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Trade-offs doctors make to become mothers: Interview study
Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.
Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.
“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.
The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.
Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.
In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.
Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
Results ‘alarming’
“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.
As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.
Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.
And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
Lack of support ‘pronounced in medicine’
In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”
The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.
“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”
They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.
They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.
Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.
They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.
They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.
“How do two women, two men, or a single person try to conceive?” they ask.
Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.
She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.
Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.
“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.
Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.
Department leaders should be asking what female physicians need and what flexibility is needed, she said.
The COVID-19 pandemic showed how bad things could get, she said.
In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.
“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.
COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.
Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.
Hospitals must find alternative approaches to the historical reliance on residents to provide clinical service needs, she said in an interview.
“It’s not just about educating women or ensuring access to fertility services – it’s also about making it more possible and acceptable for women to combine their pursuit of a medical career and beginning a family during the peak years of fertility.”
She said the medical profession – dedicated to human well-being – seems to carve out an exception when it comes to optimizing the well-being of its future members.
“It breaks my heart to read about how hard we have made it for women to succeed in our profession,” she said.
This study was funded by the American Society for Reproductive Medicine. The authors report no relevant financial relationships. Dr. Marshall, Dr. Salles, Dr. Jagsi, and Dr. Morgan report no relevant financial relationships.
Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.
Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.
“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.
The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.
Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.
In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.
Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
Results ‘alarming’
“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.
As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.
Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.
And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
Lack of support ‘pronounced in medicine’
In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”
The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.
“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”
They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.
They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.
Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.
They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.
They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.
“How do two women, two men, or a single person try to conceive?” they ask.
Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.
She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.
Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.
“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.
Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.
Department leaders should be asking what female physicians need and what flexibility is needed, she said.
The COVID-19 pandemic showed how bad things could get, she said.
In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.
“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.
COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.
Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.
Hospitals must find alternative approaches to the historical reliance on residents to provide clinical service needs, she said in an interview.
“It’s not just about educating women or ensuring access to fertility services – it’s also about making it more possible and acceptable for women to combine their pursuit of a medical career and beginning a family during the peak years of fertility.”
She said the medical profession – dedicated to human well-being – seems to carve out an exception when it comes to optimizing the well-being of its future members.
“It breaks my heart to read about how hard we have made it for women to succeed in our profession,” she said.
This study was funded by the American Society for Reproductive Medicine. The authors report no relevant financial relationships. Dr. Marshall, Dr. Salles, Dr. Jagsi, and Dr. Morgan report no relevant financial relationships.
Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.
Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.
“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.
The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.
Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.
In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.
Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
Results ‘alarming’
“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.
As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.
Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.
And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
Lack of support ‘pronounced in medicine’
In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”
The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.
“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”
They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.
They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.
Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.
They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.
They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.
“How do two women, two men, or a single person try to conceive?” they ask.
Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.
She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.
Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.
“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.
Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.
Department leaders should be asking what female physicians need and what flexibility is needed, she said.
The COVID-19 pandemic showed how bad things could get, she said.
In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.
“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.
COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.
Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.
Hospitals must find alternative approaches to the historical reliance on residents to provide clinical service needs, she said in an interview.
“It’s not just about educating women or ensuring access to fertility services – it’s also about making it more possible and acceptable for women to combine their pursuit of a medical career and beginning a family during the peak years of fertility.”
She said the medical profession – dedicated to human well-being – seems to carve out an exception when it comes to optimizing the well-being of its future members.
“It breaks my heart to read about how hard we have made it for women to succeed in our profession,” she said.
This study was funded by the American Society for Reproductive Medicine. The authors report no relevant financial relationships. Dr. Marshall, Dr. Salles, Dr. Jagsi, and Dr. Morgan report no relevant financial relationships.
FROM JAMA NETWORK OPEN
European committee recommends approval of baricitinib for severe alopecia areata
The European Medicines Agency’s ( (AA).
The development, which was announced in a May 20, 2022, press release from the manufacturer, Eli Lilly and Incyte, marks the first step toward European regulatory approval of baricitinib (Olumiant) for patients with severe AA, and it is now referred to the European Commission for final action. A decision is expected within the next 2 months.
The committee based its positive opinion on the results of the phase 3 BRAVE-AA1 and BRAVE-AA2 trials, recently published in the New England Journal of Medicine, which evaluated the efficacy and safety of baricitinib in 1,200 patients with severe AA, according to the press release. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score of ≤20 at week 36. In both studies, 1 out of 3 patients treated with baricitinib 4-mg achieved 80% or more scalp hair coverage, compared with 1 out of 20 patients and 1 out of 50 patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (P ≤ .001 for all comparisons to placebo).
According to safety profile information from the phase 3 BRAVE-AA clinical program, few patients discontinued treatment because of adverse events (2.6% or less across both studies), and most treatment-emergent adverse events were mild or moderate in severity.
In February 2022, the Food and Drug Administration granted priority review for baricitinib in adults with severe AA. Lilly expects additional regulatory decisions in the United States and Japan in 2022.
Baricitinib is approved in the United States as a treatment for adults with moderate to severe rheumatoid arthritis. Prescribing information can be viewed here.
The European Medicines Agency’s ( (AA).
The development, which was announced in a May 20, 2022, press release from the manufacturer, Eli Lilly and Incyte, marks the first step toward European regulatory approval of baricitinib (Olumiant) for patients with severe AA, and it is now referred to the European Commission for final action. A decision is expected within the next 2 months.
The committee based its positive opinion on the results of the phase 3 BRAVE-AA1 and BRAVE-AA2 trials, recently published in the New England Journal of Medicine, which evaluated the efficacy and safety of baricitinib in 1,200 patients with severe AA, according to the press release. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score of ≤20 at week 36. In both studies, 1 out of 3 patients treated with baricitinib 4-mg achieved 80% or more scalp hair coverage, compared with 1 out of 20 patients and 1 out of 50 patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (P ≤ .001 for all comparisons to placebo).
According to safety profile information from the phase 3 BRAVE-AA clinical program, few patients discontinued treatment because of adverse events (2.6% or less across both studies), and most treatment-emergent adverse events were mild or moderate in severity.
In February 2022, the Food and Drug Administration granted priority review for baricitinib in adults with severe AA. Lilly expects additional regulatory decisions in the United States and Japan in 2022.
Baricitinib is approved in the United States as a treatment for adults with moderate to severe rheumatoid arthritis. Prescribing information can be viewed here.
The European Medicines Agency’s ( (AA).
The development, which was announced in a May 20, 2022, press release from the manufacturer, Eli Lilly and Incyte, marks the first step toward European regulatory approval of baricitinib (Olumiant) for patients with severe AA, and it is now referred to the European Commission for final action. A decision is expected within the next 2 months.
The committee based its positive opinion on the results of the phase 3 BRAVE-AA1 and BRAVE-AA2 trials, recently published in the New England Journal of Medicine, which evaluated the efficacy and safety of baricitinib in 1,200 patients with severe AA, according to the press release. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score of ≤20 at week 36. In both studies, 1 out of 3 patients treated with baricitinib 4-mg achieved 80% or more scalp hair coverage, compared with 1 out of 20 patients and 1 out of 50 patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (P ≤ .001 for all comparisons to placebo).
According to safety profile information from the phase 3 BRAVE-AA clinical program, few patients discontinued treatment because of adverse events (2.6% or less across both studies), and most treatment-emergent adverse events were mild or moderate in severity.
In February 2022, the Food and Drug Administration granted priority review for baricitinib in adults with severe AA. Lilly expects additional regulatory decisions in the United States and Japan in 2022.
Baricitinib is approved in the United States as a treatment for adults with moderate to severe rheumatoid arthritis. Prescribing information can be viewed here.
Climate change, medical education, and dermatology
The recent article on including the impact of climate on health in medical education programs shines an important light on the challenge – and urgent need – of integrating climate change training into medical education. These nascent efforts are just getting underway across the country, with some programs – notably Harvard’s C-CHANGE (Center for Climate, Health, and the Global Environment) program, mentioned in the article, and others, such as the University of Colorado’s Climate Medicine diploma course – leading the way. A number of publications, such as the editorial titled “A planetary health curriculum for medicine” published in 2021 in the BMJ, offer a roadmap to do so.
Medical schools, residency programs, and other medical specialty programs – including those for advanced practice providers, dentists, nurses, and more – should be incorporating climate change and its myriad of health impacts into their training pathways. The medical student group, Medical Students for a Sustainable Future, has put forth a planetary health report card that evaluates training programs on the strength of their focus on the intersections between climate and health.
While the article did not specifically focus on dermatology, these impacts are true in our field as well. The article notes that “at least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change.” Notably in dermatology, the International Journal of Women’s Dermatology devoted an entire 124-page themed issue to climate change and dermatology in January, 2021, while JAMA Dermatology editor Kanade Shinkai, MD, PhD, called out climate change as one of the journal’s priorities in her annual editorial, stating, “Another priority for the journal is to better understand the effect of climate change on human health, specifically skin disease.”
The impacts of climate change in dermatology range from heat-related illness (a major cause of climate-associated mortality, with the skin serving as an essential thermoregulatory organ) to changing patterns of vector-borne illnesses to pollution and wildfire smoke flaring inflammatory skin diseases, to an increase in skin cancer, and more. While incorporation of health issues relating to climate change is important at a medical school level, it is also critical at the residency training – and board exam/certification – level as well.
Beyond the importance of building climate education into undergraduate and graduate medical education, it is also important that practicing physicians, post-residency training, remain up to date and keep abreast of changing patterns of disease in our rapidly changing climate. Lyme disease now occurs in Canada – and both earlier and later in the year even in places that are geographically used to seeing it. Early recognition is essential, but unprepared physicians may miss the early erythema migrans rash, and patients may suffer more severe sequelae as a result.
Finally, it’s important that medical organizations are aware of not just the health implications of climate change, but also potential policy impacts. Health care is a major emitter of CO2, and assistant secretary for health for the U.S. Department of Health and Human Services, Admiral Rachel L. Levine, MD, with the National Academy of Medicine, has appropriately pledged to reduce health care carbon emissions as part of the necessary steps that we must all take to avert the worst impacts of a warming world. The field of medicine and individual providers should educate themselves and actively work toward sustainability in health care, to improve the health of their patients, populations, and future generations.
Dr. Rosenbach is associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, and is the founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues. Dr. Rosenbach is speaking on behalf of himself and not the AAD.
The recent article on including the impact of climate on health in medical education programs shines an important light on the challenge – and urgent need – of integrating climate change training into medical education. These nascent efforts are just getting underway across the country, with some programs – notably Harvard’s C-CHANGE (Center for Climate, Health, and the Global Environment) program, mentioned in the article, and others, such as the University of Colorado’s Climate Medicine diploma course – leading the way. A number of publications, such as the editorial titled “A planetary health curriculum for medicine” published in 2021 in the BMJ, offer a roadmap to do so.
Medical schools, residency programs, and other medical specialty programs – including those for advanced practice providers, dentists, nurses, and more – should be incorporating climate change and its myriad of health impacts into their training pathways. The medical student group, Medical Students for a Sustainable Future, has put forth a planetary health report card that evaluates training programs on the strength of their focus on the intersections between climate and health.
While the article did not specifically focus on dermatology, these impacts are true in our field as well. The article notes that “at least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change.” Notably in dermatology, the International Journal of Women’s Dermatology devoted an entire 124-page themed issue to climate change and dermatology in January, 2021, while JAMA Dermatology editor Kanade Shinkai, MD, PhD, called out climate change as one of the journal’s priorities in her annual editorial, stating, “Another priority for the journal is to better understand the effect of climate change on human health, specifically skin disease.”
The impacts of climate change in dermatology range from heat-related illness (a major cause of climate-associated mortality, with the skin serving as an essential thermoregulatory organ) to changing patterns of vector-borne illnesses to pollution and wildfire smoke flaring inflammatory skin diseases, to an increase in skin cancer, and more. While incorporation of health issues relating to climate change is important at a medical school level, it is also critical at the residency training – and board exam/certification – level as well.
Beyond the importance of building climate education into undergraduate and graduate medical education, it is also important that practicing physicians, post-residency training, remain up to date and keep abreast of changing patterns of disease in our rapidly changing climate. Lyme disease now occurs in Canada – and both earlier and later in the year even in places that are geographically used to seeing it. Early recognition is essential, but unprepared physicians may miss the early erythema migrans rash, and patients may suffer more severe sequelae as a result.
Finally, it’s important that medical organizations are aware of not just the health implications of climate change, but also potential policy impacts. Health care is a major emitter of CO2, and assistant secretary for health for the U.S. Department of Health and Human Services, Admiral Rachel L. Levine, MD, with the National Academy of Medicine, has appropriately pledged to reduce health care carbon emissions as part of the necessary steps that we must all take to avert the worst impacts of a warming world. The field of medicine and individual providers should educate themselves and actively work toward sustainability in health care, to improve the health of their patients, populations, and future generations.
Dr. Rosenbach is associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, and is the founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues. Dr. Rosenbach is speaking on behalf of himself and not the AAD.
The recent article on including the impact of climate on health in medical education programs shines an important light on the challenge – and urgent need – of integrating climate change training into medical education. These nascent efforts are just getting underway across the country, with some programs – notably Harvard’s C-CHANGE (Center for Climate, Health, and the Global Environment) program, mentioned in the article, and others, such as the University of Colorado’s Climate Medicine diploma course – leading the way. A number of publications, such as the editorial titled “A planetary health curriculum for medicine” published in 2021 in the BMJ, offer a roadmap to do so.
Medical schools, residency programs, and other medical specialty programs – including those for advanced practice providers, dentists, nurses, and more – should be incorporating climate change and its myriad of health impacts into their training pathways. The medical student group, Medical Students for a Sustainable Future, has put forth a planetary health report card that evaluates training programs on the strength of their focus on the intersections between climate and health.
While the article did not specifically focus on dermatology, these impacts are true in our field as well. The article notes that “at least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change.” Notably in dermatology, the International Journal of Women’s Dermatology devoted an entire 124-page themed issue to climate change and dermatology in January, 2021, while JAMA Dermatology editor Kanade Shinkai, MD, PhD, called out climate change as one of the journal’s priorities in her annual editorial, stating, “Another priority for the journal is to better understand the effect of climate change on human health, specifically skin disease.”
The impacts of climate change in dermatology range from heat-related illness (a major cause of climate-associated mortality, with the skin serving as an essential thermoregulatory organ) to changing patterns of vector-borne illnesses to pollution and wildfire smoke flaring inflammatory skin diseases, to an increase in skin cancer, and more. While incorporation of health issues relating to climate change is important at a medical school level, it is also critical at the residency training – and board exam/certification – level as well.
Beyond the importance of building climate education into undergraduate and graduate medical education, it is also important that practicing physicians, post-residency training, remain up to date and keep abreast of changing patterns of disease in our rapidly changing climate. Lyme disease now occurs in Canada – and both earlier and later in the year even in places that are geographically used to seeing it. Early recognition is essential, but unprepared physicians may miss the early erythema migrans rash, and patients may suffer more severe sequelae as a result.
Finally, it’s important that medical organizations are aware of not just the health implications of climate change, but also potential policy impacts. Health care is a major emitter of CO2, and assistant secretary for health for the U.S. Department of Health and Human Services, Admiral Rachel L. Levine, MD, with the National Academy of Medicine, has appropriately pledged to reduce health care carbon emissions as part of the necessary steps that we must all take to avert the worst impacts of a warming world. The field of medicine and individual providers should educate themselves and actively work toward sustainability in health care, to improve the health of their patients, populations, and future generations.
Dr. Rosenbach is associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, and is the founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues. Dr. Rosenbach is speaking on behalf of himself and not the AAD.
Rabies: CDC updates and simplifies preexposure prophylaxis vaccination recommendations
Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.
The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100.
The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.
Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.
The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.
Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.
Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”
There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.
The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”
The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.
Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”
He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”
Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.”
Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.
Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.
The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100.
The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.
Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.
The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.
Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.
Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”
There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.
The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”
The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.
Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”
He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”
Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.”
Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.
Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.
The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100.
The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.
Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.
The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.
Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.
Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”
There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.
The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”
The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.
Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”
He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”
Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.”
Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.
Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many Americans missing an opportunity to prevent dementia
(ADRD), including hypertension, low levels of physical activity, and obesity, new research shows.
Data from the Centers for Disease Control and Prevention reveal that among nearly 162,000 adults aged 45 and older who were surveyed in 2019 as part of the Behavioral Risk Factor Surveillance System (BRFSS), nearly half had high blood pressure and did not achieve aerobic physical activity recommendations. These were the two most common modifiable risk factors for ADRD.
In addition, more than one-third (35%) of adults were obese, 19% had diabetes, 18% had depression, 15% were smokers, 11% had hearing loss, and 10% were binge drinkers.
The findings were published online in the CDC’s Morbidity and Mortality Weekly Report.
A missed prevention opportunity
More than 1 in 10 (11.3%) adults surveyed reported subjective cognitive decline (SCD), an early indicator of possible future ADRD.
The prevalence of SCD increased from about 4% among adults with no modifiable risk factors for ADRD to 25% for those with four or more risk factors.
Adults with SCD were more apt to report having almost all modifiable risk factors and were more likely to report four or more risk factors (34%) than were peers without SCD (13%)
The prevalence of SCD ranged from a high of about 29% in those with depression and 25% in those with hearing loss to 11% in those who reported binge drinking.
In line with previous research, the findings indicate that American Indian or Alaska Native, Black or African American, and Hispanic populations were more likely to have modifiable risk factors for ADRD than other racial groups, the researchers reported.
The CDC’s National Healthy Brain Initiative supports culturally tailored interventions that address ADRD risk factors specifically in these populations.
In 2021, the federal government’s National Plan to Address Alzheimer’s Disease was updated to include a new goal to reduce risk factors for ADRD.
“Given the prevalence of modifiable risk factors for ADRD and anticipated growth of the older adult population and those with ADRD, this new goal has the potential to benefit a large proportion of U.S. adults,” the investigators wrote.
“In addition to helping patients discuss concerns about memory loss, health care professionals should also screen patients for modifiable risk factors, counsel patients with risk factors, and refer them to effective programs and interventions where recommended,” they advised.
A recent report from the Lancet Commission on Dementia Prevention, Intervention, and Care found that modifying 12 risk factors over the life course could delay or prevent 40% of dementia cases.
A version of this article first appeared on Medscape.com.
(ADRD), including hypertension, low levels of physical activity, and obesity, new research shows.
Data from the Centers for Disease Control and Prevention reveal that among nearly 162,000 adults aged 45 and older who were surveyed in 2019 as part of the Behavioral Risk Factor Surveillance System (BRFSS), nearly half had high blood pressure and did not achieve aerobic physical activity recommendations. These were the two most common modifiable risk factors for ADRD.
In addition, more than one-third (35%) of adults were obese, 19% had diabetes, 18% had depression, 15% were smokers, 11% had hearing loss, and 10% were binge drinkers.
The findings were published online in the CDC’s Morbidity and Mortality Weekly Report.
A missed prevention opportunity
More than 1 in 10 (11.3%) adults surveyed reported subjective cognitive decline (SCD), an early indicator of possible future ADRD.
The prevalence of SCD increased from about 4% among adults with no modifiable risk factors for ADRD to 25% for those with four or more risk factors.
Adults with SCD were more apt to report having almost all modifiable risk factors and were more likely to report four or more risk factors (34%) than were peers without SCD (13%)
The prevalence of SCD ranged from a high of about 29% in those with depression and 25% in those with hearing loss to 11% in those who reported binge drinking.
In line with previous research, the findings indicate that American Indian or Alaska Native, Black or African American, and Hispanic populations were more likely to have modifiable risk factors for ADRD than other racial groups, the researchers reported.
The CDC’s National Healthy Brain Initiative supports culturally tailored interventions that address ADRD risk factors specifically in these populations.
In 2021, the federal government’s National Plan to Address Alzheimer’s Disease was updated to include a new goal to reduce risk factors for ADRD.
“Given the prevalence of modifiable risk factors for ADRD and anticipated growth of the older adult population and those with ADRD, this new goal has the potential to benefit a large proportion of U.S. adults,” the investigators wrote.
“In addition to helping patients discuss concerns about memory loss, health care professionals should also screen patients for modifiable risk factors, counsel patients with risk factors, and refer them to effective programs and interventions where recommended,” they advised.
A recent report from the Lancet Commission on Dementia Prevention, Intervention, and Care found that modifying 12 risk factors over the life course could delay or prevent 40% of dementia cases.
A version of this article first appeared on Medscape.com.
(ADRD), including hypertension, low levels of physical activity, and obesity, new research shows.
Data from the Centers for Disease Control and Prevention reveal that among nearly 162,000 adults aged 45 and older who were surveyed in 2019 as part of the Behavioral Risk Factor Surveillance System (BRFSS), nearly half had high blood pressure and did not achieve aerobic physical activity recommendations. These were the two most common modifiable risk factors for ADRD.
In addition, more than one-third (35%) of adults were obese, 19% had diabetes, 18% had depression, 15% were smokers, 11% had hearing loss, and 10% were binge drinkers.
The findings were published online in the CDC’s Morbidity and Mortality Weekly Report.
A missed prevention opportunity
More than 1 in 10 (11.3%) adults surveyed reported subjective cognitive decline (SCD), an early indicator of possible future ADRD.
The prevalence of SCD increased from about 4% among adults with no modifiable risk factors for ADRD to 25% for those with four or more risk factors.
Adults with SCD were more apt to report having almost all modifiable risk factors and were more likely to report four or more risk factors (34%) than were peers without SCD (13%)
The prevalence of SCD ranged from a high of about 29% in those with depression and 25% in those with hearing loss to 11% in those who reported binge drinking.
In line with previous research, the findings indicate that American Indian or Alaska Native, Black or African American, and Hispanic populations were more likely to have modifiable risk factors for ADRD than other racial groups, the researchers reported.
The CDC’s National Healthy Brain Initiative supports culturally tailored interventions that address ADRD risk factors specifically in these populations.
In 2021, the federal government’s National Plan to Address Alzheimer’s Disease was updated to include a new goal to reduce risk factors for ADRD.
“Given the prevalence of modifiable risk factors for ADRD and anticipated growth of the older adult population and those with ADRD, this new goal has the potential to benefit a large proportion of U.S. adults,” the investigators wrote.
“In addition to helping patients discuss concerns about memory loss, health care professionals should also screen patients for modifiable risk factors, counsel patients with risk factors, and refer them to effective programs and interventions where recommended,” they advised.
A recent report from the Lancet Commission on Dementia Prevention, Intervention, and Care found that modifying 12 risk factors over the life course could delay or prevent 40% of dementia cases.
A version of this article first appeared on Medscape.com.
FROM MMWR
RSV kills 100,000 kids under age 5 a year worldwide
Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.
Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.
They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.
Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.
This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.
The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
Messages for prevention
Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.
Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”
Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”
Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.
It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.
Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.
Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.
“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
Pandemic changed patterns
This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.
However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.
“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.
A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.
“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
Most deaths occurring outside hospitals
A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.
The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”
The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.
This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.
The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.
The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.
Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.
They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.
Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.
This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.
The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
Messages for prevention
Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.
Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”
Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”
Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.
It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.
Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.
Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.
“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
Pandemic changed patterns
This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.
However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.
“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.
A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.
“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
Most deaths occurring outside hospitals
A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.
The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”
The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.
This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.
The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.
The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.
Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.
They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.
Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.
This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.
The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
Messages for prevention
Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.
Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”
Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”
Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.
It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.
Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.
Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.
“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
Pandemic changed patterns
This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.
However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.
“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.
A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.
“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
Most deaths occurring outside hospitals
A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.
The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”
The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.
This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.
The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.
The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET
Persistent dry cough
On the basis of the patient's presentation, history, and imaging results, the likely diagnosis is metastatic small cell lung cancer (SCLC). Most patients with SCLC present with hematogenous metastases; only about one third present with limited disease confined to the chest that is amenable to multimodal therapy. Patients with SCLC often present with symptoms of widespread metastases, including weight loss, bone pain, and neurologic compromise. It is uncommon for patients to present with a solitary peripheral nodule. In earlier stages, the differential diagnosis of SCLC spans other neuroendocrine lung tumors and NSCLC, in particular, basaloid carcinoma, extrapulmonary small cell tumors, and lymphoma.
Because the concentration of circulating tumor cells in SCLC is among the highest of any solid tumor, SCLC is characterized by a rapid doubling time, high growth fraction, and early development of widespread metastases. It is likely for this reason that CT screening does not seem effective in detecting early-stage SCLC. Common sites of SCLC metastasis are the contralateral lung, the brain, liver, adrenal glands, and bone. Most cases of SCLC are caused by smoking.
Metastatic spread is often evident on radiologic exam, sometimes showing pleural and pericardial effusions. In general, workup for SCLC includes imaging (contrast-enhanced CT or F-FDG PET–CT of the chest, abdomen, and pelvis and brain MRI with contrast), blood tests (cell count, liver and kidney function, and lactate dehydrogenase), and ECG. Biopsies are generally procured by bronchoscopy with or without endobronchial ultrasonography; if accessible, a biopsy of a distal metastatic site may be obtained. Diagnosis of SCLC is confirmed by histopathologic examination via cytology.
Patients with extensive-stage SCLC are typically treated with systemic chemotherapy with or without immunotherapy. In the early stages, SCLC is very responsive to cytotoxic therapies, with response rates over 60% even in patients with metastatic disease. Until recently, the only second-line therapy for recurrent metastatic SCLC was the topoisomerase I inhibitor topotecan. However, lurbinectedin was granted accelerated approval for second-line therapy after demonstrating a 35% response rate in a single-arm phase 2 study of 105 patients. In addition, the anti–programmed cell death protein 1 monoclonal antibodies nivolumab and pembrolizumab were granted accelerated approval for third-line use. Finally, the National Comprehensive Cancer Network guidelines note that participation in clinical trials should be strongly encouraged for all patients with SCLC.
Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.
Karl J. D'Silva, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
On the basis of the patient's presentation, history, and imaging results, the likely diagnosis is metastatic small cell lung cancer (SCLC). Most patients with SCLC present with hematogenous metastases; only about one third present with limited disease confined to the chest that is amenable to multimodal therapy. Patients with SCLC often present with symptoms of widespread metastases, including weight loss, bone pain, and neurologic compromise. It is uncommon for patients to present with a solitary peripheral nodule. In earlier stages, the differential diagnosis of SCLC spans other neuroendocrine lung tumors and NSCLC, in particular, basaloid carcinoma, extrapulmonary small cell tumors, and lymphoma.
Because the concentration of circulating tumor cells in SCLC is among the highest of any solid tumor, SCLC is characterized by a rapid doubling time, high growth fraction, and early development of widespread metastases. It is likely for this reason that CT screening does not seem effective in detecting early-stage SCLC. Common sites of SCLC metastasis are the contralateral lung, the brain, liver, adrenal glands, and bone. Most cases of SCLC are caused by smoking.
Metastatic spread is often evident on radiologic exam, sometimes showing pleural and pericardial effusions. In general, workup for SCLC includes imaging (contrast-enhanced CT or F-FDG PET–CT of the chest, abdomen, and pelvis and brain MRI with contrast), blood tests (cell count, liver and kidney function, and lactate dehydrogenase), and ECG. Biopsies are generally procured by bronchoscopy with or without endobronchial ultrasonography; if accessible, a biopsy of a distal metastatic site may be obtained. Diagnosis of SCLC is confirmed by histopathologic examination via cytology.
Patients with extensive-stage SCLC are typically treated with systemic chemotherapy with or without immunotherapy. In the early stages, SCLC is very responsive to cytotoxic therapies, with response rates over 60% even in patients with metastatic disease. Until recently, the only second-line therapy for recurrent metastatic SCLC was the topoisomerase I inhibitor topotecan. However, lurbinectedin was granted accelerated approval for second-line therapy after demonstrating a 35% response rate in a single-arm phase 2 study of 105 patients. In addition, the anti–programmed cell death protein 1 monoclonal antibodies nivolumab and pembrolizumab were granted accelerated approval for third-line use. Finally, the National Comprehensive Cancer Network guidelines note that participation in clinical trials should be strongly encouraged for all patients with SCLC.
Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.
Karl J. D'Silva, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
On the basis of the patient's presentation, history, and imaging results, the likely diagnosis is metastatic small cell lung cancer (SCLC). Most patients with SCLC present with hematogenous metastases; only about one third present with limited disease confined to the chest that is amenable to multimodal therapy. Patients with SCLC often present with symptoms of widespread metastases, including weight loss, bone pain, and neurologic compromise. It is uncommon for patients to present with a solitary peripheral nodule. In earlier stages, the differential diagnosis of SCLC spans other neuroendocrine lung tumors and NSCLC, in particular, basaloid carcinoma, extrapulmonary small cell tumors, and lymphoma.
Because the concentration of circulating tumor cells in SCLC is among the highest of any solid tumor, SCLC is characterized by a rapid doubling time, high growth fraction, and early development of widespread metastases. It is likely for this reason that CT screening does not seem effective in detecting early-stage SCLC. Common sites of SCLC metastasis are the contralateral lung, the brain, liver, adrenal glands, and bone. Most cases of SCLC are caused by smoking.
Metastatic spread is often evident on radiologic exam, sometimes showing pleural and pericardial effusions. In general, workup for SCLC includes imaging (contrast-enhanced CT or F-FDG PET–CT of the chest, abdomen, and pelvis and brain MRI with contrast), blood tests (cell count, liver and kidney function, and lactate dehydrogenase), and ECG. Biopsies are generally procured by bronchoscopy with or without endobronchial ultrasonography; if accessible, a biopsy of a distal metastatic site may be obtained. Diagnosis of SCLC is confirmed by histopathologic examination via cytology.
Patients with extensive-stage SCLC are typically treated with systemic chemotherapy with or without immunotherapy. In the early stages, SCLC is very responsive to cytotoxic therapies, with response rates over 60% even in patients with metastatic disease. Until recently, the only second-line therapy for recurrent metastatic SCLC was the topoisomerase I inhibitor topotecan. However, lurbinectedin was granted accelerated approval for second-line therapy after demonstrating a 35% response rate in a single-arm phase 2 study of 105 patients. In addition, the anti–programmed cell death protein 1 monoclonal antibodies nivolumab and pembrolizumab were granted accelerated approval for third-line use. Finally, the National Comprehensive Cancer Network guidelines note that participation in clinical trials should be strongly encouraged for all patients with SCLC.
Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.
Karl J. D'Silva, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
A 58-year-old man presents with a persistent dry cough that has developed over the past 8 weeks. He has lost about 8-10 lb in under 3 months. Height is 5 ft 10 in and weight is 172 lb (BMI 24.7). Although he quit smoking about 15 years ago, his wife still smokes. He has been screened twice for non–small cell lung cancer (NSCLC), most recently a year and a half ago. Chest radiograph shows multiple pulmonary nodules of varying sizes and a small right basal effusion.
Distal radial snuffbox technique comes up short in DISCO RADIAL
Distal radial access is not superior to conventional radial access with regard to radial artery occlusion (RAO) but is a valid alternative for use in percutaneous procedures, according to results of the DISCO RADIAL trial.
The primary endpoint of forearm RAO at discharge was not met, occurring in 0.31% of patients whose radial artery was accessed distally (DRA) at the anatomical snuffbox and in 0.91% of patients with conventional transradial access (TRA) in the intention-to-treat analysis (P = .29).
The DRA group was also twice as likely to crossover to another access point (7.5% vs. 3.7%; P = .002) and to experience radial artery spasm (5.4% vs. 2.7%; P < .015).
“The message first is that if you do a good job with transradial access you can end up with a lower [occlusion] rate,” said coprincipal investigator Adel Aminian, MD, Hôpital Civil Marie Curie, Charleroi, Belgium. “On the other hand, it’s a trade-off between a more demanding puncture for distal radial access but also a simpler hemostatic process, which I think is one of the main advantages of distal radial access.”
The results were presented during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions, and published simultaneously in JACC: Cardiovascular Interventions.
DISCO-RADIAL (Distal Versus Conventional RADIAL Access for Coronary Angiography and Intervention) is the largest trial thus far to compare TRA with the distal radial snuffbox technique, which has shown promise for reducing RAO rates in the recent single-center randomized DAPRAO and ANGIE trials.
The trial was conducted at 15 sites across Europe and Japan in 1,309 patients with an indication for percutaneous coronary procedures using the 6Fr Glidesheath Slender (Terumo). The intention-to-treat population included 657 TRA patients and 650 DRA patients.
The two groups were well matched, with most having a chronic coronary syndrome. Operators had to have performed a minimum of 100 procedures by DRA and follow systematic best practices previously reported by the investigators to prevent RAO, Dr. Aminian said.
The use of DRA did not significantly affect the duration of the coronary procedure (27 minutes vs. 24 minutes with TRA; P = .12) or average radiation dose (1298 mGy vs. 1222 mGy; P = .70).
DRA, however, reduced the need for selective compression devices (88% vs. 99.2%) and shortened the median time to hemostasis from 180 minutes to 153 minutes (P for both < .001).
“These results establish compliance to best practice recommendations for RAO avoidance as a mandatory new reference in transradial practice,” Dr. Aminian concluded. “At the same time, distal radial artery arises as a valid alternative associated with higher crossover rates but with a simpler and shorter hemostasis process.”
A show of hands revealed that about 25% of the audience used distal radial access prior to the presentation but that enthusiasm fell off following the results.
Discussant Hany Eteiba, MD, Glasgow Royal Infirmary, said: “I salute your enthusiasm for presenting a negative trial and you tried to persuade the audience to use the distal radial artery results, but nonetheless.”
Dr. Eteiba said he could see a “potential advantage in the shorter hemostasis time,” and asked whether it might be influencing the rapid turnover for day-case angioplasty.
Dr. Aminian responded that “if you do an angioplasty you have to keep the patient for a certain amount of time, but I think for your nurse work and for the health care resources, having a very short hemostasis time is very interesting. We started with a hemostasis time of 2 hours and now we’ve decreased it to 1 hour and it will decrease even more.”
Session moderator Chaim Lotan, MD, Hadassah-Hebrew University Medical Center, Jerusalem, called DISCO-RADIAL an important study and said, “the question now is what’s the indication in your eyes for using distal radial?”
Dr. Aminian said that one message from the trial is that people who are using transradial access “have to do a better job,” and reminded the audience that RAO rates at many centers are too high, at 10% or upward.
At the same time, Dr. Aminian cautioned that operators wanting to use distal radial access “need to master the technique” or they will “end up with a relatively high failure rate.”
Discussant Eliano Navarese, MD, Nicolaus Copernicus University, Toruń, Poland, said, “I still think that it is a very valid approach, we use it for almost 20 years ... but it is very true, it is very demanding. And the learning curve of 100 cases in the trial maybe needed more cases.”
In an accompanying editorial, Grigorios Tsigkas, MD, PhD, University of Patras, Rio Patras, Greece, and colleagues wrote that the incidence of forearm RAO was “surprisingly low” but could be even lower if the authors administered adequate anticoagulation.
Still, they wrote that distal transradial access “for coronary procedures in combination with the systematic implementation of best practices for RAO prevention may be the final solution against RAO.”
The editorialists suggested that exposure to radiation could be the “main limitation of this novel vascular approach” and that forthcoming trials, such as DOSE, could shed light on this issue.
Increased procedure times in the DISCO RADIAL and ANGIE trials are secondary in stable patients, Dr. Tsigkas said, but could be a limitation in patients presenting with ST-segment elevation myocardial infarction (STEMI). Ongoing research, such as the RESERVE trial from China and a Korean trial, will provide insights into the safety and feasibility of distal transradial access in STEMI.
The study was supported by Terumo Europe. Dr. Aminian reported receiving honoraria or consultation fees from Abbott, Boston Scientific, and Terumo Interventional Systems. Dr. Tsigkas reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Distal radial access is not superior to conventional radial access with regard to radial artery occlusion (RAO) but is a valid alternative for use in percutaneous procedures, according to results of the DISCO RADIAL trial.
The primary endpoint of forearm RAO at discharge was not met, occurring in 0.31% of patients whose radial artery was accessed distally (DRA) at the anatomical snuffbox and in 0.91% of patients with conventional transradial access (TRA) in the intention-to-treat analysis (P = .29).
The DRA group was also twice as likely to crossover to another access point (7.5% vs. 3.7%; P = .002) and to experience radial artery spasm (5.4% vs. 2.7%; P < .015).
“The message first is that if you do a good job with transradial access you can end up with a lower [occlusion] rate,” said coprincipal investigator Adel Aminian, MD, Hôpital Civil Marie Curie, Charleroi, Belgium. “On the other hand, it’s a trade-off between a more demanding puncture for distal radial access but also a simpler hemostatic process, which I think is one of the main advantages of distal radial access.”
The results were presented during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions, and published simultaneously in JACC: Cardiovascular Interventions.
DISCO-RADIAL (Distal Versus Conventional RADIAL Access for Coronary Angiography and Intervention) is the largest trial thus far to compare TRA with the distal radial snuffbox technique, which has shown promise for reducing RAO rates in the recent single-center randomized DAPRAO and ANGIE trials.
The trial was conducted at 15 sites across Europe and Japan in 1,309 patients with an indication for percutaneous coronary procedures using the 6Fr Glidesheath Slender (Terumo). The intention-to-treat population included 657 TRA patients and 650 DRA patients.
The two groups were well matched, with most having a chronic coronary syndrome. Operators had to have performed a minimum of 100 procedures by DRA and follow systematic best practices previously reported by the investigators to prevent RAO, Dr. Aminian said.
The use of DRA did not significantly affect the duration of the coronary procedure (27 minutes vs. 24 minutes with TRA; P = .12) or average radiation dose (1298 mGy vs. 1222 mGy; P = .70).
DRA, however, reduced the need for selective compression devices (88% vs. 99.2%) and shortened the median time to hemostasis from 180 minutes to 153 minutes (P for both < .001).
“These results establish compliance to best practice recommendations for RAO avoidance as a mandatory new reference in transradial practice,” Dr. Aminian concluded. “At the same time, distal radial artery arises as a valid alternative associated with higher crossover rates but with a simpler and shorter hemostasis process.”
A show of hands revealed that about 25% of the audience used distal radial access prior to the presentation but that enthusiasm fell off following the results.
Discussant Hany Eteiba, MD, Glasgow Royal Infirmary, said: “I salute your enthusiasm for presenting a negative trial and you tried to persuade the audience to use the distal radial artery results, but nonetheless.”
Dr. Eteiba said he could see a “potential advantage in the shorter hemostasis time,” and asked whether it might be influencing the rapid turnover for day-case angioplasty.
Dr. Aminian responded that “if you do an angioplasty you have to keep the patient for a certain amount of time, but I think for your nurse work and for the health care resources, having a very short hemostasis time is very interesting. We started with a hemostasis time of 2 hours and now we’ve decreased it to 1 hour and it will decrease even more.”
Session moderator Chaim Lotan, MD, Hadassah-Hebrew University Medical Center, Jerusalem, called DISCO-RADIAL an important study and said, “the question now is what’s the indication in your eyes for using distal radial?”
Dr. Aminian said that one message from the trial is that people who are using transradial access “have to do a better job,” and reminded the audience that RAO rates at many centers are too high, at 10% or upward.
At the same time, Dr. Aminian cautioned that operators wanting to use distal radial access “need to master the technique” or they will “end up with a relatively high failure rate.”
Discussant Eliano Navarese, MD, Nicolaus Copernicus University, Toruń, Poland, said, “I still think that it is a very valid approach, we use it for almost 20 years ... but it is very true, it is very demanding. And the learning curve of 100 cases in the trial maybe needed more cases.”
In an accompanying editorial, Grigorios Tsigkas, MD, PhD, University of Patras, Rio Patras, Greece, and colleagues wrote that the incidence of forearm RAO was “surprisingly low” but could be even lower if the authors administered adequate anticoagulation.
Still, they wrote that distal transradial access “for coronary procedures in combination with the systematic implementation of best practices for RAO prevention may be the final solution against RAO.”
The editorialists suggested that exposure to radiation could be the “main limitation of this novel vascular approach” and that forthcoming trials, such as DOSE, could shed light on this issue.
Increased procedure times in the DISCO RADIAL and ANGIE trials are secondary in stable patients, Dr. Tsigkas said, but could be a limitation in patients presenting with ST-segment elevation myocardial infarction (STEMI). Ongoing research, such as the RESERVE trial from China and a Korean trial, will provide insights into the safety and feasibility of distal transradial access in STEMI.
The study was supported by Terumo Europe. Dr. Aminian reported receiving honoraria or consultation fees from Abbott, Boston Scientific, and Terumo Interventional Systems. Dr. Tsigkas reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Distal radial access is not superior to conventional radial access with regard to radial artery occlusion (RAO) but is a valid alternative for use in percutaneous procedures, according to results of the DISCO RADIAL trial.
The primary endpoint of forearm RAO at discharge was not met, occurring in 0.31% of patients whose radial artery was accessed distally (DRA) at the anatomical snuffbox and in 0.91% of patients with conventional transradial access (TRA) in the intention-to-treat analysis (P = .29).
The DRA group was also twice as likely to crossover to another access point (7.5% vs. 3.7%; P = .002) and to experience radial artery spasm (5.4% vs. 2.7%; P < .015).
“The message first is that if you do a good job with transradial access you can end up with a lower [occlusion] rate,” said coprincipal investigator Adel Aminian, MD, Hôpital Civil Marie Curie, Charleroi, Belgium. “On the other hand, it’s a trade-off between a more demanding puncture for distal radial access but also a simpler hemostatic process, which I think is one of the main advantages of distal radial access.”
The results were presented during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions, and published simultaneously in JACC: Cardiovascular Interventions.
DISCO-RADIAL (Distal Versus Conventional RADIAL Access for Coronary Angiography and Intervention) is the largest trial thus far to compare TRA with the distal radial snuffbox technique, which has shown promise for reducing RAO rates in the recent single-center randomized DAPRAO and ANGIE trials.
The trial was conducted at 15 sites across Europe and Japan in 1,309 patients with an indication for percutaneous coronary procedures using the 6Fr Glidesheath Slender (Terumo). The intention-to-treat population included 657 TRA patients and 650 DRA patients.
The two groups were well matched, with most having a chronic coronary syndrome. Operators had to have performed a minimum of 100 procedures by DRA and follow systematic best practices previously reported by the investigators to prevent RAO, Dr. Aminian said.
The use of DRA did not significantly affect the duration of the coronary procedure (27 minutes vs. 24 minutes with TRA; P = .12) or average radiation dose (1298 mGy vs. 1222 mGy; P = .70).
DRA, however, reduced the need for selective compression devices (88% vs. 99.2%) and shortened the median time to hemostasis from 180 minutes to 153 minutes (P for both < .001).
“These results establish compliance to best practice recommendations for RAO avoidance as a mandatory new reference in transradial practice,” Dr. Aminian concluded. “At the same time, distal radial artery arises as a valid alternative associated with higher crossover rates but with a simpler and shorter hemostasis process.”
A show of hands revealed that about 25% of the audience used distal radial access prior to the presentation but that enthusiasm fell off following the results.
Discussant Hany Eteiba, MD, Glasgow Royal Infirmary, said: “I salute your enthusiasm for presenting a negative trial and you tried to persuade the audience to use the distal radial artery results, but nonetheless.”
Dr. Eteiba said he could see a “potential advantage in the shorter hemostasis time,” and asked whether it might be influencing the rapid turnover for day-case angioplasty.
Dr. Aminian responded that “if you do an angioplasty you have to keep the patient for a certain amount of time, but I think for your nurse work and for the health care resources, having a very short hemostasis time is very interesting. We started with a hemostasis time of 2 hours and now we’ve decreased it to 1 hour and it will decrease even more.”
Session moderator Chaim Lotan, MD, Hadassah-Hebrew University Medical Center, Jerusalem, called DISCO-RADIAL an important study and said, “the question now is what’s the indication in your eyes for using distal radial?”
Dr. Aminian said that one message from the trial is that people who are using transradial access “have to do a better job,” and reminded the audience that RAO rates at many centers are too high, at 10% or upward.
At the same time, Dr. Aminian cautioned that operators wanting to use distal radial access “need to master the technique” or they will “end up with a relatively high failure rate.”
Discussant Eliano Navarese, MD, Nicolaus Copernicus University, Toruń, Poland, said, “I still think that it is a very valid approach, we use it for almost 20 years ... but it is very true, it is very demanding. And the learning curve of 100 cases in the trial maybe needed more cases.”
In an accompanying editorial, Grigorios Tsigkas, MD, PhD, University of Patras, Rio Patras, Greece, and colleagues wrote that the incidence of forearm RAO was “surprisingly low” but could be even lower if the authors administered adequate anticoagulation.
Still, they wrote that distal transradial access “for coronary procedures in combination with the systematic implementation of best practices for RAO prevention may be the final solution against RAO.”
The editorialists suggested that exposure to radiation could be the “main limitation of this novel vascular approach” and that forthcoming trials, such as DOSE, could shed light on this issue.
Increased procedure times in the DISCO RADIAL and ANGIE trials are secondary in stable patients, Dr. Tsigkas said, but could be a limitation in patients presenting with ST-segment elevation myocardial infarction (STEMI). Ongoing research, such as the RESERVE trial from China and a Korean trial, will provide insights into the safety and feasibility of distal transradial access in STEMI.
The study was supported by Terumo Europe. Dr. Aminian reported receiving honoraria or consultation fees from Abbott, Boston Scientific, and Terumo Interventional Systems. Dr. Tsigkas reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EUROPCR 2022
CDC signs off on COVID boosters in children ages 5-11
Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.
The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.
At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.
ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.
They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.
CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.
“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.
Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.
“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”
Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.
Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.
“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.
The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.
Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.
“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”
At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.
COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.
Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.
“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
Responding to early data
As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.
The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.
Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
CDC seeks help tracking vaccine complications
At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.
“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.
About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.
One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.
A version of this article first appeared on Medscape.com.
Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.
The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.
At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.
ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.
They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.
CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.
“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.
Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.
“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”
Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.
Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.
“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.
The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.
Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.
“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”
At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.
COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.
Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.
“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
Responding to early data
As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.
The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.
Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
CDC seeks help tracking vaccine complications
At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.
“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.
About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.
One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.
A version of this article first appeared on Medscape.com.
Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.
The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.
At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.
ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.
They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.
CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.
“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.
Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.
“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”
Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.
Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.
“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.
The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.
Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.
“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”
At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.
COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.
Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.
“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
Responding to early data
As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.
The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.
Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
CDC seeks help tracking vaccine complications
At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.
“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.
About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.
One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.
A version of this article first appeared on Medscape.com.
Pancreatic involvement in COVID-19: What do we know?
MADRID – It involves the relationship between COVID-19 and new diagnoses of diabetes and blood glucose disorders, among others, in the post–COVID-19 period. These topics were addressed at the XXXIII National Congress of the Spanish Diabetes Society. They were also the central theme of the inaugural conference, Pancreatic Involvement During COVID-19: From Preclinical Studies to Clinical Relevance, which was led by Alexander Kleger, MD, PhD, head of the department of pancreatology at the Ulm (Germany) University Clinic for Internal Medicine.
The chair of the scientific committee of the congress, Franz Martín, MD, launched the conference by noting that the work of Dr. Kleger and his team has made it possible to ascertain that SARS-CoV-2 can infect pancreatic beta cells that produce insulin. This observation may help in understanding why patients with COVID-19 sometimes experience symptoms related to greater difficulty regulating blood glucose.
“In addition, the German expert and his group have described the abnormalities that occur in beta cells when they are infected by SARS-CoV-2, something especially important, given that knowledge of these abnormalities may be of great importance to understanding the possible appearance of more cases of diabetes in the future,” Dr. Martín added.
“Our data identify the human pancreas as a target of SARS-CoV-2 infection and suggest that pancreatic beta cell involvement could contribute to the metabolic dysregulation seen in COVID-19 patients,” Dr. Kleger pointed out.
In his speech, Dr. Kleger reviewed the evidence on the effects of SARS-CoV-2 that has been garnered since the start of the pandemic, and he presented his research group’s findings on the impact at the pancreatic level.
“Since March 2020, it has been seen that COVID-19 affected the pancreas, and studies published in August of that same year clearly spoke of both a worsening of diabetes and an increase in new cases of this disease diagnosed after SARS-CoV-2 infection. Also, the data showed how hospitalized patients with no previous history of diabetes experienced rapid increases in glucose levels 5 days after admission,” Dr. Kleger said.
Angiotensin-converting enzyme 2
As an example of the pace at which evidence on the pancreatic impact of this virus has been evolving, Dr. Kleger referred to early studies that found no angiotensin-converting enzyme 2 receptor on cells of the endocrine and exocrine pancreas. “To our surprise, in our work, we did observe the obvious presence of angiotensin-converting enzyme 2 specifically expressed in human pancreatic beta cells, something confirmed by other investigations. Another surprising aspect was verifying that the viral infection lasts longer in the pancreas than in the lungs,” said the expert.
These findings caused the researchers to realize that SARS-CoV-2 may be directly or indirectly associated with diabetes. “It is currently the subject of debate whether it may be a direct effect, infecting or directly reaching the pancreatic beta cells, or whether this involvement is a result of the effect of the infection at systemic level, in the context of the cytokine storm and the proinflammatory environment derived from it. Our current challenge is to confirm whether this virus can really replicate in pancreatic beta cells and to assess the possible existence of reinfections, among other aspects,” said Dr. Kleger.
Along with these “developing areas of knowledge,” there are several certainties regarding the link between diabetes and COVID-19. Dr. Kleger summarized the most relevant one. “Preexisting diabetes is known to be a highly prevalent comorbidity seen in 11%-22% of patients and increases the risk of severe disease and mortality.
“SARS-CoV-2 infection has also been shown to affect the exocrine pancreas, manifesting as pancreatitis in 5% of critically ill patients with COVID-19, as well as enlargement of the pancreas and abnormal levels of amylase or lipase in 7.5%-17% of patients.
“Furthermore, it is obvious that SARS-CoV-2 infection produces glycometabolic dysfunction in these patients, with increased hyperglycemia in people with type 2 diabetes and ketoacidosis in 2%-6.4% of patients with and without diabetes.”
After recovery
The most recent research reveals the persistence of this dysregulation long after recovery from COVID-19. “We’ve seen that in a significant proportion of patients, hyperglycemia is maintained for some time; in the specific case of hospitalized patients [without the need for assisted ventilation or other intensive care requirements], for up to more than 2 months after overcoming the illness.
“In the same way, there are studies that have shown that insulin resistance and hyperstimulation of pancreatic beta cells remain at pathological levels in the post–COVID-19 phase. And in line with increased insulin resistance, signs of hyperinflammation have also been detected in these patients.”
Dr. Kleger noted that another research area is the increased incidence of newly diagnosed diabetes after recovery from SARS-CoV-2 infection, “something that seems to be correlated with how severely the disease has been experienced and also depending on whether hospitalization or intensive care was needed. Likewise, retrospective studies have shown that the risk of developing type 2 diabetes is higher in COVID-19 patients, compared with those with other respiratory infections. Regarding the incidence of type 1 diabetes, there is evidence, particularly in the case of children, of a clear correlation between the pandemic waves and the increase in cases.
“Therefore, and in view of this data, we could say that, with regard to the involvement of SARS-CoV-2 in pancreatic beta cells, something is up, but we are not yet able to fully understand what it is. What can be confirmed based on the numerous studies carried out in this regard is that COVID-19 produces a metabolic dysregulation [hyperglycemia, insulin resistance, diabetic ketoacidosis] which in turn favors the development of diabetes in patients with no history of this disease,” said Dr. Kleger.
“Likewise, everything points to the existence of a definitively feasible infection in pancreatic beta cells associated with SARS-CoV-2, but there are still unknown aspects of the physiology that explain this effect that remain the subject of debate and deserve future studies,” he concluded.
Consequences of the pandemic
The experts agreed that, although COVID-19 is no longer at the center of specialist care, it is still a subject of investigation. On the conference’s opening day, an update was made on the approach to diabetes.
Care activity is gradually recovering as the time that professionals devote to COVID-19 care is reduced, “but it will take time to catch up with the care activities not carried out during the pandemic, and, unfortunately, in the coming years, we will see the repercussion of the lack or reduction of care during these years,” stressed the SED chair, Antonio Pérez Pérez, MD, director of endocrinology and nutrition of Hospital de la Santa Creu i Sant Pau, Barcelona.
Dr. Pérez stressed that the pandemic has revealed health system deficiencies in diabetes care. He added that the impact of COVID-19 on diabetes (resulting from the effects of the infection itself or from the inadequacy of prevention, diagnosis, and treatment measures) fostered a deterioration of metabolic control and a delay in the diagnosis of the disease and its complications.
“All this contributes to the fact that we currently continue to see patients with complications, especially in the case of type 2 diabetes, with more serious decompensations and diagnoses in more advanced stages of the disease. This impact has been more significant in older people from disadvantaged areas and with less capacity for self-monitoring and self-adjustment of treatment,” he added.
Describing lessons learned through the experiences accumulated in diabetes care during the pandemic, Dr. Pérez highlighted the push for virtual consultations, accessibility to drugs prescribed in electronic prescriptions, and the use of educational resources online and of telemedicine tools. “The need to invest in the health sector has also been assumed, endowing it with robustness in well-trained health personnel, to promote health education, boost efficient health organization, and invest in innovation aimed at facilitating care.”
Dr. Kleger and Dr. Pérez disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com. This article was translated from the Medscape Spanish edition.
MADRID – It involves the relationship between COVID-19 and new diagnoses of diabetes and blood glucose disorders, among others, in the post–COVID-19 period. These topics were addressed at the XXXIII National Congress of the Spanish Diabetes Society. They were also the central theme of the inaugural conference, Pancreatic Involvement During COVID-19: From Preclinical Studies to Clinical Relevance, which was led by Alexander Kleger, MD, PhD, head of the department of pancreatology at the Ulm (Germany) University Clinic for Internal Medicine.
The chair of the scientific committee of the congress, Franz Martín, MD, launched the conference by noting that the work of Dr. Kleger and his team has made it possible to ascertain that SARS-CoV-2 can infect pancreatic beta cells that produce insulin. This observation may help in understanding why patients with COVID-19 sometimes experience symptoms related to greater difficulty regulating blood glucose.
“In addition, the German expert and his group have described the abnormalities that occur in beta cells when they are infected by SARS-CoV-2, something especially important, given that knowledge of these abnormalities may be of great importance to understanding the possible appearance of more cases of diabetes in the future,” Dr. Martín added.
“Our data identify the human pancreas as a target of SARS-CoV-2 infection and suggest that pancreatic beta cell involvement could contribute to the metabolic dysregulation seen in COVID-19 patients,” Dr. Kleger pointed out.
In his speech, Dr. Kleger reviewed the evidence on the effects of SARS-CoV-2 that has been garnered since the start of the pandemic, and he presented his research group’s findings on the impact at the pancreatic level.
“Since March 2020, it has been seen that COVID-19 affected the pancreas, and studies published in August of that same year clearly spoke of both a worsening of diabetes and an increase in new cases of this disease diagnosed after SARS-CoV-2 infection. Also, the data showed how hospitalized patients with no previous history of diabetes experienced rapid increases in glucose levels 5 days after admission,” Dr. Kleger said.
Angiotensin-converting enzyme 2
As an example of the pace at which evidence on the pancreatic impact of this virus has been evolving, Dr. Kleger referred to early studies that found no angiotensin-converting enzyme 2 receptor on cells of the endocrine and exocrine pancreas. “To our surprise, in our work, we did observe the obvious presence of angiotensin-converting enzyme 2 specifically expressed in human pancreatic beta cells, something confirmed by other investigations. Another surprising aspect was verifying that the viral infection lasts longer in the pancreas than in the lungs,” said the expert.
These findings caused the researchers to realize that SARS-CoV-2 may be directly or indirectly associated with diabetes. “It is currently the subject of debate whether it may be a direct effect, infecting or directly reaching the pancreatic beta cells, or whether this involvement is a result of the effect of the infection at systemic level, in the context of the cytokine storm and the proinflammatory environment derived from it. Our current challenge is to confirm whether this virus can really replicate in pancreatic beta cells and to assess the possible existence of reinfections, among other aspects,” said Dr. Kleger.
Along with these “developing areas of knowledge,” there are several certainties regarding the link between diabetes and COVID-19. Dr. Kleger summarized the most relevant one. “Preexisting diabetes is known to be a highly prevalent comorbidity seen in 11%-22% of patients and increases the risk of severe disease and mortality.
“SARS-CoV-2 infection has also been shown to affect the exocrine pancreas, manifesting as pancreatitis in 5% of critically ill patients with COVID-19, as well as enlargement of the pancreas and abnormal levels of amylase or lipase in 7.5%-17% of patients.
“Furthermore, it is obvious that SARS-CoV-2 infection produces glycometabolic dysfunction in these patients, with increased hyperglycemia in people with type 2 diabetes and ketoacidosis in 2%-6.4% of patients with and without diabetes.”
After recovery
The most recent research reveals the persistence of this dysregulation long after recovery from COVID-19. “We’ve seen that in a significant proportion of patients, hyperglycemia is maintained for some time; in the specific case of hospitalized patients [without the need for assisted ventilation or other intensive care requirements], for up to more than 2 months after overcoming the illness.
“In the same way, there are studies that have shown that insulin resistance and hyperstimulation of pancreatic beta cells remain at pathological levels in the post–COVID-19 phase. And in line with increased insulin resistance, signs of hyperinflammation have also been detected in these patients.”
Dr. Kleger noted that another research area is the increased incidence of newly diagnosed diabetes after recovery from SARS-CoV-2 infection, “something that seems to be correlated with how severely the disease has been experienced and also depending on whether hospitalization or intensive care was needed. Likewise, retrospective studies have shown that the risk of developing type 2 diabetes is higher in COVID-19 patients, compared with those with other respiratory infections. Regarding the incidence of type 1 diabetes, there is evidence, particularly in the case of children, of a clear correlation between the pandemic waves and the increase in cases.
“Therefore, and in view of this data, we could say that, with regard to the involvement of SARS-CoV-2 in pancreatic beta cells, something is up, but we are not yet able to fully understand what it is. What can be confirmed based on the numerous studies carried out in this regard is that COVID-19 produces a metabolic dysregulation [hyperglycemia, insulin resistance, diabetic ketoacidosis] which in turn favors the development of diabetes in patients with no history of this disease,” said Dr. Kleger.
“Likewise, everything points to the existence of a definitively feasible infection in pancreatic beta cells associated with SARS-CoV-2, but there are still unknown aspects of the physiology that explain this effect that remain the subject of debate and deserve future studies,” he concluded.
Consequences of the pandemic
The experts agreed that, although COVID-19 is no longer at the center of specialist care, it is still a subject of investigation. On the conference’s opening day, an update was made on the approach to diabetes.
Care activity is gradually recovering as the time that professionals devote to COVID-19 care is reduced, “but it will take time to catch up with the care activities not carried out during the pandemic, and, unfortunately, in the coming years, we will see the repercussion of the lack or reduction of care during these years,” stressed the SED chair, Antonio Pérez Pérez, MD, director of endocrinology and nutrition of Hospital de la Santa Creu i Sant Pau, Barcelona.
Dr. Pérez stressed that the pandemic has revealed health system deficiencies in diabetes care. He added that the impact of COVID-19 on diabetes (resulting from the effects of the infection itself or from the inadequacy of prevention, diagnosis, and treatment measures) fostered a deterioration of metabolic control and a delay in the diagnosis of the disease and its complications.
“All this contributes to the fact that we currently continue to see patients with complications, especially in the case of type 2 diabetes, with more serious decompensations and diagnoses in more advanced stages of the disease. This impact has been more significant in older people from disadvantaged areas and with less capacity for self-monitoring and self-adjustment of treatment,” he added.
Describing lessons learned through the experiences accumulated in diabetes care during the pandemic, Dr. Pérez highlighted the push for virtual consultations, accessibility to drugs prescribed in electronic prescriptions, and the use of educational resources online and of telemedicine tools. “The need to invest in the health sector has also been assumed, endowing it with robustness in well-trained health personnel, to promote health education, boost efficient health organization, and invest in innovation aimed at facilitating care.”
Dr. Kleger and Dr. Pérez disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com. This article was translated from the Medscape Spanish edition.
MADRID – It involves the relationship between COVID-19 and new diagnoses of diabetes and blood glucose disorders, among others, in the post–COVID-19 period. These topics were addressed at the XXXIII National Congress of the Spanish Diabetes Society. They were also the central theme of the inaugural conference, Pancreatic Involvement During COVID-19: From Preclinical Studies to Clinical Relevance, which was led by Alexander Kleger, MD, PhD, head of the department of pancreatology at the Ulm (Germany) University Clinic for Internal Medicine.
The chair of the scientific committee of the congress, Franz Martín, MD, launched the conference by noting that the work of Dr. Kleger and his team has made it possible to ascertain that SARS-CoV-2 can infect pancreatic beta cells that produce insulin. This observation may help in understanding why patients with COVID-19 sometimes experience symptoms related to greater difficulty regulating blood glucose.
“In addition, the German expert and his group have described the abnormalities that occur in beta cells when they are infected by SARS-CoV-2, something especially important, given that knowledge of these abnormalities may be of great importance to understanding the possible appearance of more cases of diabetes in the future,” Dr. Martín added.
“Our data identify the human pancreas as a target of SARS-CoV-2 infection and suggest that pancreatic beta cell involvement could contribute to the metabolic dysregulation seen in COVID-19 patients,” Dr. Kleger pointed out.
In his speech, Dr. Kleger reviewed the evidence on the effects of SARS-CoV-2 that has been garnered since the start of the pandemic, and he presented his research group’s findings on the impact at the pancreatic level.
“Since March 2020, it has been seen that COVID-19 affected the pancreas, and studies published in August of that same year clearly spoke of both a worsening of diabetes and an increase in new cases of this disease diagnosed after SARS-CoV-2 infection. Also, the data showed how hospitalized patients with no previous history of diabetes experienced rapid increases in glucose levels 5 days after admission,” Dr. Kleger said.
Angiotensin-converting enzyme 2
As an example of the pace at which evidence on the pancreatic impact of this virus has been evolving, Dr. Kleger referred to early studies that found no angiotensin-converting enzyme 2 receptor on cells of the endocrine and exocrine pancreas. “To our surprise, in our work, we did observe the obvious presence of angiotensin-converting enzyme 2 specifically expressed in human pancreatic beta cells, something confirmed by other investigations. Another surprising aspect was verifying that the viral infection lasts longer in the pancreas than in the lungs,” said the expert.
These findings caused the researchers to realize that SARS-CoV-2 may be directly or indirectly associated with diabetes. “It is currently the subject of debate whether it may be a direct effect, infecting or directly reaching the pancreatic beta cells, or whether this involvement is a result of the effect of the infection at systemic level, in the context of the cytokine storm and the proinflammatory environment derived from it. Our current challenge is to confirm whether this virus can really replicate in pancreatic beta cells and to assess the possible existence of reinfections, among other aspects,” said Dr. Kleger.
Along with these “developing areas of knowledge,” there are several certainties regarding the link between diabetes and COVID-19. Dr. Kleger summarized the most relevant one. “Preexisting diabetes is known to be a highly prevalent comorbidity seen in 11%-22% of patients and increases the risk of severe disease and mortality.
“SARS-CoV-2 infection has also been shown to affect the exocrine pancreas, manifesting as pancreatitis in 5% of critically ill patients with COVID-19, as well as enlargement of the pancreas and abnormal levels of amylase or lipase in 7.5%-17% of patients.
“Furthermore, it is obvious that SARS-CoV-2 infection produces glycometabolic dysfunction in these patients, with increased hyperglycemia in people with type 2 diabetes and ketoacidosis in 2%-6.4% of patients with and without diabetes.”
After recovery
The most recent research reveals the persistence of this dysregulation long after recovery from COVID-19. “We’ve seen that in a significant proportion of patients, hyperglycemia is maintained for some time; in the specific case of hospitalized patients [without the need for assisted ventilation or other intensive care requirements], for up to more than 2 months after overcoming the illness.
“In the same way, there are studies that have shown that insulin resistance and hyperstimulation of pancreatic beta cells remain at pathological levels in the post–COVID-19 phase. And in line with increased insulin resistance, signs of hyperinflammation have also been detected in these patients.”
Dr. Kleger noted that another research area is the increased incidence of newly diagnosed diabetes after recovery from SARS-CoV-2 infection, “something that seems to be correlated with how severely the disease has been experienced and also depending on whether hospitalization or intensive care was needed. Likewise, retrospective studies have shown that the risk of developing type 2 diabetes is higher in COVID-19 patients, compared with those with other respiratory infections. Regarding the incidence of type 1 diabetes, there is evidence, particularly in the case of children, of a clear correlation between the pandemic waves and the increase in cases.
“Therefore, and in view of this data, we could say that, with regard to the involvement of SARS-CoV-2 in pancreatic beta cells, something is up, but we are not yet able to fully understand what it is. What can be confirmed based on the numerous studies carried out in this regard is that COVID-19 produces a metabolic dysregulation [hyperglycemia, insulin resistance, diabetic ketoacidosis] which in turn favors the development of diabetes in patients with no history of this disease,” said Dr. Kleger.
“Likewise, everything points to the existence of a definitively feasible infection in pancreatic beta cells associated with SARS-CoV-2, but there are still unknown aspects of the physiology that explain this effect that remain the subject of debate and deserve future studies,” he concluded.
Consequences of the pandemic
The experts agreed that, although COVID-19 is no longer at the center of specialist care, it is still a subject of investigation. On the conference’s opening day, an update was made on the approach to diabetes.
Care activity is gradually recovering as the time that professionals devote to COVID-19 care is reduced, “but it will take time to catch up with the care activities not carried out during the pandemic, and, unfortunately, in the coming years, we will see the repercussion of the lack or reduction of care during these years,” stressed the SED chair, Antonio Pérez Pérez, MD, director of endocrinology and nutrition of Hospital de la Santa Creu i Sant Pau, Barcelona.
Dr. Pérez stressed that the pandemic has revealed health system deficiencies in diabetes care. He added that the impact of COVID-19 on diabetes (resulting from the effects of the infection itself or from the inadequacy of prevention, diagnosis, and treatment measures) fostered a deterioration of metabolic control and a delay in the diagnosis of the disease and its complications.
“All this contributes to the fact that we currently continue to see patients with complications, especially in the case of type 2 diabetes, with more serious decompensations and diagnoses in more advanced stages of the disease. This impact has been more significant in older people from disadvantaged areas and with less capacity for self-monitoring and self-adjustment of treatment,” he added.
Describing lessons learned through the experiences accumulated in diabetes care during the pandemic, Dr. Pérez highlighted the push for virtual consultations, accessibility to drugs prescribed in electronic prescriptions, and the use of educational resources online and of telemedicine tools. “The need to invest in the health sector has also been assumed, endowing it with robustness in well-trained health personnel, to promote health education, boost efficient health organization, and invest in innovation aimed at facilitating care.”
Dr. Kleger and Dr. Pérez disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com. This article was translated from the Medscape Spanish edition.