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Too many patient call messages
In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.
Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.
There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).
The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.
Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.
Enabling a system that generates an excess of patient messages is looking for trouble.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.
Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.
There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).
The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.
Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.
Enabling a system that generates an excess of patient messages is looking for trouble.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
In a recent study published in the Journal of the American Medical Informatics Association that used EHR logs, researchers found that “Clinicians with the highest volume of patient call messages have almost 4 times the odds of burnout compared with clinicians with the fewest.” And they discovered that “No other workload measures were significantly associated with burnout.” Like the majority of papers I skim through, it states the obvious. Doesn’t it makes sense that the busiest of providers should be more vulnerable to stress related symptoms? But is that really true for every provider? Being “busy” doesn’t guarantee that you are productive nor does it mean that the stuff you are doing while you are busy is fulfilling or rewarding either emotionally or financially. Certainly, slogging through a long list of patient call messages at the end of the day does qualify as being busy, but it is more likely to generate anger and frustration than it is fulfillment.
Just because you have a large practice, does that mean that you will necessarily have more messages to review and calls to return than a provider with a smaller practice. Maybe you manage your practice and your time so well that you actually have fewer messages and calls to return and, therefore, are less vulnerable to burnout.
There are three general strategies that you might be employing that result in fewer messages and calls that require your response. It may be that you have developed a handbook of frequently asked questions and trained your staff to use it as a reference in a way that reduces the number of messages that filter to you. Creating this triage book and finding the right personnel took time, but it didn’t necessarily mean that you had to hire staff with extensive training, which can be expensive. In-house training of raw talent that has demonstrated common sense and good communication skills can be cost effective and rewarding. You probably already have discovered that continued attention to quality control is an important part of this strategy. Included in your handbook you may have included a clearcut triage system for the questions that the staff can’t answer. Is it a question you must answer (a) as soon as you finish with this patient, (b) before lunch, or (c) at the end of the day? (Category (c) is of course strongly discouraged).
The second general group of strategies you may be using to keep your calls and messages to a minimum is anticipatory guidance. As you wrap up each visit, are you anticipating what calls it might generate? This of course depends on the nature of the problem and the personality of the patient. From your experience you can probably predict most of the questions that are likely going to crop up after the patient arrives home. Preemptively answering these before patients leave and providing a personalized handout that you discuss with them may easily be saving you two or three calls a day. Because you can’t anticipate every question, you have found that promising a follow-up call in a day or 2 encourages the patients to hold their questions and wait for you or your assistant to call.
Finally, you may have discovered long ago that in many cases it is easier and more efficient to see the patient rather than having your staff spend half their time building and maintaining a communication wall around you. This is particularly true if, during the initial contact with your office, the patients have made it clear that they would like to be seen. This strategy is based on commons sense, but for many physicians and their office staff it may require a dramatic shift in attitude. You may have needed to become more comfortable squeezing in short visits at which the goal is to simply begin the dual processes of anxiety relief and diagnosis. In the beginning, you may have had to frequently remind your staff that their primary goal is patient satisfaction and not protecting you from seeing “too many” patients. Ironically, by being over protective, they may have been contributing to burnout when simply cutting to the chase and having the patient come in to be seen would have generated fewer stress-producing calls and messages.
Enabling a system that generates an excess of patient messages is looking for trouble.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Election gift for Florida? Trump poised to approve drug imports from Canada
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Noninvasive ventilation: Options and cautions for patients with COVID-19
Early on in the COVID-19 pandemic,
“We were concerned that, if we put them on high-flow nasal cannula or a noninvasive ventilation, that we would create aerosols that would then be a risk to clinicians,” Meghan Lane-Fall, MD, MSHP, FCCM, said at a Society for Critical Care Medicine virtual meeting called COVID-19: What’s Next. “However, we’ve gotten much more comfortable with infection control. We’ve gotten much more comfortable with controlling these aerosols, with making sure that our clinicians are protected with the appropriate protective equipment. We’ve also realized that patients who end up becoming intubated have really poor outcomes, so we’ve looked at our practice critically and tried to figure out how to support patients noninvasively when that’s possible.”
Respiratory support options
According to Dr. Lane-Fall, an associate professor of anesthesiology and critical care at the University of Pennsylvania, Philadelphia, there are two basic types of respiratory support in patients with moderate, severe, or critical COVID-19: noninvasive and invasive. Noninvasive options include CPAP or BiPAP which can be delivered through nasal pillows, masks, and helmets, as well as high-flow nasal oxygen. Invasive options include endotracheal intubation, tracheostomy, and extracorporeal membrane oxygenation (ECMO), usually the veno-venous (VV) form. “But it’s uncommon to need VV ECMO, even in patients who have critical COVID-19,” she said.
Factors that favor noninvasive ventilation include stably high oxygen requirements, normal mental status, ward location of care, and moderate to severe COVID-19. Factors that favor invasive ventilation include someone who’s deteriorating rapidly, “whose oxygen requirements aren’t stable or who is cardiopulmonary compromised,” said Dr. Lane-Fall, who is also co–medical director of the Trauma Surgery Intensive Care Unit at Penn Presbyterian Medical Center, also in Philadelphia. Other factors include the need for other invasive procedures such as surgery or if they have severe to critical COVID-19, “not just pneumonia, but [illness that’s] progressing into [acute respiratory distress syndrome],” she said.
Indications for urgent endotracheal intubation as opposed to giving a trial of noninvasive ventilation or high-flow nasal oxygen include altered mental status, inability to protect airway, copious amounts of secretions, a Glasgow Coma Scale score of less than 8, severe respiratory acidosis, hypopnea or apnea, shock, or an inability to tolerate noninvasive support. “This is a relative contraindication,” Dr. Lane-Fall said. “I’ve certainly talked people through the BiPAP mask or the helmet. If you tell a patient, ‘I don’t want to have to put in a breathing tube; I want to maintain you on this,’ often they’ll be able to work through it.”
Safety precautions
Aerosolizing procedures require attention to location, personnel, and equipment, including personal protective equipment (PPE), said Dr. Lane-Fall, who is an anesthesiologist by training. “When you are intubating someone, whether they have COVID-19 or not, you are sort of in the belly of the beast,” she said. “You are very exposed to secretions that occur at the time of endotracheal intubation. That’s why it’s important for us to have PPE and barriers to protect ourselves from potential exposure to aerosols during the care of patients with COVID-19.”
In February 2020, the non-for-profit Anesthesia Patient Safety Foundation published recommendations for airway management in patients with suspected COVID-19. A separate guidance was published the British Journal of Anaesthesiology based on emergency tracheal intubation in 202 patients with COVID-19 in Wuhan, China. “The idea here is that you want to intubate under controlled conditions,” said Dr. Lane-Fall, who is an author of the guidance. “You want to use the most experienced operator. You want to have full PPE, including an N95 mask, or something more protective like a powered air purifying respirator or an N95 mask with a face shield. You want the eyes, nose, and mouth of the operator covered completely.”
CPR, another aerosolizing procedure, requires vigilant safety precautions as well. “We struggled with this a little bit at our institution, because our inclination as intensivists when someone is pulseless is to run into the room and start chest compressions and to start resuscitation,” Dr. Lane-Fall said. “But the act of chest compression itself can create aerosols that can present risk to clinicians. We had to tell our clinicians that they have to put on PPE before they do CPR. The buzz phrase here is that there is no emergency in a pandemic. The idea here is that the good of that one patient is outweighed by the good of all the other patients that you could care for if you didn’t have COVID-19 as a clinician. So we have had to encourage our staff to put on PPE first before attending to patients first, even if it delays patient care. Once you have donned PPE, when you’re administering CPR, the number of staff should be minimized. You should have a compressor, and someone to relieve the compressor, and a code leader, someone tending to the airway. But in general, anyone who’s not actively involved should not be in the room.”
Risks during extubation
Extubation of COVID-19 patients is also an aerosolizing procedure not just because you’re pulling an endotracheal tube out of the airway but because coughing is a normal part of extubation. “We’ve had to be careful with how we approach extubation in COVID-19 patients,” Dr. Lane-Fall said. “Ideally you’re doing this in a negative pressure environment. We have also had to use full PPE, covering the eyes and face, and putting on a gown for precaution.”
Reintubation of COVID-19 patients is not uncommon. She and her colleagues at Penn Medicine created procedures for having intubators at the ready outside the room in case the patient were to decompensate clinically. “Another thing we learned is that it’s useful to do a leak test prior to extubation, because there may be airway edema related to prolonged intubation in these patients,” Dr. Lane-Fall said. “We found that, if a leak is absent on checking the cuff leak, the use of steroids for a day or 2 may help decrease airway edema. That improves the chances of extubation success.”
Strategies for aerosol containment
She concluded her remarks by reviewing airway control adjuncts and clinician safety. This includes physically isolating COVID-19 patients in negative pressure rooms and avoiding and minimizing aerosols, including the use of rapid intubation, “where we induce anesthesia for intubation but we don’t bag-mask the patient because that creates aerosols,” she said. The Anesthesia Patient Safety Foundation guidelines advocate for the use of video laryngoscopy so that you can visualize the glottis easily “and make sure that you successfully intubate the glottis and not the esophagus,” she said.
A smart strategy for aerosol containment is to use the most experienced laryngoscopist available. “If you are in a teaching program, ideally you’re using your most experienced resident, or you’re using fellows or attending physicians,” Dr. Lane-Fall said. “This is not the space for an inexperienced learner.”
Another way to make intubation faster and easier in COVID-19 patients is to use an intubation box, which features a plexiglass shield that enables the intubator to use their hands to get in the patient’s airway while being protected from viral droplets generated during intubation. The box can be cleaned after each use. Blueprints for an open source intubation box can be found at http://www.intubationbox.com.
Expert view on aerosol containment in COVID-19
“While there is a dearth of evidence from controlled trials, recommendations mentioned in this story are based on the best available evidence and are in agreement with guidelines from several expert groups,” said David L. Bowton, MD, FCCP, FCCM, of the department of anesthesiology at Wake Forest Baptist Health in Winston-Salem, NC. “The recommendation of Dr. Lane-Fall’s that is perhaps most controversial is the use of an intubation box. Multiple designs for these intubation/aerosol containment devices have been proposed, and the data supporting their ease of use and efficacy has been mixed [See Anaesthesia 2020;75(8):1014-21 and Anaesthesia. 2020. doi: 10.1111/anae.15188]. While bag valve mask ventilation should be avoided if possible, it may be a valuable rescue tool in the severely hypoxemic patient when used with two-person technique to achieve a tight seal and a PEEP valve and an HME over the exhalation port to minimize aerosol spread.
“It cannot be stressed enough that the most skilled individual should be tasked with intubating the patient and as few providers as possible [usually three] should be in the room and have donned full PPE. Negative pressure rooms should be used whenever feasible. Noninvasive ventilation appears safer from an infection control standpoint than initially feared and its use has become more widespread. However, noninvasive ventilation is not without its hazards, and Dr. Lane-Fall’s enumeration of the patient characteristics applicable to the selection of patients for noninvasive ventilation are extremely important. At our institution, the use of noninvasive ventilation and especially high-flow oxygen therapy has increased. Staff have become more comfortable with the donning and doffing of PPE.”
Dr. Lane-Fall reported having no financial disclosures.
Early on in the COVID-19 pandemic,
“We were concerned that, if we put them on high-flow nasal cannula or a noninvasive ventilation, that we would create aerosols that would then be a risk to clinicians,” Meghan Lane-Fall, MD, MSHP, FCCM, said at a Society for Critical Care Medicine virtual meeting called COVID-19: What’s Next. “However, we’ve gotten much more comfortable with infection control. We’ve gotten much more comfortable with controlling these aerosols, with making sure that our clinicians are protected with the appropriate protective equipment. We’ve also realized that patients who end up becoming intubated have really poor outcomes, so we’ve looked at our practice critically and tried to figure out how to support patients noninvasively when that’s possible.”
Respiratory support options
According to Dr. Lane-Fall, an associate professor of anesthesiology and critical care at the University of Pennsylvania, Philadelphia, there are two basic types of respiratory support in patients with moderate, severe, or critical COVID-19: noninvasive and invasive. Noninvasive options include CPAP or BiPAP which can be delivered through nasal pillows, masks, and helmets, as well as high-flow nasal oxygen. Invasive options include endotracheal intubation, tracheostomy, and extracorporeal membrane oxygenation (ECMO), usually the veno-venous (VV) form. “But it’s uncommon to need VV ECMO, even in patients who have critical COVID-19,” she said.
Factors that favor noninvasive ventilation include stably high oxygen requirements, normal mental status, ward location of care, and moderate to severe COVID-19. Factors that favor invasive ventilation include someone who’s deteriorating rapidly, “whose oxygen requirements aren’t stable or who is cardiopulmonary compromised,” said Dr. Lane-Fall, who is also co–medical director of the Trauma Surgery Intensive Care Unit at Penn Presbyterian Medical Center, also in Philadelphia. Other factors include the need for other invasive procedures such as surgery or if they have severe to critical COVID-19, “not just pneumonia, but [illness that’s] progressing into [acute respiratory distress syndrome],” she said.
Indications for urgent endotracheal intubation as opposed to giving a trial of noninvasive ventilation or high-flow nasal oxygen include altered mental status, inability to protect airway, copious amounts of secretions, a Glasgow Coma Scale score of less than 8, severe respiratory acidosis, hypopnea or apnea, shock, or an inability to tolerate noninvasive support. “This is a relative contraindication,” Dr. Lane-Fall said. “I’ve certainly talked people through the BiPAP mask or the helmet. If you tell a patient, ‘I don’t want to have to put in a breathing tube; I want to maintain you on this,’ often they’ll be able to work through it.”
Safety precautions
Aerosolizing procedures require attention to location, personnel, and equipment, including personal protective equipment (PPE), said Dr. Lane-Fall, who is an anesthesiologist by training. “When you are intubating someone, whether they have COVID-19 or not, you are sort of in the belly of the beast,” she said. “You are very exposed to secretions that occur at the time of endotracheal intubation. That’s why it’s important for us to have PPE and barriers to protect ourselves from potential exposure to aerosols during the care of patients with COVID-19.”
In February 2020, the non-for-profit Anesthesia Patient Safety Foundation published recommendations for airway management in patients with suspected COVID-19. A separate guidance was published the British Journal of Anaesthesiology based on emergency tracheal intubation in 202 patients with COVID-19 in Wuhan, China. “The idea here is that you want to intubate under controlled conditions,” said Dr. Lane-Fall, who is an author of the guidance. “You want to use the most experienced operator. You want to have full PPE, including an N95 mask, or something more protective like a powered air purifying respirator or an N95 mask with a face shield. You want the eyes, nose, and mouth of the operator covered completely.”
CPR, another aerosolizing procedure, requires vigilant safety precautions as well. “We struggled with this a little bit at our institution, because our inclination as intensivists when someone is pulseless is to run into the room and start chest compressions and to start resuscitation,” Dr. Lane-Fall said. “But the act of chest compression itself can create aerosols that can present risk to clinicians. We had to tell our clinicians that they have to put on PPE before they do CPR. The buzz phrase here is that there is no emergency in a pandemic. The idea here is that the good of that one patient is outweighed by the good of all the other patients that you could care for if you didn’t have COVID-19 as a clinician. So we have had to encourage our staff to put on PPE first before attending to patients first, even if it delays patient care. Once you have donned PPE, when you’re administering CPR, the number of staff should be minimized. You should have a compressor, and someone to relieve the compressor, and a code leader, someone tending to the airway. But in general, anyone who’s not actively involved should not be in the room.”
Risks during extubation
Extubation of COVID-19 patients is also an aerosolizing procedure not just because you’re pulling an endotracheal tube out of the airway but because coughing is a normal part of extubation. “We’ve had to be careful with how we approach extubation in COVID-19 patients,” Dr. Lane-Fall said. “Ideally you’re doing this in a negative pressure environment. We have also had to use full PPE, covering the eyes and face, and putting on a gown for precaution.”
Reintubation of COVID-19 patients is not uncommon. She and her colleagues at Penn Medicine created procedures for having intubators at the ready outside the room in case the patient were to decompensate clinically. “Another thing we learned is that it’s useful to do a leak test prior to extubation, because there may be airway edema related to prolonged intubation in these patients,” Dr. Lane-Fall said. “We found that, if a leak is absent on checking the cuff leak, the use of steroids for a day or 2 may help decrease airway edema. That improves the chances of extubation success.”
Strategies for aerosol containment
She concluded her remarks by reviewing airway control adjuncts and clinician safety. This includes physically isolating COVID-19 patients in negative pressure rooms and avoiding and minimizing aerosols, including the use of rapid intubation, “where we induce anesthesia for intubation but we don’t bag-mask the patient because that creates aerosols,” she said. The Anesthesia Patient Safety Foundation guidelines advocate for the use of video laryngoscopy so that you can visualize the glottis easily “and make sure that you successfully intubate the glottis and not the esophagus,” she said.
A smart strategy for aerosol containment is to use the most experienced laryngoscopist available. “If you are in a teaching program, ideally you’re using your most experienced resident, or you’re using fellows or attending physicians,” Dr. Lane-Fall said. “This is not the space for an inexperienced learner.”
Another way to make intubation faster and easier in COVID-19 patients is to use an intubation box, which features a plexiglass shield that enables the intubator to use their hands to get in the patient’s airway while being protected from viral droplets generated during intubation. The box can be cleaned after each use. Blueprints for an open source intubation box can be found at http://www.intubationbox.com.
Expert view on aerosol containment in COVID-19
“While there is a dearth of evidence from controlled trials, recommendations mentioned in this story are based on the best available evidence and are in agreement with guidelines from several expert groups,” said David L. Bowton, MD, FCCP, FCCM, of the department of anesthesiology at Wake Forest Baptist Health in Winston-Salem, NC. “The recommendation of Dr. Lane-Fall’s that is perhaps most controversial is the use of an intubation box. Multiple designs for these intubation/aerosol containment devices have been proposed, and the data supporting their ease of use and efficacy has been mixed [See Anaesthesia 2020;75(8):1014-21 and Anaesthesia. 2020. doi: 10.1111/anae.15188]. While bag valve mask ventilation should be avoided if possible, it may be a valuable rescue tool in the severely hypoxemic patient when used with two-person technique to achieve a tight seal and a PEEP valve and an HME over the exhalation port to minimize aerosol spread.
“It cannot be stressed enough that the most skilled individual should be tasked with intubating the patient and as few providers as possible [usually three] should be in the room and have donned full PPE. Negative pressure rooms should be used whenever feasible. Noninvasive ventilation appears safer from an infection control standpoint than initially feared and its use has become more widespread. However, noninvasive ventilation is not without its hazards, and Dr. Lane-Fall’s enumeration of the patient characteristics applicable to the selection of patients for noninvasive ventilation are extremely important. At our institution, the use of noninvasive ventilation and especially high-flow oxygen therapy has increased. Staff have become more comfortable with the donning and doffing of PPE.”
Dr. Lane-Fall reported having no financial disclosures.
Early on in the COVID-19 pandemic,
“We were concerned that, if we put them on high-flow nasal cannula or a noninvasive ventilation, that we would create aerosols that would then be a risk to clinicians,” Meghan Lane-Fall, MD, MSHP, FCCM, said at a Society for Critical Care Medicine virtual meeting called COVID-19: What’s Next. “However, we’ve gotten much more comfortable with infection control. We’ve gotten much more comfortable with controlling these aerosols, with making sure that our clinicians are protected with the appropriate protective equipment. We’ve also realized that patients who end up becoming intubated have really poor outcomes, so we’ve looked at our practice critically and tried to figure out how to support patients noninvasively when that’s possible.”
Respiratory support options
According to Dr. Lane-Fall, an associate professor of anesthesiology and critical care at the University of Pennsylvania, Philadelphia, there are two basic types of respiratory support in patients with moderate, severe, or critical COVID-19: noninvasive and invasive. Noninvasive options include CPAP or BiPAP which can be delivered through nasal pillows, masks, and helmets, as well as high-flow nasal oxygen. Invasive options include endotracheal intubation, tracheostomy, and extracorporeal membrane oxygenation (ECMO), usually the veno-venous (VV) form. “But it’s uncommon to need VV ECMO, even in patients who have critical COVID-19,” she said.
Factors that favor noninvasive ventilation include stably high oxygen requirements, normal mental status, ward location of care, and moderate to severe COVID-19. Factors that favor invasive ventilation include someone who’s deteriorating rapidly, “whose oxygen requirements aren’t stable or who is cardiopulmonary compromised,” said Dr. Lane-Fall, who is also co–medical director of the Trauma Surgery Intensive Care Unit at Penn Presbyterian Medical Center, also in Philadelphia. Other factors include the need for other invasive procedures such as surgery or if they have severe to critical COVID-19, “not just pneumonia, but [illness that’s] progressing into [acute respiratory distress syndrome],” she said.
Indications for urgent endotracheal intubation as opposed to giving a trial of noninvasive ventilation or high-flow nasal oxygen include altered mental status, inability to protect airway, copious amounts of secretions, a Glasgow Coma Scale score of less than 8, severe respiratory acidosis, hypopnea or apnea, shock, or an inability to tolerate noninvasive support. “This is a relative contraindication,” Dr. Lane-Fall said. “I’ve certainly talked people through the BiPAP mask or the helmet. If you tell a patient, ‘I don’t want to have to put in a breathing tube; I want to maintain you on this,’ often they’ll be able to work through it.”
Safety precautions
Aerosolizing procedures require attention to location, personnel, and equipment, including personal protective equipment (PPE), said Dr. Lane-Fall, who is an anesthesiologist by training. “When you are intubating someone, whether they have COVID-19 or not, you are sort of in the belly of the beast,” she said. “You are very exposed to secretions that occur at the time of endotracheal intubation. That’s why it’s important for us to have PPE and barriers to protect ourselves from potential exposure to aerosols during the care of patients with COVID-19.”
In February 2020, the non-for-profit Anesthesia Patient Safety Foundation published recommendations for airway management in patients with suspected COVID-19. A separate guidance was published the British Journal of Anaesthesiology based on emergency tracheal intubation in 202 patients with COVID-19 in Wuhan, China. “The idea here is that you want to intubate under controlled conditions,” said Dr. Lane-Fall, who is an author of the guidance. “You want to use the most experienced operator. You want to have full PPE, including an N95 mask, or something more protective like a powered air purifying respirator or an N95 mask with a face shield. You want the eyes, nose, and mouth of the operator covered completely.”
CPR, another aerosolizing procedure, requires vigilant safety precautions as well. “We struggled with this a little bit at our institution, because our inclination as intensivists when someone is pulseless is to run into the room and start chest compressions and to start resuscitation,” Dr. Lane-Fall said. “But the act of chest compression itself can create aerosols that can present risk to clinicians. We had to tell our clinicians that they have to put on PPE before they do CPR. The buzz phrase here is that there is no emergency in a pandemic. The idea here is that the good of that one patient is outweighed by the good of all the other patients that you could care for if you didn’t have COVID-19 as a clinician. So we have had to encourage our staff to put on PPE first before attending to patients first, even if it delays patient care. Once you have donned PPE, when you’re administering CPR, the number of staff should be minimized. You should have a compressor, and someone to relieve the compressor, and a code leader, someone tending to the airway. But in general, anyone who’s not actively involved should not be in the room.”
Risks during extubation
Extubation of COVID-19 patients is also an aerosolizing procedure not just because you’re pulling an endotracheal tube out of the airway but because coughing is a normal part of extubation. “We’ve had to be careful with how we approach extubation in COVID-19 patients,” Dr. Lane-Fall said. “Ideally you’re doing this in a negative pressure environment. We have also had to use full PPE, covering the eyes and face, and putting on a gown for precaution.”
Reintubation of COVID-19 patients is not uncommon. She and her colleagues at Penn Medicine created procedures for having intubators at the ready outside the room in case the patient were to decompensate clinically. “Another thing we learned is that it’s useful to do a leak test prior to extubation, because there may be airway edema related to prolonged intubation in these patients,” Dr. Lane-Fall said. “We found that, if a leak is absent on checking the cuff leak, the use of steroids for a day or 2 may help decrease airway edema. That improves the chances of extubation success.”
Strategies for aerosol containment
She concluded her remarks by reviewing airway control adjuncts and clinician safety. This includes physically isolating COVID-19 patients in negative pressure rooms and avoiding and minimizing aerosols, including the use of rapid intubation, “where we induce anesthesia for intubation but we don’t bag-mask the patient because that creates aerosols,” she said. The Anesthesia Patient Safety Foundation guidelines advocate for the use of video laryngoscopy so that you can visualize the glottis easily “and make sure that you successfully intubate the glottis and not the esophagus,” she said.
A smart strategy for aerosol containment is to use the most experienced laryngoscopist available. “If you are in a teaching program, ideally you’re using your most experienced resident, or you’re using fellows or attending physicians,” Dr. Lane-Fall said. “This is not the space for an inexperienced learner.”
Another way to make intubation faster and easier in COVID-19 patients is to use an intubation box, which features a plexiglass shield that enables the intubator to use their hands to get in the patient’s airway while being protected from viral droplets generated during intubation. The box can be cleaned after each use. Blueprints for an open source intubation box can be found at http://www.intubationbox.com.
Expert view on aerosol containment in COVID-19
“While there is a dearth of evidence from controlled trials, recommendations mentioned in this story are based on the best available evidence and are in agreement with guidelines from several expert groups,” said David L. Bowton, MD, FCCP, FCCM, of the department of anesthesiology at Wake Forest Baptist Health in Winston-Salem, NC. “The recommendation of Dr. Lane-Fall’s that is perhaps most controversial is the use of an intubation box. Multiple designs for these intubation/aerosol containment devices have been proposed, and the data supporting their ease of use and efficacy has been mixed [See Anaesthesia 2020;75(8):1014-21 and Anaesthesia. 2020. doi: 10.1111/anae.15188]. While bag valve mask ventilation should be avoided if possible, it may be a valuable rescue tool in the severely hypoxemic patient when used with two-person technique to achieve a tight seal and a PEEP valve and an HME over the exhalation port to minimize aerosol spread.
“It cannot be stressed enough that the most skilled individual should be tasked with intubating the patient and as few providers as possible [usually three] should be in the room and have donned full PPE. Negative pressure rooms should be used whenever feasible. Noninvasive ventilation appears safer from an infection control standpoint than initially feared and its use has become more widespread. However, noninvasive ventilation is not without its hazards, and Dr. Lane-Fall’s enumeration of the patient characteristics applicable to the selection of patients for noninvasive ventilation are extremely important. At our institution, the use of noninvasive ventilation and especially high-flow oxygen therapy has increased. Staff have become more comfortable with the donning and doffing of PPE.”
Dr. Lane-Fall reported having no financial disclosures.
FROM AN SCCM VIRTUAL MEETING
Nocturnal oxygen no help for isolated desaturation in COPD
Nocturnal oxygen therapy for patients with COPD and isolated nocturnal oxygen desaturation does not improve survival or delay disease progression, according to findings published Sept. 17 in The New England Journal of Medicine. The new report adds to evidence that the widely implemented and costly practice may be unnecessary.
Patients with COPD who do not qualify for long-term oxygen therapy (LTOT) are commonly prescribed nocturnal oxygen in the belief that it can delay disease progression, possibly by decreasing alveolar hypoventilation and ventilation-perfusion mismatch.
But investigations so far and the new study from the International Nocturnal Oxygen (INOX) Trial have not borne this out.
“There is no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with nocturnal hypoxemia in COPD. Consequently, there is no reason for physicians to screen for nocturnal hypoxemia in COPD,” study leader Yves Lacasse, MD, told Medscape Medical News.
Lacasse is from the Institut Universitaire de Cardiologie et de Pneumologie de Québec–Université Laval, Quebec, Canada.
The idea that the therapy helps is firmly entrenched.
In the early 1980s, two trials indicated that patients who had COPD and severe chronic daytime hypoxemia benefit from LTOT (15-18 hours a day or longer).
A decade later, two landmark trials (the Nocturnal Oxygen Therapy Trial and the British Medical Research Council Trial) added to evidence that LTOT may prolong life for patients with COPD and severe daytime hypoxemia.
“The good news from both trials was that oxygen saves lives. From this moment, oxygen therapy became a standard of care, and confirmatory trials would be considered unethical,” Lacasse explained.
“Oxygen therapy gained widespread acceptance by official organizations for treatment of most chronic cardiorespiratory conditions complicated by severe hypoxemia, even if proof of efficacy is lacking. New indications emerged, such as isolated nocturnal oxygen desaturation. Even in COPD, inappropriate prescriptions of home oxygen therapy are not unusual. Oxygen is everywhere,” Lacasse continued.
A meta-analysis from 2005 identified two trials that evaluated home oxygen therapy specifically for isolated nocturnal desaturation. Both found no survival benefit from nocturnal oxygen.
The study by Lacasse and colleagues assessed effects on mortality or worsening of disease (progression to LTOT) with 3-4 years of nocturnal oxygen supplementation.
Participants, whose oxygen saturation was less than 90% for at least 30% of the recording time on nocturnal oximetry, received oxygen or ambient air from a sham device as a placebo for at least 4 hours per session. The goal of treatment was nocturnal oxygen saturation exceeding 90% for at least 90% of the recorded time.
The trial protocol excluded patients with severe obesity, apnea, lung cancer, left heart failure, interstitial lung disease, or bronchiectasis.
The study was initially powered in 2010 to include 600 participants, with half to receive placebo. The study assumed mortality of 20% among control patients over 3 years; 20% of patients progressed to LTOT.
When recruiting lagged, the data safety monitoring board and steering committee extended follow-up to 4 years. In 2014, they requested an interim analysis, and recruitment ceased. Overall, 243 patients participated.
Lacasse cited several reasons for the difficulty with recruitment as well as retention: unwillingness to take the risk of receiving placebo instead of a readily available treatment, fading interest over time, and frailty that affects compliance.
Patients in the study came from 28 community or university-affiliated hospitals in Canada, Portugal, Spain, and France. At the 3-year mark, 39% of patients (48 of 123) who were assigned to nocturnal oxygen therapy and 42% (50 of 119) of those taking placebo had met criteria for LTOT or had died (difference, −3.0 percentage points; P = .64). The groups did not differ appreciably in rates of exacerbation and hospitalization.
The researchers could not analyze subgroups because the patients were very similar with regard to the severity of nocturnal oxygen desaturation, Lacasse said.
Economics enters into the picture – home oxygen therapy is second only to hospitalization as the most expensive healthcare expenditure associated with clinical care for COPD in developed countries. “The math is simple. There is enormous potential for saving money if the results of our clinical trial are applied appropriately,” said Lacasse.
William Bailey, MD, professor emeritus of pulmonary, allergy, and critical care medicine at the University of Alabama at Birmingham, agrees that the practice is overused.
“There is a built-in bias in the medical community. Most believe that anyone with lung disease benefits from oxygen. Even some of our investigators had a hard time believing the results. The study was well designed, carefully carried out, and I feel confident that the results are reliable,” he said.
Shawn P. E. Nishi, MD, director of bronchoscopy and advanced pulmonary procedures, division of pulmonary and critical care medicine, the University of Texas Medical Branch, Galveston, Texas, mentioned the study’s main limitation, which the authors readily acknowledge.
“Unfortunately, the trial had difficulty recruiting subjects, with less than half of expected enrollment achieved, and was underpowered to make any conclusions. Other studies have examined nocturnal oxygen use and have not shown a mortality benefit,” Nishi explained.
She added that the study did not evaluate use of LTOT for improving outcomes other than mortality, including quality of life, cardiovascular morbidity, depression, cognitive function, exercise capacity, and frequency of COPD exacerbations or hospitalization.
Other limitations of the study include suboptimal adherence to the therapy and interpretation of the clinical significance on the basis of a survey of Canadian pulmonologists.
This article first appeared on Medscape.com.
Nocturnal oxygen therapy for patients with COPD and isolated nocturnal oxygen desaturation does not improve survival or delay disease progression, according to findings published Sept. 17 in The New England Journal of Medicine. The new report adds to evidence that the widely implemented and costly practice may be unnecessary.
Patients with COPD who do not qualify for long-term oxygen therapy (LTOT) are commonly prescribed nocturnal oxygen in the belief that it can delay disease progression, possibly by decreasing alveolar hypoventilation and ventilation-perfusion mismatch.
But investigations so far and the new study from the International Nocturnal Oxygen (INOX) Trial have not borne this out.
“There is no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with nocturnal hypoxemia in COPD. Consequently, there is no reason for physicians to screen for nocturnal hypoxemia in COPD,” study leader Yves Lacasse, MD, told Medscape Medical News.
Lacasse is from the Institut Universitaire de Cardiologie et de Pneumologie de Québec–Université Laval, Quebec, Canada.
The idea that the therapy helps is firmly entrenched.
In the early 1980s, two trials indicated that patients who had COPD and severe chronic daytime hypoxemia benefit from LTOT (15-18 hours a day or longer).
A decade later, two landmark trials (the Nocturnal Oxygen Therapy Trial and the British Medical Research Council Trial) added to evidence that LTOT may prolong life for patients with COPD and severe daytime hypoxemia.
“The good news from both trials was that oxygen saves lives. From this moment, oxygen therapy became a standard of care, and confirmatory trials would be considered unethical,” Lacasse explained.
“Oxygen therapy gained widespread acceptance by official organizations for treatment of most chronic cardiorespiratory conditions complicated by severe hypoxemia, even if proof of efficacy is lacking. New indications emerged, such as isolated nocturnal oxygen desaturation. Even in COPD, inappropriate prescriptions of home oxygen therapy are not unusual. Oxygen is everywhere,” Lacasse continued.
A meta-analysis from 2005 identified two trials that evaluated home oxygen therapy specifically for isolated nocturnal desaturation. Both found no survival benefit from nocturnal oxygen.
The study by Lacasse and colleagues assessed effects on mortality or worsening of disease (progression to LTOT) with 3-4 years of nocturnal oxygen supplementation.
Participants, whose oxygen saturation was less than 90% for at least 30% of the recording time on nocturnal oximetry, received oxygen or ambient air from a sham device as a placebo for at least 4 hours per session. The goal of treatment was nocturnal oxygen saturation exceeding 90% for at least 90% of the recorded time.
The trial protocol excluded patients with severe obesity, apnea, lung cancer, left heart failure, interstitial lung disease, or bronchiectasis.
The study was initially powered in 2010 to include 600 participants, with half to receive placebo. The study assumed mortality of 20% among control patients over 3 years; 20% of patients progressed to LTOT.
When recruiting lagged, the data safety monitoring board and steering committee extended follow-up to 4 years. In 2014, they requested an interim analysis, and recruitment ceased. Overall, 243 patients participated.
Lacasse cited several reasons for the difficulty with recruitment as well as retention: unwillingness to take the risk of receiving placebo instead of a readily available treatment, fading interest over time, and frailty that affects compliance.
Patients in the study came from 28 community or university-affiliated hospitals in Canada, Portugal, Spain, and France. At the 3-year mark, 39% of patients (48 of 123) who were assigned to nocturnal oxygen therapy and 42% (50 of 119) of those taking placebo had met criteria for LTOT or had died (difference, −3.0 percentage points; P = .64). The groups did not differ appreciably in rates of exacerbation and hospitalization.
The researchers could not analyze subgroups because the patients were very similar with regard to the severity of nocturnal oxygen desaturation, Lacasse said.
Economics enters into the picture – home oxygen therapy is second only to hospitalization as the most expensive healthcare expenditure associated with clinical care for COPD in developed countries. “The math is simple. There is enormous potential for saving money if the results of our clinical trial are applied appropriately,” said Lacasse.
William Bailey, MD, professor emeritus of pulmonary, allergy, and critical care medicine at the University of Alabama at Birmingham, agrees that the practice is overused.
“There is a built-in bias in the medical community. Most believe that anyone with lung disease benefits from oxygen. Even some of our investigators had a hard time believing the results. The study was well designed, carefully carried out, and I feel confident that the results are reliable,” he said.
Shawn P. E. Nishi, MD, director of bronchoscopy and advanced pulmonary procedures, division of pulmonary and critical care medicine, the University of Texas Medical Branch, Galveston, Texas, mentioned the study’s main limitation, which the authors readily acknowledge.
“Unfortunately, the trial had difficulty recruiting subjects, with less than half of expected enrollment achieved, and was underpowered to make any conclusions. Other studies have examined nocturnal oxygen use and have not shown a mortality benefit,” Nishi explained.
She added that the study did not evaluate use of LTOT for improving outcomes other than mortality, including quality of life, cardiovascular morbidity, depression, cognitive function, exercise capacity, and frequency of COPD exacerbations or hospitalization.
Other limitations of the study include suboptimal adherence to the therapy and interpretation of the clinical significance on the basis of a survey of Canadian pulmonologists.
This article first appeared on Medscape.com.
Nocturnal oxygen therapy for patients with COPD and isolated nocturnal oxygen desaturation does not improve survival or delay disease progression, according to findings published Sept. 17 in The New England Journal of Medicine. The new report adds to evidence that the widely implemented and costly practice may be unnecessary.
Patients with COPD who do not qualify for long-term oxygen therapy (LTOT) are commonly prescribed nocturnal oxygen in the belief that it can delay disease progression, possibly by decreasing alveolar hypoventilation and ventilation-perfusion mismatch.
But investigations so far and the new study from the International Nocturnal Oxygen (INOX) Trial have not borne this out.
“There is no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with nocturnal hypoxemia in COPD. Consequently, there is no reason for physicians to screen for nocturnal hypoxemia in COPD,” study leader Yves Lacasse, MD, told Medscape Medical News.
Lacasse is from the Institut Universitaire de Cardiologie et de Pneumologie de Québec–Université Laval, Quebec, Canada.
The idea that the therapy helps is firmly entrenched.
In the early 1980s, two trials indicated that patients who had COPD and severe chronic daytime hypoxemia benefit from LTOT (15-18 hours a day or longer).
A decade later, two landmark trials (the Nocturnal Oxygen Therapy Trial and the British Medical Research Council Trial) added to evidence that LTOT may prolong life for patients with COPD and severe daytime hypoxemia.
“The good news from both trials was that oxygen saves lives. From this moment, oxygen therapy became a standard of care, and confirmatory trials would be considered unethical,” Lacasse explained.
“Oxygen therapy gained widespread acceptance by official organizations for treatment of most chronic cardiorespiratory conditions complicated by severe hypoxemia, even if proof of efficacy is lacking. New indications emerged, such as isolated nocturnal oxygen desaturation. Even in COPD, inappropriate prescriptions of home oxygen therapy are not unusual. Oxygen is everywhere,” Lacasse continued.
A meta-analysis from 2005 identified two trials that evaluated home oxygen therapy specifically for isolated nocturnal desaturation. Both found no survival benefit from nocturnal oxygen.
The study by Lacasse and colleagues assessed effects on mortality or worsening of disease (progression to LTOT) with 3-4 years of nocturnal oxygen supplementation.
Participants, whose oxygen saturation was less than 90% for at least 30% of the recording time on nocturnal oximetry, received oxygen or ambient air from a sham device as a placebo for at least 4 hours per session. The goal of treatment was nocturnal oxygen saturation exceeding 90% for at least 90% of the recorded time.
The trial protocol excluded patients with severe obesity, apnea, lung cancer, left heart failure, interstitial lung disease, or bronchiectasis.
The study was initially powered in 2010 to include 600 participants, with half to receive placebo. The study assumed mortality of 20% among control patients over 3 years; 20% of patients progressed to LTOT.
When recruiting lagged, the data safety monitoring board and steering committee extended follow-up to 4 years. In 2014, they requested an interim analysis, and recruitment ceased. Overall, 243 patients participated.
Lacasse cited several reasons for the difficulty with recruitment as well as retention: unwillingness to take the risk of receiving placebo instead of a readily available treatment, fading interest over time, and frailty that affects compliance.
Patients in the study came from 28 community or university-affiliated hospitals in Canada, Portugal, Spain, and France. At the 3-year mark, 39% of patients (48 of 123) who were assigned to nocturnal oxygen therapy and 42% (50 of 119) of those taking placebo had met criteria for LTOT or had died (difference, −3.0 percentage points; P = .64). The groups did not differ appreciably in rates of exacerbation and hospitalization.
The researchers could not analyze subgroups because the patients were very similar with regard to the severity of nocturnal oxygen desaturation, Lacasse said.
Economics enters into the picture – home oxygen therapy is second only to hospitalization as the most expensive healthcare expenditure associated with clinical care for COPD in developed countries. “The math is simple. There is enormous potential for saving money if the results of our clinical trial are applied appropriately,” said Lacasse.
William Bailey, MD, professor emeritus of pulmonary, allergy, and critical care medicine at the University of Alabama at Birmingham, agrees that the practice is overused.
“There is a built-in bias in the medical community. Most believe that anyone with lung disease benefits from oxygen. Even some of our investigators had a hard time believing the results. The study was well designed, carefully carried out, and I feel confident that the results are reliable,” he said.
Shawn P. E. Nishi, MD, director of bronchoscopy and advanced pulmonary procedures, division of pulmonary and critical care medicine, the University of Texas Medical Branch, Galveston, Texas, mentioned the study’s main limitation, which the authors readily acknowledge.
“Unfortunately, the trial had difficulty recruiting subjects, with less than half of expected enrollment achieved, and was underpowered to make any conclusions. Other studies have examined nocturnal oxygen use and have not shown a mortality benefit,” Nishi explained.
She added that the study did not evaluate use of LTOT for improving outcomes other than mortality, including quality of life, cardiovascular morbidity, depression, cognitive function, exercise capacity, and frequency of COPD exacerbations or hospitalization.
Other limitations of the study include suboptimal adherence to the therapy and interpretation of the clinical significance on the basis of a survey of Canadian pulmonologists.
This article first appeared on Medscape.com.
Pharmacologic Management of COPD
A Discussion of the new American Thoracic Society Clinical Practice Guideline
Chronic obstructive pulmonary disease (COPD) is caused by airway and alveolar abnormalities and is the third most common cause of death worldwide. COPD results in airflow obstruction that is not fully reversible. The diagnosis of COPD should be considered in patients over 40 years who have chronic cough and/or dyspnea, particularly if they have a history of tobacco use. The diagnosis is confirmed by a diminished forced expiratory volume in 1 second (FEV1) that is not fully reversible with the use of a bronchodilator and an FEV1/forced vital capacity ratio of less than or equal to 0.7.1
Recommendation 1
Patients with COPD who report dyspnea or exercise intolerance should be treated with both a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) (dual LAMA/LABA therapy) instead of monotherapy, the guideline says.
This recommendation represents a critical change in care and is based on strong evidence. For years practitioners have been using single bronchodilator therapy, often a LAMA as the entrance to treatment for patients with symptomatic COPD. The recommendation to begin treatment with dual bronchodilator therapy is an important one. This is the only recommendation that received a “strong” grade.
The evidence comes from the compilation of 24 randomized controlled trials that altogether included 45,441 patients. Dual therapy versus monotherapy was evaluated by examining differences in dyspnea, health-related quality of life, exacerbations (which were defined as requiring antibiotics, oral steroids, or hospitalizations), and hospitalizations independently. Marked improvements were observed for exacerbations and hospitalizations in the dual LAMA/LABA group, compared with treatment with use of a single bronchodilator. In 22,733 patients across 15 RCTs, there were 88 fewer exacerbations per 1,000 patients with a rate ratio (RR) of 0.80 (P < .002), the guideline states.
The decrease in exacerbations is a critical factor in treating patients with COPD because each exacerbation can lead to a sustained decrease in airflow and increases the risk of future exacerbations.
Recommendation 2
In COPD patients who report dyspnea or exercise intolerance, with an exacerbation in the last year, the guideline recommends triple therapy with an inhaled corticosteroid (ICS) instead of just dual LAMA/LABA therapy.
In the past many clinicians have relegated triple therapy to a “last ditch resort.” This recommendation makes it clear that triple therapy is appropriate for a broad range of patients with moderate to severe COPD.
Recommendation 3
In patients with COPD who are on triple therapy, the inhaled corticosteroid component can be withdrawn if patients have not had an exacerbation within the last year, according to the guideline.
It should be noted that the committee said that the ICS can be withdrawn, not that it necessarily needs to be withdrawn. The data showed that it would be safe to withdraw the ICS, but the data is limited in time to 1 year’s follow-up.
Recommendation 4
ATS was not able to make a recommendation for or against ICS as an additive therapy to LAMA/LABA in those without an exacerbation and elevated blood eosinophilia (defined as ≥2% blood eosinophils or >149 cell/mcL). In those with at least one exacerbation and increased blood eosinophilia, the society does recommend addition of ICS to dual LAMA/LABA therapy.
An area of ongoing discussion is at what point in disease severity, before exacerbations occur, might ICS be useful in preventing a first exacerbation. This awaits further studies and evidence.
Recommendation 5
In COPD patients with frequent and severe exacerbations who are otherwise medically optimized, the ATS advises against the use of maintenance oral corticosteroid therapy.
It has been known and accepted for years that oral steroids should be avoided if at all possible because they have little benefit and can cause significant harm. The guideline reinforces this.
The Bottom Line
Dual LAMA/LABA therapy in symptomatic patients is the standard of care. If a patient has had an exacerbation within the last year, add an ICS to the LAMA/LABA, most conveniently given in the form of triple therapy in one inhaler. Finally, even in refractory COPD, maintenance oral corticosteroids bring more harm than benefit.
Dr. Skolnik is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Matthews is a second-year resident in the family medicine residency program at Abington Jefferson Health.
References
1. Wells C, Joo MJ. COPD and asthma: Diagnostic accuracy requires spirometry. J Fam Pract. 2019;68(2):76-81.
2. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-69.
A Discussion of the new American Thoracic Society Clinical Practice Guideline
A Discussion of the new American Thoracic Society Clinical Practice Guideline
Chronic obstructive pulmonary disease (COPD) is caused by airway and alveolar abnormalities and is the third most common cause of death worldwide. COPD results in airflow obstruction that is not fully reversible. The diagnosis of COPD should be considered in patients over 40 years who have chronic cough and/or dyspnea, particularly if they have a history of tobacco use. The diagnosis is confirmed by a diminished forced expiratory volume in 1 second (FEV1) that is not fully reversible with the use of a bronchodilator and an FEV1/forced vital capacity ratio of less than or equal to 0.7.1
Recommendation 1
Patients with COPD who report dyspnea or exercise intolerance should be treated with both a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) (dual LAMA/LABA therapy) instead of monotherapy, the guideline says.
This recommendation represents a critical change in care and is based on strong evidence. For years practitioners have been using single bronchodilator therapy, often a LAMA as the entrance to treatment for patients with symptomatic COPD. The recommendation to begin treatment with dual bronchodilator therapy is an important one. This is the only recommendation that received a “strong” grade.
The evidence comes from the compilation of 24 randomized controlled trials that altogether included 45,441 patients. Dual therapy versus monotherapy was evaluated by examining differences in dyspnea, health-related quality of life, exacerbations (which were defined as requiring antibiotics, oral steroids, or hospitalizations), and hospitalizations independently. Marked improvements were observed for exacerbations and hospitalizations in the dual LAMA/LABA group, compared with treatment with use of a single bronchodilator. In 22,733 patients across 15 RCTs, there were 88 fewer exacerbations per 1,000 patients with a rate ratio (RR) of 0.80 (P < .002), the guideline states.
The decrease in exacerbations is a critical factor in treating patients with COPD because each exacerbation can lead to a sustained decrease in airflow and increases the risk of future exacerbations.
Recommendation 2
In COPD patients who report dyspnea or exercise intolerance, with an exacerbation in the last year, the guideline recommends triple therapy with an inhaled corticosteroid (ICS) instead of just dual LAMA/LABA therapy.
In the past many clinicians have relegated triple therapy to a “last ditch resort.” This recommendation makes it clear that triple therapy is appropriate for a broad range of patients with moderate to severe COPD.
Recommendation 3
In patients with COPD who are on triple therapy, the inhaled corticosteroid component can be withdrawn if patients have not had an exacerbation within the last year, according to the guideline.
It should be noted that the committee said that the ICS can be withdrawn, not that it necessarily needs to be withdrawn. The data showed that it would be safe to withdraw the ICS, but the data is limited in time to 1 year’s follow-up.
Recommendation 4
ATS was not able to make a recommendation for or against ICS as an additive therapy to LAMA/LABA in those without an exacerbation and elevated blood eosinophilia (defined as ≥2% blood eosinophils or >149 cell/mcL). In those with at least one exacerbation and increased blood eosinophilia, the society does recommend addition of ICS to dual LAMA/LABA therapy.
An area of ongoing discussion is at what point in disease severity, before exacerbations occur, might ICS be useful in preventing a first exacerbation. This awaits further studies and evidence.
Recommendation 5
In COPD patients with frequent and severe exacerbations who are otherwise medically optimized, the ATS advises against the use of maintenance oral corticosteroid therapy.
It has been known and accepted for years that oral steroids should be avoided if at all possible because they have little benefit and can cause significant harm. The guideline reinforces this.
The Bottom Line
Dual LAMA/LABA therapy in symptomatic patients is the standard of care. If a patient has had an exacerbation within the last year, add an ICS to the LAMA/LABA, most conveniently given in the form of triple therapy in one inhaler. Finally, even in refractory COPD, maintenance oral corticosteroids bring more harm than benefit.
Dr. Skolnik is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Matthews is a second-year resident in the family medicine residency program at Abington Jefferson Health.
References
1. Wells C, Joo MJ. COPD and asthma: Diagnostic accuracy requires spirometry. J Fam Pract. 2019;68(2):76-81.
2. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-69.
Chronic obstructive pulmonary disease (COPD) is caused by airway and alveolar abnormalities and is the third most common cause of death worldwide. COPD results in airflow obstruction that is not fully reversible. The diagnosis of COPD should be considered in patients over 40 years who have chronic cough and/or dyspnea, particularly if they have a history of tobacco use. The diagnosis is confirmed by a diminished forced expiratory volume in 1 second (FEV1) that is not fully reversible with the use of a bronchodilator and an FEV1/forced vital capacity ratio of less than or equal to 0.7.1
Recommendation 1
Patients with COPD who report dyspnea or exercise intolerance should be treated with both a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) (dual LAMA/LABA therapy) instead of monotherapy, the guideline says.
This recommendation represents a critical change in care and is based on strong evidence. For years practitioners have been using single bronchodilator therapy, often a LAMA as the entrance to treatment for patients with symptomatic COPD. The recommendation to begin treatment with dual bronchodilator therapy is an important one. This is the only recommendation that received a “strong” grade.
The evidence comes from the compilation of 24 randomized controlled trials that altogether included 45,441 patients. Dual therapy versus monotherapy was evaluated by examining differences in dyspnea, health-related quality of life, exacerbations (which were defined as requiring antibiotics, oral steroids, or hospitalizations), and hospitalizations independently. Marked improvements were observed for exacerbations and hospitalizations in the dual LAMA/LABA group, compared with treatment with use of a single bronchodilator. In 22,733 patients across 15 RCTs, there were 88 fewer exacerbations per 1,000 patients with a rate ratio (RR) of 0.80 (P < .002), the guideline states.
The decrease in exacerbations is a critical factor in treating patients with COPD because each exacerbation can lead to a sustained decrease in airflow and increases the risk of future exacerbations.
Recommendation 2
In COPD patients who report dyspnea or exercise intolerance, with an exacerbation in the last year, the guideline recommends triple therapy with an inhaled corticosteroid (ICS) instead of just dual LAMA/LABA therapy.
In the past many clinicians have relegated triple therapy to a “last ditch resort.” This recommendation makes it clear that triple therapy is appropriate for a broad range of patients with moderate to severe COPD.
Recommendation 3
In patients with COPD who are on triple therapy, the inhaled corticosteroid component can be withdrawn if patients have not had an exacerbation within the last year, according to the guideline.
It should be noted that the committee said that the ICS can be withdrawn, not that it necessarily needs to be withdrawn. The data showed that it would be safe to withdraw the ICS, but the data is limited in time to 1 year’s follow-up.
Recommendation 4
ATS was not able to make a recommendation for or against ICS as an additive therapy to LAMA/LABA in those without an exacerbation and elevated blood eosinophilia (defined as ≥2% blood eosinophils or >149 cell/mcL). In those with at least one exacerbation and increased blood eosinophilia, the society does recommend addition of ICS to dual LAMA/LABA therapy.
An area of ongoing discussion is at what point in disease severity, before exacerbations occur, might ICS be useful in preventing a first exacerbation. This awaits further studies and evidence.
Recommendation 5
In COPD patients with frequent and severe exacerbations who are otherwise medically optimized, the ATS advises against the use of maintenance oral corticosteroid therapy.
It has been known and accepted for years that oral steroids should be avoided if at all possible because they have little benefit and can cause significant harm. The guideline reinforces this.
The Bottom Line
Dual LAMA/LABA therapy in symptomatic patients is the standard of care. If a patient has had an exacerbation within the last year, add an ICS to the LAMA/LABA, most conveniently given in the form of triple therapy in one inhaler. Finally, even in refractory COPD, maintenance oral corticosteroids bring more harm than benefit.
Dr. Skolnik is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Matthews is a second-year resident in the family medicine residency program at Abington Jefferson Health.
References
1. Wells C, Joo MJ. COPD and asthma: Diagnostic accuracy requires spirometry. J Fam Pract. 2019;68(2):76-81.
2. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of chronic obstructive pulmonary disease. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56-69.
Many Americans still concerned about access to health care
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
Study validates OSA phenotypes in Latinos
Three previously described clinical phenotypes of obstructive sleep apnea (OSA) have been validated in a large and diverse Hispanic/Latino community-based population for the first time, according to findings presented at the virtual annual meeting of the Associated Professional Sleep Societies.
The three OSA symptom profiles present in this population – labeled “minimally symptomatic,” “disturbed sleep,” and “daytime sleepiness” – are consistent with recent findings from the Sleep Apnea Global Interdisciplinary Consortium, which were published in Sleep, but there are notable differences in the prevalence of these clusters, with the minimally symptomatic cluster much more prevalent than in prior research, reported Kevin Gonzalez, of the University of California, San Diego.
“Other biopsychosocial factors may be contributing to OSA phenotypes among Hispanics and Latinos,” Mr. Gonzalez said in his presentation. Prior research to characterize the heterogeneity of sleep apnea has not included a diverse Latino population, he emphasized.
The adults studied were aged 18-74 years and participants in the multisite Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a comprehensive study of Hispanic/Latino health and disease in the United States. Their respiratory events were measured overnight in HCHS/SOL sleep reading centers with an ARES Unicorder 5.2, B-Alert. Sleep patterns and risk factors were assessed using the Sleep Heart Health Study Sleep Habits Questionnaire and the Epworth Sleepiness Scale.
Participants meeting the criteria for moderate to severe OSA (with an Apnea Hypopnea Index of 15 or above) were included in the analysis (n = 1,623). Their average age was 52.4 ± 13.9 years, and 34.1% were female.
To identify phenotype clusters, investigators performed a latent class analysis using 15 common OSA symptoms and a survey weighted to adjust for selection bias. The three clusters offering the “best” fit for the data aligned with the previously reported phenotypes and identified daytime sleepiness in 15.3%, disturbed sleep (insomnia-like symptoms) in 37.7%, and minimally symptomatic (a low symptom profile) in 46.9%.
These phenotypes were reported in the European Respiratory Journal in 2014 in a cluster analysis of data from a sleep apnea cohort in Iceland and later replicated in the analysis of data from the Sleep Apnea Global Interdisciplinary Consortium published in Sleep in 2018. The consortium study also added two additional phenotypes, labeled “upper airway symptoms dominant” and “sleepiness dominant.”
The prevalence of a “minimally symptomatic group” in the new analysis of the Hispanics/Latinos in the United States is much higher than reported in these prior studies, at least partly, the investigators believed, because the “prior studies were clinical samples, and the people who were minimally symptomatic didn’t get to the sleep centers,” Mr. Gonzalez said in an interview after the meeting.
Patients with a phenotype of daytime sleepiness – the most common phenotype in prior research – constituted only a minority in the Hispanic/Latino population, he said.
Alberto Ramos, MD, of the University of Miami and the principal investigator, said in an interview that the research team is currently analyzing “if and how these different [phenotypic] clusters could affect the incidence of comorbidities” recorded in the HCHS/SOL study, such as hypertension, diabetes, cardiovascular disease, and cognitive decline.
For now, he said, the findings suggest that OSA may be especially underrecognized in Hispanics and Latinos and that there is more research to be done to better identify and stratify patients with varying symptomatology for more personalized treatment and for clinical trial selection. “Maybe we should expand our criteria ... broaden our [recognition] of the presentation of sleep apnea and the symptoms associated with it, not only in Hispanics but maybe in the general population,” Dr. Ramos said.
In commenting on the study, Krishna M. Sundar, MD, FCCP, director of the Sleep-Wake Center at the University of Utah, Salt Lake City, said that insomnia and daytime sleepiness are “key associations with obstructive sleep apnea and may predict different outcomes with untreated OSA.” Such heterogeneity is “only beginning to be appreciated,” he said. “The expression of OSA with these symptoms points to how OSA impacts quality of life” and how symptomatology in addition to Apnea Hypopnea Index “may be an important determinant of treatment benefit and compliance.”
The investigators reported no relevant disclosures. Dr. Sundar said that he is cofounder of Hypnoscure, software for population management of sleep apnea, but with no monies received.
Three previously described clinical phenotypes of obstructive sleep apnea (OSA) have been validated in a large and diverse Hispanic/Latino community-based population for the first time, according to findings presented at the virtual annual meeting of the Associated Professional Sleep Societies.
The three OSA symptom profiles present in this population – labeled “minimally symptomatic,” “disturbed sleep,” and “daytime sleepiness” – are consistent with recent findings from the Sleep Apnea Global Interdisciplinary Consortium, which were published in Sleep, but there are notable differences in the prevalence of these clusters, with the minimally symptomatic cluster much more prevalent than in prior research, reported Kevin Gonzalez, of the University of California, San Diego.
“Other biopsychosocial factors may be contributing to OSA phenotypes among Hispanics and Latinos,” Mr. Gonzalez said in his presentation. Prior research to characterize the heterogeneity of sleep apnea has not included a diverse Latino population, he emphasized.
The adults studied were aged 18-74 years and participants in the multisite Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a comprehensive study of Hispanic/Latino health and disease in the United States. Their respiratory events were measured overnight in HCHS/SOL sleep reading centers with an ARES Unicorder 5.2, B-Alert. Sleep patterns and risk factors were assessed using the Sleep Heart Health Study Sleep Habits Questionnaire and the Epworth Sleepiness Scale.
Participants meeting the criteria for moderate to severe OSA (with an Apnea Hypopnea Index of 15 or above) were included in the analysis (n = 1,623). Their average age was 52.4 ± 13.9 years, and 34.1% were female.
To identify phenotype clusters, investigators performed a latent class analysis using 15 common OSA symptoms and a survey weighted to adjust for selection bias. The three clusters offering the “best” fit for the data aligned with the previously reported phenotypes and identified daytime sleepiness in 15.3%, disturbed sleep (insomnia-like symptoms) in 37.7%, and minimally symptomatic (a low symptom profile) in 46.9%.
These phenotypes were reported in the European Respiratory Journal in 2014 in a cluster analysis of data from a sleep apnea cohort in Iceland and later replicated in the analysis of data from the Sleep Apnea Global Interdisciplinary Consortium published in Sleep in 2018. The consortium study also added two additional phenotypes, labeled “upper airway symptoms dominant” and “sleepiness dominant.”
The prevalence of a “minimally symptomatic group” in the new analysis of the Hispanics/Latinos in the United States is much higher than reported in these prior studies, at least partly, the investigators believed, because the “prior studies were clinical samples, and the people who were minimally symptomatic didn’t get to the sleep centers,” Mr. Gonzalez said in an interview after the meeting.
Patients with a phenotype of daytime sleepiness – the most common phenotype in prior research – constituted only a minority in the Hispanic/Latino population, he said.
Alberto Ramos, MD, of the University of Miami and the principal investigator, said in an interview that the research team is currently analyzing “if and how these different [phenotypic] clusters could affect the incidence of comorbidities” recorded in the HCHS/SOL study, such as hypertension, diabetes, cardiovascular disease, and cognitive decline.
For now, he said, the findings suggest that OSA may be especially underrecognized in Hispanics and Latinos and that there is more research to be done to better identify and stratify patients with varying symptomatology for more personalized treatment and for clinical trial selection. “Maybe we should expand our criteria ... broaden our [recognition] of the presentation of sleep apnea and the symptoms associated with it, not only in Hispanics but maybe in the general population,” Dr. Ramos said.
In commenting on the study, Krishna M. Sundar, MD, FCCP, director of the Sleep-Wake Center at the University of Utah, Salt Lake City, said that insomnia and daytime sleepiness are “key associations with obstructive sleep apnea and may predict different outcomes with untreated OSA.” Such heterogeneity is “only beginning to be appreciated,” he said. “The expression of OSA with these symptoms points to how OSA impacts quality of life” and how symptomatology in addition to Apnea Hypopnea Index “may be an important determinant of treatment benefit and compliance.”
The investigators reported no relevant disclosures. Dr. Sundar said that he is cofounder of Hypnoscure, software for population management of sleep apnea, but with no monies received.
Three previously described clinical phenotypes of obstructive sleep apnea (OSA) have been validated in a large and diverse Hispanic/Latino community-based population for the first time, according to findings presented at the virtual annual meeting of the Associated Professional Sleep Societies.
The three OSA symptom profiles present in this population – labeled “minimally symptomatic,” “disturbed sleep,” and “daytime sleepiness” – are consistent with recent findings from the Sleep Apnea Global Interdisciplinary Consortium, which were published in Sleep, but there are notable differences in the prevalence of these clusters, with the minimally symptomatic cluster much more prevalent than in prior research, reported Kevin Gonzalez, of the University of California, San Diego.
“Other biopsychosocial factors may be contributing to OSA phenotypes among Hispanics and Latinos,” Mr. Gonzalez said in his presentation. Prior research to characterize the heterogeneity of sleep apnea has not included a diverse Latino population, he emphasized.
The adults studied were aged 18-74 years and participants in the multisite Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a comprehensive study of Hispanic/Latino health and disease in the United States. Their respiratory events were measured overnight in HCHS/SOL sleep reading centers with an ARES Unicorder 5.2, B-Alert. Sleep patterns and risk factors were assessed using the Sleep Heart Health Study Sleep Habits Questionnaire and the Epworth Sleepiness Scale.
Participants meeting the criteria for moderate to severe OSA (with an Apnea Hypopnea Index of 15 or above) were included in the analysis (n = 1,623). Their average age was 52.4 ± 13.9 years, and 34.1% were female.
To identify phenotype clusters, investigators performed a latent class analysis using 15 common OSA symptoms and a survey weighted to adjust for selection bias. The three clusters offering the “best” fit for the data aligned with the previously reported phenotypes and identified daytime sleepiness in 15.3%, disturbed sleep (insomnia-like symptoms) in 37.7%, and minimally symptomatic (a low symptom profile) in 46.9%.
These phenotypes were reported in the European Respiratory Journal in 2014 in a cluster analysis of data from a sleep apnea cohort in Iceland and later replicated in the analysis of data from the Sleep Apnea Global Interdisciplinary Consortium published in Sleep in 2018. The consortium study also added two additional phenotypes, labeled “upper airway symptoms dominant” and “sleepiness dominant.”
The prevalence of a “minimally symptomatic group” in the new analysis of the Hispanics/Latinos in the United States is much higher than reported in these prior studies, at least partly, the investigators believed, because the “prior studies were clinical samples, and the people who were minimally symptomatic didn’t get to the sleep centers,” Mr. Gonzalez said in an interview after the meeting.
Patients with a phenotype of daytime sleepiness – the most common phenotype in prior research – constituted only a minority in the Hispanic/Latino population, he said.
Alberto Ramos, MD, of the University of Miami and the principal investigator, said in an interview that the research team is currently analyzing “if and how these different [phenotypic] clusters could affect the incidence of comorbidities” recorded in the HCHS/SOL study, such as hypertension, diabetes, cardiovascular disease, and cognitive decline.
For now, he said, the findings suggest that OSA may be especially underrecognized in Hispanics and Latinos and that there is more research to be done to better identify and stratify patients with varying symptomatology for more personalized treatment and for clinical trial selection. “Maybe we should expand our criteria ... broaden our [recognition] of the presentation of sleep apnea and the symptoms associated with it, not only in Hispanics but maybe in the general population,” Dr. Ramos said.
In commenting on the study, Krishna M. Sundar, MD, FCCP, director of the Sleep-Wake Center at the University of Utah, Salt Lake City, said that insomnia and daytime sleepiness are “key associations with obstructive sleep apnea and may predict different outcomes with untreated OSA.” Such heterogeneity is “only beginning to be appreciated,” he said. “The expression of OSA with these symptoms points to how OSA impacts quality of life” and how symptomatology in addition to Apnea Hypopnea Index “may be an important determinant of treatment benefit and compliance.”
The investigators reported no relevant disclosures. Dr. Sundar said that he is cofounder of Hypnoscure, software for population management of sleep apnea, but with no monies received.
REPORTING FROM SLEEP 2020
2020-2021 respiratory viral season: Onset, presentations, and testing likely to differ in pandemic
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Insomnia may have a role in generation of stressful life events
Insomnia disorder appears to play a causal role in the development of new stressful life events, especially “dependent” events for which individuals are at least partly responsible, said the investigators of an ongoing longitudinal study of people who have experienced involuntary job loss.
The “stress-generation hypothesis” has been applied for several decades in the context of depression. It posits that depressed individuals generate more stressful life events – events that create family conflict or disrupt careers, for instance – than individuals who are not depressed.
The new analysis of individuals with involuntary job loss suggests that the same can be said of insomnia. “Insomnia disorder is associated with fatigue, daytime sleepiness, impaired concentration, and difficulties in emotional regulation,” Iva Skobic, MSPH, MA, a PhD student at the University of Arizona, Tucson, said at the virtual annual meeting of the Associated Professional Sleep Societies.
“These may lead to impaired decision-making, interpersonal conflicts, difficulty meeting deadlines and keeping commitments, and other sources [of stressful life events],” she said. “This extension of the stress-generation hypothesis has important implications for harm reduction interventions for insomnia disorder.”
Investigators conducted a cross-lagged panel analysis using baseline and 3-month follow-up data from 137 individuals who completed a standardized, textual life event measure called the Life Events and Difficulties Schedule after having lost their jobs involuntarily. Participants were interviewed and their events were rated for severity by a consensus panel using operationalized criteria. The analysis employed linear regression controlling for covariates (age, gender, and race) and logistic regression that controlled for insomnia at baseline. Insomnia disorder was defined as meeting ICSD-2/3 criteria using the Duke Structured Interview for Sleep Disorders.
The findings: Insomnia disorder at baseline predicted the number of stressful life events (either dependent or interpersonal) generated within 3 months (beta, 0.70; standard error, 0.31; Tscore, 2.27; P = .03). Conversely, the number of stressful events at baseline did not predict insomnia (odds ratio, 0.97; 95% confidence interval, 0.73-1.29). There also was a trend toward increased generation of dependent events specifically among those with insomnia disorder.
Participants were a mean age of 42 years, and all had been in their previous place of employment for at least 6 months. Nearly 60% met the diagnostic threshold for insomnia at baseline. They were part of a larger ongoing study examining the linkages between job loss and sleep disturbances, obesity, and mental health – the Assessing Daily Activity Patterns through Occupational Transitions (ADAPT) study, supported by the National Heart, Lung, and Blood Institute.
This analysis on insomnia was completed before the COVID-19 pandemic began, but it and other analyses soon to be reported are highly relevant to the economic climate, said Patricia Haynes, PhD, principal investigator of ADAPT and a coauthor of the insomnia study, in an interview after the meeting.
Insomnia is a frequent comorbidity of depression and shares many of its symptoms, from increased fatigue to emotional dysregulation and an increased risk of maladaptive coping strategies. “Interestingly, the literature on the stress-generation hypothesis posits that these very symptoms are on the casual pathway between depression and stressful life events,” said Ms. Skobic at the meeting.
In commenting on the study, Krishna M. Sundar, MD, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, noted that the analysis did not include any measure of the severity of insomnia. Still, he said, “finding an association [with stress generation] at [just] 3 months with the presence of insomnia disorder is quite interesting.”
There were higher rates of insomnia in the sample than depression, Dr. Haynes said, but the analysis did not control for depression or take it into account.
“We know [from prior research] that stress clearly leads to insomnia. The big [takeaway] here is that insomnia can also lead to more stress,” she said. “It’s important to think of it as a reciprocal relationship. If we can potentially treat insomnia, we may be able to stop that cycle of other stressful events that affect both [the individuals] and others as well.”
Ms. Skobic had no disclosures.
Insomnia disorder appears to play a causal role in the development of new stressful life events, especially “dependent” events for which individuals are at least partly responsible, said the investigators of an ongoing longitudinal study of people who have experienced involuntary job loss.
The “stress-generation hypothesis” has been applied for several decades in the context of depression. It posits that depressed individuals generate more stressful life events – events that create family conflict or disrupt careers, for instance – than individuals who are not depressed.
The new analysis of individuals with involuntary job loss suggests that the same can be said of insomnia. “Insomnia disorder is associated with fatigue, daytime sleepiness, impaired concentration, and difficulties in emotional regulation,” Iva Skobic, MSPH, MA, a PhD student at the University of Arizona, Tucson, said at the virtual annual meeting of the Associated Professional Sleep Societies.
“These may lead to impaired decision-making, interpersonal conflicts, difficulty meeting deadlines and keeping commitments, and other sources [of stressful life events],” she said. “This extension of the stress-generation hypothesis has important implications for harm reduction interventions for insomnia disorder.”
Investigators conducted a cross-lagged panel analysis using baseline and 3-month follow-up data from 137 individuals who completed a standardized, textual life event measure called the Life Events and Difficulties Schedule after having lost their jobs involuntarily. Participants were interviewed and their events were rated for severity by a consensus panel using operationalized criteria. The analysis employed linear regression controlling for covariates (age, gender, and race) and logistic regression that controlled for insomnia at baseline. Insomnia disorder was defined as meeting ICSD-2/3 criteria using the Duke Structured Interview for Sleep Disorders.
The findings: Insomnia disorder at baseline predicted the number of stressful life events (either dependent or interpersonal) generated within 3 months (beta, 0.70; standard error, 0.31; Tscore, 2.27; P = .03). Conversely, the number of stressful events at baseline did not predict insomnia (odds ratio, 0.97; 95% confidence interval, 0.73-1.29). There also was a trend toward increased generation of dependent events specifically among those with insomnia disorder.
Participants were a mean age of 42 years, and all had been in their previous place of employment for at least 6 months. Nearly 60% met the diagnostic threshold for insomnia at baseline. They were part of a larger ongoing study examining the linkages between job loss and sleep disturbances, obesity, and mental health – the Assessing Daily Activity Patterns through Occupational Transitions (ADAPT) study, supported by the National Heart, Lung, and Blood Institute.
This analysis on insomnia was completed before the COVID-19 pandemic began, but it and other analyses soon to be reported are highly relevant to the economic climate, said Patricia Haynes, PhD, principal investigator of ADAPT and a coauthor of the insomnia study, in an interview after the meeting.
Insomnia is a frequent comorbidity of depression and shares many of its symptoms, from increased fatigue to emotional dysregulation and an increased risk of maladaptive coping strategies. “Interestingly, the literature on the stress-generation hypothesis posits that these very symptoms are on the casual pathway between depression and stressful life events,” said Ms. Skobic at the meeting.
In commenting on the study, Krishna M. Sundar, MD, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, noted that the analysis did not include any measure of the severity of insomnia. Still, he said, “finding an association [with stress generation] at [just] 3 months with the presence of insomnia disorder is quite interesting.”
There were higher rates of insomnia in the sample than depression, Dr. Haynes said, but the analysis did not control for depression or take it into account.
“We know [from prior research] that stress clearly leads to insomnia. The big [takeaway] here is that insomnia can also lead to more stress,” she said. “It’s important to think of it as a reciprocal relationship. If we can potentially treat insomnia, we may be able to stop that cycle of other stressful events that affect both [the individuals] and others as well.”
Ms. Skobic had no disclosures.
Insomnia disorder appears to play a causal role in the development of new stressful life events, especially “dependent” events for which individuals are at least partly responsible, said the investigators of an ongoing longitudinal study of people who have experienced involuntary job loss.
The “stress-generation hypothesis” has been applied for several decades in the context of depression. It posits that depressed individuals generate more stressful life events – events that create family conflict or disrupt careers, for instance – than individuals who are not depressed.
The new analysis of individuals with involuntary job loss suggests that the same can be said of insomnia. “Insomnia disorder is associated with fatigue, daytime sleepiness, impaired concentration, and difficulties in emotional regulation,” Iva Skobic, MSPH, MA, a PhD student at the University of Arizona, Tucson, said at the virtual annual meeting of the Associated Professional Sleep Societies.
“These may lead to impaired decision-making, interpersonal conflicts, difficulty meeting deadlines and keeping commitments, and other sources [of stressful life events],” she said. “This extension of the stress-generation hypothesis has important implications for harm reduction interventions for insomnia disorder.”
Investigators conducted a cross-lagged panel analysis using baseline and 3-month follow-up data from 137 individuals who completed a standardized, textual life event measure called the Life Events and Difficulties Schedule after having lost their jobs involuntarily. Participants were interviewed and their events were rated for severity by a consensus panel using operationalized criteria. The analysis employed linear regression controlling for covariates (age, gender, and race) and logistic regression that controlled for insomnia at baseline. Insomnia disorder was defined as meeting ICSD-2/3 criteria using the Duke Structured Interview for Sleep Disorders.
The findings: Insomnia disorder at baseline predicted the number of stressful life events (either dependent or interpersonal) generated within 3 months (beta, 0.70; standard error, 0.31; Tscore, 2.27; P = .03). Conversely, the number of stressful events at baseline did not predict insomnia (odds ratio, 0.97; 95% confidence interval, 0.73-1.29). There also was a trend toward increased generation of dependent events specifically among those with insomnia disorder.
Participants were a mean age of 42 years, and all had been in their previous place of employment for at least 6 months. Nearly 60% met the diagnostic threshold for insomnia at baseline. They were part of a larger ongoing study examining the linkages between job loss and sleep disturbances, obesity, and mental health – the Assessing Daily Activity Patterns through Occupational Transitions (ADAPT) study, supported by the National Heart, Lung, and Blood Institute.
This analysis on insomnia was completed before the COVID-19 pandemic began, but it and other analyses soon to be reported are highly relevant to the economic climate, said Patricia Haynes, PhD, principal investigator of ADAPT and a coauthor of the insomnia study, in an interview after the meeting.
Insomnia is a frequent comorbidity of depression and shares many of its symptoms, from increased fatigue to emotional dysregulation and an increased risk of maladaptive coping strategies. “Interestingly, the literature on the stress-generation hypothesis posits that these very symptoms are on the casual pathway between depression and stressful life events,” said Ms. Skobic at the meeting.
In commenting on the study, Krishna M. Sundar, MD, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, noted that the analysis did not include any measure of the severity of insomnia. Still, he said, “finding an association [with stress generation] at [just] 3 months with the presence of insomnia disorder is quite interesting.”
There were higher rates of insomnia in the sample than depression, Dr. Haynes said, but the analysis did not control for depression or take it into account.
“We know [from prior research] that stress clearly leads to insomnia. The big [takeaway] here is that insomnia can also lead to more stress,” she said. “It’s important to think of it as a reciprocal relationship. If we can potentially treat insomnia, we may be able to stop that cycle of other stressful events that affect both [the individuals] and others as well.”
Ms. Skobic had no disclosures.
FROM SLEEP 2020
Dr. Fauci: ‘About 40%-45% of infections are asymptomatic’
Anthony Fauci, MD, highlighting the latest COVID-19 developments on Friday, said, “It is now clear that about 40%-45% of infections are asymptomatic.”
Asymptomatic carriers can account for a large proportion — up to 50% — of virus transmissions, Fauci, director of the National Institute of Allergy and Infectious Diseases, told a virtual crowd of critical care clinicians gathered by the Society of Critical Care Medicine.
Such transmissions have made response strategies, such as contact tracing, extremely difficult, he said.
Lew Kaplan, MD, president of SCCM, told Medscape Medical News after the presentation: “That really supports the universal wearing of masks and the capstone message from that – you should protect one another.
“That kind of social responsibility that sits within the public health domain to me is as important as the vaccine candidates and the science behind the receptors. It underpins the necessary relationship and the interdependence of the medical community with the public,” Kaplan added.
Fauci’s plenary led the SCCM’s conference, “COVID-19: What’s Next/Preparing for the Second Wave,” running today and Saturday.
Why U.S. response lags behind Spain and Italy
“This virus has literally exploded upon the planet in a pandemic manner which is unparalleled to anything we’ve seen in the last 102 years since the pandemic of 1918,” Fauci said.
“Unfortunately, the United States has been hit harder than any other country in the world, with 6 million reported cases.”
He explained that in the European Union countries the disease spiked early on and returned to a low baseline. “Unfortunately for them,” Fauci said, “as they’re trying to open up their economy, it’s coming back up.”
The United States, he explained, plateaued at about 20,000 cases a day, then a surge of cases in Florida, California, Texas, and Arizona brought the cases to 70,000 a day. Now cases have returned to 35,000-40,000 a day.
The difference in the trajectory of the response, he said, is that, compared with Spain and Italy for example, the United States has not shut down mobility in parks, outdoor spaces, and grocery stores nearly as much as some European countries did.
He pointed to numerous clusters of cases, spread from social or work gatherings, including the well-known Skagit County Washington state choir practice in March, in which a symptomatic choir member infected 87% of the 61 people rehearsing.
Vaccine by end of the year
As for a vaccine timeline, Fauci told SCCM members, “We project that by the end of this year, namely November/December, we will know if we have a safe and effective vaccine and we are cautiously optimistic that we will be successful, based on promising data in the animal model as well as good immunological data that we see from the phase 1 and phase 2 trials.”
However, also on Friday, Fauci told MSNBC’s Andrea Mitchell that a sense of normalcy is not likely before the middle of next year.
“By the time you mobilize the distribution of the vaccinations, and you get the majority, or more, of the population vaccinated and protected, that’s likely not going to happen [until] the mid- or end of 2021,” he said.
According to the Centers for Disease Control and Prevention (CDC) case tracker, as of Thursday, COVID-19 had resulted in more than 190,000 deaths overall and more than 256,000 new cases in the United States in the past 7 days.
Fauci has warned that the next few months will be critical in the virus’ trajectory, with the double onslaught of COVID-19 and the flu season.
On Thursday, Fauci said, “We need to hunker down and get through this fall and winter because it’s not going to be easy.”
Fauci remains a top trusted source in COVID-19 information, poll numbers show.
A Kaiser Family Foundation poll released Thursday found that 68% of US adults had a fair amount or a great deal of trust that Fauci would provide reliable information on COVID-19, just slightly more that the 67% who said they trust the CDC information. About half (53%) say they trust Deborah Birx, MD, the coordinator for the White House Coronavirus Task Force, as a reliable source of information.
The poll also found that 54% of Americans said they would not get a COVID-19 vaccine if one was approved by the US Food and Drug Administration before the November election and was made available and free to all who wanted it.
Kaplan and Fauci report no relevant financial relationships.
This article first appeared on Medscape.com.
Anthony Fauci, MD, highlighting the latest COVID-19 developments on Friday, said, “It is now clear that about 40%-45% of infections are asymptomatic.”
Asymptomatic carriers can account for a large proportion — up to 50% — of virus transmissions, Fauci, director of the National Institute of Allergy and Infectious Diseases, told a virtual crowd of critical care clinicians gathered by the Society of Critical Care Medicine.
Such transmissions have made response strategies, such as contact tracing, extremely difficult, he said.
Lew Kaplan, MD, president of SCCM, told Medscape Medical News after the presentation: “That really supports the universal wearing of masks and the capstone message from that – you should protect one another.
“That kind of social responsibility that sits within the public health domain to me is as important as the vaccine candidates and the science behind the receptors. It underpins the necessary relationship and the interdependence of the medical community with the public,” Kaplan added.
Fauci’s plenary led the SCCM’s conference, “COVID-19: What’s Next/Preparing for the Second Wave,” running today and Saturday.
Why U.S. response lags behind Spain and Italy
“This virus has literally exploded upon the planet in a pandemic manner which is unparalleled to anything we’ve seen in the last 102 years since the pandemic of 1918,” Fauci said.
“Unfortunately, the United States has been hit harder than any other country in the world, with 6 million reported cases.”
He explained that in the European Union countries the disease spiked early on and returned to a low baseline. “Unfortunately for them,” Fauci said, “as they’re trying to open up their economy, it’s coming back up.”
The United States, he explained, plateaued at about 20,000 cases a day, then a surge of cases in Florida, California, Texas, and Arizona brought the cases to 70,000 a day. Now cases have returned to 35,000-40,000 a day.
The difference in the trajectory of the response, he said, is that, compared with Spain and Italy for example, the United States has not shut down mobility in parks, outdoor spaces, and grocery stores nearly as much as some European countries did.
He pointed to numerous clusters of cases, spread from social or work gatherings, including the well-known Skagit County Washington state choir practice in March, in which a symptomatic choir member infected 87% of the 61 people rehearsing.
Vaccine by end of the year
As for a vaccine timeline, Fauci told SCCM members, “We project that by the end of this year, namely November/December, we will know if we have a safe and effective vaccine and we are cautiously optimistic that we will be successful, based on promising data in the animal model as well as good immunological data that we see from the phase 1 and phase 2 trials.”
However, also on Friday, Fauci told MSNBC’s Andrea Mitchell that a sense of normalcy is not likely before the middle of next year.
“By the time you mobilize the distribution of the vaccinations, and you get the majority, or more, of the population vaccinated and protected, that’s likely not going to happen [until] the mid- or end of 2021,” he said.
According to the Centers for Disease Control and Prevention (CDC) case tracker, as of Thursday, COVID-19 had resulted in more than 190,000 deaths overall and more than 256,000 new cases in the United States in the past 7 days.
Fauci has warned that the next few months will be critical in the virus’ trajectory, with the double onslaught of COVID-19 and the flu season.
On Thursday, Fauci said, “We need to hunker down and get through this fall and winter because it’s not going to be easy.”
Fauci remains a top trusted source in COVID-19 information, poll numbers show.
A Kaiser Family Foundation poll released Thursday found that 68% of US adults had a fair amount or a great deal of trust that Fauci would provide reliable information on COVID-19, just slightly more that the 67% who said they trust the CDC information. About half (53%) say they trust Deborah Birx, MD, the coordinator for the White House Coronavirus Task Force, as a reliable source of information.
The poll also found that 54% of Americans said they would not get a COVID-19 vaccine if one was approved by the US Food and Drug Administration before the November election and was made available and free to all who wanted it.
Kaplan and Fauci report no relevant financial relationships.
This article first appeared on Medscape.com.
Anthony Fauci, MD, highlighting the latest COVID-19 developments on Friday, said, “It is now clear that about 40%-45% of infections are asymptomatic.”
Asymptomatic carriers can account for a large proportion — up to 50% — of virus transmissions, Fauci, director of the National Institute of Allergy and Infectious Diseases, told a virtual crowd of critical care clinicians gathered by the Society of Critical Care Medicine.
Such transmissions have made response strategies, such as contact tracing, extremely difficult, he said.
Lew Kaplan, MD, president of SCCM, told Medscape Medical News after the presentation: “That really supports the universal wearing of masks and the capstone message from that – you should protect one another.
“That kind of social responsibility that sits within the public health domain to me is as important as the vaccine candidates and the science behind the receptors. It underpins the necessary relationship and the interdependence of the medical community with the public,” Kaplan added.
Fauci’s plenary led the SCCM’s conference, “COVID-19: What’s Next/Preparing for the Second Wave,” running today and Saturday.
Why U.S. response lags behind Spain and Italy
“This virus has literally exploded upon the planet in a pandemic manner which is unparalleled to anything we’ve seen in the last 102 years since the pandemic of 1918,” Fauci said.
“Unfortunately, the United States has been hit harder than any other country in the world, with 6 million reported cases.”
He explained that in the European Union countries the disease spiked early on and returned to a low baseline. “Unfortunately for them,” Fauci said, “as they’re trying to open up their economy, it’s coming back up.”
The United States, he explained, plateaued at about 20,000 cases a day, then a surge of cases in Florida, California, Texas, and Arizona brought the cases to 70,000 a day. Now cases have returned to 35,000-40,000 a day.
The difference in the trajectory of the response, he said, is that, compared with Spain and Italy for example, the United States has not shut down mobility in parks, outdoor spaces, and grocery stores nearly as much as some European countries did.
He pointed to numerous clusters of cases, spread from social or work gatherings, including the well-known Skagit County Washington state choir practice in March, in which a symptomatic choir member infected 87% of the 61 people rehearsing.
Vaccine by end of the year
As for a vaccine timeline, Fauci told SCCM members, “We project that by the end of this year, namely November/December, we will know if we have a safe and effective vaccine and we are cautiously optimistic that we will be successful, based on promising data in the animal model as well as good immunological data that we see from the phase 1 and phase 2 trials.”
However, also on Friday, Fauci told MSNBC’s Andrea Mitchell that a sense of normalcy is not likely before the middle of next year.
“By the time you mobilize the distribution of the vaccinations, and you get the majority, or more, of the population vaccinated and protected, that’s likely not going to happen [until] the mid- or end of 2021,” he said.
According to the Centers for Disease Control and Prevention (CDC) case tracker, as of Thursday, COVID-19 had resulted in more than 190,000 deaths overall and more than 256,000 new cases in the United States in the past 7 days.
Fauci has warned that the next few months will be critical in the virus’ trajectory, with the double onslaught of COVID-19 and the flu season.
On Thursday, Fauci said, “We need to hunker down and get through this fall and winter because it’s not going to be easy.”
Fauci remains a top trusted source in COVID-19 information, poll numbers show.
A Kaiser Family Foundation poll released Thursday found that 68% of US adults had a fair amount or a great deal of trust that Fauci would provide reliable information on COVID-19, just slightly more that the 67% who said they trust the CDC information. About half (53%) say they trust Deborah Birx, MD, the coordinator for the White House Coronavirus Task Force, as a reliable source of information.
The poll also found that 54% of Americans said they would not get a COVID-19 vaccine if one was approved by the US Food and Drug Administration before the November election and was made available and free to all who wanted it.
Kaplan and Fauci report no relevant financial relationships.
This article first appeared on Medscape.com.