MDedge Neurology

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy.

Xywav is a novel oxybate product with a unique composition of cations, resulting in 92% less sodium than sodium oxybate (Xyrem, Jazz Pharmaceuticals) at the recommended dosage range of 6 to 9 grams, the company said in a news release.

The FDA approved the drug based on a phase 3 trial involving 201 patients who had narcolepsy with cataplexy.

As reported by Medscape Medical News from the World Sleep 2019 meeting, Xywav demonstrated highly statistically significant differences (P < .0001) in weekly number of cataplexy attacks (primary efficacy endpoint) and Epworth Sleepiness Scale scores (key secondary outcome) vs placebo.

“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy,” lead investigator Richard K. Bogan, MD, said in the company’s news release.

He noted that the average American consumes too much sodium. “Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease,” said Dr. Bogan, associate clinical professor at the University of South Carolina School of Medicine, Columbia.

“Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association,” he added.

The overall safety profile of Xywav is in line with sodium oxybate, the company said. The most common adverse reactions in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis (excessive sweating), anxiety, and vomiting.

Xywav has a boxed warning as a CNS depressant and for its potential for abuse and misuse. As a result, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

The US Drug Enforcement Agency has designated Xywav as a schedule III drug, meaning it has a moderate to low potential for physical and psychological dependence.

The company plans to launch Xywav by the end of the year. Full prescribing information and a medication guide are available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy.

Xywav is a novel oxybate product with a unique composition of cations, resulting in 92% less sodium than sodium oxybate (Xyrem, Jazz Pharmaceuticals) at the recommended dosage range of 6 to 9 grams, the company said in a news release.

The FDA approved the drug based on a phase 3 trial involving 201 patients who had narcolepsy with cataplexy.

As reported by Medscape Medical News from the World Sleep 2019 meeting, Xywav demonstrated highly statistically significant differences (P < .0001) in weekly number of cataplexy attacks (primary efficacy endpoint) and Epworth Sleepiness Scale scores (key secondary outcome) vs placebo.

“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy,” lead investigator Richard K. Bogan, MD, said in the company’s news release.

He noted that the average American consumes too much sodium. “Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease,” said Dr. Bogan, associate clinical professor at the University of South Carolina School of Medicine, Columbia.

“Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association,” he added.

The overall safety profile of Xywav is in line with sodium oxybate, the company said. The most common adverse reactions in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis (excessive sweating), anxiety, and vomiting.

Xywav has a boxed warning as a CNS depressant and for its potential for abuse and misuse. As a result, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

The US Drug Enforcement Agency has designated Xywav as a schedule III drug, meaning it has a moderate to low potential for physical and psychological dependence.

The company plans to launch Xywav by the end of the year. Full prescribing information and a medication guide are available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy.

Xywav is a novel oxybate product with a unique composition of cations, resulting in 92% less sodium than sodium oxybate (Xyrem, Jazz Pharmaceuticals) at the recommended dosage range of 6 to 9 grams, the company said in a news release.

The FDA approved the drug based on a phase 3 trial involving 201 patients who had narcolepsy with cataplexy.

As reported by Medscape Medical News from the World Sleep 2019 meeting, Xywav demonstrated highly statistically significant differences (P < .0001) in weekly number of cataplexy attacks (primary efficacy endpoint) and Epworth Sleepiness Scale scores (key secondary outcome) vs placebo.

“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy,” lead investigator Richard K. Bogan, MD, said in the company’s news release.

He noted that the average American consumes too much sodium. “Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease,” said Dr. Bogan, associate clinical professor at the University of South Carolina School of Medicine, Columbia.

“Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association,” he added.

The overall safety profile of Xywav is in line with sodium oxybate, the company said. The most common adverse reactions in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis (excessive sweating), anxiety, and vomiting.

Xywav has a boxed warning as a CNS depressant and for its potential for abuse and misuse. As a result, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

The US Drug Enforcement Agency has designated Xywav as a schedule III drug, meaning it has a moderate to low potential for physical and psychological dependence.

The company plans to launch Xywav by the end of the year. Full prescribing information and a medication guide are available online.

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

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].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

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].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

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].

The benefits of continuous positive airway pressure therapy for patients with obstructive sleep apnea are well documented, but it only works if patients can adhere to the therapy.

A large national study of older Medicare patients with obstructive sleep apnea (OSA) has identified lower socioeconomic status and comorbidities as independent risk factors for nonadherence to continuous positive airway pressure (CPAP) therapy.

“[The] present results represent the largest study to date of rates and predictors of CPAP adherence among older adults in the United States. In our national sample of Medicare beneficiaries, adherence rates were generally lower than previously reported in smaller, clinic-based studies,” Emerson M. Wickwire, PhD, of the Sleep Disorders Center and division of pulmonary and critical care medicine at the University of Maryland, Baltimore, and colleagues wrote in Sleep.

Dr. Wickwire and colleagues estimated CPAP machine adherence using a 5% sample of Medicare claims data, identifying 3,229 Medicare beneficiaries with OSA who began CPAP therapy between 2009 and 2011. Individuals in the sample were aged at least 65 years with a new diagnosis of OSA, 88.1% of beneficiaries were white, and 52.3% were male.

The researchers applied objective adherence criteria set by the Centers for Medicare & Medicaid Services, which defines CPAP adherence as a patient using CPAP for at least 4 hours on 70% of nights, or CPAP use for 21 of 30 consecutive days within 90 days after beginning therapy.

Using CPAP machine charges as a measure of who adhered to therapy, they found 1,420 of 3,229 individuals (44%) achieved adherence under these criteria, which included making 13 monthly payments during their CPAP machine’s “rent-to-own” period. Partial adherence was found in 997 individuals (30.9%) who made between 4-12 payments on their CPAP machine, while 812 individuals (25.2%) made 4 payments or fewer on their CPAP machines, which the researchers classified as nonadherence. Nonadherers tended to be slightly younger (mean, 72.5 years vs. 79.2 years; P < .001) and had a higher number of comorbidities (35.2% vs. 30.4%; P = .002), compared with individuals with high adherence. Anxiety (odds ratio, 1.34; 95% confidence interval, 1.12-1.61), anemia (OR, 1.16; 95% CI, 1.02-1.32), fibromyalgia (OR, 1.19; 95% CI, 1.03-1.38), traumatic brain injury (OR, 1.58; 95% CI, 1.21-2.07), and Medicaid eligibility (OR, 1.48; 95% CI, 1.24-1.75) were all independently associated with lower CPAP adherence. Medicaid eligibility was considered an indicator of lower socioeconomic status.

Krishna M. Sundar, MD, FCCP, director at the Sleep-Wake Center in the University of Utah pulmonary division in Salt Lake City and CHEST Physician editorial board member, said in an interview that studies have shown early signs of adherence within the first few weeks are an important indicator of overall adherence to CPAP therapy. However, the use of CPAP machine payments in the study by Dr. Wickwire and colleagues was a novel way to track adherence.

Some of the issues with nonadherence may be related to challenges in using the technology, but it is the clinician’s role to communicate with patients about the effectiveness of CPAP and identifying reasons for nonadherence while also attempting to tease out the subtle socioeconomic factors related to nonadherence, Dr. Sundar noted. “We need to alter our practice to make sure that we communicate with these patients and better understand what are the social factors in getting the CPAP or utilizing CPAP, and also following these patients more closely, especially in the first month of starting CPAP therapy.

“Just because somebody has severe sleep apnea and other comorbid conditions does not mean that they’re going to wear the CPAP,” he said. “So, the fact that socioeconomic factors play an equal if not more important role in terms of predicting CPAP adherence. That is an important takeaway.”

Octavian C. Ioachimescu, MD, FCCP, of Emory University, Atlanta, and the Atlanta Veteran Affairs Administration and CHEST Physician editorial board member, said in an interview that the study raises a major question of what is next. “What can we offer to these patients, and what is the real-world compliance to that ‘next-best’ modality?” Dr. Ioachimescu said. “What are the outcomes of these individuals in the point-of-care environment, or ‘real world?’ ”

The analysis by the authors adds the perspective of a “real-world depiction of clinical care for patients with OSA,” Dr. Ioachimescu said. “One major lesson of such an analysis is that the health care goal setting that is referential to initial, randomized, well-controlled studies on highly selected patient populations need to be reassessed periodically from the point of view of actual results in the clinics.”

Clinicians may need to borrow ideas from other therapeutic fields to help improve patient adherence, he said. “[W]e may be able to develop and implement in the future peer involvement, behavioral and cognitive approaches, motivational enhancement interventions, as well as elements of acceptance and commitment techniques, all in the larger context of more integrated and in the same time individualized approaches to therapy.”

The investigators concluded that, “relative to Medicare-only beneficiaries, those eligible for both Medicare and Medicaid were significantly less likely to adhere to CPAP. Future research should seek to develop a deeper understanding of the mechanisms through which [socioeconomic status] and other social determinants impact patient experience throughout the OSA diagnostic and treatment process, including receiving, acclimating, and adhering to CPAP therapy.”

Dr. Sundar concurred with this assessment and said more research is needed on factors impacting adherence such as poverty, homelessness, and home support systems. “It’s not just coordinating with the patient. Clearly, more work is needed in understanding the social aspects of CPAP adherence.”

This study was funded in part by an investigator-initiated grant provided by ResMed to Dr. Wickmire’s institution, the University of Maryland, Baltimore. Dr. Wickmire reported being a scientific consultant to DayZz, Eisai, Merck, and Purdue and holds shares in WellTap. Dr. Oldstone is a ResMed employee and shareholder. Dr. Sundar reported being a cofounder of Hypnoscure, which creates software for population management of sleep apnea, and an investigator in trials where ResMed and Respironics devices were used. Dr. Ioachimescu reported no relevant financial disclosures.

SOURCE: Wickwire EM et al. Sleep. 2020 Jun 23. doi: 10.1093/sleep/zsaa122.

The benefits of continuous positive airway pressure therapy for patients with obstructive sleep apnea are well documented, but it only works if patients can adhere to the therapy.

A large national study of older Medicare patients with obstructive sleep apnea (OSA) has identified lower socioeconomic status and comorbidities as independent risk factors for nonadherence to continuous positive airway pressure (CPAP) therapy.

“[The] present results represent the largest study to date of rates and predictors of CPAP adherence among older adults in the United States. In our national sample of Medicare beneficiaries, adherence rates were generally lower than previously reported in smaller, clinic-based studies,” Emerson M. Wickwire, PhD, of the Sleep Disorders Center and division of pulmonary and critical care medicine at the University of Maryland, Baltimore, and colleagues wrote in Sleep.

Dr. Wickwire and colleagues estimated CPAP machine adherence using a 5% sample of Medicare claims data, identifying 3,229 Medicare beneficiaries with OSA who began CPAP therapy between 2009 and 2011. Individuals in the sample were aged at least 65 years with a new diagnosis of OSA, 88.1% of beneficiaries were white, and 52.3% were male.

The researchers applied objective adherence criteria set by the Centers for Medicare & Medicaid Services, which defines CPAP adherence as a patient using CPAP for at least 4 hours on 70% of nights, or CPAP use for 21 of 30 consecutive days within 90 days after beginning therapy.

Using CPAP machine charges as a measure of who adhered to therapy, they found 1,420 of 3,229 individuals (44%) achieved adherence under these criteria, which included making 13 monthly payments during their CPAP machine’s “rent-to-own” period. Partial adherence was found in 997 individuals (30.9%) who made between 4-12 payments on their CPAP machine, while 812 individuals (25.2%) made 4 payments or fewer on their CPAP machines, which the researchers classified as nonadherence. Nonadherers tended to be slightly younger (mean, 72.5 years vs. 79.2 years; P < .001) and had a higher number of comorbidities (35.2% vs. 30.4%; P = .002), compared with individuals with high adherence. Anxiety (odds ratio, 1.34; 95% confidence interval, 1.12-1.61), anemia (OR, 1.16; 95% CI, 1.02-1.32), fibromyalgia (OR, 1.19; 95% CI, 1.03-1.38), traumatic brain injury (OR, 1.58; 95% CI, 1.21-2.07), and Medicaid eligibility (OR, 1.48; 95% CI, 1.24-1.75) were all independently associated with lower CPAP adherence. Medicaid eligibility was considered an indicator of lower socioeconomic status.

Krishna M. Sundar, MD, FCCP, director at the Sleep-Wake Center in the University of Utah pulmonary division in Salt Lake City and CHEST Physician editorial board member, said in an interview that studies have shown early signs of adherence within the first few weeks are an important indicator of overall adherence to CPAP therapy. However, the use of CPAP machine payments in the study by Dr. Wickwire and colleagues was a novel way to track adherence.

Some of the issues with nonadherence may be related to challenges in using the technology, but it is the clinician’s role to communicate with patients about the effectiveness of CPAP and identifying reasons for nonadherence while also attempting to tease out the subtle socioeconomic factors related to nonadherence, Dr. Sundar noted. “We need to alter our practice to make sure that we communicate with these patients and better understand what are the social factors in getting the CPAP or utilizing CPAP, and also following these patients more closely, especially in the first month of starting CPAP therapy.

“Just because somebody has severe sleep apnea and other comorbid conditions does not mean that they’re going to wear the CPAP,” he said. “So, the fact that socioeconomic factors play an equal if not more important role in terms of predicting CPAP adherence. That is an important takeaway.”

Octavian C. Ioachimescu, MD, FCCP, of Emory University, Atlanta, and the Atlanta Veteran Affairs Administration and CHEST Physician editorial board member, said in an interview that the study raises a major question of what is next. “What can we offer to these patients, and what is the real-world compliance to that ‘next-best’ modality?” Dr. Ioachimescu said. “What are the outcomes of these individuals in the point-of-care environment, or ‘real world?’ ”

The analysis by the authors adds the perspective of a “real-world depiction of clinical care for patients with OSA,” Dr. Ioachimescu said. “One major lesson of such an analysis is that the health care goal setting that is referential to initial, randomized, well-controlled studies on highly selected patient populations need to be reassessed periodically from the point of view of actual results in the clinics.”

Clinicians may need to borrow ideas from other therapeutic fields to help improve patient adherence, he said. “[W]e may be able to develop and implement in the future peer involvement, behavioral and cognitive approaches, motivational enhancement interventions, as well as elements of acceptance and commitment techniques, all in the larger context of more integrated and in the same time individualized approaches to therapy.”

The investigators concluded that, “relative to Medicare-only beneficiaries, those eligible for both Medicare and Medicaid were significantly less likely to adhere to CPAP. Future research should seek to develop a deeper understanding of the mechanisms through which [socioeconomic status] and other social determinants impact patient experience throughout the OSA diagnostic and treatment process, including receiving, acclimating, and adhering to CPAP therapy.”

Dr. Sundar concurred with this assessment and said more research is needed on factors impacting adherence such as poverty, homelessness, and home support systems. “It’s not just coordinating with the patient. Clearly, more work is needed in understanding the social aspects of CPAP adherence.”

This study was funded in part by an investigator-initiated grant provided by ResMed to Dr. Wickmire’s institution, the University of Maryland, Baltimore. Dr. Wickmire reported being a scientific consultant to DayZz, Eisai, Merck, and Purdue and holds shares in WellTap. Dr. Oldstone is a ResMed employee and shareholder. Dr. Sundar reported being a cofounder of Hypnoscure, which creates software for population management of sleep apnea, and an investigator in trials where ResMed and Respironics devices were used. Dr. Ioachimescu reported no relevant financial disclosures.

SOURCE: Wickwire EM et al. Sleep. 2020 Jun 23. doi: 10.1093/sleep/zsaa122.

The benefits of continuous positive airway pressure therapy for patients with obstructive sleep apnea are well documented, but it only works if patients can adhere to the therapy.

A large national study of older Medicare patients with obstructive sleep apnea (OSA) has identified lower socioeconomic status and comorbidities as independent risk factors for nonadherence to continuous positive airway pressure (CPAP) therapy.

“[The] present results represent the largest study to date of rates and predictors of CPAP adherence among older adults in the United States. In our national sample of Medicare beneficiaries, adherence rates were generally lower than previously reported in smaller, clinic-based studies,” Emerson M. Wickwire, PhD, of the Sleep Disorders Center and division of pulmonary and critical care medicine at the University of Maryland, Baltimore, and colleagues wrote in Sleep.

Dr. Wickwire and colleagues estimated CPAP machine adherence using a 5% sample of Medicare claims data, identifying 3,229 Medicare beneficiaries with OSA who began CPAP therapy between 2009 and 2011. Individuals in the sample were aged at least 65 years with a new diagnosis of OSA, 88.1% of beneficiaries were white, and 52.3% were male.

The researchers applied objective adherence criteria set by the Centers for Medicare & Medicaid Services, which defines CPAP adherence as a patient using CPAP for at least 4 hours on 70% of nights, or CPAP use for 21 of 30 consecutive days within 90 days after beginning therapy.

Using CPAP machine charges as a measure of who adhered to therapy, they found 1,420 of 3,229 individuals (44%) achieved adherence under these criteria, which included making 13 monthly payments during their CPAP machine’s “rent-to-own” period. Partial adherence was found in 997 individuals (30.9%) who made between 4-12 payments on their CPAP machine, while 812 individuals (25.2%) made 4 payments or fewer on their CPAP machines, which the researchers classified as nonadherence. Nonadherers tended to be slightly younger (mean, 72.5 years vs. 79.2 years; P < .001) and had a higher number of comorbidities (35.2% vs. 30.4%; P = .002), compared with individuals with high adherence. Anxiety (odds ratio, 1.34; 95% confidence interval, 1.12-1.61), anemia (OR, 1.16; 95% CI, 1.02-1.32), fibromyalgia (OR, 1.19; 95% CI, 1.03-1.38), traumatic brain injury (OR, 1.58; 95% CI, 1.21-2.07), and Medicaid eligibility (OR, 1.48; 95% CI, 1.24-1.75) were all independently associated with lower CPAP adherence. Medicaid eligibility was considered an indicator of lower socioeconomic status.

Krishna M. Sundar, MD, FCCP, director at the Sleep-Wake Center in the University of Utah pulmonary division in Salt Lake City and CHEST Physician editorial board member, said in an interview that studies have shown early signs of adherence within the first few weeks are an important indicator of overall adherence to CPAP therapy. However, the use of CPAP machine payments in the study by Dr. Wickwire and colleagues was a novel way to track adherence.

Some of the issues with nonadherence may be related to challenges in using the technology, but it is the clinician’s role to communicate with patients about the effectiveness of CPAP and identifying reasons for nonadherence while also attempting to tease out the subtle socioeconomic factors related to nonadherence, Dr. Sundar noted. “We need to alter our practice to make sure that we communicate with these patients and better understand what are the social factors in getting the CPAP or utilizing CPAP, and also following these patients more closely, especially in the first month of starting CPAP therapy.

“Just because somebody has severe sleep apnea and other comorbid conditions does not mean that they’re going to wear the CPAP,” he said. “So, the fact that socioeconomic factors play an equal if not more important role in terms of predicting CPAP adherence. That is an important takeaway.”

Octavian C. Ioachimescu, MD, FCCP, of Emory University, Atlanta, and the Atlanta Veteran Affairs Administration and CHEST Physician editorial board member, said in an interview that the study raises a major question of what is next. “What can we offer to these patients, and what is the real-world compliance to that ‘next-best’ modality?” Dr. Ioachimescu said. “What are the outcomes of these individuals in the point-of-care environment, or ‘real world?’ ”

The analysis by the authors adds the perspective of a “real-world depiction of clinical care for patients with OSA,” Dr. Ioachimescu said. “One major lesson of such an analysis is that the health care goal setting that is referential to initial, randomized, well-controlled studies on highly selected patient populations need to be reassessed periodically from the point of view of actual results in the clinics.”

Clinicians may need to borrow ideas from other therapeutic fields to help improve patient adherence, he said. “[W]e may be able to develop and implement in the future peer involvement, behavioral and cognitive approaches, motivational enhancement interventions, as well as elements of acceptance and commitment techniques, all in the larger context of more integrated and in the same time individualized approaches to therapy.”

The investigators concluded that, “relative to Medicare-only beneficiaries, those eligible for both Medicare and Medicaid were significantly less likely to adhere to CPAP. Future research should seek to develop a deeper understanding of the mechanisms through which [socioeconomic status] and other social determinants impact patient experience throughout the OSA diagnostic and treatment process, including receiving, acclimating, and adhering to CPAP therapy.”

Dr. Sundar concurred with this assessment and said more research is needed on factors impacting adherence such as poverty, homelessness, and home support systems. “It’s not just coordinating with the patient. Clearly, more work is needed in understanding the social aspects of CPAP adherence.”

This study was funded in part by an investigator-initiated grant provided by ResMed to Dr. Wickmire’s institution, the University of Maryland, Baltimore. Dr. Wickmire reported being a scientific consultant to DayZz, Eisai, Merck, and Purdue and holds shares in WellTap. Dr. Oldstone is a ResMed employee and shareholder. Dr. Sundar reported being a cofounder of Hypnoscure, which creates software for population management of sleep apnea, and an investigator in trials where ResMed and Respironics devices were used. Dr. Ioachimescu reported no relevant financial disclosures.

SOURCE: Wickwire EM et al. Sleep. 2020 Jun 23. doi: 10.1093/sleep/zsaa122.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.