MDedge Cardiology

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

Outcomes were similar for comatose patients who received 36 versus 72 hours of device-based temperature control after out-of-hospital cardiac arrest, a randomized trial shows.

“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”

At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.

The study was published online  in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
 

No significant differences

Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.

The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.

For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.

Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).

Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.

Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.

The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.

Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).

A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.

The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.

The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”

Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
 

Findings ‘very persuasive’

Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.

“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”

Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”

The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.

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

Outcomes were similar for comatose patients who received 36 versus 72 hours of device-based temperature control after out-of-hospital cardiac arrest, a randomized trial shows.

“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”

At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.

The study was published online  in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
 

No significant differences

Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.

The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.

For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.

Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).

Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.

Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.

The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.

Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).

A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.

The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.

The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”

Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
 

Findings ‘very persuasive’

Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.

“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”

Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”

The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.

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

Outcomes were similar for comatose patients who received 36 versus 72 hours of device-based temperature control after out-of-hospital cardiac arrest, a randomized trial shows.

“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”

At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.

The study was published online  in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
 

No significant differences

Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.

The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.

For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.

Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).

Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.

Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.

The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.

Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).

A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.

The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.

The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”

Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
 

Findings ‘very persuasive’

Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.

“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”

Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”

The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.

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

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

In a study published online, researchers used artificial intelligence to analyze more than 1.4 million electronic health record emails to physicians – and the results aren’t pretty.

Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.

But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:

“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.

“F***” was the most common expletive used by patients.

Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”

Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”

“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.

“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”

Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.

Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.

Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”

On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.

Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.

Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.

The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”

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

In a study published online, researchers used artificial intelligence to analyze more than 1.4 million electronic health record emails to physicians – and the results aren’t pretty.

Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.

But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:

“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.

“F***” was the most common expletive used by patients.

Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”

Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”

“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.

“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”

Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.

Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.

Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”

On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.

Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.

Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.

The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”

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

In a study published online, researchers used artificial intelligence to analyze more than 1.4 million electronic health record emails to physicians – and the results aren’t pretty.

Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.

But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:

“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.

“F***” was the most common expletive used by patients.

Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”

Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”

“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.

“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”

Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.

Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.

Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”

On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.

Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.

Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.

The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”

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

CHICAGO – A single chest x-ray could predict a patient’s 10-year risk of dying from a heart attack or stroke, say researchers who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.

Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.

The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
 

Not all data points available in EHR

But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.

Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.

The researchers trained a deep-learning model with single chest x-rays only.

They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.

Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.

They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.

“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
 

Tested against independent group

They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.

Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.

There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).

Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.

They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).

Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.

“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.

“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.

David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.

“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”

He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.

Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.

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

CHICAGO – A single chest x-ray could predict a patient’s 10-year risk of dying from a heart attack or stroke, say researchers who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.

Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.

The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
 

Not all data points available in EHR

But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.

Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.

The researchers trained a deep-learning model with single chest x-rays only.

They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.

Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.

They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.

“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
 

Tested against independent group

They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.

Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.

There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).

Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.

They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).

Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.

“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.

“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.

David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.

“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”

He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.

Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.

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

CHICAGO – A single chest x-ray could predict a patient’s 10-year risk of dying from a heart attack or stroke, say researchers who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.

Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.

The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
 

Not all data points available in EHR

But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.

Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.

The researchers trained a deep-learning model with single chest x-rays only.

They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.

Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.

They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.

“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
 

Tested against independent group

They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.

Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.

There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).

Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.

They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).

Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.

“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.

“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.

David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.

“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”

He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.

Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.

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

Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

If there’s one public health message Americans have heard loud and clear, it’s this one:

Move more.

Take more steps.

Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.

But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.

A new study suggests a different approach: You don’t have to do more. Just do what you’re already doing, but with a little more effort.

The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
 

Step it up

Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.

The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.

The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.

What’s the difference?

• Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
• Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
• Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.

Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.

Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.

That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.

And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.

That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.

“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”

The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO_2max.

Raising your VO_2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
 

Making strides

The study builds on previous research that shows the benefits of moving faster.

Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
 

Quality versus quantity

We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.

But there’s still a lot to be said for movement quantity.

“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.

A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.

“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”

Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.

“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.

What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”

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

If there’s one public health message Americans have heard loud and clear, it’s this one:

Move more.

Take more steps.

Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.

But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.

A new study suggests a different approach: You don’t have to do more. Just do what you’re already doing, but with a little more effort.

The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
 

Step it up

Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.

The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.

The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.

What’s the difference?

• Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
• Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
• Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.

Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.

Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.

That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.

And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.

That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.

“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”

The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO_2max.

Raising your VO_2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
 

Making strides

The study builds on previous research that shows the benefits of moving faster.

Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
 

Quality versus quantity

We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.

But there’s still a lot to be said for movement quantity.

“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.

A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.

“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”

Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.

“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.

What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”

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

If there’s one public health message Americans have heard loud and clear, it’s this one:

Move more.

Take more steps.

Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.

But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.

A new study suggests a different approach: You don’t have to do more. Just do what you’re already doing, but with a little more effort.

The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
 

Step it up

Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.

The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.

The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.

What’s the difference?

• Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
• Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
• Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.

Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.

Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.

That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.

And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.

That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.

“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”

The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO_2max.

Raising your VO_2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
 

Making strides

The study builds on previous research that shows the benefits of moving faster.

Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
 

Quality versus quantity

We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.

But there’s still a lot to be said for movement quantity.

“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.

A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.

“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”

Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.

“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.

What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”

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

Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.

Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
 

Kim Kardashian and Elon Musk

In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.

Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.

As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.

This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.

“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”

A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
 

At last, an effective weight-loss drug

Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.

The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.

“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
 

More demand than supply

As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January. 

“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”

In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
 

The price of access

With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it. 

“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.

It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.

Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.

“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”

Unpleasant side effects

Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.

“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”

Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”

With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.

It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring. 

By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.

“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”

Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
 

More than just weight loss

Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.

“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”

Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.

“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”

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

Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.

Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
 

Kim Kardashian and Elon Musk

In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.

Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.

As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.

This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.

“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”

A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
 

At last, an effective weight-loss drug

Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.

The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.

“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
 

More demand than supply

As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January. 

“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”

In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
 

The price of access

With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it. 

“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.

It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.

Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.

“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”

Unpleasant side effects

Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.

“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”

Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”

With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.

It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring. 

By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.

“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”

Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
 

More than just weight loss

Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.

“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”

Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.

“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”

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

Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.

Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
 

Kim Kardashian and Elon Musk

In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.

Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.

As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.

This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.

“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”

A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
 

At last, an effective weight-loss drug

Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.

The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.

“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
 

More demand than supply

As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January. 

“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”

In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
 

The price of access

With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it. 

“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.

It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.

Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.

“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”

Unpleasant side effects

Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.

“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”

Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”

With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.

It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring. 

By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.

“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”

Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
 

More than just weight loss

Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.

“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”

Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.

“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”

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

The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.

The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.

It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.

But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.

During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.” 

Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”

During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.

Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
 

How would screening happen? 

While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.

Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.

Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.

However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.

The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.

“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.

He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.

And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.

“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”

A two-pronged approach to screening could work best

Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.

“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”

Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.

“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”

He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”

While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”

But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”

During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.

Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.

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

The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.

The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.

It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.

But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.

During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.” 

Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”

During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.

Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
 

How would screening happen? 

While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.

Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.

Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.

However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.

The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.

“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.

He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.

And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.

“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”

A two-pronged approach to screening could work best

Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.

“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”

Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.

“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”

He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”

While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”

But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”

During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.

Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.

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

The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.

The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.

It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.

But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.

During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.” 

Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”

During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.

Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
 

How would screening happen? 

While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.

Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.

Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.

However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.

The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.

“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.

He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.

And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.

“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”

A two-pronged approach to screening could work best

Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.

“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”

Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.

“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”

He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”

While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”

But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”

During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.

Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.

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

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.