Ob.Gyn. News

Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.

“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”

It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”

As practices across the United States start reopening, physicians frequently hit bumps in the road, according to Kerin Bashaw, senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”

As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
 

1. Unclear or nonexistent polices and protocols

Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.

Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.

“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.

“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.

Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)

When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
 

2. Trying to see too many patients too soon

On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.

For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.

Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”

It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”

“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.

He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
 

3. Undercommunicating with patients and staff

Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.

He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.

Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.

He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
 

4. Giving inadequate staff training and holding too-high expectations

Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.

Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.

“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”

Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.

Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.

Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.

Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”

If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
 

5. Neglecting to document everything – even more so than before

The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.

Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.

Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.

Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.

Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.

Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.

All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
 

6. Forgetting about your own and your staff’s physical and mental health

Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.

“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.

That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.

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

Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.

“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”

It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”

As practices across the United States start reopening, physicians frequently hit bumps in the road, according to Kerin Bashaw, senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”

As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
 

1. Unclear or nonexistent polices and protocols

Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.

Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.

“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.

“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.

Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)

When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
 

2. Trying to see too many patients too soon

On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.

For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.

Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”

It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”

“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.

He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
 

3. Undercommunicating with patients and staff

Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.

He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.

Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.

He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
 

4. Giving inadequate staff training and holding too-high expectations

Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.

Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.

“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”

Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.

Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.

Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.

Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”

If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
 

5. Neglecting to document everything – even more so than before

The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.

Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.

Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.

Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.

Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.

Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.

All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
 

6. Forgetting about your own and your staff’s physical and mental health

Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.

“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.

That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.

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

Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.

“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”

It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”

As practices across the United States start reopening, physicians frequently hit bumps in the road, according to Kerin Bashaw, senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”

As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
 

1. Unclear or nonexistent polices and protocols

Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.

Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.

“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.

“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.

Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)

When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
 

2. Trying to see too many patients too soon

On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.

For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.

Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”

It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”

“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.

He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
 

3. Undercommunicating with patients and staff

Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.

He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.

Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.

He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
 

4. Giving inadequate staff training and holding too-high expectations

Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.

Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.

“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”

Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.

Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.

Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.

Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”

If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
 

5. Neglecting to document everything – even more so than before

The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.

Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.

Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.

Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.

Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.

Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.

All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
 

6. Forgetting about your own and your staff’s physical and mental health

Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.

“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.

That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.

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

A new study has determined a benefit of cardiac CT scans beyond assessing heart health: Evaluating fracture rate and potential osteoporosis through the bone mineral density (BMD) of thoracic vertebrae.

“Our results represent a step toward appraisal and recognition of the clinical utility of opportunistic BMD screening from cardiac CT,” wrote Josephine Therkildsen, MD, of Hospital Unit West in Herning, Denmark, and coauthors. The study was published July 14 in Radiology.

To determine if further analysis of cardiac CT could help determine BMD and its association with fracture rate, the investigators launched a prospective observational study of 1,487 Danish patients with potential coronary artery disease who underwent cardiac CT scans between September 2014 and March 2016. Their mean age was 57 years (standard deviation, 9; range, 40-80). Nearly all of the patients were white, and 52.5% (n = 781) were women.

All participants underwent a noncontrast-enhanced cardiac CT, from which volumetric BMD of three thoracic vertebrae was measured via commercially available semiautomatic software. Their mean BMD was 119 mg/cm³ (SD, 34) with no significant difference noted between male and female patients. Of the 1,487 participants, 695 were defined as having normal BMD (> 120 mg/cm³), 613 as having low BMD (80-120 mg/cm³), and 179 as having very low BMD (< 80 mg/cm³). Median follow-up was 3.1 years (interquartile range, 2.7-3.4).

Incident fracture occurred in 80 patients (5.4%), of whom 48 were women and 32 were men. Patients who suffered fractures were significantly older than patients with no fractures (mean 59 years vs. 57 years; P = .03). Of the 80 patients with fractures, 31 were osteoporosis related.

In an unadjusted analysis, participants with very low BMD had a greater rate of any fracture (hazard ratio [HR], 2.6; 95% confidence interval, 1.4-4.7; P = .002) and of osteoporosis-related fracture (HR, 8.1; 95% CI, 2.4-27.0; P = .001). After adjustment for age and sex, their rates remained significantly greater for any fracture (HR, 2.1; 95% CI, 1.1-4.2; P = .03) and for osteoporosis-related fracture (HR, 4.0; 95% CI, 1.1-15.0; P = .04).

“Opportunistic” use of scans benefits both physicians and patients

“The concept of using a CT scan that was done for a different purpose allows you to be opportunistic,” Ethel S. Siris, MD, the Madeline C. Stabile Professor of Clinical Medicine in the department of medicine at Columbia University and director of the Toni Stabile Osteoporosis Center of the Columbia University Medical Center, New York–Presbyterian Hospital, New York, said in an interview. “If you’re dealing with older patients, and if you have the software for your radiologist to use to reanalyze the CT scan and say something about the bone, it’s certainly a way of estimating who may be at risk of future fractures.

“From a practical point of view, it’s hard to imagine that it would ever replace conventional bone mineral density testing via DXA [dual-energy x-ray absorptiometry],” she added. “That said, osteoporosis is woefully underdiagnosed because people don’t get DXA tested. This study showed that, if you have access to the scan of the thoracic or even the lumbar spine and if you have the necessary software, you can make legitimate statements about the numbers being low or very low. What that would lead to, I would hope, is some internists to say, ‘This could be a predictor of fracture risk. We should put you on treatment.’ And then follow up with a conventional DXA test.

“Is that going to happen? I don’t know. But the bottom line of the study is: Anything that may enhance the physician’s drive to evaluate a patient for fracture risk is good.”
 

Whatever the reason for the scan, CT can help diagnose osteoporosis

This study reinforces that CT exams – of the chest, in particular – can serve a valuable dual purpose as osteoporosis screenings, Miriam A. Bredella, MD, professor of radiology at Harvard Medical School and vice chair of the department of radiology at Massachusetts General Hospital, Boston, wrote in an accompanying editorial.

“In the United States, more than 80 million CT examinations are performed each year, many of which could be used to screen for osteoporosis without additional costs or radiation exposure,” she wrote. And thanks to the findings of the study by Therkildsen et al., which relied on both established and new BMD thresholds, the link between thoracic spine BMD and fracture risk is clearer than ever.

“I hope this study will ignite interest in using chest CT examinations performed for other purposes, such as lung cancer screening, for opportunistic osteoporosis screening and prediction of fractures in vulnerable populations,” she added.

The authors acknowledged their study’s limitations, including a small number of fracture events overall and the inability to evaluate associations between BMD and fracture rate at specific locations. In addition, their cohort was largely made up of white participants with a certain coronary artery disease risk profile; because of ethnical differences in BMD measurements, their results “cannot be extrapolated to other ethnical groups.”

Several of the study’s authors reported potential conflicts of interest, including receiving grants and money for consultancies and board memberships from various councils, associations, and pharmaceutical companies. Dr. Bredella reported no conflicts of interest. Dr. Siris has no relevant disclosures.

SOURCE: Therkildsen J et al. Radiology. 2020 Jul 14. doi: 10.1148/radiol.2020192706.

A new study has determined a benefit of cardiac CT scans beyond assessing heart health: Evaluating fracture rate and potential osteoporosis through the bone mineral density (BMD) of thoracic vertebrae.

“Our results represent a step toward appraisal and recognition of the clinical utility of opportunistic BMD screening from cardiac CT,” wrote Josephine Therkildsen, MD, of Hospital Unit West in Herning, Denmark, and coauthors. The study was published July 14 in Radiology.

To determine if further analysis of cardiac CT could help determine BMD and its association with fracture rate, the investigators launched a prospective observational study of 1,487 Danish patients with potential coronary artery disease who underwent cardiac CT scans between September 2014 and March 2016. Their mean age was 57 years (standard deviation, 9; range, 40-80). Nearly all of the patients were white, and 52.5% (n = 781) were women.

All participants underwent a noncontrast-enhanced cardiac CT, from which volumetric BMD of three thoracic vertebrae was measured via commercially available semiautomatic software. Their mean BMD was 119 mg/cm³ (SD, 34) with no significant difference noted between male and female patients. Of the 1,487 participants, 695 were defined as having normal BMD (> 120 mg/cm³), 613 as having low BMD (80-120 mg/cm³), and 179 as having very low BMD (< 80 mg/cm³). Median follow-up was 3.1 years (interquartile range, 2.7-3.4).

Incident fracture occurred in 80 patients (5.4%), of whom 48 were women and 32 were men. Patients who suffered fractures were significantly older than patients with no fractures (mean 59 years vs. 57 years; P = .03). Of the 80 patients with fractures, 31 were osteoporosis related.

In an unadjusted analysis, participants with very low BMD had a greater rate of any fracture (hazard ratio [HR], 2.6; 95% confidence interval, 1.4-4.7; P = .002) and of osteoporosis-related fracture (HR, 8.1; 95% CI, 2.4-27.0; P = .001). After adjustment for age and sex, their rates remained significantly greater for any fracture (HR, 2.1; 95% CI, 1.1-4.2; P = .03) and for osteoporosis-related fracture (HR, 4.0; 95% CI, 1.1-15.0; P = .04).

“Opportunistic” use of scans benefits both physicians and patients

“The concept of using a CT scan that was done for a different purpose allows you to be opportunistic,” Ethel S. Siris, MD, the Madeline C. Stabile Professor of Clinical Medicine in the department of medicine at Columbia University and director of the Toni Stabile Osteoporosis Center of the Columbia University Medical Center, New York–Presbyterian Hospital, New York, said in an interview. “If you’re dealing with older patients, and if you have the software for your radiologist to use to reanalyze the CT scan and say something about the bone, it’s certainly a way of estimating who may be at risk of future fractures.

“From a practical point of view, it’s hard to imagine that it would ever replace conventional bone mineral density testing via DXA [dual-energy x-ray absorptiometry],” she added. “That said, osteoporosis is woefully underdiagnosed because people don’t get DXA tested. This study showed that, if you have access to the scan of the thoracic or even the lumbar spine and if you have the necessary software, you can make legitimate statements about the numbers being low or very low. What that would lead to, I would hope, is some internists to say, ‘This could be a predictor of fracture risk. We should put you on treatment.’ And then follow up with a conventional DXA test.

“Is that going to happen? I don’t know. But the bottom line of the study is: Anything that may enhance the physician’s drive to evaluate a patient for fracture risk is good.”
 

Whatever the reason for the scan, CT can help diagnose osteoporosis

This study reinforces that CT exams – of the chest, in particular – can serve a valuable dual purpose as osteoporosis screenings, Miriam A. Bredella, MD, professor of radiology at Harvard Medical School and vice chair of the department of radiology at Massachusetts General Hospital, Boston, wrote in an accompanying editorial.

“In the United States, more than 80 million CT examinations are performed each year, many of which could be used to screen for osteoporosis without additional costs or radiation exposure,” she wrote. And thanks to the findings of the study by Therkildsen et al., which relied on both established and new BMD thresholds, the link between thoracic spine BMD and fracture risk is clearer than ever.

“I hope this study will ignite interest in using chest CT examinations performed for other purposes, such as lung cancer screening, for opportunistic osteoporosis screening and prediction of fractures in vulnerable populations,” she added.

The authors acknowledged their study’s limitations, including a small number of fracture events overall and the inability to evaluate associations between BMD and fracture rate at specific locations. In addition, their cohort was largely made up of white participants with a certain coronary artery disease risk profile; because of ethnical differences in BMD measurements, their results “cannot be extrapolated to other ethnical groups.”

Several of the study’s authors reported potential conflicts of interest, including receiving grants and money for consultancies and board memberships from various councils, associations, and pharmaceutical companies. Dr. Bredella reported no conflicts of interest. Dr. Siris has no relevant disclosures.

SOURCE: Therkildsen J et al. Radiology. 2020 Jul 14. doi: 10.1148/radiol.2020192706.

A new study has determined a benefit of cardiac CT scans beyond assessing heart health: Evaluating fracture rate and potential osteoporosis through the bone mineral density (BMD) of thoracic vertebrae.

“Our results represent a step toward appraisal and recognition of the clinical utility of opportunistic BMD screening from cardiac CT,” wrote Josephine Therkildsen, MD, of Hospital Unit West in Herning, Denmark, and coauthors. The study was published July 14 in Radiology.

To determine if further analysis of cardiac CT could help determine BMD and its association with fracture rate, the investigators launched a prospective observational study of 1,487 Danish patients with potential coronary artery disease who underwent cardiac CT scans between September 2014 and March 2016. Their mean age was 57 years (standard deviation, 9; range, 40-80). Nearly all of the patients were white, and 52.5% (n = 781) were women.

All participants underwent a noncontrast-enhanced cardiac CT, from which volumetric BMD of three thoracic vertebrae was measured via commercially available semiautomatic software. Their mean BMD was 119 mg/cm³ (SD, 34) with no significant difference noted between male and female patients. Of the 1,487 participants, 695 were defined as having normal BMD (> 120 mg/cm³), 613 as having low BMD (80-120 mg/cm³), and 179 as having very low BMD (< 80 mg/cm³). Median follow-up was 3.1 years (interquartile range, 2.7-3.4).

Incident fracture occurred in 80 patients (5.4%), of whom 48 were women and 32 were men. Patients who suffered fractures were significantly older than patients with no fractures (mean 59 years vs. 57 years; P = .03). Of the 80 patients with fractures, 31 were osteoporosis related.

In an unadjusted analysis, participants with very low BMD had a greater rate of any fracture (hazard ratio [HR], 2.6; 95% confidence interval, 1.4-4.7; P = .002) and of osteoporosis-related fracture (HR, 8.1; 95% CI, 2.4-27.0; P = .001). After adjustment for age and sex, their rates remained significantly greater for any fracture (HR, 2.1; 95% CI, 1.1-4.2; P = .03) and for osteoporosis-related fracture (HR, 4.0; 95% CI, 1.1-15.0; P = .04).

“Opportunistic” use of scans benefits both physicians and patients

“The concept of using a CT scan that was done for a different purpose allows you to be opportunistic,” Ethel S. Siris, MD, the Madeline C. Stabile Professor of Clinical Medicine in the department of medicine at Columbia University and director of the Toni Stabile Osteoporosis Center of the Columbia University Medical Center, New York–Presbyterian Hospital, New York, said in an interview. “If you’re dealing with older patients, and if you have the software for your radiologist to use to reanalyze the CT scan and say something about the bone, it’s certainly a way of estimating who may be at risk of future fractures.

“From a practical point of view, it’s hard to imagine that it would ever replace conventional bone mineral density testing via DXA [dual-energy x-ray absorptiometry],” she added. “That said, osteoporosis is woefully underdiagnosed because people don’t get DXA tested. This study showed that, if you have access to the scan of the thoracic or even the lumbar spine and if you have the necessary software, you can make legitimate statements about the numbers being low or very low. What that would lead to, I would hope, is some internists to say, ‘This could be a predictor of fracture risk. We should put you on treatment.’ And then follow up with a conventional DXA test.

“Is that going to happen? I don’t know. But the bottom line of the study is: Anything that may enhance the physician’s drive to evaluate a patient for fracture risk is good.”
 

Whatever the reason for the scan, CT can help diagnose osteoporosis

This study reinforces that CT exams – of the chest, in particular – can serve a valuable dual purpose as osteoporosis screenings, Miriam A. Bredella, MD, professor of radiology at Harvard Medical School and vice chair of the department of radiology at Massachusetts General Hospital, Boston, wrote in an accompanying editorial.

“In the United States, more than 80 million CT examinations are performed each year, many of which could be used to screen for osteoporosis without additional costs or radiation exposure,” she wrote. And thanks to the findings of the study by Therkildsen et al., which relied on both established and new BMD thresholds, the link between thoracic spine BMD and fracture risk is clearer than ever.

“I hope this study will ignite interest in using chest CT examinations performed for other purposes, such as lung cancer screening, for opportunistic osteoporosis screening and prediction of fractures in vulnerable populations,” she added.

The authors acknowledged their study’s limitations, including a small number of fracture events overall and the inability to evaluate associations between BMD and fracture rate at specific locations. In addition, their cohort was largely made up of white participants with a certain coronary artery disease risk profile; because of ethnical differences in BMD measurements, their results “cannot be extrapolated to other ethnical groups.”

Several of the study’s authors reported potential conflicts of interest, including receiving grants and money for consultancies and board memberships from various councils, associations, and pharmaceutical companies. Dr. Bredella reported no conflicts of interest. Dr. Siris has no relevant disclosures.

SOURCE: Therkildsen J et al. Radiology. 2020 Jul 14. doi: 10.1148/radiol.2020192706.

The COVID-19 pandemic is one of the defining moments in history for this generation’s health care leaders. In 2019, most of us wrongly assumed that this virus would be similar to the past viral epidemics and pandemics such as 2002 severe acute respiratory syndrome–CoV in Asia, 2009 H1N1 influenza in the United States, 2012 Middle East respiratory syndrome–CoV in Saudi Arabia, and 2014-2016 Ebola in West Africa. Moreover, we understood that the 50% fatality rate of Ebola, a single-stranded RNA virus, was deadly on the continent of Africa, but its transmission was through direct contact with blood or other bodily fluids. Hence, the infectivity of Ebola to the general public was lower than SARS-CoV-2, which is spread by respiratory droplets and contact routes in addition to being the virus that causes COVID-19.¹ Many of us did not expect that SARS-CoV-2, a single-stranded RNA virus consisting of 32 kilobytes, would reach the shores of the United States from the Hubei province of China, the northern Lombardy region of Italy, or other initial hotspots. We could not imagine its effects would be so devastating from an economic and medical perspective. Until it did.

The first reported case of SARS-CoV-2 was on Jan. 20, 2020 in Snohomish County, Wash., and the first known death from COVID-19 occurred on Feb. 6, 2020 in Santa Clara County, Calif.^2,3 Since then, the United States has lost over 135,000 people from COVID-19 with death(s) reported in every state and the highest number of overall deaths of any country in the world.⁴ At the beginning of 2020, at our institution, Wake Forest Baptist Health System in Winston-Salem, N.C., we began preparing for the wave, surge, or tsunami of inpatients that was coming. Plans were afoot to increase our staff, even perhaps by hiring out-of-state physicians and nurses if needed, and every possible bed was considered within the system. It was not an if, but rather a when, as to the arrival of COVID-19.

Epidemiologists and biostatisticians developed predictive COVID-19 models so that health care leaders could plan accordingly, especially those patients that required critical care or inpatient medical care. These predictive models have been used across the globe and can be categorized into three groups: Susceptible-Exposed-Infectious-Recovered, Agent-Based, and Curve Fitting Extrapolation.⁵ Our original predictions were based on the Institute for Health Metrics and Evaluation model from Washington state (Curve Fitting Extrapolation). It creates projections from COVID-19 mortality data and assumes a 3% infection rate. Other health systems in our region used the COVID-19 Hospital Impact Model for Epidemics–University of Pennsylvania model. It pins its suppositions on hospitalized COVID-19 patients, regional infection rates, and hospital market shares. Lastly, the agent-based mode, such as the Global Epidemic and Mobility Project, takes simulated populations and forecasts the spread of SARS-CoV-2 anchoring on the interplay of individuals and groups. The assumptions are created secondary to the interactions of people, time, health care interventions, and public health policies.

Based on these predictive simulations, health systems have spent countless hours of planning and have utilized resources for the anticipated needs related to beds, ventilators, supplies, and staffing. Frontline staff were retrained how to don and doff personal protective equipment. Our teams were ready if we saw a wave of 250, a surge of 500, or a tsunami of 750 COVID-19 inpatients. We were prepared to run into the fire fully knowing the personal risks and consequences.

But, as yet, the tsunami in North Carolina has never come. On April 21, 2020, the COVID-19 mortality data in North Carolina peaked at 34 deaths, with the total number of deaths standing at 1,510 as of July 13, 2020.⁶ A surge did not hit our institutional shores at Wake Forest Baptist Health. As we looked through the proverbial back window and hear about the tsunami in Houston, Texas, we are very thankful that the tsunami turned out to be a small wave so far in North Carolina. We are grateful that there were fewer deaths than expected. The dust is settling now and the question, spoken or unspoken, is: “How could we be so wrong with our predictions?”

Models have strengths and weaknesses and none are perfect.⁷ There is an old aphorism in statistics that is often attributed to George Box that says: “All models are wrong but some are useful.”⁸ Predictions and projections are good, but not perfect. Our measurements and tests should not only be accurate, but also be as precise as possible.⁹ Moreover, the assumptions we make should be on solid ground. Since the beginning of the pandemic, there may have been undercounts and delays in reporting. The assumptions of the effects of social distancing may have been inaccurate. Just as important, the lack of early testing in our pandemic and the relatively limited testing currently available provide challenges not only in attributing past deaths to COVID-19, but also with planning and public health measures. To be fair, the tsunami that turned out to be a small wave in North Carolina may be caused by the strong leadership from politicians, public health officials, and health system leaders for their stay-at-home decree and vigorous public health measures in our state.

Some of the health systems in the United States have created “reemergence plans” to care for those patients who have stayed at home for the past several months. Elective surgeries and procedures have begun in different regions of the United States and will likely continue reopening into the late summer. Nevertheless, challenges and opportunities continue to abound during these difficult times of COVID-19. The tsunamis or surges will continue to occur in the United States and the premature reopening of some of the public places and businesses have not helped our collective efforts. In addition, the personal costs have been and will be immeasurable. Many of us have lost loved ones, been laid off, or face mental health crises because of the social isolation and false news.

COVID-19 is here to stay and will be with us for the foreseeable future. Health care providers have been literally risking their lives to serve the public and we will continue to do so. Hitting the target of needed inpatient beds and critical care beds is critically important and is tough without accurate data. We simply have inadequate and unreliable data of COVID-19 incidence and prevalence rates in the communities that we serve. More available testing would allow frontline health care providers and health care leaders to match hospital demand to supply, at individual hospitals and within the health care system. Moreover, contact tracing capabilities would give us the opportunity to isolate individuals and extinguish population-based hotspots.

We may have seen the first wave, but other waves of COVID-19 in North Carolina are sure to come. Since the partial reopening of North Carolina on May 8, 2020, coupled with pockets of nonadherence to social distancing and mask wearing, we expect a second wave sooner rather than later. Interestingly, daily new lab-confirmed COVID-19 cases in North Carolina have been on the rise, with the highest one-day total occurring on June 12, 2020 with 1,768 cases reported.⁶ As a result, North Carolina Gov. Roy Cooper and Secretary of the North Carolina Department of Health and Human Services, Dr. Mandy Cohen, placed a temporary pause on the Phase 2 reopening plan and mandated masks in public on June 24, 2020. It is unclear whether these intermittent daily spikes in lab-confirmed COVID-19 cases are a foreshadowing of our next wave, surge, or tsunami, or just an anomaly. Only time will tell, but as Jim Kim, MD, PhD, has stated so well, there is still time for social distancing, contact tracing, testing, isolation, and treatment.¹⁰ There is still time for us, for our loved ones, for our hospital systems, and for our public health system.

Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System and associate professor of internal medicine at Wake Forest School of Medicine. Dr. Lippert is assistant professor of internal medicine at Wake Forest School of Medicine. Mr. Payne is the associate vice president of Wake Forest Baptist Health. He is responsible for engineering, facilities planning & design as well as environmental health and safety departments. Dr. Pariyadath is comedical director of the Patient Flow Operations Center which facilitates patient placement throughout the Wake Forest Baptist Health system. He is also the associate medical director for the adult emergency department. Dr. Sunkara is assistant professor of internal medicine at Wake Forest School of Medicine. He is the medical director for hospital medicine units and the newly established PUI unit.

Acknowledgments

The authors would like to thank Julie Freischlag, MD; Kevin High, MD, MS; Gary Rosenthal, MD; Wayne Meredith, MD;Russ Howerton, MD; Mike Waid, Andrea Fernandez, MD; Brian Hiestand, MD; the Wake Forest Baptist Health System COVID-19 task force, the Operations Center, and the countless frontline staff at all five hospitals within the Wake Forest Baptist Health System.

References

1. World Health Organization. Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. 2020 June 30. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.

2. Holshue et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382: 929-36.

3. Fuller T, Baker M. Coronavirus death in California came weeks before first known U.S. death. New York Times. 2020 Apr 22. https://www.nytimes.com/2020/04/22/us/coronavirus-first-united-states-death.html.

4. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/us-map. Accessed 2020 May 28.

5. Michaud J et al. COVID-19 models: Can they tell us what we want to know? 2020 April 16. https://www.kff.org/coronavirus-policy-watch/covid-19-models.

6. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed 2020 June 30.

7. Jewell N et al. Caution warranted: Using the Institute for Health Metrics and Evaluation Model for predicting the course of the COVID-19 pandemic. Ann Intern Med. 2020;173:1-3.

8. Box G. Science and statistics. J Am Stat Assoc. 1972;71:791-9.

9. Shapiro DE. The interpretation of diagnostic tests. Stat Methods Med Res. 1999;8:113-34.

10. Kim J. It is not too late to go on the offense against the coronavirus. The New Yorker. 2020 Apr 20. https://www.newyorker.com/science/medical-dispatch/its-not-too-late-to-go-on-offense-against-the-coronavirus.

The COVID-19 pandemic is one of the defining moments in history for this generation’s health care leaders. In 2019, most of us wrongly assumed that this virus would be similar to the past viral epidemics and pandemics such as 2002 severe acute respiratory syndrome–CoV in Asia, 2009 H1N1 influenza in the United States, 2012 Middle East respiratory syndrome–CoV in Saudi Arabia, and 2014-2016 Ebola in West Africa. Moreover, we understood that the 50% fatality rate of Ebola, a single-stranded RNA virus, was deadly on the continent of Africa, but its transmission was through direct contact with blood or other bodily fluids. Hence, the infectivity of Ebola to the general public was lower than SARS-CoV-2, which is spread by respiratory droplets and contact routes in addition to being the virus that causes COVID-19.¹ Many of us did not expect that SARS-CoV-2, a single-stranded RNA virus consisting of 32 kilobytes, would reach the shores of the United States from the Hubei province of China, the northern Lombardy region of Italy, or other initial hotspots. We could not imagine its effects would be so devastating from an economic and medical perspective. Until it did.

The first reported case of SARS-CoV-2 was on Jan. 20, 2020 in Snohomish County, Wash., and the first known death from COVID-19 occurred on Feb. 6, 2020 in Santa Clara County, Calif.^2,3 Since then, the United States has lost over 135,000 people from COVID-19 with death(s) reported in every state and the highest number of overall deaths of any country in the world.⁴ At the beginning of 2020, at our institution, Wake Forest Baptist Health System in Winston-Salem, N.C., we began preparing for the wave, surge, or tsunami of inpatients that was coming. Plans were afoot to increase our staff, even perhaps by hiring out-of-state physicians and nurses if needed, and every possible bed was considered within the system. It was not an if, but rather a when, as to the arrival of COVID-19.

Epidemiologists and biostatisticians developed predictive COVID-19 models so that health care leaders could plan accordingly, especially those patients that required critical care or inpatient medical care. These predictive models have been used across the globe and can be categorized into three groups: Susceptible-Exposed-Infectious-Recovered, Agent-Based, and Curve Fitting Extrapolation.⁵ Our original predictions were based on the Institute for Health Metrics and Evaluation model from Washington state (Curve Fitting Extrapolation). It creates projections from COVID-19 mortality data and assumes a 3% infection rate. Other health systems in our region used the COVID-19 Hospital Impact Model for Epidemics–University of Pennsylvania model. It pins its suppositions on hospitalized COVID-19 patients, regional infection rates, and hospital market shares. Lastly, the agent-based mode, such as the Global Epidemic and Mobility Project, takes simulated populations and forecasts the spread of SARS-CoV-2 anchoring on the interplay of individuals and groups. The assumptions are created secondary to the interactions of people, time, health care interventions, and public health policies.

Based on these predictive simulations, health systems have spent countless hours of planning and have utilized resources for the anticipated needs related to beds, ventilators, supplies, and staffing. Frontline staff were retrained how to don and doff personal protective equipment. Our teams were ready if we saw a wave of 250, a surge of 500, or a tsunami of 750 COVID-19 inpatients. We were prepared to run into the fire fully knowing the personal risks and consequences.

But, as yet, the tsunami in North Carolina has never come. On April 21, 2020, the COVID-19 mortality data in North Carolina peaked at 34 deaths, with the total number of deaths standing at 1,510 as of July 13, 2020.⁶ A surge did not hit our institutional shores at Wake Forest Baptist Health. As we looked through the proverbial back window and hear about the tsunami in Houston, Texas, we are very thankful that the tsunami turned out to be a small wave so far in North Carolina. We are grateful that there were fewer deaths than expected. The dust is settling now and the question, spoken or unspoken, is: “How could we be so wrong with our predictions?”

Models have strengths and weaknesses and none are perfect.⁷ There is an old aphorism in statistics that is often attributed to George Box that says: “All models are wrong but some are useful.”⁸ Predictions and projections are good, but not perfect. Our measurements and tests should not only be accurate, but also be as precise as possible.⁹ Moreover, the assumptions we make should be on solid ground. Since the beginning of the pandemic, there may have been undercounts and delays in reporting. The assumptions of the effects of social distancing may have been inaccurate. Just as important, the lack of early testing in our pandemic and the relatively limited testing currently available provide challenges not only in attributing past deaths to COVID-19, but also with planning and public health measures. To be fair, the tsunami that turned out to be a small wave in North Carolina may be caused by the strong leadership from politicians, public health officials, and health system leaders for their stay-at-home decree and vigorous public health measures in our state.

Some of the health systems in the United States have created “reemergence plans” to care for those patients who have stayed at home for the past several months. Elective surgeries and procedures have begun in different regions of the United States and will likely continue reopening into the late summer. Nevertheless, challenges and opportunities continue to abound during these difficult times of COVID-19. The tsunamis or surges will continue to occur in the United States and the premature reopening of some of the public places and businesses have not helped our collective efforts. In addition, the personal costs have been and will be immeasurable. Many of us have lost loved ones, been laid off, or face mental health crises because of the social isolation and false news.

COVID-19 is here to stay and will be with us for the foreseeable future. Health care providers have been literally risking their lives to serve the public and we will continue to do so. Hitting the target of needed inpatient beds and critical care beds is critically important and is tough without accurate data. We simply have inadequate and unreliable data of COVID-19 incidence and prevalence rates in the communities that we serve. More available testing would allow frontline health care providers and health care leaders to match hospital demand to supply, at individual hospitals and within the health care system. Moreover, contact tracing capabilities would give us the opportunity to isolate individuals and extinguish population-based hotspots.

We may have seen the first wave, but other waves of COVID-19 in North Carolina are sure to come. Since the partial reopening of North Carolina on May 8, 2020, coupled with pockets of nonadherence to social distancing and mask wearing, we expect a second wave sooner rather than later. Interestingly, daily new lab-confirmed COVID-19 cases in North Carolina have been on the rise, with the highest one-day total occurring on June 12, 2020 with 1,768 cases reported.⁶ As a result, North Carolina Gov. Roy Cooper and Secretary of the North Carolina Department of Health and Human Services, Dr. Mandy Cohen, placed a temporary pause on the Phase 2 reopening plan and mandated masks in public on June 24, 2020. It is unclear whether these intermittent daily spikes in lab-confirmed COVID-19 cases are a foreshadowing of our next wave, surge, or tsunami, or just an anomaly. Only time will tell, but as Jim Kim, MD, PhD, has stated so well, there is still time for social distancing, contact tracing, testing, isolation, and treatment.¹⁰ There is still time for us, for our loved ones, for our hospital systems, and for our public health system.

Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System and associate professor of internal medicine at Wake Forest School of Medicine. Dr. Lippert is assistant professor of internal medicine at Wake Forest School of Medicine. Mr. Payne is the associate vice president of Wake Forest Baptist Health. He is responsible for engineering, facilities planning & design as well as environmental health and safety departments. Dr. Pariyadath is comedical director of the Patient Flow Operations Center which facilitates patient placement throughout the Wake Forest Baptist Health system. He is also the associate medical director for the adult emergency department. Dr. Sunkara is assistant professor of internal medicine at Wake Forest School of Medicine. He is the medical director for hospital medicine units and the newly established PUI unit.

Acknowledgments

The authors would like to thank Julie Freischlag, MD; Kevin High, MD, MS; Gary Rosenthal, MD; Wayne Meredith, MD;Russ Howerton, MD; Mike Waid, Andrea Fernandez, MD; Brian Hiestand, MD; the Wake Forest Baptist Health System COVID-19 task force, the Operations Center, and the countless frontline staff at all five hospitals within the Wake Forest Baptist Health System.

References

1. World Health Organization. Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. 2020 June 30. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.

2. Holshue et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382: 929-36.

3. Fuller T, Baker M. Coronavirus death in California came weeks before first known U.S. death. New York Times. 2020 Apr 22. https://www.nytimes.com/2020/04/22/us/coronavirus-first-united-states-death.html.

4. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/us-map. Accessed 2020 May 28.

5. Michaud J et al. COVID-19 models: Can they tell us what we want to know? 2020 April 16. https://www.kff.org/coronavirus-policy-watch/covid-19-models.

6. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed 2020 June 30.

7. Jewell N et al. Caution warranted: Using the Institute for Health Metrics and Evaluation Model for predicting the course of the COVID-19 pandemic. Ann Intern Med. 2020;173:1-3.

8. Box G. Science and statistics. J Am Stat Assoc. 1972;71:791-9.

9. Shapiro DE. The interpretation of diagnostic tests. Stat Methods Med Res. 1999;8:113-34.

10. Kim J. It is not too late to go on the offense against the coronavirus. The New Yorker. 2020 Apr 20. https://www.newyorker.com/science/medical-dispatch/its-not-too-late-to-go-on-offense-against-the-coronavirus.

The COVID-19 pandemic is one of the defining moments in history for this generation’s health care leaders. In 2019, most of us wrongly assumed that this virus would be similar to the past viral epidemics and pandemics such as 2002 severe acute respiratory syndrome–CoV in Asia, 2009 H1N1 influenza in the United States, 2012 Middle East respiratory syndrome–CoV in Saudi Arabia, and 2014-2016 Ebola in West Africa. Moreover, we understood that the 50% fatality rate of Ebola, a single-stranded RNA virus, was deadly on the continent of Africa, but its transmission was through direct contact with blood or other bodily fluids. Hence, the infectivity of Ebola to the general public was lower than SARS-CoV-2, which is spread by respiratory droplets and contact routes in addition to being the virus that causes COVID-19.¹ Many of us did not expect that SARS-CoV-2, a single-stranded RNA virus consisting of 32 kilobytes, would reach the shores of the United States from the Hubei province of China, the northern Lombardy region of Italy, or other initial hotspots. We could not imagine its effects would be so devastating from an economic and medical perspective. Until it did.

The first reported case of SARS-CoV-2 was on Jan. 20, 2020 in Snohomish County, Wash., and the first known death from COVID-19 occurred on Feb. 6, 2020 in Santa Clara County, Calif.^2,3 Since then, the United States has lost over 135,000 people from COVID-19 with death(s) reported in every state and the highest number of overall deaths of any country in the world.⁴ At the beginning of 2020, at our institution, Wake Forest Baptist Health System in Winston-Salem, N.C., we began preparing for the wave, surge, or tsunami of inpatients that was coming. Plans were afoot to increase our staff, even perhaps by hiring out-of-state physicians and nurses if needed, and every possible bed was considered within the system. It was not an if, but rather a when, as to the arrival of COVID-19.

Epidemiologists and biostatisticians developed predictive COVID-19 models so that health care leaders could plan accordingly, especially those patients that required critical care or inpatient medical care. These predictive models have been used across the globe and can be categorized into three groups: Susceptible-Exposed-Infectious-Recovered, Agent-Based, and Curve Fitting Extrapolation.⁵ Our original predictions were based on the Institute for Health Metrics and Evaluation model from Washington state (Curve Fitting Extrapolation). It creates projections from COVID-19 mortality data and assumes a 3% infection rate. Other health systems in our region used the COVID-19 Hospital Impact Model for Epidemics–University of Pennsylvania model. It pins its suppositions on hospitalized COVID-19 patients, regional infection rates, and hospital market shares. Lastly, the agent-based mode, such as the Global Epidemic and Mobility Project, takes simulated populations and forecasts the spread of SARS-CoV-2 anchoring on the interplay of individuals and groups. The assumptions are created secondary to the interactions of people, time, health care interventions, and public health policies.

Based on these predictive simulations, health systems have spent countless hours of planning and have utilized resources for the anticipated needs related to beds, ventilators, supplies, and staffing. Frontline staff were retrained how to don and doff personal protective equipment. Our teams were ready if we saw a wave of 250, a surge of 500, or a tsunami of 750 COVID-19 inpatients. We were prepared to run into the fire fully knowing the personal risks and consequences.

But, as yet, the tsunami in North Carolina has never come. On April 21, 2020, the COVID-19 mortality data in North Carolina peaked at 34 deaths, with the total number of deaths standing at 1,510 as of July 13, 2020.⁶ A surge did not hit our institutional shores at Wake Forest Baptist Health. As we looked through the proverbial back window and hear about the tsunami in Houston, Texas, we are very thankful that the tsunami turned out to be a small wave so far in North Carolina. We are grateful that there were fewer deaths than expected. The dust is settling now and the question, spoken or unspoken, is: “How could we be so wrong with our predictions?”

Models have strengths and weaknesses and none are perfect.⁷ There is an old aphorism in statistics that is often attributed to George Box that says: “All models are wrong but some are useful.”⁸ Predictions and projections are good, but not perfect. Our measurements and tests should not only be accurate, but also be as precise as possible.⁹ Moreover, the assumptions we make should be on solid ground. Since the beginning of the pandemic, there may have been undercounts and delays in reporting. The assumptions of the effects of social distancing may have been inaccurate. Just as important, the lack of early testing in our pandemic and the relatively limited testing currently available provide challenges not only in attributing past deaths to COVID-19, but also with planning and public health measures. To be fair, the tsunami that turned out to be a small wave in North Carolina may be caused by the strong leadership from politicians, public health officials, and health system leaders for their stay-at-home decree and vigorous public health measures in our state.

Some of the health systems in the United States have created “reemergence plans” to care for those patients who have stayed at home for the past several months. Elective surgeries and procedures have begun in different regions of the United States and will likely continue reopening into the late summer. Nevertheless, challenges and opportunities continue to abound during these difficult times of COVID-19. The tsunamis or surges will continue to occur in the United States and the premature reopening of some of the public places and businesses have not helped our collective efforts. In addition, the personal costs have been and will be immeasurable. Many of us have lost loved ones, been laid off, or face mental health crises because of the social isolation and false news.

COVID-19 is here to stay and will be with us for the foreseeable future. Health care providers have been literally risking their lives to serve the public and we will continue to do so. Hitting the target of needed inpatient beds and critical care beds is critically important and is tough without accurate data. We simply have inadequate and unreliable data of COVID-19 incidence and prevalence rates in the communities that we serve. More available testing would allow frontline health care providers and health care leaders to match hospital demand to supply, at individual hospitals and within the health care system. Moreover, contact tracing capabilities would give us the opportunity to isolate individuals and extinguish population-based hotspots.

We may have seen the first wave, but other waves of COVID-19 in North Carolina are sure to come. Since the partial reopening of North Carolina on May 8, 2020, coupled with pockets of nonadherence to social distancing and mask wearing, we expect a second wave sooner rather than later. Interestingly, daily new lab-confirmed COVID-19 cases in North Carolina have been on the rise, with the highest one-day total occurring on June 12, 2020 with 1,768 cases reported.⁶ As a result, North Carolina Gov. Roy Cooper and Secretary of the North Carolina Department of Health and Human Services, Dr. Mandy Cohen, placed a temporary pause on the Phase 2 reopening plan and mandated masks in public on June 24, 2020. It is unclear whether these intermittent daily spikes in lab-confirmed COVID-19 cases are a foreshadowing of our next wave, surge, or tsunami, or just an anomaly. Only time will tell, but as Jim Kim, MD, PhD, has stated so well, there is still time for social distancing, contact tracing, testing, isolation, and treatment.¹⁰ There is still time for us, for our loved ones, for our hospital systems, and for our public health system.

Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System and associate professor of internal medicine at Wake Forest School of Medicine. Dr. Lippert is assistant professor of internal medicine at Wake Forest School of Medicine. Mr. Payne is the associate vice president of Wake Forest Baptist Health. He is responsible for engineering, facilities planning & design as well as environmental health and safety departments. Dr. Pariyadath is comedical director of the Patient Flow Operations Center which facilitates patient placement throughout the Wake Forest Baptist Health system. He is also the associate medical director for the adult emergency department. Dr. Sunkara is assistant professor of internal medicine at Wake Forest School of Medicine. He is the medical director for hospital medicine units and the newly established PUI unit.

Acknowledgments

The authors would like to thank Julie Freischlag, MD; Kevin High, MD, MS; Gary Rosenthal, MD; Wayne Meredith, MD;Russ Howerton, MD; Mike Waid, Andrea Fernandez, MD; Brian Hiestand, MD; the Wake Forest Baptist Health System COVID-19 task force, the Operations Center, and the countless frontline staff at all five hospitals within the Wake Forest Baptist Health System.

References

1. World Health Organization. Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. 2020 June 30. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.

2. Holshue et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382: 929-36.

3. Fuller T, Baker M. Coronavirus death in California came weeks before first known U.S. death. New York Times. 2020 Apr 22. https://www.nytimes.com/2020/04/22/us/coronavirus-first-united-states-death.html.

4. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/us-map. Accessed 2020 May 28.

5. Michaud J et al. COVID-19 models: Can they tell us what we want to know? 2020 April 16. https://www.kff.org/coronavirus-policy-watch/covid-19-models.

6. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed 2020 June 30.

7. Jewell N et al. Caution warranted: Using the Institute for Health Metrics and Evaluation Model for predicting the course of the COVID-19 pandemic. Ann Intern Med. 2020;173:1-3.

8. Box G. Science and statistics. J Am Stat Assoc. 1972;71:791-9.

9. Shapiro DE. The interpretation of diagnostic tests. Stat Methods Med Res. 1999;8:113-34.

10. Kim J. It is not too late to go on the offense against the coronavirus. The New Yorker. 2020 Apr 20. https://www.newyorker.com/science/medical-dispatch/its-not-too-late-to-go-on-offense-against-the-coronavirus.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Obesity has been shown to have an impact on the risk of developing breast cancer and on prognosis. A new study suggests that it may also have an effect on treatment.

A high body mass index (BMI) at the time of breast cancer diagnosis could reduce the efficacy of taxane-based adjuvant chemotherapy, worsening survival outcomes, the study suggests.

That study investigated docetaxel (Taxotere), which is a “lipophilic drug, suggesting that fat present in the body could absorb part of the drug before it can reach the tumor,” commented lead author Christine Desmedt, PhD, of the Laboratory for Translational Breast Cancer Research, Department of Oncology, Leuven, Belgium.

“These results also make us wonder whether other chemotherapy drugs from the same family, like paclitaxel (Taxol), will show the same effect,” she said in a statement.

If follow-up research confirms that the findings are related solely to the pharmacologic characteristics of docetaxel, the results may also apply to its use in other types of cancer, including prostate cancer and lung cancer, she added.

The finding that taxane chemotherapy was less effective in overweight patients “is a provocative observation,” commented Harold Burstein, MD, PhD, an oncologist and clinical investigator at Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston, Massachusetts.

“It should be explored in other trials that looked at adding taxanes to standard chemotherapy,” he told Medscape Medical News.
 

Worse outcomes in patients with high BMI

The study, published online in the Journal of Clinical Oncology, was a retrospective reanalysis of data from the phase 3 BIG 2-98 trial.

It shows that overweight and obese patients treated with a chemotherapy regimen based on docetaxel had significantly worse disease-free survival (DFS) and overall survival (OS) compared with lean patients treated with the same chemotherapy regimen.

Conversely, for patients treated with an adjuvant chemotherapy regimen that did not include docetaxel, there was no difference in DFS, OS, or in the rates of distant metastases in regard to BMI.

The finding “highlights a differential response to docetaxel according to BMI, which calls for a body composition–based re-evaluation of the risk-benefit ratio of the use of taxanes in breast cancer,” say the researchers. “These results now must be confirmed in additional series.”

The findings call into question results from earlier randomized clinical trials that did not evaluate the efficacy of most cancer drugs on the basis of patient adiposity, the researchers say.

Desmedt emphasized that more research is needed “before changes in treatment can be implemented.”

Experts approached by Medscape Medical News for comment agreed.

“It is important to remember that breast cancer patients needing chemotherapy should still receive the usual chemotherapy regimens, including taxanes, regardless of their weight or habitus,” commented Burstein, who is also professor of medicine at Harvard University.

These data highlight a persistent disparity in breast cancer outcomes, he told Medscape Medical News. Previous studies have shown that overweight patients often have less favorable outcomes. “There are many contributors to poor health outcomes in people with higher BMI, including concurrent health issues such as diabetes and/or hypertension, and unfortunately, the clear link between socioeconomic status and obesity,” he added.

Megan Kruse, MD, of the department of hematology and medical oncology at the Cleveland Clinic, said she “would not make changes in my treatment recommendations based on this study alone.”

Kruse was surprised that when the analysis was restricted to patients who received a relative dose intensity ≥85% for docetaxel, the same reduced rates of DFS and OS were seen as in patients with a high BMI.

“One may have suspected, based on the overall results, that patients with inferior survival outcomes actually received less chemotherapy due to [the] tendency to cap doses of chemotherapy in patients with high BMIs,” she explained.

“Since this analysis keeps dose intensity in mind, the association between BMI and survival outcomes is stronger in my mind. It does not, however, rule out that there are other confounding factors,” Kruse told Medscape Medical News.

Whether the results can be replicated in other retrospective clinical trials remains to be seen, she commented. Noting that the investigators plan to develop a prospective pharmacokinetics study across the BMI spectrum, Kruse added: “This will be of great interest as we plan curative-intent chemotherapy trials moving forward.”

Study details

For the current study, the investigators analyzed data from all 2,887 breast cancer patients enrolled in the adjuvant BIG 2-98 trial. They compared the survival outcomes of those who received docetaxel-based chemotherapy with those who received non-docetaxel-based chemotherapy in relation to their BMI. Patients with a BMI of 18.5 to 25 kg/m were classified as lean; patients with a BMI of 25-30 were classified as overweight; and those with a BMI ≥30 were classified as obese.

The researchers also assessed a second-order interaction on the basis of treatment, BMI, and estrogen receptor (ER) status.

The results showed that in the overweight women, compared with lean women, the adjusted hazard ratios (HRs) for DFS and OS were 1.12 (95% CI, 98 – 1.50; P = .21) and 1.27 (95% CI,101 – 1.60; P = .04), respectively. For obese vs lean patients, the HRs for DFS and OS were 1.32 (95% CI, 108 – 162; P = .007) and 1.63 (95% CI, 1.27 – 2.09; P < .001), respectively.

The survival outcomes were similar when only those patients who received a relative dose intensity ≥85% for docetaxel were considered. However, when ER-negative and ER-positive tumors were considered separately, the researchers found evidence of a joint modifying role of BMI and ER status on treatment effect for DFS (adjusted P =.06) and OS (adjusted P = .04).

“[I]t appears that the benefit for docetaxel-based versus nondocetaxel-based treatment could be limited to lean and overweight patients with ER-positive tumors and, possibly, to lean patients with ER-negative tumors…,” Desmedt and colleagues comment.

It may even be possible that docetaxel-based treatment could be detrimental for overweight patients with ER-negative tumors, they note, but warn that these results should be interpreted with caution.

The investigators note that, worldwide, the proportion of women with increased adiposity has been increasing for decades. In Europe, it is estimated that more than 50% of women are overweight and obese. In the United States, almost 64% of women have a BMI >25 kg/mg².

Previous studies have shown that, in postmenopausal women, a high BMI is associated with a higher risk of developing breast cancer and that, in women who do develop breast cancer, the prognosis is worse. In addition, a recent study demonstrated that increased adiposity can raise the risk for breast cancer in postmenopausal women whose BMI is in the normal range.

The study was funded in part by Fondation Cancer Luxemburg and Associazione Italiana per la Ricerca sul Cancro AIRC. Desmedt has disclosed no relevant financial relationships. A number of study coauthors reported relationships with industry.

This story first appeared on Medscape.com.

Obesity has been shown to have an impact on the risk of developing breast cancer and on prognosis. A new study suggests that it may also have an effect on treatment.

A high body mass index (BMI) at the time of breast cancer diagnosis could reduce the efficacy of taxane-based adjuvant chemotherapy, worsening survival outcomes, the study suggests.

That study investigated docetaxel (Taxotere), which is a “lipophilic drug, suggesting that fat present in the body could absorb part of the drug before it can reach the tumor,” commented lead author Christine Desmedt, PhD, of the Laboratory for Translational Breast Cancer Research, Department of Oncology, Leuven, Belgium.

“These results also make us wonder whether other chemotherapy drugs from the same family, like paclitaxel (Taxol), will show the same effect,” she said in a statement.

If follow-up research confirms that the findings are related solely to the pharmacologic characteristics of docetaxel, the results may also apply to its use in other types of cancer, including prostate cancer and lung cancer, she added.

The finding that taxane chemotherapy was less effective in overweight patients “is a provocative observation,” commented Harold Burstein, MD, PhD, an oncologist and clinical investigator at Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston, Massachusetts.

“It should be explored in other trials that looked at adding taxanes to standard chemotherapy,” he told Medscape Medical News.
 

Worse outcomes in patients with high BMI

The study, published online in the Journal of Clinical Oncology, was a retrospective reanalysis of data from the phase 3 BIG 2-98 trial.

It shows that overweight and obese patients treated with a chemotherapy regimen based on docetaxel had significantly worse disease-free survival (DFS) and overall survival (OS) compared with lean patients treated with the same chemotherapy regimen.

Conversely, for patients treated with an adjuvant chemotherapy regimen that did not include docetaxel, there was no difference in DFS, OS, or in the rates of distant metastases in regard to BMI.

The finding “highlights a differential response to docetaxel according to BMI, which calls for a body composition–based re-evaluation of the risk-benefit ratio of the use of taxanes in breast cancer,” say the researchers. “These results now must be confirmed in additional series.”

The findings call into question results from earlier randomized clinical trials that did not evaluate the efficacy of most cancer drugs on the basis of patient adiposity, the researchers say.

Desmedt emphasized that more research is needed “before changes in treatment can be implemented.”

Experts approached by Medscape Medical News for comment agreed.

“It is important to remember that breast cancer patients needing chemotherapy should still receive the usual chemotherapy regimens, including taxanes, regardless of their weight or habitus,” commented Burstein, who is also professor of medicine at Harvard University.

These data highlight a persistent disparity in breast cancer outcomes, he told Medscape Medical News. Previous studies have shown that overweight patients often have less favorable outcomes. “There are many contributors to poor health outcomes in people with higher BMI, including concurrent health issues such as diabetes and/or hypertension, and unfortunately, the clear link between socioeconomic status and obesity,” he added.

Megan Kruse, MD, of the department of hematology and medical oncology at the Cleveland Clinic, said she “would not make changes in my treatment recommendations based on this study alone.”

Kruse was surprised that when the analysis was restricted to patients who received a relative dose intensity ≥85% for docetaxel, the same reduced rates of DFS and OS were seen as in patients with a high BMI.

“One may have suspected, based on the overall results, that patients with inferior survival outcomes actually received less chemotherapy due to [the] tendency to cap doses of chemotherapy in patients with high BMIs,” she explained.

“Since this analysis keeps dose intensity in mind, the association between BMI and survival outcomes is stronger in my mind. It does not, however, rule out that there are other confounding factors,” Kruse told Medscape Medical News.

Whether the results can be replicated in other retrospective clinical trials remains to be seen, she commented. Noting that the investigators plan to develop a prospective pharmacokinetics study across the BMI spectrum, Kruse added: “This will be of great interest as we plan curative-intent chemotherapy trials moving forward.”

Study details

For the current study, the investigators analyzed data from all 2,887 breast cancer patients enrolled in the adjuvant BIG 2-98 trial. They compared the survival outcomes of those who received docetaxel-based chemotherapy with those who received non-docetaxel-based chemotherapy in relation to their BMI. Patients with a BMI of 18.5 to 25 kg/m were classified as lean; patients with a BMI of 25-30 were classified as overweight; and those with a BMI ≥30 were classified as obese.

The researchers also assessed a second-order interaction on the basis of treatment, BMI, and estrogen receptor (ER) status.

The results showed that in the overweight women, compared with lean women, the adjusted hazard ratios (HRs) for DFS and OS were 1.12 (95% CI, 98 – 1.50; P = .21) and 1.27 (95% CI,101 – 1.60; P = .04), respectively. For obese vs lean patients, the HRs for DFS and OS were 1.32 (95% CI, 108 – 162; P = .007) and 1.63 (95% CI, 1.27 – 2.09; P < .001), respectively.

The survival outcomes were similar when only those patients who received a relative dose intensity ≥85% for docetaxel were considered. However, when ER-negative and ER-positive tumors were considered separately, the researchers found evidence of a joint modifying role of BMI and ER status on treatment effect for DFS (adjusted P =.06) and OS (adjusted P = .04).

“[I]t appears that the benefit for docetaxel-based versus nondocetaxel-based treatment could be limited to lean and overweight patients with ER-positive tumors and, possibly, to lean patients with ER-negative tumors…,” Desmedt and colleagues comment.

It may even be possible that docetaxel-based treatment could be detrimental for overweight patients with ER-negative tumors, they note, but warn that these results should be interpreted with caution.

The investigators note that, worldwide, the proportion of women with increased adiposity has been increasing for decades. In Europe, it is estimated that more than 50% of women are overweight and obese. In the United States, almost 64% of women have a BMI >25 kg/mg².

Previous studies have shown that, in postmenopausal women, a high BMI is associated with a higher risk of developing breast cancer and that, in women who do develop breast cancer, the prognosis is worse. In addition, a recent study demonstrated that increased adiposity can raise the risk for breast cancer in postmenopausal women whose BMI is in the normal range.

The study was funded in part by Fondation Cancer Luxemburg and Associazione Italiana per la Ricerca sul Cancro AIRC. Desmedt has disclosed no relevant financial relationships. A number of study coauthors reported relationships with industry.

This story first appeared on Medscape.com.

Obesity has been shown to have an impact on the risk of developing breast cancer and on prognosis. A new study suggests that it may also have an effect on treatment.

A high body mass index (BMI) at the time of breast cancer diagnosis could reduce the efficacy of taxane-based adjuvant chemotherapy, worsening survival outcomes, the study suggests.

That study investigated docetaxel (Taxotere), which is a “lipophilic drug, suggesting that fat present in the body could absorb part of the drug before it can reach the tumor,” commented lead author Christine Desmedt, PhD, of the Laboratory for Translational Breast Cancer Research, Department of Oncology, Leuven, Belgium.

“These results also make us wonder whether other chemotherapy drugs from the same family, like paclitaxel (Taxol), will show the same effect,” she said in a statement.

If follow-up research confirms that the findings are related solely to the pharmacologic characteristics of docetaxel, the results may also apply to its use in other types of cancer, including prostate cancer and lung cancer, she added.

The finding that taxane chemotherapy was less effective in overweight patients “is a provocative observation,” commented Harold Burstein, MD, PhD, an oncologist and clinical investigator at Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston, Massachusetts.

“It should be explored in other trials that looked at adding taxanes to standard chemotherapy,” he told Medscape Medical News.
 

Worse outcomes in patients with high BMI

The study, published online in the Journal of Clinical Oncology, was a retrospective reanalysis of data from the phase 3 BIG 2-98 trial.

It shows that overweight and obese patients treated with a chemotherapy regimen based on docetaxel had significantly worse disease-free survival (DFS) and overall survival (OS) compared with lean patients treated with the same chemotherapy regimen.

Conversely, for patients treated with an adjuvant chemotherapy regimen that did not include docetaxel, there was no difference in DFS, OS, or in the rates of distant metastases in regard to BMI.

The finding “highlights a differential response to docetaxel according to BMI, which calls for a body composition–based re-evaluation of the risk-benefit ratio of the use of taxanes in breast cancer,” say the researchers. “These results now must be confirmed in additional series.”

The findings call into question results from earlier randomized clinical trials that did not evaluate the efficacy of most cancer drugs on the basis of patient adiposity, the researchers say.

Desmedt emphasized that more research is needed “before changes in treatment can be implemented.”

Experts approached by Medscape Medical News for comment agreed.

“It is important to remember that breast cancer patients needing chemotherapy should still receive the usual chemotherapy regimens, including taxanes, regardless of their weight or habitus,” commented Burstein, who is also professor of medicine at Harvard University.

These data highlight a persistent disparity in breast cancer outcomes, he told Medscape Medical News. Previous studies have shown that overweight patients often have less favorable outcomes. “There are many contributors to poor health outcomes in people with higher BMI, including concurrent health issues such as diabetes and/or hypertension, and unfortunately, the clear link between socioeconomic status and obesity,” he added.

Megan Kruse, MD, of the department of hematology and medical oncology at the Cleveland Clinic, said she “would not make changes in my treatment recommendations based on this study alone.”

Kruse was surprised that when the analysis was restricted to patients who received a relative dose intensity ≥85% for docetaxel, the same reduced rates of DFS and OS were seen as in patients with a high BMI.

“One may have suspected, based on the overall results, that patients with inferior survival outcomes actually received less chemotherapy due to [the] tendency to cap doses of chemotherapy in patients with high BMIs,” she explained.

“Since this analysis keeps dose intensity in mind, the association between BMI and survival outcomes is stronger in my mind. It does not, however, rule out that there are other confounding factors,” Kruse told Medscape Medical News.

Whether the results can be replicated in other retrospective clinical trials remains to be seen, she commented. Noting that the investigators plan to develop a prospective pharmacokinetics study across the BMI spectrum, Kruse added: “This will be of great interest as we plan curative-intent chemotherapy trials moving forward.”

Study details

For the current study, the investigators analyzed data from all 2,887 breast cancer patients enrolled in the adjuvant BIG 2-98 trial. They compared the survival outcomes of those who received docetaxel-based chemotherapy with those who received non-docetaxel-based chemotherapy in relation to their BMI. Patients with a BMI of 18.5 to 25 kg/m were classified as lean; patients with a BMI of 25-30 were classified as overweight; and those with a BMI ≥30 were classified as obese.

The researchers also assessed a second-order interaction on the basis of treatment, BMI, and estrogen receptor (ER) status.

The results showed that in the overweight women, compared with lean women, the adjusted hazard ratios (HRs) for DFS and OS were 1.12 (95% CI, 98 – 1.50; P = .21) and 1.27 (95% CI,101 – 1.60; P = .04), respectively. For obese vs lean patients, the HRs for DFS and OS were 1.32 (95% CI, 108 – 162; P = .007) and 1.63 (95% CI, 1.27 – 2.09; P < .001), respectively.

The survival outcomes were similar when only those patients who received a relative dose intensity ≥85% for docetaxel were considered. However, when ER-negative and ER-positive tumors were considered separately, the researchers found evidence of a joint modifying role of BMI and ER status on treatment effect for DFS (adjusted P =.06) and OS (adjusted P = .04).

“[I]t appears that the benefit for docetaxel-based versus nondocetaxel-based treatment could be limited to lean and overweight patients with ER-positive tumors and, possibly, to lean patients with ER-negative tumors…,” Desmedt and colleagues comment.

It may even be possible that docetaxel-based treatment could be detrimental for overweight patients with ER-negative tumors, they note, but warn that these results should be interpreted with caution.

The investigators note that, worldwide, the proportion of women with increased adiposity has been increasing for decades. In Europe, it is estimated that more than 50% of women are overweight and obese. In the United States, almost 64% of women have a BMI >25 kg/mg².

Previous studies have shown that, in postmenopausal women, a high BMI is associated with a higher risk of developing breast cancer and that, in women who do develop breast cancer, the prognosis is worse. In addition, a recent study demonstrated that increased adiposity can raise the risk for breast cancer in postmenopausal women whose BMI is in the normal range.

The study was funded in part by Fondation Cancer Luxemburg and Associazione Italiana per la Ricerca sul Cancro AIRC. Desmedt has disclosed no relevant financial relationships. A number of study coauthors reported relationships with industry.

This story first appeared on Medscape.com.

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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