” messages highlight the potential consequences of not agreeing or adhering to treatment.
In the study, Mr. Kassardjian and coinvestigators evaluated 90 patients with psoriasis who were randomized to receive a gain-framed or loss-framed message about a hypothetical new biologic injectable medication for psoriasis and psoriatic arthritis (PsA). More than half were male (64.4%), white (53.3%), and non-Hispanic or Latino (55.6%); and about one-fourth of the participants (27.8%) also had psoriatic arthritis (PsA).
The gain-framed message emphasized “the chance to reduce psoriasis severity, reduce joint pain, and improve how you feel overall,” while the loss-framed message described the downsides of not taking medication – missing out “on the chance to improve your skin, your joints, and your overall health,” with the possibility that psoriasis may get worse, “with worsening pain in your joints from psoriatic arthritis,” and feeling “worse overall.” Both messages included the side effects of the theoretical injectable, a small risk of injection-site pain and skin infections. After receiving the message, participants ranked their likelihood of taking the medication on an 11-point Likert scale, with a score of 0 indicating that they would “definitely” not use the medication and a score of 10 indicating that they would “definitely” use the medication.
Scores among those who received the loss-framed message were a mean of 8.84, compared with 7.11 among patients who received the gain-framed message (between-group difference; 1.73; P less than .0001). When comparing patients with and without PsA, the between-group difference was 1.90 for patients with PsA (P less than .0001) and 1.08 for patients who did not have PsA (P = .002). Comparing the responses of those with PsA and those without PsA, the between-group difference was 1.08 (P = .03). While PsA and non-PsA patients favored the loss-framed messages, “regardless of the framing type, PsA patients always responded with a greater preference for the therapy,” Mr. Kassardjian said.
Gender also had an effect on responsiveness to gain-framed or loss-framed messaging. Both men and women ranked the loss-framed messaging as making them more likely to use the medication, but the between-group difference for women (2.00; P = .008) was higher than in men (1.49; P = .003). However, the total men compared with total women between-group differences were not significant.
“In clinical practice, physicians regularly weigh the benefits and risks of treatment. In order to communicate this information to patients, it is important to understand how framing these benefits and risks impacts patient preferences for therapy,” Mr. Kassardjian said. “While most available biologics are effective and have tolerable safety profiles, many psoriasis patients may be hesitant to initiate these therapies. Thus, it is important to convey the benefits and risks of these systemic agents in ways that resonate with patients.”
Mr. Kassardjian reports receiving the Dean’s Research Scholarship at the University of Southern California, funded by the Wright Foundation at the time of the study. Senior author April Armstrong, MD, disclosed serving as an investigator and/or consultant for AbbVie, BMS, Dermavant, Dermira, Eli Lilly, Janssen, Leo Pharma, Kyowa Hakko Kirin, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB.
SOURCE: Kassardjian A. SID 2020, Abstract 489.
, held virtually.
“We typically explain to patients the benefits of treatment,” Ari A. Kassardjian, BS, of the University of Southern California, Los Angeles, said in his presentation. “However, explaining to them the harmful effects on their skin and joint diseases, such as exacerbation of psoriasis and/or psoriatic arthritis, could offer some patients a new perspective that may influence their treatment preferences; and ultimately, better communication may lead to better medication adherence in patients.”
In the study he presented, explaining to patients possible outcomes without treatment was more effective in getting them to agree to treatment than was messaging that focused on the positive effects of a therapy (reducing disease severity and pain, and improved health).
He noted that the impact of framing choices in terms of gain or loss on decision-making has been measured in other areas of medicine, including in patients with multiple sclerosis where medication adherence is an issue (J Health Commun. 2017 Jun;22[6]:523-31). “Gain-framed” messages focus on the benefits of taking a medication, while “loss-framed” messages highlight the potential consequences of not agreeing or adhering to treatment.
In the study, Mr. Kassardjian and coinvestigators evaluated 90 patients with psoriasis who were randomized to receive a gain-framed or loss-framed message about a hypothetical new biologic injectable medication for psoriasis and psoriatic arthritis (PsA). More than half were male (64.4%), white (53.3%), and non-Hispanic or Latino (55.6%); and about one-fourth of the participants (27.8%) also had psoriatic arthritis (PsA).
The gain-framed message emphasized “the chance to reduce psoriasis severity, reduce joint pain, and improve how you feel overall,” while the loss-framed message described the downsides of not taking medication – missing out “on the chance to improve your skin, your joints, and your overall health,” with the possibility that psoriasis may get worse, “with worsening pain in your joints from psoriatic arthritis,” and feeling “worse overall.” Both messages included the side effects of the theoretical injectable, a small risk of injection-site pain and skin infections. After receiving the message, participants ranked their likelihood of taking the medication on an 11-point Likert scale, with a score of 0 indicating that they would “definitely” not use the medication and a score of 10 indicating that they would “definitely” use the medication.
Scores among those who received the loss-framed message were a mean of 8.84, compared with 7.11 among patients who received the gain-framed message (between-group difference; 1.73; P less than .0001). When comparing patients with and without PsA, the between-group difference was 1.90 for patients with PsA (P less than .0001) and 1.08 for patients who did not have PsA (P = .002). Comparing the responses of those with PsA and those without PsA, the between-group difference was 1.08 (P = .03). While PsA and non-PsA patients favored the loss-framed messages, “regardless of the framing type, PsA patients always responded with a greater preference for the therapy,” Mr. Kassardjian said.
Gender also had an effect on responsiveness to gain-framed or loss-framed messaging. Both men and women ranked the loss-framed messaging as making them more likely to use the medication, but the between-group difference for women (2.00; P = .008) was higher than in men (1.49; P = .003). However, the total men compared with total women between-group differences were not significant.
“In clinical practice, physicians regularly weigh the benefits and risks of treatment. In order to communicate this information to patients, it is important to understand how framing these benefits and risks impacts patient preferences for therapy,” Mr. Kassardjian said. “While most available biologics are effective and have tolerable safety profiles, many psoriasis patients may be hesitant to initiate these therapies. Thus, it is important to convey the benefits and risks of these systemic agents in ways that resonate with patients.”
Mr. Kassardjian reports receiving the Dean’s Research Scholarship at the University of Southern California, funded by the Wright Foundation at the time of the study. Senior author April Armstrong, MD, disclosed serving as an investigator and/or consultant for AbbVie, BMS, Dermavant, Dermira, Eli Lilly, Janssen, Leo Pharma, Kyowa Hakko Kirin, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB.
SOURCE: Kassardjian A. SID 2020, Abstract 489.
, held virtually.
“We typically explain to patients the benefits of treatment,” Ari A. Kassardjian, BS, of the University of Southern California, Los Angeles, said in his presentation. “However, explaining to them the harmful effects on their skin and joint diseases, such as exacerbation of psoriasis and/or psoriatic arthritis, could offer some patients a new perspective that may influence their treatment preferences; and ultimately, better communication may lead to better medication adherence in patients.”
In the study he presented, explaining to patients possible outcomes without treatment was more effective in getting them to agree to treatment than was messaging that focused on the positive effects of a therapy (reducing disease severity and pain, and improved health).
He noted that the impact of framing choices in terms of gain or loss on decision-making has been measured in other areas of medicine, including in patients with multiple sclerosis where medication adherence is an issue (J Health Commun. 2017 Jun;22[6]:523-31). “Gain-framed” messages focus on the benefits of taking a medication, while “loss-framed” messages highlight the potential consequences of not agreeing or adhering to treatment.
In the study, Mr. Kassardjian and coinvestigators evaluated 90 patients with psoriasis who were randomized to receive a gain-framed or loss-framed message about a hypothetical new biologic injectable medication for psoriasis and psoriatic arthritis (PsA). More than half were male (64.4%), white (53.3%), and non-Hispanic or Latino (55.6%); and about one-fourth of the participants (27.8%) also had psoriatic arthritis (PsA).
The gain-framed message emphasized “the chance to reduce psoriasis severity, reduce joint pain, and improve how you feel overall,” while the loss-framed message described the downsides of not taking medication – missing out “on the chance to improve your skin, your joints, and your overall health,” with the possibility that psoriasis may get worse, “with worsening pain in your joints from psoriatic arthritis,” and feeling “worse overall.” Both messages included the side effects of the theoretical injectable, a small risk of injection-site pain and skin infections. After receiving the message, participants ranked their likelihood of taking the medication on an 11-point Likert scale, with a score of 0 indicating that they would “definitely” not use the medication and a score of 10 indicating that they would “definitely” use the medication.
Scores among those who received the loss-framed message were a mean of 8.84, compared with 7.11 among patients who received the gain-framed message (between-group difference; 1.73; P less than .0001). When comparing patients with and without PsA, the between-group difference was 1.90 for patients with PsA (P less than .0001) and 1.08 for patients who did not have PsA (P = .002). Comparing the responses of those with PsA and those without PsA, the between-group difference was 1.08 (P = .03). While PsA and non-PsA patients favored the loss-framed messages, “regardless of the framing type, PsA patients always responded with a greater preference for the therapy,” Mr. Kassardjian said.
Gender also had an effect on responsiveness to gain-framed or loss-framed messaging. Both men and women ranked the loss-framed messaging as making them more likely to use the medication, but the between-group difference for women (2.00; P = .008) was higher than in men (1.49; P = .003). However, the total men compared with total women between-group differences were not significant.
“In clinical practice, physicians regularly weigh the benefits and risks of treatment. In order to communicate this information to patients, it is important to understand how framing these benefits and risks impacts patient preferences for therapy,” Mr. Kassardjian said. “While most available biologics are effective and have tolerable safety profiles, many psoriasis patients may be hesitant to initiate these therapies. Thus, it is important to convey the benefits and risks of these systemic agents in ways that resonate with patients.”
Mr. Kassardjian reports receiving the Dean’s Research Scholarship at the University of Southern California, funded by the Wright Foundation at the time of the study. Senior author April Armstrong, MD, disclosed serving as an investigator and/or consultant for AbbVie, BMS, Dermavant, Dermira, Eli Lilly, Janssen, Leo Pharma, Kyowa Hakko Kirin, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB.
SOURCE: Kassardjian A. SID 2020, Abstract 489.
FROM SID 2020
California wildfires caused uptick in clinic visits for atopic dermatitis, itch
During the deadliest wildfire in California’s history in 2018, dermatology clinics 175 miles away at the University of California, San Francisco, experienced an increase in the number of pediatric and adult visits for pruritus and atopic dermatitis associated with air pollution created from the wildfire, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.
Not many studies have examined this potential association, but includes those that have found significant positive associations between exposure to air pollution and pruritus, the development of AD, and exacerbation of AD (J Allergy Clin Immunol. 2014 Nov;134[5]:993-9). Another study found outpatient visits for patients with eczema and dermatitis in Beijing increased as the level of particulate matter, nitrogen dioxide, and sulfur dioxide concentrations increased (Environ Sci Process Impacts. 2019 Jan 23;21[1]:163-73).
Mr. Faduda and colleagues set out to determine whether the number of appointments for and severity of skin disease increased as a result of the 2018 Camp Fire, which started in Paradise, Calif., using measures of air pollution and clinic visits in years where California did not experience a wildfire event as controls. Using the National Oceanic and Atmospheric Administration Hazard Mapping System for fire and smoke, the researchers graphed smoke plume density scores and particulate matter (PM2.5) concentrations in the area. They then calculated the number of UCSF dermatology clinic visits for AD/eczema, and measured severity of skin disease with appointments for itch symptoms, and the number of prescribed medications during that time using ICD-10 codes.
The Camp Fire rapidly spread over a period of 17 days, between Nov. 8 and 25, 2018, during which time, PM2.5 particulate matter concentrations increased 10-fold, while the NOAA smoke plume density score sharply increased. More pediatric and adult patients also seemed to be visiting clinics during this time, compared with several weeks before and several weeks after the fire, prompting a more expanded analysis of this signal, Mr. Fadadu said.
He and his coinvestigators compared data between October 2015 and February 2016 – a period of time where there were no wildfires in California – with data in 2018, when the Camp Fire occurred. They collected data on 3,448 adults and 699 children across 3 years with a total of 5,539 adult appointments for AD, 924 pediatric appointments for AD, 1,319 adult itch appointments, and 294 pediatric itch appointments. Cumulative and exposure lags were used to measure the effect of the wildfire in a Poisson regression analysis.
They found that, during the wildfire, pediatric AD weekly clinic visits were 1.75 times higher (95% confidence interval, 1.21-2.50) and pediatric itch visits were 2.10 times higher (95% CI, 1.44-3.00), compared with weeks where there was no fire. During the wildfire, pediatric AD clinic visits increased by 8% (rate ratio, 1.08; 95% CI, 1.04-1.12) per 10 mcg/m3 increase in PM2.5 concentration.
In adults, clinic visits for AD were 1.28 times higher (95% CI, 1.08-1.51) during the wildfire, compared with nonfire weeks. While there was a positive association between pollution exposure and adult AD, “this effect is less than what we observed” for pediatric AD visits, said Mr. Fadadu. Air pollution was positively associated with the development of itch symptoms in adults and more prescriptions for AD medications, but the results were not statistically significant.
“This may be explained by the fact that 80% of pediatric itch patients carried an AD diagnosis, while in contrast, only half of the adult itch patients also have a diagnosis of AD,” he said.
While there are several possible limitations of the research, including assessment of air pollution exposure, Mr. Fadadu said, “these results can inform how dermatologists counsel patients during future episodes of poor air quality, as well as expand comprehension of the broader health effects of climate change that can significantly impact quality of life.”
This study was funded by the UCSF Summer Explore Fellowship, Marguerite Schoeneman Award, and Joint Medical Program Thesis Grant.
During the deadliest wildfire in California’s history in 2018, dermatology clinics 175 miles away at the University of California, San Francisco, experienced an increase in the number of pediatric and adult visits for pruritus and atopic dermatitis associated with air pollution created from the wildfire, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.
Not many studies have examined this potential association, but includes those that have found significant positive associations between exposure to air pollution and pruritus, the development of AD, and exacerbation of AD (J Allergy Clin Immunol. 2014 Nov;134[5]:993-9). Another study found outpatient visits for patients with eczema and dermatitis in Beijing increased as the level of particulate matter, nitrogen dioxide, and sulfur dioxide concentrations increased (Environ Sci Process Impacts. 2019 Jan 23;21[1]:163-73).
Mr. Faduda and colleagues set out to determine whether the number of appointments for and severity of skin disease increased as a result of the 2018 Camp Fire, which started in Paradise, Calif., using measures of air pollution and clinic visits in years where California did not experience a wildfire event as controls. Using the National Oceanic and Atmospheric Administration Hazard Mapping System for fire and smoke, the researchers graphed smoke plume density scores and particulate matter (PM2.5) concentrations in the area. They then calculated the number of UCSF dermatology clinic visits for AD/eczema, and measured severity of skin disease with appointments for itch symptoms, and the number of prescribed medications during that time using ICD-10 codes.
The Camp Fire rapidly spread over a period of 17 days, between Nov. 8 and 25, 2018, during which time, PM2.5 particulate matter concentrations increased 10-fold, while the NOAA smoke plume density score sharply increased. More pediatric and adult patients also seemed to be visiting clinics during this time, compared with several weeks before and several weeks after the fire, prompting a more expanded analysis of this signal, Mr. Fadadu said.
He and his coinvestigators compared data between October 2015 and February 2016 – a period of time where there were no wildfires in California – with data in 2018, when the Camp Fire occurred. They collected data on 3,448 adults and 699 children across 3 years with a total of 5,539 adult appointments for AD, 924 pediatric appointments for AD, 1,319 adult itch appointments, and 294 pediatric itch appointments. Cumulative and exposure lags were used to measure the effect of the wildfire in a Poisson regression analysis.
They found that, during the wildfire, pediatric AD weekly clinic visits were 1.75 times higher (95% confidence interval, 1.21-2.50) and pediatric itch visits were 2.10 times higher (95% CI, 1.44-3.00), compared with weeks where there was no fire. During the wildfire, pediatric AD clinic visits increased by 8% (rate ratio, 1.08; 95% CI, 1.04-1.12) per 10 mcg/m3 increase in PM2.5 concentration.
In adults, clinic visits for AD were 1.28 times higher (95% CI, 1.08-1.51) during the wildfire, compared with nonfire weeks. While there was a positive association between pollution exposure and adult AD, “this effect is less than what we observed” for pediatric AD visits, said Mr. Fadadu. Air pollution was positively associated with the development of itch symptoms in adults and more prescriptions for AD medications, but the results were not statistically significant.
“This may be explained by the fact that 80% of pediatric itch patients carried an AD diagnosis, while in contrast, only half of the adult itch patients also have a diagnosis of AD,” he said.
While there are several possible limitations of the research, including assessment of air pollution exposure, Mr. Fadadu said, “these results can inform how dermatologists counsel patients during future episodes of poor air quality, as well as expand comprehension of the broader health effects of climate change that can significantly impact quality of life.”
This study was funded by the UCSF Summer Explore Fellowship, Marguerite Schoeneman Award, and Joint Medical Program Thesis Grant.
During the deadliest wildfire in California’s history in 2018, dermatology clinics 175 miles away at the University of California, San Francisco, experienced an increase in the number of pediatric and adult visits for pruritus and atopic dermatitis associated with air pollution created from the wildfire, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.
Not many studies have examined this potential association, but includes those that have found significant positive associations between exposure to air pollution and pruritus, the development of AD, and exacerbation of AD (J Allergy Clin Immunol. 2014 Nov;134[5]:993-9). Another study found outpatient visits for patients with eczema and dermatitis in Beijing increased as the level of particulate matter, nitrogen dioxide, and sulfur dioxide concentrations increased (Environ Sci Process Impacts. 2019 Jan 23;21[1]:163-73).
Mr. Faduda and colleagues set out to determine whether the number of appointments for and severity of skin disease increased as a result of the 2018 Camp Fire, which started in Paradise, Calif., using measures of air pollution and clinic visits in years where California did not experience a wildfire event as controls. Using the National Oceanic and Atmospheric Administration Hazard Mapping System for fire and smoke, the researchers graphed smoke plume density scores and particulate matter (PM2.5) concentrations in the area. They then calculated the number of UCSF dermatology clinic visits for AD/eczema, and measured severity of skin disease with appointments for itch symptoms, and the number of prescribed medications during that time using ICD-10 codes.
The Camp Fire rapidly spread over a period of 17 days, between Nov. 8 and 25, 2018, during which time, PM2.5 particulate matter concentrations increased 10-fold, while the NOAA smoke plume density score sharply increased. More pediatric and adult patients also seemed to be visiting clinics during this time, compared with several weeks before and several weeks after the fire, prompting a more expanded analysis of this signal, Mr. Fadadu said.
He and his coinvestigators compared data between October 2015 and February 2016 – a period of time where there were no wildfires in California – with data in 2018, when the Camp Fire occurred. They collected data on 3,448 adults and 699 children across 3 years with a total of 5,539 adult appointments for AD, 924 pediatric appointments for AD, 1,319 adult itch appointments, and 294 pediatric itch appointments. Cumulative and exposure lags were used to measure the effect of the wildfire in a Poisson regression analysis.
They found that, during the wildfire, pediatric AD weekly clinic visits were 1.75 times higher (95% confidence interval, 1.21-2.50) and pediatric itch visits were 2.10 times higher (95% CI, 1.44-3.00), compared with weeks where there was no fire. During the wildfire, pediatric AD clinic visits increased by 8% (rate ratio, 1.08; 95% CI, 1.04-1.12) per 10 mcg/m3 increase in PM2.5 concentration.
In adults, clinic visits for AD were 1.28 times higher (95% CI, 1.08-1.51) during the wildfire, compared with nonfire weeks. While there was a positive association between pollution exposure and adult AD, “this effect is less than what we observed” for pediatric AD visits, said Mr. Fadadu. Air pollution was positively associated with the development of itch symptoms in adults and more prescriptions for AD medications, but the results were not statistically significant.
“This may be explained by the fact that 80% of pediatric itch patients carried an AD diagnosis, while in contrast, only half of the adult itch patients also have a diagnosis of AD,” he said.
While there are several possible limitations of the research, including assessment of air pollution exposure, Mr. Fadadu said, “these results can inform how dermatologists counsel patients during future episodes of poor air quality, as well as expand comprehension of the broader health effects of climate change that can significantly impact quality of life.”
This study was funded by the UCSF Summer Explore Fellowship, Marguerite Schoeneman Award, and Joint Medical Program Thesis Grant.
FROM SID 2020
AAP releases updated guidance on male teen sexual, reproductive health
The American Academy of Pediatrics’ Committee on Adolescence has updated its guidance on addressing sexual reproductive health in male adolescents.
Since the last guidance was published by AAP in 2011, new data have been released that focus on adolescent male sexual behavior, their use of media, sexually transmitted infections (STIs), vaccination for human papillomavirus (HPV), discussions surrounding consent, and information for LGBT individuals.
“Of all these recommendations, the most significant changes are to provide more STI screening for higher risk males and vaccinate all males for HPV starting as early as age 9 years old,” lead author Laura K. Grubb, MD, director of adolescent medicine at Floating Hospital for Children at Tufts Medical Center, Boston, said in an interview.
AAP recommends pediatricians consider the following when discussing sexuality and reproductive health with adolescent males:
- Discuss the topics of sex and sexuality during routine visits and appropriate opportunities, taking the time to screen for sexual activity and identifying who is at higher risk.
- Ask male adolescent patients about social media use, how often they view pornography, and how they perceive sexually explicit material. If there is a concern that sexually explicit content is having an adverse effect on the patient, pediatricians should counsel patients and their parents on how to safely and sensibly use the Internet and social media.
- Screen for nonconsensual sexual activity during well visits and other visits, as appropriate. The principles of consent and nonconsent in the context of sexual activity should be discussed.
- For patients who are sexually active, screen for sexual problems, including any mental health issues and sexual dysfunction, and initiate counseling or pharmacotherapy where warranted.
- Coach male adolescent patients on broaching discussions about sex and family planning with their partners, including joint decision making on sexual and reproductive health. Contraception and barrier methods should be discussed and encouraged as appropriate.
- Assess each patient for appropriate STI risk, testing, and treatment/prevention for HIV, syphilis, chlamydia, and gonorrhea.
- Consider HPV vaccination for children at least 9 years old and start administration starting at 11 years old. according to the guidance.
Dr. Grubb said she hopes this guidance helps start a conversation between pediatricians and their adolescent male patients. “Talk with your male adolescents about puberty, sexuality, and reproductive health! When pediatricians are informed about these issues and take the initiative to discuss these topics with adolescent males, they are uniquely situated to help them navigate this challenging time safely and confidently.”
“I am especially excited about the significant resources this report provides for pediatricians in the supplemental document,” Dr. Grubb added. “There are so many great resources out there, especially on the Internet, for adolescents, parents, and pediatricians.”
Kelly Curran, MD, adolescent medicine specialist and assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, said in an interview that the guidance information on sexting, “sextortion,” and sexual dysfunction are important updates for pediatricians. Sextortion is defined as the “threatened dissemination of explicit, intimate, or embarrassing images of a sexual nature without consent, usually for the purpose of procuring additional images, sexual acts, money, or something else.”
“We have all seen how social media and technology has transformed adolescence, especially with the rise of sexting. We must remember that males are often the victims of ‘sextortion’ and sexual assault, especially sexual minority youth, and men may not have the support and services to which female victims have access,” said Dr. Curran, who was not a member of the committee.
Another important area where pediatricians can help educate adolescent males and their parents is the concept of consent during sexual encounters.
“As we as a society are having more frank discussions around sexual assault and rape, I think it is essential there is a continued dialogue with young people about consent. Pediatricians have an important role to play in the discussion with their patients, especially in regard to paying attention to verbal and nonverbal cues, and recognizing that consent is an ongoing process, instead of a ‘one time thing,’ ” said Dr. Curran, who is a member of the Pediatric News editorial advisory board.
One area of the new AAP guidance that surprised Dr. Curran was the number of adolescent males reporting sexual dysfunction – 4%. “While it’s something I ask about periodically in young men, I haven’t been consistently asking in visits for those who are at risk,” she said. “This guideline reminds me to screen more frequently, especially as patients may be too embarrassed to ask.”
Concerning STI screening, Dr. Curran feels guidelines from the Centers for Disease Control and Prevention and the United States Preventive Services Task Force (USPSTF) don’t go far enough, and the AAP’s guidance to provide routine STI risk assessment for all patients is more appropriate.
“We know that STIs are on the rise and adolescents experience high rates of STI, yet there are only routine screening guidelines for adolescent and young adult women and ‘at-risk’ populations or in areas of higher prevalence,” she said. “In my experience, all sexually active adolescents are ‘at risk.’ I think there should be universal screening of all sexually active adolescents and young adults.”
The paper had no funding source, and the authors reported no relevant conflicts of interest. Dr. Curran also reported no relevant conflicts of interest.
SOURCE: Grubb L et al. Pediatrics. 2020 Apr 27;145(5):e20200627.
The American Academy of Pediatrics’ Committee on Adolescence has updated its guidance on addressing sexual reproductive health in male adolescents.
Since the last guidance was published by AAP in 2011, new data have been released that focus on adolescent male sexual behavior, their use of media, sexually transmitted infections (STIs), vaccination for human papillomavirus (HPV), discussions surrounding consent, and information for LGBT individuals.
“Of all these recommendations, the most significant changes are to provide more STI screening for higher risk males and vaccinate all males for HPV starting as early as age 9 years old,” lead author Laura K. Grubb, MD, director of adolescent medicine at Floating Hospital for Children at Tufts Medical Center, Boston, said in an interview.
AAP recommends pediatricians consider the following when discussing sexuality and reproductive health with adolescent males:
- Discuss the topics of sex and sexuality during routine visits and appropriate opportunities, taking the time to screen for sexual activity and identifying who is at higher risk.
- Ask male adolescent patients about social media use, how often they view pornography, and how they perceive sexually explicit material. If there is a concern that sexually explicit content is having an adverse effect on the patient, pediatricians should counsel patients and their parents on how to safely and sensibly use the Internet and social media.
- Screen for nonconsensual sexual activity during well visits and other visits, as appropriate. The principles of consent and nonconsent in the context of sexual activity should be discussed.
- For patients who are sexually active, screen for sexual problems, including any mental health issues and sexual dysfunction, and initiate counseling or pharmacotherapy where warranted.
- Coach male adolescent patients on broaching discussions about sex and family planning with their partners, including joint decision making on sexual and reproductive health. Contraception and barrier methods should be discussed and encouraged as appropriate.
- Assess each patient for appropriate STI risk, testing, and treatment/prevention for HIV, syphilis, chlamydia, and gonorrhea.
- Consider HPV vaccination for children at least 9 years old and start administration starting at 11 years old. according to the guidance.
Dr. Grubb said she hopes this guidance helps start a conversation between pediatricians and their adolescent male patients. “Talk with your male adolescents about puberty, sexuality, and reproductive health! When pediatricians are informed about these issues and take the initiative to discuss these topics with adolescent males, they are uniquely situated to help them navigate this challenging time safely and confidently.”
“I am especially excited about the significant resources this report provides for pediatricians in the supplemental document,” Dr. Grubb added. “There are so many great resources out there, especially on the Internet, for adolescents, parents, and pediatricians.”
Kelly Curran, MD, adolescent medicine specialist and assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, said in an interview that the guidance information on sexting, “sextortion,” and sexual dysfunction are important updates for pediatricians. Sextortion is defined as the “threatened dissemination of explicit, intimate, or embarrassing images of a sexual nature without consent, usually for the purpose of procuring additional images, sexual acts, money, or something else.”
“We have all seen how social media and technology has transformed adolescence, especially with the rise of sexting. We must remember that males are often the victims of ‘sextortion’ and sexual assault, especially sexual minority youth, and men may not have the support and services to which female victims have access,” said Dr. Curran, who was not a member of the committee.
Another important area where pediatricians can help educate adolescent males and their parents is the concept of consent during sexual encounters.
“As we as a society are having more frank discussions around sexual assault and rape, I think it is essential there is a continued dialogue with young people about consent. Pediatricians have an important role to play in the discussion with their patients, especially in regard to paying attention to verbal and nonverbal cues, and recognizing that consent is an ongoing process, instead of a ‘one time thing,’ ” said Dr. Curran, who is a member of the Pediatric News editorial advisory board.
One area of the new AAP guidance that surprised Dr. Curran was the number of adolescent males reporting sexual dysfunction – 4%. “While it’s something I ask about periodically in young men, I haven’t been consistently asking in visits for those who are at risk,” she said. “This guideline reminds me to screen more frequently, especially as patients may be too embarrassed to ask.”
Concerning STI screening, Dr. Curran feels guidelines from the Centers for Disease Control and Prevention and the United States Preventive Services Task Force (USPSTF) don’t go far enough, and the AAP’s guidance to provide routine STI risk assessment for all patients is more appropriate.
“We know that STIs are on the rise and adolescents experience high rates of STI, yet there are only routine screening guidelines for adolescent and young adult women and ‘at-risk’ populations or in areas of higher prevalence,” she said. “In my experience, all sexually active adolescents are ‘at risk.’ I think there should be universal screening of all sexually active adolescents and young adults.”
The paper had no funding source, and the authors reported no relevant conflicts of interest. Dr. Curran also reported no relevant conflicts of interest.
SOURCE: Grubb L et al. Pediatrics. 2020 Apr 27;145(5):e20200627.
The American Academy of Pediatrics’ Committee on Adolescence has updated its guidance on addressing sexual reproductive health in male adolescents.
Since the last guidance was published by AAP in 2011, new data have been released that focus on adolescent male sexual behavior, their use of media, sexually transmitted infections (STIs), vaccination for human papillomavirus (HPV), discussions surrounding consent, and information for LGBT individuals.
“Of all these recommendations, the most significant changes are to provide more STI screening for higher risk males and vaccinate all males for HPV starting as early as age 9 years old,” lead author Laura K. Grubb, MD, director of adolescent medicine at Floating Hospital for Children at Tufts Medical Center, Boston, said in an interview.
AAP recommends pediatricians consider the following when discussing sexuality and reproductive health with adolescent males:
- Discuss the topics of sex and sexuality during routine visits and appropriate opportunities, taking the time to screen for sexual activity and identifying who is at higher risk.
- Ask male adolescent patients about social media use, how often they view pornography, and how they perceive sexually explicit material. If there is a concern that sexually explicit content is having an adverse effect on the patient, pediatricians should counsel patients and their parents on how to safely and sensibly use the Internet and social media.
- Screen for nonconsensual sexual activity during well visits and other visits, as appropriate. The principles of consent and nonconsent in the context of sexual activity should be discussed.
- For patients who are sexually active, screen for sexual problems, including any mental health issues and sexual dysfunction, and initiate counseling or pharmacotherapy where warranted.
- Coach male adolescent patients on broaching discussions about sex and family planning with their partners, including joint decision making on sexual and reproductive health. Contraception and barrier methods should be discussed and encouraged as appropriate.
- Assess each patient for appropriate STI risk, testing, and treatment/prevention for HIV, syphilis, chlamydia, and gonorrhea.
- Consider HPV vaccination for children at least 9 years old and start administration starting at 11 years old. according to the guidance.
Dr. Grubb said she hopes this guidance helps start a conversation between pediatricians and their adolescent male patients. “Talk with your male adolescents about puberty, sexuality, and reproductive health! When pediatricians are informed about these issues and take the initiative to discuss these topics with adolescent males, they are uniquely situated to help them navigate this challenging time safely and confidently.”
“I am especially excited about the significant resources this report provides for pediatricians in the supplemental document,” Dr. Grubb added. “There are so many great resources out there, especially on the Internet, for adolescents, parents, and pediatricians.”
Kelly Curran, MD, adolescent medicine specialist and assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, said in an interview that the guidance information on sexting, “sextortion,” and sexual dysfunction are important updates for pediatricians. Sextortion is defined as the “threatened dissemination of explicit, intimate, or embarrassing images of a sexual nature without consent, usually for the purpose of procuring additional images, sexual acts, money, or something else.”
“We have all seen how social media and technology has transformed adolescence, especially with the rise of sexting. We must remember that males are often the victims of ‘sextortion’ and sexual assault, especially sexual minority youth, and men may not have the support and services to which female victims have access,” said Dr. Curran, who was not a member of the committee.
Another important area where pediatricians can help educate adolescent males and their parents is the concept of consent during sexual encounters.
“As we as a society are having more frank discussions around sexual assault and rape, I think it is essential there is a continued dialogue with young people about consent. Pediatricians have an important role to play in the discussion with their patients, especially in regard to paying attention to verbal and nonverbal cues, and recognizing that consent is an ongoing process, instead of a ‘one time thing,’ ” said Dr. Curran, who is a member of the Pediatric News editorial advisory board.
One area of the new AAP guidance that surprised Dr. Curran was the number of adolescent males reporting sexual dysfunction – 4%. “While it’s something I ask about periodically in young men, I haven’t been consistently asking in visits for those who are at risk,” she said. “This guideline reminds me to screen more frequently, especially as patients may be too embarrassed to ask.”
Concerning STI screening, Dr. Curran feels guidelines from the Centers for Disease Control and Prevention and the United States Preventive Services Task Force (USPSTF) don’t go far enough, and the AAP’s guidance to provide routine STI risk assessment for all patients is more appropriate.
“We know that STIs are on the rise and adolescents experience high rates of STI, yet there are only routine screening guidelines for adolescent and young adult women and ‘at-risk’ populations or in areas of higher prevalence,” she said. “In my experience, all sexually active adolescents are ‘at risk.’ I think there should be universal screening of all sexually active adolescents and young adults.”
The paper had no funding source, and the authors reported no relevant conflicts of interest. Dr. Curran also reported no relevant conflicts of interest.
SOURCE: Grubb L et al. Pediatrics. 2020 Apr 27;145(5):e20200627.
FROM PEDIATRICS
Latest data on COVID-19 patients with rheumatic diseases revealed in registry
An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.
The COVID-19 Global Rheumatology Alliance (GRA) has created pediatric and adult registries for health care providers to enter information on their rheumatology patients with COVID-19. The adult registry is hosted by the University of California, San Francisco, Research Electronic Data Capture system, while the Childhood Arthritis and Rheumatology Research Alliance is supporting the pediatric registry. A separate path for data entry of both adult and pediatric cases has been established through the European League Against Rheumatism for European countries and countries with EULAR member organizations.
Prior to the creation of the registries, there were no data available to guide rheumatologists in clinical decision making for their patients, noted Jinoos Yazdany, MD, MPH, COVID-19 GRA steering committee member and chief of the division of rheumatology at Zuckerberg San Francisco General Hospital. “COVID-19 has potential to severely affect those with rheumatologic diseases or those taking immunosuppressive drugs,” she said in an interview. “The GRA registries were designed to answer critical questions that will inform the medical care of this population.”
The GRA began on Twitter, with conversations between Leonard H. Calabrese, DO, of the Cleveland Clinic; Paul Sufka, MD, of HealthPartners in St. Paul, Minn.; Philip Robinson, MBChB, PhD, of the Royal Brisbane (Australia) Hospital; and herself, Dr. Yazdany said. Dr. Robinson started work on the governance of the GRA, Dr. Yazdany designed the data infrastructure, and Dr. Sufka approached his professional networks and social media followings to promote the effort and ask for support. The COVID-19 GRA steering committee representatives include patients, private practice rheumatologists, and international investigators. Listed among official supporters of the alliance are the American College of Rheumatology and EULAR along with more than 290 medical societies, institutions, journals, and other organizations in rheumatology.
The goal of the registries is to examine the health outcomes of patients with rheumatic diseases and COVID-19 based on sociodemographic factors, comorbidities, and clinical presentations of COVID-19 as well as what role taking immunosuppressive drugs prior to a COVID-19 infection play in helping or hindering outcomes. Hydroxychloroquine, used to treat lupus and arthritis, is a potential treatment candidate for COVID-19. Biologics such as tocilizumab (Actemra) and sarilumab (Kevzara), which target interleukin-6, and anakinra (Kineret), which targets IL-1, are treatment candidates for patients who have experienced COVID-related cytokine storm syndrome, which researchers believe may contribute to worsening or fatal cases.
Dr. Yazdany, who is also vice chair of real-world data infrastructure, registry, and institutional review board/ethics for the GRA, said that there are some important high-level trends in the data thus far. “People with lupus and those taking hydroxychloroquine are becoming infected with SARS-CoV-2, which is counter to misinformation on social media. Most people with rheumatic diseases on immunosuppression are recovering, which is great news for our patients.”
One of the major strengths of the registries is that each case is entered by the rheumatologist treating the patient and contains detailed clinical information, Dr. Yazdany said. However, the registry has no control group, it is not a population surveillance study, and it may contain selection bias through rheumatologists omitting milder, undiagnosed cases.
“The Global Alliance case reporting registry represents the collective effort of hundreds of rheumatologists across the world. I have never been more inspired by the strength and collaboration of the rheumatology community,” Dr. Yazdany said.
According to a paper published in the Lancet Rheumatology, which references data on 110 cases from the combined databases up to April 1, about three-fourths of cases presented with fever (79%) and cough (77%), and about half presented with shortness of breath (50%) and myalgia (45%).
Results from the global and UCSF registries
As of April 18, 334 cases were in the global and UCSF registries, with 121 patients (36%) in the database having both COVID-19 and RA, 33 patients (10%) with psoriatic arthritis, 58 patients (17%) with systemic lupus erythematosus, 28 patients (8%) with axial spondyloarthritis, 27 patients (8%) with vasculitis, and 19 patients (6%) with Sjögren’s syndrome. There were less than five cases reported for patients with the following rheumatic diseases: inflammatory myopathy, ocular inflammation, other inflammatory arthritis, polymyalgia rheumatica, sarcoidosis, systemic sclerosis, osteoporosis, psoriasis, isolated pulmonary capillaritis, gout, and autoinflammatory disease. A majority of the patients in the registries are women (74%) aged younger than 65 years (78%) and are white (52%).
The most common comorbid conditions among patients in the registry are hypertension (33%), lung disease (18%), diabetes (11%), cardiovascular disease (10%), chronic renal insufficiency or end-stage renal disease (7%), morbid obesity (7%), and cancer (4%). Before being diagnosed with COVID-19, 219 patients (66%) in the registry were taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), which included antimalarials, azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, and tacrolimus. A total of 122 patients (37%) were taking biologic DMARDs, 101 patients were taking glucocorticoids (30%), 86 patients (26%) were taking hydroxychloroquine, 41 patients (12%) were taking NSAIDs, and 18 patients (5%) were taking a Janus kinase inhibitor.
The most recent data from the registry show that 128 patients (38%) have been hospitalized for COVID-19, and 19 patients (6%) have died. Although 104 patients (31%) resolved their infections, 177 patients (53%) have a COVID-19 infection status of “unresolved,” and 53 patients (16%) have an unknown infection status.
EULAR registry results
As of April 21, 249 cases were in the EULAR registry, including 110 hospitalizations (44%) and 37 deaths (15%). Overall, 64% of these patients were women, and they had a median age of 60 years.
The top five diagnoses of these patients were RA (39%), psoriatic arthritis (15%), spondyloarthritis (9%), systemic lupus erythematosus (9%), and gout (5%). A total of 27% had no reported comorbidities, while lung disease occurred in 26%, hypertension in 34%, diabetes in 11%, and cardiovascular disease on 11%. The registry also reported use of any DMARD in 80%, including 62% on csDMARDs, 31% on biologics, and 2% on targeted synthetic DMARDs.
Ten authors in the Lancet Rheumatology paper reported personal and institutional relationships in the form of grants, corporate sponsorships, advisory board memberships, investigator appointments, speaker’s bureau positions, personal fees, and consultancies for a variety of pharmaceutical companies, agencies, societies, and other organizations. The other authors reported no relevant conflicts of interest.
An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.
The COVID-19 Global Rheumatology Alliance (GRA) has created pediatric and adult registries for health care providers to enter information on their rheumatology patients with COVID-19. The adult registry is hosted by the University of California, San Francisco, Research Electronic Data Capture system, while the Childhood Arthritis and Rheumatology Research Alliance is supporting the pediatric registry. A separate path for data entry of both adult and pediatric cases has been established through the European League Against Rheumatism for European countries and countries with EULAR member organizations.
Prior to the creation of the registries, there were no data available to guide rheumatologists in clinical decision making for their patients, noted Jinoos Yazdany, MD, MPH, COVID-19 GRA steering committee member and chief of the division of rheumatology at Zuckerberg San Francisco General Hospital. “COVID-19 has potential to severely affect those with rheumatologic diseases or those taking immunosuppressive drugs,” she said in an interview. “The GRA registries were designed to answer critical questions that will inform the medical care of this population.”
The GRA began on Twitter, with conversations between Leonard H. Calabrese, DO, of the Cleveland Clinic; Paul Sufka, MD, of HealthPartners in St. Paul, Minn.; Philip Robinson, MBChB, PhD, of the Royal Brisbane (Australia) Hospital; and herself, Dr. Yazdany said. Dr. Robinson started work on the governance of the GRA, Dr. Yazdany designed the data infrastructure, and Dr. Sufka approached his professional networks and social media followings to promote the effort and ask for support. The COVID-19 GRA steering committee representatives include patients, private practice rheumatologists, and international investigators. Listed among official supporters of the alliance are the American College of Rheumatology and EULAR along with more than 290 medical societies, institutions, journals, and other organizations in rheumatology.
The goal of the registries is to examine the health outcomes of patients with rheumatic diseases and COVID-19 based on sociodemographic factors, comorbidities, and clinical presentations of COVID-19 as well as what role taking immunosuppressive drugs prior to a COVID-19 infection play in helping or hindering outcomes. Hydroxychloroquine, used to treat lupus and arthritis, is a potential treatment candidate for COVID-19. Biologics such as tocilizumab (Actemra) and sarilumab (Kevzara), which target interleukin-6, and anakinra (Kineret), which targets IL-1, are treatment candidates for patients who have experienced COVID-related cytokine storm syndrome, which researchers believe may contribute to worsening or fatal cases.
Dr. Yazdany, who is also vice chair of real-world data infrastructure, registry, and institutional review board/ethics for the GRA, said that there are some important high-level trends in the data thus far. “People with lupus and those taking hydroxychloroquine are becoming infected with SARS-CoV-2, which is counter to misinformation on social media. Most people with rheumatic diseases on immunosuppression are recovering, which is great news for our patients.”
One of the major strengths of the registries is that each case is entered by the rheumatologist treating the patient and contains detailed clinical information, Dr. Yazdany said. However, the registry has no control group, it is not a population surveillance study, and it may contain selection bias through rheumatologists omitting milder, undiagnosed cases.
“The Global Alliance case reporting registry represents the collective effort of hundreds of rheumatologists across the world. I have never been more inspired by the strength and collaboration of the rheumatology community,” Dr. Yazdany said.
According to a paper published in the Lancet Rheumatology, which references data on 110 cases from the combined databases up to April 1, about three-fourths of cases presented with fever (79%) and cough (77%), and about half presented with shortness of breath (50%) and myalgia (45%).
Results from the global and UCSF registries
As of April 18, 334 cases were in the global and UCSF registries, with 121 patients (36%) in the database having both COVID-19 and RA, 33 patients (10%) with psoriatic arthritis, 58 patients (17%) with systemic lupus erythematosus, 28 patients (8%) with axial spondyloarthritis, 27 patients (8%) with vasculitis, and 19 patients (6%) with Sjögren’s syndrome. There were less than five cases reported for patients with the following rheumatic diseases: inflammatory myopathy, ocular inflammation, other inflammatory arthritis, polymyalgia rheumatica, sarcoidosis, systemic sclerosis, osteoporosis, psoriasis, isolated pulmonary capillaritis, gout, and autoinflammatory disease. A majority of the patients in the registries are women (74%) aged younger than 65 years (78%) and are white (52%).
The most common comorbid conditions among patients in the registry are hypertension (33%), lung disease (18%), diabetes (11%), cardiovascular disease (10%), chronic renal insufficiency or end-stage renal disease (7%), morbid obesity (7%), and cancer (4%). Before being diagnosed with COVID-19, 219 patients (66%) in the registry were taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), which included antimalarials, azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, and tacrolimus. A total of 122 patients (37%) were taking biologic DMARDs, 101 patients were taking glucocorticoids (30%), 86 patients (26%) were taking hydroxychloroquine, 41 patients (12%) were taking NSAIDs, and 18 patients (5%) were taking a Janus kinase inhibitor.
The most recent data from the registry show that 128 patients (38%) have been hospitalized for COVID-19, and 19 patients (6%) have died. Although 104 patients (31%) resolved their infections, 177 patients (53%) have a COVID-19 infection status of “unresolved,” and 53 patients (16%) have an unknown infection status.
EULAR registry results
As of April 21, 249 cases were in the EULAR registry, including 110 hospitalizations (44%) and 37 deaths (15%). Overall, 64% of these patients were women, and they had a median age of 60 years.
The top five diagnoses of these patients were RA (39%), psoriatic arthritis (15%), spondyloarthritis (9%), systemic lupus erythematosus (9%), and gout (5%). A total of 27% had no reported comorbidities, while lung disease occurred in 26%, hypertension in 34%, diabetes in 11%, and cardiovascular disease on 11%. The registry also reported use of any DMARD in 80%, including 62% on csDMARDs, 31% on biologics, and 2% on targeted synthetic DMARDs.
Ten authors in the Lancet Rheumatology paper reported personal and institutional relationships in the form of grants, corporate sponsorships, advisory board memberships, investigator appointments, speaker’s bureau positions, personal fees, and consultancies for a variety of pharmaceutical companies, agencies, societies, and other organizations. The other authors reported no relevant conflicts of interest.
An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.
The COVID-19 Global Rheumatology Alliance (GRA) has created pediatric and adult registries for health care providers to enter information on their rheumatology patients with COVID-19. The adult registry is hosted by the University of California, San Francisco, Research Electronic Data Capture system, while the Childhood Arthritis and Rheumatology Research Alliance is supporting the pediatric registry. A separate path for data entry of both adult and pediatric cases has been established through the European League Against Rheumatism for European countries and countries with EULAR member organizations.
Prior to the creation of the registries, there were no data available to guide rheumatologists in clinical decision making for their patients, noted Jinoos Yazdany, MD, MPH, COVID-19 GRA steering committee member and chief of the division of rheumatology at Zuckerberg San Francisco General Hospital. “COVID-19 has potential to severely affect those with rheumatologic diseases or those taking immunosuppressive drugs,” she said in an interview. “The GRA registries were designed to answer critical questions that will inform the medical care of this population.”
The GRA began on Twitter, with conversations between Leonard H. Calabrese, DO, of the Cleveland Clinic; Paul Sufka, MD, of HealthPartners in St. Paul, Minn.; Philip Robinson, MBChB, PhD, of the Royal Brisbane (Australia) Hospital; and herself, Dr. Yazdany said. Dr. Robinson started work on the governance of the GRA, Dr. Yazdany designed the data infrastructure, and Dr. Sufka approached his professional networks and social media followings to promote the effort and ask for support. The COVID-19 GRA steering committee representatives include patients, private practice rheumatologists, and international investigators. Listed among official supporters of the alliance are the American College of Rheumatology and EULAR along with more than 290 medical societies, institutions, journals, and other organizations in rheumatology.
The goal of the registries is to examine the health outcomes of patients with rheumatic diseases and COVID-19 based on sociodemographic factors, comorbidities, and clinical presentations of COVID-19 as well as what role taking immunosuppressive drugs prior to a COVID-19 infection play in helping or hindering outcomes. Hydroxychloroquine, used to treat lupus and arthritis, is a potential treatment candidate for COVID-19. Biologics such as tocilizumab (Actemra) and sarilumab (Kevzara), which target interleukin-6, and anakinra (Kineret), which targets IL-1, are treatment candidates for patients who have experienced COVID-related cytokine storm syndrome, which researchers believe may contribute to worsening or fatal cases.
Dr. Yazdany, who is also vice chair of real-world data infrastructure, registry, and institutional review board/ethics for the GRA, said that there are some important high-level trends in the data thus far. “People with lupus and those taking hydroxychloroquine are becoming infected with SARS-CoV-2, which is counter to misinformation on social media. Most people with rheumatic diseases on immunosuppression are recovering, which is great news for our patients.”
One of the major strengths of the registries is that each case is entered by the rheumatologist treating the patient and contains detailed clinical information, Dr. Yazdany said. However, the registry has no control group, it is not a population surveillance study, and it may contain selection bias through rheumatologists omitting milder, undiagnosed cases.
“The Global Alliance case reporting registry represents the collective effort of hundreds of rheumatologists across the world. I have never been more inspired by the strength and collaboration of the rheumatology community,” Dr. Yazdany said.
According to a paper published in the Lancet Rheumatology, which references data on 110 cases from the combined databases up to April 1, about three-fourths of cases presented with fever (79%) and cough (77%), and about half presented with shortness of breath (50%) and myalgia (45%).
Results from the global and UCSF registries
As of April 18, 334 cases were in the global and UCSF registries, with 121 patients (36%) in the database having both COVID-19 and RA, 33 patients (10%) with psoriatic arthritis, 58 patients (17%) with systemic lupus erythematosus, 28 patients (8%) with axial spondyloarthritis, 27 patients (8%) with vasculitis, and 19 patients (6%) with Sjögren’s syndrome. There were less than five cases reported for patients with the following rheumatic diseases: inflammatory myopathy, ocular inflammation, other inflammatory arthritis, polymyalgia rheumatica, sarcoidosis, systemic sclerosis, osteoporosis, psoriasis, isolated pulmonary capillaritis, gout, and autoinflammatory disease. A majority of the patients in the registries are women (74%) aged younger than 65 years (78%) and are white (52%).
The most common comorbid conditions among patients in the registry are hypertension (33%), lung disease (18%), diabetes (11%), cardiovascular disease (10%), chronic renal insufficiency or end-stage renal disease (7%), morbid obesity (7%), and cancer (4%). Before being diagnosed with COVID-19, 219 patients (66%) in the registry were taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), which included antimalarials, azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, and tacrolimus. A total of 122 patients (37%) were taking biologic DMARDs, 101 patients were taking glucocorticoids (30%), 86 patients (26%) were taking hydroxychloroquine, 41 patients (12%) were taking NSAIDs, and 18 patients (5%) were taking a Janus kinase inhibitor.
The most recent data from the registry show that 128 patients (38%) have been hospitalized for COVID-19, and 19 patients (6%) have died. Although 104 patients (31%) resolved their infections, 177 patients (53%) have a COVID-19 infection status of “unresolved,” and 53 patients (16%) have an unknown infection status.
EULAR registry results
As of April 21, 249 cases were in the EULAR registry, including 110 hospitalizations (44%) and 37 deaths (15%). Overall, 64% of these patients were women, and they had a median age of 60 years.
The top five diagnoses of these patients were RA (39%), psoriatic arthritis (15%), spondyloarthritis (9%), systemic lupus erythematosus (9%), and gout (5%). A total of 27% had no reported comorbidities, while lung disease occurred in 26%, hypertension in 34%, diabetes in 11%, and cardiovascular disease on 11%. The registry also reported use of any DMARD in 80%, including 62% on csDMARDs, 31% on biologics, and 2% on targeted synthetic DMARDs.
Ten authors in the Lancet Rheumatology paper reported personal and institutional relationships in the form of grants, corporate sponsorships, advisory board memberships, investigator appointments, speaker’s bureau positions, personal fees, and consultancies for a variety of pharmaceutical companies, agencies, societies, and other organizations. The other authors reported no relevant conflicts of interest.
Researchers investigate impact of smoking on COVID-19 risk
but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.
Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.
“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”
Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).
“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.
They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).
Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).
“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.
However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.
Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).
Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.
“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”
The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.
but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.
Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.
“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”
Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).
“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.
They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).
Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).
“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.
However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.
Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).
Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.
“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”
The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.
but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.
Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.
“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”
Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).
“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.
They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).
Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).
“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.
However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.
Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).
Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.
“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”
The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.
Ragweed SLIT tablets improve asthma outcome scores in patients with allergic rhinoconjunctivitis
during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.
David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV1) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.
The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.
Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.
This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.
“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”
Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.
“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”
Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.
This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.
SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.
during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.
David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV1) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.
The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.
Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.
This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.
“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”
Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.
“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”
Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.
This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.
SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.
during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.
David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV1) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.
The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.
Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.
This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.
“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”
Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.
“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”
Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.
This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.
SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.
FROM AAAAI
The wide-ranging impact of hospital closures
Clinicians struggle to balance priorities
On June 26, 2019, American Academic Health System and Philadelphia Academic Health System announced that Hahnemann University Hospital, a 496-bed tertiary care center in North Philadelphia in operation for over 170 years, would close that September.
The emergency department closed 52 days after the announcement, leaving little time for physicians and staff to coordinate care for patients and secure new employment. The announcement was also made right at the beginning of the new academic year, which meant residents and fellows were forced to find new training programs. In total, 2,500 workers at Hahnemann, including more than 570 hospitalists and physicians training as residents and fellows, were displaced as the hospital closed – the largest such closing in U.S. history.
For most of its existence, Hahnemann was a teaching hospital. While trainees were all eventually placed in new programs thanks to efforts from the Accreditation Council for Graduate Medical Education (ACGME), some of the permanent staff at Hahnemann weren’t so lucky. A month after the announcement, Drexel University’s president told university employees that 40% of the staff who worked at Hahnemann would be cut as a result of the closing. Drexel, also based in Philadelphia, had long had an academic affiliation agreement for training Drexel’s medical school students as a primary academic partner. Overall, Drexel’s entire clinical staff at Hahnemann was let go, and Tower Health Medical Group is expected to hire about 60% of the former Hahnemann staff.
Kevin D’Mello, MD, FACP, FHM, a hospitalist and assistant professor of medicine at Drexel University, said residents during Hahnemann’s closure were essentially teaching themselves how to swim. “There were just no laws, no rules,” he said.
The vast majority of programs accepting applications from residents at Hahnemann were sympathetic and accommodating, he said, but a few programs applied “pressure tactics” to some of the residents offered a transfer position, despite graduate medical education rules in place to prevent such a situation from happening. “The resident says: ‘Oh, well, I’m waiting to hear from this other program,’ ” said Dr. D’Mello. “They’d say: ‘Okay, well, we’re giving you a position now. You have 12 hours to answer.’ ”
Decision makers at the hospital also were not very forthcoming with information to residents, fellows and program directors, according to a recent paper written by Thomas J. Nasca, MD, current president and CEO of ACGME, and colleagues in the journal Academic Medicine (Nasca T et al. Acad Med. 2019 Dec 17. doi: 10.1097/ACM.0000000000003133). When Dr. Nasca and colleagues went to investigate the situation at Hahnemann firsthand, “the team found that residents, fellows, and program directors alike considered their voices to have been ignored in decision making and deemed themselves ‘out of the loop’ of important information that would affect their career transitions.”
While the hospital closed in September 2019, the effects are still being felt. In Pennsylvania, the Medical Care Availability and Reduction of Error Act requires that hospitals and providers have malpractice insurance, including tail insurance for when a doctor’s insurance policy expires. American Academic announced it would not be paying tail insurance for claims made while physicians were at Hahnemann. This meant residents, fellows and physicians who worked at Hahnemann during the closure would be on the hook for paying their own malpractice insurance.
“On one hand, the risk is very low for the house staff. Lawsuits that come up later for house staff are generally dropped at some point,” said William W. Pinsky, MD, FAAP, FACC, president and CEO of the Educational Commission for Foreign Medical Graduates (ECFMG). “But who wants to take that risk going forward? It’s an issue that’s still not resolved.”
The American Medical Association, Association of American Medical Colleges (AAMC), the Philadelphia County Medical Society, and other medical societies have collectively put pressure on Hahnemann’s owners to pay for tail coverage. Beyond a Feb. 10, 2020 deadline, former Hahnemann physicians were still expected to cover their own tail insurance.
To further complicate matters, American Academic attempted to auction more than 570 residency slots at Hahnemann. The slots were sold to a consortium of six health systems in the area – Thomas Jefferson University Hospitals, Einstein Healthcare Network, Temple University Health System, Main Line Health, Cooper University Health Care, and Christiana Care Health System – for $55 million. The Centers for Medicare & Medicaid Services opposed the sale, arguing that the slots are a contract that hospitals enter into with CMS, rather than an asset to be sold. An appeal is currently pending.
The case is being watched by former physicians at Hahnemann. “American Academic said, ‘If we don’t get this $55 million, we’re not going to be able to cover this tail insurance.’ They’re kind of linking the two things,” said Dr. D’Mello. “To me, it’s almost like putting pressure to allow the sale to happen.”
Urban hospital closures disrupt health system balance
When an urban hospital like Hahnemann University Hospital closes, there is a major disruption to patient care. Patients need to relocate to other nearby centers, and they may not always be able to follow their physician to the next health center.
If patients have comorbidities, are being tracked across multiple care points, or change physicians during a hospital closure, details can be missed and care can become more complicated for physicians who end up seeing the patient at a new center. For example, a patient receiving obstetrics care at a hospital that closes will have to reschedule their delivery at another health center, noted Dr. Pinsky.
“Where patients get lost is when there’s not a physician or an individual can keep track of all that, coordinate, and help to be sure that the patient follows through,” he said.
Patients at a closing hospital need to go somewhere else for care, and patient volume naturally increases at other nearby centers, potentially causing problems for systems without the resources to handle the spike in traffic.
“I’m a service director of quality improvement and patient safety for Drexel internal medicine. I know that those sort of jumps and volumes are what increases medical errors and potentially could create some adverse outcomes,” said Dr. D’Mello. “That’s something I’m particularly worried about.”
Physicians are also reconciling their own personal situations during a hospital closure, attempting to figure out their next step while at the same time helping patients figure out theirs. In the case of international medical graduates on J-1 or H1-B visas, who are dependent on hospital positions and training programs to remain in the United States, the situation can be even more dire.
During Hahnemann’s closure, Dr. Pinsky said that the ECFMG, which represents 11,000 individuals with J-1 visas across the country, reached out to the 55 individuals on J-1 visas at the hospital and offered them assistance, including working with the Department of State to ensure they aren’t in jeopardy of deportation before they secure another training program position.
The ECFMG, AMA, AAMC, and ACGME also offered funding to help J-1 visa holders who needed to relocate outside Philadelphia. “Many of them spent a lot of their money or all their money just coming over here,” said Dr. Pinsky. “This was a way to help defray some immediate costs that they might have.”
Education and research, of which hospitalists and residents play a large role, are likewise affected during a hospital closure, Dr. Pinsky said. “Education and research in the hospital is an important contributor to the community, health care and medical education nationally overall. When it’s not considered, there can be a significant asset that is lost in the process, which is hard to ever regain.
“The hospitalists have an integral role in medical education. In most hospitals where there is graduate medical education, particularly in internal medicine or pediatrics, and where there is a hospitalist program, it’s the hospitalists that do the majority of the in-hospital or inpatient training and education,” he added.
Rural hospital closures affect access to care
Since 2005, 163 rural hospitals have closed in the United States. When rural hospitals close, the situation for hospitalists and other physicians is different. In communities where a larger health system owns a hospital, such as when Vidant Health closed Pungo District Hospital in Belhaven, N.C., in 2014 before reopening a nonemergency clinic in the area in 2016, health care services for the community may have limited interruption.
However, if there isn’t a nearby system to join, many doctors will end up leaving the area. More than half of rural hospitals that close end up not providing any kind of supplementary health care service, according to the NC Rural Health Research Program.
“A lot of the hospitals that have closed have not been owned by a system,” said George H. Pink, PhD, deputy director of the NC Rural Health Research Program at the University of North Carolina at Chapel Hill. “They’ve been independent, freestanding, and that perhaps is one of the reasons why they’re closing, is because they haven’t been able to find a system that would buy them out and inject capital into the community.”
This can also have an effect on the number of health care providers in the area, Dr. Pink said. “Their ability to refer patients and treat patients locally may be affected. That’s why, in many towns where hospitals have closed, we see a drop in the number of providers, particularly primary care doctors who actually live in the community.”
Politicians and federal entities have proposed a number of solutions to help protect rural hospitals from closure. Sen. Charles Grassley (R-Iowa), Sen. Amy Klobuchar (D-Minn.), and Sen. Cory Gardener (R-Colo.) have sponsored bills in the Senate, while Rep. Sam Graves (R-Mo.) has introduced legislation in the House. The Medicare Payment Advisory Commission has proposed two models of rural hospital care, and there are additional models proposed by the Kansas Hospital Association. A pilot program in Pennsylvania, the Pennsylvania Rural Health Model, is testing how a global budget by CMS for all inpatient and hospital-based outcomes might help rural hospitals.
“What we haven’t had a lot of action on is actually testing these models out and seeing whether they will work, and in what kinds of communities they will work,” Dr. Pink said.
Hospitalists as community advocates
Dr. D’Mello, who wrote an article for the Journal of Hospital Medicine on Hahnemann’s ownership by a private equity firm (doi: 10.12788/jhm.3378), said that the inherent nature of a for-profit entity trying to make a hospital profitable is a bad sign for a hospital and not necessarily what is in the best interest for an academic institution or for doctors who train there.
“I don’t know if I could blame the private equity firm completely, but in retrospect, the private equity firms stepping in was like the death knell of the hospital,” he said of Hahnemann’s closure.
“I think what the community needs to know – what the health care community, patient community, the hospitalist community need to know – is that there’s got to be more attention paid to these types of issues during mergers and acquisitions to prevent this from happening,” Dr. Pinsky said.
One larger issue was Hahnemann’s position as a safety net hospital, which partly played into American Academic’s lack of success in making the hospital as profitable as they wanted it to be, Dr. D’Mello noted. Hahnemann’s patient population consisted mostly of minority patients on Medicare, Medicaid, and charity care insurance, while recent studies have shown that hospitals are more likely to succeed when they have a larger proportion of patients with private insurance.
“Studies show that, to [make more] money from private insurance, you really have to have this huge footprint, because then you’ve got a better ability to negotiate with these private insurance companies,” Dr. D’Mello said. “Whether that’s actually good for health care is a different issue.”
Despite their own situations, it is not unusual for hospitalists and hospital physicians to step up during a hospital closure and advocate for their patients on behalf of the community, Dr. Pink said.
“When hospitals are in financial difficulty and there’s the risk of closure, typically, the medical staff are among the first to step up and warn the community: ‘We’re at risk of losing our service. We need some help,’ ” he said. “Generally speaking, the local physicians have been at the forefront of helping to keep access to hospital care available in some of these small communities – unfortunately, not always successfully.”
Dr. D’Mello, Dr. Pinsky, and Dr. Pink report no relevant conflicts of interest.
Clinicians struggle to balance priorities
Clinicians struggle to balance priorities
On June 26, 2019, American Academic Health System and Philadelphia Academic Health System announced that Hahnemann University Hospital, a 496-bed tertiary care center in North Philadelphia in operation for over 170 years, would close that September.
The emergency department closed 52 days after the announcement, leaving little time for physicians and staff to coordinate care for patients and secure new employment. The announcement was also made right at the beginning of the new academic year, which meant residents and fellows were forced to find new training programs. In total, 2,500 workers at Hahnemann, including more than 570 hospitalists and physicians training as residents and fellows, were displaced as the hospital closed – the largest such closing in U.S. history.
For most of its existence, Hahnemann was a teaching hospital. While trainees were all eventually placed in new programs thanks to efforts from the Accreditation Council for Graduate Medical Education (ACGME), some of the permanent staff at Hahnemann weren’t so lucky. A month after the announcement, Drexel University’s president told university employees that 40% of the staff who worked at Hahnemann would be cut as a result of the closing. Drexel, also based in Philadelphia, had long had an academic affiliation agreement for training Drexel’s medical school students as a primary academic partner. Overall, Drexel’s entire clinical staff at Hahnemann was let go, and Tower Health Medical Group is expected to hire about 60% of the former Hahnemann staff.
Kevin D’Mello, MD, FACP, FHM, a hospitalist and assistant professor of medicine at Drexel University, said residents during Hahnemann’s closure were essentially teaching themselves how to swim. “There were just no laws, no rules,” he said.
The vast majority of programs accepting applications from residents at Hahnemann were sympathetic and accommodating, he said, but a few programs applied “pressure tactics” to some of the residents offered a transfer position, despite graduate medical education rules in place to prevent such a situation from happening. “The resident says: ‘Oh, well, I’m waiting to hear from this other program,’ ” said Dr. D’Mello. “They’d say: ‘Okay, well, we’re giving you a position now. You have 12 hours to answer.’ ”
Decision makers at the hospital also were not very forthcoming with information to residents, fellows and program directors, according to a recent paper written by Thomas J. Nasca, MD, current president and CEO of ACGME, and colleagues in the journal Academic Medicine (Nasca T et al. Acad Med. 2019 Dec 17. doi: 10.1097/ACM.0000000000003133). When Dr. Nasca and colleagues went to investigate the situation at Hahnemann firsthand, “the team found that residents, fellows, and program directors alike considered their voices to have been ignored in decision making and deemed themselves ‘out of the loop’ of important information that would affect their career transitions.”
While the hospital closed in September 2019, the effects are still being felt. In Pennsylvania, the Medical Care Availability and Reduction of Error Act requires that hospitals and providers have malpractice insurance, including tail insurance for when a doctor’s insurance policy expires. American Academic announced it would not be paying tail insurance for claims made while physicians were at Hahnemann. This meant residents, fellows and physicians who worked at Hahnemann during the closure would be on the hook for paying their own malpractice insurance.
“On one hand, the risk is very low for the house staff. Lawsuits that come up later for house staff are generally dropped at some point,” said William W. Pinsky, MD, FAAP, FACC, president and CEO of the Educational Commission for Foreign Medical Graduates (ECFMG). “But who wants to take that risk going forward? It’s an issue that’s still not resolved.”
The American Medical Association, Association of American Medical Colleges (AAMC), the Philadelphia County Medical Society, and other medical societies have collectively put pressure on Hahnemann’s owners to pay for tail coverage. Beyond a Feb. 10, 2020 deadline, former Hahnemann physicians were still expected to cover their own tail insurance.
To further complicate matters, American Academic attempted to auction more than 570 residency slots at Hahnemann. The slots were sold to a consortium of six health systems in the area – Thomas Jefferson University Hospitals, Einstein Healthcare Network, Temple University Health System, Main Line Health, Cooper University Health Care, and Christiana Care Health System – for $55 million. The Centers for Medicare & Medicaid Services opposed the sale, arguing that the slots are a contract that hospitals enter into with CMS, rather than an asset to be sold. An appeal is currently pending.
The case is being watched by former physicians at Hahnemann. “American Academic said, ‘If we don’t get this $55 million, we’re not going to be able to cover this tail insurance.’ They’re kind of linking the two things,” said Dr. D’Mello. “To me, it’s almost like putting pressure to allow the sale to happen.”
Urban hospital closures disrupt health system balance
When an urban hospital like Hahnemann University Hospital closes, there is a major disruption to patient care. Patients need to relocate to other nearby centers, and they may not always be able to follow their physician to the next health center.
If patients have comorbidities, are being tracked across multiple care points, or change physicians during a hospital closure, details can be missed and care can become more complicated for physicians who end up seeing the patient at a new center. For example, a patient receiving obstetrics care at a hospital that closes will have to reschedule their delivery at another health center, noted Dr. Pinsky.
“Where patients get lost is when there’s not a physician or an individual can keep track of all that, coordinate, and help to be sure that the patient follows through,” he said.
Patients at a closing hospital need to go somewhere else for care, and patient volume naturally increases at other nearby centers, potentially causing problems for systems without the resources to handle the spike in traffic.
“I’m a service director of quality improvement and patient safety for Drexel internal medicine. I know that those sort of jumps and volumes are what increases medical errors and potentially could create some adverse outcomes,” said Dr. D’Mello. “That’s something I’m particularly worried about.”
Physicians are also reconciling their own personal situations during a hospital closure, attempting to figure out their next step while at the same time helping patients figure out theirs. In the case of international medical graduates on J-1 or H1-B visas, who are dependent on hospital positions and training programs to remain in the United States, the situation can be even more dire.
During Hahnemann’s closure, Dr. Pinsky said that the ECFMG, which represents 11,000 individuals with J-1 visas across the country, reached out to the 55 individuals on J-1 visas at the hospital and offered them assistance, including working with the Department of State to ensure they aren’t in jeopardy of deportation before they secure another training program position.
The ECFMG, AMA, AAMC, and ACGME also offered funding to help J-1 visa holders who needed to relocate outside Philadelphia. “Many of them spent a lot of their money or all their money just coming over here,” said Dr. Pinsky. “This was a way to help defray some immediate costs that they might have.”
Education and research, of which hospitalists and residents play a large role, are likewise affected during a hospital closure, Dr. Pinsky said. “Education and research in the hospital is an important contributor to the community, health care and medical education nationally overall. When it’s not considered, there can be a significant asset that is lost in the process, which is hard to ever regain.
“The hospitalists have an integral role in medical education. In most hospitals where there is graduate medical education, particularly in internal medicine or pediatrics, and where there is a hospitalist program, it’s the hospitalists that do the majority of the in-hospital or inpatient training and education,” he added.
Rural hospital closures affect access to care
Since 2005, 163 rural hospitals have closed in the United States. When rural hospitals close, the situation for hospitalists and other physicians is different. In communities where a larger health system owns a hospital, such as when Vidant Health closed Pungo District Hospital in Belhaven, N.C., in 2014 before reopening a nonemergency clinic in the area in 2016, health care services for the community may have limited interruption.
However, if there isn’t a nearby system to join, many doctors will end up leaving the area. More than half of rural hospitals that close end up not providing any kind of supplementary health care service, according to the NC Rural Health Research Program.
“A lot of the hospitals that have closed have not been owned by a system,” said George H. Pink, PhD, deputy director of the NC Rural Health Research Program at the University of North Carolina at Chapel Hill. “They’ve been independent, freestanding, and that perhaps is one of the reasons why they’re closing, is because they haven’t been able to find a system that would buy them out and inject capital into the community.”
This can also have an effect on the number of health care providers in the area, Dr. Pink said. “Their ability to refer patients and treat patients locally may be affected. That’s why, in many towns where hospitals have closed, we see a drop in the number of providers, particularly primary care doctors who actually live in the community.”
Politicians and federal entities have proposed a number of solutions to help protect rural hospitals from closure. Sen. Charles Grassley (R-Iowa), Sen. Amy Klobuchar (D-Minn.), and Sen. Cory Gardener (R-Colo.) have sponsored bills in the Senate, while Rep. Sam Graves (R-Mo.) has introduced legislation in the House. The Medicare Payment Advisory Commission has proposed two models of rural hospital care, and there are additional models proposed by the Kansas Hospital Association. A pilot program in Pennsylvania, the Pennsylvania Rural Health Model, is testing how a global budget by CMS for all inpatient and hospital-based outcomes might help rural hospitals.
“What we haven’t had a lot of action on is actually testing these models out and seeing whether they will work, and in what kinds of communities they will work,” Dr. Pink said.
Hospitalists as community advocates
Dr. D’Mello, who wrote an article for the Journal of Hospital Medicine on Hahnemann’s ownership by a private equity firm (doi: 10.12788/jhm.3378), said that the inherent nature of a for-profit entity trying to make a hospital profitable is a bad sign for a hospital and not necessarily what is in the best interest for an academic institution or for doctors who train there.
“I don’t know if I could blame the private equity firm completely, but in retrospect, the private equity firms stepping in was like the death knell of the hospital,” he said of Hahnemann’s closure.
“I think what the community needs to know – what the health care community, patient community, the hospitalist community need to know – is that there’s got to be more attention paid to these types of issues during mergers and acquisitions to prevent this from happening,” Dr. Pinsky said.
One larger issue was Hahnemann’s position as a safety net hospital, which partly played into American Academic’s lack of success in making the hospital as profitable as they wanted it to be, Dr. D’Mello noted. Hahnemann’s patient population consisted mostly of minority patients on Medicare, Medicaid, and charity care insurance, while recent studies have shown that hospitals are more likely to succeed when they have a larger proportion of patients with private insurance.
“Studies show that, to [make more] money from private insurance, you really have to have this huge footprint, because then you’ve got a better ability to negotiate with these private insurance companies,” Dr. D’Mello said. “Whether that’s actually good for health care is a different issue.”
Despite their own situations, it is not unusual for hospitalists and hospital physicians to step up during a hospital closure and advocate for their patients on behalf of the community, Dr. Pink said.
“When hospitals are in financial difficulty and there’s the risk of closure, typically, the medical staff are among the first to step up and warn the community: ‘We’re at risk of losing our service. We need some help,’ ” he said. “Generally speaking, the local physicians have been at the forefront of helping to keep access to hospital care available in some of these small communities – unfortunately, not always successfully.”
Dr. D’Mello, Dr. Pinsky, and Dr. Pink report no relevant conflicts of interest.
On June 26, 2019, American Academic Health System and Philadelphia Academic Health System announced that Hahnemann University Hospital, a 496-bed tertiary care center in North Philadelphia in operation for over 170 years, would close that September.
The emergency department closed 52 days after the announcement, leaving little time for physicians and staff to coordinate care for patients and secure new employment. The announcement was also made right at the beginning of the new academic year, which meant residents and fellows were forced to find new training programs. In total, 2,500 workers at Hahnemann, including more than 570 hospitalists and physicians training as residents and fellows, were displaced as the hospital closed – the largest such closing in U.S. history.
For most of its existence, Hahnemann was a teaching hospital. While trainees were all eventually placed in new programs thanks to efforts from the Accreditation Council for Graduate Medical Education (ACGME), some of the permanent staff at Hahnemann weren’t so lucky. A month after the announcement, Drexel University’s president told university employees that 40% of the staff who worked at Hahnemann would be cut as a result of the closing. Drexel, also based in Philadelphia, had long had an academic affiliation agreement for training Drexel’s medical school students as a primary academic partner. Overall, Drexel’s entire clinical staff at Hahnemann was let go, and Tower Health Medical Group is expected to hire about 60% of the former Hahnemann staff.
Kevin D’Mello, MD, FACP, FHM, a hospitalist and assistant professor of medicine at Drexel University, said residents during Hahnemann’s closure were essentially teaching themselves how to swim. “There were just no laws, no rules,” he said.
The vast majority of programs accepting applications from residents at Hahnemann were sympathetic and accommodating, he said, but a few programs applied “pressure tactics” to some of the residents offered a transfer position, despite graduate medical education rules in place to prevent such a situation from happening. “The resident says: ‘Oh, well, I’m waiting to hear from this other program,’ ” said Dr. D’Mello. “They’d say: ‘Okay, well, we’re giving you a position now. You have 12 hours to answer.’ ”
Decision makers at the hospital also were not very forthcoming with information to residents, fellows and program directors, according to a recent paper written by Thomas J. Nasca, MD, current president and CEO of ACGME, and colleagues in the journal Academic Medicine (Nasca T et al. Acad Med. 2019 Dec 17. doi: 10.1097/ACM.0000000000003133). When Dr. Nasca and colleagues went to investigate the situation at Hahnemann firsthand, “the team found that residents, fellows, and program directors alike considered their voices to have been ignored in decision making and deemed themselves ‘out of the loop’ of important information that would affect their career transitions.”
While the hospital closed in September 2019, the effects are still being felt. In Pennsylvania, the Medical Care Availability and Reduction of Error Act requires that hospitals and providers have malpractice insurance, including tail insurance for when a doctor’s insurance policy expires. American Academic announced it would not be paying tail insurance for claims made while physicians were at Hahnemann. This meant residents, fellows and physicians who worked at Hahnemann during the closure would be on the hook for paying their own malpractice insurance.
“On one hand, the risk is very low for the house staff. Lawsuits that come up later for house staff are generally dropped at some point,” said William W. Pinsky, MD, FAAP, FACC, president and CEO of the Educational Commission for Foreign Medical Graduates (ECFMG). “But who wants to take that risk going forward? It’s an issue that’s still not resolved.”
The American Medical Association, Association of American Medical Colleges (AAMC), the Philadelphia County Medical Society, and other medical societies have collectively put pressure on Hahnemann’s owners to pay for tail coverage. Beyond a Feb. 10, 2020 deadline, former Hahnemann physicians were still expected to cover their own tail insurance.
To further complicate matters, American Academic attempted to auction more than 570 residency slots at Hahnemann. The slots were sold to a consortium of six health systems in the area – Thomas Jefferson University Hospitals, Einstein Healthcare Network, Temple University Health System, Main Line Health, Cooper University Health Care, and Christiana Care Health System – for $55 million. The Centers for Medicare & Medicaid Services opposed the sale, arguing that the slots are a contract that hospitals enter into with CMS, rather than an asset to be sold. An appeal is currently pending.
The case is being watched by former physicians at Hahnemann. “American Academic said, ‘If we don’t get this $55 million, we’re not going to be able to cover this tail insurance.’ They’re kind of linking the two things,” said Dr. D’Mello. “To me, it’s almost like putting pressure to allow the sale to happen.”
Urban hospital closures disrupt health system balance
When an urban hospital like Hahnemann University Hospital closes, there is a major disruption to patient care. Patients need to relocate to other nearby centers, and they may not always be able to follow their physician to the next health center.
If patients have comorbidities, are being tracked across multiple care points, or change physicians during a hospital closure, details can be missed and care can become more complicated for physicians who end up seeing the patient at a new center. For example, a patient receiving obstetrics care at a hospital that closes will have to reschedule their delivery at another health center, noted Dr. Pinsky.
“Where patients get lost is when there’s not a physician or an individual can keep track of all that, coordinate, and help to be sure that the patient follows through,” he said.
Patients at a closing hospital need to go somewhere else for care, and patient volume naturally increases at other nearby centers, potentially causing problems for systems without the resources to handle the spike in traffic.
“I’m a service director of quality improvement and patient safety for Drexel internal medicine. I know that those sort of jumps and volumes are what increases medical errors and potentially could create some adverse outcomes,” said Dr. D’Mello. “That’s something I’m particularly worried about.”
Physicians are also reconciling their own personal situations during a hospital closure, attempting to figure out their next step while at the same time helping patients figure out theirs. In the case of international medical graduates on J-1 or H1-B visas, who are dependent on hospital positions and training programs to remain in the United States, the situation can be even more dire.
During Hahnemann’s closure, Dr. Pinsky said that the ECFMG, which represents 11,000 individuals with J-1 visas across the country, reached out to the 55 individuals on J-1 visas at the hospital and offered them assistance, including working with the Department of State to ensure they aren’t in jeopardy of deportation before they secure another training program position.
The ECFMG, AMA, AAMC, and ACGME also offered funding to help J-1 visa holders who needed to relocate outside Philadelphia. “Many of them spent a lot of their money or all their money just coming over here,” said Dr. Pinsky. “This was a way to help defray some immediate costs that they might have.”
Education and research, of which hospitalists and residents play a large role, are likewise affected during a hospital closure, Dr. Pinsky said. “Education and research in the hospital is an important contributor to the community, health care and medical education nationally overall. When it’s not considered, there can be a significant asset that is lost in the process, which is hard to ever regain.
“The hospitalists have an integral role in medical education. In most hospitals where there is graduate medical education, particularly in internal medicine or pediatrics, and where there is a hospitalist program, it’s the hospitalists that do the majority of the in-hospital or inpatient training and education,” he added.
Rural hospital closures affect access to care
Since 2005, 163 rural hospitals have closed in the United States. When rural hospitals close, the situation for hospitalists and other physicians is different. In communities where a larger health system owns a hospital, such as when Vidant Health closed Pungo District Hospital in Belhaven, N.C., in 2014 before reopening a nonemergency clinic in the area in 2016, health care services for the community may have limited interruption.
However, if there isn’t a nearby system to join, many doctors will end up leaving the area. More than half of rural hospitals that close end up not providing any kind of supplementary health care service, according to the NC Rural Health Research Program.
“A lot of the hospitals that have closed have not been owned by a system,” said George H. Pink, PhD, deputy director of the NC Rural Health Research Program at the University of North Carolina at Chapel Hill. “They’ve been independent, freestanding, and that perhaps is one of the reasons why they’re closing, is because they haven’t been able to find a system that would buy them out and inject capital into the community.”
This can also have an effect on the number of health care providers in the area, Dr. Pink said. “Their ability to refer patients and treat patients locally may be affected. That’s why, in many towns where hospitals have closed, we see a drop in the number of providers, particularly primary care doctors who actually live in the community.”
Politicians and federal entities have proposed a number of solutions to help protect rural hospitals from closure. Sen. Charles Grassley (R-Iowa), Sen. Amy Klobuchar (D-Minn.), and Sen. Cory Gardener (R-Colo.) have sponsored bills in the Senate, while Rep. Sam Graves (R-Mo.) has introduced legislation in the House. The Medicare Payment Advisory Commission has proposed two models of rural hospital care, and there are additional models proposed by the Kansas Hospital Association. A pilot program in Pennsylvania, the Pennsylvania Rural Health Model, is testing how a global budget by CMS for all inpatient and hospital-based outcomes might help rural hospitals.
“What we haven’t had a lot of action on is actually testing these models out and seeing whether they will work, and in what kinds of communities they will work,” Dr. Pink said.
Hospitalists as community advocates
Dr. D’Mello, who wrote an article for the Journal of Hospital Medicine on Hahnemann’s ownership by a private equity firm (doi: 10.12788/jhm.3378), said that the inherent nature of a for-profit entity trying to make a hospital profitable is a bad sign for a hospital and not necessarily what is in the best interest for an academic institution or for doctors who train there.
“I don’t know if I could blame the private equity firm completely, but in retrospect, the private equity firms stepping in was like the death knell of the hospital,” he said of Hahnemann’s closure.
“I think what the community needs to know – what the health care community, patient community, the hospitalist community need to know – is that there’s got to be more attention paid to these types of issues during mergers and acquisitions to prevent this from happening,” Dr. Pinsky said.
One larger issue was Hahnemann’s position as a safety net hospital, which partly played into American Academic’s lack of success in making the hospital as profitable as they wanted it to be, Dr. D’Mello noted. Hahnemann’s patient population consisted mostly of minority patients on Medicare, Medicaid, and charity care insurance, while recent studies have shown that hospitals are more likely to succeed when they have a larger proportion of patients with private insurance.
“Studies show that, to [make more] money from private insurance, you really have to have this huge footprint, because then you’ve got a better ability to negotiate with these private insurance companies,” Dr. D’Mello said. “Whether that’s actually good for health care is a different issue.”
Despite their own situations, it is not unusual for hospitalists and hospital physicians to step up during a hospital closure and advocate for their patients on behalf of the community, Dr. Pink said.
“When hospitals are in financial difficulty and there’s the risk of closure, typically, the medical staff are among the first to step up and warn the community: ‘We’re at risk of losing our service. We need some help,’ ” he said. “Generally speaking, the local physicians have been at the forefront of helping to keep access to hospital care available in some of these small communities – unfortunately, not always successfully.”
Dr. D’Mello, Dr. Pinsky, and Dr. Pink report no relevant conflicts of interest.
Superior turbinate eosinophilia predicts olfactory decline in patients with CRS
Olfactory decline in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery is linked to superior turbinate eosinophilia, according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.
“Dawei Wu, MD, of Beijing Anzhen Hospital, Capital Medical University in Beijing, China, said in an interview.
There has been some research in the literature pointing to the link between CRS-associated olfactory dysfunction and superior turbinate eosinophilia. In a 2017 study, Lavin et al. found eosinophil markers in the superior turbinate tissue were elevated in patients with CRS with nasal polyps. One of the gene expressions of the eosinophil marker Charcot Leyden crystal protein (CLC) was inversely associated with olfactory threshold, which led the researchers to believe there was a link between olfactory decline and superior turbinate eosinophilia in these patients (Laryngoscope. 2017 Oct;127[10]:2210-2218).
Olfactory decline associated with CRS is the most common reason for loss of smell in ear, nose, and throat clinics, Dr. Wu said, but predicting this olfactory decline after endoscopic sinus surgery can be clinically challenging.
“The distinct feature of this smell disorder is the fluctuation in olfactory dysfunction which is mainly due to the recurrence of inflammation within the olfactory cleft. Notably, the level of eosinophils within the olfactory cleft significantly and positively correlated with the degree of olfactory dysfunction in patients with CRS both pre- and postoperatively,” he said.
Dr. Wu and colleagues conducted a prospective study to determine whether there was a link in CRS patients between preoperative superior turbinate eosinophilia and olfactory dysfunction after endoscopic sinus surgery. “We aimed to explore potential predictors of postoperative olfactory decline,” Dr. Wu said.
Overall, the investigators enrolled 78 patients with CRS in the study, where they received an olfactory assessment prior to and 3 months after endoscopic sinus surgery. The investigators used Sniffin’ Sticks (Burghardt; Wedel, Germany), a 12-item psychophysical smell test that uses everyday odors to conduct the olfactory assessment. If patients had a decrease in their threshold-discrimination-identification (TDI) score after surgery, they were determined to have olfactory deterioration. Prior to surgery, investigators measured olfactory cleft opacification using CT, with the olfactory cleft endoscopy scale used after surgery. The investigators also sampled patients’ superior turbinates at the time of surgery.
The results showed 23 of 78 patients (29.49%) had olfactory decline at 3 months after endoscopic sinus surgery. Those patients with olfactory decline had significantly higher tissue, blood eosinophil levels, and TDI scores before surgery, compared with patients with CRS who did not have any loss of smell. Patients with olfactory decline also had olfactory cleft opacification and olfactory cleft endoscopy scale scores, compared with patients who had no loss of smell after surgery.
One factor that predicted olfactory decline in these patients was an absolute count of 23.5 eosinophils per high-power field in the superior turbinate, researchers said (area under the ROC curve, 0.901). “Continuous elimination of the eosinophilic inflammation within the olfactory cleft in CRS patients with olfactory dysfunction may prevent the olfactory fluctuation after endoscopic sinus surgery,” Dr. Wu said.
Dr. Wu reports no relevant conflicts of interest.
SOURCE: Wu D et al. AAAAI. Abstract L7.
Olfactory decline in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery is linked to superior turbinate eosinophilia, according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.
“Dawei Wu, MD, of Beijing Anzhen Hospital, Capital Medical University in Beijing, China, said in an interview.
There has been some research in the literature pointing to the link between CRS-associated olfactory dysfunction and superior turbinate eosinophilia. In a 2017 study, Lavin et al. found eosinophil markers in the superior turbinate tissue were elevated in patients with CRS with nasal polyps. One of the gene expressions of the eosinophil marker Charcot Leyden crystal protein (CLC) was inversely associated with olfactory threshold, which led the researchers to believe there was a link between olfactory decline and superior turbinate eosinophilia in these patients (Laryngoscope. 2017 Oct;127[10]:2210-2218).
Olfactory decline associated with CRS is the most common reason for loss of smell in ear, nose, and throat clinics, Dr. Wu said, but predicting this olfactory decline after endoscopic sinus surgery can be clinically challenging.
“The distinct feature of this smell disorder is the fluctuation in olfactory dysfunction which is mainly due to the recurrence of inflammation within the olfactory cleft. Notably, the level of eosinophils within the olfactory cleft significantly and positively correlated with the degree of olfactory dysfunction in patients with CRS both pre- and postoperatively,” he said.
Dr. Wu and colleagues conducted a prospective study to determine whether there was a link in CRS patients between preoperative superior turbinate eosinophilia and olfactory dysfunction after endoscopic sinus surgery. “We aimed to explore potential predictors of postoperative olfactory decline,” Dr. Wu said.
Overall, the investigators enrolled 78 patients with CRS in the study, where they received an olfactory assessment prior to and 3 months after endoscopic sinus surgery. The investigators used Sniffin’ Sticks (Burghardt; Wedel, Germany), a 12-item psychophysical smell test that uses everyday odors to conduct the olfactory assessment. If patients had a decrease in their threshold-discrimination-identification (TDI) score after surgery, they were determined to have olfactory deterioration. Prior to surgery, investigators measured olfactory cleft opacification using CT, with the olfactory cleft endoscopy scale used after surgery. The investigators also sampled patients’ superior turbinates at the time of surgery.
The results showed 23 of 78 patients (29.49%) had olfactory decline at 3 months after endoscopic sinus surgery. Those patients with olfactory decline had significantly higher tissue, blood eosinophil levels, and TDI scores before surgery, compared with patients with CRS who did not have any loss of smell. Patients with olfactory decline also had olfactory cleft opacification and olfactory cleft endoscopy scale scores, compared with patients who had no loss of smell after surgery.
One factor that predicted olfactory decline in these patients was an absolute count of 23.5 eosinophils per high-power field in the superior turbinate, researchers said (area under the ROC curve, 0.901). “Continuous elimination of the eosinophilic inflammation within the olfactory cleft in CRS patients with olfactory dysfunction may prevent the olfactory fluctuation after endoscopic sinus surgery,” Dr. Wu said.
Dr. Wu reports no relevant conflicts of interest.
SOURCE: Wu D et al. AAAAI. Abstract L7.
Olfactory decline in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery is linked to superior turbinate eosinophilia, according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.
“Dawei Wu, MD, of Beijing Anzhen Hospital, Capital Medical University in Beijing, China, said in an interview.
There has been some research in the literature pointing to the link between CRS-associated olfactory dysfunction and superior turbinate eosinophilia. In a 2017 study, Lavin et al. found eosinophil markers in the superior turbinate tissue were elevated in patients with CRS with nasal polyps. One of the gene expressions of the eosinophil marker Charcot Leyden crystal protein (CLC) was inversely associated with olfactory threshold, which led the researchers to believe there was a link between olfactory decline and superior turbinate eosinophilia in these patients (Laryngoscope. 2017 Oct;127[10]:2210-2218).
Olfactory decline associated with CRS is the most common reason for loss of smell in ear, nose, and throat clinics, Dr. Wu said, but predicting this olfactory decline after endoscopic sinus surgery can be clinically challenging.
“The distinct feature of this smell disorder is the fluctuation in olfactory dysfunction which is mainly due to the recurrence of inflammation within the olfactory cleft. Notably, the level of eosinophils within the olfactory cleft significantly and positively correlated with the degree of olfactory dysfunction in patients with CRS both pre- and postoperatively,” he said.
Dr. Wu and colleagues conducted a prospective study to determine whether there was a link in CRS patients between preoperative superior turbinate eosinophilia and olfactory dysfunction after endoscopic sinus surgery. “We aimed to explore potential predictors of postoperative olfactory decline,” Dr. Wu said.
Overall, the investigators enrolled 78 patients with CRS in the study, where they received an olfactory assessment prior to and 3 months after endoscopic sinus surgery. The investigators used Sniffin’ Sticks (Burghardt; Wedel, Germany), a 12-item psychophysical smell test that uses everyday odors to conduct the olfactory assessment. If patients had a decrease in their threshold-discrimination-identification (TDI) score after surgery, they were determined to have olfactory deterioration. Prior to surgery, investigators measured olfactory cleft opacification using CT, with the olfactory cleft endoscopy scale used after surgery. The investigators also sampled patients’ superior turbinates at the time of surgery.
The results showed 23 of 78 patients (29.49%) had olfactory decline at 3 months after endoscopic sinus surgery. Those patients with olfactory decline had significantly higher tissue, blood eosinophil levels, and TDI scores before surgery, compared with patients with CRS who did not have any loss of smell. Patients with olfactory decline also had olfactory cleft opacification and olfactory cleft endoscopy scale scores, compared with patients who had no loss of smell after surgery.
One factor that predicted olfactory decline in these patients was an absolute count of 23.5 eosinophils per high-power field in the superior turbinate, researchers said (area under the ROC curve, 0.901). “Continuous elimination of the eosinophilic inflammation within the olfactory cleft in CRS patients with olfactory dysfunction may prevent the olfactory fluctuation after endoscopic sinus surgery,” Dr. Wu said.
Dr. Wu reports no relevant conflicts of interest.
SOURCE: Wu D et al. AAAAI. Abstract L7.
FROM AAAAI
Focus on factors that can be controlled during surgery for a good cosmetic result
ORLANDO – Some is to focus on those within a surgeon’s control, Robert H. Gotkin, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.
“Patients often judge the surgeon by the appearance of the scar. Not fair, but that’s what happens,” said Dr. Gotkin, director of plastic surgery at a private practice in Greenvale, N.Y.
What’s in a surgeon’s control? An accurate diagnosis, operating plan, knowledge of relevant anatomy, surgical technique, and tools for managing and modulating scars, he noted. Achieving a good cosmetic outcome starts before surgery with proper surgical planning, which includes a backup plan on “how to get out of trouble.” Visualize the ideal outcome of surgery in three dimensions, and know the relevant anatomy to help with surgical marking, as well as relevant muscular and vascular anatomy, and motor nerve danger zones, he advised. When performing facial reconstruction, reconstruct defects using the cosmetic units of the face, and place scars at the borders of cosmetic units, if possible, he said.
An order of priorities during surgery is also important. In the same way a vending machine that spits out ingredients to make a coffee in the wrong order will not result in a cup of coffee, he said, the surgical plan must be in an order that makes sense.
Tension is “one of the greatest enemies in surgery,” Dr. Gotkin said. Too much tension on a closure, for example, can cut off the blood supply and result in tissue ischemia, which could result in infection and dehiscence. It’s important to know one’s limitations during surgery and when in doubt, not to perform the surgery, he added. “Never do today what you can put off until tomorrow, because a lot of things heal and get better on their own,” he said.
Tools for good surgical outcome
A surgeon performing dermatologic procedures needs an operating room with good lighting, and a set of sharp surgical instruments. Use needle holders that do not lock, and handle needles with instruments instead of your fingers to hold the needles with just the right amount of tension, Dr. Gotkin said.
“There is no question” that palming a needle holder should not be done, he added. “Granted, this is a little dogmatic, but there is no use for palming a needle holder in surgery. It makes you much less accurate.”
Suture material is another important consideration. Surgeons have their pick of braided or monofilament sutures available in absorbable and nonabsorbable material. Absorbable sutures are made with synthetic materials such as polyglactin 910 (Vicryl), poliglecaprone 25 (Monocryl) and polydioxanone (PDS), while nonabsorbable sutures include those manufactured with polypropylene (Prolene). Nonabsorbable suture materials made of polyester and stainless steel exist, but are not commonly used in dermatologic surgery, he said.
The most common needles Dr. Gotkin uses in his practice are the Ethicon P-3, P-1, PS-2, and PS-6 types for precision point reverse cutting, and the PC-1 and PC-3 types for precision cosmetic procedures. Other needles that have similar shapes are marketed under different names, he noted. For local anesthesia, surgeons can use either lidocaine hydrochloride with epinephrine, 1% (1:100,000 u) for a rapid-onset, short-acting effect, or bupivacaine hydrochloride with epinephrine, 0.5% (1:200,000 u) for a slower-onset, long-acting effect. Dr. Gotkin recommends using a combination of both in a half-half mixture (1:150,000 epinephrine) with a buffer of sodium bicarbonate since both are acidic. Instead of stretching the skin before inserting the needle, he advised pinching or rubbing the skin to distract the patient from the injection instead of stretching the skin. Small gauge needles (such as 30-gauge or 27-gauge) are best for administering local anesthetic, he said.
Factor patient health into planning
When planning surgery, consider a patient’s comorbidities, previous surgeries, as well as current medications; those include anticoagulants or systemic steroids, which can affect the outcome of surgery. For patients who have had previous surgeries, determine whether they had any surgical complications, or experienced adverse outcomes such as keloids, hypertrophic scars, or soft tissue infections.
When planning your surgical “roadmap,” the general area of the surgery can factor into how a wound heals. Consider the vascularity of local tissues, and any tension in local tissues that can increase tension on the skin such as in the scalp, the foot, the ankle, or the back. Use the patient’s relaxed skin tension lines to minimize scarring. Since they were developed while experimenting on cadavers, the Langer lines of skin tension are not always ideal to use, and Kraissl’s lines, developed by a plastic surgeon, are a better guide for surgical planning, Dr. Gotkin said.
He also advised placing surgical markers on a patient in the way they’ll be lying during surgery. “I always tell people to crosshatch the fusiform design before surgery, because once you make the incision, they may open up and everything gets distorted, particularly when a patient’s lying down,” he said. “We have to put these markings on while the patient is sitting. Then, when you put your sutures in, you can use those lines to line everything up, so that you end up with a scar that fits in how you designed it when the patient was upright.” The rule is a 3:1 or 4:1 ratio for length/width when designing a fusiform incision for excision of a lesion.
Incisions are made perpendicular to the surface of the skin instead of beveled. “Repair in tension” rather than layers, Dr. Gotkin said. “It’s important when you put a needle in the skin, pronate so that the needle goes in at 90 degrees from the skin surface,” he explained. “Follow the curve of the needle through and supinate as you’re putting the needle through. That way, you get the right amount of tension and the right amount of tissue in the grasp of the needle.”
When tying sutures, Dr. Gotkin said he uses a hand tie in addition to an instrument tie, everting the skin edges as he closes subcuticular and cuticular sutures.
During surgery, gentle handling of tissues with forceps that have teeth, rather than a smooth surface, will help avoid crushing the skin. “That’s very important in plastic surgery, and it’s very important in any surgical procedure that you do,” he said.
These technical factors are “completely under the control of the surgeon,” but above all, a good surgical plan following an accurate diagnosis is most likely to yield the best result for patients, Dr. Gotkin said. “An architect wouldn’t build a house without blueprints, so you have to do the same thing when you’re doing surgery.”
Dr. Gotkin reported no relevant financial disclosures.
ORLANDO – Some is to focus on those within a surgeon’s control, Robert H. Gotkin, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.
“Patients often judge the surgeon by the appearance of the scar. Not fair, but that’s what happens,” said Dr. Gotkin, director of plastic surgery at a private practice in Greenvale, N.Y.
What’s in a surgeon’s control? An accurate diagnosis, operating plan, knowledge of relevant anatomy, surgical technique, and tools for managing and modulating scars, he noted. Achieving a good cosmetic outcome starts before surgery with proper surgical planning, which includes a backup plan on “how to get out of trouble.” Visualize the ideal outcome of surgery in three dimensions, and know the relevant anatomy to help with surgical marking, as well as relevant muscular and vascular anatomy, and motor nerve danger zones, he advised. When performing facial reconstruction, reconstruct defects using the cosmetic units of the face, and place scars at the borders of cosmetic units, if possible, he said.
An order of priorities during surgery is also important. In the same way a vending machine that spits out ingredients to make a coffee in the wrong order will not result in a cup of coffee, he said, the surgical plan must be in an order that makes sense.
Tension is “one of the greatest enemies in surgery,” Dr. Gotkin said. Too much tension on a closure, for example, can cut off the blood supply and result in tissue ischemia, which could result in infection and dehiscence. It’s important to know one’s limitations during surgery and when in doubt, not to perform the surgery, he added. “Never do today what you can put off until tomorrow, because a lot of things heal and get better on their own,” he said.
Tools for good surgical outcome
A surgeon performing dermatologic procedures needs an operating room with good lighting, and a set of sharp surgical instruments. Use needle holders that do not lock, and handle needles with instruments instead of your fingers to hold the needles with just the right amount of tension, Dr. Gotkin said.
“There is no question” that palming a needle holder should not be done, he added. “Granted, this is a little dogmatic, but there is no use for palming a needle holder in surgery. It makes you much less accurate.”
Suture material is another important consideration. Surgeons have their pick of braided or monofilament sutures available in absorbable and nonabsorbable material. Absorbable sutures are made with synthetic materials such as polyglactin 910 (Vicryl), poliglecaprone 25 (Monocryl) and polydioxanone (PDS), while nonabsorbable sutures include those manufactured with polypropylene (Prolene). Nonabsorbable suture materials made of polyester and stainless steel exist, but are not commonly used in dermatologic surgery, he said.
The most common needles Dr. Gotkin uses in his practice are the Ethicon P-3, P-1, PS-2, and PS-6 types for precision point reverse cutting, and the PC-1 and PC-3 types for precision cosmetic procedures. Other needles that have similar shapes are marketed under different names, he noted. For local anesthesia, surgeons can use either lidocaine hydrochloride with epinephrine, 1% (1:100,000 u) for a rapid-onset, short-acting effect, or bupivacaine hydrochloride with epinephrine, 0.5% (1:200,000 u) for a slower-onset, long-acting effect. Dr. Gotkin recommends using a combination of both in a half-half mixture (1:150,000 epinephrine) with a buffer of sodium bicarbonate since both are acidic. Instead of stretching the skin before inserting the needle, he advised pinching or rubbing the skin to distract the patient from the injection instead of stretching the skin. Small gauge needles (such as 30-gauge or 27-gauge) are best for administering local anesthetic, he said.
Factor patient health into planning
When planning surgery, consider a patient’s comorbidities, previous surgeries, as well as current medications; those include anticoagulants or systemic steroids, which can affect the outcome of surgery. For patients who have had previous surgeries, determine whether they had any surgical complications, or experienced adverse outcomes such as keloids, hypertrophic scars, or soft tissue infections.
When planning your surgical “roadmap,” the general area of the surgery can factor into how a wound heals. Consider the vascularity of local tissues, and any tension in local tissues that can increase tension on the skin such as in the scalp, the foot, the ankle, or the back. Use the patient’s relaxed skin tension lines to minimize scarring. Since they were developed while experimenting on cadavers, the Langer lines of skin tension are not always ideal to use, and Kraissl’s lines, developed by a plastic surgeon, are a better guide for surgical planning, Dr. Gotkin said.
He also advised placing surgical markers on a patient in the way they’ll be lying during surgery. “I always tell people to crosshatch the fusiform design before surgery, because once you make the incision, they may open up and everything gets distorted, particularly when a patient’s lying down,” he said. “We have to put these markings on while the patient is sitting. Then, when you put your sutures in, you can use those lines to line everything up, so that you end up with a scar that fits in how you designed it when the patient was upright.” The rule is a 3:1 or 4:1 ratio for length/width when designing a fusiform incision for excision of a lesion.
Incisions are made perpendicular to the surface of the skin instead of beveled. “Repair in tension” rather than layers, Dr. Gotkin said. “It’s important when you put a needle in the skin, pronate so that the needle goes in at 90 degrees from the skin surface,” he explained. “Follow the curve of the needle through and supinate as you’re putting the needle through. That way, you get the right amount of tension and the right amount of tissue in the grasp of the needle.”
When tying sutures, Dr. Gotkin said he uses a hand tie in addition to an instrument tie, everting the skin edges as he closes subcuticular and cuticular sutures.
During surgery, gentle handling of tissues with forceps that have teeth, rather than a smooth surface, will help avoid crushing the skin. “That’s very important in plastic surgery, and it’s very important in any surgical procedure that you do,” he said.
These technical factors are “completely under the control of the surgeon,” but above all, a good surgical plan following an accurate diagnosis is most likely to yield the best result for patients, Dr. Gotkin said. “An architect wouldn’t build a house without blueprints, so you have to do the same thing when you’re doing surgery.”
Dr. Gotkin reported no relevant financial disclosures.
ORLANDO – Some is to focus on those within a surgeon’s control, Robert H. Gotkin, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.
“Patients often judge the surgeon by the appearance of the scar. Not fair, but that’s what happens,” said Dr. Gotkin, director of plastic surgery at a private practice in Greenvale, N.Y.
What’s in a surgeon’s control? An accurate diagnosis, operating plan, knowledge of relevant anatomy, surgical technique, and tools for managing and modulating scars, he noted. Achieving a good cosmetic outcome starts before surgery with proper surgical planning, which includes a backup plan on “how to get out of trouble.” Visualize the ideal outcome of surgery in three dimensions, and know the relevant anatomy to help with surgical marking, as well as relevant muscular and vascular anatomy, and motor nerve danger zones, he advised. When performing facial reconstruction, reconstruct defects using the cosmetic units of the face, and place scars at the borders of cosmetic units, if possible, he said.
An order of priorities during surgery is also important. In the same way a vending machine that spits out ingredients to make a coffee in the wrong order will not result in a cup of coffee, he said, the surgical plan must be in an order that makes sense.
Tension is “one of the greatest enemies in surgery,” Dr. Gotkin said. Too much tension on a closure, for example, can cut off the blood supply and result in tissue ischemia, which could result in infection and dehiscence. It’s important to know one’s limitations during surgery and when in doubt, not to perform the surgery, he added. “Never do today what you can put off until tomorrow, because a lot of things heal and get better on their own,” he said.
Tools for good surgical outcome
A surgeon performing dermatologic procedures needs an operating room with good lighting, and a set of sharp surgical instruments. Use needle holders that do not lock, and handle needles with instruments instead of your fingers to hold the needles with just the right amount of tension, Dr. Gotkin said.
“There is no question” that palming a needle holder should not be done, he added. “Granted, this is a little dogmatic, but there is no use for palming a needle holder in surgery. It makes you much less accurate.”
Suture material is another important consideration. Surgeons have their pick of braided or monofilament sutures available in absorbable and nonabsorbable material. Absorbable sutures are made with synthetic materials such as polyglactin 910 (Vicryl), poliglecaprone 25 (Monocryl) and polydioxanone (PDS), while nonabsorbable sutures include those manufactured with polypropylene (Prolene). Nonabsorbable suture materials made of polyester and stainless steel exist, but are not commonly used in dermatologic surgery, he said.
The most common needles Dr. Gotkin uses in his practice are the Ethicon P-3, P-1, PS-2, and PS-6 types for precision point reverse cutting, and the PC-1 and PC-3 types for precision cosmetic procedures. Other needles that have similar shapes are marketed under different names, he noted. For local anesthesia, surgeons can use either lidocaine hydrochloride with epinephrine, 1% (1:100,000 u) for a rapid-onset, short-acting effect, or bupivacaine hydrochloride with epinephrine, 0.5% (1:200,000 u) for a slower-onset, long-acting effect. Dr. Gotkin recommends using a combination of both in a half-half mixture (1:150,000 epinephrine) with a buffer of sodium bicarbonate since both are acidic. Instead of stretching the skin before inserting the needle, he advised pinching or rubbing the skin to distract the patient from the injection instead of stretching the skin. Small gauge needles (such as 30-gauge or 27-gauge) are best for administering local anesthetic, he said.
Factor patient health into planning
When planning surgery, consider a patient’s comorbidities, previous surgeries, as well as current medications; those include anticoagulants or systemic steroids, which can affect the outcome of surgery. For patients who have had previous surgeries, determine whether they had any surgical complications, or experienced adverse outcomes such as keloids, hypertrophic scars, or soft tissue infections.
When planning your surgical “roadmap,” the general area of the surgery can factor into how a wound heals. Consider the vascularity of local tissues, and any tension in local tissues that can increase tension on the skin such as in the scalp, the foot, the ankle, or the back. Use the patient’s relaxed skin tension lines to minimize scarring. Since they were developed while experimenting on cadavers, the Langer lines of skin tension are not always ideal to use, and Kraissl’s lines, developed by a plastic surgeon, are a better guide for surgical planning, Dr. Gotkin said.
He also advised placing surgical markers on a patient in the way they’ll be lying during surgery. “I always tell people to crosshatch the fusiform design before surgery, because once you make the incision, they may open up and everything gets distorted, particularly when a patient’s lying down,” he said. “We have to put these markings on while the patient is sitting. Then, when you put your sutures in, you can use those lines to line everything up, so that you end up with a scar that fits in how you designed it when the patient was upright.” The rule is a 3:1 or 4:1 ratio for length/width when designing a fusiform incision for excision of a lesion.
Incisions are made perpendicular to the surface of the skin instead of beveled. “Repair in tension” rather than layers, Dr. Gotkin said. “It’s important when you put a needle in the skin, pronate so that the needle goes in at 90 degrees from the skin surface,” he explained. “Follow the curve of the needle through and supinate as you’re putting the needle through. That way, you get the right amount of tension and the right amount of tissue in the grasp of the needle.”
When tying sutures, Dr. Gotkin said he uses a hand tie in addition to an instrument tie, everting the skin edges as he closes subcuticular and cuticular sutures.
During surgery, gentle handling of tissues with forceps that have teeth, rather than a smooth surface, will help avoid crushing the skin. “That’s very important in plastic surgery, and it’s very important in any surgical procedure that you do,” he said.
These technical factors are “completely under the control of the surgeon,” but above all, a good surgical plan following an accurate diagnosis is most likely to yield the best result for patients, Dr. Gotkin said. “An architect wouldn’t build a house without blueprints, so you have to do the same thing when you’re doing surgery.”
Dr. Gotkin reported no relevant financial disclosures.
EXPERT ANALYSIS FROM ODAC 2020
Acid-suppressant medications in infants with bronchiolitis raises later allergy risk
Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage
“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.
Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).
“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”
Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.
Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).
After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).
“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”
Dr. Robinson reported no relevant financial disclosures.
SOURCE: Robinson L. AAAAI 2020, Abstract L1
Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage
“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.
Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).
“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”
Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.
Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).
After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).
“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”
Dr. Robinson reported no relevant financial disclosures.
SOURCE: Robinson L. AAAAI 2020, Abstract L1
Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage
“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.
Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).
“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”
Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.
Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).
After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).
“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”
Dr. Robinson reported no relevant financial disclosures.
SOURCE: Robinson L. AAAAI 2020, Abstract L1
REPORTING FROM AAAAI 2020