MDedge Surgery

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

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

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

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

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Critical care staff are less likely to acquire COVID-19 infection from ICU patients than they are from areas away from the bedside, a new study has found.

Courtesy NIAID

“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.

She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.

The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.

“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”

The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.

The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.

“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”

All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.

Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).

Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.

“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”

Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.

The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.

“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”

There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.

These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.

In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.

“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”

Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”

Sixteen dysregulated genes strongly characterize hidradenitis suppurativa (HS), Andre da Costa, PhD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

He presented highlights of a multicenter translational study, which utilized whole transcriptome analysis of lesional and nonlesional skin from patients with HS and normal controls along with quantitative real-time PCR and immunohistochemistry. The purpose was to further define the molecular taxonomy of this inflammatory disease. And while this objective was achieved, the results also underscored a truism regarding the painful and scarring disease: “HS is characterized by an ever-growing complexity, which translates into multiple potential mechanistic drivers,” observed Dr. da Costa, head of immunology precision medicine at AstraZeneca in Gothenburg, Sweden.

Indeed, the study identified a panel of immune-related drivers in HS that influence innate immunity and cell differentiation in follicular and epidermal keratinocytes. The research by Dr. da Costa and coinvestigators identified a broad array of promising novel therapeutic targets in HS.

“Our findings provide evidence of an inflammatory process coupled with impaired barrier function, altered epidermal cell differentiation, and possibly abnormal microbiome activity which can be seen at the follicular and epidermal keratinocytes and also to a minor degree at the level of the skin glands,” Dr. da Costa said.

There is a huge unmet need for new therapies for HS, since at present adalimumab (Humira) is the only approved medication for this debilitating inflammatory disease. Some good news that emerged from this translational study is that some of the novel molecular mediators implicated in HS are targeted by multiple Food and Drug Administration–approved therapies that have other indications. From a drug development standpoint, repurposing a commercially available drug for a novel indication is a much more efficient and less costly endeavor than is necessary to establish the safety and efficacy of an unproven new agent.

The translational work demonstrated that the proteins calgranulin-A and -B and serpin-B4 were strongly expressed in the hair root sheaths of patients with HS. Connexin-32 and koebnerisin were present in stratum granulosum, matrix metallopeptidase-9 was strongly expressed in resident monocytes, small prolin-rich protein 3 in apocrine sweat glands and ducts as well as in sebaceous glands and ducts, and transcobalamin-1 was prominent in stratum spinosum.

Of the 19 key molecular mediators of HS identified in the study, FDA-approved agents are already available that target 12 of them. For example, apremilast (Otezla) targets interferon-gamma and tumor necrosis factor–alpha. Gentamicin targets growth arrest-specific 6 (GAS6) and interleukin-17 (IL-17). Secukinumab (Cosentyx) and ixekizumab (Taltz) target IL-17A, and brodalumab (Siliq) more broadly targets IL-17A as well as all the other IL-17 receptors. Thalidomide targets hepatocyte growth factor (HGF) and TNF-alpha. Spironolactone targets androgen receptor (AR) and TNF-alpha. Colchicine targets tubulin. Anakinra (Kineret) homes in on the IL-1 receptor. And prednisone targets NFxB.

Other key molecular mediators of HS, which are targeted by commercially available drugs, include epidermal growth factor (EGF), macrophage colony-stimulating factor (MCSF), epiregulin (EREG), fibroblast growth factor 1 (FGF1), FGF2, insulin-like growth factor 2 (IGF2), and IL-6, according to Dr. da Costa.

In addition, clinical trials are underway in HS involving totally investigational agents, including several Janus kinase inhibitors and tyrosine kinase 2 inhibitors.

The work described by Dr. da Costa had multiple funding sources, including the European Hidradenitis Suppurativa Foundation, the University of Copenhagen, the Icahn School of Medicine at Mount Sinai, AstraZeneca, and the German Federal Ministry of Education and Research. Dr. da Costa is an employee of AstraZeneca, Gothenburg, Sweden.

[email protected]

Sixteen dysregulated genes strongly characterize hidradenitis suppurativa (HS), Andre da Costa, PhD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

He presented highlights of a multicenter translational study, which utilized whole transcriptome analysis of lesional and nonlesional skin from patients with HS and normal controls along with quantitative real-time PCR and immunohistochemistry. The purpose was to further define the molecular taxonomy of this inflammatory disease. And while this objective was achieved, the results also underscored a truism regarding the painful and scarring disease: “HS is characterized by an ever-growing complexity, which translates into multiple potential mechanistic drivers,” observed Dr. da Costa, head of immunology precision medicine at AstraZeneca in Gothenburg, Sweden.

Indeed, the study identified a panel of immune-related drivers in HS that influence innate immunity and cell differentiation in follicular and epidermal keratinocytes. The research by Dr. da Costa and coinvestigators identified a broad array of promising novel therapeutic targets in HS.

“Our findings provide evidence of an inflammatory process coupled with impaired barrier function, altered epidermal cell differentiation, and possibly abnormal microbiome activity which can be seen at the follicular and epidermal keratinocytes and also to a minor degree at the level of the skin glands,” Dr. da Costa said.

There is a huge unmet need for new therapies for HS, since at present adalimumab (Humira) is the only approved medication for this debilitating inflammatory disease. Some good news that emerged from this translational study is that some of the novel molecular mediators implicated in HS are targeted by multiple Food and Drug Administration–approved therapies that have other indications. From a drug development standpoint, repurposing a commercially available drug for a novel indication is a much more efficient and less costly endeavor than is necessary to establish the safety and efficacy of an unproven new agent.

The translational work demonstrated that the proteins calgranulin-A and -B and serpin-B4 were strongly expressed in the hair root sheaths of patients with HS. Connexin-32 and koebnerisin were present in stratum granulosum, matrix metallopeptidase-9 was strongly expressed in resident monocytes, small prolin-rich protein 3 in apocrine sweat glands and ducts as well as in sebaceous glands and ducts, and transcobalamin-1 was prominent in stratum spinosum.

Of the 19 key molecular mediators of HS identified in the study, FDA-approved agents are already available that target 12 of them. For example, apremilast (Otezla) targets interferon-gamma and tumor necrosis factor–alpha. Gentamicin targets growth arrest-specific 6 (GAS6) and interleukin-17 (IL-17). Secukinumab (Cosentyx) and ixekizumab (Taltz) target IL-17A, and brodalumab (Siliq) more broadly targets IL-17A as well as all the other IL-17 receptors. Thalidomide targets hepatocyte growth factor (HGF) and TNF-alpha. Spironolactone targets androgen receptor (AR) and TNF-alpha. Colchicine targets tubulin. Anakinra (Kineret) homes in on the IL-1 receptor. And prednisone targets NFxB.

Other key molecular mediators of HS, which are targeted by commercially available drugs, include epidermal growth factor (EGF), macrophage colony-stimulating factor (MCSF), epiregulin (EREG), fibroblast growth factor 1 (FGF1), FGF2, insulin-like growth factor 2 (IGF2), and IL-6, according to Dr. da Costa.

In addition, clinical trials are underway in HS involving totally investigational agents, including several Janus kinase inhibitors and tyrosine kinase 2 inhibitors.

The work described by Dr. da Costa had multiple funding sources, including the European Hidradenitis Suppurativa Foundation, the University of Copenhagen, the Icahn School of Medicine at Mount Sinai, AstraZeneca, and the German Federal Ministry of Education and Research. Dr. da Costa is an employee of AstraZeneca, Gothenburg, Sweden.

[email protected]

Sixteen dysregulated genes strongly characterize hidradenitis suppurativa (HS), Andre da Costa, PhD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

He presented highlights of a multicenter translational study, which utilized whole transcriptome analysis of lesional and nonlesional skin from patients with HS and normal controls along with quantitative real-time PCR and immunohistochemistry. The purpose was to further define the molecular taxonomy of this inflammatory disease. And while this objective was achieved, the results also underscored a truism regarding the painful and scarring disease: “HS is characterized by an ever-growing complexity, which translates into multiple potential mechanistic drivers,” observed Dr. da Costa, head of immunology precision medicine at AstraZeneca in Gothenburg, Sweden.

Indeed, the study identified a panel of immune-related drivers in HS that influence innate immunity and cell differentiation in follicular and epidermal keratinocytes. The research by Dr. da Costa and coinvestigators identified a broad array of promising novel therapeutic targets in HS.

“Our findings provide evidence of an inflammatory process coupled with impaired barrier function, altered epidermal cell differentiation, and possibly abnormal microbiome activity which can be seen at the follicular and epidermal keratinocytes and also to a minor degree at the level of the skin glands,” Dr. da Costa said.

There is a huge unmet need for new therapies for HS, since at present adalimumab (Humira) is the only approved medication for this debilitating inflammatory disease. Some good news that emerged from this translational study is that some of the novel molecular mediators implicated in HS are targeted by multiple Food and Drug Administration–approved therapies that have other indications. From a drug development standpoint, repurposing a commercially available drug for a novel indication is a much more efficient and less costly endeavor than is necessary to establish the safety and efficacy of an unproven new agent.

The translational work demonstrated that the proteins calgranulin-A and -B and serpin-B4 were strongly expressed in the hair root sheaths of patients with HS. Connexin-32 and koebnerisin were present in stratum granulosum, matrix metallopeptidase-9 was strongly expressed in resident monocytes, small prolin-rich protein 3 in apocrine sweat glands and ducts as well as in sebaceous glands and ducts, and transcobalamin-1 was prominent in stratum spinosum.

Of the 19 key molecular mediators of HS identified in the study, FDA-approved agents are already available that target 12 of them. For example, apremilast (Otezla) targets interferon-gamma and tumor necrosis factor–alpha. Gentamicin targets growth arrest-specific 6 (GAS6) and interleukin-17 (IL-17). Secukinumab (Cosentyx) and ixekizumab (Taltz) target IL-17A, and brodalumab (Siliq) more broadly targets IL-17A as well as all the other IL-17 receptors. Thalidomide targets hepatocyte growth factor (HGF) and TNF-alpha. Spironolactone targets androgen receptor (AR) and TNF-alpha. Colchicine targets tubulin. Anakinra (Kineret) homes in on the IL-1 receptor. And prednisone targets NFxB.

Other key molecular mediators of HS, which are targeted by commercially available drugs, include epidermal growth factor (EGF), macrophage colony-stimulating factor (MCSF), epiregulin (EREG), fibroblast growth factor 1 (FGF1), FGF2, insulin-like growth factor 2 (IGF2), and IL-6, according to Dr. da Costa.

In addition, clinical trials are underway in HS involving totally investigational agents, including several Janus kinase inhibitors and tyrosine kinase 2 inhibitors.

The work described by Dr. da Costa had multiple funding sources, including the European Hidradenitis Suppurativa Foundation, the University of Copenhagen, the Icahn School of Medicine at Mount Sinai, AstraZeneca, and the German Federal Ministry of Education and Research. Dr. da Costa is an employee of AstraZeneca, Gothenburg, Sweden.

[email protected]

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

Delaying surgical reconstruction of fistula structures until after patients with hidradenitis suppurativa (HS) have been on adalimumab for a minimum of 6 months transforms primary wound closure into a highly attractive option, a pilot study suggests.

“Our experience suggests that under the effects of treatment with adalimumab, wound healing disorders with primary wound closure occur less often. And primary wound closure offers advantages over secondary wound healing: shorter length of inpatient stay, lower morbidity, fewer functional problems, and better quality of life,” Gefion Girbig, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

She noted that primary wound closure following surgery for HS is controversial. For example, current German guidelines recommend complete surgical excision of HS lesions, followed by secondary wound healing; the guidelines advise against primary wound closure. But those guidelines were issued back in 2012, years before adalimumab (Humira) achieved regulatory approval as the first and to date only medication indicated for treatment of HS.

Experts agree that while adalimumab has been a difference maker for many patients with HS, surgery is still often necessary. And many surgeons prefer secondary wound healing in HS. That’s because healing by first intention has historically often resulted in complications involving wound healing disorders and infection. These complications necessitate loosening of the primary closure to permit further wound healing by second intention, with a resultant prolonged healing time, explained Dr. Girbig, of the Institute for Health Sciences Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany).

She and her coinvestigators hypothesized that the disordered wound healing is a consequence of the underlying inflammatory disease that lies at the core of HS, and that quelling the inflammation with adalimumab for at least 6 months before performing surgery with primary closure while the anti-TNF therapy continues would reduce the incidence of wound healing disorders.

This was borne out in the group’s small observational pilot study. It included 10 patients with HS who underwent surgery only after at least 6 months on adalimumab. Six had surgery for axillary HS and four for inguinal disease. Only 2 of the 10 developed a wound healing disorder. Both had surgical reconstruction in the inguinal area. Neither case involved infection. Surgical management entailed opening part of the suture to allow simultaneous secondary wound closure.

This 20% incidence of disordered wound healing when primary closure was carried out while systemic inflammation was controlled via adalimumab is markedly lower than rates reported using primary closure without adalimumab. Dr. Girbig and her coinvestigators are now conducting a larger controlled study to confirm their findings.

She reported having no financial conflicts regarding her study.

[email protected]

Delaying surgical reconstruction of fistula structures until after patients with hidradenitis suppurativa (HS) have been on adalimumab for a minimum of 6 months transforms primary wound closure into a highly attractive option, a pilot study suggests.

“Our experience suggests that under the effects of treatment with adalimumab, wound healing disorders with primary wound closure occur less often. And primary wound closure offers advantages over secondary wound healing: shorter length of inpatient stay, lower morbidity, fewer functional problems, and better quality of life,” Gefion Girbig, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

She noted that primary wound closure following surgery for HS is controversial. For example, current German guidelines recommend complete surgical excision of HS lesions, followed by secondary wound healing; the guidelines advise against primary wound closure. But those guidelines were issued back in 2012, years before adalimumab (Humira) achieved regulatory approval as the first and to date only medication indicated for treatment of HS.

Experts agree that while adalimumab has been a difference maker for many patients with HS, surgery is still often necessary. And many surgeons prefer secondary wound healing in HS. That’s because healing by first intention has historically often resulted in complications involving wound healing disorders and infection. These complications necessitate loosening of the primary closure to permit further wound healing by second intention, with a resultant prolonged healing time, explained Dr. Girbig, of the Institute for Health Sciences Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany).

She and her coinvestigators hypothesized that the disordered wound healing is a consequence of the underlying inflammatory disease that lies at the core of HS, and that quelling the inflammation with adalimumab for at least 6 months before performing surgery with primary closure while the anti-TNF therapy continues would reduce the incidence of wound healing disorders.

This was borne out in the group’s small observational pilot study. It included 10 patients with HS who underwent surgery only after at least 6 months on adalimumab. Six had surgery for axillary HS and four for inguinal disease. Only 2 of the 10 developed a wound healing disorder. Both had surgical reconstruction in the inguinal area. Neither case involved infection. Surgical management entailed opening part of the suture to allow simultaneous secondary wound closure.

This 20% incidence of disordered wound healing when primary closure was carried out while systemic inflammation was controlled via adalimumab is markedly lower than rates reported using primary closure without adalimumab. Dr. Girbig and her coinvestigators are now conducting a larger controlled study to confirm their findings.

She reported having no financial conflicts regarding her study.

[email protected]

Delaying surgical reconstruction of fistula structures until after patients with hidradenitis suppurativa (HS) have been on adalimumab for a minimum of 6 months transforms primary wound closure into a highly attractive option, a pilot study suggests.

“Our experience suggests that under the effects of treatment with adalimumab, wound healing disorders with primary wound closure occur less often. And primary wound closure offers advantages over secondary wound healing: shorter length of inpatient stay, lower morbidity, fewer functional problems, and better quality of life,” Gefion Girbig, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

She noted that primary wound closure following surgery for HS is controversial. For example, current German guidelines recommend complete surgical excision of HS lesions, followed by secondary wound healing; the guidelines advise against primary wound closure. But those guidelines were issued back in 2012, years before adalimumab (Humira) achieved regulatory approval as the first and to date only medication indicated for treatment of HS.

Experts agree that while adalimumab has been a difference maker for many patients with HS, surgery is still often necessary. And many surgeons prefer secondary wound healing in HS. That’s because healing by first intention has historically often resulted in complications involving wound healing disorders and infection. These complications necessitate loosening of the primary closure to permit further wound healing by second intention, with a resultant prolonged healing time, explained Dr. Girbig, of the Institute for Health Sciences Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany).

She and her coinvestigators hypothesized that the disordered wound healing is a consequence of the underlying inflammatory disease that lies at the core of HS, and that quelling the inflammation with adalimumab for at least 6 months before performing surgery with primary closure while the anti-TNF therapy continues would reduce the incidence of wound healing disorders.

This was borne out in the group’s small observational pilot study. It included 10 patients with HS who underwent surgery only after at least 6 months on adalimumab. Six had surgery for axillary HS and four for inguinal disease. Only 2 of the 10 developed a wound healing disorder. Both had surgical reconstruction in the inguinal area. Neither case involved infection. Surgical management entailed opening part of the suture to allow simultaneous secondary wound closure.

This 20% incidence of disordered wound healing when primary closure was carried out while systemic inflammation was controlled via adalimumab is markedly lower than rates reported using primary closure without adalimumab. Dr. Girbig and her coinvestigators are now conducting a larger controlled study to confirm their findings.

She reported having no financial conflicts regarding her study.

[email protected]

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.

The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.

“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).

“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.

“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.

The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).

Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.

On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).

Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.

The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.

There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.

This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.

“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.

“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.

The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
 

Shorter radiotherapy regimen for breast cancer

In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.

One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.

These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.

Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.

The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.

“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”

The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.

What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.

“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.

“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
 

Radiotherapy remains reduced

Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.

“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.

“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”

By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”

The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.

No funding for the study was declared. The authors disclosed no relevant financial relationships.

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

Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.

The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.

“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).

“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.

“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.

The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).

Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.

On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).

Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.

The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.

There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.

This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.

“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.

“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.

The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
 

Shorter radiotherapy regimen for breast cancer

In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.

One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.

These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.

Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.

The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.

“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”

The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.

What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.

“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.

“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
 

Radiotherapy remains reduced

Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.

“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.

“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”

By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”

The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.

No funding for the study was declared. The authors disclosed no relevant financial relationships.

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

Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.

The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.

“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).

“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.

“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.

The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).

Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.

On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).

Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.

The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.

There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.

This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.

“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.

“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.

The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
 

Shorter radiotherapy regimen for breast cancer

In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.

One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.

These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.

Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.

The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.

“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”

The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.

What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.

“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.

“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
 

Radiotherapy remains reduced

Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.

“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.

“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”

By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”

The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.

No funding for the study was declared. The authors disclosed no relevant financial relationships.

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