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Prioritize goals of older patients with multimorbidities, gerontologist says

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When caring for older adults with multiple chronic conditions, prioritizing patient goals is more effective and efficient than trying to address each condition in isolation, said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.

Dr. Mary Tinetti

During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.

“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.

“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”

For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.

“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”


 

What is patient priorities care?

Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.

“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”

In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
 

 

 

How electronic health records can help

In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.

“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”

She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
 

Systemic obstacles and solutions

According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.

Dr. Cynthia Boyd


“Our health care system doesn’t always make it easy to do this,” Dr. Boyd said. “It’s important to acknowledge this because it can be hard to do. There’s no question,” Dr. Boyd said in an interview.

Among the headwinds that clinicians may face are clinical practice guidelines, the structure of electronic health records, and quality metrics focused on specific conditions, she explained.

“There’s a lot of things that push us – in primary care and other parts of medicine – away from the approach that’s best for people with multiple chronic conditions,” Dr. Boyd said.

Dr. Tinetti said a challenge to providing this care that she expects is for clinicians, regardless of specialty, “to feel uneasy” about transitioning away from a conventional approach.

Among Dr. Tinetti’s arguments in favor of providing patient priorities care is that “it’s going to bring more joy in practice because you’re really addressing what matters to that individual while also providing good care.”

To get the most out of patient priorities care, Dr. Boyd recommended that clinicians focus on ‘the 4 M’s’: what matters most, mentation, mobility, and medications.

In an effort to address the last of these on a broad scale, Dr. Boyd is co-leading the US Deprescribing Research Network(USDeN), which aims to “improve medication use among older adults and the outcomes that are important to them,” according to the USDeN website.

To encourage deprescribing on a day-to-day level, Dr. Boyd called for strong communication between co–managing providers.

In an ideal world, there would be a better way to communicate than largely via electronic health records, she said.

“We need more than the EHR to connect us. That’s why it’s really important for primary care providers and specialists to be able to have time to actually talk to each other. This gets into how we reimburse and organize the communication and cognitive aspects of care,” Dr. Boyd noted.

Dr. Tinetti disclosed support from the John A. Hartford Foundation, the Donaghue Foundation, the National Institute on Aging, and the Institute for Healthcare Improvement. Dr. Boyd disclosed a relationship with UpToDate, for which she coauthored a chapter on multimorbidity.

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When caring for older adults with multiple chronic conditions, prioritizing patient goals is more effective and efficient than trying to address each condition in isolation, said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.

Dr. Mary Tinetti

During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.

“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.

“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”

For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.

“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”


 

What is patient priorities care?

Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.

“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”

In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
 

 

 

How electronic health records can help

In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.

“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”

She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
 

Systemic obstacles and solutions

According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.

Dr. Cynthia Boyd


“Our health care system doesn’t always make it easy to do this,” Dr. Boyd said. “It’s important to acknowledge this because it can be hard to do. There’s no question,” Dr. Boyd said in an interview.

Among the headwinds that clinicians may face are clinical practice guidelines, the structure of electronic health records, and quality metrics focused on specific conditions, she explained.

“There’s a lot of things that push us – in primary care and other parts of medicine – away from the approach that’s best for people with multiple chronic conditions,” Dr. Boyd said.

Dr. Tinetti said a challenge to providing this care that she expects is for clinicians, regardless of specialty, “to feel uneasy” about transitioning away from a conventional approach.

Among Dr. Tinetti’s arguments in favor of providing patient priorities care is that “it’s going to bring more joy in practice because you’re really addressing what matters to that individual while also providing good care.”

To get the most out of patient priorities care, Dr. Boyd recommended that clinicians focus on ‘the 4 M’s’: what matters most, mentation, mobility, and medications.

In an effort to address the last of these on a broad scale, Dr. Boyd is co-leading the US Deprescribing Research Network(USDeN), which aims to “improve medication use among older adults and the outcomes that are important to them,” according to the USDeN website.

To encourage deprescribing on a day-to-day level, Dr. Boyd called for strong communication between co–managing providers.

In an ideal world, there would be a better way to communicate than largely via electronic health records, she said.

“We need more than the EHR to connect us. That’s why it’s really important for primary care providers and specialists to be able to have time to actually talk to each other. This gets into how we reimburse and organize the communication and cognitive aspects of care,” Dr. Boyd noted.

Dr. Tinetti disclosed support from the John A. Hartford Foundation, the Donaghue Foundation, the National Institute on Aging, and the Institute for Healthcare Improvement. Dr. Boyd disclosed a relationship with UpToDate, for which she coauthored a chapter on multimorbidity.

When caring for older adults with multiple chronic conditions, prioritizing patient goals is more effective and efficient than trying to address each condition in isolation, said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.

Dr. Mary Tinetti

During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.

“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.

“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”

For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.

“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”


 

What is patient priorities care?

Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.

“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”

In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
 

 

 

How electronic health records can help

In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.

“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”

She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
 

Systemic obstacles and solutions

According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.

Dr. Cynthia Boyd


“Our health care system doesn’t always make it easy to do this,” Dr. Boyd said. “It’s important to acknowledge this because it can be hard to do. There’s no question,” Dr. Boyd said in an interview.

Among the headwinds that clinicians may face are clinical practice guidelines, the structure of electronic health records, and quality metrics focused on specific conditions, she explained.

“There’s a lot of things that push us – in primary care and other parts of medicine – away from the approach that’s best for people with multiple chronic conditions,” Dr. Boyd said.

Dr. Tinetti said a challenge to providing this care that she expects is for clinicians, regardless of specialty, “to feel uneasy” about transitioning away from a conventional approach.

Among Dr. Tinetti’s arguments in favor of providing patient priorities care is that “it’s going to bring more joy in practice because you’re really addressing what matters to that individual while also providing good care.”

To get the most out of patient priorities care, Dr. Boyd recommended that clinicians focus on ‘the 4 M’s’: what matters most, mentation, mobility, and medications.

In an effort to address the last of these on a broad scale, Dr. Boyd is co-leading the US Deprescribing Research Network(USDeN), which aims to “improve medication use among older adults and the outcomes that are important to them,” according to the USDeN website.

To encourage deprescribing on a day-to-day level, Dr. Boyd called for strong communication between co–managing providers.

In an ideal world, there would be a better way to communicate than largely via electronic health records, she said.

“We need more than the EHR to connect us. That’s why it’s really important for primary care providers and specialists to be able to have time to actually talk to each other. This gets into how we reimburse and organize the communication and cognitive aspects of care,” Dr. Boyd noted.

Dr. Tinetti disclosed support from the John A. Hartford Foundation, the Donaghue Foundation, the National Institute on Aging, and the Institute for Healthcare Improvement. Dr. Boyd disclosed a relationship with UpToDate, for which she coauthored a chapter on multimorbidity.

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Multiple studies highlight pandemic’s impact on patients with rheumatic disease

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Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

 

 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

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Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

 

 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

 

Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

 

 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

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Restrict J&J COVID vaccine in women under 50?

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Thu, 08/26/2021 - 15:47

Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.

The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.

The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins

They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.

The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.

They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”

In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).

The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.

The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.

As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.

In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.

At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.

In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.

One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.

All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.

The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.

In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.

Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.

However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.

“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.

They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.

They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.

They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.

The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.

They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.

“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.

The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.

In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).

The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.

They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.

This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.

Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.

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

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Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.

The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.

The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins

They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.

The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.

They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”

In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).

The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.

The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.

As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.

In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.

At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.

In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.

One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.

All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.

The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.

In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.

Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.

However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.

“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.

They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.

They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.

They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.

The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.

They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.

“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.

The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.

In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).

The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.

They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.

This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.

Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.

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

Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.

The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.

The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins

They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.

The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.

They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”

In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).

The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.

The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.

As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.

In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.

At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.

In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.

One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.

All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.

The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.

In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.

Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.

However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.

“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.

They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.

They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.

They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.

The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.

They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.

“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.

The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.

In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).

The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.

They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.

This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.

Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.

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

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COVID-19 coaching program provides ‘psychological PPE’ for HCPs

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Thu, 09/09/2021 - 16:19

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

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A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

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Formal geriatric assessment should be routine

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Tue, 05/11/2021 - 10:19

As the number of elderly patients with cancer continues to rise – and geriatricians remain in short supply – primary care providers and community oncologists need to incorporate formal geriatric assessment into routine practice, a geriatric oncologist said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. Grant R. Williams

A 2020 ASCO survey, which the speaker, Grant R. Williams, MD, coauthored, found that 9 out of 10 community oncologists assessed at least some older patients differently than younger patients. But only 1 out of 3 did so in a formal manner, Dr. Williams, director of the cancer and aging program at the University of Alabama at Birmingham, said during presentation at virtual meeting.

In most cases, informal geriatric assessment considers only the tip of the ‘geriatric oncology iceberg,’ including chronological age, performance status, tumor characteristics, and organ function, Dr. Williams noted.

In contrast, formal geriatric assessment dives deeper, measuring a series of additional outcome-associated factors: polypharmacy, comorbidities, falls, psychosocial dysfunction, social support, sarcopenia, nutritional deficits, cognitive impairment, and functional issues.

“All these other factors under the surface are critically important to developing a personalized and individualized cancer treatment plan for older adults,” Dr. Williams said.

He went on to explain that elderly cancer patients can be sorted into three broad categories: fit, vulnerable, and frail. Fit and frail patients are relatively easy to identify, but most elderly patients fall into the vulnerable category, Dr. Williams noted.

“It’s really more challenging to identify those individuals across the spectrum than those at the extremes,” Dr. Williams said, noting that formal geriatric assessment can detect problems not found routinely.
 

Formal geriatric assessment’s value

Geriatric assessment can be used for risk modeling and making life-expectancy calculations. It can also be used as an interventional tool, guiding cancer treatment selection, he said. Furthermore, it can open doors to general health interventions, such as occupational therapy, to reduce fall risk.

Beneficial interventions identified by geriatric assessment have been shown to improve function, reduce chemotherapy toxicities, improve quality of life, and extend survival, Dr. Williams noted.

Formal geriatric assessment may be particularly useful for primary care providers considering referral to an oncologist, he said.

“I think performing a geriatric assessment [prior to referral] would be a great idea. And that’s twofold: Even before you send them to the oncologist, it gives you an idea of how they may tolerate treatment, and frankly, it may give you an idea that they don’t need a referral to the oncologist if they’re particularly frail,” noted Dr. Williams.
 

Alternatives to formal assessments

When asked how providers can incorporate formal assessments into a busy day at the clinic, Dr. Williams encouraged the use of abbreviated formal assessments, then adding further testing if needed.

“Given known time and support staff restraints, modified geriatric assessment tools have been developed that are either mostly or completely patient-reported,” he said in an interview, referring to the Cancer and Aging Research Group (CARG) Geriatric Assessment and the Cancer and Aging Resilience Evaluation (CARE), respectively.

“[These assessments] can easily be completed before clinical visits or while in the waiting room,” Dr. Williams noted. “The additional objective tests, such as Timed Up and Go, and Mental Status Exam, can be completed if deemed necessary based on these initial assessments.”

Martine Extermann, MD, PhD, provided her suggestions in an interview for what physicians can do to get better outcomes for this patient group.

Courtesy Dr. Extermann
Dr. Martine Extermann


“The secret of successful anti-cancer treatment in an older person is to be proactive with supportive care,” said Dr. Extermann, leader of the senior adult oncology program at H. Lee Moffitt Cancer Center & Research Institute, Tampa, Fla. “You have to really plan ahead, identify the support gaps, identify the potential problems, and prevent them thoroughly. The upfront work of good patient evaluation will save you a lot of trouble down the line,” she added.

Ms. Extermann also mentioned the challenges to providing care to geriatric patients with cancer, including a lack of financial incentive for physicians to specialize in geriatrics.
 

 

 

Gerontology remains a practice gap

Oncologists who don’t perform geriatric assessments are probably missing more than they think, Dr. Extermann said in an interview.

“Many oncologists don’t fully realize the importance of [geriatric assessment] yet,” Dr. Extermann said. “They kind of think that their internal medicine training will carry through, and they’ll be able to identify everything; actually, we know very well we miss half of what is found by geriatric assessment clinically.”

Gerontology remains a practice gap, Dr. Extermann said, not only within oncology, but across specialties.

“One of the big problems with the U.S. health care system is we don’t have enough geriatricians, and the reason we don’t have enough geriatricians is because we don’t pay them,” she said.

“Geriatrics is the only specialty where you do more training to be paid less, because Medicare doesn’t reimburse geriatric assessment, [and] it doesn’t reimburse geriatric consultation. [This] doesn’t motivate universities to create geriatric clinics and geriatric programs because they will lose money, basically, doing that. If we want to really solve the problem, we have to solve the reimbursement problem up front,” she explained.

Dr. Williams disclosed financial relationships with Carevive Health Systems, Cardinal Health, the National Cancer Institute, and the American Cancer Society. Dr. Extermann reported no conflicts of interest.
 

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As the number of elderly patients with cancer continues to rise – and geriatricians remain in short supply – primary care providers and community oncologists need to incorporate formal geriatric assessment into routine practice, a geriatric oncologist said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. Grant R. Williams

A 2020 ASCO survey, which the speaker, Grant R. Williams, MD, coauthored, found that 9 out of 10 community oncologists assessed at least some older patients differently than younger patients. But only 1 out of 3 did so in a formal manner, Dr. Williams, director of the cancer and aging program at the University of Alabama at Birmingham, said during presentation at virtual meeting.

In most cases, informal geriatric assessment considers only the tip of the ‘geriatric oncology iceberg,’ including chronological age, performance status, tumor characteristics, and organ function, Dr. Williams noted.

In contrast, formal geriatric assessment dives deeper, measuring a series of additional outcome-associated factors: polypharmacy, comorbidities, falls, psychosocial dysfunction, social support, sarcopenia, nutritional deficits, cognitive impairment, and functional issues.

“All these other factors under the surface are critically important to developing a personalized and individualized cancer treatment plan for older adults,” Dr. Williams said.

He went on to explain that elderly cancer patients can be sorted into three broad categories: fit, vulnerable, and frail. Fit and frail patients are relatively easy to identify, but most elderly patients fall into the vulnerable category, Dr. Williams noted.

“It’s really more challenging to identify those individuals across the spectrum than those at the extremes,” Dr. Williams said, noting that formal geriatric assessment can detect problems not found routinely.
 

Formal geriatric assessment’s value

Geriatric assessment can be used for risk modeling and making life-expectancy calculations. It can also be used as an interventional tool, guiding cancer treatment selection, he said. Furthermore, it can open doors to general health interventions, such as occupational therapy, to reduce fall risk.

Beneficial interventions identified by geriatric assessment have been shown to improve function, reduce chemotherapy toxicities, improve quality of life, and extend survival, Dr. Williams noted.

Formal geriatric assessment may be particularly useful for primary care providers considering referral to an oncologist, he said.

“I think performing a geriatric assessment [prior to referral] would be a great idea. And that’s twofold: Even before you send them to the oncologist, it gives you an idea of how they may tolerate treatment, and frankly, it may give you an idea that they don’t need a referral to the oncologist if they’re particularly frail,” noted Dr. Williams.
 

Alternatives to formal assessments

When asked how providers can incorporate formal assessments into a busy day at the clinic, Dr. Williams encouraged the use of abbreviated formal assessments, then adding further testing if needed.

“Given known time and support staff restraints, modified geriatric assessment tools have been developed that are either mostly or completely patient-reported,” he said in an interview, referring to the Cancer and Aging Research Group (CARG) Geriatric Assessment and the Cancer and Aging Resilience Evaluation (CARE), respectively.

“[These assessments] can easily be completed before clinical visits or while in the waiting room,” Dr. Williams noted. “The additional objective tests, such as Timed Up and Go, and Mental Status Exam, can be completed if deemed necessary based on these initial assessments.”

Martine Extermann, MD, PhD, provided her suggestions in an interview for what physicians can do to get better outcomes for this patient group.

Courtesy Dr. Extermann
Dr. Martine Extermann


“The secret of successful anti-cancer treatment in an older person is to be proactive with supportive care,” said Dr. Extermann, leader of the senior adult oncology program at H. Lee Moffitt Cancer Center & Research Institute, Tampa, Fla. “You have to really plan ahead, identify the support gaps, identify the potential problems, and prevent them thoroughly. The upfront work of good patient evaluation will save you a lot of trouble down the line,” she added.

Ms. Extermann also mentioned the challenges to providing care to geriatric patients with cancer, including a lack of financial incentive for physicians to specialize in geriatrics.
 

 

 

Gerontology remains a practice gap

Oncologists who don’t perform geriatric assessments are probably missing more than they think, Dr. Extermann said in an interview.

“Many oncologists don’t fully realize the importance of [geriatric assessment] yet,” Dr. Extermann said. “They kind of think that their internal medicine training will carry through, and they’ll be able to identify everything; actually, we know very well we miss half of what is found by geriatric assessment clinically.”

Gerontology remains a practice gap, Dr. Extermann said, not only within oncology, but across specialties.

“One of the big problems with the U.S. health care system is we don’t have enough geriatricians, and the reason we don’t have enough geriatricians is because we don’t pay them,” she said.

“Geriatrics is the only specialty where you do more training to be paid less, because Medicare doesn’t reimburse geriatric assessment, [and] it doesn’t reimburse geriatric consultation. [This] doesn’t motivate universities to create geriatric clinics and geriatric programs because they will lose money, basically, doing that. If we want to really solve the problem, we have to solve the reimbursement problem up front,” she explained.

Dr. Williams disclosed financial relationships with Carevive Health Systems, Cardinal Health, the National Cancer Institute, and the American Cancer Society. Dr. Extermann reported no conflicts of interest.
 

As the number of elderly patients with cancer continues to rise – and geriatricians remain in short supply – primary care providers and community oncologists need to incorporate formal geriatric assessment into routine practice, a geriatric oncologist said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. Grant R. Williams

A 2020 ASCO survey, which the speaker, Grant R. Williams, MD, coauthored, found that 9 out of 10 community oncologists assessed at least some older patients differently than younger patients. But only 1 out of 3 did so in a formal manner, Dr. Williams, director of the cancer and aging program at the University of Alabama at Birmingham, said during presentation at virtual meeting.

In most cases, informal geriatric assessment considers only the tip of the ‘geriatric oncology iceberg,’ including chronological age, performance status, tumor characteristics, and organ function, Dr. Williams noted.

In contrast, formal geriatric assessment dives deeper, measuring a series of additional outcome-associated factors: polypharmacy, comorbidities, falls, psychosocial dysfunction, social support, sarcopenia, nutritional deficits, cognitive impairment, and functional issues.

“All these other factors under the surface are critically important to developing a personalized and individualized cancer treatment plan for older adults,” Dr. Williams said.

He went on to explain that elderly cancer patients can be sorted into three broad categories: fit, vulnerable, and frail. Fit and frail patients are relatively easy to identify, but most elderly patients fall into the vulnerable category, Dr. Williams noted.

“It’s really more challenging to identify those individuals across the spectrum than those at the extremes,” Dr. Williams said, noting that formal geriatric assessment can detect problems not found routinely.
 

Formal geriatric assessment’s value

Geriatric assessment can be used for risk modeling and making life-expectancy calculations. It can also be used as an interventional tool, guiding cancer treatment selection, he said. Furthermore, it can open doors to general health interventions, such as occupational therapy, to reduce fall risk.

Beneficial interventions identified by geriatric assessment have been shown to improve function, reduce chemotherapy toxicities, improve quality of life, and extend survival, Dr. Williams noted.

Formal geriatric assessment may be particularly useful for primary care providers considering referral to an oncologist, he said.

“I think performing a geriatric assessment [prior to referral] would be a great idea. And that’s twofold: Even before you send them to the oncologist, it gives you an idea of how they may tolerate treatment, and frankly, it may give you an idea that they don’t need a referral to the oncologist if they’re particularly frail,” noted Dr. Williams.
 

Alternatives to formal assessments

When asked how providers can incorporate formal assessments into a busy day at the clinic, Dr. Williams encouraged the use of abbreviated formal assessments, then adding further testing if needed.

“Given known time and support staff restraints, modified geriatric assessment tools have been developed that are either mostly or completely patient-reported,” he said in an interview, referring to the Cancer and Aging Research Group (CARG) Geriatric Assessment and the Cancer and Aging Resilience Evaluation (CARE), respectively.

“[These assessments] can easily be completed before clinical visits or while in the waiting room,” Dr. Williams noted. “The additional objective tests, such as Timed Up and Go, and Mental Status Exam, can be completed if deemed necessary based on these initial assessments.”

Martine Extermann, MD, PhD, provided her suggestions in an interview for what physicians can do to get better outcomes for this patient group.

Courtesy Dr. Extermann
Dr. Martine Extermann


“The secret of successful anti-cancer treatment in an older person is to be proactive with supportive care,” said Dr. Extermann, leader of the senior adult oncology program at H. Lee Moffitt Cancer Center & Research Institute, Tampa, Fla. “You have to really plan ahead, identify the support gaps, identify the potential problems, and prevent them thoroughly. The upfront work of good patient evaluation will save you a lot of trouble down the line,” she added.

Ms. Extermann also mentioned the challenges to providing care to geriatric patients with cancer, including a lack of financial incentive for physicians to specialize in geriatrics.
 

 

 

Gerontology remains a practice gap

Oncologists who don’t perform geriatric assessments are probably missing more than they think, Dr. Extermann said in an interview.

“Many oncologists don’t fully realize the importance of [geriatric assessment] yet,” Dr. Extermann said. “They kind of think that their internal medicine training will carry through, and they’ll be able to identify everything; actually, we know very well we miss half of what is found by geriatric assessment clinically.”

Gerontology remains a practice gap, Dr. Extermann said, not only within oncology, but across specialties.

“One of the big problems with the U.S. health care system is we don’t have enough geriatricians, and the reason we don’t have enough geriatricians is because we don’t pay them,” she said.

“Geriatrics is the only specialty where you do more training to be paid less, because Medicare doesn’t reimburse geriatric assessment, [and] it doesn’t reimburse geriatric consultation. [This] doesn’t motivate universities to create geriatric clinics and geriatric programs because they will lose money, basically, doing that. If we want to really solve the problem, we have to solve the reimbursement problem up front,” she explained.

Dr. Williams disclosed financial relationships with Carevive Health Systems, Cardinal Health, the National Cancer Institute, and the American Cancer Society. Dr. Extermann reported no conflicts of interest.
 

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COVID-19 outcomes similar with ECMO or mechanical ventilation

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Thu, 08/26/2021 - 15:47

 

Severely ill COVID-19 patients treated with extracorporeal membrane oxygenation (ECMO) had similar survival to hospital discharge and long-term outcomes as survivors treated with mechanical ventilation alone, results of a new, multicenter study suggest.

Importantly, the study also showed that survivors, regardless of the treatment they received, experienced significant deficits following their stay in the ICU and were suffering problems with physical, psychological, and cognitive functioning for months afterward.

At 3 months after discharge, 50% of the survivors reported cognitive dysfunction, ICU-acquired weakness and depression, anxiety, or PTSD; over 25% still required supplemental oxygen; and only one in six survivors were back at work.

The findings were presented April 30 at the American Association for Thoracic Surgery annual meeting.

The study represents the efforts of a multidisciplinary team that included cardiothoracic surgeons, critical care doctors, medical staff at long-term care facilities, and physical therapists in addition to other specialists. The research followed patients at five academic centers: the University of Colorado, the University of Virginia, the University of Kentucky, Johns Hopkins University, and Vanderbilt University.

“We were a multidisciplinary team, a whole variety of people to really track the long-term outcomes for patients who have been critically ill from COVID-19 and survived to hospital discharge,” presenting author Lauren J. Taylor, MD, fellow at the University of Colorado at Denver, Aurora, said in an interview.

It’s unclear currently what happens to these patients once they leave the hospital, she noted. “This is information we have not had, but when we followed these patients in these multidisciplinary clinics, there was a high level of either physical, emotional, or cognitive dysfunction, even for patients who were well enough to be living at home at the time of follow-up.

“So, if you have somebody living at home and they come into the clinic, you assume they are functioning pretty well, but when you actually provide them with cognitive and psychological testing and check their physical capabilities, you find a high degree of deficits throughout the entire cohort of this study,” she said.

The study was prompted by discussion with patients’ family members about the rationale, risks, and benefits of ECMO cannulation in patients with COVID-19 failing mechanical ventilation, senior author Jessica V. Rove, MD, also from the University of Colorado, said in an interview.

“We wanted to find out what their hospital course would be like and what cognitive, physical, or emotional deficits might they experience if they survive,” Dr. Rove said.

The investigators compared 262 mechanically ventilated patients with 46 patients cannulated for ECMO who were hospitalized between March and May 2020.

ECMO patients were younger and traveled farther but there were no significant differences in gender, race, or body mass index.

ECMO patients were mechanically ventilated for longer durations (median, 26 days vs. 13 days) and were more likely to receive inhaled pulmonary vasodilators, neuromuscular blockade, investigational COVID-19 therapies, blood transfusions, and inotropes.

They also experienced greater bleeding and clotting events (P < .01).

Despite a more complex critical illness course, patients treated with ECMO had similar survival at discharge and long-term outcomes, compared with those who were treated with mechanical ventilation alone.

The survival rate for ECMO patients was 69.9%, and for mechanically ventilated patients it was 69.6%.

Of the 215 survivors, 66.5% had documented follow-up within 3 months of discharge from hospital. Most survivors (93.9%) were living at home; a small percentage (16.1%) had returned to work or their usual activities, and 26.2% were still using supplemental oxygen.

These rates did not differ significantly based on ECMO status and rates of physical, psychological, and cognitive deficits did not differ significantly.

“The cognitive, emotional, and physical deficits seen in survivors of critical illness from COVID-19 can only be treated if diagnosed,” Dr. Rove said.

“Detrimental effects can potentially be ameliorated with use of best practices in the ICU, maximizing acute rehabilitation services where indicated, and follow-up with providers in multidisciplinary post-ICU clinics who can assess and treat these patients to optimize survivorship,” she said.

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

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Severely ill COVID-19 patients treated with extracorporeal membrane oxygenation (ECMO) had similar survival to hospital discharge and long-term outcomes as survivors treated with mechanical ventilation alone, results of a new, multicenter study suggest.

Importantly, the study also showed that survivors, regardless of the treatment they received, experienced significant deficits following their stay in the ICU and were suffering problems with physical, psychological, and cognitive functioning for months afterward.

At 3 months after discharge, 50% of the survivors reported cognitive dysfunction, ICU-acquired weakness and depression, anxiety, or PTSD; over 25% still required supplemental oxygen; and only one in six survivors were back at work.

The findings were presented April 30 at the American Association for Thoracic Surgery annual meeting.

The study represents the efforts of a multidisciplinary team that included cardiothoracic surgeons, critical care doctors, medical staff at long-term care facilities, and physical therapists in addition to other specialists. The research followed patients at five academic centers: the University of Colorado, the University of Virginia, the University of Kentucky, Johns Hopkins University, and Vanderbilt University.

“We were a multidisciplinary team, a whole variety of people to really track the long-term outcomes for patients who have been critically ill from COVID-19 and survived to hospital discharge,” presenting author Lauren J. Taylor, MD, fellow at the University of Colorado at Denver, Aurora, said in an interview.

It’s unclear currently what happens to these patients once they leave the hospital, she noted. “This is information we have not had, but when we followed these patients in these multidisciplinary clinics, there was a high level of either physical, emotional, or cognitive dysfunction, even for patients who were well enough to be living at home at the time of follow-up.

“So, if you have somebody living at home and they come into the clinic, you assume they are functioning pretty well, but when you actually provide them with cognitive and psychological testing and check their physical capabilities, you find a high degree of deficits throughout the entire cohort of this study,” she said.

The study was prompted by discussion with patients’ family members about the rationale, risks, and benefits of ECMO cannulation in patients with COVID-19 failing mechanical ventilation, senior author Jessica V. Rove, MD, also from the University of Colorado, said in an interview.

“We wanted to find out what their hospital course would be like and what cognitive, physical, or emotional deficits might they experience if they survive,” Dr. Rove said.

The investigators compared 262 mechanically ventilated patients with 46 patients cannulated for ECMO who were hospitalized between March and May 2020.

ECMO patients were younger and traveled farther but there were no significant differences in gender, race, or body mass index.

ECMO patients were mechanically ventilated for longer durations (median, 26 days vs. 13 days) and were more likely to receive inhaled pulmonary vasodilators, neuromuscular blockade, investigational COVID-19 therapies, blood transfusions, and inotropes.

They also experienced greater bleeding and clotting events (P < .01).

Despite a more complex critical illness course, patients treated with ECMO had similar survival at discharge and long-term outcomes, compared with those who were treated with mechanical ventilation alone.

The survival rate for ECMO patients was 69.9%, and for mechanically ventilated patients it was 69.6%.

Of the 215 survivors, 66.5% had documented follow-up within 3 months of discharge from hospital. Most survivors (93.9%) were living at home; a small percentage (16.1%) had returned to work or their usual activities, and 26.2% were still using supplemental oxygen.

These rates did not differ significantly based on ECMO status and rates of physical, psychological, and cognitive deficits did not differ significantly.

“The cognitive, emotional, and physical deficits seen in survivors of critical illness from COVID-19 can only be treated if diagnosed,” Dr. Rove said.

“Detrimental effects can potentially be ameliorated with use of best practices in the ICU, maximizing acute rehabilitation services where indicated, and follow-up with providers in multidisciplinary post-ICU clinics who can assess and treat these patients to optimize survivorship,” she said.

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

 

Severely ill COVID-19 patients treated with extracorporeal membrane oxygenation (ECMO) had similar survival to hospital discharge and long-term outcomes as survivors treated with mechanical ventilation alone, results of a new, multicenter study suggest.

Importantly, the study also showed that survivors, regardless of the treatment they received, experienced significant deficits following their stay in the ICU and were suffering problems with physical, psychological, and cognitive functioning for months afterward.

At 3 months after discharge, 50% of the survivors reported cognitive dysfunction, ICU-acquired weakness and depression, anxiety, or PTSD; over 25% still required supplemental oxygen; and only one in six survivors were back at work.

The findings were presented April 30 at the American Association for Thoracic Surgery annual meeting.

The study represents the efforts of a multidisciplinary team that included cardiothoracic surgeons, critical care doctors, medical staff at long-term care facilities, and physical therapists in addition to other specialists. The research followed patients at five academic centers: the University of Colorado, the University of Virginia, the University of Kentucky, Johns Hopkins University, and Vanderbilt University.

“We were a multidisciplinary team, a whole variety of people to really track the long-term outcomes for patients who have been critically ill from COVID-19 and survived to hospital discharge,” presenting author Lauren J. Taylor, MD, fellow at the University of Colorado at Denver, Aurora, said in an interview.

It’s unclear currently what happens to these patients once they leave the hospital, she noted. “This is information we have not had, but when we followed these patients in these multidisciplinary clinics, there was a high level of either physical, emotional, or cognitive dysfunction, even for patients who were well enough to be living at home at the time of follow-up.

“So, if you have somebody living at home and they come into the clinic, you assume they are functioning pretty well, but when you actually provide them with cognitive and psychological testing and check their physical capabilities, you find a high degree of deficits throughout the entire cohort of this study,” she said.

The study was prompted by discussion with patients’ family members about the rationale, risks, and benefits of ECMO cannulation in patients with COVID-19 failing mechanical ventilation, senior author Jessica V. Rove, MD, also from the University of Colorado, said in an interview.

“We wanted to find out what their hospital course would be like and what cognitive, physical, or emotional deficits might they experience if they survive,” Dr. Rove said.

The investigators compared 262 mechanically ventilated patients with 46 patients cannulated for ECMO who were hospitalized between March and May 2020.

ECMO patients were younger and traveled farther but there were no significant differences in gender, race, or body mass index.

ECMO patients were mechanically ventilated for longer durations (median, 26 days vs. 13 days) and were more likely to receive inhaled pulmonary vasodilators, neuromuscular blockade, investigational COVID-19 therapies, blood transfusions, and inotropes.

They also experienced greater bleeding and clotting events (P < .01).

Despite a more complex critical illness course, patients treated with ECMO had similar survival at discharge and long-term outcomes, compared with those who were treated with mechanical ventilation alone.

The survival rate for ECMO patients was 69.9%, and for mechanically ventilated patients it was 69.6%.

Of the 215 survivors, 66.5% had documented follow-up within 3 months of discharge from hospital. Most survivors (93.9%) were living at home; a small percentage (16.1%) had returned to work or their usual activities, and 26.2% were still using supplemental oxygen.

These rates did not differ significantly based on ECMO status and rates of physical, psychological, and cognitive deficits did not differ significantly.

“The cognitive, emotional, and physical deficits seen in survivors of critical illness from COVID-19 can only be treated if diagnosed,” Dr. Rove said.

“Detrimental effects can potentially be ameliorated with use of best practices in the ICU, maximizing acute rehabilitation services where indicated, and follow-up with providers in multidisciplinary post-ICU clinics who can assess and treat these patients to optimize survivorship,” she said.

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

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High variability found in studies assessing hemophilia-related pain

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Tue, 05/04/2021 - 16:22

Chronic pain is a common condition among people with hemophilia and is associated with joint deterioration because of repeated joint bleeds. This systematic review and meta-analysis aimed to determine the prevalence of chronic pain because of hemophilia and to analyze its interference in the lives of patients, according to Ana Cristina Paredes, a PhD student at the University of Minho, Braga, Portugal, and colleagues.

finger bleeding
Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

The manuscripts included in the study, which was published online in the Journal of Pain, were mostly observational, cross-sectional studies and one prospective investigation, published between 2009 and 2019.

The issue of pain is particularly important among people with hemophilia, as many adult patients suffer from distinct degrees of arthropathy and associated chronic pain, due to the lifelong occurrence of hemarthrosis, the authors noted. In an important distinction, according to the authors, people with hemophilia may therefore experience both acute pain during bleeds and chronic pain caused by joint deterioration. Acute pain ceases with the resolution of the bleeding episode, but the chronic pain is significantly more challenging, since it persists in time and may trigger changes in the nervous system, leading to peripheral or central sensitization.

Data in the assessed studies were collected from a variety of sources: hemophilia centers, online surveys, by mail, or through a national database, with return rates ranging from 29.2% to 98%. Overall, these studies comprised 4,772 adults, with individual sample sizes ranging from 21 to 2,253 patients, the authors added.
 

Conflicting results

Overall, there was a widely varying prevalence of hemophilia-related chronic pain reported across studies. Additionally, methodologies and sample characteristics varied widely. The meta-analyses revealed high heterogeneity between studies, and, therefore, pooled prevalence estimates values must be interpreted with caution, the authors stated.

All of the 11 selected studies included for meta-analysis and review reported on the prevalence of chronic pain caused by hemophilia. Chronic pain was assessed using direct questions developed by the authors in eight studies and using the European Haemophilia Therapy Standardization Board definition in three studies. The prevalence for global samples ranged widely from 17% to 84%.

Although there was high heterogeneity, the random-effects meta-analysis including all studies demonstrated a pooled prevalence of 46% of patients reporting chronic pain. Subgroup analyses of studies including all disease severities (mild, moderate, and severe; seven studies) revealed a pooled prevalence of 48%, but also with high heterogeneity. Looking at severe patients only (six studies), the chronic pain prevalence ranged from 33% to 86.4%, with a pooled prevalence of 53% and high heterogeneity, the authors added.

The wide disparity of the chronic pain prevalence seen across the studies is likely because of the fact that some investigations inquired about pain without distinguishing between acute (hemarthrosis-related) or chronic (arthropathy-related) pain, and without clarifying if the only focus is pain caused by hemophilia, or including all causes of pain complaints, according to the researchers.

“Concerning hemophilia-related chronic pain interference, it is striking that the existing literature does not distinguish between the impact of acute or chronic pain. Such a distinction is needed and should be made in future studies to ensure accurate accounts of hemophilia-related pain and to fully understand its interference according to the type of pain (acute vs. chronic). This information is relevant to promote targeted and effective treatment approaches,” the researchers concluded.

The research was supported by a Novo Nordisk HERO Research Grant 2015, the Portuguese Foundation for Science and Technology, and the Foundation for Science and Technology in Portugal. The authors declared they had no conflicts of interest.

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Chronic pain is a common condition among people with hemophilia and is associated with joint deterioration because of repeated joint bleeds. This systematic review and meta-analysis aimed to determine the prevalence of chronic pain because of hemophilia and to analyze its interference in the lives of patients, according to Ana Cristina Paredes, a PhD student at the University of Minho, Braga, Portugal, and colleagues.

finger bleeding
Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

The manuscripts included in the study, which was published online in the Journal of Pain, were mostly observational, cross-sectional studies and one prospective investigation, published between 2009 and 2019.

The issue of pain is particularly important among people with hemophilia, as many adult patients suffer from distinct degrees of arthropathy and associated chronic pain, due to the lifelong occurrence of hemarthrosis, the authors noted. In an important distinction, according to the authors, people with hemophilia may therefore experience both acute pain during bleeds and chronic pain caused by joint deterioration. Acute pain ceases with the resolution of the bleeding episode, but the chronic pain is significantly more challenging, since it persists in time and may trigger changes in the nervous system, leading to peripheral or central sensitization.

Data in the assessed studies were collected from a variety of sources: hemophilia centers, online surveys, by mail, or through a national database, with return rates ranging from 29.2% to 98%. Overall, these studies comprised 4,772 adults, with individual sample sizes ranging from 21 to 2,253 patients, the authors added.
 

Conflicting results

Overall, there was a widely varying prevalence of hemophilia-related chronic pain reported across studies. Additionally, methodologies and sample characteristics varied widely. The meta-analyses revealed high heterogeneity between studies, and, therefore, pooled prevalence estimates values must be interpreted with caution, the authors stated.

All of the 11 selected studies included for meta-analysis and review reported on the prevalence of chronic pain caused by hemophilia. Chronic pain was assessed using direct questions developed by the authors in eight studies and using the European Haemophilia Therapy Standardization Board definition in three studies. The prevalence for global samples ranged widely from 17% to 84%.

Although there was high heterogeneity, the random-effects meta-analysis including all studies demonstrated a pooled prevalence of 46% of patients reporting chronic pain. Subgroup analyses of studies including all disease severities (mild, moderate, and severe; seven studies) revealed a pooled prevalence of 48%, but also with high heterogeneity. Looking at severe patients only (six studies), the chronic pain prevalence ranged from 33% to 86.4%, with a pooled prevalence of 53% and high heterogeneity, the authors added.

The wide disparity of the chronic pain prevalence seen across the studies is likely because of the fact that some investigations inquired about pain without distinguishing between acute (hemarthrosis-related) or chronic (arthropathy-related) pain, and without clarifying if the only focus is pain caused by hemophilia, or including all causes of pain complaints, according to the researchers.

“Concerning hemophilia-related chronic pain interference, it is striking that the existing literature does not distinguish between the impact of acute or chronic pain. Such a distinction is needed and should be made in future studies to ensure accurate accounts of hemophilia-related pain and to fully understand its interference according to the type of pain (acute vs. chronic). This information is relevant to promote targeted and effective treatment approaches,” the researchers concluded.

The research was supported by a Novo Nordisk HERO Research Grant 2015, the Portuguese Foundation for Science and Technology, and the Foundation for Science and Technology in Portugal. The authors declared they had no conflicts of interest.

Chronic pain is a common condition among people with hemophilia and is associated with joint deterioration because of repeated joint bleeds. This systematic review and meta-analysis aimed to determine the prevalence of chronic pain because of hemophilia and to analyze its interference in the lives of patients, according to Ana Cristina Paredes, a PhD student at the University of Minho, Braga, Portugal, and colleagues.

finger bleeding
Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

The manuscripts included in the study, which was published online in the Journal of Pain, were mostly observational, cross-sectional studies and one prospective investigation, published between 2009 and 2019.

The issue of pain is particularly important among people with hemophilia, as many adult patients suffer from distinct degrees of arthropathy and associated chronic pain, due to the lifelong occurrence of hemarthrosis, the authors noted. In an important distinction, according to the authors, people with hemophilia may therefore experience both acute pain during bleeds and chronic pain caused by joint deterioration. Acute pain ceases with the resolution of the bleeding episode, but the chronic pain is significantly more challenging, since it persists in time and may trigger changes in the nervous system, leading to peripheral or central sensitization.

Data in the assessed studies were collected from a variety of sources: hemophilia centers, online surveys, by mail, or through a national database, with return rates ranging from 29.2% to 98%. Overall, these studies comprised 4,772 adults, with individual sample sizes ranging from 21 to 2,253 patients, the authors added.
 

Conflicting results

Overall, there was a widely varying prevalence of hemophilia-related chronic pain reported across studies. Additionally, methodologies and sample characteristics varied widely. The meta-analyses revealed high heterogeneity between studies, and, therefore, pooled prevalence estimates values must be interpreted with caution, the authors stated.

All of the 11 selected studies included for meta-analysis and review reported on the prevalence of chronic pain caused by hemophilia. Chronic pain was assessed using direct questions developed by the authors in eight studies and using the European Haemophilia Therapy Standardization Board definition in three studies. The prevalence for global samples ranged widely from 17% to 84%.

Although there was high heterogeneity, the random-effects meta-analysis including all studies demonstrated a pooled prevalence of 46% of patients reporting chronic pain. Subgroup analyses of studies including all disease severities (mild, moderate, and severe; seven studies) revealed a pooled prevalence of 48%, but also with high heterogeneity. Looking at severe patients only (six studies), the chronic pain prevalence ranged from 33% to 86.4%, with a pooled prevalence of 53% and high heterogeneity, the authors added.

The wide disparity of the chronic pain prevalence seen across the studies is likely because of the fact that some investigations inquired about pain without distinguishing between acute (hemarthrosis-related) or chronic (arthropathy-related) pain, and without clarifying if the only focus is pain caused by hemophilia, or including all causes of pain complaints, according to the researchers.

“Concerning hemophilia-related chronic pain interference, it is striking that the existing literature does not distinguish between the impact of acute or chronic pain. Such a distinction is needed and should be made in future studies to ensure accurate accounts of hemophilia-related pain and to fully understand its interference according to the type of pain (acute vs. chronic). This information is relevant to promote targeted and effective treatment approaches,” the researchers concluded.

The research was supported by a Novo Nordisk HERO Research Grant 2015, the Portuguese Foundation for Science and Technology, and the Foundation for Science and Technology in Portugal. The authors declared they had no conflicts of interest.

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Weight-related COVID-19 severity starts in normal BMI range, especially in young

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Thu, 08/26/2021 - 15:47

The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.

Dr. Krishnan Bhaskaran

“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.

“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.

The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.

“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial (Lancet Diabetes Endocrinol 2021 Apr 29; doi: 10.1016/S2213-8587[21]00109-1).

Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.

For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.

Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.


 

Risk rises from BMI of 23 kg/m²

In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).

The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).

In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).

“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.

The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).

In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).

“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.

Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.

Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.

Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”

Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.

“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.

Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.

The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.

Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.

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The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.

Dr. Krishnan Bhaskaran

“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.

“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.

The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.

“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial (Lancet Diabetes Endocrinol 2021 Apr 29; doi: 10.1016/S2213-8587[21]00109-1).

Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.

For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.

Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.


 

Risk rises from BMI of 23 kg/m²

In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).

The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).

In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).

“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.

The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).

In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).

“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.

Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.

Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.

Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”

Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.

“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.

Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.

The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.

Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.

The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.

Dr. Krishnan Bhaskaran

“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.

“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.

The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.

“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial (Lancet Diabetes Endocrinol 2021 Apr 29; doi: 10.1016/S2213-8587[21]00109-1).

Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.

For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.

Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.


 

Risk rises from BMI of 23 kg/m²

In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).

The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).

In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).

“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.

The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).

In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).

“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.

Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.

Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.

Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”

Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.

“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.

Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.

The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.

Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.

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New child COVID-19 cases drop for second consecutive week

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Thu, 08/26/2021 - 15:47

New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Trends in COVID-19 cases among children, United States

Despite that drop, however, children made up a larger share (22.4%) of all cases reported during the week of April 23-29, compared with the previous week, when the proportion reached what was then a pandemic high of 20.8%, based on data in the weekly AAP/CHA report.

New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.

Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.

There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.

The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.

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New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Trends in COVID-19 cases among children, United States

Despite that drop, however, children made up a larger share (22.4%) of all cases reported during the week of April 23-29, compared with the previous week, when the proportion reached what was then a pandemic high of 20.8%, based on data in the weekly AAP/CHA report.

New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.

Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.

There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.

The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.

New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Trends in COVID-19 cases among children, United States

Despite that drop, however, children made up a larger share (22.4%) of all cases reported during the week of April 23-29, compared with the previous week, when the proportion reached what was then a pandemic high of 20.8%, based on data in the weekly AAP/CHA report.

New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.

Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.

There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.

The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.

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FDA set to okay Pfizer vaccine in younger teens

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Thu, 08/26/2021 - 15:47

The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.

In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine  is already authorized for use teens and adults ages 16 and older.

The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.

“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.

Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.

A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.

The risk for severe illness and death from COVID-19 rises with age.

Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.

Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.

As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.

Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.

If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.

Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.

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

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The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.

In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine  is already authorized for use teens and adults ages 16 and older.

The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.

“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.

Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.

A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.

The risk for severe illness and death from COVID-19 rises with age.

Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.

Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.

As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.

Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.

If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.

Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.

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

The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.

In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine  is already authorized for use teens and adults ages 16 and older.

The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.

“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.

Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.

A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.

The risk for severe illness and death from COVID-19 rises with age.

Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.

Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.

As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.

Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.

If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.

Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.

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

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