Journal of Clinical Outcomes Management

Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the Food and Drug Administration warns.

The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

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

Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the Food and Drug Administration warns.

The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

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

Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the Food and Drug Administration warns.

The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

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

Clustered erythematous macular to papular lesions, especially those that stop at clothing lines, are a frequent manifestation of insect bites. In this case, the lesions lacked a central punctum that is common in many insect bites, so the most likely culprit was bed bugs. It is likely that this patient’s friend inadvertently brought the bed bugs into the home in her luggage or packed belongings. Over time, they spread around the home, causing the patient’s bites and inflammation. When questioned, the patient noted that she could actually see bugs around the couch in her home.

The scientific name for bed bugs is Cimex lectularis. Bed bugs require a blood meal from a host to survive, but they do not remain attached to the human body. Instead, they live in nearby fabrics. Bed bugs are visible to the naked eye when they are in the open, although they usually remain along the seams of fabric, edges of bedding, or in cracks and crevices. Often the feces of bed bugs will collect and be seen as dark spots or streaks on bedding.¹

Treatment hinges on the eradication of the bed bugs. The erythematous itching lesions will resolve spontaneously over 1 to 2 weeks. Topical corticosteroids, including hydrocortisone, can be used as necessary to control the itching. Oral antihistamines can also help with itching.

Eradication of all the bed bugs in the home can be difficult and warrant professional extermination services. Washing clothing in hot water of at least 140 °F will kill the insects. Freezing items below –4 °F for at least 2 hours is also effective but may not be possible with home freezers.

It’s worth noting that resistance to insecticides has developed, making chemical eradication difficult. An alternative extermination protocol involves heating an entire home to the required temperatures to eradicate the infestation.¹

This patient noted that she had already thrown away the couch, clothes, and bedding where she had seen the insects and had sprayed her apartment with insecticide. She was counseled to contact a professional exterminator to further evaluate the home for any additional areas of infestation and treat if any bed bugs were still in the home. She was also counseled to use loratadine 10 mg/d orally and topical 1% hydrocortisone ointment, as needed, for the itching and inflammation.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Clustered erythematous macular to papular lesions, especially those that stop at clothing lines, are a frequent manifestation of insect bites. In this case, the lesions lacked a central punctum that is common in many insect bites, so the most likely culprit was bed bugs. It is likely that this patient’s friend inadvertently brought the bed bugs into the home in her luggage or packed belongings. Over time, they spread around the home, causing the patient’s bites and inflammation. When questioned, the patient noted that she could actually see bugs around the couch in her home.

The scientific name for bed bugs is Cimex lectularis. Bed bugs require a blood meal from a host to survive, but they do not remain attached to the human body. Instead, they live in nearby fabrics. Bed bugs are visible to the naked eye when they are in the open, although they usually remain along the seams of fabric, edges of bedding, or in cracks and crevices. Often the feces of bed bugs will collect and be seen as dark spots or streaks on bedding.¹

Treatment hinges on the eradication of the bed bugs. The erythematous itching lesions will resolve spontaneously over 1 to 2 weeks. Topical corticosteroids, including hydrocortisone, can be used as necessary to control the itching. Oral antihistamines can also help with itching.

Eradication of all the bed bugs in the home can be difficult and warrant professional extermination services. Washing clothing in hot water of at least 140 °F will kill the insects. Freezing items below –4 °F for at least 2 hours is also effective but may not be possible with home freezers.

It’s worth noting that resistance to insecticides has developed, making chemical eradication difficult. An alternative extermination protocol involves heating an entire home to the required temperatures to eradicate the infestation.¹

This patient noted that she had already thrown away the couch, clothes, and bedding where she had seen the insects and had sprayed her apartment with insecticide. She was counseled to contact a professional exterminator to further evaluate the home for any additional areas of infestation and treat if any bed bugs were still in the home. She was also counseled to use loratadine 10 mg/d orally and topical 1% hydrocortisone ointment, as needed, for the itching and inflammation.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Clustered erythematous macular to papular lesions, especially those that stop at clothing lines, are a frequent manifestation of insect bites. In this case, the lesions lacked a central punctum that is common in many insect bites, so the most likely culprit was bed bugs. It is likely that this patient’s friend inadvertently brought the bed bugs into the home in her luggage or packed belongings. Over time, they spread around the home, causing the patient’s bites and inflammation. When questioned, the patient noted that she could actually see bugs around the couch in her home.

The scientific name for bed bugs is Cimex lectularis. Bed bugs require a blood meal from a host to survive, but they do not remain attached to the human body. Instead, they live in nearby fabrics. Bed bugs are visible to the naked eye when they are in the open, although they usually remain along the seams of fabric, edges of bedding, or in cracks and crevices. Often the feces of bed bugs will collect and be seen as dark spots or streaks on bedding.¹

Treatment hinges on the eradication of the bed bugs. The erythematous itching lesions will resolve spontaneously over 1 to 2 weeks. Topical corticosteroids, including hydrocortisone, can be used as necessary to control the itching. Oral antihistamines can also help with itching.

Eradication of all the bed bugs in the home can be difficult and warrant professional extermination services. Washing clothing in hot water of at least 140 °F will kill the insects. Freezing items below –4 °F for at least 2 hours is also effective but may not be possible with home freezers.

It’s worth noting that resistance to insecticides has developed, making chemical eradication difficult. An alternative extermination protocol involves heating an entire home to the required temperatures to eradicate the infestation.¹

This patient noted that she had already thrown away the couch, clothes, and bedding where she had seen the insects and had sprayed her apartment with insecticide. She was counseled to contact a professional exterminator to further evaluate the home for any additional areas of infestation and treat if any bed bugs were still in the home. She was also counseled to use loratadine 10 mg/d orally and topical 1% hydrocortisone ointment, as needed, for the itching and inflammation.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Drinking two or more cups of coffee a day was associated with twice the risk of death from cardiovascular disease among people with severe hypertension, according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.

What to know

People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.

Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.

An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.

Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.

Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.

This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.

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

Drinking two or more cups of coffee a day was associated with twice the risk of death from cardiovascular disease among people with severe hypertension, according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.

What to know

People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.

Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.

An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.

Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.

Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.

This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.

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

Drinking two or more cups of coffee a day was associated with twice the risk of death from cardiovascular disease among people with severe hypertension, according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.

What to know

People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.

Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.

An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.

Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.

Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.

This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.

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

Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?

In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.

For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.

This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.

“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.

When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”

Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
 

Okay to breach patient confidentiality?

More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.

“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.

In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.

Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.

Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
 

Support for physician-assisted dying?

Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.

Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”

However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.

As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.

Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.

More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.

Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”

The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.

Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.

This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
 

Romancing a patient?

More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.

Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.

“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.

Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.

In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.

“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.

Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”

But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.

Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”

When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.

“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.

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

Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?

In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.

For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.

This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.

“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.

When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”

Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
 

Okay to breach patient confidentiality?

More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.

“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.

In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.

Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.

Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
 

Support for physician-assisted dying?

Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.

Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”

However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.

As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.

Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.

More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.

Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”

The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.

Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.

This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
 

Romancing a patient?

More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.

Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.

“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.

Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.

In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.

“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.

Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”

But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.

Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”

When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.

“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.

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

Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?

In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.

For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.

This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.

“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.

When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”

Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
 

Okay to breach patient confidentiality?

More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.

“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.

In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.

Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.

Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
 

Support for physician-assisted dying?

Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.

Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”

However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.

As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.

Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.

More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.

Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”

The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.

Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.

This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
 

Romancing a patient?

More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.

Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.

“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.

Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.

In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.

“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.

Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”

But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.

Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”

When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.

“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.

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

Physician groups saw staff-to-physician ratios decline even as their workforce expenses rose between 2019 and 2021, according to recent reports from the American Medical Group Association (AMGA) and the Medical Group Management Association (MGMA).

As patients started to return to doctors’ offices as the pandemic eased in 2021, physician groups found it increasingly difficult to recruit and retain lower-level clinicians, including medical assistants and LPNs, officials from both associations told this news organization. Many clinics had to raise their pay scales to be competitive with employers in other fields, and some had to hire higher-priced RNs to keep their practices running.

The AMGA report was based largely on data from groups of over 500 physicians, mostly affiliated with health systems. According to a news release accompanying the report, the ratio between full-time equivalent (FTE) clinic staff and health care professionals in direct patient care dropped by 11.3% between 2019 and 2021. The ratio of medical assistants (MAs) to clinicians declined by a greater percentage.

In the MGMA report, which represented about 4,000 practices ranging from very small (two doctors) to very large groups, total support staff per FTE primary-care physician dropped by 18% from 2019 to 2021 in independent groups and by 13% in hospital-affiliated groups. The ratios decreased by smaller amounts in surgical practices.

In contrast, nonsurgical specialty groups under both types of ownership saw their staffing ratios rise slightly.

Although it’s unclear why medical specialties increased their staff while other types of specialties lost employees, Ron Holder, MHA, chief operating officer of MGMA, said that some specialists may have opened more ancillary facilities and hired new employees to recoup revenue lost during the pandemic.
 

Expenses rise sharply

The AMGA report found that staffing expenses for the surveyed groups increased by 15% between 2019 and 2021.

“We saw a decrease in staff and an increase in expenses during that time period, and there are a few reasons for that,” Rose Wagner, RN, chief operating officer of AMGA, said. “Groups increased salaries to maintain staff. We also saw lower-paid staff find other jobs outside of health care. For example, medical assistants and receptionists could find jobs outside of health care that paid more. [Open positions] got back-filled with other higher paid staff, such as RNs, doing lower skilled jobs.”

Mr. Holder added that rising wages in other sectors made leaving physician groups more attractive for employees.

“Three years ago, there weren’t many positions in a medical practice where you were competing with Chick-fil-A or Taco Bell,” he said. In Denver, where Mr. Holder is based, “every restaurant in town is now advertising $17-$19 [hourly] starting pay just to do fast food. That causes practices to either lose employees or pay more for the employees they have. So that raises per-employee expense significantly,” he said.

Mr. Holder noted that inflation also has driven up wages as employees demand higher pay to keep up with the cost of living.
 

Unusual exodus of employees

Fred Horton, MHA, president of AMGA Consulting, said he has never seen so many people leaving health care for other occupations.

Some exits resulted from practices laying people off early in the pandemic, but most staff members who left practices were seeking higher pay, he said. In addition, Ms. Wagner noted, some staff members didn’t want to be exposed to COVID at work.

“There was an exodus from health care that was different from what we’d experienced in the past,” Mr. Horton added. “It’s still extremely challenging to get up to the staffing levels that are appropriate.”

Mr. Holder, however, said that the situation is slowly improving. “Health care is fairly recession-proof, because people need it. So when you see companies in other industries closing shop or reducing their head count, that actually helps health care recruiting in some jobs. And people are coming back to the workplace who previously were worried about COVID or didn’t want to get the vaccine.”
 

Paying more for nurses

In 2021, groups adopted a variety of tactics to adapt to the pandemic and respond to patient demand, the AMGA survey shows. Forty percent of system-affiliated groups and 18% of independent practices changed registered nurses’ responsibilities, in many cases having them do the work of medical assistants who were in short supply.

Some practices hired RNs, who have historically been utilized less by primary care than by surgical specialties, Mr. Holder noted. Other clinics paid temp agencies to supply nurses at a steep cost.

“When you’re short staffed, you end up paying more overtime, you end up paying temporary agencies at higher dollars, and you hire higher skilled people to do lower-skilled work,” Ms. Wagner said.

Meanwhile, many physician groups tried to cope with the physician shortage by bringing on more advanced practice clinicians (APCs), including nurse practitioners (NPs) and physician assistants (PAs). Seventy percent of the AMGA groups used this strategy, the report revealed.

“The use of APCs has been steadily increasing as groups try to adopt a lower-cost care model in the midst of a nationwide physician shortage,” Ms. Wagner said in the press release.
 

Changes in patient care

About half of the groups in the AMGA survey said they changed their staff structure to allow APCs to carry their own patient panels. Although most of these clinicians were probably under physician supervision, nearly half of the states now allow NPs to practice autonomously.

Mr. Horton cautioned that APCs can’t fully substitute for physicians and require the same support staff that doctors do if they have their own panels. In primary care groups, Mr. Holder noted, the average salary of an APC “is continuing to rise, and there isn’t a huge difference between what they and doctors make.”

Nevertheless, he added, “there are more NPs and PAs being added to the marketplace all the time, whereas [physician] residency programs aren’t really growing. There are caps on the number of residency positions, and some physicians are retiring. So the clock is ticking to the point where someday doctors will be grossly outnumbered by NPs.”

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

Physician groups saw staff-to-physician ratios decline even as their workforce expenses rose between 2019 and 2021, according to recent reports from the American Medical Group Association (AMGA) and the Medical Group Management Association (MGMA).

As patients started to return to doctors’ offices as the pandemic eased in 2021, physician groups found it increasingly difficult to recruit and retain lower-level clinicians, including medical assistants and LPNs, officials from both associations told this news organization. Many clinics had to raise their pay scales to be competitive with employers in other fields, and some had to hire higher-priced RNs to keep their practices running.

The AMGA report was based largely on data from groups of over 500 physicians, mostly affiliated with health systems. According to a news release accompanying the report, the ratio between full-time equivalent (FTE) clinic staff and health care professionals in direct patient care dropped by 11.3% between 2019 and 2021. The ratio of medical assistants (MAs) to clinicians declined by a greater percentage.

In the MGMA report, which represented about 4,000 practices ranging from very small (two doctors) to very large groups, total support staff per FTE primary-care physician dropped by 18% from 2019 to 2021 in independent groups and by 13% in hospital-affiliated groups. The ratios decreased by smaller amounts in surgical practices.

In contrast, nonsurgical specialty groups under both types of ownership saw their staffing ratios rise slightly.

Although it’s unclear why medical specialties increased their staff while other types of specialties lost employees, Ron Holder, MHA, chief operating officer of MGMA, said that some specialists may have opened more ancillary facilities and hired new employees to recoup revenue lost during the pandemic.
 

Expenses rise sharply

The AMGA report found that staffing expenses for the surveyed groups increased by 15% between 2019 and 2021.

“We saw a decrease in staff and an increase in expenses during that time period, and there are a few reasons for that,” Rose Wagner, RN, chief operating officer of AMGA, said. “Groups increased salaries to maintain staff. We also saw lower-paid staff find other jobs outside of health care. For example, medical assistants and receptionists could find jobs outside of health care that paid more. [Open positions] got back-filled with other higher paid staff, such as RNs, doing lower skilled jobs.”

Mr. Holder added that rising wages in other sectors made leaving physician groups more attractive for employees.

“Three years ago, there weren’t many positions in a medical practice where you were competing with Chick-fil-A or Taco Bell,” he said. In Denver, where Mr. Holder is based, “every restaurant in town is now advertising $17-$19 [hourly] starting pay just to do fast food. That causes practices to either lose employees or pay more for the employees they have. So that raises per-employee expense significantly,” he said.

Mr. Holder noted that inflation also has driven up wages as employees demand higher pay to keep up with the cost of living.
 

Unusual exodus of employees

Fred Horton, MHA, president of AMGA Consulting, said he has never seen so many people leaving health care for other occupations.

Some exits resulted from practices laying people off early in the pandemic, but most staff members who left practices were seeking higher pay, he said. In addition, Ms. Wagner noted, some staff members didn’t want to be exposed to COVID at work.

“There was an exodus from health care that was different from what we’d experienced in the past,” Mr. Horton added. “It’s still extremely challenging to get up to the staffing levels that are appropriate.”

Mr. Holder, however, said that the situation is slowly improving. “Health care is fairly recession-proof, because people need it. So when you see companies in other industries closing shop or reducing their head count, that actually helps health care recruiting in some jobs. And people are coming back to the workplace who previously were worried about COVID or didn’t want to get the vaccine.”
 

Paying more for nurses

In 2021, groups adopted a variety of tactics to adapt to the pandemic and respond to patient demand, the AMGA survey shows. Forty percent of system-affiliated groups and 18% of independent practices changed registered nurses’ responsibilities, in many cases having them do the work of medical assistants who were in short supply.

Some practices hired RNs, who have historically been utilized less by primary care than by surgical specialties, Mr. Holder noted. Other clinics paid temp agencies to supply nurses at a steep cost.

“When you’re short staffed, you end up paying more overtime, you end up paying temporary agencies at higher dollars, and you hire higher skilled people to do lower-skilled work,” Ms. Wagner said.

Meanwhile, many physician groups tried to cope with the physician shortage by bringing on more advanced practice clinicians (APCs), including nurse practitioners (NPs) and physician assistants (PAs). Seventy percent of the AMGA groups used this strategy, the report revealed.

“The use of APCs has been steadily increasing as groups try to adopt a lower-cost care model in the midst of a nationwide physician shortage,” Ms. Wagner said in the press release.
 

Changes in patient care

About half of the groups in the AMGA survey said they changed their staff structure to allow APCs to carry their own patient panels. Although most of these clinicians were probably under physician supervision, nearly half of the states now allow NPs to practice autonomously.

Mr. Horton cautioned that APCs can’t fully substitute for physicians and require the same support staff that doctors do if they have their own panels. In primary care groups, Mr. Holder noted, the average salary of an APC “is continuing to rise, and there isn’t a huge difference between what they and doctors make.”

Nevertheless, he added, “there are more NPs and PAs being added to the marketplace all the time, whereas [physician] residency programs aren’t really growing. There are caps on the number of residency positions, and some physicians are retiring. So the clock is ticking to the point where someday doctors will be grossly outnumbered by NPs.”

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

Physician groups saw staff-to-physician ratios decline even as their workforce expenses rose between 2019 and 2021, according to recent reports from the American Medical Group Association (AMGA) and the Medical Group Management Association (MGMA).

As patients started to return to doctors’ offices as the pandemic eased in 2021, physician groups found it increasingly difficult to recruit and retain lower-level clinicians, including medical assistants and LPNs, officials from both associations told this news organization. Many clinics had to raise their pay scales to be competitive with employers in other fields, and some had to hire higher-priced RNs to keep their practices running.

The AMGA report was based largely on data from groups of over 500 physicians, mostly affiliated with health systems. According to a news release accompanying the report, the ratio between full-time equivalent (FTE) clinic staff and health care professionals in direct patient care dropped by 11.3% between 2019 and 2021. The ratio of medical assistants (MAs) to clinicians declined by a greater percentage.

In the MGMA report, which represented about 4,000 practices ranging from very small (two doctors) to very large groups, total support staff per FTE primary-care physician dropped by 18% from 2019 to 2021 in independent groups and by 13% in hospital-affiliated groups. The ratios decreased by smaller amounts in surgical practices.

In contrast, nonsurgical specialty groups under both types of ownership saw their staffing ratios rise slightly.

Although it’s unclear why medical specialties increased their staff while other types of specialties lost employees, Ron Holder, MHA, chief operating officer of MGMA, said that some specialists may have opened more ancillary facilities and hired new employees to recoup revenue lost during the pandemic.
 

Expenses rise sharply

The AMGA report found that staffing expenses for the surveyed groups increased by 15% between 2019 and 2021.

“We saw a decrease in staff and an increase in expenses during that time period, and there are a few reasons for that,” Rose Wagner, RN, chief operating officer of AMGA, said. “Groups increased salaries to maintain staff. We also saw lower-paid staff find other jobs outside of health care. For example, medical assistants and receptionists could find jobs outside of health care that paid more. [Open positions] got back-filled with other higher paid staff, such as RNs, doing lower skilled jobs.”

Mr. Holder added that rising wages in other sectors made leaving physician groups more attractive for employees.

“Three years ago, there weren’t many positions in a medical practice where you were competing with Chick-fil-A or Taco Bell,” he said. In Denver, where Mr. Holder is based, “every restaurant in town is now advertising $17-$19 [hourly] starting pay just to do fast food. That causes practices to either lose employees or pay more for the employees they have. So that raises per-employee expense significantly,” he said.

Mr. Holder noted that inflation also has driven up wages as employees demand higher pay to keep up with the cost of living.
 

Unusual exodus of employees

Fred Horton, MHA, president of AMGA Consulting, said he has never seen so many people leaving health care for other occupations.

Some exits resulted from practices laying people off early in the pandemic, but most staff members who left practices were seeking higher pay, he said. In addition, Ms. Wagner noted, some staff members didn’t want to be exposed to COVID at work.

“There was an exodus from health care that was different from what we’d experienced in the past,” Mr. Horton added. “It’s still extremely challenging to get up to the staffing levels that are appropriate.”

Mr. Holder, however, said that the situation is slowly improving. “Health care is fairly recession-proof, because people need it. So when you see companies in other industries closing shop or reducing their head count, that actually helps health care recruiting in some jobs. And people are coming back to the workplace who previously were worried about COVID or didn’t want to get the vaccine.”
 

Paying more for nurses

In 2021, groups adopted a variety of tactics to adapt to the pandemic and respond to patient demand, the AMGA survey shows. Forty percent of system-affiliated groups and 18% of independent practices changed registered nurses’ responsibilities, in many cases having them do the work of medical assistants who were in short supply.

Some practices hired RNs, who have historically been utilized less by primary care than by surgical specialties, Mr. Holder noted. Other clinics paid temp agencies to supply nurses at a steep cost.

“When you’re short staffed, you end up paying more overtime, you end up paying temporary agencies at higher dollars, and you hire higher skilled people to do lower-skilled work,” Ms. Wagner said.

Meanwhile, many physician groups tried to cope with the physician shortage by bringing on more advanced practice clinicians (APCs), including nurse practitioners (NPs) and physician assistants (PAs). Seventy percent of the AMGA groups used this strategy, the report revealed.

“The use of APCs has been steadily increasing as groups try to adopt a lower-cost care model in the midst of a nationwide physician shortage,” Ms. Wagner said in the press release.
 

Changes in patient care

About half of the groups in the AMGA survey said they changed their staff structure to allow APCs to carry their own patient panels. Although most of these clinicians were probably under physician supervision, nearly half of the states now allow NPs to practice autonomously.

Mr. Horton cautioned that APCs can’t fully substitute for physicians and require the same support staff that doctors do if they have their own panels. In primary care groups, Mr. Holder noted, the average salary of an APC “is continuing to rise, and there isn’t a huge difference between what they and doctors make.”

Nevertheless, he added, “there are more NPs and PAs being added to the marketplace all the time, whereas [physician] residency programs aren’t really growing. There are caps on the number of residency positions, and some physicians are retiring. So the clock is ticking to the point where someday doctors will be grossly outnumbered by NPs.”

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

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

COVID-19 remains deadlier than influenza in severe cases requiring hospitalization, a new study shows.

People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.

The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”

The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022. 

Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%. 

Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.

“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.

While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.

A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.

Four coauthors reported receiving grants and personal fees from various sources.

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

COVID-19 remains deadlier than influenza in severe cases requiring hospitalization, a new study shows.

People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.

The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”

The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022. 

Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%. 

Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.

“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.

While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.

A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.

Four coauthors reported receiving grants and personal fees from various sources.

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

COVID-19 remains deadlier than influenza in severe cases requiring hospitalization, a new study shows.

People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.

The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”

The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022. 

Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%. 

Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.

“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.

While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.

A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.

Four coauthors reported receiving grants and personal fees from various sources.

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

In a proof-of-concept feasibility study among adults with difficult-to-treat asthma and body mass index ≥ 30kg/m², an evidence-based, dietitian-led program resulted in clinically important improvements in asthma control and quality of life over 16 weeks compared to usual care.

The Counterweight-Plus weight management program (CWP) used in the study includes 12 weeks of total diet replacement (TDR), stepwise food reintroduction in weeks 13-18, and weight loss maintenance up to 1 year, according to a report by Varun Sharma, MBChB, and fellow researchers at University of Glasgow.

Difficult-to-treat asthma, found among about 17% of asthma-affected patients, may be attributed to factors such as poor inhaler technique, treatment nonadherence, and comorbidities such as obesity. Obesity is frequently associated with difficult-to-treat, uncontrolled asthma and increased morbidity and mortality. Among multifactorial effects of obesity on asthma are direct ones on thoracic wall mechanics, increased airway closure, airway hyper-responsiveness and airway inflammation. Prior research showing that weight loss may improve asthma outcomes has been conducted among heterogeneous asthma populations, with no clear consensus regarding optimal methods of weight management, according to the authors.

They tested whether use of the CWP compared to usual care (1:1) would improve asthma control and quality of life in this population of patients with obesity. The TDR phase comprised a low-energy liquid diet consisting of 825-853 kcal/day (approximately 59% carbohydrate, 13% fat, 26% protein, 2% fiber), with meals supplied dried in sachets by the dietitian team and reconstituted with water by the participants. A review by the dietitian team at 1 week was followed by reviews every other week.

The primary outcome was difference in change in Asthma Control Questionnaire (ACQ6) from baseline (visit 1) to 16 weeks (visit 2), between CWP and usual care.

The single-center trial included 33 evaluable adult patients (75 years or younger; mean age 53 years; 63% women) with asthma (as per Global Initiative for Asthma guidelines) that was difficult to treat (as per Scottish Intercollegiate Guidelines Network/British Thoracic Society guidelines). The study population consisted of patients with frequent exacerbations with uncontrolled disease as reflected by the median interquartile range (IQR) for oral corticosteroid courses in the previous 12 months of 3 (2 to 5) and mean ACQ6 of 2.8 (2.4 to 3.1). Mean overall Asthma Quality of Life Questionnaire (AQLQ) was 3.8 (3.4 to 4.2). Median weight was 101.7 (91.4 to 118.7) kg, with a median BMI of 37.5 (35.0 to 42.3) kg/m². Recruitment was discontinued before the target of 40 patients because the CWP dropout rate (n = 2) was lower than expected.

The researchers reported that the mean change in ACQ6 over 16 weeks was –0.45 for CWP and 0.23 for usual care with a mean difference of –0.69 (P = .048) between groups. The secondary outcome of mean change in overall AQLQ was 0.81 for CWP and 0.08 for usual care with a mean difference of 0.76 (P = .013) between groups.

No unexpected serious adverse events or intervention-related adverse events were observed during the trial.

“In this pragmatic open label, randomized, controlled trial we showed that delivery of a supported low-calorie total diet replacement program (Counterweight-Plus) to patients with difficult-to treat asthma and obesity, was safe and led to significant improvements in asthma control and quality of life compared to usual care over 16 weeks,” the authors wrote.

“Findings from the study are a welcome addition to this field of study,” Diego J. Maselli, MD, associate professor of medicine and interim chief, division of pulmonary diseases and critical care, UT Health at San Antonio, said in an interview. “Over the past years there has been an increase in the focus of comorbid conditions that may influence asthma control, particularly in severe disease.  Obesity is an important comorbid condition because, although by itself it may have an effect on asthma patients, it is also associated with other comorbidities such as gastroesophageal reflux disease, obstructive sleep apnea, anxiety, depression, and others that in turn can affect asthmatics. Also, obesity may influence pulmonary physiology and it’s considered a proinflammatory state by many, and this can favor uncontrolled disease.”  

While underscoring the clinically relevant weight loss and improvements in ACQ6 and AQLQ, Dr. Maselli said that the study did not follow the patients long enough to determine if weight loss was associated with a reduction in exacerbations and other long-term outcomes in asthma such as resource utilization and changes in maintenance medications, which may be explored in future studies.

“It remains to be seen if the weight loss of these types of programs can be sustained over longer periods of time, given the considerable caloric restriction in the initial stages of the weight reduction program. Interestingly, the majority of the patients in the study did not exhibit features of type 2 inflammation and had low-T2 endotype with low eosinophil count and low FeNO [fractional exhaled nitric oxide],” Dr. Maselli added. “Although obesity has been linked to this phenotype, the vast majority of [people with asthma], about 80%, have high T2 phenotype. Future studies are still need with larger and more representative samples and with longer follow-up times to determine the effects of weight loss on asthma outcomes, especially in severe asthma,” he concluded.

The trial was funded by an NHS Greater Glasgow and Clyde Endowment Fund grant. Several of the authors reported having received travel awards to attend conferences and funding from Cambridge Weight Plan and one author is an employee of and another a medical adviser for Counterweight Ltd., the developer of the program used. Other authors reported receiving funding from a variety of pharmaceutical companies. Dr. Maselli reported no relevant conflicts.

In a proof-of-concept feasibility study among adults with difficult-to-treat asthma and body mass index ≥ 30kg/m², an evidence-based, dietitian-led program resulted in clinically important improvements in asthma control and quality of life over 16 weeks compared to usual care.

The Counterweight-Plus weight management program (CWP) used in the study includes 12 weeks of total diet replacement (TDR), stepwise food reintroduction in weeks 13-18, and weight loss maintenance up to 1 year, according to a report by Varun Sharma, MBChB, and fellow researchers at University of Glasgow.

Difficult-to-treat asthma, found among about 17% of asthma-affected patients, may be attributed to factors such as poor inhaler technique, treatment nonadherence, and comorbidities such as obesity. Obesity is frequently associated with difficult-to-treat, uncontrolled asthma and increased morbidity and mortality. Among multifactorial effects of obesity on asthma are direct ones on thoracic wall mechanics, increased airway closure, airway hyper-responsiveness and airway inflammation. Prior research showing that weight loss may improve asthma outcomes has been conducted among heterogeneous asthma populations, with no clear consensus regarding optimal methods of weight management, according to the authors.

They tested whether use of the CWP compared to usual care (1:1) would improve asthma control and quality of life in this population of patients with obesity. The TDR phase comprised a low-energy liquid diet consisting of 825-853 kcal/day (approximately 59% carbohydrate, 13% fat, 26% protein, 2% fiber), with meals supplied dried in sachets by the dietitian team and reconstituted with water by the participants. A review by the dietitian team at 1 week was followed by reviews every other week.

The primary outcome was difference in change in Asthma Control Questionnaire (ACQ6) from baseline (visit 1) to 16 weeks (visit 2), between CWP and usual care.

The single-center trial included 33 evaluable adult patients (75 years or younger; mean age 53 years; 63% women) with asthma (as per Global Initiative for Asthma guidelines) that was difficult to treat (as per Scottish Intercollegiate Guidelines Network/British Thoracic Society guidelines). The study population consisted of patients with frequent exacerbations with uncontrolled disease as reflected by the median interquartile range (IQR) for oral corticosteroid courses in the previous 12 months of 3 (2 to 5) and mean ACQ6 of 2.8 (2.4 to 3.1). Mean overall Asthma Quality of Life Questionnaire (AQLQ) was 3.8 (3.4 to 4.2). Median weight was 101.7 (91.4 to 118.7) kg, with a median BMI of 37.5 (35.0 to 42.3) kg/m². Recruitment was discontinued before the target of 40 patients because the CWP dropout rate (n = 2) was lower than expected.

The researchers reported that the mean change in ACQ6 over 16 weeks was –0.45 for CWP and 0.23 for usual care with a mean difference of –0.69 (P = .048) between groups. The secondary outcome of mean change in overall AQLQ was 0.81 for CWP and 0.08 for usual care with a mean difference of 0.76 (P = .013) between groups.

No unexpected serious adverse events or intervention-related adverse events were observed during the trial.

“In this pragmatic open label, randomized, controlled trial we showed that delivery of a supported low-calorie total diet replacement program (Counterweight-Plus) to patients with difficult-to treat asthma and obesity, was safe and led to significant improvements in asthma control and quality of life compared to usual care over 16 weeks,” the authors wrote.

“Findings from the study are a welcome addition to this field of study,” Diego J. Maselli, MD, associate professor of medicine and interim chief, division of pulmonary diseases and critical care, UT Health at San Antonio, said in an interview. “Over the past years there has been an increase in the focus of comorbid conditions that may influence asthma control, particularly in severe disease.  Obesity is an important comorbid condition because, although by itself it may have an effect on asthma patients, it is also associated with other comorbidities such as gastroesophageal reflux disease, obstructive sleep apnea, anxiety, depression, and others that in turn can affect asthmatics. Also, obesity may influence pulmonary physiology and it’s considered a proinflammatory state by many, and this can favor uncontrolled disease.”  

While underscoring the clinically relevant weight loss and improvements in ACQ6 and AQLQ, Dr. Maselli said that the study did not follow the patients long enough to determine if weight loss was associated with a reduction in exacerbations and other long-term outcomes in asthma such as resource utilization and changes in maintenance medications, which may be explored in future studies.

“It remains to be seen if the weight loss of these types of programs can be sustained over longer periods of time, given the considerable caloric restriction in the initial stages of the weight reduction program. Interestingly, the majority of the patients in the study did not exhibit features of type 2 inflammation and had low-T2 endotype with low eosinophil count and low FeNO [fractional exhaled nitric oxide],” Dr. Maselli added. “Although obesity has been linked to this phenotype, the vast majority of [people with asthma], about 80%, have high T2 phenotype. Future studies are still need with larger and more representative samples and with longer follow-up times to determine the effects of weight loss on asthma outcomes, especially in severe asthma,” he concluded.

The trial was funded by an NHS Greater Glasgow and Clyde Endowment Fund grant. Several of the authors reported having received travel awards to attend conferences and funding from Cambridge Weight Plan and one author is an employee of and another a medical adviser for Counterweight Ltd., the developer of the program used. Other authors reported receiving funding from a variety of pharmaceutical companies. Dr. Maselli reported no relevant conflicts.

In a proof-of-concept feasibility study among adults with difficult-to-treat asthma and body mass index ≥ 30kg/m², an evidence-based, dietitian-led program resulted in clinically important improvements in asthma control and quality of life over 16 weeks compared to usual care.

The Counterweight-Plus weight management program (CWP) used in the study includes 12 weeks of total diet replacement (TDR), stepwise food reintroduction in weeks 13-18, and weight loss maintenance up to 1 year, according to a report by Varun Sharma, MBChB, and fellow researchers at University of Glasgow.

Difficult-to-treat asthma, found among about 17% of asthma-affected patients, may be attributed to factors such as poor inhaler technique, treatment nonadherence, and comorbidities such as obesity. Obesity is frequently associated with difficult-to-treat, uncontrolled asthma and increased morbidity and mortality. Among multifactorial effects of obesity on asthma are direct ones on thoracic wall mechanics, increased airway closure, airway hyper-responsiveness and airway inflammation. Prior research showing that weight loss may improve asthma outcomes has been conducted among heterogeneous asthma populations, with no clear consensus regarding optimal methods of weight management, according to the authors.

They tested whether use of the CWP compared to usual care (1:1) would improve asthma control and quality of life in this population of patients with obesity. The TDR phase comprised a low-energy liquid diet consisting of 825-853 kcal/day (approximately 59% carbohydrate, 13% fat, 26% protein, 2% fiber), with meals supplied dried in sachets by the dietitian team and reconstituted with water by the participants. A review by the dietitian team at 1 week was followed by reviews every other week.

The primary outcome was difference in change in Asthma Control Questionnaire (ACQ6) from baseline (visit 1) to 16 weeks (visit 2), between CWP and usual care.

The single-center trial included 33 evaluable adult patients (75 years or younger; mean age 53 years; 63% women) with asthma (as per Global Initiative for Asthma guidelines) that was difficult to treat (as per Scottish Intercollegiate Guidelines Network/British Thoracic Society guidelines). The study population consisted of patients with frequent exacerbations with uncontrolled disease as reflected by the median interquartile range (IQR) for oral corticosteroid courses in the previous 12 months of 3 (2 to 5) and mean ACQ6 of 2.8 (2.4 to 3.1). Mean overall Asthma Quality of Life Questionnaire (AQLQ) was 3.8 (3.4 to 4.2). Median weight was 101.7 (91.4 to 118.7) kg, with a median BMI of 37.5 (35.0 to 42.3) kg/m². Recruitment was discontinued before the target of 40 patients because the CWP dropout rate (n = 2) was lower than expected.

The researchers reported that the mean change in ACQ6 over 16 weeks was –0.45 for CWP and 0.23 for usual care with a mean difference of –0.69 (P = .048) between groups. The secondary outcome of mean change in overall AQLQ was 0.81 for CWP and 0.08 for usual care with a mean difference of 0.76 (P = .013) between groups.

No unexpected serious adverse events or intervention-related adverse events were observed during the trial.

“In this pragmatic open label, randomized, controlled trial we showed that delivery of a supported low-calorie total diet replacement program (Counterweight-Plus) to patients with difficult-to treat asthma and obesity, was safe and led to significant improvements in asthma control and quality of life compared to usual care over 16 weeks,” the authors wrote.

“Findings from the study are a welcome addition to this field of study,” Diego J. Maselli, MD, associate professor of medicine and interim chief, division of pulmonary diseases and critical care, UT Health at San Antonio, said in an interview. “Over the past years there has been an increase in the focus of comorbid conditions that may influence asthma control, particularly in severe disease.  Obesity is an important comorbid condition because, although by itself it may have an effect on asthma patients, it is also associated with other comorbidities such as gastroesophageal reflux disease, obstructive sleep apnea, anxiety, depression, and others that in turn can affect asthmatics. Also, obesity may influence pulmonary physiology and it’s considered a proinflammatory state by many, and this can favor uncontrolled disease.”  

While underscoring the clinically relevant weight loss and improvements in ACQ6 and AQLQ, Dr. Maselli said that the study did not follow the patients long enough to determine if weight loss was associated with a reduction in exacerbations and other long-term outcomes in asthma such as resource utilization and changes in maintenance medications, which may be explored in future studies.

“It remains to be seen if the weight loss of these types of programs can be sustained over longer periods of time, given the considerable caloric restriction in the initial stages of the weight reduction program. Interestingly, the majority of the patients in the study did not exhibit features of type 2 inflammation and had low-T2 endotype with low eosinophil count and low FeNO [fractional exhaled nitric oxide],” Dr. Maselli added. “Although obesity has been linked to this phenotype, the vast majority of [people with asthma], about 80%, have high T2 phenotype. Future studies are still need with larger and more representative samples and with longer follow-up times to determine the effects of weight loss on asthma outcomes, especially in severe asthma,” he concluded.

The trial was funded by an NHS Greater Glasgow and Clyde Endowment Fund grant. Several of the authors reported having received travel awards to attend conferences and funding from Cambridge Weight Plan and one author is an employee of and another a medical adviser for Counterweight Ltd., the developer of the program used. Other authors reported receiving funding from a variety of pharmaceutical companies. Dr. Maselli reported no relevant conflicts.

Treatment with the diabetes drug metformin shows a significant, dose-dependent effect in lowering SARS-CoV-2 viral load within days of administration, according to the latest analysis of the phase 3 COVID-OUT trial. These findings add to a multitude of benefits the drug has been shown to have in COVID infection.

COVID-OUT did not meet its primary endpoint, but it did show important secondary outcomes including a 42% reduction in ED visits and in hospitalizations and/or deaths by day 14, and a 58% reduction in hospitalizations/death by day 28. A further subanalysis has shown a 42% reduction in long COVID, compared with placebo.

“In this phase 3 randomized controlled trial, metformin showed prevention of severe COVID, prevention of long COVID, and an antiviral effect, and this is consistent with other data,” said coauthor Carolyn Bramante, MD, University of Minnesota, Minneapolis, in presenting the findings at the Conference on Retroviruses & Opportunistic Infections.
 

Study details

For the new subanalysis, the authors further evaluated the effects of metformin treatment on SARS-CoV-2 viral load.

A total of 1,323 patients in the study, enrolled at six centers, were randomized to treatment either with metformin 1,000 mg per day on days 2-5 and 1,500 mg per day on days 6 to 14 (n = 187), or to ivermectin 390-470 mcg/kg per day for 3 days (n = 187), fluvoxamine 50 mg twice daily for 14 days, and/or an exact-matching placebo in a 2 x 3 factorial trial design.

The subanalysis on viral load included 483 patients from the trial who were treated with metformin versus 462 who received placebo, who were all enrolled within 3 days of a documented SARS-CoV-2 infection and less than 7 days after symptom onset.

The patients had a median age of 46 years, and all had either overweight or obesity. Only about 2% had diabetes, and only patients considered low-risk were excluded from the trial, including those under age 30 and those with a body mass index under 25.

About half of patients had received a primary vaccine and about 5% had received a vaccine booster. SARS-CoV-2 variants that were prominent during the study included Alpha, Delta, and Omicron.

The viral samples available on days 1, 5, and 10 showed a mean change in viral load from baseline to follow-up; the viral load was significantly lower with metformin versus placebo (–0.64 log10 copies/mL), representing a 4.4-fold greater decrease in viral load with metformin.

The mean rate of undetectable SARS-CoV-2 viral load at day 5 was 49.9% in the metformin group versus 54.6% in the placebo group (odds ratio, 1.235), and the undetectable rate at day 10 was 14.3% in the metformin group and 22.6% in the placebo group (OR, 1.663; P = .003).

An increased antiviral effect corresponded with increases in metformin dosing on days 6 through 14. Furthermore, the antiviral effect became stronger when metformin was started earlier in the course of infection.

Of note, the antiviral effect was more pronounced among those who were not vaccinated (mean, –0.95 log copies/mL), compared with the vaccinated (mean, –0.39 log copies/mL).

The antiviral effect with metformin was similar to that seen with nirmatrelvir at day 5 and was greater than nirmatrelvir at day 10.

No similar relationships in SARS-CoV-2 viral load were observed between ivermectin or fluvoxamine and placebo.

The findings are consistent with results of other recent observational studies, including research showing metformin to be associated with reductions in COVID-19 severity in patients with prediabetes, Dr. Bramante noted.

The authors’ previous analysis looking at long COVID in the COVID-OUT study showed that metformin treatment during acute COVID significantly reduced the risk for a diagnosis of long COVID versus placebo at 300 days following randomization, with a hazard ratio of 0.59 after adjustment for the study drug and vaccination at baseline.

Dr. Bramante noted that metformin’s potential antiviral properties have long been speculated, with some of the earliest research on the drug suggesting less severe outcomes in influenza, and more recently, RNA assays suggesting effects against other RNA viruses, including the Zika virus.

In terms of COVID, Dr. Bramante noted that the drug has plenty of potentially favorable benefits.

“Metformin is very safe and is known to have very few contraindications, so the next steps could be to consider looking at this in terms of a combination therapy,” she said.
 

‘Data from other studies are conflicting’

Commenting on the study, Diane V. Havlir, MD, cautioned that “metformin is currently not recommended in treatment guidelines, [and] data from other studies are conflicting; side effects can be an issue, and the study presented here was in a select population,” she said in an interview.

However, “what is both new and interesting in this presentation is the reduction of viral load, which [was observed] in the samples collected not only on days 1-5, but also days 6-14,” said Dr. Havlir, who is professor and associate chair of clinical research, department of medicine, and chief of the division of HIV, infectious diseases and global medicine and director of the AIDS Research Institute at the University of California, San Francisco.

Key questions the findings raise include whether the results correlate with clinical outcomes or transmission, and whether the findings are generalizable to other populations and settings, Dr. Havlir said.

Ultimately, “we need to continue to pursue all aspects of outpatient treatments for COVID to address questions like these for new and existing agents,” she added.

The trial received funding from the Parsemus Foundation, the Rainwater Charitable Foundation, Fast Grants, and the United Health Group. The authors and Dr. Havlir disclosed no relevant financial relationships.

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

Treatment with the diabetes drug metformin shows a significant, dose-dependent effect in lowering SARS-CoV-2 viral load within days of administration, according to the latest analysis of the phase 3 COVID-OUT trial. These findings add to a multitude of benefits the drug has been shown to have in COVID infection.

COVID-OUT did not meet its primary endpoint, but it did show important secondary outcomes including a 42% reduction in ED visits and in hospitalizations and/or deaths by day 14, and a 58% reduction in hospitalizations/death by day 28. A further subanalysis has shown a 42% reduction in long COVID, compared with placebo.

“In this phase 3 randomized controlled trial, metformin showed prevention of severe COVID, prevention of long COVID, and an antiviral effect, and this is consistent with other data,” said coauthor Carolyn Bramante, MD, University of Minnesota, Minneapolis, in presenting the findings at the Conference on Retroviruses & Opportunistic Infections.
 

Study details

For the new subanalysis, the authors further evaluated the effects of metformin treatment on SARS-CoV-2 viral load.

A total of 1,323 patients in the study, enrolled at six centers, were randomized to treatment either with metformin 1,000 mg per day on days 2-5 and 1,500 mg per day on days 6 to 14 (n = 187), or to ivermectin 390-470 mcg/kg per day for 3 days (n = 187), fluvoxamine 50 mg twice daily for 14 days, and/or an exact-matching placebo in a 2 x 3 factorial trial design.

The subanalysis on viral load included 483 patients from the trial who were treated with metformin versus 462 who received placebo, who were all enrolled within 3 days of a documented SARS-CoV-2 infection and less than 7 days after symptom onset.

The patients had a median age of 46 years, and all had either overweight or obesity. Only about 2% had diabetes, and only patients considered low-risk were excluded from the trial, including those under age 30 and those with a body mass index under 25.

About half of patients had received a primary vaccine and about 5% had received a vaccine booster. SARS-CoV-2 variants that were prominent during the study included Alpha, Delta, and Omicron.

The viral samples available on days 1, 5, and 10 showed a mean change in viral load from baseline to follow-up; the viral load was significantly lower with metformin versus placebo (–0.64 log10 copies/mL), representing a 4.4-fold greater decrease in viral load with metformin.

The mean rate of undetectable SARS-CoV-2 viral load at day 5 was 49.9% in the metformin group versus 54.6% in the placebo group (odds ratio, 1.235), and the undetectable rate at day 10 was 14.3% in the metformin group and 22.6% in the placebo group (OR, 1.663; P = .003).

An increased antiviral effect corresponded with increases in metformin dosing on days 6 through 14. Furthermore, the antiviral effect became stronger when metformin was started earlier in the course of infection.

Of note, the antiviral effect was more pronounced among those who were not vaccinated (mean, –0.95 log copies/mL), compared with the vaccinated (mean, –0.39 log copies/mL).

The antiviral effect with metformin was similar to that seen with nirmatrelvir at day 5 and was greater than nirmatrelvir at day 10.

No similar relationships in SARS-CoV-2 viral load were observed between ivermectin or fluvoxamine and placebo.

The findings are consistent with results of other recent observational studies, including research showing metformin to be associated with reductions in COVID-19 severity in patients with prediabetes, Dr. Bramante noted.

The authors’ previous analysis looking at long COVID in the COVID-OUT study showed that metformin treatment during acute COVID significantly reduced the risk for a diagnosis of long COVID versus placebo at 300 days following randomization, with a hazard ratio of 0.59 after adjustment for the study drug and vaccination at baseline.

Dr. Bramante noted that metformin’s potential antiviral properties have long been speculated, with some of the earliest research on the drug suggesting less severe outcomes in influenza, and more recently, RNA assays suggesting effects against other RNA viruses, including the Zika virus.

In terms of COVID, Dr. Bramante noted that the drug has plenty of potentially favorable benefits.

“Metformin is very safe and is known to have very few contraindications, so the next steps could be to consider looking at this in terms of a combination therapy,” she said.
 

‘Data from other studies are conflicting’

Commenting on the study, Diane V. Havlir, MD, cautioned that “metformin is currently not recommended in treatment guidelines, [and] data from other studies are conflicting; side effects can be an issue, and the study presented here was in a select population,” she said in an interview.

However, “what is both new and interesting in this presentation is the reduction of viral load, which [was observed] in the samples collected not only on days 1-5, but also days 6-14,” said Dr. Havlir, who is professor and associate chair of clinical research, department of medicine, and chief of the division of HIV, infectious diseases and global medicine and director of the AIDS Research Institute at the University of California, San Francisco.

Key questions the findings raise include whether the results correlate with clinical outcomes or transmission, and whether the findings are generalizable to other populations and settings, Dr. Havlir said.

Ultimately, “we need to continue to pursue all aspects of outpatient treatments for COVID to address questions like these for new and existing agents,” she added.

The trial received funding from the Parsemus Foundation, the Rainwater Charitable Foundation, Fast Grants, and the United Health Group. The authors and Dr. Havlir disclosed no relevant financial relationships.

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

Treatment with the diabetes drug metformin shows a significant, dose-dependent effect in lowering SARS-CoV-2 viral load within days of administration, according to the latest analysis of the phase 3 COVID-OUT trial. These findings add to a multitude of benefits the drug has been shown to have in COVID infection.

COVID-OUT did not meet its primary endpoint, but it did show important secondary outcomes including a 42% reduction in ED visits and in hospitalizations and/or deaths by day 14, and a 58% reduction in hospitalizations/death by day 28. A further subanalysis has shown a 42% reduction in long COVID, compared with placebo.

“In this phase 3 randomized controlled trial, metformin showed prevention of severe COVID, prevention of long COVID, and an antiviral effect, and this is consistent with other data,” said coauthor Carolyn Bramante, MD, University of Minnesota, Minneapolis, in presenting the findings at the Conference on Retroviruses & Opportunistic Infections.
 

Study details

For the new subanalysis, the authors further evaluated the effects of metformin treatment on SARS-CoV-2 viral load.

A total of 1,323 patients in the study, enrolled at six centers, were randomized to treatment either with metformin 1,000 mg per day on days 2-5 and 1,500 mg per day on days 6 to 14 (n = 187), or to ivermectin 390-470 mcg/kg per day for 3 days (n = 187), fluvoxamine 50 mg twice daily for 14 days, and/or an exact-matching placebo in a 2 x 3 factorial trial design.

The subanalysis on viral load included 483 patients from the trial who were treated with metformin versus 462 who received placebo, who were all enrolled within 3 days of a documented SARS-CoV-2 infection and less than 7 days after symptom onset.

The patients had a median age of 46 years, and all had either overweight or obesity. Only about 2% had diabetes, and only patients considered low-risk were excluded from the trial, including those under age 30 and those with a body mass index under 25.

About half of patients had received a primary vaccine and about 5% had received a vaccine booster. SARS-CoV-2 variants that were prominent during the study included Alpha, Delta, and Omicron.

The viral samples available on days 1, 5, and 10 showed a mean change in viral load from baseline to follow-up; the viral load was significantly lower with metformin versus placebo (–0.64 log10 copies/mL), representing a 4.4-fold greater decrease in viral load with metformin.

The mean rate of undetectable SARS-CoV-2 viral load at day 5 was 49.9% in the metformin group versus 54.6% in the placebo group (odds ratio, 1.235), and the undetectable rate at day 10 was 14.3% in the metformin group and 22.6% in the placebo group (OR, 1.663; P = .003).

An increased antiviral effect corresponded with increases in metformin dosing on days 6 through 14. Furthermore, the antiviral effect became stronger when metformin was started earlier in the course of infection.

Of note, the antiviral effect was more pronounced among those who were not vaccinated (mean, –0.95 log copies/mL), compared with the vaccinated (mean, –0.39 log copies/mL).

The antiviral effect with metformin was similar to that seen with nirmatrelvir at day 5 and was greater than nirmatrelvir at day 10.

No similar relationships in SARS-CoV-2 viral load were observed between ivermectin or fluvoxamine and placebo.

The findings are consistent with results of other recent observational studies, including research showing metformin to be associated with reductions in COVID-19 severity in patients with prediabetes, Dr. Bramante noted.

The authors’ previous analysis looking at long COVID in the COVID-OUT study showed that metformin treatment during acute COVID significantly reduced the risk for a diagnosis of long COVID versus placebo at 300 days following randomization, with a hazard ratio of 0.59 after adjustment for the study drug and vaccination at baseline.

Dr. Bramante noted that metformin’s potential antiviral properties have long been speculated, with some of the earliest research on the drug suggesting less severe outcomes in influenza, and more recently, RNA assays suggesting effects against other RNA viruses, including the Zika virus.

In terms of COVID, Dr. Bramante noted that the drug has plenty of potentially favorable benefits.

“Metformin is very safe and is known to have very few contraindications, so the next steps could be to consider looking at this in terms of a combination therapy,” she said.
 

‘Data from other studies are conflicting’

Commenting on the study, Diane V. Havlir, MD, cautioned that “metformin is currently not recommended in treatment guidelines, [and] data from other studies are conflicting; side effects can be an issue, and the study presented here was in a select population,” she said in an interview.

However, “what is both new and interesting in this presentation is the reduction of viral load, which [was observed] in the samples collected not only on days 1-5, but also days 6-14,” said Dr. Havlir, who is professor and associate chair of clinical research, department of medicine, and chief of the division of HIV, infectious diseases and global medicine and director of the AIDS Research Institute at the University of California, San Francisco.

Key questions the findings raise include whether the results correlate with clinical outcomes or transmission, and whether the findings are generalizable to other populations and settings, Dr. Havlir said.

Ultimately, “we need to continue to pursue all aspects of outpatient treatments for COVID to address questions like these for new and existing agents,” she added.

The trial received funding from the Parsemus Foundation, the Rainwater Charitable Foundation, Fast Grants, and the United Health Group. The authors and Dr. Havlir disclosed no relevant financial relationships.

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

A new study shows the Pfizer vaccine is safe and highly effective against COVID-19 in children as young as 6 months old.

A three-dose series of the Pfizer COVID-19 vaccine was 73% effective at preventing symptomatic COVID-19 in children aged 6 months to 4 years, the researchers found. They also found that an examination of reactions and safety results “did not suggest any concerns.”

The study, published in the New England Journal of Medicine, included 1,776 children aged 6 months to 2 years old, and 2,750 children aged 2-4 years. Children were randomly assigned to receive either the three-shot series of the Pfizer vaccine or placebo shots. Participants received the first dose of the vaccine by March 31, 2022, and lived in Brazil, Finland, Poland, Spain, or the United States.

The authors wrote that having safe and effective COVID vaccines for young children is important to protect them from hospitalization or death and because young children play a role in spreading highly transmissible variants of the virus. COVID hospitalizations for children under 5 years old peaked at a rate of 14.5 per 100,000 in January 2022, the authors wrote, noting that the Omicron virus variant appeared to affect young children more severely than the previous variant, Delta.

When the researchers evaluated vaccine effectiveness by age group, they found that it prevented symptomatic COVID in 75.8% of children aged 6 months to 2 years, and in 71.8% of children aged 2-4 years.

Less than 0.5% of participants reported severe reactions to the vaccine. The most common reactions reported were tenderness or pain. Reactions typically appeared within the first couple days following vaccine administration and resolved within 2 days. No cases of inflammation of the heart muscle or its lining were reported among participants.

Uptake of COVID vaccines for young children has been lower than other age groups in the United States. The Centers for Disease Control and Prevention says 10% of children younger than 5 have received at least one dose of a COVID-19 vaccine, and 5% have completed a primary vaccine series.

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

A new study shows the Pfizer vaccine is safe and highly effective against COVID-19 in children as young as 6 months old.

A three-dose series of the Pfizer COVID-19 vaccine was 73% effective at preventing symptomatic COVID-19 in children aged 6 months to 4 years, the researchers found. They also found that an examination of reactions and safety results “did not suggest any concerns.”

The study, published in the New England Journal of Medicine, included 1,776 children aged 6 months to 2 years old, and 2,750 children aged 2-4 years. Children were randomly assigned to receive either the three-shot series of the Pfizer vaccine or placebo shots. Participants received the first dose of the vaccine by March 31, 2022, and lived in Brazil, Finland, Poland, Spain, or the United States.

The authors wrote that having safe and effective COVID vaccines for young children is important to protect them from hospitalization or death and because young children play a role in spreading highly transmissible variants of the virus. COVID hospitalizations for children under 5 years old peaked at a rate of 14.5 per 100,000 in January 2022, the authors wrote, noting that the Omicron virus variant appeared to affect young children more severely than the previous variant, Delta.

When the researchers evaluated vaccine effectiveness by age group, they found that it prevented symptomatic COVID in 75.8% of children aged 6 months to 2 years, and in 71.8% of children aged 2-4 years.

Less than 0.5% of participants reported severe reactions to the vaccine. The most common reactions reported were tenderness or pain. Reactions typically appeared within the first couple days following vaccine administration and resolved within 2 days. No cases of inflammation of the heart muscle or its lining were reported among participants.

Uptake of COVID vaccines for young children has been lower than other age groups in the United States. The Centers for Disease Control and Prevention says 10% of children younger than 5 have received at least one dose of a COVID-19 vaccine, and 5% have completed a primary vaccine series.

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

A new study shows the Pfizer vaccine is safe and highly effective against COVID-19 in children as young as 6 months old.

A three-dose series of the Pfizer COVID-19 vaccine was 73% effective at preventing symptomatic COVID-19 in children aged 6 months to 4 years, the researchers found. They also found that an examination of reactions and safety results “did not suggest any concerns.”

The study, published in the New England Journal of Medicine, included 1,776 children aged 6 months to 2 years old, and 2,750 children aged 2-4 years. Children were randomly assigned to receive either the three-shot series of the Pfizer vaccine or placebo shots. Participants received the first dose of the vaccine by March 31, 2022, and lived in Brazil, Finland, Poland, Spain, or the United States.

The authors wrote that having safe and effective COVID vaccines for young children is important to protect them from hospitalization or death and because young children play a role in spreading highly transmissible variants of the virus. COVID hospitalizations for children under 5 years old peaked at a rate of 14.5 per 100,000 in January 2022, the authors wrote, noting that the Omicron virus variant appeared to affect young children more severely than the previous variant, Delta.

When the researchers evaluated vaccine effectiveness by age group, they found that it prevented symptomatic COVID in 75.8% of children aged 6 months to 2 years, and in 71.8% of children aged 2-4 years.

Less than 0.5% of participants reported severe reactions to the vaccine. The most common reactions reported were tenderness or pain. Reactions typically appeared within the first couple days following vaccine administration and resolved within 2 days. No cases of inflammation of the heart muscle or its lining were reported among participants.

Uptake of COVID vaccines for young children has been lower than other age groups in the United States. The Centers for Disease Control and Prevention says 10% of children younger than 5 have received at least one dose of a COVID-19 vaccine, and 5% have completed a primary vaccine series.

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