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FDA approves new treatment for Dravet syndrome

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Thu, 12/15/2022 - 14:40

The US Food and Drug Administration (FDA) has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.

Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy (SUDEP).

Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.

The FDA approved fenfluramine for Dravet syndrome based on the results of two randomized, double-blind, placebo-controlled phase 3 trials involving children ages 2 to 18 years with Dravet syndrome.

In both studies, children treated with fenfluramine experienced significantly greater reductions in the frequency of convulsive seizures than did their peers who received placebo. These reductions occurred within 3 to 4 weeks, and remained generally consistent over the 14- to 15-week treatment periods, the FDA said.

“There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available antiseizure medications,” Joseph Sullivan, MD, who worked on the fenfluramine for Dravet syndrome studies, said in a news release. 

Given the “profound reductions” in convulsive seizure frequency seen in the clinical trials, combined with the “ongoing, robust safety monitoring,” fenfluramine offers “an extremely important treatment option for Dravet syndrome patients,” said Dr. Sullivan, director of the Pediatric Epilepsy Center of Excellence at the University of California San Francisco (UCSF) Benioff Children’s Hospital.

Fenfluramine is an anorectic agent that was used to treat obesity until it was removed from the market in 1997 over reports of increased risk of valvular heart disease when prescribed in higher doses and most often when prescribed with phentermine. The combination of the two drugs was known as fen-phen.

In the clinical trials of Dravet syndrome, the most common adverse reactions were decreased appetite; somnolence, sedation, lethargy; diarrheaconstipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbanceincreased blood pressure; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; and status epilepticus.

The Fintepla label has a boxed warning stating that the drug is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Due to these risks, patients must undergo echocardiography before treatment, every 6 months during treatment, and once 3 to 6 months after treatment is stopped.

If signs of VHD, PAH, or other cardiac abnormalities are present, clinicians should weigh the benefits and risks of continuing treatment with Fintepla, the FDA said.

Fintepla is available only through a risk evaluation and mitigation strategy (REMS) program, which requires physicians who prescribe the drug and pharmacies that dispense it to be certified in the Fintepla REMS and that patients be enrolled in the program.

As part of the REMS requirements, prescribers and patients must adhere to the required cardiac monitoring to receive the drug.

Fintepla will be available to certified prescribers in the United States in July. Zogenix is launching Zogenix Central, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available online.
 

This article first appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.

Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy (SUDEP).

Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.

The FDA approved fenfluramine for Dravet syndrome based on the results of two randomized, double-blind, placebo-controlled phase 3 trials involving children ages 2 to 18 years with Dravet syndrome.

In both studies, children treated with fenfluramine experienced significantly greater reductions in the frequency of convulsive seizures than did their peers who received placebo. These reductions occurred within 3 to 4 weeks, and remained generally consistent over the 14- to 15-week treatment periods, the FDA said.

“There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available antiseizure medications,” Joseph Sullivan, MD, who worked on the fenfluramine for Dravet syndrome studies, said in a news release. 

Given the “profound reductions” in convulsive seizure frequency seen in the clinical trials, combined with the “ongoing, robust safety monitoring,” fenfluramine offers “an extremely important treatment option for Dravet syndrome patients,” said Dr. Sullivan, director of the Pediatric Epilepsy Center of Excellence at the University of California San Francisco (UCSF) Benioff Children’s Hospital.

Fenfluramine is an anorectic agent that was used to treat obesity until it was removed from the market in 1997 over reports of increased risk of valvular heart disease when prescribed in higher doses and most often when prescribed with phentermine. The combination of the two drugs was known as fen-phen.

In the clinical trials of Dravet syndrome, the most common adverse reactions were decreased appetite; somnolence, sedation, lethargy; diarrheaconstipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbanceincreased blood pressure; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; and status epilepticus.

The Fintepla label has a boxed warning stating that the drug is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Due to these risks, patients must undergo echocardiography before treatment, every 6 months during treatment, and once 3 to 6 months after treatment is stopped.

If signs of VHD, PAH, or other cardiac abnormalities are present, clinicians should weigh the benefits and risks of continuing treatment with Fintepla, the FDA said.

Fintepla is available only through a risk evaluation and mitigation strategy (REMS) program, which requires physicians who prescribe the drug and pharmacies that dispense it to be certified in the Fintepla REMS and that patients be enrolled in the program.

As part of the REMS requirements, prescribers and patients must adhere to the required cardiac monitoring to receive the drug.

Fintepla will be available to certified prescribers in the United States in July. Zogenix is launching Zogenix Central, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available online.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.

Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy (SUDEP).

Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.

The FDA approved fenfluramine for Dravet syndrome based on the results of two randomized, double-blind, placebo-controlled phase 3 trials involving children ages 2 to 18 years with Dravet syndrome.

In both studies, children treated with fenfluramine experienced significantly greater reductions in the frequency of convulsive seizures than did their peers who received placebo. These reductions occurred within 3 to 4 weeks, and remained generally consistent over the 14- to 15-week treatment periods, the FDA said.

“There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available antiseizure medications,” Joseph Sullivan, MD, who worked on the fenfluramine for Dravet syndrome studies, said in a news release. 

Given the “profound reductions” in convulsive seizure frequency seen in the clinical trials, combined with the “ongoing, robust safety monitoring,” fenfluramine offers “an extremely important treatment option for Dravet syndrome patients,” said Dr. Sullivan, director of the Pediatric Epilepsy Center of Excellence at the University of California San Francisco (UCSF) Benioff Children’s Hospital.

Fenfluramine is an anorectic agent that was used to treat obesity until it was removed from the market in 1997 over reports of increased risk of valvular heart disease when prescribed in higher doses and most often when prescribed with phentermine. The combination of the two drugs was known as fen-phen.

In the clinical trials of Dravet syndrome, the most common adverse reactions were decreased appetite; somnolence, sedation, lethargy; diarrheaconstipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbanceincreased blood pressure; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; and status epilepticus.

The Fintepla label has a boxed warning stating that the drug is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Due to these risks, patients must undergo echocardiography before treatment, every 6 months during treatment, and once 3 to 6 months after treatment is stopped.

If signs of VHD, PAH, or other cardiac abnormalities are present, clinicians should weigh the benefits and risks of continuing treatment with Fintepla, the FDA said.

Fintepla is available only through a risk evaluation and mitigation strategy (REMS) program, which requires physicians who prescribe the drug and pharmacies that dispense it to be certified in the Fintepla REMS and that patients be enrolled in the program.

As part of the REMS requirements, prescribers and patients must adhere to the required cardiac monitoring to receive the drug.

Fintepla will be available to certified prescribers in the United States in July. Zogenix is launching Zogenix Central, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available online.
 

This article first appeared on Medscape.com.

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Will primary care physicians be COVID-19’s next victims?

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In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. Those arguments resonated with Kenny Lin, MD, MPH, a family physician, professor at Georgetown University School of Medicine, and a regular contributor to Medscape. He spoke with Dr. Frieden about his concerns.

Dr. Kenneth W. Lin

Dr. Lin: Why did you feel that it was important to write this piece focused on primary care?

Dr. Frieden:
I’m glad you asked that question. Given all that is going on, one might ask, what is the importance of primary care? We’ve got this epidemic going on that requires public health and hospital systems. Why voice concern about primary care now?

When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.
 

Dr. Lin: I agree. In my own practice we haven’t had to furlough anyone, but we’ve put people on forced paid time off. We’ve been reallocating physicians to other parts of our health system. It is definitely a concern. A solo practitioner or someone in a rural practice would most likely be even much more heavily hit. You’ve argued that the neglect of our public health system on a national level has led to many preventable deaths from COVID-19. Do you feel that something similar has happened in primary care? How could a stronger, better-funded primary care infrastructure better prepare us for the next pandemic?

Dr. Thomas R. Frieden

Dr. Frieden: All over the world, we see an overemphasis on hospital care and an underemphasis on primary care, outpatient care, family medicine. As a result, we pay more. We have larger risks, and we don’t prevent diseases that we could prevent. It’s fundamentally about the economic incentives of our health care system. Of course, that often reflects the political reality of different profit centers and cost centers of care. That won’t change with tweaking around the edges. It will only change if we change the way we pay for health care. Money talks. We need to start paying at least part of what we pay based on health outcomes.

Many years ago a colleague and I wrote an article, “Health Care as If Health Mattered.” If you step back and look at how we pay for health care, very little, if any, of our payment structure is based on how much health the care system delivers. Part of that can be addressed by going to capitated models, which I think do better. But you have also got to put into those capitated systems some quality and outcome measures that are both valid and not too burdensome to report on. That’s not easy. We could talk a lot about some of the information systems and payment systems, but I think the bottom line is that we need to be able to deal not only with health emergencies, but also with preventive care, care of chronic diseases, and behavioral health care in ways that maximize health.

One of the ways to do that is simple, monthly, capitated payments along with what I call a registry-based outcomes system.

I’m a tuberculosis specialist by training. In tuberculosis there really is a great information system. We track every single patient who has been diagnosed, and we hold every clinician accountable for whether or not they’ve successfully treated that patient. An optimal health care system should do the same with treatment of hypertension, diabetes, seizure disorder, and other common conditions in which treatment makes a really big difference. Preventive care, especially vaccine delivery, is another example.

I understand that physicians will point out that patients may not come in for that care, or they’re hard to deal with, or they refuse recommended treatment. We don’t expect 100%. But we should expect that, if we’re paying for health care, we should get health.

To do that, I think we need much more support for primary care, both in terms of the absolute amount of dollars going in and the administrative support. Some of our systems are so complicated that you can’t manage them without a billing department. How does a one- or two-physician practice deal with systems that will take dozens of hours a week to manage? You have to deal with the administrative complexity, the structure of the incentives, and the structure of care.

I think these are all things that we have to address. But for a minute, let’s helicopter up and look at the big picture. Without additional help from Congress, tens of thousands of primary care physicians could go out of business in the coming weeks. This is a crisis, and this will be very hard to rebuild. We don’t have a strong, resilient primary care infrastructure today, and if we’re not careful it’ll be even weaker as we try to rebuild.

It has been encouraging to see some of the care innovations that have occurred in response to the pandemic. I’m particularly encouraged by the widespread interest in and support for telemedicine. Telemedicine is a very important way of making care safer, more accessible, less expensive, more efficient. There have been a lot of restrictions on it, not just in the United States but globally, for many years. It’s really interesting to see those restrictions rapidly change. I give credit to the Centers for Medicare & Medicaid Services for quick changes in this area.

Now, telemedicine isn’t a cure-all. There are lots of things you can’t do from a distance. It’s a pale reflection of reality, compared with an in-person first visit with a patient. But it’s a whole lot better than nothing. If we look at some of the best health systems in the United States, they’ve gone to as much as 80% of clinical visits done by telemedicine. I don’t think we’re going to go back. Even if COVID is no longer the threat that it is today, if you can do things more quickly, more efficiently, and more conveniently for both patients and doctors, do them. Obviously, it won’t be all visits, but it could be a large proportion of visits and an important part of strengthening our primary care system.

My initiative, Resolve to Save Lives, which is part of the global health organization Vital Strategies, has done work in the area of public health around the world. I am really struck by how weak primary care systems are in so many countries. Strong primary care systems are the exception rather than the rule, but they’re also a best buy in health care. They’re crucially important, and they’re going to work differently in different countries, in different states, in different communities. We need to do a better job of supporting primary care, building primary care, and paying for primary care.
 

 

 

Dr. Lin: You’ve identified two needs. The immediate need is that primary care practices need revenue now to not have to close in the immediate aftermath or the ongoing COVID epidemic, but also there’s the long term, the percentage of health care dollars that are going to primary care in the long term. You pointed out in your article that currently 5% or less of health care spending is in primary care, which is a lot less percentage-wise than in many other countries. I think the question always comes up is that we want to increase that share, but the money has to come from somewhere. Where is that extra money going to come from?
Dr. Frieden: I’m not an expert in health care finance, but one thing I’ve learned over the years is that one person’s waste, fraud, and abuse is somebody else’s profit center. It’s not going to be easy. On the one hand, we do need to think about more efficient ways to organize primary care; on the other hand, we have to figure out a way to internalize some of the savings. If you give good primary care and, therefore, someone doesn’t get hospitalized, you can actually lose money in the current system, whereas you’re saving the system a lot of money by preventing that hospitalization.

I think our health system does have significant inefficiencies in terms of the number of tests and interventions that are done that are really not proven to help patients. It has been demonstrated for decades now that the usual economic incentives don’t operate in health care. In health care, supply often generates demand. The number of gallbladder operations is proportional not to population but to the number of gallbladder surgeons. That’s a problem, and it’s a problem that we’re going to have to assess. “Gatekeeper” is an unpleasant word, but if a primary care practitioner could be the advocate for patients so that we’re not pushing for patients to get more care or to get less care but to get the right care, we have the potential to reduce costs while improving quality.
 

Dr. Lin: You accurately point out that the fee-for-service payment system has been the major culprit in the declining revenues of primary care practices since the start of the pandemic. But for the majority of primary care physicians, including myself, fee-for-service is all that we’ve ever known. Do you think that primary care is ready for such an abrupt financing change, particularly in a very short period of time?Dr. Frieden: You’re certainly accurate in saying that nothing about health care finance is easy. Trying to address these problems at the national or state level has been extremely difficult. I think that the pilot programs in Medicare are very important. Medicaid is a particular challenge because it’s a state-based program and many of the costs are driven by nursing home and long-term care. When you take those costs out, the actual funding per patient or per provider is quite low in most places.

It’s hard enough to reorganize if you’ve got ample resources, but to reorganize when they are insufficient is particularly hard. I would say only that there are no quick and simple answers to this question, but there is a widespread understanding that what we’re doing now doesn’t make sense. We pay top dollar and we get – despite fantastic doctors and fantastic hospitals – lousy outcomes. I’m a public health physician. I’m an internal medicine and infectious disease specialist. Fundamentally, I look at the data. If you think of our health care system as a patient, the patient is not doing well. We’re not functional to the degree we need to be, particularly when you think of what an enormous outlier our per capita expenditures are [compared with other developed countries] – almost twice the average upper-income country and 25% more than any other upper-income country.

Now, anyone who tells you that change is going to be pain-free is not leveling with you. In addition to things like telemedicine, we have to make much more use of team-based care and task sharing. There are lots of things that doctors are doing these days that they really shouldn’t.
 

Dr. Lin: In your recent op-ed, you noted the pivot to telehealth that primary care practices have made very quickly in response to the pandemic. That certainly was the experience for my practice. But what are some other strategies that you think are important to support the goal of better care delivery in our primary care practices?Dr. Frieden: Another really important innovation is team-based care. There are lots of things that doctors are doing today that nurses, nurse practitioners, physician assistants, and community health workers can do better and for less money. Frankly, I think that should increase the job satisfaction of physicians, to be doing work that is specific to the physician, requiring either more patient interaction or advanced reasoning or experience.

In my own field of tuberculosis control, I learned how to treat tuberculosis because the nurse at the TB clinic kept correcting me because that’s all she did. She did tuberculosis care, so she had seen everything. Even though I’d finished an infectious disease fellowship and internal medicine residency, the public health nurse knew TB a whole lot better than I did.

Similarly, as we work on hypertension control, you can protocolize most of this care and do a much better job. That’s been proven for more than 40 years, and yet we still don’t do it.

One of the big parts of being able to do more with the same or fewer resources is going to be more team-based care. That’s really a task-sharing approach. I think of that as a triple win: You get better care for lower costs with more employment. What’s not to like?
 

Dr. Lin: I’m hopeful, as you are, that many of these innovations that have been made by necessity will persist beyond the duration of COVID-19. As you said, the health care system has been really difficult to change, and it often takes something like this to galvanize enough consensus that things need to change.

Dr. Frieden: I think the bottom line here is that we should pay our primary health care providers to keep us healthy and ensure that we have a payment system that lets them do that without risking bankruptcy. That’s not too much to ask of our system. It’s important for our health. It’s important for our economy. It’s important for our communities.

Dr. Lin teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journal American Family Physician. Follow him on Twitter. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for MedStar Georgetown University Hospital and received income in an amount equal to or greater than $250 from UpToDate, Wiley-Blackwell, and American Academy of Family Physicians.

Dr. Frieden is a physician with advanced training in internal medicine, infectious disease, public health, and epidemiology. He has served as director of the Centers for Disease Control and Prevention and as commissioner of the New York City Health Department. Currently he is president and CEO of Resolve to Save Lives. Follow him on Twitter. Thomas R. Frieden, MD, MPH, has disclosed no relevant financial relationships.

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

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In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. Those arguments resonated with Kenny Lin, MD, MPH, a family physician, professor at Georgetown University School of Medicine, and a regular contributor to Medscape. He spoke with Dr. Frieden about his concerns.

Dr. Kenneth W. Lin

Dr. Lin: Why did you feel that it was important to write this piece focused on primary care?

Dr. Frieden:
I’m glad you asked that question. Given all that is going on, one might ask, what is the importance of primary care? We’ve got this epidemic going on that requires public health and hospital systems. Why voice concern about primary care now?

When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.
 

Dr. Lin: I agree. In my own practice we haven’t had to furlough anyone, but we’ve put people on forced paid time off. We’ve been reallocating physicians to other parts of our health system. It is definitely a concern. A solo practitioner or someone in a rural practice would most likely be even much more heavily hit. You’ve argued that the neglect of our public health system on a national level has led to many preventable deaths from COVID-19. Do you feel that something similar has happened in primary care? How could a stronger, better-funded primary care infrastructure better prepare us for the next pandemic?

Dr. Thomas R. Frieden

Dr. Frieden: All over the world, we see an overemphasis on hospital care and an underemphasis on primary care, outpatient care, family medicine. As a result, we pay more. We have larger risks, and we don’t prevent diseases that we could prevent. It’s fundamentally about the economic incentives of our health care system. Of course, that often reflects the political reality of different profit centers and cost centers of care. That won’t change with tweaking around the edges. It will only change if we change the way we pay for health care. Money talks. We need to start paying at least part of what we pay based on health outcomes.

Many years ago a colleague and I wrote an article, “Health Care as If Health Mattered.” If you step back and look at how we pay for health care, very little, if any, of our payment structure is based on how much health the care system delivers. Part of that can be addressed by going to capitated models, which I think do better. But you have also got to put into those capitated systems some quality and outcome measures that are both valid and not too burdensome to report on. That’s not easy. We could talk a lot about some of the information systems and payment systems, but I think the bottom line is that we need to be able to deal not only with health emergencies, but also with preventive care, care of chronic diseases, and behavioral health care in ways that maximize health.

One of the ways to do that is simple, monthly, capitated payments along with what I call a registry-based outcomes system.

I’m a tuberculosis specialist by training. In tuberculosis there really is a great information system. We track every single patient who has been diagnosed, and we hold every clinician accountable for whether or not they’ve successfully treated that patient. An optimal health care system should do the same with treatment of hypertension, diabetes, seizure disorder, and other common conditions in which treatment makes a really big difference. Preventive care, especially vaccine delivery, is another example.

I understand that physicians will point out that patients may not come in for that care, or they’re hard to deal with, or they refuse recommended treatment. We don’t expect 100%. But we should expect that, if we’re paying for health care, we should get health.

To do that, I think we need much more support for primary care, both in terms of the absolute amount of dollars going in and the administrative support. Some of our systems are so complicated that you can’t manage them without a billing department. How does a one- or two-physician practice deal with systems that will take dozens of hours a week to manage? You have to deal with the administrative complexity, the structure of the incentives, and the structure of care.

I think these are all things that we have to address. But for a minute, let’s helicopter up and look at the big picture. Without additional help from Congress, tens of thousands of primary care physicians could go out of business in the coming weeks. This is a crisis, and this will be very hard to rebuild. We don’t have a strong, resilient primary care infrastructure today, and if we’re not careful it’ll be even weaker as we try to rebuild.

It has been encouraging to see some of the care innovations that have occurred in response to the pandemic. I’m particularly encouraged by the widespread interest in and support for telemedicine. Telemedicine is a very important way of making care safer, more accessible, less expensive, more efficient. There have been a lot of restrictions on it, not just in the United States but globally, for many years. It’s really interesting to see those restrictions rapidly change. I give credit to the Centers for Medicare & Medicaid Services for quick changes in this area.

Now, telemedicine isn’t a cure-all. There are lots of things you can’t do from a distance. It’s a pale reflection of reality, compared with an in-person first visit with a patient. But it’s a whole lot better than nothing. If we look at some of the best health systems in the United States, they’ve gone to as much as 80% of clinical visits done by telemedicine. I don’t think we’re going to go back. Even if COVID is no longer the threat that it is today, if you can do things more quickly, more efficiently, and more conveniently for both patients and doctors, do them. Obviously, it won’t be all visits, but it could be a large proportion of visits and an important part of strengthening our primary care system.

My initiative, Resolve to Save Lives, which is part of the global health organization Vital Strategies, has done work in the area of public health around the world. I am really struck by how weak primary care systems are in so many countries. Strong primary care systems are the exception rather than the rule, but they’re also a best buy in health care. They’re crucially important, and they’re going to work differently in different countries, in different states, in different communities. We need to do a better job of supporting primary care, building primary care, and paying for primary care.
 

 

 

Dr. Lin: You’ve identified two needs. The immediate need is that primary care practices need revenue now to not have to close in the immediate aftermath or the ongoing COVID epidemic, but also there’s the long term, the percentage of health care dollars that are going to primary care in the long term. You pointed out in your article that currently 5% or less of health care spending is in primary care, which is a lot less percentage-wise than in many other countries. I think the question always comes up is that we want to increase that share, but the money has to come from somewhere. Where is that extra money going to come from?
Dr. Frieden: I’m not an expert in health care finance, but one thing I’ve learned over the years is that one person’s waste, fraud, and abuse is somebody else’s profit center. It’s not going to be easy. On the one hand, we do need to think about more efficient ways to organize primary care; on the other hand, we have to figure out a way to internalize some of the savings. If you give good primary care and, therefore, someone doesn’t get hospitalized, you can actually lose money in the current system, whereas you’re saving the system a lot of money by preventing that hospitalization.

I think our health system does have significant inefficiencies in terms of the number of tests and interventions that are done that are really not proven to help patients. It has been demonstrated for decades now that the usual economic incentives don’t operate in health care. In health care, supply often generates demand. The number of gallbladder operations is proportional not to population but to the number of gallbladder surgeons. That’s a problem, and it’s a problem that we’re going to have to assess. “Gatekeeper” is an unpleasant word, but if a primary care practitioner could be the advocate for patients so that we’re not pushing for patients to get more care or to get less care but to get the right care, we have the potential to reduce costs while improving quality.
 

Dr. Lin: You accurately point out that the fee-for-service payment system has been the major culprit in the declining revenues of primary care practices since the start of the pandemic. But for the majority of primary care physicians, including myself, fee-for-service is all that we’ve ever known. Do you think that primary care is ready for such an abrupt financing change, particularly in a very short period of time?Dr. Frieden: You’re certainly accurate in saying that nothing about health care finance is easy. Trying to address these problems at the national or state level has been extremely difficult. I think that the pilot programs in Medicare are very important. Medicaid is a particular challenge because it’s a state-based program and many of the costs are driven by nursing home and long-term care. When you take those costs out, the actual funding per patient or per provider is quite low in most places.

It’s hard enough to reorganize if you’ve got ample resources, but to reorganize when they are insufficient is particularly hard. I would say only that there are no quick and simple answers to this question, but there is a widespread understanding that what we’re doing now doesn’t make sense. We pay top dollar and we get – despite fantastic doctors and fantastic hospitals – lousy outcomes. I’m a public health physician. I’m an internal medicine and infectious disease specialist. Fundamentally, I look at the data. If you think of our health care system as a patient, the patient is not doing well. We’re not functional to the degree we need to be, particularly when you think of what an enormous outlier our per capita expenditures are [compared with other developed countries] – almost twice the average upper-income country and 25% more than any other upper-income country.

Now, anyone who tells you that change is going to be pain-free is not leveling with you. In addition to things like telemedicine, we have to make much more use of team-based care and task sharing. There are lots of things that doctors are doing these days that they really shouldn’t.
 

Dr. Lin: In your recent op-ed, you noted the pivot to telehealth that primary care practices have made very quickly in response to the pandemic. That certainly was the experience for my practice. But what are some other strategies that you think are important to support the goal of better care delivery in our primary care practices?Dr. Frieden: Another really important innovation is team-based care. There are lots of things that doctors are doing today that nurses, nurse practitioners, physician assistants, and community health workers can do better and for less money. Frankly, I think that should increase the job satisfaction of physicians, to be doing work that is specific to the physician, requiring either more patient interaction or advanced reasoning or experience.

In my own field of tuberculosis control, I learned how to treat tuberculosis because the nurse at the TB clinic kept correcting me because that’s all she did. She did tuberculosis care, so she had seen everything. Even though I’d finished an infectious disease fellowship and internal medicine residency, the public health nurse knew TB a whole lot better than I did.

Similarly, as we work on hypertension control, you can protocolize most of this care and do a much better job. That’s been proven for more than 40 years, and yet we still don’t do it.

One of the big parts of being able to do more with the same or fewer resources is going to be more team-based care. That’s really a task-sharing approach. I think of that as a triple win: You get better care for lower costs with more employment. What’s not to like?
 

Dr. Lin: I’m hopeful, as you are, that many of these innovations that have been made by necessity will persist beyond the duration of COVID-19. As you said, the health care system has been really difficult to change, and it often takes something like this to galvanize enough consensus that things need to change.

Dr. Frieden: I think the bottom line here is that we should pay our primary health care providers to keep us healthy and ensure that we have a payment system that lets them do that without risking bankruptcy. That’s not too much to ask of our system. It’s important for our health. It’s important for our economy. It’s important for our communities.

Dr. Lin teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journal American Family Physician. Follow him on Twitter. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for MedStar Georgetown University Hospital and received income in an amount equal to or greater than $250 from UpToDate, Wiley-Blackwell, and American Academy of Family Physicians.

Dr. Frieden is a physician with advanced training in internal medicine, infectious disease, public health, and epidemiology. He has served as director of the Centers for Disease Control and Prevention and as commissioner of the New York City Health Department. Currently he is president and CEO of Resolve to Save Lives. Follow him on Twitter. Thomas R. Frieden, MD, MPH, has disclosed no relevant financial relationships.

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

 

In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. Those arguments resonated with Kenny Lin, MD, MPH, a family physician, professor at Georgetown University School of Medicine, and a regular contributor to Medscape. He spoke with Dr. Frieden about his concerns.

Dr. Kenneth W. Lin

Dr. Lin: Why did you feel that it was important to write this piece focused on primary care?

Dr. Frieden:
I’m glad you asked that question. Given all that is going on, one might ask, what is the importance of primary care? We’ve got this epidemic going on that requires public health and hospital systems. Why voice concern about primary care now?

When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.
 

Dr. Lin: I agree. In my own practice we haven’t had to furlough anyone, but we’ve put people on forced paid time off. We’ve been reallocating physicians to other parts of our health system. It is definitely a concern. A solo practitioner or someone in a rural practice would most likely be even much more heavily hit. You’ve argued that the neglect of our public health system on a national level has led to many preventable deaths from COVID-19. Do you feel that something similar has happened in primary care? How could a stronger, better-funded primary care infrastructure better prepare us for the next pandemic?

Dr. Thomas R. Frieden

Dr. Frieden: All over the world, we see an overemphasis on hospital care and an underemphasis on primary care, outpatient care, family medicine. As a result, we pay more. We have larger risks, and we don’t prevent diseases that we could prevent. It’s fundamentally about the economic incentives of our health care system. Of course, that often reflects the political reality of different profit centers and cost centers of care. That won’t change with tweaking around the edges. It will only change if we change the way we pay for health care. Money talks. We need to start paying at least part of what we pay based on health outcomes.

Many years ago a colleague and I wrote an article, “Health Care as If Health Mattered.” If you step back and look at how we pay for health care, very little, if any, of our payment structure is based on how much health the care system delivers. Part of that can be addressed by going to capitated models, which I think do better. But you have also got to put into those capitated systems some quality and outcome measures that are both valid and not too burdensome to report on. That’s not easy. We could talk a lot about some of the information systems and payment systems, but I think the bottom line is that we need to be able to deal not only with health emergencies, but also with preventive care, care of chronic diseases, and behavioral health care in ways that maximize health.

One of the ways to do that is simple, monthly, capitated payments along with what I call a registry-based outcomes system.

I’m a tuberculosis specialist by training. In tuberculosis there really is a great information system. We track every single patient who has been diagnosed, and we hold every clinician accountable for whether or not they’ve successfully treated that patient. An optimal health care system should do the same with treatment of hypertension, diabetes, seizure disorder, and other common conditions in which treatment makes a really big difference. Preventive care, especially vaccine delivery, is another example.

I understand that physicians will point out that patients may not come in for that care, or they’re hard to deal with, or they refuse recommended treatment. We don’t expect 100%. But we should expect that, if we’re paying for health care, we should get health.

To do that, I think we need much more support for primary care, both in terms of the absolute amount of dollars going in and the administrative support. Some of our systems are so complicated that you can’t manage them without a billing department. How does a one- or two-physician practice deal with systems that will take dozens of hours a week to manage? You have to deal with the administrative complexity, the structure of the incentives, and the structure of care.

I think these are all things that we have to address. But for a minute, let’s helicopter up and look at the big picture. Without additional help from Congress, tens of thousands of primary care physicians could go out of business in the coming weeks. This is a crisis, and this will be very hard to rebuild. We don’t have a strong, resilient primary care infrastructure today, and if we’re not careful it’ll be even weaker as we try to rebuild.

It has been encouraging to see some of the care innovations that have occurred in response to the pandemic. I’m particularly encouraged by the widespread interest in and support for telemedicine. Telemedicine is a very important way of making care safer, more accessible, less expensive, more efficient. There have been a lot of restrictions on it, not just in the United States but globally, for many years. It’s really interesting to see those restrictions rapidly change. I give credit to the Centers for Medicare & Medicaid Services for quick changes in this area.

Now, telemedicine isn’t a cure-all. There are lots of things you can’t do from a distance. It’s a pale reflection of reality, compared with an in-person first visit with a patient. But it’s a whole lot better than nothing. If we look at some of the best health systems in the United States, they’ve gone to as much as 80% of clinical visits done by telemedicine. I don’t think we’re going to go back. Even if COVID is no longer the threat that it is today, if you can do things more quickly, more efficiently, and more conveniently for both patients and doctors, do them. Obviously, it won’t be all visits, but it could be a large proportion of visits and an important part of strengthening our primary care system.

My initiative, Resolve to Save Lives, which is part of the global health organization Vital Strategies, has done work in the area of public health around the world. I am really struck by how weak primary care systems are in so many countries. Strong primary care systems are the exception rather than the rule, but they’re also a best buy in health care. They’re crucially important, and they’re going to work differently in different countries, in different states, in different communities. We need to do a better job of supporting primary care, building primary care, and paying for primary care.
 

 

 

Dr. Lin: You’ve identified two needs. The immediate need is that primary care practices need revenue now to not have to close in the immediate aftermath or the ongoing COVID epidemic, but also there’s the long term, the percentage of health care dollars that are going to primary care in the long term. You pointed out in your article that currently 5% or less of health care spending is in primary care, which is a lot less percentage-wise than in many other countries. I think the question always comes up is that we want to increase that share, but the money has to come from somewhere. Where is that extra money going to come from?
Dr. Frieden: I’m not an expert in health care finance, but one thing I’ve learned over the years is that one person’s waste, fraud, and abuse is somebody else’s profit center. It’s not going to be easy. On the one hand, we do need to think about more efficient ways to organize primary care; on the other hand, we have to figure out a way to internalize some of the savings. If you give good primary care and, therefore, someone doesn’t get hospitalized, you can actually lose money in the current system, whereas you’re saving the system a lot of money by preventing that hospitalization.

I think our health system does have significant inefficiencies in terms of the number of tests and interventions that are done that are really not proven to help patients. It has been demonstrated for decades now that the usual economic incentives don’t operate in health care. In health care, supply often generates demand. The number of gallbladder operations is proportional not to population but to the number of gallbladder surgeons. That’s a problem, and it’s a problem that we’re going to have to assess. “Gatekeeper” is an unpleasant word, but if a primary care practitioner could be the advocate for patients so that we’re not pushing for patients to get more care or to get less care but to get the right care, we have the potential to reduce costs while improving quality.
 

Dr. Lin: You accurately point out that the fee-for-service payment system has been the major culprit in the declining revenues of primary care practices since the start of the pandemic. But for the majority of primary care physicians, including myself, fee-for-service is all that we’ve ever known. Do you think that primary care is ready for such an abrupt financing change, particularly in a very short period of time?Dr. Frieden: You’re certainly accurate in saying that nothing about health care finance is easy. Trying to address these problems at the national or state level has been extremely difficult. I think that the pilot programs in Medicare are very important. Medicaid is a particular challenge because it’s a state-based program and many of the costs are driven by nursing home and long-term care. When you take those costs out, the actual funding per patient or per provider is quite low in most places.

It’s hard enough to reorganize if you’ve got ample resources, but to reorganize when they are insufficient is particularly hard. I would say only that there are no quick and simple answers to this question, but there is a widespread understanding that what we’re doing now doesn’t make sense. We pay top dollar and we get – despite fantastic doctors and fantastic hospitals – lousy outcomes. I’m a public health physician. I’m an internal medicine and infectious disease specialist. Fundamentally, I look at the data. If you think of our health care system as a patient, the patient is not doing well. We’re not functional to the degree we need to be, particularly when you think of what an enormous outlier our per capita expenditures are [compared with other developed countries] – almost twice the average upper-income country and 25% more than any other upper-income country.

Now, anyone who tells you that change is going to be pain-free is not leveling with you. In addition to things like telemedicine, we have to make much more use of team-based care and task sharing. There are lots of things that doctors are doing these days that they really shouldn’t.
 

Dr. Lin: In your recent op-ed, you noted the pivot to telehealth that primary care practices have made very quickly in response to the pandemic. That certainly was the experience for my practice. But what are some other strategies that you think are important to support the goal of better care delivery in our primary care practices?Dr. Frieden: Another really important innovation is team-based care. There are lots of things that doctors are doing today that nurses, nurse practitioners, physician assistants, and community health workers can do better and for less money. Frankly, I think that should increase the job satisfaction of physicians, to be doing work that is specific to the physician, requiring either more patient interaction or advanced reasoning or experience.

In my own field of tuberculosis control, I learned how to treat tuberculosis because the nurse at the TB clinic kept correcting me because that’s all she did. She did tuberculosis care, so she had seen everything. Even though I’d finished an infectious disease fellowship and internal medicine residency, the public health nurse knew TB a whole lot better than I did.

Similarly, as we work on hypertension control, you can protocolize most of this care and do a much better job. That’s been proven for more than 40 years, and yet we still don’t do it.

One of the big parts of being able to do more with the same or fewer resources is going to be more team-based care. That’s really a task-sharing approach. I think of that as a triple win: You get better care for lower costs with more employment. What’s not to like?
 

Dr. Lin: I’m hopeful, as you are, that many of these innovations that have been made by necessity will persist beyond the duration of COVID-19. As you said, the health care system has been really difficult to change, and it often takes something like this to galvanize enough consensus that things need to change.

Dr. Frieden: I think the bottom line here is that we should pay our primary health care providers to keep us healthy and ensure that we have a payment system that lets them do that without risking bankruptcy. That’s not too much to ask of our system. It’s important for our health. It’s important for our economy. It’s important for our communities.

Dr. Lin teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journal American Family Physician. Follow him on Twitter. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for MedStar Georgetown University Hospital and received income in an amount equal to or greater than $250 from UpToDate, Wiley-Blackwell, and American Academy of Family Physicians.

Dr. Frieden is a physician with advanced training in internal medicine, infectious disease, public health, and epidemiology. He has served as director of the Centers for Disease Control and Prevention and as commissioner of the New York City Health Department. Currently he is president and CEO of Resolve to Save Lives. Follow him on Twitter. Thomas R. Frieden, MD, MPH, has disclosed no relevant financial relationships.

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

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COVID-19: ‘dramatic’ surge in out-of-hospital cardiac arrests in NYC

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Thu, 08/26/2021 - 16:04

 

The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests (OHCAs) that placed a huge burden on first responders, a new analysis shows.

During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.

In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.

“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.

The study was published online June 19 in JAMA Cardiology.



New York City has the largest and busiest EMS system in the United States, serving a population of more than 8.4 million people and responding to more than 1.5 million calls every year.

To gauge the impact of COVID-19 on first responders, Dr. Prezant and colleagues analyzed data for adults with OHCA who received EMS resuscitation from March 1, when the first case of COVID-19 was diagnosed in the city, through April 25, when EMS call volume had receded to pre-COVID-19 levels.

Compared with the same period in 2019, the COVID-19 period had an excess of 2,653 patients with OHCA who underwent EMS resuscitation attempts (3,989 in 2020 vs. 1,336 in 2019, P < .001), an incidence rate triple that of 2019 (47.5 vs. 15.9 per 100,000).

On the worst day – Monday, April 6 – OHCAs peaked at 305 cases, an increase of nearly 10-fold compared with the same day in 2019.

Despite the surge in cases, the median response time of available EMS units to OHCAs increased by about 1 minute over 2019, a nonsignificant difference. Although the average time varied, median response time during the COVID-19 period was less than 3 minutes.

A more vulnerable group

Compared with 2019, patients suffering OHCA during the pandemic period were older (mean age 72 vs. 68 years), less likely to be white (20% white vs. 33%) and more likely to have hypertension (54% vs. 46%), diabetes (36% vs. 26%), physical limitations (57% vs. 48%) and cardiac rhythms that don’t respond to defibrillator shocks (92% vs. 81%).

Compared with 2019, the COVID-19 period had substantial reductions in return of spontaneous circulation (ROSC) (18% vs. 35%; P < .001) and sustained ROSC (11% vs. 25%; P < .001). The case fatality rate was 90% in the COVID-19 period vs. 75% a year earlier.

“The tragedy of the COVID-19 pandemic is not just the number of patients infected, but the large increase in OHCAs and deaths,” Dr. Prezant and colleagues said.

Identifying patients with the greatest risk for OHCA and death during the COVID-19 pandemic “should allow for early, targeted interventions in the outpatient setting that could lead to reductions in out-of-hospital deaths,” they noted.

“Vulnerable patient populations need outreach, telephonic medicine, televideo medicine, home visits, not just temperature monitoring but home O2 saturation monitoring,” Dr. Prezant said in an interview. “Barriers need to be removed, not just for this pandemic but for the future – no matter what the trigger is.”
 

 

 

Unsung heroes

In an Editor’s Note in JAMA Cardiology, Robert O. Bonow, MD, Northwestern University, Chicago, and colleagues said the American people owe a debt of gratitude to first responders for their “heroic work” triaging, resuscitating, and transporting thousands of people affected by COVID-19. 

Dr. Robert O. Bonow

“Although the typically bustling NYC streets remained eerily deserted, the characteristic cacophony of sounds of the ‘City that Never Sleeps’ was replaced by sirens wailing all hours of the night,” they wrote.

First responders to OHCAs in the COVID-19 era place themselves at extremely high risk, in some cases without optimal personal protective equipment, they pointed out. “Sadly,” many first responders have fallen ill to COVID-19 infection, they added.

As of June 1, 29 EMS workers and volunteers across the United States had died of COVID-19.

They are James Villecco, Gregory Hodge, Tony Thomas, Mike Field, John Redd, Idris Bey, Richard Seaberry, and Sal Mancuso of New York; Israel Tolentino, Reuven Maroth, Liana Sá, Kevin Leiva, Frank Molinari, Robert Weber, Robert Tarrant, Solomon Donald, Scott Geiger, John Farrarella, John Careccia, Bill Nauta, and David Pinto of New Jersey; Kevin Bundy, Robert Zerman, and Jeremy Emerich of Pennsylvania; Paul Cary of Colorado; Paul Novicki of Michigan; David Martin of Mississippi; Billy Birmingham of Missouri; and John “JP” Granger of South Carolina.

“We offer their families, friends, and colleagues our sincerest condolences and honor their memory with our highest respect and gratitude,” Dr. Bonow and colleagues wrote.

This study was supported by the City of New York and the Fire Department of the City of New York. The authors have disclosed no relevant financial relationships.
 

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

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The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests (OHCAs) that placed a huge burden on first responders, a new analysis shows.

During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.

In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.

“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.

The study was published online June 19 in JAMA Cardiology.



New York City has the largest and busiest EMS system in the United States, serving a population of more than 8.4 million people and responding to more than 1.5 million calls every year.

To gauge the impact of COVID-19 on first responders, Dr. Prezant and colleagues analyzed data for adults with OHCA who received EMS resuscitation from March 1, when the first case of COVID-19 was diagnosed in the city, through April 25, when EMS call volume had receded to pre-COVID-19 levels.

Compared with the same period in 2019, the COVID-19 period had an excess of 2,653 patients with OHCA who underwent EMS resuscitation attempts (3,989 in 2020 vs. 1,336 in 2019, P < .001), an incidence rate triple that of 2019 (47.5 vs. 15.9 per 100,000).

On the worst day – Monday, April 6 – OHCAs peaked at 305 cases, an increase of nearly 10-fold compared with the same day in 2019.

Despite the surge in cases, the median response time of available EMS units to OHCAs increased by about 1 minute over 2019, a nonsignificant difference. Although the average time varied, median response time during the COVID-19 period was less than 3 minutes.

A more vulnerable group

Compared with 2019, patients suffering OHCA during the pandemic period were older (mean age 72 vs. 68 years), less likely to be white (20% white vs. 33%) and more likely to have hypertension (54% vs. 46%), diabetes (36% vs. 26%), physical limitations (57% vs. 48%) and cardiac rhythms that don’t respond to defibrillator shocks (92% vs. 81%).

Compared with 2019, the COVID-19 period had substantial reductions in return of spontaneous circulation (ROSC) (18% vs. 35%; P < .001) and sustained ROSC (11% vs. 25%; P < .001). The case fatality rate was 90% in the COVID-19 period vs. 75% a year earlier.

“The tragedy of the COVID-19 pandemic is not just the number of patients infected, but the large increase in OHCAs and deaths,” Dr. Prezant and colleagues said.

Identifying patients with the greatest risk for OHCA and death during the COVID-19 pandemic “should allow for early, targeted interventions in the outpatient setting that could lead to reductions in out-of-hospital deaths,” they noted.

“Vulnerable patient populations need outreach, telephonic medicine, televideo medicine, home visits, not just temperature monitoring but home O2 saturation monitoring,” Dr. Prezant said in an interview. “Barriers need to be removed, not just for this pandemic but for the future – no matter what the trigger is.”
 

 

 

Unsung heroes

In an Editor’s Note in JAMA Cardiology, Robert O. Bonow, MD, Northwestern University, Chicago, and colleagues said the American people owe a debt of gratitude to first responders for their “heroic work” triaging, resuscitating, and transporting thousands of people affected by COVID-19. 

Dr. Robert O. Bonow

“Although the typically bustling NYC streets remained eerily deserted, the characteristic cacophony of sounds of the ‘City that Never Sleeps’ was replaced by sirens wailing all hours of the night,” they wrote.

First responders to OHCAs in the COVID-19 era place themselves at extremely high risk, in some cases without optimal personal protective equipment, they pointed out. “Sadly,” many first responders have fallen ill to COVID-19 infection, they added.

As of June 1, 29 EMS workers and volunteers across the United States had died of COVID-19.

They are James Villecco, Gregory Hodge, Tony Thomas, Mike Field, John Redd, Idris Bey, Richard Seaberry, and Sal Mancuso of New York; Israel Tolentino, Reuven Maroth, Liana Sá, Kevin Leiva, Frank Molinari, Robert Weber, Robert Tarrant, Solomon Donald, Scott Geiger, John Farrarella, John Careccia, Bill Nauta, and David Pinto of New Jersey; Kevin Bundy, Robert Zerman, and Jeremy Emerich of Pennsylvania; Paul Cary of Colorado; Paul Novicki of Michigan; David Martin of Mississippi; Billy Birmingham of Missouri; and John “JP” Granger of South Carolina.

“We offer their families, friends, and colleagues our sincerest condolences and honor their memory with our highest respect and gratitude,” Dr. Bonow and colleagues wrote.

This study was supported by the City of New York and the Fire Department of the City of New York. The authors have disclosed no relevant financial relationships.
 

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

 

The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests (OHCAs) that placed a huge burden on first responders, a new analysis shows.

During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.

In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.

“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.

The study was published online June 19 in JAMA Cardiology.



New York City has the largest and busiest EMS system in the United States, serving a population of more than 8.4 million people and responding to more than 1.5 million calls every year.

To gauge the impact of COVID-19 on first responders, Dr. Prezant and colleagues analyzed data for adults with OHCA who received EMS resuscitation from March 1, when the first case of COVID-19 was diagnosed in the city, through April 25, when EMS call volume had receded to pre-COVID-19 levels.

Compared with the same period in 2019, the COVID-19 period had an excess of 2,653 patients with OHCA who underwent EMS resuscitation attempts (3,989 in 2020 vs. 1,336 in 2019, P < .001), an incidence rate triple that of 2019 (47.5 vs. 15.9 per 100,000).

On the worst day – Monday, April 6 – OHCAs peaked at 305 cases, an increase of nearly 10-fold compared with the same day in 2019.

Despite the surge in cases, the median response time of available EMS units to OHCAs increased by about 1 minute over 2019, a nonsignificant difference. Although the average time varied, median response time during the COVID-19 period was less than 3 minutes.

A more vulnerable group

Compared with 2019, patients suffering OHCA during the pandemic period were older (mean age 72 vs. 68 years), less likely to be white (20% white vs. 33%) and more likely to have hypertension (54% vs. 46%), diabetes (36% vs. 26%), physical limitations (57% vs. 48%) and cardiac rhythms that don’t respond to defibrillator shocks (92% vs. 81%).

Compared with 2019, the COVID-19 period had substantial reductions in return of spontaneous circulation (ROSC) (18% vs. 35%; P < .001) and sustained ROSC (11% vs. 25%; P < .001). The case fatality rate was 90% in the COVID-19 period vs. 75% a year earlier.

“The tragedy of the COVID-19 pandemic is not just the number of patients infected, but the large increase in OHCAs and deaths,” Dr. Prezant and colleagues said.

Identifying patients with the greatest risk for OHCA and death during the COVID-19 pandemic “should allow for early, targeted interventions in the outpatient setting that could lead to reductions in out-of-hospital deaths,” they noted.

“Vulnerable patient populations need outreach, telephonic medicine, televideo medicine, home visits, not just temperature monitoring but home O2 saturation monitoring,” Dr. Prezant said in an interview. “Barriers need to be removed, not just for this pandemic but for the future – no matter what the trigger is.”
 

 

 

Unsung heroes

In an Editor’s Note in JAMA Cardiology, Robert O. Bonow, MD, Northwestern University, Chicago, and colleagues said the American people owe a debt of gratitude to first responders for their “heroic work” triaging, resuscitating, and transporting thousands of people affected by COVID-19. 

Dr. Robert O. Bonow

“Although the typically bustling NYC streets remained eerily deserted, the characteristic cacophony of sounds of the ‘City that Never Sleeps’ was replaced by sirens wailing all hours of the night,” they wrote.

First responders to OHCAs in the COVID-19 era place themselves at extremely high risk, in some cases without optimal personal protective equipment, they pointed out. “Sadly,” many first responders have fallen ill to COVID-19 infection, they added.

As of June 1, 29 EMS workers and volunteers across the United States had died of COVID-19.

They are James Villecco, Gregory Hodge, Tony Thomas, Mike Field, John Redd, Idris Bey, Richard Seaberry, and Sal Mancuso of New York; Israel Tolentino, Reuven Maroth, Liana Sá, Kevin Leiva, Frank Molinari, Robert Weber, Robert Tarrant, Solomon Donald, Scott Geiger, John Farrarella, John Careccia, Bill Nauta, and David Pinto of New Jersey; Kevin Bundy, Robert Zerman, and Jeremy Emerich of Pennsylvania; Paul Cary of Colorado; Paul Novicki of Michigan; David Martin of Mississippi; Billy Birmingham of Missouri; and John “JP” Granger of South Carolina.

“We offer their families, friends, and colleagues our sincerest condolences and honor their memory with our highest respect and gratitude,” Dr. Bonow and colleagues wrote.

This study was supported by the City of New York and the Fire Department of the City of New York. The authors have disclosed no relevant financial relationships.
 

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

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Daily Recap: COVID-19 care delays mean excess cancer deaths; flu vaccine recommendations

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Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-related care delays mean excess cancer deaths

There could be 10,000 excess deaths from breast and colorectal cancer over the next 10 years as a result of missed screenings, delays in diagnosis, and reductions in oncology care caused by the COVID-19 pandemic, according to predictions generated by a National Cancer Institute model.

The number of excess deaths per year would peak in the next year or two, likely sooner for colorectal cancer than for breast cancer.

In an editorial published June 19 in Science, NCI Director Norman “Ned” Sharpless, MD, highlighted the modeling. In an interview, he pointed out that this analysis is conservative because the researchers evaluated only two types of cancer. They chose breast and colorectal cancer because these are common cancers – accounting for about one-sixth of all cancers – with relatively high screening rates.

“We didn’t model other cancer types, but we have no reason to think that we’re not going to see the same thing with other types of malignancies,” he said. “That is a significant amount of excess mortality.” Read more.

Diabetes control in U.S. youth has worsened over time

Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, according to data reported at the virtual American Diabetes Association scientific sessions. This finding comes despite the increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets.

A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still statistically significant.

“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study, was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute, said in an interview. Read more.

CDC advisors approve flu vaccine recommendations for 2020-2021

A pair of new vaccines for adults aged 65 years and older will be available for the 2020-2021 flu season – Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations. Read more.

How can we better engage black men as patients?

In a new commentary, Kevin M. Simon, MD, seeks to answer a key question: “How do psychiatrists and other mental health clinicians better engage men of color?” Dr. Simon, a psychiatrist at Boston Children’s Hospital, recommends creating a comfortable environment, allowing for storytelling, assuring confidentiality, being aware of nonverbal language, and being respectful.

“Those on the front lines providing mental health services should understand black men’s mental health from an ecological perspective. Beyond the emotional burden that mental illness imposes on the individual, there are more considerable interpersonal and societal implications for the state of black men’s mental health. As such, in our full capacity like other men, black men play an essential role within families, churches, neighborhoods, and organizations,” Dr. Simon wrote. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

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Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-related care delays mean excess cancer deaths

There could be 10,000 excess deaths from breast and colorectal cancer over the next 10 years as a result of missed screenings, delays in diagnosis, and reductions in oncology care caused by the COVID-19 pandemic, according to predictions generated by a National Cancer Institute model.

The number of excess deaths per year would peak in the next year or two, likely sooner for colorectal cancer than for breast cancer.

In an editorial published June 19 in Science, NCI Director Norman “Ned” Sharpless, MD, highlighted the modeling. In an interview, he pointed out that this analysis is conservative because the researchers evaluated only two types of cancer. They chose breast and colorectal cancer because these are common cancers – accounting for about one-sixth of all cancers – with relatively high screening rates.

“We didn’t model other cancer types, but we have no reason to think that we’re not going to see the same thing with other types of malignancies,” he said. “That is a significant amount of excess mortality.” Read more.

Diabetes control in U.S. youth has worsened over time

Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, according to data reported at the virtual American Diabetes Association scientific sessions. This finding comes despite the increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets.

A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still statistically significant.

“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study, was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute, said in an interview. Read more.

CDC advisors approve flu vaccine recommendations for 2020-2021

A pair of new vaccines for adults aged 65 years and older will be available for the 2020-2021 flu season – Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations. Read more.

How can we better engage black men as patients?

In a new commentary, Kevin M. Simon, MD, seeks to answer a key question: “How do psychiatrists and other mental health clinicians better engage men of color?” Dr. Simon, a psychiatrist at Boston Children’s Hospital, recommends creating a comfortable environment, allowing for storytelling, assuring confidentiality, being aware of nonverbal language, and being respectful.

“Those on the front lines providing mental health services should understand black men’s mental health from an ecological perspective. Beyond the emotional burden that mental illness imposes on the individual, there are more considerable interpersonal and societal implications for the state of black men’s mental health. As such, in our full capacity like other men, black men play an essential role within families, churches, neighborhoods, and organizations,” Dr. Simon wrote. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-related care delays mean excess cancer deaths

There could be 10,000 excess deaths from breast and colorectal cancer over the next 10 years as a result of missed screenings, delays in diagnosis, and reductions in oncology care caused by the COVID-19 pandemic, according to predictions generated by a National Cancer Institute model.

The number of excess deaths per year would peak in the next year or two, likely sooner for colorectal cancer than for breast cancer.

In an editorial published June 19 in Science, NCI Director Norman “Ned” Sharpless, MD, highlighted the modeling. In an interview, he pointed out that this analysis is conservative because the researchers evaluated only two types of cancer. They chose breast and colorectal cancer because these are common cancers – accounting for about one-sixth of all cancers – with relatively high screening rates.

“We didn’t model other cancer types, but we have no reason to think that we’re not going to see the same thing with other types of malignancies,” he said. “That is a significant amount of excess mortality.” Read more.

Diabetes control in U.S. youth has worsened over time

Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, according to data reported at the virtual American Diabetes Association scientific sessions. This finding comes despite the increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets.

A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still statistically significant.

“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study, was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute, said in an interview. Read more.

CDC advisors approve flu vaccine recommendations for 2020-2021

A pair of new vaccines for adults aged 65 years and older will be available for the 2020-2021 flu season – Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations. Read more.

How can we better engage black men as patients?

In a new commentary, Kevin M. Simon, MD, seeks to answer a key question: “How do psychiatrists and other mental health clinicians better engage men of color?” Dr. Simon, a psychiatrist at Boston Children’s Hospital, recommends creating a comfortable environment, allowing for storytelling, assuring confidentiality, being aware of nonverbal language, and being respectful.

“Those on the front lines providing mental health services should understand black men’s mental health from an ecological perspective. Beyond the emotional burden that mental illness imposes on the individual, there are more considerable interpersonal and societal implications for the state of black men’s mental health. As such, in our full capacity like other men, black men play an essential role within families, churches, neighborhoods, and organizations,” Dr. Simon wrote. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

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Suicide thoughts, attempts in adolescence correlate with mental health symptoms

Have resources ready to facilitate suicide screening
Article Type
Changed
Thu, 06/25/2020 - 15:33

About one in five adolescents has thought about suicide, about 10% have experienced serious suicidal ideation, and 7% have attempted suicide by age 20 years, according to a longitudinal study of Canadian adolescents published online in Pediatrics.

AlexRaths/Thinkstock

In multivariable analyses, depression and anxiety were independently associated with passive and serious suicidal ideation at some ages, but none of the externalizing problems were significantly associated with passive or serious suicidal ideation. However, “both depressive and conduct symptoms [were] independently associated with suicidal risk,” the researchers found. Most adolescents with suicidal ideation or suicide attempt met criteria for at least one mental health problem.

“These findings suggest that suicide risk should be systematically assessed in adolescents who present with mental health symptoms and not solely in adolescents with clinically diagnosed mental disorders,” said Massimiliano Orri, PhD, and colleagues. Dr. Orri is affiliated with the McGill Group for Suicide Studies, Douglas Mental Health University Institute, Montreal, and the University of Bordeaux (France).

To document the prevalence of passive or serious suicidal ideation and suicide attempt from ages 13-20 years and examine correlations with mental health symptoms, Dr. Orri and colleagues analyzed data from 1,618 participants in the Quebec Longitudinal Study of Child Development. The population-based study follows individuals born in 1997 and 1998 in Quebec. Participants answered questions about suicidal ideation or suicide attempt in the past year at ages 13, 15, 17, or 20 years (“Did you ever think about suicide?” “Did you ever seriously think of attempting suicide?” and “How many times did you attempt suicide?”). The researchers assessed symptoms of mental health problems using self-report questionnaires.

Lifetime prevalence of suicide-related outcomes was higher for female participants than for male participants. The prevalence of passive suicidal ideation was 28% in females versus 15% in males. The prevalence of serious suicidal ideation was 12% in females versus 8% in males. The prevalence of suicide attempt was 9% in females versus 4% in males. “Sex differences in suicidal ideation and suicide attempt might be attributed to various factors, such as mental health (e.g., higher prevalence of depression in female participants) or social stigma (e.g., greater stigma around suicide in male than in female participants),” the authors wrote.

In the entire cohort, the prevalence of passive suicidal ideation increased from 12% at 13 years to 18% at 17 years. The prevalence of serious suicidal ideation increased from 3% at 13 years to 10% at 20 years. The prevalence of suicide attempt was approximately 4% at each age.

“Although having a major depressive episode is a well-known risk factor of suicidal ideation and suicide attempt, our study adds to the general body of knowledge by showing associations with suicide-related outcomes across the full spectrum of depressive symptoms,” Dr. Orri and colleagues wrote. “This suggests that youth who present with depressive symptoms (and not solely those who are clinically depressed) may be more likely to experience suicidal ideation or attempt suicide.”

The estimated rates of serious suicidal ideation and attempted suicide by age 20 years are consistent with previous U.S. and Canadian surveys. Sample attrition, the use of different questionnaires in early and late adolescence, and the lack of information about substance use and psychotic symptoms are among the study’s limitations.

Six of the authors were supported by grants from a variety of Canadian and European agencies and the American Foundation for Suicide Prevention. All of the authors said they had no relevant financial disclosures.

SOURCE: Orri M et al. Pediatrics. 2020 Jun 8. doi: 10.1542/peds.2019-3823.

Body

 

Interestingly, this study by Orri et al. found that there was not a peak in suicide attempts in mid-adolescence; instead, rates of attempts were stable throughout adolescence and serious suicidal ideation actually increased with age. This was an unexpected finding for me, and something I will be more mindful about in my clinical practice when seeing older teens and young adults. Additionally, all mental health problems – not just depression – evaluated in univariate analyses in the study were associated with suicidal thoughts and attempts. On multivariable analysis that accounted for the impact of the effect of comorbid mental health symptoms, depressive symptoms had the highest and most consistent correlation to suicidal thoughts, and conduct symptoms were associated with an increase in suicide attempts. The authors conclude that youth with mental health symptoms – not just those who meet diagnostic criteria – should be assessed for suicide risk.

Dr. Kelly Curran
I think this recommendation is important for pediatricians to include in care for teens. When we think about all of the topics we screen and counsel about – healthy diet and exercise, dental health, injury prevention, and screen time, to name just a few – it can seem overwhelming to “add one more thing” when many clinicians already feel stretched for time. Others may shy away because of their own discomfort or perceptions of patient or family distress around the topic or avoid screening because they feel they lack the skills or resources to help patients with suicidal thoughts. However, mental health problems – including suicide – are incredibly common and cause significant morbidity and mortality. Screening for suicide is important – remember, too, that you can save a life and decrease the second leading cause of death in teens!

In my subspecialty practice, we screen every new patient for suicide regardless of the reason for their visit and more often for those with mental health symptoms. I know this may seem onerous, but screening and counseling typically take under 5 minutes – and in many instances around 1-2 minutes. Having ready-to-go resources including mental health professionals to refer to, screening algorithms (such as protocols published in MedEdPORTAL or Family Practice Management), and suicide prevention resources for patients and family for those who screen positive can help expedite this process. I think these recommendations can be adapted with relative ease into any visit for a teen or young adult who is presenting with a mental health complaint.

Kelly A. Curran, MD, is an assistant professor of pediatrics at the University of Oklahoma in Oklahoma City. She is a member of the Pediatric News editorial advisory board. Dr. Curran said she had no relevant financial disclosures.

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Body

 

Interestingly, this study by Orri et al. found that there was not a peak in suicide attempts in mid-adolescence; instead, rates of attempts were stable throughout adolescence and serious suicidal ideation actually increased with age. This was an unexpected finding for me, and something I will be more mindful about in my clinical practice when seeing older teens and young adults. Additionally, all mental health problems – not just depression – evaluated in univariate analyses in the study were associated with suicidal thoughts and attempts. On multivariable analysis that accounted for the impact of the effect of comorbid mental health symptoms, depressive symptoms had the highest and most consistent correlation to suicidal thoughts, and conduct symptoms were associated with an increase in suicide attempts. The authors conclude that youth with mental health symptoms – not just those who meet diagnostic criteria – should be assessed for suicide risk.

Dr. Kelly Curran
I think this recommendation is important for pediatricians to include in care for teens. When we think about all of the topics we screen and counsel about – healthy diet and exercise, dental health, injury prevention, and screen time, to name just a few – it can seem overwhelming to “add one more thing” when many clinicians already feel stretched for time. Others may shy away because of their own discomfort or perceptions of patient or family distress around the topic or avoid screening because they feel they lack the skills or resources to help patients with suicidal thoughts. However, mental health problems – including suicide – are incredibly common and cause significant morbidity and mortality. Screening for suicide is important – remember, too, that you can save a life and decrease the second leading cause of death in teens!

In my subspecialty practice, we screen every new patient for suicide regardless of the reason for their visit and more often for those with mental health symptoms. I know this may seem onerous, but screening and counseling typically take under 5 minutes – and in many instances around 1-2 minutes. Having ready-to-go resources including mental health professionals to refer to, screening algorithms (such as protocols published in MedEdPORTAL or Family Practice Management), and suicide prevention resources for patients and family for those who screen positive can help expedite this process. I think these recommendations can be adapted with relative ease into any visit for a teen or young adult who is presenting with a mental health complaint.

Kelly A. Curran, MD, is an assistant professor of pediatrics at the University of Oklahoma in Oklahoma City. She is a member of the Pediatric News editorial advisory board. Dr. Curran said she had no relevant financial disclosures.

Body

 

Interestingly, this study by Orri et al. found that there was not a peak in suicide attempts in mid-adolescence; instead, rates of attempts were stable throughout adolescence and serious suicidal ideation actually increased with age. This was an unexpected finding for me, and something I will be more mindful about in my clinical practice when seeing older teens and young adults. Additionally, all mental health problems – not just depression – evaluated in univariate analyses in the study were associated with suicidal thoughts and attempts. On multivariable analysis that accounted for the impact of the effect of comorbid mental health symptoms, depressive symptoms had the highest and most consistent correlation to suicidal thoughts, and conduct symptoms were associated with an increase in suicide attempts. The authors conclude that youth with mental health symptoms – not just those who meet diagnostic criteria – should be assessed for suicide risk.

Dr. Kelly Curran
I think this recommendation is important for pediatricians to include in care for teens. When we think about all of the topics we screen and counsel about – healthy diet and exercise, dental health, injury prevention, and screen time, to name just a few – it can seem overwhelming to “add one more thing” when many clinicians already feel stretched for time. Others may shy away because of their own discomfort or perceptions of patient or family distress around the topic or avoid screening because they feel they lack the skills or resources to help patients with suicidal thoughts. However, mental health problems – including suicide – are incredibly common and cause significant morbidity and mortality. Screening for suicide is important – remember, too, that you can save a life and decrease the second leading cause of death in teens!

In my subspecialty practice, we screen every new patient for suicide regardless of the reason for their visit and more often for those with mental health symptoms. I know this may seem onerous, but screening and counseling typically take under 5 minutes – and in many instances around 1-2 minutes. Having ready-to-go resources including mental health professionals to refer to, screening algorithms (such as protocols published in MedEdPORTAL or Family Practice Management), and suicide prevention resources for patients and family for those who screen positive can help expedite this process. I think these recommendations can be adapted with relative ease into any visit for a teen or young adult who is presenting with a mental health complaint.

Kelly A. Curran, MD, is an assistant professor of pediatrics at the University of Oklahoma in Oklahoma City. She is a member of the Pediatric News editorial advisory board. Dr. Curran said she had no relevant financial disclosures.

Title
Have resources ready to facilitate suicide screening
Have resources ready to facilitate suicide screening

About one in five adolescents has thought about suicide, about 10% have experienced serious suicidal ideation, and 7% have attempted suicide by age 20 years, according to a longitudinal study of Canadian adolescents published online in Pediatrics.

AlexRaths/Thinkstock

In multivariable analyses, depression and anxiety were independently associated with passive and serious suicidal ideation at some ages, but none of the externalizing problems were significantly associated with passive or serious suicidal ideation. However, “both depressive and conduct symptoms [were] independently associated with suicidal risk,” the researchers found. Most adolescents with suicidal ideation or suicide attempt met criteria for at least one mental health problem.

“These findings suggest that suicide risk should be systematically assessed in adolescents who present with mental health symptoms and not solely in adolescents with clinically diagnosed mental disorders,” said Massimiliano Orri, PhD, and colleagues. Dr. Orri is affiliated with the McGill Group for Suicide Studies, Douglas Mental Health University Institute, Montreal, and the University of Bordeaux (France).

To document the prevalence of passive or serious suicidal ideation and suicide attempt from ages 13-20 years and examine correlations with mental health symptoms, Dr. Orri and colleagues analyzed data from 1,618 participants in the Quebec Longitudinal Study of Child Development. The population-based study follows individuals born in 1997 and 1998 in Quebec. Participants answered questions about suicidal ideation or suicide attempt in the past year at ages 13, 15, 17, or 20 years (“Did you ever think about suicide?” “Did you ever seriously think of attempting suicide?” and “How many times did you attempt suicide?”). The researchers assessed symptoms of mental health problems using self-report questionnaires.

Lifetime prevalence of suicide-related outcomes was higher for female participants than for male participants. The prevalence of passive suicidal ideation was 28% in females versus 15% in males. The prevalence of serious suicidal ideation was 12% in females versus 8% in males. The prevalence of suicide attempt was 9% in females versus 4% in males. “Sex differences in suicidal ideation and suicide attempt might be attributed to various factors, such as mental health (e.g., higher prevalence of depression in female participants) or social stigma (e.g., greater stigma around suicide in male than in female participants),” the authors wrote.

In the entire cohort, the prevalence of passive suicidal ideation increased from 12% at 13 years to 18% at 17 years. The prevalence of serious suicidal ideation increased from 3% at 13 years to 10% at 20 years. The prevalence of suicide attempt was approximately 4% at each age.

“Although having a major depressive episode is a well-known risk factor of suicidal ideation and suicide attempt, our study adds to the general body of knowledge by showing associations with suicide-related outcomes across the full spectrum of depressive symptoms,” Dr. Orri and colleagues wrote. “This suggests that youth who present with depressive symptoms (and not solely those who are clinically depressed) may be more likely to experience suicidal ideation or attempt suicide.”

The estimated rates of serious suicidal ideation and attempted suicide by age 20 years are consistent with previous U.S. and Canadian surveys. Sample attrition, the use of different questionnaires in early and late adolescence, and the lack of information about substance use and psychotic symptoms are among the study’s limitations.

Six of the authors were supported by grants from a variety of Canadian and European agencies and the American Foundation for Suicide Prevention. All of the authors said they had no relevant financial disclosures.

SOURCE: Orri M et al. Pediatrics. 2020 Jun 8. doi: 10.1542/peds.2019-3823.

About one in five adolescents has thought about suicide, about 10% have experienced serious suicidal ideation, and 7% have attempted suicide by age 20 years, according to a longitudinal study of Canadian adolescents published online in Pediatrics.

AlexRaths/Thinkstock

In multivariable analyses, depression and anxiety were independently associated with passive and serious suicidal ideation at some ages, but none of the externalizing problems were significantly associated with passive or serious suicidal ideation. However, “both depressive and conduct symptoms [were] independently associated with suicidal risk,” the researchers found. Most adolescents with suicidal ideation or suicide attempt met criteria for at least one mental health problem.

“These findings suggest that suicide risk should be systematically assessed in adolescents who present with mental health symptoms and not solely in adolescents with clinically diagnosed mental disorders,” said Massimiliano Orri, PhD, and colleagues. Dr. Orri is affiliated with the McGill Group for Suicide Studies, Douglas Mental Health University Institute, Montreal, and the University of Bordeaux (France).

To document the prevalence of passive or serious suicidal ideation and suicide attempt from ages 13-20 years and examine correlations with mental health symptoms, Dr. Orri and colleagues analyzed data from 1,618 participants in the Quebec Longitudinal Study of Child Development. The population-based study follows individuals born in 1997 and 1998 in Quebec. Participants answered questions about suicidal ideation or suicide attempt in the past year at ages 13, 15, 17, or 20 years (“Did you ever think about suicide?” “Did you ever seriously think of attempting suicide?” and “How many times did you attempt suicide?”). The researchers assessed symptoms of mental health problems using self-report questionnaires.

Lifetime prevalence of suicide-related outcomes was higher for female participants than for male participants. The prevalence of passive suicidal ideation was 28% in females versus 15% in males. The prevalence of serious suicidal ideation was 12% in females versus 8% in males. The prevalence of suicide attempt was 9% in females versus 4% in males. “Sex differences in suicidal ideation and suicide attempt might be attributed to various factors, such as mental health (e.g., higher prevalence of depression in female participants) or social stigma (e.g., greater stigma around suicide in male than in female participants),” the authors wrote.

In the entire cohort, the prevalence of passive suicidal ideation increased from 12% at 13 years to 18% at 17 years. The prevalence of serious suicidal ideation increased from 3% at 13 years to 10% at 20 years. The prevalence of suicide attempt was approximately 4% at each age.

“Although having a major depressive episode is a well-known risk factor of suicidal ideation and suicide attempt, our study adds to the general body of knowledge by showing associations with suicide-related outcomes across the full spectrum of depressive symptoms,” Dr. Orri and colleagues wrote. “This suggests that youth who present with depressive symptoms (and not solely those who are clinically depressed) may be more likely to experience suicidal ideation or attempt suicide.”

The estimated rates of serious suicidal ideation and attempted suicide by age 20 years are consistent with previous U.S. and Canadian surveys. Sample attrition, the use of different questionnaires in early and late adolescence, and the lack of information about substance use and psychotic symptoms are among the study’s limitations.

Six of the authors were supported by grants from a variety of Canadian and European agencies and the American Foundation for Suicide Prevention. All of the authors said they had no relevant financial disclosures.

SOURCE: Orri M et al. Pediatrics. 2020 Jun 8. doi: 10.1542/peds.2019-3823.

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ACIP approves flu vaccine recommendations for 2020-2021

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Tue, 02/07/2023 - 16:49

 

A pair of new vaccines for adults aged 65 years and older will be available for the 2020-2021 flu season – Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.

The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.

The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.

Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.

Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.

Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.

Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.

New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.

ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”

The ACIP members had no financial conflicts to disclose.
 

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A pair of new vaccines for adults aged 65 years and older will be available for the 2020-2021 flu season – Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.

The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.

The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.

Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.

Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.

Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.

Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.

New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.

ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”

The ACIP members had no financial conflicts to disclose.
 

 

A pair of new vaccines for adults aged 65 years and older will be available for the 2020-2021 flu season – Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.

The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.

The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.

Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.

Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.

Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.

Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.

New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.

ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”

The ACIP members had no financial conflicts to disclose.
 

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Diabetes control in U.S. youth has worsened over time

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Tue, 05/03/2022 - 15:09

 

Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.

The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.

“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
 

Urgent need to improve glycemic control in youth with diabetes

The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.

Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).

Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.

By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.

In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.

A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).



“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.

“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.

Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.

“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.

 

 

Other countries improving, U.S. getting worse

Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.

“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.

“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.

And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”

Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
 

Barriers to care, type 1 diabetes is “very labor intensive”

Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”

Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.

Such programs in diabetes have shown some success, he said.

Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”

“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”

Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”

Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.

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

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Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.

The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.

“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
 

Urgent need to improve glycemic control in youth with diabetes

The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.

Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).

Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.

By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.

In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.

A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).



“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.

“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.

Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.

“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.

 

 

Other countries improving, U.S. getting worse

Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.

“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.

“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.

And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”

Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
 

Barriers to care, type 1 diabetes is “very labor intensive”

Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”

Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.

Such programs in diabetes have shown some success, he said.

Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”

“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”

Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”

Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.

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

 

Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.

The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.

“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
 

Urgent need to improve glycemic control in youth with diabetes

The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.

Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).

Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.

By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.

In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.

A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).



“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.

“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.

Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.

“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.

 

 

Other countries improving, U.S. getting worse

Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.

“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.

“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.

And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”

Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
 

Barriers to care, type 1 diabetes is “very labor intensive”

Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”

Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.

Such programs in diabetes have shown some success, he said.

Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”

“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”

Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”

Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.

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

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Ringing the alarm about black youth suicide

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Thu, 10/29/2020 - 13:56

A “growing and disturbing” increase in suicidal behavior among black youth has quietly been underway in the United States during the past several decades, even while rates in white and Latino youth have declined, Michael A. Lindsey, PhD, MSW, MPH, declared at the virtual annual meeting of the American Association of Suicidology.

Until recently this trend remained below the radar of public awareness. That’s changing. Dr. Lindsey was coauthor of a December 2019 report to Congress prepared in collaboration with the Congressional Black Caucus entitled, “Ring the Alarm: The Crisis of Black Youth Suicide In America.” Release of the report was accompanied by submission of an omnibus bill aimed at addressing the issue comprehensively, including what Dr. Lindsey considers to be the single most important policy imperative: providing federal resources to support more and better school mental health services proportionate to student needs.

“Black youth, relative to white youth, do not receive treatment for depression, which may be a precursor issue. They’re often disconnected from mental health therapy. This is perhaps a reason why we’re seeing this uptick in suicide expression among black youth,” according to Dr. Lindsey, executive director of the McSilver Institute for Poverty Policy and Research and professor of poverty studies at New York University.

Investigators at Ohio State University analyzed youth suicide data for the years 2001-2015 obtained from the Centers for Disease Control and Prevention. They determined that black children aged 5-12 years had an 82% higher incidence of completed suicide than white children (JAMA Pediatr. 2018 Jul 1;172[7]:697-9).

This report was followed by a study of trends in suicidal behaviors among U.S. high school students during 1991-2017. The study, led by Dr. Lindsey, used data from the Youth Risk Behavior Survey covering the years 1991-2017 to document an overall 19% prevalence of thoughts about suicide, while 15% of high school students had a suicide plan. During the study years there was a 73% increase in suicide attempts among black adolescents, while rates in white and Latino teens fell by 7.5% and 11.4%, respectively (Pediatrics. 2019 Nov;144[5]:e20191187).

Dr. Lindsey cited multiple reasons for undertreatment of depression in black youth. The lack of adequate mental health services in many schools figures prominently. As a result of this situation, mental health problems in black youth are often misinterpreted as conduct problems, leading to well-documented overuse of school suspensions and expulsions.



“We tend to oversuspend and expel black kids from school for problems that are treatable. This becomes a major, major issue in the pathway from schools to prisons,” he said.

Another factor in underutilization of mental health services by black youth is the stigma involved. Many black families see mental health therapy as irrelevant. Dr. Lindsey has received grant support from the National Institute of Mental Health for development of engagement interventions that focus on stigma reduction and enhancing family support for mental health therapy in black youth. He has found that, once those barriers are lowered, therapies seem to be as effective in black youth as in other populations, despite the cultural differences.

Yet another potential explanation for the racial disparity in pediatric suicide might be that suicide may, in some cases, be more of an impulsive behavior in black youth. Dr. Lindsey presented data from a soon-to-be-published analysis of Youth Risk Behavior Survey data on nearly 5,000 adolescents with suicidal thoughts, plans, and/or attempts within the previous 12 months. About 23% had suicidal thoughts only, 37% had suicidal thoughts and a plan, another 37% had thoughts, plans, and suicide attempts, and 3% had attempts without thoughts or a plan.

Black youth were 3.7 times more likely than white youth to have attempted suicide in the absence of background suicidal thoughts and 3.3 times more likely to have attempted suicide without having suicidal thoughts and plans.

He and his coinvestigators identified a similar pattern of suicide as an impulsive behavior in youths of all races with a history of sexual assault. They were 4.2 times more likely to have attempted suicide without prior suicidal thoughts than individuals without such a history and 3.9 times more likely to have attempted suicide without thinking about it or having a plan.

“This has implications for screening and prevention; warning signs may not be present,” he said.

Dr. Lindsey reported having no financial conflicts regarding his presentation.

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A “growing and disturbing” increase in suicidal behavior among black youth has quietly been underway in the United States during the past several decades, even while rates in white and Latino youth have declined, Michael A. Lindsey, PhD, MSW, MPH, declared at the virtual annual meeting of the American Association of Suicidology.

Until recently this trend remained below the radar of public awareness. That’s changing. Dr. Lindsey was coauthor of a December 2019 report to Congress prepared in collaboration with the Congressional Black Caucus entitled, “Ring the Alarm: The Crisis of Black Youth Suicide In America.” Release of the report was accompanied by submission of an omnibus bill aimed at addressing the issue comprehensively, including what Dr. Lindsey considers to be the single most important policy imperative: providing federal resources to support more and better school mental health services proportionate to student needs.

“Black youth, relative to white youth, do not receive treatment for depression, which may be a precursor issue. They’re often disconnected from mental health therapy. This is perhaps a reason why we’re seeing this uptick in suicide expression among black youth,” according to Dr. Lindsey, executive director of the McSilver Institute for Poverty Policy and Research and professor of poverty studies at New York University.

Investigators at Ohio State University analyzed youth suicide data for the years 2001-2015 obtained from the Centers for Disease Control and Prevention. They determined that black children aged 5-12 years had an 82% higher incidence of completed suicide than white children (JAMA Pediatr. 2018 Jul 1;172[7]:697-9).

This report was followed by a study of trends in suicidal behaviors among U.S. high school students during 1991-2017. The study, led by Dr. Lindsey, used data from the Youth Risk Behavior Survey covering the years 1991-2017 to document an overall 19% prevalence of thoughts about suicide, while 15% of high school students had a suicide plan. During the study years there was a 73% increase in suicide attempts among black adolescents, while rates in white and Latino teens fell by 7.5% and 11.4%, respectively (Pediatrics. 2019 Nov;144[5]:e20191187).

Dr. Lindsey cited multiple reasons for undertreatment of depression in black youth. The lack of adequate mental health services in many schools figures prominently. As a result of this situation, mental health problems in black youth are often misinterpreted as conduct problems, leading to well-documented overuse of school suspensions and expulsions.



“We tend to oversuspend and expel black kids from school for problems that are treatable. This becomes a major, major issue in the pathway from schools to prisons,” he said.

Another factor in underutilization of mental health services by black youth is the stigma involved. Many black families see mental health therapy as irrelevant. Dr. Lindsey has received grant support from the National Institute of Mental Health for development of engagement interventions that focus on stigma reduction and enhancing family support for mental health therapy in black youth. He has found that, once those barriers are lowered, therapies seem to be as effective in black youth as in other populations, despite the cultural differences.

Yet another potential explanation for the racial disparity in pediatric suicide might be that suicide may, in some cases, be more of an impulsive behavior in black youth. Dr. Lindsey presented data from a soon-to-be-published analysis of Youth Risk Behavior Survey data on nearly 5,000 adolescents with suicidal thoughts, plans, and/or attempts within the previous 12 months. About 23% had suicidal thoughts only, 37% had suicidal thoughts and a plan, another 37% had thoughts, plans, and suicide attempts, and 3% had attempts without thoughts or a plan.

Black youth were 3.7 times more likely than white youth to have attempted suicide in the absence of background suicidal thoughts and 3.3 times more likely to have attempted suicide without having suicidal thoughts and plans.

He and his coinvestigators identified a similar pattern of suicide as an impulsive behavior in youths of all races with a history of sexual assault. They were 4.2 times more likely to have attempted suicide without prior suicidal thoughts than individuals without such a history and 3.9 times more likely to have attempted suicide without thinking about it or having a plan.

“This has implications for screening and prevention; warning signs may not be present,” he said.

Dr. Lindsey reported having no financial conflicts regarding his presentation.

A “growing and disturbing” increase in suicidal behavior among black youth has quietly been underway in the United States during the past several decades, even while rates in white and Latino youth have declined, Michael A. Lindsey, PhD, MSW, MPH, declared at the virtual annual meeting of the American Association of Suicidology.

Until recently this trend remained below the radar of public awareness. That’s changing. Dr. Lindsey was coauthor of a December 2019 report to Congress prepared in collaboration with the Congressional Black Caucus entitled, “Ring the Alarm: The Crisis of Black Youth Suicide In America.” Release of the report was accompanied by submission of an omnibus bill aimed at addressing the issue comprehensively, including what Dr. Lindsey considers to be the single most important policy imperative: providing federal resources to support more and better school mental health services proportionate to student needs.

“Black youth, relative to white youth, do not receive treatment for depression, which may be a precursor issue. They’re often disconnected from mental health therapy. This is perhaps a reason why we’re seeing this uptick in suicide expression among black youth,” according to Dr. Lindsey, executive director of the McSilver Institute for Poverty Policy and Research and professor of poverty studies at New York University.

Investigators at Ohio State University analyzed youth suicide data for the years 2001-2015 obtained from the Centers for Disease Control and Prevention. They determined that black children aged 5-12 years had an 82% higher incidence of completed suicide than white children (JAMA Pediatr. 2018 Jul 1;172[7]:697-9).

This report was followed by a study of trends in suicidal behaviors among U.S. high school students during 1991-2017. The study, led by Dr. Lindsey, used data from the Youth Risk Behavior Survey covering the years 1991-2017 to document an overall 19% prevalence of thoughts about suicide, while 15% of high school students had a suicide plan. During the study years there was a 73% increase in suicide attempts among black adolescents, while rates in white and Latino teens fell by 7.5% and 11.4%, respectively (Pediatrics. 2019 Nov;144[5]:e20191187).

Dr. Lindsey cited multiple reasons for undertreatment of depression in black youth. The lack of adequate mental health services in many schools figures prominently. As a result of this situation, mental health problems in black youth are often misinterpreted as conduct problems, leading to well-documented overuse of school suspensions and expulsions.



“We tend to oversuspend and expel black kids from school for problems that are treatable. This becomes a major, major issue in the pathway from schools to prisons,” he said.

Another factor in underutilization of mental health services by black youth is the stigma involved. Many black families see mental health therapy as irrelevant. Dr. Lindsey has received grant support from the National Institute of Mental Health for development of engagement interventions that focus on stigma reduction and enhancing family support for mental health therapy in black youth. He has found that, once those barriers are lowered, therapies seem to be as effective in black youth as in other populations, despite the cultural differences.

Yet another potential explanation for the racial disparity in pediatric suicide might be that suicide may, in some cases, be more of an impulsive behavior in black youth. Dr. Lindsey presented data from a soon-to-be-published analysis of Youth Risk Behavior Survey data on nearly 5,000 adolescents with suicidal thoughts, plans, and/or attempts within the previous 12 months. About 23% had suicidal thoughts only, 37% had suicidal thoughts and a plan, another 37% had thoughts, plans, and suicide attempts, and 3% had attempts without thoughts or a plan.

Black youth were 3.7 times more likely than white youth to have attempted suicide in the absence of background suicidal thoughts and 3.3 times more likely to have attempted suicide without having suicidal thoughts and plans.

He and his coinvestigators identified a similar pattern of suicide as an impulsive behavior in youths of all races with a history of sexual assault. They were 4.2 times more likely to have attempted suicide without prior suicidal thoughts than individuals without such a history and 3.9 times more likely to have attempted suicide without thinking about it or having a plan.

“This has implications for screening and prevention; warning signs may not be present,” he said.

Dr. Lindsey reported having no financial conflicts regarding his presentation.

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Medscape Article

New quadrivalent meningococcal vaccine joins VFC arsenal

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Fri, 06/26/2020 - 12:36

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

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A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

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Daily Recap: Healthy lifestyle may stave off dementia; Tentative evidence on marijuana for migraine

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Here are the stories our MDedge editors across specialties think you need to know about today:

First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome

The first official U.S. case of Guillain-Barré syndrome (GBS) associated with COVID-19 has been reported by neurologists from Allegheny General Hospital in Pittsburgh, further supporting a link between the virus and neurologic complications, including GBS.

Physicians in China reported the first case that initially presented as acute GBS. Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.

“This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted. Read more. 

 

Five healthy lifestyle choices tied to dramatic cut in dementia risk

Combining four of five healthy lifestyle choices has been linked to up to a 60% reduced risk for Alzheimer’s dementia in new research that strengthens ties between healthy behaviors and lower dementia risk. “I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigator Klodian Dhana, MD, PhD, said in an interview. 

They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise; light to moderate alcohol consumption; consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities.

“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Luca Giliberto, MD, PhD. Read more.

Marijuana for migraine? Some tentative evidence

Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.

“A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Jefferson headache fellow Claire Ceriani, MD, in an interview. Read more.

 

 

Inside Mercy’s mission to care for non-COVID patients in Los Angeles

When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable. “We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission.

Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. 

Care aboard the ship ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support. Special Feature.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

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Here are the stories our MDedge editors across specialties think you need to know about today:

First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome

The first official U.S. case of Guillain-Barré syndrome (GBS) associated with COVID-19 has been reported by neurologists from Allegheny General Hospital in Pittsburgh, further supporting a link between the virus and neurologic complications, including GBS.

Physicians in China reported the first case that initially presented as acute GBS. Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.

“This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted. Read more. 

 

Five healthy lifestyle choices tied to dramatic cut in dementia risk

Combining four of five healthy lifestyle choices has been linked to up to a 60% reduced risk for Alzheimer’s dementia in new research that strengthens ties between healthy behaviors and lower dementia risk. “I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigator Klodian Dhana, MD, PhD, said in an interview. 

They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise; light to moderate alcohol consumption; consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities.

“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Luca Giliberto, MD, PhD. Read more.

Marijuana for migraine? Some tentative evidence

Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.

“A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Jefferson headache fellow Claire Ceriani, MD, in an interview. Read more.

 

 

Inside Mercy’s mission to care for non-COVID patients in Los Angeles

When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable. “We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission.

Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. 

Care aboard the ship ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support. Special Feature.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome

The first official U.S. case of Guillain-Barré syndrome (GBS) associated with COVID-19 has been reported by neurologists from Allegheny General Hospital in Pittsburgh, further supporting a link between the virus and neurologic complications, including GBS.

Physicians in China reported the first case that initially presented as acute GBS. Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.

“This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted. Read more. 

 

Five healthy lifestyle choices tied to dramatic cut in dementia risk

Combining four of five healthy lifestyle choices has been linked to up to a 60% reduced risk for Alzheimer’s dementia in new research that strengthens ties between healthy behaviors and lower dementia risk. “I hope this study will motivate people to engage in a healthy lifestyle by not smoking, being physically and cognitively active, and having a high-quality diet,” lead investigator Klodian Dhana, MD, PhD, said in an interview. 

They defined a healthy lifestyle score on the basis of the following factors: not smoking; engaging in 150 min/wk or more of physical exercise; light to moderate alcohol consumption; consuming a high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%); and engaging in late-life cognitive activities.

“What needs to be determined is how early should we start ‘behaving.’ We should all aim to score four to five factors across our entire lifespan, but this is not always feasible. So, when is the time to behave? Also, what is the relative weight of each of these factors?” said Luca Giliberto, MD, PhD. Read more.

Marijuana for migraine? Some tentative evidence

Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.

“A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Jefferson headache fellow Claire Ceriani, MD, in an interview. Read more.

 

 

Inside Mercy’s mission to care for non-COVID patients in Los Angeles

When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable. “We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission.

Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. 

Care aboard the ship ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support. Special Feature.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

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