MDedge Emergency Medicine

In the management of acute and chronic stroke, smartphone apps enhance communication between first responders and waiting hospital staff and reduce door-to-needle time, according to a literature review.

“In clinical practice, guideline-driven patient care is very important in improving diagnosis and outcomes, and apps provide a very practical and easy way to check available guidelines,” senior author Fabio Pilato, MD, a neurologist at Università Campus Bio-Medico, Rome, told this news organization.

The review was published  in the Journal of Stroke.
 

Reviewing the literature

“My colleagues and I wanted to discover whether smartphone apps, besides just facilitating communication between doctors and their patients, could improve patient care,” said Dr. Pilato. “We wanted to see if there were any apps that could guide clinical decisions according to guidelines and whether there were some being used in acute stroke management,” he added.

The investigators reviewed 43 studies of stroke-related mobile phone apps that were designed for the clinical management of stroke between June 1, 2007, when the first iPhone was introduced, and Jan. 31, 2022.

The apps were classified into the following three groups, according to their purpose: primary prevention apps, acute stroke management apps, and postacute stroke apps.
 

Prevention and management

The investigators found one primary prevention app, the Stroke Riskometer, that was based on an algorithm derived from the Framingham Stroke Risk Score and was designed to educate patients about diet, physical activity, and the warning signs of stroke. However, their review failed to show that the app was beneficial, compared with standard cardiovascular risk reduction.

Apps appeared to aid acute stroke management, according to the researchers. Prehospital apps, such as iLAMA, Smartphone-Assisted Pre-Hospital Medical Information System, FAST-ED, Egyptian Stroke Network, Act Fast, and the Mayo Clinic Acute Stroke Evaluation app were found to speed up stroke recognition, activate emergency medical services for speedier transport to the hospital, and facilitate communication with in-hospital stroke teams. All these prehospital apps reduced door-to-needle time.

The JOIN app also was shown to significantly reduce door-to-needle time, compared with no app support, in several studies. JOIN consists of a chat, a DICOM viewer, and an encrypted two-way video system for video calls between practitioners, as well as a milestones time stamp to record every step from home to hospital transportation to therapy onset. 

StopStroke, another app that focuses on instant communication among physicians and allows real-time sharing of clinical data of stroke patients, reduced door-to-image and door-to-needle time, compared with no app.

Act Fast, which uses a National Institutes of Health Stroke Scale (NIHSS) calculator, a thrombolysis checklist, and a toolbox to share images and notes among practitioners involved in the decision-making process, decreased door-to-needle time by 16 minutes, compared with no app.

In a study of medical residents, adherence to guidelines was higher in participants who used the Mayo Clinic Acute Stroke Evaluation app, compared with those who did not. Door-to-needle time also was reduced by 16 minutes in the app-assisted group, compared with controls.
 

Postacute stroke apps

The Rehabilitation Guardian app, consisting of a health reminder, consultation, health information, and patient diary, gives medical information and provides rehabilitation exercises. Patients can enter their clinical information, and the medical staff can access it and assist with the rehab process remotely.

As for apps for chronic management and secondary prevention, Dr. Pilato and colleagues found that the PRESTRO app, which combines motivational support for a healthy lifestyle and tells patients to take their medications and measure their blood pressure, successfully got patients to be more physically active, compared with those who did not use the app.

Another app for secondary prevention, the Korea University Health Monitoring System for Stroke (KUHMS2), reduced blood pressure and glucose levels in patients who used it, compared with those who did not.

Lose It, a weight loss app, is an electronic food journal that shows the values of the macronutrients of foods that the patient consumes, as well as a daily calorie count. The Engaging Everyday Activities app effectively reminds patients who have had transient ischemic attacks about daily activities that can reduce their risk for a recurrent attack.

Movies4Stroke features educational videos about first aid, rehabilitation, how to improve swallowing, and stroke risk factors.

AFib 2gether allows patients to enter their clinical data and calculates their annual stroke risk scores. The information is provided to a health care provider before the next visit to help the patient make an informed decision about anticoagulation therapy.

“We believe that the widespread use of smartphones and apps may improve patient care in every part of the world and in particular in those parts where updated guideline consultation is not readily available. However, in our study we found that apps to implement guidelines by a clinical decision support system are still lacking. Our hope is that these apps will increase in the future,” said Dr. Pilato.
 

No panacea

Commenting on this review for this article, Amy Guzik, MD, associate professor of neurology at Wake Forest University School of Medicine, Winston-Salem, N.C., said that all physicians are looking for opportunities to use technology, especially in stroke, to diagnose and treat patients in the best way they can.

“Figuring out ways to increase efficiency and get the word out to our patients is very important to us and is probably why there are so many apps out there,” said Dr. Guzik.

“There are some ways such apps could be particularly useful. One is in remote hospitals that might not have a neurologist. Helping with the diagnosis and determining what is a bad stroke that needs to go to a higher level of medical care, or whether it is something the local hospital could take care of, would be useful,” said Dr. Guzik.

“Also helping EMS figure out which hospital to go to, or once they are on their way, being able to talk to the neurologist or neurosurgeon or the emergency room doctor and make a plan before the patient gets here, so we can expedite care when the patient arrives, is where apps can be particularly useful,” she added.

There are limitations to what apps can do, however. In the case of stroke, patients may often have important barriers that do not allow them to use apps at all, she said.

“Regardless of how they are being taken care of, a lot of our stroke patients will have problems with technology. A stroke can make texting difficult. Patients may have language difficulties, weakness, or cognitive impairment. They are relying on caregivers. All of this makes it difficult for a tech solution to be the automatic solution, unless things are done in a thoughtful way to make sure that it is appropriate for stroke patients.

“Also, there are a lot of elderly patients who may not necessarily be the most tech savvy and do not have as much digital literacy as younger patients. Another limitation to consider is that some people may not even have easy access to technology. So we must make sure that this is all done with an equity focus,” said Dr. Guzik.

The study was funded by the Associazione Nazionale fra le Imprese Assicuratrici (ANIA). Dr. Pilato and Dr. Guzik reported no relevant financial relationships.

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

In the management of acute and chronic stroke, smartphone apps enhance communication between first responders and waiting hospital staff and reduce door-to-needle time, according to a literature review.

“In clinical practice, guideline-driven patient care is very important in improving diagnosis and outcomes, and apps provide a very practical and easy way to check available guidelines,” senior author Fabio Pilato, MD, a neurologist at Università Campus Bio-Medico, Rome, told this news organization.

The review was published  in the Journal of Stroke.
 

Reviewing the literature

“My colleagues and I wanted to discover whether smartphone apps, besides just facilitating communication between doctors and their patients, could improve patient care,” said Dr. Pilato. “We wanted to see if there were any apps that could guide clinical decisions according to guidelines and whether there were some being used in acute stroke management,” he added.

The investigators reviewed 43 studies of stroke-related mobile phone apps that were designed for the clinical management of stroke between June 1, 2007, when the first iPhone was introduced, and Jan. 31, 2022.

The apps were classified into the following three groups, according to their purpose: primary prevention apps, acute stroke management apps, and postacute stroke apps.
 

Prevention and management

The investigators found one primary prevention app, the Stroke Riskometer, that was based on an algorithm derived from the Framingham Stroke Risk Score and was designed to educate patients about diet, physical activity, and the warning signs of stroke. However, their review failed to show that the app was beneficial, compared with standard cardiovascular risk reduction.

Apps appeared to aid acute stroke management, according to the researchers. Prehospital apps, such as iLAMA, Smartphone-Assisted Pre-Hospital Medical Information System, FAST-ED, Egyptian Stroke Network, Act Fast, and the Mayo Clinic Acute Stroke Evaluation app were found to speed up stroke recognition, activate emergency medical services for speedier transport to the hospital, and facilitate communication with in-hospital stroke teams. All these prehospital apps reduced door-to-needle time.

The JOIN app also was shown to significantly reduce door-to-needle time, compared with no app support, in several studies. JOIN consists of a chat, a DICOM viewer, and an encrypted two-way video system for video calls between practitioners, as well as a milestones time stamp to record every step from home to hospital transportation to therapy onset. 

StopStroke, another app that focuses on instant communication among physicians and allows real-time sharing of clinical data of stroke patients, reduced door-to-image and door-to-needle time, compared with no app.

Act Fast, which uses a National Institutes of Health Stroke Scale (NIHSS) calculator, a thrombolysis checklist, and a toolbox to share images and notes among practitioners involved in the decision-making process, decreased door-to-needle time by 16 minutes, compared with no app.

In a study of medical residents, adherence to guidelines was higher in participants who used the Mayo Clinic Acute Stroke Evaluation app, compared with those who did not. Door-to-needle time also was reduced by 16 minutes in the app-assisted group, compared with controls.
 

Postacute stroke apps

The Rehabilitation Guardian app, consisting of a health reminder, consultation, health information, and patient diary, gives medical information and provides rehabilitation exercises. Patients can enter their clinical information, and the medical staff can access it and assist with the rehab process remotely.

As for apps for chronic management and secondary prevention, Dr. Pilato and colleagues found that the PRESTRO app, which combines motivational support for a healthy lifestyle and tells patients to take their medications and measure their blood pressure, successfully got patients to be more physically active, compared with those who did not use the app.

Another app for secondary prevention, the Korea University Health Monitoring System for Stroke (KUHMS2), reduced blood pressure and glucose levels in patients who used it, compared with those who did not.

Lose It, a weight loss app, is an electronic food journal that shows the values of the macronutrients of foods that the patient consumes, as well as a daily calorie count. The Engaging Everyday Activities app effectively reminds patients who have had transient ischemic attacks about daily activities that can reduce their risk for a recurrent attack.

Movies4Stroke features educational videos about first aid, rehabilitation, how to improve swallowing, and stroke risk factors.

AFib 2gether allows patients to enter their clinical data and calculates their annual stroke risk scores. The information is provided to a health care provider before the next visit to help the patient make an informed decision about anticoagulation therapy.

“We believe that the widespread use of smartphones and apps may improve patient care in every part of the world and in particular in those parts where updated guideline consultation is not readily available. However, in our study we found that apps to implement guidelines by a clinical decision support system are still lacking. Our hope is that these apps will increase in the future,” said Dr. Pilato.
 

No panacea

Commenting on this review for this article, Amy Guzik, MD, associate professor of neurology at Wake Forest University School of Medicine, Winston-Salem, N.C., said that all physicians are looking for opportunities to use technology, especially in stroke, to diagnose and treat patients in the best way they can.

“Figuring out ways to increase efficiency and get the word out to our patients is very important to us and is probably why there are so many apps out there,” said Dr. Guzik.

“There are some ways such apps could be particularly useful. One is in remote hospitals that might not have a neurologist. Helping with the diagnosis and determining what is a bad stroke that needs to go to a higher level of medical care, or whether it is something the local hospital could take care of, would be useful,” said Dr. Guzik.

“Also helping EMS figure out which hospital to go to, or once they are on their way, being able to talk to the neurologist or neurosurgeon or the emergency room doctor and make a plan before the patient gets here, so we can expedite care when the patient arrives, is where apps can be particularly useful,” she added.

There are limitations to what apps can do, however. In the case of stroke, patients may often have important barriers that do not allow them to use apps at all, she said.

“Regardless of how they are being taken care of, a lot of our stroke patients will have problems with technology. A stroke can make texting difficult. Patients may have language difficulties, weakness, or cognitive impairment. They are relying on caregivers. All of this makes it difficult for a tech solution to be the automatic solution, unless things are done in a thoughtful way to make sure that it is appropriate for stroke patients.

“Also, there are a lot of elderly patients who may not necessarily be the most tech savvy and do not have as much digital literacy as younger patients. Another limitation to consider is that some people may not even have easy access to technology. So we must make sure that this is all done with an equity focus,” said Dr. Guzik.

The study was funded by the Associazione Nazionale fra le Imprese Assicuratrici (ANIA). Dr. Pilato and Dr. Guzik reported no relevant financial relationships.

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

In the management of acute and chronic stroke, smartphone apps enhance communication between first responders and waiting hospital staff and reduce door-to-needle time, according to a literature review.

“In clinical practice, guideline-driven patient care is very important in improving diagnosis and outcomes, and apps provide a very practical and easy way to check available guidelines,” senior author Fabio Pilato, MD, a neurologist at Università Campus Bio-Medico, Rome, told this news organization.

The review was published  in the Journal of Stroke.
 

Reviewing the literature

“My colleagues and I wanted to discover whether smartphone apps, besides just facilitating communication between doctors and their patients, could improve patient care,” said Dr. Pilato. “We wanted to see if there were any apps that could guide clinical decisions according to guidelines and whether there were some being used in acute stroke management,” he added.

The investigators reviewed 43 studies of stroke-related mobile phone apps that were designed for the clinical management of stroke between June 1, 2007, when the first iPhone was introduced, and Jan. 31, 2022.

The apps were classified into the following three groups, according to their purpose: primary prevention apps, acute stroke management apps, and postacute stroke apps.
 

Prevention and management

The investigators found one primary prevention app, the Stroke Riskometer, that was based on an algorithm derived from the Framingham Stroke Risk Score and was designed to educate patients about diet, physical activity, and the warning signs of stroke. However, their review failed to show that the app was beneficial, compared with standard cardiovascular risk reduction.

Apps appeared to aid acute stroke management, according to the researchers. Prehospital apps, such as iLAMA, Smartphone-Assisted Pre-Hospital Medical Information System, FAST-ED, Egyptian Stroke Network, Act Fast, and the Mayo Clinic Acute Stroke Evaluation app were found to speed up stroke recognition, activate emergency medical services for speedier transport to the hospital, and facilitate communication with in-hospital stroke teams. All these prehospital apps reduced door-to-needle time.

The JOIN app also was shown to significantly reduce door-to-needle time, compared with no app support, in several studies. JOIN consists of a chat, a DICOM viewer, and an encrypted two-way video system for video calls between practitioners, as well as a milestones time stamp to record every step from home to hospital transportation to therapy onset. 

StopStroke, another app that focuses on instant communication among physicians and allows real-time sharing of clinical data of stroke patients, reduced door-to-image and door-to-needle time, compared with no app.

Act Fast, which uses a National Institutes of Health Stroke Scale (NIHSS) calculator, a thrombolysis checklist, and a toolbox to share images and notes among practitioners involved in the decision-making process, decreased door-to-needle time by 16 minutes, compared with no app.

In a study of medical residents, adherence to guidelines was higher in participants who used the Mayo Clinic Acute Stroke Evaluation app, compared with those who did not. Door-to-needle time also was reduced by 16 minutes in the app-assisted group, compared with controls.
 

Postacute stroke apps

The Rehabilitation Guardian app, consisting of a health reminder, consultation, health information, and patient diary, gives medical information and provides rehabilitation exercises. Patients can enter their clinical information, and the medical staff can access it and assist with the rehab process remotely.

As for apps for chronic management and secondary prevention, Dr. Pilato and colleagues found that the PRESTRO app, which combines motivational support for a healthy lifestyle and tells patients to take their medications and measure their blood pressure, successfully got patients to be more physically active, compared with those who did not use the app.

Another app for secondary prevention, the Korea University Health Monitoring System for Stroke (KUHMS2), reduced blood pressure and glucose levels in patients who used it, compared with those who did not.

Lose It, a weight loss app, is an electronic food journal that shows the values of the macronutrients of foods that the patient consumes, as well as a daily calorie count. The Engaging Everyday Activities app effectively reminds patients who have had transient ischemic attacks about daily activities that can reduce their risk for a recurrent attack.

Movies4Stroke features educational videos about first aid, rehabilitation, how to improve swallowing, and stroke risk factors.

AFib 2gether allows patients to enter their clinical data and calculates their annual stroke risk scores. The information is provided to a health care provider before the next visit to help the patient make an informed decision about anticoagulation therapy.

“We believe that the widespread use of smartphones and apps may improve patient care in every part of the world and in particular in those parts where updated guideline consultation is not readily available. However, in our study we found that apps to implement guidelines by a clinical decision support system are still lacking. Our hope is that these apps will increase in the future,” said Dr. Pilato.
 

No panacea

Commenting on this review for this article, Amy Guzik, MD, associate professor of neurology at Wake Forest University School of Medicine, Winston-Salem, N.C., said that all physicians are looking for opportunities to use technology, especially in stroke, to diagnose and treat patients in the best way they can.

“Figuring out ways to increase efficiency and get the word out to our patients is very important to us and is probably why there are so many apps out there,” said Dr. Guzik.

“There are some ways such apps could be particularly useful. One is in remote hospitals that might not have a neurologist. Helping with the diagnosis and determining what is a bad stroke that needs to go to a higher level of medical care, or whether it is something the local hospital could take care of, would be useful,” said Dr. Guzik.

“Also helping EMS figure out which hospital to go to, or once they are on their way, being able to talk to the neurologist or neurosurgeon or the emergency room doctor and make a plan before the patient gets here, so we can expedite care when the patient arrives, is where apps can be particularly useful,” she added.

There are limitations to what apps can do, however. In the case of stroke, patients may often have important barriers that do not allow them to use apps at all, she said.

“Regardless of how they are being taken care of, a lot of our stroke patients will have problems with technology. A stroke can make texting difficult. Patients may have language difficulties, weakness, or cognitive impairment. They are relying on caregivers. All of this makes it difficult for a tech solution to be the automatic solution, unless things are done in a thoughtful way to make sure that it is appropriate for stroke patients.

“Also, there are a lot of elderly patients who may not necessarily be the most tech savvy and do not have as much digital literacy as younger patients. Another limitation to consider is that some people may not even have easy access to technology. So we must make sure that this is all done with an equity focus,” said Dr. Guzik.

The study was funded by the Associazione Nazionale fra le Imprese Assicuratrici (ANIA). Dr. Pilato and Dr. Guzik reported no relevant financial relationships.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

An international group representing leading endocrinology associations has recommended that the name “diabetes insipidus” – which in some cases has led to harm – be changed to eliminate confusion with “diabetes mellitus” and to reflect the former condition’s pathophysiology.

The new proposed names are arginine vasopressin deficiency (AVP-D) for central (also called “cranial”) etiologies and arginine vasopressin resistance (AVP-R) for nephrogenic (kidney) etiologies.

“What we’re proposing is to rename the disease according to the pathophysiology that defines it,” statement co-author Joseph G. Verbalis, MD, professor of medicine and chief of endocrinology and metabolism at Georgetown University Medical Center, Washington, told this news organization.

The statement advises that henceforth the new names be used in manuscripts and the medical literature while keeping the old names in parentheses during a transition period, as in “AVP-deficiency (cranial diabetes insipidus)” and “AVP-resistance (nephrogenic diabetes insipidus).”

The condition formerly known as diabetes insipidus is relatively rare, occurring in about 1 person per 10-15,000 population. It is caused by either deficient production or resistance in the kidney to the hormone AVP, normally produced by the hypothalamus and stored in the pituitary gland. AVP, also called antidiuretic hormone, regulates the body’s water level and urine production by the kidney.

Both etiologies lead to extreme thirst and excessive production of urine. Common causes of the deficiency include head trauma or brain tumor, while resistance in the kidney is often congenital. It is currently treated with a synthetic form of AVP called desmopressin and fluid replacement.
 

What’s in a name?

The proposal to change the name by the Working Group for Renaming Diabetes Insipidus is endorsed by The Endocrine Society, European Society of Endocrinology, Pituitary Society, Society for Endocrinology, European Society for Paediatric Endocrinology, Endocrine Society of Australia, Brazilian Endocrine Society, and Japanese Endocrine Society and is under review by several other societies. It was published as a position statement in several of those society’s journals, with more to follow.

Historically, the word “diabetes,” a Greek word meaning “siphon,” was used in the 1st and 2nd century BC to describe excess flow of urine. The Latin word “mellitus” or “honey” was added in the late 17th century to describe the sweetness of the urine in the dysglycemic condition.

A century later, the Latin word “insipidus,” meaning insipid or tasteless, was coined to distinguish between the two types of polyuria, the position statement details.

In the late 19th to early 20th century, the vasopressor and antidiuretic actions of posterior pituitary extracts were discovered and used to treat people with both the central and nephrogenic etiologies, which were also recognized around that time, yet the name “diabetes insipidus” has persisted.

“From a historical perspective, the name is perfectly appropriate. At the time it was identified, and it was realized that it was different from diabetes mellitus, that was a perfectly appropriate terminology based on what was known in the late 19th century – but not now. It has persisted through the years simply because in medicine there’s a lot of inertia for change ... It’s just always been called that. If there’s not a compelling reason to change a name, generally there’s no move to change it,” Dr. Verbalis observed.  
 

‘Dramatic cases of patient mismanagement’ due to name confusion

Unfortunately, the urgency for the change arose from tragedy. In 2009, a 22-year-old man was admitted to the orthopedics department of a London teaching hospital for a hip replacement. Despite his known panhypopituitarism and diabetes insipidus, the nurses continually checked his blood glucose but didn’t give him desmopressin or sufficient fluids. Laboratory testing showed normal glucose, but his serum sodium was 149 mmol/L. The morning after his operation, he had a fatal cardiac arrest with a serum sodium of 169 mmol/L. 

“The nurses thought he had diabetes mellitus ... So that was death due to failure to recognize that diabetes insipidus is not diabetes mellitus,” Dr. Verbalis said. “If he had been admitted to endocrinology, this wouldn’t have happened. But he was admitted to orthopedics. Non-endocrinologists are not so aware of diabetes insipidus, because it is a rare disease.”

In 2016, National Health Service England issued a patient safety alert about the “risk of severe harm or death when desmopressin is omitted or delayed in patients with cranial diabetes insipidus,” citing at least four incidents within the prior 7 years where omission of desmopressin had resulted in severe dehydration and death, with another 76 cases of omission or delay that were acted on before the patients became critically ill.

Further impetus for the name change came from the results of an anonymous web-based survey of 1,034 adult and pediatric patients with central diabetes insipidus conducted between August 2021 and February 2022. Overall, 80% reported encountering situations in which their condition had been confused with diabetes mellitus by health care professionals, and 85% supported renaming the disease.

There was some divergence in opinion as to what the new name(s) should be, but clear agreement that the term “diabetes” should not be part of it.  

“We’ve only become recently aware that there are dramatic cases of patient mismanagement due to the confusion caused by the word ‘diabetes.’ We think patients should have a voice. If a legitimate patient survey says over 80% think this name should be changed, then I think we as endocrinologists need to pay attention to that,” Dr. Verbalis said.

But while endocrinologists are the ones who see these patients the most often, Dr. Verbalis said a main aim of the position statement “is really to change the mindset of non-endocrinologist doctors and nurses and other health care professionals that this is not diabetes mellitus. It’s a totally different disease. And if we give it a totally different name, then I think they will better recognize that.”

As to how long Dr. Verbalis thinks it will take for the new names to catch on, he pointed out that it’s taken about a decade for the rheumatology field to fully adopt the name “granulomatosis with polyangiitis” as a replacement for “Wegener’s granulomatosis” after the eponymous physician’s Nazi ties were revealed.

“So we’re not anticipating that this is going to change terminology tomorrow. It’s a long process. We just wanted to get the process started,” he said.

Dr. Verbalis has reported consulting for Otsuka.

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

An international group representing leading endocrinology associations has recommended that the name “diabetes insipidus” – which in some cases has led to harm – be changed to eliminate confusion with “diabetes mellitus” and to reflect the former condition’s pathophysiology.

The new proposed names are arginine vasopressin deficiency (AVP-D) for central (also called “cranial”) etiologies and arginine vasopressin resistance (AVP-R) for nephrogenic (kidney) etiologies.

“What we’re proposing is to rename the disease according to the pathophysiology that defines it,” statement co-author Joseph G. Verbalis, MD, professor of medicine and chief of endocrinology and metabolism at Georgetown University Medical Center, Washington, told this news organization.

The statement advises that henceforth the new names be used in manuscripts and the medical literature while keeping the old names in parentheses during a transition period, as in “AVP-deficiency (cranial diabetes insipidus)” and “AVP-resistance (nephrogenic diabetes insipidus).”

The condition formerly known as diabetes insipidus is relatively rare, occurring in about 1 person per 10-15,000 population. It is caused by either deficient production or resistance in the kidney to the hormone AVP, normally produced by the hypothalamus and stored in the pituitary gland. AVP, also called antidiuretic hormone, regulates the body’s water level and urine production by the kidney.

Both etiologies lead to extreme thirst and excessive production of urine. Common causes of the deficiency include head trauma or brain tumor, while resistance in the kidney is often congenital. It is currently treated with a synthetic form of AVP called desmopressin and fluid replacement.
 

What’s in a name?

The proposal to change the name by the Working Group for Renaming Diabetes Insipidus is endorsed by The Endocrine Society, European Society of Endocrinology, Pituitary Society, Society for Endocrinology, European Society for Paediatric Endocrinology, Endocrine Society of Australia, Brazilian Endocrine Society, and Japanese Endocrine Society and is under review by several other societies. It was published as a position statement in several of those society’s journals, with more to follow.

Historically, the word “diabetes,” a Greek word meaning “siphon,” was used in the 1st and 2nd century BC to describe excess flow of urine. The Latin word “mellitus” or “honey” was added in the late 17th century to describe the sweetness of the urine in the dysglycemic condition.

A century later, the Latin word “insipidus,” meaning insipid or tasteless, was coined to distinguish between the two types of polyuria, the position statement details.

In the late 19th to early 20th century, the vasopressor and antidiuretic actions of posterior pituitary extracts were discovered and used to treat people with both the central and nephrogenic etiologies, which were also recognized around that time, yet the name “diabetes insipidus” has persisted.

“From a historical perspective, the name is perfectly appropriate. At the time it was identified, and it was realized that it was different from diabetes mellitus, that was a perfectly appropriate terminology based on what was known in the late 19th century – but not now. It has persisted through the years simply because in medicine there’s a lot of inertia for change ... It’s just always been called that. If there’s not a compelling reason to change a name, generally there’s no move to change it,” Dr. Verbalis observed.  
 

‘Dramatic cases of patient mismanagement’ due to name confusion

Unfortunately, the urgency for the change arose from tragedy. In 2009, a 22-year-old man was admitted to the orthopedics department of a London teaching hospital for a hip replacement. Despite his known panhypopituitarism and diabetes insipidus, the nurses continually checked his blood glucose but didn’t give him desmopressin or sufficient fluids. Laboratory testing showed normal glucose, but his serum sodium was 149 mmol/L. The morning after his operation, he had a fatal cardiac arrest with a serum sodium of 169 mmol/L. 

“The nurses thought he had diabetes mellitus ... So that was death due to failure to recognize that diabetes insipidus is not diabetes mellitus,” Dr. Verbalis said. “If he had been admitted to endocrinology, this wouldn’t have happened. But he was admitted to orthopedics. Non-endocrinologists are not so aware of diabetes insipidus, because it is a rare disease.”

In 2016, National Health Service England issued a patient safety alert about the “risk of severe harm or death when desmopressin is omitted or delayed in patients with cranial diabetes insipidus,” citing at least four incidents within the prior 7 years where omission of desmopressin had resulted in severe dehydration and death, with another 76 cases of omission or delay that were acted on before the patients became critically ill.

Further impetus for the name change came from the results of an anonymous web-based survey of 1,034 adult and pediatric patients with central diabetes insipidus conducted between August 2021 and February 2022. Overall, 80% reported encountering situations in which their condition had been confused with diabetes mellitus by health care professionals, and 85% supported renaming the disease.

There was some divergence in opinion as to what the new name(s) should be, but clear agreement that the term “diabetes” should not be part of it.  

“We’ve only become recently aware that there are dramatic cases of patient mismanagement due to the confusion caused by the word ‘diabetes.’ We think patients should have a voice. If a legitimate patient survey says over 80% think this name should be changed, then I think we as endocrinologists need to pay attention to that,” Dr. Verbalis said.

But while endocrinologists are the ones who see these patients the most often, Dr. Verbalis said a main aim of the position statement “is really to change the mindset of non-endocrinologist doctors and nurses and other health care professionals that this is not diabetes mellitus. It’s a totally different disease. And if we give it a totally different name, then I think they will better recognize that.”

As to how long Dr. Verbalis thinks it will take for the new names to catch on, he pointed out that it’s taken about a decade for the rheumatology field to fully adopt the name “granulomatosis with polyangiitis” as a replacement for “Wegener’s granulomatosis” after the eponymous physician’s Nazi ties were revealed.

“So we’re not anticipating that this is going to change terminology tomorrow. It’s a long process. We just wanted to get the process started,” he said.

Dr. Verbalis has reported consulting for Otsuka.

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

An international group representing leading endocrinology associations has recommended that the name “diabetes insipidus” – which in some cases has led to harm – be changed to eliminate confusion with “diabetes mellitus” and to reflect the former condition’s pathophysiology.

The new proposed names are arginine vasopressin deficiency (AVP-D) for central (also called “cranial”) etiologies and arginine vasopressin resistance (AVP-R) for nephrogenic (kidney) etiologies.

“What we’re proposing is to rename the disease according to the pathophysiology that defines it,” statement co-author Joseph G. Verbalis, MD, professor of medicine and chief of endocrinology and metabolism at Georgetown University Medical Center, Washington, told this news organization.

The statement advises that henceforth the new names be used in manuscripts and the medical literature while keeping the old names in parentheses during a transition period, as in “AVP-deficiency (cranial diabetes insipidus)” and “AVP-resistance (nephrogenic diabetes insipidus).”

The condition formerly known as diabetes insipidus is relatively rare, occurring in about 1 person per 10-15,000 population. It is caused by either deficient production or resistance in the kidney to the hormone AVP, normally produced by the hypothalamus and stored in the pituitary gland. AVP, also called antidiuretic hormone, regulates the body’s water level and urine production by the kidney.

Both etiologies lead to extreme thirst and excessive production of urine. Common causes of the deficiency include head trauma or brain tumor, while resistance in the kidney is often congenital. It is currently treated with a synthetic form of AVP called desmopressin and fluid replacement.
 

What’s in a name?

The proposal to change the name by the Working Group for Renaming Diabetes Insipidus is endorsed by The Endocrine Society, European Society of Endocrinology, Pituitary Society, Society for Endocrinology, European Society for Paediatric Endocrinology, Endocrine Society of Australia, Brazilian Endocrine Society, and Japanese Endocrine Society and is under review by several other societies. It was published as a position statement in several of those society’s journals, with more to follow.

Historically, the word “diabetes,” a Greek word meaning “siphon,” was used in the 1st and 2nd century BC to describe excess flow of urine. The Latin word “mellitus” or “honey” was added in the late 17th century to describe the sweetness of the urine in the dysglycemic condition.

A century later, the Latin word “insipidus,” meaning insipid or tasteless, was coined to distinguish between the two types of polyuria, the position statement details.

In the late 19th to early 20th century, the vasopressor and antidiuretic actions of posterior pituitary extracts were discovered and used to treat people with both the central and nephrogenic etiologies, which were also recognized around that time, yet the name “diabetes insipidus” has persisted.

“From a historical perspective, the name is perfectly appropriate. At the time it was identified, and it was realized that it was different from diabetes mellitus, that was a perfectly appropriate terminology based on what was known in the late 19th century – but not now. It has persisted through the years simply because in medicine there’s a lot of inertia for change ... It’s just always been called that. If there’s not a compelling reason to change a name, generally there’s no move to change it,” Dr. Verbalis observed.  
 

‘Dramatic cases of patient mismanagement’ due to name confusion

Unfortunately, the urgency for the change arose from tragedy. In 2009, a 22-year-old man was admitted to the orthopedics department of a London teaching hospital for a hip replacement. Despite his known panhypopituitarism and diabetes insipidus, the nurses continually checked his blood glucose but didn’t give him desmopressin or sufficient fluids. Laboratory testing showed normal glucose, but his serum sodium was 149 mmol/L. The morning after his operation, he had a fatal cardiac arrest with a serum sodium of 169 mmol/L. 

“The nurses thought he had diabetes mellitus ... So that was death due to failure to recognize that diabetes insipidus is not diabetes mellitus,” Dr. Verbalis said. “If he had been admitted to endocrinology, this wouldn’t have happened. But he was admitted to orthopedics. Non-endocrinologists are not so aware of diabetes insipidus, because it is a rare disease.”

In 2016, National Health Service England issued a patient safety alert about the “risk of severe harm or death when desmopressin is omitted or delayed in patients with cranial diabetes insipidus,” citing at least four incidents within the prior 7 years where omission of desmopressin had resulted in severe dehydration and death, with another 76 cases of omission or delay that were acted on before the patients became critically ill.

Further impetus for the name change came from the results of an anonymous web-based survey of 1,034 adult and pediatric patients with central diabetes insipidus conducted between August 2021 and February 2022. Overall, 80% reported encountering situations in which their condition had been confused with diabetes mellitus by health care professionals, and 85% supported renaming the disease.

There was some divergence in opinion as to what the new name(s) should be, but clear agreement that the term “diabetes” should not be part of it.  

“We’ve only become recently aware that there are dramatic cases of patient mismanagement due to the confusion caused by the word ‘diabetes.’ We think patients should have a voice. If a legitimate patient survey says over 80% think this name should be changed, then I think we as endocrinologists need to pay attention to that,” Dr. Verbalis said.

But while endocrinologists are the ones who see these patients the most often, Dr. Verbalis said a main aim of the position statement “is really to change the mindset of non-endocrinologist doctors and nurses and other health care professionals that this is not diabetes mellitus. It’s a totally different disease. And if we give it a totally different name, then I think they will better recognize that.”

As to how long Dr. Verbalis thinks it will take for the new names to catch on, he pointed out that it’s taken about a decade for the rheumatology field to fully adopt the name “granulomatosis with polyangiitis” as a replacement for “Wegener’s granulomatosis” after the eponymous physician’s Nazi ties were revealed.

“So we’re not anticipating that this is going to change terminology tomorrow. It’s a long process. We just wanted to get the process started,” he said.

Dr. Verbalis has reported consulting for Otsuka.

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

Florida is seeing a spike in deadly infections caused by the “flesh-eating” bacteria Vibrio vulnificus following Hurricane Ian. 

At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release. 

Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said. 

“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”

Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.

“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement.  “Individuals with wound infections should also seek care promptly.”

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

Florida is seeing a spike in deadly infections caused by the “flesh-eating” bacteria Vibrio vulnificus following Hurricane Ian. 

At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release. 

Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said. 

“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”

Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.

“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement.  “Individuals with wound infections should also seek care promptly.”

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

Florida is seeing a spike in deadly infections caused by the “flesh-eating” bacteria Vibrio vulnificus following Hurricane Ian. 

At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release. 

Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said. 

“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”

Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.

“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement.  “Individuals with wound infections should also seek care promptly.”

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

A pregnant patient who had COVID-19 showed up at a hospital with respiratory difficulty caused by her illness. Physicians had to perform an emergency delivery of her near-term baby.

The infant survived, but the woman lost oxygen during the ordeal and suffered hypoxic brain damage. She is now suing an obstetrician, a pulmonologist, and an intensive care unit physician for medical malpractice.

The plaintiff contends there was a failure “to adequately recognize and treat her condition,” said Peter Kolbert, senior vice president for claim and litigation services for Healthcare Risk Advisors, part of TDC Group, which includes national medical liability insurer The Doctors Company.

“The physicians involved vehemently disagree and believe they treated her appropriately,” Mr. Kolbert said. “In fact, we believe their actions were heroic.”

In another case, a patient with COVID-19 and multiple comorbidities was admitted to a hospital. Physicians sedated and intubated the patient to maintain her airway. She recovered, but the patient now alleges doctors were negligent because she developed ulcers during her hospital stay. The case occurred during the height of the pandemic. In addition to the hospital, a pulmonologist, an ICU physician, and an acute care physician are named in the suit.

Both of these lawsuits are being defined as COVID claims because at the time, the plaintiffs either had COVID and needed care because of COVID, or because the care that physicians provided was affected by COVID in some way.

In the second case, the patient had COVID and needed treatment. During her recovery, ulcers developed. A significant aspect of this case is that it occurred during the height of the pandemic. Hospitals were overcrowded, the staff was swamped, and resources were limited. One factor may be that physicians were doing the best they could at the time but that the pandemic affected the extent of care they could provide.

Physicians have long worried about the legal consequences of COVID-19 and whether lawsuits might arise from the care that was provided or that was delayed by the pandemic. Now, new data reflect the grim news: COVID claims have arrived. These cases from the claims database of The Doctors Company are just two examples of many COVID-related claims that have been levied since the pandemic started.

Currently, there are 162 open COVID-related claims in The Doctors Company database, according to Mr. Kolbert. A September 2022 benchmark report from Aon and the American Society for Health Care Risk Management indicates that 245 claims that pertain to patients with confirmed or suspected COVID-19 have been filed since the pandemic began. The findings in this report stem from an analysis of 95,600 hospital and physician liability claims that occurred between 2012 and 2021.

Of the 245 cases, 89 claims have been closed. The average cost was $43,000 per claim, said Kanika Vats, a director and actuary for Aon, a global firm that provides risk, reinsurance, and health solutions. Six of the claims cost $300,000 or more; the highest settlement was for $700,000.

“Most of the allegations in these claims revolve around delay in treatment or delay in diagnosis,” Ms. Vats said.
 

Which specialties are involved in legal actions?

Physicians working in acute care settings such as emergency departments and urgent care centers are the primary targets in COVID-related lawsuits involving doctors, say legal analysts. However, other specialties are also being affected. Physicians being sued include some who practiced telemedicine during the pandemic.

In one case, a primary care physician saw a patient via telemedicine because the physical medical office was closed. The patient was evaluated virtually and was sent for bloodwork and an x-ray.

The patient is now suing the primary care physician, alleging that failure to immediately send her to a hospital resulted in tuberculosis going untreated and that the failure led to a bad outcome. The allegation is that the physician underevaluated the case during the telemedicine visit, Mr. Kolbert said.

Drew Graham, an attorney at Hall Booth Smith PC, which is based in New York, said that most of the COVID-related liability claims he has seen involve facilities that provide postacute care, such as nursing homes and assisted living facilities. His firm has also seen a small number of COVID-related claims against physicians.

At least two of the claims involved allegations of improper treatment of COVID during hospitalizations, he said. Another involved a telehealth visit in which the patient claimed the virtual care that was provided was improper and that their condition required an in-person examination. Mr. Graham declined to specify the specialties of the physicians sued.

The Medical Professional Liability Association reports similar trends in COVID-related claims. Long-term facilities and hospitals are the most common focus of COVID-19 claims, followed by emergency medicine, primary care, and ob/gyn medical specialties, according to Kwon Miller, manager of data and analytics for MPL Association, a national trade association for medical liability insurers that operates a large claims database.

Between January 2020 and June 2022, the MPL Association Data Sharing Project recorded 280 COVID-19 events. “Events” refers to notifications, licensing board inquiries, and claims involving COVID. Of these events, 180 were closed with no indemnity payment, and 13 were closed with an average indemnity payment of $3,816, Mr. Miller said.

Complaints of delayed care associated with the pandemic are also on the rise. For example, one patient is suing a gastroenterologist for delaying his colonoscopy, alleging the postponement led to a delayed colon cancer diagnosis and worse prognosis, Mr. Kolbert said.

“It was delayed because all elective procedures at the time were being put off,” he said. “The patient claims that had they received the scheduled screening, the cancer would have been diagnosed at stage I as opposed to stage III.”
 

Why isn’t federal immunity shielding physicians?

A pressing question about the growing number of COVID claims is why state and federal immunity isn’t preventing such lawsuits.

In 2020, the U.S. Department of Health & Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19. The act allows an exception for negligence claims associated with death or serious injury caused by willful misconduct.

At the same time, most states implemented laws or executive orders shielding physicians from liability claims related to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proven.

Mr. Graham said some COVID-related claims against physicians have included allegations of gross negligence to avoid the application of state immunity, while others combine allegations of deviations from standard of care unrelated to the pandemic.

Some plaintiffs are attempting to skirt the protections by making complaints sound as if they’re not related to COVID-19, Mr. Kolbert said. That way, they don’t have to prove gross negligence or willful misconduct at all.

“The filings at first blush may not tell you it’s a COVID case, but it may be a COVID case,” he said. “Plaintiffs’ attorneys are trying to assert that COVID defenses do not apply and that these cases are ‘traditional physician negligence’ claims. They’re trying to plead around the protections.”

The federal and state immunities are likely keeping the volume of COVID claims down overall and are discouraging some complaints from moving forward, attorneys say.

But because some plaintiffs are downplaying or ignoring the COVID association, it’s likely that more COVID lawsuits exist than anyone realizes, according to Mr. Kolbert.

“I expect there’s an underestimation of how many COVID claims are really out there,” he said.
 

What does the future hold for COVID claims?

Currently, the frequency and the severity of COVID claims are low, Ms. Vats said. She believes the cost of such claims will continue to remain at low levels.

“But again, there is a lot of uncertainty,” she said. “This year, states have started to roll back their immunity protections, and in a lot of states, there is no cap in awarding [noneconomic] damages. There could well be a scenario where they allege wrongful death, and in a state with no cap on the pain and suffering component, if juries continue to behave the way they have been behaving, we could see aberration verdicts.”

Another lingering issue concerns which court systems have jurisdiction in cases involving COVID-related claims. Because of the nationwide response to the pandemic, Mr. Graham thinks it makes sense that federal courts handle the cases, but the plaintiffs’ bar has generally been opposed to federal jurisdiction.

“A second issue is the long-term impact of COVID litigation on our providers,” he said. “If the protections in place to limit liability are determined to be ineffective, our state and federal leaders must act aggressively and in a bipartisan way to make sure our health care providers are protected when we face the next crisis.”

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

A pregnant patient who had COVID-19 showed up at a hospital with respiratory difficulty caused by her illness. Physicians had to perform an emergency delivery of her near-term baby.

The infant survived, but the woman lost oxygen during the ordeal and suffered hypoxic brain damage. She is now suing an obstetrician, a pulmonologist, and an intensive care unit physician for medical malpractice.

The plaintiff contends there was a failure “to adequately recognize and treat her condition,” said Peter Kolbert, senior vice president for claim and litigation services for Healthcare Risk Advisors, part of TDC Group, which includes national medical liability insurer The Doctors Company.

“The physicians involved vehemently disagree and believe they treated her appropriately,” Mr. Kolbert said. “In fact, we believe their actions were heroic.”

In another case, a patient with COVID-19 and multiple comorbidities was admitted to a hospital. Physicians sedated and intubated the patient to maintain her airway. She recovered, but the patient now alleges doctors were negligent because she developed ulcers during her hospital stay. The case occurred during the height of the pandemic. In addition to the hospital, a pulmonologist, an ICU physician, and an acute care physician are named in the suit.

Both of these lawsuits are being defined as COVID claims because at the time, the plaintiffs either had COVID and needed care because of COVID, or because the care that physicians provided was affected by COVID in some way.

In the second case, the patient had COVID and needed treatment. During her recovery, ulcers developed. A significant aspect of this case is that it occurred during the height of the pandemic. Hospitals were overcrowded, the staff was swamped, and resources were limited. One factor may be that physicians were doing the best they could at the time but that the pandemic affected the extent of care they could provide.

Physicians have long worried about the legal consequences of COVID-19 and whether lawsuits might arise from the care that was provided or that was delayed by the pandemic. Now, new data reflect the grim news: COVID claims have arrived. These cases from the claims database of The Doctors Company are just two examples of many COVID-related claims that have been levied since the pandemic started.

Currently, there are 162 open COVID-related claims in The Doctors Company database, according to Mr. Kolbert. A September 2022 benchmark report from Aon and the American Society for Health Care Risk Management indicates that 245 claims that pertain to patients with confirmed or suspected COVID-19 have been filed since the pandemic began. The findings in this report stem from an analysis of 95,600 hospital and physician liability claims that occurred between 2012 and 2021.

Of the 245 cases, 89 claims have been closed. The average cost was $43,000 per claim, said Kanika Vats, a director and actuary for Aon, a global firm that provides risk, reinsurance, and health solutions. Six of the claims cost $300,000 or more; the highest settlement was for $700,000.

“Most of the allegations in these claims revolve around delay in treatment or delay in diagnosis,” Ms. Vats said.
 

Which specialties are involved in legal actions?

Physicians working in acute care settings such as emergency departments and urgent care centers are the primary targets in COVID-related lawsuits involving doctors, say legal analysts. However, other specialties are also being affected. Physicians being sued include some who practiced telemedicine during the pandemic.

In one case, a primary care physician saw a patient via telemedicine because the physical medical office was closed. The patient was evaluated virtually and was sent for bloodwork and an x-ray.

The patient is now suing the primary care physician, alleging that failure to immediately send her to a hospital resulted in tuberculosis going untreated and that the failure led to a bad outcome. The allegation is that the physician underevaluated the case during the telemedicine visit, Mr. Kolbert said.

Drew Graham, an attorney at Hall Booth Smith PC, which is based in New York, said that most of the COVID-related liability claims he has seen involve facilities that provide postacute care, such as nursing homes and assisted living facilities. His firm has also seen a small number of COVID-related claims against physicians.

At least two of the claims involved allegations of improper treatment of COVID during hospitalizations, he said. Another involved a telehealth visit in which the patient claimed the virtual care that was provided was improper and that their condition required an in-person examination. Mr. Graham declined to specify the specialties of the physicians sued.

The Medical Professional Liability Association reports similar trends in COVID-related claims. Long-term facilities and hospitals are the most common focus of COVID-19 claims, followed by emergency medicine, primary care, and ob/gyn medical specialties, according to Kwon Miller, manager of data and analytics for MPL Association, a national trade association for medical liability insurers that operates a large claims database.

Between January 2020 and June 2022, the MPL Association Data Sharing Project recorded 280 COVID-19 events. “Events” refers to notifications, licensing board inquiries, and claims involving COVID. Of these events, 180 were closed with no indemnity payment, and 13 were closed with an average indemnity payment of $3,816, Mr. Miller said.

Complaints of delayed care associated with the pandemic are also on the rise. For example, one patient is suing a gastroenterologist for delaying his colonoscopy, alleging the postponement led to a delayed colon cancer diagnosis and worse prognosis, Mr. Kolbert said.

“It was delayed because all elective procedures at the time were being put off,” he said. “The patient claims that had they received the scheduled screening, the cancer would have been diagnosed at stage I as opposed to stage III.”
 

Why isn’t federal immunity shielding physicians?

A pressing question about the growing number of COVID claims is why state and federal immunity isn’t preventing such lawsuits.

In 2020, the U.S. Department of Health & Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19. The act allows an exception for negligence claims associated with death or serious injury caused by willful misconduct.

At the same time, most states implemented laws or executive orders shielding physicians from liability claims related to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proven.

Mr. Graham said some COVID-related claims against physicians have included allegations of gross negligence to avoid the application of state immunity, while others combine allegations of deviations from standard of care unrelated to the pandemic.

Some plaintiffs are attempting to skirt the protections by making complaints sound as if they’re not related to COVID-19, Mr. Kolbert said. That way, they don’t have to prove gross negligence or willful misconduct at all.

“The filings at first blush may not tell you it’s a COVID case, but it may be a COVID case,” he said. “Plaintiffs’ attorneys are trying to assert that COVID defenses do not apply and that these cases are ‘traditional physician negligence’ claims. They’re trying to plead around the protections.”

The federal and state immunities are likely keeping the volume of COVID claims down overall and are discouraging some complaints from moving forward, attorneys say.

But because some plaintiffs are downplaying or ignoring the COVID association, it’s likely that more COVID lawsuits exist than anyone realizes, according to Mr. Kolbert.

“I expect there’s an underestimation of how many COVID claims are really out there,” he said.
 

What does the future hold for COVID claims?

Currently, the frequency and the severity of COVID claims are low, Ms. Vats said. She believes the cost of such claims will continue to remain at low levels.

“But again, there is a lot of uncertainty,” she said. “This year, states have started to roll back their immunity protections, and in a lot of states, there is no cap in awarding [noneconomic] damages. There could well be a scenario where they allege wrongful death, and in a state with no cap on the pain and suffering component, if juries continue to behave the way they have been behaving, we could see aberration verdicts.”

Another lingering issue concerns which court systems have jurisdiction in cases involving COVID-related claims. Because of the nationwide response to the pandemic, Mr. Graham thinks it makes sense that federal courts handle the cases, but the plaintiffs’ bar has generally been opposed to federal jurisdiction.

“A second issue is the long-term impact of COVID litigation on our providers,” he said. “If the protections in place to limit liability are determined to be ineffective, our state and federal leaders must act aggressively and in a bipartisan way to make sure our health care providers are protected when we face the next crisis.”

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

A pregnant patient who had COVID-19 showed up at a hospital with respiratory difficulty caused by her illness. Physicians had to perform an emergency delivery of her near-term baby.

The infant survived, but the woman lost oxygen during the ordeal and suffered hypoxic brain damage. She is now suing an obstetrician, a pulmonologist, and an intensive care unit physician for medical malpractice.

The plaintiff contends there was a failure “to adequately recognize and treat her condition,” said Peter Kolbert, senior vice president for claim and litigation services for Healthcare Risk Advisors, part of TDC Group, which includes national medical liability insurer The Doctors Company.

“The physicians involved vehemently disagree and believe they treated her appropriately,” Mr. Kolbert said. “In fact, we believe their actions were heroic.”

In another case, a patient with COVID-19 and multiple comorbidities was admitted to a hospital. Physicians sedated and intubated the patient to maintain her airway. She recovered, but the patient now alleges doctors were negligent because she developed ulcers during her hospital stay. The case occurred during the height of the pandemic. In addition to the hospital, a pulmonologist, an ICU physician, and an acute care physician are named in the suit.

Both of these lawsuits are being defined as COVID claims because at the time, the plaintiffs either had COVID and needed care because of COVID, or because the care that physicians provided was affected by COVID in some way.

In the second case, the patient had COVID and needed treatment. During her recovery, ulcers developed. A significant aspect of this case is that it occurred during the height of the pandemic. Hospitals were overcrowded, the staff was swamped, and resources were limited. One factor may be that physicians were doing the best they could at the time but that the pandemic affected the extent of care they could provide.

Physicians have long worried about the legal consequences of COVID-19 and whether lawsuits might arise from the care that was provided or that was delayed by the pandemic. Now, new data reflect the grim news: COVID claims have arrived. These cases from the claims database of The Doctors Company are just two examples of many COVID-related claims that have been levied since the pandemic started.

Currently, there are 162 open COVID-related claims in The Doctors Company database, according to Mr. Kolbert. A September 2022 benchmark report from Aon and the American Society for Health Care Risk Management indicates that 245 claims that pertain to patients with confirmed or suspected COVID-19 have been filed since the pandemic began. The findings in this report stem from an analysis of 95,600 hospital and physician liability claims that occurred between 2012 and 2021.

Of the 245 cases, 89 claims have been closed. The average cost was $43,000 per claim, said Kanika Vats, a director and actuary for Aon, a global firm that provides risk, reinsurance, and health solutions. Six of the claims cost $300,000 or more; the highest settlement was for $700,000.

“Most of the allegations in these claims revolve around delay in treatment or delay in diagnosis,” Ms. Vats said.
 

Which specialties are involved in legal actions?

Physicians working in acute care settings such as emergency departments and urgent care centers are the primary targets in COVID-related lawsuits involving doctors, say legal analysts. However, other specialties are also being affected. Physicians being sued include some who practiced telemedicine during the pandemic.

In one case, a primary care physician saw a patient via telemedicine because the physical medical office was closed. The patient was evaluated virtually and was sent for bloodwork and an x-ray.

The patient is now suing the primary care physician, alleging that failure to immediately send her to a hospital resulted in tuberculosis going untreated and that the failure led to a bad outcome. The allegation is that the physician underevaluated the case during the telemedicine visit, Mr. Kolbert said.

Drew Graham, an attorney at Hall Booth Smith PC, which is based in New York, said that most of the COVID-related liability claims he has seen involve facilities that provide postacute care, such as nursing homes and assisted living facilities. His firm has also seen a small number of COVID-related claims against physicians.

At least two of the claims involved allegations of improper treatment of COVID during hospitalizations, he said. Another involved a telehealth visit in which the patient claimed the virtual care that was provided was improper and that their condition required an in-person examination. Mr. Graham declined to specify the specialties of the physicians sued.

The Medical Professional Liability Association reports similar trends in COVID-related claims. Long-term facilities and hospitals are the most common focus of COVID-19 claims, followed by emergency medicine, primary care, and ob/gyn medical specialties, according to Kwon Miller, manager of data and analytics for MPL Association, a national trade association for medical liability insurers that operates a large claims database.

Between January 2020 and June 2022, the MPL Association Data Sharing Project recorded 280 COVID-19 events. “Events” refers to notifications, licensing board inquiries, and claims involving COVID. Of these events, 180 were closed with no indemnity payment, and 13 were closed with an average indemnity payment of $3,816, Mr. Miller said.

Complaints of delayed care associated with the pandemic are also on the rise. For example, one patient is suing a gastroenterologist for delaying his colonoscopy, alleging the postponement led to a delayed colon cancer diagnosis and worse prognosis, Mr. Kolbert said.

“It was delayed because all elective procedures at the time were being put off,” he said. “The patient claims that had they received the scheduled screening, the cancer would have been diagnosed at stage I as opposed to stage III.”
 

Why isn’t federal immunity shielding physicians?

A pressing question about the growing number of COVID claims is why state and federal immunity isn’t preventing such lawsuits.

In 2020, the U.S. Department of Health & Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19. The act allows an exception for negligence claims associated with death or serious injury caused by willful misconduct.

At the same time, most states implemented laws or executive orders shielding physicians from liability claims related to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proven.

Mr. Graham said some COVID-related claims against physicians have included allegations of gross negligence to avoid the application of state immunity, while others combine allegations of deviations from standard of care unrelated to the pandemic.

Some plaintiffs are attempting to skirt the protections by making complaints sound as if they’re not related to COVID-19, Mr. Kolbert said. That way, they don’t have to prove gross negligence or willful misconduct at all.

“The filings at first blush may not tell you it’s a COVID case, but it may be a COVID case,” he said. “Plaintiffs’ attorneys are trying to assert that COVID defenses do not apply and that these cases are ‘traditional physician negligence’ claims. They’re trying to plead around the protections.”

The federal and state immunities are likely keeping the volume of COVID claims down overall and are discouraging some complaints from moving forward, attorneys say.

But because some plaintiffs are downplaying or ignoring the COVID association, it’s likely that more COVID lawsuits exist than anyone realizes, according to Mr. Kolbert.

“I expect there’s an underestimation of how many COVID claims are really out there,” he said.
 

What does the future hold for COVID claims?

Currently, the frequency and the severity of COVID claims are low, Ms. Vats said. She believes the cost of such claims will continue to remain at low levels.

“But again, there is a lot of uncertainty,” she said. “This year, states have started to roll back their immunity protections, and in a lot of states, there is no cap in awarding [noneconomic] damages. There could well be a scenario where they allege wrongful death, and in a state with no cap on the pain and suffering component, if juries continue to behave the way they have been behaving, we could see aberration verdicts.”

Another lingering issue concerns which court systems have jurisdiction in cases involving COVID-related claims. Because of the nationwide response to the pandemic, Mr. Graham thinks it makes sense that federal courts handle the cases, but the plaintiffs’ bar has generally been opposed to federal jurisdiction.

“A second issue is the long-term impact of COVID litigation on our providers,” he said. “If the protections in place to limit liability are determined to be ineffective, our state and federal leaders must act aggressively and in a bipartisan way to make sure our health care providers are protected when we face the next crisis.”

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

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

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

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

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

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

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

Visits to the emergency department for asthma increase more than a year before a failed inspection by the U.S. Department of Housing and Urban Development (HUD), according to a new study presented at the annual meeting of the American College of Emergency Physicians.

While links between asthma and low-quality housing prone to harboring allergens have been well-documented, the current study takes the extra step of looking at housing down to the level of individual land parcels and suggests that asthma hospital visits can be used to identify hazardous housing earlier.

“Emergency department visits for asthma provide a leading indicator that can be used by health departments or housing authorities to direct housing inspections and remediation of poor housing conditions, track improvements in housing quality, measure housing department performance, support resident grievances, and inform funding allocation decisions,” said the study’s lead researcher, Elizabeth Samuels, MD, who is assistant professor of epidemiology and emergency medicine at Brown University, Providence, R.I.

Researchers retrospectively looked at cases of children and adults in the Greater New Haven area of Connecticut seen at the Yale New Haven Hospital ED for asthma-related problems between March 2013 and August 2017. The region has the fifth-highest prevalence of asthma in the United States, the researchers point out, due to its air quality, pollens, and quality of its housing. More than half of residences were built before 1,940, compared with about 13% nationally. Patient addresses were matched with HUD inspection records.

The review encompassed 11,429 ED visits by 6,366 individuals; 54% were insured by Medicaid, and 42% were Black. Controlling for patient and neighborhood data, researchers found that increased asthma ED visits at the parcel level were associated with decreased HUD inspection scores to a highly significant degree (P < .001).

They also found that there was a relationship in terms of timing between asthma ED visits and inspection scores: asthma ED visits increased more than 1 year before a failed HUD inspection. They also found that asthma ED visits were not elevated at housing units that passed inspection. Using asthma ED visits to predict failed housing inspections produced a specificity rate of 92.3% in an adjusted model, Dr. Samuels noted.

“This approach represents a novel method of early identification of dangerous housing conditions, which could aid in the prevention of asthma-related morbidity and mortality,” Dr. Samuels said.

The investigators noted that, of the parcels with the top three incidence rates of asthma ED visits, “all of them have been closed or demolished.”

In addition to limiting exposure of patients with asthma to the allergens of mold, mice and rats, and cockroaches, improving poor-quality housing earlier could help asthma by reducing stress, she said.

“There is also an increasing evidence base that psychosocial stress increases the risk of asthma attacks, and it’s therefore possible that living in poor housing conditions – often highly stressful situations – drives exacerbation risk via this pathway,” she said. “Synergistic effects between these pathways are also possible or even likely.”

Neeta Thakur, MD, associate professor of medicine at the University of California, San Francisco, who researches asthma, said the findings could lead to a strategy for improving poor-quality housing more quickly. As it is, inspections are too infrequent, often prompted by resident complaints.

“Once the complaints get to a certain threshold, then there might be an inspection that happens, and if there is a periodic review of the buildings, they often happen few and far between,” she said. “We could actually use some of the information that we’re already getting from something like ED visits and see if there is a pattern.”

An important follow-up would be to see whether asthma outcomes improve after housing deficiencies are addressed and whether the predictive capacity of ED visits occurs in other places.

“Would you then see a decline in the ED visit rates from individuals living in those buildings?” Dr. Thakur said. “It’s important to find a leading indicator, but you want to be sure that that leading indicator is useful as something that can be intervened upon.”

Dr. Samuels and Dr. Thakur have reported no relevant financial relationships.

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

Visits to the emergency department for asthma increase more than a year before a failed inspection by the U.S. Department of Housing and Urban Development (HUD), according to a new study presented at the annual meeting of the American College of Emergency Physicians.

While links between asthma and low-quality housing prone to harboring allergens have been well-documented, the current study takes the extra step of looking at housing down to the level of individual land parcels and suggests that asthma hospital visits can be used to identify hazardous housing earlier.

“Emergency department visits for asthma provide a leading indicator that can be used by health departments or housing authorities to direct housing inspections and remediation of poor housing conditions, track improvements in housing quality, measure housing department performance, support resident grievances, and inform funding allocation decisions,” said the study’s lead researcher, Elizabeth Samuels, MD, who is assistant professor of epidemiology and emergency medicine at Brown University, Providence, R.I.

Researchers retrospectively looked at cases of children and adults in the Greater New Haven area of Connecticut seen at the Yale New Haven Hospital ED for asthma-related problems between March 2013 and August 2017. The region has the fifth-highest prevalence of asthma in the United States, the researchers point out, due to its air quality, pollens, and quality of its housing. More than half of residences were built before 1,940, compared with about 13% nationally. Patient addresses were matched with HUD inspection records.

The review encompassed 11,429 ED visits by 6,366 individuals; 54% were insured by Medicaid, and 42% were Black. Controlling for patient and neighborhood data, researchers found that increased asthma ED visits at the parcel level were associated with decreased HUD inspection scores to a highly significant degree (P < .001).

They also found that there was a relationship in terms of timing between asthma ED visits and inspection scores: asthma ED visits increased more than 1 year before a failed HUD inspection. They also found that asthma ED visits were not elevated at housing units that passed inspection. Using asthma ED visits to predict failed housing inspections produced a specificity rate of 92.3% in an adjusted model, Dr. Samuels noted.

“This approach represents a novel method of early identification of dangerous housing conditions, which could aid in the prevention of asthma-related morbidity and mortality,” Dr. Samuels said.

The investigators noted that, of the parcels with the top three incidence rates of asthma ED visits, “all of them have been closed or demolished.”

In addition to limiting exposure of patients with asthma to the allergens of mold, mice and rats, and cockroaches, improving poor-quality housing earlier could help asthma by reducing stress, she said.

“There is also an increasing evidence base that psychosocial stress increases the risk of asthma attacks, and it’s therefore possible that living in poor housing conditions – often highly stressful situations – drives exacerbation risk via this pathway,” she said. “Synergistic effects between these pathways are also possible or even likely.”

Neeta Thakur, MD, associate professor of medicine at the University of California, San Francisco, who researches asthma, said the findings could lead to a strategy for improving poor-quality housing more quickly. As it is, inspections are too infrequent, often prompted by resident complaints.

“Once the complaints get to a certain threshold, then there might be an inspection that happens, and if there is a periodic review of the buildings, they often happen few and far between,” she said. “We could actually use some of the information that we’re already getting from something like ED visits and see if there is a pattern.”

An important follow-up would be to see whether asthma outcomes improve after housing deficiencies are addressed and whether the predictive capacity of ED visits occurs in other places.

“Would you then see a decline in the ED visit rates from individuals living in those buildings?” Dr. Thakur said. “It’s important to find a leading indicator, but you want to be sure that that leading indicator is useful as something that can be intervened upon.”

Dr. Samuels and Dr. Thakur have reported no relevant financial relationships.

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

Visits to the emergency department for asthma increase more than a year before a failed inspection by the U.S. Department of Housing and Urban Development (HUD), according to a new study presented at the annual meeting of the American College of Emergency Physicians.

While links between asthma and low-quality housing prone to harboring allergens have been well-documented, the current study takes the extra step of looking at housing down to the level of individual land parcels and suggests that asthma hospital visits can be used to identify hazardous housing earlier.

“Emergency department visits for asthma provide a leading indicator that can be used by health departments or housing authorities to direct housing inspections and remediation of poor housing conditions, track improvements in housing quality, measure housing department performance, support resident grievances, and inform funding allocation decisions,” said the study’s lead researcher, Elizabeth Samuels, MD, who is assistant professor of epidemiology and emergency medicine at Brown University, Providence, R.I.

Researchers retrospectively looked at cases of children and adults in the Greater New Haven area of Connecticut seen at the Yale New Haven Hospital ED for asthma-related problems between March 2013 and August 2017. The region has the fifth-highest prevalence of asthma in the United States, the researchers point out, due to its air quality, pollens, and quality of its housing. More than half of residences were built before 1,940, compared with about 13% nationally. Patient addresses were matched with HUD inspection records.

The review encompassed 11,429 ED visits by 6,366 individuals; 54% were insured by Medicaid, and 42% were Black. Controlling for patient and neighborhood data, researchers found that increased asthma ED visits at the parcel level were associated with decreased HUD inspection scores to a highly significant degree (P < .001).

They also found that there was a relationship in terms of timing between asthma ED visits and inspection scores: asthma ED visits increased more than 1 year before a failed HUD inspection. They also found that asthma ED visits were not elevated at housing units that passed inspection. Using asthma ED visits to predict failed housing inspections produced a specificity rate of 92.3% in an adjusted model, Dr. Samuels noted.

“This approach represents a novel method of early identification of dangerous housing conditions, which could aid in the prevention of asthma-related morbidity and mortality,” Dr. Samuels said.

The investigators noted that, of the parcels with the top three incidence rates of asthma ED visits, “all of them have been closed or demolished.”

In addition to limiting exposure of patients with asthma to the allergens of mold, mice and rats, and cockroaches, improving poor-quality housing earlier could help asthma by reducing stress, she said.

“There is also an increasing evidence base that psychosocial stress increases the risk of asthma attacks, and it’s therefore possible that living in poor housing conditions – often highly stressful situations – drives exacerbation risk via this pathway,” she said. “Synergistic effects between these pathways are also possible or even likely.”

Neeta Thakur, MD, associate professor of medicine at the University of California, San Francisco, who researches asthma, said the findings could lead to a strategy for improving poor-quality housing more quickly. As it is, inspections are too infrequent, often prompted by resident complaints.

“Once the complaints get to a certain threshold, then there might be an inspection that happens, and if there is a periodic review of the buildings, they often happen few and far between,” she said. “We could actually use some of the information that we’re already getting from something like ED visits and see if there is a pattern.”

An important follow-up would be to see whether asthma outcomes improve after housing deficiencies are addressed and whether the predictive capacity of ED visits occurs in other places.

“Would you then see a decline in the ED visit rates from individuals living in those buildings?” Dr. Thakur said. “It’s important to find a leading indicator, but you want to be sure that that leading indicator is useful as something that can be intervened upon.”

Dr. Samuels and Dr. Thakur have reported no relevant financial relationships.

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